The Ethics of Sampling and Drug Diversion - PowerPoint PPT Presentation

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The Ethics of Sampling and Drug Diversion

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Influence of samples can lead to prescription of brand name drugs instead of generics ... Prevent diversion of prescription drugs ... – PowerPoint PPT presentation

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Title: 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.
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