drug disposal labeling to improve safety fda update on drug disposal labeling activities james r....
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Drug Disposal Labelingto Improve Safety
FDA Update on Drug Disposal Labeling Activities
James R. Hunter, R.Ph., MPHControlled 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…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
Benefits Risks
Drug Approval
• Safe and effective for use as described in product label
• Product’s benefit outweighs its risk
Pre-ClinicalTesting
R&D
IND
Clinical Research & Development
Post-MarketingSurveillance
Phase I
Phase III
Phase II
NDA
Phase IV
Risk Assessment During Product Lifecycle
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.
REMS• Scope
– 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 Policyhttp://www.whitehousedrugpolicy.gov/drugfact/factsht/proper_disposal.html
FDA Consumer Health Information June 23, 2008
http://www.fda.gov/consumer/updates/drug_disposal062308.html
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.
FDA Supports Drug Take-Back Programs
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!