FDA Announces New Risk Reduction Plan for Rx Opoids

The Food and Drug Administration (FDA) has unveiled a new plan designed to curb the misuse of prescription opioids. The long-awaited and controversial Risk Evaluation and Mitigation Strategy (REMS) for long-acting and extended-release opioids includes mandatory prescriber and patient education. FDA has released the new plan in advance of an advisory committee meeting scheduled for July 22 and 23. They are seeking input from stakeholders and the public. The new proposal is advocating more oversight, but the FDA has dropped a number of earlier ideas such as prescriber accreditation and patient registration programs. Prescriber education is in the plan, but the burden will be on drug manufacturers to offer training and demonstrate improvements in prescribing through surveys. The plan does not require any formal prescriber enrolment or real- time verification of training. The plan is also advocating a medication guide to inform people of the safe use, storage, and disposal of long-acting and extended- release opioids. The medication guide would be provided to patients each time a prescription is dispensed.