Research
`
`Original Investigation
`Characterizing the Relationship Between Free Drug Samples
`and Prescription Patterns for Acne Vulgaris and Rosacea
`
`Michael P. Hurley, MS; Randall S. Stafford, MD, PhD; Alfred T. Lane, MD, MA
`
`IMPORTANCE Describing the relationship between the availability of free prescription drug
`samples and dermatologists’ prescribing patterns on a national scale can help inform policy
`guidelines on the use of free samples in a physician’s office.
`
`OBJECTIVES To investigate the relationships between free drug samples and dermatologists’
`local and national prescribing patterns and between the availability of free drug samples and
`prescription costs.
`
`DESIGN, SETTING, AND PARTICIPANTS Cross-sectional study investigating prescribing practices
`for acne, a common dermatologic condition for which free samples are often available. The
`settings were, first, the offices of nationally representative dermatologists from the National
`Disease and Therapeutic Index (an IMS Health Incorporated database) and, second, an
`academic medical center clinic without samples. Participants were ambulatory patients who
`received a prescription from a dermatologist for a primary initial diagnosis of acne vulgaris or
`rosacea in 2010.
`
`MAIN OUTCOMES AND MEASURES National trends in dermatologist prescribing patterns, the
`degree of correlation between the availability of free samples and the prescribing of
`brand-name medications, and the mean cost of acne medications prescribed per office visit
`nationally and at an academic medical center without samples.
`
`RESULTS On a national level, the provision of samples with a prescription by dermatologists
`has been increasing over time, and this increase is correlated (r = 0.92) with the use of the
`branded generic drugs promoted by these samples. Branded and branded generic drugs
`comprised most of the prescriptions written nationally (79%), while they represented only
`17% at an academic medical center clinic without samples. Because of the increased use of
`branded and branded generic drugs, the national mean total retail cost of prescriptions at an
`office visit for acne was conservatively estimated to be 2 times higher (approximately $465
`nationally vs $200 at an academic medical center without samples).
`
`CONCLUSIONS AND RELEVANCE Free drug samples can alter the prescribing habits of
`physicians away from the use of less expensive generic medications. The benefits of free
`samples in dermatology must be weighed against potential negative effects on prescribing
`behavior and prescription costs.
`
`JAMA Dermatol. doi:10.1001/jamadermatol.2013.9715
`Published online April 16, 2014.
`
`Editorial
`
`Supplemental content at
`jamadermatology.com
`
`Author Affiliations: Department of
`Health Research and Policy, Stanford
`University School of Medicine,
`Stanford, California (Hurley);
`Stanford Prevention Research Center,
`Program on Prevention Outcomes
`and Practices, Stanford University
`School of Medicine, Stanford,
`California (Stafford); Department of
`Dermatology and Pediatrics, Stanford
`University School of Medicine,
`Stanford, California (Lane).
`Corresponding Author: Alfred T.
`Lane, MD, MA, Department of
`Dermatology and Pediatrics, Stanford
`University School of Medicine, 700
`Welch Rd, Ste 301 (Mail Code 5896),
`Palo Alto, CA 94304 (alfred.lane
`@stanford.edu).
`
`
`
`Copyright 2014 American Medical Association. All rights reserved.Copyright 2014 American Medical Association. All rights reserved.
`
`E1
`
`

`

`Research Original Investigation
`
`Free Drug Samples for Acne Vulgaris and Rosacea
`
`T he availability of free drug samples in physicians’
`
`offices has received considerable attention.1-5 A sur-
`vey conducted in 2003-2004 found that 78% of sur-
`veyed physicians had received drug samples; that physi-
`cians practicing in solo, 2-person, or group practices had
`higher odds of receiving samples than those in hospital,
`health maintenance organization, or university or medical
`school settings; and that these odds were dependent on
`medical specialty.1 As physicians continue to receive and
`provide free samples in clinical practice, it is important to
`better delineate how physician access to these samples can
`affect their prescribing behavior.
