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Drug Topics
10 more unsolicited tips for new grads 15 A resource for the uninsured 28
AC AN VIEW
TE C
VOL. 158 NO. 11
RI IN
AL
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Drug Topics®
®
Voice of the Pharmacist DrugTopics.com November 2014
Nov em b er 2014
PharmD options
C E: M T M ES S EN T IAL S F O R W EIG H T M AN AG EM EN T
page 38
VOL . 15 8 N O. 11
CREDIT: 2.0
Earn CE credit for this activity at DrugTopics.com/cpe
MTM essentials
for weight management
Page 56
twitter.com/Drug_Topics
facebook.com/DrugTopics
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®
EDITORIAL ADVISORY BOARD
Philip P. Burgess, RPh, MBA Salvatore J. Giorgianni, Jr. Gene Memoli Jr., RPh, FASCP
Chairman PharmD, BSc, CMHE Director
Community Pharmacy Foundation Consultant Pharmacist Customer Development, Omnicare
Illinois Board of Pharmacy Griffon Consulting Group, Inc. Cheshire, Conn.
Chicago, Ill. Chair, Men’s Health Caucus,
American Public Health Association
Advisory Board, Pharmacist Partners, LLC
Perry Cohen, PharmD, FAMCP and The Men’s Health Network Marvin R. Moore, PharmD
The Pharmacy Group LLC Pharmacy manager and co-owner
Glastonbury, Conn. Mary E. Inguanti The Medicine Shoppe/
RPh, MPH, FASCP Pharmacy Solutions Inc.
Vice President, Strategic Accounts Two Rivers, Wisc.
Integrated Sales, CareFusion
San Diego, Calif.
David J. Fong, PharmD Brian Romig, RPh, MBA
Former community chain store Vice President
senior pharmacy executive Debbie Mack, BS Pharm, RPh Corporate Pharmacy Director
Danville, Calif. Director Supply Chain
Pharmacy Regulatory Affairs Adventist Health System
Wal-Mart Health and Wellness Altamonte Springs, Fla.
Bentonville, Ark.
Anna Garrett Jack Rosenberg, PharmD, PhD
PharmD, BCPS Professor Emeritus
President Frederick S. Mayer, RPh, MPH Pharmacy Practice and Pharmacology
Dr. Anna Garrett President Long Island University
Asheville, N.C. Pharmacists Planning Service Inc. Brooklyn, N.Y.
San Rafael, Calif.
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For reliability and quality,
our roots go deep
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CONTENTS
N O V E M B E R 2014 VO L . 1 5 8 N O . 1 1
DrugTopics.com
COVER STORY
PharmD options
For RPhs who want to
return to school but need
to keep working, several
Kelly Howard, PharmD
pharmacy programs offer a More tips for new grads PAGE 15
nontraditional path. PAGE 38
• January 2015: MTM opportunities in caring for the patient with cardiovascular disease
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CONTENTS
N O V E M B E R 2014 VO L . 1 5 8 N O . 1 1
CONTINUING EDUCATION
What’s happening now at
MTM essentials for weight management
As providers on the front lines of
the obesity epidemic, pharmacists SOCIAL MEDIA
are uniquely qualifed to match JOIN US ONLINE!
Read the latest breaking news
meds to patients. They can also and give us your feedback!
monitor for adverse effects and facebook.com/DrugTopics
help guide and motivate patients twitter.com/Drug_Topics
seeking to lose weight. PAGE 56
DT BLOG
Pain management and
opiate reduction
A pharmacist has developed a
COUNTER POINTS 31 UPFRONT IN DEPTH 7-step approach to treating pain
Techno tips for patients and reducing opiate use — and
13 DISPENSED AS WRITTEN providers don’t want to hear about
Games insurers play 32 UPFRONT IN DEPTH it. What’s that about? Get the story
NCPA pushes H.R. 4577 at www.drugtopics.com.
14 VOICES
Pill-happy? Sez who? CLINICAL WEB EXCLUSIVES
15 IN MY VIEW 48 MEDICATION SAFETY New combo pill for T2DM
http://drugtopics.com/xigduo
More tips for new grads Metronidazole and ADRs
Video: Protecting pharmacy data
21 IN MY VIEW 52 NEW DRUG REVIEW http://drugtopics.com/pharmdata
Not in my pharmacy, you don’t Dalbavancin How to boost your MTM
reimbursements
22 VIEW FROM THE ZOO 54 ANTICOAGULATION THERAPIES http://drugtopics.com/MTMbilling
My friend, the drug addict VTE therapy outcomes
DIGITAL EDITION
76 JP AT LARGE REGULATORY & LEGAL
Can’t keep a good man down
55 OIG WARNING
ISSUES & TRENDS Beware of drugmaker coupons
Drug Topics (ISSN# 0012-6616) is published monthly and Drug Topics Digital Edition (ISSN# 1937-8157) is issued every week by Advanstar Communications,
Inc., 131 West First St., Duluth, MN 55806-2065. One-year subscription rates: $61 in the United States & Possessions; $109 in Canada and Mexico; all
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Inter@ctive
TRENDING NOW
http://drugtopics.com/tobaccosurcharge
Protecting your pharmacy against
data breaches
Chad Leedy, director of retail
compliance for ANXeBusiness Corp.,
discusses what pharmacies need
TWITTER.COM/DRUG_TOPICS to do to avoid data breaches such
as those experienced by Target and
Follow us on Twitter to receive Home Depot.
the latest news and participate
in the discussion.
A few recent tweets and retweets from and about Drug Topics
ali mcbride ChurchStreetRx
@sheik2411 @ChurchStreetRx
@Drug_Topics: #Pharmacy reimbursement Drug Topics @Drug_Topics Hospitals
How to make the most of #MTM. bit. infuriated by Genentech’s price hikes of
ly/1pIulxQ” For oncology specialty sites.... three critical #CancerDrugs. Story @TIME.
This is a must! ti.me/ZY357B
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Counter Points
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Counter Points
Voices
It’s not the pharmacists
Re: “Are pharmacists pill-happy?” [Dennis Miller,
Sept. 25, drugtopics.com]: you will “cure” or vastly improve 60%-
Our entire healthcare system revolves around the quick- 65% of ALL ILLNESS.
By putting on some muscle mass
fx consumer culture that ensures grand profts for corpo- (at the expense of fat mass) you will “cure”
rations, and unfortunately most people buy into it. I enjoy metabolic syndrome and type 2 diabetes
having the conversations with customers who are tired of and hypertension and anxiety and insom-
nia and arthritis and ... and .... and ...
the pills and want to investigate other options. These con-
Mark Burger
versations, however, are the exception. POSTED AT WWW.DRUGTOPICS.COM
Most people I encounter want to be told what to do and
aren’t interested in the details or thinking for themselves. BOP unchained
Re: “Should only pharmacists lead state
Better to depend on the Big-Pharma-trained MD to solve boards?” [Mark Lowery, Sept. 5, drug-
their problems with a pile of meds or the many pharmacists topics.com]: Yes! Boards should be made
whose mantra is “better living through chemistry” ... It is up of pharmacists and a consumer advo-
MUCH easier to swallow pills than it is to take responsibility cate. No board member should be con-
nected to a chain. Ideally, board members
for one’s health. would be retired pharmacists current with
Dr. M. Crown their registrations and completely familiar
POSTED AT WWW.DRUGTOPICS.COM with all laws and regulations. This would
ensure a fair decision to any pharmacy
involved in violation of the law.
Pharmacy in action For pharmacists who say they don’t Robert Katz, RPh
In my pharmacy, when someone comes in have the time for lifestyle counseling, STAMFORD, CONN.
for an OTC pain reliever, we ask, “Where here are three quick questions/responses:
is your pain?” and then we steer them 1. Do you have 3BMs/day? If “No,”
toward a lifestyle change. (This might then we need to talk about fber and/or Clarifcation: In “California pharm
mean a paid consult with the pharmacist). probiotics/diet change. techs to take on more responsibility
Digestion. If they come in for an 2. Do you eat protein for break- under new law,” published Sept. 29
antacid, same thing. “How long have fast? Really? Tell me what that is. Oat- at www.drugtopics.com, it was
you had heartburn? Does it happen at meal? Fruit? Peanut butter? Toast? No, reported that the California Society of
night? Do you get bloated after meals? I’m sorry but that is not enough protein. Health-System Pharmacists (CSHP)
Gas? Here, let me show you how you You need 30 g in the a.m. Try Greek and the California Pharmacists
can take care of that once and for all, and yogurt, fsh, eggs (2 eggs = 15 g protein), Association (CPhA) pushed for passage
get healthier, overall, in the process.” chicken breasts, bacon, sausage, etc. of S.B. 1039. However, CSHP was the
Osteoporosis. “Don’t like those Fosa- 3. What is you HbA1c (or fruc- only sponsor of the bill, which was
max pills? Let us tell you how the bone tosamine) level? Oh! HbA1c of 5.6%? signed into law by Governor Jerry
maintains itself and what you can do to That’s too high. Yes, I know, your doc- Brown in mid-September.
prevent thin bones. It starts with your diet. tor said it is okay, but it is NOT. Aver-
Here’s some vitamin D3 + K2; take one age blood sugars above 95 mg/dL are
daily with food. Get your level of vitamin damaging your arteries and your brain. We want to hear from you
D up between 50 and 80 ng/mL. Here’s a Alzheimer’s disease is type 3 diabetes. Printed and e-mailed letters should be brief
7-minute scientifc exercise chart [http://bit. Start walking 30 minutes daily, with and include the writer’s name, address,
daytime phone number, and date of the
ly/7minchart]. If you can spare 7 minutes a couple of 5-10 lb dumbbells. Eventu- issue you are referencing: Editor,
daily and do this, it will keep your bones ally, you should be curling the dumbells Drug Topics, 24950 Country Club Blvd., Suite
strong.” (Print this out and have copies repeatedly while walking. This will cure 200, North Olmsted, OH 44070-5351.
E-mail address: drugtopics@advanstar.com.
ready to hand to patients. Tell them the your diabetes. Letters may be edited for length, style,
intensity should be 8 out of 10.) By ÒcuringÓ digestive problems content, and clarity at our discretion.
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Counter Points
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Counter Points
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Counter Points
Case in point to prescribe drugs. The labeling of these product, move it to prescription status, or
A year ago, on September 25, 2013, FDA products made them prescription drugs, modify the labeling to address misbrand-
sent Standard Homeopathic Company a but they were all sold as nonprescription, ing charges while the company and FDA
warning letter. You can see it at this gov- over-the-counter products. Therefore, remain, apparently, in dialogue. It is likely
ernment website: http://bit.ly/SHCwarning. because the products did not bear the “Rx that its stalling actions have allowed it to
The letter reveals that after examining Only” symbol restricting them to prescrip- reap additional proft.
Standard’s website, the district director of tion status, they were all misbranded.
FDA’s compliance branch found numer- The labeling was also found to be false Best defense
ous Hyland’s homeopathic products to be or misleading because it represented the The best line of defense is an informed
misbranded, in violation of the Federal products as suitable for use by consum- pharmacist. When patients ask about
Food, Drug, and Cosmetic Act. ers to treat conditions not appropriate for homeopathic products, it is our profession-
Some examples: “Arnicaid” was said treatment with OTC drugs. al, legal, and moral obligation to disclose
by Standard to be useful for nerve injury the lack of evidence of their safety and
due to blows. “Hyland’s Teething Tablets” Company response effcacy, and their illegal marketing. We
were said to be useful for reducing red- FDA warned the company that uncorrect- should then recommend products of prov-
ness and infammation of the gums. The ed violations could result in legal action en safety and effcacy, and refer patients to
purported uses of “Hyland’s Vaginitis” without further notice, including seizure their prescribers when appropriate.
and “Hyland’s Restless Legs” are self-ex- and injunction without limitation. Selling misbranded homeopathic
planatory, as are “Hyland’s Infant Earache In the face of such clearly delineated products is a dishonest act on the part of
Drops” and “Earache Tablets.” The letter violations of the law and such strict pen- the individual pharmacist, and making
cites dozens of other such examples. alties, did the company take immediate claims for the safety and effcacy of any
FDA also took note of customer action to avert further trouble? Did it homeopathic product is fraudulent. In a
reviews found at the Standard website eliminate the language in question or re- larger sense, homeopathic products make
and stated that “your frm is responsible strict sales of the products to prescription- a mockery of the concept of pharmaceuti-
for ensuring that statements made by cus- only? cal care and cast a cloud over all of us who
tomers and included on your websites do To see whether the company com- value our patients’ health over proft.
not cause your product to be misbranded plied, one need look at only one exam- Other healthcare professionals have
under sections 502 and 503 of the FD&C ple cited by FDA, Standard’s claims for every right to regard community pharma-
Act [21 U.S.C. 353(b)(1)].” “Hyland’s Vaginitis,” as found at http://www. cists who peddle homeopathic products as
hylands.ca/products/vaginitis.php, on August little better than snake-oil salesmen. We
The issues 19, 2014, almost a year after FDA issued must strive to be better than that.
