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FDA to Require Opioid Drug Makers to Provide Safe-Prescribing Training

The U.S. Food and Drug Administration (FDA) recently announced that it will require manufacturers of immediate-release (IR) opioids to provide training to health care providers who prescribe IR opioids, including training on safe prescribing practices and consideration of non-opioid alternatives. The new requirement is the latest step in the agency’s attempt to curb the misuse of opioid drugs.

As we have previously discussed on this San Diego Injury Blog, many Americans who are addicted to opioids were initially exposed to opioids via a legal prescription. Many addicted patients then moved on to higher dose formulations or more accessible illegal street drugs.

According to the FDA, approximately 90 percent of all opioid pain medications prescribed (160 million prescriptions annually) are for IR formulations like hydrocodone and acetaminophen or oxycodone and acetaminophen combinations. To help prevent the misuse of such “gateway” drugs, the FDA recently notified 74 manufacturers of IR opioid analgesics intended for use in the outpatient setting that their drugs will now be subject to a more stringent set of requirements under a Risk Evaluation and Mitigation Strategy (REMS).

Manufacturers of extended release/long acting opioid analgesics have been subject to a similar REMS since 2012. As detailed by the FDA, the sponsors of the ER/LA opioid analgesics have been providing unrestricted grants to accredited continuing education providers for the development of education courses for health care professionals based on content outlined by FDA, which the agency calls the “Blueprint.”

In addition to extending these requirements to manufacturers of IR formulations, the FDA is also adding content on pain management to the educational “Blueprint” required under the REMS. This includes principles related to acute and chronic pain management; non-pharmacologic treatments for pain; and pharmacologic treatments for pain (both non-opioid analgesic and opioid analgesic). The revised Blueprint will also cover information about the safe use of opioids, and basic information about addiction medicine and opioid use disorders.

In addition, training will now be made available to other health care professionals who are involved in the management of patients with pain, including nurses and pharmacists. “FDA believes that all health care professionals involved in the management of patients with pain should be educated about the safe use of opioids so that when they write or dispense a prescription for an opioid analgesic, or monitor patients receiving an opioid analgesic, they can help ensure that the product is properly indicated for the patient and used under appropriate clinical care,” FDA Commissioner Scott Gottlieb wrote in a blog post.

Given the number of patients that are negligently prescribed opioids, the FDA’s new requirement is welcome news. According to the agency, it is also considering “whether there are circumstances when FDA should require some form of mandatory education for health care professionals, and how the agency would pursue such a goal.”

If you or a loved one was negligently prescribed opioids, don’t hesitate to contact a San Diego medical malpractice lawyer at the Law Offices of Robert Vaage for a free consultation.