volume 23, issue 9 - New York City Pharmacists Society

Transcription

volume 23, issue 9 - New York City Pharmacists Society
NEW YORK CITY PHARMACISTS SOCIETY
VOLUME 23, ISSUE 9 PSSNY helpline 1-800-632-8822
The Voice of Pharmacy in the Big Apple
DECEMBER 2014
www.NYCPS.org
President’s Message
Every year’s end
is a chance for
each to reflect on
the progress we’ve
made on our own
personal journeys,
while beginning to think ahead
about our personal goals for the
New Year.
That kind of self-assessment
is helpful for organizations, too.
So let’s consider the progress
we’ve made in 2014, along with
the most productive areas for
focus in 2015.
For
starters,
it’s
only
appropriate to recognize again
the valuable contributions of our
PSSNY/NYCPS leadership team.
Their hard work and commitment
have been making a steady
difference in helping our voices be
heard in Albany, while attracting
new members to make our point
of view feel even “louder” to
legislators’ ears.
We made undeniable advances in 2014:
* We increased our own NYCPS
membership by 5%. PSSNY
membership also has enjoyed
an increase. It’s the simplest
of math: the bigger we are,
the more we count. We must
all work to keep up our membership growth.
This is the typical questions that
pharmacists will ask of me. As you
are aware, the Drug Enforcement
Administration
(DEA)
through
their Office of Diversion Control
(Diversion) are responsible to prevent
and detect diversion of controlled
substances in Schedules II through
V. From the moment a controlled
substance is manufactured until
it is dispensed as a prescription,
DEA has responsibility to enforce
the federal laws and regulations for
the purchase, sale, disposal and the
reporting by theft or significant loss
of controlled substances by DEA
registrants.
continued on page 20
IN THIS ISSUE
President’s Message.......................1
Page 3
Page 1
Why is DEA Asking Me About
Those Prescriptions?.......................1
Chairman’s Report..........................3
Treasurer’s Report...........................4
A Message from PSSNY
President Elect Roger Paganelli........6
Secretary’s Report...........................8
NPCA...........................................10
ISMP............................................11
News from Around the
Pharmacy World............................12
RX and the Law............................19
The New York City Pharmacists Society
111 Broadway, Suite 2002, New York, NY 10006
PAAS...........................................11
ADDRESS SERVICE REQUESTED
OFFICERS
Ron DelGaudio, President
718-230-3535
Parthiv Shah, President Elect
718-292-4244
Aniedi Etuk, Vice-President
212-222-3652
Bill Scheer, Treasurer
917-805-4207
Jim Schiffer, Secretary
212-616-7040
BOARD OF DIRECTORS
Alex Perchuk, Chairman
718-835-2000
Charles Catalano 718-358-1300
Mike Agovino718-543-3116
Charlie Ciaccio718-452-3261
Vito Columbo718-418-9700
Jim DeTura718-292-1856
Aneidi Etuk212-222-3652
Russell Gellis212-877-3480
Carol Georgiadis718-762-7111
Roy Greif718-363-3300
Robert Hopkins
516-852-1405
Ray Macioci718-823-1085
Boris Mantell 718-591-1040
John Navarra212-213-5570
Joseph Navarra212-213-5570
Boris Natenzon718-720-3710
Roger J. Pagenelli718-364-6100
Dhiren Patel212-281-0488
Richard Schirripa212-860-4152
PSSNY REGIONAL REPS
Parthiv ShahBronx
Dhiren Patel
Manhattan
Boris Natenzon
Brooklyn, Staten Island
Robert HopkinsQueens
RECORDING SECRETARY, ACTING
Mike Agovino
718-543-3116
NEWSLETTER
Jim Schiffer, Senior Editor
Designed, Printed & Mailed by:
Prestige Litho and Letter 631-231-7300
Why is DEA Asking Me
About Those Prescriptions?
Chairman’s Report
S e e A b ov e
continued on page 21
If there is a “d” or “VD” on your label...
you’re deliquent or Very Deliquent. please remit.
For further information call 1-800-632-8822
President’s Message
Why Is Dea Asking
Me About Those
Prescriptions?
page 2 DECEMBER 2014
For over 60 years, Kinray has been the full-line, full-service
pharmaceutical wholesaler for independent pharmacies.
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© 2014 Cardinal Health. All rights reserved. KINRAY and the Kinray LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.
NYCPS NEWSLETTER
NYCPS NEWSLETTER
DECEMBER 2014 page 3
Chairman’s
Report
Greetings. We almost made it, year is almost gone.
Thanksgiving, Grey Thursday, Black Friday and Cyber
Monday are all behind us.
According to analysts, this year’s retail sales by
comparison, remind me of the state of our pharmacy
business. This year all the big box stores took a
financial hit due to the changes in shopping as the
result of changes in on line technology. This draws my
comparison to the constant changes in the healthcare
environment. In order for us to survive in this crazy
health care environment , we must be willing to change
and adapt as that is the only true key for our survival.
It seems a bit premature to write about discussing
or planning New Year’s resolutions, but by the time you
get this newsletter it will be very timely. We need to get
through this busy month of December and the holiday
season filled with all the parties, and get togethers.
After all, the holiday season should be a fun time but
it is stressful enough, but it’s never too soon to think
on how to make your pharmacy better. I know it’s an
ongoing struggle to constantly adapt to all the changes
and innovations, but doing so it’s a key to survival.
Friends it’s never easy in our profession of pharmacy,
especially on the business end and from here on it will
not get easier.
Yes we will all agree that 2014 has been a tough
year but we are still standing!
A few things we should remember. First, the
Affordable Care Act the penalties will kick in on January
1st, 2015. If you are a pharmacy owner you should
review the Federal requirements on the NCPA website
it’s a wealth of information (www.ncpanet.org). Consider
joining NCPA if you are not already a member. They
are the only national pharmacy organization dedicated
exclusively to the survival of independent pharmacy.
Next thing, is to keep in mind that the NYC sick day
law went into effect as of April 1, 2014 and this law
(thank you Mayor DeBlasio) does require employers to
carry over the unused days to the next year. There are
certain rules and you can look them up on the NYC.
Gov website. Third, I do encourage everyone of our
members to log onto the PSSNY website (www.pssny.
org) and even download an app on your phone it’s a
wealth of information. In our daily practice we just can’t
keep up with all this information, especially now when
every penny counts and the 3rd parties and the PBMs
are trying to recoup funds from us through their sneaky
audits and many times devious audits. These audits
are brutal and you really can’t prepare for them, every
pharmacy has something missing or some kind of error
is found. Did you know that if you dispense Suboxone
to treat drug addicts through an authorized prescriber
both the normal DEA number and the “X” number of the
prescriber need to be written or printed on the hard copy
of the script? Ask your colleagues if any third party audit
recouped money on these scripts for not having both
numbers written on the physical prescription. You will
agree that these audits are getting worse and worse.