The FDA letter went on to indicate that its letter. The wording on the website
these products raise several legal issues. remains identical to the wording ques- Steven Pray is Bernhardt Professor at
First, the conditions for which these tioned by the FDA almost a year earlier. the College of Pharmacy at Southwestern
products were marketed required diagno- It appears that to date, Standard Ho- Oklahoma State University. Contact him at
sis and treatment by a practitioner licensed meopathic has failed to rename the steve.pray@swosu.edu.
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Counter Points
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During this fu season,
you have an opportunity to
help protect more of your adult
patients against herpes zoster
Actor portrayal.
About ZOSTAVAX
ZOSTAVAX is a live attenuated virus vaccine indicated for prevention of herpes zoster (shingles) in individuals
50 years of age and older. ZOSTAVAX is not indicated for the treatment of zoster or postherpetic neuralgia.
ZOSTAVAX should not be used for prevention of primary varicella infection (Chickenpox).
Reference: 1. Centers for Disease Control and Prevention (CDC). Prevention of herpes zoster: recommendations of the Advisory Committee
on Immunization Practices (ACIP). MMWR Recomm Rep. 2008;57(RR-5):1–30.
Copyright © 2014 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved. VACC-1123879-0003 07/14
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ZOSTAVAX® (Zoster Vaccine Live)
BRIEF SUMMARY OF PRESCRIBING INFORMATION
INDICATIONS AND USAGE Systemic adverse reactions and experiences reported during Days 1-42 at an incidence of ≥1% in
ZOSTAVAX is a live attenuated virus vaccine indicated for prevention of herpes zoster (shingles) either vaccination group were headache (ZOSTAVAX 9.4%, placebo 8.2%) and pain in the extremity
in individuals 50 years of age and older. (ZOSTAVAX 1.3%, placebo 0.8%), respectively.
Limitations of Use of ZOSTAVAX: The overall incidence of systemic adverse experiences reported during Days 1-42 was higher for
• ZOSTAVAX is not indicated for the treatment of zoster or postherpetic neuralgia (PHN). ZOSTAVAX (35.4%) than for placebo (33.5%).
• ZOSTAVAX is not indicated for prevention of primary varicella infection (Chickenpox). Shingles Prevention Study (SPS) in Subjects 60 Years of Age and Older: In the SPS, the largest
CONTRAINDICATIONS clinical trial of ZOSTAVAX, subjects received a single dose of either ZOSTAVAX (n=19,270) or
Hypersensitivity: Do not administer ZOSTAVAX to individuals with a history of anaphylactic/ placebo (n=19,276). The racial distribution across both vaccination groups was similar: White
anaphylactoid reaction to gelatin, neomycin or any other component of the vaccine. Neomycin (95%); Black (2.0%); Hispanic (1.0%) and Other (1.0%) in both vaccination groups. The gender
allergy manifested as contact dermatitis is not a contraindication to receiving this vaccine. distribution was 59% male and 41% female in both vaccination groups. The age distribution of
Immunosuppression: ZOSTAVAX is a live, attenuated varicella-zoster vaccine and administration subjects enrolled, 59-99 years, was similar in both vaccination groups.
may result in disseminated disease in individuals who are immunosuppressed or immunodefcient. The Adverse Event Monitoring Substudy of the SPS, designed to provide detailed data on the safety
Do not administer ZOSTAVAX to immunosuppressed or immunodefcient individuals including those proLle of the zoster vaccine (n=3,345 received ZOSTAVAX and n=3,271 received placebo) used
with a history of primary or acquired immunodeLciency states, leukemia, lymphoma vaccination report cards (VRC) to record adverse events occurring from Days 0 to 42 postvaccination
or other malignant neoplasms affecting the bone marrow or lymphatic system, AIDS or other (97% of subjects completed VRC in both vaccination groups). In addition, monthly surveillance for
clinical manifestations of infection with human immunodefciency viruses, and those on hospitalization was conducted through the end of the study, 2 to 5 years postvaccination.
immunosuppressive therapy. The remainder of subjects in the SPS (n=15,925 received ZOSTAVAX and n=16,005 received
Pregnancy: Do not administer ZOSTAVAX to pregnant women. It is not known whether ZOSTAVAX placebo) were actively followed for safety outcomes through Day 42 postvaccination and passively
can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. followed for safety after Day 42.
However, naturally occurring varicella-zoster virus (VZV) infection is known to sometimes cause fetal Serious Adverse Events Occurring 0-42 Days Postvaccination: In the overall SPS study population, serious
harm. Therefore, ZOSTAVAX should not be administered to pregnant women, and pregnancy should adverse events occurred at a similar rate (1.4%) in subjects vaccinated with ZOSTAVAX or placebo.
be avoided for 3 months following administration of ZOSTAVAX. In the AE Monitoring Substudy, the rate of SAEs was increased in the group of subjects who
WARNINGS AND PRECAUTIONS received ZOSTAVAX as compared to the group of subjects who received placebo (Table 2).
Hypersensitivity Reactions: Serious adverse reactions, including anaphylaxis, have occurred with
ZOSTAVAX. Adequate treatment provisions, including epinephrine injection (1:1,000), should be Table 2
Number of Subjects with ≥1 Serious Adverse Events (0-42 Days Postvaccination)
available for immediate use should an anaphylactic/anaphylactoid reaction occur. in the Shingles Prevention Study
Transmission of Vaccine Virus: Transmission of vaccine virus may occur between vaccinees and
susceptible contacts. Cohort ZOSTAVAX Placebo Relative Risk
n/N % n/N % (95% CI)
Concurrent Illness: Deferral should be considered in acute illness (for example, in the presence of
fever) or in patients with active untreated tuberculosis. Overall Study Cohort 255/18671 254/18717 1.01
(60 years of age and older) 1.4% 1.4% (0.85, 1.20)
Limitations of Vaccine Effectiveness: Vaccination with ZOSTAVAX does not result in protection
of all vaccine recipients. 60-69 years old 113/10100 101/10095 1.12
The duration of protection beyond 4 years after vaccination with ZOSTAVAX is unknown. The need 1.1% 1.0% (0.86, 1.46)
for revaccination has not been defned. 70-79 years old 115/7351 132/7333 0.87
ADVERSE REACTIONS 1.6% 1.8% (0.68, 1.11)
The most frequent adverse reactions, reported in ≥1% of subjects vaccinated with ZOSTAVAX, were ≥80 years old 27/1220 21/1289 1.36
headache and injection-site reactions. 2.2% 1.6% (0.78, 2.37)
Clinical Trials Experience: Because clinical trials are conducted under widely varying conditions, AE Monitoring Substudy Cohort 64/3326 41/3249 1.53
rates of adverse reactions observed in the clinical trials of a vaccine cannot be directly compared to (60 years of age and older) 1.9% 1.3% (1.04, 2.25)
rates in the clinical trials of another vaccine and may not refect the rates observed in practice.
60-69 years old 22/1726 18/1709 1.21
ZOSTAVAX Effcacy and Safety Trial (ZEST) in Subjects 50 to 59 Years of Age: In the ZEST study,
subjects received a single dose of either ZOSTAVAX (N=11,184) or placebo (N=11,212). The racial 1.3% 1.1% (0.66, 2.23)
distribution across both vaccination groups was similar: White (94.4%); Black (4.2%); Hispanic 70-79 years old 31/1383 19/1367 1.61
(3.3%) and Other (1.4%) in both vaccination groups. The gender distribution was 38% male and 2.2% 1.4% (0.92, 2.82)
62% female in both vaccination groups. The age distribution of subjects enrolled, 50 to 59 years, ≥80 years old 11/217 4/173 2.19
was similar in both vaccination groups. All subjects received a vaccination report card (VRC) to 5.1% 2.3% (0.75, 6.45)
record adverse events occurring from Days 1 to 42 postvaccination. N=number of subjects in cohort with safety follow-up
In the ZEST study, serious adverse events occurred at a similar rate in subjects vaccinated with n=number of subjects reporting an SAE 0-42 Days postvaccination
ZOSTAVAX (0.6%) or placebo (0.5%) from Days 1 to 42 postvaccination.
In the ZEST study, all subjects were monitored for adverse reactions. An anaphylactic reaction was Among reported serious adverse events in the SPS (Days 0 to 42 postvaccination), serious
reported for one subject vaccinated with ZOSTAVAX. cardiovascular events occurred more frequently in subjects who received ZOSTAVAX
Most Common Adverse Reactions and Experiences in the ZEST Study: The overall incidence of (20 [0.6%]) than in subjects who received placebo (12 [0.4%]) in the AE Monitoring Substudy. The
vaccine-related injection-site adverse reactions within 5 days post-vaccination was greater for frequencies of serious cardiovascular events were similar in subjects who received
subjects vaccinated with ZOSTAVAX as compared to subjects who received placebo (63.6% for ZOSTAVAX (81 [0.4%]) and in subjects who received placebo (72 [0.4%]) in the entire study cohort
ZOSTAVAX and 14.0% for placebo). Injection-site adverse reactions occurring at an incidence (Days 0 to 42 postvaccination).
≥1% within 5 days post-vaccination are shown in Table 1. Serious Adverse Events Occurring Over the Entire Course of the Study: Rates of hospitalization were
similar among subjects who received ZOSTAVAX and subjects who received placebo in the AE
Table 1 Monitoring Substudy, throughout the entire study.
Injection-Site Adverse Reactions Reported in ≥1% of Adults Who Received ZOSTAVAX
or Placebo Within 5 Days Post-Vaccination in the ZOSTAVAX Effcacy and Safety Trial Fifty-one individuals (1.5%) receiving ZOSTAVAX were reported to have congestive heart failure
(CHF) or pulmonary edema compared to 39 individuals (1.2%) receiving placebo in the AE Monitoring
ZOSTAVAX Placebo Substudy; 58 individuals (0.3%) receiving ZOSTAVAX were reported to have congestive heart failure
Injection-Site Adverse Reaction (N = 11094) % (N = 11116) %
(CHF) or pulmonary edema compared to 45 (0.2%) individuals receiving placebo in the overall study.
Solicited* In the SPS, all subjects were monitored for vaccine-related SAEs. Investigator-determined,
Pain 53.9 9.0 vaccine-related serious adverse experiences were reported for 2 subjects vaccinated with
Erythema 48.1 4.3 ZOSTAVAX (asthma exacerbation and polymyalgia rheumatica) and 3 subjects who received
Swelling 40.4 2.8
placebo (Goodpasture’s syndrome, anaphylactic reaction, and polymyalgia rheumatica).
Unsolicited Deaths: The incidence of death was similar in the groups receiving ZOSTAVAX or placebo during
Pruritis 11.3 0.7 the Days 0-42 postvaccination period; 14 deaths occurred in the group of subjects who received
Warmth 3.7 0.2 ZOSTAVAX and 16 deaths occurred in the group of subjects who received placebo. The most
Hematoma 1.6 1.6
Induration 1.1 0.0 common reported cause of death was cardiovascular disease (10 in the group of subjects who
received ZOSTAVAX, 8 in the group of subjects who received placebo). The overall incidence
*Solicited on the Vaccination Report Card of death occurring at any time during the study was similar between vaccination groups: 793
Copyright © 2014 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved. VACC-1123879-0003 07/14
NCPA’s toolkit includes a sample news release, social media posts, phone scripts, and a Power Point presentation.
