Drug expiration

Drug expiration is the date after which a drug might not be suitable for use as manufactured. Consumers can determine the shelf life for a drug by checking its pharmaceutical packaging for an expiration date.

Drugs which are past their shelf life can decompose[1] and either be ineffective[2] or even harmful[3]. Standard advice from drug manufacturers and some health organizations is to dispose of drugs after the expiration date printed on the packaging. However, the published expiration date is not an absolute indication that a drug has spoiled. Consumers and organizations sometimes use expired drugs for medical treatment either as a cost saving measure or because they otherwise cannot access drugs which are not expired. Medical authorities find it difficult to discuss when consumers can safely use drugs after the printed expiration date because it is difficult to obtain clear information.

Labeled expiration date versus true expiration

Manufacturers print expiration dates on drug bottle labels.[4] The labeled expiration date is a manufacturer's promise for a time until which the drug will have full efficacy and be safe as manufactured.[4] The labeled expiration date is not an indication of when a drug has become ineffective or unsafe to use.[4] Many drugs are effective for years after their expiration dates.[4] However, it is difficult for anyone including researchers and physicians to find information to verify how much any given drug will degrade in efficacy or become unsafe over time.[4][5] Drug manufacturers never support the use of drugs after the expiration date because that could make them liable if something went wrong.[6]

The expiration date printed on drug packaging will differ from the true expiration date of the drug.[7] Before the true expiration of a drug, its active ingredient will retain its potency.[8] Also before expiration, no components of the drug will degrade to become harmful.[8] Since products continually change over time, the characteristics of any drug are not unchanging but instead estimated with assay measurements to be within the specification required by the government regulator where the drug is sold.[7] As a general estimate, a drug becomes unfit for use when 10% of the active ingredient is degraded.[9]

Before choosing an expiration date to print the manufacturer must first decide a true expiration date.[7] After a manufacturer has decided what true expiration date it has set, then it will decide another date to make public and advertise on the packaging of the drug.[7] The printed expiration date will always be sooner than the true expiration date, because the drug should always be effective and safe before the labeled expiration date if kept properly.[7]

Options for expired drugs

Disposal
Main article: Drug disposal

The United States' Center for Drug Evaluation and Research officially recommends that drugs past their expiration date be disposed.[10] It has been argued that this practice is wasteful, since consumers and medical facilities are encouraged to purchase fresh medication to replace their expired products, also resulting in additional profits for pharmaceutical firms.[11]

Consumer use as normal

Some consumers can face the difficult position of being unable to afford their medication, and choosing between using expired medication or forgoing medication.[12] An epipen is an example of an expensive medication which someone might consider using after expiration because of inability to purchase newer medication.[12][13] Some common drugs which authorities say are always unsafe if expired include nitroglycerin, insulin, and liquid antibiotics.[4]

Consumers sometimes store drugs which they ought not use, regardless of being expired. People who have leftover antibiotics might feel that they can use them safely if they are not expired, or even if they are expired.[14] Medical authorities recommend that no one use prescription drugs except under a physician's care.[14] Authorities also encourage care in storing over-the-counter drugs, discarding them on a regular schedule, and using them as directed when appropriate.[15]

Drug recycling
Main article: Drug recycling

Drug recycling is a fringe and experimental concept but in some places it happens.[16] Sometimes, an individual or organization will have valuable medicine which they do not intend to use.[16] If that medication could be used by other people before its expiration, then sometimes, interested parties discuss drug recycling to transfer ownership of the drugs away from the party which will not use them to the party which needs them.[16] In such discussions, anyone considering the transfer of drugs will also consider if drugs could be used before their expiration.[16]

