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A Comprehensive Approach to Manage Drug Shortages


April 2019 - Vol. 16 No. 4 - Page #6

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:

  • Alternative sourcing
  • Allocating/rationing the remaining supply
  • Identifying alternative medications
  • Outsourcing
  • Implementing restrictions
  • Utilizing in-house production

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:

  • Specific Details of the Shortage. Identify the duration and cause of the shortage. Determine whether similar products are also impacted. The manufacturer can provide this detailed information; check the FDA and ASHP shortage websites as well.1,2
  • Inventory on Hand. At the onset of a shortage, identify all available inventory in all storage areas, including pharmacies, ADCs, overstock areas, floor stock, code carts, trays, and satellite locations.
  • Utilization and Supply Remaining. Once the available inventory is identified, the health system’s utilization rate must be determined, either through evaluation of historical usage or by predicting usage (if anticipated changes to utilization are known). Thereafter, a Days Remaining count should be calculated to provide a timeline for shortage management strategy development.
  • Operational Alternatives. Investigate operational alternatives prior to considering therapeutic alternatives or patient prioritization. Operational strategies may include repackaging, utilizing pharmacy-prepared doses, adopting a different vial size or package size, batching, or other changes.
  • Therapeutic Alternatives. Assessing therapeutic substitutions should occur when clinical management strategies and/or restrictions become necessary. If similar agents are available, those therapeutic alternatives may be acceptable options. However, reasonable therapeutic alternatives may not be available for certain agents; thus, allocation, restrictions, or patient prioritization may be required.
  • Patient Prioritization. At times, it may be warranted to identify clinical restrictions or select the patient populations that are deemed most appropriate to receive the limited supply of drug therapy. These restrictions should be based on approved indications, formulary restrictions, medication use evaluation results, national guidelines for use, or other widely accepted criteria.

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:

  • Inventory management
  • Product preparation and dispensing
  • Electronic system updates
  • Ordering and verification processes
  • Medication administration

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:

  • Targeted messaging to affected user groups (ie, staff huddles)
  • Routine messages communicating updates to a larger audience (ie, email communications)
  • Employing a reference database that allows clinicians to research pertinent information
  • Maximizing use of real-time alerts in the EHR

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

  1. US Food and Drug Administration. FDA Drug Shortages. Current and Resolved Drug Shortages and Discontinuations Reported to FDA. www.accessdata.fda.gov/scripts/drugshortages/default.cfm. Accessed February 26, 2019.
  2. American Society of Health-System Pharmacists. Drug Shortages. www.ashp.org/Drug-Shortages. Accessed February 26, 2019.
  3. Centers for Disease Control and Prevention. Current Vaccine Shortages & Delays. www.cdc.gov/vaccines/hcp/clinical-resources/shortages.html. Accessed February 26, 2019.
  4. Institute for Safe Medication Practices. Drug Shortages Continue to Compromise Patient Care (January 11, 2018). www.ismp.org/resources/drug-shortages-continue-compromise-patient-care. Accessed February 26, 2019.
  5. Fox ER, McLaughlin MM. ASHP Guidelines on Managing Drug Product Shortages. Am J Health-Syst Pharm. 2018;75(21):1742-1750.

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:


SIDEBAR 2

The University of Virginia Health System’s Management Process for Two Recent Drug Shortages

CASE STUDY #1

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

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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