CONTINUING EDUCATION
In-service hours
Pharm tech certifcation: PTCB announces Pharmacy technicians should also be aware that the number of
in-service hours that PTCB will accept is dropping from 10 to
2015 changes
fve, and will be phased out altogether in 2018. PTCB defnes
The Pharmacy Technician Certifcation Board (PTCB) is fol- “in-service” as “certain projects or training earned at a CPhT’s
lowing through on changes announced in 2013 concerning workplace under a pharmacist’s supervision.”
recertifcation requirements for Certifed Pharmacy Techni- The 2013 plan noted that the acceptable limit for CE hours
cians (CPhTs). A recent announcement presented two pro- derived from college or university coursework will drop from
gram modifcations that will be implemented in 2015. 15 to 10 in 2016, and it emphasized that any pharm tech wish-
ing to recertify would have to complete an hour of CE focused
CE objectives on medication safety by 2014 and 20 hours of CE specifc to
Pharm techs interested in recertifying should be aware that any pharmacy technicians by 2015.
continuing education (CE) hours they earn will need to pertain PTCB’s recent statement noted that “[t]he revised CE require-
specifcally to CPhTs if they want to apply those units to their ments are meant to ensure that CPhTs are continually educated
recertifcation. That means that each CE should have objectives through programs specifc to the knowledge required in today’s
written specifcally for pharmacy technicians, in addition to any pharmacy settings,” refecting the changes that will be seen in
written for pharmacists. According to PTCB, many CE providers pharmacy technicians’ roles as the healthcare system evolves.
already do this, and others are planning to develop such units. — Julianne Stein, Content Channel Manager
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Up front
DEVICE DRAWBACKS
Best practices implemented by the health system to prevent
Hospital-system study shows that insulin pen sharing of insulin pens between patients included one-on-one
problems may persist, despite best practices staff education regarding the safe use of insulin pens; scanning of
both the patient barcode and the patient- and order-specifc bar-
Despite diligent efforts by a multihospital system to reduce code on the insulin pen; an electronic medication administration
errors associated with insulin pens, says a new report, many record (eMAR) at the bedside; an effective monitoring system;
errors continue to dog their use. and a highly visible alert that notifed the nurse when the scan
In 2013, when the Institute for Safe Medication Practices revealed an invalid order for the patient.
(ISMP) suggested that hospitals consider transitioning away from
insulin pens, a multihospital system convened an interdisciplinary Serious errors
team to evaluate the issue. In the areas of greatest risk, the health In one of the most serious errors, a nurse who misunderstood
system identifed safety measures and best practices that would the alert administered a dose of insulin to her patient using the
allow for proper use of insulin pens and, at the time, recom- scanned pen and then manually documented administration,
mended continued use of pens. according to ISMP. Because she was carrying two insulin pens
in her pocket, she inadvertently used the wrong patient’s pen
Discouraging data to deliver the dose. “Unfortunately, the patient whose pen was
However, after a three-month test of the best practices, the used in error tested positive for active hepatitis C,” ISMP wrote.
health system reported discouraging data to ISMP. Because of the occurrence of a few different “shared insulin
“The frequency of ‘wrong patient’s pen’ alerts at the bedside pen” errors, the multihospital system decided to replace use of
that were detected, and administration avoided, with patient- insulin pens with use of 3-mL vials of rapid-acting insulin.
and order-specifc barcode scanning gives us great pause when “For now, the hospital system is not convinced that the ben-
we think about what this means for thousands of U.S. hospi- efts of using insulin pens in hospitals (e.g., accurate dosing) out-
tals that are ill-equipped to implement the same best practices weigh the risks — even if every nurse knows that pens should
and monitor their effectiveness,” ISMP wrote in the October 23 not be shared, and best practices are implemented,” ISMP wrote.
edition of its Acute Care ISMP Medication Safety Alert! newsletter. — Christine Blank, Contributing Editor
Now Available!
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Issues & Trends
Up front
In Depth
Julia Talsma, Content Channel Director
N
OVA ScriptsCentral (NSC), a For the past seven years,
nonproft pharmacy serving 26 NSC has grown from a full-
safety-net clinics throughout time staff of four employees
northern Virginia, provides more than assisted by volunteers to a
free or low-cost prescriptions for unin- staff of eight, including one
sured children and adults. According to full-time and one part-time
Interim Executive Director Donney John, pharmacist and two phar-
PharmD, the nonproft pharmacy partners macy technicians. NSC staff
with each clinic to work directly with medi-
provide patient- cal staff at the partner clin-
centered care. ics, filling prescriptions for
Since 2007, brand-name and generic
NSC has been able medications indicated for The staff of Nova ScriptsCentral serves the patients of 26
to provide $30 most chronic diseases, includ- safety-net clinics throughout northern Virginia.
million worth of ing mental health conditions
medications to the and HIV. NSC also offers patient counsel- The ALL/PHASE study is a program
most vulnerable ing by telephone and supplies clinic staff focusing on reduction of cardiovascular
Donney John
residents of Alex- with talking points to relay to patients disease that Kaiser initiated in 2003. The
andria, Arlington, about new drugs. A-L-L regimen employs aspirin, lisinopril,
Fairfax/Falls Church, Loudoun, and Prince and lipid-lowering therapy; P-H-A-S-E
William, Va. The need for these prescrip- Partnerships represents “Preventing Heart Attacks and
tions and care continues. NSC’s community health centers and Strokes Everyday,” through exercise, life-
“There is a big demand for medica- free clinic members have partnered with style changes for weight reduction, and
tion access. The only way the majority Northwestern, Harvard, Louisiana State, smoking cessation.
of [uninsured] patients get medications and Emory Universities in a study testing Kaiser found that patients who
is through NOVA Scripts,” said John, a a simplifed English-language prescription adhered for one year to the ALL/PHASE
practicing pharmacist, healthcare consul- label for low-literacy populations. The bot- program, including to standard-dose ACE
tant, and entrepreneur. “Without us, pa- tom of the simplifed Rx label displays the inhibitors and statins, had a 60% reduc-
tients would have no access to life-saving pharmacy name, creating enough space to tion in myocardial infarction and stroke.
medications such as prescription inhalers, make the important information promi- Kaiser extended its program with fund-
insulin, or other chronic disease meds.” nent: the patient’s name, the disease to be ing to safety-net clinics in the mid-Atlantic
treated, and directions on how and when region to help improve clinical outcomes.
IMAGE COURTESY OF NOVA SCRIPTSCENTRAL
New model to take the medication. “The study started early this year.
This program, in which multiple safety-net “The new labels take the guesswork We are using text messaging to patients’
clinics share one pharmacy, is unique to out of pill-taking by placing the number cell phones and automated messag-
Virginia and the metropolitan area at this of pills for morning, noon, evening, or ing to landlines to engage patients and
time, but it could serve as a national mod- bedtime in a graphic representation or encourage them to take their medica-
el for prescription access for the uninsured. universal medicine schedule,” John said. tions. We also troubleshoot any bar-
“We want to share best practices and NSC also is working with approxi- riers for why they may not be taking
some of the struggles that we have had mately 300 patients from two partner their medicines,” John said. “Although
and overcome to help others who want safety-net clinics who are taking part in we have a small team [at NSC], we can
to start a charitable nonproft pharmacy a two-year medication adherence study, make a profound impact on thousands of
[such as NSC],” John said. funded through Kaiser Permanente. people on a yearly basis.”
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Issues & Trends
Up front
In Depth
Julia Talsma, Content Channel Director
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Issues & Trends
Up front
In Depth
Joel Claycomb, PharmD
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Issues & Trends
Up front
In Depth
Julia Talsma, Content Channel Director
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Issues & Trends
Up front
In Depth
Julia Talsma, Content Channel Director
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Cover Story
Jill Sederstrom
PharmD options
Six pharmacy schools offer nontraditional path for RPhs
W
hile opportunities for pharmacists are growing in who wanted to get a PharmD degree I think have done
the healthcare arena, those who lack a doctor- so, so our applicant pool is declining. Plus there’s the fact
ate of pharmacy degree could face some rough that it’s extremely hard for us to offer it across the country,
seas ahead. nationally at least, because of the diffculty of fnding clerk-
Many pharmacy leadership positions now require appli- ship sites in the student practitioner’s area.”
cants to have the PharmD degree, rather than BS Pharm or Despite the smaller number of programs, pharmacists
an equivalent, and it’s now the only track offered for new with bachelor’s degrees who plan to
graduates who enter the feld. continue practicing in pharmacy in
At the same time, the number of pharmacy schools that the years ahead may want to at least
offer a nontraditional option for pharmacists already practic- consider pursuing the higher degree,
ing in the feld is on the decline. said Ruth E. Nemire, PharmD, EdD,
Two institutions, Idaho State University and Campbell associate executive vice president and
University, have recently made the decision to discontinue chief academic officer of American
GETTY IMAGES / ISTOCKPHOTO
their nontraditional option for PharmD students, leaving Association of Colleges of Pharmacy.
fewer than half a dozen programs still available in the Unit- “I think many people have
Ruth Nemire
ed States. thought that the PharmD was a spe-
“The applicant pool is dropping,” said Vaughn Culbert- cialty pharmacy degree, but in 2014 it
son, PharmD, director of the nontraditional PharmD pro- is not just a specialty pharmacy degree anymore,” she said,
gram at Idaho State University. “Most of the BS practitioners adding that in the years ahead it will only become more
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Cover Story
prevalent. “We are going to need the The following is a breakdown of each school’s unique
pharmacists out there providing pri- features.
mary care and ambulatory care in
places that we haven’t been before.” Howard University
Howard University, located in Washington D.C., has one of
The value of going back the more signifcant credit-hour requirements for nontradi-
Alla Marks, PharmD, made the deci- tional programs but allows the lowest
sion to go back to school to earn her average time to complete the degree.
Alla Marks doctorate after fnding that opportuni- Youness R. Karodeh, PharmD,
ties were closed to her at work. At the RPh, assistant dean and program
time, she was working as a therapeutic specialist at a large director for the Non-traditional Doctor
pharmaceutical company and wanted to apply for a position of Pharmacy Program, said the pro-
as medical science liaison within the organization. gram is distinctive because it is self-
“I was not even able to interview for it, because I didn’t paced and somewhat fast-tracked.
have my PharmD,” she said. “That gave me the wakeup “It’s not an easy program,” he
Youness Karodeh
that said, wait a minute, even by working in a specifc in- said. “Any professional degree at a
stitution, without the PharmD, I am not even considered.” doctoral level really requires a lot of
So, in her early 40s, she decided to return to school. Ulti- hard work, but because our applicants are already licensed
mately she ended up serving a pharmacy practice residency pharmacists practicing in the United States, they do have
at a Veterans Affairs medical center while also completing a strong background, they do have strong skills, and the
her PharmD degree through a nontraditional program. courses that are offered in the didactic portion of the pro-
“It was just really about managing time. I had to live gram are new techniques and knowledge that will augment
away from my husband on the weekdays and then come to their previous schooling.”
Northern Virginia on the weekends to spend time with him, The school requires students to complete 65 credit hours,
but basically it was just managing time,” she said. including 35 credit hours of didactic course work and 30
Marks is now an associate professor and director of credit hours for the experiential aspect of the program.
professional education at Shenandoah University, where The didactic portion of the program is online and can
she manages the school’s nontraditional PharmD program. be completed at a student’s own pace; however, the school
For her, she said, it was a decision that ultimately paid off. does require that all students participate in two executive
“I am glad for it, because I wouldn’t have had the weekends held on campus.
experiences I’ve had in academia if I hadn’t done that,” Students are responsible for fnding their own site to
she said. fulfll the experiential component of the program, which
can be completed anywhere in the United States.
