Storage of certain groups of medicines. Features of storage of finished medicines

Rules for the storage of medicines within the framework of order 706n

The storage of medicines is regulated by the order of the Ministry of Health and Social Development of the Russian Federation of August 23, 2010 N 706n "On Approval of the Rules for the Storage of Medicines".

Order 706n provides a classification of drugs that require protection from external factors - moisture, light, temperature, and so on. The following groups of medicines are distinguished, each of which has its own storage rules:

1. medicines that require protection from exposure to a humid environment and light;

The room for such drugs should be inaccessible to light and well ventilated, the air in the room should be dry, the permissible humidity should be up to 65%. This group includes, for example, silver nitrate, iodine (react to light) and hygroscopic substances (react to moisture).

1. medicines that, if stored improperly, can dry out and volatilize;

This group includes alcohols, ammonia, ethers and formaldehydes. Preparations of this group require a certain temperature regime - from 8 to 15 ° C.

1. drugs that require a special temperature regime;

Drugs exposed to high or low temperatures are stored strictly in accordance with the recommended temperatures indicated by the manufacturer on the primary or secondary packaging of medicines. Adrenaline, novocaine, antibiotics, hormonal drugs (react to temperatures above 25 ° C) and insulin solution, formaldehydes (react to low temperatures) require a special temperature regime.

1. medicines that are affected by gases contained in the environment.

This group includes organ preparations, morphine and so on. The packaging of drugs should not be damaged, the room should not have intense lighting and extraneous odors. The recommended temperature regime is observed - from 15 to 25 ° С.

Where to store medicines?

Medicines are placed in specially designated places - cabinets, open shelves and refrigerators. If drugs are narcotic or are subject to quantitative accounting, the cabinet in which they are placed is sealed to restrict access to it.

Storage rooms for medicines should have opening windows, refrigerators and air conditioners to ensure the right temperature. A thermometer and a hygrometer are installed to determine the temperature and humidity level in the room where the preparations are stored. These appliances are located away from radiators and windows.

How to decipher the terms of storage of medicines?

The conditions for storing medicines are described on the packaging or shipping container, in the instructions for use. Information about the storage conditions of medicines is also placed on the shipping container in the form of handling and warning signs - "Do not throw", "Protect from sunlight" and the like.

Sometimes it is difficult for health workers to decipher the storage conditions of medicines indicated on the packages. For example, the manufacturer indicated that the medicine should be stored at room temperature or in a cool place. What is room temperature? Cool - how many degrees Celsius?

The State Pharmacopoeia of the Russian Federation gave a breakdown of the recommended storage conditions for medicines:

• 2 - 8 °C - providing a cold place (storage in the refrigerator);
• 8 - 15 °С - cool conditions;
• 15 - 25 °C - room temperature.

Storage in a freezer provides for a temperature regime of medicines from -5 to -18 ° C, storage in deep freezing conditions - a temperature regime below -18 ° C.

Medicines with special storage conditions

Special storage conditions for medicines are observed for the following medicines:

• Explosive and flammable.
• Psychotropic and narcotic drugs.

Explosive medicines must not be shaken or hit when moving. They are stored away from radiators and daylight.

Requirements for the storage of narcotic drugs are specified in the Federal Law "On Narcotic Drugs and Psychotropic Substances". Premises for the storage of such drugs are equipped with additional security measures in accordance with the order of the Ministry of Internal Affairs and the Federal Drug Control Service of the Russian Federation No. 855/370 of September 11, 2012 and the order of the Ministry of Health of the Russian Federation No. 484n of July 24, 2015. The essence of the regulatory requirements is that the premises where psychotropic and narcotic drugs are stored must be additionally strengthened. Medicines are stored in metal cabinets and safes that are subject to sealing. Similar rules have been established for medicines subject to subject-quantitative accounting.

How to control the storage of medicines?

A nurse monitors compliance with the rules for storing medicines. This is stated in the order of the Ministry of Health of the Russian Federation dated July 23, 2010 No. 541n. Nurses on duty and senior nurses once per shift record the temperature and humidity parameters in the rooms where medicines are stored, identify medicines on the shelf card, and keep records of medicines with a limited shelf life. Expired medicines are placed in a quarantine area and stored separately from other medicines, and then they are transferred for disposal.

