Fixing the Market
To try to get ahead of the problem, VA joined with five healthcare systems in 2018 to create Civica Rx, a not-for-profit generic drug company. Today, three philanthropies and 42 health systems representing more than 1,100 hospitals with more than 200,000 beds in 46 states collaborate through Civica Rx. The VA continues to work in consultation with company to address its particular needs.
Civica Rx aims to stabilize the supply of antibiotics, anesthetics, cardiac medications, pain management medications, and other sterile injectable medicines that have been subject to recurrent shortages for participating health systems. It is working with multiple FDA-approved generic drug manufacturers to re-enter or increase capacity for generic drugs needed by hospitals, developing abbreviated new drug applications for generic drugs, and building its own manufacturing facilities.
In October, the company provided its first branded medications to hospitals, vials of vancomycin. Another antibiotic, daptomycin, was expected to be distributed in November, followed by 15 other medications in the next few months.
The collaboration addresses some of the root causes of shortages identified in on October inter-agency Drug Shortage Task Force report. Led by the FDA, the task force includes officials from several agencies including the VA and the DoD as well as the Centers for Medicare & Medicaid Services and the Office of the Assistant Secretary for Preparedness and Response within the Department of Human Services.
That report found that three factors contribute to the ongoing shortages. Manufacturers lack incentives to produce less profitable drugs, leading some to exit the market and others to redirect capacity to more lucrative products. The market does not recognize and reward manufacturers who pursue a higher quality strategy and have systems that alert them to impending supply chain issues. Further, logistical and regulatory challenges, intensified by extended supply chains and contracts that enable both parties to easily walk away, make it recovering from disruptions difficult.
Natural disasters and other unexpected situations also affect drug supplies. Hurricane Maria wiped out Puerto Rico’s significant pharmaceutical manufacturing industry, leading to a critical shortage of bags of saline solution used for intravenous administration of medications as well as 10 drugs.
Swine fever in China killed 150 million of the nation’s 440 million pigs, affecting the production of heparin, which is made from porcine mucosa. That prompted widespread concern about availability of the blood thinner and an inquiry from the House Energy and Commerce Committee.
The FDA reported that “the majority of manufacturers reported no such issues related to African swine fever” in October, but said the agency “continues to be in regular contact with U.S. heparin suppliers and manufacturers as this situation evolves.” The agency noted that certain presentations of heparin have been in shortage, but overall supply was sufficient to meet market needs. To help ensure that supply, the FDA allowed Baxter to import certain heparin products from the U.K., even though those products do not have explicit FDA approval.
Zacher said that the heparin shortage is not impacting care for veterans, but Massachusetts General Hospital’s chief of pharmacy told NBC news that “heparin, is right now, is on major shortage for us and across the country.”
Heparin highlighted another common concern—undeclared shortages. While manufacturers were telling the FDA they would not face critical issues as a result of the loss of Chinese pigs, the American Society of Health-System Pharmacists reported at the same time that a number of manufacturers said they were experiencing shortages. Fresenius Kabi had heparin “on a protective allocation due to a potential shortage of raw ingredient” and Pfizer reported shortages related to manufacturing delays.
- Chen SI, Fox ER, Hall MK, Ross JS, Bucholz EM, Krumholz HM, Venkatesh AK. Despite Federal Legislation, Shortages Of Drugs Used In Acute Care Settings Remain Persistent And Prolonged. Health Aff (Millwood). 2016 May 1;35(5):798-804. doi: 10.1377/hlthaff.2015.1157.