FDA Introduces New Safety Measures for Opioid Medications - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

FDA Introduces New Safety Measures for Opioid Medications


ePT--the Electronic Newsletter of Pharmaceutical Technology

On July 9, 2012, 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 opioid 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 opioid therapy, choosing patients appropriately, monitoring patients, and counseling patients on the safe use of these types of opioids
  • 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 opioid 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 opioids to patients. However, according to the FDA press release, the Obama Administration is pursuing legislation that would make opioid prescriber training mandatory and link training to registration with the Drug Enforcement Agency.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
23%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
7%
All of the above.
47%
No government involvement in patient treatment or drug development.
9%
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here