`Advocates and opponents of free drug samples com-
`monly outline several reasons for supporting or discouraging
`the practice. Samples can be beneficial for patients when used
`to provide otherwise expensive medications to the unin-
`sured or poor. Samples of alternative medications or formu-
`lations can be provided to allow patients to choose a pre-
`ferred medication, possibly leading to higher adherence.6 In
`addition,physicianscanmoreeasilyoffernewmedicationsthat
`could have advantages over existing generic alternatives. How-
`ever, national studies3,7-9 have repeatedly shown that pa-
`tients who commonly receive samples are often not those who
`would financially benefit from their free provision. There are
`also concerns that samples do not adequately relay con-
`sumer medical information to the patient as a pharmacist oth-
`erwise would, which could lead to potentially dangerous drug
`interactions, allergic reactions, or harmful adverse effects.10
`Samplesalsoaddindirectlytothecostofmedications,andtheir
`aggregate retail value represents approximately $16 billion
`spent by pharmaceutical companies each year.9
`Conflicting evidence exists surrounding the key question
`of whether the availability of samples alters the prescribing
`habits of physicians. While some studies2,11,12 show that ac-
`cess to samples influences prescribing decisions, other
`studies13,14 are less definitive. Surveys demonstrate that phy-
`sicians do not believe that access to samples influences their
`behavior, although the availability of drug samples may lead
`them to prescribe a medication that differs from their pre-
`ferred drug choice.5,15,16 Many of these studies are limited in
`scope or design by focusing on single-center observations or
`by relying on physician self-report.
`To better understand how physician prescribing behav-
`ior may be altered by the provision of drug samples, we inves-
`tigated sampling and prescribing patterns specifically in
`dermatology.17,18 Free drug samples provided by pharmaceu-
`tical companies are widely available in private, office-based
`dermatology practices. We investigated prescription pat-
`terns for patients with acne vulgaris and rosacea for the fol-
`lowing reasons: (1) acne is one of the most common indica-
`tions treated by dermatologists,19 (2) medications for acne are
`heavily sampled, (3) acne treatment recommendations have
`not changed considerably in the past decade,20,21 and (4) mul-
`tiple bioequivalent branded, branded generic, and generic
`medication alternatives exist. Branded generic drugs are spe-
`cifically defined as products that have novel dosage forms of
`off-patent products or the use a trade name for a molecule that
`is off patent.
`
`In this study, we assess national temporal trends related
`to the provision of free drug samples by dermatologists. We
`use data from a large academic medical center (AMC) with-
`out samples to contrast nationally representative data on the
`prescriptions most commonly written by dermatologists for
`acne.
`
`Methods
`Data Sources
`This study was approved by the Stanford Institutional Re-
`view Board. The informed consent process was waived to pro-
`tect the identity of the participants under 45 CFR 164.512(i)(2)
`(ii)(A),(B),(C).Ouranalysisofacnetreatmentpatternsexamined
`localdataandnationallyrepresentativeinformation.Localdata
`for this study were extracted from Stanford University’s Epic
`electronicdatabaseviatheCenterforClinicalInformaticsusing
`the Stanford Translational Research Integrated Database En-
`vironment (STRIDE) tool.22
`National data for this study were obtained from the Na-
`tional Disease and Therapeutic Index (NDTI).23 The NDTI is a
`survey of primarily office-based US physicians conducted by
`IMS Health Incorporated (http://www.imshealth.com), pro-
`viding nationally representative data on physicians, patients,
`and treatments.24 Included physicians are selected from the
`master lists of the American Medical Association and the
`American Osteopathic Association through random sam-
`pling. The geographic and specialty distributions of the se-
`lectedphysiciansaredesignedtomirrornationalpatterns.Each
`quarter, approximately 3500 physicians are surveyed on 2 con-
`secutive workdays and are asked to detail their clinical en-
`counters with every patient. Physicians self-report patient di-
`agnoses, visit characteristics, patient demographics, and their
`own demographic information. A unique record is generated
`for each diagnosis, in which the physician reports all new or
`continuing medications from the encounter, including pre-
`scribed and sampled medications.
