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How inadequate drug shortage management tools impact hospital-system pharmacies

BD Institute for Medication Management Excellence

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Urgent and labor-intensive

How inadequate drug shortage management tools impact hospital-system pharmacies


PUBLISHED: Jun 24, 2019

Dennis A. Tribble, PharmD, FASHP, Director, Clinical Innovation, Medical Affairs at BD

Aryana Sepassi, PharmD, Senior Analyst, Health Economics Outcomes Research, BD


Introduction

Shortages of drugs have become a chronic condition in health-system pharmacies over the last five to seven years, and are a critical issue for both US1,2,3 and European4,5 health-system pharmacies. Excess costs for health systems are generated by higher costs of shorted medications and the extra labor required to manage shortages. Incurred costs vary by hospital and inventory size,2 although markups for shorted medications have been noted to be as high as 3000%.6 Incremental labor costs have been estimated to be between $25,000 and $49,000 annually per hospital, which extends to a national increase in labor cost of $216 million annually.2

Drug shortages have been shown to drive up drug costs. Increased drug costs at five VA sites studied ranged from $150,000 to $750,000 annually1, however, this did not include costs for procedures that had to be deferred or canceled because required drugs were not available. Roughly 70% of health systems nationwide report a delay in treatment due to drug shortages.7

Within the VA system, the impact of drug shortages is uneven, and some researchers have proposed that more centralized shortage management could leverage that disparity to move shortage medications to where they’re most needed, as well as reduce the effort expended at each facility.1

Audience participation comments at a presentation on managing shortages at the June 2018 Summer Meeting of the American Society of Health-System Pharmacists (ASHP)8,9 further described management of shortages as a “daily crisis”, and decried the lack of a more systematic way to handle shortages. Most reported using spreadsheets as tools to keep track of the shortages they manage.

Both the US Food and Drug Administration (FDA)10 and ASHP11 maintain listings of known drug shortages. Both databases require the user to specify the products they are looking for, which means that they can assist providers dealing with a currently known product. They may help to determine the scope and timeline of shortages a pharmacist encounters, but may be less useful in learning about new shortages because the user must log into these lists and scan them to determine what new items are on shortage.12,13 Because the methods and editorial practices for these lists are different, their contents differ as well—to be better informed, pharmacists must monitor both, adding complexity to a health-system pharmacy’s management of drug shortages.

Unmet need

The processes by which shortages occur are complex and beyond the ability of pharmacists to address directly.14

In our experience as hospital pharmacists, there are few tools available to manage shortages once they reach the pharmacy and most are inadequate.13 Pharmacist participants at the ASHP Summer Meeting session on drug shortages8 described that pharmacists often find themselves reacting to shortages as they’re detected in ordering and receiving, requiring them to print reports and/or inquire of multiple systems to locate the information they need to manage the shortage. Additionally, once a shortage has been detected, substantial communications are required between pharmacists, nurses and physicians to change existing treatments of patients, and plan for future treatments, in order to compensate for shorted medications.14

As a result of these shortcomings, pharmacy buyers need to dedicate more time each day to investigate other purchasing options for shorted medications, while pharmacy technicians may need to spend additional time compounding medications that are shorted. The result can be that all such management is urgent and labor-intensive. Not surprisingly, hospital pharmacies generally have to dedicate staff to shortage management that could be otherwise deployed to pharmaceutical care.2 Tools that have the potential to reduce both the effort to become prospectively aware of shortages and the effort to capture the data necessary to manage the shortages may provide immediate relief.

Our vision for better tools

The future of drug shortage management will require robust data and more effective tools 16 with the potential to:

  • Support an enterprise view of shortages that permits management to be centralized, rather than replicated at each facility.14
  • Support creation of shortage cases that permit continuous tracking of progress, prioritized by urgency and criticality.16
  • Assemble and present current inventories of shorted products and their proposed substitutes to maintain awareness of which shortage cases most urgently require attention.10,11
  • Automate review of current databases to provide better awareness of what items are in short supply, and automatically mark formulary items with known shortage information.
  • Alert pharmacy staff to new shortages as they appear and shortages that have resolved or are due to resolve.
  • Maintain a shortage processing workflow that
    • Leads the user through steps in managing the shortage,
    • Assembles the necessary information in one place for review by
      • Identifying inventory and consumption data on shorted drugs and substitutes
      • Identifying locations of low usage from which items may be transferred
      • Identifying patients potentially affected by a new shortage
    • Recommends drug supply movements both within and between facilities in a given health system, and
    • Updates par levels of substitution products to ensure that they remain in supply.

