Non-Sterile to Sterile Compounding: An Unconventional Response During the COVID-19 Pandemic.

The drug supply chain has suffered many interruptions over the past decade. The COVID-19 pandemic exacerbated an already fragile infrastructure for supplying critical medications to hospitals and health-systems. The purpose of this paper is to provide insight to the history, thought-processes, and response to critical medication shortages during the COVID-19 pandemic, with a focus on hydromorphone infusions and the action steps taken to engage in non-sterile to sterile (NSTS) compounding. Over a period of 6 weeks, we compounded 1,613 NSTS hydromorphone infusion bags. All lots were cleared for sterility, particulate, potency, and endotoxin testing by an outside FDA registered laboratory. We did not have any safety reports filed specific to the NSTS compounded hydromorphone infusion bags. Over a period of 15 weeks, 715 infusions were consumed. The drug supply chain suffers frequent interruptions and critical shortages, particularly in times of a natural disaster or a global pandemic. Non-sterile to sterile compounding is often associated with risks of inaccuracies, impurities, and contamination. There are instances in which non-sterile to sterile compounding is appropriate and should be considered in times of drug shortages to support the care of hospitalized patients.

Management of a parenteral opioid shortage using ASHP guidelines.

PURPOSE: Management of an acute shortage of parenteral opioid products at a large hospital through prescribing interventions and other guideline-recommended actions is described. SUMMARY: In early 2018, many hospitals were faced with a shortage of parenteral opioids that was predicted to last an entire year. The American Society of Health-System Pharmacists (ASHP) has published guidelines on managing drug product shortages. This article describes the application of these guidelines to manage the parenteral opioid shortage and the impact on opioid dispensing that occurred in 2018. Our approach paralleled that recommended in the ASHP guidelines. Daily dispensing reports generated from automated dispensing cabinets and from the electronic health record were used to capture dispenses of opioid medications. Opioid prescribing and utilization data were converted to morphine milligram equivalents (MME) to allow clinical leaders and hospital administrators to quickly evaluate opioid inventories and consumption. Action steps included utilization of substitute opioid therapies and conversion of opioid patient-controlled analgesia (PCA) and opioid infusions to intravenous bolus dose administration. Parenteral opioid supplies were successfully rationed so that surgical and elective procedures were not canceled or delayed. During the shortage, opioid dispensing decreased in the inpatient care areas from approximately 2.0 million MME to 1.4 million MME and in the operating rooms from 0.56 MME to 0.29 million MME. The combination of electronic health record alerts, increased utilization of intravenous acetaminophen and liposomal bupivacaine, and pharmacist interventions resulted in a 67% decline in PCA use and a 65% decline in opioid infusions. CONCLUSION: A multidisciplinary response is necessary for effective management of drug shortages through implementation of strategies and practices for notifying clinicians of shortages and identifying optimal alternative therapies.