Selecting a program
There are no separate accreditation requirements for nontra- Idaho State University
ditional PharmD programs, according to Greg Boyer, PhD, For almost a quarter of a century, Idaho State University
assistant executive director and director of the professional has offered pharmacists a nontraditional route to obtain-
degree program accreditation for the Accreditation Council ing a PharmD, but Culbertson said the school has probably
for Pharmacy Education. Instead, he said, the ACPE evalu- already enrolled its fnal group of students in the program
ates the Doctor of Pharmacy degree as a whole, regardless this fall.
of the number of pathways offered to achieve the degree. He said the school will reconsider the issue next autumn,
“Essentially, if any one pathway falls short of the expec- but at present it is planning to discontinue its nontraditional
tations of the ACPE accreditation standards, then the entire program, which launched in 1990.
program is impacted and found lacking on the compromised At present, students enrolled in the program must com-
standard or standards,” he said. plete 37 semester credits in didactic education and complete
While a handful of schools across the country have cho- three six-week clerkships.
sen to offer a nontraditional option as part of their PharmD “We videotape all of our classes taught to the traditional
program, each program is structured differently. students here on campus, so that they have an opportu-
“They have some very big differences in how they nity to go back and review lectures and so forth. So what
provide their courses, in their practice experiences, and we’ve done is taken content from the video fles we have
what the requirements are for those practice experiences,” and restructured it into coursework that is appropriate for
Nemire said. practicing pharmacists,” he said.
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Cover Story
Pharmacists enrolled in the program receive a DVD with either in the United States or Canada,
lectures they can work through on their own, and students titled the North American-Trained
take exams where they live by reporting to a proctor who Doctor of Pharmacy program, and
administers the tests. The school makes every effort to another new track specifically for
secure clerkships near the student’s home base, but the dif- pharmacists licensed outside North
ficulty of finding clerkship locations is one reason the school America, titled the International-
plans to discontinue the program, Culbertson said. Trained Doctor of Pharmacy program.
“There are so many schools now that it is difficult find- The North American track, which
ing clerkship sites that aren’t already saturated with tradi- Kari Franson started in 1999, is a hybrid of dis-
tional student enrollments and experiential programs and so tance-based learning and local expe-
forth,” he said, adding that legal requirements and a declin- riential education. According to Kari Franson, PharmD, PhD,
ing applicant pool also factored into the decision. associate dean for professional education at the University
To date, 319 graduates have completed the program, of Colorado, the program requires a total of 65 credits, 30
which typically takes an average of three-and-a-half or four of which are experiential.
years to finish. “We’ve increased the amount of experiential learning
over time, because we recognized that’s what people want,”
Shenandoah University she said.
Twice a year, Shenandoah University admits a new cohort The program, which typically enrolls between 30 and 60
of about 30 students into its Non-traditional Doctor of Phar- students a year, enables students to complete most of the
macy Pathway program. didactic requirements online at their own pace. The experi-
The program begins with six terms of online didactic ential requirements include six advanced pharmacy practice
learning courses, which run consecutively, and moves on to experiences that can be performed either within the student’s
the experiential portion of the program, which includes acute home state or in Colorado. The school permits completion of
care, ambulatory care, and medication information rotations. one elective rotation outside of the United States.
While the lecture material, exams, assignments, and “We ask our students to complete several clinical rota-
quizzes are exactly the same as those given to traditional tions and really demonstrate their clinical abilities while they
students, participants in the nontraditional program are able are in the program,” she said.
to work through the course material at their own pace dur- It takes students just under four years, on average, to
ing the semester. complete the entire program.
“Everything is activated on the first day of the term, so The International track, which launched this year with
that they can study at their pace, but we give them a guided three students, requires 90 credit hours. More credit hours
calendar of how to take exams every two weeks,” she said. are required for this track, Franson said, because interna-
A central aspect of Shenandoah University’s program is tional students must also be taught U.S. laws.
its cohort-based design, under which students who enroll at
the same time work consecutively through the six didactic University of Florida
courses together. The nontraditional PharmD program at the Univer-
“We find that it’s much more successful in terms of sity of Florida differs from some of the other pro-
graduation rate, because they have each other as support grams in that it offers students a blended learning
and they do group projects together, so they have the active experience that includes attendance at
learning,” Marks said. monthly live day-long sessions as well
Students who received their bachelor’s degrees in the United completion of online coursework.
States can seek sites close to home for fulfillment of their three Sven A. Normann, PharmD,
experiential rotations, of which each accounts for five credits. DABAT, assistant dean of pharmacist
International students in the program may have to take an ad- education and international affairs,
ditional rotation to gain more experience working in a retail or said that during each of the program’s
hospital pharmacy setting in the United States. nine semesters, students are required
According to Marks, completion of the program takes an to attend three live sessions in which
Sven Normann
average of about two-and-a-half years. All students must they give case presentations, take
complete it within seven years. exams, receive their assignments,
and present on pharmacy topics. For completion of the live
University of Colorado component of the program, the school has 18 regional sites
The iPharmD program at the University of Colorado offers
two separate tracks: one for licensed pharmacists working Continued on pg. 47
TABLE 1
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Medication Safety
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For more than 20 years, GREENSTONE has established a strong legacy of delivering
more than medicine. With a dedication to providing value and excellence in
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Medication Safety
Warfarin
In another case study, Howard- The WHO International Agency for Research on Cancer
Thompson A, Hurdle AC, Arnold LB,
et al, 3 recounted the case of a 78-year-
and the U.S. National Toxicology program both list
old white woman who had visited a metronidazole as a possible carcinogen, although the
walk-in clinic and received prescrip-
tions for metronidazole (250 mg Q8H
relationship of metronidazole exposure to cancer in
for fve days) and levofoxacin (500 humans has not been clearly established.
mg QD for six days). The patient did
not inform the physician that she was
on 7 mg warfarin therapy daily. dose adjustments are necessary wher- Drugs that must be avoided during
Nine days later, she was admitted for ever these drugs are required for treat- metronidazole treatments include disul-
profuse nosebleeds, with an internation- ment of a patient on metronidazole. fram, carbocisteine, BCG vaccine, pimo-
al normalized ratio (INR) value of 8.0. zide, and ethyl alcohol.
According to the authors, this Carcinogenicity Drugs that may be used with
adverse event was attributable to a Unlike chloramphenicol, metronidazole extreme caution during metronidazole
metronidazole-induced elevation in does not cause irreversible hematologi- treatments include mycophenolate, fos-
plasma warfarin levels, because it cal toxicities, but it has been shown to phenytoin, systemic fuorouracil, calci-
inhibits the in vivo metabolism of be carcinogenic in studies of animals, neurin inhibitors, aripiprazole, tegafur,
S-warfarin, the most active isomer in although not of humans. dofetilide, phenobarbital, ritonavir, and
the warfarin racemic mixture. Studies in experimental animals tipranavir.
Metronidazole is an inhibitor of (rats and mice) have proven metroni- Some medications and vaccines that
the CYP2C9 enzyme, an element of dazole carcinogenicity.5,6 The hydroxy may be used with close monitoring
the cytochrome P450 enzyme sys- metabolite, which is more potent than during metronidazole therapy include
tem that is responsible for S-warfarin the parent compound, has been impli- typhoid vaccine, vitamin K antagonist,
metabolism. cated in many lab animals. lomitapide, mebendazole, busulphan,
The WHO International Agency and sodium picosulfate.
Organ function for Research on Cancer and the U.S.
The consistent and very frequent use National Toxicology Program both list References
of metronidazole in gynecological clin- metronidazole as a possible carcinogen, 1. Edwards DL, Fink PC, Van Dyke PO. Disulfram-like
reaction associated with intravenous trimethoprim-
ics and for the treatment of B. fragi- although the relationship of metronida- sulfamethoxazole and metronidazole. Clin Pharm.
lis infections of the GI tract presents a zole exposure to cancer in humans has 1986;5(12):999–1000.
number of risks for the occurrence of not been clearly established. 2. Krulewitch CJ. An unexpected adverse drug effect.
J Midwifery Womens Health. 2003;48(1):67-68.
adverse drug reactions, especially in
3. Howard-Thompson A, Hurdle AC, Arnold LB, et al.
patients who are social drinkers, in those Side effects Intracerebral hemorrhage secondary to a warfarin-
with undiagnosed hepatic disease, and Some more commonly seen side effects metronidazole interaction. Am J Geriatr Pharmaco-
ther. 2008;6(1):33–36.
in those with renal dysfunction. Metro- of metronidazole include numbness,
4. Farrell G, Baird-Lambert J, Cvejic M, et al. Disposi-
nidazole volume of distribution and sys- tingling sensations in hands or feet, tion and metabolism of metronidazole in patients
temic clearance are reduced by 21% and irritability, hallucinations, headaches, with liver failure. Hepatology. 1984;4(4):722–726.
66% respectively in liver failure, causing convulsions, dizziness, drowsiness, sore 5. Bendesky A, Menendez D, Ostrosky-Wegman P.
an elimination half-life prolongation of throat, loss of appetite, cloudy urine, Is metronidazole carcinogenic? Mutat Res. 2002;
511(2):133-144.
152%.4 loss of bladder control, joint or muscle 6. Menendez D, Bendesky A, Rojas E, et al. Role of
If metronidazole is given concur- pain, skin rash, chills, black or tarry P53 functionality in the genotoxicity of metroni-
rently with mebendazole, the risks of stool, skin redness, blistering, peeling, dazole and its hydroxy metabolite. Mutat Res.
2002;501(1–2):57–67.
toxic epidermal necrolysis and Stevens- or loosening of the skin, vaginal irrita-
Johnson syndrome are heightened. tion, eye pain, fever, continuing diar-
Similarly, if it is given with busulphan, rhea, Stevens-Johnson syndrome, blad- Oluwole Williams practices pharmacy in the
there is a 79%–87% elevation of busul- der infammation, and acute pancreatic Philadelphia, Penn., area. Contact him at
phan trough concentrations. Therefore infammation. pharmwillie@yahoo.co.uk.
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Clinical
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Clinical
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Regulatory & Legal
T
he U.S. Department of Health coupons constitute remuneration under to address the issues raised by the OIG
and Human Services’ Office of the federal anti-kickback statute. As a concerning copayment coupons.
Inspector General (OIG) recent- result, drug manufacturers who purpose- For example, pharmacies currently
ly estimated that more than two mil- fully use coupons to induce purchases of accepting coupons might draft and adopt
lion Medicare Part D benefciaries use prescriptions payable by a federal health- new policies that refect the OIG’s report
copayment coupons to buy drugs care program will violate the anti-kick- and special advisory bulletin. In addition,
through their federal prescription plans. back statute. pharmacies that permit copayment cou-
Patients beneft from drug manufacturer In addition, if the offer of copayment pons should train staff to verify that the
coupons because they enable consumers coupons violates the anti-kickback stat- person presenting the copayment cou-
to opt for expensive brand-name drugs ute, claims for prescriptions resulting pon is not a benefciary of a federal or
for little to no out-of-pocket copayment from such violations could be construed state healthcare program.
cost. Manufacturers beneft from copay- as fraudulent claims under the False Pharmacies may receive additional
ment coupons because they may help a Claims Act. guidance on the use of coupons from the
brand-name drug keep its market share, drug manufacturers that produce them,
once a generic version is approved. Pharmacy practices as the OIG recommended that manufac-
In September 2014, the OIG issued The OIG report and bulletin also turers take action to prevent the use of
a report noting that the use of copay- addressed pharmacy practices with copayment coupons for drugs paid for by
ment coupons by benefciaries of fed- regard to coupons. federal healthcare programs.
eral healthcare programs can lead to Pharmacies risk violating federal The OIG report also recommended
increased healthcare costs for the feder- laws when they accept remuneration that manufacturers and pharmacies pro-
al government and greater prescription for the purchase of drugs for which a vide additional transparency to highlight
drug costs for healthcare insurers. federal healthcare program may make the use of coupons within pharmacy
a payment. The OIG specifically stated claims.
