What will happen if I take an expired drug?
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| What will happen if I take an expired drug? |
\Have you ever come across a day when you felt unwell, so you went to search in the medicine box to find the required medicine, but soon you are confused when you see the expiry date to discover that the medicine has expired? Depending on your personality, you may decide that you should throw away the medicine immediately and replace it with a new one, or you may think that it is okay to use it this time if you do not want to go to the trouble of going to buy a new medicine or lose money!
Which of the two options is more correct? Getting an answer is not easy!
What does the expiration date mean?
Since 1979, the US Food and Drug Administration (FDA) has required drug companies to put expiration dates on all prescription and over-the-counter medications. The validity period affixed to the drug package - the period between the production date and the expiry date - is the period during which the drug manufacturer guarantees you its full safety and efficacy (the concentration of the active substance is between 90%-115%), as long as it is stored in the manner indicated on the package; That is, while the expiration date of a drug does not mean that it has expired, there is no guarantee that the drug will be safe and effective after it expires.
To determine the expiration date, drug companies perform “stability tests” for their drug products. These tests are carried out in different stages, where the medicine is stored in special rooms for certain periods at different temperatures and humidity that simulate normal, medium and extreme storage conditions (40°C +/- 2°C), with the aim of placing the medicine under the maximum possible storage conditions that can accelerate product deterioration within a short period. Then samples are taken for analysis every period, for example after 0, 3, 6 months, to see changes in the drug composition during storage.
Most medicines have a shelf life of 2 to 5 years as a maximum. However, many drugs may have longer shelf lives than prescribed, just because there is no one to test them.
It is not without risks
"The expiration date of a drug is an important part of deciding whether a product is safe to use and will work as intended," says Elisa Bernstein, deputy director of the Food and Drug Administration's (FDA) Office of Compliance.
Medicines are just chemical compounds that are liable to deteriorate over time and changing surrounding conditions. And the danger of expired products comes from the possibility of chemical or physical changes in the drug formula that may result in the available quantity of the active substance becoming insufficient to achieve the required therapeutic effect. It could become very dangerous if a life-saving drug turns out to be ineffective. For example, minophylline suppositories are used to treat shortness of breath in patients with asthma and respiratory diseases.
The original compound may break down into new compounds that may be toxic or harmful to the patient's health. In 1963, a report was published linking the use of a dissolving drug containing the antibiotic tetracycline to a form of kidney damage known as Fanconi syndrome in three of the patients. The report suggests that the compounds epi-anhydrotetracycline and anhydrotetracycline resulting from the degradation of tetracycline is the cause, but there is some controversy about the validity of the results of this report. In addition, this drug combination is no longer used in the United States.
What about on the ground?
“There are no published reports of poisoning due to ingestion, injection, or application of a currently used medicinal formulation after the expiry date,” states a study published in The Medical Letter on Drugs and Therapeutics in 2016.
In a study conducted by the Poison Control Center of the University of California College of Pharmacy in 2012, 8 drugs (14 different active substances) were examined in a retail pharmacy, which had expired for a period ranging from 28 to 40 years, in order to test their drug efficacy. It was clear from the results that 86% of the tested active substances retained their full effectiveness (i.e. present in concentrations ≥ 90%), even three of them were present in concentrations exceeding 110%.
In another 2017 study, the effectiveness of 40 Epipen injection pens, pens containing the hormone adrenaline used for life-threatening allergic reactions, was evaluated. It turned out that all the pens contained more than 80% of the initial dose of adrenaline, even for pens that were four years past their expiry date.
“If I were the person who was hypersensitive to bee stings, I would want to take a life-saving medication,” says lead researcher Lee Cantrell. In the meantime, if an expired Epipen is all I have, I'm going to use it. It is better than nothing.” This is provided that the solution is not cloudy or yellow.
However, patients are still advised to replace expired pens if new ones are available, to ensure safety. With the need to take this into account by the drug manufacturers, to re-evaluate the expiry date of the product and consider the possibility of prolonging it. That is exactly what happened in August 2018, when the US Food and Drug Administration announced that it was extending expiration dates by an additional four months for some expired or near-expiration Epipen lots, in response to an ongoing shortage of the drug on the market.
Adjustable validity period!
In preparation for emergencies, such as a terrorist attack, a flu outbreak or an earthquake, governments and some private sector entities stockpile medical supplies to cope in case available medical supplies run out. However, replacing this stock every few years due to its expiration date could cause a significant financial loss. This prompted the US Department of Defense to agree with the US Food and Drug Administration to launch the Shelf Life Extension Program (SLEP) in 1986.
A 2015 Mayo Clinic Proceedings commentary states that the SLEP data can be used to extend the shelf life of more established drugs that have been followed for many years. For example, if a drug ciprofloxacin that has been in federal supply has been active for more than 20 years, the FDA might consider giving that drug an extended shelf life to the general public as well, at least at pharmacies that have maintained optimal storage conditions.
Another option is to force drug companies to complete long-term stability tests throughout the marketing period while extending the shelf life of the product whenever it allows. Such a policy could save a lot of money. The Tufts Medical Center in Massachusetts, for example, gets rid of expired drugs every year worth $200,000.
It may also contribute to alleviating the shortage of drugs in the market and the consequent increase in prices, as it turned out that there is a shortage of 12 out of 15 drugs that the SLEP program decided were the best performers in the expiry date tests, from 2013 until the date of the comment in 2015. This is in addition to the environmental benefits that will result from a lower rate of release of drugs into the environment.
What's inside your medicine rules
Given the controversy surrounding the issue of usability of expired drugs—despite the evidence that many drugs are expiring after their expiration date—and the absence of official statements to guide healthcare workers and consumers of drugs in such situations, no one can provide definitive answers.
However, there are some related recommendations from Drugs.com, which advises that, as a general rule, the expiration date should be adhered to if:
Medicines used in the treatment of chronic diseases and critical conditions, such as: epilepsy medicines, heart medicines, cancer medicines, and others, as the lack of effectiveness of these medicines may lead to serious consequences.
Medications that lose their effectiveness easily: such as insulin (treatment of diabetes), nitroglycerin (treatment of angina), biological treatments, vaccines, and blood products, as these are more sensitive and can break easily.
- Antibiotics, as the possibility of bacteria resistance increases if the amount of medicine is less than the required dose, and contraceptive drugs that are preferred to work with discipline, otherwise they may fall into trouble.
Eye drops: the possibility of microbial infection increases.
Sometimes the smell and appearance of a medicine, the crumbling of tablets, the cloudiness or discoloration of the solution, and the drying of creams and ointments may give you a warning to avoid using it.
On the other hand, if the expired medication you want to use is intended to treat a minor health problem, such as a headache or mild pain, it may be safe to take, even if there is a possibility that it will not be 100% effective.
It is also important to consider the conditions in which you store your medication. Poor storage, especially one that exposes the medicine to direct sunlight, high temperature and humidity, may lead to spoilage of the medicine even before it expires, which means that storing the medicine in the bathroom - where the humidity and temperature is high - is rather not a good idea! The more you store your medication in the right conditions, the more you can help extend its effectiveness. Therefore, the attached storage instructions should always be adhered to according to the type of product, and the medicines should be placed in a cool, dry place away from light, while keeping the bottle caps tightly closed.
Finally, it should be noted that the expiry date shown on the package differs from the expiration date of some products after opening them, such as eye drops, oral medications and antibiotics after they are dissolved in water.