Volume 1, Issue 1 - Correct Rx Pharmacy Services

DOSE
A Publication of Correct Rx Pharmacy Services, Inc.
Volume 1 . Issue 1 . 2007
INSIDE
Program Management
Clinical Information
Meds of Abuse
Barcode Scanning
Contents
8 Correct Rx
Company Profile
10 The Value of the
Correct Rx Services
On-Site Visit
16 Implementation
of a Clinical
Pharmacy Program in
Correctional Facilities
12 Effective Program
Management
18 Grapefruit and
Medications: A
Potential for
Adverse Events
24 Medications of Abuse:
Patient Screening
Other Features
7 Greetings from the President
23 New Drug Profile: Atripla
26 Barcode Scanning
Technology
28 Clinical Management
of Hepatitis B
Virus Infection
800.636.0501 . 803-A Barkwood Court . Linthicum, MD 21090 . www.correctrxpharmacy.com . [email protected]
Dose is published by Innovative Publishing Ink.
For more information on how your company can have its own publication, contact Aran Jackson at 502.423.7272.
Innovative Publishing Ink . 10629 Henning Way, Suite 8 . Louisville, KY 40241 . 502.423.7272 . www.ipipublishing.com
Correct Rx Pharmacy Services, Inc. is neither accountable for the content of paid advertisements nor does it endorse same. No outside parties influenced the text or participated in the editing of this publication. Professional standards of care
were taken to ensure accuracy; however, the authors and editors do not attest that the information contained herein is free of errors or omissions. Sound clinical judgment is the responsibility of every professional in addition to full consultation
of all prescribing information prior to medication administration.
Correct Rx
5
Greetings from the President
W
elcome to our inaugural edition of Correct
Rx’s journal publication. This journal has
been in the works for some time, and we
are very proud of the results. It is our intent to publish
a new edition twice a year. So you, as our valued friend
and client, can eagerly look forward to receiving each
new issue.
The growth has been evident not only in the number
of orders being filled, but also in the number of
Correct Rx associates.
Good Corporate Citizens: Correct Rx is not only an
institutional pharmacy recognized for professional
excellence, but it is also a company that is
made up of good corporate citizens. Being
part of an organization that reaches out to
the community to help the less fortunate
is something to celebrate. Correct Rx is
just that kind of company.
Although Correct Rx is just barely four
years young, we have developed a wonderful clinical and management team
whose depth of talent and experience
have provided innovative approaches to
Making a Difference in the Lives We
the institutional pharmacy arena. This
Serve: When it comes to reasons to celmanagement team has risen to each new
ebrate, nothing is more significant than
challenge with vigor and enthusiasm.
the fact that the associates at Correct Rx
When I challenged them to produce a
can positively say what they do and how
biannual top-notch publication, they
well they perform their job makes a difresponded with an overwhelmingly posiEllen
H.
Yankellow
,
Pharm.D.
ference. Every day, our associates fill
tive reply. This energy and genius will be
and dispense essential — and in some
the springboard for a journal that will
cases,
life-saving
— medications. Our clinical team
address a myriad of informative topics in a professional
has been busy developing a model of medication
and useful format.
therapy management that provides much-needed
patient education and therapeutic oversight for the
It is natural to begin the president’s letter with a reflecchronically ill. Not many Americans in the worktion of our achievements since our start in 2003, with
force wake up every morning and go to their respeca particular focus on the previous year’s accomplishtive places of employment knowing that what they
ments. So, in addition to a professional publication,
do will improve the lives of their clients and the
what do we have to celebrate at Correct Rx?
greater society they serve.
Awards: 2006-2007 marked another year of business
Now this is something to celebrate!
awards and recognitions. After 2005, we were not certain that there were any more awards to win, but 2006
I hope you enjoy the first edition and thank you for makproved to be a banner year! Correct Rx won the Ernst
ing Correct Rx a nationally recognized “small giant” in
and Young Entrepreneur of Year award for Maryland
the institutional pharmacy business. A pharmacy that is
in the Health Care Category. This award came with a
well known for quality, integrity, caring and accuracy.
trip to Palm Springs, where we joined all the other
There is no doubt Correct Rx’s corporate culture of carregional winners for the national event. Jay Leno was
ing and accuracy has served us well and will continue to
the host of this gala, and we certainly were excited to
be our guiding mission well into the future.
be shoulder-to-shoulder with the business elite of this
country. Correct Rx was also recognized by the
Governor’s Office of Minority Affairs as one of the
Top 100 Minority Business Enterprises in Maryland.
Continued Growth: Another important reason to
celebrate has been our continued healthy growth in
both the correctional and senior care marketplace.
Correct Rx
With sincere thanks,
Ellen H. Yankellow
President and CEO
7
Correct Rx
8
Correct Rx
Correct Rx Pharmacy Services, Inc. is a “small
giant” in the institutional pharmacy marketplace, placing emphasis on quality and providing a new paradigm for pharmacy services that
includes the following elements: operational
efficiency, utilization review, quality assurance
initiatives, Web site barcode technology and,
most important, clinical programs centered on
medication therapy management. The value of
Correct Rx Pharmacy’s onsite visits by fully credentialed clinical pharmacists is measured by
improved patient outcomes, resulting in fewer
complications and reduced overall costs to its
clients. This model is certainly not new to pharmacy, but it is significantly different from the
Company Profile
traditional system, which is based primarily on
dispensing and distribution activities. Correct Rx
believes this is a prescription to cure rising drug
costs for the clients they serve.
Jill Molofsky, R.Ph., Ellen H. Yankellow, Pharm.D. and James Tristani, R.Ph.
Correct Rx
Correct Rx Pharmacy currently provides comprehensive pharmaceutical services in more than 24
states from their state-of-the-art pharmacy, located
next to the Baltimore/Washington International
Thurgood Marshall Airport. This strategic location was intentionally selected to facilitate a quick
response time for all new and refill orders. The
close proximity to the airport has provided Correct
Rx with a competitive advantage for both transmission and delivery of orders to our customers.
Each client is given the same level of attention,
whether it is a 15-bed assisted living facility or a
27,000-client statewide correctional system. More
than 64 percent of Correct Rx’s clients come from
referrals. All of the owners at Correct Rx are
licensed pharmacists, with more than 70 years of
combined institutional pharmacy experience. In
addition, Correct Rx is a certified MBE/DBE business. For more information, contact Ellen H.
Yankellow, Pharm.D., President and CEO, at
(800) 636-0501, fax (410) 636-9706 or visit our
company Web site: www.correctrxpharmacy.com.
9
Do You Know the Value of the Correct Rx
Pharmacy Services On-Site Pharmacist Visit?
How many times have you heard the phrase “Let me check with my
manager”? Correct Rx Pharmacy Services utilizes a unique model to
provide on-site pharmacist visits to eliminate barriers to success.
The visits are performed by fully credentialed clinical pharmacists
with a focus on the safe, reliable and cost-effective utilization of
medications. The personal attention and face-to-face interaction
our clients receive are instrumental in communicating expectations,
discussing issues, and resolving problems.
