Where to store medicines. Indoor temperature according to the labor code at different times of the year "What will become of him?"

What should be the temperature in the freezer?For storing frozen food, food industry experts recommend setting the freezer to -18 ° C. Why is this temperature chosen?

We have prepared some interesting facts about this temperature standard and the reasons for its introduction among food and refrigeration equipment manufacturers.

During the development phase of refrigeration technology, -10 ° C was considered the optimal temperature for storing frozen food. However, later this indicator changed: the advantages of low temperatures in the freezer were revealed. In the late 1930s, the American Fruit and Vegetable Association proposed a temperature of 0 ° F (-17.8 ° C) as the standard for storing frozen food. The decision was made due to the fact that 0 is a round number, and not for some other scientific reason. After some time, this temperature, rounded up in Celsius to -18 ° C, was determined as the standard for storing frozen food in a freezer in Europe.

What is the optimal temperature in the freezer according to the EU directive?

In 1964, the International Academy of Refrigeration recommended -18 ° C as the minimum temperature for storing frozen food. State and international committees agreed with the suggested recommendations and approved the given freezer temperature in the standards, norms and laws. Then, based on the 1967 Code of Practice for Frozen Food, the EU Commission created its own directive for fast-freezing food, and in 1989 a minimum temperature level of -18 ° C was introduced for storing frozen food.

Actually low temperatures reduce the speed in the freezer chemical reactions and the spread of microorganisms. Although there is no exact relationship between the rate of reactions and a decrease in temperature, the Van't Hoff rule is often used for calculations, since it can show, with some error, the dependence of the temperature and the rate of chemical processes in products (the rate of chemical reactions doubles or more with each increase in temperature by 10 ° C).

Experts have found that at low temperatures in the freezer (-30 ° C to -18 ° C), the rate of chemical reaction in fruits and vegetables slows down two to three times. For sensitive substances, this means that the vitamin content decreases much faster when high temperaturesah than with optimal. After one year of storage at -12 ° C, the vitamin C content of vegetables is about 20% of the amount of this vitamin in foods that are stored at -18 ° C in the freezer. The colder the air in the freezer, the better quality frozen food.

Thus, the answer to the question: "What should be the temperature in the freezer?" - the value is -18 ° C. It is considered a trade-off between food quality and energy use, as lower temperatures increase the power consumption of the device.

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When we lay out our purchases, we do not hesitate to put sour cream in the refrigerator. After all, everyone knows that left warm fermented milk product overnight will turn into an inedible mass. But why, returning from the pharmacy, can we calmly put a bag of medicines in a closet or on a coffee table? Where can such carelessness lead and how to deal with it?

Storage that destroys

The average home medicine cabinet owner often goes to two extremes. The first, and most common, is the fear of room temperature. For some reason, many people are sure that medicines should only be stored in the refrigerator.

In my practice, I have often met lovers of "cold storage" and faced the fact that the most obvious evidence of wrongness can not make stubborn people change their habits. Even my own aunt - a very educated and intelligent lady - and she invariably puts her impressive first-aid kit on the top shelf of the refrigerator, not paying attention to the protests of the niece-pharmacist.

The second extreme is traditional Russian frivolity. Perhaps it will not be lost. What will become of him? These and, probably, many other excuses are found among the adherents of a carefree way of storing medicines. Home first aid kits are placed where it is convenient for the owner. And it’s also good if it occurs to him to hide all the medicines in a dark cabinet. And it happens that the most "suitable" place is the bathroom or even the bedside table.

Both the first and second extremes are equally dangerous. What is the risk of improper storage of medicines?

"What will become of him?"

Any medicine - a complex system, consisting of an active substance, stabilizers, binders, colorants, sweeteners and other auxiliary substances. Each of them individually and the entire drug conglomerate as a whole need to maintain certain conditions. Preservation here depends on the influence of temperature, humidity and light.

An increase or decrease in temperature, even a slight one, is detrimental to many drugs. Heat ethyl alcohol and you will witness a simple example demonstrating the transformation of this component of the tincture into an inactive compound.

