Presented at the 2008 International Symposium on Pharmaceuticals in the Home and Environment:...

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

Special Considerations for Unused Drugs Subject to Restricted Distribution Programs

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


About CelgeneAbout 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


Why is Celgene Interested in the Issue of Unused Pharmaceuticals?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


What is a Restricted Distribution Program?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)


Risk Management OptionsRisk Management Options

Riskcomm.

Packagingrestrictions

Informedconsents

Manageddistribution

Productwithdrawal

Monitoringadverse events

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

RiskInterventions

Voluntaryefforts


Two Examples of Restricted Distribution DrugsTwo 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.


Adopted RiskMap ProgramsAdopted 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


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

• Goal:– Prevent fetal exposure

• Program Components:– Education

• Physicians, nurses and pharmacists• Patients

– Active risk aversion– Controlled distribution


S.T.E.P.S.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


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


State Efforts Targeting Unused DrugsState 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


Drug RepositoriesDrug Repositories

• 28 state programs• Programs differ by state

– Cancer-specific– Drugs eligible for donation– Donating entities– Receiving entities


States with Drug Donation/Repository ProgramsStates with Drug Donation/Repository Programs

General Drug Donation/Repository Program

Cancer-specific Program

Both General and Cancer-specific Programs


Drug Take-back ProgramsDrug 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)


Why Should Restricted Distribution Drugs be Treated Differently?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


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


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


Issues to Consider for Repositories and Take-back ProgramsIssues 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


Proposed ActionsProposed 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


Thank youThank you

Questions?

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