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Expired Medications, What’s the Cost?

April Graves, PharmD, BCPS, BCPPS, CPHQ and Matthew Tupps, PharmD, MHA

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Introduction

Expired medications cost health-system pharmacies hundreds of thousands of dollars a year.  In 2017-2018, one 1100 bed hospital in Maryland focused on 16 medications that were part of emergency kits and found that redistributing the medications to be used within two weeks of their expiration date resulted in an estimated total annualized cost avoidance of over $100,000.1 A mid-sized hospital in Boston reported that expired medications account for approximately $200,000 a year.2 When you consider that there are over 6000 hospitals in the United States alone3, the expense of wasting expired medications is vast.

 

History 

In 1978 the FDA required labeling for all prescription and most over-the-counter drug products to contain expiration dates.4 Expiration dates reflect the period in which testing has shown a product to retain its strength, quality, and purity when it is stored according to the labeled storage conditions.4 Expired medications can have economical, environmental, and patient safety implications.5

 

Safety Risks 

In a health system, expired medications pose a risk to patients whether they’re found in  central pharmacy storage locations or automated dispensing cabinets (ADCs).  When a patient has an order for a medication located in an ADC and that med is expired, two things can happen: the medication may be administered to a patient without noticing the expiration date or it will be returned to the pharmacy.  The potential risks associated with taking an expired medication can range from untreated symptoms to new complications.6,7  Furthermore, certain medications degrade into compounds that may be harmful. For example, case studies have reported kidney damage when the antibiotic, tetracycline breaks down.8   Eye drops and liquid antibiotics are susceptible to bacterial contamination when they are used beyond their expiration date.9

If the medication isn’t given, no harm comes to the patient, right?  When medication inventory isn’t managed efficiently, the availability of medications may be compromised.  If the expired medications are thought to be part of the usable inventory, how does the buyer know to purchase new stock?  The scenario of an expired medication in an ADC may impact medication availability, ultimately leading to delays in patient care.  We’ve seen this safety impact when drug shortages occur but, in this case, the lack of visibility to expired medication could create an iatrogenic drug shortage.10

 

Regulatory Risks

Along with the above patient safety concerns that have been identified, expired medications that are in patient care areas can also lead to regulatory risks.  Federal law dictates that outdated drugs and biologicals must not be available for patient use.11  In order to receive Medicare/Medicaid payments, hospitals are required to follow the federal requirements, specifically checking for expired medications is part of the hospital survey.12 The Joint Commission medication safety standards have medication storage recommendations which include removal of all expired, damaged, and/or contaminated medications.13  Due to the above patient safety risks and the identified regulatory requirements, many health systems will take the approach of managing expirations dates on all medications and removing those medications when they have reached a predetermined window of that expiration date (7 days, 30 days, 60 days, etc).  While these practices may aid in mitigating expired medications administration to patients or discovery during a regulatory audit, the practice ultimately leads to unnecessary waste of medications that are within the predetermined window.14

 

Inventory Management – Expired Medications

ADCs are used as the primary distribution model in the hospital setting.15 Pharmacy technicians are responsible for managing the inventory within the ADCs, part of that workflow includes daily refills of medications that fall below the minimum value set (minimum PAR) for each medication.  Though, checking for expired doses during daily refills is included in the pharmacy technician’s workflow, it can be a difficult task to complete secondary to the historically manual process.14 The ASHP Guideline on Medication Cost Management emphasizes that data must be at the core of managing medication inventory.16   ISMP’s Guidelines for the Safe Use of Automated Dispensing Cabinets requires medication tracking on all medications stocked in the ADC and to remove medications as appropriate.15  Some pharmacy technicians may run a report and look through assigned ADCs on a predetermined cadence to remove expired medications, but that is only as good as the data that was entered and identifies medications that have already expired.14  Being able to identify medications that are likely to expire in their current location and offer a suggested location for usage can provide tools to pharmacy staff in health systems to redistribute medications that would have expired into a new location where it can be used.  

