Special Considerations for Unused Drugs Subject to Restricted Distribution Programs

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Special Considerations for Unused Drugs Subject
to Restricted Distribution Programs

• Presented at the 2008 International Symposium on
  Pharmaceuticals in the Home and Environment
  Catalysts for Change, November 10-11, 2008
• Colleen ChawlaManager, State Government
  RelationsCelgene Corporation

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About Celgene

• A global biopharmaceutical company dedicated to
  helping healthcare providers turn incurable blood
  cancers into chronic, manageable diseases.
• Five FDA-approved products
• More than 2,300 employees worldwide
• Based in Summit, NJ

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Why is Celgene Interested in the Issue of Unused
Pharmaceuticals?

• Commitment to patient safety
• Drugs are subject to FDA-mandated restricted
  distribution programs created by Celgene in
  cooperation with the FDA and intended to protect
  patients
• Absent proper precautions, some proposed
  solutions could circumvent FDA-mandated
  restricted distribution programs and create
  serious health risks for patients or others
• Drug Collection and Takeback Programs
• Drug Repository/Reuse Programs

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What is a Restricted Distribution Program?

• 15 drugs are required by the FDA to have Risk
  Minimization Action Plans (RiskMAPs)
• Strategic safety programs designed to meet
  specific goals and objectives in minimizing
  product risks while preserving its benefits.
• A handful of those meet these goals by using
  restricted distribution programs

following the Food and Drug Administration
Amendments Act of 2007, referred to as Risk
Evaluation and Mitigation Strategies (REMS)
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Risk Management Options
Risk Interventions
Risk comm.
Packaging restrictions
Informed consents
Managed distribution
Product withdrawal
Voluntary efforts
Monitoring adverse events

• Labeling
• Box warnings
• Medication guides
• Patient labeling
• Dear Dr. letters
• Health advisories
• Educational forums
• Posting of papers
• Sales force outreach

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Two Examples of Restricted Distribution Drugs

• Thalomid (thalidomide)
• First approved in the US in 1998 for the
  treatment of certain conditions associated with
  Erythema Nodosum Leprosum, and, approved in 2006,
  for the treatment of patients with newly
  diagnosed multiple myeloma.
• A known human teratogen.
• Revlimid (lenalidomide)
• Approved in 2005 for certain types of
  myelodysplastic syndromes and, in 2006, for the
  treatment of multiple myeloma patients who have
  received at least one prior therapy.
• An analogue of thalidomide.

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Adopted RiskMap Programs

• S.T.E.P.S.
• System for Thalidomide Education and Prescribing
  Safety
• Approved in 1998

• RevAssist
• RevAssist program for Revlimid education and
  prescribing safety
• Approved in 2005

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S.T.E.P.S. RiskMAP Overview

• Goal
• Prevent fetal exposure
• Program Components
• Education
• Physicians, nurses and pharmacists
• Patients
• Active risk aversion
• Controlled distribution

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S.T.E.P.S.

• System for Thalidomide Education and Prescribing
  Safety S.T.E.P.S.
• Clear product labeling
• Required registration of all prescribers,
  patients, and pharmacists
• A patient acknowledgement / informed consent form
  
• Authorization validation prior to dispense
• A required telephonic survey for patients and
  prescribers
• Required pregnancy testing in females of
  childbearing potential
• Compliance with measures to prevent pregnancy
• Educational brochure and video tape
• Patient counseling
• Restricted prescriptions
• Distribution of Thalomid from Celgene only to
  registered pharmacies

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Patient Return of Unused Thalomid Also a Part of
S.T.E.P.S.

• Patients contact Celgene Customer Care at
  1-888-423-5436
• Customer Care gathers information on the drug to
  be returned and issues Return Authorization
• Customer Care mails a prepaid UPS mailing label
  to use for return of the drug
• Patient returns the drug via UPS
• At the warehouse, returned drug cross-referenced
  with Return Authorization
• Information logged into database
• Returned product incinerated in accordance with
  local laws

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State Efforts Targeting Unused Drugs

• Drug Donation/Repository Programs
• Allow individuals or institutions to donate
  unused medications so that they may be
  re-dispensed to patients in need
• Drug Take-back Programs
• Provide for the collection of unused medications
  for proper disposal

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Drug Repositories

• 28 state programs
• Programs differ by state
• Cancer-specific
• Drugs eligible for donation
• Donating entities
• Receiving entities

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States with Drug Donation/Repository Programs
General Drug Donation/Repository
Program Cancer-specific Program Both General and
Cancer-specific Programs
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Drug Take-back Programs

• Iowa and Maine have enacted take-back legislation
• Many other states have considered legislation
  (CA, MA, IL, NY, OR, PA, VA, WA, WI)

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Why Should Restricted Distribution Drugs be
Treated Differently?

• To protect patient safety
• In the case of Thalomid and Revlimid, no fetal
  exposure
• Compliance with handling restrictions
• To protect public safety
• Ensure safe handling
• Avoid diversion

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Why Should Restricted Distribution Drugs be
Treated Differently? (cont.)

• To ensure adherence to FDA-mandated restricted
  distribution programs
• Designed to protect patients
• Deviation compromises patient protections
• Restricted distribution programs may provide for
  the safe return and disposal of drugs by patients
• Utilization of existing return programs allows
  for more accurate inventory control

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Why Should Restricted Distribution Drugs be
Treated Differently? (cont.)

• To avoid preventable exposures that could impact
  the availability of these drugs for those who
  need them
• Fetal exposure could cause drugs to be pulled
  from the market
• Patients that rely on these drugs would be denied
  access to these therapies
• Research on the effectiveness of these drugs for
  other diseases would cease

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Issues to Consider for Repositories and Take-back
Programs

• Repositories
• Distribution of restricted distribution drugs
  without the benefit of education, counseling, and
  other precautions could pose a significant danger
  to patients
• Specific prohibition against sharing the drug
• Liability for health care practitioners and the
  state
• Take-back Programs
• Unsafe handling could pose a significant threat
  to the public health
• Prudent to take advantage of existing programs

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Proposed Actions

• Repositories
• Exempt drugs subject to restricted distribution
  programs from being donated or re-dispensed
  through repository programs
• Take-back programs
• Direct patients and others to utilize existing
  drug-specific return programs when available
• Ensure program protocols include proper handling
  precautions (i.e., appropriate personal
  protection devices)
• Ensure disposal methods are consistent with
  manufacturer-recommended disposal

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Thank you

• Questions?