10
Correct Rx
The alternative method that
includes supporting clients
through the telephone and
use of contracted consultants
is a well-accepted practice;
however, these arrangements
are not ideal. They often
decrease efficiency of communication and have the potenby Helena H. Kim,
tial to delay problem resoluPharm.D.
tion that threatens the success
of our clients. Contracted
consultants are not intimately familiar with our policies
or our clients. The additional expense of travel to send a
member of the management team or a specialized clinical pharmacist from Correct Rx to perform these visits is
more than justified to Correct Rx Pharmacy Services.
The on-site visit, performed by a Correct Rx pharmacist,
is a reflection of our commitment to our clients.
Operations
The Correct Rx on-site visits are designed to provide
valuable insight into the operations at the facility level.
The operations management program helps clients to
minimize error rates, follow delivery schedules, comply
with standards for reports and meetings, perform all
CQI initiatives, measure outcomes, review medication
room audits, follow safety and security protocols, and
adhere to regulations. Our management team has
more than 20 years of correctional pharmacy experience to benefit our clients.
Inspections and Audits
Inspections of medication storage areas, inventory
records and administration processes are required by
all states as an integral and routine practice to ensure
quality, safety and compliance with state and federal
laws. Correct Rx Pharmacy is familiar with standards
on medication handling and administration established by the National Commission on Correctional
Health Care (NCCHC), the American Correctional
Association (ACA) and the Joint Commission on
Accreditation of Healthcare Organization (JCAHO).
The goal is to establish, maintain and even exceed
standards in between accreditations — not just prepare
for them. Even the best-maintained organizations are
faced with the continual challenge of training replacement staff or staying informed of new changes in standards of practice. Our pharmacists are able to identify
deficiencies and provide recommendations or specific
training to address issues that threaten quality and
safety of medication use.
Pharmacy and Therapeutics Committee Meetings
The Pharmacy and Therapeutics meeting is a forum
established and tailored to meet your many needs,
Correct Rx
including continual monitoring of medication use,
applying pharmacoeconomic principles, developing a
sound formulary, managing of drug costs, and knowledge regarding standards of care. When comparable
medications offer marginally improved therapeutic benefits, clinical pharmacists can help to determine the costutility level at which the additional expense is justified.
Because they often have a significant impact on pharmacy expenditures and clinical outcomes in the correctional setting, specific emphasis is placed on HIV, hepatitis C
and psychotropic medications. During Pharmacy and
Therapeutics meetings, Correct Rx Pharmacy Services
provides an analysis of medication utilization data.
Correct Rx breaks the information down into formulary
costs, non-formulary costs, HIV medications costs, hepatitis C medication costs and psychotropic medication
costs. The analysis also presents performance indicators
such as cost per patient and number of orders per
patient. Medication expenditures are analyzed by chronic disease states such as asthma, hypertension and diabetes. The pharmacists track and trend the utilization
data in order to identify changes in prescribing pattern
or the patient population.
Clinical Newsletter
As part of the Pharmacy and Therapeutics meeting,
Correct Rx Pharmacy Services provides a clinical
newsletter to update providers about new developments in clinical therapeutics. The newsletter contains
disease state reviews — focused on the clients’ needs
and interests, new drug reviews, journal article reviews
and formulary comparisons. Also included are the new
medications, new indications, new formulations and
new generic medications. This service usually comes at
a very high cost; however, our clients receive this service at no additional cost. Correct Rx Pharmacy
Services works in collaboration with the providers to
make therapeutic recommendations that are designed
to get the best possible outcomes.
Real Value
Correct Rx Pharmacy Services’ clinical department is
known for its innovative clinical initiatives, always
designed to improve patient care while complying
with accreditation standards and assisting with maintaining a budget. Attention to detail and personalized
on-site pharmacist visits bring real value to Correct
Rx’s clients and the patients they serve. Our clients
and their first-line staff have a direct line of communication to our management team for a rapid
response to any issues identified or the implementation of an on-the-stop resolution, sometimes by
rolling up our sleeves.
We like doing things the “Correct Way,” and we
know you will, too!
11
Effective Program
A short time ago, I
was asked to write a
few words about
effective program management. While I
have spent a great
deal of time pondering this topic and
attempting to place
by John R. Nattans, M.C.
words around someDirector of Program
Services and Quality
thing that is often
Assurance
elusive and malleable,
I find the greatest
truth to be that you have to first — and above
all else — be confident and absolutely sure the
organization you are affiliated with provides
an optimal service or has a quality product.
I have the good fortune to work for one of the
premier institutional pharmacies in the
nation. My ability to engage in esoteric discussion regarding effective program management
would not be possible without the vision and
leadership of the owners, the wisdom and talent of our clinical pharmacists, and the dedication to detail and commitment of our
employees throughout all phases of operations
of Correct Rx Pharmacy Services, Inc.
12
Notwithstanding the aforementioned truths,
the key to effective program management boils
down to a few essential elements: program
understanding, communication, building relationships, managing your personnel, quality
assurance (QA) and continuous quality
improvement (CQI), and delivering the goods.
Program Understanding
The primary task of effective program management is to clearly define the program to
be managed. One has to examine the expectations of the client and how effectiveness
will be operationalized. In other words,
what does the contract include? What does
the client expect? And how will your organization deliver on each of these items? Line
by line, item by item, the program manager
must know what is being asked for and how
it will be addressed. One word of caution:
never underestimate the idiosyncrasies of
each contract. The delivery of goods and
services may be similar between contracts,
but it is never exactly the same. True project
understanding requires attention to detail
and individualized approaches to contract
compliance. There are tried and true methods that will get the job done, but the effec-
tive program manager understands the
nuances and makes adjustments congruent
to the needs of the client, the setting and the
population being served.
Communication
Communication is the lifeblood of effective
program management. First, let us examine
communication skills and fundamentals. I
cannot stress enough the importance of listening. Creative solutions will always present
themselves if we spend the time to listen carefully to the problem. One must listen for the
content and read the nonverbal cues. As any
program manager will tell you, there never
seems to be enough hours in the day. When
we take the time to listen, however, we learn
very quickly the issues to be addressed, the
priority, the reinforcements that may be
needed and, most importantly, where the
industry is headed.
Certainly, all individuals should be treated with
respect and dignity. One must try not to rush
through conversations or finish the thoughts of
others — this tends to communicate that the
other person is not important or that you do
not have time for that individual. It would be
Correct Rx
Management
imprudent to list all the skills needed for effective communication in this article, but rest
assured that this topic is well covered in the literature. There are numerous staff development
opportunities regarding effective communication that should be employed by all staff on a
regular basis — this includes program managers. These skills require attention.
Oral communication should be clear and
with purpose. A program manager represents
the company (e.g., regularly scheduled meetings, telephone calls, impromptu problemsolving sessions) and should be prepared.
One should have a good idea of what will be
Program Understanding
Communication
Building Relationships
Managing Staff
QA & CQI
Delivering the Goods
Correct Rx
presented before speaking. A word of caution
— do not pretend to know something you
do not. If you are asked to speak about something for which you are not qualified or not
prepared, it is best to withhold your
thoughts. In these times, be sure that you
understand what is being requested, and then
get back to the person with an answer, or get
the person in touch with the person who is
qualified to answer. For example, Correct Rx
has many intelligent, highly trained and
experienced clinical pharmacists who are all
well equipped to address numerous clinical
questions posed by physicians. The program
manager should triage clinical questions to
the appropriate expert. An effective program
manager does not need to have all the
answers. Rather, he or she utilizes the most
effective resources in resolving issues.
