706 order for the storage of medicinal products. General rules for the storage of medicinal substances. Storage of finished medicinal products

An important role in the provision of high-quality and effective medical care is played by the proper storage of medicines in health facilities. In a medical organization, stocks of drugs that provide a 5–10-day requirement are placed in offices and premises run by a senior (chief) nurse, and stocks of drugs that provide a daily requirement are located in departments and at nurses' posts. It is necessary to create the right conditions for the storage of medicines, taking into account their quantity and physico-chemical properties, as well as to ensure the safety from unwanted or illegal use of drugs, especially potent, poisonous and narcotic drugs, psychotropic substances and their precursors.

The main regulatory documents on the rules for the storage of medicines in the Russian Federation are:

§ Order of the Ministry of Health and Social Development of Russia dated August 23, 2009 No. 706n “On approval of the rules for the storage of medicines” (hereinafter - Order of the Ministry of Health and Social Development of Russia dated August 23, 2010 No. 706n);

§ Order of the Ministry of Health and Social Development of Russia dated May 16, 2011 No. 397n “On approval of special requirements for the storage conditions of narcotic drugs and psychotropic substances duly registered in the Russian Federation as medicines intended for medical use, in pharmacies, medical institutions, scientific -research, educational organizations and organizations of wholesale trade in medicines”;

§ Decree of the Government of the Russian Federation of December 31, 2009 No. 1148 “On the procedure for storing narcotic drugs, psychotropic substances and their precursors”.

To store medicines at the nurse's station, there are cabinets that must be locked with a key.

1. Medicines for external and internal use are stored at the nurse's station in a lockable cabinet on different shelves marked "For external use", "For internal use".

2. The nurse groups medicinal substances for internal use: in one cell of the cabinet she places drugs that lower blood pressure, in another - diuretics, in the third - antibiotics.

3. Strong-smelling medicines (Vishnevsky's liniment, Finalgon ointment) are stored separately so that the smell does not spread to other medicines. Flammable substances (alcohol, ether) are also stored separately.

4. Alcoholic tinctures and extracts are stored in bottles with tightly ground or well-screwed stoppers, as due to the evaporation of alcohol, they can become more concentrated over time and cause an overdose. The preparations are stored in a cool place at a temperature of + 8 to + 15 ° C in the primary and secondary (consumer) packaging of the manufacturer.

5. Drugs requiring protection from light (eg prozerin, silver nitrate) should be stored away from light. In order to avoid direct sunlight or other bright directional light, as well as ultraviolet rays, it is necessary to use a reflective film, blinds, visors, etc., on these drugs.

6. Perishable products (water infusions, decoctions, medicines, serums, vaccines, rectal suppositories) are stored in a refrigerator at a temperature of + 2 ... + 10 ° C. The shelf life of infusions, decoctions, mixtures in the refrigerator is no more than 2 days.

7. All sterile solutions in ampoules and vials are stored in the treatment room.

8. Separately, in technically fortified premises that meet the requirements of the Federal Law of January 8, 1998 No. 3-FZ “On Narcotic Drugs and Psychotropic Substances”, the following are stored:

§ narcotic and psychotropic drugs;

§ strong and poisonous medicines controlled in accordance with international legal norms.

9. The shelf life of sterile solutions made in a pharmacy for parchment rolling is three days, and for metal rolling - 30 days. If during this time they are not implemented, they should be returned to the head nurse.

10. Signs of unsuitability are:

ü in sterile solutions- change in color, transparency, the presence of flakes;

ü in infusions, decoctions- turbidity, discoloration, the appearance of an unpleasant odor;

ü at ointments- discoloration, delamination, rancid smell;

ü in powders, tablets- color change.

11. A nurse has no right:

ü change the form of medicines and their packaging;

ü the same medicines from different packages are combined into one;

ü replace and correct labels on medicines;

ü store medicinal substances without labels.

Premises or places of storage of medicines should be equipped with air conditioners, refrigerators, vents, transoms, second lattice doors - all this is necessary to create temperature conditions.

In the premises where medicines are stored, it is necessary to have devices for recording air parameters: thermometers, hygrometers, psychrometers. The nurse of the department during the work shift once a day should record the readings of these devices in a special journal in the places where medicines are stored.

At home, a separate place should be allocated for the storage of medicines, inaccessible to children and people with mental disorders. But at the same time, medicines that a person takes for pain in the heart or suffocation should be available at any time.

The rules for the storage of medicines in health facilities are currently regulated by the Ministry of Health of the Russian Federation.

Order 706n rules for the storage of medicines in their work are guided by pharmacy and medical organizations.

Consider the general rules for storing drugs and features.

Let's pay attention to the main violations of medical institutions in this area.

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Order 706n rules for the storage of medicines

The rules for the storage of medicines determine how medicines of different properties and potential dangers should be stored.

Medicines for medical purposes are divided into the following groups:

• LP affected by temperature (high or low). They should be stored in strict accordance with the recommended temperatures.

On the packaging of medicines, the manufacturer usually indicates which mode they recommend, as a rule, it is no more than +25 ° C. Such drugs are novocaine, adrenaline and other drugs in solutions.

Samples and special collections of standard procedures for nursing, which can be downloaded.

Oil and ether solutions, insulin, ammonia react to low temperatures.

The order regulating the storage of medicines should be strictly observed because such medicines, after being in low temperatures, completely change and lose their useful qualities.

• Preparations that can lose their properties under the influence of moisture and light.

Medicines in this group include, for example, silver nitrate and prozerin, which react to light, and mustard or gypsum, which lose their properties when exposed to moisture.

The storage of medicines that react to light should be given special attention. If necessary, rooms are equipped with thick blinds, stickers that reflect light and other devices that reduce the flow of light entering them.

Where to store drugs with a limited shelf life

The rules establish special requirements for expired medicines.

Their placement is allowed only in separately allocated (quarantine zones), so that they cannot mix with normal drugs. In practice, this is a marked separate shelf or a special safe.

In this regard, the expiration dates of drugs should be constantly monitored. By order of the head physician of the medical institution, the residual expiration date, which is considered limited, is approved. For example, these are the last 6 months of the expiration date.

In the order, such drugs are considered as medicines with a limited shelf life.



