Opioid Prescribers Confront Multiple Regulatory Agencies

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Report from PAINWeek 2017

Fear of regulatory scrutiny is increasing among pain management practitioners who prescribe opioid analgesics, as agencies issue more stringent regulations and appear to “pile on” across overlapping jurisdictions, according to a speaker at the PAINWeek 2017 meeting, September 5-9 in Las Vegas.

“It’s a really crowded field. A lot of different groups and organizations have joined the field of becoming regulatory agencies that have, or want to have a say in what we do when we’re caring for patients with pain,” Kevin Zacharoff, MD, Board-Certified Anesthesiologist and Clinical Instructor at SUNY told attendees.

In his presentation on opening day of the meeting, “The Regulatory Agency Will See You Now,” Zacharoff described the roles, and sometimes conflicting rules of familiar agencies such the Centers for Medicare and Medicaid (CMS), The Joint Commission, the Federation of State Medical Boards (FSMB) and the Drug Enforcement Administration (DEA). In addition, he pointed to an increasing involvement into controlled drug prescribing by a range of other policy and monitoring bodies such as the National Committee for Quality Assurance (NCQA) and the Office of National Drug Control Policy (ONDCP).

The sometimes conflicting roles and rules of familiar agencies such as CMS, JCAHO, FSMB, DEA as well as deeper  involvement of policy bodies such as NCAQ and ONDCP have made opioid prescribing feel even more risky. 

To the rhetorical question of “So what?” he offered examples of new measures being announced or enacted in just the three States he is licensed in, Arizona, New York and Pennsylvania.

In Arizona, on June 5, Governor Ducey declared a state of emergency due to the opioid epidemic, and issued an executive order, the “Enhanced Surveillance Advisory.”  The order mandates health professionals report suspected opioid overdoses, cases of neonatal abstinence, and the administration of naloxone, in the same manner that is required for suspected child abuse.

In New York, mandatory prescriber education comprising three hours of course work or training on pain management, palliative care, and addiction was to be completed by July 1, 2017, and every three years thereafter.

In Pennsylvania, new requirements for the Prescription Drug Monitoring Program went into effect January 2017, necessitating prescribers to query the database prior to prescribing a benzodiazepine or opioid.

Pennsylvania also announced the formation of the Safe and Effective Prescribing Practices Task Force. This body, comprising representatives from various State agencies, medical associations, provider advocates and community members, was charged with developing guidelines for nine medical specialties on the safe and effective use of opioids in the treatment of pain.

Next: State and Federal Agencies May not Synch

States, Feds May not Synch

“If you think about it, there are all these competing guidelines and recommendations that are swirling around,” Zacharoff said. He described those issued by Federal agencies which may not synch with those of States and State associations, and-given the example of new guidelines issued by the Centers for Disease Control (CDC)-are sometimes inconsistent within the Federal level.

A report commisioned by the Food and Drug Administration (FDA) and issued by the National Academies of Sciences, Engineering, and Medicine (NASEM) in July, however, was described by Zacharoff as a significant step toward considering the impact of opioid prescribing on society as well as the individual patient. The report,Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use, was developed as an update to the 2011 report from the Institute of Medicine (IOM) on treating pain in America.

The current report was prepared by the NASEM Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse. The Committee’s intent, Zacharoff indicated, “was to identify actions the FDA should take, along with other agencies and organizations… to specifically figure out how to incorporate individual and scientific considerations into the risk-benefit analysis.”

In contrast to previous protocols for reviewing and approving pain medications, Zacharoff explained, the FDA is now challenged to develop a review process that goes beyond evaluating drug effects on the individual patient.

“When opioid analgesics are being considered, or any medication for chronic pain for that matter, some justification of a risk-benefit analysis to people other than the patient will be considered,” he said.

“When opioid analgesics are being considered, or any medication for chronic pain for that matter, some justification of a risk-benefit analysis to people other than the patient will be considered."

Additional recommendations in the report include increasing investment in research on pain and opioid use disorder and facilitating reimbursement for comprehensive therapeutic approaches to pain; improve reporting, invest in data, and increase transparency in drug reviews; strengthen post-approval oversight; and establish comprehensive educational materials for patients and healthcare providers.

“So, there are a lot of cooks in the kitchen,” Zacharoff reiterated. “I think you need to think about your State level requirements, as a good starting point. What is it that your State is requiring of you as healthcare providers, and what is it that they’re saying should be done.”