Managing ongoing drug shortages is particularly challenging as these shortages now occur across the spectrum of drug therapies and are not limited to specific types of medications, formulations, or therapeutic classes.
Coping with these disruptions can prove frustrating and time-consuming for pharmacists and providers, yet proactive management is critical, as the risks of ineffective or inefficient management can be deadly for patients. Moreover, because multiple shortages can occur simultaneously, a comprehensive approach is crucial to minimize the impact of shortages on patient care.
The University of Virginia Health System (UVA) is a tertiary-care, academic medical center with approximately 615 beds, over 29,000 inpatient admissions per year, and a level 1 trauma center with over 62,000 ED visits per year. Our clinics receive nearly one million patient visits annually. Complex patient needs throughout the health system, in conjunction with frequent drug shortages, can complicate the intricacies of providing excellent patient care. Thus, UVA developed a multifaceted strategy to address drug shortages, including utilizing a drug shortages task force to oversee all shortage management in order to assuage the impact of shortages on patient care and workflow.
UVA’s Drug Shortage Management Approach
The UVA pharmacy department leads the health system’s effort to manage drug shortages and reduce their impact on patients. Each day, new drugs are identified as unable to procure, triggering an investigation into alternatives. At any given point, the department is tracking more than 300 unique drug product shortages to assess their impact, develop and implement management strategies, and communicate to stakeholders across the health system.
Drug shortages are a relentless reality of daily workflow for the pharmacy department. Although shortages vary in severity and patient impact, all require a thorough assessment and a robust management strategy.
The methods of procuring and distributing medications are often health system-specific; therefore, each organization will require a unique framework for implementing mitigation plans that address inventory management during shortages. The UVA pharmacy department utilizes medication carousels to store drug inventory in the central pharmacy of the medical center. Additionally, over 200 automated dispensing cabinets (ADCs) are located throughout patient care units, procedural areas, and ambulatory clinic areas to provide quick access to medications. Bar code medication administration (BCMA) is utilized throughout the inpatient care areas, and we are in the process of expanding BCMA into procedural and ambulatory practice areas. A fully integrated electronic health record (EHR) facilitates medication ordering, distribution, administration, and documentation in patient care areas.
The Drug Shortages Task Force
Our health system’s approach to shortage management has evolved over time as shortages have increased in quantity, complexity, and in their potential to impact patient care. Multiple shortage management guidance documents indicate a multidisciplinary team should be involved in implementing a systematic approach to decision-making in response to shortages. The UVA Drug Shortages Task Force is an interdisciplinary team whose goal is to develop and oversee drug shortage management plans. As a subcommittee of the P&T committee, the task force has the authority to develop and enforce formulary restrictions to mitigate the impact of shortages on patient care. It is essential that this group comprises interdisciplinary representation of all stakeholders impacted by drug shortages; therefore, the team includes key members who assess drug shortages, implement management strategies, and monitor changes in an expedited fashion. See TABLE 1 for a description of UVA Drug Shortages Task Force members and their responsibilities.
Meeting twice weekly, the task force assesses and manages drug shortages in real time. All pharmacy staff are invited to attend task force huddles and meetings, and are strongly encouraged to attend if a drug shortage could potentially affect patient care in their practice area. The task force evaluates shortages and identifies appropriate management strategies, which may include:
Each of these strategies delivers benefits as well as risks (see TABLE 2). National guidelines for drug shortage management guide all task force initiatives (see SIDEBAR 11-5).
Discussions regarding how to ration or allocate resources are sometimes required to manage a shortage; these conversations can be difficult, particularly when the agent is considered a critical drug therapy. When these issues arise, key physician stakeholders in the respective areas are engaged to provide clinical guidance and help determine a management plan. Should a drug shortage create an ethical dilemma regarding allocation or rationing of drug supply, the physician champions enlist the Ethics Committee for guidance.
Shortage Management Considerations
Identify and Assess the Impact of the Shortage
Drug shortage management begins when the first piece of information regarding a supply interruption is received; this could include a notification from a manufacturer or supplier, or an inability to restock to desired levels. Upon identification of a potential shortage, accurately assessing the situation is vital. The assessment should include the following components5:
When assessing the depth and breadth of a shortage, and identifying operational or therapeutic alternatives, it is essential that the drug shortage task force consider the downstream impact of the shortage to providers and to the organization, including the risks and safety concerns related to:
Incorporate safe medication use practices throughout the drug shortage management plan. Utilizing a safety and error reporting tool to capture issues from frontline providers can be helpful; monitor this database throughout a shortage to reduce safety concerns.
In addition, do not neglect to investigate the financial impact of the shortage on the health system, including the additional costs of purchasing alternative therapies, added labor to support the process changes, technical system changes, contract or purchasing compliance, and the costs of in-house pharmacy preparation and the overhead associated with these preparations.
Communication
Proactively communicate drug shortages information to frontline care providers of multiple disciplines, including (but not limited to) physicians, nurses, respiratory therapists, and nutritionists. Experience has shown that physicians, in particular, desire to understand why the shortage is occurring. Communication strategies may include:
Leveraging the EHR for drug shortage communication can critically improve drug shortage management. Alerts can be added upon order entry, including pertinent restrictions or patient criteria, as well as the available alternative medications. Incorporating this information in the EHR is key to help clinicians appropriately respond to shortages and select suitable alternatives for patients.
Implementation
After the drug shortage management strategy has been chosen, implement the plan. Specific execution steps include outlining the various action steps, determining timelines, and identifying task owners. Common strategies at UVA include inventory management, dispensing workflow changes, and technology optimization.