Storage of flammable and explosive medicines in accordance with Order No. 706n

Order 706n of the rules for the storage of medicines also establishes the features of the placement of explosive and flammable medicines.

Such products have an increased danger due to the content of glycerin, sulfur, alcohols and ethers, turpentine, etc. in their composition. In this regard, it is necessary to ensure their separate location from other medicines.

In addition, explosive preparations must not be placed near:

• medicines containing alkalis;
• gas cylinders;
• mineral acids;
• inorganic salts, which, in combination with organic preparations, can form a flammable mixture;
• dressing materials.

How to store potassium permanganate

Storage conditions for potassium permanganate in accordance with the rules must meet the following requirements:

How to store ether

To store medicines in a medicine containing ether, choose places that are away from heating elements and fire, the place must be protected from bright light. This is due to the fact that ether for anesthesia is flammable.

In order to ensure safe conditions for storing flammable medicines in medicines, including ether, it is recommended to place them separately from other medical devices, preferably in a specially designated room.

Storage of nitrogen and oxygen in cylinders

There are several important rules for saving nitrous oxide and oxygen in cylinders:

1. According to GOST 26460-85, cylinders are placed under a canopy on the territory of a medical institution or in separate warehouses to ensure their protection from the sun and moisture.
2. According to PPBO 07-91 dated 08/09/1990, oxygen cylinders are placed in fireproof cabinets located outside the medical facility at a distance of at least 4 meters from window and door openings.
3. If more than 10 40-liter oxygen cylinders are stored, they are placed in a separate room. Its walls should be made without windows, made of safe materials, the distance from other rooms should be at least 25 meters.
4. Warehouses intended for placing nitrogen cylinders must be equipped with ventilation, and the cylinders themselves should be placed at a safe distance from heating radiators (at a distance of at least 1 meter).
5. Explosive medicines are stored in fireproof safes outside the place of their permanent storage at the hospital. In addition, the premises must be equipped with fire alarms.

Rules and requirements for the storage of potent and poisonous drugs in order 706n

As follows from the rules for storing medicines in a medical facility, for potent and poisonous medicines, rooms are needed that have special security equipment. The mode of work with them is similar to the rules for storing drugs.

Thus, it is possible to store potent drugs in the same room as drugs. At the same time, potent and toxic substances must be stored either in different safes or on different shelves of metal cabinets.

Note that some drugs were excluded from the list of poisonous and potent, and transferred to the list of drugs. For example, these are Midazolam, Brotizolam, Lorazepam, Estazolam, Phenobarbital, etc.

Therefore, such medicinal products should be stored in accordance with the rules applicable to narcotic drugs and their precursors.

How to control retention rules

Compliance with the rules is controlled by the head nurse, as well as the sisters on duty of the departments.

For control purposes, they perform the following duties:

• once per shift, temperature and air parameters are recorded in the places of preservation;
• nurses and head nurses identify medicines in storage areas using a rack card;
• records are kept of medicines that have a limited shelf life in order to control their timely use;
• when medicines reach the expiration date, they should be placed in a quarantine area and stored separately from other medicines. Subsequently, they are transferred for destruction.

Checklist of Roszdravnadzor - storage of medicines in medical organizations

Look at the checklist in the Chief Nurse System, according to which the storage of medicines in a medical organization is checked.

The checklist consists of 62 questions and is approved by Appendix 2 to Order No. 9438. The inspectors will evaluate the drug storage quality assurance system, premises, equipment and documentation.

How to decipher the storage conditions of drugs

In some cases, it is very difficult for health workers to adhere to the rules for storing medicines in the clinic, which are recommended by their manufacturer on consumer packaging.

For example, many manufacturers indicate that the drug should be stored at room temperature or in a cool place, without specifying which air temperature complies with these rules.

The State Pharmacopoeia of the Russian Federation has deciphered the recommended conditions for the preservation of drugs:

• 8-15°C cool or cold conditions;
• 15-25°C "room" temperature;
• 2-25°С temperature up to 25°С;
• 2-8°C temperature not exceeding 8°C.

When to draw up a shelving card

The procedure for storing medicines in the hospital department requires that when storing medicines, shelving cards should be kept on them. These are special cards that provide basic information about the medicine and the conditions for saving it.

The rack card is started on the newly received medicine. If the medical institution received a drug of the same dosage, release form and the same series, you can leave the old card. If medicines with other characteristics, for example, a different form of release, have been received, a new card should be issued. An example of filling out a rack card look in the System Chief Nurse.

Order 706n establishes in clause 10 a specific list of information that is permissible to be reflected in such a card; health workers are not entitled to reduce it.

GENERAL PHARMACOPEIAN AUTHORIZATION

Storage of medicines OFS.1.1.0010.15
Introduced for the first time

This General Pharmacopoeia Article establishes general requirements for the storage of pharmaceutical substances, excipients and medicinal products and applies to all organizations in which medicinal products are stored, taking into account the type of activity of the organization.

Storage of medicinal herbal raw materials and medicinal herbal preparations is carried out in accordance with the General Pharmacopoeia Monograph "Storage of medicinal herbal raw materials and medicinal herbal preparations".

Storage - the process of storing medicinal products until they are used within the established expiration date, which is an integral part of the circulation of medicinal products.

General requirements for storage rooms

medicines and organization of their storage

Storage of medicines should be carried out in the premises intended for these purposes. The device, composition, size of storage areas, their operation and equipment should ensure proper storage conditions for various groups of medicines.

The complex of premises for storage should include:

The room (zone) of acceptance, intended for unpacking and receiving packages with medicines and their preliminary examination;

Premises (area) for sampling medicines in accordance with the requirements of the General Pharmacopoeia Monograph "Sampling";

Premises (zone) for quarantine storage of medicines;

Premises for medicines requiring special storage conditions;

A room (area) for storing rejected, returned, recalled and/or expired medicines. These medicinal products and their places of storage must be clearly marked.

The storage area is allocated in a common storage room in the absence of a separate isolated room.

The decoration of the premises for the storage of medicines must meet the current sanitary and hygienic requirements, the internal surfaces of the walls and ceilings must be smooth, allowing the possibility of wet cleaning.

