FDA and Opioids: Too Much Regulation or Not Enough?

SILVER SPRING, Md. — If the FDA is looking for a streamlined approach to respond to the opioid crisis, it didn’t come from a public meeting of the agency’s Opioid Policy Steering Committee.

At the meeting Tuesday, academics, physicians, patients, advocates, and industry officials shared sometimes conflicting recommendations on how the FDA can best handle the problem.

Advocates generally fell into two camps: pain patients and their supporters, concerned that opioids are being over-regulated and becoming harder to access, and people who have lost loved ones to addiction and overdoses, and would like to see stronger restrictions on such products.

Meanwhile, healthcare experts stressed addiction and overdose prevention, better provider education and awareness efforts, and the elimination of “doctor-shopping.”

In September 2017, the FDA issued a request for comment, which said the national crisis is one that requires “action by federal agencies that may in some instances be unprecedented.” The notice solicited public input to help the agency determine what it should leverage to respond to the crisis.

President Trump declared the opioid epidemic a public health emergency a month later. Approximately 64,000 people died from opioid overdoses in 2016.

The FDA notice included a handful of direct questions for stakeholders, such as:

How can the agency use the available public health data to influence opioid related regulatory decisions?What changes can the agency make with regard to “dispensing and packaging” to encourage proper prescribing practices?Should mandatory education be required for clinicians who prescribe opioids?

At the recent meeting, agency officials also discussed whether to specify dose limits, the creation of a nationwide prescription history database, and how to assess the impact of prescription drug monitoring programs (PDMP).

With regard to provider education, “there is no evidence, in the published literature, that mandatory education increases knowledge or changes behavior and practice,” pointed out Norman Kahn, MD, of the Conjoint Committee on Continuing Education. “If the goal is to count the number of people who complete the education, then of course we should make it mandatory.”

“If … the goal is to make people learn and change the behavior and practice, that doesn’t happen with mandatory education. That happens with voluntary education,” he stressed.

Kahn said he has discussed the idea of an “adaptive learning” approach with the Centers for Medicare and Medicaid Services. He said he has hopes that such an approach might count as an improvement program under the Merit-Based Incentive Payment System (MIPS).

Another concern is the language used to describe opioids, stated Diana Zuckerman, PhD, of the National Center for Health Research. She said “abuse deterrent” may mean different things to doctors, patients, and family members.

She urged the FDA to include education on the meaning of “abuse deterrent” within its Risk Evaluation and Mitigation Strategies (REMS) because “too often it’s misinterpreted to mean it’s not as addictive.”

But Zuckerman also questioned the value of REMS itself, claiming that the “vast majority” of physicians don’t even know REMS exists. Following the implementation of REMS, one prescriber-based survey found 48% of respondents said they did not change their prescribing habits, she noted. Also, while 49% said they made use of the patient counseling documents, that means roughly half did not, she added.

On the advocates’ side, Richard Lawhern, PhD, co-founder of the Alliance for the Treatment of Intractable Pain, urged the FDA to “stand down” from additional regulations on opioids.

He said that the agency is chasing the wrong crisis, as more regulation “is going to make the real crisis worse,” by driving patients into the realm of heroin and/or other illegal street drugs. He also urged the FDA to “remove and rewrite” its practice standards regarding opioids, and he dismissed the Centers for Disease Control and Prevention’s revised guidelines as “nonsense.”

Emily Walden, of Louisville, Kentucky, called on the FDA to remove the highest dose opioids from the market and “immediately delay any new approvals.” Her 22-year-old son died because of an opioid addiction, she said.

She also pressed the agency to end its use of enriched enrollment in clinical trial design. The FDA describes the method as a way to “increase the likelihood that data collected during a clinical trial will demonstrate that an effective drug is effective.”

Other topics discussed at the meeting included the need to increase e-prescribing, improve PDMP, and integrate both into electronic health records (EHR) systems.

Robert Heary, MD, of the American Association of Neurological Surgeons, suggested providers complete a short (less than 5 minutes), standardized form, with each opioid prescription, to explain why the prescription is medically justified. If a national PDMP were established, data from those forms could feed into it and be cross-checked at the pharmacy.

He noted that having a connected PDMP would prevent doctor-shopping across state lines.

Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research called it a “bold proposal,” but questioned how much of a burden these additional measures would be for providers.

Patrice Harris, MD, an American Medical Association trustee and chair of the AMA’s Opioid Task Force expressed skepticism about the capacity of today’s EHRs. Recommendations on e-prescribing “overstate and overestimate the current capabilities of today’s electronic systems,” she said, adding that e-prescribing “in its current state” may not be suited to “explain medical necessity.”

While physicians may prefer e-prescribing, the pin numbers, passwords, and authentication processes can be “onerous” and may take time away from direct patient care, she added.

last updated 01.31.2018

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