 

Conclusion

Medication costs account for the bulk of a health-system pharmacy’s annual budget while drug costs continue to rise.16 Containing drug cost involves managing purchases and analyzing drug-use patterns.  Being able to identify your average usages and knowing the expiration dates on your inventory in all storage locations can allow pharmacy systems to be more agile with medication inventory, ultimately leading to reducing medication waste caused by expired drugs.  

References

  1. Uba RO, Priftanji D, Hill JD. Redistribution of short-dated emergency medications as a cost avoidance and drug shortage management strategy. Am J Health Syst Pharm. 2020;77(18):1504-1509. doi:10.1093/ajhp/zxaa200
  2. Diven DG, Bartenstein DW, Carroll DR. Extending Shelf Life Just Makes Sense. Mayo Clin Proc. 2015;90(11):1471-1474. doi:10.1016/j.mayocp.2015.08.007
  3. American Hospital Association.  Fast Facts on U.S. Hospitals, 2023. Published May 2023.  Accessed September 19, 2023. https://www.aha.org/statistics/fast-facts-us-hospitals
  4. 43 FR 45013-45336, September 29, 1978
  5. Alnahas F, Yeboah P, Fliedel L, Abdin AY, Alhareth K. Expired Medication: Societal, Regulatory and Ethical Aspects of a Wasted Opportunity. Int J Environ Res Public Health. 2020;17(3):787. Published 2020 Jan 27. doi:10.3390/ijerph17030787
  6. Nawarskas JJ, Koury J, Lauber DA, Felton LA. Open-Label Study of the Stability of Sublingual Nitroglycerin Tablets in Simulated Real-Life Conditions. Am J Cardiol. 2018;122(12):2151-2156. doi:10.1016/j.amjcard.2018.08.048
  7. Ogunshe A, Adinmonyema P. Evaluation of bacteriostatic potency of expired oral paediatric antibiotics and implications on infant health. Pan Afr Med J. 2014;19:378. Published 2014 Dec 15. doi:10.11604/pamj.2014.19.378.2156
  8. Varavithya W, Chulajata R, Ayudthya PS, Preeyasombat C. Fanconi syndrome caused by degraded tetracycline. J Med Assoc Thai. 1971;54(1):62-67.
  9. Beery S, Miller C, Sheridan D. Can medications become harmful after the expiration date?. Nursing. 2019;49(8):17. doi:10.1097/01.NURSE.0000569816.48032.19
  10. Shaban H, Maurer C, Willborn RJ. Impact of Drug Shortages on Patient Safety and Pharmacy Operation Costs. Fed Pract. 2018;35(1):24-31.
  11. 42 CFR 482.25, November 6, 2023.
  12. Centers for Medicare & Medicaid Services. State Operations Manual Appendix A – Survey Protocol, Regulations and Interpretive Guidelines for Hospitals.  Published July 21, 2023.  Accessed September 19, 2023.  https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/som107ap_a_hospitals.pdf
  13. Mansur, Jeannell.  Top Joint Commission Compliance Challenges. Published November 2015.  Accessed September 19, 2023.  https://www.pppmag.com/article/1784
  14. Nanni AN, Rana TS, Schenkat DH. Screening for expired medications in automated dispensing cabinets. Am J Health Syst Pharm. 2020;77(24):2107-2111. doi:10.1093/ajhp/zxaa318
  15. Institute for Safe Medication Practice.  Guidelines for the Safe Use of Automated Dispensing Cabinets.  Published February 7, 2019.  Accessed September 19, 2023.  https://www.ismp.org/resources/guidelines-safe-use-automated-dispensing-cabinets
  16. ASHP Expert Panel on Medication Cost Management. ASHP guidelines on medication cost management strategies for hospitals and health systems.  Am J Health Syst Pharm. 2008;65(14):1368-1384. doi:10.2146/ajhp080021
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