sodium literacy - Ontario Medical Review

Transcription

July/August 2011
Volume 78 Number 7
www.oma.org
OMA Health Promotion Campaign:
p g
sodium literacy
the dangers of hidden salt
OMA Advantages
Hospital physician leaders gather to review current
issues, changing roles and responsibilities
Affinity program delivers unique value, expanded
menu of products and services to OMA members
Public Affairs Update
Physician Burnout
OMA advances health care as top election priority
Understanding causes, symptoms and treatment
Health Care Connect
Interpretive Bulletin
Patient registration and attachment rates strong,
new fee codes and incentives introduced
New radiology codes — second opinion and after
hours premiums
PM41144507
Physician Leadership
July11_OMR_Cover_9.indd 1
Dedicated to Doctors. Committed to Patients.
7/15/11 9:05 AM
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OMR Full 63.pdf 1
4/14/2011 2:29:49 PM
Executive, Board, Council,
Committee Chairs
Executive Committee
Board of Directors
President
District
Dr. M.S. Kennedy, Thunder Bay
1
Dr. D.J. Hellyer, Windsor
Dr. C. Pinto, Etobicoke
President Elect
2
Dr. M. MacLeod, London
Dr. A. Studniberg, Scarborough
Dr. D. Weir, Toronto
Dr. M. Toth, Aylmer
11 Dr. S. Chris, North York
Dr. L. Colman, Etobicoke
Dr. C. Jyu, Scarborough
Elected by Council
Past President
3
Dr. C. Cressey, Palmerston
Dr. A. Donohue, Ottawa
Dr. M. MacLeod, London
4
Dr. V. Tandan, Hamilton
Dr. W. Tanner, Toronto
Dr. R. Tytus, Hamilton
Dr. V. Walley, Peterborough
Chair of the Board
Dr. S. Wooder, Stoney Creek
5
Dr. S. Whatley, Mount Albert
Dr. J. Tracey, Brampton
Honorary Treasurer
Dr. V. Tandan, Hamilton
6
Dr. J. Ludwig, Peterborough
Secretary
7
Dr. A. Steacie, Brockville
Dr. M. Toth, Aylmer
8
Dr. G. Beck, Ottawa
Dr. A. Kapur, Ottawa
Dr. D. Weir, Toronto
Dr. S. Wooder, Stoney Creek
Academic Representative
Dr. R.K. Edwards, Kingston
Council
Chair
9
Dr. P. Bonin, Sudbury
10 Dr. M.S. Kennedy, Thunder Bay
Dr. A. Hudak, Orillia
Vice-Chair
Dr. E. Barker, Wiarton
Committee Chairs
Agreement
(OMA-Ministry of Health and
Long-Term Care)
Agreement Board Co-ordinating
Committee
Dr. M. Toth
Governance
Member Services
Board Governance Committee
(Board Co-ordinating Committee)
Dr. M. Toth
Member Services (Board Co-ordinating
Committee) Dr. V. Walley
Annual Meeting Planning Committee
Dr. M. MacLeod
Forms Committee
Dr. A. Studniberg
Audit Committee Dr. R. Mann
Joint Committee on the Schedule
of Benefits
Dr. P. Conlon
Board Planning Committee Dr. D. Weir
Medical Audit Oversight Committee
Dr. D. Hellyer
Medical Services Payment Committee
Dr. L. Colman
Public & Political Advocacy
Committee on Committees Dr. R. Mann
Communications Advisory Committee
(Board Co-ordinating Committee)
Dr. D. Weir
Council Committee on Structure & Bylaws
Dr. J. Willett
Outreach to Women Physicians Committee
Dr. R. Forman
Budget Committee Dr. V. Tandan
Nominations Committee Dr. M. MacLeod
Staffing Committee Dr. V. Walley
Physician Services Committee
Dr. M. Toth
Health Policy
REVISED_July/Aug11_executive_committee_p1.indd 1
Quality Management Program-Laboratory
Services Advisory Council Dr. V. Walley
Awards Committee Dr. J. Willett
Physician LHIN Tripartite Committee
Dr. T. Nicholas
Workplace Safety & Insurance Board
Steering Committee
Dr. J. Tracey
Physician Health Program Advisory Panel
Dr. D. Puddester
(OMA Section Chairs, see page 8)
Health Policy (Board Co-ordinating
Committee) Dr. S. Chris
Revalidation Committee Dr. A. Kapur
11-07-08 11:20 AM
Getting the pulse on kidney protection.
Chronic kidney disease is a major health problem, affecting
up to 2.3 million Canadians.1
Hypertension and diabetes are individual risk factors for nephropathy;
having both together increases risk even further.1,2
Both hypertension and diabetes are leading causes of renal failure;3
that’s why Novartis is committed to actively researching prevention
of nephropathy in this high-risk population.
Novartis: Dedicated to kidney protection in patients
with hypertension and diabetes.
© Novartis Pharmaceuticals Canada Inc. 2011
Agency:
Customer:
Boomworks
Novartis
References: 1. Levin A, Hemmelgarn B, Culleton B et al. Guidelines for the management of chronic
kidney disease. CMAJ 2008;179:1154-62. 2. Petit W, Jr. and Adamec C. The encyclopedia of
endocrine diseases and disorders. New York, NY: Facts on File, Inc.; 2005. 3. National Kidney Disease
Education Program. Chronic kidney disease overview. Available at: www.nkdep.nih.gov/professionals/
chronic_kidney_disease.htm. Accessed January 12, 2011.
July/August 2011
Volume 78 Number 7
www.oma.org
FEATURES
July/August 2011
Volume 78 Number 7
www.oma.org
9
OMA Health Promotion Campaign:
p g
sodium literacy
the dangers of hidden saltt
OMA Advantages
Hospital physician leaders gather to review current
issues, changing roles and responsibilities
Affinity program delivers unique value, expanded
menu of products and services to OMA members
Physician Burnout
OMA advances health care as top election priority
Understanding causes, symptoms and treatment
Health Care Connect
Interpretive Bulletin
Patient registration and attachment rates strong,
New radiology codes — second opinion and after
hours premiums
PM41144507
Physician Leadership
Dedicated to Doctors. Committed to Patients.
14 OMA promotes
sodium literacy, dangers
of a high-salt diet
In late July, the OMA will unveil the
second phase of its In-Office Health
Promotion pilot program, focusing on hidden salt awareness and
the dangers of a high-salt diet. As
with Phase I — which centred on
raising public awareness about
anaphylaxis and severe food allergies — the new campaign will make
patient-friendly materials available
to physician offices on a voluntary
basis. The materials provide basic
information to patients on how they
can improve their sodium literacy
and reduce their sodium intake.
With greater awareness and better
understanding of salt, sodium, and
possible health effects, it is hoped
that patients will be able to make
more informed, healthier food
choices, and ultimately reduce their
health risk.
Publications Mail
Agreement # 41144507
Undeliverables, please return to:
Ontario Medical Review
150 Bloor St. West, Suite 900
Toronto, Ontario M5S 3C1
ONTARIO MEDICAL REVIEW
July/Aug11_table_contents_p3_p5_p7.indd 1
Editorial: Dedication to patients
The OMA is a leading advocate for the patients of Ontario and the enhancement of patient care within the health-care system. We back this up on a daily
basis, as an Association, and through the actions of our members. It was
particularly rewarding to attend the recent Patients’ Choice Award ceremony
in Windsor as the President of the OMA —on behalf of all members — to
show support and recognition for local physicians, and publicly celebrate the
patient-physician relationship and all that it means.
10 Public Affairs update: OMA advances health care
as top priority in provincial election
Throughout the first half of the year, Ontario’s doctors championed several
patient advocacy initiatives and bolstered strategic communication
programs to remind patients, the media, members of provincial parliament
and candidates that health care continues to be the top priority among the
electorate, and to drive the health-care agenda forward in advance of the
October 6 provincial election.
16 OMA Advantages affinity program delivers unique
value, expanded menu of products and services
The OMA Advantages affinity program continues to grow and diversify, offering
members a broad range of products and services uniquely tailored to reflect
physicians’ professional and personal interests at exclusive OMA rates.
In addition to strengthening and enhancing offerings by Via Rail, Porter
Airlines, Campbell Moving Systems, and Sea Courses Inc., the OMA has
negotiated new offerings with Mercedes Benz, Bell, Nexgen Wireless (Telus),
and Rogers.
20 Health Care Connect program benefits patients and
physicians — new fee codes, incentives introduced
Many family physicians across Ontario have participated in the Health Care
Connect Program during its first two years, attaching nearly 80% of all
complex/vulnerable patients registered. A review of the program highlights
the multiple benefits of Health Care Connect for physicians and patients,
including a summary of new fees and fee enhancements recently introduced.
23 Windsor physicians receive Patients’ Choice
Awards for exceptional care
The Patients’ Association of Canada has once again partnered with the OMA
to acknowledge exceptional physician care, presenting Patients’ Choice
Awards to Dr. Barry Emara, chief ophthalmologist at Hotel Dieu Grace Hospital,
and Dr. Kouslai Naidoo, a family physician from Windsor, at a reception held
June 20 at the University of Windsor.
3
July/August 2011
11-07-15 4:22 PM
Unbiased Support t Peer Mentors t Practice Advisors t Funding
Transition to an EMR
with peace of mind
56% of primary care physicians in
Ontario have decided to adopt an
EMR with OntarioMD’s help
From practice assessments to vendor
selection, we’re here to guide you
every step of the way
Take the ﬁrst step today. Talk to one of our practice
advisors about the funding opportunity available
until September 30, 2011
Contact OntarioMD at 1-866-744-8668 or
[email protected]
OntarioMD, a subsidiary of the OMA, manages Ontario’s
EMR Adoption Program, funded by eHealth Ontario
July/August 2011
Volume 78 Number 7
www.oma.org
FEATURES
Editor
Jeff Henry
28 Interpretive Bulletin: New Radiology Codes —
Managing Editor
Elizabeth Petruccelli
Second Opinion and After Hours Premiums
Associate Editor
Matthew Radford
The Education and Prevention Committee has prepared an Interpretive
Bulletin that provides physicians, particularly radiologists, with information
on several new fee codes introduced in the Schedule of Benefits for the
interpretation of diagnostic imaging studies.
Advertising/Circulation Co-ordinator
Kim Secord
35 OMA congratulates Ontario’s new medical graduates!
The OMA wishes to acknowledge and congratulate the 2011 graduates
of Ontario’s six medical schools. The Association applauds each student’s
extraordinary achievement, and commitment to the future of patient care.
A complete listing of this year’s medical graduates is provided.
Production Co-ordinator
Angelica Santacroce
Classifieds Co-ordinator
Margaret Lam
Art Direction
Artful Dodger Communications Inc.
Publisher’s Notes
Published 11 times yearly by the
Ontario Medical Association
150 Bloor St. West
Suite 900
Toronto, Ontario
M5S 3C1
Tel. 416.599.2580 or
Toll-free 1.800.268.7215
Fax 416.340.2232
Email: [email protected]
OMA website: www.oma.org
42 Ontario Medical Student Bursary Fund Charity Golf
Tournament raises $160,000
More than 180 physicians, medical students, and corporate donors attended
the 7th annual Ontario Medical Student Bursary Fund Charity Golf Tournament,
held June 17 at Angus Glen Golf Club. The event raised more than $160,000,
with all proceeds directed toward financially eligible Ontario medical students in
the form of non-repayable bursaries.
45 Sport Med 2011 Symposium highlights
The annual Sport Med Symposium features lectures and workshops on the
assessment, prevention and management of sport and exercise injuries.
Key topics addressed during this year’s event included activity levels and
chronic illness in children, backyard trampoline injuries, throwing injuries of the
shoulder, and injury prevention in soccer.
(continued on page 7)
ISSN 0030 302X
Any opinions expressed in articles and
claims made in advertisements are
the opinions of the authors/advertisers
and do not imply endorsement by the
Ontario Medical Association.
The Ontario Medical Review welcomes
readers’ views. Letters to the editor
should be addressed to Ontario Medical
Review, 150 Bloor St. West, Suite
900, Toronto, Ontario M5S 3C1; fax
416.340.2232; email: jeff.henry@oma.
org. Note: letters may be edited for
space and clarity. Please include name,
address and daytime phone number.
(Additional “Publisher’s Notes” appear
on page 7)
CAPSULE NEWS
6
Make health care the #1 issue in the Ontario election — order your
OMA office display poster today!
13 Negotiations update: Council workshop, member consultation plan
32 OMA to co-host Canadian Conference on Physician Health,
October 28-29, 2011, in Toronto
34 Trillium Gift of Life Network launches online registry at “BeADonor.ca”
44 Thank you to OMSBF 2011 Charity Golf Tournament sponsors
62 OMA Outreach to Women Physicians Committee seeks new member
5
July/August 2011
11-07-15 4:22 PM
Order Your New OMA Ofﬁce
Display Poster Today!
Make Health Care the #1 Issue in the Ontario Election
The OMA has launched a provincewide
communications campaign that aims to
keep health care top of mind among voters
and candidates for the upcoming October
provincial election. As part of the Association’s
ongoing strategic communications efforts,
the campaign includes a new segment of the
popular Life’s Work advertisements, which are
running on television (CTV, CBC), in the Globe
So are Ontario’s doctors. They have a plan to improve
our health care system. But they need your help.
and Mail and Toronto Star, as well as regional
In this fall’s provincial election, let the candidates know:
there is no issue more important than health care.
newspapers and radio.
Learn more at oma.org.
Physicians are encouraged to get involved
and show support for improved health care in
Ontario by displaying a new OMA office poster
shown opposite. The 11” x 17” colour poster
reinforces physicians as leaders in health care,
and encourages patients to ensure that health
ONTARIO’S DOCTORS
Your life is our life’s work
care is a priority issue in the next provincial
election.
If you don’t have one, download a QR code reader for your smartphone.
Scan the code to read Ontario’s doctors’ plan to improve health care.
The posters are complimentary to OMA members. Please contact the OMA Response Centre via e-mail
([email protected]), or call 416.599.2580 or 1.800.268.7215 to order copies, or follow the links on the
Campaign home page (https://www.oma.org/Mediaroom/Pages/PolicyPlatform.aspx).
July/Aug11_ad_campaign_poster_p6.indd 1
11-07-08 11:25 AM
July/August 2011
Volume 78 Number 7
www.oma.org
Publisher’s Notes
(continued from page 5)
REPRINTING OF ARTICLES
Material in the Ontario Medical Review
may not be reproduced in whole or
in part without the express written
permission of the Ontario Medical
Association. Requests for reprinting or
use of articles should be forwarded in
writing to the OMA c/o the Editor.
COLUMNS
18 OMA connects hospital physician leaders across
Ontario to address current issues, challenges
The second annual OMA Hospital Physician Leadership Day focused on
informing delegates about current and emerging hospital-based issues,
and increasing awareness and understanding about the changing roles and
responsibilities of physician leadership positions in Ontario hospitals.
24 Electronic Medical Records: enhanced diabetes
SUBSCRIPTION RATES
The Ontario Medical Review is
distributed to all members of the
Ontario Medical Association. Others
may subscribe to the Review at the
following rates: in Canada $55;
in the United States $62; in other
countries $79 (Canadian funds).
Single copies are $6, back issues $7.
HST applicable.
DISPLAY ADVERTISING
Current display advertising rate card,
effective January 1, 2011, available on
request. Advertising representative:
Marg Churchill
Keith Communications Inc.
1599 Hurontario Street
Unit 301
Mississauga, Ontario
L5G 4S1
Tel. 905.278.6700 / 1.800.661.5004
Fax: 905.278.4850
CLASSIFIEDS ADVERTISING
Classifieds advertising inquiries should
be directed to:
Margaret Lam
Tel. 416.340.2263 / 1.800.268.7215,
ext. 2263, Fax: 416.340.2232
The Ontario Medical Review is required
to comply with the provisions of the
Ontario Human Rights Code 1990 in
its editorial and advertising policies,
and assumes no responsibility or
endorses any claims or representation
offered or expressed by advertisers.
The Ontario Medical Review urges
readers to investigate thoroughly any
opportunities advertised.
identification and management
EMRs have the data processing and communications capabilities needed to
create and support practice-wide chronic disease management programs.
This month’s column describes how some Ontario physicians are using their
EMR systems to help improve the level of care for patients with diabetes.
26 Ask the EMR Expert
“Ask the EMR Expert” addresses physician queries regarding the cost of
adopting an electronic medical record system; the level of EMR connectivity
to hospitals, labs, and other physicians across the province; the use of flow
sheets; and how to optimize preventive care bonuses.
57 OMA Insurance Update: insurance planning
strategies for “pre-retirement” physicians
Insurance Services presents the third of a four-part series designed to help
physicians manage their insurance and financial needs at each stage of their
career — from early practice to retirement. The month’s column offers practical
advice for physicians entering the “pre-retirement” phase of practice.
60 Practice Management: physician burnout —
understanding causes, symptoms and treatment
Physicians are at greater risk of burnout than most professionals.
Understanding the causes, symptoms and treatment of burnout can help
physicians address problems in their early stages — before burnout has a
chance to take root — and help build health, well-being, and resilience.
DEPARTMENTS
1
8
OMA Executive, Board, Council,
Committee Chairs
53 Health Policy Report
OMA Section Chairs
74 Classifieds
50 Board of Directors Reports:
April-June, 2011
7
54 In Memoriam
80 Medectoon
80 Advertisers’ Index
July/August 2011
11-07-15 4:22 PM
Section Chairs
Addiction Medicine Dr. R. Cooper
Allergy and Clinical Immunology
Dr. B. Wong
Hematology and Medical Oncology
Dr. P. Kuruvilla
Plastic Surgery Dr. D.S. Woolner
Hospitalist Medicine Dr. L. Bustani
Psychiatric Hospitals, Schools
Dr. S. Allain
Anesthesiology Dr. J. Watson
HSO Physicians Dr. J. Craig
Psychiatry Dr. D. Brownstone
Cardiac Surgery Dr. V. Rao
Hyperbaric Medicine Dr. A.W. Evans
Public Health Physicians Dr. H. Shapiro
Cardiology Dr. W. Hughes
Independent Physicians
Dr. J. Szmuilowicz
Radiation Oncology Dr. G. Morton
Chronic Pain Physicians Dr. H. Jacobs
Clinical Hypnosis Dr. M. Dales
Clinical Teachers Dr. R. Edwards
College and University Student Health
Dr. D. Lowe
Community Health Centre & Aboriginal
Health Access Centre Physicians
Dr. I. Tamari
Infectious Diseases Dr. N. Rau
Internal Medicine Dr. M. Wilson
Interns and Residents Dr. C. McNeil
Laboratory Medicine Dr. C.M. McLachlin
Medical Students
Ms. S. Kenny, Ms. M. Olszewski
Nephrology Dr. C. Edwards
Complementary and Integrative Medicine
Dr. R. Banner
Neurology Dr. E. Klimek
Critical Care Medicine Dr. M. Warner
Neuroradiology Dr. S. Symons
Dermatology Dr. S. Gupta
Neurosurgery Dr. F. Gentili
Diagnostic Imaging Dr. M. Prieditis
Nuclear Medicine Dr. C. Marriott
Emergency Medicine Dr. M. Haluk
Obstetrics and Gynecology Dr. B. Mundle
Endocrinology and Metabolism
Dr. J. Shaban
Occupational and Environmental Medicine
Dr. M. Cividino
French-Speaking Physicians Dr. T. Dufour
Ophthalmology Dr. N. Nijhawan
Gastroenterology Dr. D. Baron
Orthopedic Surgery Dr. D. MacKinlay
General and Family Practice Dr. J. Lusis
Otolaryngology - Head and Neck Surgery
Dr. O. Smith
Genetics Dr. L. Velsher
Geriatrics and Long-Term Care Dr. A. Baker
GP Psychotherapy Dr. M. Paré
Group Practice Dr. G. Maley
REVISED_July/Aug11_section_chairs_p8.indd 1
Reproductive Biology Dr. C. Librach
Respiratory Disease Dr. H. Ramsdale
Rheumatology Dr. P. Baer
Rural Practice Dr. S. Cooper
Sleep Disorders Dr. A. Soicher
Sport and Exercise Medicine
Dr. T. Jevremovic
Surgery, General Dr. A. Maciver
Surgical Assistants Dr. D. Esser
Thoracic Surgery Dr. R. Zeldin
Urology Dr. F. Papanikolaou
Vascular Surgery Dr. D. Szalay
Palliative Medicine Dr. D. Cargill
Pediatrics Dr. H. Yamashiro
Physical Medicine and Rehabilitation
Dr. D. Berbrayer
8
July/August 2011
11-07-08 11:46 AM
EDITORIAL
Dedication to Patients
HE PATIENTS’ ASSOCIATION OF CANADA, TOGETHER WITH THE OMA, RECENTLY HONOURED TWO WINDSOR-
T
AREA PHYSICIANS FOR THEIR EXTRAORDINARY COMMITMENT TO PATIENT CARE, AND CONTRIBUTIONS TO
ENHANCE THE PATIENT-CARE EXPERIENCE IN THE HEALTH-CARE SYSTEM.
Ophthalmologist Dr. Barry Emara and
family physician Dr. Kouslai Naidoo
are the recipients of the 2011 Patients’
Choice Award, nominated by their
patients for providing exceptional care
and dedication in the Windsor community (see p. 23).
It was particularly rewarding to
attend the Patients’ Choice ceremony
at the Schulich School of Medicine
& Dentistry, Windsor program as the
President of the OMA —on behalf of
all members — to show support and
recognition for local physicians, and
publicly celebrate the patient-physician
relationship and all that it means.
The OMA is a leading advocate
for the patients of Ontario and the
enhancement of patient care within the
health-care system. We back this up
on a daily basis, as an Association, and
through the actions of our members.
This dedication to our patients, the
bond that we share, is a true privilege
and one that I am proud to uphold in my
practice, as a medical teacher, and a
physician leader with the OMA.
Together, we have made significant
accomplishments in improving patient
access to care in the province of Ontario.
A progress report on the Health Care
Connect (HCC) program, a joint initiative between the Ministry of Health and
Long-Term Care and OMA, shows that
Ontario doctors have taken on more than
76,000 patients and 80 per cent of all
registered complex/vulnerable patients
JulyAug11_editorial_p9A.indd 1
registered with HCC since the program’s
inception two years ago (see p. 20).
District 9 Director Dr. Pierre Bonin
describes how Health Care Connect is
providing benefits to patients and physicians alike. Recently, in response to
physician feedback, the Ministry and
OMA introduced new incentives that
will allow physicians to grow their practices and attach even more patients
through the HCC referral process.
In fact, since 2004, more than 1.2
million Ontario patients have gained
access to a physician who were previously unattached. We have made great
progress in this area, and are determined to keep working to ensure that
every citizen in this province has his or
her own physician.
A key component in this effort is
ensuring that the province of Ontario is
recognized globally as a desirable and
preferred location to train and practice.
I believe that we have made good progress in this regard as well.
The provisions of our current Master
Agreement have served as important
catalysts to implement enhancements
in every area of the health-care system.
Working together with government and other partners in health
care, we have achieved many efficiencies, and introduced new and innovative approaches to care delivery and
resource management.
We have embraced patient-centred
care and established important poli9
cies to guide the profession forward,
maintaining a strong focus on evidence,
outcomes and a healthy working environment.
The province of Ontario has welcomed more than 2,000 new physicians
since 2004. First-year medical school
enrolment has increased from 700 students to 900 students over five years.
The OMA congratulates the recent
graduates from Ontario’s six medical
schools. The complete list of names
appears on pages 35-39, and was
published recently in the National Post.
Preventive health and health promotion are key elements in the OMA’s
platform document, which outlines the
Association’s recommendations to
improve the health-care system today
and in the future (see p. 10).
The OMR cover features our latest health promotion initiative, which
focuses on raising public awareness
about the health effects of hidden salt
and the dangers of a high-salt diet (see
p. 14). Our objective in this program
is to provide reliable resources to our
patients and their families, and to assist
the public in making informed, healthy
food choices.
The campaign is scheduled to rollout
in late July, and members will be invited
to participate via the OMA electronic
communication network.
Dr. Stewart Kennedy
OMA President
July/August 2011
11-07-15 4:27 PM
FEATURE
OMA advances health care as top
priority in provincial election:
strategic communications, patient advocacy initiatives
reinforce OMA platform priorities
by Emily Jephcott
OMA Public and Corporate Affairs Department
N OCTOBER 6, 2011, A PROVINCIAL ELECTION WILL BE HELD IN ONTARIO. THROUGHOUT THE FIRST HALF
O
OF THIS YEAR, ONTARIO’S DOCTORS HAVE UNDERTAKEN SEVERAL INITIATIVES TO REMIND PATIENTS, THE
MEDIA, MEMBERS OF PROVINCIAL PARLIAMENT (MPPs), AND CANDIDATES, THAT HEALTH CARE CONTINUES TO BE
THE NUMBER ONE PRIORITY AMONG THE ELECTORATE, AND TO DRIVE THE HEALTH-CARE AGENDA FORWARD.
OMA Platform Update
Following the January 27 release of
the OMA platform — “Better care.
Healthier patients. A stronger Ontario.”
— Board members and local physicians met with MPPs of all political
stripes across the province.
OMA Past President Dr. Mark MacLeod and CEO Jonathan Guss met
with senior advisors from all three main
political parties to brief them on the
OMA policy recommendations.
Meetings have also been held with
Minister of Health and Long-Term
Care Deb Matthews, as well as the
health critics from both the Progressive
Conservative Party and the New
Democratic Party.
Dr. MacLeod met with 12 MPPs,
including five cabinet ministers — the
Minister of Health and Long-Term Care,
Minister of Labour, Minister of Training,
Colleges and Universities, Minister of
Education, and the Attorney General.
OMA Board Members have had 17
meetings with local MPPs, including
eight cabinet ministers.
REVISED_July/Aug11_public_affairs_update_pp10-11.indd 1
The meetings are part of a multifaceted campaign to ensure physicians provide input and have a voice in
the platform development processes
of the provincial parties.
Other steps taken to advance recognition and awareness of the platform include television, radio and print
advertising, and an increased social
media presence.
The OMA platform was launched
at a news conference, which generated significant media coverage.
Stories appeared in the Toronto Star,
Toronto Sun, and on CBC Radio and
Television.
Following the launch, OMA Public
Affairs has been vigilant in promoting
the recommendations of Ontario’s
doctors through news releases, letters
to the editor, and interviews with the
OMA President.
During the past four months, the
OMA platform has been referenced
directly or indirectly in more than 130
media stories, and based on circulation and audience estimates, created
10
in excess of 50 million impressions.
On March 29, the Ontario government unveiled its 2011 provincial budget, which included an investment in
a comprehensive Mental Health and
Addictions Strategy, starting with children and youth. By 2013-14, funding
to support the strategy will grow to $93
million per year.
Government also announced it will
increase funding to the community
services sector, including long-term
care homes, by approximately 3%
annually.
Investing in mental health and community support are both recommendations contained in the OMA platform.
On May 29, the Ontario PC Party
released its policy platform, entitled
“Changebook.”
Among its health-care policies, the
PCs have committed to increasing the
number of long-term care beds, investing in home care services and, most
notably, increasing the number of residency school positions for Ontario students who have received their medical
July/August 2011
11-07-08 11:39 AM
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See prescribing summary on page
6/14/11 11:00:24 AM
%*%:06,/08
Negotiations Update:
OMA Council workshop report,
member consultation plan
50% to 80%
of psoriasis patients
have
SCALP INVOLVEMENT
BUTPNFTUBHFPGUIFJS
DPOEJUJPO by OMA Negotiation and Implementation Department
Council Workshop
During the recent OMA Annual General Meeting, Council delegates took
part in a half-day negotiations workshop designed to initiate dialogue and
brainstorming, as we look ahead to framework bargaining in 2012.
The session included a presentation by Dr. Vasanthi Srinivasan, Assistant
Deputy Minister, Health System Strategy, Ministry of Health and Long-Term
Care, who outlined the Ministry’s strategic priorities for the upcoming year.
These included a focus in the areas of prevention, support and access.
Council members had fulsome discussions on the barriers and deficiencies in the health-care system that inhibit work in these particular areas, as
well as the necessary supports or additional resources and investments
that would enable improvements.
Discussions centred around: ambulatory care-sensitive conditions,
aging at home and Home First, mental health and addictions, timely access
to primary care, emergency departments, hospitals and related organiza-
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tions, and health human resources.
Other areas that physicians felt needed to be addressed included the
need for improved information flow, institutional capital issues, non-physician community supports for patients (CCAC, mental health, community
labs) and non-medical supports.
While the session was not designed to establish negotiating positions for
the OMA, the discussion will be used to find those issues that can perhaps
lead to common ground discussions with government in the next Master
Agreement negotiation.
Member Consultation
The Negotiations Committee is finalizing its member consultation plan,
which will roll out in the fall. This includes a negotiations-focused survey
to be sent to all physicians in early September, a physician leader day for
Section and geographic leaders in October, and presentations to members
at each venue during the upcoming OMA President’s Tour.
Also, Sections and regional physician leaders are being asked to consult
with their constituent members to develop and then submit their respective
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negotiations priorities.
This consultation is fundamental to informing the process for establishing
the mandate of the Negotiations Committee, and the subsequent deliberations with government.
JulyAug11_negotiations_cap_news_p13.indd 1
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13
11-07-11 10:31 AM
FEATU
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FEATURE
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TU
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RE
In-Office Health Promotion Pilot Program: Phase II
OMA campaign promotes sodium literacy,
dangers of hidden salt in food:
patient information materials available for physician offices
by John Wellner
T
HE OMA WILL SOON UNVEIL THE SECOND PHASE OF ITS IN-OFFICE HEALTH PROMOTION PILOT PROGRAM,
FOCUSING ON HIDDEN SALT AWARENESS AND THE DANGERS OF A HIGH-SALT DIET. THE PILOT INITIATIVE
— WHICH BEGAN IN 2010 WITH THE LAUNCH OF THE OMA CAMPAIGN TO RAISE PUBLIC AWARENESS ABOUT
ANAPHYLAXIS AND SEVERE FOOD ALLERGIES — IS PART OF THE OMA’S ONGOING EFFORT TO EXTEND ITS
HEALTH PROMOTION MESSAGING BEYOND NEWSPAPERS, RADIO, AND SOCIAL MEDIA COVERAGE, INTO THE
MEDICAL PRACTICE.
This public awareness initiative is not
meant to replace the important communication between physicians and
patients, but rather to provide an additional source of health information by
making patient-focused materials, such
as pamphlets and posters, available to
physicians on a voluntary basis.
posters for their practice could request
hard copies for free, or download these
materials from the OMA website.
The initial pilot resulted in more than
1,700 brochures and 600 posters
being distributed to OMA members for
display in their offices, with many more
being downloaded.
Phase I: Anaphylaxis Awareness
Last year’s pilot on anaphylaxis awareness was a great success. Physicians
who wished to receive pamphlets or
Phase II: Finding the Hidden Salt in
Food
Many Canadians are unaware of how
much salt is in their food, and the nega-
Sodium feature template_5.indd 1
14
tive effects it can have on their health.
Phase II of the pilot program provides basic information on how patients
can improve their sodium literacy and
reduce their sodium intake. With greater
awareness and better understanding
of the sodium in salt, and its possible
health effects, it is hoped that patients
will be able to make more informed,
healthier food choices, and ultimately
reduce their health risk.
The patient materials include a
pamphlet entitled “Hidden Salt & Your
July/August 2011
7/14/11 8:49 AM
OMA Health Promotion
Health,” as well as a colourful office
poster featuring the headline, “Do you
know how much salt your food contains?”
The pamphlet describes:
t )PXTPEJVNJTJNQMJDBUFEJOIZQFStension and stroke risk.
t )PXNVDITPEJVNTIPVMECFDPOsumed versus how much the average Canadian actually consumes.
t )PXUIFNBKPSJUZPGTPEJVNDPOsumed is actually already present in
prepared foods that we purchase,
rather than added as table salt at the
stove or dinner table.
The pamphlet emphasizes that
while the nutrition facts label on packaged foods is essential for managing
sodium intake, as consumers, patients
need to better educate themselves
about high-sodium foods, and which
foods contain the most hidden sodium.
It also describes how many people
are surprised to learn that some of
their favourite pre-packaged foods,
like frozen pizzas, soups and canned
vegetables, can contain a very high salt
content.
The information is presented in a
manner designed to be helpful to physicians who wish to further engage their
patients about this important risk factor,
or simply provide them with something
to take home for post-visit reading.
To help promote patient interest,
one element of the material includes a
challenge to patients to find the hidden
salt in their diets by reading the labels of
any packaged food products they currently use at home.
First, patients are encouraged to
select a number of prepared food items
they may have in their cupboard or
freezer, such as soups, snacks, canned
fish or meat, and frozen dinners. Then,
without reading the labels, they are
asked to arrange them, in order, from
the item they think contains the most
salt per serving, to that which contains
the least. Finally, they are challenged
to test their knowledge by reading the
package labels to determine how many
milligrams of sodium are contained in
one serving of each item selected, and
to see whether they guessed the correct order. In other words, did they find
the hidden salt?
Sodium feature template_5.indd 2
the OMA is encouraging patients to find
the hidden salt in their diets by reading
labels on packaged food products
This initiative reflects policies recommended in the OMA election platform
document — “Better care. Healthier
patients. A stronger Ontario.” — which
suggest the need for “A public education campaign to inform Ontarians about
the impacts of sodium on their health,
ways to detect sodium in their diet, and
tools to help sodium reduction.”
To obtain copies of the patient
pamphlet and office poster, contact the OMA Response Centre at
1.800.268.7215, or order them online
at: www.oma.org/sodium.
cautioned that “there was not enough information to understand the effect of these
changes in salt intake on deaths or cardiovascular disease.” Taylor also found that in
the short term, up to two years after study
participants were advised to reduce salt,
there was a trend of reduced deaths, but in
the longer term, after about 10 years, that
benefit disappeared. Taylor believes that is
because people were not able to maintain
their lower-sodium-intake behaviour.2
References
1.
Taylor RS, Ashton KE, Moxham T, Hooper
L, Ebrahim S. Reduced Dietary Salt for the
Note: In early July, significant media attention was given to a Cochrane Review
entitled Reduced Dietary Salt for the
Prevention of Cardiovascular Disease: A
Meta-Analysis of Randomized Controlled
Trials.1 Contrary to some newspaper headlines, this study does not find that sodium is
innocent of blame for cardiovascular harm,
but rather that the randomized controlled
trials examined neither had a large enough
sample size, nor followed the patients for
long enough to find conclusive, statistically
significant proof of reduced cardiovascular
events. Lead study author, Professor Rod
Taylor from Peninsula College of Medicine
and Dentistry in the United Kingdom,
15
Prevention of Cardiovascular Disease: A
Meta-Analysis of Randomized Controlled
Trials (Cochrane Review). Am J Hypertens.