Alcohol-based extracts and tinctures that are exposed to high temperatures will quickly and inevitably deteriorate - there is no longer any preservative to prevent decay. Low temperatures can also adversely affect medications. Place the dioxidine antiseptic bottle close to the freezer, and you will see how the clear solution turns into intricate crystals.

When a change in physical or chemical properties can be seen with the naked eye, it is not so bad. Sediment, cloudiness or crystallization will tell you that something is wrong with the drug and will force the suspicious liquid to be put aside. More often metamorphoses are latent. And then you continue to take pills, not suspecting that instead of a medicine, a harmless substance at best enters the body.

Another factor that can easily destroy a drug is high humidity... The components of medicinal products easily absorb moisture from the air if the humidity exceeds 60%, and in the case of medicinal herbs 40% is enough, and now your drugs are turning into drugs with an unknown effect.

And, of course, you should know and remember that almost all drugs are afraid sunlight, and even more so its direct rays. Ultraviolet light penetrates the packaging and catalyzes a wide variety of chemical and physical processes in tablets and syrups. At the same time, all these reactions are not accompanied by visible evidence of decay, and, therefore, it is almost impossible to suspect that something was wrong. This is how negligent consumers of pharmaceutical products are "treated", and then they are outraged by the ineffectiveness of drugs and the volumes of counterfeit products that seem to have filled the pharmacy shelves.

Attention to the medicine label!

How to protect yourself from unpredictable consequences? It couldn't be easier! The drug manufacturers have already studied and recorded everything. We are only required to read the information and act in accordance with the instructions. By the way, storage requirements are usually indicated on the outer packaging and are duplicated at the very end of the instructions for use.

Information on the storage rules for vials of tinctures and extracts is usually printed on the label. The patient's task is to find the necessary data on a label dotted with small inscriptions. An inexperienced consumer is sometimes faced with another difficulty - pharmacists like to use expressions that are not always understood by mere mortals.

Indeed, what is meant by the laconic phrase "Keep in a cool place"? Where to put the medicine that does not like direct actions sun rays? And how many degrees should it be at room temperature - 18 or maybe 25?

It turns out that a cool place is a refrigerator door with its 10-15 ° C, room temperature does not exceed 22 ° C, and preparations that decompose under the influence of light should be placed in cabinets with closed doors.

Marina Pozdeeva

Photo thinkstockphotos.com

We usually try to store all drugs that we quite often purchase at the pharmacy in a certain place at home. And rightly so - everything should be at hand.
A separate case is when a first aid kit is completed for going out of town (for example, to a summer cottage), abroad, for a car, for an office.
Bringing new medicine home carefully read the instructions for it... Before you find a "place to live" for the drug, look at the end of the instructions - there is always a section "Storage conditions",where factors such as:


  • acceptable storage temperature,
  • shine,
  • humidity,
  • contact with air,
  • accessibility for family members, etc.
The expiration date indicated on the packaging of the drug will be accurate only if you stored the drug according to the rules dictated by the manufacturer. Otherwise, at best, the drug will simply lose its properties, and at worst, toxic components are formed in it as a result of chemical reactions. So do what the instructions ask you to do - it's for your own safety!
So -- main factors affecting medications:

Temperature:

Store the medicine at a temperature not higher than specified in the annotation.
Solid and gaseous (aerosols) dosage forms are usually stored at room temperature in a dark place, avoiding heating by the sun's rays.
Most medicines are designed to be stored when average room temperature - from 15 to 22 degrees Celsius. Some medicines can be stored at 25 ° C and even at 30 ° C. There will be a warning about this in the instructions.
If the medicine label says: “ Store in a cool, dark place" or " in a dry and cool place", this means that it must be kept at a temperature not exceeding 15 ° C, that is, in the refrigerator. Those preparations that are recommended to be stored at a temperature not higher than 5 ° C should also be put there.
Only the shelves need to be used different:

  • medicines that need to be stored at a lower temperature (eg candles) should be placed on a shelf close to the freezer.
  • in a cooler atmosphere, it is desirable to store soft dosage forms (ointments, plasters, suppositories). They can usually be stored on the middle shelves of the refrigerator.
  • medicines that should simply be stored in a cool place - store on the lowest shelf - away from the freezer.
Medicines in the refrigerator must be additionally protected from moisture (for example by putting in a box or plastic bag).
Heat and frost are absolutely not suitable for storing medicines! It is better not to use frozen medicines. Some preparations have a special warning - "Do not freeze!"