A few dates to remember, the PSSNY Mid-winter
convention, which I hope to see many of you there, is
January 8-11 at Saratoga Springs New York. And another
important date, Independent Pharmacists / Pharmacy
Owners Lobby Day is March 3,2015 and the Pharmacy
Lobby Day is April 14,2015., both held at the state capital
in Albany. Mark those dates on your calendar.
Happy and Healthy New Year to all of you and your
families. Happy 2015!
~ Alex Perchuk
Chairman, NYCP
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page 4 DECEMBER 2014
NYCPS NEWSLETTER
Treasurer’s
Corner
NEW YEAR, NEW BATTLE
Another year is almost over, having gone by so
quickly. It seems second nature now, that it means we
begin again to formulate our strategic game plan for
the upcoming legislative session in Albany. We have
been led in Albany by dedicated leaders who passed
the AMMO legislation to stop mandatory mail order in
New York State, stopped the carve out of “specialty
drugs” from the Medicaid Managed Care program
and stopped the implementation of the crippling MAC
pricing for Medicaid at less than cost pricing.
Our strong leadership has been all that stood
between us and a catastrophic marketplace in which
to practice pharmacy. We have had growing support
from rank and file pharmacists in this effort to stem
the chipping away at our pharmacy practices, our
businesses. So many times it seems as if there is a
concerted effort to make us non-profit, or at least nonprofitable.
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We will again be called to step up our commitment to
keeping our profession safe from outside interference.
March 3, 2015 is the day we all get a chance to go
as a unified force and speak to our lawmakers about
the issues we need to have action on in this coming
year. That is Pharmacy Owners Lobby Day. We will
be working to address the issue of reimbursement
by PBMs. The generic marketplace has become a
nightmare, prices going up overnight by hundreds of
percent. An issue in that we find it hard to be reimbursed
properly by the PBMs. We are seeking relief from slow
response to the increases, which make it infeasible to
dispense these drugs, for the last time I checked we
were not yet non profits.
As a prelude to this campaign we need to make sure
all the elected representatives in our work and home
districts are contacted by a pharmacist from their district.
We need more of you who are still sitting on the sidelines
to get into the game. Good leadership is essential to craft
the plan needed to accomplish this goal, but we need
the involvement of all the New York City pharmacists to
make the voice we speak to the legislators with to be
heard over the many others who are working to prevent
pharmacy from achieving this goal.
We are building on the successes of the past few
years, we have accomplished things we were told
we did not have a chance to get past. Perseverance
paid off, these were tangible victories for community
pharmacy. We need all our members to be a part of
our push for a more equitable pharmacy environment.
Think of it as an investment in your business, an
investment in the future of pharmacy.
We get a lot of requests for donations from all sorts
of charities at the end of the year. Well think of this as
a request for a donation, not of money but of your time
to benefit your bottom line. We cannot afford to ignore
the world that is beyond the pharmacy department, we
need to embrace the challenge if we want to survive.
The battles will always be there, they can only be won
with your help, are you up to this challenge?
Happy New Year one and all and lets all work
together to help our profession and our pharmacies
survive in 2015.
- Bill Scheer
©2014
NYCPS NEWSLETTER
DECEMBER 2014 page 5
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page 6 DECEMBER 2014
A Message FROm pssny
president elect
roger paganelli
Happy holidays to all members of our organized
family of pharmacy!
The national and state election results are out and
the republicans are the majority in the NYS legislature.
Naturally there’s challenges regardless of the majority,
but PSSNY legislative committee has been strategizing
for some time, waiting to see who our strategic sponsors
will be in the senate and assembly for our upcoming
agenda. The committee continues to deliberate over a
senate sponsor for the AMMO reform bill. At the same
time we have engaged our assembly sponsor, Linda
Rosenthal, on the MAC appeal/Fair generic pricing
bill to narrow the focus and finalize the language for
the upcoming session that will start in January. We
also plan on meeting with our senate sponsor, Kemp
Hannon, as we near the beginning of the session.
The committee is also discussing a Fair Audit piece of
legislation to add to our 2015-16 legislative agenda. I
NYCPS NEWSLETTER
don’t have details on that right now, but stay tuned.
SAVE THE DATE- INDEPENDENT PHARMACIST’S AND PHARMACY OWNER’S LOBBY DAY
IS MARCH 3RD This is our day to make a difference
in Albany as we make appointments with senate and
assembly people in each of our districts to explain the
importance of our proposed legislation and why they
should vote for it.
The committee continues to work on other legislative
issues, along with the above mentioned, and you will
hear about those in upcoming articles.
Membership is another area where I concentrate
my efforts and I’m proud to be on such an active committee. Dhiren Patel and Richard Schirippa are Committee co-chairs and under their guidance, along with
Jamie Cullis of the PSSNY staff, membership is growing. Prior to the January 2014 Midwinter Conference,
there hadn’t been a working membership committee.
Our database of membership was extremely inaccurate and absolutely impossible to determine who was
paid, when they were due for renewal, how long they
were members, whether they made donations to PAC
or otherwise. There was no effort to update email, personal or any other pertinent info of the membership.
After 9 months, with 2-4 meetings per month, I’m confident that we are in a much better place with our membership. Our membership numbers are slowly increasing and efforts to grow and retain existing members
are being worked on constantly by a committed group
of volunteers. Look for a membership promotional offer
in the new year. It’s critically important that we all encourage our colleagues to join. Remember that membership is every member’s business and that joining
PSSNY is a smart business decision that will give you
a substantial return on your investment.
In closing, I would like to see some new faces,
along with the old familiar ones, at the upcoming
Midwinter convention in Saratoga January 9-11 Visit
pssny.org for registration and all details. Volunteer
today in some capacity. Think about giving back to
your community, the community of pharmacy. There’s
a tremendous amount of work to do and with many
hands, the load is light!
Again, Happy Holiday Season to All!
- Roger Paganelli
PSSNY President Elect / Legislative Chairman
NYCPS NEWSLETTER
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DECEMBER 2014 page 7
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page 8 DECEMBER 2014
NYCPS NEWSLETTER
Secretary’s
R eport
DECEM
BER
2014
Is Community Pharmacy being duped into working
on a NYS Medicaid Project that is going nowhere? Time
and time again we have been asked to get involved
in a government initiative in order to better serve our
communities, to better serve our patients. So with that as
a backdrop I review the status of another initiative known
as DSRIP, DSRIP is the acronym for the NYS Medicaid,
“Delivery System Reform Incentive Payment Program”.
Community Pharmacies here in the metropolitan New
York City area have been encouraged to get involved
with the NYS Department of Health DSRIP program.
The DSRIP concept is a controversial one at best. New
York State applied to the federal government for a waiver
from the traditional Medicaid payment methodology in
order to find a way to save additional Medicaid dollars
on the care for our NY Medicaid patients.