In each storage room, it is necessary to maintain the climatic regime, observing the temperature and air humidity established by the pharmacopoeial monograph or regulatory documentation for medicinal products. The necessary air exchange in the storage rooms is created using air conditioners, supply and exhaust ventilation or other equipment. Natural and artificial lighting in storage rooms must ensure that all operations carried out in the room are carried out accurately and safely. If necessary, the protection of medicines from solar radiation should be provided.

Premises for the storage of medicines must be equipped with the necessary number of measuring instruments (thermometers, hygrometers, psychrometers, etc.) verified in the established manner for monitoring and recording temperature and humidity, carried out at least once a day. Measuring instruments are placed at a distance of at least 3 m from doors, windows and heaters in a place accessible for reading readings, at a height of 1.5 - 1.7 m from the floor. At the same time, they are recommended to be placed in places where there is the greatest probability of temperature and humidity fluctuations or deviations from the required parameters are most often observed.

Registration records should demonstrate the temperature and humidity regimes established for the premises, and in case of their discrepancy, corrective actions.

Storage rooms should be equipped with a sufficient number of cabinets, safes, shelving, storage boxes, pallets. Equipment must be in good condition and clean.

Racks, cabinets and other equipment should be installed in such a way as to provide access to medicines, free passage of personnel and, if necessary, the availability of loading and unloading operations, as well as the accessibility of equipment, walls, floors of the cleaning room.

In the premises for the storage of medicines, an appropriate sanitary regime must be maintained. The frequency and methods of cleaning the premises must comply with the requirements of regulatory documents. Sanitary disinfectants used must be safe, and the risk of contaminating stored medicinal products with these products must be excluded.

Special instructions should be developed for cleaning up spilled or spilled medicinal products in order to completely eliminate and prevent contamination of other medicinal products.

When performing work in the premises for the storage of medicines, employees must wear special clothes and shoes, observe the rules of personal hygiene.

Medicinal products are placed in storage rooms in accordance with the storage conditions specified in the pharmacopoeial monograph or regulatory documentation for medicinal products, taking into account their physicochemical and hazardous properties, pharmacological and toxicological effects, type of dosage form of the medicinal product and method of its application, aggregate drug state. When using computer technology, it is allowed to place medicines alphabetically, by codes.

Racks, cabinets, shelves intended for storage of medicines must be identified. It is also necessary to identify stored medicines using a rack card, using computer technology - using codes and electronic devices.

With the manual method of unloading and loading operations, the height of the stacking of medicines should not exceed 1.5 m. When using mechanized devices, when carrying out unloading and loading operations, medicines should be stored in several tiers. At the same time, the total height of the placement of medicines on the racks should not exceed the capabilities of the loading and unloading mechanisms.

Medicinal products in storage rooms should be placed in cabinets, on racks, pedestals, pallets, etc. It is not allowed to place medicines on the floor without a pallet. Pallets can be placed on the floor in one row or on racks in several tiers, depending on the height of the rack. It is not allowed to place pallets with medicines in several rows in height without the use of racks.

When creating storage conditions for a single medicinal product, it is necessary to be guided by the requirements specified in the pharmacopoeial monograph or regulatory documentation for this medicinal product, established by the manufacturer (developer) of the medicinal product based on the results of a stability study in accordance with the General Pharmacopoeia Monograph "Expiry Dates of Medicinal Products".

Storage of medicinal products is carried out in packaging (consumer, group) that meets the requirements of the regulatory documentation for this medicinal product.

Storage of medicinal products is carried out at a relative humidity of not more than 60 ± 5%, depending on the corresponding climatic zone (I, II, III, IVA, IVB), if special storage conditions are not specified in the regulatory documentation.

Medicines should be stored in a way that prevents contamination, mixing and cross-contamination. Extraneous odors in storage rooms should be avoided.

The organization's established accounting system for medicines with a limited shelf life should be implemented. If several batches of the same name of the medicinal product are in storage, then the medicinal product, the expiration date of which expires earlier than the others, should be taken first for use.

Rejected medicinal products must be identified and stored in an appropriate room (area) in conditions that do not allow their unauthorized use.

Features of storage of certain groups of medicines

Medicines with hazardous properties (flammable, explosive, radiopharmaceutical, caustic, corrosive, compressed and liquefied gases, etc.) should be stored in specially arranged rooms equipped with additional safety and security equipment. During storage, it is necessary to ensure the safety and declared quality of medicinal products, prevent the possibility of manifestation of their dangerous properties by medicinal products and create safe working conditions for employees working with such medicinal products.

When arranging premises and organizing the storage of hazardous medicines, it is necessary to be guided by the requirements of federal laws and regulatory legal acts of the Russian Federation.

Storage of narcotic and psychotropic medicines must be carried out in accordance with federal laws and regulatory legal acts of the Russian Federation.

When storing medicines that require protection from the influence of environmental factors (light, temperature, atmospheric composition of air, etc.), it is necessary to ensure the storage regime specified in the pharmacopoeial monograph or regulatory documentation. Deviations from the regulated conditions are allowed once only for a short period (no more than 24 hours), unless special conditions, for example, permanent storage in a cold place, are specified separately.

Medicines that can change their properties under the action of light energy (oxidize, recover, decompose, change their color, etc.) are photo- or light-sensitive; light-resistant drugs are photostable. The influence of light energy can be manifested in the impact of direct sunlight, scattered light in the visible region of the light spectrum and radiation in the ultraviolet region.

Labeling of photosensitive drugs, as a rule, contains the instruction: "Keep in a place protected from light." Medicinal products requiring protection from light should be stored in rooms or specially equipped areas that provide protection from natural and artificial lighting. Pharmaceutical substances that require protection from light should be stored either in packages made of light-shielding materials or in a dark room or cabinets. If glass containers for medicines are used as packaging for pharmaceutical substances that are especially sensitive to light, the container must be pasted over with black opaque paper.

Photosensitive medicinal products should be packed in light-protective secondary (consumer) packaging and / or should be stored in a place protected from light.

Medicines that, when in contact with water, moisture, can release gases, etc., are moisture sensitive. Labeling of moisture-sensitive medicinal products, as a rule, contains an indication: "Keep dry". When storing such medicinal products, it is necessary to create conditions so that the relative humidity does not exceed 50% at room temperature(under normal storage conditions) or equivalent vapor pressure at another temperature. Compliance with the requirement also provides for the storage of a moisture-sensitive medicinal product in airtight (moisture-tight) consumer packaging that provides the specified protection and compliance with storage conditions when handling the medicinal product.

