Use of Expired Medications During Drug Product Shortages
Linda F. McElhiney, PharmD, MSP, RPh, FIACP, FASHP, FACA
Drug product shortages have been an ongoing problem for health-systems, facilities, clinics, and pharmacies for decades. They have caused delays in or adversely affected the proper care and treatment of patients. There is a financial burden on health-systems because of higher drug acquisition and personnel costs. It is an extremely frustrating situation for everyone involved, from the patients to the healthcare providers and first responders.1,2
What options are available to relieve these drug product shortages? Some health-systems and facilities "stock up" in anticipation of a drug product shortage; however, this practice tends to create false shortages, and patients that need the drugs may not be able to obtain them because no one wants to release any of their supply. Some health-systems and facilities purchase drug products on the "gray market." These products may not be manufactured in U.S. Food and Drug Administration (FDA)-registered facilities, and there is a risk that the quality may be substandard. Compounding the medication in-house or contracting with an outsourcing facility may be a good viable option if the compounding pharmacy or outsourcing facility meets the legal standards (United States Pharmacopeia standards for traditional compounding and cGMP standards for the outsourcing facility) and the dosage form can be properly prepared. Finally, one option that has been considered and even used to alleviate drug product shortages is the use of expired medications; however, this option is heavily burdened with ethical or moral issues, risks to the patients, and liability issues for the healthcare provider.
There are studies that have demonstrated that most drug products retain at least 90% of their potency for several years.3 The American Medical Association concluded in 2001, based on the Federal Shelf Life Extension Program (SLEP), that the actual shelf life of some products is longer than the labeled expiration date. With a few exceptions, such as nitroglycerin, insulin, and some antibiotics, most drugs were stable and retained their potency. The SLEP was started in 1985 when the U.S. Department of Defense arranged for the FDA to test a $1 billion stockpile of drugs to see if the expiration date could be extended. Today SLEP is the most extensive scientific survey of expired drugs.4 When a drug is on backorder and a facility or health-system has the drug product that is ready to expire, check into the SLEP data through the FDA. Although unlikely, also check with the drug manufacturer to see if the company has done its own stability testing to extend the expiration date.
The FDA warns that using expired medical products "is risky and possibly harmful to your health." Medications can change in chemical composition or decrease in effectiveness, but the FDA occasionally allows use of specific batches of expired medications after they are tested for safety.5 During the 2009 H1N1 flu epidemic, Tamiflu was in short supply and there was a stockpile of the drug ready to expire. Under SLEP, several lots of Tamiflu were tested and the expiration dates were extended for up to 6.5 years from the original manufacturer expiration dates.6
Ultimately, the health-systems or facilities have to make an informed decision while balancing what is best for the patients. Is it better to forgo treatment and wait until the drug product is available or should expired drug products be used so that treatment is not delayed? Is the risk of an adverse drug event (ADE) high if an expired drug product is administered to the patient? Does using an expired drug product during a drug shortage increase the health-system's or facility's liability if a patient suffers an ADE? Explore this option carefully and gather all of the information, such as data from SLEP, before making a decision. To learn more about SLEP, visit the Association of State and Territorial Health Officials website at http://www.astho.org/Programs/Preparedness/Public-Health-Emergency-Law/Emergency-Use-Authorization-Toolkit/Federal-Shelf-Life-Extension-Program-Fact-Sheet/.
- American Society of Health-System Pharmacists. ASHP guidelines on managing drug product shortages in hospitals and health systems. Am J Health-Syst Pharm 2009; 66(15): 1399-1406.
- Kollars B. Drug shortage list climbs to 300+. What are hospitals, politicians, manufacturers doing about it? Med City News [MedCity News Website.] December 12, 2013. Available at http://medcitynews.com/2013/12/. Accessed September 10, 2014
- Anderson L. Drug Expiration Dates-Are They Still Safe to Take? [Drugs.com Website.] February 10, 2014. Available at www.drugs.com/article/drug-expiration-dates.html?printable=1. Accessed September 15, 2014.
- Douglas JF. Out of date, out of order, out of options? The ethics of time expiry. J NI Ethics Forum 2008; 5: 33-41.
- Purvis C. Drug shortages push first responders to use expired meds. Security Management July 13, 2012. Available at: www.securitymanagement.com/print/10080?page=0%2C1. Accessed September 10, 2014.
- U.S. Department of Health & Human Services. U.S. Food and Drug Administration. Stockpiled Antivirals at or Nearing Expiration. [FDA Website.] October 22, 2010. Available at: www.fda.gov/newsevents/publichealthfocus/ucm154962.htm. Accessed September 15, 2014.