Anti-kickback statute that pharmacies that accept coupons for In sum, pharmacies should reevalu-
The OIG determined that coupons were copayments owed by Medicare, Medic- ate their acceptance of drug manufactur-
being used for drugs covered by federal aid, or other federal healthcare program er coupons and establish safeguards to
healthcare programs. As discussed below, benefciaries “may be subject to sanctions.” prevent the use of copayment coupons
it is a violation of the anti-kickback stat- In addition to potential sanctions by benefciaries in transactions involving
ute to offer coupons to induce the pur- under the anti-kickback statute and the a federal healthcare payer.
chase of drugs paid for by federal health- False Claims Act, pharmacies that offer
care programs. The OIG deemed that or accept copayment coupons may face This article is not intended as legal advice and
current safeguards used by drug manu- penalties for beneficiary inducement. should not be used as such. When legal ques-
facturers are unreliable. The OIG found The government may assess civil mone- tions arise, pharmacists should consult with
that letters warning pharmacists not to tary penalties for benefciary inducement attorneys familiar with the relevant drug and
submit claims for federal reimbursement when a pharmacy offers or accepts a pharmacy laws.
in connection with the coupons and copayment coupon to induce a federal
manufacturers’ use of pharmacy claims or state healthcare program benefciary Ned Milenkovich is a partner and head of
edits did not prevent the processing of to use that particular pharmacy. the health, drug, and pharmacy legal prac-
coupons for the purchase of drugs paid tice at Roetzel and Andress LPA. He is also a
for by federal healthcare programs. Immediate action member of the Illinois State Board of Phar-
In an accompanying advisory bulle- Pharmacies that accept copayment macy. Contact Ned at 312-582-1676 or at
tin, the OIG proclaimed that copayment coupons should take immediate steps nmilenkovich@ralaw.com.
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CREDIT: 2.0
Continuing Education
EARN CE CREDIT FOR THIS ACTIVITY AT WWW.DRUGTOPICS.COM AN ONGOING CE PROGRAM OF THE UNIVERSITY OF CONNECTICUT
SCHOOL OF PHARMACY AND DRUG TOPICS
educationaL oBJectiVeS
Goal: To discuss the prevalence, health
consequences, and nonpharmacologic and
pharmacologic treatment options for obesity,
focusing on the recommendations made in
the 2013 AHA/ACC/TOS guideline for the
management of overweight and obesity in
adults.
After participating in this activity,
pharmacists will be able to:
● Explain the epidemiological impact and
prevalence of overweight and obesity.
● Identify the diagnostic criteria used for
classifcation of excess body weight.
● Identify comorbidities and health risks
associated with excess body weight.
● discuss the role of nonpharmacologic
●
therapy for weight management in adults.
describe approved pharmacologic treatment MtM essentials for
weight management
strategies for patients with excess body
weight.
Abstract
CEUs (2 contact hours) for completing the activity,
passing the quiz with a grade of 70% or better, and
completing an online evaluation. Statements of
credit are available via the online system and your
Overweight and obesity are major concerns in the United States, with two-thirds
participation will be recorded with CPE Monitor within of adults being either overweight or obese. Obesity is associated with various
72 hours of submission. comorbidities and health risks, leading to increases in morbidity and mortality rates
and healthcare costs. Approaches to weight loss and management include both
ACPE# 0009-9999-14-012-H01-P pharmacologic and nonpharmacologic therapies, such as lifestyle modifcations,
FDA-approved medications for weight loss, and bariatric surgery. Weight loss
Grant Funding: There is no grant funding for this treatment should be tailored to patient-specifc factors and oftentimes will require
activity.
several different methods. Pharmacists are uniquely qualifed to select appropriate
medications for weight loss based on the patient’s comorbidities and potential drug-
Activity Fee: There is no fee for this activity.
drug interactions. Pharmacists can also help monitor for adverse effects and weight
loss effcacy and can serve as a resource to guide and motivate patients through
Initial release date: 11/10/2014
both pharmacologic and nonpharmacologic aspects of weight loss attempts.
Expiration date: 11/10/2016
To obtain CPE credit, visit www.drugtopics.com/cpe Faculty: danielle Wojtaszek, Pharmd, devra dang, Pharmd, BcPS, cde, FnaP,
and click on the “Take a Quiz” link. This will direct
and Judy t. chen, Pharmd, BcPS, cde, FnaP
you to the UConn/Drug Topics website, where you will
dr. Wojtaszek is a postdoctoral fellow in primary care, university of Connecticut School of Pharmacy,
click on the Online CE Center. Use your NABP E-Profle
Storrs, Conn. dr. dang is associate clinical professor, university of Connecticut School of Pharmacy, Storrs,
ID and the session code 14DT12-FKX42 to access
IMAGE: GETTY IMAGES / FLICKR RF
Conn. dr. Chen is clinical associate professor, Purdue university, College of Pharmacy, Indianapolis, Ind.
the online quiz and evaluation. First-time users must
pre-register in the Online CE Center. Test results will Faculty Disclosure: dr. Wojtaszek, dr. dang, and dr. Chen have no actual or potential confict of interest
be displayed immediately and your participation will associated with this article.
be recorded with CPE Monitor within 72 hours of com- Disclosure of Discussions of Off-Label and Investigational Uses of Drugs: This activity may contain
pleting the requirements. discussion of unlabeled/unapproved use of drugs in the united States and will be noted if it occurs. The
content and views presented in this educational program are those of the faculty and do not necessarily
For questions concerning the online CPE represent those of Drug Topics or university of Connecticut School of Pharmacy. Please refer to the offcial
activities, e-mail: cpehelp@advanstar.com. information for each product for discussion of approved indications, contraindications, and warnings.
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o
besity continues to be a ma- The prevalence of obesity in the united also associated with gastrointestinal (eg,
jor health concern in the united States varies depending on sex, ethnicity, gastroesophageal refux disease, choleli-
States. More than 78 million age, and socioeconomic status. Obesity thiasis), liver (eg, nonalcoholic fatty liver
adults in the united States were obese in is more prevalent among women (36.1%) disease), and musculoskeletal (eg, osteo-
2011 to 2012.1 Obesity is related to many than among men (33.5%).1 Among men, arthritis) conditions.9 furthermore, individu-
negative health consequences, including the prevalence of obesity is slightly higher als who are obese have an increased risk
cardiovascular disease (CVd), diabetes, at higher income levels, whereas among of developing dyslipidemia, sleep apnea
and cancer, and has a significant effect women, the prevalence of obesity is high- and other respiratory conditions, increased
on morbidity and healthcare costs.2,3 An er at lower income levels.8 non-Hispanic surgical risks, and certain cancers, such
estimated 300,000 premature deaths black adults have the highest prevalence as uterine, kidney, cervical, and thyroid
are related to obesity in the united States of obesity (47.8%), followed by Hispanic cancers.10,11 Excess body fat affects virtu-
annually.3 In 2008, it was estimated that (42.5%), and non-Hispanic white (32.6%) ally all organ systems.
the annual medical costs of obesity in the adults; non-Hispanic Asian adults have Although obesity is commonly recog-
united States were $147 billion, and medi- the lowest prevalence of obesity (10.8%).1 nized by the general public and has been
cal spending for obese patients was ap- In 2011 to 2012, the prevalence of obe- identified as the second most common
proximately 42% higher than for patients of sity was higher among middle-aged adults factor contributing to preventable death in
normal weight.4 The American Medical As- aged 40 to 59 years than among younger the united States, diffculties in manage-
sociation offcially recognized obesity as a adults aged 20 to 39 years or older adults ment of this chronic condition remains a
chronic disease state in June 2013 in hope aged 60 years or older.1 universal challenge for healthcare profes-
of changing the way the medical community sionals, patients, and the entire healthcare
manages this common medical condition.2,5 comorbidities and health system. The evidence-based guideline for
risks associated with the management of overweight and obesity
Epidemiological impact excess body weight in adults released in november 2013 re-
and prevalence Obesity presents a major public health fects a joint effort by the Obesity Society
Approximately two out of three adults in concern, and a plethora of evidence contin- (TOS), American Heart Association (AHA),
the united States are either overweight or ues to link excess body fat with numerous and American College of Cardiology (ACC)
obese.6 The prevalence of obesity in the health conditions. Obesity and overweight to curb the rising prevalence of obesity. This
united States, which had been increasing are also associated with an increased guideline, which incorporates new quality
since the 1960s, appears to have leveled risk in all-cause mortality. A chronic condi- evidence, is reviewed in this article.10
off starting in 2003.6,7 Although the preva- tion commonly associated with obesity is
lence of obesity in the united States did type 2 diabetes mellitus. It is estimated Assessment and
not signifcantly change between 2003 to that 15% to 25% of obese patients de- diagnostic criteria
2004 and 2011 to 2012 according to the velop insulin resistance and type 2 diabe- Body mass index (BMI), which is commonly
national Health and nutrition Examination tes.9 Another well-known complication of used in clinical practice, is a reasonable tool
Survey (nHAnES), this condition remains obesity involves the cardiovascular sys- to assess the extent of excess weight in
a major healthcare concern.7 In 2011 tem—individuals who are obese have an adults by estimating body fat. BMI is calcu-
to 2012, the prevalence of obesity was increased risk of hypertension, coronary lated from an individual’s height and weight.
34.9% in adults aged 20 years or older heart disease (CHd), and cerebrovascular The patient’s height and weight should be
and 16.9% in children aged 2 to 19 years.7 accident.10 Overweight and obesity are measured while he or she is wearing light
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clothing and no shoes. The following equa- Assessment of obesity should incorpo- associated with a reduction in the need
tions are used to calculate BMI: rate BMI, waist circumference, and other for diabetes medications and a 0.6% to
BMI = weight (lb) / [height (in)]2 × 703, or clinical considerations such as sex, age, 1% reduction in hemoglobin A1C.10 The
BMI = weight (kg) / [height (m)]2 musculature, and comorbid conditions. Pa- 2013 AHA/ACC/TOS obesity guideline
Among overweight and obese adults, tients with sudden weight gain, abnormal notes that in observational case-control
greater BMI values are correlated with an fat distribution, or extreme obesity warrant studies, individuals with type 2 diabetes
increased risk for CVd, type 2 diabetes mel- close evaluation from healthcare providers. who lost 9 to 13 kg had a 25% decrease
litus, and all-cause mortality compared to in mortality compared to those in weight-
adults with normal BMI. However, BMI may Weight management stable groups.10 Improvements in lipid pro-
overestimate body fat in persons who are Primary prevention is the best manage- fles and lowered blood pressure are also
very muscular, such as body builders and ment strategy to curb the obesity epidem- evident in patients experiencing weight
athletes, and may underestimate body fat ic. Maintaining a healthy diet and obtain- loss. A 5% weight loss achieved over four
in persons with low muscle mass, such as ing adequate physical activity are the key years with intensive lifestyle interventions
the elderly. components of this strategy. In patients in overweight or obese adults with type
The BMI cut points for overweight and who are already overweight or obese, the 2 diabetes is associated with a reduction
obesity identifed in the 1998 Clinical guide- weight loss strategy should frst aim to pre- in the need for lipid-lowering medications
lines on the Identifcation, Evaluation, and vent further weight gain and then aim to and a lower number of patients prescribed
Treatment of Overweight and Obesity in achieve gradual and realistic weight reduc- antihypertensives.10
Adults should continue to be used to identify tion, maintain the weight loss, and enable
adults at elevated risk for type 2 diabetes life-long lifestyle changes to prevent weight Lifestyle modifications
mellitus, CVd, and all-cause mortality.12 A regain and relapse. A frst step in the dia- for weight loss and
BMI below 18.5 kg/m2 is considered under- logue with the overweight or obese patient maintenance
weight. A BMI between 18.5 and 24.9 kg/m2 can be to discuss the potential health To achieve weight loss, an energy defcit
is classifed as normal weight. A BMI of 25 consequences of excess body fat. If the through either reduced caloric intake or
kg/m2 or more is considered overweight, patient is ready for lifestyle changes, he or increased physical activity is required. The
and a BMI of 30 kg/m2 or more is consid- she should be encouraged to achieve sus- 2013 AHA/ACC/TOS obesity guideline rec-
ered obese. Patients with a BMI of 40 kg/ tained weight loss between 5% and 10% ommends that ideally weight loss attempts
m2 or greater are considered to have ex- of baseline body weight within the frst six should be overseen by a trained intervention-
treme obesity.10 months.10 According to the 2013 AHA/ ist, such as a registered dietitian, psycholo-
Waist circumference is another tool ACC/TOS obesity guideline, even lifestyle gist, exercise specialist, health counselor,
used to assess the degree of obesity in modifcations that produce a sustained or individual who has received creditable
adults. Waist circumference is considered weight loss of just 3% to 5% can result in instruction in weight management.10
to be the most practical anthropometric health benefts, such as clinically mean- Although a variety of dietary approaches
measurement for evaluating abdominal fat ingful reductions in triglycerides, blood resulting in a calorie-restricted diet have
and assessing the risk of comorbidities. glucose, hemoglobin A1C, and the risk of been described, three dietary interventions
The patient’s waist circumference should developing type 2 diabetes mellitus.10 have been recommended to achieve a
be measured at annual visits or more fre- reduction in dietary energy intake in over-
quently in overweight and obese adults. In- Weight loss benefits weight and obese individuals.10 The first
creased waist circumference (>40 inches in Weight loss has been shown to have ben- method is adherence to a recommended
men or >35 inches in women) parallels with efts on various cardiovascular risk fac- energy intake target with a reasonable
increased risk of morbidities and mortality. tors. In overweight and obese individuals, energy defcit for weight loss. This energy
Therefore, the greater the waist circumfer- an average weight loss of 2.5 to 5.5 kg intake target is 1200 to 1500 kcal/day
ence, the greater the risks of CVd, type 2 maintained for two or more years has been in women and 1500 to 1800 kcal/day in
diabetes mellitus, and all-cause mortality shown to reduce the risk of the develop- men, adjusted based on each patient’s
even in individuals with normal body weight ment of type 2 diabetes by 30% to 60%.10 body weight and physical activity level. The
(BMI 18.5–24.9 kg/m2).12 Weight loss of 5% to 10% over one year is second method estimates an individual’s
energy requirements based on expert guide-
lines and incorporates a prescribed energy
pause&ponder defcit of 30%, 500 kcal/day (which equates
to approximately one pound of weight loss
What are some ways to identify and engage patients per week), or 750 kcal/day.10,13 The third
who can beneft from weight loss in the community method recommends a lower calorie intake
pharmacy setting? achieved through the restriction of particu-
lar food groups, the elimination of particular
food groups, or adherence to a prescribed
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TABLE 1
Guide to SelectinG treatment for obeSity
BMI category
Treatment 25-26.9 27-29.9 30-34.9 35-39.9 ≥40
Diet, physical activity, With comorbidities With comorbidities + + +
and behavior change
Pharmacotherapy With comorbidities + + +
Surgery With comorbidities +
Abbreviations: BMI, body mass index in kg/m2.
