Access to the PPM Journal and newsletters is FREE for clinicians.
Issue 1, Volume 3
Abuse-Deterrent Technologies
14 Articles in this Series
The effect of a potentially tamper-resistant oxycodone
Commentary: Why Prescribers Need to Adopt Abuse-Deterrent Opioids
Review: The Impact of Abuse-Deterrent Formulations on Prescribing and Abuse
Abuse-Deterrence Guidance Further Highlights Federal Focus
The Burden of Undiagnosed Opioid Abuse Among the Commercially Insured
Reductions in Reported Deaths Following Introduction of Abuse-Deterrent Oxycodone ER (OxyContin)
Abuse-Deterrent Opioids—Evaluation and Labeling
Generic patches containing fentanyl: abuse deterrent evaluation
FDA Advisory Committee Meetings on Abuse-Deterrent Opioids
Regulatory Update: FDA Takes Additional Abuse-Deterrent Steps
Related: At-Risk Patients and Urine Drug Monitoring
Extended-Release Formulations Enter US Market
Development and Impact of Prescription Opioid ADF Technologies
Trends in Opioid Analgesic Abuse and Mortality in the United States

Regulatory Update: FDA Takes Additional Abuse-Deterrent Steps

2018;FDA:Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain:

Agency equally targets manufacturers, distributors, and physicians in effort to reduce opioid overdose, addiction, and misuse

In its continued efforts to end the declared public health emergency regarding opioid abuse, misuse, and addiction, FDA announced it is moving forward with strengthening appropriate prescribing practices, better packaging, and healthcare provider education programs.  Commissioner Scott Gottlieb, MD, shared several actions taken just this week to achieve these goals, which, he said, “are indicative of the kinds of steps we need to take as we confront this epidemic.” 

To start, the agency released an updated version of its Opioid Analgesic REMS Education Blueprint for Health Care Providers involved in the Treatment and Monitoring of Patients with Pain. The updated blueprint, which grew out of the 2012 Opioid Analgesic REMS and the revised 2017 Extended-Release/Long-Acting Opioid Analgesic education blueprint, has grown to include more information on recommended principles for HCP education, the management of acute and chronic pain through both pharmacologic and nonpharmacologic means, and addiction medicine.The document is meant to facilitate continuing education activities for healthcare providers involved in assessing, monitoring and treating for pain. 

In connection with the blueprint, Dr. Gottlieb noted that further stakeholder input is being sought from both private and public representatives to address the declared crisis, including a hearing held January 30 to put together a plan for strengthening oversight of opioids. In addition to seeking ways to “reduce exposure to opioids through our influence on prescribers,” the agency is looking at manufacturers and distributors with an eye toward improving abuse-deterrent packaging and labeling.

“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 explained. Such changes are particularly applicable to immediate-release opioid products and those indicated for short-term use.

To start, the agency has asked the manufacturer (Johnson & Johnson) of loperamide, indicated to treat short-term diarrhea and which contains opioid-based ingredients, to reduce the amount of opioid product in its distribution chain. While loperamide is safe when used at its approved doses (8 mg per day over-the-counter, and 16 mg per day prescription), the medication has reportedly been used in large quantities by drug abusers, as well as those attempting to treat opioid withdrawal symptoms, according to the FDA statement.

The product’s labeling was adjusted in spring 2017 to include a warning label regarding the ingestion of high doses. FDA has now asked the company to implement packaging limitation and unit of dose packaging changes to further deter abuse.

The agency has also asked distributors to voluntarily assist in monitoring/reducing large quantity sales of the product. Said Dr. Gottlieb, “I believe anyone who is distributing health care products has an obligation to be a partner in helping address the most pressing public health challenges like opioid abuse…. You have a social contract to take voluntary steps to help address public health challenges.”

FDA hopes that packaging tweaks such as that being requested for loperamide may assist in reducing opioid misuse and abuse. “If more immediate release drugs, in particular, were packaged in three or six-day blister packs; then more doctors may opt for these shorter durations of use,” explained Dr. Gottlieb in the FDA announcement. While physicians are being to asked to strengthen their protocols for prescribing opioids, manufacturers and distributors of opioid-containing products may also need to be on the lookout for additional packaging and labeling requests from the agency. 

-Reported by Angie Drakulich

Next Article:
Related: At-Risk Patients and Urine Drug Monitoring
close X