case study

Essay

No More Free Drug Samples? Susan Chimonas

1 *, Jerome P. Kassirer

2

1 Center on Medicine as a Profession, Columbia University, New York, New York, United States of America, 2 Tufts University School of Medicine, Boston, Massachusetts,

United States of America

Everybody likes something free, and

free prescription drug samples are no

exception. Patients love to receive them,

and doctors feel good about handing them

out. The practice of providing free drug

samples is based on the tacit assumption

that ‘‘sampling’’ does much more good

than harm. In two separate news releases

within the past year by the Pharmaceutical

Research and Manufacturers of America

(PhRMA), the trade organization that

represents the country’s largest and lead-

ing drug companies, a senior vice presi-

dent claimed that free samples improve

patient care, foster appropriate medication

use, and help millions of financially

struggling patients. He averred further

that samples benefit physicians by expos-

ing them to new treatment options [1,2].

In this essay, we question the assumption

that good trumps harm when prescription

drugs are provided free to practicing

doctors. We argue that ‘‘sampling’’ is not

effective in improving drug access for the

indigent, does not promote rational drug

use, and raises the cost of care.

Who Actually Receives the Samples?

Studies show who receives the free

drugs. A nationally representative survey

in the United States found that fewer than

one-third of all sample recipients were low

income (defined as less than 200% of the

poverty line); by contrast, those in the

highest income category were most likely

to have received free samples. Moreover,

low-income uninsured patients were less

likely to receive free samples than those

who had continuous health insurance [3].

These findings are supported by an

analysis of a large database of individuals

who had received at least one prescription

drug in a given year. In this study, indigent

patients were less likely to receive samples

than those classified as non-poor [4].

Often samples never reach their intend-

ed audience. Many samples are appropri-

ated by physicians for personal or family

use or end up in an ‘‘unknown destina-

tion’’ [5,6]. And in one study, nearly half

of pharmaceutical representatives sur-

veyed reported using samples themselves

or giving them to their friends and

relatives [7]. These studies indicate that

samples often reach the wrong people and

are frequently misused.

Quality of Care

Samples can have negative consequenc-

es. When low-income patients are given a

‘‘starter pack’’ of samples and a prescrip-

tion to fill for the remaining period of

treatment, they might not be able to afford

the cost of the extension, thus leading to

discontinuity of treatment. In pharmacies,

drugs are labeled, catalogued, stored, and

carefully dispensed. In drugstores, phar-

macists often identify potentially harmful

drug interactions, intercept inadvertent

medication errors, and offer a patient-

friendly printout of instructions. In doc-

tors’ offices, however, detailed patient

education regarding sample use rarely

occurs, and when it does, it usually lacks

information about drug interactions or

instructions on how the drug should be

taken [8]. Given the lack of oversight by a

skilled pharmacist, there is a risk that

expiration dates could be overlooked.

Moreover, if distribution is inadequately

documented in patients’ records, some

people who receive samples in doctors’

offices may not be notified or told to

discontinue the medication in the event of

a product recall or the emergence of new

drug complications.

The samples that drug representatives

offer are almost never time-worn and well-

tested drugs, nearly never generics, and

usually comprise the newest agents on the

market. As such, they expose patients to

risks not yet identified in clinical trials.

The experience with Vioxx is a case in

point. By 2002, only three years after

Vioxx was introduced, it became the most

widely distributed sample [3], and two

years later the drug was withdrawn from

the market because of an excess risk of

myocardial infarctions and strokes [9].

Needless to say, Vioxx was not the only

drug given extensively as samples and later

found to enhance risk. Samples given to

pediatric patients have similarly been

associated with notable safety concerns.

In 2004, four of the 15 medications most

frequently given as samples to children in

the US received new or revised ‘‘black

box’’ warnings from the US Food and

Drug Administration within two years of

approval [10]. Finally, patients may not be

the only ones at risk from distribution of

free samples. Physicians who offer samples

to patients and fail to supply appropriate

cautions and warnings about the use of

these drugs may be subject to liability,

along with the company that promoted the

drug [11].

Charity and Education, or Marketing?