+ represents that treatment is indicated regardless of comorbidities.
Source: Ref 13
food diet. Many different dietary plans using nish group (P=0.007). In each study group, program and should be counseled to start
this third method are available, and each only approximately 25% of initial participants slowly and gradually increase the intensity
can lead to weight loss in overweight and lost more than 5% of baseline body weight and duration of exercise.
obese adults as long as a reduced energy at one year, and only approximately 10% of Behavioral modifcation should also be
intake is achieved.10 The major plans include initial participants lost more than 10% of included in the weight loss plan.10 Behavior-
low-fat diets, low-carbohydrate diets, higher- baseline body weight. Patient adherence al therapy is a structured behavioral change
protein diets, and balanced dietary plans. gradually declined over time similarly among program that uses self-monitoring of diet
Low-fat diets are generally defned as all the diet groups. Only 53% of participants and exercise habits to increase the patient’s
those that provide less than 30% of total in the Atkins group, 65% in the Zone group, awareness of healthy behaviors.10,17 Behav-
calories from fat.10 Some dietary plans (eg, 65% in the Weight Watchers group, and 50% ior is reinforced by various methods such as
Pritikin and Ornish diets) are considered very in the Ornish group completed the study. A using social support, setting realistic goals,
low-fat diets as they allow only 10%-20% of strong association between dietary adher- addressing barriers to change, controlling
total daily calories to come from fat.14 Low- ence and weight loss was demonstrated in stimuli, planning meals, managing stress,
carbohydrate diets usually limit the amount this study, suggesting that sustained adher- and using behavioral contracting and rein-
of carbohydrate intake (approximately 20 g/ ence to a diet is more important for suc- forcement.17 The 2013 AHA/ACC/TOS obe-
day, which equates to approximately one- cessful weight management than the type sity guideline recommends that overweight
third of a typical American bagel or one-half of diet used.15 The 2013 AHA/ACC/TOS and obese individuals who would beneft
of a 12-oz can of soda) while intake of fat obesity guideline recommends that over- from weight loss should participate in a be-
is relatively high (approximately 60%).10,14 weight or obese patients who would beneft havioral modifcation program for six months
Examples of low-carbohydrate diets are from weight loss should choose a calorie- or more.10 Ideally, the overweight or obese
the Atkins and South Beach diets.14 Higher restricted diet based on food preferences patient should engage in a high-intensity (at
protein diets include approximately 25% of and health status (including comorbidities) least 14 sessions in six months) compre-
total daily calories from protein. An example so that they can adhere to the diet.10 hensive weight loss intervention program
is the Zone diet, which recommends 30% Increased physical activity is another overseen by a trained interventionist; this
of daily calories to come from protein, 40% important component of weight loss, as it program should include a reduced calorie
from carbohydrate, and 30% from fat.10 increases energy expenditure and has been diet, increased aerobic physical activity for
Balanced dietary plans are those such as shown to help in weight maintenance. Physi- at least 150 minutes per week, and behav-
Weight Watchers; these plans include a cal activity as monotherapy has demonstrat- ior therapy that enforces self-monitoring of
fairly equal distribution of calories from car- ed modest weight loss, but when combined caloric intake, physical activity, and weight.10
bohydrates, fat, and protein. with reduced calorie intake and behavioral
A randomized clinical trial that com- modifcations, physical activity may enhance pharmacologic therapy
pared the weight loss effcacy of four types weight loss.16 The current recommendation In the overall weight management treat-
of diets, including Atkins, Ornish, Weight is that adults should perform at least 30 ment plan, pharmacologic therapy is
Watchers, and Zone diets, demonstrated minutes of moderate-intensity exercise (for intended to serve only as an adjunct to
that all four resulted in modest statistically example, brisk walking, bicycling, or yoga) comprehensive lifestyle interventions. A
signifcant weight loss at one year, with no on most (fve or more) days of the week. healthy diet and adequate physical activity
statistically signifcant difference in weight The 2013 AHA/ACC/TOS obesity guideline continue to be the cornerstones of weight
loss among the diets (P=0.40).15 The mean recommends that adults should exercise for management. Therefore, patients should
weight loss at one year was 2.1 kg in the 200 to 300 minutes per week to achieve not relinquish their lifestyle modifcations
Atkins group (P=0.009), 3.2 kg in the Zone long-term weight loss maintenance for more after drug therapy has been initiated.
group (P=0.002), 3 kg in the Weight Watch- than one year.10 Patients should obtain med- Pharmacotherapy may be considered as
ers group (P<0.001), and 3.3 kg in the Or- ical clearance before beginning any exercise an option to reinforce lifestyle modifca-
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tions by helping patients better adhere plethora of nonprescription and herbal prod- reduced-calorie diet and increased physi-
to a lower-calorie diet to achieve weight ucts marketed for obesity, only medications cal activity.
loss goals and improved health outcomes. that are approved by the food and drug Ad- The choice of medication is dependent
Pharmacotherapy for weight loss can be ministration (fdA) for weight management on the side effect profle and potential for
considered in obese patients with a BMI should be recommended. drug-drug interactions (Table 2). In addition
of 30 kg/m2 or more and in overweight The major currently available fdA- to the aforementioned guidelines for the
patients with a BMI of 27 kg/m2 or more approved medications for weight manage- initiation of pharmacologic therapy as an
with at least one obesity-related comorbid ment (orlistat, lorcaserin, phentermine, adjunct to lifestyle interventions, the patient
condition such as diabetes, hypertension, phentermine/topiramate Er, naltrexone/ should also be motivated to lose weight.
or dyslipidemia (Table 1).10,13 Even though buproprion Er) carry the same indication: If, after initiation of pharmacotherapy, the
there are several prescription medications patient selection based on the above patient does not achieve at least 5% weight
with weight reduction potential, as well as a BMI criteria and only as an adjunct to a Continued on page 61
TABLE 2
fda-aPProVed medicationS for WeiGht manaGement
in oVerWeiGht and obeSe adultS
Generic name/ Availability Contraindications Adverse effects Major drug-drug Comments
Drug class interactions
Indicated for short-term use (≤12 wk)
Phentermine/ Rx (C-IV) During or within Pulmonary hypertension, valvular MAOIs, tricyclic Avoid taking doses close to
Sympatho- 14 days of taking heart disease, increased BP, antidepressants, bedtime to prevent insomnia.
mimetic agent MAOIs, history of CVD tachycardia, GI disturbances, antihypertensive
Diethylpropion/ Rx (C-IV) including uncontrolled xerostomia, CNS stimulation, and other CVD
hypertension, psychiatric disturbances, drugs, CNS-acting If tolerance to the anorectic
Sympatho- effect occurs, drug should be
mimetic agent hyperthyroidism, insomnia, increased convulsive drugs, other
glaucoma, agitated episodes in epileptic patients anorectic agents discontinued.
Phendimetrazine Rx (C-III) states, history of drug (diethylpropion), risk of abuse
Sympatho- abuse, hypersensitivity and dependence
mimetic agent to sympathomimetic
Benzphetamine/ Rx (C-III) amines, pregnancy,
Sympatho- nursing, pulmonary
mimetic agent hypertension
Indicated for long-term use (however, very limited data are available for use > 1 year)
Orlistat/GI lipase Prescription, Pregnancy, chronic GI symptoms (loose oily stools, Cyclosporine, Administered three times daily
inhibitor 120 mg malabsorption fecal urgency or incontinence, levothyroxine, with fat-containing meals
Over-the- syndrome, cholestasis, fatulence, abdominal cramping), warfarin, (during or up to one hour after
counter, 60 mg hypersensitivity to reduced absorption of fat-soluble antiepileptic drugs, meals).
orlistat vitamins and beta carotene, oral contraceptives Limit fat intake to ≤30% per
increases in urinary oxalate, day distributed over three main
cholelithiasis, pancreatitis, liver meals to avoid GI adverse
injury (rare) effects.
Bedtime administration of
multivitamin that replaces
normal dietary intake of
fat-soluble vitamins is
recommended.
Lorcaserin/ Rx (C-IV) Pregnancy, nursing Headache, dizziness, fatigue, Serotonergic Discontinue if 5% weight loss is
5-HT2C receptor nausea, dry mouth, constipation, drugs (increased not achieved by week 12.
agonist impaired cognitive function, risk of serotonin Avoid in patients with severe
hypoglycemia in diabetic patients, syndrome), CYP renal impairment. Use with
serotonin syndrome, decreased 2D6 substrates, caution in patients with severe
heart rate, valvular heart disease, MAOIs hepatic impairment.
psychiatric disturbance, suicidal
behavior and ideation, decreased
white and red blood cell count,
priapism, prolactinemia
Continued on page 61
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loss of initial body weight after 12 weeks sis a mean weight loss 3.6 kg greater than and abuse potential of these medications
on the maximum dose, the provider may the weight loss seen with placebo when cannot be ruled out; for these reasons,
consider discontinuing the medication.10 patients were treated with 15 to 30 mg of these agents must be limited to treatment
phentermine daily.18 duration of 12 weeks or less.18
Sympathomimetic agents Some concerns with the sympathomi-
four sympathomimetic agents are approved metic agents are elevations in heart rate Orlistat
for the short-term (≤12 weeks) manage- and blood pressure and the potential for Orlistat is a gastrointestinal lipase inhibitor
ment of obesity: phentermine, diethylpropi- addiction.18,19 The use of sympathomimetic that inhibits gastric and pancreatic lipases
on, phendimetrazine, and benzphetamine.18 agents is also limited by contraindications that break down dietary triglycerides into
These drugs work to suppress appetite by in patients with CVd and moderate to se- absorbable free fatty acids, thereby de-
increasing the activity of norepinephrine vere hypertension, which are common dis- creasing systemic fat absorption.2,24 Orlistat
and dopamine in the satiety center of the ease states in obese patients.20-23 Because is available in the united States as both
hypothalamus.3,18 Phentermine, which is of a lack of studies lasting six months or prescription (120-mg capsules) and over-
the most widely prescribed medication for longer, the long-term effcacy and safety the-counter (60-mg capsules) formulations.