The federal government granted this Medicaid waiver (in
this waiver, for the feds it was a no brainer, as the feds had
nothing to lose) as this strange reconfiguration of Medicaid
payments to local hospitals appears at best to be somewhat
of a smoke and mirror maneuver by the Cuomo administration
to squeeze more value out of the Medicaid dollars. The
savings is to be achieved by providing better coordination of
health care to our NY Medicaid patients upon their discharge
as an inpatient at hospitals. There appears to be a large
percentage of Medicaid patients who relapse back into the
hospital after being sent home. These relapses cost both New
York State and the federal government millions and millions of
dollars annually. You may ask how is these savings through
DSRIP is going to be achieved. The answer is that the hope
is to reduce the number of hospital readmissions by Medicaid
patients by preventing health relapses by more intensive and
aggressive follow up care of the patient’s condition. This is
supposedly achieved by better follow up care, treatment and
more aggressive and efficient care in our Medicaid patients
especially those who suffer from some common core disease
states that many of our state’s Medicaid patients suffer from,
such as hypertension, diabetes, asthma and obesity. The
theory is that if better follow up care is available, these patients
will not need to be readmitted to the hospital for inpatient care
which is much more costly than outpatient or home care.
The problem is that this process which was approved
by the federal Centers for Medicaid and Medicare Services
(CMS) with no funding to get it started. Therefore it will force
New York State to create the savings internally without any
federal funds being used for such creative savings. That in
itself is a problem because NYS has to find the money to
fund this new initiative by reconfiguring existing payments.
Governor Cuomo is leaning on several state and municipal
hospital systems. One such big player in this process is
the NYC Health and Hospitals Corporation (HHC) which
Governor Cuomo is counting on to be a big participant with
successful outcomes in this DSRIP initiative.
There is one serious glitch in this concept. Recently the
New York City Citizen’s Budget Committee,(CBC) a non
government watchdog group released a policy brief that
depicted HHC’s finances as “troubled,” and said that its plan
to reverse course was “was at best risky and may prove
unachievable.” This policy brief said HHC would exhaust
its cash reserves by fiscal 2016 if aggressive measures
were not taken. HHC’s financial results for 2014 showed an
operating loss of $103 million, a significant improvement over
CBC’s estimate of a $535 million operating loss. Dr. Raju said
HHC has achieved $700 million in savings this year, citing it
as evidence that the system is taking action to improve its
financial viability. Still, he confirmed that HHC faces many
financial challenges, as outlined in the CBC report.
At the end of the day, if this DSRIP concept is going to
work, with real meaningful value with savings generated, NYS
can keep half of the savings as the federal government keeps
the other half as the program is generally a 50-50 split on
costs between the federal and state governments (note that
NYS shares their 50% share with local sate counties). What
I wish to bring out is that it has been reported in Crain’s NY
Magazine that the NYC HHC is running short of cash. NYC
HHC is led by Ram Raju MD, and he is concerned about
HHC funding and he is also troubled over the fact that the
voluntary and private hospitals of New York City are not pulling
their weight by leaving many of the uninsured patients at the
doorstep pf the NYC HHC. My concern is that pharmacies
will rise to the occasion, as we always do, and look after these
patients and whatever savings will be achieved— if any—will
be diverted right to these hospitals that are managing these
DSRIP initiatives with the excuse that these funds are needed
to keep these institutions operating.
While we look back at the first year of Mayor DeBlasio’s
administration, we see another year of trials and tribulations
of our profession they call pharmacy. We need to approach
Mr. DeBlasio in the coming year and show him the value that
we community pharmacies serve towards the health of New
Yorkers. Mr. DeBlasio claims that he is concerned about small
business and their survival in New York City yet he continues
to push on with additional operational costs for all business
owners such as his mandatory paid sick time for business with
five or more employees. We need to seize the opportunity to
grab Mr. DiBlasio’s ear and explain how pharmacies in New
York City are not recognized for their huge contribution toward
the wellbeing of the neglected New Yorkers.
Folks lets see what the New Year brings us and lets
see if we can make any headway with working on saving
our profession by some commons sense recognition of our
value by our elected officials in New York City. Also lets see
where this DSRIP program goes. Yes sometimes I appear
to be pessimistic on my perception of the profession, but I
do believe deep down that we have the capability of making
lemonade out of all of the lemons that come our way.
Happy and Healthy Holidays and a Blessed New
Year 2015 to all.
- Jim Schiffer
Secretary NYCPS
NYCPS NEWSLETTER
DECEMBER 2014 page 9
page 10 DECEMBER 2014
NYCPS NEWSLETTER
Campaign Part 2:
Get Any Willing
Pharmacy Enacted
My last column detailed how NCPA is working with
other pharmacy stakeholders to lead a coordinated and
unified grassroots campaign to get more support from
the U.S. Congress for H.R. 4577 (the Ensuring Seniors
Access to Local Pharmacies Act) to address Medicare
“preferred pharmacy” drug plans. I used “I’m Just a Bill,”
an episode from the old Saturday morning Schoolhouse
Rock television series as an example of how constituents
have to drive legislative action. However, “I’m Just
a Bill” does leave out an important tool in persuading
lawmakers to act on specific legislative ideas - targeted
advocacy advertising. That’s what this column is about.
David Ogilvy, who helped to shape the modern
advertising industry, once said, “The more informative
your advertising, the more persuasive it will be.” We
took that advice to heart in our attempt to amplify our
message.
NCPA released two 60-second radio advertisements which aired coast to coast in select states. Our
members can use them as ads on your local radio
stations, on your phone IVR systems for consumers
calling into your pharmacy, and as content for your
pharmacy’s websites.
The first ad, “George and Joan,” is about a married
couple newly eligible for Medicare and their frustration
that their prescription drug plan forces them to choose
between two unpalatable options: either pay larger
copays or switch to a designated pharmacy not of
their choosing. George complains, “A bunch of darn
bureaucrats. Joan, we’re 67-years-old and have been
running our lives and paying taxes. Now, they tell us
how to live.” The ad concludes with a closing pitch
for listeners to contact their members of Congress to
urge their support for H.R. 4577 by saying, “It’s time
politicians know - greater access to medicine starts
with more choices for you.”
The second ad, “Rigged,” details how the game is
“rigged” for the benefit of the insurance middlemen,
who effectively tell seniors where to get their
prescription drugs by making it more expensive to go
to another pharmacy. A female voice says, “Three huge
corporations control about 70 percent of all pharmacy
benefits in our country - 70 percent!” Then she says,
“That’s big money! And that blocks local community
pharmacists from having a real shot at competing.”
Finally, she concludes, “Don’t let bureaucrats and big
money restrict your access to the medicine you need.”
According to the IAB Internet Advertising Report, in
2013 online ads actually surpassed broadcast television
advertising for the first time in terms of revenue.
Reflecting the increasing importance of online media,
NCPA created banner ads for websites. The ads make
the case for patient access to medication and pharmacy
choice and can be hyperlinked to more information
at NCPA’s dedicated “any willing pharmacy” web
page: www.ncpanet.org/pharmacychoice. Community
pharmacies can feature the ads on their websites or
sponsor them as advertisements on local online news
outlets such as newspapers. The ads were produced
in industry-standard sizes (300x250 and 728x90) and
offer another avenue for building support for H.R. 4577.
