Drug expiration

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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.

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Drugs which are past their shelf life can decompose [1] and either be ineffective [2] or even harmful. [2] 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. [3]

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 date when the drug will become ineffective. [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 is deemed to be unfit for use when 10% of the active ingredient is degraded. [9] [10]

Before choosing an expiration date to print the manufacturer must 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

The United States' Center for Drug Evaluation and Research officially recommends that drugs past their expiration date be disposed. [11] 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. [12]

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. [13] An epipen is an example of an expensive medication which someone might consider using after expiration because of inability to purchase newer medication. [13] [14] 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. [15] Medical authorities recommend that no one use prescription drugs except under a physician's care. [15] Authorities also encourage care in storing over-the-counter drugs, discarding them on a regular schedule, and using them as directed when appropriate. [16]

Drug recycling

Drug recycling is a fringe and experimental concept but in some places it happens. [17] Sometimes, an individual or organization will have valuable medicine which they do not intend to use. [17] 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. [17] In such discussions, anyone considering the transfer of drugs will also consider if drugs could be used before their expiration. [17]

Shelf Life Extension Program

To reduce the cost to the military of maintaining stockpiles of certain pharmaceuticals, the United States Department of Defense (DoD) and the Food and Drug Administration (FDA) 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 US$2.1 billion on replacing stockpiled medications. [12] [18]

While testing and stability assessment found that 88% of the lots were effective at least one year after their expiration date, with an average extension of 66 months, the additional stability period was very variable. For antibiotics studied, the mean extension for ciprofloxacin was 55 months, and for amoxicillin 23 months. [10]

Related Research Articles

<span class="mw-page-title-main">Food and Drug Administration</span> United States federal agency

The United States Food and Drug Administration is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.

<span class="mw-page-title-main">Medication</span> Substance used to diagnose, cure, treat, or prevent disease

A medication is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy (pharmacotherapy) is an important part of the medical field and relies on the science of pharmacology for continual advancement and on pharmacy for appropriate management.

<span class="mw-page-title-main">Over-the-counter drug</span> Medication available without a prescription

Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a requirement for a prescription from a healthcare professional, as opposed to prescription drugs, which may be supplied only to consumers possessing a valid prescription. In many countries, OTC drugs are selected by a regulatory agency to ensure that they contain ingredients that are safe and effective when used without a physician's care. OTC drugs are usually regulated according to their active pharmaceutical ingredient (API) rather than final products. By regulating APIs instead of specific drug formulations, governments allow manufacturers the freedom to formulate ingredients, or combinations of ingredients, into proprietary mixtures.

<span class="mw-page-title-main">Pharmacy</span> Clinical health science

Pharmacy is the science and practice of discovering, producing, preparing, dispensing, reviewing and monitoring medications, aiming to ensure the safe, effective, and affordable use of medicines. It is a miscellaneous science as it links health sciences with pharmaceutical sciences and natural sciences. The professional practice is becoming more clinically oriented as most of the drugs are now manufactured by pharmaceutical industries. Based on the setting, pharmacy practice is either classified as community or institutional pharmacy. Providing direct patient care in the community of institutional pharmacies is considered clinical pharmacy.

<span class="mw-page-title-main">Prescription drug</span> Medication legally requiring a medical prescription before it can be dispensed

A prescription drug is a pharmaceutical drug that is permitted to be dispensed only to those with a medical prescription. In contrast, over-the-counter drugs can be obtained without a prescription. The reason for this difference in substance control is the potential scope of misuse, from drug abuse to practicing medicine without a license and without sufficient education. Different jurisdictions have different definitions of what constitutes a prescription drug.

<span class="mw-page-title-main">Shelf life</span> Length of time that a commodity may be stored before it degrades

Shelf life is the length of time that a commodity may be stored without becoming unfit for use, consumption, or sale. In other words, it might refer to whether a commodity should no longer be on a pantry shelf, or no longer on a supermarket shelf. It applies to cosmetics, foods and beverages, medical devices, medicines, explosives, pharmaceutical drugs, chemicals, tyres, batteries, and many other perishable items. In some regions, an advisory best before, mandatory use by or freshness date is required on packaged perishable foods. The concept of expiration date is related but legally distinct in some jurisdictions.