To maintain a low moisture content during storage of medicinal products, in established cases, desiccants are used, provided that their direct contact with the medicinal product is excluded.

Medicines with hygroscopic properties must be stored at a relative humidity of not more than 50% in a package that is a glass container for medicines, hermetically sealed, or in a package with additional protection, for example, in a bag made of polyethylene film, in accordance with the requirements of a pharmacopoeial monograph or normative documentation.

Some groups of drugs change their properties under the influence of atmospheric gases, such as oxygen or carbon dioxide. To ensure the protection of medicines from the effects of gases, storage of medicines is recommended to be carried out in sealed packaging made of materials that are not permeable to gases. Packaging, if possible, should be filled to the top and sealed tightly.

Medicines that are actually volatile medicines or medicines containing a volatile solvent; solutions and mixtures of volatile substances; drugs that decompose with the formation of volatile products require storage conditions that protect them from volatilization and drying. It is recommended to store medicines in a cool place, in hermetically sealed packaging made of materials impervious to volatile substances or in primary and secondary (consumer) packaging in accordance with the requirements specified in the monograph or regulatory documentation.

Medicines, which are pharmaceutical substances containing water of crystallization (crystal hydrates), exhibit the properties of hygroscopic substances. Storage of crystalline hydrates is recommended to be carried out in hermetically sealed packaging in accordance with the requirements specified in the monograph or regulatory documentation. Usually, crystalline hydrates are stored at a temperature of 8 to 15 °C and a relative air humidity of not more than 60%.

Drugs that change their properties under the influence of ambient temperature are heat-sensitive. Drugs can change their properties under the influence of room and higher temperatures (thermolabile drugs) or under the influence of low temperatures, including freezing.

When storing heat-sensitive medicinal products, it is necessary to ensure the temperature regime regulated by the requirements of the pharmacopoeial monograph or regulatory documentation, indicated on the primary and/or secondary (consumer) packaging of the medicinal product.

Thermolabile drugs should be stored in specially equipped rooms (refrigerators) or in storage rooms equipped with a sufficient number of refrigerators and cabinets. For the storage of thermolabile drugs, pharmaceutical refrigerators or refrigerators for blood and its products should be used.

Proper quality of immunobiological medicinal products, safety and efficacy of their use is ensured by the cold chain system, which must be carried out at all its four levels.

Refrigerators (chambers, cabinets) must be set at a temperature corresponding to the temperature regime for storing medicinal products contained in them. Storage of immunobiological medicinal products should be carried out at a temperature not exceeding 8 °C. Cooled air must be provided to each package of the immunobiological medicinal product in the refrigerator. Joint storage of immunobiological medicinal products with other medicinal products in the refrigerator is not allowed.

To monitor the temperature regime of storage of thermolabile medicines, all refrigerators (chambers, cabinets) must be provided with thermometers. Continuous monitoring of the temperature regime is carried out using, the readings of which are recorded at least twice a day.

The temperature regime on the shelves of the refrigerator is different: the temperature is lower near the freezer, higher - near the opening door panel.

Providing a cold place means storing medicines in a refrigerator at a temperature of 2 to 8 ° C, avoiding freezing. Cool storage refers to the storage of medicines at temperatures between 8 and 15°C. In this case, storage of medicines in a refrigerator is allowed, with the exception of medicines that, when stored in a refrigerator at a temperature below 8 ° C, can change their physico-chemical characteristics, for example, tinctures, liquid extracts, etc. Storage at room temperature implies a temperature regime of 15 to 25 °C or, depending on climatic conditions, up to 30 °C. Storage in the freezer ensures the temperature regime of medicines from -5 to -18 °C. Storage under deep freezing conditions provides for a temperature regime below -18 ° C.

It is advisable to place medicines in areas and on the shelves of the refrigerator, corresponding to their temperature storage regime. Do not store immunobiological medicinal products on the door panel of the refrigerator.

In storage rooms, it is necessary to provide storage conditions for medicinal products that require protection from exposure to low temperatures, for which the lower limit of the temperature storage regime is established in the pharmacopoeial monograph or regulatory documentation.

It is not allowed to freeze medicines that have the relevant requirements in the monograph or regulatory documentation and are indicated on the primary or secondary packaging, including insulin preparations, adsorbed immunobiological preparations, etc.

It is not allowed to freeze medicines placed in packaging that can break down when frozen, for example, medicines in ampoules, glass vials, etc.

The definitions used in the pharmacopoeia, which characterize the temperature regimes for storing medicines, are given in the table.

It is necessary to ensure compliance with the conditions for storing medicines and maintaining their integrity during transportation.

For medicines that are particularly sensitive to temperature changes (vaccines, sera and other immunobiological drugs, insulin medicines, etc.), during transportation, the temperature regime regulated by the Pharmacopoeia Monograph or regulatory documentation must be observed.

Table - Definitions characterizing the modes of storage of medicines

Storage mode	Temperature range, °С
Store at a temperature not exceeding 30 °C	from 2 to 30 °C
Store at a temperature not exceeding 25 ° C	from 2 to 25 °C
Store at a temperature not exceeding 15 ° C	from 2 to 15 °C
Store at a temperature not exceeding 8 °C	from 2 to 8 °С
Store at a temperature not lower than 8 °C	from 8 to 25 °С
Store at a temperature of 15 to 25 °C	from 15 to 25 °С
Store at a temperature of 8 to 15 °C	from 8 to 15 °C
Store at -5 to -18 °C	from -5 to -18 °С
Store below -18°C

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3. Premises for the storage of medicinal products must be maintained at a certain temperature and air humidity to ensure the storage of medicinal products in accordance with the requirements of the medicinal product manufacturers indicated on the primary and secondary (consumer) packaging.

4. Premises for the storage of medicines must be equipped with air conditioners and other equipment to ensure the storage of medicines in accordance with the requirements of manufacturers of medicines indicated on the primary and secondary (consumer) packaging, or it is recommended to equip the premises with vents, transoms, second lattice doors.

5. Premises for the storage of medicines should be provided with racks, cabinets, pallets, and storage boxes.

6. Finishing of premises for storing medicines (internal surfaces of walls, ceilings) should be smooth and allow for wet cleaning.

