Accounting and storage of medicines and products in medical institutions. Features of storage of finished medicines

"On approval of the Rules for the storage of medicines"

Published on October 13, 2010. Enters into force on October 24, 2010. Registered with the Ministry of Justice of the Russian Federation on October 4, 2010. Registration No. 18608

Rules for storing medicines

I. General provisions

1. These Rules establish requirements for premises for storing medicines for medical use (hereinafter referred to as medicines), regulate the storage conditions of these medicines and apply to

  • drug manufacturers,
  • organization of wholesale trade in medicines,
  • pharmacy organizations,
  • medical and other organizations operating in the circulation of medicines,
  • individual entrepreneurs who have a license for pharmaceutical activities or a license for medical activities (hereinafter referred to as organizations, individual entrepreneurs, respectively).

II. General requirements for the design and operation of drug storage premises

2. The design, composition, size of areas (for organizations of wholesale trade in medicines), operation and equipment of premises for storing medicines must ensure them safety.
3. In the premises for storing medicines, certain temperature And air humidity, allowing for the storage of medicines in accordance with the requirements of the manufacturers of medicines specified on the primary and secondary (consumer) packaging.
4. Premises for storing medicines must be equipped air conditioners and other equipment that allows for the storage of medicines in accordance with the requirements of the manufacturers of medicines specified on the primary and secondary (consumer) packaging, or it is recommended to equip the premises with windows, transoms, and second lattice doors.
5. Premises for storing medicines must be provided racks, cabinets, pallets, stockpiles.
6. The finishing of premises for storing medicines (internal surfaces of walls, ceilings) must be smooth and allow for the possibility of wet cleaning.

III. General requirements for premises for storing medicines and organizing their storage

7. Premises for storing medicines must be equipped with devices for registration of air parameters(thermometers, hygrometers (electronic hygrometers) or psychrometers). The measuring parts of these devices must be located at a distance of at least 3 m from doors, windows and heating devices. Devices and (or) parts of devices from which readings are visually read must be located in a place accessible to personnel at a height of 1.5-1.7 m from the floor.
The readings of these instruments must be recorded daily in a special magazine (map) registration on paper or electronically with archiving (for electronic hygrometers), which is maintained by the responsible person. The registration log (card) is stored for one year, not counting the current one. Control devices must be certified, calibrated and verified in accordance with the established procedure.
8. Medicines are placed in storage rooms in accordance with the requirements of the regulatory documentation indicated on the packaging of the medicinal product, taking into account:

  • physicochemical properties of medicines;
  • pharmacological groups (for pharmacy and medical organizations);
  • method of application (internal, external);
  • state of aggregation of pharmaceutical substances (liquid, bulk, gaseous).
When placing medicines, the use of computer technologies is allowed (alphabetically, by code).
9. Separately, in technically fortified premises that meet the requirements of Federal Law of January 8, 1998 N 3-FZ "On narcotic drugs and psychotropic substances"(Collected Legislation of the Russian Federation, 1998, No. 2, Art. 219; 2002, No. 30, Art. 3033, 2003, No. 2, Art. 167, No. 27 (Part I), Art. 2700; 2005, No. 19, Article 1752; 2006, No. 43, Article 4412; 2007, No. 30, Article 3748, No. 31, Article 4011; 2008, No. 52 (part 1), Article 6233; 2009, No. 29, Art. 3614; 2010, No. 21, Article 2525, No. 31, Article 4192) are stored:

  • narcotic and psychotropic drugs;
  • potent and poisonous medicines controlled in accordance with international legal standards.
10. Shelving (cabinets) for storing medicines in medicine storage rooms must 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 shelving, walls, and floors for cleaning.
Racks, cabinets, shelves intended for storing medicines must be numbered.
Stored medicinal products must also be identified using rack card, containing information about the stored medicinal product (name, release form 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 maintain accounting for medicines with a limited shelf life on paper or electronically 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 logs. The procedure for maintaining records of these medicines is established by the head of the organization or individual entrepreneur.
12. When identifying drugs with expired they must be kept separately from other groups of medicines in a specially designated and designated (quarantine) area.