<span class="mw-page-title-main">Off-label use</span> Use of pharmaceuticals for conditions different from that for which they were approved

Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although most studies of off-label use focus on prescription drugs.

<span class="mw-page-title-main">Ear drop</span> Form of medication placed in ears

Ear drops are a form of topical medication for the ears used to treat infection, inflammation, impacted ear wax and local anesthesia. They are commonly used for short-term treatment and can be purchased with or without a prescription. Before using ear drops, refer to the package insert or consult a health professional for the amount of drops to use and the duration of treatment.

<span class="mw-page-title-main">Pill splitting</span>

Pill-splitting refers to the practice of splitting a tablet or pill to provide a lower dose of the active ingredient, or to obtain multiple smaller doses, either to reduce cost or because the pills available provide a larger dose than required. Many pills that are suitable for splitting come pre-scored so that they may easily be halved.

Direct-to-consumer advertising (DTCA) refers to the marketing and advertising of pharmaceutical products directly to consumers as patients, as opposed to specifically targeting health professionals. The term is synonymous primarily with the advertising of prescription medicines via mass media platforms—most commonly on television and in magazines, but also via online platforms.

<span class="mw-page-title-main">Food safety</span> Scientific discipline

Food safety is used as a scientific method/discipline describing handling, preparation, and storage of food in ways that prevent foodborne illness. The occurrence of two or more cases of a similar illness resulting from the ingestion of a common food is known as a food-borne disease outbreak. This includes a number of routines that should be followed to avoid potential health hazards. In this way, food safety often overlaps with food defense to prevent harm to consumers. The tracks within this line of thought are safety between industry and the market and then between the market and the consumer. In considering industry-to-market practices, food safety considerations include the origins of food including the practices relating to food labeling, food hygiene, food additives and pesticide residues, as well as policies on biotechnology and food and guidelines for the management of governmental import and export inspection and certification systems for foods. In considering market-to-consumer practices, the usual thought is that food ought to be safe in the market and the concern is safe delivery and preparation of the food for the consumer. Food safety, nutrition and food security are closely related. Unhealthy food creates a cycle of disease and malnutrition that affects infants and adults as well.

A counterfeit medication or a counterfeit drug is a medication or pharmaceutical item which is produced and sold with the intent to deceptively represent its origin, authenticity, or effectiveness. A counterfeit drug may contain inappropriate quantities of active ingredients, or none, may be improperly processed within the body, may contain ingredients that are not on the label, or may be supplied with inaccurate or fake packaging and labeling. Counterfeit drugs are related to pharma fraud. Drug manufacturers and distributors are increasingly investing in countermeasures, such as traceability and authentication technologies, to try to minimise the impact of counterfeit drugs. Antibiotics with insufficient quantities of an active ingredient add to the problem of antibiotic resistance.

<span class="mw-page-title-main">Environmental impact of pharmaceuticals and personal care products</span> Effects of drugs on the environment

The environmental effect of pharmaceuticals and personal care products (PPCPs) is being investigated since at least the 1990s. PPCPs include substances used by individuals for personal health or cosmetic reasons and the products used by agribusiness to boost growth or health of livestock. More than twenty million tons of PPCPs are produced every year. The European Union has declared pharmaceutical residues with the potential of contamination of water and soil to be "priority substances".[3]

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 Extension Program (SLEP), which evaluates the long-term effectiveness of medications stockpiled by the DoD and other government agencies. The program was established in 1986.

<span class="mw-page-title-main">Drug packaging</span> Packaging for pharmaceutical preparations

Pharmaceutical packaging is the packages and the packaging processes for pharmaceutical preparations. It involves all of the operations from production through drug distribution channels to the end consumer.

