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Classwide Opioids REMS: A Good Idea, Implement Carefully
Date:5/26/2009

ns with no REMS to avoid the burdens REMS impose on them?
  • Will pain medication costs increase?
  • Will important pain medications be removed from formularies?
  • Will drug abusers shift their abuse to other licit or illicit substances?
  • Will a controlled-release opioid REMS discourage innovation in the development of new pain medications?

    • "We run the risk of serious unintended consequences to people living with chronic pain in the effort to prevent misuse and abuse of these important medications. It would be of great concern if the REMS led health care providers to prescribe drugs not encumbered by the REMS even though they might be less optimal, and put patients at risk for adverse consequences like gastrointestinal bleeds or liver disease," said Sidney H. Schnoll, M.D., Ph.D., Vice President, Risk Management, Pinney Associates, and Clinical Professor, Internal Medicine and Psychiatry, Medical College of Virginia, Virginia Commonwealth University. "Critical to the opioid REMS will be having in place comprehensive scientific methods to measure both positive and negative effects on patients and non-patients."

    A central element of the Food and Drug Administration Act of 2007 (FDAAA), REMS can be an important tool in ensuring patient safety. Outside of pain treatment, FDA has applied REMS to make available medications to patients with few or no alternatives, such as people with leprosy and narcolepsy. Ultimately, the classwide, controlled-release opioids REMS has the potential to greatly benefit public health, but should be carefully implemented so as to protect patient access to these crucial pain medications while reducing unintended consequences such as accidental overdose and abuse.

    Pinney Associates counsels the pharmaceutical industry on science, public health and health policy issues related to drug
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    SOURCE Pinney Associates
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