According to article 14.43 of the Code of Administrative Offenses of the Russian Federation, violation of the requirements for the storage of medicines entails the imposition of an administrative fine:

• for citizens - from 1,000 to 2,000 thousand rubles;
• for officials - from 10,000 to 20,000 thousand rubles;
• for legal entities - from 100,000 to 300,000 thousand rubles.

-Roszdravnadzor reported on law enforcement practice for the second quarter of 2017,- comments medical lawyer Alexei Panov. - About a thousand inspections of compliance with the rules for storing medicines were carried out, in 528 cases violations were committed. Administrative fines imposed on 26 million rubles.

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The organization of storage of drugs should ensure separate storage of drugs grouped according to the following classification criteria: toxicological group, pharmacological group,

Classification features of drug groups for separate storage

type of application, state of aggregation, physical and chemical properties, expiration date, dosage form.

So, depending on the toxicological group, drugs related to:

List A (poisonous and narcotic substances);

List B (strong);

General list.

Lists A and B are lists of drugs approved for medical use by the State Pharmacological Committee, registered by the Ministry of Health of the Russian Federation and requiring special security and control measures during the storage, manufacture and use of these drugs due to high pharmacological and toxicological risks.

Taking into account the pharmacological group, for example, vitamins, antibiotics, cardiac, sulfa drugs, etc. should be stored separately.

The sign "type of application" determines the separate storage of drugs for external and internal use.

Medicinal substances "angro" are stored taking into account their state of aggregation: liquid, loose, gaseous, etc.

In accordance with the physico-chemical properties and the influence of various environmental factors, drug groups are distinguished:

Requiring protection from light;

From exposure to moisture;

From volatilization and drying;

From exposure to elevated temperature;

From exposure to low temperatures;

From exposure to gases contained in the environment;

odorous and coloring;

Disinfectants.

When organizing separate storage of medicines, it is also necessary to take into account the expiration date, especially if it is relatively short, for example, 6 months, 1 year, 3 years.

An important feature that should be taken into account when storing separately is the type of dosage form: solid, liquid, soft, gaseous, etc.

Have nearby drugs that are consonant in name;

Place nearby drugs for internal use, which have very different higher single doses, and also arrange them in alphabetical order.

Failure to comply with the rules for separate storage of drugs described above can lead not only to deterioration or loss of consumer properties of the drug, but also to the mistake of pharmaceutical personnel when dispensing a high-quality, but wrong drug and, as a result, to a threat to the life or health of the patient.

During storage, complete visual control of the state of the container, external changes in drugs and medical devices is carried out at least once a month. In the event of a change in drugs, their quality control should be carried out in accordance with the NTD and GF.

Currently, medical institutions and pharmacies that deal with a variety of medicines are guided by the Order of the Ministry of Health of the Russian Federation No. The article lists the main points regarding the storage conditions of medicines. In addition, the issue of control over the execution of the storage order, as well as types of violations, is touched upon.

Rules for the storage of medicines

The rules for the storage of medicines require the standardization of premises that must meet certain requirements:

• to maintain a certain temperature and constant air exchange, it is necessary to have an air conditioner, refrigeration units, air vents, ventilation, as well as certified devices that record temperature and humidity (it is recommended to place such devices at a distance of three meters from doors, windows and heating systems)
• in the room where medicines are stored, it is necessary to regularly carry out wet cleaning, so the walls and ceilings must be even.

Medicines differ in their properties and the likely threat to others, therefore, Order No. 706n has developed its own storage rules for each group of medicines. According to the Order, the following groups are distinguished:

Medications exposed to temperature

A change in temperature can affect the nature of the properties of medicinal products, therefore, it is necessary to strictly follow the recommendations indicated on the packaging of the drug regarding its observance in accordance with the rules for storing medicinal products. So, plus indicators are usually limited to 25 degrees, at this temperature drugs can be stored in solutions (adrenaline, novocaine).