+VMEPJBKI
"WBJMBCMFGSPNIUUQXXXOBUVSFDPNBKI
KPVSOBMWBPQODVSSFOUQEGBKIB
pdf. Accessed: 2011 Jul 13.
2.
Doheny K. Heart benefits from cutting back
on salt? Study shows reducing salt lowers
blood pressure; evidence inconclusive on
preventing heart disease. [Internet]. Atlanta,
GA: WebMD; 2011 Jul 6. [about 5 screens].
Available from: http://www.webmd.com/
heart-disease/news/20110706/heart-benefits-from-cutting-back-on-salt. Accessed:
2011 Jul 13.
July/August 2011
7/14/11 8:50 AM
FEATURE
Tracking the “Advantages” of
OMA membership:
OMA affinity program delivers unique value, expanded
menu of preferred products and services
by OMA Member Services
T
HE OMA ADVANTAGES AFFINITY PROGRAM CONTINUES TO GROW AND DIVERSIFY, OFFERING MEMBERS
A BROAD RANGE OF PRODUCTS AND SERVICES UNIQUELY TAILORED TO REFLECT PHYSICIANS’ PROFES-
SIONAL AND PERSONAL INTERESTS AT EXCLUSIVE OMA RATES.
Since the program launch last fall,
more than 6,000 discounted offerings have been arranged by members
through the OMA Advantages program.
Dr. Virginia Walley, Chair of the OMA
Member Services Board Co-ordinating
Committee, says: “Our goal in developing the Advantages program is to
provide physicians and medical practices with high-quality value propositions that are generally unavailable to
the individual physician or practice
consumer. We’re committed to delivering that.”
Preference-driven arrangements
with vendors
Meeting and exceeding member needs,
preferences and priorities continues to
be the guiding principle behind the customized, responsive OMA Advantages
program.
Members have told the OMA that
they want programs that offer better
value than current market discounts,
or those that provide exclusive benefits.
Also, members want to be informed
about revitalized services or new offerONTARIO MEDICAL REVIEW
REVISED_July/Aug11_tracking_advantages_pp16-17.indd 1
ings as soon as they become available.
A listing of members’ top-desired
categories of discounts appears in the
sidebar right. This listing reflects the
findings of member research undertaken during the Advantages program
development stage.
“Geographical reach is also essential, ensuring that our discounted
products, benefits and services are
accessible wherever OMA members
live and practise in Ontario,” says Dr.
Walley.
For example, OMA members indicated a strong interest in professional
and personal telecommunication products.
The OMA responded by negotiating plans with Bell, Nexgen Wireless
(Telus), and Rogers to provide competitively priced home office and business
telephone, wireless, Internet, and cable
products and services.
To provide members with choice
and options, and to ensure all have
access to discounted products and
services, the OMA entered into nonexclusive arrangements with these
companies.
16
OMA Members’
Preferred Categories of
Discounts
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July/August 2011
11-07-18 9:20 AM
FEATURE
Spotlight on Local Leadership
OMA Hospital Physician Leadership Day
connects hospital leaders provincewide:
the changing hospital/physician relationship —
current issues, member engagement opportunities
HE OMA RECENTLY HOSTED DOZENS OF MEDICAL STAFF ASSOCIATION PRESIDENTS AND HOSPITAL CHIEFS
T
OF STAFF FROM ACROSS THE PROVINCE FOR THE SECOND ANNUAL HOSPITAL PHYSICIAN LEADERSHIP DAY,
HELD MAY 28 IN TORONTO.
The event focused on informing hospital physician leaders about current
and emerging issues, and increasing
awareness and understanding about
the changing roles and responsibilities of physician leadership positions
in Ontario hospitals. The day also provided a forum for open dialogue among
members to share local experiences
and best practices.
Dr. Ved Tandan, OMA Treasurer and
Chair of the Hospital Issues Committee,
stressed that hospital-physician relations, and physician leadership in hospitals are key priorities for the OMA:
“We believe it’s very important to connect with hospital leaders and we are
developing a strategy to establish and
nurture these relationships,” he said.
Former OMA President and OMA
Hospital Issues Committee member
Dr. Tom Dickson opened the session
with an overview of the 2011 Ontario
Hospital Association/OMA joint professional staff prototype bylaw. The prototype is a guide to assist local hospital
administration and professional staff in
crafting their own local document.
Dr. Dickson explained several substantive changes to previous versions
of the bylaw, such as the removal of the
July/Aug11_member_outreach_pp18-19.indd 1
definition of privileges, the removal of the
appendices, and the description of the
Professional Staff Human Resources
Plan. He stated that the OMA is pleased
with the joint venture with the OHA,
and hopes the collaboration continues.
Information about the bylaw is available on the OMA website (https://www.
oma.org/Member/Resources/Issues/
Pages/OHAOMAbylaw.aspx).
Dr. Tandan addressed the new issue
of non-voting physician board members. His presentation outlined fiduciary
duties to the corporation, including the
importance of board confidentiality and
loyalty, avoiding conflicts of interest,
and participation in in camera meetings.
The role of the board member is very
important though often not well understood, as physicians receive little or no
training on their rights and responsibilities at the hospital board table.
Dr. Tandan’s presentation on the
role of a non-voting board member was
particularly helpful for a number of physicians, including Dr. John Mahoney,
President of the MSA at the Ottawa
Hospital. “The issue of non-voting physicians on the board is still controversial, and the Medical Staff Associations
around the province are trying to figure
18
out the new lay of the land; it’s clear
that we need a more defined role at the
board table,” said Dr. Mahoney.
Jessica Katul, senior policy analyst, OMA Health Policy, described
the background and origins of Health
Quality Ontario, an independent agency
created by the government from a
number of distinct organizations that
merged in 2011.
The role of Health Quality Ontario
has evolved from its predecessors to
be the overseer of quality in the provincial health-care system. Its role includes
the creation of clinical guidelines and
recommendations on medical devices
and health services. The agency will
also receive quality improvement plans
from every hospital, which will contain a
number of mandated indicators.
OMA Chief Strategist Ron Sapsford
discussed the concept of PatientBased Payment and the principles
behind it. Patient-Based Payment is a
method of paying hospitals based on
the number of patients treated and
the quality of services provided. It will
leverage a complex formula called the
Health-Based Allocation Model. The
new system is complex, but is being
validated with the hope that it will be
July/August 2011
11-07-11 9:34 AM
Hospital Physician Leadership Day
used in the near future. There are a variety of system and physician-specific
policy issues to consider, and the OMA
is working with the government and
other stakeholder groups on the details.
Cynthia MacWilliam, director of
administration for the OMA Physician
Health Program (PHP), presented
on the Physician Workplace Support
Program, an offshoot of the PHP.
She explained that the Physician
Health Program has seen a significant increase in issues related to the
workplace, including hospitals. The
Physician Workplace Support Program
is a comprehensive basket of services
that supports physicians in the hospital
workplace, both for the distressed physician and their physician leader.
Dr. John Gray, Executive Director
and CEO of the Canadian Medical
Protective Association (CMPA),
described changing hospital-physician
relationships, the collection of physicians’ personal information, and physician disruptive behaviour.
The CMPA is keen to ensure physicians understand the implications of
moving away from a privileges model,
maintain their ability to advocate for
their patients, and understand why it is
important to be engaged.
The CMPA is also clear that physicians’ personal information should be
valued and kept as private as possible,
that requirements should be fair, and
that regulatory Colleges should be the
body to collect health information.
Dr. Gray expressed the importance
of addressing disruptive behaviour in a
productive and collaborative manner,
with a resolution in the best interests
of all involved. “Identifying disruptive
behaviour is often a subjective exercise
that requires professional judgment.
Hospitals, Colleges and physician
leaders should put in place constructive approaches to resolve disruptive behaviour before such behaviour
impacts the work environment or the
professional practice of the individuals
involved,” said Dr. Gray.
Following the plenary session,
participants broke into a variety of
geographically-based groups. The
purpose was to address local issues
and suggest ways in which the OMA
July/Aug11_member_outreach_pp18-19.indd 2
could assist hospital physician leaders to become more connected and
informed. Participants highlighted the
importance of medical staff engagement and strong physician leadership
in times of change, and how important
it is to engage with the CEO and Board
of the hospital in a productive manner.
Dr. Cristina Popa, MSA President at
Markham Stouffville Hospital, said “It is
a time of changes in health care, and
physicians need to be part of the decision-making. The traditional relationship between physicians and hospitals
is evolving. Physicians need to make
sure that the accountability and responsibilities are shared by everybody.”
Dr. Gray congratulated the OMA on
organizing the conference, noting “physicians have an important perspective
and must remain engaged in healthcare decision-making — this starts in
hospitals. Hospitals should be encouraging physicians to become involved,
but this does not always seem to be
case. This conference is a great start to
improving that engagement.”
Dr. Ken Derksen, Chief of Staff
at Headwaters Health Care Centre,
enjoyed the opportunities the meet-
ing provided. “It was a very balanced
day with a variety of topics useful for all
physician leaders. We are embarking
on a revision/renewal of our professional staff bylaws and the very balanced update provided helped move
our process along considerably. The
OMA approach was collaborative and
reflected the reality of a team approach
to leadership within a hospital community,” said Dr. Derksen.
Planning is underway to host similar events. To find out more about
OMA meetings, representation,
or how to contact your local OMA
Regional Manager, please visit the
Member Community page on the
OMA website, or call 416.599.2580 or
1.800.268.7215.
“Spotlight on Local Leadership” is a monthly
feature that highlights physician leadership
and advocacy initiatives at the community
level. Prepared by OMA Member Outreach
Services, articles report on physician efforts
across the province to advance member
engagement, and foster consultation and
dialogue with health system stakeholders,
such as LHINs, hospitals, and other health
professional groups and organizations.
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SERVING THE NEEDS OF HEALTH CARE PROFESSIONALS ACROSS ONTARIO FOR OVER 35 YEARS
19
July/August 2011
11-07-11 9:34 AM
FEATURE
Ontario Health Care Connect program
benefitting patients and physicians:
patient registration and attachment rates strong,
by Peter Brown, OMA Health Policy Department
Sampada Kukade, OMA Public and Corporate Affairs Department
/ '&#36"3: 5)& 0/5"3*0 (07&3/.&/5 -"6/$)&% )&"-5) $"3& $0//&$5 )$$
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To date, more than 138,000 unattached patients have registered with
HCC, and physicians have accepted
more than 76,000 patients through the
program.
All primary care physicians in patient
enrolment models (PEMs) are eligible to
participate in the HCC program.
PEM physicians receive an incentive
payment for attaching complex/vulnerable patients through HCC (Q053A).
Non-complex/vulnerable patients do
not qualify for a specific incentive, however, when attached through HCC,
these patients do not apply to billing thresholds for existing unattached
patient codes, such as Q013 and
Q033.
In response to physician feedback
about HCC, the Ministry of Health and
Long-Term Care and the OMA have
agreed to the introduction of two new
fees and fee enhancements for both
complex/vulnerable and non-complex/
vulnerable patients.
These new codes better reflect how
physicians want to grow their practices,
and provide for the necessary flexibility to ensure the incentive matches the
July/Aug11_health_care_connect_pp20-21.indd 1
health status of the patient. Note: all
family physicians in a patient enrolment
model who enrol patients from HCC are
eligible to bill the new fees (Q056A and
Q057A) described below.
t 2")$$6QHSBEF1BUJFOU
Status): This code applies when a
physician accepts a non-complex/
vulnerable patient though HCC but,
after the initial assessment, believes
that the patient is complex/vulnerable. A rationale from the physician for
the decision must be recorded in the
patient’s chart. Physicians billing this
code receive a one-time payment
of $850 and must enrol the patient,
committing to provide ongoing care
for a minimum of one year.
t 2")$$(SFBUFS5IBO5ISFF
Months): To better reflect physician
need to ensure a balanced practice
and to provide unattached, noncomplex/vulnerable patients with
access to a family physician, physicians can now bill Q057A and
receive a $200 incentive for accepting these patients who have been
registered with HCC for more than
three months.
20
Patients searching for a family physician can register for HCC via telephone
or online. When registering, patients are
required to complete a health needs
questionnaire. Patients are then prioritized for HCC referral to a family physician based on their answers.
A clinical expert panel recommended
criteria that would identify patients as
either complex/vulnerable or non-complex/vulnerable. Care Connectors (registered nurses) work to refer patients to
family physicians who are accepting new
patients.
When patients register with HCC,
they are encouraged to continue to
search for a family physician on their
own. In a situation where an unattached
patient who has registered with HCC
comes to the practice office, to qualify
for the HCC Q-codes, physicians or the
office staff are required to call their local
Care Connector (dial 310-CCAC from
anywhere in the province) and indicate
their wish to have the specific patient
referred.
PEM physicians are using HCC to
grow their practices for many reasons.
By accepting patients through HCC,
July/August 2011
11-07-06 3:34 PM
Health Care Connect
family physicians are able to learn
about a prospective patient’s health
needs prior to referral, which can better equip the physician to anticipate
the patient’s care needs and to actively
work towards both an effective casemix of patients and a balanced roster
of patients.
0."%JTUSJDU%JSFDUPS%S1JFSSF
Bonin, a family physician in Sudbury,
has been accepting patient referrals
GSPN)$$TJODF#FMPX%S#POJO
describes his experience with HCC,
some of the benefits of this program,
and his view on the enhancement of the
new HCC Q-codes:
Q. Why did you decide to accept patients
through Health Care Connect?
A. In Sudbury, there are so many unattached patients with complex health
problems who need a family doctor.
Since I implemented “Advanced
Access” into my practice, I increased
my ability to see more patients, which
allowed me to increase my roster size.
But I had to do it in an organized and
balanced way.
As family doctors, we want to help
FWFSZPOFUPQSPWJEFUIFCFTUDBSF
QPTTJCMFCVUJGXFBSFOUDBSFGVMXF
can let our practice demand exceed
our ability to provide care. This doesn’t
help anyone.
Health Care Connect let me increase
my roster size in a controlled, measured
and predictable way. The health needs
questionnaire is a real benefit as it gives
me a sense of the patient’s needs.
Q. Have you found HCC to be a useful tool in managing your day-to-day
practice? If so, how?
A. Health Care Connect has proven to
be a valuable resource to add patients
to my practice. My staff used to spend
a lot of time managing a wait list, establishing the health status of new patients,
and preparing this information for me.
When I see a patient referred by
HCC for the first time, I spend less time
understanding their health status and
more time determining what their health
needs are.
The one thing I really like is that my
staff can handle much of the administrative relationship with the Care
July/Aug11_health_care_connect_pp20-21.indd 2
Connectors at the CCAC. My role
focuses on determining which patients
to accept based on what’s presented
by my staff.
Q. One of the recent changes is a Qcode that allows physicians to qualify
for a higher incentive payment if they
feel a non-complex/vulnerable patient
is indeed complex/vulnerable. How do
you, as a physician, determine whether
a non-complex/vulnerable patient is
complex/vulnerable?
A. I see this new Q-code as a real
enhancement to the incentive payments related to Health Care Connect.
I’ve had a few patients referred to me
through HCC as non-complex-vulnerable, only to find after my initial assessment that their health status was much
worse and their health-care needs were
much higher. Some of these patients
have been unattached for some time
and their health status has changed.
For example, I’ve had patients with
undiagnosed hypertension or diabetes,
or patients who did not disclose mental
health issues who come through HCC
as non-complex-vulnerable. When I
meet them, I discover their conditions
have worsened, they’ve not disclosed
something to the Care Connector, or
they have undiagnosed conditions.
The health needs questionnaire
administered by HCC is a good tool,
and is quite often accurate; however, it
is sometimes limited because it’s based
on the patient’s knowledge of their own
health conditions.
This new Q-code allows the family
physician to determine the health status
of the patient and adjust the incentive
to more accurately reflect the needs of
the patient.
Q. What would you say to eligible physicians who are not accepting patients
through Health Care Connect?
A. I would say, “Why not?” I know
Health Care Connect is not for everyone, but if you are growing your practice, this program allows you to do so
in a controlled, measured way. It does
a lot of the health information gathering
for you, and it takes an administrative
burden off your staff.
The incentives are quite good. I’m
21
in a Family Health Organization, so a
complex/vulnerable patient means a
$350 payment, and an increase of
$500 to the capitation payment for the
patient for one year. I know my fee-forTFSWJDFDPMMFBHVFTHFUPGBMMUIFJS
fees billed for the patient for one year.
The new HCC Q-codes provide
some guarantee that the incentive will
match the patient’s care demand. The
new code for non-complex patients
that have waited on HCC for three
months or more is most welcome.
These patients have lower health
needs, and this qualifies for a $200
incentive payment, which means that
when I’ve hit my Q013 cap, I can still
receive an incentive for the unattached
patients I’m taking into my practice.
I would suggest that any physician
looking to take new patients into their
practice give the CCAC a call and ask
to speak to the Care Connector.
For additional information, contact the
OMA, or your local Care Connector at 310CCAC (from anywhere in Ontario).
Do you have an
OMA-related
question and don’t
know who to
contact?
Send the Response
Centre an email at
[email protected] or call
1.800.268.7215 and
press 0.
July/August 2011
11-07-06 3:34 PM
FEATURE
Windsor physicians receive Patients’ Choice
Awards for exceptional care:
Dr. Barry Emara and Dr. Kouslai Naidoo honoured
by Catherine Flaman
HE PATIENTS’ ASSOCIATION OF CANADA HAS ONCE AGAIN PARTNERED WITH THE OMA TO ACKNOWLEDGE
T
EXCEPTIONAL PHYSICIAN CARE, PRESENTING PATIENTS’ CHOICE AWARDS TO TWO WINDSOR-AREA PHYSICIANS.
Patients’ Choice Awards
Established in 2010, the Patients’
Choice Awards provide patients living
in various Ontario communities with a
unique opportunity to publicly acknowledge exceptional care offered by area
physicians.
The nomination process, which
REVISED_July/Aug11_patient_choice_awards_p23.indd 1
is conducted via submissions to the
PAC website, encourages patients to
share the positive experiences they
have had with their physicians, and
provides valuable insight into ways to
improve patient care services locally
and across the province. The OMA
and PAC will be participating in at least
two more Patients’ Choice Awards
events in 2011.
The OMA wishes to thank the nominators, physicians, the PAC, spon-
sors, and all those who took the time to
attend the Windsor event.
For more information on the
Patients’ Choice Awards, please contact Catherine Flaman, OMA Public
and Corporate Affairs Department,
at 416.599.2580 or 1.800.268.7215,
ext. 3114, or by email at: catherine.
[email protected]. For more information on the Patients’ Association of
Canada, please visit the PAC website
at: www.patientsassociation.ca.
PHOTO: NANCY DALE
Dr. Barry Emara, chief ophthalmologist
at Hotel Dieu Grace Hospital, and Dr.
Kouslai Naidoo, a family physician from
Windsor, were honoured at a reception held June 20 at the University of
Windsor’s new medical school building.
More than 50 people attended the
ceremony, including patients, physicians, community leaders, and medical students. Patients’ Association of
Canada President Sholom Glouberman
and OMA President Dr. Stewart
Kennedy presented the awards.
In his remarks to the audience, Mr.
Glouberman noted, “In the health-care
system, everybody has a voice, and we
are attempting to give patients a stronger voice.”
In a heart-felt acceptance speech,
Dr. Emara told attendees, “It’s the ultimate honour, really, for a patient to
nominate you for something like this.”
Dr. Naidoo’s patient nominator commented, “She is my angel in medicine. I
cannot say enough about her.”
The OMA and PAC are pleased to
recognize these outstanding physicians.
From left: Patients’ Association of Canada President Sholom Glouberman, Patients’
Choice Award recipients Dr. Barry Emara, Dr. Kouslai Naidoo, and OMA President
Dr. Stewart Kennedy.
23
July/August 2011
11-07-08 11:51 AM
FEATURE
Electronic Medical Records
EMRs facilitate enhanced diabetes
identification and management
by OntarioMD
HRONIC DISEASE MANAGEMENT (CDM) REQUIRES THAT FAMILY PHYSICIANS TRACK AND PROCESS
C
LARGE AMOUNTS OF INFORMATION OVER LONG PERIODS OF TIME FOR MANY PATIENTS. ADDING TO
THE COMPLEXITY IS THE NEED TO CO-ORDINATE AND COLLABORATE WITH PATIENTS, OTHER HEALTH-CARE
PROFESSIONALS AND OTHER HEALTH SERVICES. EMRS HAVE THE DATA PROCESSING AND COMMUNICATIONS
CAPABILITIES NEEDED TO CREATE AND SUPPORT PRACTICE-WIDE CDM PROGRAMS.
In this two-part article, we show how
some Ontario physicians are using their
EMR systems to help improve the level
of care for their patients with diabetes.
Part 1, below, focuses on how the physicians use EMRs to identify and manage patients with diabetes. Part 2 will
deal with how physicians use EMRs
during patient visits, and for electronic
communications with patients.
Dr. Catherine Faulds of the London
Family Health Team has been an EMR
user since 2008. She is the Ontario
recipient of the 2010 Family Physician
of the Year Award, presented by
the College of Family Physicians of
Canada. Dr. Faulds won because of
the exceptional patient care she offers,
including her 116 patients with diabetes. Aided by her EMR, Dr. Faulds
worked with her patients and obtained
significant improvements in health
outcomes. Between June 2008 and
March 2011, Dr. Faulds achieved the
following:
t 0QUPNFUSJTUWJTJUTGPSSFUJOPQBUIZ
testing went from 45% to 91%.
t 1BUJFOUTXJUIBO-%-VOEFSXFOU
from 23% to 73%.
t 1BUJFOUTXJUIBO)C"DVOEFS
went from 64% to 72%.
July/Aug11_EMR_diabetes_pp24-25.indd 1
t 1BUJFOUTXJUITFMGNBOBHFNFOU
goals went from 18% to 100%.
“We concentrated on helping our
patients with diabetes,” says Dr.
Faulds. “We put a nurse in place. We
put a program in place. But we couldn’t
have achieved our improved outcomes
without the EMR.”
Helping manage information
Dr. Faulds can search the EMR database and produce reports that give her
valuable insights.
“Using the EMR, I was able to see
that there were 116 patients with diabetes on my roster, but I was seeing
only 88 of them. People were getting
lost, but now we follow up with each of
them. We know who they are. We have
their lab results at our fingertips. We
take the attitude that we can improve
the outcomes — and that is what has
happened. We’ve seen the numbers
improve dramatically since the start. It
has really changed the whole style of
how I practise,” she says.
In a similar manner, Dr. Sanjeev
Goel, of White Elephant Downtown
Brampton Family Health Team, is using
his EMR to identify patients who need
special, ongoing attention.
Dr. Goel explains, “We’ll look at the
whole list of patients with diabetes and
see who hasn’t come in for a while, who
is uncontrolled, and we’ll call them in.
That wasn’t possible before. We didn’t
have that picture of the whole practice.”
Dr. Betty Choi-Fung, of Scarborough
Academic Health Team, has more than
300 patients with diabetes in her practice. She felt that she was scrambling
to care for them. With her EMR, Dr.
Diabetes in Ontario
The Canadian Diabetes Association estimates that 1.1 million people or 8.3%
of the Ontario population had diabetes in 2010. This is estimated to grow to
1.9 million people, or 12% of the population, by 2020.
Diabetes is a provincial CDM priority. Ontario’s Diabetes Strategy provides
physicians with numerous tools and incentives to combat this disease.
24
July/August 2011
11-07-04 11:27 AM
EMRs and Diabetes Management
Choi-Fung is able to approach the management of diabetes patients systematically. She cites the following example:
“Two of my patients were able to come
off medication. It wouldn’t have been
possible without an EMR. With it, we
can recall and remind them. Whenever
our patients with diabetes call the office,
even if it’s about something else, our
receptionists check the EMR. If it’s
time for their blood test, we tell them.
It reminds our patients that they have
a role to play in maintaining their health
and it keeps them on their toes.”
One of the reasons why EMRs are
so useful for controlling diabetes is the
fact that the three largest community
labs can send the test results directly
to OntarioMD-certified EMRs. This and
other information is fed into flowsheets.
“Right away, the lab information
is populated into the flowsheet and
marked if it’s above or below target,”
explains Dr. Goel. “We have the global
picture of the patient. Are they hitting
targets? With paper, it was difficult to
flag things and find information quickly.
Now, with the EMR, we’re much less
likely to miss something because of
time constraints.”
EMRs can also help improve the
efficiency of visits. EMRs have flags to
automate tasks at the front desk, and
staff can keep track of the location of
patients within the clinic during a visit.
Is the patient in an examination room or
the waiting room? Is the patient alone
or with a caregiver?
Dr. Michelle Greiver of the North
York Family Health Team uses this
capability to improve the office experience of her patients with diabetes. She
says, “We aim to have patients spend
most of their visit time on activities that
are useful, and less time just sitting in
the waiting room. We flag diabetics in
the scheduler so that the secretaries
do an automated blood pressure and
a weight and enter those in the EMR
before the patient sees the doctor or
nurse. In February 2011, the time our
patients spent in the office averaged 35
minutes. Visits are much smoother and
quicker.”
An additional benefit of EMRs is their
capacity to help plan and track services
tied to bonuses, or that can be billed
July/Aug11_EMR_diabetes_pp24-25.indd 2
only a specific number of times per
year. The associated codes for these
services are entered into a patient’s
record. Subsequently, reminders
appear over the course of the year until
the services have been carried out.
Dr. Faulds explains, “I have a
reminder system that’s built into the
patient’s chart. For example, I can tag
a patient record to remind me to perform three K codes and one Q code on
that patient per year. Later in the year,
if I see that these are still outstanding,
then I can investigate. Has the patient
not been in? Have I been billing incorrectly? So it’s a good check on your billing too.”
Conclusion
In summarizing her EMR experience,
Dr. Faulds notes, “My EMR has made a
huge difference to quality improvement
implementation. I know all my patients
with diabetes. I see them on a regular basis and I believe their measures
for optimal care have improved. I can
look at trends in patient care, evaluate
them and effectively implement quality
improvements.”
Dr. Goel also has a vision for using
his EMR in the care of his patients with
diabetes.
“I want to take my EMR to the
next stage,” he says. “I want to take it
beyond being just a medical record. I
want to transform it into a practice
management tool for tracking values
and outcomes for our patients with diabetes as a whole.”
EMRs enable physicians to improve
the management of chronic diseases.
This article shows how four doctors
use their EMR’s capability to effectively
identify and manage their patients with
diabetes, thereby offering better care.
The OMR EMR Adoption column is provided by OntarioMD, a subsidiary of the
OMA. OntarioMD manages Ontario’s EMR
Adoption Program, funded by eHealth
Ontario. For more information on EMR
Adoption, visit www.ontariomd.ca, email
[email protected], or call toll-free
1.866.744.8668. The deadline for applying
is September 30, 2011. Email peer.leader.
[email protected] if you would like
a Peer Leader to answer your questions
and support your adoption of an OntarioMD
certified EMR, a free service for physicians
funded by Canada Health Infoway.
Did you know that OMA’s Practice Management
and Advisory Services (PMAS) can help you
manage your practice?
PMAS provides practice management services to assist
physicians with:
/
/
/
/
/
Billing issues with respect to OHIP, WSIB, and thirdparty requests
Office management
Starting a practice
Retirement or winding down a practice
Medical records
Contact us:
Practice Management & Advisory Services
email: [email protected]
tel: 1.800.268.7215
25
July/August 2011
11-07-04 11:27 AM
FEATURE
Electronic Medical Records
“Ask the EMR Expert”
the cost of EMR adoption, hospital connectivity,
flow sheets, optimizing preventive care bonuses
by Darren Larsen, MD
)*4.0/5)i"4,5)&&.3&91&35w"%%3&44&41):4*$*"/26&3*&43&("3%*/(5)&$0450'&.3"%015*0/
T
)041*5"-$0//&$5*7*5:64&0''-084)&&54"/%)0850015*.*;&13&7&/5*7&$"3&#0/64&4
Q. What percentage of the EMR cost
is covered?
A. EMR funding is designed to cover
70% of the acquisition, implementation
and communication costs of a typical
electronic medical record (EMR) over a
three-year period. It is important to keep
in mind that variability due to the environment and context in which you are
implementing, and the type of system
hardware you select, will impact your
costs and the coverage ratio. However,
these variable costs are purely discretionary and within your control.
Funding comes to you directly and
is available for the purchase of any
OntarioMD-certified EMR offering.
OntarioMD will provide you with unbiased support and guidance in transitioning to an EMR.
OntarioMD is a wholly owned subsidiary of the OMA, and manages
Ontario’s EMR Adoption Program,
funded by eHealth Ontario.
t 4VCNJU&.3GVOEJOHJORVJSJFTUP
[email protected]
Q. Does an EMR allow me to connect
to other elements in the health-care
system?
A. Yes! Hospital Report Manager (HRM)
allows you to connect to hospitals in
many parts of the province, and is being
rolled out regionally.
July/Aug11_EMR_expert_p26.indd 1
5IF0OUBSJP-BC*OGPSNBUJPO4ZTUFN
0-*4
JTJODMVEFEJO&.34QFDJGJDBUJPO
4, and will be available in 2012. In addition, soon there will be ePrescribing
and a variety of ways to connect to
other physicians (e.g., eConsults and
eReferrals).
Connectivity to more hospitals, labs,
and physicians, is rapidly expanding.
To date, 56% of Ontario’s primary care
physicians are adopting EMRs. The
true benefits of sharing EMR patient
data throughout Ontario’s eHealth system are being realized.
t -JOLTFNSBEWJTPSDPNPOUBSJPNEDB
Q. Can I use flow sheets with an EMR?
A. The short answer is yes. Electronic
versions of paper flow sheets are usually displayed as tables, populated with
data from within the EMR (e.g., labs,
text, service dates, etc.). Many EMRs
have visit forms for the disorders we
usually follow on flow sheets (e.g., CHF,
diabetes, etc.), but rather than being
viewed side-to-side, as they are with
paper, they are displayed sequentially in
the same progress note. Other ways of
analyzing your information over time are
also available, and there are very powerful tools that you can use to engage
with your patients and aid in patient
education. These include graphing
functions, lab tables, and pictures.
26
Q. How can I optimize my preventive
care bonuses with an EMR?
A. In the early stages of EMR implementation it is difficult to optimize your
preventive care bonuses electronically
because you will not have sufficient
patient data within the system. You will
need to analyze the paper tracking sheet
supplied by the Ministry of Health and
Long-Term Care. However, as time goes
on, more and more clinical profiles will
be in place, patients will be receiving their
mammograms, flu shots, etc., tracking codes and exclusion codes will be
entered, and the accuracy of searches
for those who have not had the recommended services becomes ever greater.
After one full preventive care cycle
(two to three years after your EMR goes
live) you will have a very accurate picture of who has or has not received preventive care services. Then, by running
a simple search, you can target those
patients to receive the service needed
before the March 31 cut-off date.
Essentially, the task of analyzing your
roster becomes automated, proactive
management of your patients is possible, and your preventive care bonuses
can be optimized with greater ease.
To submit queries to “Ask the EMR Expert,”
email Dr. Darren Larsen at: communications
@ontariomd.com.
July/August 2011
11-07-06 12:39 PM
Take Advantage of the OMA’s affinity program.
Travel and Leisure
Fitness and Health
Moving and Relocation
Services
Medical Office
Communications
Car Lease and
Purchase
Wireless
Communications
OMA Advantages provides OMA members with special offers and
services to benefit your personal and professional life.
Please visit our website to learn more about this exclusive program.
www.oma.org/Advantages
AdvantagesAd201107_v4a.indd 1
11-06-22 9:09 AM
Education and Prevention Committee Interpretive Bulletin - Volume 9, No. 4
New Radiology Codes:
Second Opinion and After Hours Premiums
(Revised August 11, 2011)
INTRODUCTION
What is the Education and Prevention Committee (EPC)?
The Ministry of Health and Long-Term Care and the Ontario Medical Association (OMA) have jointly established the
Education and Prevention Committee (EPC). The EPC’s primary goal is to educate physicians about submitting OHIP
claims that accurately reflect the services provided and that are in compliance with the law.
What is an Interpretive Bulletin?
Interpretive Bulletins are prepared jointly by the Ministry and the OMA to provide general advice and guidance to physicians
on specific billing matters. They are provided for education and information purposes only, and express the Ministry’s and
OMA’s understanding of the law at the time of publication. The information provided in this Bulletin is based on the July 1,
2011, Schedule of Benefits – Physician Services (Schedule). While the OMA and Ministry make every effort to ensure that
this Bulletin is accurate, the Health Insurance Act (HIA) and Regulations are the only authority in this regard and should be
referred to by physicians. Changes in the statutes, regulations, or case law may affect the accuracy or currency of the information provided in this Bulletin. In the event of a discrepancy between this Bulletin and the HIA or its Regulations and/or
Schedule under the regulations, the text of the HIA, Regulations and/or Schedule prevail.
EPC Bulletins are available on the OMA website (http://www.oma.org/Resources/Pages/EPCbulletins.aspx). The Schedule
is available on the Ministry website (http://www.health.gov.on.ca/english/providers/program/ohip/sob/sob_mn.html).
Purpose
institution or facility are referred to a radiologist (“consultant
radiologist”) at a different institution or facility for his/her written interpretation.” Note: “institution” is intended to mean
a hospital/hospital corporation and “facility” is intended to
mean an Independent Health Facility (IHF) licensed under
the Independent Health Facilities Act.
The purpose of this Interpretive Bulletin is to provide physicians, particularly radiologists, with information on several
new fee codes introduced in the Schedule for interpretation
of diagnostic imaging studies. These new codes are intended
to assist physicians to improve patient care by reducing
repeat tests, reducing wait times, and facilitating quicker
treatment for patients. The new fee codes are for diagnostic
imaging second opinions for Computed Tomography (CT)
or Magnetic Resonance Imaging (MRI) studies (A330, A332,
C330 and C332), and after hours premiums for urgent interpretations of CTs and MRIs (E406, E407 and E408).
When an expert second opinion is medically necessary
(e.g., where there is some uncertainty about an important
diagnosis), a fee may be eligible for payment:
t 1SPWJEFEUIFTFDPOEJOUFSQSFUBUJPOPQJOJPOJTSFGFSSFEUP
a radiologist (the “consultant radiologist”) who is working
at a different hospital/hospital corporation or IHF than
where the images were made and first interpreted;
t 8IFOUIFTFDPOEPQJOJPOJTOPUCFJOHVTFEGPSDPNparison purposes with images made in the consultant
radiologist’s institution or facility;
Second opinion for CT or MRI studies
Second opinion for CT or MRI studies is defined on page
A119 of the Schedule as “the service rendered when CT or
MRI images made and interpreted by a radiologist at one
28
July/August 2011
t 8IFOUIFTUVEZJTGPSTQFDJGJFEBOBUPNJDBMSFHJPOTTFF
“Specified anatomical regions”); and
t 8IFOUIFNFEJDBMSFDPSESFRVJSFNFOUTBSFNFU
In this example, if Dr. A asks another radiologist working in
the same hospital, or at another physical site of the same
hospital corporation, no claim for a second opinion is eligible for payment.
