The pharmaceutical industry is to be trained on how to safely prescribe opioids, highly potent drugs approved for persistent pain that requires treatment for an extended period.
A risk evaluation and mitigation strategy (REMS) has been approved by the US Food and Drug Administration (FDA) to ensure that the industry addresses the prescription drug abuse, misuse and overdose epidemic in the country.
Go deeper with GlobalData
The REMS introduces new safety measures designed to improve the safe use of extended-release and long-acting opioids.
Over 20 companies that manufacturer opioids, including King Pharmaceuticals, which produces Avinza (morphine); and Purdue Pharma, which makes Palladone (Hydromorphone), will be required to make education programmes available to prescribers based on an FDA blueprint.
It is expected that companies will meet this obligation by providing educational grants to continuing education providers, who will develop and deliver the training.
According to the Centers for Disease Control and Prevention, 14,800 Americans died from overdoses involving opioids in 2008. In 2009, there were 15,597 deaths involving these medications – nearly four times as many deaths compared to 1999.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataFDA commissioner, Margaret A Hamburg, said: "Misprescribing, misuse and abuse of extended-release and long-acting opioids are a critical and growing public health challenge."
"The FDA’s goal with this REMS approval is to ensure that healthcare professionals are educated on how to safely prescribe opioids and that patients know how to safely use these drugs," added Hamburg.
The REMS will also require companies to make available FDA-approved patient education materials on the safe use of these drugs.
The companies will be expected to perform periodic assessments of the implementation of the REMS and the success of the programme in meeting its goals.
The FDA will then review these assessments and may require additional elements to achieve the goals of the programme.
Office of National Drug Control Policy director, Gil Kerlikowske, welcomed the news: "We commend the FDA for taking action to save lives by increasing access to prescriber education.
"Since day one, the Obama Administration has been laser focused on addressing the prescription drug abuse epidemic and today’s action is an important contribution to this comprehensive effort," added Kerlikowske.
