How is the expiration date of drugs determined?

We have many questions about the expiration date of medications. Are there any medications that can be taken after their expiration date? What medications should be thrown away literally on the same day as indicated on the package? How to store medications? For many of us, the answers to these questions are important, because not everyone can afford to endlessly replace old medications with new ones.

What does "best before" mean?

The expiration date of the drug means that the manufacturer guarantees the full indicated effect of the drug and the degree of safety described in the instructions only until this date. All medicines, prescription and non-prescription, dietary supplements and herbs sold in pharmacies must have an expiration date indicated. Since many drugs cannot remain stable forever, the manufacturer does not promise that the drug will have the desired effect after the expiration date.

The stability of the drug's chemical compounds is tested in laboratories before the drug is released onto the market. The date indicated on the package is relevant until the tablets, capsules or liquid have access to air. That is, simply put, until you open the jar or open the blister cell. From this point on, the original expiration date of the medicine cannot be relied upon. However, according to experiments with the stability of chemical compounds, the shelf life of an unopened drug may be much longer than indicated.

On the packaging there is the phrase “Use before...” or an indication of how long after opening the package the drug should be used. For example, it is often written on eye drops that after opening the sealed cap they can be used for no longer than a month, and in some cases a maximum of two weeks. After this period, the drug may cease to have a therapeutic effect and even become dangerous.

Should you update the medications in your home medicine cabinet?

Indeed, over time, the effectiveness of the drug may decrease, but in most cases it remains even after a decade. According to the study results, the exceptions are medications such as nitroglycerin, insulin, and antibiotic solutions. Storing medications in a cool place, such as the refrigerator, significantly extends their shelf life.

So should we update the medications in our home medicine cabinet? The indicated shelf life of the medicine guarantees you its effectiveness, for which you paid money when purchasing it. Otherwise, the manufacturer is not responsible for its effectiveness and possible side effects.

Note that if a pharmaceutical company is forced to conduct clinical trials aimed at extending the shelf life of drugs, this may hinder the introduction of new and better drugs. The next time you find yourself in such a dilemma, take our information into consideration.

If several years have passed since the expiration date of the drug, and its maximum effectiveness is extremely important to you, you should still buy a new package. If you have any doubts about the safety and effectiveness of a particular medicine, contact your pharmacist at the pharmacy. He will provide you with complete information on the drugs you are interested in.

Do expired medications lose their beneficial properties?

In 2001, the AMA (American Medical Association) concluded that the actual lifespan of an unopened drug is longer than what is stated on the package. For the study, 3,000 units of drugs were taken, representing 122 different drugs. 88% of drugs (2652 drug units) fully retained their properties for an average of 66 months after their expiration date. Of those 2,652 units, only 18% eventually degraded to the point where they were no longer usable. Among the well-preserved drugs were amoxicillin, ciprofloxacin, diphenhydramine and morphine sulfate injection. The shelf life of these drugs varied from 12 to 184 months (!) after the expiration date.

Based on these results, it becomes clear that the lifespan of many drugs is significantly underestimated. However, in reality, ordinary patients who come to the pharmacy and the pharmacists standing behind the counter have no way of knowing how long a particular medicine can be stored. The actual lifespan of the drug depends on the ingredients included in its composition, on the presence/absence of preservatives, on temperature fluctuations in the pharmacy, at home and during transportation, on light and humidity, and on many other conditions.

Responsibility for the absence of a log

Since the order for drugs with a limited shelf life No. 706n of the Ministry of Health and Social Development of the Russian Federation obliges the maintenance of appropriate documentation, administrative responsibility for the lack of a registration book falls on:

• pharmacies;
• organizations for wholesale and retail trade in medicines;
• medical organizations, hospitals, clinics;
• private entrepreneurs who have a license for pharmaceutical and medical activities;
• drug manufacturers.

Is it safe to take expired medications?

To date, there are no reports of any currently available expired causing harm to humans.