<span class="mw-page-title-main">Expiration date</span> Determined date to end the use of something

An expiration date or expiry date is a previously determined date after which something should no longer be used, either by operation of law or by exceeding the anticipated shelf life for perishable goods. Expiration dates are applied to selected food products and to some other manufactured products like infant car seats where the age of the product may impact its safe use.

<span class="mw-page-title-main">Drug disposal</span> Safe disposal of unused drugs

Drug disposal is the discarding of drugs. Individuals commonly dispose of unused drugs that remain after the end of medical treatment. Health care organizations dispose of drugs on a larger scale for a range of reasons, including having leftover drugs after treating patients and discarding of expired drugs. Failure to properly dispose of drugs creates opportunities for others to take them inappropriately. Inappropriate disposal of drugs can also cause drug pollution.

An unused drug or leftover drug is the medicine which remains after the consumer has quit using it. Individual patients may have leftover medicines at the end of their treatment. Health care organizations may keep larger amounts of drugs as part of providing care to a community, and may have unused drugs for a range of reasons. The unused drugs should be destroyed utterly to eliminate the toxic effects of undisposed drugs on flora and fauna. The improper disposal of unused drugs could be the reason for the contamination of Surface, Ground and Drinking Water. Discharge of unused antibiotics and disinfectants in the sewage system may ruin the aquatic life or contamination of drinking water.

The distribution of medications has special drug safety and security considerations. Some drugs require cold chain management in their distribution.

<span class="mw-page-title-main">Drug labelling</span>

Drug labelling is also referred to as prescription labelling, is a written, printed or graphic matter upon any drugs or any of its container, or accompanying such a drug. Drug labels seek to identify drug contents and to state specific instructions or warnings for administration, storage and disposal. Since 1800s, legislation has been advocated to stipulate the formats of drug labelling due to the demand for an equitable trading platform, the need of identification of toxins and the awareness of public health. Variations in healthcare system, drug incidents and commercial utilization may attribute to different regional or national drug label requirements. Despite the advancement in drug labelling, medication errors are partly associated with undesirable drug label formatting.

References

  1. ↑ Dawson, Michael (1994). "Expiry dates". Australian Prescriber. 17 (2): 46–48. doi: 10.18773/austprescr.1994.051 .
  2. 1 2 Research, Center for Drug Evaluation and (2019-07-17). "Don't Be Tempted to Use Expired Medicines". FDA.
  3. ↑ Alnahas, Faez (2020). "Expired Medication: Societal, Regulatory and Ethical Aspects of a Wasted Opportunity". International Journal of Environmental Research and Public Health. MDPI. 17 (3): 787. doi: 10.3390/ijerph17030787 . PMC   7037917 . PMID   32012703.
  4. 1 2 3 4 5 6 "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. 1 2 3 4 5 Shao, Jun; Chow, Shein-Chung (1 January 2001). "Drug Shelf-Life Estimation". Statistica Sinica. 11 (3): 737–745. JSTOR   24306844.
  8. 1 2 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. 1 2 Paauw, Douglas S. (2 October 2023). "More on Using Expired Medications". Medscape.
  11. ↑ 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.
  12. 1 2 "The Myth of Drug Expiration Dates". ProPublica. 2017-07-18. Retrieved 18 July 2017.
  13. 1 2 Skinner, Ginger (26 August 2016). "What You Need to Know About Expired EpiPens". Consumer Reports. Retrieved 30 March 2017.
  14. ↑ 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.
  15. 1 2 Carr, Teresa (18 July 2016). "How Long Do Antibiotics Last?". Consumer Reports . Retrieved 30 March 2017.
  16. ↑ Skinner, Ginger (20 September 2015). "Is it OK to Use Expired Neosporin?". Consumer Reports . Retrieved 30 March 2017.
  17. 1 2 3 4 Pomerantz, JM (23 April 2004). "Recycling expensive medication: why not?". MedGenMed. 6 (2): 4. PMC   1395800 . PMID   15266231.
  18. ↑ 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". Journal of Pharmaceutical Sciences. 95 (7): 1549–1560. doi:10.1002/jps.20636. PMID   16721796.
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