7. Premises for the storage of medicines must be equipped with devices for recording air parameters (thermometers, hygrometers (electronic hygrometers) or psychrometers). The measuring parts of these devices must be placed at a distance of at least 3 m from doors, windows and heating devices. Devices and (or) parts of devices from which visual readings are taken should be located in a place accessible to personnel at a height of 1.5 - 1.7 m from the floor.

The readings of these devices must be recorded daily in a special log (card) of registration on paper or in electronic form with archiving (for electronic hygrometers), which is maintained by a responsible person. The log (card) of registration is stored for one year, not counting the current one. Control devices must be certified, calibrated and verified in the prescribed manner.

8. Medicinal products are placed in the storage rooms in accordance with the requirements of the regulatory documentation indicated on the packaging of the medicinal product, taking into account:

physico-chemical properties of medicines;

pharmacological groups (for pharmacy and medical organizations);

method of application (internal, external);

aggregate state of pharmaceutical substances (liquid, bulk, gaseous).

When placing medicines, it is allowed to use computer technologies (alphabetically, by codes).

9. Separately, in technically fortified premises that meet the requirements of the Federal Law of January 8, 1998 N 3-FZ "On Narcotic Drugs and Psychotropic Substances" (Sobraniye Zakonodatelstva Rossiyskoy Federatsii, 1998, N 2, Art. 219; 2002, N 30 , item 3033; 2003, N 2, item 167, N 27 (part I), item 2700; 2005, N 19, item 1752; 2006, N 43, item 4412; 2007, N 30, item 3748, N 31, item 4011; 2008, N 52 (part I), item 6233; 2009, N 29, item 3614; 2010, N 21, item 2525, N 31, item 4192), stored:

narcotic and psychotropic drugs;

potent and poisonous drugs that are controlled in accordance with international legal norms.

10. Shelves (cabinets) for storing medicines in the premises for storing medicines should be installed in such a way as to ensure access to medicines, free passage of personnel and, if necessary, loading devices, as well as accessibility of shelves, walls, floors for cleaning .

Racks, cabinets, shelves intended for storing medicines must be numbered.

Stored medicinal products must also be identified using a rack card containing information about the stored medicinal product (name, form of release and dosage, batch number, expiration date, manufacturer of the medicinal product). When using computer technology, identification using codes and electronic devices is allowed.

11. In organizations and individual entrepreneurs, it is necessary to keep records of medicines with a limited shelf life on paper or in electronic form with archiving. Control over the timely sale of medicines with a limited shelf life should be carried out using computer technology, rack cards indicating the name of the medicine, series, expiration date or expiration date registers. The procedure for keeping records of these medicines is established by the head of the organization or individual entrepreneur.

12. If expired medicinal products are identified, they must be stored separately from other groups of medicinal products in a specially designated and designated (quarantine) area.

13. Premises for the storage of flammable and explosive medicines must fully comply with current regulations.

14. In order to ensure the storage of flammable and explosive medicinal products according to the principle of uniformity in accordance with their physical and chemical, flammable properties and the nature of the packaging, the premises for the storage of drug wholesalers and drug manufacturers (hereinafter referred to as warehouse premises) are divided into separate premises (compartments) with a fire resistance limit of building structures of at least 1 hour.

15. The quantity of flammable medicinal products required for packaging and manufacturing of medicinal products for medical use per one work shift may be kept in production and other premises. The remaining amount of flammable drugs at the end of the shift is transferred to the next shift or returned to the main storage place.

16. The floors of storage rooms and unloading areas should have a hard, even surface. It is forbidden to use boards and iron sheets to level the floors. Floors must provide convenient and safe movement of people, goods and vehicles, be of sufficient strength and withstand loads from stored materials, and ensure simplicity and ease of cleaning the warehouse.

17. Warehouses for the storage of flammable and explosive medicines must be equipped with fireproof and stable racks and pallets designed for the appropriate load. Racks are installed at a distance of 0.25 m from the floor and walls, the width of the racks should not exceed 1 m and, in the case of storing pharmaceutical substances, have flanges of at least 0.25 m. Longitudinal aisles between the racks should be at least 1.35 m.

18. For the storage of flammable and explosive medicines in pharmacies and individual entrepreneurs, isolated rooms are allocated, equipped with automatic fire protection and alarm systems (hereinafter referred to as rooms for storing flammable and explosive medicines).

19. In pharmacies and individual entrepreneurs, it is allowed to store pharmaceutical substances with flammable and combustible properties in a volume of up to 10 kg outside the premises for storing flammable and explosive medicines in built-in fireproof cabinets. Cabinets must be removed from heat-removing surfaces and passages, with doors not less than 0.7 m wide and not less than 1.2 m high. Free access must be organized to them.

It is allowed to store explosive medicines for medical use (in secondary (consumer) packaging) for use for one work shift in metal cabinets outside the premises for storing flammable and explosive medicines.

20. The amount of flammable medicines allowed for storage in storage rooms for flammable and explosive medicines located in buildings for other purposes should not exceed 100 kg in bulk.

Premises for the storage of flammable and explosive medicinal products used for the storage of flammable pharmaceutical substances in quantities exceeding 100 kg must be located in a separate building, and the storage itself must be carried out in glass or metal containers isolated from the premises for the storage of flammable medicinal products of other groups.

21. It is forbidden to enter the premises for the storage of flammable and explosive medicines with open sources of fire.

22. Medicinal products stored in warehouses should be placed on racks or on undercarriages (pallets). It is not allowed to place medicines on the floor without a pallet.

Pallets can be placed on the floor in one row or on racks in several tiers, depending on the height of the rack. It is not allowed to place pallets with medicines in several rows in height without the use of racks.

23. With the manual method of unloading and loading operations, the height of the stacking of medicines should not exceed 1.5 m.

When using mechanized devices for unloading and loading operations, medicinal products should be stored in several tiers. At the same time, the total height of placing medicines on the racks should not exceed the capabilities of mechanized handling equipment (lifts, trucks, hoists).

24. Medicines that require protection from the action of light are stored in rooms or specially equipped places that provide protection from natural and artificial lighting.

25. Pharmaceutical substances that require protection from light should be stored in containers made of light-protective materials (orange glass glass containers, metal containers, packaging made of aluminum foil or polymeric materials painted black, brown or orange), in a dark room or cabinets. .

