Letter to the Editor

Drug expiry debate: the myth and the reality

Dan Gikonyo, Anthony Gikonyo, Duncan Luvayo, Premanand Ponoth

Department of Cardiology and Cardiothoracic & Vascular Surgery

The Karen Hospital, Nairobi, Kenya.

Keywords: Medication, drugs, drug expiry, drug efficacy.

DOI: https://dx.doi.org/10.4314/ahs.v19i3.49
Cite as: Gikonyo D, Gikonyo A, Luvayo D, Ponoth P. Drug expiry debate: the myth and the reality. Afri Health Sci. 2019;19(3):
2737-2739. https://dx.doi.org/10.4314/ahs.v19i3.49

Introduction Proper storage of medications may help to extend their

There is so much wastage of drugs as they are not used potency. The bathroom and medicine cabinet are not
in time. Medications are expensive, and in the Asian and ideal places to store medications due to heat and hu-
African continents, where many have the problem of af- midity. Similarly, medications should not be left in a hot
fordability the debate is to see if the medication could be car. Medications remain most stable in dry, cool spaces
used even after the expiry date without losing the efficacy. away from light. Keep the prescription bottle caps tightly
Most of drug expiration dates information is from the closed and always keep medications out of reach of chil-
study conducted by the Food and Drug Administration dren and pets.
at the request of the military. With a large and expensive
stockpile of drugs, the military faced tossing out and re- Expiry date
placing its drugs every few years. What they found from The 2015 commentary in Mayo Clinic Proceedings, “Ex-
the study is 90% of more than 100 drugs, both prescrip- tending Shelf Life Just Makes Sense,” suggested that drug
tion and over-the-counter, were perfectly good to use makers could be required to set a preliminary expiration
even 15 years after the expiration date. date and then update it after long-term testing. An inde-
Hence, the expiration date doesn't really indicate a point pendent organization could also do testing similar to that
at which the medication is no longer effective or has be- done by the FDA extension program or data from the
come unsafe to use. extension program could be applied to properly stored
What does an expiration date mean? medications1
The expiration date is the final day that the manufacturer The United States' Center for Drug Evaluation and Re-
guarantees the full potency and safety of a medication. search officially recommends that drugs past their expira-
Drug expiration dates exist on most medication labels, in- tion date be disposed. It has been argued that this prac-
cluding prescription, over-the-counter (OTC) and dietary tice is wasteful, since consumers and medical facilities are
(herbal) supplements. encouraged to purchase fresh medication to replace their
expired products, also resulting in additional profits for
Corresponding author: pharmaceutical firms.
Premanand Ponoth,
Department of Cardiology According to the Food and Drug Administration (FDA)
and Cardiothoracic & Vascular Surgery study gets to the heart of medicine expiration and safety.
The Karen Hospital, Nairobi, Kenya. Updated: August 13, 2017, it turns out that the expira-
Email: [email protected] tion date on a drug does stand for something, but prob-

African © 2019 Gikonyo et al. Licensee African Health Sciences. This is an Open Access article distributed under the terms of the Creative commons Attribution
Health Sciences License (https://creativecommons.org/licenses/BY/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the
original work is properly cited.