The content of your communication is
equally important. Make sure your client is
well informed regarding your performance
— not only those things that are going well.
Do not shy away from the issues that are
problematic. In fact, most clients appreciate
this forthright communication, and it may,
in fact, help establish goodwill. Do not be
confused, though; there must also be a corrective action plan. Once the plan is in place,
it must be executed. Perhaps the most important element of effective program management is honesty and integrity. In this context,
it means effectively communicating what you
are going to do to resolve an issue and then
making sure you follow through.
All written communication reflects upon the
company. It should always look professional
and be informative. Also, it must be timely
and accurate. Whether it is a statistical report
full of interesting charts and graphs or a narrative summary of events, the document
should be neat, accurate, timely, informative
and professional.
An effective program manager ensures that
the client is knowledgeable about what is
being provided. If you are going to spend the
time to manage an effective program and
ensure that you are producing a quality product and service, do not hesitate to share your
accomplishments. The unique skills and services your company provides as a value-added
bonus should not be left silent.
13
Building Relationships
The effective program manager must know
how to build positive relationships. There
are many different people involved in a
contract, each at different times, and all are
critical to the delivery of service. Certainly,
it is crucial to understand who your client
is, the hierarchy of his or her organization,
and the appropriate person to whom specific information should be directed — it is
perhaps more important to know the people fulfilling the roles and their personal
style preferences. Less obvious, yet equally
important, are those with whom you need
to collaborate and cooperate. In our business, this includes the health care providers
and the institutional staff. Without building effective relationships with these people, I am afraid all efforts to deliver a substantive product or service will be thwarted.
Always keep in mind that, behind all of our
agendas, busy schedules and lists of things
to accomplish, there is a shared humanity.
Managing Staff
Another essential element to being an effective
program manager is managing your own personnel effectively. First, you must know what
roles are needed in your program design. Once
14
this is established, search for the right people
to fill the job vacancies. Be sure you select
properly qualified individuals who mesh with
your organization’s culture and vision. Cutting
corners on talent and/or compensation packages is a critical mistake that prevents some
program managers from achieving excellence.
There certainly will be a budget, and some
negotiations are inevitable, but if the right person comes along at the right time, it may be
well worth the investment in your company’s
future to bring that person on board.
This leads very nicely into the next point —
staff retention is the ultimate goal. The ability to retain your employees allows for a focus
on staff development, delivering the goods
and, ultimately, continuous quality improvement. Staff turnover saps the energy from
otherwise effective program designs.
Lastly, make sure there is two-way communication. Listening to your employees provides opportunities for understanding that
might otherwise go unnoticed. This process
also provides the employees with opportunities to invest in the program. Employees
who are invested and believe they are making a difference are usually more willing to
put forth the extra effort that is needed for
optimal performance. An effective program
manager may not have all the answers but
must know where to find them. Personnel
working on the front lines often are the
sources of the most useful information.
QA & CQI
A well designed quality assurance (QA) and
continuous quality improvement (CQI) program ensures your clients’ satisfaction and
happiness. Quality assurance, in layman’s
terms, is the process of guaranteeing the delivery of a good product or service. In definable
terms, there has to be a way to measure your
performance. These programs should be
based upon contractual obligations and professional standards. For example, at Correct
Rx, we have specific quality assurance programs that certify the accuracy of the prescription being filled, timeliness of the delivery
and clinical initiatives that result in optimal
care for our clients. At Correct Rx, we understand that the one way we can distinguish
ourselves from our competitors is to make
certain that we are not only meeting the
industry standards, but we are meeting our
own self-imposed Gold Standards. Through
the constant monitoring of these key indicators, we can be assured that we are delivering
a quality pharmacy service.
Correct Rx
“ .”
The ability to retain your employees allows for
focus on staff development, delivering the goods
and, ultimately, continuous quality improvement.
But being good just isn’t good enough. The
status quo will not do. All too often,
Continuous Quality Improvement (CQI) programs are simply used to address deficiencies.
Let’s not be mistaken: it is essential to address
any deficiency through corrective action
planning. Sometimes it is inevitable, but an
effective quality assurance program should
catch any slips well before your program
becomes deficient. Rather than being reactive, an effective program manager uses a
proactive CQI program. If you want to
maintain your edge on your competitors, you
must unceasingly look for ways to improve.
Finding ways to advance the delivery of
goods and services while saving the client
money is a good rule of thumb.
Implementing a proactive CQI program
ensures your customers that you will not only
meet expectations, but you will exceed them.
Delivering the Goods
While one must understand the program,
effectively communicate, build relationships,
manage your staff, and implement QA and
CQI programs, there comes a time when you
Correct Rx
must deliver the goods. The effective program manager delivers on the promises made
when the contract was secured.
“Delivering the goods” means doing what
you said you are going to do. The contract
outlines how the goods and services will be
delivered. The program manager must
ensure that the client receives what they
are paying for and more. In some ways, the
program manager is in charge of maintaining clients. The best way to maintain a
client is to deliver what you said you
would do in the manner you said it would
be accomplished. When you fall short,
effectively communicate what happened,
outline a corrective action plan, and deliver on the revised plan. More importantly,
keep searching for ways to improve your
product or service by listening to the needs
of your clients and assessing the results of
your QA and CQI programs. This guarantees that you are providing a value added
service that exceeds expectations.
The effective program manager ultimately
is responsible for delivering the goods.
All in all, there is a multitude of functions that
a program manager performs. Essentially, you
must first select a company that provides a quality service or product. Secondly, you must
immerse yourself into “that which is to be managed” in order to gain a true understanding and
create a clear vision. All managers know that
effective communication is a critical component that will need constant attention. The
implementation of your program is often completely reliant on the relationships you build
with your client, co-vendors and other representatives with whom your service will impact.
Your job will be a lot easier if you employ comprehensive quality assurance measures and
proactive CQI programs that seek to keep your
company on the leading edge of your industry.
At some point, it all boils down to “delivering
the goods” — making sure that you not only
meet expectations but also exceed them.
While there are numerous other tasks and
skills that are employed by effective program
managers, I have identified in this discussion
a few I have found to be essential. I hope you
find this information useful in your pursuit
of effective program management.
15
Implementation of a Clinical Pharma
Correct Rx Pharmacy Services has
developed and implemented a fullservice clinical pharmacy program
for
correctional
facilities. This clinical service proby Hui W. Seo, Pharm.D.
vides a multi-disciplinary approach
to chronic care clinics and acute care units.
Clinical pharmacy services affect many facets
of patient care in communities, institutions
and managed care organizations and are considered to be a valuable resource — shown to
be effective in improving patient care and
related outcomes.
The pharmaceutical care concept encompasses
a broad range of activities performed by pharmacists. A clinical pharmacy service promotes
the safe, efficacious and cost-effective use of
medications to achieve positive outcomes and
improve the well being of patients’ lives. At
one end of the spectrum of pharmaceutical
care, pharmacists provide patient counseling
in the community to educate patients on
appropriate use of medications. On the other
end of the
spectrum is
the pharmacist-provider with prescribing
authority, operating under a collaborative practice agreement with physicians. In the middle,
there exist services for formulary management,
pharmacist-managed coumadin clinics, rounding with medical teams in acute/urgent care
units (e.g. surgical intensive care units and
medical intensive care units), and clinical
research. This list is not all-inclusive.
