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The Ethics of Sampling and
Drug Diversion
History of Drug Samples
– Originally introduced to allow patients to confirm
that they had no adverse reaction to prescription
medication
– Became viewed as a valuable promotional tool
– Also used as a way to subsidize treatment for
patients who have trouble affording medicine
Effectiveness of Sampling
– In 2001, over $10B spent on sampling (~64% of
all industry spending focused on prescribers)
– 2002 study revealed over 70% of physicians
more likely to prescribe a drug when samples
available during office visit
IMS HEALTH Public Affairs (April 1, 2002). “IMS Study: U.S. Physicians Responsive to Patient Requests for BrandName Drugs”. Press Release. Retrieved on 2008-10-04.
– Influence of samples can lead to prescription of
brand name drugs instead of generics
Andrews, Michelle (September 5, 2008). “An Unexpected Cost of Using Free Drug Samples”. U.S. News and World
Report.
Ethical Question
Is the current usage of drug
samples within the
healthcare industry ethical?
Government Regulations
 21 CFR Part 203
– Prescription Drug Marketing Act of 1987 (PDMA)
• Federal response to 1985 report from Congressional Committee on
Energy and Commerce that concluded that “American consumers can
no longer purchase prescription drugs with the certainty that the
products are safe and effective” and that “the integrity of the distribution
system is insufficient to prevent the introduction of substandard,
ineffective, or counterfeit drugs.”
http://www.pdmaalliance.org/history.html
• Updated over the last 20 years to account for changes in the
pharmaceutical industry (technology, etc.)
PDMA
 Goals
– Prevent diversion of prescription drugs
– Ensure that drugs sold in the U.S. are safe
and effective
– Increase safeguards against sale of
adulterated, misbranded, or counterfeit drugs
– Prevent sale and abuse of drug samples
provided by pharmaceutical companies
Ethical Responsibility
 Pharmaceutical companies may sample “any
person licensed or authorized by state law to
prescribe drugs”
 Pharmaceutical companies are responsible for
verifying status of licensed prescribers and
preventing diversion of their drug samples
 Violations are monitored and handled by the
FDA, and can result in fines and/or prison time
(21 CFR 203.3(r))
Ethical Question
What aspects should be
included in a pharmaceutical
company’s sample
accountability program?
Example of Sample
Accountability Program Aspects
 Prescriber signature verification program
 Confirmation of prescriber state license status
 Sample storage locations kept on file and
audited annually
 Reconciliation of sales representative sample
inventory each month/quarter
 Reconciliation of all samples sent
 Require signature of representatives when
receiving samples
 Regular training and recertification of sales force
Current Events
 2006 ruling by North Carolina Dept. of
Revenue include samples when
determining property tax for medical
offices since they are not inventory (not
sold for profit)
 North Carolina Medical Society (NCMS)
working to have samples excluded
www.ncmedsoc.org (June 20, 2008). “NCMS Bulletin, Vol. 59, Issue 25”. Retrieved on 2008-10-4.
Drug Diversion
 DEA describes it as the struggle of
balancing the need to provide medications
to improve the quality of life while working
to prevent the diversion of those
substances and the chemicals used to
make them for illegal use.
 Drug Diversion Video
Drug Diversion
 What are some of the ethical issues
brought up by the video?
 Who is responsible for controlling the
product once it is dispensed?
Drug Diversion
 “Diverters” – Often small brokers who
purchase drug intended for nursing
homes, hospices, and AIDS clinics.
 Drugs are sold at a discount to retail, but
these brokers are not to sell to the general
public.
 The drugs are then sold back to the
controlled market or through internet
pharmacies.
U.S. Prescription Drug System Under Attack; Multibillion-Dollar Shadow Market Is Growing Stronger; [FINAL Edition 1] Gilbert M. Gaul and Mary Pat
Flaherty. The Washington Post. Washington, D.C.: Oct 19, 2003. pg. A.01
Drug Diversion
 Diverted drugs may be stored improperly or
tampered with. In St. Charles, Mo., a cancer
patient received diluted medicine.
 The networks set-up to sell diverted drug also
allow for counterfeit drugs to enter the market.
 The PDMA, when passed in 1987, required a
pedigree for all drug showing prior sales.
Smaller wholesalers fought enactment of the
requirement for 15 years.
Drug Diversion
 States have enacted laws requiring
electronic pedigree but the required dates
for complying with the laws have been
pushed back numerous times.
 A number of drug makers have serialized
drug product using RFID tags to help with
their supply chain and to prevent
diversion.
Pain Management
 OxyContin and other opioid pain
medicines have brought about new
concerns related to drug diversion.
– Over-Prescription – Complaints from
Pharmacists, Governmental Agencies, Family
Members.
– Under-Prescription – Family Members and
Patients.
– Criminal vs. Standard of Care
Diane E Hoffmann, Anita J Tarzian. "Achieving the right balance in oversight of physician opioid prescribing for pain: The role of state
medical boards. " The Journal of Law, Medicine & Ethics 31.1 (2003): 21-23,7-8,24-40,4-5. Research Library Core. ProQuest. 6 Oct.
2008
Pain Management
 The four ethical principles for clinical
guidance apply to Pain Management:
– Respect for Patients Autonomy
– Beneficence
– Nonmaleficence
– Justice
 What other examples of these principles
would you apply to pain management?
Diversion of AIDS Drugs
 Serostim is a bioengineered human growth
hormone that is prescribed to prevent wasting in
AIDS patients.
 According to New York States Medicare fraud
unit it makes up 40-50% of the cost of diverted
drugs in New York State.
 Abused by Body Builders to gain muscle mass,
AIDS patients sell it on the black market for less
then the retail cost, often selling up to ¾ of their
supply.
THOMAS ZAMBITO DAILY NEWS STAFF WRITER. "PUMPED BY AIDS DRUG Some bodybuilders break the law to score Serostim :[SPORTS FINAL Edition
2]. " New York Daily News [New York, N.Y.] 2 Jun 2003, 5. ProQuest National Newspapers Premier. ProQuest. 11 Oct. 2008
Diversion of AIDS Drugs
 Federal prosecutors targeted Serono, the drug
maker, for their marketing practice.
 New York state’s Medicare office made it priority
for investigation.
 Serono in response changed how they
monitored their supply chain.
 Medicare in New York has seen their bill for
Serostim drop from $50 million to $20 million.
 Serono has seen a drop in sales to $95 million
from $125 million in 2001.
 Who’s responsible for preventing diversion?
Performance Enhancing Drugs
 Cycling is one of the most cited examples
of doping in sports.
 EPO provided cyclist with a 5 to 15%
increase in performance.
 Cyclist are the most tested professional
athletes, but the dopers are often ahead of
the testers.
Performance Enhancing Drugs
 What is the responsibility of drug makers?
– Amgen was asked in the past to add markers
to EPO. They responded "It would essentially
be a new drug, Changing the drug would
change what is put into the human body …
We're not in the drug-testing business. We
develop human therapeutics for sick people."
– Roche responded this year by provided
they’re new CERA compound to WADA
before the drug was approved.
Performance Enhancing Drugs
 Should there be testing in amateur sports?
– What constitutes performance enhancing
drugs in amateur athletes? EPO, HGH?
What about common cold medicines, caffeine,
etc.?
– US Masters Swimming is pushing for
increased education on ethics and health
risks.
– Is taking hormones to counter treatment for
prostate cancer doping?
Conclusion
 Technology is allowing companies and
governmental agencies to catch those
trying to cheat the system more frequently
and earlier.
 However, companies are going to have to
be willing to make hard ethical choices to
ensure that drug product is not diverted in
their supply chain.