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FDA takes new steps to curb opioid crisis
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The FDA announced several new strategies today to better inform medical professionals and patients about the risks associated with opioid use.
Strategies include expanding the agency’s Risk Evaluation and Mitigation Strategy (REMS) to include immediate-release opioid analgesics intended for use in an outpatient setting; approving an updated “FDA Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain;” and giving the go-ahead to new safety labeling changes for all opioid analgesic products intended for use in an outpatient setting.
“Our new effort is aimed at arming providers with the most current and comprehensive information on the appropriate management of pain. At the same time, we’re also taking new steps to advance the development of evidence-based, indication-specific guidelines to help further guide appropriate prescribing of opioids,” FDA Commissioner Scott Gottlieb, MD, said in press release.
The FDA stated that immediate-release drugs account for about 90% of all opioid pain medications prescribed for outpatient use, necessitating the action it took today. Under the new REMS, training will be made available to health care providers who are involved in the management of patients with pain — not just prescribers. Information will also be made available about non-opioid alternatives to pain management. This new REMS will also be applied to extended-release and long-acting analgesics, which have been subject to a REMS since 2012.
The Education Blueprint will contain updated information but details on the specific information were not provided prior to this story’s posting. According to the FDA, continuing education training under the modified REMS will be available to health care providers by March of next year.
The new labeling will include information about REMS-compliant education in the precautions, warnings and box warnings sections of such labels.
This new information will “strongly encourage providers to complete a REMS-compliant education program, counsel patients and caregivers on the safe use, risks, and appropriate storage and disposal of these products, emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and to consider other tools to improve patient, household and community safety,” according to the FDA.
“Our goal is to help prevent patients from becoming addicted by decreasing unnecessary or inappropriate exposure to opioids and fostering rational prescribing to enable appropriate access to those patients who have legitimate medical need for these medicines,” Gottlieb said.
Disclosure: Gottlieb is FDA commissioner.