It is difficult to escape the conclusion that

the prime motivation behind the provision

of free samples is marketing. Samples have a

major influence on physicians’ prescribing

habits [12–15]. Samples are one of the most

effective ways sales representatives get their

foot in the door to pitch their companies’

products. The technique is effective; the

availability of samples is associated with

rapid prescription of the new drug [15]. In

The Essay section contains opinion pieces on topics of broad interest to a general medical audience.

Citation: Chimonas S, Kassirer JP (2009) No More Free Drug Samples? PLoS Med 6(5): e1000074. doi:10.1371/ journal.pmed.1000074

Published May 12, 2009

Copyright: � 2009 Chimonas, Kassirer. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Funding: This work was supported by the Institute on Medicine as a Profession, the Pew Charitable Trusts, and the Prescription Project. The funders had no role in the decision to submit this manuscript or in its preparation.

Competing Interests: The authors have declared that no competing interests exist.

* E-mail: [email protected]

Provenance: Not commissioned, externally peer reviewed

PLoS Medicine | www.plosmedicine.org 1 May 2009 | Volume 6 | Issue 5 | e1000074

one study, residents with access to samples

were more likely than their counterparts

without samples to prescribe heavily adver-

tised products and less likely to suggest an

over-the-counter alternative [16]. And a

survey based on self-reported physician

judgments suggests that the availability of

samples might even influence physicians to

prescribe drugs that would not otherwise be

their top choice [17].

Although the provenance of the casual

comments in message boards on Web sites

for pharmaceutical sales representatives is

uncertain, many of the entries reflect the

impressive influence of sampling. Some

comments are: ‘‘Without samples the

available access will be slim to none! The

ability to influence doctors will be nil’’

[18]. Another warned, ‘‘If [the companies]

are not giving you samples and expecting

you to gain access to docs with just a

reprint and a detail piece you may be in

trouble’’ [19]. As a physician explained to

The New York Times, ‘‘They are not

bringing us samples of things we

need…They are bringing us things they

want us to know about’’ [20].

Health Care Costs

Samples are not effective in lowering

patients’ costs. Indeed, evidence shows

that patients who received free samples

had higher out-of-pocket costs than their

counterparts who were not given free

samples [21]. Samples raise the cost of

health care, as companies recoup market-

ing costs through higher prices and

increased sales volume. Samples constitute

an enormous promotional outlay of phar-

maceutical companies. Between 1996 and

2000, they accounted for slightly more

than half of the total promotional dollars

spent by industry [22]. Although there is

controversy about how best to tally the

amount of money the pharmaceutical

industry spends on free samples, a recent

analysis of 2004 figures sets the retail value

of samples at approximately 16 billion US

dollars [23]. The retail value of free

samples has risen steadily, doubling be-

tween 1999 and 2003 [24] (Figure 1).

Sample distribution often intensifies dur-

ing new drug launches, or when a product

is withdrawn from the market and com-

petitors scramble to fill the vacuum [25].

Samples raise health care costs by

promoting the use of expensive products.

In the US, prescription costs grew 5-fold

from 1990 to 2006 [26] and are said to be

approaching US$200 billion annually

[27]. A substantial fraction of the increase

is attributed to a growing reliance on

expensive, brand-name medications [28]

(Figure 2). One analysis several years ago

showed that in a single year, the 50 most

heavily marketed drugs accounted for

nearly half of the increase in retail

spending on prescription drugs (the other

9,850 drugs made up the remaining sum)

[29]. These are the very products patients

are mostly likely to receive as samples.