H.R. 4577 is a common-sense solution to spurring
competition and preserving pharmacy choice for
seniors. The legislation would take a critical first step
by applying an “any willing provider” provision to
pharmacies in medically underserved areas so that
they have the opportunity to participate in all Medicare
prescription drug plans, especially the “preferred
pharmacy plans” that have proliferated over the past
couple of years.
As Congress returns in September, we hope to
ratchet up the pressure in similar fashion because we
want to ensure the voices of community pharmacies and
their patients are heard loud and clear through sustained
by grassroots pressure that comes from phone calls and
emails to each targeted congressional office.
You know Medicare beneficiaries like “George
and Joan” at your pharmacy. With the Medicare Part
D open enrollment period starting soon, they need to
know there’s action they, along with you, can take to
make a difference.
- B. Douglas Hoey, RPh, MBA
National Community Pharmacists Association CEO
NYCPS NEWSLETTER
DECEMBER 2014 page 11
Medication Safety • Preventing Errors
By the Institute for Safe Medication Practices
“Have you experienced a medication error or close call? Report such incidents in confidence to the ISMP National Medication Errors
Reporting Program (ISMP MERP) at 1-800-FAIL-SAF(E) or online at www.ismp.org to activate an alert system that reaches manufacturers, the medical community, and FDA. ISMP guarantees confidentiality of information received and respects reporters’ wishes as to the
level of detail included in publications.”
Confusion between Valtrex and Valcyte. The
generic names for Valtrex (valACYclovir) and Valcyte
(valGANciclovir) are strikingly similar, and both the brand
and generic names of the products start with the prefix
“val,” contributing to look- and sound-alike confusion.
Both have uses associated with cytomegalovirus (CMV)
and may be used in immunosuppressed patients with
human immunodeficiency virus (HIV) or transplant
patients. Valtrex is used in the treatment of shingles
(herpes zoster), cold sores (herpes labialis), genital
herpes (herpes genitalis), and as prophylaxis for
prevention of CMV in patients with advanced HIV or
after transplantation. Valcyte is used in the treatment of
CMV retinitis in patients with acquired immunodeficiency
syndrome (AIDS) and also for prevention of CMV in
kidney, heart, and kidney-pancreas transplant patients.
Also, valACYclovir is metabolized to acyclovir while
valGANciclovir is metabolized to ganciclovir, all of which
are drug names that are easily confused, too.
A 2002 report involved a doctor prescribing the
wrong drug, but other error reports involve nurses and
pharmacists who confused the drugs while transcribing
and dispensing them, or misinterpreted the drug name
due to poor handwriting. For example, a pharmacist
recently notified us about a colleague who noticed that
a heart transplant patient had received valACYclovir in
error for 10 days. The drug had been chosen incorrectly
by the prescriber from a computer selection screen.
For either of these drugs, we’d highly recommend
using both the brand and generic names when referring to
them and determining their purpose when processing the
orders. We also recommend using tall man letters when
listing the drugs in computerized inventories: consider
using valACYclovir and valGANciclovir. You might also
be able to configure a computer alert to warn of the risk of
mix-ups during order entry.
ISMP barcode readiness assessment. ISMP,
through a grant from the Agency of Healthcare Quality and
Research (AHRQ), has developed a readiness assessment
to prepare for implementation of barcoding technology
in community pharmacies. This free tool, Assessing
Barcode Verification System Readiness in Community
Pharmacies, was developed to help address the reasons
why barcode scanning has not been implemented and
to facilitate the adoption of this technology in community
pharmacies that do not currently utilize it for product
verification. This tool will help community pharmacy
owners and managers better understand the issues
related to barcode product verification systems, assess
the pharmacy’s readiness for the technology, prepare for
the selection of a system, and implement the technology
effectively. This assessment tool will serve as a conduit
to building a solid foundation upon which to install the
technology. If you are planning to implement bar-coding
technology in your community pharmacy or pharmacies,
please go to www.ismp.org/ahrq/ to access the tool!
Red Flags
Are You Protecting Your DEA License?
§1306.04 Purpose of issue of
prescription.
(a) A prescription for a controlled
substance to be effective must be
issued for a legitimate medical purpose
by an individual practitioner acting in
the usual course of his professional
practice. The responsibility for the
proper prescribing and dispensing
of controlled substances is upon
the prescribing practitioner, but a
corresponding responsibility rests
with the pharmacist who fills the
prescription. An order purporting to be
a prescription issued not in the usual
course of professional treatment or in
legitimate and authorized research is
not a prescription within the meaning
and intent of section 309 of the Act (21
U.S.C. 829) and the person knowingly
filling such a purported prescription,
as well as the person issuing it, shall
be subject to the penalties provided
for violations of the provisions of law
relating to controlled substances.
§1306.05 Manner of issuance of
prescriptions.
(a) All prescriptions for controlled
substances shall be dated as of, and
signed on, the day when issued and
shall bear the full name and address of
the patient, the drug name, strength,
dosage form, quantity prescribed,
directions for use, and the name,
address and registration number of
the practitioner.
Some of the “Red Flags” you
should watch for include:
•Drug cocktails such as an opioid,
a benzodiazepine and a muscle
relaxant.
•Multiple drugs in the same class
such as Hydrocodone/APAP tabs
and Tussionex Suspension.
continued on page 22
page 12 DECEMBER 2014
- 2014
R
E
MB
E
C
DE
NYCPS NEWSLETTER
Jim Schiffer Reporting...
News from Around
The Pharmacy World
DECEMBER 2014 EDITION
Chain News Update
In a surprising financial report, RiteAid has
shown remarkable financial resiliency in the latest
quarterly report. In published report in the first week
of December, it reports that Rite Aid has had strong
financial growth for the past two years, beginning in
December 2012. The stock price of RiteAid have
grown more than 400%. These stock price increases
have happened as Rite Aid has converted its profit
margin from negative 1.4% in 2012 to positive 1.1%
in the last one year period, thanks to the increase in
the introduction of generic drugs. Additionally, Rite Aid
has been reducing its debt-to-equity ratio from 3.5 to
0.9 and RiteAid has also invested to improve stores,
as well as a strong effort to create a new identity within
those remodeled stores and to increase the presences
of the RiteAid Wellness programs. The result of these
investments are starting to put meat on the bones and
they all help explain why Rite Aid’s stock might still be
on the upward trend. Walgreens on the other hand is
a much stronger retailer but when you look at the two
pharmacy chains side by side, you will be surprised
at the comparison. You see last year, in 2013, Rite
Aid’s profit margins were rising, however Rite Aid’s
same-store sales were basically flat for most of 2013.
However, in this current year, RiteAid same-store sales
have quickly accelerated, as the investments Rite Aid
put in place began to materialize.