IV. Requirements for premises for storing flammable and explosive medicines and organizing their storage

13. Storage facilities flammable and explosive drugs must fully comply with current regulations.
14. In order to ensure the storage of flammable and explosive medicines on the principle of homogeneity in accordance with their physico-chemical, fire hazardous properties and the nature of the packaging, storage premises for wholesale trade organizations of medicines and manufacturers of medicines (hereinafter referred to as warehouse premises) are divided into separate premises (compartments) with fire resistance limit building structures for at least 1 hour.
15. Necessary for packaging and manufacturing of medicinal products for medical use in one work shift quantities of flammable medicines 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 location.
16. The floors of warehouses and unloading areas must have hard, even coating. It is prohibited to use boards and iron sheets to level floors. Floors must ensure convenient and safe movement of people, cargo and vehicles, have sufficient strength and withstand the loads of stored materials, and ensure simplicity and ease of cleaning the warehouse.
17. Warehouses for storing flammable and explosive medicines must be equipped fireproof and resistant racks and pallets designed for the appropriate load. The 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 passages between the racks should be at least 1.35 m.
18. For the storage of flammable and explosive medicines in pharmacies and individual entrepreneurs, allocated isolated premises, equipped with automatic fire protection and alarm systems (hereinafter referred to as premises for storing flammable and explosive medicines).
19. Pharmacy organizations and individual entrepreneurs are allowed to store pharmaceutical substances that have flammable and combustible properties, in a volume of up to 10 kg outdoors for storing flammable and explosive medicines in built-in fireproof cabinets. Cabinets must be located away from heat-dissipating surfaces and passages, with doors at least 0.7 m wide and at least 1.2 m high. Free access to them must be provided.
It is allowed to store explosive drugs for medical use (in secondary (consumer) packaging) for use on one work shift in metal cabinets outdoors for storing flammable and explosive medicines.
20. The amount of flammable medicines allowed for storage in premises for storing flammable and explosive medicines located in buildings for other purposes should not exceed 100 kg in bulk.
Premises for storing flammable and explosive drugs used for storing flammable pharmaceutical substances in quantities over 100 kg must be in separate building, and the storage itself should be carried out in glass or metal containers isolated from premises for storing flammable drugs of other groups.
21. It is prohibited to enter premises for storing flammable and explosive medicines with open fire sources.

V. Features of organizing the storage of medicines in warehouses

22. Medicines stored in warehouses must be placed on racks or at podtovarniki(pallets). It is not allowed to place medicines on the floor without a tray.
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. When unloading and loading operations are carried out manually, the height of stacking of medicines should not exceed 1.5 m.
When using mechanized devices for unloading and loading operations, medicines should be stored in several tiers. At the same time, the total height of placement of medicines on the racks should not exceed the capabilities of mechanized loading and unloading equipment (lifts, trucks, hoists).

VI. Peculiarities of storage of certain groups of medicines depending on physical and physico-chemical properties, the impact of various environmental factors on them

Storing medications that require protection from light

24. Medicines that require protection from light are stored in rooms or specially equipped places that provide protection from light. natural and artificial lighting.
25. Pharmaceutical substances that require protection from light should be stored in containers made of light-protective materials(orange glass containers, metal containers, packaging made of aluminum foil or polymer materials painted black, brown or orange), in a dark room or cabinets.
To store pharmaceutical substances that are particularly sensitive to light (silver nitrate, proserin), glass containers are covered with black opaque paper.
26. Medicines for medical use that require protection from light, packaged in primary and secondary (consumer) packaging, should be stored in cabinets or on racks, provided that measures are taken to prevent entry for these medications direct sunlight or other bright directional light(use of reflective film, blinds, visors, etc.).

Storing medications that require protection from moisture

27. Pharmaceutical substances requiring protection from exposure to moisture, should be stored in a cool place at temperatures up to + 15 degrees WITH(hereinafter referred to as a cool place), in a tightly closed container made of materials impervious 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 glass containers with a hermetically sealed seal filled with paraffin on top.
29. To avoid spoilage and loss of quality, storage of medicines should be organized in accordance with the requirements printed in the form of warning notices on the secondary (consumer) packaging of the medicine.

Storage of medicines that require protection from volatilization and drying out

30. Pharmaceutical substances that require protection from volatilization and drying:

  • actual volatile drugs;
  • medicines containing a volatile solvent

  1. alcohol tinctures,
  2. liquid alcohol concentrates,
  3. thick extracts;

  • solutions and mixtures of volatile substances

  1. essential oils,
  2. ammonia solutions,
  3. formaldehyde solutions,
  4. hydrogen chloride solutions over 13%,
  5. carbolic acid solutions,
  6. ethyl alcohol of various concentrations, etc.;

  • medicinal plant materials containing essential oils;
  • medicines containing water of crystallization - crystal hydrates;
  • drugs that decompose to form volatile products

  1. iodoform,
  2. hydrogen peroxide,
  3. sodium bicarbonate;

  • medicinal products with a certain lower limit of moisture content

  1. magnesium sulfate,
  2. sodium para-aminosalicylate,
  3. sodium sulfate,
should be stored in cool place, in 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 closures is permitted 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 meet the requirements of regulatory documentation for these medicinal products.

Storage of medicines requiring protection from exposure to elevated temperatures

32. Storage of medicines requiring protection from exposure elevated temperature(heat-labile medicinal products), 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.

Storage of medicines requiring protection from exposure to low temperatures

33. Storage of medicines requiring protection from exposure low temperature(medicines, the physico-chemical state of which 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 drugs insulin not allowed.

Storage of medicines requiring protection from gases contained in the environment

35. Pharmaceutical substances requiring protection from exposure to gases

  • substances that react with oxygen in the air:

  1. various compounds of the aliphatic series with unsaturated intercarbon bonds,
  2. cyclic with side aliphatic groups with unsaturated intercarbon bonds,
  3. phenolic and polyphenolic,
  4. morphine and its derivatives with unsubstituted hydroxyl groups;
  5. sulfur-containing heterogeneous and heterocyclic compounds,
  6. enzymes and organochemicals;

  • substances that react with carbon dioxide in the air:

  1. salts of alkali metals and weak organic acids (sodium barbital, hexenal),
  2. medications containing polyhydric amines (aminophylline), magnesium oxide and peroxide, sodium hydroxide, potassium hydroxide,
should be stored in hermetically sealed container made of materials impermeable to gases, filled to the top if possible.

