The Ethics of Sampling and Drug Diversion

1
The Ethics of Sampling and Drug Diversion
2
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

3
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 Brand-Name 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.

4
Ethical Question

• Is the current usage of drug samples within the
  healthcare industry ethical?

5
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.)

6
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

7
Ethical Responsibility

• Pharmaceutical companies may sample any person
  licensed or authorized by state law to prescribe
  drugs (21 CFR 203.3(r))
• 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

8
Ethical Question

• What aspects should be included in a
  pharmaceutical companys sample accountability
  program?

9
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

10
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.

11
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

12
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?

13
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

14
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.

15
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.

16
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

17
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?

18
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 

19
Diversion of AIDS Drugs

• Federal prosecutors targeted Serono, the drug
  maker, for their marketing practice.
• New York states 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.
• Whos responsible for preventing diversion?

20
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.

21
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 theyre new
  CERA compound to WADA before the drug was
  approved.

22
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?

23
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.