Currently, Rite Aid is performing on a financial
level very similar to Walgreens. Actually, over the past
two months, Rite Aid’s same-store sales growth has
actually outperformed Walgreens. The bottom line is
that while Walgreens is a much stronger and larger
international pharmacy chain (and partial owner of
AmeriSource Bergen the national drug wholesaler),
RiteAid is catching up in terms of margins and increased
sales. One has to wonder if Walgreens is sorry that
they sold their pharmacy benefit manager unit (known
as Walgreens Health Initiatives or WHI) to Catalyst
Rx a few years ago. Does anybody remember what
happened to Catalyst Rx? They are around bigger
and stronger than ever known as Catamaran Rx.
Cigna Health signed a ten year strategic partnership
with Catamaran Rx about a year ago moving away
from Argus who had provided PBM services to Cigna.
Walgreens has other issues to think about besides the
sale of WHI to Catalyst Rx. Walgreens recently lost an
appeal on a privacy breach lawsuit resulting in a verdict
for a Walgreens patient of $1.44 million. Although
HIPAA was written into law without any private right of
action, creative lawyers have found ways to use HIPAA
as an example of health care provider’s negligence
in the handling of Protected Health Information (PHI).
The precise story involved with Walgreens is somewhat
complex. An Indiana jury ordered Walgreen Co. to pay
$1.44 million to a Walgreens patient after a Walgreens
pharmacists illegally accessed and shared this
patient’s prescription/medical information. It turns out
that this female Walgreens pharmacist was married to
a gentleman who was having an affair and was the exboyfriend of this patient. The Walgreens pharmacist has
suspicions that this patient had given the pharmacist’s
husband a sexually transmitted disease (STD), so
this pharmacist went into the Walgreens pharmacy
computer system and accessed this patient’s PHI.
This pharmacist then shared this damaging PHI with
the this Walgreen pharmacists’ husband (the cheater),
who later sent his ex-girlfriend,(the patient) a text
message indicating he knew the content of the PHI and
presumably knew what kind of medications this woman
continued on page 13
NYCPS NEWSLETTER
DECEMBER 2014 page 13
Around the Pharmacy
From page 12
was taking (allegedly connecting
the STD issue). Thus the premise
for the lawsuit. The worst part of this
soap opera, even though the patient
called the Walgreens pharmacy to
complain about this improper PHI
disclosure, the jilted pharmacist was
permitted to access the PHI once
again. The suit accused Walgreen
Co. of negligence in its supervision
of the pharmacist, and in spite of
Walgreens legal defense that the
pharmacist acted on her own, albeit
illegally and without Walgreens
permission, the judge handling the
case ruled against Walgreens. This
judge instead sent the question to
a jury, which found the company
liable for 80 percent of the damages
owed to the patient. Walgreens
appealed this decision but in early
November, an Indiana appeals court
recently upheld the $1.4 million
verdict against Walgreens and one
of its pharmacists who improperly
shared a customer’s confidential
prescription/medical
information.
A word to the wise, treat PHI with
the most extreme confidentiality
at your pharmacies. We all know
that HIPAA sometimes appears to
be a toothless tiger, but the results
of this lawsuit should place new
awareness of the importance of
following the established HIPAA
privacy protocols for all health care
providers.
We cannot end this year-end
report without talking about CVS
Health, and their retail pharmacy
chain, CVS.
Their stock price
appears to be at an all-time
high hitting over $90 a share
and they certainly don’t seem to
miss the income from tobacco
sales. However their competitors,
Walgreens and Rite Aid , who place
their cigarettes are placed when
customers are on the check-out
line, both state that helping tobacco
users quit using such is fine for
now, and neither pharmacy chain
intends to follow CVS and both
national chains will not stop selling
cigarettes, cigars and chewing
tobacco. Nevertheless, CVS is
proving that it is possible to exit the
tobacco business and still expand
their growth. CVS Health recently
reported third-quarter revenue
expanded almost 10% to $35 billion,
which was led by a 16 percent gain
in its PBM division which more than
supplemented the loss of revenue
from tobacco and cigarette sales.
Both Walgreens and RiteAid
do not have any internal pharmacy
benefit management divisions
as both have sold their PBM
operations some time ago.
I
mentioned earlier what Walgreens
did with their WHI unit and some
of you may remember that RiteAid
had created their PBM under the
name of Eagle Managed Care and
then RiteAid acquired PCS from
Eli Lilly which was more than they
could handle at the time due to
their internal business problems, so
RiteAid sold PCS (which included
Eagle Managed Care) to Advance
Paradigm, a Texas based rather
growing PBM, who then called their
new PBM operation Advance PCS.
Sometime later, that PBM was
sold to Caremark before Caremark
merged with CVS. IF you are not
dizzy from this historical review,
you are doing well. Anyway drug
store financial analysts such as
Jeff Jonas who manages funds
at Gabelli Funds, claims neither
RiteAid nor Walgreens can afford to
drop tobacco just yet, as “They’re
just not performing as well, so they
kind of need those sales….Rite Aid
needs it because of all the debt
they have to service. Walgreen has
some turmoil around the Alliance
Boots
acquisition.”
Cigarette
smoking contributes to almost
500,0000 deaths annually in the
U.S. which includes those caused
continued on page 14
page 14 DECEMBER 2014
Around the Pharmacy
From page 13
by secondhand smoke, as is
reported by the Centers for Disease
Control and Prevention. It is also
estimated that smoking shaves 10
years from life expectancy.
As a result of the increased
emphasis on smoking cessation,
there is public pressure on many
retailers including RiteAid and
Walgreens to stop cigarette sales
and the pressure is getting more and
more intense as elected officials and
anti-smoking groups have pressed
Walgreen and Rite Aid to imitate
CVS. Time will tell what will happen
with this health initiative. Because
of the PBM unit of CVS Health, it
made their decision a bit easier,
the Caremark PBM unit constitutes
54 percent of overall CVS Health
revenue. Although CVS calculated
that discontinuing tobacco sales
dropping tobacco will cost the
company around $2 billion in annual
sales, with the strength of the PBM
unit, if they have a good year in the
PBM side of the business, it would
signal that CVS Health could afford
to give up that portion of their retail
business that came from tobacco
and cigarette sales.
PBM Updates
There are several issues which
are being tackled in the PBM world.
One of the most costly aspects
of the pharmacy benefit is the
increased use of compounded
prescriptions by pharmacies that
are now emphasizing that newly
found profit centers. According
to auditors for CVS Caremark,
Express Scripts and Catamaran
Rx, all of the large PBMs are feeling
increased pressure to rein in the
use of compounded medications.
There is a group of health
insurance sponsors that believe
NYCPS NEWSLETTER
there is no real value to including
compounded medications to their
formularies. Regardless of what
the PBMs feel, many pharmacy
owners are turning to compounding
as source of financial relief as the
large PBMs are offering lower
and lower dispensing fees, while
these PBMs do not update prices
in a timely fashion and attempt to
steer the expensive medications to
their in house “specialty pharmacy
operations”. There is a fine line
between compounding valuable
medications and just preparing
questionable
pharmaceuticals
which
have
unmeasurable
therapeutic effect. In this column,
I am not voicing a personal
opinion on this very sensitive
subject but pharmacists should be
cautious on using compounded
pharmaceuticals which carry a wide
spread between dead net cost and
the sticker price (AWP) as I have
seen some community pharmacies
billing pharmacy benefit managers
hundreds of thousands of dollars
for a topical pain compound which
costs the pharmacy owner about
$4,700. If you are dealing with a
federally or state funded prescription
program you need to be careful that
your compounded medications do
not fall into the category of potential
Fraud Waste and Abuse of the
health plan parameters. You should
seek some valid studies to support
the compounds which are being
prepared at your pharmacies in the
event a pharmacy benefit manager
seeks such justification. While we
are looked upon for our health care
expertise, we are also responsible
to the payers to submit justified,
proper and appropriate billing.
