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Classwide Opioids REMS: A Good Idea, Implement Carefully

BETHESDA, Md., May 26 /PRNewswire/ -- On May 27 and 28, 2009, the Food and Drug Administration (FDA) will hear testimony about the FDA-guided effort to develop a classwide Risk Evaluation and Mitigation Strategy (REMS) for all controlled-release opioids from more than 70 patients, scientists, public health professionals, and representatives of pharmacist groups, prescriber groups, and pharmaceutical companies. Controlled-release opioids include prescription pain medications that release the medication over a period of several hours and contain fentanyl, hydromorphone, methadone, morphine, oxycodone, or oxymorphone. More than 21 million prescriptions are written every year for these medications.

Congress established REMS in the Food and Drug Administration Act of 2007 (FDAAA). Under FDAAA, for the first time FDA can require pharmaceutical companies to develop communication plans and other tools to minimize the risks associated with a medication while maintaining the medication's benefits. These tools may be educational, such as letters to prescribers reminding them of certain safety precautions. FDA can also, for example, require special certification of prescribers, limit dispensing to certain pharmacies, or require that prescribers or patients enroll in a registry.

Unlike most REMS, in which it is the patient who both benefits and is potentially at risk, for this REMS the people at risk include patients and non-patients, those who misuse or abuse the drug and are not prescribed the medication. This raises important questions about whether a REMS can both protect patients to whom a medication is prescribed and minimize use by non-patients.

  • Will it be harder for patients in pain to get the medications they need if prescribers need additional certification to prescribe?
  • Will prescribers prescribe the best pain medication for the patient, or instead prescribe medications 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 development, regulatory submissions, risk assessment, and implementation of risk management. For more information, please visit

SOURCE Pinney Associates
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