Note: “study” refers to all images related to an anatomical
region.
Example 2
Dr. X, a neurosurgeon, has been referred a patient who
had a CT at a different hospital. Dr. X has a copy of the CT
images (and the interpretation from the radiologist at the
other hospital) on disk, and requests that Dr. R, a radiologist colleague at his hospital, reviews and interprets the CT
images. Is Dr. R eligible for payment of A330?
Specified anatomical regions
The anatomical regions are head, neck, thorax, abdomen,
breast, pelvis, extremities (one or more), and spine (one or
more segments).
Medical record requirements
A consultant radiologist’s claim for rendering a second
opinion is only eligible for payment if the patient’s permanent medical record contains both the written request from
the referring physician and the consultant radiologist’s second opinion report.
Yes, provided Dr. R interprets the images, provides a written report to Dr. X, and satisfies the medical record-keeping
requirements.
Second opinions are not eligible for payment:
New after hours premiums have been introduced for urgent
CT or MRI interpretations when rendered using PACS.
These premiums are applicable to urgent CT or MRI interpretations made during weekday evenings, nights, weekends and holidays (see chart on page 30 for specific days/
times). They are only eligible for payment when:
t 5IFSFGFSSJOHQIZTJDJBOPSNBYJMMPGBDJBMTVSHFPONBLFT
a request (which may be verbal or written or electronically transmitted) during an eligible period for an urgent
interpretation for an acute care hospital inpatient, an
emergency department patient, or a hospital Urgent
Care Clinic patient for whom the interpretation is required
for urgent management of the patient;
t 5IFJOUFSQSFUBUJPOJTEPOFVTJOH1"$4BOEEJBHOPTUJD
workstations and monitors consistent with current Digital
Imaging and Communications in Medicine (DICOM)
standards;
t 5IFQIZTJDJBOQSPWJEJOHUIFJOUFSQSFUBUJPOJTQIZTJDBMMZ
present in Ontario and at a location other than the hospital where the patient is receiving the CT or MRI;
t 5IFSFGFSSJOHQIZTJDJBOPSNBYJMMPGBDJBMTVSHFPOIBTQSJWJleges at the hospital where the service is provided;
t 5IFJOUFSQSFUJOHQIZTJDJBOIBTSBEJPMPHZQSJWJMFHFTBU
the hospital where the request for the service originates;
t 5IFJOUFSQSFUBUJPOJTUSBOTNJUUFEUPUIFSFGFSSJOHQIZTJcian/surgeon within three hours of the completion of the
CT/MRI study; and
t 5IFNFEJDBMSFDPSESFRVJSFNFOUTBSFNFU
After Hours Premiums – Urgent CT or MRI
Interpreted Remotely
t 5PBDPOTVMUBOUSBEJPMPHJTUJOUIFTBNFGBDJMJUZPSJOTUJUVtion (i.e. hospital/hospital corporation or IHF) where the
image was made;
t 8IFOUIFDPOTVMUBOUQIZTJDJBOJTVTJOHUIFJNBHFTGPS
comparison purposes; or
t 8IFOUIFNFEJDBMSFDPSESFRVJSFNFOUTBSFOPUNFU
How do I know which code to use?
For a non-emergency
C330 – CT second opinion study
hospital inpatient, use
C332 – MRI second opinion study
For all other patients, use
A330 – CT second opinion study
A332 – MRI second opinion study
For complete details please see page A119 of the Schedule.
Example 1
Dr. A has just received the interpretation of a CT of the head
for a patient who has come into the emergency room; however, he has some concerns and decides to seek another
opinion from Dr. B, a radiologist at another hospital, using
a written request. Dr. B records his interpretation into the
picture archiving and communication system (PACS) and
makes it available to Dr. A, who includes it in the patient’s
medical record along with his written request for the second
opinion. What fee code should Dr. B claim?
Dr. B is eligible for payment of A330.
29
July/August 2011
Interpretation includes the review of any relevant prior images that are available on PACS.
fied in the “Note” which begins in the left column, this page);
t 1"$4JTOPUVTFE
t 5IFJOUFSQSFUJOHSBEJPMPHJTUJTOPUQIZTJDBMMZQSFTFOUJO
Ontario;
t 5IFSFGFSSJOHQIZTJDJBOEPFTOPUIBWFQSJWJMFHFTBUUIF
hospital where the service is rendered;
t 5IFJOUFSQSFUJOHSBEJPMPHJTUEPFTOPUIBWFSBEJPMPHZQSJWJleges at the hospital where the request for the interpretation originates;
t 5IFJOUFSQSFUBUJPOJTOPUUSBOTNJUUFEXJUIJOUISFFIPVSTPG
completion of the CT/MRI study; or
t 8IFOUIFNFEJDBMSFDPSESFRVJSFNFOUTBSFOPUNFU
The premium applies when an urgent request is received,
and the interpretation is rendered and available to the referring physician within three hours of completion of the scan
and completed in an eligible time period.
Note: if an urgent request for interpretation comes before an
eligible after hours period, and interpretation cannot be provided before the eligible period begins due to factors beyond
the control of the interpreting physician (e.g., appropriate
protocoling for patient safety and medical reasons, delayed
access to the CT or MRI scanner due to other urgent patient
demands or technical equipment failure, radiologist performing urgent patient procedures, PACS retrieval system
temporarily down, temporary power outage), the premium
remains eligible for payment provided all other requirements
are also met (e.g., within three hours of completion, etc.).
Note: these fee codes are not eligible for payment with
special visit premiums (C102-C110) or CT/MRI second
opinions (A/C330 and A/C332).
The following chart illustrates the appropriate fee code and
the daily maximums per physician:
These premiums are not eligible for payment when the
transmission is delayed because of other personal or nonpatient care commitments, or intentionally delayed until an
eligible after-hours period begins.
Medical record requirements
For the premium to be eligible for payment, the patient’s
permanent medical record must contain:
t 5IFUJNFPGUIFVSHFOUSFRVFTUUIFUJNFUIFJNBHFTXFSF
obtained, and the time of the transmission of the interpretations; and
t "OFYQMBOBUJPOEFTDSJQUJPOPGVODPOUSPMMBCMFGBDUPSTJGUIF
images were obtained and the urgent request for interpretation came before an eligible after hours period, but
the interpretation was delayed to an eligible period. This
explanation should be noted either in the diagnostic report
or on the PACS as part of the patient’s medical record.
Fee Code
Maximum
Daily Claims
Eligible for
Payment
Maximum Daily
Claims for a
Patient
Monday to Friday
(evenings)
(1700 - midnight)
E406A
2
1
Saturday, Sunday
and holidays
(0700 - midnight)
E407A
6
1
Nights
(midnight - 0700)
E408A
Unlimited
1
See complete details on pages GP79-80 of the Schedule.
Examples
Example 1 – Evening
Dr. R is watching television at home on Monday evening
when he receives a call at 9:00 p.m. from Dr. E in the emergency department of the hospital where they both work.
Dr. E has received a patient who was involved in a motor
vehicle accident. Dr. E requires immediate interpretation of
the patient’s CT scan because the patient is deteriorating
and the results are required immediately in order to determine the course of treatment and prevent death or further
damage to the patient. Dr. R reads the images via PACS
and transmits the findings to Dr. E at 9:25 p.m. For what
payment is Dr. R eligible?
These medical record requirements apply to the premiums
and are in addition to those required for payment of the
claim for the CT or MRI interpretation.
These premiums are not eligible for payment if one or
more of the following apply:
t 5IFSFRVFTUJTOPUBOVSHFOUPOF
t 5IFJNBHFTXFSFPCUBJOFEBOEUIFSFRVFTUGPSJOUFSQSFUBtion comes prior to an eligible period (see exception speci-
ONTARIO
NTARIO M
REVIEW
MEDICAL
EDICAL
REVIEW
Eligible Period
30
1
July/August
April 2011
Dr. R is eligible for payment of the interpretation of
the appropriate CT scan(s) for the specified anatomical
region(s), as well as the premium for the urgent interpretation (E406).
No, primarily because these are elective studies which are
not eligible for these premiums.
Example 3 – Request prior to after hours period
With uncontrollable delay
Dr. R is at home and receives an urgent request at 4:30
p.m. on Friday for interpretation. He signs into the PACS
system and is just retrieving the file when the power in his
neighbourhood goes out. It is restored at 5:30 p.m., at
which time he reads the images and transmits the findings.
Is Dr. R eligible for payment of E406?
Example 2 – Weekend
Part 1
On Saturday mornings, Dr. R routinely interprets outpatient elective CT and MRI studies remotely by PACS. Is he
eligible for the E-prefix premium for up to six of those interpretations?
No, the premium is only eligible for payment when the
request to interpret is urgent from the referring physician and necessary in order to manage the urgent care
of the patient. If, however, during the time that he is
working remotely, an urgent request does come, he is
eligible for the premium for that specific interpretation
provided the other payment requirements are met (e.g.,
both physicians have hospital privileges at the hospital
where the request originates, interpretation is transmitted back within three hours, request and transmission
times are recorded on the patient’s medical record,
etc.).
Yes, provided he meets all of the other payment requirements, including documenting the reason for the delay in
transmission.
With other delay
Dr. R is at his son’s hockey game at 4:00 p.m. when an
urgent request comes and he is unable to interpret the
completed scans and transmit the interpretation until after
the game ends at 6:00 p.m.
Despite the interpretation and transmission occurring after
5:00 p.m. and within the required three hour period, that
service would not be eligible for payment of the premium
because the delay was not beyond the physician’s control.
In other words, the physician was not available to interpret
an urgent request because of another commitment, and the
result could have been provided sooner (prior to after hours),
had the physician been available when the request came.
Part 2
On Saturday mornings, Dr. R routinely interprets outpatient
elective studies at the hospital or facility. Is he eligible for
E407 or a C-prefix (C108, C106) premium for up to six of
those interpretations?
Your feedback is welcomed and appreciated!
The Education and Prevention Committee welcomes your feedback on the Bulletins in order to help ensure that
these are effective educational tools. If you have comments or questions on this Bulletin, or suggestions for future
Bulletin topics, etc., please submit them in writing to:
Physician Services Committee Secretariat, 150 Bloor Street West, 9th Floor, Toronto, Ontario M5S 3C1
Fax: 416.340.2961; Email: [email protected]
Dr. Jane MacNaughton, Co-Chair; Dr. Larry Patrick, Co-Chair
Education and Prevention Committee
The PSC Secretariat will anonymously forward all questions, comments or suggestions to the Co-Chairs of the EPC
for review and consideration.
For specific inquiries on Schedule interpretation, please submit your questions IN WRITING to:
Health Services Branch, Physician Schedule Inquiries
370 Select Drive, P.O. Box 168, Kingston, Ontario K7M 8T4
31
July/August 2011
OMA to co-host Canadian Conference on
Physician Health, October 28-29
The Ontario Medical Association,
together with the Canadian Medical
Association and the Canadian Medical
Foundation, invites physicians to attend
the 2nd Canadian Conference on
Physician Health, to be held October
28-29 at the Hilton Toronto Hotel.
The theme for the event is “Healthier
Doctors = Healthier Communities.”
Participants will take part in two days
of interactive workshops, group discussions and skills development.
Key areas of focus will include:
t )PXEJGGFSFOUUZQFTPGDPNNVOJties enable and constrain physician
health.
t )PXJNQSPWFNFOUTJOQIZTJDJBO
health impact different physician
communities.
JulyAug11_physician_health_conference_p32.indd 1
t "DRVJTJUJPOPGUIFLOPXMFEHFBOE
skills needed to help a physician colleague.
t % F W F M P Q N F O U P G T U S B U F H J F T U P
enhance physician/trainee wellness
in the academic setting.
t %FWFMPQNFOUPGQFSTPOBMQMBOTGPS
improved health and well-being.
Keynote speakers include Dr. Brian
Goldman, host of CBC Radio’s “White
Coat, Black Art,” who will discuss
his personal experiences and those
of physicians and nurses who have
appeared on his program; and Dr.
Roberta Bondar, Canada’s first female
astronaut, who will provide insights
on organizational culture and group
dynamics.
Workshop sessions will cover more
32
than a dozen topics, ranging from coping with medicolegal stress to nutrition
for the busy physician and “caring for a
colleague.”
Delegates may choose to attend an
evening social event and performance
by renowned Canadian artist Dan Hill.
'PSBEEJUJPOBMJOGPSNBUJPOPSRVFTtions about the conference, email:
[email protected].
Registration details are available
from the CMA Centre for Physician
Health and Well-Being at: http://www.
cma.ca/2011canadianconference.
Please note: the conference will
be followed by a workshop from
the CMA’s Physician Management
Institute on self-awareness and effective leadership.
July/August 2011
11-07-12 4:22 PM
Good Health Matters
BECAUSE YOUR FAMILY NEEDS YOU
The OMA Physician Health Program is a
problems ranging from stress, burnout, emotional
confidential service for physicians, residents,
or family issues, through to substance abuse and
medical students and their family members.
psychiatric illness.
Our caring, helpful, health-care professionals offer
Confidential Toll-Free Line 1.800.851.6606
assistance to those who may be experiencing
php.oma.org
Trillium Gift of Life Network launches
“BeADonor.ca”
new online process facilitates consent for organ and
tissue donation
HE TRILLIUM GIFT OF LIFE NETWORK, IN PARTNERSHIP WITH THE MINISTRY OF HEALTH AND LONG-TERM CARE
T
AND SERVICEONTARIO, HAS LAUNCHED ONLINE DONOR REGISTRATION VIA “BEADONOR.CA.”
For the first time, Ontarians can register
their consent to organ and tissue donation quickly and conveniently from their
computer.
By making registration easy and
accessible, the Trillium Gift of Life
Network hopes to encourage Ontarians
who have not yet registered — either
because it wasn’t convenient, or they
didn’t know how — to take that step
and make it official.
Organ and tissue donation in Ontario
Currently in Ontario, there are 1,500
people waiting for an organ transplant,
and every three days one of these people will die because the call didn’t come
in time.
These are patients who may have
been on dialysis for years, or children
waiting for lungs so they can breathe on
their own — people who have no hope
beyond the generosity and kindness of
a stranger.
Every registered donor has the
potential to save up to eight lives
through organ donation, and enhance
the lives of 75 others through tissue donation, but only 19% of eligible
Ontarians are currently registered.
Everyone is a potential donor. To
date, the oldest Canadian organ donor
was over 90 years of age, while the oldest tissue donor was 102.
REVISED_July/Aug11_gift_life_p34.indd 1
“Now that registration has become
more convenient, we’ll be working
closely with the health-care community
to spread the word about the importance of registration,” he said.
“Getting more Ontarians registered
as organ and tissue donors is critically
important to prevent needless deaths
on the waiting list, and to cut the wait
time for patients in need of a transplant,” said Dr. Frank Markel, President
and CEO of Trillium Gift of Life Network.
“By increasing the number of Ontarians
who are registered donors, we can
save and enhance more lives.”
When someone registers consent to donate, the donation decision
is recorded and stored in a Ministry of
Health and Long-Term Care database
so that it can be made available at the
right time.
With evidence of a loved one’s registered consent, almost all families consent to donation. Without that evidence,
families consent only 50% of the time.
Registering consent saves lives.
“Our health-care partners have great
influence in this province, and we are
asking them to lead by example by registering and encouraging their peers to
register,” said Dr. Markel.
Covered by most
provincial formularies*
*See respective Formularies for details
(not covered in BC, AB, PEI).
34
Three ways to register consent
Many people mistakenly believe they
are registered, especially if they have
carried a signed donor card in their wallet. The traditional donor card pre-dates
Ontario’s registry, so a signed donor
card — while still valid — does not
mean an individual is registered, and it
may not be available when the information is needed.
With the addition of online registration, there are now three ways to
register consent for organ and tissue
donation in Ontario: via BeADonor.ca,
in person at a ServiceOntario centre,
or by mailing a completed Gift of Life
consent form.
For more information on organ and
tissue donation, please visit: www.
giftoflife.on.ca, or BeADonor.ca.
Pr
© 2011 Pfizer Canada Inc. Kirkland, Quebec
H9J 2M5
CADUET® C.P. Pharmaceuticals International
C.V. owner/ Pfizer Canada Inc., Licensee
TM
Pfizer Inc., owner/
Pfizer Canada Inc., Licensee
July/August 2011
11-07-08 12:02 PM
OMA Congratulates Ontario’s
New Medical Graduates!
The Ontario Medical Association would like to congratulate the 2011 medical graduates. On behalf of all physicians
across the province we would like to acknowledge your achievements and your commitment to the future of patient
care. We wish you well in your training as medical residents, and be mindful that the OMA has a support system in
place to ensure your continued success.
The OMA would like to thank each of the Ontario medical schools for their continual co-operation and contributions
to medical learning. Thank you to McMaster University, Northern Ontario School of Medicine, Queen’s University, The
University of Ottawa, The University of Toronto and The University of Western Ontario. Hard work and determination
has created increased medical training spots on satellite campuses contributing to an increase in residency positions,
helping to ensure our medical graduates have the opportunity to stay within Ontario.
The OMA would also like to thank those individuals, organizations and corporations who have donated so generously
to the Ontario Medical Student Bursary Fund. Your donations help to ensure equality and diversity within the medical
profession.
Dr. Stewart Kennedy
President, Ontario Medical Association
McMaster University
Emily Loving Aaronson
Ifrah Abdirahman
Dina Aboutouk
Tuba Aksoy
Manreet Alangh
Kinda Aljassem
Lindsay Alston
Marina Aptekman
Tarin Romi Arenson
Jeffrey Charles Bacher
Manpartap Bal
Taha Bandukwala
Robert Roch Baraniecki
Rebecca Jean Barnes
Simran Singh Basi
Natallia Beilhartz
Paul Victor Benassi
Leora Bernstein
Susan Maria Borden
Atif Rasul Butt
Cailin Campbell
Daniel Alexandre Carle
Alice Chan
Jeffrey Chan
Joan Mackenzie Chan
Natalie Hoi-Man Chan
Tiffany Chan
Harman Chaudhry
Jeyla Xiao Meng Chen
July_Aug11_Grad_Listing_pp35-39.indd 1
Melissa Yarr Wern Chin
Jacqueline Wing-Chow
Caroline Correia
Allison Marie Crombeen
Lauren Marie Davies
Lauren Marie den Boer
Gillian Sabrina Dharmai
Angie Karoline Dion
Jessica Laura Dobyns
Naheed Dosani
Andrew Scott Douglas
Jenna Katherine Dowhaniuk
Ismail Kamal El-Salfiti
Lyndsay Rein Evans
Adam Thomas Exley
Noah Farber
Nisha Maria Fernandes
Jonathan Frederick Fiddler
K. Alanna Fitzgerald-Husek
Molly Forrester
Paul Ross Gallupe
Jaclyn Christina Gilbert
Mandeep Gill
Natasha Kaur Gill
Alanna Jennifer Golden
Alexandrea Kathryn Gow
Jacqueline Green
Kathleen Margaret Gregory-Miller
Nadia Griller
Rachelle Leigh Grossman
Mariam Guirguis
Emma Clare Hapke
Melanie Joy Henry
David Allan Heywood
Katelyn Dawn Hoenselaar
Oliver Edwin Holmes
Ilana Sarah Horvath
Joanne Margaret Howey
Kathleen Barbara Huth
Anusha Jahagirdar
Rahul Jain
Rebecca Ann Jarvis
Henry Yi Jiang
Jennifer Lynne Jones
Paul Jones
Edward Eric Joy
Brittany Bernadette Julian
Han Sol Kang
Pamela Imuat Kapend
Sadia Karim
Miriam Leah Katzman
Tarek Kazem
Christine Keng
Diana Khalil
James Shiraz Khan
Sheila Klassen
Shawn Ian Klein
Martin Korzeniowski
Marcin Kowalczuk
Regine Jeanette Krechowicz
35
Anil Kurian
Martin Troy Kuuskne
Morgan Margaret Kwiatkoski
Carolyn Siu Wuan Lai
Holly Lam
Leslie Rae Lappalainen
Britta Camilla Laslo
Joseph Lee
Katy Yi-Ting Li
Yu Kit Li
Helena Liu
Rebecca Lobo
Lucy Xi Lu
Nathan Scott Ludwig
Jorin John Lukings
Jonathan David Marhong
Michelle Marlborough
Nicholas Francis Matlovich
Luigi Matteliano
Afsheen Mazhar
Leanne Michelle McAuley
Lindsay Marie McAuley
Aimee Lydia May McMillan
Chase Everett McMurren
Lindsay Melvin
Aleksander Jakob Meret
Hira Mian
Hana Mijovic
Jie Min
Jonah Be-Dah-Mizzau
July/August 2011
11-07-06 9:35 AM
2011 Ontario Medical Graduates
Anne Margaret Moffatt
Philip Mok
Amy Angela Montour
Christopher Morris
Raman Mundi
Nancy Nashid
Christine Premila O’Connor
Timothy James Oliveira
Lauren Grace O’Malley
Richard Oosthuizen
Donika Orlich
Serena Laura Orr
Leighanne Parkes
Elena Parvez
Nivedita Patel
Jeffrey Ian Pelchovitz
Gihan Christopher Perera
Stephen Michael Petis
Sen Han Phang
Eugenia Poon
Jennifer Rachel Pope
Mohammad Qadura
Ananya Raghavan
Azadeh Nikoo Rajaee
Praveen Keshava Rayar
Lauren Shoshana Reich
Christopher Richards-Bentley
Carrie Rosevear
Luke Anthony Russell
Juan Jose Russo
Jennifer Elizabeth Rycroft
Sarah Saliba
May Sara Sanaee
Maxwell Sauder
Ilya Shoimer
Rebecca Anne Skillen
Emma Kathleen Smith
Elizabeth Catherine Stanford
Tanya Stone
Mandy Man Yin Tam
Lih Yeen Tan
Michelle Bianca Thielmann
Karen Thomas
Jennifer May Thompson
Samantha Justine Trojan
Vanessa Lynn Versteeg
Robin Christina Visser
Joshua Wald
Joshua Ian Wales
Karen Kar Wai Wang
Casandra Wendzich
Jennifer Wesley
Evelyn Ming Ming Wong
Ya Chun Alyssa Wong
Jane Zhen Zhen Wu
Lin Yang
Brian Yau
Maria Yorke
Ryan Shange Yu
Yeyao Yu
Kim Zhou
Rachael Yvonne Sheppard
Kristie Jayne Skunta
Arianne Loraine St. Jacques
Katherine Elizabeth Stuart
Jason Scott Sutherland
David Vaillancourt
Tyler Paul Verdun
Candice Walton
Sheryl Catherine Wark
Kevin Scott Warwick
Travis Gordon Webster
Megan Lee Wickett
Kendra Lauren Wilkins
Kristine Frances Woodley
Jennifer Ann Zymantas
Northern Ontario School of
Medicine
Olubukunola Ayeni
Amber Antanina Parrish Bacenas
Roxanne Lucienne Baril
Sara Emmanuelle Marie Belanger
Sheena Rose-Meline Belisle
Lynn Patricia Boissonnault
Emilie Gingras Bourgeault
Melanie Adriana Buba
Laura Katherine Burke
Kathleen Anne Carten
Lindsay Rebecca Churchley
Elizabeth Francine Cooper
Sophie Lynne Corriveau
Jade Brittany Rita Coyne
Melissa Anne Crawford
Kyle James Gerald Cullingham
Lisa Nichole Currie
Dustin Jonathan Curts
Michael Joseph DiMeo
Meagan Ruth Doyle
Carla Dawn Marie Dubois
Ashley Lynn Dyson
Stacey Devonia Christina Erven
Pamela Gail Felhaber
Lindsey Katrina Forest
Penny Lee Forth
Meghan Elizabeth Garnett
Kim Christine Génier
Erin Leanne Dawn Graham
Marlon Luke Hagerty
David James Harris
Leona Natalie Johnson
Kristen Marie Kannegiesser
AnnaMaria Teresa Laakso
Michael Douglas Long
Jennifer Jo-anne McPhail
Paul Jean-Guy Miron
Andrea Felicia Mousseau
Richard Peter Nadeau
Mary Ellen Kathleen Olsten
Peter Jonathan Howard William Pace
Ian Paquette
Kiersten Jane Parr
Mélanie Monique Savignac
University of Ottawa
Vanessa Abdelhalim
Karim Abdulla
Omolayomi Akinremi
Hafsah Al-azem
Saif Al-mousawy
Julie-Eve Arseneault
Asif Ashraf
Adrienne Bacher
Lauren Badalato
Kristy Bailey
Catherine Barrett
Daniel Beamish
Vanessa Beaudoin
Joseph Bertucci
Bietel Bockretsion
Majdi Boulos
Matthew Boyle
Stéphane Brassard
Kaighley Brett
Pinella Buongiorno
Adrian Carpenter
Benjamin-Benoit Carrier
Brianne Castonguay
Joseph Catapano
Valérie Charbonneau
Tarek Chbat
Aneesh Chhabra
Emily Chiasson
Scott Chubbs
Megan Cooney
Karen Cozens
Tiffany Czilli
Stefan de Laplante
Zoe Del Bel Belluz
Varun Dev
Sebastian Dewhirst
Ugo Dodd
36
Eshay Elia
Amal Elsohemy
Joel Emery
John Esposito
Nadia Fairbairn
Amaryllis Ferrand
Chantal Ferré
Alexander Ferreira
Paul Frankish
Nicole Freeman
Julia Frei
Chantal Gallant
Geneviève Gavigan
Mireille Gharib
Pier Glaude
Salini Gopalapillai
Abigail Gradinger
Samantha Green
Amy Groom
Mélissa Guindon
Katherine Gushulak
Spencer Gutcher
Irene Ha
Lisette Haddad
Devin Hall
Carly Hansen
Dean Hansenberger
Jennifer Harrington
Jasmine Hasselback
Taryn Hodgdon
Darryl Hoffer
Husna Husainy
Marcus Jansen
Ijab Khanafer
Christopher Kim
Kathryn Kipp
Sari Kraft
Nadine Kronfli
Jessica Laks
Kayla Lam
Leslie Lamb
Alicia Lamey
Roxanne Leblanc
Julie Lebouthillier
Emily Leclair
Lise Legault
Bryan Lemenchick
Annie Levesque
Dana Levit
Amanda Loewy
Amanda Lohnes
Janice Lui
Amar Madhvani
Jacqueline Malette
July/August 2011
11-07-06 9:35 AM
Marlène Mansour
Kelly Mascioli
Adela Matejcek
Daniel McKee
Daniel Milner
Dominique Miron
Craig Mitchell
Shawn Mondoux
Timothy Moran
Sandra Naaman
Betty Ng
Michael O’Brien
Alex Omiccioli
Melissa Palardy
Edward Park
Sam Park
Siavash Piran
Elena Poliakova
Kim Pronovost
Carly Pulkkinen
Jin Qian
Marat Rafikov
Dominic Richer
Brandon Ritcey
Luis Rivero Lopez
Carly Rogenstein
Marc Roy
Vladimir Ruzhynsky
Hatem Salim
Brian Schick
Jesse Schwartz
Jessica Seibel
Michael Shaytzag
Alison Shea
Christopher Sheasgreen
Alex Shen
Nabha Shetty
Amritpal Singh
Pui Sze So
Tatiana Sotindjo
Joanna Stanisz
Melanie Strike
Albert Swedani
Marjolaine Talbot-Lemaire
Stephanie Tatzel
John Tavares
Siobhan Telfer
Neil Thomas
Margaret Thomson
Hadi Toeg
Michael Trevail
Krystal van den Heuvel
Caitlin Wade
Rebecca Wallace
Jennifer Watt
Erin Weersink
Jennifer Wilson
Kelly Wilton
Benson Wong
Jordan Wronzberg
Wendy Zhang
Jonathan Wei-Ming Lau
Jonathan Cheesum Lau
Brenda Hiu Yan Law
Kevin Matthew Yen Bing Leung
Helen Marga Emma Levin
Adrienne Louise Kit Li
Jessica Siu Hwa Liauw
Christopher Andrew Lusty
Adiel Eusebiu Mamut
Patrick John Mcgarry
Rohit Mohindra
Carla Rae Murphy
Christopher Newcombe
Jennifer Kar-Yan Ng
Laura Nancy Thuy Uyen Nguyen
Shuoyan Ning
Christopher Noss
Christina Mau Nowik
Lori-Anne Noyahr
Pavlo Ohorodnyk
Baldeep Paul
Sharon Peacock
Melissa Anne Pickles
Andra Diana Popescu
Jessica Quan
Francisco Daniel Ramirez
Nicole Ann Rocca
Nicholas Romatowski
Kathryn Lynn Rutherford
Jakub Tomasz Sawicki
Alice Schabas
Morgan Anne Schellenberg
Melissa Lynn Sheldrick
Vivek Singh
Brian Siu
David Ellis Skogstad-Stubbs
Kirsten Smerdon
Amrita Kaur Sukhi
Michael Surkont
Samantha Tam
Alan Ka Ho Tam
Ephraim Shin-Tian Tang
Kelli Thomas
Yi man Eva To
Derek Siu Chung Tsang
Kaitlyn Turnbull
Matthew Ronald Twiddy
Paul Gilbert Uy
Amelie Gabrielle Waldin
Bradley Douglas Walker
Yong-Li Zhang
Erik Zufelt
Queen’s University
Daniel Abramowitz
Fiona Mary Aiston
Howard An
Jacqueline Anand
Sarah Elizabeth Appleton
Aditi Samantha Arora
Arundip Asaduzzaman
Amandev Kaur Aulakh
Emily Beth Austin
Ehtesham Baig
Femi Bammeke
Colin Robert Bell
Cassandre Elie Benay
Bradly Joseph Biagioni
Jessica Danielle Bogach
Jessica Ashley Bosse
Charilaos Harry Brastianos
Ashley Rebecca Brissette
Julia Lorraine Cameron-Vendrig
Salina Yuen Zun Chan
Nathaniel Abram Charach
Edward Man-Tsun Cheung
Aisling Anne Clancy
Kenneth mark Collins
Artyem Dantzig
Meredith Clare Davidson
Alexander Dibrov
Amaka Ann Eneh
Maurice Anthony Ennis
Cary Fan
Kristen Alyssa Farn
Daniel Frank Finnigan
Cedric Sebastian Gabilondo
Brandon Larry Girardi
Allen Gabriel Greenwald
Adam Thomas Gruszczynski
Sandra Guirguis
Meiqi Guo
Paul Hertz
Daniel Douglas Holloway
Naim George Jada
Parambir Singh Keila
Janeva Kircher
Karmen Michael Krol
Laura Renee Lachance
37
University of Toronto
Tarek Abdelhalim
Tara Nisanne Adirim
Payal Agarwal
Sara Roxanne Ahmed
Shubarna Amin
Nisha Andany
Kathleen Armstrong
Trevor Thor Arnason
Michele Leigh Askew
Mina Atia
Ryan Edward Austin
Bharat Bahl
Paul Christopher Barnfield
Samir Bidnur
Emily Rachel Plewik Brecher
Diana Britch
Andrew D. Brown
Derek Wesley Bryant
Aaron James Campigotto
Shuo Chen
Yingming Amy Chen
Alex Won-Pang Cheng
Frederick Hong Tai Cheng
Helen Man-Ching Cheung
Victoria Cheung
Derek Chew
Hannah Hiu-Yan Chiu
Robert Cecil Dat-Yen Cho
Romy Cho
Andrew Chou
Robert Victor Ciccarelli
Nicole Adrienne Coles
Katherine Connolly
Heathcliff Pierson D’Sa
Samer Dabbo
Lopamudra Das
Mark Davis
Heidi Lauren Deboer
Jason Glade Arbon Devlin
Phedias Diamandis
Annie Mai Thu Doan
Jenna Lynn Doig
Frederick Fung Tik Dong
Stanislav Dukhovny
Peter Michael Dziak
Hayley Brooke Eisenberg
Maryam Elmi
Sarah Ellen Erdman
David Evans
Doreen Ezeife
Christopher Miguel Farlinger
Zachary Hilel Feilchenfeld
Christopher Franco
July/August 2011
11-07-06 9:35 AM
Tym Frank
Erika Jocelyn Frasca
Colleen Meghan Fuller
Jennifer Galle
Alaina Garbens
Keely Elise McMillan Johnston Giles
Roopan Kaur Gill
Adam Gladwish
Yehoshua Gleicher
Neil M Goldenberg
Jessica Ashleigh Green
Joshua Allon Greenberg
Claire Margaret Harrigan
Lara Hart
Aasim Hasany
Lowell Morgan Henriques
Valerie Melissa Hertzog
Michael James Hill
Jacqueline Leah Holiff
David Homuth
Taulee Hsieh
Alexander Francis Huang
Sarah Christina Hugh
Jeanne Zhen Huo
Kathryn Isaac
Peter Juro Jaksa
Claudine Gerrilyn James
Denise Wendy Jaworsky
Lorraine Frances Jensen
Imran Jivraj
Christopher Kandel
Faazil Kassam
Douglas Gordon Kavanagh
Christopher Kitamura
Oxana Kolenchenko
Natalie Katherine Kozij
Yonah Krakowsky
Michelle Lauren Kraus
Anil Kuchinad
Mark Christopher Kuprowski
Nafisha Lalani
Kay K Lam
Michelle Christina Lam
Pamela Lau
Kim T Le
Vu Hoan Le
Cheryl Tse-yan Lee
Hubert Lee
Monica Ka Yi Li
Matthew Ryan Lincoln
Gillian Michelle Lindzon
Shiying Liu
Venetia Lo
Melissa Shu Fen Loh
Donald Le Ly
Karla Caroline Owen Maag
Heather Margaret MacKenzie
Lindsay Diane MacKenzie
Seyed Alireza Mansouri
Rachel Zoe De Koven Markin
Allan Russell Martin
MoniqueMartin
Alicia Mattia
Kelly Elizabeth McGowan
Anya Therese McLaren
Ariel Rachelle Mendlowitz
Ines Barbara Menjak
Rebecca Joanne Zoe Menzies
Maike-Svenja Milkereit
Mark William Miller
Kelly Louise Mollon
Ingrid Morgan
Carly Morin
Katherine Muir
Farheen Mussani
Dorotea Mutabdzic
Jennifer Maria Nelli
Elena Irina Nica
Melanie Lauren Ostreicher
Modupe Tolunimi Oyewumi
Ryan Christopher Pallett
Sylvia Papp
Ryan James Patchett-Marble
Amandeep Pooni
Rajini Bertha Potechin
Elena Qirjazi
Kate Correll Quirt
Jayant Ramakrishna
Meera Ramani
Gregory C Rampersad
Babak Rashidi
Tara Rastgardani
Elissa Danielle Rennert-May
Abhitej Rewari
Rebecca Rich
Michael Romano
Jonathan Rosenberg
Daniel Marc Rosenfield
Tamar Rubin
Erin Elizabeth Ryan
Sharon Arnavaz Sadry
Deborah Penelope Sasges
John Thomas Sauve
Neville Andrew Nicholas Schepmyer
Caroline Scott
Courtney Anne Scott
Dan Segal
Reema Shah
Rupal Shah
Adil Shamji
Julia Renee Sharp
Jennifer Shea
Brandon Samuel Sheffield
Kevin Daniel Shore
Andrea N. Simpson
Emily Cheryl Yuen-Yee Siu
Vithika Sivabalasundaram
Anthony C.L. So
Craig David Speziali
Aaron Gregory Storm St-Laurent
Rosanne Maria St. Bernard
Cole Christopher Stanley
Cameron Chambers Starratt
Benjamin Ethan Steinberg
David Sussman
Ainsley Mary Sutherland
Peter Szasz
Nigel Shih-Yen Tan
Kara Elizabeth TenHoeve
Aleida Alexandra ter Kuile
Dimitry Terterov
Jenna Marie Tessolini
Julie Gabrielle Thorne
Vehniah Tjong
Christopher Shi-Jie Tran
Sarah Madeleine Troster
Pamela Lih-Pin Tsao
Hubert Brian Young Tsui
Devon William Leonard Turner
Mitchell Vainberg
Alon Vaisman
Christian Balthasar van der Pol
Stephen Christopher Van Gaal
Stephanie Dawn VandenBerg
Daniel Vilensky
Kristin Marie Wadsworth
Michael Wang
Michael Ward
Marie Laura Wegener
Melinda Ann White
Karen-Rose Wilson
Meredith Kathryn Winning
Jonathan Derek Witt
Margaret Wolfe-Wylie
Jesse Isaac Wolfstadt
Bertha Wong
Jacqueline Khet-Ling Wong
Lianne Catherine Wong
Steven Cheong Wai Wong
Nathalie Wong-Chong
Diana Dan Wu
Neng Nancy Xi
38
Hanmu Yan
Teng-Chih Yang
Elizabeth Yeboah
Jorga Zabojova
Susanna Zachara-Szczakowski
Rebecca Zener
Ryan David Zufelt
University of Western Ontario
Amna Ahmed
Abdullah Alabousi
Aiman Alak
Natasha Aleksova
Christopher Appleton
Akram Arab
Kyle Richard Armstrong
Jenna Lee Ashkanase
Michael James Ballantine
Amina Benlamri
Dax Biondi
Ken Blonde
Samantha Boshart
Emily Brennan
Ashley Elizabeth M Brown
Daniel James Patrick Burns
Sydney Card
Kyle Carter
Trevor Champagne
Ishvinder Chattha
Eileen Cheung
Lydia Yee-Chin Cheung
Thomas Cheung
Winsion Chow
Rita Jo-Yun Chuang
Eric William Clendinning
Kimberley Colangelo
Derek Cool
Gina Corrigan
Michael Craig
Natalie Ann Cram
Julia Chepkogei Creider
Matthew Jon Cruickshank
Michael Evan Czerwinski
Elise Dalton
Gregory Devet
David Diodati
Magbule Doko
Sean T. Doran
Christopher Todd Dowding
Jason James Essue
Jaroslav Christopher Fabian
David Cyril Fahmy
Mina Fereidouni
Allison Foran
July/August 2011
11-07-06 9:35 AM
Reta French
Alexandra Marie George
Angela Ajit George
Sarah Gimbel
Stephanie Lynn Go
Elizabeth Golesic
Marcus Gostelow
William Gott
David Aaron Gurau
Jeff Hawel
Evan Head
Valerie June Hill
Morgan Hillier
Laura Elizabeth Hinz
Julia Helene Hollett
Andrew Hudson
Amanda Mary Jasudavisius
Fareen Karachiwalla
Carol King
Abhijat Kitchlu
Mackenzie Jean Klages
Eva Knifed
Sarah Knowles
Jennifer Hoi Yan Kong
Vandana Kumari
Courtney Lynn Laing
Cindy Tze-Yung Lam
Jennifer Lam
Paul Lau
Christopher Lee
Edwin Lee
Lauren Anne Lessard
Yu Li
Yahui Tammy Lin
Michael Hobbs Livingston
Emma Margaret Kathle Love
Alexander Joseph Wie Lyttle
Kelly Ashley MacDonald
Amin Madani
Anthony Main
Mary Emily Rose Marcotte
Ashley Nicole McCann
Greig Lyon McCreery
Amy Eleanor McCulloch
Danny Mendelsohn
Kevin John Mitchell
Bradley Stewart Moffat
Pasquale Montaleone
Jacqueline Moreno
Christina Nicole Morgan
Kayvan Nateghifard
Marian Neelamkavil
Carly Joyce Ng
Mark Andrew Nyland
Heather Ann Osborn
Kedar Patil
Ryan Paul
Vanessa Percy
Jacqueline Rose Piggott
Nitasha Puri
Amandeep Rai
Elizabeth Anne Randle
Rebecca Verna Rappaport
Janelle Rekman
Bradley William Rowe
Joel Thomas Runk
Adam Isaac Samosh
Megan Schenke
Michael Bruce Secter
Natashia Martina Seemann
Augene Seong
Audra Lynn Smallfield
John Wilkinson Snelgrove
Scott Shaw Somerville
Leslie Anne Stephens
Paula Suffoletta
Vidya Sujana Kumar
Jacqueline Swan
Frank Peter Symons
Michel Andre Taylor
Sarah Frances Thompson
Daniel Toguri
Lap Kei Connie Tung
Benjamin Thomas Turner
Patricia Uniac
Matthew Valdis
Aurelia Valiulis
Qi Wang
Yifei Wang
Laura Catherine Wheaton
Andrew Williams
Deborah Joanne Wong
Kristi S Wood
Wang Xi
Gary Lloyd Ka Tao Yau
Jeffrey Chiyoong Yeung
Jeffrey Yao Chiun Yu
Stephen Joshua Zborovski
Caleb Solomon Grant Zelenietz
CORPORATE HOTEL DIRECTORY
OMA opens the door to
hotel discounts
As a service to its members, the OMA has obtained discount rates for hotels throughout
Metro Toronto and regions across the province. The directory is available on OMA WebLink
(www.oma.org/member) under “Member Discounts.”
