In a press release posted to its website on Tuesday evening, the Charlotte-based Premier Inc. health alliance sounded the alarm regarding prescription medications connected in some way to the COVID-19 pandemic, finding that 15 medications needed to help treat patients with the virus are already in or near nationwide shortage, even as the pandemic is surging nationwide.
As the press release began, “Premier Inc. (NASDAQ: PINC), a leading healthcare improvement company, today released data finding that 15 drugs essential to providing care for COVID-19 patients are currently in or very near shortage. Using its comprehensive data on purchasing patterns and current fill rates, Premier found that these products experienced the greatest spikes in demand during the month of March but were also unable to be supplied in the requested quantities – two early warning signals for shortages. Drugs include antimalarials and antivirals that may be an effective COVID-19 treatment, as well as antibiotics used to cure infections. Other products at risk of shortages include bronchodilators for keeping airways open, as well as sedatives and neuromuscular blockers used to intubate patients. Demand for these products was even higher in COVID-19 hotspots like New York, suggesting that products could move from regional shortages into national shortages as the disease spreads to additional communities.”
Among the drugs most affected by the current situation, the most dramatic shortage is around chloroquine, which has seen a 3,000-percent increase in orders in March, and which has a current fill rate of only 19 percent. A variant of that antimalarial drug, hydroxychloroquine, has seen a 260-percent increase in orders in March, and is at a current fill rate of just 35 percent. Chloroquine and hydroxychloroquine have been the subject of much controversy in the past couple of weeks, as President Trump, referencing a program on Fox News, has touted them as potentially valuable in the treatment of COVID-19, though the clinical evidence for their efficacy in treating the coronavirus is limited to a single French study of 20 patients. Clinical trials of the two drugs are now getting underway.
Meanwhile, in addition to those two antimalarials, several antiviral medications are now seeing sharp increases in orders. This month (March), acyclovir, ribavirin, and valacyclovir saw order increase percentages of 100 percent, 200 percent, and 20 percent, respectively, and current fill rates of 86 percent, 50 percent, and 87 percent, respectively.
“Increased demand for these products will clearly put pressure on manufacturers’ safety stocks, creating shortages that could worsen with time unless we take fast action now,” Premier president Michael J. Alkire said in a statement in the press release. “For commodity products, we can tap adjacent industries to begin production. But drug manufacturing is highly regulated, and it typically takes years and substantial investment to build additional capacity and gain U.S. Food and Drug Administration (FDA) approval. Even if the FDA expedited approvals, inspections and other actions, drug manufacturing cannot be stood up overnight. Moreover, there are also secondary concerns about where replacement ingredients will be sourced, as many of these drugs rely on active pharmaceutical ingredients (API) from overseas.”
As the press release noted, “Premier surveyed its members and found that active shortages are far more pervasive in the acute care setting, where 70 percent of acute care respondents report at least one shortage for COVID-19 drugs. In the non-acute setting, that number drops to 48 percent. Antimalarial drugs were the most commonly reported shortage (70 percent of hospital respondents), followed by bronchodilators (65 percent), antibiotics (40 percent), antivirals (38 percent) and sedatives (35 percent). Reported shortages were higher in hotspots like New York, where 77 percent of hospitals with COVID-19 cases report shortages of antimalarials, as well as antivirals (54 percent) and sedatives (39 percent).”
The health alliance recommended that the FDA leverage several strategies at once to address the issue, including partnering with the private sector to develop “a dynamic allocation process that accounts for surge demand and prioritizes the needs of acute care providers”; create “a streamlined and efficient process for accessing drugs from the Strategic National Stockpile”; that “The DEA [Drug Enforcement Administration] should temporarily increase the threshold for allocating quota” of controlled substances “to provide added flexibility and avoid bottlenecks”; and that “The government should leverage air transport to expedite transportation of necessary products,” given that active pharmaceutical ingredients and finished dose drugs produced overseas may be delayed in arriving to the U.S. because of port closures or other shipping delays. The alliance also stated that “Health systems should be allowed to temporarily transfer drugs freely between hospitals or other pharmacies without having to obtain licensure to distribute products,” and that “The current inventory levels and available safety stock for critical medications is unknown,” and therefore, “Working with private sector partners, the FDA needs to create a centralized data repository quantifying inventory levels for critical medications.”