Medicare saw the value of non-distributive
pharmacy services in the Omnibus Budget
Reconciliation Act (OBRA) in the 1980s.
OBRA required pharmacists to complete drug
regimen reviews for residents of long-term care
facilities. The subsequent OBRA 90 act
required pharmacists to provide medication
counseling on indication, safe use and potential side effects to Medicare patients. This was
later expanded and adopted to include all
patients. Today, the term medication therapy
management (MTM) is used to describe the
clinical pharmacy service provided to patients
in long-term care, institutions and the community. MTM is defined by a consensus of
pharmacy professional organizations (e.g.,
American Pharmacists Association, American
College of Clinical Pharmacist and the
National Association of Chain Drug Stores) as
a distinct service or group of services that optimize therapeutic outcomes for individual
patients.1 The central focus of MTM is the
achievement of improved outcomes through
evaluation, modification, monitoring and
education related to medication use. MTM
is now a reimbursable service under the
Medicare Modernization Act of 2003.
The Medication Therapy Management principle applied by Correct Rx Pharmacy
Services for correctional facilities includes
three separate services: chronic care clinics,
infirmaries and drug information services.
Pharmacist Chronic Care Clinics
The goal of clinical pharmacists in chronic
care clinics (PCCC) is to improve patient
outcomes through systematic and continual
medication therapy management. MTM
assures appropriate drug selection and dosing
while minimizing toxicity and resolving
problems that may threaten compliance. The
pharmacist reviews medication regimens,
meets with the patient to monitor for outcomes (both positive and adverse effects),
and provides education to the patients
regarding their disease state and medication.
PCCC was initially targeted for patients with
diabetes, hypertension, hyperlipidemia and
other cardiovascular disease states. Since
then, the clinical team has expanded PCCC
to include patients with asthma, patients on
anticoagulant therapy and patients who are
HIV-positive. The expansion of the patient
groups was a result of the demand for PCCC
cy Program in Correctional Facilities
by patients and providers who appreciated
the value of the service. The successful
acceptance by patient and providers results
from the acknowledgement that there is a
readily available health care provider to assist
in patient care. Providers appreciate the pharmacists for being a resource for information
and for providing follow-up care. The benefits
that patients receive from pharmacists include
education, continued reinforcement of medication and disease-state counseling.
The Asheville Project in North Carolina
demonstrated that a network of community
pharmacists providing disease state management for diabetics had a significant impact
on achieving hemoglobin A1C goals,
decreased sick days and decreased overall
medical costs.2 The Asheville Project was the
first study to follow diabetic patients during
a long period of time — five years. The
authors suggest that long-term continuous
monitoring and follow-up were major contributing factors to the positive results.
The American College of Clinical Pharmacy
(ACCP) has published three key reviews
regarding the value of clinical pharmacy
service. The most recent review, published in
2003, specifically looked at the cost-benefit
analysis of clinical pharmacy interventions.
They found that, on average, there was a $5
return for every $1 invested in clinical pharmacy services.3 The return was measured in
terms of the prevention of hospitalization,
prevention of adverse drug events, decrease
in hospitalization days, decrease in medication cost through cost-effective medication
selection and improvement in medication
therapy outcomes.
Other examples of pharmacists’ contributions to chronic care include a study published in CHEST that compared patients
treated with coumadin through a traditional practice model with patients treated
through a centralized pharmacist managed
coumadin clinic. The results indicated that
patients treated by a centralized pharmacistmanaged clinic had fewer complications
while treated with warfarin.4 The patients
were 39 percent less likely to experience
complications compared to the control
group. The results of the study also showed
that patients managed by pharmacists spent
more time with a therapeutic INR.
Rounding in Infirmaries
Correct Rx Pharmacy Services’ clinical pharmacists round with medical teams in the
infirmaries. The value of a multidisciplinary
team that includes a pharmacist in acute care
is also well established in most primary, secondary and tertiary medical centers. The
clinical pharmacist on infirmary rounds provides prospective medication use review. The
assessments include appropriate medication
use, dose, indication, monitoring objective
parameters (e.g., gentamicin levels and renal
function), and adverse effects. This service is
especially valuable for monitoring medications with a narrow therapeutic range (e.g.
phenytoin, gentamicin, vancomycin, valproic acid and lithium). The pharmacist is
able to provide additional attention to the
timing of laboratory collection — which is
critical in assessing therapy. In recent
reports, adverse medication outcomes
account for $47 billion per year in unintended health care costs.5 This figure most likely
under-represents the real cost of adverse
medication events. Most of the costs usually
involve drug interactions, drug overdose/
super-therapeutic drug levels and failed
intended goals of medication therapy.
Additionally, the pharmacist is able to provide real-time recommendations regarding
formulary management to postively impact
patient care and costs.
Drug Information Services
Drug information services are provided to
benefit health care providers and overall
medical costs. The benefit is derived through
avoidance of adverse medication events and
formulary management. In a review of economic benefit of clinical pharmacy services, a
drug information service provided a return of
$192.58 for every $1 spent on clinical services.4 Inquiries usually range from how medications are used to finding alternatives to nonformulary medications. This service will
eventually be offered to all provider-clients of
Correct Rx Pharmacy.
Summary
Correct Rx Pharmacy Services’ clinical programs have definitive economic and
humanistic value. Considering that the correctional population is “sicker” and in need
of more attention than other patient
groups, the opportunities for clinical interventions are abundant. The correctional
population is in greater need of clinical
pharmacy services to provide a collaborative
approach to affect positive outcomes associated with medication therapy.
References:
1. Medication Therapy Management in Community
Pharmacy Practice. Core Elements of an MTM
Service. Version 1.0. A Joint Initiative of the
American Pharmacists Association and the National
Association of Chain Drug Stores Foundation. April
29, 2005.
2. Cranor, CW; Bunting, BA; Christensen DB. The
Asheville Project: Long-Term Clinical and
Economic Outcomes of a Community Pharmacy
Diabetes Care Program.
3. Schumock, GT; Butler, MG; Meek, PD; Vermulen,
LC; Arondekar, BV; Bauman, JL. Evidence of the
Economic Benefit of Clinical Pharmacy Services:
1996-2000. Pharmacotherapy 2003; 23 (1): 113-132.
4. Witt, DM; Sadler, MA; Shanahan, RL; Mazzoli, G;
Tillman, DJ. Effect of a Centralized Clinical
Pharmacy Anticoagulation Service on the Outcomes
of Anticoagulation Therapy. CHEST May 2005; 127
(5): 1515-1522.
5. Briceland, LL. Medication Errors: An Expose of the
Problem. Medscape Pharmacists 1 (1), 2000. Medscape.
Patients frequently are
treated with multiple
medications concurrently to treat one or
more medical problems. Concomitant
intake of two or more
drugs can alter the
by Akilah Streets,
influences of each
Pharm.D.
individual drug. An
interaction takes place when the effects of one
drug are changed by the presence of another
drug, food, drink or by some environmental
chemical agent.
Grapefruit carries the American Heart
Association’s healthy “heart-check” food
mark and contains compounds that may
reduce atherosclerotic plaque formation
and inhibit cancer cell proliferation.
Grapefruit juice is purchased by 21 percent
of all households in the United States.
Unlike other citrus fruit juice, grapefruit
juice interacts with a multitude of prescription medications, raising the potential for
concern (Kane, GC, et al., 2000).
