Transcript Drug Dispoal and risk Minimization

Drug Disposal Labeling
to Improve Safety
FDA Update on Drug Disposal Labeling Activities
James R. Hunter, R.Ph., MPH
Controlled Substance Staff
Center for Drug Evaluation and Research
Office of the Center Director
Food and Drug Administration
5th Annual Unused Drug Return Conference
November 11, 2008
The opinions and information in this
presentation are those of the author and
do not necessarily reflect the views and
policies of the FDA
What I’ll Talk About Today…
• FDA roles related to prescription drug
disposal
• Assessing and managing risks during the
drug product lifecycle
• Disposal instructions in labeling as a risk
mitigation strategy for certain drugs.
• New legal authorities to improve drug
safety
• Update on related FDA activities
FDA’s Mission is to ensure that…
 Americans have access to safe and effective drug
products
 Foods are safe, wholesome, and properly labeled
 Blood used for transfusions and blood products are
safe & in adequate supply
 Medical devices are safe & effective
 Transplanted tissues are safe & effective
 Animal drugs and medicated feeds are safe &
effective, and food from treated animals is safe for
human consumption
 Radiation-emitting electronic products are safe
 Cosmetics are safe & properly labeled
FDA is an active Stakeholder in Drug
Disposal Issues
• Federal/State Entities:
–
–
–
–
–
–
–
Environmental Protection Agency
Drug Enforcement Administration
Office of National Drug Control Policy
Substance Abuse and Mental Health Services Administration
U.S. Postal Service
U.S. Fish and Wildlife
State Regulatory Authorities
• Non-Government Organizations:
– American Pharmacists Association
– News media, press
– Organizations representing local disposal initiatives
FDA Roles related to Drug Disposal
• Assessing environmental impact of new
drug products
– Part of the NDA approval process
– Exposure based on estimated drug use
• Prescription drug product labeling
– Drug disposal information not routinely included
– Typically not required
– Usually included to improve products safety profile
"All substances are poisonous, there is none
which is not a poison; the right dose differentiates
a poison from a remedy"
Paracelsus, circa 1538
Drug Approval
• Safe and effective for use as described in
product label
• Product’s benefit outweighs its risk
Risk Assessment During Product
Lifecycle
Clinical Research
& Development
PreClinical I
Testing N
D
R&D
Post-Marketing
Surveillance
Phase I
N
D Phase IV
A
Phase II
Phase III
Risk Management*
• The overall and continuing process of
minimizing risks throughout a product’s
lifecycle to optimize its benefit/risk balance
*
From the Concept Paper on Risk Management Programs
Routine Risk Minimization
• Labeling (package insert) is the cornerstone of
routine risk management efforts for most drugs
approved by the FDA
Drug Disposal Instructions in FDA Drug
Product Labeling
•
Voluntary
– not usually required
•
Usually included to increase safety
– Drug Product Specific
– Comparison of risks and benefits suggests
product disposal instructions improve benefit-risk
balance.
– When health care professional or patients must
take special steps that are “unusual” for safety
•
Required (New!)
-
If included in Risk Evaluation and Mitigation
Strategy
Types of Patient Information Labeling
• Package Insert (PI)
– Practitioner to patient instruction
• Patient Package Insert (PPI)
– May be part of PI or separate document
– Voluntary distribution except for oral contraceptives
and estrogen products
• Medication Guide (MG)
– FDA-approved patient labeling
– Dispenser required to provide MG when product is
dispensed
FDAAA (New 2008!)
• FDA Amendments Act of 2007 gives
New Authorities
– May require:
• Postmarketing studies and clinical trials
• Safety related labeling changes
• Risk Evaluation and Mitigation Strategies
(REMS)
What is a REMS?
• A Risk Evaluation and Mitigation
Strategy (REMS) is a required risk
management plan that utilizes tools
beyond routine labeling to ensure that
the benefits of a drug outweigh its
risks.
– Always includes a medication guide which
may contain specific disposal instructions.
• Scope
REMS
– Prescription drug and biologics only
• Before Approval REMS
– FDA requires sponsor to submit a REMS
– REMS needed to ensure that the benefits outweigh the risks of
the drug
– Considerations
• Size of population likely to use drug
• Seriousness of disease
• Expected benefit of the drug
• Post-Approval REMS
– New safety information shows REMS necessary to ensure that
the benefits outweigh the risks of the drug
– FDA determines REMS is needed
– FR Notice FDA-2008N-0174 (March 27, 2008): Identification of
Drug and Biological Products “Deemed” to have REMS, 16 drug
products
Disposal Instructions for Controlled
Substances
• Disposal instructions usually a part of a more
comprehensive risk mitigation strategy
– Not included in all products containing controlled substances
– Potency and formulation contribute to varying potential for
misuse, abuse, and accidental overdose
• Dangerous amounts of residual drug after use (Fentanyl
transdermal patch)
• High potency formulations (Extended release oxycodone, fentanyl
buccal tablets)
• High likelihood of misidentification: Actiq (fentanyl citrate) looks like
candy and Xyrem (sodium oxybate) is clear liquid at bedside.
– Goal of disposal is to minimize exposure risk of potentially lethal
drug to non-patients
• Make drug completely unavailable upon disposal
• Disposal by Flushing
• “Take-back” disposal option in FDA labeling limited by CSA
Fentanyl Buccal Tablet Disposal
Instructions
Recent Activities
• Identifying FDA approved drug product
labeling with drug disposal information
– drug label review
• Assessing content and consistency of drug
disposal information in product labeling
– Sponsor-initiated labeling includes take-back disposal option
• Developing guidance for FDA reviewers and
drug product sponsors
– Actively assessing drug disposal labeling policy
– Identifying and assessing sources of risk data to develop
evidence-based policy guidance
Office of National Drug Control Policy
http://www.whitehousedrugpolicy.gov/drugfact/factsht/proper_disposal.html
FDA Consumer Health Information
June 23, 2008
http://www.fda.gov/consumer/updates/drug_disposal062308.html
FDA Supports Drug Take-Back Programs
Store REYATAZ Capsules at room temperature, 59° to 86° F (15° to 30° C).
Do not store this medicine in a damp place such as a bathroom medicine
cabinet or near the kitchen sink.
Keep your medicine in a tightly closed container.
Keep all medicines out of the reach of children and pets at all times.
Do not keep medicine that is out of date or that you no longer need.
Dispose of unused medicines through community take-back disposal
programs when available or place REYATAZ in an unrecognizable,
closed container in the household trash.
Summary
• FDA is focusing increased attention to drug disposal issues and
continues to work closely with our federal partners
• FDA supports the safe disposal methods as described in the Federal
Drug Disposal Guidelines.
• For a limited number of higher risk products containing controlled
substances, disposal instructions are necessary to improve safety.
• FDA has new authorities that could require sponsors to include drug
disposal instructions as an added safety measure.
• FDA supports take-back programs, recognizing current limitations
under in the CSA to collect controlled drug products.
• FDA is actively working to develop drug disposal labeling policies
that account for the risk associated with products that are disposed
of improperly.
Safety First!