For the storage of pharmaceutical substances that are especially sensitive to light (silver nitrate, prozerin), glass containers are pasted over with black opaque paper.

26. Medicinal products for medical use that require protection from the action of light, packed in primary and secondary (consumer) packaging, should be stored in cabinets or on racks, provided that measures are taken to prevent direct sunlight or other bright directional light from reaching these medicinal products (use of reflective film, blinds, visors, etc.).

27. Pharmaceutical substances that require protection from moisture should be stored in a cool place at temperatures up to +15 degrees. C (hereinafter - a cool place), in a tightly closed container made of materials impermeable to water vapor (glass, metal, aluminum foil, thick-walled plastic containers) or in the manufacturer's primary and secondary (consumer) packaging.

28. Pharmaceutical substances with pronounced hygroscopic properties should be stored in a glass container with a hermetic seal, filled with paraffin on top.

29. In order to avoid damage and loss of quality, storage of medicinal products should be organized in accordance with the requirements indicated in the form of warning labels on the secondary (consumer) packaging of the medicinal product.

30. Pharmaceutical substances that require protection from volatilization and drying (actually volatile drugs; drugs containing a volatile solvent (alcohol tinctures, liquid alcohol concentrates, thick extracts); solutions and mixtures of volatile substances (essential oils, solutions of ammonia, formaldehyde, chloride hydrogen over 13%, carbolic acid, ethyl alcohol of various concentrations, etc.); medicinal plant materials containing essential oils; drugs containing crystallization water - crystalline hydrates; drugs that decompose with the formation of volatile products (iodoform, hydrogen peroxide, bicarbonate sodium); medicines with a certain lower limit of moisture content (magnesium sulfate, sodium paraaminosalicylate, sodium sulfate)), should be stored in a cool place, in a hermetically sealed container made of materials impervious to volatile substances (glass, metal, aluminum foil) or in primary and secondary (consumer) packaging of the manufacturer. The use of polymer containers, packaging and capping is allowed in accordance with the requirements of the State Pharmacopoeia and regulatory documentation.

31. Pharmaceutical substances - crystalline hydrates should be stored in hermetically sealed glass, metal and thick-walled plastic containers or in the manufacturer's primary and secondary (consumer) packaging under conditions that comply with the requirements of regulatory documentation for these medicinal products.

32. Organizations and individual entrepreneurs should store medicinal products that require protection from exposure to elevated temperatures (thermolabile medicinal products) in accordance with the temperature regime indicated on the primary and secondary (consumer) packaging of the medicinal product in accordance with the requirements of regulatory documentation.

33. Storage of medicines that require protection from exposure to low temperatures (medicines whose physical and chemical state changes after freezing and is not restored upon subsequent warming to room temperature (40% formaldehyde solution, insulin solutions)), organizations and individual entrepreneurs must carry out in accordance with the temperature regime indicated on the primary and secondary (consumer) packaging of the medicinal product in accordance with the requirements of regulatory documentation.

34. Freezing of insulin preparations is not allowed.

35. Pharmaceutical substances that require protection from exposure to gases (substances that react with atmospheric oxygen: various aliphatic compounds with unsaturated intercarbon bonds, cyclic compounds with side aliphatic groups with unsaturated intercarbon bonds, phenolic and polyphenolic, morphine and its derivatives with unsubstituted hydroxyl groups; sulfur-containing heterogeneous and heterocyclic compounds, enzymes and organic preparations; substances that react with atmospheric carbon dioxide: salts of alkali metals and weak organic acids (sodium barbital, hexenal), drugs containing polyhydric amines (eufillin), magnesium oxide and peroxide, sodium hydroxide, caustic potash) should be stored in a hermetically sealed container made of materials impervious to gases, if possible filled to the top.

36. Odorous medicinal products (pharmaceutical substances, both volatile and practically non-volatile, but with a strong odor) should be stored in a hermetically sealed container, impervious to odor.

37. Coloring medicinal products (pharmaceutical substances that leave a colored mark that is not washed off by ordinary sanitary and hygienic treatment on containers, closures, equipment and inventory (brilliant green, methylene blue, indigo carmine)) should be stored in a special cabinet in a tightly closed container .

38. To work with coloring medicines, it is necessary to allocate special scales, a mortar, a spatula and other necessary equipment for each item.

39. Disinfectants should be stored in hermetically sealed containers in an isolated room away from plastic, rubber and metal storage facilities and distilled water production facilities.

40. Storage of medicinal products for medical use is carried out in accordance with the requirements of the state pharmacopoeia and regulatory documentation, as well as taking into account the properties of the substances that make up them.

41. When stored in cabinets, on racks or shelves, medicinal products for medical use in secondary (consumer) packaging must be placed with the label (marking) outward.

42. Organizations and individual entrepreneurs must store medicinal products for medical use in accordance with the requirements for their storage indicated on the secondary (consumer) packaging of the specified medicinal product.

43. Bulk medicinal plant materials should be stored in a dry (no more than 50% humidity), well-ventilated area in a tightly closed container.

44. Bulk medicinal plant materials containing essential oils are stored in isolation in a well-closed container.

45. Bulk medicinal plant materials must be subject to periodic control in accordance with the requirements of the state pharmacopoeia. Grass, roots, rhizomes, seeds, fruits that have lost their normal color, smell and the required amount of active substances, as well as those affected by mold, barn pests, are rejected.

46. ​​Storage of medicinal plant materials containing cardiac glycosides is carried out in compliance with the requirements of the state pharmacopoeia, in particular, the requirement for repeated control for biological activity.

47. Bulk medicinal plant materials included in the lists of potent and toxic substances approved by Decree of the Government of the Russian Federation of December 29, 2007 N 964 "On approval of the lists of potent and toxic substances for the purposes of Article 234 and other articles of the Criminal Code of the Russian Federation, as well as large size of potent substances for the purposes of Article 234 of the Criminal Code of the Russian Federation" (Sobraniye Zakonodatelstva Rossiyskoy Federatsii, 2008, N 2, Art. 89; 2010, N 28, Art. 3703), is stored in a separate room or in a separate cabinet under lock and key.

48. Packaged medicinal herbal raw materials are stored on racks or in cabinets.

49. Storage of medical leeches is carried out in a bright room without the smell of medicines, for which a constant temperature regime is established.