Eighteen years ago, an investigation was
designed to evaluate a possible interaction
Grapefruit and
A Potential for
18
Correct Rx
between ethanol intake and felodipine, a
dihydropyridine calcium channel blocker.
Grapefruit juice was used as a flavor supplement in order to mask the alcohol taste. The
concomitant intake of non-intoxicating
amounts of ethanol and felodipine resulted
in several fold higher felodipine concentrations than observed in other investigations
of felodipine pharmacokinetics. In addition,
lower blood pressure and higher frequencies
of adverse effects were measured compared
with felodipine alone (Bailey, et al., 1989).
An examination for possible causes failed to
explain this surprising observation until a
CYP form in the human small intestine
(Kolars, et al., 1992). The main mechanism
for the enhanced bioavailability of drugs by
grapefruit juice is presumably through the
inhibition of CYP3A4 in the small intestine,
resulting in a significant reduction of drug
pre-systemic metabolism.
Lundahl, J; Regardh, C; Johansson, G; et al.
examined the effect of grapefruit juice on
the metabolism of felodipine administered
intravenously and orally. The study was a
randomized, four-way, crossover design in
12 healthy males. Single doses of felodipine
Medications:
Adverse Events
pilot research in a single volunteer was conducted to assess the role of the juice (Bailey,
et al., 1998). Further follow-up studies confirmed that grapefruit juice dramatically elevated felodipine’s bioavailability and could
alter pharmacokinetic and pharmacodynamic parameters of the drug (Bailey, et al.,
1991). This incidental discovery has led to
the publication of numerous articles regarding the interaction between grapefruit juice
and various drugs, focusing on different
aspects: interaction mechanisms, grapefruit
juice constituents that are responsible for the
interaction, drugs exhibiting the interaction
and the clinical relevance.
Cytochrome P-450 (CYP450) is a large family of enzymatic proteins that catalyze the
oxidation of substrate molecules. Many
endogenous compounds and foreign compounds — including drugs — are metabolized by CYP450 through this oxidative biotransformation. The isoenzyme cytochrome
P-450 3A4 (CYP3A4) is the predominant
Correct Rx
were given either as an intravenous infusion
for one hour (1.5 mg) or as an oral extended release (ER) tablet (10 mg). Patients were
randomized to ingest grapefruit juice (150
ml) or water 15 minutes prior to drug
intake. Whereas the grapefruit juice ingestion combined with oral administration of
felodipine had increased the mean area
under the curve (AUC), Cmax, and mean
absolute bioavailability by 72 percent, 173
percent and 112 percent respectively, the
juice did not significantly alter the pharmacokinetics of intravenously administered
felodipine. The fraction of oral felodipine
dose reaching the portal system was
increased from 45 percent to 80 percent
when grapefruit juice was taken prior to
medication administration. The pharmacokinetics of the primary metabolite, dehydrofelodipine, was affected by the intake of
juice — resulting in a 46 percent increase in
Cmax. Juice intake immediately before oral
felodipine resulted in more pronounced
haemodynamic effects of the drug as measured by diastolic blood pressure and heart
rate; however, the haemodynamic effects of
the intravenous administration were not
affected. Vascular-related adverse events
were reported more frequently when oral
drug administration was preceded by juice
intake when compared with the control
treatment. Taking grapefruit juice immediately prior to intravenous felodipine administration did not cause any alteration in the
adverse event pattern. It has been concluded
that only intestinal CYP3A4 is inhibited by
grapefruit juice, while liver CYP3A4
enzymes are not affected.
In addition to grapefruit juice, the fruit
itself should also be consumed with caution
or avoided altogether. Several studies now
indicate that grapefruit juice should be
avoided in patients taking interacting drugs
until their physician or pharmacist has
counseled them.
References:
Kane, GC, & Lipsky, JJ (2000): Drug-grapefruit
juice interactions. Mayo Clin. Proc. 75, 933-942.
Bailey, DG; Malcolm, J; Arnold, O; & Spence, JD
(1998): Grapefruit juice — drug interactions. Br. J.
Clin. Pharmacol. 46, 101-10.
Bailey, DG; Spence, JD; Edgar, B; Bayliff, CD; &
Arnold, JM (1989): Ethanol enhances the hemodynamic effects of felodipine. Clin. Invest. Med. 12,
357-362.
Bailey, DG; Spence, JD; Munoz, C; & Arnold, JM
(1991): Interaction of citrus juices with felodipine
and nifedipine. Lancet 337; 268-69.
Kolars, JC; Schmiedlin, Ren P; Schuetz, JD; Fang,
C; & Watkins, PB (1992): Identification of
rifampin-inducible P450IIIA4 (CYP3A4) in human
small bowel enterocytes. J. Clin. Invest. 90; 1871-78.
Lundahl, J; Regardh, CG; Edgar, B; & Johnsson, G
(1997): Effects of grapefruit juice ingestion æ pharmacokinetics and haemodynamics of intravenously
and orally administered felodipine in healthy men.
Eur. J. Clin. Pharmacol. 52; 139-45.
Pharmacist Letter/Prescriber Letter (2007): Potential
Drug Interactions with Grapefruit. 23:1-3.
19
Potential Drug Interactions with Grapefruit
Drugs
Grapefruit Juice Influence
Potential Risk
Amitriptyline (Elavil)
None
None
Amiodarone (Cordarone)
Increases AUC by 50 percent
Arrthymias
Benzodiazepines
Diazepam (Valium)
Midazolam (Versed)
Quazepam (Doral)
Triazolam (Halcion)
Increases AUC and plasma concentrations. No interaction seen
with IV midazolam. Alprazolam does not appear to interact.
