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A Continuing Education Activity
The Pharmacist’s Role in
Obesity Management:
A Long-term Commitment to
Improving Overall Health
Revised
edition
Jointly sponsored by Postgraduate Institute for Medicine and CME Incite
A CPE activity approved for
2.0 hours (0.20 CEUs).
Release date: October 20, 2013
Expiration date: October 20, 2015
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This activity is sponsored by an
educational grant from Vivus, Inc.
A CME activity approved for 2.00
AMA PRA Category 1 Credit(s)™.
Release date: October 20, 2013
Expiration date: October 20, 2015
This activity is sponsored by an educational grant from Vivus, Inc.
Target Audience
This continuing pharmacy education (CPE)-certified activity has been designed to
meet the educational needs of pharmacists and clinicians who manage overweight
or obese patients.
Statement of Need/Program Overview
The community pharmacist is an essential resource for overweight and obese
patients who are attempting to manage their weight. Among all health professionals,
pharmacists are perhaps most often asked about weight-loss agents, as they dispense
prescription and nonprescription therapies for weight management. In addition,
pharmacists may monitor patients’ medication profiles to detect prescription agents
that may cause weight gain, and they can provide information about proper
weight-loss programs. Pharmacists are also in a position to encourage patients to
utilize long-term weight-management goals rather than “quick-fix” over-the-counter
(OTC) products. They should stress to patients that even moderate weight loss (5%
to 10% of body weight) is extremely beneficial—especially for patients with comorbid
conditions, as well as the fact that losing weight requires a long-term commitment.
Now that clinicians and patients have 2 newly approved pharmacologic treatment
options for weight management, there is a greater-than-ever need for pharmacistspecific education. Clinical information on the safety, efficacy, and mechanism of
action (MOA) of these 2 agents is necessary for pharmacists to process, understand,
and deliver accurate counseling to patients, especially during the time when
patients drop off and pick up prescriptions.
Educational Objectives
After completing this activity, the participant should be better able to:
• Recognize the benefits of treating overweight and obese patients including the
positive impact weight loss has on comorbid conditions
• Compare the efficacy, MOA, and benefits versus risks of phentermine/
topiramate ER and lorcaserin
• Counsel patients on adverse events they may experience while using
pharmacotherapy as an adjunct to their obesity management
• Assess patients’ medications to reduce unhealthy weight gain and decrease the
incidence of obesity and associated comorbidities
• Emphasize the importance of long-term weight-management goals with their
patients
• Provide accurate and appropriate counsel as part of the treatment team
Faculty
Robert Kushner, MD
Professor of Medicine
Northwestern University Feinberg School of Medicine
Chicago, Illinois
Credit Designation
Postgraduate Institute for Medicine designates this continuing education activity for
1.0 contact hour(s) (0.1 CEUs) of the Accreditation Council for Pharmacy Education.
(Universal Activity Number 0809-9999-13-314-H01-P)
Type of Activity
Knowledge
Disclosure of Conflicts of Interest
Postgraduate Institute for Medicine (PIM) requires instructors, planners, managers
and other individuals who are in a position to control the content of this activity to
disclose any real or apparent conflict of interest (COI) they may have as related to
the content of this activity. All identified COI are thoroughly vetted and resolved
according to PIM policy. PIM is committed to providing its learners with high
quality CME activities and related materials that promote improvements or quality
in healthcare and not a specific proprietary business interest of a commercial interest.
The faculty reported the following financial relationships or relationships to
products or devices they or their spouse/life partner have with commercial
interests related to the content of this CME activity:
Name of Faculty or Presenter
Reported Financial Relationship
Robert Kushner, MD
Consulting Fees: Novo Nordisk, Retrofit, VIVUS, Zafgen
Contracted Research: Aspire Bariatrics, Weight Watchers
Jennifer Costello, PharmD, BCPS, BC-ADM
Dr Costello has nothing to disclose.
The planners and managers reported the following financial relationships or
relationships to products or devices they or their spouse/life partner have with
commercial interests related to the content of this CME activity:
The following PIM planners and managers, Laura Excell, ND, NP, MS, MA, LPC,
NCC, Trace Hutchison, PharmD, Samantha Mattiucci, PharmD, CCMEP, and Jan
Schultz, RN, MSN, CCMEP, hereby state that they or their spouse/life partner do
not have any financial relationships or relationships to products or devices with
any commercial interest related to the content of this activity of any amount during
the past 12 months.
Priya Wanchoo, MBBS has nothing to disclose.
Method of Participation and Request for Credit
There are no fees for participating and receiving CME credit for this activity. During
the period October 20, 2013, through October 20, 2015, participants must read the
learning objectives and faculty disclosures and study the educational activity.
This will need to be included with PowerPak’s Method of Participation:
Jennifer Costello, PharmD, BCPS, BC-ADM
Ambulatory Care Clinical Pharmacist
Internal Medicine Faculty Practice
Saint Barnabas Medical Center
Livingston, New Jersey
For pharmacists, transcript information will be available at www.mycpemonitor.
net immediately.
Accreditation Statement
This activity has been planned and implemented in accordance with the Essential
Areas and policies of the Accreditation Council for Continuing Medical Education
through the joint sponsorship of Postgraduate Institute for Medicine and CME
Incite. The Postgraduate Institute for Medicine is accredited by the ACCME to
provide continuing medical education for physicians.
Disclosure of Unlabeled Use
This educational activity may contain discussion of published and/or investigational
uses of agents that are not indicated by the FDA. The planners of this activity do
not recommend the use of any agent outside of the labeled indications.
Media
Monograph
Credit Designation
The Postgraduate Institute for Medicine designates this enduring material for a
maximum of 2.0 AMA PRA Category 1 Credit(s)tm. Physicians should claim only the
credit commensurate with the extent of their participation in the activity.
Accreditation Statement
Postgraduate Institute for Medicine is accredited by the Accreditation
Council for Pharmacy Education as a provider of continuing pharmacy
education.
The opinions expressed in the educational activity are those of the faculty and do
not necessarily represent the views of the planners. Please refer to the official
prescribing information for each product for discussion of approved indications,
contraindications, and warnings.