If you have any questions, please contact:
OMA Conference Planning
Tel. 416.599.2580, or 1.800.268.7215, ext. 3461
39
July/August 2011
11-07-06 9:35 AM
In need of
medical-legal
advice?
OMA Legal Services can provide advice to members on
the following issues relating to practice:
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TUSVDUVSFT
Inquiries should be directed to OMA Legal Services:
Jim Simpson
Tel. 416.340.2940 or 1.800.268.7215, ext. 2940
PRISTIQ is indicated for the symptomatic relief of major depressive
disorder. The short-term efficacy of PRISTIQ (desvenlafaxine
succinate extended-release tablets) has been demonstrated in
placebo-controlled trials of up to 8 weeks.
The most commonly observed adverse events associated with the
use of PRISTIQ (at an incidence *5% and at least twice the rate
of placebo) were nausea (22%), dizziness (13%), hyperhidrosis
(10%), constipation (9%), and decreased appetite (5%).
PRISTIQ is not indicated for use in children under the age of 18.
PRISTIQ is contraindicated in patients taking monoamine oxidase
inhibitors (MAOIs), including linezolid, an antibiotic, methylene blue,
a dye used in certain surgeries, or in patients who have taken MAOIs
within the preceding 14 days due to risk of serious, sometimes fatal,
drug interactions with selective serotonin reuptake inhibitor (SSRI) or
serotonin norepinephrine reuptake inhibitor (SNRI) treatment or with
other serotonergic drugs. These interactions have been associated
with symptoms that include tremor, myoclonus, diaphoresis, nausea,
vomiting, flushing, dizziness, hyperthermia with features resembling
neuroleptic malignant syndrome, seizures, rigidity, autonomic
instability with possible rapid fluctuations of vital signs, and mental
status changes that include extreme agitation progressing to delirium
and coma. Based on the half-life of desvenlafaxine succinate, at least
7 days should be allowed after stopping desvenlafaxine succinate
and before starting an MAOI.
PRISTIQ is contraindicated in patients demonstrating
hypersensitivity to desvenlafaxine succinate extended release,
venlafaxine hydrochloride or to any excipients in the desvenlafaxine
formulation. Concomitant use of PRISTIQ with products containing
venlafaxine is not recommended.
Recent analyses of placebo-controlled clinical trial safety
databases from selective serotonin reuptake inhibitors (SSRIs)
and other newer antidepressants suggest that use of these
drugs in patients under the age of 18 may be associated with
behavioural and emotional changes, including an increased risk
of suicide ideation and behaviour over that of placebo.
The small denominators in the clinical trial database, as well as
the variability in placebo rates, preclude reliable conclusions on
the relative safety profiles among the drugs in the class. There
are clinical trial and post-marketing reports with SSRIs and
other newer antidepressants, in both pediatrics and adults, of
severe agitation-type events that include: akathisia, agitation,
disinhibition, emotional lability, hostility, aggression and
depersonalization. In some cases, the events occurred within
several weeks of starting treatment.
Rigorous clinical monitoring for suicide ideation or other
indicators of potential for suicide behaviour is advised
in patients of all ages, especially when initiating therapy
or during any change in dose or dosage regimen.
This includes monitoring for agitation-type emotional and
behavioural changes.
Patients currently taking PRISTIQ should NOT be discontinued
abruptly, due to risk of discontinuation symptoms. At the time
that a medical decision is made to discontinue an SSRI or other
newer antidepressant drug, a gradual reduction in the dose,
rather than an abrupt cessation is recommended.
Reference: 1. Pfizer Canada Inc. PRISTIQ Product Monograph, November 2010.
Product Monograph available upon request.
Robert Lee
Tel. 416.340.2934 or 1.800.268.7215, ext. 2934
PRISTIQ® Wyeth LLC, owner /
Pfizer Canada Inc., Licensee
TM Pfizer Inc., used under license
© 2011 Pfizer Canada Inc.
Kirkland, Quebec H9J 2M5
Adam Farber
Tel. 416.340.2894 or 1.800.268.7215, ext. 2894
Jennifer Gold
Tel. 416.340.2889 or 1.800.268.7215, ext. 2889
July/Aug11_PRISTIQ_1/3P+legal_p40.indd 1
40
11-07-11 12:32 PM
FEATURE
Ontario Medical Student Bursary Fund
Charity Golf Tourney raises $160,000:
more than 180 donors tee off at Angus Glen
by Shannon Fitzpatrick
Ontario Medical Student Bursary Fund
HE 7TH ANNUAL ONTARIO MEDICAL STUDENT BURSARY FUND (OMSBF) CHARITY GOLF TOURNAMENT WAS
T
A RESOUNDING SUCCESS, GENERATING IN EXCESS OF $160,000 IN REVENUE. MORE THAN 180 PHYSICIANS,
MEDICAL STUDENTS, AND CORPORATE DONORS ATTENDED THE JUNE 17 FUNDRAISER, HELD AT THE PRESTIGIOUS ANGUS GLEN GOLF CLUB IN MARKHAM. AS WITH PAST TOURNAMENTS, ALL PROCEEDS WILL BE DIRECTED
TOWARD FINANCIALLY ELIGIBLE ONTARIO MEDICAL STUDENTS IN THE FORM OF NON-REPAYABLE BURSARIES.
Several OMSBF and OMA staff, as well
as medical student volunteers, were
on hand to greet participants as they
arrived for the 7:45 a.m. shotgun start.
Before hitting the links, golfers were
invited to warm up on the driving range,
where they received tips and instruction from a professional golf instructor.
Players also enjoyed a hot breakfast,
welcome gifts, and prizes while on the
course.
All golfers were eligible to participate
in the Hole-In-One contest, where they
had the chance to win a BMW Cooper
Mini S Series. Employees from Kela
Medical Inc., the tournament’s massage sponsor, were also stationed at
the first hole of each course to distribute
gifts to every participant.
OMSBF Tournament Co-Chairs Dr.
Stewart Kennedy, OMA President, and
Allan O’Dette of GlaxoSmithKline Inc.,
hosted the annual luncheon presentations, paying tribute to the tournament’s outstanding participants, as well
as Fund donors and sponsors.
REVISED_(v3)_July/Aug11_OMSBF_Golf_Tourney_pp42-43.indd 1
The OMSBF was excited to have illusionist Bobby Motta perform his original
magic effects following the luncheon.
A member of the Academy of Magical
Arts in Hollywood, Mr. Motta has performed for appreciative audiences
around the world. He captivated and
delighted the OMSBF crowd with his
compelling stage presence, and seeming ability to read participants’ minds.
Margaret Olszewski, a University
of Toronto medical student, thanked
donors and sponsors on behalf of all
the medical students in Ontario who
have benefitted from the Fund.
The OMSBF is grateful to all its corporate sponsors for their continued
support. Special thanks to Platinum
Sponsor MD Physician Services, and
Gold Sponsors Sun Life Financial and
New York Life Insurance.
Selected photos of the event appear
opposite. Complete photo highlights
can be viewed on the OMSBF website (http://omsbf.oma.org/Student/
tournament/golftournament.htm).
42
OMSBF Update
Established in 1999, the OMSBF
operates through the Ontario Medical
Foundation (charitable sister arm of the
OMA) to raise funds for medical students across the province who are in
financial need.
The OMSBF offers assistance in
the form of non-repayable bursaries in
the amount of $2,000 or $3,000. More
than $9.2 million has been raised to
date by the OMSBF, and over 1,200
bursaries have been disbursed to
medical students who demonstrate a
financial need.
Further Information
To obtain information on the Ontario
Medical Student Bursary Fund or to
make a donation, visit the OMSBF
website (http://omsbf.oma.org/
Student/campaign). You may also
contact Sandra Zidaric, Senior
Director, by phone at 416.340.2913
or 1.800.268.7215 ext. 2913, or via
email ([email protected]).
July/August 2011
11-07-11 3:22 PM
2
1
PHOTOS: ACE TOURNAMENT SERVICES
3
REVISED_(v3)_July/Aug11_OMSBF_Golf_Tourney_pp42-43.indd 2
1. All photos from left: Gabe Cabrera, Assistant Vice-President
of Sales, New York Life Insurance (Gold Tee Sponsor); Naguib
Gouda, OMA Executive Director, Member Services, Managing
Director, Insurance Services; Dan O’Brien, Vice-President of Sales
and Service, New York Life Insurance; Dr. Andrew Loblaw.
2. Dr. Ved Tandan, OMA Honorary Treasurer and District 4
Director; University of Toronto medical student Elsa Clouatre;
OMA CEO Jonathan Guss; Dan Carbin, Senior Advisor, Health
Policy Issues, Office of the Premier.
3. University of Toronto medical student Margaret Olszewski;
OMA President Dr. Stewart Kennedy; Elsa Clouatre; Allan
O’Dette, Director, External Relations and National Private
Markets, GlaxoSmithKline Inc. (Silver Tee Sponsor).
4. Dr. Ramesh Zacharias, President, Kela Medical Inc. (Massage
Sponsor and Silver Tee Sponsor); Richard Granville, Advisor,
Kela Medical Inc; Vikram Kharana, Chief Executive Officer,
Prudential Consulting; Dr. Jim Ku.
5. Winners of the Most Honest Team, South Course: Dr. George
Yee; William Yee; Dr. Allan Spear; Dr. Greg Athaide.
July/August 2011
4
5
11-07-11 3:22 PM
On June 17, 2011 the Ontario Medical Student
Bursary Fund (OMSBF) Charity Golf
Tournament raised more than $160,000
towards medical student bursaries.
On behalf of the medical students of Ontario and the Ontario Medical Foundation, we would like to extend our
thanks to our generous sponsors for making this an overwhelming success!
Platinum Tee
Gold Tee
Silver Tee
Bronze Tee
Media Sponsor
For more information about the OMSBF and future golf tournaments please contact Sandra Zidaric, Senior Director.
Phone: 1.800.268.7215, ext. 2985 or 2259 | Email: [email protected]
Web: http://omsbf.oma.org/Student/tournament/golftournament.htm
July2011_GolfAd_v3.indd 1
11-06-22 1:51 PM
FEATURE
Symposium Highlights
Sport Med 2011:
activity level and chronic illness in children, backyard
trampoline injuries, throwing injuries of the shoulder,
injury prevention in soccer
by Barbara Klich
M
ORE THAN 160 PHYSICIANS AND ALLIED HEALTH PROFESSIONALS ATTENDED THE 2011 SPORT
MED SYMPOSIUM, HELD FEBRUARY 4-5 IN TORONTO. PRESENTED ANNUALLY BY THE OMA
SECTION ON SPORT AND EXERCISE MEDICINE — WHICH IS CURRENTLY CELEBRATING ITS 40TH YEAR
— THE CONFERENCE FEATURES LECTURES, PLENARY SESSIONS, AND PRACTICAL WORKSHOPS ON
TOPICS RELATED TO THE ASSESSMENT, PREVENTION AND MANAGEMENT OF SPORT AND EXERCISE INJURIES. HIGHLIGHTS FROM THIS YEAR’S EVENT INCLUDE THE JOHN SUTTON MEMORIAL LECTURESHIP ON
ACTIVITY LEVEL AND CHRONIC ILLNESS IN CHILDREN, THE TOM PASHBY SPORTS SAFETY FUND LECTURESHIP
ON BACKYARD TRAMPOLINE INJURIES, AND PLENARY SESSIONS ON THROWING INJURIES OF THE SHOULDER
AND INJURY PREVENTION IN SOCCER.
The John Sutton Memorial
Lectureship: Activity Level and
Chronic Illness in Children
Dr. John Philpott, assistant professor, Section of Community Pediatrics,
University of Toronto, presented
the 2011 John Sutton Memorial
Lectureship, entitled “Activity Level
and Chronic Illness in Pediatric
Population.”
Dr. Philpott outlined the importance
of physical activity in a unique population of children with chronic illness, and
provided recommendations on activity
levels for children with conditions such
as arthritis, hemophilia, asthma, and
cystic fibrosis.1
Dr. Philpott also paid tribute to
Dr. John Sutton, and his McMaster
University colleague Dr. Oded Bar-Or,
referring to them as “two visionarONTARIO MEDICAL REVIEW
July/Aug11_sport_med_pp45-49.indd 1
ies who pioneered the study of sport
and exercise medicine, and whose
advancements have certainly served as
a guiding light for future physical activity
recommendations.”
Children with Juvenile Idiopathic
Arthritis
Dr. Philpott told delegates that children
with juvenile idiopathic arthritis (JIA)
can safely participate in sports without
disease exacerbation; should participate in impact activities and competitive contact sports if their disease is
well controlled and they have adequate physical capacity; and should be
encouraged to be physically active, as
tolerated.
Children with moderate to severe
impairment, or actively inflamed joints,
should limit activities. Dr. Philpott
45
advised that these children may gradually return to full activity following a disease flare.
He noted that children with severe
joint disease should take individualized
training within a group exercise format
for physical/social benefit, and that
physiotherapists on pediatric rheumatology health-care teams should coordinate individual exercise programs.
“If the children have neck arthritis,
they should have radiographic screening for C1-C2 instability before participation in collision sports,” said Dr.
Philpott. He recommended that this
group wear appropriately fitted mouth
guards during activities with risk of jaw
and dental injury, and that appropriate
eye protection should be worn during
activities with ocular risk (as with the
general population).
July/August 2011
11-07-04 1:22 PM
Sport Med Symposium
Children with Hemophilia
Children in this group should receive
appropriate prophylaxis to reduce the
risk of bleeding in sport, and should
undergo vigilant assessment of joint and
muscle function before sport selection.
If restrictions are required, physicians
should counsel children and their families with respect to safe alternatives.
“They should be carefully assessed
before allowing participation in contact
or collision sports, such as martial arts,
hockey, or football,” he warned.
Dr. Philpott suggested that a consultation with a sport medicine physician and/or a pediatric hematologist
might be of benefit to these children.
He also noted that a written strategy
with a coach, parent, or school should
be a requirement before sport participation in order to prevent or treat
bleeds. Protective equipment must be
worn, and it is important that the child
undergo physical therapy, or take prophylactic factor replacement therapy.
Acute bleeds must be managed with
ice, splinting, and rest, and physical
activity should be avoided until joint
pain or swelling has resolved.
“Return to sports requires individualized assessment and appropriate rehabilitation,” he said.
Children with Asthma
Dr. Philpott told delegates that if symptoms are well controlled, children with
asthma should be able to participate
in any physical activity. He noted that
swimming is less likely to trigger exercise-induced bronchospasm (EIB) than
running.
“It is important to keep an accurate
history of symptoms, trigger exposures,
treatments, and, of course, recovery
from episodes of bronchospasm,” said
Dr. Philpott.
“These children should be diagnosed with EIB by a drop of FEV1 (10%
to 15%) after a six-minute to eight-minute exercise challenge, and a positive
response to beta-2 agonist medication.
Eucapnic voluntary hyperventilation
testing is recommended in athletes.”
He advised the use of leukotriene
inhibitors, inhaled corticosteroids, and/
or long-acting beta-2 agonists for optimal long-term disease control, and to
avoid overuse of short-acting beta-2
agonists. He also suggested that children with asthma should take inhaled
beta-2 agonists 15 minutes to 30 minutes before exercise, and warned that
this group should not scuba dive if they
have asthma symptoms or abnormal
pulmonary function tests (PFTs).
Child athletes with asthma or EIB
who compete nationally or internationally should consult with a sport medicine physician regarding therapeutic
use exemption (TUE) regulations, as
criteria can change.
“Basically, if an athlete is taking the
two commonly used inhaled medications (B-2 agonist and glucocorticoids)
in the usual dosing manner, no TUE is
needed,” said Dr. Philpott. “If the testing reveals a concerning level, or the
medications are not given by inhalation,
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46
July/August 2011
11-07-04 1:22 PM
Sport Med Symposium
that is another issue, and a TUE form is
necessary — and often further documentation.”
Children with Cystic Fibrosis
Children with cystic fibrosis (CF) should
be encouraged to participate in any
physical activity, said Dr. Philpott, however, consultation with a sport medicine
physician or pediatric respirologist is
suggested. He recommended the following:
t $IJMESFOXJUI$'TIPVMEIBWFJOEJvidualized exercise programs that
include strength training.
t $IJMESFOXJUI$'SFRVJSFTVQFSWJTFE
or unsupervised home exercises that
elevate heart rate by 70% to 80% of
maximum to increase aerobic exercise tolerance.
t $IJMESFOXJUI$'XIPDPVHIEVSJOH
exercise should not necessarily stop
the activity.
t $IJMESFOXJUITFWFSF$'TIPVME
undergo exercise testing to identify
maximal heart rate, levels at which
oxygen desaturation and ventilation
limits occur, exercise-related bronchospasm, and response to therapy.
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avoid scuba diving.
“These children should drink flavoured sodium chloride-containing
fluids above thirst levels to prevent hyponatremic dehydration, and those with
diabetes mellitus require additional carbohydrates during prolonged exercise,”
said Dr. Philpott. He added that those
with an enlarged spleen or diseased liver
should avoid contact or collision sports.
Tom Pashby Sport Safety
Fund Lectureship: Backyard
Trampoline Injuries
Dr. Laura Purcell, associate clinical professor, McMaster University, presented
the 2011 Tom Pashby Sport Safety
Fund Lectureship, entitled “Backyard
Trampoline Injuries.”
Dr. Purcell told delegates that trampolining is a high-risk activity with
potential for serious injury, and that
backyard trampoline injuries are almost
exclusively a pediatric phenomenon.
“The factors contributing to injuries
include young children (under the age of
six), no training, lack of qualified superONTARIO MEDICAL REVIEW
vision, attempted manoeuvres that are
dangerous, and multiple users at the
same time on the trampoline,” she said,
adding that most injuries occur in the
summer months, on weekends, and in
the afternoon.
Dr. Purcell outlined some of the proposed safety measures designed to
help prevent trampoline injuries, including placing nets around the trampoline,
padding the springs, using spotters,
allowing only one person at a time, and
banning somersaults.
She also provided the following summary of the regulations established by
several child and sport safety bodies that
pertain specifically to trampoline use:
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Canadian Academy of Sport
Medicine joint statement, 2007:
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“Trampolines should not be
regarded as play equipment and
should not be used for recreational
purposes at home or part of outdoor
playgrounds.”
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Surgeons, 2010: “Trampolines should
not be used for unsupervised recreational activity, and never by children
younger than six years of age.”
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to guidelines established by the
Canadian Pediatric Society and
Canadian Academy of Sport
Medicine.
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1999, reaffirmed in 2006: “Trampolines should not be used at home
or in playgrounds.”
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Tips for Treating Physically Active Patients
“If an athlete is taking two commonly used inhaled medications (B-2 agonist
and glucocorticoids) for asthma in the usual dosing, no TUE is needed. If the
testing reveals a concerning level or the medications are not given by inhalation, that is another issue and a therapeutic exemption form is necessary and
often further documentation.”
Dr. John Philpott, University of Toronto
“Women playing soccer have significantly greater incidence of ACL tears than
men.”
Dr. Cathy Campbell, University of Toronto
“Injuries of both the shoulder and elbow are common in throwing and overhead sports — common sports that sustain injuries include baseball, volleyball, tennis, football throw, javelin, and racquet sports — throwing injuries
tend to be unique to these sports due to the significant demands placed on
the joint and soft tissues and diagnosis requires a good understanding of both
the mechanics of the sport and the injury itself.”
Dr. Wade Elliott, McMaster University
“Every elite male soccer player incurs approximately one performance-limiting
injury each year.”
Dr. Devin Peterson, McMaster University
“Most backyard trampoline injuries occur in the summer months (77%), on
weekends (43%) and in the afternoon (56%).”
Dr. Laura Purcell, McMaster University
“The majority of injuries in soccer are sprains, strains, and contusions, and
20% to 25% are re-injuries.”
Dr. Devin Peterson, McMaster University
47
July/August 2011
11-07-04 1:22 PM
Sport Med Symposium
FIFA — which provides a complete
soccer-specific warm up, and can easily be integrated into a daily training routine.
The program includes six running
drills (total eight minutes); six strength,
plyometric and balance exercises (10
minutes); and a three further running
drills (two minutes).
“The 11+ takes about 20 minutes to
complete and replaces the usual warmup before training,” said Dr. Campbell,
adding that before playing in a match,
only running exercises are performed
for about 10 minutes.
The different levels of difficulty
increase the program’s effectiveness
and allow coaches and players to individually adapt the program.
Dr. Campbell told delegates that the
11+ has been proven to cut injuries by
up to half, if it is performed correctly, in
conjunction with values of fair play.
She reported that women have significantly greater incidence of ACL tears
than men (six to eight times the number
of men), and this may be due to multiple
factors, including biomechanical, anatomical, and neurophysiological issues.
“The Prevention 11+ program has
been shown to reduce ACL injuries,”
said Dr. Campbell.
For more information on Prevention
11+, visit: http://f-marc.com/11plus/
index.html.
Closing remarks
In her closing remarks, incoming Chair
of the Section on Sport and Exercise
Medicine, Dr. Tatiana Jevremovic
(Fowler Kennedy Sport Medicine Clinic,
and University of Western Ontario), told
delegates that the Section has several
projects underway, including the development of a website.
“The website will allow Section members and the public access in order
to view educational material, news
updates, and other pertinent information related to Sport and Exercise
Medicine or to the Section,” she said.
Dr. Jevremovic noted that the
49
Section is working with the Canadian
Academy of Sport and Exercise
Medicine (CASEM), and is making great
strides in having the Sport and Exercise
Medicine PGY3 training standardized and recognized by the Canadian
College of Family Medicine, as well as
having an official College Certificate of
Added Training awarded upon successful completion of the CASEM
diploma exam at the conclusion of
PGY3 training.
Reference
1.
Philpott J, Houghton K, Luke A. Physical
activity recommendations for children
with specific chronic health conditions:
Juvenile idiopathic arthritis, hemophilia,
asthma and cystic fibrosis. Paediatr Child
Health. 2010 Apr;15(4):213-25. Available
from: http://www.ncbi.nlm.nih.gov/pmc/
articles/PMC2866314/pdf/pch15213.pdf.
Accessed: 2011 Jun 20.
Barbara Klich is a Toronto-based freelance
writer.
July/August 2011
11-07-04 1:22 PM
BOARD REPORT
Summary of resolutions
OMA Board of Directors Meetings
April - June, 2011
June 8-9, 2011
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of Non-Voting Directors: Advice to
Members (June 2011)w
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Academic Medicine Steering
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May 30, 2011 (Teleconference)
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May 1, 2011
Committee Appointments
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50
April 29, 2011
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July/August 2011
11-07-04 11:57 AM
Optimize chronic disease management with an EMR
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Let us help you take the first step today
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The deadline for applications is September 30, 2011
Call 1-866-744-8668 or email [email protected]
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EMR Adoption Program, funded by eHealth Ontario
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NEWSPAPER
HEALTH POLICY REPORT
A summary of current health legislation and policy developments
t CPSO Framework for Changing Scope of Practice
to Include Cosmetic Procedures
t Changes to the Reimbursement Policies for
Lucentis
by OMA Health Policy Department
CPSO Framework for Changing
Scope of Practice to Include
Cosmetic Procedures
The College of Physicians and
Surgeons of Ontario (CPSO) is implementing a new framework entitled
“Expectations of Physicians Changing
their Scope of Practice to include
Surgical Cosmetic Procedures.” This
framework is relevant to physicians
who have changed, or plan to change,
their scope of practice to include cosmetic procedures.
The CPSO relies primarily upon
certification processes from the Royal
College of Physicians and Surgeons
of Canada in order to determine which
physicians can perform cosmetic procedures. Physicians who are performing, or plan to perform, a procedure that
falls outside of the training objectives of
their residency and/or fellowship program will be required to participate in
the change in scope of practice process — which is individualized, but
generally includes training, supervision,
and assessment — before they perform surgical cosmetic procedures as
part of their practice.
While this is an objective way for the
CPSO to ensure that those practising in
the area of cosmetics have the training
and skill to do so, the OMA will review
the framework, and work with a number of specialty Sections to ensure that
July/Aug11_health_policy_p53.indd 1
the CPSO’s approach is reasonable.
OMA Staff Contact: Ada Maxwell (ext. 2942)
Changes to the Reimbursement
Policies for Lucentis
Effective May 19, 2011, Lucentis
(ranibizumab) will have its listing status
changed to Limited Use (LU). The LU criteria will be consistent with the therapeutic notes that have been in place since its
original listing. Prescriptions for patients
new to ranibizumab therapy, who meet
the LU criteria, will require inclusion of
an LU code (422) on the prescription.
Existing prescriptions will require confirmation that they meet the LU criteria,
and the LU code should be documented
on the next prescription or refill.
Physicians should note that in order
for patients to be eligible for reimbursement under the Ontario Drug Benefit
(ODB) program, all drug products,
including ranibizumab, must be dispensed by an accredited Ontario pharmacy, or a physician who is registered
with the Ministry of Health and LongTerm Care as a “dispensing physician.”
Receipts issued to patients for prescriptions by physicians who are not
registered with the Ministry as dispensing physicians are not accepted by the
ODB, and reimbursement will not be
provided to these patients.
OMA Staff Contact: Peter Brown (ext. 2989)
53
July/August 2011
11-07-04 11:21 AM
IN MEMORIAM
The OMA would like to express condolences to the families and friends of the following members.
Fagan, James
Massouda, Benjamin Jacob
Underwood, Anne Elizabeth
Bobcaygeon
Toronto
Toronto
Queen’s University, 1971
Cairo Unversity, 1950
May 2011 at age 65
April 2011 at age 84
May 2011 at age 77
Gibbs, Judith A.
San-Marina, Ion
Vandewater, Stuart Leslie
Toronto
Toronto
Kingston
McGill University, 1972
University of Bucharest, 1949
University of Toronto, 1947
October 2010 at age 87
May 2011 at age 86
Hadley, Gerald Lloyd
Sanders, Britain Marchand
Walk, Frank Sales Maria
Niagara Falls
Toronto
Parry Sound
University of Western Ontario, 1948
University of Göttingen, 1945
January 2011 at age 89
Hoaken, Paul Clement Spencer
Sussman, Arthur Howard
Woodley, Thomas Inman
Bath
Toronto
Belleville
Khonsari, Homayoun
Tuttle, Robert John Douglas
Zagoni, Marianna
Barrie
Dundas
Toronto
University of Dublin, Trinity College, 1963
Semmelweis University, 1989
The OMA publishes brief notices about deceased members as a service to their colleagues. Information concerning these members should
be sent to [email protected].
REVISED_July/Aug11_in_memoriam_p54.indd 1
54
July/August 2011
11-07-08 12:09 PM
Insurance Check-Up Have You Had One Lately?
Surprisingly, many physicians have not reviewed their insurance coverage in several years.
Your health is not the only thing that changes over time. Events take place during a lifetime
that can alter your financial situation.
t
t
t
t
t
Marriage
Children
Buying a home and/or cottage
Practice matures and income increases
Retirement.
Your insurance may not have kept pace with your changing needs. A regular review of your
insurance is essential to providing adequate protection for you and your family. The OMA
provides the services of professional non-commissioned Insurance Advisors.
Contact OMA Insurance today by phone (1.800.758.1641 / 416.340.2918) or e-mail
([email protected]) and arrange to have your insurance needs reviewed.
The best time to find out if you have enough insurance is before you need it.
Elecompack_PROOF1.pdf 1
3/24/2011 1:43:44 PM
OMA INSURANCE UPDATE
Insurance planning strategies for
“pre-retirement” physicians:
take steps now to protect your retirement income
by OMA Insurance Services
MA Insurance Services has prepared a four-part series of planning tips to help
O
physicians manage their insurance and financial needs at each stage of their
career — from early practice to retirement. The third instalment, below, offers practical advice for physicians entering the “Pre-Retirement” stage of practice.
Retirement landscape
The retirement landscape today is
vastly different than it was a generation
ago. With life expectancies increasing, medical professionals may have a
retirement period that lasts for 30 years
or more. One of the greatest risks people now face in retirement is outliving
their savings.
Fortunately, there are steps you can
take now that will help you to protect
your nest egg and also save you money
during your retirement years, when your
income is likely to be reduced.
ance can help to decrease the burden
of these costs during your recovery
period.
For physicians in the late-career
stage, it is especially important to maintain maximum coverage amounts for
both of these types of insurance. Why?
If you have to withdraw from your retirement savings to finance your recovery period when you are approaching
retirement, you may not have the time
necessary to replace these savings,
and recoup the lost returns on your
investment growth.
