Newswise — The American Pain Society (APS), www.ampainsoc.org, today warned the U.S. Food and Drug Administration (FDA) that unintended consequences from proposed Risk Evaluation and Mitigation Strategies (REMS) governing the use of opioid pain medications could impair physicians' ability to treat patients with severe, persistent pain.
In a letter signed by its Board of Directors, APS stated: "It is vital that any attempts to counter thousands of opioid-associated deaths per year will not unnecessarily increase suffering for the millions of patients worldwide currently treated with opioids for their severe acute, chronic and/or cancer pain." The letter further advised that FDA adopt REMS policies that are measurable and accountable and show care for patients who require opioids for their severe pain in order to improve or maintain their quality of life.
In February, the FDA announced it will require manufacturers of 24 short and long acting opioid medications to establish comprehensive risk management plans to reduce overdoses. The agency plans to issue guidelines to the companies for developing REMS polices that will comply with the FDA's standards.
"We have an obligation to pain care practitioners and patients to raise awareness about unintended consequences that could result if REMS are instituted unwisely," said APS President Charles E. Inturrisi, PhD. professor of pharmacology, Weill-Cornell Medical College, New York. "The FDA has been very receptive to concerns raised by the pain-care community, and we hope the comments they receive from our organization and others will be considered and applied in the final REMS decision."
According to APS, the increase in opioid-associated deaths in the U.S. likely has resulted from a combination of several factors:
"¢ Increased therapeutic use of opioids and resulting availability from unused prescriptions in unlocked medicine cabinets"¢ Inadequate public understanding of the narrow therapeutic window of prescription opioids that lead to sharing of medications and diversion "¢ Inappropriate prescribing practices that may include too rapid dose adjustments, inappropriate patient selection and excessive mixing of other sedatives with opioids"¢ Possible over identification of opioids as the cause of death in cases when a decedent has opioids in the blood but dies of other causes"¢ Differences in pharmacological mechanisms of opioids that make prescribing chronic opioids more difficult.
APS has urged FDA to consider five key standards when formulating its REMS guidelines.
1. REMS should cover the entire class of opioid medications. An attempt to regulate certain drugs will drive prescribers, users and especially misusers to other less stringently regulated opioids.2. Mandated and potentially stigmatizing patient registries for opioids should be avoided because there is no evidence showing they diminish abuse and misuse. Instead, enhancements to existing state prescription monitoring programs would be a better option.3. REMS should be measurable and reversible to be effective in curbing abuse and misuse of opioids while assuring medication access for legitimate pain patients.4. An educational curriculum for prescribers and dispensers of opioids should be offered through a variety of channels. Consider requiring demonstration of competence in basic opioid pharmacology for issuance of a DEA prescribing license.5. Educate the public on the dangers of sharing opioid prescription drugs and other drug abuse behaviors to help reduce drug diversion.
APS also suggested that consumer education should be combined with allowable, voluntary give-back programs that enable patients to return unused prescriptions and prevent unintended diversion from their medicine cabinets.
"We strongly believe professional and consumer education programs can exert a significant impact for improving awareness and reducing behaviors that are fueling the opioids abuse problem. Professional societies, such as APS, can play a vital role in helping develop educational programs within REMS programs implemented by FDA and drug manufacturers," said Inturrisi.
APS will be represented at the final public hearing held by FDA on May 27-28 to gather comments and recommendations for REMS policies.
About the American Pain SocietyBased in Glenview, Ill., the American Pain Society (APS) is a multidisciplinary community that brings together a diverse group of scientists, clinicians and other professionals to increase the knowledge of pain and transform public policy and clinical practice to reduce pain-related suffering. APS was founded in 1978 with 510 charter members. From the outset, the group was conceived as a multidisciplinary organization. APS has enjoyed solid growth since its early days and today has approximately 3,200 members. The Board of Directors includes physicians, nurses, psychologists, basic scientists, pharmacists, policy analysts and more.
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