Shine:

Drugs are destroyed most quickly when exposed to bright sunlightand accompanying warmth. Hence the best option is dark place (first aid kit in the closet)and away from heaters.
For individual medicines: syrups and solutions best stored in cardboard secondary packaging, that is, as you bought it, tablets and capsules in a blister pack (it is better not to practice like some - they buy the medicine in blisters, squeeze out the tablets and pour them into a glass jar with a lid. This is not correct from the point of view of storage - light and moisture begin to act on the tablets, and on the other hand, on such a bottle a different name of the medicine will be written or nothing at all. In an emergency, you can easily get confused. Especially unpleasant when such techniques are practiced by grandmothers with a bad memory. How many times was it that they brought pills in handfuls and forced the pharmacist to determine what they were from. It is very difficult to explain to my grandmother that all the pills are alike and to say that this is not real. They do not believe. They say - why are you standing here. Scream.

Humidity:

Pills and capsules hygroscopic and get wet easily. This is especially true for inexpensive drugs in paper packaging (for example, citramone). Therefore, they require a dry place. A room with an unstable humidity level (a bathroom, a balcony or a veranda in the country) is definitely not suitable.

Air inlet:

In the open state, it is possible for drugs to evaporate, absorb volatile substances or react with atmospheric oxygen (oxidation). Therefore, the vials are tightly closed. The tablets are stored in their original sealed packaging.

There is no more used kit in the field of medicines circulation template phrases rather than storage conditions... They are mentioned everywhere: on the packaging of substances, on the secondary packaging of a medicinal product, in licensing conditions, in guidelines on good practices, regulatory instructions for the circulation of different categories of medicines, etc. Whenever it comes to "controlled storage conditions" everyone understands by them the conditions (for example, humidity, temperature, light) that must be provided during the transportation, storage and use of a medicinal product based on the manufacturer's recommendations. Everything is clear, but the wording is confusing. Starting to think about them deeper, many questions appear, for example: "no more than +25 ° С?", And then how much will be "no less" ?; "Dry place", and when is it "wet"?; “Cool place”, isn't it “cold” ?; "Protected from light place" - is it probably dark? This is not only a domestic problem. Abroad similar phrases: “ Do not store above 25° FROM" or " Store below 25° With in a dry place", Sometimes added" "And (or)" Protect from light”, Although often there is no information about storage conditions at all.

They are widely used, found everywhere, but many are mistaken with them. There are no well-structured guidelines for interpreting storage conditions. Therefore, the subjects of the circulation market continue to wait for detailed explanations from the regulatory authorities, and the latter lives with the idea that everything is obvious and understandable from.

The very idea for this article is for understanding. This is an attempt to activate the process of public discussion by all used formulations of storage conditions for medicinal products (API and FPP). This is important, if only because the violation of storage conditions, due to their misunderstanding, is a known reason for the majority of drugs withdrawn from the market.

Storage temperature

Let's start simple. All storage temperatures are clearly standardized. This has always been important to ensure the uniformity of requirements for warehouse and transport infrastructure, to maintain product quality at all stages of its logistics chain, regardless of the geography of supply. Since 1970, only three temperature ranges for the storage of thermolabile products have been internationally agreed, including:

  • room temperature (+20 ° С),
  • refrigerator (+5 ° C) and
  • freezer (-20 ° С).

Permissible intervals and recommendations for the formulation of the temperature storage regime are presented in Table 1. Often these modes alone are not enough, it is necessary to take into account the characteristics of dosage forms, packaging materials, regional standards, climate and even frequent weather changes. This led to the introduction of additional modes at the local level. For medicines, these are:

  • -5 to -18 ° C;
  • Not higher than +8 ° С;
  • Not lower than +8 ° С;
  • Not higher than +15 ° С;
  • From +15 to +25 ° С and
  • Not higher than +30 ° С.