Conclusion

Drug shortage is now a chronic problem that creates cost to healthcare in terms of increased labor, increased medication cost13, increased opportunity for medication error, and lost revenue from canceled or deferred procedures.15

Pharmacists and pharmacy technicians are primarily tasked with dealing with drug shortages on the fly, the number, mix and frequency of which is high—and has remained so over a period of years.8,9

Pharmacists tend to deal with shortages at a facility level, meaning that efforts are often replicated across each facility in a health system.14

Tools for anticipating and dealing with shortages are lacking,13 resulting in a reactive response that increases urgency and minimizes the opportunity to plan. Tools are needed that allow pharmacists to be better informed about the current and potential impact of shortages and require less effort to manage. In our opinion, such tools can be envisioned, and need to be built for use by pharmacists.

Learn more

Each month on the BD Institute for Medication Management Excellence blog, thought leaders explore topics of critical importance to medication management, and provide additional ways to learn.

Now that you've read about drug shortage management tools, deepen your understanding of the burden of drug shortages on clinical care. Then, explore the challenges of patient-specific medication management

References

  1. Shaban H, Maurer C, Wilborn R. Impact of Drug Shortages on Patient Safety and Operational Costs. Federal Practitioner January 2018: 24-31.
  2. Kaakeh R, et al. Impact of drug shortages on U.S. health systems. Am J Health-Syst Pharm Oct 1, 2011 v68: 1811-1819.
  3. Caulder CR et al. Impact of Drug Shortages on Health-System Pharmacies in the Southeastern United States. Hospital Pharmacy 50:279-286, April 2015.
  4. DeWeerdt ED, et al. Time spent by Belgian hospital pharmacists on supply disruption and drug shortages: An exploratory study. PLoS ONE 12(3):1-15 March 28, 2017.
  5. Pauwels K, Simoens S, Casteels M, Huys I. Insights into European Drug Shortages: A Survey of Hospital Pharmacists. PLoS ONE 10(3): 1-13 March 16, 2015.
  6. Nonzee NJ et al. The drug shortage crisis in the United States, Impact on Cancer Pharmaceutical Safety. Cancer Treat Res, 2019;171:75-92.
  7. ISMP Article; “Drug Shortages Continue to Compromise Patient Care”. January 2018. Accessed 12/20 from http://www.ismp.org/resources/drug-shortages-continue-compromise-patient-care.
  8. Knight C, Tribble D. SVP Shortage: Implementing ASHP Guidance. Presented at the 2018 Summer Meeting of the American Society of Health-System Pharmacists, Denver, CO June 4, 2018.
  9. ASHP Guidelines on Managing Drug Product Shortages. Viewed at https://www.ashp.org/-/media/assets/policy-guidelines/docs/guidelines/managing-drug-product-shortages.ashx on April 25, 2019.
  10. FDA Drug Shortages, a database of known drug shortages viewed at https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm on April 25, 2019.
  11. Current Drug Shortages, a database of known drug shortages viewed at https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortages-List?page=CurrentShortages on April 25, 2019.
  12. FDA and ASHP Shortage Parameters: Contrasting the FDA (CDER) and ASHP Drug Shortage Websites: What are the differences? Viewed at (https://www.ashp.org/Drug-Shortages/Current-Shortages/FDA-and-ASHP-Shortage-Parameters) on May 24, 2019.
  13. Kaakeh R, et al. Impact of drug shortages on U.S. health systems. Am J Health-Syst Pharm Oct 1, 2011 v68: 1811-1819.
  14. Gottlieb S. FDA is Advancing New Efforts to Address Drug Shortages. Fda.gov. https://www.fda.gov/news-events/fda-voices-perspectives-fda-experts/fda-advancing-new-efforts-address-drug-shortages. Published 2019. Accessed May 22, 2019.
  15. McLaughlin M, Kotis D, Thomson K, et al. Effects on patient care caused by drug shortages: a survey. J Manag Care Pharm. 2013 Nov-Dec;19(9):783-8.
  16. Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions. Healthpolicy.duke.edu. https://healthpolicy.duke.edu/sites/default/files/atoms/files/duke-fda_drug_shortages_discussion_guide.pdf. Published 2018. Accessed May 23, 2019.
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