Storage of odorous and coloring medicines

36. Smelly medicines (pharmaceutical substances, both volatile and practically non-volatile, but having strong odor) should be stored in a hermetically sealed, odor-proof container.
37. Coloring medicines (pharmaceutical substances that leave a colored mark that is not washed off by normal 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 medicinal products, it is necessary to highlight for each name special scales, mortar, spatula and other necessary equipment.

Storage of disinfectant medicines

39. Disinfectants Medicines should be stored in hermetically sealed containers in an isolated room away from storage areas for plastic, rubber and metal products and premises for obtaining distilled water.

Storage of drugs for medical use

40. Storage of medicinal products for medical use is carried out in accordance with the requirements state pharmacopoeia And regulatory documentation, and also taking into account properties substances included in their composition.
41. When stored in cabinets, on racks or shelves, medicinal products for medical use in secondary (consumer) packaging must be placed label(marked) outward.
42. Organizations and individual entrepreneurs must store medicines for medical use in accordance with requirements for their storage indicated on the secondary (consumer) packaging of the specified medicinal product.

Storage of medicinal plant materials

43. Bulk medicinal plant materials should be stored in dry(no more than 50% humidity), in a well-ventilated area in a tightly closed container.
44. Bulk medicinal plant materials containing essential oils, stored separately in a well-closed container.
45. Bulk medicinal plant materials must be subject to periodic monitoring 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 ingredients, as well as affected by mold, barn pests, reject.
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 testing for biological activity.
47. Bulk medicinal plant materials included in the lists potent And poisonous substances approved by Decree of the Government of the Russian Federation of December 29, 2007 N 964 "On approval of 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 amounts of potent substances for the purposes of Article 234 of the Criminal Code of the Russian Federation" (Collected Legislation of the Russian Federation, 2008, No. 2, Art. 89; 2010, No. 28, Art. 3703), stored in a separate room or in a separate cabinet under lock and key.
48. Prepackaged medicinal plant materials are stored on shelves or in cabinets.

Storage of medicinal leeches

49. Storage of medicinal leeches is carried out in a bright room without the smell of medicine, for which a constant temperature regime is established.
50. The maintenance of leeches is carried out in accordance with the established procedure.

Storage of flammable drugs

51. Storage of flammable drugs

  • medicines that have flammable properties

  1. alcohol and alcohol solutions,
  2. alcohol and ether tinctures,
  3. alcohol and ether extracts,
  4. ether,
  5. turpentine,
  6. lactic acid,
  7. chloroethyl,
  8. collodion,
  9. cleol,
  10. Novikov liquid,
  11. organic oils

  • medicines that have flammable properties

  1. sulfur,
  2. glycerol,
  3. vegetable oils,
  4. medicinal plant materials)
should be carried out separately from other medicines.
52. Flammable medications are stored in tightly closed, strong glass or metal containers to prevent evaporation liquids from vessels.
53. Bottles, cylinders and other large containers with flammable and flammable medicines should be stored on shelves in one row in height. It is prohibited to store them in several rows in height using different cushioning materials.
It is not allowed to store these medicines in 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 impact-resistant containers or in one-row tipper containers.
55. At workplaces of production premises allocated in pharmacy organizations and individual entrepreneurs, flammable and combustible medicines can be stored in quantities not exceeding replacement need. In this case, the containers in which they are stored must be tightly closed.
56. It is not allowed to store flammable and highly combustible medicines in completely filled containers. The filling level should be no more than 90% volume. Alcohols in large quantities are stored in metal containers filled to no more than 75% of the volume.
57. It is not allowed to store flammable medicines together 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 produce explosive mixtures with organic substances

  1. potassium chlorate,
  2. potassium permanganate,
  3. potassium chromate, etc.
58. Medical ether and ether for anesthesia Store in industrial packaging, in a cool place, protected from light, away from fire and heating devices.

Storage of explosive drugs

59. During storage explosive medicines (medicines with explosive properties (nitroglycerin); medicines with explosive properties (potassium permanganate, silver nitrate) measures should be taken against contamination with dust.
60. Containers with explosive drugs (barbells, tin drums, bottles, etc.) must close tightly to prevent vapors from these products from entering the air.
61. Storage of bulk potassium permanganate allowed in a special compartment of warehouses (where it is stored in tin drums), in rods with ground-in stoppers, separately from other organic substances - in pharmacy organizations and individual entrepreneurs.
62. Bulk solution nitro glycerin stored in small well-closed bottles or metal vessels in a cool place, protected from light, taking precautions against fire. Move the container with nitroglycerin and weigh out this drug under conditions that prevent spillage and evaporation of nitroglycerin, as well as contact with the skin.
63. When working with diethyl ether Shaking, impacts, and friction are not allowed.
64. It is prohibited to store explosive medicines with acids and alkalis.

Storage of narcotic and psychotropic drugs

65. Narcotic And psychotropic medicines are stored in organizations in isolated premises, specially equipped with engineering and technical security equipment, and in temporary storage places 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 N 1148 (Collection of Legislation Russian Federation, 2010, No. 4, Article 394; No. 25, Article 3178).