`Drug prices used in this study were directly quoted from
`customer service representatives of a major pharmacy in July
`2013. The prices apply to a mail-in ordering system for pa-
`tients without any insurance and do not take into account any
`manufacturer incentives or pharmacy savings plans. Al-
`though these undiscounted prices are likely higher than the
`average patient’s out-of-pocket costs, they allow for a more di-
`rect comparison of prices for the purposes of our analysis.
`
`Patient Selection and Characteristics
`Deidentified local patient information on age, sex, race/
`ethnicity, and insurance status was provided for all primary
`initial diagnoses of acne vulgaris (International Classification
`of Diseases, Ninth Revision [ICD-9] code 706.1) or rosacea (ICD-9
`code 695.3) in 2010, the first full year for which complete pre-
`scription information was available. Together, these 2 diag-
`noses comprise what is informally referred to as adult acne and
`are both investigated to provide a more complete picture of
`dermatologist prescribing behavior in response to acne. Pa-
`tients in the local cohort were restricted to those treated by a
`
`E2
`
`JAMA Dermatology Published online April 16, 2014
`
`jamadermatology.com
`
`
`
`Copyright 2014 American Medical Association. All rights reserved.Copyright 2014 American Medical Association. All rights reserved.
`
`

`

`Free Drug Samples for Acne Vulgaris and Rosacea
`
`Original Investigation Research
`
`Figure 1. Trend in the Percentage of Prescriptions Written With a Sample by Dermatologists Compared
`With Physicians in Other Medical Specialties on a Nationally Projected Basis
`
`“Other” specialties include allergy,
`cardiology, surgery, endocrinology,
`family practice, general practice,
`gastroenterology, geriatrics,
`hematology, internal medicine,
`nephrology, neurology,
`obstetrics/gynecology, oncology,
`ophthalmology, pediatrics,
`psychiatry, pulmonary diseases,
`rheumatology, and urology. From the
`National Disease and Therapeutic
`Index, January 2001 to December
`2010, IMS Health Incorporated.23
`
`Dermatology
`Other
`
`20
`
`18
`
`16
`
`14
`
`12
`
`10
`
`8 6 4 2
`
`% of Prescriptions
`
`2006
`2005
`Study Year
`
`2007
`
`2008
`
`2009
`
`2010
`
`2002
`
`2003
`
`2004
`
`02
`
`001
`
`dermatologist at an AMC clinic. Free drug samples have been
`banned from the AMC clinic location since 2004, and the AMC
`isusedtocontrastnationalprescribingpatterns,wheresamples
`are ubiquitous. Analyzed prescriptions were restricted to only
`those written at a patient’s initial encounter to help control for
`confounding because of acne persistence. The same condi-
`tions were used to extract data from the NDTI database.
`
`Classification of Prescriptions
`Prescriptions extracted from the NDTI were limited to those
`written by office-based dermatologists for patients who, on
`their first visit, received a diagnosis of acne vulgaris or rosa-
`cea. “Prescriptions written with a sample” refers to entries in
`the NDTI in which the physician self-reported providing both
`a prescription for a medication and a sample of the same medi-
`cation to the patient. Where appropriate, these entries were
`kept separate from instances in which the physician only ad-
`ministered a prescription to the patient.
`Branded and branded generic drugs are analyzed and
`discussed together for the following 2 main reasons: (1) they
`are usually priced similarly compared with generic drugs
`and (2) samples for branded and branded generic drugs are
`much more prevalent relative to generics. Definitions and
`examples of drugs in each category are listed in eTable 1 in
`the Supplement.