Each of them is a special case of one of the three main temperature regimes indicated in the table. So, storage conditions from -5 to -18° FROMthis is a special case for storage in a freezer. If the standards of the USSR, and subsequently the standards of the CIS countries, assume storage in a freezer mainly in the range of -18-24 ° C, then Western countries (EU, USA) approach this issue from the standpoint of energy efficiency. At the same time, do not forget that the Soviet standards also provided for similar modes of low-temperature storage (-6; -12; -18 ° С)

Storage conditions at a temperature not higher than +8 ° FROM - this is the same basic mode of storage in a refrigerator (+ 2 ... + 8 ° С), only not so hard minimum temperature and typical for products that are not afraid of possible freezing (sub-zero temperatures). Storage at a temperature not lower than +8 ° FROM on the contrary, it assumes that cooling of the product is not allowed, which means that it cannot be placed in an ordinary household refrigerator. Sometimes these conditions are confused with the storage mode + 8 + 15 ° С (cool place). This is not true. Whenever a one-sided spacing is declared, the emphasis is on the specified value. So, storage at a temperature not lower than +8 ° С is a special case of storage at room temperature (from +8 to +25 ° С). And here is the condition “ ° FROM ", Is a special case of storing products (mainly substances, intermediate products) in a refrigerator, when storage in it is a priority, but not so severe temperature conditions are allowed at the stages of circulation (for example, refrigerators of ST, T class). This mode is interpreted as storage at a temperature of + 2 + 15 ° C.

The well-known mode " Store at temperatures from +15 to +25 ° FROM »- a special case of storage at room temperature, but is used exclusively in a professional environment to maintain the parameters of the ventilation and air conditioning system in the warehouse area. For the consumer, such a phrase cannot be acceptable due to the lack of temperature control on his part within the specified range.

The declared regime " Store at a temperature not exceeding +30 ° FROM »Also a special case of storage at room temperature, extending its range up to +30 ° С only for end users living in climatic zones III and (or) IV (A, B). For subjects of the market for the circulation of medicines, such conditions on the packaging still always mean storage in a controlled range of + 15 + 25 ° С.

Room temperature

Two of the three main modes, freezer and refrigerator, are artificially supported systems, and the issues of their functioning do not cause much debate among specialists. However, the third regime - room temperature - requires a more careful approach due to the high natural variability.

Two decades ago, the simple phrase “ Store at room temperature ". However, at the stage of harmonization of requirements for medicines within the ICH ( abbreviation for English. International Conference on Harmonization of Technical Requirement for registration of pharmaceuticals for human use)(since 1991) this term had to be abandoned, replacing it with “ Store at a temperature not exceeding +25 ° FROM ". This is due to differences in the ICH regions, in each of which the official interpretation of room temperature suggests different ranges. For example, in the United States, the room temperature is between +15 and +30 ° C, in european countries from +15 to +25 ° С, and in Japan generally from +1 to +30 ° С.

After the ICH Q1 documents have been updated, it is customary to consider the temperature range from +2 to +25 ° С for countries of the world located in climatic zones I and II, or the interval from +2 to +30 ° С for countries from III, IVA and IVB at room temperature climatic zones respectively. Distribution of countries by climatic zones suggested in guidelines The World Organization health care.

Where to look for a cool place?

Until now, storage conditions " in a cool place " declared for the storage of medicinal products. Domestic specialists are familiar with these conditions, with a range of + 8 + 15 ° C from tinctures, for which the XI ed. storage conditions in a cool place were declared. Again, it cannot be said that this is a unique domestic practice. Similar storage conditions are declared in the United States and Great Britain, where the phrase “ Store in cool, dry place».