51. Storage of flammable medicines (medicines with flammable properties (alcohol and alcohol solutions, alcohol and ether tinctures, alcohol and ether extracts, ether, turpentine, lactic acid, chloroethyl, collodion, cleol, Novikov liquid, organic oils); drugs with flammable properties (sulfur, glycerin, vegetable oils, medicinal plant materials)) should be carried out separately from other drugs.

52. Flammable medicines are stored in tightly sealed strong, glass or metal containers to prevent the evaporation of liquids from the vessels.

53. Bottles, cylinders and other large containers with flammable and easily combustible medicines should be stored on the shelves of racks in one row in height. It is forbidden to store them in several rows in height using different cushioning materials.

It is not allowed to store these medicines near heating devices. The distance from the rack or stack to the heating element must be at least 1 m.

54. Storage of bottles with flammable and highly combustible pharmaceutical substances should be carried out in containers that protect against impacts, or in cylinder-tilters in one row.

55. At the workplaces of industrial premises allocated in pharmacy organizations and individual entrepreneurs, flammable and easily combustible medicines can be stored in quantities not exceeding the shift requirement. At the same time, the containers in which they are stored must be tightly closed.

56. It is not allowed to store flammable and easily combustible medicines in fully filled containers. The degree of filling should be no more than 90% of the volume. Alcohols in large quantities are stored in metal containers, filled no more than 75% of the volume.

57. Joint storage of flammable medicines with mineral acids (especially sulfuric and nitric acids), compressed and liquefied gases, flammable substances (vegetable oils, sulfur, dressings), alkalis, as well as with inorganic salts that give explosive explosives with organic substances is not allowed. mixtures (potassium chlorate, potassium permanganate, potassium chromate, etc.).

58. Medical ether and ether for anesthesia are stored in industrial packaging, in a cool, dark place, away from fire and heating devices.

59. When storing explosive drugs (drugs with explosive properties (nitroglycerin); drugs with explosive properties (potassium permanganate, silver nitrate)) measures should be taken to prevent contamination with dust.

60. Containers with explosive drugs (barrels, tin drums, bottles, etc.) must be tightly closed to prevent vapors of these drugs from getting into the air.

61. Storage of bulk potassium permanganate is allowed in a special compartment of storage facilities (where it is stored in tin drums), in barbells with ground stoppers separately from other organic substances - in pharmacies and individual entrepreneurs.

62. Bulk nitroglycerin solution is stored in small, well-closed bottles or metal containers in a cool, dark place, taking fire precautions. Move dishes with nitroglycerin and weigh this drug should be in conditions that exclude spillage and evaporation of nitroglycerin, as well as its contact with the skin.

63. When working with diethyl ether, shaking, shock, friction is not allowed.

65. Narcotic and psychotropic drugs are stored in organizations in isolated rooms specially equipped with engineering and technical security equipment, and in places of temporary storage, subject to the requirements in accordance with the Rules for the Storage of Narcotic Drugs and Psychotropic Substances established by Decree of the Government of the Russian Federation of December 31, 2009 No. N 1148 (Sobraniye zakonodatelstva Rossiyskoy Federatsii, 2010, N 4, art. 394; N 25, art. 3178).

66. Pursuant to Decree of the Government of the Russian Federation No. 964 of 29 December 2007 “On Approval of Lists of Potent and Poisonous Substances for the Purposes of Article 234 and Other Articles of the Criminal Code of the Russian Federation, Federation" potent and toxic drugs include drugs containing potent and toxic substances included in the lists of potent and toxic substances.

67. Storage of potent and poisonous medicines under control in accordance with international legal norms (hereinafter referred to as potent and toxic medicines under international control) is carried out in premises equipped with engineering and technical security equipment similar to those provided for the storage of narcotic and psychotropic drugs.

68. Potent and poisonous medicines under international control and narcotic and psychotropic medicines may be stored in one technically fortified room.

At the same time, the storage of potent and poisonous medicines should be carried out (depending on the volume of stocks) on different shelves of the safe (metal cabinet) or in different safes (metal cabinets).

69. Storage of potent and poisonous medicines not under international control is carried out in metal cabinets sealed or sealed at the end of the working day.

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Prescription, receipt of medicines from the pharmacy is carried out by the head nurse of the department in accordance with the needs of the department at the request of the ward nurses.

Requirements for obtaining medicines from a pharmacy are issued in three copies.

For poisonous, narcotic, potent, ethyl alcohol, one more copy is issued. The requirements are signed by the chief physician and certified by the seal of the medical institution. The requirements for obtaining poisonous, narcotic, acutely scarce medicines from a pharmacy indicate the numbers of case histories, surnames, first names, patronymics of patients.

Narcotic drugs and psychotropic substances of List III must be issued to citizens on a special pink form on paper with watermarks, stamped by a medical institution and a serial number. Accounting for special prescription forms for narcotic drugs is kept in a special journal: numbered, laced, sealed and signed by the head.

When receiving medicines from a pharmacy, the head nurse checks their compliance with the prescription in the requirements (name of the drug, dosage), as well as the expiration date, date of manufacture, batch of the drug, compliance with the original factory or pharmacy packaging.

When storing medicines, the rules for placing them in groups are observed: list A (poisonous and narcotic), list B (potent)- located in a safe, under lock and key. On the inside of the safe door there should be a list of narcotic drugs indicating the values ​​of daily and single doses.

The keys to the safe are kept only by the persons appointed by the order of the medical facility, responsible for the storage and dispensing of medicines of group "A".

Other drugs are stored in the department at the nurse's station in lockable cabinets marked "External", "Internal", "Parenteral". When handing over duty, the nurse makes an entry in the appropriate journals in the form.

Stocks of narcotic medicines should not exceed the three-day requirement separation, poisonous - five days, potent - ten days.

Temperature conditions are observed in storage areas. Photosensitive products are stored in dark, closed cabinets. Odorous are stored separately, in tightly closed boxes. Decoctions, infusions, emulsions, antibiotics, suppositories, serums, vaccines, hormonal preparations, heparin, oxytocin, adrenaline are stored only in a refrigerator specially marked “for medicines”. at a temperature of +2 °C to +10 °C, intended for the storage of medicines.