`
`Statistical Analysis
`Descriptive statistics were used to characterize trends in the
`local AMC data and the national NDTI data. A Pearson prod-
`uct moment correlation was used to quantify the relation-
`shipbetweensampleavailabilityandtheproportionofbranded
`generic prescriptions written. The mean estimated cost of acne
`prescriptions at an initial visit to a dermatologist was calcu-
`lated using a weighted average of drug prescription fre-
`quency and their associated prices (taken from a consistent
`source), multiplied by the mean number of prescriptions writ-
`ten per office visit. All statistical analyses were performed with
`available software (SAS, version 9.3; SAS Institute Inc).
`
`Results
`
`National Trends in the Provision of Free Samples
`by Dermatologists
`From the NDTI, we derived temporal trends in the percent-
`age of prescriptions written with a sample in dermatology rela-
`tive to other medical specialties (Figure 1). The use of free
`samples in dermatology is comparatively high relative to other
`medical specialties. For the decade between 2001 and 2010,
`the proportion of prescriptions written with a sample relative
`to all prescriptions written increased from 12% to 18% in der-
`matology, while during the same period the aggregate propor-
`tion for all other specialties decreased from 7% to 4%.23
`The percentage of prescriptions written with a sample by
`dermatologists has increased even more, from 10% in 2001 to
`25% in 2010, for acne vulgaris and rosacea specifically.23 In di-
`rect positive correlation (r = 0.92) to this finding is the in-
`crease in the percentage of branded generics prescribed by der-
`matologists relative to branded and generic drugs for the
`indication from 38% in 2001 to 51% in 2010 (Figure 2). Be-
`cause the free samples being marketed are often for branded
`generic drugs, it makes intuitive sense that these 2 are corre-
`lated. In contrast, the percentage of generic medications pre-
`scribed has remained flat and in absolute numbers has de-
`creased in the same period.
`Investigating the actual medications that were provided
`as samples and prescribed by dermatologists in offices nation-
`wide supports the observed trends. The top 5 medications pre-
`scribed overall and with samples by office-based dermatolo-
`gists for initial encounters of patients with acne on a national
`level for 3 separate years in the past decade are listed in Table 1.
`The composition of each list is markedly different between
`years, indicating that the medication preferences of derma-
`tologists shift over time. However, when comparing within-
`year patterns, the most common medications prescribed over-
`all and the medications prescribed with a sample are similar.
`In 2005, for example, the top 4 medications prescribed with a
`
`jamadermatology.com
`
`JAMA Dermatology Published online April 16, 2014
`
`E3
`
`
`
`Copyright 2014 American Medical Association. All rights reserved.Copyright 2014 American Medical Association. All rights reserved.
`
`

`

`Research Original Investigation
`
`Free Drug Samples for Acne Vulgaris and Rosacea
`
`Table 1. Top 5 Drugs Prescribed Overall and With a Sample
`by Office-Based Dermatologists at Initial Encounters of Patients
`With Acne on a Nationally Projected Basis in 3 Different Yearsa
`
`Top 5 Drugs
`Prescribed Overall
`2010
`Epiduo
`Doxycycline hyclate
`Metrogel
`Solodyn
`Differin
`2005
`Differin
`Benzaclin
`Duac
`Retin-A Micro
`Doxycycline hyclate
`2001
`Differin
`Tetracycline hydrochloride
`Cleocin T
`Benzamycin
`Retin-A Micro
`
`Top 5 Drugs Prescribed
`With a Free Sample
`
`Epiduo
`Metrogel
`Solodyn
`Ziana
`Oracea
`
`Differin
`Duac
`Benzaclin
`Retin-A Micro
`Metrogel
`
`Differin
`Retin-A Micro
`Tazorac
`Metrolotion
`Triaz
`
`a From the National Disease and Therapeutic Index, January 2001 to December
`2010, IMS Health Incorporated.23
`
`more frequently received prescriptions for branded or branded
`generic medications, patients at the AMC were overwhelm-
`ingly prescribed generic medications. For all commonly pre-
`scribed medications, defined as drugs prescribed 3 or more
`times in 2010, at the AMC, 17% (230 of 1364) of prescriptions
`were for branded or branded generic drugs and 83% (1134 of
`1364) of prescriptions were for generic drugs (Figure 3). This
`is in contrast to medications prescribed by office-based der-
`matologists on a national level for patients manifesting acne
`for the first time, where 79% of prescriptions were branded or
`branded generic and 21% were generic.