Maintain sufficient Disability
Income Insurance and Professional
Overhead Expense Insurance
Disability Income Insurance provides a
tax-free monthly income replacement
should you find yourself having to take
time off to recover from an illness or
injury. During this time, fixed costs will
continue and can build up over time.
Professional Overhead Expense insur-
Consider Permanent Life insurance
protection
While Term Life insurance is a practical option at a younger age to cover
your temporary needs, such as mortgage protection, a child’s education, or to replace your income due
to a premature death, the late-career
stage is a good time to start thinking
about Permanent Life insurance as a
July/Aug11_insurance_update_pp57-59.indd 1
57
cornerstone of your estate plan.
As the name implies, this type of
insurance provides lifetime coverage.
There are two ways of reducing or eliminating your costs for Permanent Life
insurance in retirement:
1. Lock in lower rates at younger
ages by converting from Term to
Permanent Life insurance. If you
have OMA Flex-Term Life insurance,
there is the option to convert to lifetime term-to-100 coverage without
medical evidence at any time before
you reach the age of 65. Rates are
based on your age at the time of
conversion. At age 100, coverage
is considered “paid up” and will continue until death without any further
premiums.
2. Buy Permanent insurance with a
limited pay period. With this type of
coverage, you only pay insurance
premiums for a set length of time.
Once the limited pay period ends, no
further payments are required, and
July/August 2011
11-07-05 9:52 AM
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Phase 1:
Start of career
Phase 2:
Mid-career
(May OMR)
(June OMR)
Insurance Planning at
Each Stage of the
Physician Career Cycle
Insurance check-up:
have you had one lately?
A regular review of your insurance
is essential to ensure you are
Phase 4:
Retirement
(September OMR)
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your coverage remains in place for
your lifetime. The advantage is that
you can choose a limited pay period
that coincides with your target retirement age so that you will not have to
worry about paying premiums with
reduced retirement income.
Protect your nest egg with Long
Term Care insurance
Many of us take for granted the ability
to do things such as bathing, getting
dressed and eating. Now that we are
living longer than ever, and with constant new life-saving medical advances,
studies show that we have a significant
likelihood of needing a personal support worker at some point, whether at
home or in a facility.
Long Term Care insurance (LTCI)
provides a weekly, tax-free benefit of
up to $2,000 should you require help
with at least two activities of daily living,
or if you suffer from a cognitive impairment that requires constant supervision. This type of protection is vital to
providing suitable protection for
Phase 3:
Pre-retirement
yourself and your family.
t%JTBCJMJUZ
(July/August
OMR)
Income
Insurance
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have in retirement, especially as you will
no longer qualify for Disability Income
insurance.
As with Life insurance, LTCI is also
available with a limited pay period
feature. Along with the vital financial
assistance it provides, LTCI helps you
get the care you need without placing this considerable burden on your
established family physician who
loved his work and had planned to
keep practising for many years to
come. At age 53, he began experiencing symptoms of back strain,
followed by weakness in his left quadriceps. Although initial testing for ALS
was negative, he was eventually diagnosed with the disease.
The late career stage is a good time to start
thinking about Permanent Life insurance as a
cornerstone of your estate plan.
spouse or partner, children, family
members, and friends. The burden
often extends beyond financial considerations and includes physical
and emotional demands, as well as
a major time commitment to provide
needed assistance.
As an example, Dr. G.* was an
58
As his ALS progressed, Dr. G.
reluctantly cut back to working part
time and began to use a wheelchair
due to increasing weakness in his
arms and legs. Eventually, he had to
give up his practice entirely.
In just three years following his
diagnosis, Dr. G.’s condition deterioJuly/August 2011
11-07-05 9:52 AM
rated to the point where he relied on
in-home care for four hours per day,
seven days per week, to help him with
activities like bathing and dressing.
The cost of this care was fully covered
by his monthly LTCI benefit.
Dr. G. is especially grateful for how
Long Term Care insurance helped his
wife, Elena. At only 51 years of age, he
hopes she will have a long and healthy
life ahead, and is relieved to know she
will not have to compromise her retirement lifestyle because of costs related
to his illness. But perhaps more importantly, he is thankful she can spend their
remaining time together as his wife, not
as his caregiver.
Other important health insurance
solutions
If you do not have Critical Illness insurance, it is still possible to qualify for
coverage up to age 65. This type of
protection provides a lump sum benefit
payout if you are diagnosed with one
of the 25 conditions covered under the
plan. With a permanent plan, you can
choose to prepay over a shorter period,
yet maintain coverage for life.
As you age, your expenses for dental
care, medication, vision care and travel
insurance often increase. Extended
Health Care and Dental insurance helps
reduce your out-of-pocket costs for
these services, along with emergency
medical care.
Advice for your pre-planning needs
As an OMA member, you have access
to a wide range of valuable insurance
solutions that will help you create an
effective protection plan for your retirement years at an affordable cost.
For help finding the right insurance
solutions for your needs, contact your
non-commissioned OMA Insurance
Advisor at 1.800.758.1641, or email:
[email protected].
More information is available on the
Insurance Services website at: www.
omainsurance.com.
*For illustrative purposes, characters in the
story and scenario are fictional.
59
July/August 2011
11-07-05 9:52 AM
PRACTICE MANAGEMENT
Physician burnout:
understanding causes, symptoms and treatment
by donalee Moulton
t times, the duties of a physician can be stressful. The effect of that stress can
A
lead to burnout — and burnout can be debilitating; but it doesn’t have to be.
If physicians understand the causes, symptoms, and treatment of burnout, they are
better able to help themselves and their colleagues.
Understanding burnout
Burnout is more than stress. There
are three components: emotional
exhaustion, depersonalization, and a
reduced sense of personal accomplishment, says Dr. Joseph Lee, chair
and lead physician with The Centre for
Family Medicine family health team in
Kitchener-Waterloo.
“Emotional exhaustion refers to
the sense of having nothing more
to give to your patients and others.
Depersonalization speaks to going
through a day like an ‘automaton;’ that
is, going through the motions without
being engaged,” he notes.
A study conducted by Dr. Lee found
that physicians most commonly suffer
from the first two components of burnout. “The reduced sense of accomplishment in medicine is usually the last
component to be manifest,” he says.
In the early stages of burnout, symptoms can include irritability, loss of
concentration, gastrointestinal problems, and insomnia. As the condition
progresses, the symptoms may include
July_Aug11_practice_management_pp60-61.indd 1
apathy, persistent tiredness, increased
caffeine intake, and withdrawal from
friends and family. Finally, when the
condition becomes severe, individuals may suffer anxiety, depression, and
social isolation.
This process doesn’t happen quickly,
which is one of the reasons physicians
may not recognize the problem.
“It’s a gradual process,” says Dr.
Richard Earle (PhD), managing director of the Canadian Institute of Stress
in Toronto.
And no one, he adds, is immune.
“We’re all vulnerable.”
Burnout can be similar to depression, but it is distinct from this condition. “The difference is that burnout is
specific to the work and is not all pervasive,” explains Dr. Lee, who is also
site director of the Kitchener-Waterloo
Family Medicine Residency Program at
McMaster University in Hamilton.
“For example,” he notes, “a physician suffering from burnout may feel
emotionally exhausted, depersonalized,
and feel that he’s not doing anything
60
worthwhile when he’s seeing patients
during the week and have concomitant
poor sleep and fatigue. Yet he may feel
very well when he goes away to his cottage on the weekend. A physician who
has depression would still feel low during the weekend at the cottage.”
Understanding the causes of
burnout
Understanding burnout is easier than
detecting it, at least in oneself, and physicians are at greater risk of burnout
than most.
People in high demand — both in
terms of their time and their responsibilities — are more susceptible, notes
Dr. Earle. “This typically adds to the
stress level.” He explains that with burnout, the satisfaction scale has tipped. “It
comes down to what am I getting back
for what I’m putting out.”
Understanding how to treat burnout
As a first step, individuals need to identify their stressors. This could include
inflexible practice demands, a lack of
July/August 2011
11-07-04 11:33 AM
PRACTICE MANAGEMENT
control over working conditions, or a
host of other factors.
The flipside is also important, says
Dr. Earle. “Recognize what you enjoy —
what makes a good day for you.”
Eighty-seven (87) per cent of people
can’t describe that ideal day, he adds.
But it often involves the small things,
such as dinner with family, a long walk
with the dog, or relaxing with a good
book.
Dr. Lee’s research found that physicians typically use strategies in three
areas of their life to combat, and even
prevent, burnout: personal, occupational, and system-wide.1
In the first area, physicians may exercise, eat well, spend time with family
and friends, and explore spirituality.
At the occupational level, they may
use inter-professional teams for patient
care, advanced technology, professional development programs, and
networking to re-engage and reduce
symptoms.
“At the wider health-care system
level,” notes Dr. Lee, “there are many
issues that require thoughtful address,
including appropriate remuneration that
links objectives and rewards, fair rules
and regulations, human resource shortages, limited resources, documentation, and medico-legal concerns.”
It is also important for physicians
to reflect on their goals and to assess
whether there is an appropriate work/
life balance.
What is not an option is ignoring the
problem. The implications — for physicians and the health-care system —
are significant, says Dr. Lee. “Burnout
can cause functional impairment in the
workplace that leads to poorer work
performance. It can also lead to the
need to reduce or withdraw from practice that adds to our existing human
resource shortage in medicine.”
Fortunately, it doesn’t need to come
to that. Burnout can be addressed in its
early stages — and even before it has
had time to take root.
“Know what you can and can’t control,” stresses Dr. Earle. “Then take
action.”
July_Aug11_practice_management_pp60-61.indd 2
Dr. Michael Kaufmann, medical
director of the OMA Physician Health
Program and Professionals Health
Program (PHP), authored an excellent six-part series on the fundamental principles of physician self-care.
The “BASICS” series offers practical
suggestions for stress management,
improved health and well-being, and
building resilience. The BASICS series
is available on the PHP website at
http://www.phpoma.org/TheBasics.
html.
The PHP provides a range of direct
services to support the health, wellbeing and resilience of Ontario physicians, veterinarians and pharmacists.
They work with individuals, families and
workplaces experiencing difficulties with
substance abuse and addiction, psychiatric and mental health concerns,
stress, burnout, work-related conflict,
and a variety of family issues. For more
information visit the Physician Health
Pro g ram w eb site at http://www.
phpoma.org, or call the PHP confidential toll-free line at 1.800.851.6606.
Reference
1.
Lee FJ, Stewart M, Brown JB. Stress,
burnout, and strategies for reducing them:
what’s the situation among Canadian
family physicians? Can Fam Physician.
2008 Feb;54(2):234-5. Available from:
http://www.cfp.ca/content/54/2/234.full.
pdf+html. Accessed: 2011 Jun 16.
donalee Moulton is a professional medical
and health writer based in Halifax.
The Practice Management column is provided by the OMA Member Services
Department. Do you have a topic or question you would like to see appear in the
Ontario Medical Review? Please let the
Practice Advisory Service team know at
416.340.2911, or 1.800.268.7215, ext. 2911,
or email: [email protected].
Ten Tips to Avoid Burnout
1. Learn to pay attention to changes in your physical health, emotions
and thoughts as a result of increasing stress.
2. Attend to the quality of your diet and sleep.
3. Get regular exercise.
4. Delegate least important tasks to your staff — do less, not more.
5. Set realistic goals — what’s really important to you?
6. Learn the difference between excellence and perfectionism.
7. Reduce long hours of work — don’t mistake your job for a life.
8. Learn to deal with people who can be difficult, including your patients
and yourself.
9. Be with your spouse/partner and family as much as possible. Harmony
at home makes it easier to deal with everything life has to offer.
10. Take time off — laugh often and out loud!
61
July/August 2011
11-07-04 11:33 AM
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Outreach to Women Physicians
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Available Position:
The Outreach to Women Physicians Committee is looking for one (1) physician
to fill its committee composition.
Time Commitments:
The Outreach to Women Physicians Committee meets in person four times per
year and by teleconference approximately three times per year.
Committee Mandate:
The mandate of the Outreach to Women Physicians Committee is to advise
the OMA on how best to support medical women in practice and to encourage
them to become involved in medical politics.
Committee Scope of Authority:
1. To encourage women physicians to become involved with the OMA in particular, and in medical politics in general.
2. To facilitate the OMA’s role as a supporting organization and to encourage
understanding and positive communication between groups representing
women and organized medicine.
3. To provide leadership in the development of specific outreach activities,
including the Annual Women’s Health Care Seminar and other networking
events for women physicians.
4. To identify and make known to the OMA, issues of particular relevance to
women physicians.
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t 1IZTJDJBOTXJUIVOEFSTUBOEJOHLOPXMFEHFBOEJOUFSFTUJOUIFFYJTUJOHBOE
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If so, please submit a 2-5 page curriculum vitae (CV) and a concise covering
letter indicating your interest, skills and knowledge to the address below.
Deadline for Applications is August 26, 2011.
Please send applications to:
Ontario Medical Association Committee on Committees
Attention: Jennifer Kelly, Public and Corporate Affairs
150 Bloor Street West, Suite 900
Fax: 416.340.2244
E-mail: [email protected]
Phone: 416.599.2580, ext. 3802 or
1.800.268.7215, ext. 3802
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Safety Information
Dabigatran Etexilate 110mg and 150mg
Capsules
Prescribing Summary
This is a condensed version of the Product
Monograph. For complete information please
refer to the Product Monograph available at
www.boehringer-ingelheim.ca or by contacting
Boehringer Ingelheim (Canada) Ltd., 5180 South
Service Road, Burlington, Ontario, L7L 5H4.
Patient Selection Criteria
THERAPEUTIC CLASSIFICATION:
Anticoagulant
INDICATIONS AND CLINICAL USE
S Prevention
of stroke and systemic
embolism in patients with atrial
fibrillation, in whom anticoagulation is
appropriate.
Geriatrics (>65 years of age): Clinical
studies have been conducted in patients
with a mean age >65 years. Safety and
efficacy data are available (see CLINICAL
TRIALS in the Product Monograph).
Pharmacokinetic studies in older subjects
demonstrate an increase in exposure to
dabigatran in most of those patients,
usually in association with age-related
decline of renal function (see WARNINGS
AND PRECAUTIONS, Renal, and DOSAGE
AND ADMINISTRATION, Renal Impairment).
Pediatrics (<18 years of age): The safety
and efficacy of PRADAX have not been
established in children less than 18 years of
age. Therefore, PRADAX is not recommended
in this patient population.
CONTRAINDICATIONS
Severe renal impairment (CrCl <30mL/min)
S Hemorrhagic
manifestations, bleeding
diathesis, or patients with spontaneous
or pharmacological impairment of
hemostasis
S Lesions
at risk of clinically significant
bleeding, e.g., extensive cerebral infarction
(hemorrhagic or ischemic) within the last
6 months, or active peptic ulcer disease
with recent bleeding
S Concomitant
treatment with strong
P-glycoprotein (P-gp) inhibitors, i.e., oral
ketoconazole (see DRUG INTERACTIONS)
S Known
hypersensitivity to dabigatran or
dabigatran etexilate or to any ingredient in
the formulation or component of the
container. For a complete listing, see the
DOSAGE FORMS, COMPOSITION AND
PACKAGING section of the Product
Monograph.
S
July_Aug11_PRADAX_5P_PI_pp63-67.indd 1
WARNINGS AND PRECAUTIONS
The following Warnings and Precautions are
listed in alphabetical order.
Bleeding
As with all anticoagulants, PRADAX should be
used with caution in circumstances associated
with an increased risk of bleeding. Bleeding
can occur at any site during therapy with
PRADAX. An unexplained fall in hemoglobin
and/or hematocrit or blood pressure should
lead to a search for a bleeding site. Patients at
high risk of bleeding should not be prescribed
PRADAX (see CONTRAINDICATIONS).
Close clinical surveillance (looking for signs
of bleeding or anemia) is recommended
throughout the treatment period, especially if
risk factors are combined.
Table 1: Factors which increase hemorrhagic
risk, as identified in clinical studies
Factors increasing
dabigatran plasma levels
Moderate renal impairment (30-50 mL /min CrCl)
Pharmacodynamic
interactions
Acetylsalicylic acid
P-glycoprotein-inhibitor comedication
NSAID
Clopidogrel
Diseases/procedures
with special
hemorrhagic risks
Congenital or acquired coagulation disorders
Thrombocytopenia or functional platelet defects
Active ulcerative gastrointestinal disease
Recent gastro-intestinal bleeding
Recent biopsy or major trauma
Recent intracranial hemorrhage
Brain, spinal or ophthalmic surgery
Bacterial endocarditis
Others
Age *75 years
The measurement of dabigatran-related
anticoagulation may be helpful to avoid
excessive high exposure to dabigatran in
the presence of additional risk factors.
In patients who are bleeding, an aPTT test
may be useful to assist in determining an
excess of anticoagulant activity, despite
its limited sensitivity. An aPTT >80 sec at
trough, i.e., when the next dose is due, is
associated with a higher risk of bleeding
(see Monitoring and Laboratory Tests).
Should severe bleeding occur, treatment
with PRADAX must be discontinued and the
source of bleeding investigated promptly.
Agents that may enhance the risk of
hemorrhage should not be administered
concomitantly with PRADAX, or, if necessary,
should only be administered with caution
(see ACTION AND CLINICAL PHARMACOLOGY,
Pharmacokinetic Interactions in the Product
Monograph).
Treatments that should NOT be
administered
concomitantly
with
PRADAX due to increase in bleeding
risk include: unfractionated heparin
and heparin derivatives, low molecular
weight heparins (LMWH), fondaparinux,
bivalirudin, thrombolytic agents, GPIIb/
IIIa receptor antagonists, ticlopidine,
sulfinpyrazone, and vitamin K antagonists
63
such as warfarin.
The concomitant use of PRADAX with the
following treatments has not been studied
and may increase the risk of bleeding:
rivaroxaban, prasugrel, and the strong
P-gp inhibitors itraconazole, tacrolimus,
cyclosporine,
ritonavir,
tipranavir,
nelfinavir and saquinavir.
Unfractionated heparin may be administered
at doses necessary to maintain a patent
central venous or arterial catheter.
In patients with atrial fibrillation treated
for the prevention of stroke and systemic
embolism, the co-administration of oral antiplatelet (including aspirin and clopidogrel)
and NSAID therapies increases the risk of
bleeding by about two-fold (see ACTION
AND CLINICAL PHARMACOLOGY, Special
Populations, Pharmacokinetic Interactions
in the Product Monograph). If necessary,
co-administration of low-dose ASA, i.e.,
)100 mg daily with PRADAX may be
considered for other indications than
stroke prevention in atrial fibrillation. Note
that in the RELY trial, there is no evidence
that the addition of ASA or clopidogrel to
dabigatran, or its comparator warfarin,
improved outcomes in respect to stroke (see
CLINICAL TRIALS, Stroke Prevention in Atrial
Fibrillation in the Product Monograph).
Treatment initiation with verapamil
should be avoided in patients following
orthopedic surgery who are already treated
with PRADAX. Simultaneous initiation of
treatment with PRADAX and verapamil
should also be avoided at any time (see
DRUG
INTERACTIONS,
P-glycoprotein
inhibitors).
Interaction with P-gp inducers
The concomitant use of PRADAX with the
strong P-gp inducer, rifampicin, reduces
dabigatran plasma concentrations. Other
P-gp inducers such as St. John’s Wort or
carbamazepine are also expected to reduce
dabigatran plasma concentrations, and
should be co-administered with caution
(see DRUG INTERACTIONS and Special
Populations).
Surgery/Procedural Interventions
Patients on PRADAX who undergo surgery
or invasive procedures are at increased
risk for bleeding. In these circumstances,
temporary discontinuation of PRADAX may
be required.
Pre-operative Phase
In advance of invasive or surgical
procedures PRADAX should be stopped
temporarily due to an increased risk of
bleeding. If possible, PRADAX should be
discontinued at least 24 hours before
invasive or surgical procedures. In patients
at higher risk of bleeding (see DOSAGE AND
ADMINISTRATION) or in major surgery where
July/August 2011
11-07-04 12:52 PM
complete hemostasis may be required,
consider stopping PRADAX 2-4 days before
surgery. Clearance of dabigatran in patients
with renal insufficiency may take longer
(see DOSAGE AND ADMINISTRATION, Renal).
This should be considered in advance of
any procedures.
PRADAX is contraindicated in patients
with severe renal dysfunction (CrCl <30
mL/min). Should acute renal failure occur
before surgery is required, PRADAX should
generally be stopped at least 5 days before
major surgery.
If acute intervention is required, PRADAX
should be temporarily discontinued, due
to increased risk of bleeding. Surgery or
procedural interventions should be delayed
if possible until at least 12 hours after the
last dose of PRADAX, with risk of bleeding
weighed against the urgency of the needed
intervention.
Peri-Operative Spinal/Epidural
Anesthesia, Lumbar Puncture
Procedures such as spinal anesthesia may
require complete hemostatic function.
In patients treated with PRADAX for VTE
prevention following major orthopedic
surgery and who undergo spinal or epidural
anesthesia, or in whom lumbar puncture
is performed in follow-up to surgery, the
formation of spinal or epidural hematomas
that may result in long-term or permanent
paralysis cannot be excluded.
In the case of these peri-spinal procedures,
administration of the first dose of PRADAX
should occur after hemostasis has been
obtained and no sooner than 2 hours
following puncture or removal of catheters
related to these procedures.
The risk of these rare events may be higher
with post-operative use of indwelling
epidural catheters or the concomitant use
of other products affecting hemostasis.
Accordingly, the use of PRADAX is not
recommended in patients undergoing
anesthesia with post-operative indwelling
epidural catheters.
Post-Procedural Period
Resume treatment with PRADAX as soon as
complete hemostasis is achieved.
Renal
PRADAX is contraindicated in cases of
severe renal impairment (CrCl <30 mL/
min). Patients who develop acute renal
failure while on PRADAX should discontinue
such treatment.
S Patients with atrial fibrillation treated for
prevention of stroke and systemic embolism:
Since no dose adjustment is necessary for
most atrial fibrillation patients with moderate
renal impairment (CrCl 30-50 mL /min),
a standard daily dose of 300 mg, taken
orally as one 150 mg capsule twice daily
is recommended (see DOSAGE
Special Populations
Pregnant Women: Since there are no
studies of PRADAX in pregnant women, the
potential risk in these patients is unknown.
Animal reproductive studies did not show
any adverse effects on fertility or postnatal
development of the neonate.
Women of child-bearing potential should
avoid pregnancy during treatment with
PRADAX and when pregnant, women should
not be treated with PRADAX unless the
expected benefit is greater than the risk.
Nursing Women: Breast-feeding during
treatment with PRADAX is not recommended.
There are no clinical data available on the
excretion of dabigatran into breast milk.
Geriatrics (>65 years of age):
Pharmacokinetic studies in older subjects
demonstrate an increase in drug exposure;
especially in those patients with age-related
decline of renal function (see WARNINGS
AND PRECAUTIONS, Renal, and DOSAGE
S Patients with atrial fibrillation treated
for prevention of stroke and systemic
embolism: Patients aged 80 years and
above should be treated with a daily
dose of 220 mg taken orally as one 110
mg capsule twice daily. This alternate
dosing may also be considered for other
geriatric patients (see DOSAGE AND
ADMINISTRATION, Elderly). Use with
caution.
Pediatrics (<18 years of age): The safety
and efficacy of PRADAX have not been
established in children less than 18 years of
age. Therefore, PRADAX is not recommended
in this patient population.
Patients of low body weight (<50 kg): Since
limited data are available in these patients,
PRADAX should be used with caution.
Monitoring and Laboratory Tests
At recommended doses of PRADAX,
dabigatran prolongs coagulation time
as measured by the activated partial
thromboplastin time (aPTT), thrombin
time (TT) and ecarin clotting time (ECT).
In patients who are bleeding due to excess
activity of dabigatran, these coagulation
tests would be expected to be elevated and
may be helpful in assessing anticoagulant
activity of dabigatran, if necessary (see
ACTION AND CLINICAL PHARMACOLOGY,
Pharmacodynamics in the Product
Monograph). The aPTT is generally less
sensitive to anticoagulant activity than
either TT or ECT (see DRUG INTERACTIONS,
Drug-Laboratory Interactions).
However, the aPTT test is widely available
and provides an approximate indication of
the anticoagulation intensity achieved with
dabigatran. In patients who are bleeding,
the aPTT test may be useful to assist in
64
determining an excess of anticoagulant
activity, despite its limited sensitivity. An
aPTT greater than 80 sec at trough (when
the next dose is due) is associated with a
higher risk of bleeding. In circumstances
where there is no excess of anticoagulant
activity, the utility of aPTT is limited in
monitoring anticoagulant status of patients
taking PRADAX.
ADVERSE REACTIONS
The safety of PRADAX has been evaluated
overall in 22,126 patients.
A total of 10,084 patients were exposed to
at least one dose of dabigatran as study
medication in four active-controlled clinical
trials conducted to evaluate the safety and
effectiveness of dabigatran etexilate in the
prevention of venous thromboembolic events
(VTE) following major elective orthopedic
surgery. Of these, 5,419 were treated with
150 mg or 220 mg daily of PRADAX, while
389 received doses of less than 150 mg
daily, and 1,168 received doses in excess
of 220 mg daily.
In the RELY trial investigating the
prevention of stroke and systemic
embolism in patients with atrial fibrillation,
a total of 12,042 patients were exposed
to PRADAX. Of these, 6,059 were treated
with 150 mg twice daily of dabigatran
etexilate, while 5,983 received doses of
110 mg twice daily.
About 21% of patients with atrial fibrillation
treated with dabigatran and about 16%
of patients treated with warfarin for the
prevention of stroke and systemic embolism
(long-term treatment for up to 3 years)
experienced adverse events considered
related to treatment.
Bleeding
Bleeding is the most relevant side effect
of PRADAX. Bleeding of any type or severity
occurred in approximately 14% of patients
treated short-term for elective hip or knee
replacement surgery and in long-term
treatment in 16.5% of patients with atrial
fibrillation treated for the prevention of
stroke and systemic embolism.
Although rare in frequency in clinical
trials, major or severe bleeding may occur
and, regardless of location, may lead to
disabling, life-threatening or even fatal
outcomes.
A summary description of major and total
bleeding is provided in Table 2.
Table 2 shows the number of patients
experiencing major and total bleeding
event rates during the treatment period in
the RELY study, conducted in patients with
atrial fibrillation. In Table 2, the category of
major bleeds includes both life-threatening
and non-life threatening bleeds. Within
life-threatening, intracranial bleeds is a
subcategory of life-threatening bleeds.
July/August 2011
11-07-04 12:52 PM
Intracranial bleeds include intracerebral
(hemorrhagic stroke), subarachnoid and
subdural bleeds. For this reason, these events
may be counted in multiple categories.
Table 2: Frequency and annualized event rate
(%) of bleeding events from the RELY trial
Dabigatran etexilate
110 mg bid
N (%)
150 mg bid
N (%)
Warfarin**
N (%)
Patients randomized
6,015
6,076
6,022
Patient-years
11,899
12,033
11,794
421 (3.6)
Major bleeding event
(MBE)*
342 (2.9)
399 (3.3)
Hazard ratio vs.
warfarin (95% CI)
0.80 (0.70, 0.93)
0.93 (0.81, 1.07)
p-value
Life threatening MBE
Hazard ratio vs.
warfarin (95% CI)
p-value
Intra-cranial
hemorrhage (ICH)+
Hazard ratio vs.
warfarin (95% CI)
p-value
Any bleeding event a
Hazard ratio vs.
warfarin (95% CI)
p-value
0.0026
0.3146
147 (1.2)
179 (1.5)
0.67 (0.54, 0.82)
0.80 (0.66, 0.98)
0.0001
0.0305
27 (0.2)
38 (0.3)
0.30 (0.19, 0.45)
0.41 (0.28, 0.60)
< 0.0001
< 0.0001
1,754 (14.7)
1,993 (16.6)
0.78 (0.73, 0.83)
0.91 (0.85, 0.96)
< 0.0001
0.0016
218 (1.9)
90 (0.8)
2,166 (18.4)
*Adjudicated bleeds
**Dose-adjusted warfarin to an INR of 2.0 – 3.0
+
ICH consists of adjudicated hemorrhagic stroke and subdural and/or
subarachnoid hemorrhage.
aInvestigator-reported bleeding events
Major bleeding fulfilled one or more of the
following criteria:
S Bleeding associated with a reduction in
hemoglobin of at least 20 grams per litre or
leading to a transfusion of at least 2 units
of blood or packed cells;
S Symptomatic bleeding in a critical area or
organ: intraocular, intracranial, intraspinal
or intramuscular with compartment
syndrome, retroperitoneal bleeding, intraarticular bleeding or pericardial bleeding.
Major bleeds were classified as lifethreatening if they fulfilled one or more of
the following criteria:
S Fatal bleed; symptomatic intracranial
bleed; reduction in hemoglobin of at least
50 grams per litre; transfusion of at least
4 units of blood or packed cells; a bleed
associated with hypotension requiring
the use of intravenous inotropic agents;
a bleed that necessitated surgical
intervention.
Clinical Trial Adverse Drug Reactions:
Because clinical trials are conducted under
very specific conditions, the adverse reaction
rates observed in the clinical trials may not
reflect the rates observed in practice and
should not be compared to the rates in the
clinical trials of another drug. Adverse drug
reaction information from clinical trials is
useful for identifying drug-related adverse
events and for approximating rates.
Table 3: Common Adverse Reactions
observed in *1% of dabigatran-treated
patients with atrial fibrillation in the
active- controlled trial, RELY
Bleeding and anemia*
110 mg N (%)
150 mg N (%)
Warfarin
N (%)
5,983 (100)
6,059 (100)
5,998 (100)
825 (13.8)
599 (10.0)
747 (12.3)
Anemia
73 (1.2)
97 (1.6)
74 (1.2)
Epistaxis
66 (1.1)
67 (1.1)
107 (1.8)
Gastrointestinal
hemorrhage
196 (3.3)
277 (4.6)
155 (2.6)
Urogenital hemorrhage
66 (1.1)
84 (1.4)
96 (1.6)
Gastrointestinal
disorders*
735 (12.3)
772 (12.7)
220 (3.7)
Abdominal pain
135 (2.3)
134 (2.2)
15 (0.3)
Diarrhea
75 (1.3)
71 (1.2)
11 (0.2)
Dyspepsia
250 (4.2)
234 (3.9)
13 (0.2)
Nausea
58 (1.0)
73 (1.2)
12 (0.2)
*Aggregate incidence presented for all adverse reactions within the body
system, including those reactions occurring <1% and not listed in the
Table above.Gastrointestinal adverse reactions occurred more often with
dabigatran etexilate than warfarin. These were related to dyspepsia
(including upper abdominal pain, abdominal pain, abdominal
discomfort, epigastric discomfort), or gastritis-like symptoms (including
GERD, esophagitis, erosive gastritis, gastric hemorrhage, hemorrhagic
gastritis, hemorrhagic erosive gastritis, gastrointestinal ulcer).
Gastrointestinal (GI) hemorrhage occurred at a higher frequency with
PRADAX compared to warfarin (see Table 3). GI adjudicated major
bleeds were reported at 1.1%, 1.6%, and 1.1% (annualized rates) in
the DE 110 mg, DE 150 mg and warfarin groups, respectively. GI lifethreatening bleeds occurred with a frequency of 0.6%, 0.8% and 0.5%
in the DE 110 mg, DE 150 mg and warfarin groups, respectively. Any GI
bleeds occurred with a frequency of 5.4%, 6.1% and 4.0% in the DE
110 mg, DE 150 mg and warfarin groups, respectively. The underlying
mechanism of the increased rate of GI bleeding has not been
established (see CLINICAL TRIALS, Prevention of stroke and systemic
embolism in patients with atrial fibrillation in the Product Monograph).
Allergic reactions or drug hypersensitivity including urticaria,
bronchospasm, rash and pruritus have been reported in patients who
received dabigatran etexilate. Rare cases of anaphylactic reactions
have also been reported.
Less Common Clinical Trial Adverse Drug
Reactions (<1%)
Observed with exposure to dabigatran 110 mg
bid and 150 mg bid during the RELY trial,
an active-controlled clinical trial for the
prevention of stroke and systemic embolism
in patients with atrial fibrillation:
Blood and lymphatic system disorders:
thrombocytopenia
Vascular disorders: hematoma,
hemorrhage
Gastrointestinal disorders:
gastrointestinal ulcer, gastroesophagitis,
gastro-esophageal reflux disease, vomiting,
dysphagia
Hepatobiliary disorders: hepatic function
abnormal/liver function test abnormal,
hepatic enzyme increased
Skin and subcutaneous tissue disorders:
skin hemorrhage, urticaria, rash, pruritus
Musculoskeletal and connective tissue
and bone disorders: hemarthrosis
Renal and urinary disorders: hematuria
General disorders and administration
site conditions: injection site hemorrhage,
catheter site hemorrhage
Injury, poisoning and procedural
complications: incision site hematoma,
traumatic hematoma, incision site
hemorrhage
Immune system disorder: drug
hypersensitivity
Respiratory disorders: hemoptysis,
bronchospasm
Nervous system disorders: intracranial
hemorrhage
For abnormal liver function tests reported in
the RE-LY trial, please see Table 5.
To report an adverse event, contact your
65
Regional Adverse Reaction Monitoring
Office at 1-866-234-2345, or contact:
Boehringer Ingelheim (Canada) Ltd., Drug
Safety at 1-800-263-5103 ext. 4603.
DRUG INTERACTIONS
Based on in vitro evaluation, neither dabigatran
etexilate nor its active moiety, dabigatran,
have been shown to be metabolized by the
human cytochrome P450 system, nor did they
exhibit effects on human CYP P450 isozymes.
Concomitant use of PRADAX with treatments
that interfere with hemostasis or coagulation
increases bleeding risk (see WARNINGS AND
PRECAUTIONS, Bleeding). Co-administration
of PRADAX with other anticoagulants
has not been adequately studied and is
not recommended.
In the RELY trial, conducted in patients
with atrial fibrillation, a two-fold increase
in major bleeding was seen in both
dabigatran study treatment arms, as well
as that of the comparator, warfarin, when
ASA was administered concomitantly (see
Special Populations, Pharmacokinetic
Interactions in the Product Monograph;
CLINICAL TRIALS, Stroke Prevention in Atrial
Fibrillation in the Product Monograph; and
DOSAGE AND ADMINISTRATION).
Drug-Drug Interactions
Transporter
interactions:
Dabigatran
etexilate, but not dabigatran, is a
substrate with moderate affinity for the
efflux P-glycoprotein (P-gp) transporter.
Therefore, potent P-glycoprotein inducers
or inhibitors may be expected to impact
exposure to dabigatran.
P-glycoprotein inhibitors: P-gp inhibitors
like verapamil, quinidine and amiodarone
may be expected to increase systemic
exposure to dabigatran, see Table 4
below. The strong P-glycoprotein inhibitor
ketoconazole, when administered orally, is
contraindicated (see CONTRAINDICATIONS).