Also remember that pharmacists
must remember that their usual
and customary prices need to be
reflected in compounding prices
submitted to PBMs. With all of that as
background music, a group of three
major compounding pharmacies
are suing Express Scripts based on
patients being denied their access
to pharmaceutical products with
on- going harm to these patients
as they cannot have access to their
compounded medications as a
result. These three compounding
pharmacies are located in Texas
and Louisiana. Express Scripts
believes that the litigation is
without merit.
The other issue that the PBMs
are tackling is the increase of new
branded pharmaceuticals which
offer questionable value over
existing non patented products.
For instance do we really need a
75mg dosage form of Doxycycline?
Well if you think we do then just
follow up with Actilate Tablets which
has a 75mg and a 150mg dosage
form at a price of about $1,450 per
bottle. How about a new form of
Lidoderm patches with a touch of
menthol? Just check out Terocin
Patches and see how much of a
dent it puts in your budget, if you did
not have an Rx card. Supposedly
this pharmaceutical patch adds
some enhanced pain relief, but this
too is a very pricey product and is
driving the drug spend through the
roof of the various plan sponsors.
While we have a free market place
for the drug industry, it seems at
times that greed it getting in the way
of logic and generic substitution.
Another relevant issue, we watch
the PBMs, the Manufacturers, the
Health Insurers all make money
based on the movement of industry
yet independent pharmacies are
disappearing like Tyrannosaurus rex.
Pharmaceutical
Manufacturer News
As we are headed to the presses,
Merck is in discussions with Cubist
Pharmaceuticals to purchase their
continued on page 16
NYCPS NEWSLETTER
DECEMBER 2014 page 15
page 16 DECEMBER 2014
Around the Pharmacy
From page 14
company at a price of around $8.4
billion. Initially the offer appeared
to be around $ 7 billion but Merck
pushed up the numbers to make
sure this deal would happened.
Merck appears to be offering over
$105 per share of stock of Cubist
which is about a 40% increase
over the December 5th share price
of Cubist. Cubist is a maker of
antibiotics, and Cubist is planning
on introducing four new antibiotic
products within the next 5 years to
fight the resistant types of bacterial
infections. There is a huge threat
of drug-resistant bugs and this has
pushed the public health agencies
to urge pharmaceutical companies
to invest in new antibiotics, which
is a field of the pharmaceutical
industry has apparently abandoned
NYCPS NEWSLETTER
while the industry leaders seem
to spend their attention on more
profitable therapeutic areas such as
cancer or hepatitis C.
Months ago Pfizer spun off their
animal health business under the
new corporate name Zoetis, and the
animal health company is the subject of potential takeover status. It
seems that activist investor Bill Ackman purchased a position in Zoetis
in a sizeable amount of stock, 8.5%
through his hedge fund, Pershing
Square Capital Management LP in
mid-November. Pershing Square
Capital Management LP, intends to
push the management of Zoetis for
an increase in value to shareholders. That usually means pressure
on the company, such as Zoetis for
a sale, restructuring or increased
dividends and share buybacks. The
investment of Ackman has attracted
suitors to check out Zoetis, such as
Bayer and possibly Eli Lilly. Bayer
has already increased its life sciences business with another deal
earlier this year back in May when
they agreed to buy Merck’s overthe-counter products (which included a rather health Schering Plough
OTC division which included Claritin), for $14.2 billion. Eli Lilly is also
in the animal health business and
purchased a division of Novartis.
Under this April 2014 agreement,
Lilly acquires all assets of Novartis
Animal Health for a price of approximately $5.4 billion. Lilly will pay for
this acquisition with approximately
$3.4 billion of cash and $2.0 billion
in debt to be issued. Eli Lilly and
Zoetis appear to be the two large
animal health pharmaceutical players in the industry and Bayer would
try and capture that Zoetis business
to add to its extensive Rx and OTC
portfolio. The other industry news
continued on page 17
NYCPS NEWSLETTER
DECEMBER 2014 page 17
Around the Pharmacy
From page 16
advantage of being headquartered
in Ireland.
as I reported last month was the
acquisition of Allergan by Actavis.
This was a long battle as Bausch
& Lomb was fighting to grab Allergan for months, but Allergan rejected their offer and finally made a
deal to be acquired by Actavis and
it is going to be folded into Actavis
which is looked upon as a mega
brand/generic company. Actavis as
I reported in the last newsletter has
been gobbling up company after
company. It has brand name Forest Laboratories and Warner Chilcott products alongside Watson,
and Purepac generics while it also
has the large drug distributor known
as Anda. Actavis has made one of
those famous inversion tax deals
when they acquired Warner Chilcott
they also obtained a home court tax
Update on Affordable Care Act
As has been reported in
newspapers throughout the past
few months, the annual registration
period for those enrolling in health
insurance through state and federal
exchanges expires on December
15th. There are some new insurance
companies which have entered the
market to bring new choices to our
uninsured or those who chose to
change insurance companies. The
biggest complaint which has been
heard from physicians, between the
reduced reimbursement from state
Medicaid programs and then the
reduced payments from the new
health exchanged based insurance
companies, there are many
individual health care providers
who are leaving their private
practice and are joining hospital
based medical practices in order
to stay financially afloat. When
you consider the overhead that a
physician must incur to operate an
office, rent, utilities, payroll, billing
collections, then add malpractice
issues, it is enough to choke a
small practitioner.
That concept
is continuing on the medical center
level as well.
Brooklyn based
Lutheran Medical Center has
recently announced a merger plan
with Manhattan based New York
University Medical Center. You see
NYU Medical Center has negotiated
much better rates of payment from
the various health insurers because
these health insurers need NYU
Medical Center, a world respected
health care center, as part of their
profile of network hospitals. The
difference in reimbursement for
a physician who is in the NYU
continued on page 18
page 18 DECEMBER 2014
Around the Pharmacy
From page 17
network, versus a physician in the
Lutheran Medical Center network
for a health insurance company can
be a difference of 40%. Medicare
reimbursement is the benchmark
for payments to physicians and
many of the smaller local hospitals
get paid at Medicare minus 15%
to minus 25%, while hospitals like
NYU Medical Center may be getting
Medicare plus 15% or Medicare
Plus 25%.