At low temperatures, some medicines - essential and oily solutions, insulin - lose their medicinal properties. The temperature regimes of storage were discussed in detail in the State Pharmacopoeia of the Russian Federation.

Drugs sensitive to light and moisture

It is possible to prevent the effects of exposure to daylight or artificial lighting on medicines if, in accordance with the rules for storing medicines, they are kept in containers made of light-protective materials in dark places. In addition, for preparations that are especially sensitive to light (prozerin, silver nitrate), additional protective equipment is provided - black opaque paper, which is pasted over the container, and thick blinds or stickers are hung in the room itself that block or reflect light.

In order for the effect of moisture not to affect the quality of medicines, it is necessary to strictly monitor the level of humidity in the room (within 65%). Storage of drugs in a cool room in a hermetically sealed container creates the conditions for preserving their medicinal qualities.

Drugs susceptible to environmental gases

The list of drugs that react with gases from the environment is quite extensive (sodium barbital, hexenal, magnesium peroxide, morphine, aminophylline and many other compounds). Such preparations should be stored at a temperature of +15 to +25°C in hermetically sealed containers.

Preparations subject to drying and evaporation

This group includes drugs with volatile properties: alcohols, essential oils, ammonia solutions, formaldehydes, crystalline hydrates, etc. They should be stored in glass, metal or aluminum containers, impervious to volatile substances. Proper storage conditions for such medicines, including temperature, can always be found on the manufacturer's packaging.

Storage conditions for other medicines

• with a limited shelf life. In medical institutions, it is necessary to record the availability of drugs with a limited shelf life and carefully monitor the timing of their implementation; for this purpose, a log of the expiration dates of medicines is kept. When providing medical services, you should first of all choose those medicines whose expiration date ends earlier. According to the terms of storage of expired medicines, they are kept separately from other medicines in a specially designated area (marked shelf or safe).
• requiring subject-quantitative accounting. For medicinal products containing narcotic, poisonous and potent components, the law provides for more stringent storage conditions, which must be strictly observed. They can be kept in one isolated room, equipped with engineering and technical security equipment. These funds are stored in metal cabinets that have the appropriate inscriptions, are locked and are sealed daily at the end of the day. Such medicines are certainly subject to subject-quantitative accounting, which implies the maintenance of documentation, which records the intake of medicines and their further movement.
• flammable and explosive preparations. The content of such medicines should be monitored with particular care, since irresponsible storage of them can cause a fire and harm the health of healthcare workers and patients. These include preparations containing alcohol, turpentine, glycerin and other flammable substances. Storage conditions for such medicines require places that are isolated and equipped with an automatic fire alarm system. Contain such medicines in glass or metal containers away from heat sources. They cannot adjoin dressings due to their flammable properties, mineral acids, compressed gases, inorganic salts and alkalis. Preparations containing ether also belong to the group of flammable substances, they should be stored in cool, dark places, away from open flames. Potassium permanganate, in combination with some substances (ethers, alcohol, sulfur) that acquires explosive properties, must be stored at room temperature and protected from moisture and bright light. The solution of the substance must be kept in tightly sealed containers for five years. The shelf life of the powder is not limited.

How to ensure the storage of medicines in a medical institution

Compliance with the rules for storing medicines in medical institutions should be monitored by the head nurse or nurse on duty, performing the following actions:

• fixing temperature indicators and air humidity in storage facilities (once per shift);
• checking the compliance of the names of funds with the specified groups;
• checking the release date of drugs in order to prevent the use of expired products. The head sister controls the movement of unusable items to the quarantine zone and their subsequent disposal.

Pharmaceutical packaging does not always contain information about the specific storage temperature of medicines in medical institutions - manufacturers often limit themselves to the words “in a cool place” or “at room temperature”. In order to avoid difficulties with the correct reading and subsequent violations, the State Pharmacopoeia of the Russian Federation established temperature limits that correspond to these recommendations. According to them, cold conditions are a temperature of 2 - 8 ° C, cool conditions are considered a temperature of 8 - 15 ° C, "room" means a temperature regime of 15 - 25 ° C (sometimes up to 30 ° C).

