FDA Expands Indication of Antiviral Therapy to Include Post-Exposure Influenza Prevention
November 23, 2020 09:45pm
A coalition of health care industry leaders hosted a meeting Thursday in Washington, DC, to examine how to address this problem.
A coalition of health care industry leaders seeking to address drug shortages recently hosted a summit in Washington, DC, to examine vulnerabilities in the supply chain and ways that they might be strengthened.
The daylong meeting brought together representatives of clinician groups, government officials, and supply chain entities, including pharmaceutical companies to discuss disaster preparedness and response efforts, as well as potential risks to national security, because of drug shortages.
“The persistent shortages of critical, lifesaving medications already dangerously interfere with patient care and place a tremendous strain on daily operations in hospitals across the country,” Paul W. Abramowitz, PharmD, ScD, (Hon), FASHP, and the chief executive officer of theAmerican Society of Health-System Pharmacists(ASHP), said in a statement.
The summit “Drug Shortages as a Matter of National Security: Improving the Resilience of the Nation’s Health Care Critical Infrastructure” was an invitation-only event. In addition to the ASHP, officials from the American Hospital Association, the American Society of Anesthesiologists (ASA), the American Society of Clinical Oncology, and the Institute for Safe Medication Practices were among the participants.
Prior to the summit, ASA President James D. Grant, MD, MBA, FASA, said that participants planned to work together to develop actionable solutions that could ensure patients had continued access to a secure and stable supply of medications.
“These unprecedented and dangerous shortages of drugs are affecting 98% of physician anesthesiologists across the country with potential serious consequences to our patients’ safety and quality of care,” he said in a statement.
In an interview following the summit, Michael Ganio, PharmD, MS, BCPS, CPHIMS, FASHP, director of pharmacy practice and quality for the ASHP, said that though drug shortages have been an issue for a couple of decades, recent disasters, such as last year’s Hurricane Maria, have exposed critical vulnerabilities in the supply chain.
However, contaminations, military conflicts, and trade wars can all contribute to drug shortages, he said.
“We really wanted to explore those topics and see what our colleagues have done to mitigate [the shortages],” Ganio said.
Representatives from throughout the supply chain discussed steps that they have taken to help safeguard against shortages, Ganio said.
One company highlighted improvements made to a manufacturing plant that would allow it to continue producing medications in the event of a disaster, he said.
Having a disaster preparedness plan in place is key and might rely on receiving FDA approvals to allow production of drugs to be moved to alternative sites and to use alternate suppliers of raw materials, Ganio said.
“It’s encouraging to know there are lessons learned from shortages, but we still have work to do,” he said.
“We identified some key points that should help, but it's really difficult to prepare for a disaster. There are only so many contingency plans you can develop," Ganio said.
A need for more transparency also was discussed at the summit, he said, citing as an example drug manufacturing plants in an area of North Carolina that recently was affected by Hurricane Florence.
“Unfortunately, we have no idea what’s made in that area,” Ganio said. “One plant makes vaccines, but what [type of] vaccines?”
Ganio acknowledged that while “too much” transparency could have a negative impact if buyers begin overstocking medications in advance of a shortage, more transparency can also help the supply chain.
“Giving a health system 2 weeks' [notice] instead of 2 days makes a huge difference,” he said.
Summit participants also discussed the notion of compiling a list of critical drugs that could receive priority focus and guaranteed to be made available.
However, a consensus would be difficult to attain, and the FDA does not have the authority to require manufacturers to produce their medications, Ganio said.
Regardless, the topic of drug shortages is receiving attention that is needed, he said.
“Hopefully, we’ll have a resolution,” Ganio said.
This article was originally published atPharmacyTimes.com.
Summit on drug shortages to examine impact on national security and health care infrastructure [news release]. Washington, DC; September 19, 2018: ASHP website.ashp.org/news/2018/09/19/summit-on-drug-shortages-to-examine-impact-on-national-security-and-health-care-infrastructure. Accessed September 19, 2018.