September 2018 saw a new broadened Risk Evaluation and Mitigation Strategy (REMS) for prescribing immediate-release opioid analgesics in out-patient departments, released by the FDA which doctors need to take note of.

Extended-release and long-acting opioids have been under REMS since 2012 but the new guidelines include them too. As per the new REMS program, health care professionals handling pain management need to undergo training which includes physicians, nurses and pharmacists as well.  This requirement has been introduced for the first time. The study material should also include information pertaining to alternatives to opioid drugs for mitigation of pain, as per the new REMS.

A new booklet containing updated educational matter has already been approved by the FDA.

A new label displaying information for the medical professional’s knowledge which is a requirement of the new REMS is under the process for attaining approval from the FDA.

 “Our new effort is aimed at arming providers with the most current and comprehensive information on the appropriate management of pain,” FDA Commissioner Scott Gottlieb, MD, said in a statement. “Appropriate prescribing practices and education are important steps that we are prioritizing to help address the human and financial toll of this crisis.”

Dr. Gottlieb further said that the new REMS is charted to assist physicians and provide them with the recent updates on the necessary dosage for a particular condition and that the “aim is to reduce overall dispensing as a way to further reduce exposure to these drugs. 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.”