Medicines in solid form, in the form of tablets and capsules, are the most stable of all. Preparations in liquid form, emulsions and suspensions, especially those requiring refrigeration, may lose some of their important properties as they expire. This is important to understand if a person’s health or life depends on treatment. It's one thing if you took a painkiller and it didn't work. It’s a different story when you are prescribed antibacterial therapy that does not allow for delay. Imagine a person with acute pneumonia who takes antibiotics for several days that do not work. The disease will worsen, and the patient may end up dying.

Injection solutions should be thrown away if they change color or become clear. Auto-injectors (pen syringes for quick self-injections) cannot be used after the expiration date. Preparations containing preservatives (the same eye drops mentioned) are not stable and should be replaced with fresh ones as often as indicated in the instructions. If you use them too long, you may get a bacterial infection because bacteria multiply quickly in liquid media.

Insulin can break down after the expiration date. Nitroglycerin taken for chest pain loses its effectiveness very quickly - carefully read the instructions and packaging.

If you find that the initially loose drug clumps, or the medicine has an unusually strong odor, or it has dried out, although it initially looked normal, the medicine should be thrown away.

How is the expiration date of drugs determined?

10/25/2014 How to determine whether it is time to throw away the medicine, or whether it can still be used for medicinal purposes? Blindly following the expiration dates of pharmaceutical drugs is quite stupid. According to many patients, medications can be used for several months after the expiration date of the medications has come to an end. And that's true. Based on the surveys carried out, this statement is correct.

Many proven medications retained their medicinal properties for a long time after their expiration date had expired. But how accurately is it possible to believe this? According to doctors, the expiration date of medications is not an empty phrase. What they think about this is outlined below.

How to determine what is good and what is no longer good:

• Many medications for internal consumption can continue to be used for a year after the expiration date. It is possible to store the following groups of medications: painkillers, headache medications, allergy and flu medications, and stomach pain pills.
• After the expiration date, you will have to say goodbye to the following drugs: nitroglycerin, antibiotics, drugs that are necessary to strengthen the vital functions of the body, suspensions and medicines in the form of a balm.
• It will be necessary to get rid of all medications prescribed for children.

Life-saving medications are not to be trifled with.

The manufacturer who produces drugs is required to determine how long any drug retains its properties by 95%. This is how the shelf life of medications is determined. Medical drugs that have an expiration date lose their effectiveness, not their usefulness.

As doctors of pharmacology say, it matters in the dose ratio, how much medicine is required to achieve the desired effect. You can only rely on luck when it comes to cough medicine. Nothing extraordinary will happen if you drink it after the expiration date. The only downside is that the person will simply continue to cough and that’s it. But it’s another matter if the necessary influence is not exerted by adrenaline, which comes to the aid of patients from shock.

A single fairy tale formula has not yet been derived

It can be assumed that after the expiration date, the effectiveness of the drug became 95%. You can think about how many useful substances will remain in a medicinal product after another six months have passed after the expiration date? It could be 93%, or maybe 37%. But, unfortunately, such studies are not carried out. Companies involved in pharmaceutical research will not waste extra money on unnecessary tests.

It is from such statements that one can conclude that if you need to be absolutely sure of the 100% effectiveness of the drug, then you need to purchase it with an effective expiration date. The production date and expiration date are always indicated on the medicine packaging.

We need to get rid of liquid forms of medications

This must be done for the following reasons:

• Solutions, gelatin capsules and liquids have a small margin of safety, and their usefulness expires faster than solid forms of drugs.
• Liquid forms of medications can become extremely difficult for human life if pathogenic microbes get into them.
• For liquid preparations, the expiration date must be strictly observed. As soon as it ends, you need to get rid of the medications. Otherwise, unwanted unnecessary actions may appear.

How to properly store medications

Herbal medicines should always be stored correctly. This needs to be monitored closely at all times. As implied, the medicine should always be kept in a cool and dark place. Before getting rid of expired medication, you need to remember where the medicine was stored. If an unopened bottle of medicine has been lying in a cool, dark drawer for many years, it may be effective. But, as often happens, the first aid kit is usually located in the most inappropriate place for it. For example, in a warm room or in the glove compartment of a car...

