The FDA announced a temporary policy for certain Risk Evaluation and Mitigation Strategy (REMS) requirements for the duration of the COVID-19 public health emergency that has important implications for patients taking opioids.
“For drugs subject to these REMS with laboratory testing or imaging requirements, health care providers prescribing and/or dispensing these drugs should consider whether there are compelling reasons not to complete these tests or studies during the [public health emergency],” reads the guidance for industry and health care providers.
“Clinicians must understand that the information represents the FDA’s current thinking on the topic and should be viewed only as recommendations,” said Joseph V. Pergolizzi Jr., MD, the co-founder of MelRose Pain Solutions, in Naples, Fla., and a Pain Medicine News editorial board advisory board member. “The recommendations highlight the need to be cognizant of self-isolating, social distancing and/or subject quarantining during this pandemic.”
Dr. Pergolizzi noted that pain specialists and primary care physicians treating pain should adhere to the elements to assure safe use as part of the REMS for a drug. “This includes properly educating both patients and practitioners,” he said. “You want to be able to spend the time talking to your patients and providing them with the appropriate educational material.”
For continually prescribing opioids, implementing a comprehensive opioid risk management plan (ORMP) is crucial, Dr. Pergolizzi said. “This means that every 30 days when you are managing the patient and prescribing a Schedule II opioid, you normally are going to examine and talk to your patient and make sure there are no aberrant behaviors. You are also going to conduct your ORMP, do a pill count and/or urine testing, among other tasks, plus ensure that functionality is being achieved by being on an opioid.”
The implementation of stay-at-home measures, social distancing, and self- or mandatory quarantine for COVID-19 can greatly hinder normal patient interaction and impede continuous patient education, when patients are being prescribed Schedule II opioids for noncancer pain.
“How do we renew those prescriptions effectively?” Dr. Pergolizzi asked. “This is why we need societies like the New York State Pain Society and the American Medical Association, or the state medical boards, to step up and provide guidance because currently we are working in the dark.”
Dr. Pergolizzi recommends that medical societies and boards promptly release an expert consensus panel, which can be easily accomplished through various electronic methods such as e-Delphi research, an online method for decision-making processes.
Telemedicine may be adequate for patient interactions and possibly for prescribing a Schedule II drug. “But some states do not allow a Schedule II drug to be electronically prescribed,” Dr. Pergolizzi said. Switching to a Schedule III drug like buprenorphine (transdermal patch or buccal film) also is feasible in many instances, despite the potential challenges of changing medication.
“We need to start thinking outside the box and start collaborating,” Dr. Pergolizzi said. “We also need to realize that amid this COVID crisis, pain still exists. We need to be addressing our patients because they need to have access to their medications.”
In March, the Drug Enforcement Administration (DEA) published an information page, which contains important guidance on COVID-19 and the national drug supply, electronic prescribing of controlled substances, telemedicine and medication-assisted treatment, as well as other important federal and state information (deadiversion.usdoj.gov/coronavirus.html).
“Pain clinicians should use these two trusted references—the FDA and DEA—for guidance,” Dr. Pergolizzi said. “We also need everyone to talk together in order to not lose sight of the pain patient among this pandemic.”
—Bob Kronemyer
Dr. Pergolizzi reported acting as a consultant/speaker and researcher for BioDelivery Sciences, Bridge Therapeutics, Enalare Therapeutics, Neumentum, Salix Pharmaceuticals, Scilex Pharmaceuticals and US WorldMeds.