If not otherwise specifically described, close
clinical surveillance (looking for signs of bleeding
or anemia), along with a sense of caution is
required when dabigatran is co-administered
with strong P-glycoprotein inhibitors.
P-glycoprotein inducers: The concomitant
use of PRADAX with the strong P-gp inducer
rifampicin, reduces dabigatran plasma
concentration. Other P-gp inducers such as
carbamazepine and St John’s Wort are also
expected to reduce the systemic exposure of
dabigatran. Less potent inducers such as
tenofovir can potentially reduce systemic
exposure. Caution is advised when coadministering these drug products.
P-glycoprotein substrates: Dabigatran
etexilate is not expected to have a clinically
meaningful interaction with P-glycoprotein
substrates that do not also act as inhibitors
or inducers of P-gp.
July/August 2011
11-07-04 12:52 PM
Table 4: Summary of Drug-Drug Interactions
Proper name
Ref*
Effect
Clinical comment
Amiodarone
CT
Dabigatran exposure in healthy
subjects was increased by 60%
in the presence of amiodarone
(see ACTION AND CLINICAL
PHARMACOLOGY, Special
Populations, Pharmacokinetic
Interactions in the Product
Monograph).
Adjust dosing for patients
treated for prevention of VTE
after hip- or knee-replacement
surgery to 150 mg daily PRADAX
with amiodarone. Caution should
be exercised.
No dose adjustment is generally
recommended for AF patients.
Use with caution. Occasional
testing of aPTT may be
considered to rule out excessive
anticoagulant effect.
Antacids (aluminium
compounds, sodium
bicarbonate, calcium
and/or magnesium
compounds, or
combinations of
these)
CT
In population PK analyses, a
reduction in dabigatran exposure
by 35% was seen over the first
24 hours following surgery.
Thereafter, (>24 hours after
surgery), a reduction of about
11% was observed.
Diminished clinical effect may
occur, as may be expected for
any drug resulting in an increase
in gastric pH during PRADAX
administration. PRADAX should
be administered at least 2 hours
before taking an antacid.
Co-administration with PRADAX
should be avoided within 24
hours after orthopedic surgery.
Atorvastatin
CT
When dabigatran etexilate was
co-administered with atorvastatin,
exposure of atorvastatin, and
atorvastatin metabolites were not
significantly changed. Dabigatran
concentrations were decreased
about 20%.
No dose adjustment is
recommended.
Clarithromycin
CT
subjects was increased by
about 15% in the presence of
clarithromycin (see ACTION
AND CLINICAL PHARMACOLOGY,
Special Populations,
Pharmacokinetic Interactions in
the Product Monograph).
recommended. Caution should
be exercised.
Diclofenac
CT
co-administered with diclofenac,
pharmacokinetics of both drugs
appeared unchanged.
recommended.
Use with caution (see
WARNINGS AND PRECAUTIONS,
Bleeding, Table 1.)
Digoxin
CT
co-administered with digoxin, no
PK-interaction was observed.
recommended.
Ketoconazole
CT
Dabigatran exposure was
increased 150% after single and
multiple doses of ketoconazole
Monograph).
Co-administration
with PRADAX is
contraindicated.
(see CONTRAINDICATIONS).
Pantoprazole
CT
co-administered with
pantoprazole, a decrease in
dabigatran AUC of about 30 %
was observed.
In the Phase III study, RELY, PPI
co-medication did not result
in lower trough levels and on
average only slightly reduced
post-dose concentrations (-11%)
Monograph).
recommended. Diminished
clinical effect may occur, as
may be expected for any drug
resulting in an increase in
gastric pH during PRADAX
administration.
Rifampicin
CT
After 7 days of treatment
with 600 mg rifampicin qd
total dabigatran AUC0-' and
Cmax were reduced by 67%
and 66% compared to the
reference treatment, respectively
Monograph).
Concomitant use of PRADAX with
rifampicin should, in general,
be avoided. Concomitant use
would be expected to result
in substantially diminished
anticoagulant effect of PRADAX.
When dabigatran etexilate,
given at 150 mg once daily,
was co-administered with
moderate doses of oral
verapamil, the Cmax and AUC
of dabigatran were increased,
but the magnitude of this
change varied depending on the
timing of administration and
the formulation of verapamil
used (see ACTION AND CLINICAL
Monograph).
Dosing should be reduced to 150
mg PRADAX daily in patients
surgery who concomitantly
receive dabigatran etexilate and
verapamil. To minimize potential
for interaction, PRADAX should
be given at least two hours
before verapamil.
Caution should be exercised.
subjects was increased by 53 %
in the presence of quinidine.
Adjust dosing for patients
surgery to 150 mg daily PRADAX.
Verapamil
Quinidine
CT
CT
Although no dose adjustment is
recommended for AF patients,
to minimize potential for
interaction, PRADAX should be
given at least two hours before
verapamil.
Although no dose adjustment is
recommended for AF patients, to
minimize potential for interaction, PRADAX should be given at
least two hours before quinidine,
if possible.
*C = Case Study; CT = Clinical Trial; T = Theoretical
Drug-Food Interactions
Food does not affect the bioavailability
of PRADAX but delays the time-to-peak
plasma concentrations by 2 hours.
Drug-Herb Interactions
Drug-herb interactions have not been
investigated. Potent P-gp inducers such as
St. John’s Wort (Hypericum perforatum) may
be expected to affect systemic exposure
of dabigatran. Co-administration of these
products is not recommended.
Drug-Laboratory Interactions
No single test (aPTT, TT, ECT) is adequate
to reliably assess the anticoagulant
activity of dabigatran following PRADAX
administration. At therapeutic levels of
dabigatran, thrombin time (TT) is the best
measure of the pharmacodynamic effect
of dabigatran because of its linear and
sensitive relationship with dabigatran
exposure (WARNINGS AND PRECAUTIONS,
Monitoring
and
Laboratory
Tests;
Pharmacodynamics, in the Product
Monograph).
The aPTT test is widely available and
provides an approximate indication of the
anticoagulation intensity achieved with
dabigatran. In patients who are bleeding,
the aPTT test may be useful to assist in
determining an excess of anticoagulant
activity, despite its limited sensitivity. An
aPTT greater than 80 sec at trough (when the
next dose is due) is associated with a higher
risk of bleeding.
Note that a PT (INR) test is not useful to assess
the anticoagulant activity of PRADAX.
Drug-Lifestyle Interactions
No direct interaction between dabigatran
etexilate and alcohol was demonstrated in
animal models or has been hypothesized.
The effect of PRADAX on the ability to
drive and use machines has not been
investigated. However, no such interaction
is to be expected.
Administration
v
DOSAGE AND ADMINISTRATION
PRADAX should be taken orally, with the
entire capsule to be swallowed whole. The
capsule should not be chewed, broken, or
opened.
PRADAX should be taken regularly, as
prescribed, to ensure optimal effectiveness.
All temporary discontinuations should be
avoided, unless medically indicated.
Recommended Dose and Dosage Adjustment
S Prevention
of stroke and systemic
fibrillation: The recommended dose of
PRADAX is 300 mg daily, taken orally as
one 150 mg capsule twice a day.
Elderly:
S Prevention of stroke and systemic
fibrillation: Patients aged 80 years and
above should be treated with a dose of
220 mg of PRADAX daily, taken orally as
one 110 mg capsule twice a day (see
WARNINGS AND PRECAUTIONS, Geriatrics,
and CLINICAL TRIALS, Prevention of Stroke
and Systemic Embolism in Patients with
Atrial Fibrillation, Tables 24 and 25, in the
Product Monograph).
S The usual recommended dose for most
geriatric patients under the age of 80
years is 300 mg daily, taken orally as
one 150 mg capsule twice a day (see
66
CLINICAL TRIALS, Prevention of Stroke
and Systemic Embolism in Patients with
Atrial Fibrillation, Tables 24 and 25, in
the Product Monograph). However, in
geriatric patients, especially those over
the age of 75 with at least one other risk
factor for bleeding (see WARNINGS AND
PRECAUTIONS, Bleeding, Table 2), the
administration of a dose of 220 mg of
PRADAX daily, taken orally as one 110 mg
capsule twice a day, may be considered.
It should be noted, however, that the
effectiveness of stroke prevention may be
expected to be lessened with this dosage
regimen, compared to that of the usual
one of 300 mg of PRADAX daily. As with
any anticoagulant, caution is required
when prescribing PRADAX to the elderly
(see CONTRAINDICATIONS, and WARNINGS
AND PRECAUTIONS, Bleeding).
Patients at risk of bleeding: Prevention of
stroke and systemic embolism in patients
with atrial fibrillation: Patients with an
increased risk of bleeding (see WARNINGS
AND PRECAUTIONS, Bleeding, Table 1),
should be closely monitored clinically
(looking for signs of bleeding or anemia).
In such patients, a dose of 220 mg, given
as 110 mg twice daily may be considered.
A coagulation test, such as aPTT (see
WARNINGS AND PRECAUTIONS, Monitoring
and Laboratory Tests), may help to identify
patients with an increased bleeding risk
caused by excessive dabigatran exposure.
As for any anticoagulant, PRADAX is NOT
indicated in patients at excessive risk of
bleeding (see CONTRAINDICATIONS).
Renal impairment: Following oral dosing
with dabigatran etexilate, there is a
direct correlation of systemic exposure
to dabigatran with degree of renal
impairment
(see
WARNINGS
AND
PRECAUTIONS, Renal). The kidneys account
for 85% of dabigatran clearance.
There are no data to support use in patients with
severe renal impairment (CrCl <30 mL /min).
Given the substantial increase in
dabigatran exposure observed in this
patient population, treatment with PRADAX
is not recommended (see CONTRAINDICATIONS, and ACTION AND CLINICAL
PHARMACOLOGY, Renal Insufficiency in the
Product Monograph).
embolism having moderate renal
impairment (CrCl 30-50 mL /min): No
dose adjustment is recommended (see
CLINICAL TRIALS, Prevention of Stroke and
Systemic Embolism in Patients with Atrial
Fibrillation, Renal Impairment in the
Product Monograph). Patients with
moderate renal impairment (CrCl 30-50
mL /min) should be treated with a daily
July/August 2011
11-07-04 12:52 PM
dose of PRADAX at 300 mg taken orally as
one 150 mg capsule twice daily, with
caution. Regular assessment of renal
status is required in these patients (see
CONTRAINDICATIONS, WARNINGS AND
PRECAUTIONS, Renal). A coagulation test,
such as aPTT (see WARNINGS AND
PRECAUTIONS, Monitoring and Laboratory
Tests), may help to identify patients with
an increased bleeding risk caused by
excessive dabigatran exposure.
Creatinine clearance can be estimated using
the Cockroft-Gault formula as follows:
Creatinine clearance (mL/min) =
Males:
(140-age (years)) x weight (kg)
72 x serum creatinine (mg/100mL)
Females: 0.85 x (140-age (years)) x weight (kg)
72 x serum creatinine (mg/100mL)
P-glycoprotein inhibitors: P-gp inhibitors
like verapamil, quinidine, and amiodarone
may be expected to increase systemic
exposure to dabigatran. Combination use
with oral ketoconazole is contraindicated
embolism: No dose adjustment is
recommended in patients concomitantly
receiving amiodarone, quinidine or
verapamil (see DRUG INTERACTIONS,
Ta b l e 4 , S u m m a r y o f D r u g - D r u g
Interactions; and ACTION AND CLINICAL
PHARMACOLOGY, Special Populations,
Pharmacokinetic interactions in the
Product Monograph). Patients should be
treated with a daily dose of 300 mg
PRADAX taken orally as one 150 mg
capsule twice daily. To minimize potential
for interaction, PRADAX should be given
at least two hours before verapamil (see
Special Populations, Pharmacokinetic
interactions in the Product Monograph).
Caution should be exercised. Close
clinical surveillance is recommended.
Drugs that increase gastric pH, such as
antacids, protein pump inhibitors (PPI):
Diminished clinical effect for antacids may
occur (see DRUG INTERACTIONS, Table 4,
Summary of Drug-Drug Interactions). Although
no dosage adjustment is generally necessary,
administer PRADAX at least two hours before
antacids, if possible, to minimize interaction
potential. No dose adjustment is required for
pantoprazole or other PPIs.
Concomitant antithrombotic use:
Concomitant use of ASA or clopidogrel with
PRADAX in patients with atrial fibrillation
approximately doubled the risk of major
bleed, irrespective of dose of PRADAX used.
A similar increase was noted with such
concomitant use with the study comparator,
warfarin. These observations contrasted
with little apparent additional improvement
in stroke and systemic embolic events with
combined antithrombotic use and PRADAX
(or warfarin).
Concomitant use of PRADAX with an
antithrombotic is not recommended for
prevention of cardiogenic thromboembolic
stroke in patients with atrial fibrillation.
Concomitant use of ASA or other antiplatelet
agents based on medical need to prevent
myocardial infarction should be undertaken
with caution. Close clinical surveillance is
recommended.
Acute myocardial infarction (AMI):
Consideration should be given to
discontinuing PRADAX in the setting of
acute myocardial infarction should the
treatment of myocardial infarction involve
invasive procedures, such as percutaneous
coronary revascularization, or coronary
artery bypass surgery. Similar consideration
should be given if thrombolytic therapy is
to be initiated, because bleeding risk may
increase. Patients with AMI should be treated
according to current clinical guidelines for
that disorder. In this setting, PRADAX may
be resumed for the prevention of stroke and
systemic embolism upon completion of these
revascularization procedures.
Children: Since PRADAX has not been
investigated in patients <18 years of age,
treatment is not recommended.
Patient Body Weight: Population PK
modelling shows that patients with a body
weight of about 120 kg have about 20%
lower drug exposure. Patients with a body
weight of about 48 kg have about 25%
higher drug exposure compared to patients
with average weight. No dose adjustment
deemed necessary.
Switching from PRADAX treatment to
parenteral anticoagulant:
S In patients with atrial fibrillation treated
for prevention of stroke and systemic
embolism: wait 12 hours after the last
dose of PRADAX before switching to a
parenteral anticoagulant.
Switching from parenteral anticoagulants
treatment to PRADAX: If deemed medically
appropriate, treatment with PRADAX should
be initiated 0-2 hours prior to the time that
the next dose of the alternate therapy would be
due, or at the time of discontinuation in case
of continuous treatment (e.g., intravenous
unfractionated heparin, [UFH]).
Switching from Vitamin K antagonists to
PRADAX: If deemed medically appropriate,
PRADAX should only be started after Vitamin
K antagonists have been discontinued, and
the patient’s INR is found to be below 2.0.
Cardioversion: Patients can be maintained
on PRADAX while being cardioverted.
Missed Dose: Prevention of stroke and
systemic embolism in patients with atrial
67
fibrillation: If the prescribed dose of PRADAX
is not taken at the scheduled time, the dose
should be taken as soon as possible on the
same day. A forgotten PRADAX dose may
still be taken up to 6 hours prior to the next
scheduled dose. From 6 hours prior to the
next scheduled dose on, the missed dose
should be omitted. Patients should not
take a double dose to make up for missed
individual doses. For optimal effect and
safety, it is important to take PRADAX
regularly twice a day, at approximately
12-hour intervals.
Administration
PRADAX may be taken with food, or on an
empty stomach with water.
The capsule should be swallowed intact. It
should not be opened, broken, or chewed (see
ACTION AND CLINICAL PHARMACOLOGY in the
full Product Monograph, Pharmacokinetics in
SUPPLEMENTAL PRODUCT INFORMATION
Adverse Reactions:
Liver Function Tests: In the long-term RELY study, observed
abnormalities of liver function tests (LFT) are presented below
in Table 5.
Table 5: Liver Function Tests in the RELY trial
Total treated
110 mg twice daily
N (%)
150 mg twice daily
N (%)
Warfarin
N (%)
5,983 (100.0)
6,059 (100.0)
5,999 (100.0)
ALT or AST >3xULN
118 (2.0)
106 (1.7)
125 (2.1)
ALT or AST >5xULN
36 (0.7)
45 (0.7)
50 (0.8)
ALT or AST >3xULN +
Bilirubin >2xULN
11 (0.2)
14 (0.2)
21 (0.4)
OVERDOSAGE
There is no antidote to dabigatran etexilate or dabigatran.
Doses of PRADAX beyond those recommended expose the
patient to increased risk of bleeding. Excessive anticoagulation
may require discontinuation of PRADAX. In the event of
hemorrhagic complications, treatment must be discontinued
and the source of bleeding investigated. Since dabigatran is
excreted predominantly by the renal route, adequate diuresis
must be maintained. Appropriate standard treatment,
e.g., surgical hemostasis as indicated and blood volume
replacement, should be undertaken. In addition, consideration
may be given to the use of fresh whole blood or the transfusion
of fresh frozen plasma.
As protein binding is low, dabigatran can be dialysed, although
there is limited clinical experience in using dialysis in this setting.
Activated prothrombin complex concentrates (e.g., FEIBA) or
recombinant Factor VIIa or concentrates of coagulation factors
II, IX or X, may be considered. There is some experimental
evidence to support the role of these agents in reversing
the anticoagulant effect of dabigatran but their usefulness
in clinical settings has not yet been clearly demonstrated.
Consideration should also be given to administration of
platelet concentrates in cases where thrombocytopenia is
present or long-acting antiplatelet drugs have been used.
All symptomatic treatment should be given according to the
physician’s judgement.
For management of a suspected drug overdose,
contact your regional Poison Control Centre.
Product Monograph is available upon request or at
www.boehringer-ingelheim.ca
Boehringer Ingelheim (Canada) Ltd.
5180 South Service Road
Burlington, ON L7L 5H4
PRADAX™ is a trademark of Boehringer Ingelheim Pharma GmnH & Co.
KG, used under license by Boehringer Ingelheim (Canada) Ltd.
November 8, 2010
July/August 2011
11-07-04 12:52 PM
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July/August 2011
11-07-04 12:54 PM
Rigorous clinical monitoring for suicidal ideation or other indicators of potential for suicidal behaviour is advised in
patients of all ages especially when initiating therapy or during any change in dose or dosage regimen. This includes
monitoring for agitation-type emotional and behavioural changes.
Patients currently taking PRISTIQ should NOT be discontinued abruptly, due to risk of discontinuation symptoms (see
WARNINGS AND PRECAUTIONS, Discontinuation Symptoms, below). At the time that a medical decision is made to
discontinue an SSRI or other newer antidepressant drug, a gradual reduction in the dose, rather than an abrupt
cessation, is recommended. (See Dosage and Administration).
Concomitant Use of PRISTIQ with Venlafaxine
Prescribing Summary
Since desvenlafaxine is the major active metabolite of venlafaxine, concomitant use of PRISTIQ with products containing
Venlafaxine is not recommended since the combination of the two will lead to additive desvenlafaxine exposure.
Monitoring and Laboratory Tests
Serum Lipids: increases in cholesterol (total and LDL) and triglycerides were observed in some patients treated with
desvenlafaxine succinate in placebo-controlled pre-marketing clinical trials, particularly with higher doses. Measurement of
serum lipid levels should be considered during treatment.
Therapeutic Category: Antidepressant
Action: Serotonin and Norepinephrine Reuptake Inhibitor (SNRI)
Indications and Clinical Use
Heart Rate and Blood Pressure: increases in heart rate and blood pressure were observed in some patients in clinical trials,
particularly with higher doses. Measurement of blood pressure is recommended prior to initiating treatment and regularly
during treatment with desvenlafaxine succinate (see ADVERSE REACTIONS, Vital Sign Changes).
Adults: PRISTIQ® desvenlafaxine Extended-Release Tablets is indicated for: the symptomatic relief of major depressive
disorder. The short-term efficacy of PRISTIQ extended-release tablets has been demonstrated in placebo-controlled trials
of up to 8 weeks.
Pediatrics (<18 years of age): PRISTIQ is not indicated for use in children under the age of 18. Safety and efficacy in the
pediatric population have not been established (see WARNINGS AND PRECAUTIONS, POTENTIAL ASSOCIATION WITH
BEHAVIOURAL AND EMOTIONAL CHANGES, INCLUDING SELF-HARM).
Self-Harm: rigorous clinical monitoring for suicidal ideation or other indicators of potential for suicidal behaviour is advised in
patients of all ages. Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety,
agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness),
hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially when
initiating therapy or during any change in dose or dosage regimen. (See WARNINGS AND PRECAUTIONS, POTENTIAL
ASSOCIATION WITH BEHAVIOURAL AND EMOTIONAL CHANGES, INCLUDING SELF-HARM).
CONTRAINDICATIONS
P Desvenlafaxine must not be used concomitantly in patients taking monoamine oxidase inhibitors (MAOIs), including
linezolid, an antibiotic, methylene blue, a dye used in certain surgeries, or in patients who have taken MAOIs within
the preceding 14 days due to the risk of serious, sometimes fatal, drug interactions with selective serotonin reuptake
inhibitor (SSRI) or serotonin norepinephrine reuptake inhibitor (SNRI) treatment or with other serotonergic drugs. These
interactions have been associated with symptoms that include tremor, myoclonus, diaphoresis, nausea, vomiting, flushing,
dizziness, hyperthermia with features resembling neuroleptic malignant syndrome, seizures, rigidity, autonomic instability
with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to
delirium and coma. Based on the half-life of desvenlafaxine succinate, at least 7 days should be allowed after stopping
desvenlafaxine succinate and before starting an MAOI
P Hypersensitivity to desvenlafaxine succinate extended-release, venlafaxine hydrochloride or to any excipients in the
desvenlafaxine formulation. For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section
of the Product Monograph
Psychiatric
Mania/hypomania: mania/hypomania may occur in a small proportion of patients with mood disorders who have
received medication to treat depression, including desvenlafaxine succinate. During phase 2 and phase 3 studies, mania
was reported for approximately 0.1% of patients treated with PRISTIQ. Activation of mania/hypomania has also
been reported in a small proportion of patients with major affective disorder who were treated with other marketed
antidepressants. As with all antidepressants, PRISTIQ should be used cautiously in patients with a history or family history
of mania or hypomania.
Neurologic
Seizures: cases of seizures have been reported in pre-marketing trials with PRISTIQ. Desvenlafaxine succinate should
be prescribed with caution in patients with a seizure disorder. Desvenlafaxine has not been systematically evaluated in
patients with a seizure disorder.
SPECIAL POPULATIONS
Pregnant Women: the safety of desvenlafaxine in human pregnancy has not been established. The extent of exposure to
PRISTIQ in pregnancy during clinical trials was very limited. There are no adequate and well-controlled studies in pregnant
women. Therefore, desvenlafaxine should be used during pregnancy only if the potential benefits justify the potential risks.
If desvenlafaxine succinate is used until or shortly before birth, discontinuation effects in the newborn should be considered.
Post-marketing reports indicate that some neonates exposed to SNRIs, SSRIs, or other newer antidepressants late in the
third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding.
Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis,
apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia,
tremor, jitteriness, irritability, and constant crying. These features are consistent with either a direct toxic effect of SNRIs, SSRIs
and other newer antidepressants, or, possibly a drug discontinuation syndrome. It should be noted that, in some cases, the
clinical picture is consistent with serotonin syndrome (see DRUG INTERACTIONS). When treating a pregnant woman with
PRISTIQ during the third trimester, the physician should carefully consider the potential risks and benefits of treatment.
Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy.
Labour and Delivery: the effect of desvenlafaxine on labour and delivery in humans is unknown. PRISTIQ should be used
during labour and delivery only if the potential benefits justify the potential risks.
Nursing Women: desvenlafaxine (O-desmethylvenlafaxine) is excreted in human milk. Because of the potential for serious
adverse reactions in nursing infants from PRISTIQ, a decision should be made whether or not to discontinue nursing or to
discontinue the drug, taking into account the importance of the drug to the mother. Only administer PRISTIQ to breastfeeding
women if the expected benefits outweigh any possible risk.
Pediatric: safety and effectiveness in patients less than 18 years of age have not been established.
Geriatrics ( *65 years of age): of the 3,292 patients in clinical trials with PRISTIQ, 5% were 65 years of age or older.
No overall differences in safety or efficacy were detected between these subjects and younger subjects; however
in the short-term placebo-controlled trials, there was a higher incidence of systolic orthostatic hypotension in patients
*65 years of age compared to all adults treated with desvenlafaxine. For elderly patients, possible reduced renal clearance
of desvenlafaxine should be considered when determining dose (see Dosing Considerations, Geriatrics and ACTION AND
CLINICAL PHARMACOLOGY, Geriatrics). Greater sensitivity of some older individuals cannot be ruled out.
Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-Like Reactions: as with other serotonergic agents,
Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions, a potentially life-threatening condition,
have been reported with SNRIs and SSRIs alone, including PRISTIQ treatment, particularly with concomitant use of
other agents that may affect the serotonergic neurotransmitter systems [such as triptans, serotonin reuptake inhibitors,
sibutramine, MAOIs (including linezolid, an antibiotic, and methylene blue), St. John’s Wort (Hypericum perforatum) and/
or lithium] and with drugs that impair metabolism of serotonin or with antipsychotics or other dopamine antagonists.
Serotonin Syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, and coma), autonomic
instability (e.g., tachycardia, labile blood pressure, and hyperthermia), neuromuscular aberrations (e.g., hyperreflexia,
incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea). Serotonin Syndrome, in its most
severe form, can resemble NMS, which includes hyperthermia, muscle rigidity, autonomic instability with possible rapid
fluctuation of vital signs, and mental status changes.
If concomitant treatment with desvenlafaxine and other agents that may affect the serotonergic and/or dopaminergic
neurotransmitter system such as another SSRI, a Selective Serotonin and Norepinephrine Reuptake Inhibitor (SNRI) or
a 5-hydroxytryptamine receptor agonist (triptan) is clinically warranted, careful observation of the patient is advised,
particularly during treatment initiation and dose increases. The concomitant use of desvenlafaxine with serotonin precursors
(such as tryptophan supplements) is not recommended (see DRUG INTERACTIONS, Serotonin Syndrome).
Treatment with PRISTIQ and any concomitant serotonergic or antidopaminergic agents, including antipsychotics, should be
discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated.
Ophthalmologic
Narrow Angle Glaucoma: mydriasis has been reported in association with desvenlafaxine; therefore, patients with raised
intraocular pressure or those at risk of acute narrow-angle glaucoma (angle-closure glaucoma) should be monitored
(see ADVERSE REACTIONS).
Gastrointestinal
Potential for Gastrointestinal Obstruction: because the PRISTIQ tablet does not appreciably change in shape in the
gastrointestinal tract, PRISTIQ should not be administered to patients with pre-existing gastrointestinal narrowing (pathologic
or iatrogenic, such as small bowel inflammatory disease, “short gut” syndrome due to adhesions or decreased transit
time, past history of peritonitis, cystic fibrosis, chronic intestinal pseudo-obstruction, or Meckel’s diverticulum). There have
been rare reports of obstructive symptoms in patients with known strictures in association with the ingestion of other
drugs in nondeformable controlled-release formulations, and very rare reports of obstructive symptoms associated with
the use of nondeformable controlled-release formulations in patients without known gastrointestinal stricture. Due to the
controlled-release design, PRISTIQ tablets should only be used in patients who are able to swallow the tablets whole.
(See DOSAGE AND ADMINISTRATION; Recommended Dose and Dosage Adjustment).
Safety Information
POTENTIAL ASSOCIATION WITH BEHAVIOURAL AND EMOTIONAL CHANGES, INCLUDING SELF-HARM.
Pediatrics: Placebo-Controlled Clinical Trial Data
Recent analyses of placebo-controlled clinical trial safety databases from Selective Serotonin Reuptake Inhibitors
(SSRIs) and other newer anti-depressants suggest that use of these drugs in patients under the age of 18 may be
associated with behavioural and emotional changes, including an increased risk of suicidal ideation and behaviour
over that of placebo.
ADVERSE REACTIONS
The safety of PRISTIQ in major depressive disorder was evaluated in 3,292 patients exposed to at least one dose of PRISTIQ.
The most commonly observed adverse reactions (incidence of 5% or greater for the DVS SR pooled 50- to 400-mg doses,
and incidence higher than placebo) in DVS SR-treated MDD patients in short-term placebo controlled trials were: nausea,
headache, dry mouth, hyperhydrosis, dizziness, insomnia, constipation, decreased appetite, somnolence, fatigue, tremor,
and vomiting, and, in men, erectile dysfunction and ejaculation delayed.
The small denominators in the clinical trial database, as well as the variability in placebo rates, preclude reliable
conclusions on the relative safety profiles among the drugs in the class.
Adults and Pediatrics: Additional Data
There are clinical trial and post-marketing reports with SSRIs and other newer antidepressants, in both pediatrics and
adults, of severe agitation-type adverse events coupled with self-harm or harm to others. The agitation-type events
include: akathisia, agitation, disinhibition, emotional lability, hostility, aggression, depersonalization. In some cases,
the events occurred within several weeks of starting treatment.
July_Aug11_PRISTIQ_3P_PI_pp69-71.indd 1
Adverse Events Reported as Reasons for Discontinuation of Treatment in MDD Clinical Trials
In the 8-week placebo-controlled, pre-marketing trials for MDD, 12% of the 1,834 patients who received PRISTIQ (50-400 mg/day)
discontinued treatment due to an adverse experience, compared with 3% of the 1,116 placebo-treated patients in those trials.
69
July/August 2011
11-07-04 12:11 PM
At the recommended dose of 50 mg, the discontinuation rate due to an adverse experience for PRISTIQ (4.1%) was similar
to the rate for placebo (3.8%) and only 1% of patients discontinued due to nausea. The most common adverse reactions
leading to discontinuation (i.e., leading to discontinuation in at least 2% and incidence higher than placebo) of the PRISTIQtreated patients in short-term trials of up to 8 weeks were: nausea (4%); dizziness, headache and vomiting (2% each).
Use in patients with hepatic impairment: no dosage adjustment is necessary for patients with hepatic impairment
(see ACTION AND CLINICAL PHARMACOLOGY, Hepatic Insufficiency).
To report adverse events:
Pfizer Canada Inc.
T 1-800-463-6001 F 1-866-463-6001
Discontinuation of Therapy: a gradual reduction in the dose rather than abrupt cessation is recommended whenever
possible. Discontinuation regimens should take into account the individual circumstances of the patient, such as duration
of treatment and dose at discontinuation (see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS).
DRUG-DRUG INTERACTIONS
Monoamine Oxidase Inhibitors: desvenlafaxine succinate is contraindicated in patients taking MAOIs. Desvenlafaxine
succinate must not be used in combination with a monoamine oxidase inhibitor (MAOI), or within at least 14 days of
discontinuing treatment with an MAOI. Based on the half-life of desvenlafaxine succinate, at least 7 days should be
allowed after stopping desvenlafaxine succinate before starting an MAOI (see CONTRAINDICATIONS).
Serotonin Syndrome: as with other serotonergic agents, serotonin syndrome, a potentially life-threatening condition, may
occur with desvenlafaxine treatment, particularly with concomitant use of other agents that may affect the serotonergic
neurotransmitter system [including triptans, SSRIs, other SNRIs, lithium, sibutramine, tramadol, or St. John’s Wort
(Hypericum perforatum), with drugs which impair metabolism of serotonin (such as MAOIs, including linezolid, an
antibiotic which is a reversible non-selective MAOI, and methylene blue); see CONTRAINDICATIONS], or with serotonin
precursors (such as tryptophan supplements). Serotonin syndrome symptoms may include mental status changes,
autonomic instability, neuromuscular aberrations and/or gastrointestinal symptoms (see WARNINGS AND PRECAUTIONS).
If concomitant treatment of desvenlafaxine with an SSRI, an SNRI or a 5-hydroxytryptamine receptor agonist (triptan)
is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose
increases. The concomitant use of desvenlafaxine with serotonin precursors (such as tryptophan supplements) is
not recommended.
Central Nervous System (CNS) Active Agents
The risk of using desvenlafaxine succinate in combination with other CNS-active drugs has not been systematically evaluated.
Consequently, caution is advised when desvenlafaxine succinate is taken in combination with other CNS-active drugs.
Drugs that Interfere with Hemostasis (e.g., NSAIDs, Aspirin, and Warfarin)
Serotonin release by platelets plays an important role in hemostasis. Epidemiological studies of case-control and cohort
design that have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake
and the occurrence of upper gastrointestinal bleeding. These studies have also shown that concurrent use of an NSAID or
aspirin may potentiate this risk of bleeding. Altered anticoagulant effects, including increased bleeding, have been reported
when SSRIs and SNRIs are coadministered with warfarin. Patients receiving warfarin therapy should be carefully monitored
when PRISTIQ is initiated or discontinued.
Geriatrics (*65 years of age): no dosage adjustment is required solely on the basis of age; however, possible reduced
clearance of PRISTIQ should be considered when determining dose (see ACTION AND CLINICAL PHARMACOLOGY, Geriatrics).
Adverse Reactions in MDD Clinical Trials
PRISTIQ was evaluated for safety in 3,292 patients diagnosed with major depressive disorder who participated in multiple-dose pre-marketing trials,
representing 1,289 patient-years of exposure. Among these 3,292 PRISTIQ-treated patients, 1,834 patients participated in 8-week, placebo-controlled
trials at doses ranging from 50 to 400 mg/day. Of the total 3,292 subjects exposed to at least 1 dose of PRISTIQ, 1070 were exposed to PRISTIQ
for greater than 6 months and 274 were exposed for 1 year.
Adverse Reactions Occurring at an Incidence of *1% among PRISTIQ-treated Patients in Short-Term Placebo-controlled Trials
The following adverse reactions (Table 1) occurred at *1% and are listed alphabetically by body system.
Reported adverse events were classified using a standard MedDRA-based Dictionary terminology.
Table 1: Adverse Reactions (*1% in Any PRISTIQ Group): Percentage of Subjects in Short-Term, Placebo-Controlled MDD Studies
System Organ Class
Preferred Term
PRISTIQ
Placeboa
n=1116
50 mg b
n=317
100 mgb
n=424
200 mgb
n=307
400 mgb
n=317
50-400 mga
n=1834
2
1
1
1
3
<1
2
1
3
2
2
1
1
2
1
1
2
1
Mydriasis
<1
Vision blurred
1
Gastrointestinal disorders
Nausea
11
Dry mouth
8
Constipation
4
Diarrhea
9
Vomiting
2
General disorders and administration site conditions
Fatigue
4
Chills
1
Feeling jittery
1
Asthenia
1
2
3
2
4
6
4
6
4
4
4
22
11
9
11
3
26
17
9
9
4
36
21
10
7
6
41
25
14
5
9
32
20
11
8
6
7
1
1
1
7
<1
2
2
10
3
3
1
11
4
3
1
8
2
2
1
1
1
1
2
1
1
2
1
2
2
2
1
2
5
8
10
10
9
1
1
<1
1
1
1
25
6
4
2
1
1
<1
20
13
4
2
2
1
<1
22
10
9
3
2
1
1
29
15
12
9
1
1
2
25
16
12
9
3
2
1
25
13
9
6
2
2
1
6
3
2
0
1
<1
1
9
3
2
<1
2
1
<1
12
5
3
2
3
1
1
14
4
2
2
3
1
2
15
4
4
6
2
2
2
12
4
3
2
2
1
1
<1
<1
1
2
2
1
<1
1
1
4
3
3
4
1
10
1
11
1
18
2
21
<1
15
1
<1
1
1
2
2
2
Cardiac disorders
Palpitations
Tachycardia
Ear and labyrinth disorders
Tinnitus
Eye disorders
Administration
General
PRISTIQ is not indicated for use in children under 18 years of age (see WARNINGS AND PRECAUTIONS, Potential
Association with Behavioural and Emotional Changes, Including Self-Harm).