Shelf Life Extension Program
Main article: Shelf Life Extension Program

To reduce the cost to the military of maintaining stockpiles of certain pharmaceuticals, the United States Department of Defense and the Food and Drug Administration operate a joint initiative known as the Shelf Life Protection Program (SLEP), which evaluates the long-term effectiveness of medications stockpiled by the DoD and other government agencies. Under the program, medications are tested for safety and stability for extended periods of time in controlled storage conditions. In many cases, medications tested were found to be effective for years past their printed expiry dates; a 2006 study by the Journal of Pharmaceutical Sciences found that two-thirds of 122 medications tested through SLEP remained effective for an average of at least four additional years. In 2016, the DoD reported that the program had helped save the department $2.1 billion on replacing stockpiled medications.[11][17]

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References
  1. Dawson, Michael. "Expiry dates". doi:10.18773/austprescr.1994.051. Cite journal requires |journal= (help)
  2. Research, Center for Drug Evaluation and (2019-07-17). "Don't Be Tempted to Use Expired Medicines". FDA.
  3. Research, Center for Drug Evaluation and (2019-07-17). "Don't Be Tempted to Use Expired Medicines". FDA.
  4. "Drug Expiration Dates — Do They Mean Anything?". Harvard Health Publications. 2 September 2015. Retrieved 30 March 2017.
  5. "On call: Drug expiration dates - Harvard Health". Harvard Health Publications. August 2009. Retrieved 2 May 2017.
  6. "Drugs Past Their Expiration Date". JAMA. 315 (5): 510–1. 2 February 2016. doi:10.1001/jama.2016.0048. PMID 26836735.
  7. Shao, Jun; Chow, Shein-Chung (1 January 2001). "DRUG SHELF-LIFE ESTIMATION". Statistica Sinica. 11 (3): 737–745. JSTOR 24306844.
  8. Waterman, Kenneth C. (2009). "Understanding and Predicting Pharmaceutical Product Shelf-Life". In Huynh-Ba, Kim (ed.). Handbook of stability testing in pharmaceutical development : regulations, methodologies, and best practices. New York: Springer. pp. 115–135. doi:10.1007/978-0-387-85627-8_6. ISBN 978-0387856261.
  9. Neighmond, Patti (6 February 2017). "Is Medicine Still Good After The Expiration Date?". NPR.org. Retrieved 30 March 2017.
  10. Center for Drug Evaluation and Research (11 January 2016). "Don't Be Tempted to Use Expired Medicines". Food and Drug Administration. Retrieved 2 May 2017.
  11. "The Myth of Drug Expiration Dates". ProPublica. 2017-07-18. Retrieved 18 July 2017.
  12. Skinner, Ginger (26 August 2016). "What You Need to Know About Expired EpiPens". Consumer Reports. Retrieved 30 March 2017.
  13. Rachid, Ousama; Simons, F. Estelle R.; Wein, Michael B.; Rawas-Qalaji, Mutasem; Simons, Keith J. (April 2015). "Epinephrine doses contained in outdated epinephrine auto-injectors collected in a Florida allergy practice". Annals of Allergy, Asthma & Immunology. 114 (4): 354–356.e1. doi:10.1016/j.anai.2015.01.015. PMID 25707326.
  14. Carr, Teresa (18 July 2016). "How Long Do Antibiotics Last?". Consumer Reports. Retrieved 30 March 2017.
  15. Skinner, Ginger (20 September 2015). "Is it OK to Use Expired Neosporin?". Consumer Reports. Retrieved 30 March 2017.
  16. Pomerantz, JM (23 April 2004). "Recycling expensive medication: why not?". MedGenMed : Medscape General Medicine. 6 (2): 4. PMC 1395800. PMID 15266231.
  17. Lyon, Robbe C.; Taylor, Jeb S.; Porter, Donna A.; Prasanna, Hullahalli R.; Hussain, Ajaz S. (July 2006). "Stability profiles of drug products extended beyond labeled expiration dates" (PDF). Journal of Pharmaceutical Sciences. 95 (7): 1549–1560. doi:10.1002/jps.20636. PMID 16721796.
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