Disclaimer
Participants have an implied responsibility to use the newly acquired information
to enhance patient outcomes and their own professional development. The
information presented in this activity is not meant to serve as a guideline for
patient management. Any procedures, medications, or other courses of diagnosis
or treatment discussed or suggested in this activity should not be used by clinicians
without evaluation of their patient’s conditions and possible contraindications and/
or dangers in use, review of any applicable manufacturer’s product information,
and comparison with recommendations of other authorities.
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Pharmacist Intervention: A Golden
Opportunity
At the end of this activity,
pharmacists and clinicians
should be better able to:
Among all health care professionals, pharmacists are perhaps most
often asked about weight-loss agents, as they dispense prescription
drugs and advise patients about taking nonprescription therapies
for weight management on a day-to-day basis. While prescription
drugs require rigorous clinical trial data to obtain FDA approval,
over-the-counter (OTC) products are often under-studied for
efficacy and patient safety. Pharmacists are in a unique position to
encourage patients to establish realistic weight loss goals and utilize
safe, long-term weight-management strategies.
• Recognize the benefits of treating overweight and
obese patients including the positive impact of weight
loss on comorbid conditions
• Assess patients’ medications to reduce unhealthy
weight gain and decrease the incidence of obesity
and associated comorbidities
• Emphasize the importance of long-term weightmanagement goals with their patients
• Compare the efficacy, mechanism of action, and
benefits versus risks of phentermine/topiramate
extended-release and lorcaserin
• Counsel patients on adverse events they may
experience while using pharmacotherapy as an
adjunct to their obesity management
Pharmacists should stress to patients that even moderate weight
loss (5% to 10% of body weight) is extremely beneficial—especially
for patients with comorbid conditions. Patients who have not been
successful in losing 5% to 10% body weight with lifestyle
modifications alone now have 2 newly approved pharmacologic
treatment options for weight management: lorcaserin and
phentermine/topiramate extended-release (PHEN/TPM ER).
These medications (reviewed below) are to be used as adjuncts to
lifestyle intervention and may be considered for patients with a
BMI of 27.0 to 29.9 kg/m2 with at least 1 weight-related comorbidity
or a BMI ≥30.0 kg/m2 with or without comorbidities.
Obesity: A Heavy Burden Across The
United States
Obesity is a complex, chronic condition that is defined by excess body
fat. Body-mass index (BMI), as calculated by kilograms of weight divided
by patient height in meters squared (ie, kg/m2), is an abbreviated
measure of total body fat that can easily be calculated in everyday
practice. A classification of “overweight” occurs in any individual whose
BMI is calculated to be between 25.0 and 29.9 kg/m2, whereas obesity is
defined by a calculated BMI of ≥30 kg/m2, with the severity of obesity
further divided into classes I through III. The rise in obesity class from I
to III (severe/extreme obesity) corresponds with increased morbidity
from obesity-related diseases along with an increased mortality risk.1,2
Obesity—particularly visceral adiposity—has been linked to development
of many other cardiovascular risk factors, such as hypertension, insulin
resistance/type 2 diabetes, and dyslipidemia.3 Excess weight also plays a
major role in sleep apnea, increased incidence of certain types of cancer,
osteoarthritis, and even mental health illnesses such as depression. The
American Medical Association (AMA) and the American
Association of Clinical Endocrinologists (AACE) recognize
obesity as a disease, and it is the responsibility of all health care
professionals, including pharmacists, to encourage and support
patients to achieve a healthy weight.
As of June 2013, the American
Medical Association recognized
obesity as a disease,
recommending a range of
medical interventions to
advance obesity treatment.
Summary of Key Responsibilities for Pharmacists
• Perform a review of current medications
•M
onitor patients’ medication profiles to detect prescription
agents that may cause weight gain (See Table 1.)
•P
roactively inform patients about possible adverse events to
ensure they are aware of potential side effects, allowing them to
make informed decisions about continuing therapy
•P
rovide information about evidence-based weight-loss programs
•A
nswer frequently asked questions regarding nonpharmacologic/
pharmacologic agents used to manage weight (eg, warnings/
contraindications, drug interactions, etc)
Table 1. Medications That May Cause
Weight Gain.4
Atypical Antipsychotics
Mirtazapine
Chlorpromazine
Paroxetine
Insulin/sulfonylureas
Prednisone (for long periods)
Lithium
Sodium valproate
Medroxyprogesterone
Tricyclic antidepressants
(such as amitriptyline,
imipramine, and doxepin)
The Pharmacist’s Role in Obesity Management:
A Long-term Commitment to Improving Overall Health
3
Recently Approved Treatments For
Obesity: Prescriptions For Change
Prior to the recent approvals of lorcaserin (June 2012) and PHEN/
TPM ER (July 2012), the only pharmacotherapeutic agent approved
for long-term use was orlistat (approved in 1999). Orlistat is
currently available by prescription or OTC. Phentermine has been
available for many years as a short-term (~12 weeks) adjunct to a
well-balanced weight-management regimen.5,6 (See Table 2.)
After more than 10 years without a new long-term treatment
option for weight management, patients now have PHEN/TPM ER
and lorcaserin to assist them with weight reduction and
maintenance. Both drugs need to be used as adjuncts to lifestyle
modification and are not intended for short-term, stand-alone
care.7-10 (See Table 3.)
Table 2. Previously Available Pharmacotherapies for Weight Management.5,6
Phentermine
37.5 mg Daily
Agent
MOA
Central
Noradrenergic
Orlistat
120 mg TID
60 mg TID (OTC)
Peripheral
Pancreatic lipase inhibitor
Approval
Short-term use
DEA Schedule IV
Chronic
Not scheduled
Also available OTC
Common
adverse effects
• Restlessness
• Insomnia
• Increase in pulse
• Increase in BP
•G
I symptoms including oily spotting, flatus with discharge, fecal
urgency, fatty/oily stool, and others less frequently
• I ncrease in urinary oxalate
Abbreviations: BP, blood pressure; GI, gastrointestinal; MOA, mechanism of action; OTC, over the counter; TID, three times daily
Table 3. Recently Approved Pharmacotherapies for Weight Management.7-10
Agent
Approval status
Phentermine/topiramate Extended-Release
(PHEN/TPM ER)
Lorcaserin
Approved July 2012
Approved June 2012
September 2012
June 2013
MOA
Phentermine stimulates norepinephrine release from hypothalamic neurons.
