ER/LA Opioid Analgesics REMS Program Companies Announce Request for Applications for Educational Grants

NEW YORK--(BUSINESS WIRE)--The Extended-Release (ER) and Long-Acting (LA) Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS) Program Companies (RPC) have posted Requests for Applications for the first and second cycles of RPC-supported REMS educational grants on its website (www.ER-LA-OpioidREMS.com).

The RPC, which includes manufacturers of ER/LA opioid analgesics, will be providing educational grants to accredited continuing medical education/continuing education (CME/CE) providers to independently develop certified educational activities for prescribers of these medications. The RPC will have no input in the development or content of these activities. These certified education programs will be designed to ensure that the benefits of ER/LA opioid analgesics outweigh the risks in patients whose clinicians have determined these medications to be an appropriate treatment option.

To be eligible to receive RPC educational grant support, the accredited provider who will assume primary responsibility for the CME/CE activity must submit the grant request. This provider MUST be engaged in or represent healthcare professionals who provide direct patient care (e.g., schools of medicine, pharmacy or nursing, hospitals, medical societies, professional associations, or governmental organizations). This provider may collaborate with other providers, organizations, or educational planner(s) to assist in the development and/or execution of a proposed educational activity.

Core information on safe prescribing and safe use of these medications has been developed and published by the US Food & Drug Administration (FDA) in the Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics (“FDA Blueprint”). The Blueprint is posted on the FDA website for use by accredited CME/CE Providers in developing the actual CME/CE activities (http://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM277916.pdf).

About the RPC

On July 9, 2012, the FDA approved the final ER/LA Opioid Analgesics REMS, which had been in development since April 19, 2011, when the FDA notified manufacturers of ER/LA opioid analgesics of the requirement to submit a proposal for a single, shared REMS. Companies with approved drug applications for ER/LA opioid analgesics signed the REMS Program Agreement. These companies are known as REMS Program Companies (RPC), representing a consortium of approved drug application holders of branded and generic ER/LA opioid analgesic drug products that was formed for the specific purpose of implementing this REMS.