Storage of potent and poisonous medicines, medicines subject to subject-quantitative accounting

66. In accordance with Decree of the Government of the Russian Federation of December 29, 2007 N 964 “On approval of 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 amounts of potent substances for the purposes of Article 234 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 substances and toxic substances.
67. Storage of potent and poisonous medicines under control in accordance with international legal standards (hereinafter referred to as potent and poisonous medicines under international control) is carried out in premises equipped with engineering and technical security means similar to those provided for the storage of narcotic and psychotropic drugs.
68. It is allowed to store potent and poisonous medicines under international control, and narcotic and psychotropic medicines in one technically fortified room.
In this case, the storage of potent and poisonous medicines should be carried out (depending on the volume of supplies) on different shelves of a safe (metal cabinet) or in different safes (metal cabinets).
69. Storage of potent and poisonous medicines that are not under international control is carried out in metal cabinets, sealed or sealed at the end of the working day.
70. Medicines subject to subject-quantitative accounting in accordance with the order of the Ministry of Health and Social Development of the Russian Federation dated December 14, 2005 N 785 “On the procedure for dispensing medicines” (registered with the Ministry of Justice of the Russian Federation on January 16, 2006 N 7353), with the exception of narcotic, psychotropic, potent and poisonous medicines, are stored in metal or wooden cabinets, sealed or sealed at the end of the working day.
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Order No. 646n in paragraph 3 gives the head of the subject of circulation of medicinal products (hereinafter referred to as medicinal products) the obligation to provide a set of measures to ensure that employees comply with the rules for storing and (or) transporting medicinal products. The subject of the appeal in this case is understood as any of the organizations that are subject to the said order, including a medical organization and its separate divisions (outpatient clinics, paramedic and paramedic-obstetric stations, centers (departments) of general medical (family) practice) located in rural areas. settlements where there are no pharmacies. It follows from the above that every medical organization involved in the storage of medicines must, starting in 2017, comply with the “new” rules for good storage practices.

The set of measures of the head of a medical organization is called a quality system and includes a wide variety of actions to ensure compliance with the Rules of storage and transportation. In particular, to implement a quality system for storing medicinal products, a medical organization requires:

  1. Approve regulations for employees to perform actions during the storage and transportation of medicines.
  2. Approve procedures for servicing and checking measuring instruments and equipment.
  3. Approve the procedure for maintaining entries in journals and reporting procedures.
  4. Organize control over compliance with standard operating procedures.

At the same time, the new rules for storing and transporting medicines require the head of a medical organization to approve additional documents regulating the procedure for receiving, transporting, and disposing of medicines. These actions are called standard operating procedures.

Approval of regulations (standard operating procedures) for employees to perform actions during the storage and transportation of medicines

To introduce a quality system and implement standard operating procedures, the head of a medical organization issues an order and instructs the responsible person to develop and submit for approval regulations (instructions) for performing various actions during the storage of medicines. The Rules for Good Storage Practices have not established a specific list of such instructions. Taking into account the “breakdown” of standard operating procedures for the reception, transportation and placement of drugs, it is advisable to divide the process of storing drugs in a medical organization into the same stages and detail each stage in the instructions, for example, approve the following documents:

1. Instructions for accepting medications from the carrier

Instructions on the procedure for taking medicines from the carrier (transport organization) must set out a list of actions of an employee of a medical organization upon receipt of a batch of medicines and contain instructions on what circumstances the employee should clarify when preparing documents for each batch of medicines. Thus, the employee should be aware that, in accordance with the Good Storage and Transport Practices, drugs with a shorter expiration date are released for transportation first. The remaining shelf life is agreed upon with the recipient of the medicine in preparation for transportation. If the remaining shelf life of the drug is short, when agreeing to receive the drug, it is better for the medical organization to refuse such a delivery in order to avoid subsequent write-off of the entire received batch.

When accepting a drug, the employee must check the compliance of the drug being taken with the accompanying documentation in terms of assortment, quantity and quality (checks the name, quantity of drugs with the delivery note or delivery note and invoice, checks the appearance of the container).

As part of standard operating procedures, a medical organization, before taking medications, must plan the transportation of medications, analyzing and assessing possible risks. In particular, before delivery, the carrier finds out whether the medicine has special storage conditions and whether the carrier will be able to provide them during transportation. Although this is the responsibility of the carrier and not the medical organization, the latter also has an interest in ensuring that the transport company is aware of the conditions for transporting a particular drug in order to obtain it suitable for use. In this regard, it is recommended, at the request of the carrier, to provide complete information about the quality characteristics of medicines, the conditions of their storage and transportation, including temperature, lighting, requirements for containers and packaging.

We should also pay attention to the packaging. A worker involved in taking medications should pay attention to the quality of the container, as well as the presence on the container of information about the name, series of drugs being transported, the date of their release, the number of packages, the name and location of the drug manufacturer, their expiration date and conditions of storage and transportation. . The absence of this information may indirectly indicate possible violations of transportation conditions or even counterfeit goods. If discrepancies or damage to the container are detected, the drugs should not be taken - they must be returned to the supplier with the drawing up of an appropriate report and the implementation of the return procedure provided for in the contract. An employee of a medical organization must be instructed on the procedure for completing the procedure for returning such a product.

