Transcript Overstamp Guidelines

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 Chawla
Manager, State Government Relations
Celgene Corporation
Presented at the 2008 International Symposium on Pharmaceuticals in the Home and Environment: Catalysts for Change, November 10-11, 2008 and to be used
for this purpose only. Please do not forward
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
Presented at the 2008 International Symposium on Pharmaceuticals in the Home and Environment: Catalysts for Change, November 10-11, 2008 and to be used
for this purpose only. Please do not forward
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
Presented at the 2008 International Symposium on Pharmaceuticals in the Home and Environment: Catalysts for Change, November 10-11, 2008 and to be used
for this purpose only. Please do not forward
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)
Presented at the 2008 International Symposium on Pharmaceuticals in the Home and Environment: Catalysts for Change, November 10-11, 2008 and to be used
for this purpose only. Please do not forward
Risk Management Options
Risk
Interventions
Risk
comm.
Packaging
restrictions
Informed
consents
 Labeling
 Box warnings
 Medication guides
 Patient labeling
 Dear Dr. letters
 Health advisories
 Educational forums
 Posting of papers
 Sales force outreach
Voluntary
efforts
Managed
distribution
Product
withdrawal
Monitoring
adverse events
Presented at the 2008 International Symposium on Pharmaceuticals in the Home and Environment: Catalysts for Change, November 10-11, 2008 and to be used
for this purpose only. Please do not forward
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.
Presented at the 2008 International Symposium on Pharmaceuticals in the Home and Environment: Catalysts for Change, November 10-11, 2008 and to be used
for this purpose only. Please do not forward
Adopted RiskMap Programs
S.T.E.P.S.®
RevAssist®
System for Thalidomide
Education and
Prescribing Safety
RevAssist® program for
Revlimid education and
prescribing safety
Approved in 1998
Approved in 2005
Presented at the 2008 International Symposium on Pharmaceuticals in the Home and Environment: Catalysts for Change, November 10-11, 2008 and to be used
for this purpose only. Please do not forward
S.T.E.P.S. RiskMAP Overview
• Goal:
– Prevent fetal exposure
• Program Components:
– Education
• Physicians, nurses and pharmacists
• Patients
– Active risk aversion
– Controlled distribution
Presented at the 2008 International Symposium on Pharmaceuticals in the Home and Environment: Catalysts for Change, November 10-11, 2008 and to be used
for this purpose only. Please do not forward
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
Presented at the 2008 International Symposium on Pharmaceuticals in the Home and Environment: Catalysts for Change, November 10-11, 2008 and to be used
for this purpose only. Please do not forward
Patient Return of Unused Thalomid®
Also a Part of S.T.E.P.S.®
• Patients contact Celgene Customer Care at 1-888423-5436
• 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
Presented at the 2008 International Symposium on Pharmaceuticals in the Home and Environment: Catalysts for Change, November 10-11, 2008 and to be used
for this purpose only. Please do not forward
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
Presented at the 2008 International Symposium on Pharmaceuticals in the Home and Environment: Catalysts for Change, November 10-11, 2008 and to be used
for this purpose only. Please do not forward
Drug Repositories
• 28 state programs
• Programs differ by state
–
–
–
–
Cancer-specific
Drugs eligible for donation
Donating entities
Receiving entities
Presented at the 2008 International Symposium on Pharmaceuticals in the Home and Environment: Catalysts for Change, November 10-11, 2008 and to be used
for this purpose only. Please do not forward
States with Drug
Donation/Repository Programs
General Drug Donation/Repository Program
Cancer-specific Program
Both General and Cancer-specific Programs
Presented at the 2008 International Symposium on Pharmaceuticals in the Home and Environment: Catalysts for Change, November 10-11, 2008 and to be used
for this purpose only. Please do not forward
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)
Presented at the 2008 International Symposium on Pharmaceuticals in the Home and Environment: Catalysts for Change, November 10-11, 2008 and to be used
for this purpose only. Please do not forward
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
Presented at the 2008 International Symposium on Pharmaceuticals in the Home and Environment: Catalysts for Change, November 10-11, 2008 and to be used
for this purpose only. Please do not forward
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
Presented at the 2008 International Symposium on Pharmaceuticals in the Home and Environment: Catalysts for Change, November 10-11, 2008 and to be used
for this purpose only. Please do not forward
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
Presented at the 2008 International Symposium on Pharmaceuticals in the Home and Environment: Catalysts for Change, November 10-11, 2008 and to be used
for this purpose only. Please do not forward
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
Presented at the 2008 International Symposium on Pharmaceuticals in the Home and Environment: Catalysts for Change, November 10-11, 2008 and to be used
for this purpose only. Please do not forward
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 drugspecific 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
Presented at the 2008 International Symposium on Pharmaceuticals in the Home and Environment: Catalysts for Change, November 10-11, 2008 and to be used
for this purpose only. Please do not forward
Thank you
Questions?
Presented at the 2008 International Symposium on Pharmaceuticals in the Home and Environment: Catalysts for Change, November 10-11, 2008 and to be used
for this purpose only. Please do not forward