by Brian Malkin
Less than a week after the Centers for Disease Control and Prevention ("CDC") reported on the growing epidemic of opioid pain reliever ("OPR") overdoses, which we reported on here and asked for FDA to take action, FDA announced in a Federal Register Notice that FDA had developed a draft blueprint entitled "Blueprint for Prescriber Education for the Long-Acting/Extended-Release Opioid Class-Wide REMS" ("Blueprint") . FDA has obviously been thinking about ways that its class-wide opioid Risk Evaluation and Mitigation Strategies ("REMS") can have an impact on the growing prescription drug abuse crisis. FDA's latest Blueprint appears triggered, at least in part, by a report released by the Obama Administration on April 19, 2011 entitled, "Epidemic: Responding to America's Prescription Drug Abuse Crisis", which we reported on here.
As indicated in FDA's Notice, FDA issued letters to application holders for long-acting and extended-release innovator and generic opioid drug products requiring them to submit a REMS within 120 days and providing certain elements that had to be included in each of the REMS. FDA's "central component" was the requirement for a cost-free, drug education program for prescribers, yet there is no prerequirement for training for prescribing. Instead, FDA requested that application holders set goals for numbers of prescribers trained, collect information about the number of prescribers who took the courses, and report the information to FDA as part of the required periodic assessments for REMS.
FDA's Blueprint is meant to provide the basic outline and core messages for continuing education that should be offered to all prescribers of long-acting and extended-release opioids, suggesting that the message be delivered in 2-3 hours. According to the Notice, the outline requires information weighing the risks and benefits of opioid therapy, choosing patients appropriately, managing and monitoring patients, and counseling patients on the safe use of these drugs. The education must also include information how to recognize evidence of, and the potential for opioid misuse, abuse, and addiction.
While the Blueprint goes a long way to provide valuable information to the prescribers who choose to be educated, it remains unclear why FDA is not mandating the prescriber education for all prescribers as a precondition to dispensing the medication to patients or more effectively targeting the perceived source of the problem. At least suggested by CDC's report, the majority of OPR overdoses seem to be attributed to a relatively small percentage of OPR prescribers with more loose prescribing practices. How could FDA's mandated REMS reach the prescribers who would most benefit from the training? One might think then it would make sense to either mandate the education for all prescribers (i.e., an even-playing-field approach) or at least mandate the training for prescribers who have had documented instances of OPR misuse or abuse (i.e., a more targeted approach to save resources). How, for example, will FDA's requirement lead the prescribers who need the training to take it rather than provide more information to the majority of prescribers who are already being cautions about prescribing OPRs? Also, why should the training exclude immediate-release OPRs? CDC's report did not single out extended-release and long-acting opioids as the only source of the problem with OPRs.
FDA's mandated REMS and Blueprint also does not seem to go far enough in its recommendations. For example, while the Blueprint describes the possibility for patient prescriber agreements ("PPAs") (i.e., agreements signed at the time of prescribing providing mutual commitments and goals in the treatment between prescriber and physician) and suggests a treatment plan, why are these PPAs only something prescribers should be "aware of"? Without making PPAs a requirement, it would seem most prescribers may choose to operate without them. Similarly, it would seem that other voluntary elements such as patient treatment plans, reassessments whether OPRs are still necessary, and plans to withdraw patients from OPRs including tapering doses, as well as the risks associated with diversion should be reconsidered as elements of the mandated class-wide REMS.
State legislators should consider passing complementary regulations to help provide pharmacists with the appropriate tools to be "gatekeepers" to prevent addictive OPRs from getting in the wrong hands. In Delaware, for example, new laws have been passed to require special "tamper-proof" prescription pads and prescribers will soon be able to electronically prescribe controlled drugs directly to a patient's pharmacy--measures designed to help prevent counterfeit prescriptions and to collect more detailed information about every prescription for controlled drugs written by Delaware doctors.
FDA has asked for comments on their draft education Blueprint by December 7, 2011.