According to the new Rules for Good Storage and Transportation Practices, carrier employees sent on a flight are instructed on the procedure for preparing insulated containers for the transportation of medicines (taking into account seasonal characteristics), as well as on the possibility of reusing cold packs. In addition to the new transportation rules, they must take into account the instructions for the drugs, as well as the conditions of transportation mentioned in other regulations. For example, the conditions for transporting immunobiological medicinal products are contained in SP 3.3.2.3332-16, approved. Resolution of the Chief State Sanitary Doctor of the Russian Federation dated February 17, 2016 N 19, which, among other things, strictly prohibits the use of “cold chain” equipment for the joint transportation of the specified drugs and food products, other drugs, raw materials, materials, equipment and items that may affect the quality of the transported drugs or damage their packaging. When transporting medical products, the readings of each temperature indicator must be monitored during loading and unloading of drugs; the readings are recorded in a special journal for recording the movement of medical products twice a day - at the first, second and third levels of the “cold chain”, and once a day on working days - at fourth level. Also in the log should be noted facts of planned or emergency shutdown of refrigeration equipment, breakdowns and violations of temperature conditions.

In real life, of course, one cannot rely on the carrier’s strict compliance with the specified obligations to instruct its employees, as well as on the responsible attitude of such employees to the performance of their labor functions. During transportation, it is difficult to exclude the human factor, which entails a violation of the conditions of transportation - in order to save money, faulty cold elements are used several times, food and other raw materials are placed along with medicines, the temperature is entered into the log “as you please,” usually right before arriving at the recipient of the medicine. There are cases when the carrier’s refrigeration equipment is not equipped with thermometers at all or they do not work, always showing the same value. It happens that the arriving car, due to technical characteristics or due to the route laid out, obviously could not meet the temperature requirements, but was released by the transport company for the trip.

Although transportation rules require that information about cases of violation of the temperature storage conditions and damage to packaging identified during the transportation of a medicinal product be communicated to the sender and recipient of the medicinal products, in practice, of course, this requirement is not always observed. Carriers do not want to accept the risk of compensation for damage caused due to non-compliance with transportation rules and may seek to conceal this information.

All these points must be taken into account when accepting the medicine and noted in the instructions of the employee of the medical organization that if there are reasonable doubts about compliance with the temperature regime and other conditions during transportation, the identified circumstances should be reflected in documentary form and reported to management. The new storage rules give a medical organization the right to send a request to the supplier demanding confirmation of the circumstances of compliance with the conditions of transportation of a particular drug. If such confirmation is not received, the organization has the right to refuse to accept medications delivered in violation of the conditions of transportation.

2. Instructions for placing (transporting) medicinal products into the storage area

The instructions should reflect that when an employee accepts medications, the transport container is cleared of visual contamination - wiped, dust, stains, etc. are removed, and only after that is brought into the premises or storage area of ​​the medicine, and further storage of the medicine is carried out taking into account the requirements registration dossier for medicinal products, instructions for medical use, information on packages, on shipping containers.

The instructions should describe the rules for disposing of medicinal products, taking into account the Rules for Good Storage Practices. It is worth noting and conveying to the employee what not to do: for example, placing medications on the floor without a pallet, placing pallets on the floor in several rows, storing food products, tobacco products, etc. with medications.

Since, in accordance with the Rules of Good Storage Practice, racks (cabinets) for storing medicinal products must be marked, must have rack cards located in the visible area, and ensure the identification of medicinal products in accordance with the accounting system used by the subject of medicinal products circulation, in the storage instructions medications and the employee’s job description should reflect the responsibility for labeling racks (cabinets) and filling out rack cards.

If a medical organization uses an electronic data processing system instead of rack cards, the employee must be required to fill out data in such a system. New storage rules allow the identification of drugs in such a system using codes. This means that there is no need to enter the full names of the types of drugs or their locations each time - it is enough to assign a code for a particular value and approve a code correspondence table, which greatly simplifies office work.

Because in rooms and areas, storage temperature and humidity conditions must be maintained corresponding to the storage conditions specified in the registration dossier of the medicinal product, instructions for medical use and on the packaging; the instructions for storing medicinal products should mention the placement of drugs in accordance with the specified regimes and the responsibilities monitor changes in temperature and humidity by the worker.

The same instructions may reflect the procedures for cleaning premises (areas) for storing medicines - they are carried out in accordance with standard operating procedures that are the same for all subjects storing medicines. In this case, standard operating procedures mean the measures described in section 11 of SanPin 2.1.3.2630-10 “Sanitary and epidemiological requirements for organizations engaged in medical activities” - these measures are the same for all premises of a medical organization (with some exceptions): treatment at least 2 times a day, general cleaning at least once a month, washing windows at least 2 times a year, etc. In the storage instructions, you can simply make a reference to the instructions for wet cleaning of premises of a medical organization, so as not to clutter the document with unnecessary information.

An employee of a medical organization must be instructed that persons who do not have access rights determined by standard operating procedures are not allowed into the premises (areas) for storing medicinal products, i.e. persons whose job responsibilities are not related to the reception, transportation, placement and use of medications.

