The Ethics of Sampling and Drug Diversion

1. The Ethics of Sampling and Drug Diversion

2. 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 History of Drug Samples

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. 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.) Government Regulations

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 company’s 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 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?

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 they’re 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.