Tuesday, February 10, 2009

FDA, Opioids, and Risk Evaluation and Mitigation Strategies

I noticed in the news today that the Food and Drug Administration (FDA) has plans to increase regulation of certain narcotic prescription pain medications, including OxyContin and morphine and Fentanyl patches. The FDA already regulates these medications as Schedule II narcotics but has not had the ability or authority to do more than make recommendations and monitor prescribing patterns. In 2007 a law was passed, the Risk Evaluation and Mitigation Strategies (REMS), that allows the FDA greater authority in it's ability to require both manufacturers of these drugs and prescribing physicians to follow certain guidelines.

The FDA is responding to a significant problem in that these medications, while successfully treating pain in cancer patients and chronic pain patients, are increasingly becoming drugs of misuse, abuse, diversion, and addiction. Prescription pain medications are now the number one abused substance after nicotine and alcohol. Pain medications have overtaken marijuana as the most commonly used drug in teenagers and their use is increasing. Here at Cottonwood abuse of these medications are the most commonly presenting addiction after alcoholism. Again, after alcoholism the addiction and misprescribing of these medications are the second most common reason for disciplinary actions of state boards of medicine. In addition to the addiction potential these medications are dangerous in overdoses and have been responsible for many deaths. These drugs can be lethal when mixed with certain sedatives and are believed to have been responsible for the tragic death of actor Heath Ledger last year.

Something clearly needs to be done about this problem. I support the FDA in taking a stronger stance on this issue. It is unclear what the new regulations will be but I am sure will include required additional training for physicians who wish to prescribe certain opioid pain medications. My support comes with some trepidation however. This will be the first regulatory action that will affect physician autonomy in prescribing. While necessary in this case I do have some concerns that REMS can be used in the future to limit physician autonomy in other areas of prescribing such as use of psychophamacologic medications in which proposed restrictions are motivated more by an ideological and political agenda rather than based upon science. We will have to wait and see.

Thought for the day

Change brings both opportunity and risk.

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