The problem is different. There are differences between our countries in the perception of this temperature range. For example, the European Pharmacopoeia does not provide such conditions for commercial medicines. The term "cool place" itself is present, but with the proviso that its use is applicable when describing analytical methods in pharmacopoeial monographs. There are no such storage conditions in the ICH Q1 guidelines, which establish the rules for studying the stability of all drugs in one of three standardized regimens (see table). But the USA (USP-NF) does not exclude them. Pharmacopoeial monograph " General requirements and remarks "USP interprets" a cool place "as" a place with a temperature of +8 to +15 ° C "and the caveat that" the drug for which such storage is intended can also be stored in the refrigerator, unless otherwise specified in the private monograph " ... A similar interpretation is suggested in the WHO guidelines as “ Store at a temperature not exceeding +15° FROM"(From +2 to +15 ° C) and in the new Russian pharmacopoeia GF XIII ed. ... But these conditions are not exactly the same (see above). It turns out that in international practice, unlike Soviet standards, storage in a cool place is considered as a special case, such a kind of intermediate mode between the refrigerator (from +2 to +8 ° C) and room temperature (from +2 to +25 ° C), assuming storage in the range from +2 to +15 ° С. And only the declared conditions " Store at a temperature not exceeding +15 ° C, avoid cooling "Will correspond to the usual mode of + 8 + 15 ° С.

Storage conditions in a cool place are more typical for substances and intermediates in work in progress, reagents and samples in analytical tests. This is beneficial for the suppliers of substances, since the product can be permanently stored in a stationary refrigerator and transported under less severe conditions of an insulated body. This is necessary to clarify the conditions for handling reagents in the analytical laboratory. But this is inconvenient for the finished product. Here, this mode rather causes problems at the end of the distribution chain. For example, when selling in a pharmacy, it is necessary to constantly explain to the patient that the drug should be stored in the refrigerator or at room temperature, but away from sources of heat radiation - this can be a cabinet in the kitchen, away from a gas or electric stove, and a wardrobe in the living room, which located away from windows and fireplace, and even a bedside table in the hallway ... wherever there are no sources of heat radiation.

How to find yourself a problem?

The choice of storage temperature for a medicinal product is always carried out at the stage of its development and depends on many factors, not least commercial ones, for example: the appointment of the shelf life, logistics costs, special handling conditions, etc. The choice of one of the three main storage modes, provides the same understanding of its temperature range for all subjects of the drug distribution chain, from the distributor to pharmacies and the patient. Declaration of any other conditions may provoke their unintentional violation due to ignorance or misunderstanding, lack of technical capabilities. It may happen that distributors and (or) pharmacies do not have an equipped area for non-standard storage, which means that this will either automatically require the cost of its creation and subsequent maintenance, or will increase the risk of improper storage of the drug in standard areas. For example, until now, some domestic production have a storage mode at a temperature of + 18 + 20 ° C. These are drugs of "retirement age", the standardization of which was carried out back in the days of the USSR according to the GF IX - XI ed., When "room temperature meant storage at + 18 + 20 ° C", and the manufacturers still have not updated their registration dossier. I am sure that all of us are interested in seeing how entities that still have licenses for wholesale and retail trade ensure compliance with the stated conditions in a very narrow range of up to 2 ° C.

You never have to look for a problem. It is enough: 1) to think a little, 2) to investigate stability simultaneously in adjacent (standardized) temperature regimes, and 3) to choose the main regime or, at worst, its particular case, which provides beneficial competitive advantages. The regulator must also: 1) think about all actors (manufacturers, distributors, pharmacies and patients); 2) do not allow registration with non-standard storage regimes, and upon approval of a particular case 3) obtain convincing evidence of its necessity, the absence of an alternative, and 4) include explanations in the instructions for medical use and (or) the package insert.

The temperature is not the most a big problem in the interpretation of the declared storage conditions of medicines. Where more interesting story about protected from lightand dry place.

Protected from light place

Often, those produced for the market of post-Soviet countries contain the phrase “ Store in a dark place ».

Based on the definition provided in the Pharmacopoeias, “if the product documentation specifies storage conditions in a“ dark place ”, this always means that measures should be taken to prevent ingestion direct sunlight , any other bright light , and ultraviolet rays , for example, by using dishes made of special glass or other opaque material, working in a darkened room, and even using furniture painted from the inside black, etc. "

This phrase does not have a clear explanation from the domestic regulatory authorities. And it is she who has been exciting all pharmacists for several decades. Firstly, it is not clear what she refers to, Secondly it is not clear what we are afraid of... For example, what does the phrase “Store in a dark place” on the package (secondary packaging) of the medicinal product refer to? Maybe it belongs to the package itself, which contains the container with the drug? Either to the container itself (primary packaging), or directly to the dosage form itself?

