Prescribers and other stakeholders may submit comments about the Food and Drug Administration’s draft document outlining the main messages to be included in educational programs that will be required for prescribing certain opioid products, the agency announced in the federal register on Nov. 4.
An education program for prescribers and patients is the central component of the Risk Evaluation and Mitigation Strategy (REMS) now required for brand-name and generics of long-acting (LA) and extended-release (ER) formulations of buprenorphine, fentanyl, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol. The REMS addresses the risk of abuse and misuse of these products, which has become a major public health problem in recent years. This week, the Centers for Disease Control and Prevention released a report saying the number deaths due to overdoses of prescription pain medications is now greater than is the number of deaths due to heroin and cocaine combined.
REMS is required by the FDA for certain products to ensure that the benefits of a drug continue to outweigh its risks.
Health care professionals who prescribe these products "are in a key position to balance the benefits of prescribing ER/LA opioids to treat pain against the risks of serious adverse outcomes including addiction, unintentional overdose, and death," according to the document, titled "Blueprint for Prescriber Continuing Education."
The blueprint includes sections on assessing patients for treatment; initiating treatment, modifying dosing, and discontinuing treatment; and counseling patients and caregivers on how to use these drugs safely.
The federal register notice says that the agency expects that prescriber training should be provided to prescribers at no cost by "accredited, independent, continuing education providers," funded by "unrestricted grants" from the drug manufacturers.
The deadline for comments on the blueprint is Dec. 4, 2011.
Comments can be submitted electronically or by writing to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, Md., 20852.