Almost everyone has a home first aid kit. Who among us hasn’t happened while searching for the right pill or ointment to discover that its expiration date has already expired? Alas, not for everyone this is a reason to throw the medicine in the trash. Some hope for chance, others, especially older people, regret throwing away expensive medications or rely on the opinion of homegrown experts from the Internet and continue to take expired medications.
PharmMedProm asked how the expiration date of drugs is determined, whether it is possible to take expired drugs and what the consequences may be, the specialists who know the answer to this question best: pharmaceutical manufacturers.
Our main expert is Margarita Aleksandrovna Sarvalova, quality director of the Russian innovative pharmaceutical company . Since 1997, Valenta Pharm has been developing and producing original prescription and over-the-counter drugs in such therapeutic areas as immunology, virology and antibacterial therapy, psychoneurology, gastroenterology, and urology. The company's portfolio includes Ingavirin®, Grammidin®, Normomed®, Trimedat®, Exportal®, Antareit®, Nanotropil®, Teraligen®, Phenazepam®, Aminazin® and other drugs, well known and popular among Russians.
How do manufacturers determine the expiration date of drugs?
The shelf life of medicinal products is a certain period of time during which the medicinal product fully meets all the requirements of the regulatory documentation in accordance with which it was produced and stored.
During the pharmaceutical development stage, the manufacturer conducts various tests on the drug to determine its initial shelf life. It is established experimentally during storage for a certain time in conditions and packaging regulated by regulatory documentation and, as data accumulates, the shelf life can be changed. If the drug remains stable, that is, all its declared properties and composition remain unchanged, the verified shelf life is fixed in the regulatory documentation for the drug.
Rosselkhoznadzor's response
Rosselkhoznadzor has deciphered how to set expiration dates. In the “Best before” field you need to enter a date before which the products can be used and transferred to contractors. Expiration dates are not considered inclusive, therefore, with the onset of the first second of the next period, the product will be regarded as expired.
Example
We issue a VSD for a pack of cottage cheese. The “Best before” field indicates the date 05/20/2020. According to the response from Rosselkhoznadzor, the Mercury system considers this batch to be overdue as of 05/20/2020 at 00:00:00. On May 19, you can still work with the product. From the first second of May 20 it will be considered overdue.
Sometimes expiration dates are indicated by date intervals. For example, from June to July. In its response, Rosselkhoznadzor explained that in the near future it will introduce a mechanism in which goods will be considered expired upon the earliest date in the interval. Start filling out the “Best before” field in advance, taking this information into account, so that Rosselkhoznadzor does not have any questions later.
What happens if you take a medicine that is a month past its expiration date? What about a year?
It doesn't matter if it's a month or a year, what matters is that the expiration date has expired. You may not get the expected therapeutic effect, and the side effects of the drug may increase, and many times over. The “anti-effect,” of course, is highly individual for different medications, but the rule is the same for all – using a medicine that has expired is dangerous. For some reason, many people are afraid to consume sour cream and yoghurt, which expired just a couple of days ago, but at the same time they have no doubt that medicine that is overdue for a month can still be taken. Although the potential harm from expired yogurt and expired medicine may not even be comparable!
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Natalya Morgunova, Director of the Department of Clinical Research, Product Registration and Medical Programs at Novo Nordisk on the correct storage of insulin: “Insulin has a strictly defined shelf life, based on data from stability studies. Using expired insulin is prohibited! Before using insulin, you must check the expiration date indicated by the manufacturer, and also familiarize yourself with the storage conditions specified in the instructions. Being a protein hormone, insulin should not be exposed to low (insulin should never be frozen) or high temperatures, as well as sudden temperature changes. Therefore, it is very important to follow the rules for its storage - insulin stocks should be kept in the refrigerator at a temperature of 2 to 8 ° C, and open, currently used insulin can be stored at room temperature for 4 to 6 weeks, depending on the type of drug.”
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Contents of the concept “remaining shelf life”
First of all, you need to understand that any product that has not expired is of high quality. This, accordingly, affects the nature of violations of the provisions of the state contract on the shelf life. If the requirements for the remaining shelf life are violated, the provisions of Art. 475 of the Civil Code of the Russian Federation on the consequences of transferring goods of inadequate quality. The same applies to penalties provided for in the contract. Thus, in one of the cases, the state customer tried to recover from a supplier who supplied medicines with an expiration date less than the remaining one a penalty for violating quality requirements. The court noted that the shelf life in itself is not a qualitative characteristic of the product: during the shelf life, the product is completely suitable for use, and the drug, in particular, retains all its quality characteristics.
Is the shelf life of opened medications reduced?
For not all drugs, opening the packaging affects the shelf life. Much depends on the packaging itself. If it is individual for each single dose of the drug, then opening one dose will in no way affect the others. The packaging may be the same for a multi-dose drug, but even in this case the stated expiration date may not change. If opening the package affects the shelf life of the drug, information about this must be placed on the package and can be included in the instructions for the drug.
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Alexander Zharnikov, head of the project office “Development of Bacteriophages” of NPO Microgen (Natsimbio Holding of the Rostec State Corporation) on how to properly store and use bacteriophages : “Bacteriophage preparations are living microorganisms that cause the death of pathogenic bacterial cells. To maintain the activity of bacteriophages, special conditions are needed - a special nutrient medium in which they are placed in glass vials at production, and a storage method specified in the instructions for use: at a temperature of +2-+8℃ in a place protected from light. The lifespan of bacteriophages, that is, the shelf life of the drug, subject to storage conditions, is limited to 2 years. Bacteriophages can be stored and used within the expiration date after opening, but for this it is necessary to follow special rules, which are described in detail in the instructions for the drugs. Before use, the bottle with the bacteriophage must be shaken and checked to see if the drug is transparent and if there is any sediment at the bottom. If there is, it is no longer recommended to use it. A drug that has expired cannot be used, because its activity may decrease and this will negatively affect the results of treatment.”
