Over the past several years, increased attention has been paid to the use of opioids to treat chronic pain in America. Much of this focus has been in response to a worsening opioid crisis, as patients and non-patients continue to have access to an increasing supply of powerful opioid pain-relieving medications.
Ready access to these drugs has enabled patients, and sometimes their family members, to become addicted to these medications. Alarmingly, this commonly leads to heroin or synthetic opioid abuse.
{mosads}Recently, the Trump administration declared a public health emergency over the developing opioid crisis in America. In an effort to find a solution to this epidemic, the U.S. Food and Drug Administration (FDA) recently held a public hearing, “Opioid Policy Steering Committee: Prescribing Intervention — Exploring a Strategy for Implementation.”
The purpose of this meeting was to receive stakeholder input on how the FDA might, under its Risk Evaluation and Mitigation Strategy (REMS) authority, improve the safe use of opioid analgesics by curbing overprescribing to decrease the occurrence of new addictions and limit misuse and abuse of opioid analgesics. I had the distinct honor of representing the national neurosurgical societies at this meeting.
Given that this crisis is at least partially due to the abundance of readily-available and powerful opioid medications, the efforts to reduce the illicit use of opioids as well as their overall availability seem reasonable. Neurosurgeons certainly agree with efforts to limit the use of opioids to clinical situations that warrant their use.
During my presentation to the FDA on behalf of the American Association of Neurological Surgeons (AANS), Congress of Neurological Surgeons (CNS), the AANS/CNS Section on Pain and AANS/CNS Section on Disorders of the Spine and Peripheral Nerves, the groups presented several recommendations to help tackle the opioid crisis.
Create a national prescription drug monitoring program (PDMP) to replace the patchwork system of State PDMPs. The current system of disjointed isolated state-based databases enables patients living near state borders to get multiple prescriptions in different states if adjacent states are not sharing information and making it accessible to clinicians.
The REMS document and national PDMP will be checked by the pharmacist at the time of medication dispensing as a safeguard against inappropriate and/or duplicate prescribing.
This document would explain the need for the opioid prescription, and would further support the quantity of medication being prescribed. For example, a patient with a newly-diagnosed, acute pain syndrome will be subject to the five to seven day day opioid supply limit, whereas a patient with a stable, chronic pain syndrome on maintenance opioid therapy will have access to a 30-day supply.
This documentation, which need not be overly burdensome and lengthy, would restrict the amount of inappropriately supplied pills and would also limit denials of medically-necessary medication.
We acknowledge that this opioid justification form represents an additional regulatory burden for prescribers and pharmacists. But this minimal, upfront time commitment by the prescriber and pharmacist will save time wasted on unnecessary appeals of prescription denials, will ensure that our patients get their medically-necessary opioid therapy, and will limit the availability of excess opioids pills for abuse.
Indeed, upon hearing our recommendations, FDA drug center director, Janet Woodcock, applauded organized neurosurgery for what she characterized as a “bold proposal” toward creating medical documentation to justify opioid prescriptions.
The opioid crisis is upon us with enormous impact, and America’s neurosurgeons greatly appreciate the opportunity to work with the FDA, and we stand ready to work with other stakeholders to curb the opioid crisis while preserving patient access to medically-necessary medicines to ease their pain and suffering.
Robert F. Heary, M.D. is professor of neurosurgery at Rutgers New Jersey Medical School and chair of the American Association of Neurological Surgeons and Congress of Neurological Surgeons committee on Drugs and Devices.