Such ridiculous questions, and the answer is obvious, but until now in the acts of inspection of pharmacies, inspectors from regulatory bodies of different subordination record violations of the type: “At the time of the inspection, it was revealed that drugs were secondary consumer packaging which is indicated "Store in a dark place" were in a refrigerator with glass doors from direct access of artificial lighting", Beautifully accompanied by a subsequent order to eliminate the violation," by gluing the refrigerator door with an opaque film. " In the opinion of the inspectors, “to display on showcases and on shelves in the sales area, including refrigerators with glass doors, is only possible empty secondary packaging, and drugs in primary packaging must be removed from them and stored in a closed cabinet, painted on the inside with black paint". - It is written on the package! Read on!

Here the next question arises: “Why? What are we afraid of? " Indeed, light can affect the structure of substances, cause changes in them, provoke decomposition and deterioration of other critical characteristics. But, excuse me! This may be relevant for substances, while the drug is already in a protective package and, obviously, the influence of light is exaggerated here.

Look at the world (USP, Eur.Ph.), look at the WHO and ICH guidelines. Everywhere the following rule is stated: “ photosensitive medicines must be packed in light-protective consumer packaging and ( or ) should be stored in a dark place. " Responsibility for protecting a medicinal product from light is always assigned to the owner of the registration dossier. It is he who must choose an acceptable method of protection: either by selecting a dosage form (for example, coating tablets with a shell, filling into hard capsules), or by packaging the drug in a light-proof primary package (for example, aluminum tubes, foil, dark glass vials, etc.) and ( or) protective secondary packaging. And then the phrase "Store in a place protected from light" on the drug packaging becomes essentially useless for the participants in the drug distribution chain, including the patient.

It is also useful to recall the request of Novartis Consumer Health Switzerland to russian market... In December 2003, at her request, the Institute for Medicinal Products Standardization, Moscow, at that time considered a specialized expert organization, provided the following clarifications (out. No. 1650 dated December 15, 2003): “Packaging of the drug in such primary packaging as vials dark glass, aluminum tube, disposable sachets made of a combined material polyethylene / aluminum foil / polyethylene / paper, an opaque plastic bottle made of low density polyethylene, an opaque plastic tube with their subsequent insertion into secondary consumer packaging (box or cardboard box) allows to provide storage conditions for the drug "In a dark place" with natural and artificial lighting in a pharmacy. "

This response is identical to the interpretation of foreign regulatory authorities, which recognize the placement of the dosage form inside the primary and / or secondary packaging as a “light protected place”. And only in exceptional cases, when such protection is impossible without losing the quality of the dosage form, it is necessary to choose the least evil and use the warning inscription in the labeling of the medicinal product “ Store in the original package"And (or)" Protect from light».

Returning to the question "What are we afraid of?" there is another answer. Direct sunlight, especially falling vertically (not tangentially) or a high-power artificial light source located in the immediate vicinity of the drug, is not only able to penetrate into the container (it seems to be sorted out with this), but will also heat the consumer, group and even transport packaging and its contents, thereby provoking aging of the drug, negatively affecting its safety and effectiveness.

Therefore, the phrase "in the dark place" remains necessary for the text regulatory documents, establishing the requirements and rules for the acceptance, storage, shipment and transportation of medicines. This means that a prolonged exposure of the drug (regardless of the type of its packaging) to the sun, including near windows in a warehouse or in areas of acceptance and (or) shipment, as well as near other light sources generating strong thermal radiation, must not be allowed.

And all would be fine, only this is not the last problem with the storage of medicines. There is also a "dry place" - perhaps the most mysterious place on the labeling of drugs.