the management of obesity in the united of the sympathomimetic agents are un- In randomized, placebo-controlled tri-
States, has demonstrated in a meta-analy- known.18 Therefore, the cardiovascular risk Continued on page 62
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the end of one year with lorcaserin treat- kg with lorcaserin twice daily, 4.7 kg with lor- were not statistically signifcant.
ment (47.5%) than with placebo (20.3%; caserin once daily, and 2.9 kg with placebo. Although lorcaserin has been shown to
P<0.001). Similarly, more participants lost An increase in high-density lipoprotein (HdL) be an effective weight loss agent as com-
10% or more of their baseline body weight cholesterol level and a decrease in triglycer- pared to placebo, it is important to note
with lorcaserin (22.6%) than with placebo ide level were also observed with both lorca- that less than 50% of patients in the lorca-
(7.7%; P<0.001). Average weight loss at serin groups versus placebo, although these serin groups in these studies were able to
one year was 5.8 kg in the lorcaserin group differences were not statistically signifcant. achieve a 5% weight loss and less than 25%
and 2.2 kg in the placebo group (P<0.001). The Behavioral Modifcation and Lorca- were able to achieve a 10% weight loss. Ad-
More participants (67.9%) who continued serin for Obesity and Overweight Manage- ditionally, there was a high dropout rate in
to receive lorcaserin in the second year of ment in diabetes Mellitus (BLOOM-dM) the lorcaserin groups in all of these studies,
the study maintained their weight loss as study evaluated the effcacy of lorcaserin for ranging from approximately 21% to 45%.29-31
compared to those who were switched to weight loss in participants aged 18 to 65 Lorcaserin’s selective activation of
placebo (50.3%; P<0.001). In addition, fast- years with a BMI of 27 to 45 kg/m2 and type 5-HT2C receptors over other 5-HT receptor
ing glucose, hemoglobin A1C levels, total 2 diabetes.31 Patients were randomized to subtypes diminishes the risk of adverse ef-
cholesterol, LdL cholesterol, and triglyceride receive either lorcaserin 10 mg twice daily, fects such as psychiatric changes due to
levels were statistically signifcantly lower at lorcaserin 10 mg once daily, or placebo, 5-HT2A activation and valvulopathy due to
one year in participants who received lorca- along with lifestyle modifcation interven- 5-HT2B activation.2,3 Although the three
serin than in those who received placebo, tions. The proportion of participants who major effcacy trials did not show a statisti-
although these levels had increased in both achieved at least 5% weight loss after the cally greater incidence of valvulopathy with
groups after two years. frst year was signifcantly greater in the lor- lorcaserin than with placebo, the numerical
The Behavioral Modifcation and Lorca- caserin groups (37.5% for twice-daily dosing prevalence of valvulopathy was still some-
serin Second Study for Obesity Manage- and 44.7% for once-daily dosing) than in the what greater.18,29-31 Therefore, the fdA has
ment (BLOSSOM) evaluated the effects of placebo group (16.1%; P<0.001). Similarly, requested that the manufacturer conduct a
lorcaserin on body weight and cardiovascu- a signifcantly greater proportion of partici- postmarketing trial to evaluate the long-term
lar risk factors in participants aged 18 to 65 pants in the lorcaserin groups achieved at cardiovascular effects of lorcaserin.3,18
years with a BMI of 30 to 45 kg/m2 or 27 least 10% weight loss (16.3% for twice-daily Lorcaserin moderately inhibits CYP2d6-
to 29.9 kg/m2 with certain comorbid con- dosing and 18.1% for once-daily dosing) mediated metabolism; therefore, con-
ditions.30 Participants were randomized to as compared to the placebo group (4.4%; comitant administration of this agent with
receive either 10 mg lorcaserin twice daily, P<0.001). In patients who completed the CYP2d6 substrates should be avoided.28
10 mg lorcaserin once daily, or placebo for study, average weight loss was 5.6 kg with Because of lorcaserin’s serotonergic activ-
52 weeks, along with lifestyle modifcation lorcaserin twice daily, 5.9 kg with lorcaserin ity, this medication should also be avoided
interventions. Signifcantly more participants once daily, and 1.9 kg with placebo. Ad- in combination with other serotonergic or
in the lorcaserin groups had lost at least ditionally, mean hemoglobin A1C, fasting antidopaminergic drugs because of an in-
5% of body weight at one year (47.2% for plasma glucose levels, and heart rate de- creased risk of serotonin syndrome and neu-
twice-daily dosing and 40.2% for once-daily creased signifcantly more in the lorcaserin roleptic malignant syndrome-like reactions.28
dosing) as compared to the placebo group groups than in the placebo group (P<0.001; The patient’s response to lorcaserin
(25%; P<0.001). Similarly, signifcantly more P<0.001; P=0.03 for twice-daily lorcaserin; should be assessed at 12 weeks of therapy.
participants in the lorcaserin groups had and P<0.001; P<0.001; P=0.01 for daily lor- If a patient has not lost at least 5% of his/her
lost at least 10% of body weight (22.6% for caserin, respectively). Although there were baseline weight by week 12, the drug should
twice-daily dosing and 17.4% for once-daily also decreases in cholesterol and triglycer- be discontinued, as it is unlikely that the pa-
dosing) as compared to the placebo group ide levels and blood pressure with lorcaserin tient will achieve and sustain clinically mean-
(9.7%; P<0.001). Mean weight loss was 5.8 groups versus placebo, these differences ingful weight loss with continued treatment.28
Phentermine/topiramate ER
pause&ponder Phentermine/topiramate extended-release
(Er) is one of two fdA-approved combina-
an obese patient comes to your community tion products for the management of over-
pharmacy expressing frustration in her attempts to weight and obesity. Phentermine is a sym-
lose weight with diet and exercise. She requests some pathomimetic amine anorectic; topiramate
information about medications for weight loss, as is an antiepileptic drug whose exact mecha-
she would like to stop lifestyle modifcation therapy. nism of action for weight loss is unknown.
What would you say to this patient to educate
The weight loss effect of topiramate may
her on effective strategies for weight loss and to
be the result of appetite suppression and
determine whether she is an appropriate candidate
for medication therapy? increased satiety caused by increased ac-
tivity of gamma aminobutyrate, modulation
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Continuing Education MtM eSSentiaLS FoR WeigHt ManageMent
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continuing education
TABLE 3
baseline body weight, the medication should reproductive potential must have a negative drug combination.2,3,18 In addition, phen-
be discontinued, as it is unlikely that the pa- pregnancy test before phentermine/topira- termine/topiramate Er is associated with
tient will achieve and sustain clinically mean- mate Er is initiated and monthly thereafter. various other potential adverse effects, such
ingful weight loss with continued treatment. Women should also be counseled to use ef- as dizziness, constipation, paresthesia,
discontinuation of phentermine/topiramate fective contraception while taking the medi- glaucoma, mood disorders, and insomnia.32
Er 15/92 mg should be done gradually to cation. If the patient does become pregnant
avoid the possible risk of causing a seizure. during therapy, the medication should be Naltrexone/bupropion ER
This should be achieved by taking a dose discontinued immediately.32 naltrexone/bupropion Er is a combina-
every other day for at least one week before Clinical trials of phentermine/topiramate tion medication that was approved by the
discontinuing the medication.32 Er demonstrated a small increase in resting fdA in September 2014 for chronic weight
Women of reproductive potential who heart rate.18,33-35 In the COnQuEr trial, more management as an adjunct to a reduced-
are treated with phentermine/topiramate patients in the phentermine/topiramate calorie diet and physical activity.36 naltrex-
Er must be educated on the teratogenic Er groups had increases in heart rate of one is an opioid receptor antagonist that
risk of the medication. Topiramate causes more than 10 beats per minute at two con- has been shown to reduce the subjective
an increased risk of fetal oral clefts with ex- secutive visits than patients in the placebo euphoric effects of alcohol and opiates, and
posure in the frst trimester of pregnancy.32 group.34 Because of concern regarding the therefore is thought to assist in weight loss
Because of this risk, phentermine/topira- drug’s long-term effect on cardiovascular attempts by reducing the subjective reward
mate Er is only to be dispensed by certi- risk, the fdA has required the manufacturer of food intake.37 Bupropion is an antidepres-
fed pharmacies under the risk Evaluation to conduct a postmarketing trial to evaluate sant that is a nonselective inhibitor of the
and Mitigation Strategy (rEMS).32 Women of the long-term cardiovascular safety of this dopamine and norepinephrine transporters,
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Continuing Education MTM ESSENTIALS FOR WEIGHT MANAGEMENT
and its use has been reported to result in to 24% to 60.4% with placebo; 26.3% to tial to cause seizures. To avoid the risk of
weight loss.37 55.2% achieved at least 10% weight loss seizures in other patients, the dose of nal-
Four randomized, placebo-controlled tri- with naltrexone/bupropion ER as compared trexone/bupropion ER should be gradually
als demonstrated the weight loss effcacy of to 8% to 30.2% with placebo. Overall, the escalated over four weeks, the bupropion
naltrexone/bupropion ER—Contrave Obesity study results demonstrated that patients component should not exceed a dose of
Research I Study (COR-I), Contrave Obesity who completed one year of therapy with na- 360 mg daily, doses should be divided into
Research II Study (COR-II), Contrave Obe- ltrexone/bupropion ER achieved a greater a twice-daily regimen, and the medication
sity Research Behavior Modifcation Study average weight loss than those treated with should not be administered with high-fat
(COR-BMOD), and Contrave Obesity Re- placebo—5.9% to 11.5% with naltrexone/ meals.42 Naltrexone/bupropion ER should
search Diabetes Study (COR-Diabetes).38-41 bupropion ER 32 mg/360 mg versus 1.4% not be used in patients with uncontrolled
In all of these studies, signifcantly more to 7.3% with placebo. hypertension, as bupropion can cause in-
patients achieved at least 5% or 10% Because of the bupropion component, creases in blood pressure and heart rate.42
weight loss with naltrexone/bupropion ER naltrexone/bupropion ER has a black box The FDA is requiring that the manufacturer
than with placebo (P<0.001 in all studies, warning regarding an increased risk of sui- conduct a postmarketing cardiovascular
except P<0.0001 in COR-I). In patients who cidal thoughts and behaviors associated outcomes trials to assess the cardiovascu-
completed one year of treatment, 53.1% with the medication. Naltrexone/bupropion lar risk associated with using naltrexone/
to 80.4% achieved at least 5% weight loss ER is contraindicated in patients with sei- bupropion ER. Because of the naltrexone
with naltrexone/bupropion ER as compared zure disorders, as bupropion has the poten- component, the medication should not be
TEST QUESTIONS
1. Which of the following is (are) comorbidities lose weight and has been following a strict regarding waist circumference except:
associated with obesity? diet and exercise plan for several months with a. The greater the waist circumference, the
a. Sleep apnea favorable results greater the risk of CVD, type 2 diabetes
b. Type 1 diabetes mellitus, and all-cause mortality
c. Gallbladder disease 4. Which of the following are “inappropriate” b. The cut points used to identify patients
d. A and C counseling points for an overweight or obese who may be at increased risk for comorbid
patient? conditions are as follows: women >102 cm
2. Which of the following is a reasonable weight a. Educate about the importance of maintaining (>40 in); men >88 cm (>35 in)
loss goal for an overweight/obese patient? achieved weight loss through reduced caloric c. The patient’s waist circumference should be
a. 10% of baseline body weight in three months intake, increased physical activity, and measured at least annually in overweight and
b. 5% to 10% of baseline body weight in six behavior therapy obese adults
months b. Advise the patient to start a high-intensity d. Waist circumference is the most practical
c. 10% to 15% of baseline body weight in six physical activity program before assessing for measurement in daily clinical practice for
months individual readiness and obtaining medical assessing abdominal fat content before and
d. 20% of baseline body weight in six months clearance during weight loss treatment
c. Educate about the many potential health
3. It is appropriate to consider pharmacotherapy risks associated with an increased BMI 7. What are the components of a comprehensive
as part of a weight management program for d. Recommend that the patient should continue weight reduction therapeutic strategy
which of the following patients? a comprehensive weight loss maintenance according to the AHA/ACC/TOS guideline?
