Will U.S. drug supplies meet demand if Michigan hospitals see a second surge?
In a Thursday press conference, Henry Ford Hospital System’s chief clinical officer expressed measured confidence over the question of unstable drug supplies for COVID-19 patients.
Dr. Betty Chu said the hospital system was “comfortable” with its current stock of sedatives, but acknowledged that maintaining it would be “an ongoing problem — especially if we see a second surge of patients.”
Shortages of sedatives and painkillers, which make patients on mechanical ventilation comfortable, have been challenging U.S. hospitals since the beginning of the pandemic. For clients of Vizient, a company that helps hospitals negotiate contracts with drug companies, as of April 8 only 47 percent of April orders for these drugs were being filled.
As with the disease, the national drug shortage has hit Michigan unevenly. According to spokespeople from Spectrum Health in Grand Rapids and Sparrow Health System in Lansing, their hospital systems are not experiencing sedative shortages, but keeping an eye on levels and frequently communicating with wholesalers.
In Southeast Michigan, the shortage is already showing itself. Like Henry Ford, Beaumont Health is relatively comfortable with its supply, but concerned about another sharp rise in patients.
No matter the region, hospitals are relying on the inventory of wholesalers to respond to potential future shortages. So far those reserves have sufficed, but per Dr. Chu’s point, a second surge may scrape the barrel. And experts warn that lack of transparency in the global pharmaceutical supply chain makes it impossible to know exactly how much of these critical drugs we have left.
“Generally wholesalers only have a month or two of stock on hand,” said Dave Margraf, a pharmaceutical research scientist at the University of Minnesota’s Center for Infectious Disease Research and Policy. “Once that month is over, is there enough coming in from overseas and U.S. manufacturers to meet a second dip in the drugs we have? This is an unknown.”
Wholesalers bail out Beaumont — the first time
Beaumont’s pharmacy director, Annette Karageanes, said the hospital system now has enough sedatives and painkillers for about a month at current demand. Just a few weeks ago, that window was 48 hours.
“[The COVID-19 patients] were consuming much higher than normal amounts of the drugs per day than what we’re used to with the typical vent patients” — on average, up to 50 percent more, she said.
Through Beaumont's regional healthcare coalition, she requested backup supplies, but the emergency shipment wasn't going to arrive on time.
That was on March 31. Three days later, Karageanes gathered Beaumont’s drug vendors on a call and explained that they needed sedatives, painkillers, neuromuscular relaxants and other supplies. While waiting, Beaumont’s pharmacists made do with what they had.
Fentanyl, a drug that’s made headlines as an especially potent contributor to the opioid crisis, is commonly prescribed as both a painkiller and sedative in hospitals. Because vials large enough to fill a COVID-19 patient’s IV bag weren’t available, the pharmacy technicians started emptying the smaller ones.
“My goodness me,” said Karageanes. “Opening up 50 vials of one drug to make one bag, which we were making about 400 a day of across the health system, was pretty laborious.”
This sort of piecemeal labor sustained supplies until the vendors filled the order, in time to prevent total depletion. The backup supplies came a few days later, a week after they were requested.
It's unclear where those backup supplies came from. Bob Wheaton, a spokesperson for Michigan's health department, said that some supplies have come from the Strategic National Stockpile, while others have come from the state's private purchases.
"Since that point we have reached out directly to [hospital systems] to clarify what the needs are to maintain situational awareness," Wheaton said.
Possibly the only place in the world where one can get complete information about pharmaceutical provenance is New Zealand. Before drug companies can market on the island nation, they must provide data about where their products come from.
Margraf, with CIDRAP at the University of Minnesota, has been using the resulting database to inform research about the supply chain for drugs sold in the US. The goal of the research project, called the Resilient Drug Supply Project, is to bring more transparency to the murky pathways between obtaining raw materials and delivering drugs to patients.
This project started 16 months ago. According to Margraf, drug shortages are a perennial problem that the coronavirus pandemic is emphasizing to the extreme.
Drug manufacturers and wholesalers are not required to consistently report inventory levels. The FDA publishes a drug-shortage list, but according to Margraf, it only gets updated when manufacturers notify the FDA of a shortage, often giving “vague” reasons.
The American Society of Health-System Pharmacists also publishes a shortage list, which relies on voluntary reports from hospital systems, practitioners, and patients for timely information about drug supply in hospitals.
“Both lists are valuable, but insufficient to address the immediate needs of local shortages during the pandemic,” Margraf explained in an email follow-up.
In the Thursday press conference, Dr. Chu noted that in light of the shortage Henry Ford is working with compounding pharmacies, which combine existing pharmaceutical ingredients to meet unique patient needs. The FDA announced this month that it is temporarily easing restrictions on compounders so they can accelerate production of these drugs.
But according to Steven Lucio, a VP of pharmacy solutions at Vizient, freedom to manufacture doesn’t solve a root problem. The Association for Accessible Medicines, a pharmaceutical industry group, estimates that 87 percent of facilities that produce active pharmaceutical ingredients are located overseas.
“If you don’t just have those active materials lying around, you’ve got to source it, and those sources may not be immediately available,” said Lucio.
Many of the Michigan health systems that responded to a request for comment on this article (Detroit Medical Center and Ascension Michigan did not) highlighted wholesalers as central to their plans for ensuring sufficient drug supplies for their COVID-19 patients.
But through initial research, Margraf has observed backup drug supplies first being shipped to the coasts. He’s worried about what that could mean if, as Dr. Chu warns, a second surge does hit Michigan.
“Are there going to be drugs left for the Midwest? We don’t know,” he said.