Drug and Minibag Shortages: How We Got Here and What We Can Do

LISA SCHULMEISTER, MN, RN, FAAN | February 20, 2018
The fight against cancer has gotten tougher because of shortages of drugs and minibags. At cancer treatment facilities across the country, pharmacy and nursing staff now have to keep a keen eye on drugs and admixture supplies, anticipate the needs of patients being treated, and, when necessary, identify alternate preparation and administration techniques when a drug is unavailable and minibags are in short supply.

So how did we get here? What can we as clinicians do about these shortages that affect patient care? Oncology drug short­ages are not new. For more than a decade, certain drugs—primarily older generic drugs like methotrexate—have been in short supply from time to time. In some cases, drugs have been unavailable for weeks to months.

According to the Food and Drug Administration (FDA), at the height of the drug shortage in 2011, the number of drugs in short supply had more than tripled, from 74 in 2005 to 267 in 2011. To address these escalating shortages, the 2012 Safety and Innovation Act gave the FDA the flexibility to identify new sources of drugs and expedite FDA inspections of manufactur­ing facilities. The act also requires drug manufacturers to notify the FDA when production problems affecting lifesaving drugs occur. The FDA then alerts the public and provides updates via its Drug Shortage Database. Clinicians can sign up on this site to receive e-mail notifications of drug shortages as they happen.

Since 2012, the FDA notes, drug shortages have been decreasing, with an average of 175 active shortages in 2017. Six drugs used in the treatment of cancer currently are in short supply (as of January 2018): dexrazoxane, ethiodized oil (used for chemoembolization), etoposide, leucovorin, methotrexate, and asparaginase Erwinia chrysanthemi.

Compounding this shortage is the shortage of intravenous (IV) minibag solutions used to administer these drugs. The minibag shortage has been attributed to hurricane-damaged manufacturing facilities in the Caribbean. However, manufac­turing or quality problems at other facilities not affected by weather events, as well as mergers, acquisitions, and plant clo­sures, have also contributed to the current shortage of minibags.

To address the shortage, the FDA is temporarily allowing US manufacturers to import IV fluids from other countries. For example, minibags of 9% sodium chloride manufactured by Baxter’s facility in Ireland and marketed in Europe are being imported into the United States. Clinicians need to be aware that bar codes on imported IV fluids may not register accurately on US scanning systems, and procedures should be followed to assure that the correct IV fluid is being used. Also, although the administration ports appear similar to those of US products, the administration port for Baxter’s imported VIAFLO (non-PVC) containers needs to be twisted off rather than pulled off.

Another concern about the importation of drugs and fluids into the United States is the stability and extent of the inter­national supply. While importation has reduced shortages in the United States, it is possible that drug and minibag short­ages could become worldwide shortages. The implications for patient care, especially cancer treatment, are disturbing. Drug shortages lead to drug substitution and, in some cases, omission of a needed drug in a cancer treatment regimen. The potential effect on treatment outcomes is unknown but most likely not beneficial.

Strategies to address minibag shortages have been com­piled by the American Society of Health-System Pharmacists (ASHP) and the University of Utah Drug Information Service. Suggestions include inventory control and pharmacy operational strategies. For instance, the amount and location of drugs and fluids should be assessed on a system-wide basis, rather than unit-level, and the areas of greatest need should be prioritized. When appropriate, some drugs that are usually administered via a minibag infusion can be administered as an IV bolus (push) or, if an oral equivalent agent is available, administered by mouth.

Because of the potential for inadvertent intrathecal admin­istration, anticancer drugs are rarely, if ever, administered by syringe and instead are typically infused via minibags. Therefore, temporarily administering anticancer and other drugs in syringes requires that nursing staff review the proper procedures for verifying the medication, especially the route of administration, and review how IV bolus drugs should be administered. Many facilities are now preparing premedications used with cancer treatment regimens in syringes. Consequently, patient education is also needed so that patients are informed about changes in how their treatments are delivered.

One of the cautions outlined in the ASHP and Utah Drug Information Service guidelines to address the minibag shortage is to not underestimate the informatics resources that are needed during the time of this shortage. Medication records, order sets, and treatment protocols need to be revised for route changes of some IV medications. Making these changes and then reviewing them for accuracy is labor intensive but necessary.

It’s predicted that the shortage of drugs and minibags is not one that will be resolved in the near future. Clinicians need to use available resources, such as the FDA’s drug shortage website and guidelines for managing shortages. Most of all, whenever drugs are substituted or given by a different route, patient safety measures need to be implemented.

NOTE (added after the February print Oncology Nursing News—in which this article first appeared—went to press): On February 1, 2018, the Food and Drug Administration (FDA) released an update on the IV solution shortage, and extended the expiration dates of some products after new safety tests found that extended expiration dates meet FDA safety standards.

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