`
`Costs Associated With Acne Prescriptions
`Because the percentages of branded, branded generic, and ge-
`neric medications prescribed on a national level contrasted
`starklywiththosewrittenattheAMCandbecausebrandedand
`branded generic drugs are more expensive than generics, there
`were also cost differences between the 2 groups. The mean re-
`tail cost of medications prescribed for acne was much higher
`nationally compared with the AMC. Using the top 20 most pre-
`scribed medications, which is approximately 63% of all pre-
`scriptions written in each database, and accounting for the dif-
`ference in the number of prescriptions written per visit at each
`site, the mean estimated costs of medications per patient visit
`nationally were $465 using estimates from the NDTI and $200
`for the AMC (eTable 3 in the Supplement). In other words, the
`national mean retail cost of the prescriptions received at an of-
`fice visit for acne is conservatively 2 times higher compared
`with the AMC, where samples were unavailable.
`
`Figure 2. Percentage of Prescriptions Written With a Sample
`and the Percentage of Branded Generic Drugs as Prescribed
`by Office-Based Dermatologists for Patients With Acne Vulgaris
`and Rosacea on a Nationally Projected Basis
`
`% of Prescriptions Written With a Sample
`
`25
`
`20
`
`15
`
`10
`
`5 0
`
`% of branded generic drugs
`% of prescriptions written
`with a sample
`
`2001 2002 2003 2004 2005 2006 2007 2008
`Study Year
`
`2009
`
`2010
`
`55
`
`50
`
`45
`
`40
`
`35
`
`30
`
`% of Branded Generic Drugs
`
`From the National Disease and Therapeutic Index, January 2001 to December
`2010, IMS Health Incorporated.23
`
`sample were also the top 4 medications for which a prescrip-
`tion was written, both with and without an accompanying
`sample. This implies that most of the commonly prescribed
`drugs for acne were available and dispensed as samples in the
`office and that these frequently prescribed medications were
`preferred in years when samples for them were available.
`
`National vs AMC Prescription Patterns
`Nationally representative data from the NDTI database were
`compared with local data from an AMC. The patient charac-
`teristics at each site are listed in eTable 2 in the Supplement.
`In general, the AMC cohort was older, had fewer patients of
`white race/ethnicity, and had a higher percentage of
`patients covered by public insurance (defined as Medicare
`or Medicaid).
`The 10 most commonly prescribed medications by der-
`matologists at the first diagnosis of acne in 2010 are listed in
`Table 2. Of the most commonly prescribed medications na-
`tionally, 9 of 10 are classified as branded or branded generic
`medications,andsamplesarecommonlygivenwithallofthem,
`ranging from 33% to 62% of the time. In fact, 12 of 15 most com-
`monly sampled medications were also within the top 15 most
`prescribed overall to patients (data not shown). Of 9 branded
`or branded generic medications, 8 have less expensive, com-
`mercially available generic equivalents.
`Dermatologists nationally and at the AMC prescribed dif-
`ferent medications for patients with acne vulgaris and rosa-
`cea in 2010 (Table 2). Only 1 of 10 most commonly prescribed
`medications at the AMC was also commonly prescribed on a
`national level. Expanding the comparison to the top 20 most
`frequently prescribed medications still only resulted in a 35%
`overlap (7 of 20 medications) between the AMC and the na-
`tional estimates.