3. Instructions for storing medications that require special storage conditions

This document should examine point by point the features of storing various categories of drugs, for example, it should be noted that flammable and explosive drugs are stored away from fire and heating devices, and workers must avoid mechanical impact on such drugs. It should be stated in the instructions that medicines subject to subject-quantitative accounting, with the exception of narcotic, psychotropic, potent and poisonous medicines, are stored in metal or wooden cabinets, sealed or sealed at the end of the working day. The list of such drugs is established by Order of the Ministry of Health of Russia dated April 22, 2014 N 183n; an employee of a medical organization must know this list and be able to sort medications taking into account the specified list.

Medicines containing narcotic drugs and psychotropic substances must be stored in accordance with the legislation of the Russian Federation on narcotic drugs and psychotropic substances - first of all, taking into account the requirements of Order of the Ministry of Health of Russia dated July 24, 2015 N 484n. Thus, this Order prescribes the storage of narcotic and psychotropic medicines in premises belonging to the 4th category, or in places of temporary storage in safes (containers) located in the appropriate premises or places. Therefore, the employee who is given the keys to the safe must be identified. Typically, such an employee is a financially responsible person and receives a key “on signature.” The instructions should note the inadmissibility of handing over the keys to strangers, the procedure for handing over the key to the post and the prohibition on taking the keys home.

This order also indicates that at the end of the working day, narcotic and psychotropic medicines must be returned to the place of main storage of narcotic and psychotropic medicines - the medical worker should be required to check compliance with this requirement and reflect the procedure for action when a shortage is detected.

In medical organizations, on the inside of the doors of safes or metal cabinets where the specified drugs are stored, lists of stored drugs should be posted indicating their highest single and highest daily doses. Additionally, in medical organizations, tables of antidotes for poisoning with these drugs are placed in storage areas. It would be correct to assign to a specific employee the responsibility for generating these lists and monitoring the relevance of the information contained in them.

Medical organizations must store narcotic and psychotropic drugs manufactured by drug manufacturers or pharmacy organizations, therefore, the instructions may indicate the inadmissibility of self-production of such drugs by employees. The safe or cabinet with the specified drugs is sealed or sealed at the end of the working day - the sealing procedure must also be reflected in the instructions.

Storage of medicines containing potent and toxic substances, which are controlled in accordance with international legal standards, is carried out in premises equipped with engineering and technical security measures similar to those provided for the storage of narcotic and psychotropic medicines. The list of such drugs is contained in Decree of the Government of the Russian Federation of December 29, 2007 N 964. Taking into account these requirements, a medical organization must provide a security alarm, familiarize employees with the principles of its operation, appoint an employee responsible for servicing this system (personal service or with the help of a third party). organizations under contract).

Storage of medicines in a medical institution must comply with the general requirements of the Ministry of Health.

However, in practice they are often violated. Let us recall the basic rules for storing medications of different groups, and consider the typical mistakes of medical institutions when organizing storage processes. R

Let's find out who is responsible for improper storage of medications.

From the article you will learn:

  • Rules for storing medicines
  • Rules for storing drug groups
  • Requirements for storage conditions of drugs


Rules for storing medicines

Storage of medicines is one of the basic processes of circulation of medicines. Order of the Ministry of Health and Social Development of the Russian Federation No. 706n dated August 23, 2010 approved a list of rules according to which the storage of medicines is organized in medical institutions of the Russian Federation. Order "On approval of the Rules for the storage of medicines"

This document provides a classification of medicines that require protection from environmental factors - light, temperature, moisture, etc. The following groups of drugs have been identified, for each of which there are different storage rules: a group of products that require protection from exposure to a humid environment and light; medicines that, if stored improperly, can dry out and evaporate; medications that should be stored at a certain temperature; drugs that can deteriorate when exposed to gases contained in the environment.

What documents approve the rules for storing medicines?

As mentioned above, the rules for storing medicines were approved by Order No. 706n.

In addition, there are other documents that establish additional storage conditions for medicines:

1. Order of the Ministry of Health No. 771 of October 29, 2015 (list of pharmacopoeial articles).

2. Order of the Ministry of Health No. 676n dated August 31, 2016 (description of good practices for storing and transporting medicines);

3. Order of the Ministry of Health No. 770 dated October 28, 2015 (changes to the list of pharmacopoeial monographs).

Rules for storing medicines are also fixed in the local documentation of the medical organization. Such documents include SOPs - standard operating procedures that describe in detail the storage conditions of medicines, the actions of medical staff, etc. The content of such standard documents includes the following sections: requirements for the transportation of medicines; measures to protect drugs from environmental influences; rules for admitting health workers to rooms to place medications; rules for cleaning these premises; the procedure for conducting audits of compliance with procedures and the results of these audits; liability of health workers who violated standard procedures.


Rules for storing drug groups

The rules for storing medicines must be observed taking into account the group of belonging of a particular medicine.
Medicines must be placed in specially designated areas. These are cabinets, open shelves,...

If the drugs are classified as narcotic drugs or are subject to PCU, the cabinet in which they are placed must be sealed. It is advisable to use a refrigerator safe with a burglary resistance class.

Other drugs can be stored on shelves so that their consumer packaging is visible.

Conditions for storing medicines include equipping storage rooms with opening windows, pharmaceutical refrigerators and air conditioners.

This allows you to ensure a suitable temperature regime.

Storage conditions for medicines

Let's look at some rules for storing medications from different groups.

