American Pain Society Urges FDA to Modify Restricted Distribution Program

In a letter to the Food and Drug Administration, the American Pain Society (APS) petitioned the agency, on behalf of the terminally ill and their families, to modify a restricted distribution program for the newly approved pain medication Onsolis, a short-acting product that delivers fentanyl through the mouth's mucous membranes.

"We recognize that some opioid products because of their potency and potential for abuse and unintentional death may require additional limitations to assure safe use, but restrictions for Onsolis and perhaps other medications could affect access to the best quality pain relief for patients suffering from cancer-related pain at the end of life and inhibit physicians from delivering the best therapeutic care," APS wrote.

On July 16, FDA approved Onsolis but required that it be made available only through a restricted distribution program from specialty pharmacies. APS said the restriction poses serious concerns for terminal patients in hospitals. "Trans-mucosal fentanyl is used in acute situations and often at the end of life," APS noted, "and not allowing hospital and institutional pharmacies to stock these medications for immediate use denies access to a medication that might be the best option to ease acute or chronic pain in the final days of life."

APS also said patient education requirements for Onsolis are overly burdensome because many terminal cancer patients are cognitively impaired, may not have family or caregivers, and are living in institutional settings. "In these cases, a counseling requirement is impractical and will have unintended consequences on clinical decision making, access to care, and the quality of pain relief," APS wrote.

APS urged FDA to solicit advice from pain and palliative care organizations to help mitigate the unintended consequences of the drug access restrictions, known as REMS. APS believes it is vital that any attempts to reduce the number of opioid-associated deaths per year not unnecessarily increase suffering for the millions of patients worldwide who require opioid treatment for their severe acute, chronic, and/or cancer-related pain.

In February, 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 FDA's standards. The approval of Onsolis with restrictions is the first implementation of a REMS action for an opioid medication.

In a previously published letter to FDA dated June 29, APS 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.
  6. 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.

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