FDA: Limiting Opioids Won't Curb Crisis, Responsible Prescribing Will

By Beth Leipholtz 07/16/18

The FDA commissioner issued a statement addressing the stigma aimed at pain patients and the need for providers to take a patient-centric approach.

FDA Commissioner Scott Gottlieb
FDA Commissioner Scott Gottlieb Photo via YouTube

Strict opioid prescribing regulations are harming some chronic pain patients, according to U.S. Food and Drug Administration Commissioner Scott Gottlieb.

On Monday, July 9, the FDA released a statement about its Patient-Focused Drug Development Meeting, during which Gottlieb brought up the struggles some patients face because of strict opioid prescribing laws. 

According to PatientEngagementHIT, there are some instances in which patients, such as those those facing “metastatic cancer pain management and chronic migraine management,” are best fit for a long-term opioid prescription.

“Tragically, we know that for some patients, loss of quality of life due to crushing pain has resulted in increased thoughts of or actual suicide,” Gottlieb said in the statement. “This is unacceptable. Reflecting this, even as we seek to curb overprescribing of opioids, we also must make sure that patients with a true medical need for these drugs can access these therapies.”

While Gottlieb acknowledges that prescribing regulations are necessary in order to fight the opioid crisis, he also says those strategies are negatively affecting patients who rely on the medications for pain management.

Gottlieb and his colleagues have learned through patient workgroups that patients in need of pain management say they feel stigmatized and have a difficult time building healthy relationships with care providers.

According to Gottlieb, simply banning opioids or increasing the difficulty of obtaining a prescription is not the solution to the issue. He says instead, better education needs to be available to providers and opioid prescribing should take a “patient-centric” approach, taking patient “preferences, needs, and patient education approaches” into account.

“Balancing the need to maintain access with the mandate to aggressively confront the addiction crisis starts with good medical management,” Gottlieb said in the statement. “All patients in pain should benefit from the skillful and appropriate care of their pain. It’s also critical that we take this same aggressive approach to changing the culture of medicine around treating pain… Patients in pain deserve thoughtful, careful and tailored approaches to the treatment of their medical conditions.”

The statement also outlines steps the FDA has taken to push responsible prescribing methods. For example, the FDA released a blueprint for drug manufacturers focusing on how they can educate prescribers. Additionally, the FDA is working with medical professionals to develop resources for clinicians.

“We need to be mindful of this history, learn from it and make sure that we act aggressively to confront new trends that may continue to fuel the current crisis or lead to a new epidemic of addiction,” Gottlieb explained.

The FDA also stated that combating the opioid crisis should not involve limiting or banning opioids, but instead has to do with better education about practices.

“Our goal is to support more rational prescribing practices, as well as identify and encourage development of new treatment options that don’t have the addictive features of opioids,” Gottlieb said in the statement. “In this way, we’ll help ensure that we’re not unnecessarily putting patients as risk of addiction by overprescribing opioids, while also maintaining appropriate access to care for patients with serious pain. In pursuing these goals, we must make sure that patients inform our work.”

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Beth is a Minnesota girl who got sober at age 20. By day she is a website designer, and in her spare time she enjoys writing about recovery at www.lifetobecontinued.com, doing graphic design and spending time with her boyfriend and three dogs. Find Beth on LinkedInInstagram and Twitter.