FDA Outlines Steps to Mitigate Overprescribing of Opioid Drugs and Changes to Packaging

By Akia Thorpe -

January 31, 2018

The US Food and Drug Administration (FDA) has released a revised blueprint, Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain, for opioid prescriber education as part of a method to address lowering the rate of new addiction. Additionally, the FDA held a hearing on January 30, 2018 with a broad group of stakeholders—private and public—to seek feedback on how the agency can strengthen its oversight of opioids. Also, the FDA outlined possible changes in requirements for packaging of opioid drugs.

FDA Commissioner Scott Gottlieb says educating physicians with proper practices is a priority. “Appropriate prescribing practices and education are important steps within our statutory authority to help address the human and financial toll of this crisis,” Gottlieb said in a January 30, 2018 statement. “We can and must do more to arm physicians—who are the gatekeepers of prescription opioids—with the most current and comprehensive guidance on the appropriate management of pain.”

The revised blueprint contains core content for training that drug manufacturers are required to make available to prescribers. The revised blueprint broadens content to include information on acute and chronic pain management, safe use of opioids, or other non-opioid or non-drug treatments as well as material on addiction medicine and opioid use disorders.

Once finalized later in 2018, together with the FDA’s Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS), which requires manufacturers to ensure that the benefits of a drug or biological product outweigh its risks, the blueprint will apply to manufacturers of both immediate-release opioid analgesics and extended release/long-acting formulations. It will also be required to be offered, for the first time, to other healthcare professionals who are involved in managing patients with pain, including nurses and pharmacists, in addition to prescribers. The FDA says the revised blueprint is being released in advance to ensure these continuing educational materials and activities are made available in a timely manner.

Gottlieb says the January 2018 hearing served as an opportunity to receive input from a broad group stakeholders as the FDA explores new approaches to encourage appropriate prescribing of opioid analgesics through the FDA’s REMS authorities. Discussions at the meeting, including possible packaging, storage, and disposal solutions, as well as the revised blueprint are in addition to broader ongoing considerations by the FDA about whether mandatory prescriber education is appropriate and how the agency would operationalize such a requirement.

The agency’s Opioid Policy Steering Committee, which the FDA established in May 2017 to solicit suggestions on the crisis, is considering ways to use the FDA’s REMs authorities to augment existing prescribing and dispensing practices, such as using electronic prescribing systems and interfacing with state prescription drug monitoring programs while maintaining appropriate prescribing for patients in medical need.

Changes in packaging for opioid drugs

FDA Commissioner Gottlieb also outlined possible changes for packaging opioid drugs as a means to combat addiction. “We’re also actively exploring how we can use changes in packaging as a way to give providers better options for tailoring how much they prescribe to the clinical need,” he said in the January 30, 2018 statement. “This is especially true when it comes to immediate-release formulations of opioid drugs like Vicodin [acetaminophen and hydrocodone] and Percocet [acetaminophen and oxycodone], which are typically meant for short-term use. If more immediate-release opioid drugs, in particular, were packaged in three- or six-day blister packs, then more doctors may opt for these shorter durations of use. Additionally, provided the FDA concluded that there was sufficient scientific support for these shorter durations of use, this could provide the basis for further regulatory action to drive more appropriate prescribing,” he said.

Toward that end, Gottlieb said that the agency has taken a new action related to how one opioid product is packaged as a way to help address a growing problem of abuse and misuse of this product. The FDA is requesting that sponsors of over-the-counter (OTC) loperamide, which is used to help control short-term symptoms of diarrhea, change the way they label and package these drugs to stem abuse and misuse. The FDA added a warning to the product label in the spring of 2017 to warn of ingesting high doses of loperamide, including from abuse and misuse. Gottlieb said that evidence suggests that package limitations and use of unit-dose packaging may reduce medication overdose and death.

Gottlieb said the agency has now sent letters to the OTC manufacturers requesting that they implement changes consisting of packaging limitations and unit-of-dose packaging. He added that the FDA plans to reach out to those who distribute loperamide online, through retail websites, to ask them to take voluntary steps to address the abuse issue. “The new packaging should help make limits on sales more easily achieved,” said Gottlieb in his statement. “The abuse of loperamide requires the purchase of extremely large quantities. Often this is done through the purchase of large bottles of loperamide, which is a common configuration in which the pill form of the medication is currently packaged. Today’s {January 30, 2018] action is intended to change how the product is packaged, to eliminate these large- volume containers. We know that many of the bulk purchases of these large volumes are being made online through major online web retailers.”

Source: FDA (Commissioner statement) and FDA (revised blueprint)