Topiramate is an anticonvulsant, and its MOA is thought to be mediated
through modulation of GABA receptors, inhibition of carbonic anhydrase,
and antagonism of glutamate.
Selectively targets the
5-HT2C receptor
Common adverse
events
• Dry Mouth
• Paraesthesia
• Constipation
• Dysgeusia
• Insomnia
• Dizziness
• Headache
•U
pper Respiratory
Infection
• Nasopharyngitis
• Dizziness
• Nausea
Contraindications
• Pregnancy (Category X)
• Glaucoma
• Hyperthyroidism
• During or within 14 days following MAOI therapy
• Pregnancy (Category X)
Availability
Abbreviations: GABA, gamma-aminobutyric acid; MAOI, monoamine oxidase inhibitor; MOA, mechanism of action
4
The Pharmacist’s Role in Obesity Management:
A Long-term Commitment to Improving Overall Health
With these approvals comes the responsibility of health care
professionals to identify and monitor patients who could most
benefit from a weight-management program that includes changes
in diet, exercise, and, potentially, a pharmacologic agent. PHEN/
TPM ER and lorcaserin are approved for patients with clinically
defined obesity (BMI of ≥30 kg/m2) or for patients with a BMI of
≥27 kg/m2 and at least 1 comorbidity including hypertension, high
cholesterol, or type 2 diabetes mellitus.9,10 In addition to potential
adverse events, pharmacists should be aware of the drug-drug and
drug-herb interactions with PHEN/TPM ER and lorcaserin. (See
Table 4.)
Pharmacists are in a unique
position to encourage patients
to establish realistic weight-loss
goals and utilize long-term
weight-management strategies.
Table 4. Potential Drug-Drug and Drug-Herb Interactions With Weight-Loss Agents.9,10
Phentermine/topiramate Extended-Release
(PHEN/TPM ER)
Lorcaserin
PHEN/TPM ER should not be used in combination with a
MAOI or in patients who have taken MAOIs within the prior
14 days.
Development of potentially life-threatening serotonin
syndrome or neuroleptic malignant syndrome-like reactions can
occur in patients taking the following drugs or supplements in
combination with lorcaserin:
• SNRIs • SSRIs
• TCAs
• Bupropion
• Triptans
• St. John’s Wort
• Tryptophan
• Dextromethorphan
• Lithium
• Tramadol
• Antipsychotics
• Other dopamine antagonists
Patients should be educated on the s/sx of serotonin syndrome
(such as agitation, hallucinations, coma, tachycardia, labile
blood pressure, hyperthermia, hyperreflexia, incoordination,
nausea, vomiting, diarrhea, and muscle rigidity, etc).
Treatment with lorcaserin and any concomitant serotonergic
or antidopaminergic agents, including antipsychotics, should
be discontinued immediately if s/sx develop, and patients
should be advised to seek symptomatic treatment.
Concomitant use of topiramate with any other carbonic
anhydrase inhibitor (eg, zonisamide, acetazolamide, or
dichlorphenamide) may increase the incidence or severity of
metabolic acidosis and may also increase the risk of kidney stone
formation. Patients who have a predisposing condition for
metabolic acidosis who are given PHEN/TPM ER concomitant
with another carbonic anhydrase inhibitor, should be monitored
for the appearance or worsening of metabolic acidosis.
Serotonergic and dopaminergic agents that are potent 5-HT2B
receptor agonists have been shown to increase the risk for
cardiac valvulopathy. Patients should be advised not to take
lorcaserin in combination with these agents (eg, cabergoline).
Non–potassium-sparing diuretics may potentiate the potassiumwasting action of these diuretics. Concomitant administration
of hydrochlorothiazide alone with topiramate alone has been
shown to increase the Cmax and AUC of topiramate by 27% and
29%, respectively. Patients should be monitored for
hypokalemia when PHEN/TPM ER is taken together with
non–potassium-sparing medicinal products.
Lorcaserin can increase the risk of priapism, and only limited
experience exists for its use in combination with medications
indicated for erectile dysfunction (eg, phosphodiesterase type 5
inhibitors). Patients should be advised to use caution when
taking these medications together.
Abbreviations: AUC, area under the curve; Cmax, maximum concentration; SNRI, serotonin-norepinephrine reuptake inhibitor; SSRI, selective serotonin reuptake
inhibitor; s/sx, signs and symptoms; TCA, tricyclic antidepressant
The Pharmacist’s Role in Obesity Management:
A Long-term Commitment to Improving Overall Health
5
Clinical Pearl: Staying On-Label
Phentermine is a sympathomimetic amine appetite suppressant,
which was a component of the 1990s “fen-phen” (fenfluraminephentermine) combination therapy. However, the valvulopathy
issues associated with this combination appetite suppressant, which
ultimately led to its discontinued use, were caused by off-target
effects on the 5-HT2B receptors in the heart from the fenfluramine/
dexfenfluramine component, not the phentermine component
(which has no serotonergic effects).11 Phentermine was and
continues to be indicated and used as a monotherapy for short-term
weight reduction. It should be noted that even the highest dose of
PHEN/TPM ER (15/92 mg) contains doses of phentermine that are
lower than previously approved for the individual 37.5-mg
formulation. Topiramate, a carbonic anhydrase inhibitor, increases
satiety (feeling of fullness). Topiramate immediate-release (IR) is a
FDA-approved drug in monotherapy formulations for epilepsy at
200 to 400 mg and migraine prevention at 100 mg daily. Topiramate
in the PHEN/TPM ER combination uses a lower dose than the
monotherapy option. The immediate-release phentermine
component in PHEN/TPM ER provides therapeutic effects to
reduce appetite early in the day and is combined with topiramate
ER that provides persistent therapeutic effects throughout the
whole day.12 Substituting PHEN/TPM ER with phentermine and
topiramate is not an equivalent therapy with regards to dosing or
drug release and it is not AB-rated for substitutions; furthermore,
the generic components are not approved by the FDA for the
chronic management of weight loss and weight maintenance. The
low-dose combination product also appears to be more effective
than either drug used as monotherapy for long-term weight loss.13
Pharmacists should explain this difference to patients if they ask for
the generic drugs, and they should not dispense anything other
than the FDA-approved on-label PHEN/TPM ER formulation for
weight management.
