While the Trump administration has touted the potential for certain drug combinations such as chloroquine and azithromycin to treat severely ill COVID-19 patients, new data shows those medicines may be in short supply.
Premier, a health improvement company, looked at data (PDF) on purchasing patterns and current fill rates and found that 15 essential drugs experienced the greatest spikes in demand during the month of March but were also unable to be supplied in the requested quantities.
That's two early warning signals that those drugs are running low, according to Premier.
Shortages are most common in the hospital setting and are most acute in New York, where the majority of COVID-19 patients are receiving care.
Antimalarial drugs hydroxychloroquine and chloroquine are at risk of being depleted soon, according to Premier's data. Hydroxychloroquine has seen a 260% increase in demand in March and the fill rate drop to 35%, while orders for chloroquine increased 3,000% in March and the fill rate dropped to 19%.
Antibiotics used to cure infections are currently depleted as well. Orders for azithromycin increased 170% in March and the fill rate dropped to 60%.
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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, Premier said.
“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,” says Premier President Michael Alkire. “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, Alkire noted.
There are also secondary concerns about where replacement ingredients will be sourced, as many of these drugs rely on active pharmaceutical ingredients (APIs) from overseas, he said.
Drugs used for ventilator patients—such as sedatives and neuromuscular blockers—are also running low, according to a recent report from Vizient. Drugs such as dexmedetomidine, etomidate, ketamine, lorazepam, midazolam and propofol have seen a 51% increase in demand for March and the fill rate drop to 63%, Vizient reported.
It's among a number of supply chain challenges hospitals have begun facing in the wake of the COVID-19 pandemic including lack of adequate personal protective equipment (PPE) and drugs. Experts have said part of the problem is the impact of the pandemic on China, a key manufacturer of PPE and active ingredients for drugs.
In the acute care setting, 70% of respondents report at least one shortage for COVID-19 drugs. In the non-acute setting, that number drops to 48%, Premier data show.
Antimalarial drugs were the most commonly reported shortage (70% of hospital respondents), followed by bronchodilators (65%), antibiotics (40%), antivirals (38%) and sedatives (35%).
Reported shortages were higher in hot spots like New York, where 77% of hospitals with COVID-19 cases report shortages of antimalarials, as well as antivirals (54%) and sedatives (39%).
RELATED: Coronavirus outbreak could slam hospital supply chains for drugs, protective equipment
“As distributors and government agencies think about how supplies need to be allocated for the future, it’s important that a dynamic allocation process is developed that matches available supply to areas with greatest need," Alkire said. "In addition, any dynamic allocation process needs a two-fold approach: balancing the COVID-19 surge demand in hospitals with the consistent demand from non-acute and retail pharmacies whose patients utilize the drugs for chronic conditions.”
Premier offered a number of recommendations for the government and FDA that, if used in tandem, could help stabilize the supply chain to prevent or ease shortages:
- Allocation: Working alongside private sector partners, the nation needs a dynamic allocation process that accounts for surge demand and prioritizes the needs of acute care providers.
- Accessing the strategic national stockpile (SNS): The current process for accessing the SNS is cumbersome and state-specific. The administration should create a streamlined and efficient process for accessing drugs from the SNS.
- Drug Enforcement Administration (DEA) Quotas: The DEA should temporarily increase the threshold for allocating quota to provide added flexibility and avoid bottlenecks.
- Transportation: Active pharmaceutical ingredients and finished dose drugs that are produced overseas may be delayed in arriving to the U.S. due to port closures or other shipping delays. The government should leverage air transport to expedite transportation of necessary products.
- Transfers: Health systems should be allowed to temporarily transfer drugs freely between hospitals or other pharmacies without having to obtain licensure to distribute products.
- Safety Stock: The current inventory levels and available safety stocks for critical medications is unknown. The FDA needs to create a centralized data repository quantifying inventory levels for critical medications.
- Domestic Capacity: To ramp up domestic manufacturing, FDA should leverage line and tech transfers to increase manufacturing of critical drugs at U.S.-based pharmaceutical manufacturers. President Trump can utilize the Defense Production Act to speed the process.
- API Continuity: The FDA should leverage the new authority granted under Section 3112 of the CARES Act (HR 748) to require API manufacturers to begin reporting supply disruptions immediately. The FDA should also leverage this new authority to require manufacturers to disclose their exact API sources and locations of finished dosage drugs.
- Capital Constraints: Manufacturers and distributors may be hesitant to increase inventory levels due to financial constraints. The Administration should consider providing 0% interest loans to these entities to accommodate surge demand.