African Health Sciences Vol 19 Issue 3, September, 2019 2737

ably not what you think it does. Since a law was passed fer in terms of their forms, dosage, and stability. Usual-
in 1979, drug manufacturers are required to stamp an ex- ly, drugs in liquid forms (e.g. solutions and suspensions)
piration date on their products. This is the date at which are not as stable as those in the solid forms (e.g. tablets
the manufacturer can still guarantee the full potency and and capsules). It has been reported that bioavailability
safety of the drug. of EpiPen® (epinephrine auto-injectors) were reduced
when administered between 1 to 90 months after the la-
Medical authorities state that expired medicine is safe to belled expiration date compared with those that were not
take, even those that expired years ago. It's true the ef- yet expired5
fectiveness of a drug may decrease over time, but much
of the original potency still remains even a decade after Potency and efficacy
the expiration date. Excluding nitroglycerin, insulin, and Medication's potency gradually decreases starting from
liquid antibiotics, most medications are as long-lasting as the moment of its manufacture. This process is not in
the ones tested by the military. Placing a medication in a any way spontaneous after the expiry date.
cool place, such as a refrigerator, will help a drug remain Expired drugs have not necessarily lost their potency and
potent for many years. efficacy. The expiration date is only an assurance that the
labeled potency will last at least until that date. Ongo-
Solid dosage forms, such as tablets and capsules, appear ing research shows that stored under optimal conditions,
to be most stable past their expiration date. Drugs that many drugs retain 90% of their potency for at least five
exist in solution or as a reconstituted suspension, and years after the labeled expiration date, and sometimes
that require refrigeration (such as amoxicillin suspen- longer. Even 10 years after the expiration date many
sion), may not have the required potency if used when pharmaceuticals retain a significant amount of their orig-
outdated. Loss of potency can be a major health concern, inal potency.2
especially when treating an infection with an antibiotic. In
addition, antibiotic resistance may occur with sub-potent Solid dosage forms, such as tablets and capsules, are most
medications. Drugs that exist in solution, especially in- stable past their expiration date. Drugs that exist in solu-
jectable drugs, should be discarded if the product forms tion or as a reconstituted suspension may not have the
a precipitant or looks cloudy or discolored. required potency if used when outdated.
The best evidence of acceptable potency of the medica-
A study by Khanchandani on efficacy, safety concern and tions beyond their expiration date is provided by the Shelf
disposal practices followed for expired drug preparations Life Extension Program (SLEP) undertaken by the FDA
among medical personnel, found that 89.39% had knowl- for the Department of Defense. The aim of the SLEP
edge that expiry date depends on both manufacturing and program was to reduce medication costs for the military.
storing condition.Ninety one percent subject responded SLEP has found that 88% of 122 different drugs stored
correctly that the drug should be best stored in cool dry under ideal conditions should have their expiration dates
and dark places. During the study they found out that extended more than 1 year, with an average extension of
majority consider expired drug use is not safe but 89.39% 66 months, and a maximum extension of 278 months.3
subject were aware about not using insulin, liquid antibi- Certain medications have a narrow therapeutic index and
otic, nitroglycerin after expiry. The testing conducted by little decreases in the pharmacological activity can result
the US FDA ultimately covered more than 100 drugs pre- in serious consequences for patients. Monoclonal an-
scription and OTC drugs. The result showed that about tibodies should be included in this group. These drugs
90% were safe and effective as long as 15 years past their should not be used beyond the expiry date.
original expiration date. Loel Dawis, expiration date chief
said that with a handful of exception notably nitroglycer- Conclusion
in, Insulin and Liquid antibiotic most drugs are probably The 2015 commentary in Mayo Clinic Proceedings, “Ex-
as durable as the agency tested.4. tending Shelf Life Just Makes Sense,” suggested that drug
A study done by Simons on outdated EpiPen and EpiPen makers could be required to set a preliminary expiration
Jr auto injectors: past their prime, noted that, drugs dif- date and then update it after long-term testing. Even

2738 African Health Sciences Vol 19 Issue 3, September, 2019

though the literature denotes western circumstances, we ration Dates." Report 1 of the Council on Scientific Af-
can take a leaf or two to modify to work around it, so fairs (A-01). July 25, 2001.
that it will be beneficial to the African continent, espe-3. Lee Cantrell. Stability of Active Ingredients in
cially more so in the peripheral outreach health centers Long-Expired Prescription Medications. Arch Intern Med.
in Africa where availability and storage of medicines are 2012;172(21):1685-1687
a challenge. 4. Khanchandani R, Srivastava B, Sinha A, Gaur S, Gaur
S, Bharat S. Efficacy, safety concern and disposal practic-
References es followed for expired drug preparations among medical
1. Drugs past their expiration date. Med Lett Drugs Ther. personnel
2015 Dec 7; 57(1483):164-5. The Medical Letter 5. Simons FE, GU X, Simons KJ. Outdated EpiPen and
2. American Medical Association. "Pharmaceutical Expi- EpiPen Jr auto injectors: past their prime? Journal Allergy
Clinical Immunology 2000; 105:1025–30.

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