A 15-year-old adolescent female was scheduled for two surgical procedures on a Monday morning. The surgeon for the second procedure uses a harmonic scalpel. The OR nursing coordinator discovered on the previous Friday that the OR had no harmonic scalpels in stock and escalated this to hospital materials management. The nurse coordinator was assured that the harmonic scalpels would be delivered over the weekend. Pt taken to the OR and the first procedure completed. It was then noted that the harmonic scalpels were not available and materials does not have weekend staff to confirm delivery. This should have been checked prior to bringing the patient back to the OR. Pt remained asleep under anesthesia for over an hour until we could secure a harmonic scalpel from a nearby hospital.

This report highlights a series of gaps/errors resulting in an avoidable incident where a patient had to remain under anesthesia until the proper instrument was available. The COVID pandemic accentuated supply chain challenges in health care, but these challenges have been in existence for many years. Brandeau et al. published an article in 2007 that proposed strategies to expedite and improve potential supply chain disruptions in the event of a bioterrorism attack (Am J Disaster Med 2007;2:231-47).

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Outsourcing and consolidation of health care supply manufacturing can contribute to shortages. Puerto Rico was devasted by Hurricane Maria in 2017. Baxter’s I.V. fluid manufacturing operations were primarily in Puerto Rico, and the hurricane set off a nationwide shortage of normal saline I.V. products (asamonitor.pub/47Ggh3H). In retrospect, however, there have been intermittent shortages of certain I.V. fluids since 2014.

The United States maintains a cache of medical supplies and medications known as the Strategic National Stockpile (asamonitor.pub/47zPYfD). This cache is meant to provide additional supplies to support local areas in the event of a major public health emergency. The Centers for Disease Control and Prevention (CDC) convened a workshop in 2016, the results of which can be found in a document titled “The Nation’s Medical Countermeasure Stockpile: Opportunities to Improve the Efficiency, Effectiveness, and Sustainability of the CDC Strategic National Stockpile: Workshop Summary (2016)” (asamonitor.pub/3uIRxcC). The document contains an entire section devoted to potential supply chain challenges.

Over the last two to three decades, due to ever increasing costs associated with storage, hospitals and health care institutions have shifted to “just in time” models for inventory rather than store supplies on site or in hospital-owned or leased warehouses. This change made hospitals even more dependent upon efficient supply chain processes to maintain operations. Unfortunately, the pandemic caused severe disruptions in the supply chain, and medication and supply shortages have become ubiquitous in hospitals. A number of factors contribute to this problem, including shortages of raw materials, manufacturing issues, financial constraints, regulatory hurdles, transportation delays, and shortages in the workforce. A 2022 report by Kauman Hall included a survey of hospital executives indicating that only 9% of respondents had not experienced any disruptions in their supply chain. Among respondents, 71% experienced distribution delays, 58% had issues with raw products and sourcing, and 50% reported challenges with using nondomestic suppliers. The report added that geopolitical strife could lead to further supply chain disruptions (asamonitor.pub/3T6tONH). Shortages range from medical devices to medications to personal protective equipment and disposable equipment. The unpredictability of sudden disruptions in the supply chain makes this problem even more challenging and complex.

Anesthesiology is heavily dependent upon medications. In the recent past, we have experienced shortages of I.V. fluids, morphine, ketamine, albuterol, and hydromorphone, just to mention a few. The American Society of Health-System Pharmacists (ASHP) recently reported that there were 305 active drug shortages in the third quarter of 2023, which is the highest number reported since 2014. ASA has been well-aware of drug shortages for many years and developed foundational policy recommendations in 2018 during a summit that included the American Society of Clinical Oncology (ASCO), the American Hospital Association, ASHP, and the Institute for Safe Medication Practices. ASA has backed legislation to help mitigate drug shortages. In 2023, ASA convened a drug shortages workgroup to update the 2018 recommendations. This workgroup provides feedback on the Stop Drug Shortages Act and will continue to provide medical expertise in crafting future legislation (ASA Monitor 2023;87:29).

