During last month’s Joint Meeting of the Anesthetic and Life Drugs Advisory Committee (ALSDAC) & Drug Safety and Risk Management Advisory Committee (DSaRM), the Accreditation Council for Pharmacy Education (ACPE) delivered comments regarding Risk Evaluation and Mitigation Strategies (REMS) for extended-release and long-acting opioid analgesics.
The presentation, which was delivered by ACPE Executive Director Peter H. Vlasses, PharmD, focused on how REMS-required pharmacist education could be provided efficiently and effectively through established quality mechanisms provided through Continuing Pharmacy Education (CPE). He outlined the size of the CPE enterprise almost 400 accredited providers creating over 30,000 activities with close to 5 million participants.
His comments were similar to those delivered by Murray Kopelow, M.D., M.S., Chief Executive and Secretary for the Accreditation Council for Continuing Medical Education (ACCME).
Accordingly, “ACPE expressed support for educational strategies that link pharmacist continuing education credit to programs that are developed and delivered in accordance with ACCME Standards for Commercial Support, which ACPE has adopted.” Vlasses called for this support because “linking REMS education to ACPE-accredited CPE would align incentives for pharmacists to participate in these programs and would directly support pharmacist re-licensure requirements in all states and territories in the U.S.”
One of the main reasons ACPE is urging this support is due to the fact that “CPE activities have been shown to advance other public health initiatives such as pharmacist-delivered immunizations and the provision of medication therapy management to patients.” With approximately four percent of CPE activities completed by pharmacists in 2008-2009 related to opioid education, ACPE also discussed the ability to designate REMS specific educational programs in the future.
By acknowledging the future need for CPE, Vlasses asserted that ACPE and CPE providers “have an important and unique opportunity to link current CPE requirements with the need to provide REMS-related education to pharmacists nationwide.”
He recognized that “CPE providers should be encouraged to develop independent activities that support the proper use of medications under REMS and that ACPE will be working with other key stakeholders to track, evaluate and measure the effectiveness of these activities.”
It was noted how CPE providers, if asked, can produce specific CPE to support proper use of drugs under REMS; evaluate or measure effectiveness of REMS educational activities; and facilitate change and data, including individual pharmacist CPE documentation.
Vlasses concluded his presentation by noting that since “ACPE and ACCME believe that their accredited providers can serve a vital role in realizing effective REMS education in many drug classes,” FDA should recognize and utilize accredited CE providers as an “important component of REMS educational initiatives.”
With REMS pharmacists will play a key role in the delivery. Eventually they will verify physician’s eligibility to prescribe certain drugs including follow on biologics. In addition, pharmacists will require education to further ensure safe dispensing and proper dosing of REMS mandated pharmaceuticals.