Initial Treatment: the recommended dose of PRISTIQ (desvenlafaxine succinate) extended-release tablets is 50 mg once
daily, with or without food. In clinical studies, no additional benefit was demonstrated at doses greater than 50 mg/day.
In clinical studies, doses of 50-400 mg/day were shown to be effective, although no additional benefit was demonstrated
at doses greater than 50 mg/day, and adverse events and discontinuations were more frequent at higher doses. If the
physician, based on clinical judgment, decides a dose increase above 50 mg/day is warranted for an individual patient,
the maximum dose should not exceed 100 mg/day. Patients should be periodically reassessed to determine the need
for continued treatment.
Investigations
Blood pressure increased
Weight decreased
Metabolism and nutrition disorders
Decreased appetite
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
Nervous system disorders
Headache
Dizziness
Somnolence
Tremor
Paraesthesia
Dysgeusia
Disturbance in attention
It is recommended that PRISTIQ be taken at approximately the same time each day. PRISTIQ tablets must be swallowed
whole with liquids, and must not be chewed, divided or crushed. The medication is contained within a non-absorbable shell
designed to release the drug at a controlled rate. The tablet shell, along with insoluble core components, is eliminated
from the body; patients should not be concerned if they occasionally notice something that looks like a tablet in their
stool. Due to the controlled-release design, PRISTIQ tablets should only be used in patients who are able to swallow the
tablets whole.
Psychiatric disorders
Missed Dose: a patient missing a dose should take it as soon as they remember to. If it is almost time for the next dose,
the missed dose should be skipped. The patient should be cautioned against taking two doses concomitantly to “make up”
for the missed dose.
Insomnia
Anxiety
Abnormal dreams
Anorgasmia
Libido decreased
Orgasm abnormal
Nervousness
Discontinuing PRISTIQ: symptoms associated with discontinuation of PRISTIQ, other SNRIs and SSRIs have been
reported (see WARNINGS AND PRECAUTIONS, Discontinuation Symptoms and ADVERSE REACTIONS, Discontinuation
symptoms). Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the
dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease
in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered.
Subsequently, the physician may continue decreasing the dose, but at a more gradual rate. As the lowest dosage strength
of PRISTIQ is 50 mg, it is recommended that dose reduction from 50 mg/day should proceed to 50 mg every other
day before discontinuation.
Renal and urinary disorders
Urinary hesitation
Respiratory, thoracic and mediastinal disorders
Yawning
Skin and subcutaneous tissue disorders
Switching Patients from Other Antidepressants to PRISTIQ
Discontinuation symptoms have been reported when switching patients from other antidepressants, including
venlafaxine, to PRISTIQ. Tapering of the initial antidepressant may be necessary to minimize discontinuation symptoms
Hyperhidrosis
Rash
Vascular disorders
Hot flush
Switching Patients to or from a Monoamine Oxidase Inhibitor
At least 14 days should elapse between discontinuation of an MAOI and the initiation of therapy with desvenlafaxine
succinate. In addition, based on the half-life of desvenlafaxine succinate, at least 7 days should be allowed after
stopping desvenlafaxine succinate before starting an MAOI.
MDD=major depressive disorder.
a. Includes data from all short-term, placebo-controlled studies including fixed-dose and flexible-dose studies.
b. Only includes data from short-term, placebo-controlled, fixed-dose studies.
Classifications of adverse events are based on the Medical Dictionary for Regulatory Activities (MedDRA).
Note: <1% indicates an incidence less than 0.5%, but greater than zero.
Dosing Considerations
SEXUAL FUNCTION ADVERSE REACTIONS
Patients with severe renal impairment and end-stage renal disease: the recommended dose in patients with severe
renal impairment (24-hr CrCl <30 mL/min) or end-stage renal disease (ESRD) is 50 mg every other day. Because of
individual variability in clearance in these patients, individualization of dosage may be desirable. Supplemental doses
should not be given to patients after dialysis (see ACTION AND CLINICAL PHARMACOLOGY, Renal Insufficiency).
Table 2 shows the incidence of sexual function adverse reactions that occurred in 1% or more of PRISTIQ-treated MDD patients in the 50 mg dose group
(8-week, placebo-controlled, fixed and flexible-dose, pre-marketing clinical trials).
70
July/August 2011
11-07-04 12:11 PM
Table 2: Sexual Dysfunction Adverse Reactions (*1% in Men or Women in Any PRISTIQ Group) During the On-Therapy Period: Percentage
of Subjects in Short-Term, Placebo-Controlled MDD Studies
Preferred Terma
Placebo b
DVS SR
50 mgc
DVS SR
100 mgc
DVS SR
200 mgc
DVS SR
400 mgc
DVS SR
50-400 mg b
Men only d
Erectile dysfunction
Ejaculation delayed
Anorgasmia
Libido decreased
Ejaculation disorder
Ejaculation failure
Orgasm abnormal
1
<1
0
1
<1
0
0
3
1
0
4
0
1
0
6
5
3
5
1
0
1
8
7
5
6
2
2
2
11
6
8
3
5
2
3
7
5
4
4
2
1
1
Women only e
Anorgasmia
Libido decreased
Orgasm abnormal
0
<1
<1
1
1
1
1
2
1
0
1
1
3
1
1
1
1
1
Table 4: Proportion (%) of Subjects With Lipid Abnormalities of Potential Clinical Significance for All Short-Term, Placebo-Controlled Clinical Trials
PRISTIQ
Supine systolic bp (mm Hg)
Supine diastolic bp (mm Hg)
5
<1
1
0
1
2
1
3
2
1
4
6
3
Placebo
50 mg
100 mg
200 mg
400 mg
-1.4
-0.6
1.2
0.7
2.0
0.8
2.5
1.8
2.1
2.3
-0.3
0.0
1.3
-0.4
1.3
-0.6
0.9
-0.9
4.1
-1.1
Pulse rate
Supine pulse (bpm)
Weight (kg)
At the final on-therapy assessment in the 6-month, double-blind, placebo-controlled phase of a long-term trial in patients who had responded to PRISTIQ
during the initial 12-week, open-label phase, there was no statistical difference in mean weight change between PRISTIQ- and placebo-treated patients.
Table 6 provides the incidence of patients meeting criteria for sustained hypertension (defined as treatment-emergent supine diastolic blood pressure
*90 mm Hg and *10 mm Hg above baseline for 3 consecutive visits).
Table 6: Incidence (%) of Patients with Sustained Hypertension for All Short-Term Fixed-Dose Clinical Trials
PRISTIQ
Placebo
Sustained hypertension
0.5
50 mg
1.3
100 mg
0.7
200 mg
1.1
400 mg
2.3
Adverse Reactions Identified During Post-Approval Use
The following adverse reaction has been identified during post-approval use of PRISTIQ. Because post-approval reactions are reported voluntarily from
a population of uncertain size, it is not always possible to reliably estimate their frequency.
Skin and subcutaneous tissue disorders – angioedema
Adverse Events Identified During Post-Approval Use
The following adverse events have been identified during post-approval use of PRISTIQ. Because post-approval events are reported voluntarily from
a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Gastrointestinal – gastrointestinal bleeding
Psychiatric – hallucinations
Immunologic – photosensitivity reactions
Skin and subcutaneous tissue disorders – severe cutaneous reactions (such as Stevens-Johnson Syndrome, toxic epidermal necrolysis, and/or
erythema multiforme)
DRUG-DRUG INTERACTIONS
Potential for other drugs to affect desvenlafaxine succinate (see also ACTION AND CLINICAL PHARMACOLOGY)
Inhibitors of CYP3A4: CYP3A4 is a minor pathway for the metabolism of PRISTIQ. In a clinical study, ketoconazole (200 mg BID) increased the area under
the concentration vs. time curve AUC of PRISTIQ (400 mg single dose) by about 43% and Cmax by about 8%. Concomitant use of PRISTIQ with potent
inhibitors of CYP3A4 may result in higher concentrations of PRISTIQ.
Inhibitors of other CYP enzymes: based on in vitro data, drugs that inhibit CYP isozymes 1A1, 1A2, 2A6, 2D6, 2C8, 2C9, 2C19, and 2E1 are not expected
to have significant impact on the pharmacokinetic profile of desvenlafaxine.
Potential for desvenlafaxine to affect other drugs (see also ACTION AND CLINICAL PHARMACOLOGY)
Drugs metabolized by CYP2D6: clinical studies have shown that desvenlafaxine does not have a clinically relevant effect on CYP2D6 metabolism at the
dose of 100 mg daily. When desvenlafaxine succinate was administered at a dose of 100 mg daily in conjunction with a single 50 mg dose of desipramine,
a CYP2D6 substrate, the AUC of desipramine increased approximately 17%. When 400 mg of desvenlafaxine was administered (8 times the recommended
50 mg dose), the AUC of desipramine increased approximately 90%. Concomitant use of desvenlafaxine with a drug metabolized by CYP2D6 may result
in higher concentrations of that drug.
Drugs metabolized by CYP3A4: in vitro, desvenlafaxine does not inhibit or induce the CYP3A4 isozyme. In a clinical study, PRISTIQ (400 mg daily)
was co-administered with a single 4 mg dose of midazolam (a CYP3A4 substrate). The AUC and Cmax of midazolam decreased by approximately 31%
and 16%, respectively. Concomitant use of PRISTIQ with a drug metabolized by CYP3A4 may result in lower exposure to that drug.
Drugs metabolized by CYP1A2, 2A6, 2C8, 2C9 and 2C19: in vitro, desvenlafaxine does not inhibit CYP1A2, 2A6, 2C8, 2C9, and 2C19 isozymes
and would not be expected to affect the pharmacokinetics of drugs that are metabolized by these CYP isozymes.
P-glycoprotein transporter
In vitro, desvenlafaxine is not a substrate or an inhibitor for the P-glycoprotein transporter.
Table 3: Estimated and 90% Confidence Interval for QTc Changes from Time-Matched Baseline Relative to Placebo at Hour 8 after Dose
with Different Heart Rate Corrections a
The pharmacokinetics of desvenlafaxine are unlikely to be affected by drugs that inhibit the P-glycoprotein transporter and desvenlafaxine is not likely
to affect the pharmacokinetics of drugs that are substrates of the P-glycoprotein transporter.
Drug-Food Interactions
Food does not alter the bioavailability of desvenlafaxine.
Population QT Correction (ms)
10.92
(8.62, 13.22)
10
Blood Pressure
ECG Changes: electrocardiograms were obtained from 1,492 PRISTIQ-treated patients with major depressive disorder and 984 placebo-treated patients
in clinical trials lasting up to 8 weeks. No clinically relevant differences were observed between PRISTIQ-treated and placebo-treated patients for QT,
QTc, PR, and QRS intervals. In a thorough QTc study with prospectively determined criteria, desvenlafaxine did not cause QT prolongation. No difference
was observed between placebo and desvenlafaxine treatments for the QRS interval (see ACTION AND CLINICAL PHARMACOLOGY). A thorough QTc
study was designed to assess the potential effect of 200 and 600 mg of PRISTIQ on QT interval prolongation.
10.80
(8.44, 13.16)
4
PRISTIQ
Orthostatic Hypotension: Of the 3,292 patients in clinical trials with PRISTIQ, 5% were 65 years of age or older. No overall differences in safety or efficacy
were detected between these subjects and younger subjects; however, in the short-term placebo-controlled trials, there was a higher incidence of orthostatic
hypotension in patients *65 years of age compared to patients <65 years of age treated with desvelafaxine. Greater sensitivity of some older individuals
cannot be ruled out. For elderly patients, possible reduced renal clearance of desvenlafaxine should be considered when determining dose (see Dosing
Considerations, Geriatrics and ACTION AND CLINICAL PHARMACOLOGY, Geriatrics).
Moxifloxacin 400 mg
(Active control)
4
Vital Sign Changes
Tables 5 and 6 summarize the changes that were observed in placebo-controlled, short-term, premarketing trials with PRISTIQ in patients with MDD.
Table 5: Mean Changes, Vital Signs, at Final On-Therapy for All Short-term, Fixed-dose Controlled Trials
Discontinuation Symptoms: adverse drug reactions reported in association with abrupt discontinuation, dose reduction or tapering of treatment
in MDD clinical trials at a rate of *5% include: dizziness, nausea, headache, irritability, diarrhea, anxiety, abnormal dreams, fatigue, and
hyperhidrosis. In general, discontinuation events occurred more frequently with longer duration of therapy (see DOSAGE AND ADMINISTRATION and
WARNINGS AND PRECAUTIONS).
0.98
(-1.42, 3.38)
3
*3.7 mmol/L
Ischemic cardiac adverse events: in clinical trials, there were uncommon reports of ischemic cardiac adverse events, including myocardial ischemia,
myocardial infarction, and coronary occlusion requiring revascularization; these patients had multiple underlying cardiac risk factors. More patients
experienced these events during desvenlafaxine treatment as compared to placebo (see WARNINGS AND PRECAUTIONS/Cardiovascular/
Cerebrovascular).
-2.43
(-4.90, 0.04)
2
a. Includes data from all short-term, placebo-controlled studies including fixed-dose and flexible-dose studies.
Proteinuria
In placebo-controlled studies 6.4% of subjects treated with PRISTIQ, had treatment-emergent proteinuria. Proteinuria was usually of trace amounts,
and was not associated with increases in BUN or creatinine or adverse events. The mechanism of the enhanced protein excretion is not clear but
may be related to noradrenergic stimulation.
Ear and labyrinth disorders: Common: tinnitus.
Eye disorders: Common: mydriasis, vision blurred.
Gastrointestinal disorders: Very common: nausea, dry mouth, constipation; Common: vomiting, diarrhea.
General disorders and administration site conditions: Very common: fatigue; Common: asthenia, chills, feeling jittery, irritability; Uncommon: drug
withdrawal syndrome.
Immune system disorders: Uncommon: hypersensitivity.
Investigations: Common: weight decreased, weight increased, blood pressure increased; Uncommon: blood cholesterol increased, blood prolactin
increased, blood triglycerides increased, liver function test abnormal.
Metabolism and nutrition disorders: Very common: decreased appetite.
Musculoskeletal, connective tissue, and bone disorders: Common: musculoskeletal stiffness.
Nervous system disorders: Very common: headache, dizziness; Common: somnolence, tremor, disturbance in attention, paraesthesia, dysgeusia;
Uncommon: syncope; Rare: convulsion, dystonia.
Psychiatric disorders: Very common: insomnia; Common: orgasm abnormal, anorgasmia, anxiety, nervousness, libido decreased, abnormal dreams;
Uncommon: depersonalization, hypomania.
Renal and urinary disorders: Common: urinary hesitation; Rare: proteinuria.
Reproductive system and breast disorders: Common: erectile dysfunction,* ejaculation delayed,* ejaculation disorder,* ejaculation failure*; Uncommon:
sexual dysfunction.
Respiratory, thoracic, and mediastinal disorders: Common: yawning; Uncommon: epistaxis.
Skin and subcutaneous tissue disorders: Very common: hyperhidrosis; Common: rash.
Vascular disorders: Common: hot flush; Uncommon: orthostatic hypotension.
* Frequency is calculated based on men only.
PRISTIQ 600 mg b
50-400 mga
n=1834
Triglycerides
Cardiac disorders: Common: palpitations, tachycardia.
3.18
(0.87, 5.50)
400 mg
n=317
Increase *1.29 mmol/L and absolute
value *4.91 mmol/L
Adverse reactions are categorized by system organ class and listed in order of decreasing frequency using the following definitions:
Very common: *10% of patients
Common: *1% and <10% of patients
Uncommon: *0.1% and <1% of patients
Rare: *0.01% and <0.1% of patients
Very rare: <0.01% of patients
1.5
(-0.88, 3.88)
200 mg
n=307
LDL Cholesterol
The following list is a list of MedDRA preferred terms that reflect adverse events that have been determined to be adverse drug reactions throughout the
dose range studied (50 to 400 mg) during any premarketing MDD trials.
PRISTIQ 200 mg b
100 mg
n=424
Increase *1.29 mmol/L and absolute
value *6.75 mmol/L
ADVERSE DRUG REACTIONS - ALL MDD CLINICAL TRIALS
A total of 3,292 subjects were exposed to at least 1 dose of PRISTIQ ranging from 50 to 400 mg/day in MDD clinical trials. Long-term safety was
evaluated in 1,070 subjects in MDD who were exposed to desvenlafaxine succinate for at least 6 months (180 days) and 274 subjects in MDD who
were exposed for 1 year (356 days).
Fridericia’s QT Correction (ms)
50 mg
n=317
Total Cholesterol
a. Medical Dictionary for Regulatory Activities (MedDRA) terms.
b. Includes data from all short-term, placebo-controlled studies including fixed-dose and flexible-dose studies.
c. Only includes data from short-term, placebo-controlled, fixed-dose studies.
d. Percentage based on the number of men (placebo, n=403; DVS SR 50 mg, n=108; DVS SR 100 mg, n=157; DVS SR 200 mg,
n=131; DVS SR 400 mg=154; DVS SR 50-400 mg, n=723).
e. Percentage based on the number of women (placebo, n=713; DVS SR 50 mg, n=209; DVS SR 100 mg, n=267; DVS SR 200 mg,
n=176; DVS SR 400 mg=163; DVS SR 50-400 mg, n=1111).
Treatment
Placeboa
n=1116
Drug-Herb Interactions
St. John’s Wort: in common with SSRI's, pharmacodynamic interactions between PRISTIQ and the herbal remedy St. John’s Wort may occur and may result
in an increase in undesirable effects (see DRUG INTERACTIONS, Serotonin Syndrome).
Drug-Lifestyle Interactions
Ethanol: as with all CNS-active drugs, patients should be advised to avoid alcohol consumption while taking desvenlafaxine succinate.
For complete prescribing information please refer to the Product Monograph.
PRISTIQ® Wyeth LLC, owner / Pfizer Canada Inc., Licensee
TM Pfizer Inc., used under license
© 2011 Pfizer Canada Inc., Kirkland, Quebec H9J 2M5
a. Mean (90% confidence intervals)
b. The PRISTIQ doses of 200 and 600 mg were 2 and 6 times the maximum recommended dose, respectively.
Abnormal Hematologic and Clinical Chemistry Findings
Serum Lipids
Elevations in fasting serum total cholesterol, LDL cholesterol, and triglycerides occurred in the controlled trials. Some of these abnormalities were considered
potentially clinically significant (see WARNINGS AND PRECAUTIONS, Serum Cholesterol Elevation and Monitoring and Laboratory Tests, Serum Lipids).
The percentage of subjects who exceeded a predetermined threshold for values of outliers is represented in Table 4.
71
July/August 2011
11-07-04 12:11 PM
Nursing Women: The safety of calcipotriol and/or topical corticosteroids for
use in nursing women has not been established. The use of Dovobet® is not
recommended in nursing women.
Pediatrics (<18 years of age): There is no clinical trial experience with the
use of Dovobet® in children. Children may demonstrate greater susceptibility
to systemic steroid-related adverse effects due to a larger skin surface area to
body weight ratio as compared to adults.

MONITORING AND LABORATORY TESTS
Treatment with Dovobet® in the recommended amounts does not generally result in
changes in laboratory values. In patients at risk for hypercalcaemia it is recommended
that baseline serum calcium levels be obtained before starting treatment with
subsequent monitoring of serum calcium levels at suitable intervals.
Prescribing Summary
ADVERSE REACTIONS
In clinical trials, the most common adverse reaction associated with Dovobet®
was pruritus. Pruritus was usually mild and no patients were withdrawn from
treatment. Calcipotriol is associated with local reactions such as transient
lesional and perilesional irritation.
THERAPEUTIC CLASSIFICATION
Topical corticosteroids can cause the same spectrum of adverse effects
associated with systemic steroid administration, including adrenal suppression.
Adverse effects associated with topical corticosteroids are generally local
and include: dryness, itching, burning, local irritation, striae, atrophy of the
skin or subcutaneous tissues, telangiectasia, hypertrichosis, folliculitis, skin
hypopigmentation, allergic contact dermatitis, maceration of the skin, miliaria,
or secondary infection. If applied to the face, acne rosacea or perioral dermatitis
can occur. In addition, there are reports of the development of pustular
psoriasis from chronic plaque psoriasis following reduction or discontinuation
of potent topical corticosteroid products.
Topical Antipsoriatic Agent Vitamin D Analogue/Corticosteroid
Dovobet® ointment is indicated for the topical treatment of psoriasis vulgaris for
up to 4 weeks. Dovobet® should not be used on the face.
CONTRAINDICATIONS
Known hypersensitivity to any of the ingredients of Dovobet® ointment; not for
ophthalmic use; treatment of viral, fungal or bacterial skin infections, tuberculosis
of the skin, syphilitic skin infections, chicken pox, eruptions following
vaccinations, and in viral diseases such as herpes simplex, varicella and vaccinia.
Rare cases of hypersensitivity reaction have been reported.
To report an adverse reaction please notify Health Canada at 1-866-234-2345 or
LEO Pharma Inc. at 1-800-263-4218.
Safety Information
DRUG INTERACTIONS
There is no experience of concomitant therapy with other antipsoriatic drugs.
General
If Dovobet® is used in excess of the maximum recommended weekly amount of
100 g, it is important to monitor the serum calcium levels at regular intervals due
to the risk of hypercalcaemia secondary to excessive absorption of calcipotriol.
If the serum calcium level becomes elevated, therapy should be discontinued
and the serum calcium level monitored until it returns to normal.
Administration
Dovobet® is FOR TOPICAL USE ONLY. Not for ophthalmic use. There is no clinical
trial experience with the use of Dovobet® in children.
Skin
Dovobet® should not be used on the face since this may give rise to itching and
erythema of the facial skin. Patients should be instructed to wash their hands
after each application of Dovobet® in order to avoid inadvertent transfer to the
face. Should facial dermatitis develop in spite of these precautions, Dovobet®
therapy should be discontinued.
Dovobet® should be applied topically to the affected areas once daily for up
to 4 weeks. After satisfactory improvement has occurred, the drug can be
discontinued. If recurrence takes place after discontinuation, treatment may be
reinstituted.
Prolonged use of corticosteroid-containing preparations may produce striae or
atrophy of the skin or subcutaneous tissues. Therefore, it is recommended that
corticosteroid treatment be interrupted periodically, and that one area of the
body be treated at a time. Topical corticosteroids should be used with caution
on lesions of the face, groin and axillae as these areas are more prone to atrophic
changes than other areas of the body. If skin atrophy occurs, discontinue
treatment. There may be a risk of rebound psoriasis when discontinuing
corticosteroids after prolonged periods of use.
The maximum recommended adult dose of Dovobet® ointment is 100 g per week.
SUPPLEMENTAL SAFETY INFORMATION
Missed Dose
If a dose is missed, the patient should apply Dovobet® as soon as he/she remembers and then continue on
as usual.
Overdosage
Carcinogenesis
Due to the calcipotriol component of Dovobet® (calcipotriol and betamethasone dipropionate), excessive
administration (i.e. more than the recommended weekly amount of 100 g) may cause elevated serum calcium,
which rapidly subsides when treatment is discontinued. In such cases, it is recommended to monitor serum
calcium levels once weekly until they return to normal. Excessive or prolonged use of topical corticosteroids can suppress pituitary-adrenal function, resulting in secondary adrenal insufficiency and manifestations
of hypercorticoidism, including Cushing’s disease. Recovery is usually prompt and complete upon steroid
discontinuation. In cases of chronic toxicity, slow withdrawal of corticosteroids is recommended.
Calcipotriol when used in combination with ultraviolet radiation (UVR) may enhance
the known skin carcinogenic effect of UVR. (See TOXICOLOGY, Carcinogenicity, in
Endocrine and Metabolism
Application on large areas of damaged skin, under occlusive dressings, or in skin
folds should be avoided since it increases systemic absorption of corticosteroids
and the risk of adverse effects such as adrenal suppression with the potential for
glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations
of Cushing’s syndrome, hyperglycaemia and glucosuria can also be produced
in some patients by systemic absorption of topical corticosteroids. Occlusive
dressings should not be applied if body temperature is elevated.
For further information, please contact Medical Information at LEO Pharma Inc. 1-800-263-4218.
®
Registered trademark of LEO Pharma A/S used under license and distributed by LEO Pharma Inc.,
Thornhill, ON.
All of the adverse effects associated with systemic use of corticosteroids,
including adrenal suppression, may also occur following topical administration of
corticosteroid-containing products such as Dovobet®, especially in children.
SPECIAL POPULATIONS
Pregnant Women: The safety of calcipotriol and/or topical corticosteroids for
use during pregnancy has not been established. The use of Dovobet® is not
recommended in pregnant women.
July_Aug11_DOVOBOET_1P_PI_p72.indd 1
LEO Pharma Inc. Thornhill, Ontario L3T 7W8
www.leo-pharma.com/canada
72
July/August 2011
11-07-04 12:06 PM
calcium levels be obtained before starting treatment and subsequent monitoring
of serum calcium levels at suitable intervals. (see OVERDOSAGE)
ADVERSE REACTIONS
Approximately 8% of patients treated with Xamiol® experienced an adverse
reaction. Based on data from clinical trials, the most common adverse reaction
is pruritus. The following adverse reactions led to discontinuation of the
treatment with Xamiol® in 0.1-0.2% of patients: pruritus, skin pain or irritation,
dermatitis, eye irritation, rash, burning sensation, face oedema, folliculitis and
dry skin. Other adverse reactions were observed for the individual drug
substances calcipotriol and betamethasone dipropionate. Systemic effects due
to topical use of corticosteroids in adults occur infrequently but can be severe.
50 mcg/g calcipotriol (as monohydrate) and 0.5 mg/g betamethasone (as dipropionate) gel
Prescribing Summary
To report an adverse reaction please notify Health Canada at 1-866-234-2345
or LEO Pharma Inc. at 1-800-263-4218.
DRUG INTERACTIONS
THERAPEUTIC CLASSIFICATION
There is no experience of concomitant therapy with other antipsoriatic drugs.
Topical Antisporiatic Agent Vitamin D Analogue/Corticosteroid.
Administration
Xamiol® (calcipotriol and betamethasone dipropionate) gel is indicated for the
topical treatment of moderate to severe scalp psoriasis for up to 4 weeks.
CONTRAINDICATIONS
Known hypersensitivity to Xamiol® (calcipotriol and betamethasone dipropionate)
or any ingredient; ophthalmic use; patient with known disorders of calcium
metabolism; viral lesions of the skin; fungal or bacterial skin infections;
parasitic infections; skin manifestations in relation to tuberculosis or syphilis;
perioral dermatitis, atrophic skin; striae atrophicae; fragility of skin veins;
ichthyosis; vulgaris and rosacea acne; rosacea; ulcers and wounds; guttate,
erythrodermic, exfoliative and pustular psoriasis; severe renal insufficiency
or severe hepatic disorders.
Xamiol® (calcipotriol and betamethasone dipropionate) is not recommended
for use in patients below the age of 18 years. Xamiol® is FOR TOPICAL USE
ONLY and not for ophthalmic use.
Xamiol® should be applied to affected areas of the scalp once daily for up
to 4 weeks. After satisfactory improvement has occurred, the drug can be
discontinued. If recurrence takes place after discontinuation, treatment may be
reinstituted. The maximum daily dose including other calcipotriol-containing
products on the body should not exceed 15 g and the maximum weekly dose
should not exceed 100 g. If a dose is missed, the patient should apply Xamiol®
when remembered, but only once a day and then continue on as usual.
Safety Information
ADVERSE REACTIONS
General
Two pivotal and 4 supporting controlled clinical studies were conducted in scalp psoriasis. The incidence of
patients with at least one ADR was lowest in the Xamiol® gel group.
Due to the content of calcipotriol, hypercalcaemia may occur if the maximum
weekly dose (100 g) is exceeded. Serum calcium is quickly normalized
when treatment is discontinued. The risk of hypercalcaemia is minimal at
recommended dosing.
Table 1. Adverse Drug Reactions Occurring in q 1% of Patients for the Pivotal Scalp Studies:
safety analysis set
Detailed and/or
summarized
report
Carcinogenesis
Number
of
Patients
Calcipotriol when used in combination with ultraviolet radiation (UVR) may
enhance the known skin carcinogenic effect of UVR.
Primary System
Organ Class1
Preferred Term1
Endocrine and Metabolism
Nervous system disorders
Xamiol® contains a potent group III steroid and concurrent treatment with
other steroids on the scalp must be avoided. Application on large areas of
broken skin or under occlusive dressings should be avoided since it increases
systemic absorption of corticosteroids; adverse effects such as adrenocortical
suppression with the potential for glucocorticosteroid insufficiency after
withdrawal of treatment; manifestations of Cushing’s syndrome, and affects
on the metabolic control of diabetes mellitus can also be produced in some
patients by systemic absorption of topical corticosteroids.
Facial skin is very sensitive to corticosteroids and Xamiol® is not indicated for
use in this area. The patients must wash their hands after each application to
avoid accidental transfer to the face, mouth and eyes. If facial dermatitis or
corticosteroid related adverse effects develop, Xamiol® should be discontinued.
There may be a risk of generalised pustular psoriasis or of rebound psoriasis
when discontinuing corticosteroids after prolonged periods of use. Patients
who apply Xamiol® to exposed skin (e.g. a bald scalp) should avoid both
natural and artificial sunlight.
%
Number
of
Patients
Number
of
Patients
%
%
Gel vehicle
(n=135)
Number
of
Patients
%
Headache
6
0.5
11
1.0
1
0.2
1
0.7
Burning
sensation
2
0.2
6
0.5
10
1.8
0
0.0
Pruritus
25
2.3
18
1.6
45
8.2
7
5.2
Skin irritation
5
0.5
5
0.5
15
2.7
3
2.2
Alopecia
4
0.4
6
0.5
3
0.5
2
1.5
Erythema
4
0.4
4
0.4
16
2.9
1
0.7
Dry skin
1
0.1
3
0.3
6
1.1
0
0.0
0.0
3
0.5
3
2.2
General disorders and administration site conditions
Pain
1
0.1
0
1
Coded according to MedDRA version 6.1
SPECIAL POPULATIONS
OVERDOSAGE:
Pregnant Women: The safety of calcipotriol and/or topical corticosteroids for
use during pregnancy has not been established. The use of Xamiol® is not
recommended in pregnant women.
Nursing Women: The safety of calcipotriol and/or topical corticosteroids for
use in nursing women has not been established. The use of Xamiol® is not
recommended in nursing women.
Pediatrics (<18 years of age): There is no clinical trial experience with the
use of Xamiol® in children, use is therefore not recommended. Children may
demonstrate greater susceptibility to systemic steroid related adverse effects
due to a larger skin surface area to body weight ratio as compared to adults.
Use of Xamiol® (calcipotriol and betamethasone dipropionate) above the recommended dose may cause
elevated serum calcium which should rapidly subside when treatment is discontinued. In such cases,
it is recommended to monitor serum calcium levels once weekly until they return to normal. Excessive
prolonged use of topical corticosteroids may suppress the pituitary-adrenal functions, resulting in secondary
adrenal insufficiency which is usually reversible. If this occurs, symptomatic treatment is indicated. In
cases of chronic toxicity, treatment with Xamiol® must be discontinued gradually.
® Registered trademark of LEO Pharma A/S used under license by LEO Pharma Inc., Thornhill, ON.
Full Product Monograph available on request by contacting LEO Pharma Inc. at 1-800-263-4218.
MONITORING AND LABORATORY TESTS
LEO Pharma Inc. Thornhill, Ontario L3T 7W8
www.leo-pharma.com/canada
In patients at risk of hypercalcaemia, it is recommended that baseline serum
Jul_Aug11_XAMIOL_1P_PI_p73.indd 1
Calcipotriol gel
(n=548)
Skin and subcutaneous tissue disorders
Skin
Betamethasone
gel
(n=1104)
Xamiol® gel
(n=1093)
73
July/August 2011
11-07-04 12:55 PM
Classifieds
GENERAL INFORMATION
Advertisements are accepted by mail, email or
fax. Copy deadline, notice of cancellation and/
or changes to existing advertisements must
be submitted in writing no later than the 10th
of the month prior to the month of publication. A proof copy of your classified ad will be
faxed to your attention for approval prior to
publication.
Payment: Payment is accepted by VISA, Mastercard or American Express. Please provide
credit card information by phone only to Margaret Lam at 416.340.2263 or 1.800.268.7215,
ext. 2263, at time of booking.
Rates: $50 for first 4 lines (minimum), each line
approximately 35 characters; $5 per line thereafter; $5 for each line of contact information.
Spot colour billed at $20 per issue.
A Classified Advertisement Insertion Order
Form is posted online: www.oma.org/
Resources/Documents/AdOrder.pdf
OFFICE SPACE AVAILABLE
Bayview and Elgin Mills: New medical space available with Shoppers
Drug Mart within property. Leasehold
improvements and rent subsidy available.
Contact: Lorraine
Tel. 905.882.2320
Boxgrove Medical Centre — now
open: Four-storey, 60,000 sq. ft. medical building located at the 9th Line and
Highway 407. Prime medical space
available for lease. X-ray, lab, rehab
and urgent care on-site.
Contact: Howard
Tel. 416.357.7509
Burlington — medical space available: Ideal for multi-doctor/specialist
practice. 2,500 sq. ft. Well built-out
with reception area, six exam rooms,
one office, boardroom and kitchenette.
Ample parking, fully handicap accessible. Building shared with physiotherapy
clinic.
Contact: Harrison Livermore
Martel Commercial Real Estate Inc.,
Brokerage
Tel. 905.332.6601, ext. 120
REVISED (v2)_July/Aug11_classifieds_pp74-79.indd 1
Send advertisements to:
Margaret Lam
Ontario Medical Association
150 Bloor Street West, Suite 900
Tel. 1.800.268.7215, ext. 2263 or
416.340.2263
Fax: 416.340.2232
The Ontario Medical Review is required to comply with the provisions of the Ontario Human
Rights Code 1990 in its editorial and advertising policies, and assumes no responsibility or
endorses any claims or representation offered
or expressed by advertisers.