Table 5. C
omparing Weight-Loss Efficacy of PHEN/TPM ER and Lorcaserin
at 1 Year.7,8,15-17
Drug, Study, Treatment
Lorcaserin
Mean Change in
Body Weight (kg)
BLOOM8/BLOSSOM15 studies combined
10 mg BID
Placebo
BLOOM-DM study
Mean Change in
Body Weight (%)
Patients Losing ≥5% of
Body Weight (%)
-5.8
-5.8
47
-2.6
-2.5
23
-4.7
-4.5
38
-1.6
-1.5
16
-12.6
-10.9
67
-1.9
-1.6
17
-8.1
-7.8
62
-10.2
-9.8
70
-1.4
-1.2
21
16
10 mg BID
Placebo
PHEN/TPM ER
EQUIP17 study
15 mg/92 mg
Placebo
CONQUER study
7
7.5 mg/46 mg
15 mg/92 mg
Placebo
Abbreviation: BID, twice daily
6
The Pharmacist’s Role in Obesity Management:
A Long-term Commitment to Improving Overall Health
Efficacy
Substituting PHEN/TPM ER
with phentermine and topiramate
is not an equivalent therapy
with regards to dosing or drug
release; furthermore, the
generic components are not
AB-rated, and cannot be
legally substituted.
PHEN/TPM ER, the combination of the sympathomimetic amine
appetite suppressant phentermine, and the carbonic anhydrase
inhibitor topiramate, is available in various dosages: 3.75/23 mg,
7.5/46 mg, 11.25/69 mg, and 15/92 mg. When used in conjunction
with diet and exercise, PHEN/TPM ER 7.5/46 mg and 15/92 mg
produced an average weight loss of 8% to 11% of original body
weight in clinical trials.14 Lorcaserin is a first-in-class selective
5-HT2C receptor agonist that suppresses appetite to regulate food
intake. When used in conjunction with diet and exercise, lorcaserin
at 10-mg twice daily (BID) produced an average weight loss of 5%
to 6% of original body weight in clinical trials.14 (See Table 5.) Both
agents are now included in the recently published 2013 AACE
Comprehensive Diabetes Management Algorithm. (See Figure 1.)
Figure 1. 2013 AACE Obesity Treatment Algorithm.18
ST EP 1
E V A L U AT I O N F O R C O M P L I C AT I O N S A N D S TA G I N G
CARDIOMETABOLIC DISEASE
BIOMECHANICAL COMPLICATIONS
NO COMPLICATIONS
BMI ≥ 27 WITH COMPLICATIONS
BMI 25–26.9,
or BMI ≥ 27
Stage Severity of Complications
STEP 2
LOW
MD/RD counseling; web/remote program; structured multidisciplinary program
Medical Therapy:
phentermine; orlistat; lorcaserin; phentermine/topiramate ER
Surgical Therapy (BMI ≥ 35):
ST EP 3
HIGH
(i) Therapeutic targets for improvement in complications,
(ii) Treatment modality and
(iii) Treatment intensity for weight loss based on staging
S E L E C T:
Lifestyle Modification:
MEDIUM
Lap band; gastric sleeve; gastric bypass
If therapeutic targets for improvements in complications not met, intensify lifestyle and/or medical
and/or surgical treatment modalities for greater weight loss
Reprinted with permission from American Association of Clinical Endocrinologists. Garber AJ, Abrahamson MJ, Barzilay JI, et al. AACE Comprehensive Diabetes
Management Algorithm. Endocr Pract. 2013;19:327-336.
The Pharmacist’s Role in Obesity Management:
A Long-term Commitment to Improving Overall Health
7
PHEN/TPM ER Prescribing And
Administration 9
PHEN/TPM ER is available at certified retail pharmacies as well as
via mail order through the Qsymia Home Delivery Network. There
are several considerations that should be taken into account when
initiating treatment with PHEN/TPM ER, particularly in women of
reproductive potential in whom a pregnancy test is recommended
prior to initiation of therapy. Patients may come to the pharmacy
with 2 individual prescriptions: 1 for PHEN/TPM ER 3.75/23 mg
(titration dose for 14 days) and 1 for PHEN/TPM ER 7.5/46 mg.
While both prescriptions may be filled at once, patients should be
instructed to take PHEN/TPM ER 3.75/23 mg once daily in the
morning for 14 days. After the 2-week period with the titration dose,
patients should begin taking PHEN/TPM ER 7.5/46 mg once daily in
the morning. Patients can take PHEN/TPM ER with or without food
and should be counseled not to combine the capsules or take more
than directed. Patients will be monitored for weight loss benefit and
tolerability at the discretion of the prescribing clinician, and it is
recommended that women of child-bearing potential take monthly
pregnancy tests (which may be performed at home). (See Figure 2.)
Following 12 weeks of treatment with PHEN/TPM ER 7.5/46 mg,
patients are evaluated by the prescribing clinician for weight loss.
• For patients who experience ≥3% loss of baseline body weight,
PHEN/TPM ER 7.5/46 mg therapy can be continued long term
with regular monitoring by the prescribing clinician.
• For patients who experience <3% loss of baseline body weight,
PHEN/TPM ER therapy should be either discontinued or the
therapy dose escalated.
- Dose escalation: Patients should be instructed to take PHEN/
TPM ER 11.25/69 mg (titration dose for 14 days) once daily in
the morning. After the 2-week period with the titration dose,
patients should begin taking PHEN/TPM ER 15/92 mg once
daily in the morning.
For patients who have undergone dose escalation to PHEN/TPM ER
15/92 mg, evaluation of weight loss will occur after 12 weeks by the
prescribing clinician.
• For patients who experience ≥5% loss of baseline body weight,
PHEN/TPM ER 15/92 mg therapy can be continued long term
with regular monitoring by the prescribing clinician.
• For patients who experience <5% loss of baseline body weight at
this stage, PHEN/TPM ER therapy should be discontinued, as it is
unlikely that the patient will achieve and maintain clinically
meaningful weight loss with continued treatment.
Dose Modification Considerations:
• Patients who have moderate liver impairment (Child-Pugh score
7 to 9) should not exceed 7.5/46 mg once daily.
