NACDS, others suggest different approaches for opioid management than labeling changes

During an FDA hearing last week on the use and possible restriction of opioids for the treatment of chronic pain, the National Association of Chain Drug Stores (NACDS) and other industry stakeholders pressed their cases for opioid management in the wake of the prescription drug abuse epidemic.

Among the questions FDA asked stakeholders and the general public is what the impact would be of restricting opioid drugs to the treatment of severe pain only. It also asked what data there are to support establishing a maximum daily dose for opioids or for establishing a maximum duration for continuous treatment with opioids. This is the third major meeting the agency has held in 10 months on opioid drugs for pain treatment.

Kevin Nicholson, vice president of government affairs at the NACDS, urged FDA, “not to recommend unworkable provisions such as poorly conceived labeling changes and arbitrary limits on opioid pain medications. Combatting prescription drug abuse must take a holistic approach.”

Nicholson told the FDA panel that prescribers “should be properly educated about the risks and benefits of prescription drugs, especially those that have elevated abuse potential.”

Noting that NACDS and other industry stakeholders have worked with FDA over several years on a Risk Evaluation and Management Strategy (REMS) for the transmucosal fentanyl products, he said that if the model is successful, the association hopes it will serve as a model for future REMS.

Jaime Threadgill, a Chattanooga, Tenn.-based pharmacist, told the FDA panel last week that “the experiment with the states providing policy has failed.”

She asserted that a national approach is required with a national prescription drug monitoring program (PDMP) and provider accountability.

Threadgill told the regulators that after Tennessee began its PDMP database, “it quickly noticed that 20% of its providers were prescribing slightly more than 80% of the opioids used by Tennesseans.”

But she also noted that the state shares boarders with states that do not share information with Tennessee or that do not have restrictive pain clinic registrations or similar law enforcement.

The state had a seven-fold increase in admissions to treatment abuse centers from 2000 to 2010, she said.

FDA has an archive of the webcast and is expected to have a transcript in upcoming weeks. Comments by Nicholson and Threadgill can be found on Panel 6 of the archive.

The public can comment at www.regulations.gov: “Impact of Approved Drug Labeling on Chronic Opioid Therapy.”