Increased sedaton
Budesonide (Entocor ECt)
Increases oral absorption
Hypercorticism
Buspirone (BuSpar)
Increases absorption and plasma concentration
Not clinically significant
Caffeine
Decreases caffeine clearance
Increased nervousness or insomnia
Calcium Channel Blockers
Amlodipine (Norvasc)
Diltiazem (Cardizem)
Felodipine (Plendil)
Nicardipine (Cardene)
Nifedipine (Procardia)
Nimodipine (Nimotop)
Nisoldepine (Sular)
Verapamil (Calan)
Increases AUC and serum concentrations, most likely the
result of grapefruit inhibiting the intestinal metabolism by
CYP3A4. No data on Isradipine (DynaCirc)
Flushing, headache, tachycardia, hypotension
Carbamazepine (Tegretol)
Increases AUC, peak and trough concentrations
Dizziness, ataxia, drowsiness, nausea, vomiting, tremor agitation
Carvedilol (Coreg)
Increases bioavailability of a single dose by 16 percent
Not clinically significant
Cilostazol (Pletal)
Increases peak
Not clinically significant
Cisapride (Propulsid)
Increases AUC
None
Clarithromycin (Biaxin)
Delays absorption
Not clinically significant
Clomipramine (Anafranil)
Increases plasma concentration
Dry mouth, somnolence, dizziness, fatigue
Clozapine (Clozaril)
None
None
Cyclosporine (Neoral)
Increases AUC
Nephrotoxicity, hepatotoxicity, increased immunosuppression
Desloratidine (Clarinex)
None
None
Dextromethorphan (Robitussin)
AUC increased
Drowsiness
Digoxin (Lanoxin)
Slight increase in AUC
Not clinically significant
Fluvoxamine (Luvox)
Peak and AUC increased
Nausea
HMG CoA Reductase Inhibitors
Atorvastatin (Lipitor)
Lovastatin (Mevacor)
Simvastatin (Zocor)
Increases absorption and plasma concentration
Headache, GI complaints, muscle pain
Haloperidol (Haldol)
None
None
Losartan (Cozaar)
Reduces AUC of active metabolite
Hypotension, dizziness, tachycardia, syncope, hyperkalemia
Methadone (Dolophine)
Increases peak levels and AUC
Not clinically significant
Saquinavir (Fortovase)
Increases absorption and plasma concentration
Fatigue, headache, insomnia, anxiety
Sertraline (Zoloft)
Increases serum concentration
Unknown
Sildenafil (Viagra)
Increases AUC
Hypotension, tachycardia
Tacrolimus (Prograf )
Increases trough
Hypertension, headache, tremor, insomnia
Theophylline (Theo-Dur)
Decreases AUC and delays time to peak
None
Warfarin (Coumadin)
No effect up to three glasses a day
Increased INR with > than 3 glasses
20
Correct Rx
New Drug Profile
ATRIPLA
On July 12, 2006, through a joint venture
by Bristol-Myers Squibb and Gilead
Sciences, Atripla was developed as the first
once-daily single tablet regimen for adults
with HIV-1 infection. Atripla is the result
of the FDA’s push to simplify the dosing of
HIV medications for patients. Efavirenz,
emtricitabine and tenofovir as a single pill
administered once daily is shown to be
equally efficacious and safe as administering the three medications individually. The
U.S. Department of Health and Human
Services (DHHS) lists the three components of Atripla to be among the preferred
agents for the treatment of HIV-1. The cost
of taking Atripla is equivalent to taking the
three medications individually or taking the
emtricitabine/tenofovir combination with
the efavirenz.
Description: Atripla is a fixed-dose combination containing 600 milligrams of efavirenz,
200 milligrams of emtricitabine and 300 milligrams of tenofovir DF.
Dose: One tablet orally once daily on an
empty stomach. Dosing at bedtime can
improve the tolerability of nervous-system
symptoms. Patients with CrCl < 50 mL/min
should not receive Atripla.
Mechanism of Action:
• Efavirenz is a non-nucleoside reverse
transcriptase inhibitor.
• Emtricitabine is a synthetic nucleoside
analog of cytidine.
Correct Rx
• Tenofovir disoproxil fumarate is an acyclic
nucleoside phosphate analog of adenosine 5’-monophosphate.
FDA-Approved Indication: Use alone as a
complete regimen or in combination with
other antiretroviral agents for the treatment
of HIV-1 infection in adults.
Warnings:
• Lactic acidosis and severe hepatomegaly
with steatosis, including fatal cases, have
been reported with the use of nucleoside
analogs alone or in combination with
other antiretrovirals.
• Atripla is not indicated for the treatment of chronic hepatitis B virus
(HBV) infection and the safety and
efficacy of Atripla have not been established in patients coinfected with HBV
and HIV. Severe acute exacerbations of
hepatitis B have been reported in
patients who have discontinued
Emtriva or Viread. Hepatic function
should be monitored closely with both
clinical and laboratory follow-up for at
least several months in patients who
discontinue Atripla and are coinfected
with HIV and HBV. If appropriate, initiation of anti-hepatitis B therapy may
be warranted.
Drug Interactions:
• Atripla should not be administered concurrently with astemizole, cisapride,
midazolam, triazolam or ergot deriva-
•
•
•
•
•
tives because competition for CYP3A4
by efavirenz could result in inhibition of
metabolism of these drugs and create
the potential for serious and/or lifethreatening adverse events (eg, cardiac
arrhythmias, prolonged sedation or respiratory depression).
Atripla should not be administered with
voriconazole because efavirenz significantly decreases voriconazole plasma
concentrations.
Atripla should not be coadministered
with lamivudine, including Combivir,
Epivir, Epivir-HBV, Epzicom or Trizivir.
Patients should avoid taking St. John’s
Wort when taking Atripla due to
decreased efavirenz plasma levels.
Rifabutin concentrations are decreased by
50 percent. Consider doubling rifabutin
dose in regimens where rifabutin is given
two or three times a week.
See package insert for complete drug
interactions.
Adverse Reactions: See individual package
insert for side-effect profile. Most significant
adverse reactions include nervous system
symptoms, psychiatric symptoms and rash.
Lab Interactions: The efavirenz portion of
Atripla can cause false positive tests for
cannabinoids when the DEDIA DAU
Multilevel THC assay is used.
Please refer to www.atripla.com for more
information.
23
Medications of Abuse:
A 2004 survey
administered by the
Bureau of Justice
Statistics stated that,
based on the DSMIV criteria, 55 percent of state inmates
and 45 percent of
federal inmates were
identified with issues
by Kesha N. O’Reilly,
Pharm.D.
stemming from substance dependency
or abuse. The majority of these individuals
had an extensive criminal record, consisting
of at least three prior sentences of probation
or incarceration. More than a third of state
and a fourth of federal inmates committed
crimes while under the influence of drugs.
In addition, 17 percent of state and 18 per-
24
cent of federal prisoners committed crimes
to obtain money for drugs1. Agents of substance abuse may be illicit drugs, alcohol or
prescription medications.
including their past patterns of alcohol, illicit drug and prescription drug use.
Consequently, screening results may impact
the medical providers’ prescribing habits.2, 3
Substance abuse does not discontinue once
inmates enter the correctional facilities.
Inmates may manipulate policies and procedures to demand medication under the guise
of controlling their addiction. Medical
screening plays an important role in identifying substance-use history. Medical providers
must integrate basic screening questions into
all histories and physical examinations.
Medical conditions, such as acute or chronic
pain, anxiety disorders and attention-deficit
disorders, may contribute to substance abuse.
Physicians treating such patients must ask
them about their substance-use history,
Prescription medications are common agents
of abuse in the community and correctional
settings. Opioid analgesics, sedative hypnotics and stimulants are common medications that have a high potential for abuse. In
addition, abuse has been documented in
anticholinergics, such as benztropine (Cogentin®), trihexyphenidyl (Artane®), and
diphenhydramine (Benadryl®)2, 3.
There have been several reports of increased
illicit use of newer prescribed psychotropic
medications in correctional facilities.
Bupropion (Wellbutrin®, GlaxoSmithKline),
Correct Rx
Patient Screening
gabapentin (Neurontin®, Pfizer), olanzapine
(Zyprexa®, Eli Lilly), and quetiapine (Seroquel®, AstraZeneca) are on the wish lists of
many inmates seeking a quick fix. In addition,
these medications become very popular commodities for negotiation. Olanzapine and quetiapine are abused for their sedative and anxiolytic activity. Inmates want to sleep and dissociate themselves. Bupropion, an antidepressant with dopaminergic and noradrenergic
properties, is crushed and snorted for stimulant effects. The contents of a gabapentin capsule are inhaled intranasally to numb the irritating nasal effect of bupropion4, 5.
There have been several reports of inmates —
those with documented mental health issues
and in need of these medications — finding
themselves on the wrong end of an addict’s
Correct Rx
solution. The drug abusers harass, sometimes
verbally and physically, inmates with legitimate need of these medications. When all
else fails, some prisoners falsely display symptoms of mental health problems in hopes of
obtaining the pills directly6.