8
•P
atients who have moderate (creatinine clearance [CrCl] ≥30 and
<50 mL/min) or severe (CrCl <30 mL/min) renal impairment
should not exceed 7.5/46 mg once daily.
•P
HEN/TPM ER discontinuation: Patients should be instructed to
discontinue the top dose of PHEN/TPM ER 15/92 mg gradually
by taking a dose every other day for at least 1 week prior to
stopping treatment altogether, due to the potential of precipitating
a seizure from rapidly changing topiramate concentrations.
Risk Evaluation and Mitigation Strategy
A Risk Evaluation and Mitigation Strategy (REMS) is an approach
used to inform health care professionals and patients of known or
potential serious risks associated with a medication. The purpose of
the PHEN/TPM ER REMS is to inform health care professionals of
the increased risk of congenital malformations, specifically orofacial
clefts, in infants exposed to the topiramate component of PHEN/
TPM ER during the first trimester of pregnancy. Prescribing
clinicians are encouraged to complete a voluntary training activity
at QsymiaREMS.com. It reviews the importance of educating
women of reproductive potential on pregnancy prevention such as
a recommendation for negative pregnancy tests prior to initiating
therapy and then monthly, use of appropriate contraception (see
Table 6), and the need to discontinue PHEN/TPM ER immediately
if pregnancy occurs.19,20
The QsymiaREMS.com Web site offers numerous resources to
patients, clinicians, and pharmacists including patient medication
guides, pregnancy prevention guidelines, dose-management
checklists, and a pharmacy hotline that provides dispensing support
at 1-855-302-6698.19 PHEN/TPM ER is provided through certified
pharmacies which can be found online or on the mobile-enabled
“FindQsymia.com” Web site.
Lorcaserin Prescribing
And Administration 10
Lorcaserin is available in 10-mg tablets and is dosed BID. Patients
can take lorcaserin with or without food, preferably before
morning and evening meals. Patients will be monitored for
tolerability at the discretion of the prescribing clinician, and
women of child-bearing potential should be discouraged from
becoming pregnant or breastfeeding. Following 12 weeks of BID
treatment with lorcaserin, patients are evaluated by the prescribing
clinician for weight loss and tolerability. For those patients who
experience ≥5% loss of baseline body weight, lorcaserin therapy at
10 mg BID can be continued long term with regular monitoring by
the prescribing clinician. For those patients who experience <5%
loss of baseline body weight, lorcaserin therapy should be
discontinued, as it is unlikely that the patient will achieve and
maintain clinically meaningful weight loss with treatment
continuation. (See Figure 2.)
The Pharmacist’s Role in Obesity Management:
A Long-term Commitment to Improving Overall Health
Figure 2. Dosing Algorithms for Lorcaserin and PHEN/TPM ER.9,10
Lorcaserin
PHEN/TPM ER
10 mg twice daily for 12 weeks
3.75/23 mg for 14 days
<5%
weight loss
≥5%
weight loss
7.5/46 mg for 12 weeks
Discontinue
Maintain
10 mg BID
<3% weight loss
Discontinue
≥3% weight loss
Escalate Dose
Maintain
7.5/46 mg
11.25/69 mg for 14 days
15/92 mg for 12 weeks
<5%
weight loss
≥5%
weight loss
Discontinue
Maintain
15/92 mg
Table 6. Contraception Counseling Chart.19
CONTRACEPTIVE METHODS TO REDUCE RISK OF PREGNANCY IN WOMEN UNDERGOING PHEN/TPM ER THERAPY
OPTION 1 – Highly Effective Methods to Use Alone
Intrauterine device (IUD) or intrauterine system (IUS)
– Copper IUD
– Levonorgestrel-releasing IUS
Progestin implant
Tubal sterilization
Male partner’s vasectomy
OPTION 2 – Acceptable Methods to Use Together
Choose First Method
Hormonal Contraception
Estrogen and progestin
– Oral (the pill)
– Transdermal patch
– Vaginal ring
Progestin only
– Oral
– Injection
Choose Second Method
AND
OPTION 3 – Acceptable Methods to Use Together
Choose First Method
Barrier Method
– Diaphragm (with spermicide)
– Cervical cap (with spermicide)
Barrier Method
– Diaphragm (with spermicide)
– Cervical cap (with spermicide)
–M
ale condom (with or without spermicide)
Choose Second Method
AND
Barrier Method
– Male condom (with or without spermicide)
The Pharmacist’s Role in Obesity Management:
A Long-term Commitment to Improving Overall Health
9
Pharmacologic weight loss not
recommended in pregnancy.
Effective Counseling: Avoid Treatment
Discontinuation
It is extremely important to proactively tell patients about the
common adverse events they may experience before they start
taking these medications to decrease unnecessary treatment
discontinuation. (See Tables 7 and 8.)
Table 7. Most Common Adverse Events of PHEN/TPM ER.7,9
PHEN/TPM ER 7.5/46
(n=498)
PHEN/TPM ER 15/92
(n=994)
Placebo
(n=993)
14
21
2
Constipation
15
17
6
Dysgeusia
7
10
1
Insomnia
6
10
5
Dizziness
7
10
3
Adverse Events (%)
Dry Mouth
Paraesthesia
13
21
2
Population includes all patients who received ≥1 dose of PHEN/TPM ER or placebo
Table 8. Most Common Adverse Events of Lorcaserin.8,10
Lorcaserin 10 mg BID
n=1593, Year 1
Lorcaserin 10 mg BID
n=573, Years 1 and 2
Placebo
n=1584, Year 1
14.8
14.5
11.9
Nasopharyngitis
13.4
16.4
12.0
8.2
1.7
3.8
Nausea
7.5
3.5
5.4
Adverse Events (%)
Headache
Upper Respiratory
Infection
Dizziness
18.0
7.2
Population includes all patients who received ≥1 dose of lorcaserin or placebo
Abbreviation: BID, twice daily
10
The Pharmacist’s Role in Obesity Management:
A Long-term Commitment to Improving Overall Health
11.0
Patients who are taking SSRIs,
SNRIs, TCAs, dextromethorphan,
triptans, or tryptophan should
be educated about the risk of
serotonin syndrome when
taking lorcaserin.