The
problem
with
the
implementation of the Affordable
Care Act is that there are too many
reimbursement variations based on
capitalistic based provider network
NYCPS NEWSLETTER
perceptions. When you look at the
demise of Long Island College
Hospital, it has more to do with
reimbursement anemia (or lack of
respectable reimbursement from
the major insurance companies)
than any sort of mismanagement by
the hospital administrators. Health
insurance companies want to show
their patients enrolled that they have
a good provider network. Hospital
access is the most important
aspect of the health insurance
profile. Prescriber choices are not
as important. However, the quality
practitioners who are independent
operators are getting offered smaller
rates of reimbursement over the
practitioners who are affiliated with
major teaching hospitals such as
NYU, Columbia Presbyterian, etc.
It seems that there are incentives
which were built into the ACA
which give hospital based medical
practices an advantage over the
actual private practices which we
were used to seeing in the days
of Dr. Marcus Welby. It seems
that hospitals are given incentives
by CMS to take the risk on caring
for large pools of patients. The
Accountable Care Organizations
also seem to slant the profit towards
single medical institutions actually
own the medical practices of the
prescribers/ physicians. While I
support many of the initiatives of
Obamacare and the ACA, we must
do a better job of encouraging
our youth to enter the medical
profession and care for the
health of future Americans.
The ACA is a start at health
care reform but not an end
all to it. We need to preserve
medical entrepreneurship,
autonomy and physician
ownership
that
are
seriously eroding in today’s
healthcare environment. Let
us see how the enrollment
numbers pan out for the
new year. Hopefully the
enrollment will start to pick
up in year two of the ACA.
Time will tell. However we
must not lose sight of the
need for an expansion of
the physicians (which is a
vanishing breed) who will
care for our citizens of this
country.
It is time to say
goodnight. I tried to cover
many issues and concerns
of our profession. Hope you
all have a Merry Christmas,
Happy Hanukah, and a
Happy, Healthy Prosperous
New Year.
- Jim Schiffer
©2014 James R. Schiffer
NYCPS NEWSLETTER
AND
THE
L AW
DECEMBER 2014 page 19
RECORDKEEPING ISN’T THAT
IMPORTANT, IS IT?
This series, Pharmacy and the Law, is presented by Pharmacists Mutual Insurance Company and the New York City Pharmacists Society through
Pharmacy Marketing Group, Inc., a company dedicated to providing quality products and services to the pharmacy community.
Terry at Midtown Pharmacy was dealing with
another recurring frustration. Their usual generic brand
of atenolol was backordered again. Terry ordered in a
couple of 100 count bottles to hold them over until their
usual brand was available again. Terry didn’t bother to
update their computer database to reflect this change
because she would then just have to change it back
again 2 days from now. The change isn’t really that
important anyway, right?
Wrong. Your documentation is the only thing you
will have later to prove what you did today. We all
forget things, especially when they come up weeks or
months later. Consider the following claim scenario.
A pharmacy was sued by a former patient over
some faulty transdermal fentanyl patches. The patient
alleged that he was injured due to the patch releasing
the medication too quickly. The patient’s profile
indicated that he received the patch manufactured
by company A. Company A’s product had in fact
been recalled due to this very problem. The patient
was sure that the excessive dose delivered had
caused him to be hospitalized. The pharmacy staff
went through months of anxiety and expense while
producing records and being deposed. What everyone
learned at the end was that the patch received by the
patient wasn’t manufactured by company A. He had
received patches manufactured by company B. This
was discovered when reviewing the invoices from the
time period in question. Company B’s product had
been purchased because of the recall of company A’s
patches. However, the patient profile indicated that the
patient had received Company A’s patches. Proper
recordkeeping would have most likely prevented this
pharmacy from suffering through months of litigation.
A second consideration here is billing. In today’s
world, it is more important than ever to bill for what
was actually dispensed. Third party payers expect and
demand that their customers receive the product that
is billed to the third party payer. While the 2 different
fentanyl patches discussed above may be clinically
interchangeable, they are probably not the same
when it comes to acquisition cost or reimbursement
rates. One of them may have been non-formulary,
for example. This difference is multiplied if one
product is the brand name one. Clinically, none of
the differences are significant. However, we aren’t
talking about therapeutics. We are talking finances
and recordkeeping. This sort of discrepancy can lead
to repayment demands, even penalties and interest,
following an audit.
The importance of recordkeeping shouldn’t be
overlooked. In litigation, documentation is everything.
If it wasn’t documented, it wasn’t done. Many cases
have turned on seemingly small documentation issues.
Perpetual inventory totals, timecards, delivery records,
pick-up logs, documentation of counseling (or refusal
of counseling) are some other examples of records that
have become key points in a case. The lesson here is
that no record is too small or too trivial to be skipped
over. Update those inventory changes as they come
in. It may seem burdensome at the time, but there are
potential benefits later.
© Don R. McGuire Jr., R.Ph., J.D., is General Counsel,
Senior Vice President, Risk Management & Compliance
at Pharmacists Mutual Insurance Company.
This article discusses general principles of law and
risk management. It is not intended as legal advice.
Pharmacists should consult their own attorneys and
insurance companies for specific advice. Pharmacists
should be familiar with policies and procedures of their
employers and insurance companies, and act accordingly.
page 20 DECEMBER 2014
NYCPS NEWSLETTER
President’s Message:
From page 1
*
We achieved important legislative victories,
including our triumphant defeat of AAC/COD,
protecting us all from onerous and unwarranted
cuts in our reimbursement. Our partnership with
the chains in fighting this implementation proved to
be very effective.
* Another way in which we amplified our impact was
with a successful outreach to patient advocacy
groups. Having them support our efforts by
contacting their legislators, too, definitely helped
put an end to the flawed pricing methodology that
some had sought to impose on us. Our patient
advocacy campaign helped us achieve the unity
and strength we must continue to build for our own
sake and that of our patients.
All in all, we enjoyed a very productive year—
advancing our profession despite those who work
against us. How do we build on our momentum in 2015?
Let’s start in Saratoga Springs, NY, with our important
Mid-Winter convention.
Then come join us for the latest updates and
strategies for Pharmacy Day on Tuesday March 3, 2015.
It’s a great time to earn Continuing Education credits,
interact with your colleagues, and strengthen our ability
to act as one cohesive voice opposing those who seek
to diminish us.
Our “big picture” goals for 2015 involve membership
… communication … and unified action. The only way to
maximize our abilities is to act as a strong and effective
force: like a team of Pharmacist Ninjas, working together
to turn our principles into action!
Ninjas were the legendary figures of imaginary
and mystery in ancient Japan. (Even basketball star,
Shaquille O’Neal, admired them so much that he
compared himself to a Ninja out on the court.) So effective
was this historic force from centuries ago, Japanese lore
imagined that their training included the ability to walk on
water and to make themselves invisible.
Well,
Pharmaceutical
Ninjas are an entirely
different breed. Instead of
being invisible, our quest
is to be highly visible and
audible to the lawmakers
who affect our profession.
If we put out the word,
“Hey, guys, we need you to
reach out to your legislators
now on XYZ legislation,” we should be so well-organized
and responsive, and with such a robust membership,
that the result is… BOOM! We are heard in Albany, loud
and clear!
