UpdateonDevelopmentsattheUSFDA_DrugDisposalLabeling.ppt

1、Drug Disposal Labelingto Improve SafetyFDA 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,

2、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 Ill Talk About Today,FDA roles related to prescription drug disposal Assessing and managing risks during the drug product lifecycle Disposal instructions in

3、 labeling as a risk mitigation strategy for certain drugs. New legal authorities to improve drug safety Update on related FDA activities,FDAs Mission is to ensure that,Americans have access to safe and effective drug products Foods are safe, wholesome, and properly labeled Blood used for transfusion

4、s and blood products are safe the right dose differentiates a poison from a remedy Paracelsus, circa 1538,Drug Approval,Safe and effective for use as described in product label Products benefit outweighs its risk,Risk Assessment During Product Lifecycle,Risk Management*,The overall and continuing pr

5、ocess of minimizing risks throughout a products 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 Disposa

6、l 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

7、 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 o

8、ral 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 ch

9、anges 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 ma

10、y 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 Expe

11、cted 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 pr

12、oducts,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 overdos

13、e 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 d

14、isposal 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

15、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 d

16、isposal labeling policy Identifying and assessing sources of risk data to develop evidence-based policy guidance,Office of National Drug Control Policy/drugfact/factsht/proper_disposal.html,FDA Consumer Health Information June 23, 2008,/consumer/upd

17、ates/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 childre

18、n 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 t