August 13, 2010 — The US Food and Drug Administration (FDA) reports that new opioid recommendations will be unveiled early next year. The agency told Medscape Medical News the risk evaluation and mitigation strategies, known as REMS, are scheduled to be approved in 2011, with roll out and implementation to follow.

Regulators had been projecting a summer release, but a recent advisory committee vote against the agency’s proposal was a blow to the plan. Most committee members agreed that safety measures for opioids are urgently needed but voiced concern that the current approach does not go far enough to protect the public.

According to some reports, there are more deaths from opioid overdoses than from heroin and cocaine overdoses combined.

„FDA is currently reviewing the input from the advisory committee and the public,“ said Karen Mahoney, from the agency’s Center for Drug Evaluation and Research. „We have not yet made any final decisions on the REMS program. Once final decisions are made, FDA will communicate these requirements to the manufacturers, and they will have up to 120 days to submit a program for FDA’s review and approval.“

Herbert Neuman, MD, vice president of medical affairs and chief medical officer at Covidien Pharmaceuticals, says he is eagerly awaiting the new plan. The company already has REMS in place for hydromorphone extended-release (Exalgo). „We will modify our approach to comply with whatever the requirements will be,“ Dr. Neuman said during an interview, adding that he looks forward to the clarity a final decision will afford.

The advisory committee’s 25 to 10 vote against the first proposal, which was largely favored among industry, sent a strong message to regulators that new recommendations will require more teeth.

The plan will alter the prescribing landscape for opioid therapies and is expected to have important implications for an estimated 4 million patients.

Mandatory Education

Advisory committee members recommended mandatory training for prescribers. They called on Congress to initiate new legislation to link physician education to the existing Drug Enforcement Administration registration system. More than 1 million clinicians are currently registered to prescribe opioids.

The committee, led by Jeffrey Kirsch, MD, from the Oregon Health and Science University in Portland, argued that the overwhelming public health problem of opioid misuse is in part beyond the regulatory control of the FDA and will require a multidisciplinary approach.

It is a view shared by many, including Seddon Savage, MD, president of the American Pain Society, who recently told Medscape Medical News that Drug Enforcement Administration involvement is „the best long-term solution.“

Perry Fine, MD, president elect of the American Academy of Pain Medicine, says he agrees. „The Drug Enforcement Administration is already involved, so it makes sense to include education.“ Dr. Fine points out that in the absence of a well-designed uniform curriculum focused on opioid therapies in medical schools, continuing education is necessary. „We need to learn about opioids in the same way we learn about sterile technique or appropriate use of antibiotics,“ he said.

The advisory committee called on regulators to add immediate-release drugs to the current plan, which presently includes only extended-release and long-acting formulations.

All Controlled Drugs

Dr. Fine has concerns about whether all drug schedules will be included in the REMS, or just schedule II products. „This wasn’t brought up by the FDA or the advisory committee, and it could have a chilling effect on prescriptions,“ he said. If only schedule II compounds have more stringent requirements, then physicians may opt out by prescribing less-monitored alternatives. „They may not prescribe the most useful drug, and focus instead on other nonmedical issues, putting patients in an even more vulnerable position than they already are in.“

Dr. Fine says electronic health records may help — a patient’s electronic file could record all physician visits and prescription refills. „This is a concern not only with opioids, but with all medications that could have contraindications for a variety of reasons,“ he noted.

The timeline for the FDA’s plan has moved more than once. Dr. Fine says this is not surprising. „It is an extraordinary undertaking that will have enormous implications, and it is important to carefully weigh the consequences of any proposed action,“ he said. „It’s important the FDA does something reasonable and responsible.“

source: http://www.medscape.com/viewarticle/726875