How do we solve this growing epidemic?
Preventative steps must be explored to better
monitor the aforementioned issues of drug
abuse in the prison system. The mismanagement of inmate care has a lasting effect on the
overall rehabilitation module, with each case
spawning monetary and social consequences.
We, as pharmacists and medical administrators, must do all we can do proactively to
solve this medicinal riddle.
Sources:
1. Mumola, CJ; Karberg, JC. Bureau of Justice
Statistics Special Report: Drug Use and Dependence,
State and Federal Prisoners, 2004. NCJ October 2006
2. Longo, LP, et al. Addiction: Part II. Identification
and Management of the Drug-Seeking Patient. Am
Fam Physician 2000; 61:2401-8
3. Christensen, RC. Screening for anticholinergic
abuse in patients with chronic mental illness. Am J of
Emerg Med. 2003; 21(6):508
4. Christensen, RC; Garces, LK. The growing abuse
of commonly prescribed psychiatric medications. Am
J of Emerg Med. 2006; 24(1):137-8
5. Pierre, JM; et al. Intranasal Quetiapine Abuse. Am
J Psychiatry. 2004; 161(9):1718
6. Della Volpe. Intervention Reduces Abuse of
Psychotropic Medications in Correctional Facility.
Pharmacy Practice News. 2005; 32:09
25
barcode scanning
technology
In an effort to provide
improved services to
our customers, Correct
Rx Pharmacy Services
embarked on a project
to investigate the utility
of advanced technology. The goal was to
enhance the process of
delivering services to
by Don Bossle
our customers and ease
the processing of orders by the facilities. After
much research, Correct Rx determined that barcode scanning technology would provide the
greatest benefit.
Internal Process Improvements
Barcode scanning improves both the timeliness
and the accuracy of the shipping department.
Correct Rx ships thousands of orders a day
from our centralized pharmacy. Prior to imple-
26
menting the barcode scanning technology,
each order had to be manually inspected before
being placed into the shipping container.
Phase 1: Internal Verification of Orders
Phase 1 of the barcode scanning project was
implementing the use of radio-frequency
scanners in our shipping department. The
scanners communicate with the main computer system to verify that the order being
scanned is a valid order and that the medication is being placed into the proper shipping
carton. The scanner indicates a conflict by
displaying a visual alert on the scanner screen
in addition to an auditory alert. A shipping
manifest is printed for the facilities once the
orders for the day have been completed. The
report identifies the pharmacy personnel that
scanned each order into the carton; the report
also shows orders that have not yet been
scanned. A supervisor then investigates any
discrepancies. Due to the implementation of
the barcode scanning technology, Correct Rx
has experienced increased accuracy in the
shipping department with the benefit of
accountability for each medication order.
Correct Rx has received positive feedback
from all of our customers.
Customer Enhancements
In addition to Correct Rx improving our own
internal process, the barcoding technology
was developed to assist the customers at the
facility level. As a result of Phase 1, Correct
Rx can post shipping reports electronically
on our Web site after the orders are completed. Customers can login on a secure site with
a personal identification and password and
see the shipping report before they even
receive the shipment. The facility can also
view discrepancies — and their reason — via
the Web site. This allows the clients to be
Correct Rx
proactive in handling any potential problems with
their medications. Phase 2 of the barcode project
involved using the scanners to check in the orders
received from Correct Rx. At a large facility, Correct
Rx found that the barcode scanner can reduce a twohour process to less than 15 minutes per day. Phase
3 of the barcode project allowed refills to be
reordered via the Internet.
Phase 2: Checking in Orders
Prior to the use of scanners, the facilities manually
checked the orders in by comparing each medication
label against the printed manifest that was included
with their daily shipment. This was very time-consuming for the health care staff. Phase 2 of the barcode project was to install barcode scanners at the
facility, so the health care staff could use the scanners
to check in the orders online. The scanning program
is a Web-based application and does not require software that has to be loaded onto the computer. Once
the facility processes the shipment, staff members can
verify if any orders were missing. Any missing items
in the shipment are alerted to show in red on the
computer. These reports are maintained electronically for 30 days.
Phase 3: Medication Reorders
Phase 3 of the barcode scanning project made online
medication reordering possible. Before the scanners
were in use, refills were reordered by removing the
refill stickers from the original label, affixing them to a
reorder form, photocopying the form (so as to not jam
the fax machine), and faxing that form to the pharmacy. Now, facilities utilizing a scanner can log into our
Web site, choose the reorder function, and scan the
barcodes. Reorders can be processed in bulk or as each
group of patients are reviewed. The reorders are electronically transmitted to Correct Rx, and a report is
generated for the facility. This report acts as a confirmation in the verification process. Scanning reorders
via the Internet saves nursing time and reduces the
possibility of error in the reorder process.
Barcode & Data Collection Systems
Let us analyze your applications today!
Inventory control
Lab management
Order validation
(RF and web)
Asset tracking
Workflow
Admissions
Cycle count
Med cart automation
Services:
Products:
Functional analysis
Software development
Integration
Barcode printers
Support and service
Scanners
Equipment maintenance
Portable terminals
Warehousing, RF
infrastructure, RFID
Future Enhancements
Correct Rx foresees additional technological enhancements in the future. With the coming of electronic
medical records, we will be able to use the same scanners to document the delivery of the medication
directly to the patient.
Correct Rx is very excited about the results of this
project and is looking into other technologies that
we can adopt to improve service to our customers.
We believe that the use of barcode technology has
propelled Correct Rx to the forefront of our industry and has given us a competitive advantage in the
marketplace. We must continue to investigate electronic tools that will make it easier for clients to
transact business with Correct Rx. Please stay tuned
for future technological improvements.
Correct Rx
Custom and stock labels
301-596-7500
9693 Gerwig Lane, Suite J
Columbia, MD 21046
[email protected]
27
Clinical Management of
Hepatitis B Virus Infection
28
Correct Rx
Hepatitis B virus (HBV) is a public health problem
worldwide; approximately 30 percent of the world’s
population has serologic evidence of past infection.
by Sankung Sise,
Pharm.D.
HBV is the cause of nearly 1 million deaths per year.
There are 350 million chronic carriers worldwide. HBV is common in Asia, Africa and the
Middle East. In North America, the incidence of
known carriers is about one person in a 1,000. In
the United States, more than 1 million individuals are reported to have chronic HBV infection.
Carriers of HBV are at increased risk of developing cirrhosis, hepatic decompensation and hepatocellular carcinoma.
Transmission
The hepatitis B virus is transmitted by the exchange of body fluids (e.g., blood, semen, breast
milk and saliva). In Southeast Asia, China, and
sub-Sahara Africa, the virus is usually transmitted perinatally or in early childhood. In the
United States and the Western world, the virus is
transmitted through unprotected sexual intercourse, intravenous drug abusers who share needles and syringes, health care workers in contact
with potentially contaminated blood or body
fluids, and anyone in intimate contact with an
infected person.
The hepatitis B virus is a DNA virus that replicates within infected liver cells (hepatocytes). The
DNA particle is enclosed in a nucleocapsid, or
core antigen, which is surrounded by a spherical
envelope (surface antigen). If the virus gets past
the immune system, its initial response when
entering the body of a new host is to infect a liver
cell. After it attaches to the membrane of a hepatocyte, the core particle enters the cell and releases its contents of DNA and DNA polymerase
into the liver cell nucleus.
