FDA Introduces New Safety Measures for Opioid Medications
FDA approved a risk evaluation and mitigation strategy for extended-release and long-acting opioid medications.
FDA approved a risk evaluation and mitigation strategy (REMS) for extended-release and long-acting opioid medications. The REMS is part of a federal initiative to address the potential for misuse and abuse of prescription drugs, and will affect more than 20 companies that produce extended-release or long-acting opoid drugs. Companies will be required to make educational programs available to prescribers based on a blueprint provided by FDA. In addition, companies will be required to make FDA-approved patient education materials available, and to perform periodic assessments of the implementation of the REMS.
There are three key components to the initiative:
- Training for prescribers that includes information on the risks and benefits of opiod therapy, choosing patients appropriately, monitoring patients, and counseling patients on the safe use of these types of opiods
- An updated medication guide and patient counseling document
- Assessment and auditing, to determine whether companies have achieved FDA-established goals for the percentage of prescribers completing the training, and to assess whether the REMS is adversely affecting the ability of patients to access necessary pain medication.
Of note, the REMS applies only to extended-release and long-acting opoid medications, not to immediate release formulations, because FDA has concluded that there is a disproportionate safety problem (i.e., abuse, misuse, and overdose potential) associated with these products that must be addressed. At this time, prescriber training is voluntary, and not a precondition for prescribing extended-release or long-lasting opoids to patients. However, according to the FDA press release, the Obama Administration is pursuing legislation that would make opoid prescriber training mandatory and link training to registration with the Drug Enforcement Agency.
The Solution Lies with SOLBIOTE™: Achieving Sustainability, a Growing Focus in Biopharma
October 28th 2024The nexus between biopharmaceuticals and sustainability is seemingly far apart, however, it is increasingly recognized as an inevitable challenge. It is encouraged to take a sustainable approach to reducing the environmental impact of the production and supply of medicines while improving people's health; delivering the well-being of people and the planet. Yosuke Shimojo (Technical Value Support Section Manager, Nagase Viita) will unveil how SOLBIOTE™, a portfolio of injectable-grade saccharide excipients, would be a key for the biopharmaceutical development and achieving sustainability for a better future of the industry.
