Grappling with national saline and opioid shortages
How health care institutions are managing
In April, the American Society of Health-System Pharmacists (ASHP) more than 300 pharmacists from hospitals of various sizes, assessing the recovery of a preexisting small-volume parenteral (SVP) solution shortage and the impact of a current limit on injectable opioids. Findings revealed a tremendous strain on daily operations in most hospitals across the country, with associated negative impacts on patient care. Still, in the face of some of the worst drug shortages in American history, the lessons learned have paved the way to recent clinical and industry advancements that help mitigate shortages and prevent them from reoccurring.
“Drug shortages put a strain on health care personnel and on other drugs in the supply chain,” said Michael Ganio, PharmD, MS, BCPS, FASHP, director of pharmacy practice and quality at ASHP.
Indeed, expressing strain, 98.4% of the respondents described their hospitals as having been affected by the injectable opioid shortage, with 96.2% rating their situations as either severe or moderate. The report indicated that 86.4% of participants were still affected by the SVP shortage, though this had improved from 99.1% during a previous survey in November 2017.
Drug shortages are a historical occurrence, but they are more acute and long lasting.
Hurricanes Irma and Maria struck Puerto Rico in the 2017 hurricane season, immobilizing Baxter International’s manufacturing plant and exacerbating a that had persisted since 2014. Only three companies provide the United States with saline, and Baxter supplies for about 50% of hospitals, but has no buffer in manufacturing capacity. This deficiency, combined with the ensuing demand from an intense flu season, has left health care institutions desperate for saline and subsequently put strain on the supplies of SVP dextrose solution, as well.
Pfizer Inc., which equips 60% of American hospitals with injectable opioids, also had not put away for emergencies when production at a newly acquired plant was halted in 2017 due to facility upgrades and quality issues. Alongside this, DEA had for production of opioid analgesics and removed preexisting redundancies in an effort to ease the reputed opioid epidemic. While U.S. hospitals are still scrambling for solutions to minimize the negative clinical impacts this will have on patients, Pfizer is projecting sustained through the first quarter of 2019.
The Institute of Safe Medication Practices (ISMP) conducted a survey on shortages of more than 300 hospital pharmacy staff in fall 2017, when the national SVP saline solution and injectable opioid shortages started. Their revealed that a majority of respondents felt that drug shortages were compromising patient care. More than 70% reported being unable to provide patients with the recommended drug or treatment for their condition due to shortages, and nearly one-half thought that this resulted in patients receiving a less effective drug.
“If a drug that is normally preferred for an indication is in short supply, a therapeutic substitution may be an option. However, it’s likely that the drug in short supply is preferred because it is more effective or has fewer side effects,” explained Ganio. “If a shortage is severe or lasts a long time, the increased demand for a therapeutic substitution may cause a shortage of that drug, too.”
Medication shortages occupy extensive human and financial resources at the institutional level. Many hospitals require full-time staff to and the tasks associated with this process, which cut in to the time normally devoted to patient care and medication safety. In turn, limitations on drug supply present with unique risks and contribution to excess error.
Ganio added that “workarounds may also require additional work, like updating the electronic health record or smart infusion pumps so that they match the current drug that is available. In shortages that vary from week to week, it can be difficult to maintain these electronic resources in a timely manner.”
Much of what must be addressed during or to prevent drug shortages involves securing and maintaining supply, although these costs unfortunately are absorbed by hospitals. This may include creating back-up inventory of SVP saline solutions and whatever injectable opioids are currently available, changing par levels, purchasing excess inventory from wholesalers, using new distributors or outsourcers, or purchasing more expensive brands, generics, or therapeutic alternatives. To secure precious saline and opioids, some health care systems borrow or purchase them from one another, purchase directly from manufacturers, or obtain them in different strengths and concentrations.
Certain measures taken by hospitals help limit or extend drug use to make them more available. Many have reported rationing or restricting injectable opioids and SVPs. This has been accomplished by establishing criteria for using products, restricting their access via override in automated dispensing cabinets, and providing kits for emergency drugs.
Almost all health care institutions will devote resources to keep medical staff informed about drug shortages. Communication and education in advance of and throughout the current saline and opioid shortages could be a deciding factor in the matter of safety. To avoid error, many departments establish regular meetings with pharmacy staff to address shortages and allocate resources to staff education about the safe dosing of alternative drugs.
Resources for managing institutional-level issues with the current SVP saline solution and injectable opioid shortages are available:
- FDA drug shortages: https://apha.us/drug_shortages
- “Drug Shortages” mobile app for iPhone and Android
- ASHP drug shortages database: https://apha.us/ASHP_database
- ASHP and University of Utah guidance on SVP solution shortages: https://apha.us/SVP_guidance
- ASHP guidance on the injectable opioid shortage: https://apha.us/injectable_shortage
- ISMP newsletter on managing drug shortages: https://apha.us/managing_shortages
In spite of recent outcomes regarding deficits in injectable opioids and SVP saline solutions, regulatory agencies have successfully worked to lessen the amount of drug shortages in recent years.
For the full article, please visit for the upcoming August 2018 issue of Pharmacy Today’s Health-System Edition.