The United States Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently took to the FDA Voice blog to announce that the administration has sent letters to 74 manufacturers of immediate-release (IR) opioids, alerting them to the newer and stricter requirements that their drugs will be subject to under the administration’s Risk Evaluation and Mitigation Strategy (REMS).
IR opioids will now be subject to the same regulatory requirements as extended release/long-acting (ER/LA) opioids. The REMS will require these manufacturers to make training available to health care professionals who could prescribe the IR opioids to patients. They have offered training on ER/LA opioids since 2012, and this will expand the number of opioid products covered by REMS from 64 ER/LA products to 277 IR opioid products. The training will focus on safe prescribing practices, opioid use disorders and alternative pain treatments over opioid use. Beyond prescribing physicians the training will also be available to other health professionals like nurses and pharmacists. Some patients who are exposed to IR opioids via an initial prescription may become addicted to them and then move on to other more powerful drugs. His post reported that 90 percent of pain medication prescriptions are for IR opioids.
In addition to IR opioids, extended release opioids have become part of the addiction and overdose problem. Many of the extended release/long-acting opioids have abuse-deterrent formulations which are intended to be resistant to misuse, though most of them are only available as brand names. Patients who do try to tamper with these are at risk of overdose. Another part of the steps the administration is taking is to issue a document to guide drug manufacturers hoping to submit generic versions of these drugs for approval.
The administration expects the process of extending REMS to IR drugs to take about a year.
Read the post here.