16 Clinical
Pharmacy Practice News • August 2022
Medication Safety
Drug Shortages Continue … And Proliferate By Bob Kronemyer
Erin Fox, PharmD, the senior director of Drug Information and Support Services at University of Utah Health, in Salt Lake City, agreed that a lack of transparency is a concern. Without complete disclosure from the pharmaceutical manufacturing sector, it will continue to be difficult for pharmacies to get ahead of a potential shortage, she told Pharmacy Practice News.
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any medications commonly used in anesthesiology and pain medicine are in serious shortage, according to an American Society of Health-System Pharmacists (ASHP) member survey (bit.ly/3M6CxsR). “Although I am not surprised by [these] drug shortages, I am quite alarmed by the impact they are having,” said principal investigator Michael Ganio, PharmD, a senior director of pharmacy practice and quality for ASHP, in Bethesda, Md. “Drug shortages have been problematic for 20 years now, but we had been doing fairly well until recent years.” Dr. Ganio noted that Hurricane Maria had caused shortages of some saline products and sterile water in Puerto Rico in 2017. “We then did better until the COVID-19 pandemic hit,” he said. “We had problems securing anesthesiology medications and drugs for ventilators. Then things seemed to improve some. But now, with supply chain issues and workforce challenges, drug shortages are becoming very prevalent again.” The survey, conducted in March 2022, was inspired by anecdotal reports of drug shortages by ASHP members and an increase in the number of reports of shortages in the ASHP service database. “There was also an overall concern for the availability of some of these products,” Dr. Ganio said.
Almost Everyone Affected Of the 345 respondents, most worked primarily in a hospital setting. More than 99% of participants reported being negatively affected by shortages of critical drugs. “A lot of other surveys show a high percentage, but rarely are they nearly 100%,” Dr. Ganio said. “I think our finding underscores how severe the shortages are at the moment.” Moreover, 50% of respondents were severely affected by basic sterile injectables like sterile water and flush syringes, local anesthetics, injectable narcotics, saline bags, pre-filled emergency syringes, concentrated electrolyte injections, and some heparin products. In addition, 7% of respondents reported more than one drug shortage–related medication safety event that caused at least temporary patient harm. These medication safety events most often involved drugs in short supply: pre-filled 50% dextrose syringes or other dextrose solutions, heparin, injectable opioids, and antibiotics. (A July check of the ASHP Drug Shortages list showed that many of these agents, including 10% dextrose injection, still were in short supply.)
Incentives Needed
‘Now, with supply chain issues and workforce challenges, drug shortages are becoming very prevalent again.’ —Michael Ganio, PharmD
of respondents increased internal/ To combat shortages, individual cen- insourced sterile preparation producters should consolidate inventory and tion and that about one-third of respondetermine how many days supplies will dents repackaged 0.9% saline and/or 5% last. Perhaps the center will need to dextrose from large bags, while more ration supplies or seek alternate suppli- than 20% purchased drugs from a gray ers. “Centers might also be able to pur- market wholesaler. chase from a 503B outsourcing facility, which can sometimes meet some of the Incentives Needed demand that the commercial manufacAs noted in a joint statement from ASHP turers cannot meet,” Mr. Ganio said. and the American Medical Association, Therapeutic alternatives also can alle- the American Society of Anesthesiologists, viate drug shortages, although these the Association for Clinical Oncology and alternatives may not be as effective, USP (bit.ly/3a09Orx), incentivizing the have different side effects or may be development of advanced manufacturing more expensive, he noted. “During the technology for critical drugs and active beginning of the pandemic, it was very pharmaceutical ingredients is one of five common for anesthesiologists not to recommendations to bolster the quality have their anesthesia agent of choice and resilience of the U.S. healthcare supand have to use a second-line treatment.” ply chain. Implementing alternative drugs also The other recommendations are: entails considerable effort in educat- • improving the function and coming staff and updating electronic health position of the Strategic National records and dispensing cabinets. Stockpile (SNS); “There are also usually anesthesia trays • engaging pharmacists, physicians, in the OR that are stocked uniformly, so other clinicians and supply chain if you have to change out a product in experts to develop processes for one tray, you have to change it out in all maintaining and refreshing products trays,” Dr. Ganio said. “Communication in the SNS; and education are vitally important to • incentivizing quality and resilience; prevent errors when you are used to a and specific product or concentration of a • replicating requests for critical drug product being in a specific location. You manufacturing transparency and cannot overcommunicate a change, paroversight for medical devices and ticularly for concentration changes.” ancillary supplies, such as personal The survey found that roughly 75% protective equipment.
How to Combat Shortages
There also is a lack of clarity about the larger supply chain, Dr. Ganio noted. “What do [those disruptions] mean?” he asked. “Product that has been shipped and waiting to arrive at port? Trucks moving across country? Raw materials? There is certainly some workforce concern. I know there are drug manufacturers that have had omicron outbreaks within their staff, which reduces attendance and productivity.” One long-term solution advocated by ASHP is improving transparency to identify and begin addressing some of the root causes of drug shortages. “Some of our proposals reimagine the SNS to keep a buffer inventory, so there would be prespecified amounts of product—maybe a two- to threemonth supply—available immediately to help mitigate that type of shortage,” Dr. Ganio said. New forms of manufacturing technologies that are more reliable would help, too. However, medications that are made exclusively in the United States are just as vulnerable to supply interruptions as those produced internationally. “We have found that anytime you concentrate drug manufacturing to any one region, especially to one facility, you are predisposed to a supply disruption,” said Dr. Ganio, who cited the example of shortages of injectable morphine, hydromorphone and fentanyl from a plant in Kansas in 2018 and 2019, due to quality concerns and difficulty acquiring raw materials. The war in Ukraine has likely caused shortages in plastic because of oil disruptions. “There could also be raw material issues with plastic over time here in the U.S.,” he said. Over time, Dr. Ganio said he expects some of these drug shortages to return to baseline. “Unfortunately, though, baseline still represents more than 100 drugs in shortage at any given time for the past 10 to 15 years,” he said. Some projections anticipate a return to baseline by fall of 2022, while others predict a full year. Dr. Ganio reported no relevant financial disclosures.