a. A 30-year-old overweight man (BMI, 28.9 program to reduce weight regain a. Aerobic physical activity for ≤150 minutes
kg/m2) with no comorbid conditions who is per week and regular self-monitoring of food
motivated to lose weight and just started a 5. All of the following statements are true intake, physical activity, and weight
new diet and exercise regimen regarding bariatric surgery except: b. Aerobic physical activity for ≥150 minutes
b. A 62-year-old obese woman (BMI, 42.5 kg/m2) a. There is insuffcient evidence to recommend per week and regular self-monitoring of food
with type 2 diabetes, hypertension, and for or against bariatric surgery for individuals intake, physical activity, and weight
hyperlipidemia who expresses frustration with a BMI <35 kg/m2 c. Aerobic physical activity for 120 minutes
with her weight and has been nonadherent b. Adjustable gastric banding and Roux-en-Y per week and regular self-monitoring of food
to her medications and current exercise and gastric bypass are examples of bariatric intake, physical activity, and weight
diet plan surgical procedures d. Aerobic physical activity for ≥300 minutes per
c. A 45-year-old obese woman (BMI, 32.2 kg/m2) c. All patients with a BMI ≥30 kg/m2 are week only
with type 2 diabetes who has been adherent appropriate candidates for bariatric surgery
to a diet and exercise regimen for more than d. One criteria for eligibility for bariatric surgery 8. BMI most likely overestimates body fat in
six months but has failed to achieve the failure to achieve suffcient weight loss even individuals who are:
weight loss goals set by her provider despite with adherence to lifestyle modifcation a. Very muscular b. Elderly
her motivation to lose weight strategies c. Underweight d. Morbidly obese
d. A 25-year-old overweight man (BMI, 26.1 kg/
m2) with hypertension who is motivated to 6. All of the following statements are true
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continuing education
taken by patients who are using opioids, un- despite the benefts from weight loss with choice of medication should be based on a
dergoing treatment for opioid dependence, phentermine/topiramate Er, this drug is patient’s comorbidities, risk of adverse drug
or experiencing acute opiate withdrawal.36 associated with many adverse effects and events, and potential drug-drug interactions
response to naltrexone/bupropion Er requires special dispensing because of its (Table 2).20-24,28,32,42
should be assessed after 12 weeks on the teratogenic risk. Similarly both lorcaserin
maintenance dose. If the patient has not and naltrexone/bupropion Er have the po- criteria for bariatric
achieved at least 5% weight loss by this tential for a variety of adverse reactions and surgery
time, the medication should be discontin- drug-drug and drug-disease interactions. Even though comprehensive lifestyle inter-
ued, as it is unlikely that clinically meaning- Because of the lack of systemic absorp- ventions are the foundation of weight loss
ful weight loss will be achieved with contin- tion with orlistat, the common adverse ef- management, some patients who are con-
ued treatment.42 fects are mainly gastrointestinal symptoms. sidered obese with high medical risks and
These adverse effects are bothersome to who are unable to achieve suffcient weight
Summary of pharmacologic agents many patients but can be controlled with loss goals may be appropriate candidates
The fdA-approved medications for weight dietary fat restrictions. Although orlistat is for bariatric surgery. The criteria for bariatric
loss have each demonstrated modest available as a nonprescription formulation, surgery include extreme obesity (BMI ≥40
weight loss potential when used as an ad- which increases availability to patients, the kg/m2) or obesity (BMI ≥35 kg/m2) in con-
junct to diet and exercise, with the great- dose is half that of the prescription formula- junction with obesity-related comorbid condi-
est amount of weight loss demonstrated tion and has lower weight loss effcacy when tions such as diabetes.10 furthermore, pa-
in phentermine/topiramate Er studies. compared with the prescription dose. The tients should be motivated to lose weight
9. Which of the following treatment option(s) 14. When can pharmacotherapy options be c. Diethylpropion
will be most effective in a 30-year-old person considered in patients who are trying to lose d. Orlistat
with a BMI of 30 kg/m2? weight as an adjunct to lifestyle modifcation
a. Reduced caloric intake therapy? 17. What action should be taken if a patient has
b. Increased physical activity and behavior a. When BMI is ≥30 kg/m2 not lost at least 5% of baseline body weight
therapy b. When BMI is ≥25 kg/m2 with at least one after 12 weeks of treatment with lorcaserin?
c. Increased physical activity and reduced obesity-related comorbid condition a. Discontinue lorcaserin
caloric intake c. When BMI is ≥27 kg/m2 with at least one b. Increase dose of lorcaserin and evaluate
d. Reduced caloric intake, increased physical obesity-related comorbid condition weight loss again after an additional 12
activity, and behavior therapy d. Both a and c weeks of therapy
c. Counsel patient on diet and exercise
10. What is the prevalence of overweight and 15. Phentermine/topiramate ER is only dispensed d. Both b and c
obesity in U.S. adults? by certifed pharmacies under a REMS
a. One out of three b. Two out of three program. What is the risk involved with 18. Which of the following medications is
c. Two out of four d. Three out of four phentermine/topiramate ER treatment approved for long-term treatment of obesity?
that requires this restricted access to the a. Orlistat b. Phentermine
11. Which of the following diets is an example of medication? c. Diethylpropion d. Both a and b
a low-fat diet? a. It may decrease absorption of fat-soluble
a. South Beach diet b. The Zone diet vitamins, therefore causing nutritional 19. Orlistat may reduce the absorption of
c. The Ornish diet d. All of the above defciency in patients who are on a calorie- fat-soluble vitamins and beta carotene;
restricted diet therefore, what medication considerations
12. How much exercise is recommended by the b. The topiramate component of the medication should be observed while a patient is taking
AHA/ACC/TOS obesity guideline to achieve causes an increased risk of fetal oral orlistat?
long-term weight loss maintenance for more clefts with exposure in the frst trimester of a. Take a multivitamin at bedtime
than one year? pregnancy b. Avoid in combination with serotonergic drugs
a. 30 minutes of exercise at least fve days per c. The phentermine component of the c. Monitor INR closely in patients taking
week or more medication is associated with an increased concomitant warfarin
b. 200 to 300 minutes of exercise per week risk of valvulopathy d. Both a and c
c. 30 minutes of exercise on three days per week d. The medication can cause seizures upon
d. 150 minutes of exercise per week sudden discontinuation 20. Which of the following are potential adverse
effects associated with naltrexone/
13. Which of the following are components of 16. Which medication for weight loss has been bupropion ER?
behavior modifcation therapy? shown in a four-year study to reduce the a. Suicidal ideation
a. Stimulus control incidence of progression to type 2 diabetes b. Seizures
b. Behavioral contracting as compared to placebo? c. Increased blood pressure and heart rate
c. Setting realistic goals a. Phentermine/topiramate ER d. All of the above
d. All of the above b. Lorcaserin
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Continuing Education MtM eSSentiaLS FoR WeigHt ManageMent
and have a history of being unable to body weight, many patients will require a adjunct to lifestyle interventions, which are
achieve suffcient weight loss even with ad- reduction in the dose or number of their still the mainstays of weight loss treatment.
herence with lifestyle modifcations with or prescribed medications after surgery. Ad- Patients eligible for bariatric surgery should
without pharmacotherapy. The current AHA/ ditionally, because of changes in the gastro- be counseled on the various surgical pro-
ACC/TOS obesity guideline does not recom- intestinal tract with the various techniques cedure options and the short-term risks, as
mend bariatric surgery for individuals with a of surgical manipulation, most patients will well as the long-term side effects and po-
BMI <35 kg/m2 (Table 1). Patients undergo- require supplementation with vitamins and tential need for alterations of currently pre-
ing bariatric surgery need to be aware of minerals after surgery, and the absorption scribed medications. All patients undergo-
the immediate surgical risks as well as the of medications for comorbid conditions may ing a weight loss treatment plan who take
need for long-term postoperative follow-up also be affected. medications for diabetes and hypertension
and dietary changes. Strict eligibility crite- should be advised to closely monitor for hy-
ria are often in place for these procedures, patient education on poglycemia and hypotension as weight loss
including demonstrated ability to adhere to weight management can lead to a decrease in blood glucose
comprehensive lifestyle modifcation plan for overweight and obese patients and and blood pressure.
and medications, medical clearance, and those with an elevated waist circumfer-
a psychological evaluation. ence, healthcare professionals should conclusion
The available bariatric surgical pro- provide education on the increased risks Weight loss and weight management in-
cedures include laparoscopic adjustable of CVd, type 2 diabetes, other comorbidi- volve various methods, including reduced
gastric banding (LAgB), laparoscopic roux- ties, and all-cause mortality associated caloric intake, increased physical activity,
en-Y gastric bypass (rYgB), open rYBg, with increased BMI. In general, overweight behavioral therapy, fdA-approved medi-
biliopancreatic diversion (BPd) with and and obese adults should be counseled on cations, and bariatric surgery. The deci-
without duodenal switch, and sleeve gas- the benefits that sustained weight loss sion regarding which treatments to use
trectomy. Although the current guidelines (eg, even a 3%-5% sustained reduction in should be based on patient-specifc fac-
do not recommend one particular bariatric initial baseline body weight) can achieve. tors, such as BMI, comorbidities, dietary
surgical procedure over another, the choice In particular, the benefts of reductions in preferences, and potential for drug inter-
actions. Although there are various weight
Even lifestyle modifcations that produce loss options available for overweight and
obese patients, lifestyle modifcations with
a sustained weight loss of just 3% to 5% reduced caloric intake, increased physical
activity, and behavioral therapy, must be
can result in health benefts. the foundation of any weight loss plan.
Pharmacists can play an important role in
of a specifc procedure should be based triglyceride, blood glucose, and hemoglo- the management of overweight and obese
on various patient factors such as age, se- bin A1C levels and the reduced risk of the patients in their weight loss attempts by
verity of obesity, comorbid conditions, and development of type 2 diabetes should be providing education on health complica-
complication risks for each individual. emphasized to patients. tions of excess body weight, assisting
Bariatric surgery is currently the most All overweight and obese adult patients in the selection of the most appropriate
effective treatment for patients with morbid should be encouraged to participate in a lifestyle modifcation strategies and medi-
obesity. Bariatric surgery is associated with comprehensive lifestyle program that in- cations, educating the patient about the
a reduced incidence of type 2 diabetes and cludes a reduced-calorie diet, increased potential adverse effects and drug interac-
an increased likelihood of disease remis- physical activity, and behavioral strategies tions of weight loss drugs, and providing
sion.10,43 There has also been evidence of for at least 6 months. Patients who have support and motivation to help patients
reductions in blood pressure and the use lost weight should be further encouraged to reach their weight loss goals. •
of blood pressure medications, as well as participate in a long-term (at least one year) References are available online at www.
favorable changes in cholesterol levels and lifestyle maintenance program. drugtopics.com/cpe.
other obesity-related comorbid conditions. After a patient begins taking a medica-
For immediate cpE credit,
Evidence has also demonstrated that total tion for weight loss, pharmacists should
take the test now online at
mortality is decreased with bariatric surgery educate him or her on the medication’s
compared with nonsurgical management.10 side effects, lack of adequate long-term
The mean weight reduction at 2 to effcacy and safety data, and effcacy of
3 years post-surgery is 20% to 35% of medications for weight loss as compared
baseline body weight.10 Because bariatric to lifestyle modifcations. In addition, pa- www.drugtopics.com/cpe
surgery can lead to biochemical changes tients should be informed that pharma- once there, click on the link below
Free cpE Activities
and a substantial reduction in baseline cologic therapy is intended to be only an
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Product Updates WHAT’S NEW
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WHAT’S NEW Product Updates
New Products 6
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Final Word
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It takes a compassionate heart and an analytical mind to get new
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NOW AVAILABLE!
Two Points
of Reference.
Mylan.com
*Trademark of Google Inc.
†
Registered trademark of Apple, Inc.
‡
Registered trademark of Research in Motion (RIM).
Copyright 2014 Mylan Inc.
NON-2014-0329 MYNMKT544 10/14
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black ES528279_DRTP1114_CV4_FP.pgs 11.06.2014 00:09 ADV