- Tackling the nationwide opioid crisis requires a nuanced approach that recognizes safe prescribing protocols while still ensuring patient access to painkillers they genuinely need, according to FDA Commissioner Scott Gottlieb.
In a statement announcing the agency’s Patient-Focused Drug Development Meeting taking place on July 9, Gottlieb acknowledged that strict opioid prescribing laws often do a great deal of harm to some patients. There are some situations, including for metastatic cancer pain management and chronic migraine management, in which a long-term opioid prescription is the best fit for a patient.
Those patients should not be stigmatized or barred from accessing their treatments, Gottlieb said.
“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 explained. “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.”
To be clear, FDA agrees that more judicious opioid prescribing is necessary for combatting the opioid crisis. These drugs are being prescribed at an exceptionally high rate, Gottlieb acknowledged, and need better regulation to prevent patients from developing a potentially lethal addiction.
But current strategies for quelling opioid prescribing has begun to do some harm to patients who legitimately need the medications, Gottlieb added. Through patient workgroups with FDA, Gottlieb and colleagues have learned that legitimate pain management patients feel stigmatized and face challenges in building healthy patient-provider relationships.
The key is to ensure opioid prescribing is thoughtful, Gottlieb said. The opioid crisis in many ways stemmed from providers who prescribed too many opioids too often, as well as drug manufacturers that promoted opioids for “unapproved purposes,” Gottlieb pointed out.
A strict ban on opioids or making these drugs next to impossible to access is not a viable solution, given the patients who genuinely need the medication. Instead, providers need better education about when to prescribe opioids and how to detect warning signs that a patient may be getting hooked on an opioid. Opioid prescribing should be patient-centric, taking into account specific patient preferences, needs, and patient education approaches.
“Patients in pain deserve thoughtful, careful and tailored approaches to the treatment of their medical conditions,” Gottlieb said.
The Patient-Focused Drug Development meeting aims to understand the needs and experiences of patients who truly need opioids. Specifically, FDA wants to know about the impact of chronic pain on patients’ everyday lives, treatment approaches with combination drug therapies, and other alternative, non-medicinal therapies.
FDA has taken other actions to promote the responsible prescribing of opioid treatments for chronic pain and other legitimate pain issues. A recent FDA blueprint for drug manufacturers focuses on how drug makers can educate prescribers about opioid use. The blueprint also highlights issues about opioid misuse and addiction.
The agency is also connecting with professional medical societies to create resources for clinicians about opioid use and prescribing, Gottlieb reported. These guidelines could help clinicians determine situations during which they should or should not prescribe an opioid for pain management.
The key to combatting the opioid crisis is rooting efforts in clinician education, Gottlieb said. Much of the current opioid crisis stems from limited provider understanding of the drug. That fact should fuel a thirst for knowledge going forward, he said.
“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.
Ideally, more provider education about opioid addiction and prescribing will lead to more judicious prescribing. Combatting the opioid crisis should not include limiting opioids, FDA suggested. Instead, it should be rooted in more responsible and thoughtful prescribing habits.
This will include prescribing opioids to patients who legitimately qualify, in addition to educating patients about responsible use and red flags for potential misuse or addiction.
“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 concluded. “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.”