`The prescription variations between the AMC and na-
`tional offices can be explained by examining the different pro-
`portions of branded, branded generic, and generic medica-
`tions that were prescribed in 2010. Nationally, while patients
`
`E4
`
`JAMA Dermatology Published online April 16, 2014
`
`jamadermatology.com
`
`
`
`Copyright 2014 American Medical Association. All rights reserved.Copyright 2014 American Medical Association. All rights reserved.
`
`

`

`Free Drug Samples for Acne Vulgaris and Rosacea
`
`Original Investigation Research
`
`Table 2. Top 10 Drugs and Their Generic Equivalents Prescribed by Dermatologists Nationally
`and at an Academic Medical Center (AMC) at Initial Encounters of Patients With Acne in 2010a
`
`% of Prescriptions
`Written With
`a Sample
`51
`
`National Estimate
`Drug Prescribed
`Generic Equivalent
`Epiduo
`Adapalene–benzoyl
`peroxide
`
`AMC
`
`Drug Prescribed
`Tretinoin
`
`Generic Equivalent
`…
`
`4
`48
`45
`
`42
`49
`
`55
`
`47
`
`33
`
`62
`
`Doxycycline hyclate
`Metrogel
`Solodyn
`
`Differin
`Finacea
`
`Ziana
`
`Duac
`
`Benzaclin
`
`Oracea
`
`…
`Metronidazole
`Minocycline
`hydrochloride
`Adapalene
`…
`
`Clindamycin
`phosphate–tretinoin
`Clindamycin–benzoyl
`peroxide
`Clindamycin– benzoyl
`peroxide
`Doxycycline
`
`Doxycycline hyclate
`Benzoyl peroxide
`Clindamycin
`phosphate
`Adapalene
`Triamcinolone
`acetonide
`Metronidazole
`
`…
`…
`…
`
`…
`…
`
`…
`
`Metrocream
`
`Metronidazole
`
`Cephalexin
`
`Minocycline
`hydrochloride
`
`…
`
`…
`
`Abbreviation: ellipsis, unavailable.
`a From the Stanford Translational
`Research Integrated Database
`Environment (STRIDE) project22
`and the National Disease and
`Therapeutic Index, January 2001 to
`December 2010, IMS Health
`Incorporated.23
`We show that nationally representative data are incongru-
`ent with locally observed prescription patterns in the ab-
`sence of samples. This is important in part to demonstrate the
`broad effect that sample provision can have on prescribing pat-
`terns, as well as to emphasize the large cost implications that
`are a result of this modified behavior. Specifically, the in-
`creased prescribing of branded generics, as shown in Figure 3,
`increases overall costs to the health care system. Reiffen and
`Ward25 demonstrate that the introduction of a branded ge-
`neric drug, which is essentially a generic version of a manu-
`facturer’s currently branded drug introduced before patent ex-
`piration, can result in higher drug prices in the long run. They
`show that generic prices are pushed higher with the entry of
`branded generic medications into the market, which in turn
`implies that branded generics, as a strategy for drug manu-
`facturers, can be advantageous by increasing the firm’s prof-
`its. Previous research has shown that physicians in general are
`unaware of the costs of the drugs they are prescribing.26 This
`takes on significance relative to the estimates by Payette and
`Grant-Kels,27 which show that an average cost savings of $60
`per prescription could be achieved by switching from a brand
`name to a generic dermatologic medication. With rising retail
`costs of prescription drugs,28 it will be ever more important
`for physicians to be cognizant of how pharmaceutical market-
`ing practices can affect their habits and potentially inflate the
`costs of prescribed drugs.
