REMS and Pharmacy pharmacist to every patient receiving the drug. - PDF document

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

Joint Commission of Pharmacy ACPE Practitioners (JCPP) Vision • Founded in 1932 for accreditation of professional Pharmacy education and continuing education will programs, by: prepare pharmacists to: – National Association of Boards of Pharmacy (NABP) (regulators) 1.provide patient-centered and population-based – American Association of Colleges of Pharmacy (AACP) care that optimizes medication therapy (educators), and 2.manage health care system resources to improve – American Pharmacists Association (APhA) (practitioners) therapeutic outcomes • Accreditation of CE Providers added in 1975; 3.promote health improvement, wellness, and accreditation of Certificate Programs (1999-2008) disease prevention • ACPE is an autonomous, independent, not-for- JCPP Vision forms basis of ACPE standards for JCPP Vision forms basis of ACPE standards for profit agency with headquarters in Chicago, IL degree programs and CPE providers degree programs and CPE providers ACPE Accredited CPE and Pharmacist Relicensure • +/- 280,000 licensed pharmacists in U.S. CPE Provider Demographics • All state or territory pharmacy boards require Group (Total n = 396) Percentage CPE for pharmacist relicensure Colleges or schools 21% • Avg. of 15 CPE hours per year required • Close to 400 ACPE-accredited CPE providers Educational companies 23% • CPE from an ACPE-accredited provider is: Hospitals, Health Care Networks 15% – accepted for mandatory licensure requirements Local, State or National Associations 21% by state boards of pharmacy Publishers, Government Agencies, etc. 20% – accepted between state boards for license transfer, or multiple licenses

www.acpe�accredit.org:�ACPE�CPE�Activity�Database Definition of CE for the Profession of Pharmacy Universal Activity Number Intended Audience 197 – 000 – 07 – 001 – L 05-T P: Pharmacist T: Pharmacy technician Provider ID Cosponsor Sequential Topic Designator (001-998) Designator Number 01: Disease State/Drug (000, 999 ) therapy 02: AIDS therapy 03: Law (related to Development/ pharmacy practice) Release Year 04: General Pharmacy 05: Patient Safety (as Format Designator defined by NPSF) L: Live activity H: Home study C: Combined ACPE CPE Enterprise Changes in ACPE CE Enterprise Academic Yr 2008-2009; n = 396 providers Academic Year 2001-2002 2008-2009 # CPE Providers 392 396 Participant Type Activities Participant # # CPE Activities 15,729 30,744 Participants 1,794,928 4,878,998 25,513 3,062,909 (RPh and PT) PHARMACISTS Live CPE 701,564 843,824 (39%) (17%) PHARMACY Homestudy CPE 1,086,230 4,031,547 5,231 1,816,089 TECHNICIANS (60%) (83%) Combined CPE 7,134 3,627 (1%) (<1%)

ACPE CPE Enterprise ACPE CPE Enterprise n = 396 providers Academic Yr 2008-2009; n = 396 providers Keyword Activities Participants Number of Number of 2008-2009 Activities Participants Pain�Management 759 159,177 Opioids/Opiates 266 38,525 REMS-relevant 1,225 229,588 Activities Addiction 221 28,450 Substance�Abuse 144 23,644 All 30,744 4,878,998 Narcotics 108 35,992 Activities Drug�Diversion 95 11,711 Standards for Continuing Pharmacy CPE Tracker: In Development… Education: CPE Activities • Collaboration with National Activity Activity Learning Assessment Association of Boards of Pharmacy Purpose Assessment Feedback (NABP) Knowledge Transmit Questions/recall • Capture individual pharmacist CPE knowledge of facts � 0.25 hr activities (title, format, date, etc.) Must be Application Apply Case studies/ provided to all • Stored in secure electronic data base information � 1.0 hr application of participants of pharmacists’ profiles at NABP principles Practice Instill Hands-on, • Could develop REMS specific tracking knowledge, workplace system � 15 hr skills, attitudes

Standards�for�Continuing�Pharmacy� Standards for Commercial Support Education:�Evaluation • ACPE has formally adopted ACCME Standards for Commercial Support as part Standard�11:�Evaluation�of�CPE�Activities of CPE accreditation standards Standard�12:�Evaluation�of�Achievement�and�Impact�of� • Definition CPE�Mission�and�Goals � Participation Application-based Practice-based Knowledge-based – A ‘commercial interest’ is any entity producing, � Satisfaction CPE Activity CPE Activity CPE Activity � Learning marketing, reselling, or distributing health care � Performance Practice-based goods or services consumed by, or used on, � Patient�Health CPE Activity, if � Population�Health patients. Providers of clinical service directly to applicable patients are not ‘commercial interests’ As with CME Providers, CPE Providers, If Asked Can: • Produce specific CPE to support proper use of drugs under REMS • Evaluate, or measure, effectiveness of REMS educational activities • Facilitate change and data, including individual pharmacist CPE documentation