Input from Professional Organizations

A few years ago, a widely acclaimed

report on medical errors from the Institute

of Medicine took a hard look at free

samples. It noted the growing unease in

the medical profession about the way

samples are distributed, the lack of docu-

mentation of medication use, and the by-

passing of drug-interaction checks and

counseling [30]. Nonetheless, pharmaceu-

tical companies clearly believe that sam-

pling is an effective sales strategy or they

would not spend so much of their

advertising budget on it, and they continue

to distribute samples to individual physi-

cians despite opposition against the prac-

tice from a number of groups. The

American Society of Health-System Phar-

macists, a 35,000-member national pro-

fessional association of pharmacists in

hospitals and health systems, has opposed

the use of samples [31]. The Joint

Commission, which accredits and certifies

more than 15,000 health care organiza-

tions and programs in the US, requires

that all stages of the medication use

process—selection, storage, ordering, dis-

pensing, administration, and monitor-

ing—must be appropriately integrated

into a comprehensive medication manage-

ment system, and this policy applies across

the board (K. Powers, personal communi-

cation, January 23, 2009). In fact, the

Commission reportedly identified lax doc-

umentation of drug samples as one of the

top ten abuses of hospital-practice stan-

dards [32]. The Association of American

Medical Colleges and the Association of

Faculties of Medicine of Canada recom-

mend distribution of samples only under

carefully controlled conditions—namely,

by setting up centralized systems at

medical centers for accepting and distrib-

uting the drugs [33,34]. These policies are

part of a comprehensive approach in

North America to reduce the influence of

the pharmaceutical industry on the med-

ical profession.

Alternatives to Samples

‘‘Sampling’’ is predominately an Amer-

ican problem. Many European countries

provide universal health coverage, includ-

ing prescription drugs. They negotiate

with pharmaceutical companies on prices,

formally assess the benefits and risks of

new drugs, and decide which drugs they

will pay for. Under such circumstances,

providing new drugs free to doctors has

little marketing potential. Discussions

abounded at the beginning of 2009 about

incorporating many of the health system

attributes of European countries into the

American health care system, but given

the impressive power of lobbyists, many

observers doubt that such comprehensive

reform will take place. Assuming that the

US population will not be covered by a

comprehensive prescription drug benefit,

alternatives to samples must be available.

Many generic and over-the-counter med-

ications are highly effective and have been

proven safe by years on the market. They

also cost a fraction of the price. RxOu-

treach.com provides generic drugs to

patients at or below 250% of the Federal

Poverty Level, at a cost of US$20–US$40

for a 90-day supply [35]. Wal-Mart Figure 1. Retail value of US samples, in billions of dollars. doi:10.1371/journal.pmed.1000074.g001

Essay

PLoS Medicine | www.plosmedicine.org 2 May 2009 | Volume 6 | Issue 5 | e1000074

recently announced that it would offer

hundreds of generic drugs for only US$4

per month, and many of its competitors

are expected to follow suit [36].

Most pharmaceutical companies offer

‘‘patient assistance programs’’ that provide

free or low-cost medications to those who

cannot afford them. New resources in the

US, including NeedyMeds.com and RxAs-

sist.org, have made information about

these patient assistance programs more

accessible. Although some patients have

found these programs cumbersome, time-

consuming, and difficult to navigate, many

clinics help patients facilitate their appli-

cations.

Many American and Canadian hospi-

tals and medical centers have begun to

replace samples with voucher systems. At

the University of Michigan, the University

of Pennsylvania, the University of Wis-

consin, and the Puget Sound Health

Alliance, for example, physicians give

patients drug vouchers, which are then

filled without charge by the hospital

pharmacy [37]. This system allows pa-

tients to leave the hospital with a trial

supply of medication in hand while

ensuring adequate documentation and

tracking. Yet some US institutions, appre-

ciating the cost implications, have taken a

bold step and have barred their physicians

from giving free samples or vouchers to

patients [38,39].

A Call for Change

It is unrealistic to expect pharmaceuti-

cal companies to give up one of their most

potent marketing techniques voluntarily.

Thus, if we are convinced that using free

samples is counterproductive in terms of

the quality and cost of care, only the

medical profession can seek a halt to the

practice. The voucher approach is an

improvement over our current method of

sample distribution, but we favor having

our institutions eliminate the use of

samples. We call on medical societies,

including the American Medical Associa-

tion, to educate their practitioner mem-

bers about alternatives to free samples and

to re-examine their guidelines on accep-

tance of samples.

The tradition of physicians dispensing

samples has many serious disadvantages

and is as anachronistic as bloodletting and

high colonic irrigations. As the profession

begins to slowly extract itself from the

influential grip of industry, it must also

deal with the undue influence of free

samples.

Author Contributions

ICMJE criteria for authorship read and met: SC

JPK. Wrote the first draft of the paper: SC.

Contributed to the writing of the paper: SC

JPK. Rewrote the first draft and edited

subsequent drafts: JPK.

References

1. Johnson K (2008) PhRMA defends distribution of pharmaceutical samples. Available: http://www.

phrma.org/news_room/press_releases/phrma_

defends_distribution_of_pharmaceutical_samples. Accessed 2 April 2009.