Expired antibiotics must be disposed of

These medications should not be used after the expiration date has expired. Such medications have increased toxicity. This is especially true for tetracycline. As it was revealed, it belongs to those drugs that, after expiration of the expiration date, exhibit toxic effects.

Where are medications usually packaged?

They are packaged in pharmacies in smaller containers, and the final deadline for selling the products is set. It’s impossible to say for sure, but such “repackaging” will not have a positive effect on the shelf life of the medicinal product.

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How to store medications

Proper storage of medications can extend their useful life. It is a bad idea to store medications in the bathroom or other warm and/or humid area. In addition, many drugs do not tolerate long trips in a heated car interior. The vast majority of medications should be stored in a cool, dark, dry place. All medications must be tightly closed and completely inaccessible to children and animals.

If you need to take medicine on the go and there is no way to store it in a cool place, purchase a small cooler bag in which you will put medicines that require refrigeration.

How to determine how long to use medications after opening?

After opening the package, there are special requirements for shelf life:

conclusions

Still, how dangerous is it to take expired medications? In addition to the unstable drugs listed above, the situation with the rest is as follows. If you desperately need this particular drug, but there is no way to buy a new one, take it. Medicine has no evidence that it will harm you. However, if we are talking about the treatment of chronic diseases or your condition is potentially life-threatening, do not waste money on a new package of medicine.

Most often, painkillers, antipyretics and antihistamines the home medicine cabinet It is quite safe to take these medications, even if they are long past their expiration date. However, be prepared for the fact that they will not have the expected effect in full. The same applies to tablets and capsules poured from the original packaging into a travel tablet box.

Magazine form

The legislation does not regulate the form in which a log of drugs with a limited shelf life is kept, therefore each organization develops it individually according to a convenient option in the form:

• paper media;
• electronic media;
• rack cards.

In addition to the fact that drugs with a limited shelf life are subject to mandatory registration, Federal Law No. 61 “On the Circulation of Medicines” in Article Art. 58.1, part 3, obliges to maintain documentation of transactions related to the circulation of medicines for medical use. Special forms have been defined for this purpose.

Greed pills

And for those who didn’t make it in time for the broadcast, we talk about the most interesting topics of the programs.

Is it possible to take medications that have expired?

Sometimes you reach into your home medicine cabinet for medicine. It's a scratch, and the expiration date on it came out the day before yesterday. So what should we do? Run to the pharmacy for a new one? And this is time, and sometimes a lot of money. Maybe you can close your eyes and swallow a pill? But we were taught that medicines are not something to joke about - greed in this matter can backfire.

On the other hand, NATO suppliers in the United States conducted an audit of drug warehouses and unexpectedly discovered that some drugs retain their properties 10 years after the expiration date.

So is it possible to use expired medications? Pharmacologist, Professor Ivan KOZLOV .

Pills

For safety reasons, pharmaceutical companies slightly underestimate the shelf life of drugs. Therefore, if necessary (if it is not possible to purchase a new drug), you can independently extend the shelf life of the tablets indicated on the packaging by a maximum of 2 months.

But in any case, you can take expired tablets only if they were stored in a closed package and have not changed color and structure (have not become loose, do not crumble, etc.). However, if the color and structure of the tablet changes, you cannot take it, even if the expiration date has not yet expired.

If you use special pill boxes for taking medications (where they are laid out for the day or for the week), remember: the maximum shelf life of the medicines in them is 10 days. So it is not advisable to prepare them more than a week in advance.

Medicinal syrups

Medicinal syrups are a favorable environment for the proliferation of microbes due to the presence of sugar. Under no circumstances should they be consumed after the expiration date.

Solutions for injections

Do not use ampoules with expired injection solutions as they may be toxic.

Do not use injection solutions, even if they have not expired, if they have changed color or have a cloudy sediment - this can be fatal.