Non-compliance with the order of storage of medicines

Violations in the storage of medicines identified during control activities may result in various administrative penalties. Institutions conducting medical activities should not ignore the well-known rule: the order of storage of medicines requires keeping them in different places - this requirement is not observed quite often. Among the most common violations are also those related to the absence or malfunction of thermometers and hygrometers and non-compliance with expiration dates: expired drugs are not transferred to a special area or the organization forgets to record the expiration dates of medicines.

In order to avoid claims from regulatory authorities, it is necessary to take into account the information on the storage of medicines indicated on the packaging of drugs, and ensure the appropriate climatic regime. In summer, for example, the temperature can exceed 30°C, so you should pay attention even to those medicines that do not require storage in refrigerators.

The device, composition, size of areas and equipment of storage facilities for pharmacy warehouses and pharmacies must meet all the requirements of the current regulatory and technical documentation (SNiP, guidelines, regulatory internal documentation, etc.).

2. The device, operation and equipment of storage facilities should ensure the safety of medicines and medical products.

3. Storage rooms in accordance with established standards are provided with security and fire fighting equipment.

4. Storage rooms must maintain a certain temperature and humidity, the frequency of which must be checked at least once a day. To monitor these parameters, warehouses must be provided with thermometers and hygrometers, which are fixed on the internal walls of the storage away from heating devices at a height of 1.5 - 1.7 m from the floor and at a distance of at least 3 m from the doors.

Each department should have a record of temperature and relative humidity.

5. In order to maintain clean air, storage rooms in accordance with the current regulatory and technical documentation (SNiP, guidelines, etc.) should be equipped with mechanically driven supply and exhaust ventilation. If it is not possible to equip storage rooms with supply and exhaust ventilation, it is recommended to equip window vents, transoms, second lattice doors, etc.

6. Pharmacy warehouses and pharmacies are equipped with central heating devices. It is not allowed to heat the premises with gas appliances with an open flame or electric heaters with an open electric coil.

7. In warehouses and pharmacies located in a climatic zone with large deviations from the permissible norms of temperature and relative humidity, storage rooms must be equipped with air conditioners.

8. Storage rooms must be provided with the necessary number of racks, cabinets, pallets, storage boxes, etc.

The racks are installed in such a way that they are at a distance of 0.6 - 0.7 m from the outer walls, at least 0.5 m from the ceiling, and at least 0.25 m from the floor. The racks in relation to the windows should be located so that the aisles are illuminated, and the distance between the racks is at least 0.75 m, providing free access to the goods.

9. The premises of pharmacy warehouses and pharmacies must be kept clean; the floors of the premises should be periodically (but at least once a day) cleaned with a wet method using approved detergents.

Employees of pharmacy organizations often have questions regarding the display of medicines and other pharmacy products on display cases. Many of these questions relate to the rules for storing dietary supplements in a pharmacy. “Explain whether it is possible to put dietary supplements along with medicines on the same shelf?” - such a laconic letter from a pharmacist from Bryansk was found in the editorial mail of Katren-Style. It would seem, well, what could be super complicated in ordering shop windows. However, the problem is that this topic is not properly regulated.

After March 2, 2014, the Industry Standard “Rules for the dispensing (sale) of medicines in pharmacies became invalid. Basic Provisions (Order of the Ministry of Health of the Russian Federation No. 80 of 03/04/2003) ”, which contained very vague, but at least some regulation of display placement - on this topic, if not a vacuum, then a very rarefied space has formed in the legislation. As a result, pharmacy workers do not have clear rules from the regulator on how to lay it out correctly, and inspectors, on the contrary, have the opportunity to pardon or punish at their discretion. And yet we will try to highlight this topic.

Showcase is also storage

Any product accepted by a pharmacy can have only two states - it is either stored or released. And the presence of a package on a pharmacy showcase - be it an over-the-counter drug or dietary supplement - is one of the storage options, during which consumers are informed about this product, its availability in a pharmacy, price, dosage, dosage form, etc. Maybe it is therefore, regulators do not consider it necessary or urgent to separately regulate the display case issue - after all, the topic of storage is regulated in the relevant regulatory legal act.

