The FDA says the REMS is part of an initiative to deal with the misuse, drug abuse, and overdose "epidemic". New safety measures have been introduced to lower risks and improve the proper and safe use of opioid medications, while making sure patients in pain do not lose access.
FDA Commissioner Margaret A. Hamburg, M.D., 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 health care professionals are educated on how to safely prescribe opioids and that patients know how to safely use these drugs."
Over 20 companies that make these opioid analgesics will be affected by the new ER/LA opioid REMS. Companies will now have to provide doctors with education programs "based on an FDA Blueprint".
The FDA says it expects manufacturers to provide grants to CE (continuing education) providers, who will devise and deliver training to prescribers.
Manufacturers will also have to provide patients with FDA-approved materials on how to use these medications safely. They are also expected to carry out periodic assessments of the implementation of the REMS, and to make sure their programs meet its goals. Periodically, the FDA itself will review these assessments.
Gil Kerlikowske, director of the Office of National Drug Control Policy, said:
"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."
According to IMS Health, 22.9 million prescriptions of ER/LA opioids were dispensed last year. An IMS Health estimate said that over 320,000 prescribers registered with the DEA (Drug Enforcement Administration) wrote at least one ER/LA opioid analgesic prescription last year.
According to the Centers for Disease Control and Prevention, ER/LA opioid analgesics:
- Caused 14,800 deaths in the USA from overdoses in 2008
- Caused 15,597 deaths in the USA from overdoses in 2009
- The number of deaths in 2009 was four times greater than in 1999
"Misuse and abuse of prescription opioids is a complex problem and demands a holistic response. The new REMS program is one component of a multi-agency, national strategy to address this important public health issue."
The ER/LA opioid analgesics REMS has the following key components:
- Training doctors - educational programs which will include data on assessing the risks and benefits of opioid therapy, choosing which patients are best suited for these types of medications, monitoring and managing patients, explaining to patients how to use these drugs safely. The training will also include how to look out for signs of opioid misuse, abuse and addiction.
- Patient counseling and updated medication guide - consumer-friendly literature on how to use, store, and get rid of ER/LA opioid analgesics safely. There will also be instructions on how to consult your doctor before making any changes in your treatment regime, signs of potential overdose and emergency contact instructions.
- Assessing and Auditing - manufacturers of ER/LA opioid analgesics will have to achieve certain goals regarding percentage of prescribers completing their training, as well as assessing how well doctors understand the important risk information over time. The FDA will also assess whether patient access to vital pain medication has been affected in any way.
Doctors do not have to take the training, it is not compulsory, and neither is it a precondition for ER/LA opioid prescribing.