2. Johnson K (2008) PhRMA statement on free

pharmaceutical samples. Available: http://www. phrma.org/news_room/press_releases/phrma_

statement_on_free_pharmaceutical_samples/. Accessed 2 April 2009.

3. Cutrona SL, Woolhandler S, Lasser KE, Bor DH,

McCormick D, et al. (2008) Characteristics of recipients of free prescription drug samples: A

nationally representative analysis. Am J Pub Health 98: 284–289.

4. Limcangco MR, Stuart B, Briesacher B (2003) Do

physicians use drug samples to increase access for needy patients? [abstract]. Academy Health Annual

Meeting; 27 June 2003; Nashville, Tennessee, United States. Available: http://gateway.nlm.nih.

gov/MeetingAbstracts/ma?f = 102275615.html.

Accessed 2 April 2009.

5. Morelli DM, Koenignsberg MR (1992) Sample

medication dispensing in a residency practice.

J Fam Pract 34: 42–48.

6. Westfall JM, McCabe J, Nicholas RA (1997)

Personal use of drug samples by physicians and

office staff. JAMA 278: 141–143.

7. Tong KL, Lien C (1995) Do pharmaceutical representatives misuse their drug samples? Can

Fam Physician 41: 1363–1366.

8. Backer EL, Lebsack JA, Van Tonder RJN,

Crabtree BF (2000) The value of pharmaceutical representative visits and medication samples in

community-based family practices. J Fam Pract 49: 811–816.

9. Topol EJ (2004) Failing the public health— Rofexicob, Merck, and the FDA. N Engl J Med

351: 1707–1709.

10. Cutrona SL, Woolhandler S, Lasser KE, Bor DH,

Himmelstein DU, et al. (2008) Free drug samples in the United States: Characteristics of pediatric

recipients and safety concerns. Pediatrics 122: 736–742.

11. Poser S (2007) Unlabeled prescription drug samples and the ‘learned intermediary’: The case

for liability without preemption. Food Drug Law J 62: 653–694.

12. [No authors listed] (2006 November 30) Verispan Reports: Samples have the most influence on

physicians’ prescribing habits. Business Wire.

Available: http://findarticles.com/p/articles/ mi_m0EIN/is_/ai_n27070393. Accessed 2 April

2009.

13. Morgan MA, Dana J, Loewenstein G, Zinberg S,

Schulkin J (2006) Interactions of doctors with the

pharmaceutical industry. J Med Ethics 32:

559–563.

14. Groves KEM, Sketris I, Tett SE (2003) Prescrip- tion drug samples—Does this marketing strategy

counteract policies for quality use of medicines?

J Clin Pharm Ther 28: 259–271.

15. Peay MY, Peay ER (1988) The role of commer- cial sources in the adoption of a new drug. Soc Sci

Med 26: 1183–1189.

16. Adair RF, Holmgren LR (2005) Do drug samples influence resident prescribing behavior? A ran-

domized trial. Am J Med 118: 881–884.

17. Chew LD, O’Young TS, Hazlet TK, Bradley KA, Maynard C, et al. (2000) A physician survey of

the effect of drug sample availability on physi-

cians’ behavior. J Gen Intern Med 15: 478–483.

18. [No authors listed] (2006) Samples. Café Pharma

message boards. Available: http://www.cafepharma.

com/boards/showthread.php?t = 109012. Accessed 7 April 2009.

19. [No authors listed] (2007) Restricting samples.

Café Pharma message boards. Available: http:// www.cafepharma.com/boards/showthread.

php?t = 116272. Accessed 2 April 2009.

20. Petersen M (2000) Growing opposition to free drug samples; Ultimate costs and safety are cited. The

New York Times. Available: http://query.nytimes.

com/gst/fullpage.html?sec = health&res = 9800E5

Figure 2. Factors driving growth in drug spending, 1993–2003. doi:10.1371/journal.pmed.1000074.g002

Essay

PLoS Medicine | www.plosmedicine.org 3 May 2009 | Volume 6 | Issue 5 | e1000074

DC163BF936A25752C1A9669C8B63. Accessed

2 April 2009.

21. Alexander GC, Zhang J, Basu A (2008) Charac-

teristics of patients receiving pharmaceutical

samples and association between sample receipt

and out-of-pocket prescription costs. Med Care

46: 394–402.