Added Value
Classified ads are posted online https://www.
oma.org/Pages/OntarioMedicalReview.
aspx and accessible to OMA members and the
general public.
Following are the classified
advertising deadline dates
for the next six issues.
ISSUE
DEADLINE
October 2011
September 9
November 2011
October 10
December 2011
November 10
January 2012
December 1
February 2012
January 9
March 2012
February 10
Dufferin/Clark: A turnkey medical
office up to 2,500 sq. ft. Great location, four exam rooms and a reception,
free parking. Beside dentist, physiotherapist, dietician, and a pharmacy.
Dense residential and commercial
area.
Contact: Hany
Tel. 647.501.4269
Kennedy/Steeles — for lease —
prime office space: Immediate occupancy in well-maintained medical building with established pharmacy, X-ray,
dentist, physiotherapist, GPs and pediatrician. TTC at door, steps from GO
Train and Steeles Avenue. Free parking. Medical professionals welcome.
Tel. 416.297.8112
Free rent: Family physicians in Toronto
needed! Furnished office. Eight exam
rooms. Medical building at busy intersection.
Contact: Joe
Tel. 416.564.7585
Mississauga — densely populated area
close to Dixie Road on Dundas Street.
Great visibility in a high traffic area beside
TD Bank. Good signage and parking.
Contact: Peter
Tel. 416.566.8496
Hamilton — downtown: Brand new,
bright and clean 1,300 sq. ft. medical clinic with five exam rooms located at 225 John St., L8N 2C7, in
a busy plaza surrounded by highrise
apartments, with free parking and
beside a pharmacy. Ideal for doctor’s
office or walk-in clinic. Available immediately.
Tel. 905.972.9666
North Etobicoke — a turnkey medical
office available for an attractive split or
flat fee. It offers four examination rooms,
reception and spacious waiting area.
Can accommodate up to two full-time
or three part-time physicians. Current
practice serves 60 patients daily. It is a
great location to start new practice or
relocate. Call for more details.
Tel. 416.270.3034
Office space available for a medical walk-in clinic inside a pharmacy in
Bathurst and St. Clair area.
Contact: Matt
Tel. 416.652.9171
74
July/August 2011
11-07-08 12:14 PM
Classifieds
Office space in North York: Parttime family doctor looking for another
part-time family doctor or specialist
to cost-share office space. Located
in modern medical building with free
parking and easy subway access at
Yonge/Finch.
Contact: Dr. Todd Levy
Tel. 416.573.8339
On Steeles near York University: Busy
plaza, 2,800 sq. ft. on main floor. Ample
free parking, beside a dentist and optometrist. Reasonable rent at $12 per
sq. ft. net.
Contact: Sam
Tel. 416.629.7711
PAR-Med Realty Ltd.: Specializing in
medical office building leasing, property management, and building sales.
We have over 70 medical office buildings in our portfolio throughout Ontario. For leasing inquiries:
Contact: Brad Stoneburgh
Tel. 416.364.5959, ext. 403
Website: www.par-med.com
Physician, ON: Looking for practice
site? Recently renovated clinic available
in beautiful Niagara region. High patient
potential. Close proximity to Niagara
Falls, St. Catharines and Welland. Very
reasonable terms. Interested?
Contact: Sam
Tel. 647.403.8846
Yorkville (Holt Renfrew Centre) —
Möcelle OfficeMD™ provides luxury furnished small medical offices/rooms and
virtual clinics at a prestigious address.
Möcelle OfficeMD™ means instant
prestige for your practice and access to
some of Canada’s most affluent individuals. Rent the number of rooms you need,
only on the days you need, with shared
waiting room and restrooms. Enjoy the
benefits of a full-service office without
the capital outlay, hassles and overhead.
Featuring on-demand nursing/admin.
support staff, appointment booking, file
storage, mail/fax handling, printing and
photocopying. Rooms available from
$150/day and virtual clinics from $395/
month. To schedule a viewing:
Tel. 416.964.6150
FOR SALE
POSITIONS VACANT
Hamilton, ON — busy medical walk-in
clinic for sale: Established in 1992.
High traffic, high visibility, fully equipped
for medical and minor surgical procedures. EMR or paper. Three separate
examination rooms. Free parking. Located in medical building with pharmacy,
lab, X-ray and physio. Close to many
hospitals. Open to best offer.
Email: [email protected], or
[email protected]
10-20 F/T and P/T family medicine
required to work in state-of-the-art
clinics in Markham (Mandarin and/
or Cantonese, and English-speaking
patients), Vaughan and downtown Toronto areas. Position also available for
Tamil-speaking GP or of South Asian
background.
Contact: Dr. Richard Hackman
Tel. 416.821.9020
REAL ESTATE
70:30 split or better: South Ottawa.
Family medicine or specialists. Flexible
schedule, full EMR, excellent nursing and
resident support, full time, part time or
locum, and opportunity of joining FHO.
Enjoy life, earn a phenomenal wage, get
home for a hot meal and stop fretting
about stuff! Let us do all the administrative work.
Contact: Faiza
Tel. 613.692.5433
Disney/Orlando real estate, former
Ontario resident.
Contact: Kathy Jaworski
Exit Realty Cozy Homes
Email: kat-fl[email protected]
LOCUM TENENS
London, Hyde Park & Oxford: New
walk-in clinic. Locum physician needed
immediately for a very busy walk-in clinic
and medical practice. EMR, state-ofthe-art. 70:30 split.
Contact: Dr. Bhalla
Tel. 519.641.3627
POSITIONS WANTED
Family physician looking to take
over existing practice or replace retiring physician in Toronto (North York or
Scarborough).
$200/hour: GP required immediately
at Mississauga outpatient clinic. Hours:
8 a.m. to 11 p.m. seven days a week.
Contact: Angela
Tel. 905.272.5200
$250 per hour minimum: Pediatrician,
internist, surgeon, subspecialist in
busy outpatient clinic in Mississauga.
Contact: Dr. Stein
Tel. 416.464.0238
Added Value for
Classified Advertisers
Classified advertisements published in the
Ontario Medical Review are posted on the OMA website
at no additional charge (https://www.oma.org/Pages/
OntarioMedicalReview.aspx).
For more information, please contact:
Margaret Lam, Classifieds Co-ordinator
Tel. 416.340.2263 or 1.800.268.7215, ext. 2263
75
July/August 2011
11-07-08 12:14 PM
Classifieds
A new medical centre is opening in
Burlington (Appleby Line and Uppermiddle), and is looking for F/T or P/T
family physicians for a walk-in clinic to
start in September 2011.
Contact: Najat
Tel. 647.831.8551
(between 11 a.m. and 9 p.m.)
Atikokan, Ontario: The canoeing
capital of Canada is recruiting family
physicians to join our present group of
five. Situated in northwest Ontario, we
are an entry point for Ontario’s wilderness Quetico Park. Come and enjoy
Atikokan’s community spirit, recreational opportunities, and numerous
lakes for fishing and swimming. Atikokan is a rural family practice, working collaboratively with the Atikokan
Family Health Team. We use an electronic medical record and our practice
includes inpatient hospital care and
emergency department work. Atikokan’s accredited hospital has PACS,
video-conference technology and
Meditech access. Family physicians
are funded by the RPNGA. We are also
seeking locum physicians, funded by
HealthForceOntario’s locum program.
Contact: Dr. John Fotheringham
Chief of Staff
Tel. 807.597.4215, 807.597.2721 (clinic)
Website: www.aghospital.on.ca
Brampton, Ontario: Full-time/parttime family physicians and GP psy cho thera pist required for busy family
practice/walk-in clinic. Attractive modern office. Option to join FHG. High feefor-service split or flat monthly rate.
Best EMR.
Tel. 416.949.3830
Fax: 647.340.2586
EKGs, PFTs, venipuncture for income
supplement.
Contact: Mr. Samuel
Tel. 647.400.0401
Downtown Toronto: Yonge and College
new medical office. Close to many hospitals. High traffic, high visibility. New,
fully equipped medical office in busiest
part of Yonge St., 13 exam rooms plus
three offices. EMR or paper, P/T, F/T,
one or many GPs. Move existing practice or build up from walk-in clinic. Very
attractive split or flat rent.
Contact: David
Tel. 416.895.4745
Etobicoke, ON — exciting opportunity for doctors: Street level at Dundas
and Islington in heavy residential area.
Ideal for a walk-in/family practice. Set
up ready to go. F/T or P/T. Relocate or
start a new practice. EMR or paper. Split
negotiable or subsidized lease.
Tel. 416.882.9265
Family physician, Toronto: Associate
needed for busy FHO practice, full time
or part time.
Family and walk-in doctor: Locum/part
time/full time. Instant full practice. Extremely busy! Congenial colleagues and low
overhead. EMR, FHG, partnership option,
>700K billing for a five-day work week.
Contact: Thomas Van
Tel. 647.227.5088
Busy walk-in clinic: Weston Road at
Hwy. 401 — 10 to 12 patients/hour.
Very competitive split. P/T or F/T.
Contact: Dr. Howard Goldman
Tel. 647.458.2541
Fax: 416.240.8870
Fitness Institute North York (premium
health club/rehab clinic) — is looking
for a part-time general/family physician
to manage medical cases and support rehab clinic. Excellent opportunity/
space to open your practice with attractive split. The Fitness Institute has
over 2,500 members and is home to the
Gary Roberts High Performance Centre.
Please visit website to learn more about
the Fitness Institute.
Email: drdang@fitnessinstitute.com
Website: www.fitnessinstitute.com
D o w n s v i e w, O n t a r i o : P a p e r l e s s
computerized new clinic in a medical
building with pharmacy, lab and X-ray.
No set-up cost. Part time or full time.
Move existing practice or build up
from walk-in clinic. Support staff for
Full-time or part-time medical doctors
required for a busy walk-in located in
downtown Mississauga.
Contact: Adel
Tel. 416.904.2929 or
905.897.6160 (office)
76
GP needed for Spanish and Portuguese-speaking patients in two locations in the GTA. Terms negotiable.
Tel. 416.749.2084 or 905.270.2713
Fax: 905.270.3626
Hamilton, ON — busy, well-established
walk-in clinic requires P/T or F/T doctor.
Clinic is state-of-the-art, modern and
fully equipped. EMR or paper. Flexible
hours. Very competitive split.
Email: [email protected], or
[email protected]
Internal medicine and/or subspecialties required immediately for outpatient coverage in Mississauga. FT/
PT/locum. No on-call. Top take-home
pay.
Contact: Dr. Sekely
Tel. 416.464.0238
Kitchener, Ontario: Family physician
wanted to replace retiring doctor Sept.
30/11. FHO practice of three physicians.
Tel. 519.578.2415
Medical ophthalmological practice in
a three-person group in Mississauga,
ON. Available on July 1, 2011.
Contact: Bob Kelly
MedVisit Doctors Housecall Service:
Greater Toronto or Ottawa. P/T or F/T.
New higher OHIP fees and housecall
bonuses now in effect. Flexible shifts.
Drivers available.
Contact: Dr. Burko
Tel. 416.631.0298
Website: www.medvisit.ca/doctors
Mississauga — walk-in/family/locum:
New grads welcome. Busy clinic with
congenial group of family physicians
(part of FHG) looking for part-time walkin or locum. Competitive split, lab onsite, supportive environment with “hallway consultations” encouraged. Flexible
hours.
Tel. 416.844.8340
North Etobicoke — walk-in clinic:
Flexible hours. Work as much or as little
as you wish.
Tel. 416.834.2807
July/August 2011
11-07-08 12:14 PM
Classifieds
North York Loblaws Superstore: Busy,
expanded walk-in clinic/family practice
located inside Loblaws seeking family
physicians, pediatrician and specialists.
Physicians required for walk-in shifts as
well as opportunity to relocate an existing practice or build a new practice.
Flexible hours and very attractive split.
Tel. 647.206.0790
Obstetrician/gynecologist — full
time/part time: Instant full practice in
a group of 14 GPs and 20 plus specialists. Extremely busy. Congenial colleagues and low overhead. EMR, PACS.
Contact: Thomas Van
Tel. 647.227.5088
Opportunity in Richmond Hill & midtown Toronto, Ontario: Well-established family practice seeking physician
full time or part time. Walk-in shifts also
available. No financial commitments,
clinics are fully EMR integrated (EMR
training included). On-site lab. Aboveaverage compensation package.
Tel. 905.884.1017 (direct office line)
Email: [email protected],
[email protected]
Ottawa Centre East: Sunshine Medical
Clinic is looking for physicians. Join us.
Low overhead. EMR.
Tel. 613.695.9001
Ottawa — family medicine: Full-time
or part-time positions available in an
attractive building in a beautiful new
community. Free parking.
Contact: Dr. Ashikian
Tel. 613.822.0171 (9 a.m. to noon,
or 1 p.m. to 3 p.m., Monday to Friday)
Fax: 613.822.1838
Ottawa West, ON: Semi-retiring, solo,
FHG family physician, looking for fulltime or part-time physician(s), (FP or
specialist), to share office or rent entire
space (three exam rooms). Reputable
medical building in an ideal location,
with lab, X-ray, pharmacy and plenty
of parking spaces on-site. Possibilities
of joining FHO, taking over practice or
building your own. Retiring doctor willing to assist in settling down. Great for
new graduates or physicians who want
to relocate.
Tel. 613.729.9463
Email: mjboffi[email protected]
Physician career opportunity —
Toronto Memory Program is presently looking for additional physicians from the following disciplines
to join our expanding memory clinic:
cognitive neurology, general neurology, geriatrics, inter nal medicine,
geriatric and general psychiatry, family medicine and those with a care
of the elderly fellowship. Founded in
1996, Toronto Memory Program is a
multidisciplinary, community-based,
OHIP funded, medical facility specializing in the diagnosis and treatment
of Alzheimer’s disease and related
disorders. Our medical director, Dr.
Sharon Cohen, is a Canadian-trained
neurologist specializing in behaviour
and cognition and an internationally
recognized expert in this field. Physicians provide consultations and ongoing care for patients and are supported by trained clinical assistants.
Our memory clinic serves the needs
of referring physicians and patients
from the Greater Toronto Area and
surrounding regions. Toronto Memory
Program has a well-established clinical research program and is involved
in a large number of multi-national
Phase II-IV dementia treatment trials.
Opportunities exist for physicians to
be trained as co-investigators. For
further information, please contact the
Toronto Memory Program.
Contact: Dr. Ian Cohen
Tel. 416.386.9761
Physicians needed — enjoy medicine more: Enjoy medicine again! If
you have an interest in this important
clinical area. We would like you to join
our busy clinic. We need family doctors, GPs, GP pyschotherapists, psychiatrists, semi-retired, part time or
full time. We are open weekends and
weeknights. We provide comfortable
offices, professional staff, excellent
financial arrangements, professional
supervision, and CME programs are
available.
Contact: Dr. Michael Paré
Tel. 416.229.2399 or 1.888.229.8088
Website: www.medicalpsychclinic.org
Psychiatrists, medical psychotherapists are needed at a busy private
mental health clinic.
Contact: Sue
Tel. 416.778.1496
77
PT/FT family physician/specialist:
Are you looking for an interesting mix of
family practice and walk-in clinic? Are
you looking to move your established
practice? PT/FT family physicians/
specialists needed for a new established
clinic/walk-in shift in North York, Ontario.
Contact: 416.629.1515
Richmond Hill, Ontario: Richmond Hill
After-Hours Clinic requires phy sicians
for daytime shifts 9 a.m. to 5 p.m.,
as well as evenings and weekends.
Guaranteed minimum 70:30 split.
Contact: Dr. Ian Zatzman
Tel. 905.884.7711
Fax: 905.553.5360
Scarborough, Ontario: F/T, P/T family
physicians required for medical clinic
serving mainly Cantonese and Mandarin speaking seniors. Open to public.
Pharmacy on-site.
Contact: Martin Chai
Tel. 416.299.0555, ext. 12
Specialists — Brampton, Ontario:
Dermatologist, pediatrician, internist,
and psychiatrist required for medical
centre with several GPs and large patient base. Attractive modern office with
seven days/week reception service. Feefor-service split or low flat monthly rate.
Tel. 416.949.3830
Fax: 647.340.2586
Surgical assistant — cardiac surgery:
Applicants are invited for a position
within the Advanced Cardiac Surgery
Program at Trillium Health Centre as a
cardiac surgery assistant. The division
is a community-based cardiac surgery
practice located in Mississauga, Ontario.
Primary responsibility will be providing assistance in the cardiac operating
rooms. On-call commitment with HOCC
stipend is expected. Experience is required. All applicants must possess an
Ontario licence and OHIP billing number.
Fur further information please contact
us. Only candidates meeting all of the
above criteria will be considered.
Contact: Mrs. M. Huber
Tel. 905.848.7580, ext. 3113
Fax: 905-848-7515
July/August 2011
11-07-08 12:14 PM
Classifieds
St. Joseph’s Health Centre Toronto is
a fully accredited community teaching
hospital associated with the University
of Toronto. We provide primary, secondary and tertiary services to a culturally
diverse community in southwest Toronto.
The Department of Psychiatry has currently two openings for psychiatrists
licensed to practise in the province of
Ontario. 1. Full-time geriatric psychiatrist. 2. Full-time or part-time outpatient
general psychiatrist with skills and experience in working directly with primary
care providers in Community Health
Clinics and Family Health Teams. New
graduates completing their training June
2011 are welcome. Please send CV.
Contact: Fil Sibbio
Administrative Assistant
Mental Health and Addiction Program
Tel. 416.530.6710
Windsor Essex Area: Family physician needed to replace doctor retiring
due to ill health. 1,500 rostered patients. More waiting to enrol. Walk-ins
possible. Refurbished, spacious rooms
fully equipped. Set your own hours. Can
join FHO/FHG. No hospital or weekend
work. No financial obligation.
Tel. 519.776.5181 (office),
519.991.2020 (cell)
The Dryden Regional Health Centre:
Full-time/locum ER opportunity. Choose
your hours in a fully modern facility centrally located between Winnipeg and
Thunder Bay. CT scan, digital X-ray/US
services 24/7, on-site lab 24/7, EMR
and highly trained/locum friendly nursing staff. $175/hour for all shifts in July
and August. Work 12 or 24-hour shifts
at your discretion. The DRHC provides
an attractive financial incentive for one
full-time position; travel costs covered
for locum work. In Dryden, you are five
minutes from the lake, work, your children’s school, shopping, fine dining and
five minutes from getting away from it all.
Contact: Chuck Schmitt
Tel. 807.223.8808
Website: www.docjobs.ca
Practice for sale — turnkey: Great
GTA location. Modern, bright medical
office. Close proximity to hospitals.
Minutes from major highways. Easy
access, ample parking.
Tel. 416.888.1362
Toronto — walk-in physician required
immediately for very busy clinic in the
Bathurst/Eglinton area. EMR, excellent
patient population. Weekday and some
weekend shifts.
Contact: Dr. Ian Cohen
Tel. 647.282.0678
Vaughan — specialist: Full-time or
part-time opportunity for a consultant
physician in a pediatric office. Brand new
medical building with ancillary services
on-site. Turnkey operation. Staff and
EMR provided. Available immediately.
Contact: Adriana
Tel. 905.303.3448
PRACTICES
Cosmetic practice for sale: Wellestablished (since 2003), full-service
MedSpa in Peterborough. Large Botox
& filler practice. Cutera Xeo-Titan Laser,
Omnilux & Liposonix fat reduction. Practice is debt free. Lucrative opportunity.
Asking 350K.
Tel. 705.740.1078
Two Vancouver psychiatric practices
available on full-time or part-time
basis. Start-up possible within fourto-five months, including patients with
lengthy waiting lists, referring physicians, receptionist, and any other
assistance as necessary.
Contact: Dr. L. Matrick
Tel. 604.681.5821 or 604.684.8846
SERVICES AVAILABLE
Adept Medical Billing Service provides
full-service OHIP claims submission for
all specialties, locums and hospitalist
groups. Monthly reports, rejections
follow-up and ongoing review of outstanding accounts. Competitive rates.
Contact: Isobel Findlay
Tel. 705.277.2972 or 905.243.4277
Website: www.adeptbilling.com
Arya & Sher, health lawyers: Practice focused on representing medical
practitioners, clinics, hospitals, and
health-care companies. Business and
regulatory issues, including professional
incorporations, business registrations,
contracts, partnership/shareholder
issues, tax and estate planning, em78
ployment, leasing, medical real estate,
and regulatory matters.
Contact: Kashif Sher, LLB, MBA
Tel. 416.218.8373
Website: www.aryasher.com
Billing agent — electronic data
transfer to MOHLTC for all practices,
specialties and locums. Medical Billing
and Secretarial Services.
Contact: Edith Erdelyi
Tel. 416.576.6788
Experience and knowledge matter:
Insurance broker specializing in disability
and life insurance, financial/retirement
planning and planned giving programs
for sole practitioners and professional
corporations. Dedicated to giving highquality and personalized service since
1986.
Contact: James Corrigan, RHU, CLU
Tel. 866.235.1754, ext. 23
Website: www.thelivingbenefitsgroup.
com
Free record storage for closing
practices: RSRS is Canada’s leading
paper and digital storage provider. No
prohibitive fees to patients. Physician
managed since 1997.
Tel. 1.888.563.3732, ext. 221
Website: www.RSRS.com
Going EMR? Need to scan your patient
records? We can find you an affordable
solution that fits your budget. For more
information and many references:
Contact: Sid Soil, DOCUdavit Solutions
Tel. 1.888.781.9083, ext. 105
Medical Transcription Services: Telephone dictation and digital recorder
files. PIPEDA compliant; excellent
quality, next business day service. All
specialties, patient notes, letters, reports, including medical-legal and IME
reports.
Tel. 416.503.4003 or 1.866.503.4003
Website: www.2ascribe.com
Moving or moved to EMR? Still have
lots of paper? RSRS scans your records and offers full electronic access
to your active patient records. It’s easier than you think. PHIPA compliant.
Contact: RSRS
Tel. 1.888.563.3732, ext. 221
Website: www.RSRS.com
July/August 2011
11-07-08 12:14 PM
Classifieds
Retiring, moving or closing your
practice? Physician’s estate? DOCUdavit Medical Solu tions provides free
paper or electronic patient record storage with no hidden costs.
Contact: Sid Soil, DOCUdavit Solutions
Tel. 1.888.781.9083, ext. 105
Sunmed OHIP Billing Software: Simple,
easy to use, stable 20 years.
Contact: John
Tel. 416.240.9220
UPCOMING EVENTS
Caribbean CME cruises: December
2-12 (Surgery/Infectious Diseases).
December 26-January 2 (Obesity Management). March 11-18 (Dermatology/
Women’s Health). March 18-25 (Cardiology/Endocrinology). Companion cruises
free.
Contact: Sea Courses Cruises
Tel. 1.888.647.7327
Website: www.seacourses.com
China CME cruise & tour: October
28-November 12, 2011. Beijing, Yangtze River, Xian, Suzhou, Shanghai. 26.5
hours CME: Cardiology & Endocrinology. Companion cruise and tour free.
Tel. 1.888.647.7327
CME October 14-16, 2011: Ontario
Association of Pathologists AGM and
Cancer Care Ontario/OAP Symposium, Deerhurst Resort, Huntsville,
Ontario. Keynote: Dr. Martin J. Trotter,
Professor, Department of Pathology
and Lab Medicine, University of Calgary.
“Menacing moles”: a practical guide to
mimicry in melanocytic lesions.
Tel. 519.272.3144
Fax: 519.271.9703
Website: www.ontariopathologists.org
(For full program details.)
Exotic CME cruises: Tahiti/Cook Island
(May 12-23, 2012). Russia River (August
10-12, 2012). Galapagos (October 1222, 2012). Companion cruises free.
Tel. 1.888.647.7327
Refresher course for general practitioner anesthetists: Hyatt Regency,
Vancouver, BC, October 22, 2011. By
September 9: $325. By October 7:
$375. After October 7: $425 (if space
permitting). This course covers a wide
spectrum of problems relevant to the
provision of anesthesia in community
hospitals. Didactic presentations will
review case selection in GP anesthesia,
regional anesthesia, airway problems,
stabilization of major trauma and recent useful advances in the practice
of anesthesia. In addition, there will be
case presentations with panel discussions and audience participation covering obstetrics, pediatrics and adult
anesthesia.
Contact: Winnie Yung
UBC Department of Anesthesiology,
Pharmacology & Therapeutics
Tel. 604.875.4575
EQUIPMENT FOR SALE
Cosmetic laser — owner retiring:
Cutera Xeo-Titan platform preferred by
most derms and plastic surgeons. High
income for skin tightening IPL, fractionation, veins, rosacea, hair, warts and
toenail fungus. $75K or OBO.
Tel. 705.740.1078
Liposonix machine: High intensity
focused ultrasound device for fat reduction. Lose 1-3 inches permanently.
One year new. Owner retiring. $90K or
OBO.
Tel. 705.740.1078
Surplus Restylane/Perlane: Owner
retiring. $150/syringe.
Tel. 705.740.1078
Navigating Your CME
Opportunities
Use the OMA’s Continuing Medical Education Locating
Service to find the right CME opportunity for you.
With access to thousands of courses, conferences and cruises
worldwide, we can customize a list of professional development
opportunities for you.
You can also search our database and list of quality websites
focusing on Canadian CME opportunities.
For information, contact Information Management:
tf: 1.800.268.7215, ext. 2915
email: [email protected]
http://www.oma.org/Benefits/CMELocating.aspx
79
July/August 2011
11-07-08 12:14 PM
Copyright: Randy Glasbergen
Medec
“For more sounds of the ocean, subscribe to my podcast,
then share your favorite vacation stories on my blog!”
Advertisers’ Index
A&L Computers................................... 59
OMA CME Locating Service ................ 79
OntarioMD ....................................... 4,51
Ayra & Sher Health Lawyers ................ 59
OMA Committee Vacancy ................... 62
Optimed Software ............................... 46
Boehringer Ingelheim....................... OBC
OMA Corporate Hotel Directory ........... 39
Pfizer Canada ............ 11,17,34,40-41,48
BPA Worldwide ................................... 52
OMA Insurance Services .............. 55,IBC
Cappellacci DaRoza LLP ..................... 19
OMA Legal Services ............................ 40
Record Storage and Retrieval
Services .............................................. 49
Eagle Ridge Development ................... 22
OMA Office Display Poster .................... 6
WSIB Ontario ...................................... 32
Elecompack Systems Inc .................... 56
OMA Physician Health Program .......... 33
Jon Baines Tours PTY Ltd ................... 53
Prescribing Information:
Klinix Software Inc ..............................IFC
OMA Practice Management and
Advisory Services ................................ 25
Leo Pharma ................................... 12,13
OMA Response Centre ....................... 21
Dovobet .............................................. 72
Novartis ................................................. 2
OMR Added Value............................... 75
Pradax ...........................................63-67
OMA Advantage Partner Discount
Program .............................................. 27
OMR Classifieds .................................. 62
Pristiq .............................................69-71
OMSBF Golf Sponsor Thank You ........ 44
Xamiol ................................................. 73
July/Aug11_medectoon_p80.indd 1
80
Caduet ................................................ 68
July/August 2011
11-07-12 4:05 PM
Starting July 4, 2011, OMA Insurance is
launching a NEW group insurance program
Through a partnership with The Personal Insurance Company and
HUB International, OMA members can now receive
exceptional service and meaningful savings on:
Auto Insurance
Home Insurance
Office/Clinic Insurance
For a quote, or to provide us with the expiry date of your current
policy, please visit us at www.oma.org/physicianoffer
gp y
or call 1.877.277.7165.
Dedica
Doctors
Certain conditions apply. Auto insurance not offered in Manitoba, Saskatchewan and British Columbia due to government-run plans.
The OMA Auto & Home Insurance Program is underwritten by The Personal Insurance Company and Office/Clinic Insurance is underwritten
by Novex Insurance Company through HUB International Limited.
Dedicated to Docto
Doctors.
Patients.
Dedicated
ated to Doctors.. Committed to Patients.
P&C_OMR_201107_v4.indd 1
11-06-27 4:16 PM
NEW PrPRADAX™ 150 mg BID
NOW INDICATED FOR THE PREVENTION OF STROKE AND SYSTEMIC EMBOLISM IN
PATIENTS WITH ATRIAL FIBRILLATION, IN WHOM ANTICOAGULATION IS APPROPRIATE.1
HELP
PREVENT STROKE WITH PRADAX
AND SYSTEMIC EMBOLISM
For patients with atrial fibrillation, PRADAX demonstrated:
35% reduced risk of
59% reduced risk of
Dabigatran 150 mg BID (1.1%/yr)
vs. warfarin (1.7%/yr), p=0.0001.
Dabigatran 150 mg BID (0.3%/yr)
vs. warfarin (0.8%/yr), p<0.0001.
stroke or systemic embolism
vs. warfarin1-3*†
‡
intracranial bleeding
vs. warfarin1-3*§
PRADAX (dabigatran etexilate) is indicated for the prevention of stroke and systemic embolism in
patients with atrial fibrillation, in whom anticoagulation is appropriate.
PRADAX is contraindicated in patients with: severe renal impairment (CrCL <30 mL/min);
hemorrhagic manifestations, bleeding diathesis, or patients with spontaneous or pharmacological
impairment of hemostasis; lesions at risk of clinically significant bleeding, e.g. extensive cerebral
infarction (hemorrhagic or ischemic) within the last 6 months, active peptic ulcer disease with
recent bleeding; concomitant treatment with the strong P-glycoprotein (P-gp) inhibitors, i.e. oral
ketoconazole, and with known hypersensitivity to dabigatran, dabigatran etexilate or to any
ingredient in the formulation or component of the container.
Bleeding is the most relevant side effect of PRADAX; bleeding of any type or severity occurred in
long-term treatment in 16.5% of patients with atrial fibrillation treated for the prevention of stroke
and systemic embolism. As with all anticoagulants, PRADAX should be used with caution in
circumstances associated with an increased risk of bleeding. Bleeding can occur at any site during
therapy with PRADAX. An unexplained fall in hemoglobin and/or hematocrit or blood pressure should
lead to a search for a bleeding site. Patients at high risk of bleeding should not be prescribed
PRADAX. Close clinical surveillance (looking for signs of bleeding or anemia) is recommended
throughout the treatment period, especially if risk factors are combined. Should severe bleeding
occur, treatment with PRADAX must be discontinued and the source of bleeding investigated
promptly. Patients who develop acute renal failure must discontinue PRADAX. In patients who are
bleeding, an aPTT test may be useful to assist in determining an excess of anticoagulant activity,
despite its limited sensitivity. An aPTT >80 sec at trough, i.e. when the next dose is due, is
associated with a higher risk of bleeding.
Agents that may enhance the risk of hemorrhage should not be administered concomitantly with
PRADAX, or, if necessary, should only be administered with caution. Treatments that should NOT
be administered concomitantly with PRADAX due to increase in bleeding risk include:
unfractionated heparin and heparin derivatives, low molecular weight heparins (LMWH),
fondaparinux, bivalirudin, thrombolytic agents, GPIIb/IIIa receptor antagonists, ticlopidine,
sulfinpyrazone and vitamin K antagonists such as warfarin. The concomitant use of
PRADAX with the following treatments has not been studied and may increase the risk of
bleeding: rivaroxaban, prasugrel and the strong P-gp inhibitors itraconazole, tacrolimus,
cyclosporine, ritonavir, tipranavir, nelfinavir and saquinavir. Unfractionated heparin may be
administered at doses necessary to maintain a patent central venous or arterial catheter. In
patients with atrial fibrillation treated for the prevention of stroke and systemic embolism, the
co-administration of oral anti-platelet (including ASA and clopidogrel) and NSAID therapies
increases the risk of bleeding by about two-fold (see ACTION and CLINICAL PHARMACOLOGY,
No INR
monitoring
or dose titration1
Special Populations, Pharmacokinetic Interactions). If necessary, co-administration of low-dose
ASA, i.e. )100 mg daily with PRADAX may be considered for other indications than stroke
prevention in atrial fibrillation. The concomitant use of PRADAX with the strong P-gp inducer,
rifampicin, reduces dabigatran plasma concentrations. Other P-gp inducers such as St. John’s
Wort or carbamazepine are also expected to reduce dabigatran plasma concentrations and should
be co-administered with caution.
The most common adverse events observed in *1% of PRADAX 150 mg BID patients and 110 mg
BID patients was anemia (1.6%, 1.2%), epistaxis (1.1%, 1.1%), gastrointestinal hemorrhage
(4.6%, 3.3%), urogenital hemorrhage (1.4%, 1.1%), abdominal pain (2.2%, 2.3%), diarrhea (1.2%,
1.3%), dyspepsia (3.9%, 4.2%) and nausea (1.2%, 1.0%), respectively. Gastrointestinal adverse
reactions occurred more often with dabigatran etexilate than warfarin. These were related to
dyspepsia (including upper abdominal pain, abdominal pain, abdominal discomfort, epigastric
discomfort) or gastritis-like symptoms (including GERD, esophagitis, erosive gastritis, gastric
hemorrhage, hemorrhagic gastritis, hemorrhagic erosive gastritis and gastrointestinal ulcer).
Gastrointestinal hemorrhage occurred at a higher frequency with PRADAX 150 mg BID and
110 mg BID (4.6%, 3.3%, respectively) compared to warfarin (2.6%). The underlying mechanism
of the increased rate of GI bleeding has not been established.
Allergic reactions or drug hypersensitivity including urticaria, bronchospasm, rash and pruritus have
been reported in patients who received dabigatran etexilate. Rare cases of anaphylactic reactions
have also been reported.
Patients at an increased risk of bleeding should be closely monitored clinically. A coagulation test,
such as aPTT may help to identify patients with an increased bleeding risk caused by excessive
dabigatran exposure.
For complete prescribing information, please refer to the Product Monograph.
*A randomized non-inferiority trial of 18,113 AF patients at risk of stroke. Patients received dabigatran
110 mg BID or 150 mg BID (blinded arm) and adjusted doses of warfarin (unblinded arm).
†Stroke or systemic embolism: dabigatran 150 mg BID (n=6076, no. of events=134)
vs. warfarin (n=6022, no. of events=202).
‡Intracranial bleeding includes adjudicated hemorrhagic stroke, subarachnoid, and/or subdural bleeding.
§Intracranial bleeding: dabigatran 150 mg BID (no. of events=38) vs. warfarin (no. of events=90).
References: 1. Pradax Product Monograph. Boehringer Ingelheim (Canada) Ltd., 11/08/10. 2. Connolly SJ et al. Dabigatran
versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med. 2009;361:1139–1151. 3. Connolly SJ et al. Newly
Identified Events in the RE-LY Trial. N Engl J Med. 2010;363:1875-1876 supp appendix.
Pradax™ is a trademark used under license by Boehringer Ingelheim (Canada) Ltd.
BOE9815_01AA_FP_JRNL.indd 1
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