Medication Safety
Medication safety expertise is paramount when developing and reviewing drug shortage management strategies. Despite the challenging realities of drug shortages, the top priority is to maintain safe medication practices throughout the health system, which requires incorporating safe medication practices throughout the shortage and monitoring practice with safety reporting tools. In particular, changes made during a shortage must be aligned within the EHR.
For example, the pharmacy informatics team can work collaboratively with the health system order set teams to ensure that the required changes are made in a timely manner. Keeping the EHR up to date drives the end user clinicians toward the available medications. Be sure to incorporate additions and deletions of available medications, as well as best practice alerts and limited medication administration alerts to communicate to the end user the reasons for the change and to denote the recommended alternative therapy.
At UVA, any clinical prescribing changes are validated by clinical and operational stakeholders, and bar code scanning integration is utilized in all care areas so that patients receive the correct medication. In addition, medication error reporting and review systems must be monitored during a drug shortage. These safety precautions help to confirm that medication use during a shortage is equally as safe as when the shortage has resolved.
Overcoming Challenges
UVA encountered an emergency situation recently when our primary 503B compounding facility was no longer licensed in the state of Virginia. While we were not privy to the exact drivers that led to this result, we were made aware that within a few weeks we would not receive a large number of medications that had been primarily sourced from this vendor.
Because many of these drugs were also on national shortage, we needed to quickly develop and implement a new procurement strategy. Thus, the decision was made to begin compounding these products in-house. Additionally, we began a market search for new 503B vendors that could meet both our portfolio and volume requirements. The first step was to engage our contracting department and then attempt to expedite negotiations with a new vendor.
These events led to an in-depth, organization-wide discussion of the possibility of investing in internal development of 503B compounding capabilities to mitigate the impact of external vendor challenges. As pharmacy departments strive to manage the impact of persistent drug shortages, other organizations may be considering this option as well.
Conclusion
The successful navigation of drug shortages is contingent on an organization’s capacity to quickly identify the shortage, proactively develop a mitigation plan, and efficiently put that plan into action. Utilizing a drug shortage task force has been instrumental in UVA’s approach to shortages management. In addition, we have found value in involving key stakeholders, including physician practice leaders, early on in the process, as well as employing an active communication strategy and maximizing use of the EHR. As shortages appear to be ongoing, utilizing a comprehensive approach moving forward is prudent.
Case studies of UVA’s management process for two recent drug shortages appear in SIDEBAR 2.
Robert D’Eramo, PharmD, is a PGY2 health system pharmacy administration resident at the University of Virginia (UVA) Medical Center. He is a graduate of the Virginia Commonwealth University School of Pharmacy, where he received his PharmD in 2017. Robert completed a PGY1 pharmacy residency at the UVA health system in 2018 and is currently pursuing a Master of Health Administration from Virginia Commonwealth University. His professional interests include health system and workflow optimization, infusion management practices, pharmacy technician advancement, and clinical pharmacy service expansion.
Kate Bidwell Horton, PharmD, BCPS, is a medication use policy pharmacy coordinator for the UVA Health System. She received her PharmD from Virginia Commonwealth University School of Pharmacy. Kate completed a PGY1 pharmacy residency at the Ohio State University Wexner Medical Center and a PGY2 residency in critical care at UVA.
Stacey B. Pattie, PharmD, BCPS, is a medication use policy pharmacy coordinator for the UVA Health System. She received her PharmD from the University of North Carolina at Chapel Hill and completed a pharmacy practice residency at UVA.
Danielle A. Griggs, PharmD, MBA, MS, BCPS, is the pharmacy manager for procurement, utilization management, and business services at the University of Virginia Medical Center in Charlottesville, Virginia. She completed her PharmD and MBA at the University of Kentucky, and received an MS from the University of North Carolina Eshelman School of Pharmacy. Danielle completed a health system pharmacy administration residency training at UNC Hospitals and Clinics. Her professional interests include pharmacy supply chain and contracting, drug shortages, utilization management, and pharmacy business development.
References
SIDEBAR 1
National Guidance for Drug Shortage Management
The UVA Drug Shortage Task Force utilizes various informational and best practice guidance documents to manage shortages. National listings of drug shortages are available from the FDA and ASHP1,2; these websites list drugs currently on shortage and provide high-level guidance on individual drug shortages. Information provided includes:
Guidance for how to respond to drug shortages is provided by various organizations, including the FDA, Centers for Disease Control and Prevention (CDC, for vaccine shortages), and the Institute for Safe Medication Practices (ISMP).1-4 Hospitals, providers, and pharmacists should use these resources when developing drug shortage management plans.
ASHP recently issued guidelines on managing drug shortages, including key concepts that should be included in drug shortage management plans.5 Components of ASHP’s guidelines include:
UVA utilizes many of these strategies and incorporates this methodology into the work of the drug shortage task force.
SIDEBAR 2
The University of Virginia Health System’s Management Process for Two Recent Drug Shortages
CASE STUDY #1
Thiamine 200 mg/2 mL Vials for Injection
Notification was received of a possible shortage due to the inability to reorder the needed amount. This notification triggered an investigation into the shortage situation, as well as an assessment of days remaining on-hand based on current usage and purchase data. National shortage references were consulted to identify additional information, including the reason driving the shortage and the expected duration of the shortage.
CASE STUDY #2
Dexmedetomidine Premix Bottle 400 mcg/100 mL and 200 mcg/50 mL
Notification was received of a possible shortage due to the inability to reorder the needed amount. This notification triggered an investigation into the shortage situation, as well as an assessment of days remaining on-hand based on current usage and purchase data. National shortage references were consulted to identify additional information, including the reason driving the shortage and the expected duration of the shortage.
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