From within the cell nucleus, the hepatitis B
DNA, via messenger RNA, causes the liver cell to
produce surface proteins (HBs), the core protein
(HBc), DNA polymerase, the HBe protein, HBx
protein, and possibly other as yet undetected proteins and enzymes. The incubation of the hepatitis
B virus is about six to 25 weeks.
Correct Rx
Acute Hepatitis B Infection
Acute hepatitis B occurs in approximately 35 percent of infected adults. Acute hepatitis can be categorized as mild, severe or fulminant. Signs and
symptoms of acute HBV include fever, jaundice,
nausea, abdominal pain and malaise. A diagnosis is
made by serologic detection of IgM anti-HBc and
hepatitis B surface antigen (HBsAg).
No effective therapies are available for acute HBV
infection; treatment is based on supportive therapy. Individuals with acute HBV should be monitored during convalescence and prevent development into chronic HBV infection.
Chronic Hepatitis B Infection
Diagnosis of chronic HBV infection is confirmed
by the serologic detection of HBsAg on two separate occasions, six months apart. Alternatively,
diagnosis for HBV may be made with the onetime detection of HBsAg, if patient is total-HBcpositive, IgM anti-HBc-negative and has elevated
ALT level for three consecutive months (ALT levels more than 1.3 times the upper limit of normal).
The goal is to prevent the spread of virus to other
people, improve the patient’s quality of life, and
cure the disease where possible.
Treatment Indications
• HBsAg-positive documented for 6-12 months
• Active viral replication (HBV DNA >10 5 cps/mL)
• Chronic liver inflammation by elevated ALT level
• Necroinflammation of liver biopsy
References:
Befeler, A.S., and Di bisceglie, A.M. Hepatitis B. Infect Dis
Clin North Am 2000; 14:617-32.
Lok, A.S., and Mcmahon, B.J. Chronic Hepatitis B ASSLD
practice guidelines.
Lok, A.S., and Mcmahon, B.J. Chronic hepatitis B: Update
of recommendations. Hepatology 2004:39:857-61.
29
Medication
Indication
Comments
Adefovir
Hepsera
Treatment of chronic hepatitis
B in adults with evidence of
active viral replication and
either evidence of persistent
elevations in serum aminotransferases or histologically
active disease
• 10mg PO QD without regard to food
• Dosage adjustment necessary in renal impairment
• Optimal duration of treatment is unknown
• Black Box warning on acute exacerbations of hepatitis in patients who
have discontinued anti-hepatitis B therapy. Hepatic function should be
monitored closely with both clinical and laboratory follow-up for at least
several months in patients who discontinue anti-hepatitis B therapy.
• Black Box warning on nephrotoxicity in patients who have underlying
renal problems
• Black Box warning on the emergence of HIV resistance in chronic HBV
patients with unrecognized or untreated HIV infection
• Black Box warning on lactic acidosis and severe hepatomegaly with steatosis
Entecavir
Baraclude
Treatment of chronic hepatitis
B virus infection in adults with
evidence of active viral replication and either evidence of
persistent elevations in serum
aminotransferases or histologically active disease
• > 16 years: 0.5 mg PO QD on empty stomach
• History of hepatitis B viremia while receiving lamivudine or known
lamivudine resistance mutations: 1mg PO QD
• Dosage adjustment is necessary in renal impairment.
• Black Box warning on lactic acidosis and sever hepatomegaly with steatosis
• Optimal duration of treatment is unknown.
• Black Box warning on severe acute exacerbations of hepatitis B has been
reported in patients who have discontinued anti-hepatitis B therapy.
Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue
anti-hepatitis B therapy.
Lamivudine
Epivir HBV
Treatment is indicated for the
treatment of chronic hepatitis
B associated with evidence of
hepatitis B viral replication and
active liver inflammation
• 100mg PO QD
• Same drug to treat HIV in lower doses. Dose appropriately. If patient is
co-infected, the higher dosage is indicated.
• Dosage adjustment necessary in renal impairment
• Optimal duration of treatment is unknown.
• Black Box warning on lactic acidosis and severe hepatomegaly with steatosis
• Black Box warning on severe acute exacerbations of hepatitis B has been
reported in patients who are co-infected with HBV and HIV and have
discontinued Epivir. Hepatic function should be monitored closely, with
both clinical and laboratory follow-up for at least several months in
patients who discontinue anti-hepatitis B therapy.
Telbivudine
Tyzeka
Treatment of chronic hepatitis
B in adult patients with evidence of viral replication and
either evidence of persistent
elevations in serum aminotransferases or histologically
active disease
• 600mg PO QD regardless of food
• Dosage adjustment necessary in renal impairment
• Optimal duration of treatment is unknown.
• Black Box warning on lactic acidosis and severe hepatomegaly with steatosis
• Black Box warning on acute exacerbations of hepatitis in patients who
have discontinued anti-hepatitis B therapy. Hepatic function should be
monitored closely with both clinical and laboratory follow-up for at least
several months in patients who discontinue anti-hepatitis B therapy.
Interferon alfa-2b
Intron A
Treatment of chronic hepatitis
B in patients 1 year of age or
older with compensated liver
disease. Patients who have
been HBsAg-positive for at
least 6 months and have evidence of HBV replication with
elevated serum ALT
• Adults: 30 to 35 mIU SQ or IM QW dosed either as 5mIU QD or
10mIU TIW for 16 weeks
• Children: 3mIU/m2 SQ TIW x 1 week then dose escalation to 5mIU/m2
SQ TIW (max:10 mIU TIW) for 16 to 24 weeks.
• Dosage adjustments necessary if decreased WBC, granulocyte count or
platelet count
• Prior to treatment, it is recommended that liver biopsy be performed to
establish the presence of chronic hepatitis and the extent of liver damage.
• Baseline CBC and platelet counts should be done prior to therapy
Pegylated interferon alfa-2a
Pegasys
Treatment of adult patients
with HBeAg-positive and
HBeAg-negative chronic hepatitis B virus infection who have
compensated liver disease and
evidence of viral replication
and liver inflammation
• 180mcg SQ QW for 48 weeks in abdomen or thigh
• In patients with end-stage renal disease requiring hemodialysis: dosage of
135mcg is indicated
• Black Box warning may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic and infectious disorders.
Biologic and Immunological Agents
Drug Class
Antivirals
Hepatitis B Treatment Options
30
Correct Rx
32
Correct Rx
Correct Rx
33
To be successful in any
business, you need the right
kind of help. Let us help you
create a quality publication
that you can be proud of.
For more information,
contact Aran Jackson at 502.423.7272
or [email protected].
www.ipipublishing.com
34
Correct Rx
A Prescription to Cure Rising Drug Costs
Medication Therapy Management • Collaborative Interventions • Ask a Pharmacist - Clinical Drug Information Service
Formulary Management • On-Site Visits by Experienced Clinical Pharmacists • Innovative Web-Based Technology
1.800.636.0501
Ellen H. Yankellow, PharmD, President and CEO
www.correctrxpharmacy.com
“If it’s the right way, it’s the correct way.”
“If it’s the right way, it’s the correct way.”