We’ve made progress toward this kind of clout, and
we can make more in 2015. You can help us be powerful
Pharmacist Ninjas by taking the time to read and absorb
our communications and then turn them into Action!
When our request goes out for letters and calls to
your legislators, be sure to do your part: Write that
letter! Make that call! That kind of communication and
action is how we’ll achieve further legislative success,
regardless of who opposes us.
The more you involve your patients and their
advocacy groups when appropriate – so that they speak
up, too – the more we will be heard.
The more you get non-member pharmacists to join
our ranks, the better.
And the more active you are – as a member and
a PAC contributor – the more we’ll continue to rack up
victories as we did with AAC/COD … and the better and
healthier our profession and our businesses will be.
So enjoy the holiday season and be thankful for all
we’ve achieved. But come back in 2015 ready to go
and to grow as Pharmaceutical Ninjas … otherwise
known as PSSNY and NYCPS. Happy Holidays in the
meantime!
- Ron Del Gaudio
NYCPS President
NYCPS NEWSLETTER
DECEMBER 2014 page 21
DEA:
From page 1
DEA Diversion is broken down into two groups. The
Tactical Diversion Squad (TDS) which is responsible
for the investigation of diversion by prescribers
and pharmacies. When you read of a prescriber or
pharmacist being arrested for illegal distribution, most
likely it would be the DEA TDS group that would have
initiated an investigation. The make-up of the TDS are
DEA special agents, diversion investigators and local
or state law enforcement who will work closely with
state regulatory entities. Generally, a pharmacist is
approached by TDS members investigating a specific
prescriber and the pharmacist is asked why they filled
a controlled substance prescription.
On the other hand, the Diversion Group is made up
of diversion investigators and in some cases members
of the state health and pharmacy boards. With regards to
their duties, this group will be looking at your compliance
with DEA regulations. Their interest would center on
recordkeeping, security of controlled substances and
the due diligence of prescribers and pharmacists. Any
action could result in an administrative or civil action
against the registrant and their DEA registration.
Generally, the Diversion Group would most
likely respond to a theft or significant loss that you
reported on a DEA Form 106. Other times, their arrival
at your pharmacy came from your supplier or in some
cases your competitor. Your supplier will question
excessive purchases especially of those most likely
to be in the crosshairs of a DEA investigation. On the
other hand if you are constantly filling those controlled
substances in the crosshairs of DEA, your competitor
will know if patients are paying with cash and yes they
will give you up. Those controlled substances that are
in the crosshairs of DEA are as follow.
- Oxycodone 30mg Tablets
- Hydromorphone 8mg Tablets
- Morphine Sulfate IR 30mg Tablets
- Methadone 10mg Tablets
- Hydrocodone 10mg Tablets
The aforementioned controlled substances are
most likely to cause some type of action by DEA
personnel. So you ask what I should do to prevent DEA
from making me a target of their investigation. You
need to remember your corresponding responsibilities
as a pharmacist and to maintain a due diligence policy
for your staff pharmacists and pharmacy technicians.
Both apply to the prescriber and the patient.
With regards to prescribers, know your prescribers.
The areas of concern is their field of medicine, board
certification, their education and most important has
the medical board taken legal actions against their
medical license for excessive prescribing of controlled
substances or prescribing outside their field of
medicine. For the New York State prescribers, the best website
is www.nydoctorprofile.com which is a state run website
to assist patients when looking for the history of their
doctor. I have spoken with some pharmacists who have
filled an Oxycodone 30mg tablets prescription written
by a pediatric or OBGYN doctor for a 50 year old man
and has filled the prescriptions that call for 180 dosage
units. In many cases, this is the only prescription
written by the prescriber making me wonder if the only
two number they learned was 30 and 180. At the same
time the excuse is, “I don’t have the time”.
Now for patients, you need to take a different view. For
example, if a known patient sees a known prescriber
and you think that the prescription is good, most likely
you will fill it. What if I told you that the same patient
saw four doctors in the same month and got opioids
from those doctors, would you still fill the prescription?
Doctor shoppers and drug abusers come in different
age and size. I have seen a 76 grandmother identified
by DEA as a doctor-shopper. You say why? For her, it
was the economy.
Besides getting their drivers’ license and verifying
the legitimacy of the controlled substance prescription,
what else do you have to do to determine the legitimacy
of the prescription? There is one tool that doesn’t cost
you anything and can save you from the cross-hairs
of DEA or the New York State Bureau of Narcotics
Enforcement (BNE). If you didn’t use it yesterday while
you filled your controlled substance prescription, you
need to re-evaluate you pharmacy polices. The tool
is the New York State “I-Stop” Prescription Monitoring
Program (PMP) especially when you are filling a
cash prescription for those aforementioned controlled
substances.
Remember the goal is to determine the legitimacy
of any controlled substance whether it’s an opioid or
cough medicine. Actions by DEA or BNE can be costly
to a pharmacy. Generally, $200K for the fine and $300K
for the attorneys. Can you afford it?
~ Carlos M. Aquino
page 22 DECEMBER 2014
PAAS
From page 11
•
Controlled
and
non-controlled
prescriptions where patient only
requests to fill the controlled drugs,
especially if the prescriber specifies
to fill all or none.
• Requests to pay cash for controlled
drugs and insurance for noncontrolled.
• Quantities that exceed standards of
treatment such as a 30-day supply
of cough syrup.
• Missing required elements:
​- Patient full name and address
- Prescriber name, address,
​
DEA# and signature (no
stamps
or
pre-printed
signatures)
​- Drug name, strength, dosage
form, quantity and directions
NYCPS NEWSLETTER
for use.
•Prescribers that write the same
drugs, directions and quantities for
every patient regardless of age,
weight, gender and medication
history.
•Prescriptions that are from other
cities or states outside of your usual
business area.
• More than one unrelated patient that
presents with the same or similar
prescriptions within a short time
frame.
•
State Drug Monitoring reports
that show multiple prescribers,
pharmacies
and/or
multiple
controlled substances.
Finally, make sure controlled
substance prescriptions have a valid
signature. From 21 CFR § 1306.05(d):
(d) A practitioner may sign a paper
prescription in the same manner as he
would sign a check or legal document
(e.g., J.H. Smith or John H. Smith).
Where an oral order is not permitted,
paper prescriptions shall be written
with ink or indelible pencil, typewriter, or
printed on a computer printer and shall
be manually signed by the practitioner.
A computer-generated prescription
that is printed out or faxed by the
practitioner must be manually signed.
PAAS recommends that you be
alert to these and other Red Flags
and always verify and document
that controlled prescriptions are
for a legitimate medical purpose
and meet all of the requirements
under the CSA. Drug abusers and
diverters are always looking for new
ways to get their drugs. Don’t let a
bad prescriber or patient destroy your
pharmacy and your reputation.
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NYCPS NEWSLETTER
DECEMBER 2014 page 23
page 24 DECEMBER 2014
NYCPS NEWSLETTER