! Do not store medicines without packaging with an expiration date on it. When you throw away the box of the drug, you lose not only the expiration date, but also the instructions for use - keep this in mind when struggling for compact storage. Do not cut off empty cells from the blister: it is easy to miss and end up with scraps that don’t even have the name of the product on them.

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Molecular stability

The FDA has approved the antibiotic ciprofloxacin hydrochloride, called Cipro, from Bayer. One batch had an expiration date until March 1989. More than 10 years later, the FDA found that the pill was still in excellent condition, and they extended it for another 24 months, after which there was a total extension of 8 more years, and when the drug came to the FDA for research in 2011, it was unable to pass them. It turns out that its shelf life was... from 1985 to 2009 - 24 years!

Albert Poirier, director of quality assurance at Bayer, says that:

“I am not at all surprised by this result, since Cipro is a very stable drug molecule in tablet form. We set expiration dates based on patient safety. We want the drug to be used for no more than 3 years. We wouldn't want people to use our drugs for 5, 10 or 20 years. During this time, we will make much more effective and safe formulas that will have a better effect on the body. Moreover, we cannot study it over such a long period of time and do not know how patients will store this drug.”

Another common drug in tablet form is Chlorpromazine (Thorazine), a tranquilizer known as chlorpromazine. The batch, which had an expiration date of December 1996 - was unused and unopened, as was the case with all other drugs that participated in the program - was tested in July 2004 and extended for two years.

Other medicines that have had their shelf life extended by at least two years:

• Diazepam, sold as Valium;
• Cimetidine, sold as Tagamet;
• Phenytoin, sold as Dilantin;
• All tetracycline antibiotics;
• Penicillin.

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History of shelf life of drugs

Some manufacturers first began putting expiration dates on drugs in 1960, although they were not forced to do so. When the Federal Agency began requiring this in 1979, it wanted to establish uniform testing and reporting guidelines. But for now, the FDA requires that manufacturers analyze a drug's potential, its uniqueness, potency, quality and purity, according to certain manufacturer guidelines. If a company has tested its drug for two years, then the drug should not expire beyond that period.

Shelf life is up to two years, does not entail daily testing and statistics during this time. Most often, the drug is tested in a closed atmosphere of intense heat and humidity for several months, and then a chemical analysis of it and the strength of each ingredient is analyzed. The FDA also uses chemical analysis in testing for possible shelf life extensions, but does not test the drug in humans . The test conditions are such that any drug that has a shelf life of 2 years is likely to be greatly underestimated and the actual shelf life is much longer, which the FDA and drug companies are in full agreement on.

How to determine the expiration date of drugs

Back in 1979, drug manufacturers were required to indicate expiration dates on packages. Within the specified period, the effectiveness and safety of the medicine are guaranteed.

The timing is determined in special stability studies, which are carried out in two modes: one batch of the drug is stored under the correct conditions, and the other is stored in sunlight, in a hot room or in high humidity. In some countries (for example, in the EU), the expiration date that can be indicated on the packaging is limited - and then the date will be indicated five years after release, even if the medicine does not deteriorate in twenty years (for example, activated carbon can be stored forever). Published by Harvard Medical School in 2003, it talks about a study conducted by the US FDA commissioned by the military.

For years, the Army has been replacing its stockpile of expensive medications because they had expired. The study looked at over a hundred medications, prescription and over-the-counter, and found that 90% of them were still usable fifteen years after their expiration date.

The effectiveness of the drugs did not change or decreased slightly, and safety remained at the same level - the only exceptions were tetracycline, insulin, nitroglycerin and antibiotics in liquid form.

The drug was stored in a closet, but it needed to be at a low temperature.

Put it in the refrigerator or throw it away?

For good measure, it's better to throw it away.

It is unlikely that the healing effect of the medicine will last. A small effect is possible, but not fully. Do not violate the storage temperature!

Read more about storage mode here.

You will find a list of medications for your home first aid kit in a new article. Be healthy! Treat yourself consciously! Even more in the Telegram channel: