Placement and equipment of material rooms in a pharmacy. Compliance with storage rules in the pharmacy

Requirements for pharmacies are regulated by the industry standard “Rules for the dispensing (sale) of medicines in pharmacies. Basic provisions”, approved by order of the Ministry of Health of the Russian Federation No. 80 dated March 4, 2003. One of the main requirements is to ensure conditions for proper storage and safety of drugs; its implementation directly depends on the premises and equipment of the pharmacy. In this case, you need to take into account the form of conducting pharmacy activities - through a pharmacy, pharmacy point or pharmacy kiosk. Regardless of the type of pharmacy organization, all premises must be combined into a single block, isolated from other objects, but the entrance to the pharmacy can also be made through the premises of another organization.

The pharmacy must have the following premises:

shopping room;
room for receiving and unpacking;
material room;
premises for staff and administration.

An industrial pharmacy engaged in the manufacture of drugs must have, in addition to the above, the following premises: a washing room, a distillation room, and a room for the production of medicines.

Pharmacy premises:

shopping room;
room or area for receiving and unpacking;
space for material room and staff.

Pharmacy kiosk premises:

a single room for one workplace without a sales area.

* Employees of a pharmacy point and pharmacy kiosk must be provided with unimpeded access to the use of a sanitary facility located in the building where the pharmacy premises are located.

The area of the facility must be sufficient to carry out pharmaceutical activities, taking into account its type and volume. On the premises of pharmacy facilities, the placement of units that are not functionally related to the implementation of pharmacy activities is not allowed.

The requirements for the premises of a pharmacy are especially relevant at the very beginning of a business, when the process of obtaining a pharmaceutical license takes place - it may simply not be issued if the premises of a pharmacy organization do not meet the standards.

If we're talking about about a full-fledged pharmacy, it is necessary to think through and arrange the most important systems: ventilation, water supply, sewerage, heating. Needless to say, electricity is a requirement. The operation of these systems is aimed not only at creating comfortable conditions for employees, but also at ensuring proper storage conditions for medicines.

The internal surfaces of walls, ceilings, and floors of pharmacy premises must allow wet cleaning using disinfectants. Most best option– ceramic tiles or durable enamels. The decoration of administrative and amenity premises of pharmacy facilities allows the use of wallpaper, carpeting, parquet, oil paints, etc. The floor covering must be smooth without any disturbances to the relief, with an anti-slip surface.

Pharmacy facilities must be equipped with equipment appropriate to the volume and nature of the pharmaceutical activities carried out. It is necessary to install special furniture for storing drugs, including racks and pallets. Refrigeration equipment, temperature control devices and microclimate recording are required.

Any equipment and devices located in a pharmacy must have a technical passport and are subject to regular, timely maintenance. Equipment for the production of sterile dosage forms is tested for performance, taking into account permissible deviations.

When placing material rooms, you should ensure their convenient connection with the relevant departments (prescription and manual sales), as well as with the basement. The manager's office must have a direct connection with the hall for serving visitors. In the basement it is necessary to allocate and specially equip a room for flammable explosive substances (alcohol, ether, etc.), for disinfectants and acids, mineral waters, etc. In pharmacies, sanitary facilities should be provided: a locker room - planned for pharmacies I -IV category, can be located both on the first and basement floors; rest room - provided in pharmacies I-V categories, preferably located on the ground floor; shower room - located in pharmacies of categories I-IV; it is advisable to place it in the basement; room for washing clothes - is provided in the basement and only in pharmacies of categories III and IV, since pharmacies of categories I and II are usually located in big cities and use city communal laundries, and in pharmacies of categories V and VI there is no need to have separate rooms for washing linen due to the small quantity; the toilet is located in pharmacies of all categories, preferably on the ground floor. In Fig. 36 shows an approximate layout of premises in a category II pharmacy that meets the above requirements.

Rice. 36. Layout diagram of a category II pharmacy.

Taking into account the smaller volume of work in pharmacies of categories IV, V and VI, the composition of the premises for them has been significantly changed. In category VI pharmacies, the service room is combined with an assistant’s room, and prescriptions are taken, medications are prepared and dispensed in a common room. Starting from category III pharmacies, the independent analytical room is replaced by a table for the analytical chemist, located in the assistant's room. In category IV-VI pharmacies, the manager’s office is combined with the office.

The height of production premises for pharmacies of categories I and II must be at least 3.5 m; in pharmacies of categories III-VI located in residential buildings, the height can be equal to the height of the floor of the house. However, the height of such premises as the service room, assistant room, aseptic room, packaging room, washing room, vat-sterilization room must be at least 3 m, it increases due to the basement part of the building. Premises located in the basement must have a height of at least 2.2 m.

The decoration of premises is of great hygienic importance. The walls and ceilings of industrial premises require finishing that ensures impeccable cleanliness and thorough cleaning. Taking these requirements into account, it is recommended that in the washing room, vat-sterilization room, assistant room, shower room, restroom, and laundry room, wall panels to a height of at least 1.8 m should be faced with glazed tiles or painted with light-colored oil paint. The walls above the panels in these rooms can be painted with water-based paints. Aseptic walls up to the ceiling should be tiled with large glazed tiles or painted with high-quality oil paints. It is advisable to paint the wall panels of the material rooms, packaging room, analytical chemist's room and dressing room with oil paints. IN administrative premises and the rest room, water-based paints are allowed for wall decoration. Ceilings in all rooms should be without stucco decorations, painted with water-based paints. The aseptic ceiling must be finished with white oil paint.

Floors in production, administrative and sanitary premises must be insulated, smooth, and convenient for wet cleaning. In the public service hall on the visitors' square, ceramic tiles or relin, linoleum are used as flooring materials; in other departments of the hall, the assistant's room, the analytical chemist's room, the packaging room, material rooms, and administrative rooms, the floors should be covered with rolled material. In aseptic flooring, polyvinyl acetate mastics are recommended, but roll coverings such as Relin can also be used with mandatory seam welding if the Relin is the size less area premises. In the washing room, vat-sterilization room, shower room, restroom and room for washing clothes, it is necessary to install waterproof floors made of ceramic tiles or moisture-resistant synthetic materials. The floor in these rooms should be 3 cm lower than the floor of the rooms adjacent to them. In the washing and vat-sterilization rooms, removable wooden gratings should be installed at workplaces.

From a sanitary point of view great importance has finishing of pharmacy equipment (assistant tables, cabinets, turntables, display cases, etc.). The equipment must be light in color and have a smooth surface that is resistant to processing warm water with soap. The inside surface of table drawers should be painted with light oil paint. It is advisable to cover the covers of assistant tables and the disks of turntables with plastic. For certain parts of the equipment (for example, for the axes of turntables, handles of drawers), the use of plexiglass is recommended.

Pages: 5

Valid Editorial from 18.04.2007

Name of document	ORDER of the Ministry of Health of the Russian Federation dated 03/04/2003 N 80 (as amended on 04/18/2007) "ON APPROVAL OF THE INDUSTRY STANDARD" RULES FOR THE DISpensE (SALE) OF MEDICINES IN PHARMACY ORGANIZATIONS. BASIC PROVISIONS"
Document type	order, standard
Receiving authority	Ministry of Health of the Russian Federation
Document Number	80
Acceptance date	01.01.1970
Revision date	18.04.2007
Registration number in the Ministry of Justice	4272
Date of registration with the Ministry of Justice	17.03.2003
Status	valid
Publication	The document was not published in this form (as amended on 03/04/2003 - " Russian newspaper", N 52, 03/20/2003; "Bulletin of normative acts of federal executive authorities", N 19, 05/12/2003)
Navigator	Notes

ORDER of the Ministry of Health of the Russian Federation dated 03/04/2003 N 80 (as amended on 04/18/2007) "ON APPROVAL OF THE INDUSTRY STANDARD" RULES FOR THE DISpensE (SALE) OF MEDICINES IN PHARMACY ORGANIZATIONS. BASIC PROVISIONS"

III. Premises and equipment of pharmacy organizations

3.1. All premises of a pharmacy organization must be located in a building (structure) and functionally combined into a single block, isolated from other organizations. It is allowed to enter (exit) a pharmacy organization through the premises of another organization.

The pharmacy organization should provide the possibility of entry (exit) for people with impaired musculoskeletal system functions.

3.2. On the premises of pharmacy organizations it is not allowed to locate units that are not functionally related to the types of activities specified in the licenses.

3.3. A pharmacy organization must have a sign indicating the type of organization (in accordance with the license for pharmaceutical activities) in Russian and national languages: “Pharmacy”, “Pharmacy point”, “Pharmacy kiosk”, “Pharmacy store”; organizational and legal form and form of ownership; brand name organizations; location (according to constituent documents), as well as the organization’s operating hours, addresses and telephone numbers of nearby and on-duty pharmacies.

The name of the type of pharmacy organization must be written in a font the size of which allows the inscription to be clearly distinguished at any time of the day from a distance of at least 25 meters. When a pharmacy is located inside a building, the sign must be on the outer wall of the building.

Pharmacy organization providing medicinal assistance at night, must have an illuminated sign with information about work at night, indicating hours of operation, and a bell for the visitor to call a pharmacy employee.

3.4. When a pharmacy organization is closed for sanitary work, repairs, re-equipment, or in connection with its liquidation, the population is notified of this by an announcement posted on the front door 5 days before the closure of the pharmacy organization. The advertisement indicates the address of the nearest pharmacy organizations. When a pharmacy organization is closed due to repairs or liquidation, the head of the pharmacy organization notifies the licensing authority that issued the license.

3.5. The composition, dimensions of premises and equipment of a pharmacy organization are determined by the current sanitary, hygienic, construction and other norms and rules.

dated August 23, 2004 N 92)

3.6. If the layout of the premises of pharmacy organizations changes during the validity of the license, the licensee informs the licensing authority about this in the prescribed manner.

3.7. The premises of pharmacy organizations must meet technical, sanitary, fire safety and other licensing requirements and conditions.

3.8. Pharmacy organizations must have centralized systems for power supply, heating, water supply, supply and exhaust ventilation, and sewerage.

When organizing pharmacy points at medical institutions, they can be equipped with an air conditioning system; administrative and utility premises may be shared. Pharmacy organizations located outside cities may have autonomous heating, sewerage and water supply.

3.9. The internal surfaces of walls and ceilings must be smooth and allow for wet cleaning. The floors of production premises and material rooms must have a dust-free coating that is resistant to mechanization and wet cleaning using disinfectants. Finishing materials for premises must comply with the requirements of relevant regulatory documents.

The decoration of administrative and amenity premises allows the use of wallpaper, carpeting, parquet, oil paints, etc.

3.10. Premises for storing medicinal products (drugs) in pharmacies must be equipped with special equipment to ensure their storage taking into account the physicochemical, pharmacological and toxicological properties, as well as the requirements of quality standards for medicinal products and the State Pharmacopoeia Russian Federation and their proper preservation.

The premises of pharmacy organizations located in the city must be equipped with security alarm systems connected to a remote control with round-the-clock centralized surveillance or guarded around the clock by a security company licensed to this type activities.

3.11. Premises for storing narcotic drugs, psychotropic substances, poisonous and potent substances must be equipped with multi-line security alarm systems with each line connected to separate numbers of centralized surveillance consoles, in this case:

Additional alarm lines protect the internal volumes and areas of premises, safes (metal cabinets) used for storing narcotic drugs, psychotropic, toxic and potent substances;

Workplaces of personnel performing operations with narcotic drugs, psychotropic, toxic and potent substances, as well as premises for their storage, are equipped with alarms.

(as amended by Order of the Ministry of Health and Social Development of the Russian Federation dated September 13, 2005 N 576)

3.12. The entrance door to premises for storing narcotic drugs, psychotropic substances, toxic and potent substances must be metal or wooden, upholstered with iron on both sides with a folded sheet over the end of the door or on the inner surface of the door, with a thickness of at least 40 mm; the frame of the doorway must be made of a steel profile, inside - a lattice metal door.

3.13. Premises for storing narcotic drugs, psychotropic substances, toxic and potent substances must be equipped with internal bars on window openings (or bars between frames) made of steel rod with a diameter of at least 16 mm. The rods must be welded at each node and form cells no larger than 150 x 150 mm.

3.14. Access to production premises and goods storage premises is granted to persons authorized in accordance with the established procedure. Access of unauthorized persons to these premises is prohibited.

3.15. The pharmacy organization must be equipped with appropriate light, sound and fire alarms, providing all conditions for the safety of inventory and fire safety.

3.16. Pharmacy organizations must have a special room (cabinet) for storing detergents and disinfectants, equipment and materials used in cleaning premises and processing equipment.

3.17. The total area of administrative and service premises of pharmacy organizations depends on the number of personnel and is calculated in accordance with current norms and regulations.

3.18. In the dressing room, outer clothing and shoes should be stored separately from sanitary clothing and shoes.

3.19. A pharmacy organization must be equipped with equipment and supplies in accordance with the functions performed:

Production premises must be equipped with pharmacy furniture, technological and other equipment permitted for use, inventory in accordance with current regulatory documents that take into account the volume and nature of the pharmacy organization’s activities;

All devices used in a pharmacy must have technical passports that are retained throughout the entire period of operation. It is necessary to regularly verify instruments and devices used in a pharmacy organization in accordance with the requirements of regulatory documents;

To store narcotic drugs and psychotropic substances, if you have a license to work with these groups, you must have safes; for storing potent and toxic substances- metal cabinets;

The sales area must be equipped with display cases that provide visibility and safety of medications and other groups of goods approved for dispensing from pharmacies, as well as ensure ease of use for the pharmacy staff. It is possible to openly display over-the-counter medications and other goods approved for sale from pharmacies;

Premises for storing medicines and other goods permitted for dispensing from pharmacies must be equipped with cabinets, racks, pallets, and stockpiles for their storage; storage rooms for thermolabile medicinal products must be equipped with equipment that ensures the necessary conditions storage;

Premises for storing medicines and other goods permitted for dispensing from pharmacies must be equipped with instruments for recording air parameters (thermometers, hygrometers or psychrometers), which are placed on the inner wall of the room, 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. The readings of these devices must be recorded daily in a special journal (card), which is kept by the responsible person throughout the year and stored for a year, not counting the previous year. Control devices must be certified, calibrated and verified in accordance with the established procedure;

Cabinets for storing outer and sanitary clothing, shoes in the dressing room;

Detergent and disinfectants, household equipment used in cleaning premises and processing equipment.

All equipment and external design of premises in pharmacy organizations must meet sanitary, hygienic, fire safety and occupational safety and health requirements.

3.20. Racks and cabinets for storing medicines and other goods permitted for dispensing from pharmacies in material rooms must be installed as follows:

The distance to the external walls is at least 0.6 - 0.7 m;

The distance to the ceiling is at least 0.5 m;

Distance from the floor is not less than 0.25 m;

Aisles between racks are at least 0.75 m;

A rack card indicating the name of the medicinal product, series, expiration date, and number of storage units is attached to all racks, cabinets, and shelves.

Work on receiving pharmaceutical goods Tasks and functions of the inventory department : Inventory department Features: 1) determination of the current need for medicines and products medical purposes 2) timely submission of orders for them 3) acceptance of goods in terms of quantity and quality 4) ensuring proper storage 5) organization of subject-quantitative accounting 6) carrying out laboratory and packaging work 7) release of goods to other separate departments structural divisions, medical and preventive institutions Placement and equipment of material rooms: IN material rooms - goods are placed whose storage conditions do not require low temperature.The material room is located separately and is equipped with special shelves and cabinets for storing goods. No entry allowed sun rays and also high humidity. The room is located in the inventory department. The inventory department includes the following premises: · unpacking room; · storerooms (for storing drugs, finished medicines, thermolabile, mineral waters, containers, dishes, auxiliary materials, medicinal plant materials, dressings); · premises for servicing medical institutions (for receiving and processing orders, forwarding). In the reserves department, laboratory (preparation of concentrates for burette installations, semi-finished and finished medicinal products for in-pharmacy preparation - in-pharmacy procurement) and packaging work can be carried out. To carry out these works, a special room is allocated, which is equipped with the necessary technological equipment, as well as items for mechanization of production processes (defect room). ). Medicines are stored in physical cabinets and safes, and medical products are stored in cabinets and on shelves. Storage of medicines is carried out taking into account the possibility of their location. In this case, systematization is carried out according to pharmacological groups, state of aggregation (liquid separately from bulk, gaseous, etc.), the nature of dosage forms, physicochemical properties, and membership in lists. Poisonous medicines included in List A, regardless of the dosage form (with the exception of especially poisonous ones), are stored separately, in metal cabinets specially designated for this purpose under lock and key. Narcotic drugs are stored only in safes. On the inside of the doors of the safe and cabinet in which list A drugs are stored, there is the inscription “Venena”, and on the inside of the doors of the cabinet in which list B drugs are stored there is the inscription “Heroica” and a list of poisonous, potent drugs indicating higher single and daily doses. The inscriptions on the rods in which poisonous medicines are stored are written on Latin in white letters on a black background, and on bars containing potent drugs in red letters on a white background; in both cases, the highest single and daily doses are indicated on the bars. Metal bars are made on the windows of the material rooms in which poisonous, narcotic drugs are stored, and the doors are lined with iron. After finishing work, the doors are locked and sealed. Material rooms and safes in which narcotic drugs are stored have a security light and sound alarm. The supply of poisonous and narcotic medicines does not exceed the monthly requirement. The reserve department is headed by the head and his deputies. In addition, pharmacists-technologists and packers can work in the department. Workplace of a pharmacist in the inventory department: The pharmacist's workplace for storing supplies contains: a chair, a tabletop or a table with small cabinets for storing equipment. Availability of a computer, line machine, printer. The inventory includes: boxes and cabinets for storing goods, trolleys on wheels, baskets for carrying goods. For packaging goods: stationery knife, tape Normative base: The work of the pharmacist in the inventory department is regulated by: -Order of the Ministry of Health of Russia dated November 13, 1996 No. 377 “On approval of requirements for organizing storage in pharmacies of various groups of medicines and medical products”; · -Order of the Ministry of Health of Russia dated July 16, 1997 No. 214 “On quality control of medicines manufactured in pharmacy organizations (pharmacies)”; · -Order of the Ministry of Health of Russia dated November 5, 1997 No. 318 “On approval of the Instructions on the procedure for storing and handling medicines and medical products with flammable and explosive properties in pharmaceutical (pharmacy) organizations”; · -Order of the Ministry of Health and Social Development of Russia dated November 12, 1997 No. 330 “On measures to improve the accounting, storage, prescribing and use of narcotic drugs and psychotropic substances” (as amended and additionally); · -Order of the Ministry of Health of Russia dated March 15, 2002 No. 80 “On approval of the industry standard “Rules for the wholesale trade of medicines. Basic provisions” (with amendments and additions). · Work on receiving goods pharmacy assortment took place in both pharmacies and almost daily. The main task was to accept the goods from the supplier as soon as possible, check for Quality and quantity (instruction No. P-6 dated June 15, 1965 on quantity and instructions No. P-7 April 25, 1966 on quality). Acceptance of goods takes place in several stages. At the first stage, the pharmacist checks the quantity of goods by location, then checks the documentation, puts the pharmacy stamp and personal signature, after which he releases the courier. The second stage is to check the goods in terms of quantity and immediately quality. The quantity is checked against the invoice data, as well as the series indicated on the product and in the documents. After inspection, the product is curled, shaded and sent to the material room. Hatching is carried out throughout the product, the required product is sent to the sales floor with price tags. Products that need to be stored in a cool place are sent to the refrigerator. Examples of accompanying documents: - waybill (Appendix No. 4) - invoice - price agreement protocol - certificate (declaration. Reg. ud, passport) of conformity (Appendix No. 4) - packing list Books of accounting of received goods, acceptance of goods. Reception of goods and containers must be carried out in strict accordance with GOSTs, technical conditions, special conditions deliveries, etc. according to the number of pieces and gross weight, which is noted in the primary documents. Reception of goods by number of units and net weight is carried out on site (in the pharmacy) with the involvement of a representative of the supplier (before opening the container). In this case, a note is made about the start and end time of receiving goods. If discrepancies are found between the actual quantity and quality of the valuables received and the corresponding data specified in the supplier’s accompanying documents, the head of the pharmacy, and in his absence, the first deputy, creates a commission that draws up an act in Form N 2-AP. When accepting goods delivered in bulk, financially responsible persons on all copies of the invoice returned to the driver or forwarder, confirming the fact of acceptance of the goods, affix a stamp in Form N 1-AP, certify with their signature, and in the absence of a stamp, put the seal of the pharmacy. When the supplier delivers to the pharmacy goods packed in boxes, containers, bags or other types of packaging, sealed and sealed, the financially responsible persons on all copies of the invoices confirm the fact of acceptance by the number of places with their signatures and seal. In case of a discrepancy (if any) between the actual availability of goods and the invoice data, a note is made about the start and end time of goods acceptance. When the supplier delivers goods to a pharmacy, in addition to checking the gross weight and number of items, the pharmacy representative may require opening the container and checking the net weight and the number of units in each location. In case of detection of shortage or damage to the cargo accepted by the pharmacy at the station railway, water pier or at the airport, the cargo receiver must require the administration of the transport organization to draw up a commercial act. In this case, it is necessary, as in the case of doubt about the usefulness of the arrived cargo (due to soaking, a long stay in transit, etc.), to open the corresponding cargo packages to check its contents, identify the actual amount of damage and include all deviations associated with in the indicated cases, into a commercial act. All goods received at the pharmacy are received and registered in the register of goods receipt by group according to Form N 5-AP. At the end of the month, the journal totals are calculated at two prices (retail and wholesale). Accounting for the movement of goods (including prescription and material utensils, boxes) is carried out in the pharmacy only in in value terms at sale price. Medicines subject to subject-quantitative accounting are recorded separately in quantitative terms in the register of poisonous, narcotic, scarce medicines and ethyl alcohol in form N 10-AP. The pharmacy manager keeps records of goods in a register (statement), which is also a commodity report in Form N 25-AP. The report is prepared in two copies. Received material values, according to which a report on damage, defects and damage was drawn up, is included in the total pharmacy account in Form N 72-AP on account 004 “Inventory assets accepted for safekeeping”. Organization of storage of pharmaceutical products: Requirements for the design and operation of storage premises: In order to ensure High Quality and safety of medicines and medical products in pharmacies, creation safe conditions labor when working with them, there are instructions for organizing the storage in pharmacies of various groups of medicines and medical products. The design, composition, size of the area and equipment of the storage premises of pharmaceutical warehouses and pharmacies must meet all the requirements of the current regulatory and technical documentation SNiP, guidelines, regulatory internal documentation, etc. Medicines, medical products in storage rooms must be placed taking into account the fullest use of space, creation the best conditions labor for warehouse and pharmacy workers, the possibility of using mechanization means and ensuring pharmaceutical order. Medicines and medical products should be placed on racks, in cabinets, and, if necessary, on the floor, having previously placed a tray, a shelf, a special plate, etc. The design, operation and equipment of storage premises must ensure the safety of medicines and medical products. Storage premises are provided with security and fire safety equipment in accordance with established standards. Storage areas must be maintained at a certain temperature and air humidity, and inspection frequency must be carried out at least once a day. To monitor these parameters, warehouses must be equipped with thermometers and hygrometers, which are mounted on the internal walls of the warehouse 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 must have a temperature and relative humidity recorder. To maintain air purity, storage rooms in accordance with current regulatory and technical documentation (SNiP, methodological recommendations, etc.) should be equipped with supply and exhaust ventilation with mechanical drive. If it is impossible to equip storage rooms with supply and exhaust ventilation, it is recommended to equip vents, transoms, second lattice doors, etc. Pharmacy warehouses and pharmacies are equipped with central heating devices. Heating of premises with gas appliances with an open flame or electric heating appliances with an open electric coil is not allowed. Storage facilities must be provided required quantity racks, cabinets, pallets, stockpiles, etc. The racks are installed in such a way that they are located at a distance of 0.6-0.7 m from the external 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 must be located so that the aisles are illuminated, and the distance between the racks is at least 0.75 m, ensuring free access to the goods. The premises of pharmaceutical warehouses and pharmacies must be kept clean; the floors of the premises should be cleaned periodically (but at least once a day) wet method using approved detergents. Basic principles of storage. Medicines and medical products in storage rooms must be placed taking into account the fullest use of space, the creation of the best working conditions for warehouse and pharmacy workers, the possibility of using mechanization means and ensuring pharmaceutical order. Medicines and medical products should be placed on shelves, in cabinets, and, if necessary, on the floor, having previously placed a tray, a shelf, a special plate, etc. In storage rooms, medicines are placed separately: - in strict accordance with toxicological groups; - poisonous, narcotic and potent medicines must be stored in accordance with current requirements; - in accordance with pharmacological groups; - depending on the method of application (internal, external); - medicinal substances "angro" in accordance with the state of aggregation (liquid separately from bulk, gaseous, etc.); - in accordance with the physico-chemical properties of drugs and the influence of various factors external environment; - taking into account the established shelf life for medicinal products with limited shelf life; - taking into account the nature of the various dosage forms. Medical products should be stored separately in groups: - rubber products; - plastic products; - dressings and auxiliary materials; - medical equipment products. During storage, a continuous visual inspection of the condition of the container and external changes in medicines and medical products should be carried out at least once a month. If a container is damaged, its defects must be immediately repaired or the contents must be transferred to another container. In case of external changes in medicines, their quality is monitored in accordance with the requirements of the State Pharmacopoeia (SP) and other regulatory and technical documents (NTD) and their suitability for use is determined in the prescribed manner. In storage premises, as well as on the territory of the warehouse, it is necessary to systematically carry out measures to combat rodents, insects and other pests. Requirements for the storage of various groups of medicines and medical products. All medicines, depending on the physical and physical and chemical properties, the impact of various environmental factors on them, are divided into: - requiring protection from light, - requiring protection from moisture, - requiring protection from volatilization and drying, - requiring protection from exposure elevated temperature, - requiring protection from low temperatures, - requiring protection from the effects of gases contained in the environment, odorous, coloring and a separate group of medicines - disinfectants. Features of storing medicines that require protection from light: Medicines that require protection from light include: antibiotics, herbal remedies(tinctures, extracts, concentrates from plant raw materials), herbal medicinal raw materials, organopreparations, vitamins and vitamin preparations; corticosteroids, essential oils, fixed oils, coated preparations, salts of hydroiodic and hydrobromic acids, halogen-substituted compounds, nitro- and nitroso compounds, nitrates, nitrites, amino and admide compounds, phenolic compounds, phenothiazine derivatives. Medicines that require protection from light should be stored in containers made of light-protective materials ( glass containers orange glass, metal containers, packaging made of aluminum foil or polymeric materials painted black, brown or orange colors), in a dark room or cabinets painted inside with black paint with tightly fitting doors or in tightly packed drawers with a tightly fitting lid. For storing particularly sensitive to light medicinal substances(silver nitrate, proserine, etc.) glass containers are covered with black opaque paper. Peculiarities of storage of medicines requiring protection from moisture. Medicines that require protection from moisture include: hygroscopic substances and preparations (for example, potassium acetate, dry extracts, herbal medicinal raw materials, hydrolyzing substances, nitric, nitrogenous, hydrogen halide and phosphoric acid, salts of alkaloids, sodium organometallic compounds, glucosides, antibiotics, enzymes, dry organopreparations), medicinal substances characterized by the FS as “very easily soluble in water”, as well as medicinal substances, the moisture content of which should not exceed the limit established by the Global Fund and other scientific and technical documents , and medicinal substances oxidized by atmospheric oxygen. Medicines that require protection from exposure to atmospheric water vapor should be stored in a cool place, in tightly closed containers made of materials impermeable to water vapor (glass, metal, aluminum foil, thick-walled plastic containers). Medicines with pronounced hygroscopic properties should be stored in a dry place in glass containers with an airtight seal, filled with paraffin on top. When closing containers with such medicinal substances, it is necessary to carefully wipe the throat and stopper. Peculiarities of storage of medicines that require protection from volatilization and drying out. Medicines that require protection from volatilization include: - volatile substances themselves; - medicinal products containing a volatile solvent ( alcohol tinctures, liquid alcohol concentrates, thick extracts); - solutions and mixtures of volatile substances (essential oils, solutions of ammonia, formaldehyde, hydrogen chloride over 13%, carbolic acid, ethanol different concentrations, etc.); - medicinal plant materials containing essential oils; - medicinal preparations containing water of crystallization - crystal hydrates; - medicinal substances that decompose to form volatile products (iodoform, hydrogen peroxide, chloramine B, sodium bicarbonate); - medicinal substances with a lower limit of moisture content established by regulatory and technical documentation (magnesium sulfate, sodium para-aminosalicylate, sodium sulfate, etc.). Medicines that require protection from volatilization and drying out should be stored in a cool place, in hermetically sealed containers made of materials impenetrable to volatilization (glass, metal, aluminum foil). The use of polymer containers, packaging and closures is permitted in accordance with the Global Fund and other normative and technical documentation. Peculiarities of storage of medicines requiring protection from exposure to elevated temperatures. Medicines that require protection from exposure to elevated temperatures include: - a group of medicinal substances that require protection from volatilization and drying; - fusible substances; - immunobiological preparations; - antibiotics; - organopreparations; - hormonal drugs; - vitamins and vitamin preparations; - preparations containing glycosides; - medical fats and oils; - fat-based ointments and other substances. Medicines that require protection from exposure to elevated temperatures should be stored at room (18-20 degrees C), cool (or cold - 12-15 degrees C) temperature. In some cases more is required low temperature storage (for example, for ATP - 3-5 degrees C), which should be indicated on the label or in the instructions for use of the drug. Immunobiological preparations should be stored in industrial packaging separately by name, at the temperature indicated for each name on the label or in the instructions for use. Immunobiological preparations of the same name are stored in batches, taking into account their expiration date. It is necessary to strictly comply with the requirements for the timely replacement of serums and vaccines in a minimum supply with freshly produced ones. Immunobiological preparations should be subjected to visual inspection during storage at least once a month. Antibiotics should be stored in industrial packaging at room temperature unless otherwise indicated on the label. Organic preparations should be stored in a cool and dry place, protected from light, at a temperature of 0+15 degrees. C, unless otherwise indicated on the labels or in the instructions for use. Burov's liquid must be stored in a cool place. If cloudy, the solution is filtered and checked for compliance with all the requirements of the State Fund. Opalescence of the solution is allowed. Peculiarities of storage of medicines requiring protection from exposure to low temperatures. Medicines that require protection from the effects of low temperatures include those whose physicochemical state changes after freezing and is not restored upon subsequent warming to room temperature (40% formaldehyde solution, insulin solutions, etc.). A 40% solution of formaldehyde (formalin) should be stored at a temperature not lower than +9 degrees C. When a precipitate appears, keep at room temperature, then the solution is carefully drained and used in accordance with the actual formaldehyde content. Glacial acetic acid should be stored at a temperature not lower than +9 degrees C. If a precipitate appears, the acid is kept at room temperature until the precipitate dissolves. If the precipitate does not dissolve, the liquid part of the acid is drained and used in accordance with the actual content of acetic acid in the preparation. Medical fatty oils must be stored at temperatures ranging from +4 to +12 degrees C. When sediment appears, they are kept at room temperature, decanted and checked for compliance with all the requirements of the State Fund. If sediment appears, oils are not used in medical practice. Freezing of insulin preparations is unacceptable. Features of storage of odorous and coloring medicines and parapharmaceutical products. The odorous group consists of both volatile and practically non-volatile drugs with a strong odor. The group of coloring medicinal products includes substances, their solutions, mixtures, preparations, etc., leaving a colored mark on containers, closures, equipment and other objects that is not washed off by ordinary sanitary and hygienic treatment (diamond green, methylene blue, indigo carmine and etc.). Odorable medicines should be stored separately in hermetically sealed containers, impervious to odor, separately by name. Medicines and parapharmaceutical products should be stored separately. Coloring medicines must be stored in a special cabinet in tightly closed containers, separately by name. To work with dyes, it is necessary to allocate special scales, a mortar, a spatula and other equipment for each item. Features of storage of finished medicines Storage of finished medicines must meet the requirements of the Global Fund and all general requirements of these instructions for the storage of medicines, taking into account the properties of the ingredients included in their composition. All finished medicinal products must be placed and installed in the original packaging with the label (marking) facing out. A rack card is attached to the racks, shelves, and cabinets, which indicates the name of the medicine, series, expiration date, and quantity. The card is printed on thick paper and issued for each newly received series to monitor its timely implementation. In addition, the department should have a card index of expiration dates. Drugs that are subject to re-control and have expired are stored separately from others until analysis results are received. Tablets and dragees are stored separately from other medicines in their original packaging, which protects them from external influences and designed for holidays for individual patients and medical institutions. Tablets and dragees should be stored in a dry place and, if necessary, protected from light. Dosage forms for injections should be stored in a cool place, protected from light, in a separate cabinet or isolated room and taking into account the nature of the container (fragility), unless otherwise indicated on the packaging. Liquid dosage forms (syrups, tinctures) should be stored in a hermetically sealed container filled to the top in a cool place, protected from light. Precipitates that fall out during storage of tinctures are filtered out, and if the filtered tincture, after quality control, meets the established requirements of the State Fund, it is considered suitable for use. Plasma replacement (and detoxification) solutions are stored in isolation at a temperature ranging from 0 degrees C to 40 degrees C, protected from light. In some cases, freezing of the solution is allowed if this does not affect the quality of the drug. Extracts are stored in a glass container, sealed with a screw cap and a stopper with a gasket, protected from light. Liquid and thick extracts are stored at a temperature of 12-15 degrees C. Precipitation that falls in liquid extracts over time, filtered and, if the extracts, after quality control, meet the established requirements of the Global Fund, they are considered suitable for use. Ointments and liniments are stored in a cool, dark place in a tightly closed container. If necessary, storage conditions are combined depending on the properties of the incoming ingredients. For example, drugs containing volatile and thermolabile substances are stored at a temperature not exceeding 10 degrees C. Suppositories should be stored in a dry, cool place, protected from light. Most medicines in aerosol containers should be stored at a temperature from +3 to +20 degrees C. In a dry place, protected from light, away from fire and heating devices. Aerosol packages should be protected from impacts and mechanical damage. Regulatory framework for storing medications. funds and medical information: -ORDER of the Ministry of Health of the Russian Federation dated August 23, 2010 N 706n; “On approval of rules for storing medicines” - ORDER of the Ministry of Health of the Russian Federation dated November 13, 1996 N 377 (as amended by Order of the Ministry of Health and Social Development of the Russian Federation dated August 23, 2010 N 706n) “On approval of instructions for organizing storage in pharmacies of various groups of medicines and medical products " Design of labels in OZ: The procedure for forming free retail prices for medications: These issues are discussed in the Procedure for setting prices for medicines and medical products (separate issues) (Appendix No. 5 to the Order of the Prime Minister of the Moscow Government dated October 6, 1997 No. 1093-RP). In cases where the terms of the agreement between Russian companies stipulate that payment will be made as medicines are sold and their cost is indicated in foreign currency, the trade markup should be applied to the price converted into rubles at the exchange rate of the Central Bank of the Russian Federation on the date of receipt of medicines on buyer's warehouse. If the contract stipulates that the supplier of medicines provides the consumer with a percentage discount from the free wholesale (selling) price of medicines and indicates this in the payment document, the wholesale or trade markup is applied to the price reduced by the amount of this discount. In cases where the supplier indicates to the consumer in the payment document that, of the total quantity of medicines supplied, a part of certain medicines is sold as a natural discount, such a discount should be considered by analogy with a percentage discount. If the agreement stipulates that, as a result of joint cooperation, the supplier sells medicines of other names without payment in addition to the main supply, their further sale is carried out with the addition of a wholesale or trade markup, depending on the type of sale of the goods, to the prices indicated by the supplier in the invoice for the goods. Income from the sale of medicines received free of charge is used for the results of financial and economic activities. When a pharmaceutical enterprise produces medicines from customer-supplied raw materials and then presents the costs of their production to the owner of the raw materials, free wholesale (sales) prices for domestic finished products can be formed by the owner of the raw materials based on their cost, as well as supply and demand on the wholesale market. Moreover, all costs for the production of such products must be reflected on the balance sheet of the owner of the finished product. An organization or entrepreneur that has supplied customer-supplied raw materials to an organization that has a license for the production of medical products and has entered into an agreement on joint activities with the manufacturing organization, which states that the owner of the product ready for sale is the owner of the raw materials, have the right to independently form selling wholesale prices. Pharmacy enterprises (firms) engaged in wholesale trading activities and those containing pharmacies on their balance sheet (without the right legal entity), but having licenses to retail subject to separate accounting for the wholesale and retail levels, retail prices for medicines and medical products are formed using two surcharges simultaneously (wholesale and retail). Prices for medicines manufactured by pharmacies are based on the cost of ingredients according to retail prices, packaging and manufacturing tariffs. Tariffs for the manufacture of medicines are free and determined by pharmacies. The exchange of medicines and medical products is carried out in the following order: - at the retail level - at retail prices set by pharmacies taking into account the trade markup; - in the wholesale link - at wholesale prices formed by the wholesale link, taking into account the trade markup. The exchange of imported medicines and medical products purchased by wholesale organizations at the expense of their own foreign currency funds is carried out at selling prices formed in accordance with current regulatory documents. Further sales of goods received through exchange are carried out at the exchange price without the use of any trade markups. Registration of price tags: The design of price tags is regulated by Decree of the Government of the Russian Federation dated January 19, 1998 N 55 (as amended on October 4, 2012) “On approval of the Sales Rules individual species goods, a list of durable goods that are not subject to the buyer’s requirement to provide him free of charge for the period of repair or replacement of a similar product, and a list of non-food products of good quality that cannot be returned or exchanged for a similar product of a different size, shape, size, style, color or configuration" (with amendments and additions coming into force from 01/01/2013) According to the resolution, "the seller is obliged to ensure the availability of uniform and clearly written price tags for the goods sold, indicating the name of the product, its grade, price per weight or unit of goods, signature financially responsible person or the seal of the organization, the date of registration of the price tag."

Thousands of assortment items on the computer, tens of thousands of packages on pharmacy shelves, and all of them bring health to our customers! True, only if we store them correctly. The abundance of goods in the pharmacy and the multitude of storage modes will confuse the average person, but for us, professionals in the pharmaceutical market, it is not difficult to comply with the requirements of the pharmacopoeia.

Temperature and humidity in a pharmacy

Storage of medicinal products for medical use is carried out in accordance with the requirements state pharmacopoeia And regulatory documentation, as well as taking into account the properties of the substances included in their composition. In addition to the pharmacopoeia, the microclimate of a pharmacy is regulated by three main documents: Order of the Ministry of Health of the Russian Federation No. 377 of November 13, 1996 “On approval of requirements for the organization of storage in pharmacies of various groups of medicines and medical products”, Order of the Ministry of Health and social development RF dated August 23, 2010 No. 706n “On approval of the Rules for the storage of medicines” and Order of the Ministry of Health of the Russian Federation dated 10.21.97 No. 309 “On approval of instructions on the sanitary regime of pharmacy organizations.”

The State Pharmacopoeia of the Russian Federation (12th edition, put into effect in 2009) contains detailed information about temperature conditions x storage of medicines and substances for their manufacture:

in the refrigerator: 2-8⁰C
cold or cool place: 8-15⁰C
room temperature: 15-25⁰C
warm storage mode: 40-50⁰C
hot storage mode: 80-90⁰C
water bath temperature: 98-100⁰C
ice bath temperature: 0⁰С
deep cooling: below – 15⁰C

In a pharmacy that offers visitors only finished dosage forms, usually the first three temperature modes are used, and constant monitoring of air humidity is carried out. An electronic hygrometer or psychrometer is used to measure relative humidity. There may be only one hygrometer in a small pharmacy, but a thermometer should be available not only near the pharmacy shelves, but also in refrigerators. All instruments must be properly certified and calibrated. The thermometer is placed on the interior walls of the room 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. The recommended air temperature in the pharmacy premises is 16-20⁰С, relative air humidity is up to 60% (in some areas up to 70%). It is in this interval that it is ensured proper storage most dosage forms that have a “room temperature” storage mode (for example, most manufacturers recommend storing aerosols at a temperature of 3-20⁰C).

Checking the temperature and humidity in a pharmacy rests with the pharmacist: at least once a day, instrument readings are entered into a card (log) for recording temperature and relative humidity, which must be kept in each department of the pharmacy. There should be separate accounting cards not only in sales departments, but also in storage areas - the material room, the goods acceptance area. A log of air temperature and humidity can be kept in in electronic format with data archiving for the last year. Handwritten journals and accounting cards are stored for one year, not counting the current one (Order No. 706n).

If the air temperature in the pharmacy does not meet the required temperature, it is worth taking care of air conditioning or additional heating. Heating and ventilation systems must be located so as to exclude sharp changes temperatures and excessive heating of the drug storage area. When you turn on the air conditioner, do not forget to control the humidity: even the most modern climate systems tend to “dehydrate” the environment.

It is advisable to have at least two refrigerators or a two-chamber refrigerated display case in the pharmacy with the ability to separately set temperatures. The storage temperature for ATP is 3-5⁰С, many suppositories are stored at a temperature of 8-15⁰С - it is impossible to store them in the same refrigerator compartment.

Where to identify the product?

A common mistake when receiving goods at a pharmacy is placing boxes brought by the warehouse forwarder on the floor. This is unacceptable: both in the storage area and in the receiving area there must be pallets and racks on which boxes of goods can be placed.

Information about the storage mode of the drug is always present in the annotation to it and on the secondary (consumer) packaging, if available, therefore, in the process of accepting goods from the distributor’s warehouse, you can not rely on memory, but follow the manufacturer’s instructions (Order No. 377). Temperature requirements are also described in the accompanying delivery documents: many pharmaceutical warehouses mark drugs that must be stored in the refrigerator with a special icon; There is necessary information and in documents confirming the quality of the product (certificate, hygiene certificate, etc.).

Often in the annotation there is a recommendation to store the drug in a dry place. Pharmacopoeia considers dry a place with a relative humidity of not more than 40% at room temperature. During inspections of pharmacies by Roszdravnadzor, violations of this storage regime are often encountered - not all pharmacy organizations can allocate a separate room and provide such low humidity there for storing herbs and a number of other drugs that should be stored in a dry place. The pharmacy is recommended to allocate a separate room for such drugs and dry the air in it to the required humidity.

An excellent knowledge of regulatory documents comes to the aid of the pharmacist. Order No. 706n, issued many years after Order No. 377, states: “Bulk medicinal plant materials must be stored in a dry (no more than 50% humidity), well-ventilated area in a tightly closed container. Packaged medicinal plant materials are stored on shelves or in cabinets.” Despite the fact that this provision somewhat contradicts the pharmacopoeia, one should be guided by it: medicinal raw materials in the manufacturer’s packaging are pre-packaged and can be stored in display cabinets in the sales area. Yes, sometimes a pharmacy manager has to be a bit of a lawyer to defend his point of view during an inspection!

Some pharmaceutical products require additional protection from light (herbal medicinal raw materials, antibiotics, tinctures and extracts, vitamin complexes, essential oils, nitrates and many others). They arrive at the pharmacy in packaging made from light-protective materials, but they should be stored in a dark room or in tightly closed cabinets or on racks, provided that measures are taken to prevent direct contact with these medications. sunlight or other bright directional light (use of reflective film, blinds, visors, etc.).

Narcotic, psychotropic, potent and poisonous drugs have their own special rules storage, but their compliance is more related to ensuring safety than maintaining the quality of the drug in the pharmacy. The rules for storing narcotic drugs and psychotropic substances are established by Decree of the Government of the Russian Federation of December 31, 2009 N 1148.

Requires special attention placement of flammable drugs in a pharmacy– alcohol, alcohol solutions, tinctures, extracts, organic oils and a number of other products. For their storage, a separate cabinet should be allocated away from heating devices (at least 1 meter), in which bottles can only be placed in one row in height.

In a pharmacy, the rules for storing drugs are usually followed, but what happens after the drug is sold? Many of our customers place a first aid kit in the bathroom or kitchen, which negatively affects the quality of medicines and can significantly reduce their effectiveness, because it gets hotter in the kitchen while cooking, and hot drinks drinkers in the bathroom water procedures they can “raise” the temperature to 50⁰С and even higher, and the air humidity does not meet the required level. When completing the sale, be sure to remind the client of the need to follow the rules for storing the drug at home!

Published: 02/20/2013