According to federal documents, the Food and Drug Administration (FDA) is reconsidering if physicians who prescribe opioid painkillers should be required to take safety training courses.
Experts from the FDA Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee will meet in May to review risk management plans put in place almost 4 years ago and to provide advice and recommendations to the Agency on the FDA’s regulatory issues. Advisers will discuss results from assessments of the extended-release and long-acting (ER/LA) Opioid Analgesics Risk Evaluation and Mitigation Strategies (REMS). The Agency will then seek the committees’ recommendations on whether the REMS with Elements to Assure Safe Use (ETASU) assures safe use, is not “unduly burdensome to patient access to drugs,” and helps minimize the burden to the healthcare delivery system.
In February 2016, the FDA had proposed a new action plan consisting of 8 new measures intended to reassess their approach to opioid medications. They announced plans to work with outside experts to assess the public health consequences of opioids as well as an increase in requirements on drug companies to obtain postmarketing data on the long-term impact of ER/LA opioids.
Currently, the ER/LA Opioid Analgesics REMS requires prescriber training to be available to healthcare providers who prescribe ER/LA opioid analgesics. The FDA will evaluate possible changes to the ER/LA Opioid Analgesics REMS, including broadening the scope and content of prescriber training, and expanding the REMS program to include immediate-release opioids.
Comments may be submitted regarding the ER/LA Opioid Analgesics REMS program in general and whether it should be modified. Comments may include:
- Alternative methodologies for evaluating the overall impact of the program on knowledge and behavior by prescribers and patients;
- Overall impact of the REMS on the adverse events it is intended to mitigate;
- Whether the FDA Blueprint or other tools (eg, Medication Guide or Patient Counseling Document) should be revised and/or expanded;
- Use of the continuing education as a component of the REMS as a mechanism for providing prescriber training;
- Whether to expand the REMS program to include immediate-release opioids; and
- How additional REMS tools or ETASU (eg, required prescriber or pharmacist training, required patient agreements), if recommended, may impact the healthcare delivery system and patient access to ER/LA opioid analgesics.
For more information visit Regulations.gov.