`On a national level, the percentage of prescriptions writ-
`ten with a free sample by dermatologists for patients with acne
`has increased over time. As dermatologists increasingly pro-
`vide samples in their practice, the proportion of branded ge-
`neric medications prescribed also increases over time at a simi-
`lar rate. By virtue of what is made available to dermatologists
`as samples, most sampled medications are categorized as
`branded generic medications. The observed national trend
`whereby an increase in sample use has coincided with the in-
`creased prescription of branded generic medications sug-
`gests that dermatologists are increasingly likely to prescribe
`drug samples that are made available. Furthermore, derma-
`
`Figure 3. Percentage of All Branded, Branded Generic, and Generic Drugs
`for Acne Vulgaris and Rosacea Prescribed During a Patient’s Initial Visit
`in 2010 at an Academic Medical Center (AMC) and on a Nationally
`Projected Basis
`
`National
`AMC
`
`Branded
`
`Branded Generic
`Drug Category
`
`Generic
`
`90
`
`80
`
`70
`
`60
`
`50
`
`40
`
`30
`
`20
`
`10
`
`0
`
`% of Prescriptions
`
`Analyses are restricted to prescriptions written more than 3 times in 2010 at the
`AMC. From the Stanford Translational Research Integrated Database
`Environment (STRIDE) project22 and the National Disease and Therapeutic
`Index, January 2001 to December 2010, IMS Health Incorporated.23
`
`Discussion
`
`The receipt of free samples by physicians is prevalent and
`controversial. The purported beneficial and harmful effects
`of the provision of free drug samples and the degree to
`which their availability can influence physician prescribing
`behavior are uncertain. In this study, we used local and
`national data to highlight how the provision of samples is
`associated with the prescribing behavior of dermatologists
`and how the availability of samples correlates with the pre-
`scription of more expensive branded generic drugs over less
`expensive generic alternatives. Our analysis also suggests
`that longitudinal prescribing preferences are at least in part
`related to what is contemporaneously available as free
`samples.
`
`jamadermatology.com
`
`JAMA Dermatology Published online April 16, 2014
`
`E5
`
`
`
`Copyright 2014 American Medical Association. All rights reserved.Copyright 2014 American Medical Association. All rights reserved.
`
`

`

`Research Original Investigation
`
`Free Drug Samples for Acne Vulgaris and Rosacea
`
`tologists’ preferences for acne medications change over time
`but largely coincide with what medications are available as
`samples in that period. In other words, dermatologists are pro-
`viding more samples, are prescribing more branded generic
`drugs as sample use increases, and are mirroring the specific
`medications they are prescribing to what is distributed to them
`by pharmaceutical representatives.
`Our study has several limitations. The causal nature of the
`relationshipbetweentheavailabilityoffreesamplesandapref-
`erence for more expensive branded medications may be uncer-
`tain. The observed differences in prescribing habits may be at-
`tributed to other forms of pharmaceutical marketing that were
`notadequatelycapturedinourstudy,suchasthenumberofvis-
`its by or gifts from pharmaceutical representatives. The use of
`co-payment discount cards, which can also influence prescrib-
`ing patterns, was not captured in this study and is an area that
`should be explored in future investigations. The observed dif-
`ferences in prescribing patterns could also be a reflection of the
`culture and the preferences of the dermatologists at the AMC,
`independentofthepresenceofdrugsamples.Specifically,broad
`differences in ethical norms at AMCs and private dermatology
`practices with regard to interactions with pharmaceutical com-
`panies could be contributing to these observations. There were
`also differences in patient demographics between patients at
`theAMCandonanationallevel,butwecouldnotperformamul-
`tivariate regression analysis to account for such factors be-
`cause of the nature of the data in the NDTI.
`Given these limitations, the AMC data primarily serve to
`contrast the national data and offer an alternative scenario to
`national data that otherwise suggests a larger systemic prob-
`lem. The retail value of the medications assessed in this study
`
`does not reflect the value of the prescriptions that were actu-
`ally filled and is a proxy for the actual cost to the health care
`system. Patients are likely to obtain branded and branded ge-
`neric drugs at a much less expensive out-of-pocket price than
`listed, but this does not change the fact that some entity in the
`health care system is shouldering the burden of these costs.
