Drug shortages have become a chronic problem in U.S. health care, affecting a wide range of patients, according to the 2019 report of a multiagency task force convened by the Food and Drug Administration (FDA). The shortages are also lasting longer than in previous years, with sometimes devastating effects on patients who may receive riskier or less effective alternative therapies.
Fifty-six percent of hospitals reported they had changed or delayed treatment for patients because of drug shortages, according to the FDA report. Children with acute lymphoblastic leukemia were among those affected; nine of 11 drugs for this curable cancer have frequently been unavailable over the last decade. The University of Utah Drug Information Service, meanwhile, identified 282 active U.S. drug shortages as of June 30, 2019, up from 224 a year earlier. And, according to the American Association of Nurse Anesthetists, even lidocaine-used to relieve the burning sensation of the commonly used anesthetic propofol-is in short supply, resulting in agitation in patients as they undergo sedation.
Struggling with scarcity. To understand how U.S. hospitals manage during shortfalls, a research team in 2017 surveyed pharmacy practice managers and pharmacy leaders belonging to the American Society of Health-System Pharmacists about their experiences. All 791 respondents reported shortages, with the most severe falling into six categories: analgesics, antibiotics, nonopioid anesthetics or sedatives, cardiac medications, chemotherapeutics, and intravenous fluids. Reporting on their survey in JAMA Internal Medicine, the researchers said health care professionals had little advance notice of supply interruptions, leaving them scrambling to find alternative safe therapies. Ninety-two percent of the pharmacy managers stated they received, on average, less than one month's notice before an active shortage, and 35% acknowledged they had no administrative mechanisms in place to address shortfalls.
With supplies of critical medications in danger of being exhausted with no assurance of prompt replenishment, the pharmacists employed various mitigation strategies. Substitution was the leading method to avert full depletion (84%), followed by medication hoarding (81%) and controlled distribution through a central pharmacy (79%). Over half of respondents said they excluded certain medications from sharing programs with other hospitals. And, 34% of respondents admitted to rationing drugs among patients. Rationing was more common at large hospitals (300 or more beds) and at academic and academically affiliated hospitals compared with community and smaller hospitals.
In rationing, 52% of respondents relied solely on the care team to determine allocation methods, 48% used committees, and 4.9% employed committees that included an ethicist. Notably, only 36% of patients were informed their care was influenced by rationing. Some observers concluded that patients were not told to avoid increasing their stress levels. But others said the lack of transparency about drug rationing endangers patients' health.
The FDA report noted that another survey calculated labor costs incurred by hospitals to address medication shortages and came up with an annual total of $359 million, which the agency concluded was likely a significant underestimate.
Causes and potential cures. The FDA-led task force-prompted by Congressional alarm over the cost and public health risks of ongoing drug shortages-identified market economics as a major cause. Manufacturers have little incentive to invest in producing less profitable drugs, and the FDA cannot compel companies to boost production. In addition, just-in-time inventory practices have reduced stockpiles of essential drugs like the anticoagulant heparin. Finally, a shift to more overseas production has escalated logistical, regulatory, and quality control hurdles.
To address these problems, the task force made several recommendations to alter undermining market forces. Among them:
* establish a comprehensive database to track drug shortages and assess their impact on patient outcomes, health care delivery, and costs
* create a transparent rating scheme to reward mature quality management systems
* improve private sector contracting practices-which currently are aimed solely at price-cutting-to incentivize pharmaceutical manufacturers to build reliable drug supplies
* extend drug expiration dates to the maximum safe shelf life
Implementing these solutions is the greater challenge-and one that will not be surmounted easily. Changing market dynamics takes time. Consequently, drug shortages will likely persist for the foreseeable future.-Lucy Wang Halpern