1. Medicines that should be protected from light. Medicines from this group are stored in places where light access is limited. To do this, reflective film is applied to the windows or they are covered with blinds, etc. Pharmaceutical refrigerators must have special glass in the door that does not allow ultraviolet rays to pass through, or the door must be solid.

2. Medicines that need to be protected from moisture. The room for such drugs should be well ventilated. The air in it must be dry, the permissible humidity is up to 65%.

3. Medicines that are prone to drying out and volatilization. Special storage conditions are ensured by maintaining optimal air temperature - from 8 to 15C. Hydrogen peroxide, iodine, etc. are prone to volatilization.

4. Storage of medications under special temperature conditions. There are drugs that can deteriorate in high or low temperatures. Recommendations for the storage temperature of a particular drug are indicated by the manufacturer on the primary or secondary packaging.

5. Drugs that may deteriorate due to exposure to gases in the air. The packaging of the drugs should not be damaged, there should be no intense lighting or foreign odors in the room. The recommended temperature in the office is observed.

The conditions under which medications must be stored are usually described: on the packaging or shipping container of the medications; in the instructions for medical use of the drug; in the state register of medicines. These terms and conditions must be clearly legible. The language of instructions is Russian. Information about the storage conditions of medicines is also placed on the shipping container in the form of handling and warning signs. For example: “Do not throw”, “Keep away from sunlight”, etc.


Requirements for storage conditions of drugs

Storage of drugs belonging to the group of poisonous and potent drugs is carried out in special premises. They must be equipped with security engineering and technical devices. In additionally reinforced premises, both narcotic and other potent drugs can be stored simultaneously.

Depending on the available supply of drugs, they are stored on separate shelves or in different sections of the cabinet. Drug storage regulations require that potent drugs not under international control be stored in metal cabinets, which are sealed at the end of the day by a responsible healthcare professional. It is important to use, which provides protection against unauthorized access and allows you to set the exact temperature conditions for storing medicines.

What kind of premises should be used for storing medicines?

A medical organization must comply with the requirements for premises that are planned to be used for storing medicines. Let us highlight a few general rules: it is important that the room has sufficient capacity for convenient and separate storage of drugs from different groups; zoning of the premises involves the allocation of a general zone, a special zone and a quarantine zone. Drugs whose expiration dates have expired are stored separately; storage areas should be well lit; household premises are separated from areas in which medicines are stored; personal belongings of healthcare workers, drinks and food should not be stored together with medications; the optimal temperature for certain groups of drugs is ensured in the room; equipment for routine and general cleaning of the premises is stored in separate cabinets; the room must be free from the possibility of animals, rodents and insects entering it; Shelf maps are placed next to the racks for medicines, which allow you to quickly find the right drug; the premises must be equipped with a security system; the operational rules for the use of refrigerators, air conditioners and other premises systems (fire safety, security, etc.) are observed; preparations for recording temperature and other air parameters must undergo periodic verification and calibration.

Medicines with special storage conditions

Special storage conditions for medicines are observed for the following medicines: 1. Psychotropic and narcotic medicines. 2. Explosive and flammable. 3. Drugs whose properties are affected by environmental conditions.

For example, explosive medications should not be shaken or struck when moving. They are stored away from heating radiators and daylight.

It is prohibited to store photosensitive drugs in the primary packaging. They are placed in secondary packaging that has light-protective properties. For drugs that are sensitive to high and low temperatures, it is necessary to comply with the temperature regime recommended by their manufacturer.

Storage of immunobiological drugs requires special attention. We are talking about the “cold chain” principle, which ensures the maintenance of optimal temperature to preserve the beneficial properties of the drug at all stages of its transportation and movement. Spoiled drugs are stored separately from other drugs and will be destroyed later. Requirements for the storage of narcotic drugs are specified in the Federal Law “On Narcotic Drugs and Psychotropic Substances”. Premises for their storage are equipped with additional protection measures in accordance with the requirements of Order No. 370 of the Federal Drug Control Service of Russia dated September 11, 2012. Special requirements for the storage of such drugs are also contained in the departmental order of the Ministry of Health of the Russian Federation No. 484n dated July 24, 2015.

The essence of these requirements is that the premises for storing narcotic drugs must be further strengthened. Medicines are placed in metal cabinets, pharmaceutical refrigerators, and refrigerator safes, which are subject to sealing at the end of the work shift by the responsible health workers. Similar rules have been established for medications that are subject to subject-quantitative accounting.

Errors when storing medicines

The rules for storing medicines discussed above are often violated in practice in medical institutions.

Common mistakes include the following:

  • medicines are stored in violation of the requirements specified on their packaging from the manufacturer;
  • regular medications are stored together with medications whose expiration dates have expired;
  • in a medical institution, the expiration dates of medications are not taken into account in a special journal;
  • There are no devices in medical institutions to monitor temperature indicators in medicine storage rooms.

Who is responsible for improper storage of medications?

Accounting, storage and use of medications are the duties of a nurse.

This is indicated in the order of the Ministry of Health and Social Development of Russia dated July 23, 2010 No. 541n. According to Part 1 of Article 14.43 of the Code of the Russian Federation on Administrative Offenses, violation of the requirements for the circulation of medicines is an administrative offense.

In this case, the nurse will face a fine - from 1000 to 2000 rubles.

A medical institution may be fined from 100,000 to 300,000 rubles.