Medicines must be used within the established expiration dates.

Narcotic, poisonous, ethyl alcohol, acutely scarce drugs are subject to quantitative accounting, control, which is carried out in a special book, numbered, laced and sealed and signed by the head physician of the medical institution. The labels of all drugs containing narcotic drugs must be stamped in black ink "Poison".

As powders, tablets and ampouled narcotic drugs accumulate, they are produced no later than the 30th day of each month. destruction: powders and tablets - by burning, ampouled preparations - by crushing. In the "Journal of accounting for unused narcotic drugs and prescriptions for their prescribing" a note is made on the number of destroyed drugs.

Order 330"On measures to improve the accounting, storage, prescribing and use of narcotic drugs."

PRESCRIBING MEDICINAL SUBSTANCES FOR THE MEDICAL DEPARTMENT

The doctor, daily examining patients in the department, writes down in the case history or prescription list the medicines necessary for this patient, their doses, frequency of administration and routes of administration.

The ward nurse makes a daily selection of appointments, copying the prescribed drugs in the "Book of appointments". Information about the injections is transmitted to the procedural nurse who performs them.

The list of prescribed drugs that are not available at the post or in the treatment room is submitted to the head nurse of the department.

The head nurse (if necessary) writes out, in a certain form, an invoice (requirement) for receiving medicines from a pharmacy in 2 copies in Latin, which is signed by the head. department. The department must have a 3-day supply of necessary medicines.

When receiving medicines from a pharmacy, the head nurse checks their compliance with the order.

On dosage forms made in a pharmacy, there must be a certain color of the label:

for external use - yellow

for indoor use - white

for parenteral administration - blue

(on vials with sterile solutions).

The labels should have clear names of drugs, designations of concentration, dose, dates of manufacture and the signature of the pharmacist who manufactured these dosage forms.

Some medicinal substances

included in list A(poisonous drugs) Atropine Cocaine DikainMorphine Omnopon Promedol Prozerin Strychnine Strophanthin Reserpine Sovkain Platifillin

Some drugs on list B(potent medicinal substances) Nicotinic acid Adonizide Amyl nitrite Analgin Adrenaline Barbamyl Barbital Aminazine Chloral hydrate Codeine Caffeine Cordiamine Cititone Ephedrine Lobelin Luminal Nitroglycerin in solution Norsulfazol Novocain Ftivazide Papaverine Pituitrin Sulfodimesin Insuli Levomycetin Mezaton Phthalazol Prednisolone

GENERAL STORAGE REQUIREMENTS

MEDICINES IN THE DEPARTMENT

To store medicines at the nurse's station, there are cabinets that must be locked with a key.

In the cabinet, medicinal substances are placed in groups (sterile, internal, external) on separate shelves or in separate cabinets. Each shelf should have a corresponding indication (“For external use”, “For internal use”, etc.).

Medicinal substances for parenteral and enteral administration should be placed on the shelves according to their intended purpose (antibiotics, vitamins, antihypertensives, etc.).

Larger dishes and packages are placed at the back, and smaller ones at the front. This makes it possible to read any label and quickly take the right medicine.

Medicinal substances included in List A, as well as expensive and acutely scarce drugs are stored in a safe.

Preparations that decompose in the light (therefore they are produced in dark bottles) are stored in a place protected from light.

Strong-smelling drugs (iodoform, Vishnevsky ointment, etc.) are stored separately so that the smell does not spread to other drugs.

Perishable drugs (infusions, decoctions, potions), as well as ointments, vaccines, serums, rectal suppositories and other drugs are stored in the refrigerator.

Alcoholic extracts, tinctures are stored in vials with tightly ground stoppers, as due to the evaporation of alcohol, they can become more concentrated over time and cause an overdose.

The shelf life of sterile solutions made in a pharmacy is indicated on the bottle. If during this time they are not sold, they must be poured out, even if there are no signs of unsuitability.

Signs of unsuitability are:

in sterile solutions - a change in color, transparency, the presence of flakes;

infusions, decoctions - turbidity, discoloration, the appearance of an unpleasant odor;

in ointments - discoloration, delamination, rancid smell;

in powders, tablets - discoloration.

13. A nurse has no right:

change the form of medicines and their packaging;

combine the same drugs from different packages into one;

replace and correct labels on medicines;

store medicinal substances without labels.

RULES OF STORAGE AND ACCOUNTING OF NARCOTIC DRUGS.

Narcotic drugs are discharged from the pharmacy to the medical department on a separate request (in several copies), which is signed by the head physician of the health facility and stamped.

Narcotic drugs are stored in a safe, on the inner surface of the door of which there should be a list of drugs indicating the highest single and daily doses.

The keys to the safe are kept by the doctor on duty and are handed over by shift.

Narcotic drugs are subject to subject-quantitative accounting.

Narcotic drugs are administered to the patient only on the written prescription of the doctor and in his presence.

6. An entry about the introduction of the drug must be made in the book of registration of narcotic drugs, stored in a safe.

In the drug accounting book, all sheets must be numbered, laced, and the free ends of the cord are sealed on the last sheet of the book with a paper sheet, on which the number of pages is indicated, the head of the medical institution or his deputies is signed and sealed.

Separate sheets are allocated for accounting for each drug. The following entries are made in the drug register:

Name of the medical institution

BOOK of registration of narcotic drugs in departments and offices

Empty drug ampoules are not thrown away, but are collected and transferred along with the unused ampoules to the shift, and ultimately the empty ampoules are given to the head nurse.

When handing over the keys to the safe, they check the correspondence of the entries in the register (the number of used ampoules and the balance) with the actual number of filled and used ampoules, and put their signatures in the journal, the one who transferred and accepted the keys. Empty ampoules from narcotic drugs are handed over by the head nurse according to the act of a special commission approved by the head of the health facility, in the presence of which the ampoules are destroyed.

FOR THE DESTRUCTION OF USED NARCOTIC DRUG AMPOULES IN HEALTH CARE INSTITUTIONS

made the destruction of used ampoules from narcotic drugs, for the period from the number (in words) of the number of patients who were used narcotic substances (full name of the patient and no. of the case history).

The ampoules are destroyed by crushing.

The act is kept for 3 years.

Each department of health care facilities should have tables of higher single and daily doses of poisonous and potent substances and antidotes for poisoning.