`Also, although organizations such as The Joint Commission29
`act to regulate drug sampling nationally, variation may exist
`between practices at AMCs. For example, while the AMC in this
`studydoesnothaveanysamples,othersmayhavefreesamples
`for over-the-counter medications, which may affect prescrip-
`tion patterns. From a care delivery standpoint, patient expec-
`tations and satisfaction were not documented between the 2
`sites. Cost aside, a patient’s perception of the quality of care
`maybehigherbecauseoftheavailabilityofsamples.Ifso,prac-
`ticing physicians must weigh this fact when considering the
`benefits and drawbacks of providing drug samples.
`
`Conclusions
`While there are many benefits and drawbacks of providing free
`drugsamples,minimizingtheirusehasbeenadvocatedbypro-
`fessional organizations and by physician practices. Derma-
`tologists, and physicians more generally, should be aware of
`how the availability of free samples influences physician pre-
`scribingbehaviorandincreaseshealthcareexpenses.Thenega-
`tive consequences of free drug samples affect clinical prac-
`tice on a national level, and policies should be in place to
`properly mitigate their inappropriate influence on prescrib-
`ing patterns.
`
`ARTICLE INFORMATION
`Accepted for Publication: November 13, 2013.
`Published Online: April 16, 2014.
`doi:10.1001/jamadermatol.2013.9715.
`Author Contributions: Mr Hurley and Dr Lane had
`full access to all the data in the study and take
`responsibility for the integrity of the data and the
`accuracy of the data analysis.
`Study concept and design: All authors.
`Acquisition, analysis, or interpretation of data: All
`authors.
`Drafting of the manuscript: Hurley.
`Critical revision of the manuscript for important
`intellectual content: All authors.
`Statistical analysis: Hurley.
`Study supervision: Lane.
`Conflict of Interest Disclosures: Dr Stafford
`reports past expert testimony for Mylan
`Pharmaceuticals, a manufacturer of generic
`medications, regarding patterns of doxycycline use
`in the treatment of rosacea. No other disclosures
`were reported.
`Funding/Support: Dr Stafford’s contribution to this
`study was supported in part by midcareer
`mentoring award K24-HL086703 from the
`National Heart, Lung, and Blood Institute. The
`Stanford Translational Research Integrated
`Database Environment (STRIDE) project was
`supported by grant UL1 RR025744 from the
`National Center for Research Resources and the
`
`National Center for Advancing Translational
`Sciences, National Institutes of Health.
`Role of the Sponsor: The funding sources had no
`role in the design and conduct of the study;
`collection, management, analysis, and
`interpretation of the data; preparation, review, or
`approval of the manuscript; and decision to submit
`the manuscript for publication.
`Disclaimer: The statements, findings, conclusions,
`views, and opinions contained and expressed in this
`article are based in part on data obtained under
`license from the following IMS Health Incorporated
`information service: National Disease and
`Therapeutic Index (1997-2009), IMS Health
`Incorporated. The statements, findings,
`conclusions, views, and opinions contained and
`expressed herein are neither representative of the
`official views of the National Institutes of Health nor
`necessarily those of IMS Health Incorporated or any
`of its affiliated or subsidiary entities.
`Previous Presentation: This study was previously
`published as an abstract and presented as a poster
`at the 72nd Annual Meeting of the Society for
`Investigative Dermatology; May 10, 2012; Raleigh,
`North Carolina; and at the 38th Annual Meeting of
`the Society for Pediatric Dermatology; July 12, 2012;
`Monterey, California.
`Additional Contributions: David Peng, MD, MPH
`(Department of Dermatology, Keck School of
`Medicine of USC, University of Southern California,
`Los Angeles) and Jean Tang, MD (Department of
`
`Dermatology, Stanford University School of
`Medicine) critically reviewed the manuscript, and
`Raymond R. Balise, PhD (Department of Health
`Research and Policy, Stanford University School of
`Medicine) provided valuable guidance. We thank
`the Stanford Center for Clinical Informatics and the
`STRIDE project.
`
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