It means Order of the Ministry of Health and Social Development of the Russian Federation of August 23, 2010 No. 706n "On Approval of the Rules for the Storage of Medicines". As for "Instructions for the organization of storage in pharmacies of various groups of medicines and medical products" (Order of the Ministry of Health of the Russian Federation of November 13, 1996 No. 377), then most of its articles are no longer valid. Only its norms apply to medical devices and medical equipment, dressings and auxiliary material, plastic and rubber products.

In Order No. 706n, even the words “showcase” and “layout” are absent. But, probably, there is not a single pharmacy or pharmacy point, in which part of the medicinal products would not be stored in the pre-showcase and showcase part of the pharmacy hall. In this way, Rules for the storage of medicines Order No. 706n naturally applies to the pharmacy hall.

What follows from Order No. 706n

Pay attention to the name of the order - it really concerns almost exclusively medicines. Clause 8 of section III of the order determines that they are placed in storage rooms - we have already mentioned above that these are also pre-showcase and showcase parts of pharmacy halls - taking into account:

• pharmacological groups;
• physical and chemical properties;
• method of application (internal, external);
• aggregate state of pharmaceutical substances (liquid, bulk, gaseous);

and also in accordance with the requirements of the regulatory and technical documentation indicated on the packaging of the medicinal product.

Order No. 706n does not contain any separate instructions on how to store dietary supplements, medical devices, personal hygiene products, mineral water, cosmetics, etc. in a pharmacy - including on a display case. They are not in "Hygienic requirements for the organization of production and circulation of biologically active food additives" (SanPiN 2.3.2. 1290–03). Therefore, from a formal point of view, some interpret this in such a way that dietary supplements can be placed with drugs “of the same direction” on the same display shelf.

However, this conclusion seems doubtful. Firstly, dietary supplements, in fact, cannot be “of the same direction” with drugs, because they are not drugs (the impact on the same body systems does not mean anything yet).

Secondly, “orientation” does not mean belonging to one pharmacological group, which, by the way, cannot contain both drugs and non-drugs, that is, dietary supplements. And since in Order No. 706n and in the above paragraph it is about streamlining the storage of exactly medicines and precisely by pharmacological groups, it is obvious that in none of the places of storage - including in the window - medicines can not be placed together with dietary supplements .

In order not to be misled

There is also another side of the topic. We should not forget about Article 10 of the Law "On the Protection of Consumer Rights" (dated 07.02.1992 No. 2300-1), which prescribes that customers be provided with the necessary and reliable information about goods, enabling them to make the right choice.

Imagine, a consumer approaches a showcase where not only medicines of the same pharmacological group are placed, but also dietary supplements “of the same direction”. The phrase "It is not a medicine", of course, according to clause 4.4 of SanPiN 2.3.2. 1290-03, is present on the packaging of dietary supplements, but, as a rule, it is printed in small print, and is not striking from afar.

Therefore, looking at a shop window, it is easy to miss such a phrase, to miss it. In addition, when laying out, it may be on the side of the package that is not accessible to the eye. As a result, the buyer may automatically assume that this product, as well as the drugs located around it, is a medicine, although, we emphasize, this can hardly be called a deliberate misleading by the pharmacy. However, the consumer may decide to purchase this particular name, believing it to be medicinal. And only at home, looking at the packaging or instructions, will find that it is not.

Thus, the joint display of medicines and dietary supplements on the same display shelf creates the risk of unconscious misinformation of the consumer, violation of his rights, defined by Article 10 of the Law "On Protection of Consumer Rights". And so it should also be avoided.

The conclusions are as follows. Medicines and any dietary supplements are not recommended to be laid out on the same display shelf. For the storage of dietary supplements in a pharmacy, it is better to provide separate display spaces, which should be accompanied by the inscription "Biologically active food supplements." On the ordering of various dietary supplements within the framework of such a showcase SanPiN 2.3.2. 1290–03 reports nothing. It only contains an indication that dietary supplements should be stored taking into account their physical and chemical properties, under the conditions specified by the manufacturer, observing the regimes of temperature, humidity and illumination.