Bibliography:

  1. WHO guide to good storage practices for pharmaceuticals. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-seventh report. Geneva, World Health Organization, 2003, Annex 9 (WHO Technical Report Series, No. 908)
  2. ICH Q1A (R2) Guideline Stability Testing of New Drug Substances and Products, 2003.
  3. Stability testing of active pharmaceutical ingredients and finished pharmaceutical products, Annex 2, WHO Technical Report Series, No. 953, 2009
  4. GF XIII State Pharmacopoeia of the Russian Federation, pp. 208-216, 2015
  5. United States Pharmacopoeia (USP-NF)
  6. GF XII, p. 212-213 (OFS 1.1.0010.15).
  7. Instructions for organizing storage in pharmacies of various groups of medicines and medical products, approved by Order of the Ministry of Health of the Russian Federation dated November 13, 1996, No. 377.
  8. Rules for the storage and transportation of medicines, medical devices and medical equipment in conditions that ensure the preservation of their safety, effectiveness and quality, approved. By the Decree of the Government of the Republic of Kazakhstan dated 23.12. 2011 No. 1595
  9. Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products, Annex 9, WHO Technical Report Series, No.961, 2011.
  10. Stability testing: Photostability testing of new drug substances and products, ICH Q1B, 1996
  11. GOST 16317-87 Refrigerating devices. Electric household. General technical conditions.

Many people are constantly taking various medications. But "chemistry" is a capricious thing: as soon as the storage conditions of the preparation (temperature, humidity) change, an undesirable reaction occurs immediately. Its consequences can be different - some drugs lose their properties, and some can be poisoned

Heat is a risk factor for medications in summer. The director of the Department of State Regulation of Wholesale and Retail Trade of Medicines spoke about the rules for storing medicines in the hot season Public service Ukraine on Medicines Alexander Krapivny.

When the medicine turns into a dummy

We are used to keeping medicines in the medicine cabinet at room temperature. But not everyone knows that in the summer heat, many drugs must be placed in the refrigerator. Indeed, under the influence of high temperatures, drugs can change their properties.

- First of all, this concerns hormonal preparations, antibiotics and drugs made on the basis of bacterial cultures (vaccines, serum). Sometimes it takes very little time for a drug of this type to irreversibly change its action. For example, if the insulin ampoules are at an elevated temperature for more than an hour, then the medicine will not help in a month, and the first remedy for heart attacks, nitroglycerin, will lose its qualities in a day. For people with cardiovascular disease and patients diabetes mellitus such negligence can cost life. Therefore, the expiration date indicated on the packaging of medicines will be true only if the correct temperature regime is observed during storage, - warns Alexander Krapivny.

It is also necessary to remember that drugs are destroyed even faster under the influence of sunlight. Therefore, if in the heat you forgot the medicine on the windowsill (this is especially true for those drugs that are produced in transparent packaging), then after an hour you can throw it away.

- Most medicines are stored at room temperature from 15 to 25 degrees Celsius. There are drugs that can safely “survive” the 30-degree heat. Therefore, carefully read the instructions for the storage conditions. If the packaging of the medicinal product reads: " Store in a cool, dark place" or "in a cool and dry place", then this means that the medicine must be stored at a temperature not exceeding 15 ° C, in other words, it must be placed in the refrigerator (preferably on the lower side shelf). There should also be medicines, which should be kept at a temperature not higher than 5 ° C. But before putting the medicine in the refrigerator, it should be packed in a plastic bag to protect it from excessive moisture, advises Alexander Krapivny.

Also, do not store medicines in a broken or damaged primary packaging. For example, some people save half a pill, it is better to throw such drugs away. Medicines in vials are kept tightly sealed, since when opened, some medicines can evaporate, absorb and release volatile substances or react with atmospheric oxygen.

Check your first aid kit

Now is the time to revise your medicine cabinet. Throw away medications that have passed the expiration date without regret. And if the first-aid kit has been in the heat for several days (at temperatures above 25 ° C), you should part with the drugs that are afraid of high temperatures. First of all, these are vaccines, hormones. Ampoules in which sediment has appeared and tablets that have changed color should also go to the trash can. Medicines that are stored at temperatures up to 25 ° C must be refrigerated. Without fear of the consequences in the first-aid kit, you can leave only brilliant green, iodine, bandage and cotton wool.