Pharmacist-To-Pharmacist
Take-Home Points
Proactive Involvement
These new anti-obesity drugs are adjuncts to weight-loss regimens;
nonobese patients hoping to lose “a few pounds” are not the
indicated population. Patients on PHEN/TPM ER or lorcaserin
have true obesity-related health concerns and will rely on
pharmacists to answer multiple questions about the risks and
potential benefits of their treatments.
In addition to partnering with physicians, pharmacists should
encourage lifestyle modifications, which include reduced-calorie
diets, increased physical activity, and the importance of setting
moderate and achievable weight-loss goals of 5% to 10%.
Patients on these medications will want to know when the drug
will work, what side effects they may expect, how to manage side
effects, and what risks might be specific to them or their drug
therapy. With training, pharmacists can educate patients about
weight loss, communicate crucial safety recommendations, and
monitor for drug interactions or adverse events. Specific
observations and questions on suicidal thoughts or changing
psychiatric symptoms, pregnancy prevention, and new-onset
cardiac symptoms can identify patients with increased safety risk
before a serious event occurs.
Patient Resources for Weight Loss
Along with active intervention, pharmacists should emphasize the
Weight-control Information Network (WIN) from the National
Institutes of Health (NIH) and related resources that help patients
with behavior change and managing their expectations and goals
for weight loss. WIN NIH hosts a Facebook page for patient
interaction and updated tools, and the Centers for Disease Control
and Prevention (CDC) provides interactive BMI calculators and
diet/exercise trackers for patients. Programs for healthy weight loss
are available from the National Heart, Lung, and Blood Institute
(NHLBI; LEARN module), the American Diabetic Association, the
Mayo Clinic, and local YMCA diabetes prevention programs. (See
Fast Links Resources below.)
Conclusion
The approval of these 2 new effective weight-loss therapies
provides additional options for clinicians to address excess weight,
when used as an adjunct to lifestyle modification. For obese
individuals or those with a BMI of 27 kg/m2 or greater who
struggle to lose weight with diet and exercise alone and who have
or are developing obesity-related comorbidities, these agents can
offer 5% to 10% weight loss that can be maintained over time with
treatment. When used as part of a balanced approach to better
health, lorcaserin and PHEN/TPM ER are filling an unmet need in
obesity treatment, such that they may lead to a successful reduction
in excess weight and subsequent reduction in the onset and
progression of several cardiometabolic comorbidities. Postmarket
reports could expand the therapeutic potential of these drugs,
confirm their safe application, and give health care professionals
added clarity on how best to incorporate these 2 new important
drug options into clinical practice for the treatment of obesity.
The Pharmacist’s Role in Obesity Management:
A Long-term Commitment to Improving Overall Health
11
References
1. National Institutes of Health. Clinical guidelines on the identification, evaluation, and treatment of overweight and obesity in
adults. The evidence report. 1998. http://www.nhlbi.nih.gov/guidelines/obesity/ob_gdlns.pdf. Accessed November 8, 2013.
2. Weight-Control Information Network of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Overweight and obesity statistics. Oct 2012. http://www.win.niddk.nih.gov/statistics/. Accessed November 8, 2013.
3. K
aplan NM. The deadly quartet: upper-body obesity, glucose intolerance, hypertriglyceridemia, and hypertension. Arch Intern
Med. 1989;149(7):1514-1520.
4. Leslie WE, Hankey CR, Lean ME. Weight gain as an adverse effect of some commonly prescribed drugs: a systematic review.
QJM. 2007;100(7):395-404.
5. A
dipex-P [package insert]. Sellersville, PA: Teva Pharmaceuticals Co; 2012. http://www.accessdata.fda.gov/drugsatfda_docs/
label/2012/085128s065lbl.pdf. Accessed November 8, 2013.
6. Xenical [package insert]. South San Francisco, CA: Genetech USA Inc; 2012. http://www.accessdata.fda.gov/drugsatfda_docs/
label/2012/020766s029lbl.pdf. Accessed November 8, 2013.
7. Gadde KM, Allison DB, Ryan DH, et al. Effects of low-dose, controlled-release, phentermine plus topiramate combination on
weight and associated comorbidities in overweight and obese adults (CONQUER): a randomised, placebo-controlled, phase 3
trial. Lancet. 2011;377(9774):1341-1352.
8. Smith SR, Weissman NJ, Anderson CM, et al. Multicenter, placebo-controlled trial of lorcaserin for weight management.
N Engl J Med. 2010;363(3):245-256.
9. Qsymia [package insert]. Mountain View, CA: VIVUS, Inc; 2012. http://www.accessdata.fda.gov/drugsatfda_docs/
label/2012/022580s000lbl.pdf. Accessed November 8, 2013.
10. B
elviq [package insert]. Zofingen, Switzerland: Arena Pharmaceuticals GmbH; 2012. http://www.accessdata.fda.gov/
drugsatfda_docs/label/2012/022529lbl.pdf. Accessed November 8, 2013.
11. J ick H, Vasilakis C, Weinrauch LA, et al. A population-based study of appetite-suppressant drugs and the risk of cardiac-valve
regurgitation. N Engl J Med. 1998;339(11):719-724.
12. B
ays H. Phentermine, topiramate and their combination for the treatment of adiposopathy (‘sick fat’) and metabolic disease.
N Engl J Med. 1998;339:719-724.
13. A
ronne LJ, Wadden TA, Peterson C, et al. Evaluation of Phentermine and Topiramate versus Phentermine/Topiramate
Extended-Release in Obese Adults. Obesity. 2013;21(11):2163-2171.
14. Colman E, Golden J, Roberts M, Egan A, Weaver J, Rosebraugh C. The FDA’s assessment of two drugs for chronic weight
management. N Engl J Med. 2012;367(17):1577-1579.
15. F
idler MC, Sanchez M, Raether B, et al; BLOSSOM Clinical Trial Group. A one-year randomized trial of lorcaserin for weight
loss in obese and overweight adults: the BLOSSOM trial. J Clin Endocrinol Metab. 2011;96(10):3067-3077.
16. O
’Neil PM, Smith SR, Weissman NJ, et al. Randomized placebo-controlled clinical trial of lorcaserin for weight loss in type 2
diabetes mellitus: the BLOOM-DM study. Obesity (Silver Spring). 2012;20(7):1426-1436.
17. A
llison DB, Gadde KM, Garvey WT, et al. Controlled-release phentermine/topiramate in severely obese adults: a randomized
controlled trial (EQUIP). Obesity (Silver Spring). 2012;20(2):330-342.
