The Joint Commission surveyors will now check to see if hospitals are compliant with the Food and Drug Administration’s (FDA) ban on powdered medical gloves. The ban went into effect in January, with the administration citing the powder’s potential to cause severe airway and wound inflammation, granulomas, and post-surgical adhesions in the tissue between internal organs. Powdered latex gloves also carry the risk of allergic reaction in patients. The Joint Commission will now issue citations on the powdered glove ban under LD 04.01.01, element of performance 2.
“This ban is about protecting patients and healthcare professionals from a danger they might not even be aware of,” said Jeffrey Shuren, MD, director of FDA’s Center for Devices and Radiological Health, in a press release. “We take bans very seriously and only take this action when we feel it’s necessary to protect the public health.”
On February 24, the U.S. Senate voted to confirm Robert Califf, MD, as the new Food and Drug Administration (FDA) commissioner. The Senate vote in Califf’s favor was 89-4, ending a yearlong debate over his suitability.
Califf, a former medical researcher at Duke University, was nominated for the position by President Obama back in January 2015. Despite having widespread support from many patient advocacy groups, academics, and medical societies, his confirmation had been delayed by a small group of senators who said they were concerned about how Califf’s links to the pharmaceutical industry would affect his response to the prescription opioid epidemic.
Amidst the growing opioid epidemic, the Food and Drug Administration (FDA) has now released details about its Opioid Action Plan. The fact sheet details the agency’s policy changes and the outcomes it hopes will result.
Expanding use of advisory committees
- The FDA will convene an expert advisory committee before approving any new drug application for an opioid that does not have abuse-deterrent properties.
- The Pediatric Advisory Committee will make recommendations regarding a framework for pediatric opioid labeling before any new labeling is approved.
- The FDA will consult an advisory committee on abuse-deterrent formulation (ADF) opioids when it raises novel issues.
Outcome:Before the approval of any new opioid that does not have abuse-deterrent properties and expert advice on pediatric opioid labeling, it will be reviewed by external experts who will give advice on the drug. In addition, there will be opportunity for public input for every new opioid.
Develop warnings and safety information for immediate-release (IR) opioid labeling
- The agency is developing changes to IR opioid labeling, including additional warnings and safety information, similar to the labeling for extended-release/long-acting (ER/LA) opioid analgesics.
Outcome:Better information for doctors about the risks and how to prescribe safely.
Strengthen postmarket requirements
- There is a substantial lack of an evidence base to guide the use of opioid medications, particularly for their long-term use.
- The agency is strengthening the requirements for drug companies to generate postmarket data on the long-term impact of using ER/LA opioids.
Outcome:Better evidence on the serious risks of misuse and abuse associated with long-term use of opioids, predictors of opioid addiction and other important issues.
Update Risk Evaluation and Mitigation Strategy (REMS) Program
- ER/LA opioids are currently subject to a REMS program that requires sponsors to fund low-cost or free continuing medical education courses on the appropriate use of ER/LAs.
- The FDA will update the REMS program requirements for opioids after considering advisory committee recommendations and review of existing requirements.
Outcome: Increase the number of prescribers who receive training on pain management and safe prescribing of opioid drugs to decrease inappropriate opioid prescribing.
Expand access to ADFs to discourage abuse
- The FDA will issue draft guidance with its recommendations for the approval standards for generic ADFs.
- Release of this guidance is a high priority, since the availability of less costly generic products should accelerate prescribers’ uptake of ADFs.
Outcome:Spur innovation and generic ADF product development.
Support better treatment
- The FDA is reviewing options, including over-the-counter availability, to make naloxone more accessible to treat opioid overdose, building on the agency’s recent approval of intranasal naloxone.
- The FDA also supports the Centers for Disease Control and Prevention guidelines for prescribing opioids and will facilitate the development of evidence and improved treatments.
Outcome:Broader access to overdose treatment, safer prescribing and use of opioids, and ultimately, new classes of pain medicines without the same risks as opioids.
Reassess the risk-benefit approval framework for opioid use
- The FDA will seek advice from its Science Board in March 2016 on how to take into account our evolving understanding of the risks of opioids, not only to the patient but also the risks of misuse by other persons who obtain them.
- The FDA is already working with the National Academies of Sciences, Engineering, and Medicine on the same topic.
- Once completed the reports will be made publicly available.
Outcome:Formal incorporation of the broader public health impact of opioid abuse in approval decisions.