ASHP offers recommendations for opioid drug labeling

As FDA takes an increased interest in the prescribing of narcotic medications, due to higher levels of prescribing and increased overdoses over the recent years, the American Society of Health-System Pharmacists (ASHP) stressed the importance of understanding the causes of pain and issues of patient access to appropriate drug therapy.

“ASHP’s vision is that medication use will be optimal, safe, and effective for all people all of the time,” ASHP’s Christopher J. Topoleski, director, federal regulatory affairs, told Formulary. “That vision includes our commitment to reducing prescription drug abuse, including misuse, addiction, and overdose of drugs such as opioids. However, ASHP is concerned that should FDA restrict treatment with opioids to severe pain only, the Agency may create additional challenges for prescribers and patients as well as barriers to access.”

ASHP cautioned the agency against making distinctions between “cancer” and “non-cancer” pain and recommended an approach that looks more closely at the causes of a patient’s pain (g, neuropathic, central, inflammatory).

According to Topoleski, ASHP does not believe a maximum daily dose should be established. “This is a clinical decision that is best made by the prescriber and to impose a mandatory maximum duration limit would be contrary to the practice of medicine,” he said. “Maximum daily doses, if established too conservatively, would have a crippling effect on treating some patient populations [eg, advanced cancer, palliative, and hospice care] where providers would be hesitant to prescribe the doses needed for pain control for fear of litigation.”

FDA has not made any recommendations on whether or not to change labeling for opioids and at this point have requested information from healthcare professionals and patients on the impact of any changes to labeling. “The majority of comments to FDA have cautioned against the adverse and unintended consequences that severe restrictions in labeling can have on patient access and care,” Topoleski said. “ASHP would encourage hospitals, health systems, and payers to continue to leave the appropriate course of treatment for moderate to severe chronic pain to the healthcare team treating patients in all settings and to not implement universal limits on dose or duration.”

“I'm not sure FDA’s proposal will get to the root of the problem,” said Michelle Hilaire, PharmD, CDE, BCPS, clinical pharmacist, at the School of Pharmacy, University of Wyoming, Fort Collins Family Medicine Residency Program. “Simplifying pain down to cancer versus non-cancer, can limit legitimate patients from getting adequate pain control and prohibits providers from using their best judgment in creating treatment plans.  Increasing restrictions would mean hospitals would have to address treatment plans and protocols and possibly decreased patient quality of life due to regulations. Providers are feeling more and more restrictions toward patient care and unfortunately patients will be the ones who may suffer.”