In response to these challenges, a white paper with several recommendations was published by a coalition of stakeholders, including the American Medical Association (AMA), ASA, ASHP, ASCO, and the United States Pharmacopeia (USP) (asamonitor.pub/3tgOrfo). It should be noted that of the five recommendations listed below, the USP endorsed only recommendations 1-3. The remaining groups supported all five recommendations.

  1. Incentivize advanced manufacturing technology and develop new continuous manufacturing technology for critical drugs and active pharmaceutical ingredients.
  2. Improve the function and composition of the Strategic National Stockpile.
  3. Improve multinational cooperation on supply chain resilience.
  4. Incentivize quality and resilience.
  5. Replicate asks for critical drug manufacturing transparency and oversight for medical device and ancillary supplies (e.g., PPE).

On a more granular level, there are some steps hospitals can take – many of which are in place at a number of facilities. Instituting countermeasures requires communication and cooperation by the pharmacy, the anesthesiology department, the hospital supply chain operations team, and perhaps the hospital’s pharmacy and therapeutics committee.

  1. Each hospital should maintain a drug shortage list and inform anesthesia leadership about any drugs that can impact anesthesia care.
  2. The pharmacy should be specific about drug shortages, i.e., whether shortages are across all concentrations or in select concentrations. In the recent past, there have been shortages of lower concentrations of hydromorphone and in higher concentrations of ketamine.
  3. The pharmacy should provide data regarding current inventory, drug usage based upon historical data, and the projected date the hospital will run out of the drug, assuming no new supplies and no change in administration patterns.
  4. Pharmacy leadership should meet with anesthesia leadership to craft a mitigation strategy. Depending upon the medication, strategies may include:
    • Substitutions: If there is a shortage within a class of drugs (e.g., morphine), one could restrict or even remove all morphine in the OR and use other opioids.
    • Using different concentrations: There has been a recent shortage of 100 mg/ml ketamine. One could identify special situations where this concentration is important but otherwise have everyone use lower concentrations of the drug.
    • Dilutions: During the pandemic, we witnessed a shortage of single-dose hydromorphone. Interestingly, hydromorphone for PCA usage was not impacted, and some hospital pharmacies diluted the PCA drug for single use administration.
    • Using smaller aliquots: This strategy may be more applicable to the pediatric population, but it can be applied to adults. In this countermeasure, one can use a larger bottle/vial of a medication and split in into single-dose units. This action would have to be performed in the pharmacy and should not be done in the OR, and it should be part of an overall plan to decrease wastage.
    • Consider whether medications may be used beyond their expiration date.

Patient safety should always be our first priority, and measures should be instituted to prevent a medication error should there be a need to change a commonly used medication or concentration. These measures can include education, visual cues such as using special syringes, and the use of order sets. While anesthesiologists are intimately familiar with conversion factors of the various opioids, this may not be true for nonanesthesia providers. The use of clinical decision support tools and computerized prescriber order entry in the electronic medical record can help decrease the potential for medication errors.

Medication supply chain challenges often force hospital pharmacies to use a number of different suppliers. This may result in a hospital having different vials/packaging for the same medication. There should be a communication chain between the pharmacy and the anesthesiology department to alert providers about such changes, and countermeasures should be implemented to mitigate the possibility of a medication error.

Drug shortages may also be an opportunity to standardize clinical practices, and it would be difficult to argue that standardization does not improve patient safety. For example, if providers were primarily using two opioids for a specific procedure based on clinician preference, a shortage of one of those opioids may present an opportunity to standardize this practice. Similarly, there has been an ongoing shortage of albuterol. This is an opportunity to encourage the use of metered-dose inhalers, which may actually decrease cost without any change in patient outcome.

Equipment and medication shortages will probably continue to be a problem for the foreseeable future. Hospitals and individual clinical units should work closely with the pharmacy and hospital supply chain leadership to devise processes that not only warn clinicians of impending shortages but also lead to implementation of countermeasures. Patient safety considerations must be taken into account for all countermeasures.

This entry was written by Dr. Tetsu Uejima on behalf of the AIRS Committee.