The second quarter of 2023 ended with 309 active drug shortages. This is the highest total in nearly a decade and is approaching the all-time high of 320 shortages, according to a new report from the American Society of Health-System Pharmacists (ASHP).
For the report, ASHP surveyed more than 1,100 of its members over June and July — all but 1% of respondents said their health system is experiencing drug shortages. One-third of survey respondents categorized their organization’s drug shortage as critical, meaning their health system has turned to rationing drugs, delaying care, or canceling treatments and procedures.
Drug shortages have two major impacts on health systems, said Michael Ganio, ASHP’s senior director of pharmacy practice and quality, in a recent interview. They create a lot of extra work for the pharmacy department, and they force clinicians to make tough decisions about patient care that could potentially result in worse patient outcomes, he explained.
Ganio also explained that most of the recent drug shortages that the general public might be familiar with — such as those for amoxicillin, ADHD drugs and children’s pain medication — are due to an increased demand. This is not the cause for a typical drug shortage, though. Shortages caused by increased demand only made up 2 or 3% of total drug shortages in the second quarter, he declared.
Most drug shortages stem from quality issues — but this doesn’t necessarily mean that the drug itself is poor in quality, Ganio pointed out. Rather, it usually means that a regulatory body like the FDA has deemed one or more of the manufacturers’ processes, such as recordkeeping or daily cleaning, as having poor quality.
When this happens, the FDA often orders the drugmaker to halt the release of its products until they can be tested by an independent third-party lab. If the testing finds that these products are okay to distribute for patient care, the FDA will allow for their release, but it still could be months before the manufacturer changes its processes and receives the green light to make more drugs, Ganio explained.
The resulting drug shortages can significantly add to the workloads of hospital pharmacy workers.
“The bulk of shortage management falls on the pharmacy. That means trying to find alternative sources and the medication — whether it’s different suppliers, whether it’s 503B outsourcing facilities, preparing it in-house and compounding it themselves, or purchasing different package sizes or concentrations and what’s normally stocked. That’s all happening within the pharmacy,” Ganio declared.
This extra work intensifies burnout levels among healthcare workers, possibly contributing to more employees leaving the field. But even more problems arise when a shortage becomes so severe that the pharmacy cannot manage it using the types of strategies Ganio described above.
When drug shortages get this serious, hospitals usually convene a committee to examine their utilization of the drugs that are experiencing shortages. The committee then tries to determine which patients might be able to switch to a clinically appropriate alternative. Sometimes this means switching from an intravenous form of a drug to its oral form, and sometimes it means beginning a completely new therapy.
These treatment modifications can have little or no effect on the patient in certain cases, but the impact can be significant in others, Ganio said.
“For example, if you were to switch a patient from amoxicillin to augmentin — which is amoxicillin with an added ingredient — you’re broadening the coverage of bacteria that are covered. We want to remain focused and try to treat a narrow range of bacteria so as to not contribute to resistance. But at the end of the day, that augmentin is going to work fine for the patient and have very similar side effects,” he explained.
But the difference is a lot starker when it comes to handling chemotherapy drug shortages, Ganio pointed out.
When these types of drugs experience a severe shortage, hospitals sometimes have to make decisions about which patients can and cannot receive the medication. This tough choice can mean that patients lose their access to the drug that is in shortage, and in these cases, they will likely have to switch to an entirely new treatment regimen, Ganio declared.
“Now you’re talking about changes in potential overall survival, the side effects of the regimen and potentially the cost of the regimen. And decision-making committees will usually pull in experts from whatever specialty or discipline is affected by the shortage. The hard part about these shortages is that these chemotherapy drugs are often used in a very wide variety of treatment regimens for blood cancers for solid organ cancers. So you have these different specialties come to the table to try to determine which patients should be prioritized,” he said.
These decisions are incredibly difficult for health systems to navigate and often require an ethicist to be brought in, Ganio pointed out.