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Myths about drug expiration dates
For pharmacist and toxicologist Lee Cantrell, it was an opportunity to answer a long-lingering question: Could drugs from the days of bell-bottom jeans still be active?
The question is far from idle. U.S. pharmacies regularly dispose of large quantities of expired prescription drugs. Roy Gerona and Lee Cantrell knew that the date indicated on the packages was only the period until which the American regulator and manufacturer guaranteed the activity and quality of the drug. As a rule, this is two or three years. But this does not mean that the drugs are ineffective once the period has expired.
After Cantrell and Gerona published their findings in the Archives of Internal Medicine, some readers accused them of being irresponsible. To which the authors replied that in no case are they encouraging people to take expired medications. They're talking about improvements to the registration process that could save billions of dollars.
What about the FDA?
It must be said that the idea of indicating an expiration date is at least half a century old; it was then that the FDA began to require this information to be added to packaging. To determine the shelf life, a drug is tested at elevated temperature, humidity to find out how the drug breaks down under stress and “accelerated aging”, after which the pharmaceutical company proposes its shelf life, and the regulator accepts it or not.
There is no legal requirement to extend the shelf life after drug approval. According to Ian Wu, an analytical chemist who specializes in long-term drug stability studies and a member of the American Pharmaceutical Sciences Association, most companies are not interested. Moreover, considering the high cost and duration of the procedure.
And the American Medical Association too
In the 2000s, the American Medical Association (AMA) questioned the consistency of the expiration date on the packaging with the actual one. After reviewing the procedures, the AMA concluded that the actual shelf life of drugs is longer, resulting in multimillion-dollar losses, high prices, and reduced access to drugs for certain patients. The AMA has sent letters to the FDA, the US Pharmacopoeial Convention, and the Pharmaceutical Research and Manufacturers Association of America (PhRMA) to revise the deadline.
An FDA study following the resolution found that two-thirds of the 122 expired drugs tested were stable. The result was an increase in the shelf life of “stable” drugs by an average of more than 4 years. And the SLEP program, the Service Life Extension Program, helped with this.
SLEP program
It's no secret that US agencies have been stockpiling drugs for decades. Among them are the Department of Defense, the Centers for Disease Control and Prevention, and the US Department of Veterans Affairs. Massive quantities of drugs, antidotes and vaccines, worth tens of billions of dollars, are stored in secure locations across the country. Stockpiles can only be opened in the event of a large-scale emergency. Maintaining inventory is expensive, in part because of the need to maintain proper temperature and humidity.
Over time, departments began to realize that not everything is so clear with regard to deadlines. As a result, in 1986, the US regulator was approached by the Department of Defense with a request to extend the shelf life of certain drugs.
In response, the FDA and the Department of Defense created the Shelf Life Extension Program (SLEP). SLEP data only confirmed the opinion that many drugs, under normal conditions, are stored much longer than the period indicated on the package.
How to properly store medications?
Only in accordance with the manufacturer's recommendations. Information about the storage method is always present on the packaging and in the instructions for the medicinal product. Don't neglect it.
For example, a cool and dry place is definitely not a bathroom cabinet, where many people like to store a first aid kit. This should be a shelf, closet or bedside table away from radiators and other heat sources, including the heating rays of the sun, in which room temperature is maintained without sudden fluctuations.
If the box says “keep away from sunlight,” then you should not assume that the cardboard packaging is sufficient protection for such a product. The sun's rays are not only bright light, but also ultraviolet radiation and heat that heats the box or bottle. It is better to store a product with this mark in a closed cabinet.
Why do medications lose their properties over time even when stored correctly?
Under the influence of various factors, for example, light, humidity, temperature and others, physical, chemical and biological phenomena can occur in the dosage form, changing its properties and even composition. “Deterioration” should be understood as a change in the properties of a medicinal product, which can negatively affect its quality, effectiveness and safety. In this case, the appearance of the drug may remain unchanged. It is extremely important to take medications only within the expiration date, and to strictly follow storage conditions in accordance with the manufacturer's recommendations.
3 USEFUL TIPS FOR STORING YOUR HOME FIRST KIT
- Different medications have different storage conditions. Set aside several places at home for a first aid kit: in the refrigerator and in a cabinet or bedside table with doors, closed from sunlight and away from radiators, out of the reach of children. Do not place transparent containers containing medications that require protection from sunlight on open shelves. When you buy a new medicine, be sure to read how and where it should be stored and put it in the appropriate place.
- At least once every two to three months, audit the medications stored in the first aid kit, this also applies to disposable syringes, bandages, plasters, and so on. Check the expiration date and storage conditions just in case. If you accidentally left a drug in the cabinet that was supposed to be stored in the refrigerator, and it remained warm for several days, then it is better not to use it.
- Do not transfer medications to another container, even if it is more convenient. Some people like to transfer the tablets from the blister into an empty bottle of another medicine. It is very dangerous! You may forget what kind of drug is in the bottle, and what its expiration date is, and you may violate storage conditions.
Interviewed by Alexandra Komarova
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