IRVING, Texas–(BUSINESS WIRE)–Following its participation in the March 11 meeting at the White House with members of the Coronavirus task force, Vizient is sharing the list of recommendations it provided to the Trump administration, U.S. Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) that focus on supply strategies for personal protective equipment (PPE) and medications.
The company also applauds the administration for its decision to invoke the Defense Production Act to expand production of hospital masks and other PPE for the nation’s hospitals.
Vizient’s recommended strategies to CMS for avoiding health care supply chain disruption due to COVID-19 include:
- Provide guidance on what providers can do to locally reprocess PPE, invest in sterilization machines so PPE (including N-95 masks) can be reused instead of thrown away, and approve sterilization for single use devices such as eye shields or glasses.
- Nasal swabs that work with testing systems are critical and are on significant back order. Consider working with major manufacturers on strategies to increase capacity and expedite shipping. Consider expediting approval of alternative swabs.
- Empower the FDA to demand weekly volume reports from manufacturers regarding active pharmaceutical ingredient (API) and finished dosage form availability. Under the current framework, FDA (and by extension the healthcare marketplace) has very limited insight into the origination point for API (including redundancy of supply) and other components of finished dosage forms (e.g. excipients, raw materials, vial stoppers). Manufacturers should be compelled to provide this information on a routine and timely basis so FDA can monitor in real-time any anticipated disruptions and implement other actions as appropriate. To the extent possible, FDA should share this information with the healthcare marketplace including public disclosure of the reason for the shortage (e.g., lack of API availability, manufacturing issue). Additionally, manufacturers should also be compelled to disclose their plans regarding supply chain manufacturing redundancy strategies to avoid disruptions and drug shortages.
- Require retailers to take down all personal protective equipment (PPE) for sale and redirect inventory to the healthcare delivery system.
- Redirect PPE from other health related industries (veterinarian and dental use) and any setting where it is not a necessity to the healthcare delivery system. Additionally, evaluate whether PPE such as facial protection, gowns, gloves, etc. used in other non-health related industries (e.g., manufacturing, chemicals, labs) can be repurposed for use in the healthcare setting (similar to the temporary approval of off-label use of NIOSH industrial grade masks).
- Throughout our experience with drug shortages of many products, we have seen examples of situations where secondary distributors/”gray” market participants offer pharmaceuticals in limited supply at greatly inflated and exorbitant prices. We would encourage the federal government through FTC to increase its vigilance for such actions. We also ask for a streamlined process for healthcare providers and others to notify FTC of such actions.
- If an essential medication is currently protected from competition due to market exclusivity but is unable to meet market demand, the government could consider a temporary suspension of that exclusivity, if other suppliers would be able to provide product through an expedited approval mechanism.
To see a complete listing of Vizient’s recommendations to the administration and CMS, please click here.
Vizient is the nation’s largest member-driven health care performance improvement company, providing innovative supply chain capabilities, data-driven solutions and expertise that lead to improved patient outcomes and lower costs.
About Vizient, Inc.
Vizient, Inc. provides solutions and services that improve the delivery of high-value care by aligning cost, quality and market performance for more than 50% of the nation’s acute care providers, which includes 95% of the nation’s academic medical centers, and more than 20% of ambulatory providers. Vizient provides expertise, analytics and advisory services, as well as a contract portfolio that represents more than $100 billion in annual purchasing volume, to improve patient outcomes and lower costs. Vizient has earned a World’s Most Ethical Company designation from the Ethisphere Institute every year since its inception. Headquartered in Irving, Texas, Vizient has offices throughout the United States. Learn more at www.vizientinc.com.