18. G
arber AJ, Abrahamson MJ, Barzilay JI, et al. AACE comprehensive diabetes management algorithm. Endocr Pract.
2013;19(2):327-336.
19. V
IVUS, Inc. Qsymia risk evaluation and mitigation strategy (REMS). http://QsymiaREMS.com. Accessed November 8, 2013.
20. F
DA REMS Approval: Qsymia (phentermine and topiramate extended-release) capsules (4/2013).
http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/
UCM312598.pdf. Accessed November 8, 2013.
12
The Pharmacist’s Role in Obesity Management:
A Long-term Commitment to Improving Overall Health
Fast Links Resources for Health Care Professionals
Adverse event reporting to the FDA:
www.MedWatch.com or at 1-800-FDA-1088
AHA’s Answers by Heart patient fact sheets:
http://www.heart.org/HEARTORG/Conditions/More/ToolsForYourHeartHealth/
Answers-by-Heart-Fact-Sheets_UCM_300330_Article.jsp
Lorcaserin (Belviq) safety information:
http://www.belviq.com/
BMI calculator for patients and health care professionals at NHLBI:
http://www.nhlbi.nih.gov/guidelines/obesity/BMI/bmicalc.htm
Qsymia REMS resources, voluntary health care provider training program,
pharmacy training and pharmacy certification information, and certified
pharmacy-locator tool:
www.Qsymia.com
Qsymia support:
www.VIVUS.com (adverse event reporting at [email protected] or 1-888-998-4887)
Your Weighting Room:
A Physician Resource Center: http://www.yourweightingroom.com/Default.aspx
Fast Links Resources for Patients
LEARN:
http://medicalcenter.osu.edu/patientcare/healthcare_services/center_for_wellness_
prevention/comprehensive_weight_management/weight_management/LEARN/Pages/
index.aspx)
WIN:
http://win.niddk.nih.gov/
WIN on Facebook:
https://www.facebook.com/win.niddk.nih.gov
The Pharmacist’s Role in Obesity Management:
A Long-term Commitment to Improving Overall Health
13
Notes
14
The Pharmacist’s Role in Obesity Management:
A Long-term Commitment to Improving Overall Health
✁
4 Fast Facts
New Pharmacotherapies
for Weight Management
Fact
1
Phentermine/topiramate extended-release (PHEN/TPM ER)
and lorcaserin are approved for patients with clinically
defined obesity.
• Patients with clinically defined obesity have a BMI of ≥30 kg/m2 or ≥27 kg/m2
and at least 1 weight-related comorbidity including hypertension, high cholesterol,
or type 2 diabetes mellitus.
• These new pharmacotherapies are to be used as adjuncts to lifestyle intervention.
Fact
2
PHEN/TPM ER cannot be substituted with generic
alternatives.
• Substituting PHEN/TPM ER with phentermine and topiramate is not
an equivalent therapy with regard to dosing or drug release, and it is not
AB-rated for substitutions.
• The generic components are not approved by the FDA for chronic
management of weight loss and weight maintenance.
Fact
3
Treatment with lorcaserin and any concomitant serotonergic
or antidopaminergic agents, including antipsychotics,
should be discontinued immediately if signs and symptoms
of serotonin syndrome develop.
• Patients should be educated about the signs and symptoms of serotonin
syndrome when starting treatment with lorcaserin.
Fact
4
Pharmacologic weight loss is not recommended during
pregnancy.
• Women of childbearing potential are eligible to take PHEN/TPM ER, but
need to be informed and aware of the risk information and recommendations
for use of effective contraception and monthly pregnancy testing, as well as the
need to discontinue PHEN/TPM ER if they become pregnant.
Quick Reference Guide
Dosing Algorithms for Lorcaserin and PHEN/TPM ER
Lorcaserin
PHEN/TPM ER
10 mg twice daily for 12 weeks
3.75/23 mg for 14 days
<5%
weight loss
≥5%
weight loss
7.5/46 mg for 12 weeks
Discontinue
Maintain
10 mg BID
<3% weight loss
≥3% weight loss
Escalate Dose
Discontinue
Maintain
7.5/46 mg
11.25/69 mg for 14 days
15/92 mg for 12 weeks
<5%
weight loss
≥5%
weight loss
Discontinue
Maintain
15/92 mg
Common Adverse Events and Contraindications
Agent
Phentermine/topiramate Extended-Release
(PHEN/TPM ER)
Lorcaserin
Common adverse events
• Dry mouth
• Paraesthesia
• Constipation
• Dysgeusia
• Insomnia
• Dizziness
• Headache
• Upper respiratory infection
• Nasopharyngitis
• Dizziness
• Nausea
Contraindications
• Pregnancy (Category X)
• Glaucoma
• Hyperthyroidism
• During or within 14 days following MAOI therapy
• Pregnancy (Category X)
MAOI, monoamine oxidase inhibitor.
✁
New Pharmacotherapies
for Weight Management
The Pharmacist's Role in Obesity Management:
A Long-term Commitment to Improving Overall Health
POSTTEST QUESTIONS
1. Medications that can potentially cause weight gain include:
A. Atypical antipsychotics
D. A and B
B. Lithium
E. A, B, and C
C. Liraglutide
4. Which of the following pharmacotherapies for chronic weight
management received FDA approval in 2012?
A. Liraglutide
B. Phentermine
C. Liraglutide and phentermine/topiramate ER
D. Lorcaserin and phentermine/topiramate ER
2. A visibly obese adult who takes medication to control their high
blood pressure, high cholesterol, and type 2 diabetes requests a
consultation with you regarding what steps to take to improve
their health. The best counseling advice for this patient is to:
A. Explain they would need to decrease their BMI to 25 in order to
see any major health benefits
B. Explain they would need to decrease their BMI to 27 in order to
see any major health benefits
C. Explain the benefits of a 5% to 10% reduction in weight on their
health conditions and suggest ways they could get started with
making lifestyle changes
D. Explain the benefits of a 20% to 30% reduction
in weight on their health conditions and suggest ways they could
get started with making lifestyle changes
5. Weight-loss medications:
A. Are contraindicated during pregnancy (as is weight loss in general)
B. Should not be used while taking any medication for depression
C. Can be useful as stand-alone therapies
D. Are indicated for anyone with a BMI >25
6. What is a realistic percent weight-loss outcome at
6 months following nonsurgical weight-loss treatment?
