REMS and Pharmacy Continuing Education
Peter H. Vlasses, PharmD, DSc (Hon.), BCPS Executive Director
Food and Drug Administration Center for Drug Evaluation and Research Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee & Drug Safety and Risk Management Advisory Committee UMUC Conference Center at the Marriot, Adelphi, MD July 22, 2010, 3 pm
REMS Elements & Pharmacy
MEDICATION GUIDE – Document written for patients highlighting important safety information about the drug; this document must be distributed by the pharmacist pharmacist to every patient receiving the drug. COMMUNICATION PLAN – Plan to educate healthcare professionals educate healthcare professionals on the safe and appropriate use of the drug and consists of tools and materials that will be disseminated to the appropriate stakeholders. ELEMENTS TO ASSURE SAFE USE (EASU) – These are strictly controlled systems or requirements put into place to enforce the appropriate use of a drug. Examples of EASUs include distribution of the drug restricted to certain specialty pharmacies specialty pharmacies. IMPLEMENTATION PLAN – A description of how certain EASUs will be implemented. TIMETABLE FOR SUBMISSION OF ASSESSMENTS – The frequency of assessment of the REMS performance assessment of the REMS performance with regard to meeting the goal(s) and
- bjective(s). FDA requires that assessments be conducted at 18 months, 3
years, and 7 years post-launch, at a minimum.
Overview
- Introduction to ACPE
- Continuing Pharmacy Education
(CPE)
- CPE Accreditation Data
- REMS and CPE: An Opportunity
- Questions and Answers
ACPE
- National agency for accreditation of
pharmacy education
- ACPE accredits:
– Professional degree programs (i.e., Doctor of Pharmacy degree, Pharm D) Recognized by:
- U.S. Department of Education
- Council on Higher Education Accreditation (CHEA)