22. Rosenthal MB, Berndt ER, Donohue JM,

Frank RG, Epstein AM (2002) Promotion of

prescription drugs to consumers. N Engl J Med

346: 498–505.

23. Gagnon M-A, Lexchin J (2008) The cost of

pushing pills: A new estimate of pharmaceutical

promotion expenditures in the United States.

PLoS Med 5: e1. doi:10.1371/journal.pmed.

0050001.

24. IMS Health (2004) Total US promotional spend

by type, 2003. Fairfield (CT): IMS Health.

25. Ipsos Ideas Library (2003) Is direct-to-consumer

advertising for drug samples effective? Available:

http://www.ipsos-ideas.com/article.cfm?id = 2139.

Accessed 2 April 2009.

26. Kaiser Family Foundation (2008) Prescription

drug trends. Available: http://www.kff.org/

rxdrugs/upload/3057_07.pdf. Accessed 2 April

2009.

27. Pear R (2006 January 10) Growth of national

health spending slows along with drug sales. The

New York Times. Available: http://www.nytimes.

com/2006/01/10/national/10health.html. Ac-

cessed 2 April 2009. 28. Kaiser Family Foundation (2004) Prescription

drug trends. Available: http://www.kff.org/

rxdrugs/upload/Prescription-Drug-Trends-Octo- ber-2004-UPDATE.pdf. Accessed 2 April 2009.

29. The National Institute for Health Care Manage- ment Research and Educational Foundation

(2001) Prescription drugs and mass media adver-

tising, 2000. Available: http://www.nihcm.org/ ñihcmor/pdf/DTCbrief2001.pdf. Accessed 2

April 2009. 30. The National Academies, Institute of Medicine

(2006) Medication errors injure 1.5 million people and cost billions of dollars annually; Report offers

comprehensive strategies for reducing drug-relat-

ed mistakes. Available: http://www8.nationala- cademies.org/onpinews/newsitem.aspx?Recor-

dID = 11623. Accessed 2 April 2009. 31. American Society of Health-System Pharmacists

(2006) Drug samples (policy position 9702).

Available: http://www.ashp.org/s_ashp/doc1c. asp?CID = 512&DID = 7300#9702. Accessed 2 April 2009.

32. Charatan F (2000) Hospital bans free drug

samples. West J Med 174: 236–237. 33. Association of American Medical Colleges (2008)

Industry funding of medical education: Report of

an AAMC Task Force. Available: https://servic- es.aamc.org/Publications/showfile.cfm?file = ver-

sion114.pdf&prd_id = 232&prv_id = 281&pd-

f_id = 114. Accessed 2 April 2009. 34. Association of Faculties of Medicine of Canada

(2008) Association of Faculties of Medicine of

Canada Endorses AAMC policies regarding industry funding of medical education. Available:

http://www.afmc.ca/news-whats-new-details-e. php?id = 85. Accessed 2 April 2009.

35. Rx Outreach (2009) Patient assistance program

for discount prescription drugs. Available: http:// rxoutreach.com. Accessed 2 April 2009.

36. Associated Press (2006 October 26) Wal-Mart adds 12 states to $4 generic drug plan; Total now 27.

USA Today. Available: http://www.usatoday. com/money/industries/retail/2006-10-26-walmart-

drugs_x.htm. Accessed 2 April 2009.

37. The Prescription Project (2008) Samples: Best practices for academic medical centers. Available:

http://www.imapny.org/usr_doc/amc/Samples. doc. Accessed 2 April 2009.

38. Jordan E (2009 January 23) U of I to bar free drug

samples, gifts. DesMoines Register. Available: http://www.pharmfree.org/news?id = 0022. Ac-

cessed 2 April 2009. 39. University of Wisconsin-Madison (2009) Policy

recommendations from the Task Force on Industry Conflict of Interest in the Clinical

Setting. Available: http://media.jsonline.com/

documents/uwdocsclinical022709.pdf. Accessed 2 April 2009.

Essay

PLoS Medicine | www.plosmedicine.org 4 May 2009 | Volume 6 | Issue 5 | e1000074