A. <1%
B. 3% to 5%
C. 5% to 10%
D. 15% to 20%
3. An obese (BMi ≥30) person with hypertension has been
unsuccessful in his/her weight loss goals (5% reduction) after 6
months of lifestyle modification. Which of the following strategies
is the best to consider next for weight loss?
A. Continue current lifestyle modification for another 6 months
B. Continue current exercise activities
C. Consider treatment with a pharmacotherapeutic agent for weight loss
D. Bariatric surgery
7. The American Medical Association recognizes
obesity as a:
A. Disease
B. Choice that is made by some patients
C. Side effect that cannot be prevented
D. Condition that cannot be improved once it
has occurred
EVALUATION FORM
Please complete the following evaluation questions to receive your certificate.
1. What degree best describes you?
❒ MD/DO
❒ PA/PA-C
❒ PharmD/RPh
❒ PhD
❒ NP
❒ RN
❒ Other, please specify: ________________________________________
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
2. What is your area of specialization?
❒ Family Medicine
❒ General Practice
❒ Internal Medicine
❒ Endocrinology, Metabolism
❒ OB/GYN & Women’s Health ❒ Cardiology, General
❒ Pharmacy
❒ Other, please specify:_________________
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
3. Which of the following best describes your primary practice setting?
❒ Solo Practice
❒ Group Practice
❒ Government
❒ University/teaching system
❒ Community Hospital
❒ HMO/managed care
❒ Non-profit/community
❒ I do not actively practice ❒ Other, please specify: ________________________________________
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
4. How long have you been practicing medicine?
❒ More than 20 years
❒ 11-20 years
❒ 5-10 years
❒ 1-5 years
❒ Less than 1 year
❒ I do not directly provide care
5. Approximately how many patients do you see each week?
❒ Less than 50
❒ 50-99
❒ 100-149
❒ 150-199
❒ 200+
❒ I do not directly provide care
6. How many patients do you currently see each week that are overweight or obese?
❒ Fewer than 5
❒ 6-15
❒ 16-25
❒ 36-45
❒ 46-55
❒ 56 or more
15
❒ 26-35
❒ I do not directly provide care
7. rate how well the activity supported your achievement
of these learning objectives:
A. Recognize the benefits of treating overweight and obese patients including
the positive impact weight loss has on comorbid conditions
B. Assess patients’ medications to reduce unhealthy weight gain and decrease
the incidence of obesity and associated comorbidities
C. Emphasize the importance of long-term weight-management
goals with their patients
D. Compare the efficacy, MOA, and benefits versus risks of
phentermine/topiramate ER and lorcaserin
E. Counsel patients on adverse events they may experience while using
pharmacotherapy as an adjunct to their obesity management
F. Provide accurate and appropriate counsel as part of the treatment team
8. rate how well the activity achieved the following:
A. The faculty were effective in presenting the material
B. The content was evidence based
C. The educational material provided useful information for my practice
D. The activity enhanced my current knowledge base
E. The activity provided appropriate and effective opportunities for active
learning (eg, case studies, discussion, Q&A, etc.)
F. The opportunities provided to assess my own learning were appropriate
(eg, questions before, during or after the activity)
Strongly
Agree
Agree
Strongly
Neutral Disagree Disagree
5432 1
5432 1
5432 1
5432 1
5432 1
5432 1
Strongly
Agree
Agree
Strongly
Neutral Disagree Disagree
5432 1
5432 1
5432 1
5432 1
5432 1
5432 1
9. Based upon your participation in this activity, do you intend to change your practice behavior? (choose only one of the
following options)
❒ I do plan to implement changes in my practice based on the information presented
❒ My current practice has been reinforced by the information presented
❒ I need more information before I will change my practice
10. Thinking about how your participation in this activity will influence your patient care, how many of your patients are likely
to benefit? Please use a number (eg, 250): –––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
11. if you plan to change your practice behavior, what type of changes do you plan to implement? (check all that apply)
❒ Apply latest guidelines
❒ Change in diagnostic testing
❒Change in differential diagnosis
❒ Change in pharmaceutical therapy
❒Choice of treatment/management approach
❒Other, please specify: ––––––––––––––
❒ Change in non-pharmaceutical therapy ❒Change in current practice for referral
––––––––––––––––––––––––––––––––––
12. How confident are you that you will be able to make your intended changes?
❒ Very confident
❒Somewhat confident
❒Unsure
❒Not very confident
13. Which of the following do you anticipate will be the primary barrier to implementing these changes?
❒ Formulary restrictions
❒ Patient adherence/compliance
❒ Treatment related adverse events
❒ Time constraints
❒ Insurance/financial issues
❒ Other, please specify: ––––––––––––––
❒ System constraints
❒ Lack of multidisciplinary support
––––––––––––––––––––––––––––––––––
14. Was the content of this activity fair, balanced, objective, and free of bias?
❒ Yes ❒ No, please explain: ––––––––––
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
15. Please list any clinical issues/problems within your scope of practice you would like to see addressed in future educational activities:
request for Credit (*required fields)
Would you be willing to participate in a post-activity follow-up survey?
❒Yes ❒No
Name*––––––––––––––––––––––––––––––––––––––––––––––––––––––––– Degree*–––––––––––––––––––––––––––––––––––––––––
Organization ––––––––––––––––––––––––––––––––––––––––––––––––––– Specialty*–––––––––––––––––––––––––––––––––––––––
Address* ––––––––––––––––––––––––––––––––––––––––– City––––––––––––––––––––––––––– State–––––– ZIP*–––––––––––––––
Telephone ––––––––––––––––––––––––––––– Fax ––––––––––––––––––––– Email*–––––––––––––––––––––––––––––––––––––––––
For Physicians only
❒ I participated in the entire activity and claim 2.0 credits.
❒ I participated in only part of the activity and claim _____ credits.
For Pharmacists only (please print legibly)
NABP ePID (maximum of 10 digits) ___ ___ ___ ___ ___ ___ ___ ___ ___ ___
Date of birth (MMDD) ___ ___ ___ ___
16
Notes