FDA Releases New Educational Material for Opioid Prescribers
[Thursday, September 20, 2018] This week FDA released an educational guidance for prescribers of opioid drugs intended to limit opioid prescription through increased diligence by the physicians. The FDA guidance is very similar to that from CDC released last year for the same purpose. Most of the patients get opioid drugs via prescriptions from their physicians, hence the best way to limit opioids is to have physicians write fewer prescriptions for these highly addictive drugs. Since FDA does not directly have jurisdiction over physicians, it is implementing this educational program as a part of the REMS program for opioid drugs. The recommendations are logical and follow the commonsense steps for reducing prescriptions and, in turn, addiction. The guidance starts with explaining pain reported by the patients in the context of the underlying cause and impact on the quality of life of the patient. A ten-point patient assessment is recommended to evaluate the pain reported by a given patient prior to making therapeutic decisions. Just like the CDC guidance from last year, the guidance then goes on to suggest a step-wise pain management plan starting with non-pharmacologic treatments, followed by non-opioid pain drugs, then low-dose acute duration opioids and using higher doses and chronic uses only as a last resort in patients who are non-responsive or under-responsive to the other treatment options. Despite efforts from the FDA, CDC and other government agencies over the last several years, opioid addiction is a growing problem. The main reason is that patients want immediate relief from pain and fear that the new proposals will limit drugs that they need to manage their pain. The gradual pain management program advocated by CDC and FDA is hard to implement by physicians pressured by their patients to prescribe stronger medication that can provide quick relief even if there is a risk for addiction. An average physician finds it challenging to spend the extra time needed for the suggestions made by the FDA. It is hard to imagine that the main reason for doctor writing more prescriptions is that they are unaware of the harms of opioid drugs or that they don’t understand pain. So, it is anybody’s guess if these new educational programs will the intended effect. Coupled to these efforts should be emphasis on payors such as insurance companies, and medical boards to mandate that physicians follow the step-wise pain management program and justify every opioid drug prescription. Without mandatory actions, the FDA guidance may have the same fate as the CDC guidance, of good information that is not practically hard to implement.
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