Examples of violations and subsequent punishments

Temperature violation- Resolution of the Supreme Court of the Russian Federation of December 8, 2014 No. 307-AD14-700
100,000 rub.

There are no instruments in the treatment rooms certified by metrological control bodies - Resolution of the Supreme Court of the Russian Federation of February 3, 2016 No. 305-AD1518634
100,000 rub.

There is no daily recording of air temperature and humidity; there is no device for recording air humidity parameters (hygrometer); there is no specially designated and designated (quarantine) zone; no records are kept of medicines with a limited shelf life - Resolution of the Supreme Court of the Russian Federation of January 19, 2015 No. 306-AD144327
100,000 rub.

The premises for storing basic supplies of medicines and medical products at the head nurse of a health care facility unit must meet technical, sanitary, fire safety and other licensing requirements and conditions, and be isolated from other premises of the unit. The internal surfaces of walls and ceilings must be smooth and allow for wet cleaning. The floor of the room must have a dust-free coating that is resistant to mechanization and wet cleaning using disinfectants. The use of unpainted wooden surfaces is not allowed. Materials for finishing premises must meet the requirements of relevant regulatory documents.

The storage room for medicines and medical products must be equipped with special equipment to ensure their storage and proper safety, taking into account the physicochemical, pharmacological and toxicological properties, as well as the requirements of quality standards for medicines and the State Pharmacopoeia of the Russian Federation, namely:

· Cabinets, racks, pallets for storing medicines and medical products, as well as lockable metal cabinets and safes for storing certain groups of medicines;

· Refrigerators for storing thermolabile medicines;

· Devices 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;

· Detergents and disinfectants to ensure sanitary conditions.

The equipment must be resistant to wet cleaning using disinfectants and meet sanitary, hygienic, fire safety and labor protection requirements.

General requirements for the storage of medicines and medical products

Medicines and medical products in departments must be stored in locked cabinets, with obligatory division into groups: “External”, “Internal”, “Injection”, “Eye drops”, etc. In addition, in each compartment of the cabinet (for example, “ Internal”) there should be a division of medicines into tablets, mixtures, etc.; Powders and tablets are usually stored on the top shelf, and solutions on the bottom.

Storage of finished medicinal products must be carried out in compliance with external conditions (temperature, humidity, lighting conditions) specified by the manufacturer in the instructions for the drug, and general requirements. All finished medicinal products must be packed and installed in original industrial or pharmacy packaging with the label (marking) facing out.

Tablets and dragees are stored separately from other medications in a dry place and, if necessary, protected from light.

Injection dosage forms should be stored in a cool, dark place in a separate cabinet (or cabinet compartment).

Liquid dosage forms (syrups, tinctures) should be stored in a place protected from light.

Plasma replacement solutions are stored separately in a cool place, protected from light. Ointments and liniments are stored in a cool place, protected from light, in a tightly closed container. Preparations containing volatile and thermolabile substances are stored at a temperature not exceeding +10 C.

Suppositories are stored in a dry, cool place, protected from light.

Most medicines in aerosol containers should be stored at a temperature from +3 to +20 C in a dry place, protected from light, away from heating devices. Aerosol packages should be protected from impacts and mechanical damage.

Infusions, decoctions, emulsions, serums, vaccines, organopreparations, solutions containing benzylpenicillin, glucose, etc. are stored only in refrigerators (+2 - +10 C).

Immunobiological preparations should be stored 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 the expiration date.

Medicinal plant materials should be stored in a dry, well-ventilated area.

Medicines that have a strong odor (iodoform, Lysol, ammonia, etc.) and are highly flammable (ether, ethyl alcohol) are stored in a separate cabinet. Coloring medications (iodine, brilliant green, etc.) are also stored separately.

Storage of medications in the operating room, dressing room, and treatment room is organized in instrumental glass cabinets or on surgical tables. Each bottle, jar, and package containing a medicinal product must have an appropriate label.

Narcotic drugs and psychotropic substances, potent and toxic substances must be stored in safes. In technically fortified premises, it is allowed to store narcotic drugs and psychotropic substances in metal cabinets. Safes (metal cabinets) must be kept closed. After the end of the working day, they must be sealed or sealed. Keys to safes, seals and seals must be kept by financially responsible persons authorized to do so by order of the chief physician of a healthcare institution.

Narcotic drugs and psychotropic substances, potent and toxic substances received by shift medical personnel must be stored in a closed and sealed safe attached to the floor or wall in a specially designated room. On the inside of the safe door there is a list of narcotic drugs and psychotropic substances indicating the highest single and daily doses. Narcotic drugs and psychotropic substances for parenteral, internal and external use must be stored separately.

Responsible for organizing the storage and distribution of narcotic drugs and psychotropic substances to patients are the head of the health care facility or his deputies, as well as persons authorized to do so by order of the health care facility.

Units of health care facilities must have tables of the highest single and daily doses of narcotic drugs and psychotropic substances, as well as tables of antidotes for poisoning by them, in storage areas and at the posts of doctors and nurses on duty. Medical products should be stored separately from medicines and in groups: rubber products, plastic products, dressings and auxiliary materials, medical equipment products.

The procedure for storing medicines and medical products is regulated by Order of the Ministry of Health of the Russian Federation dated November 13, 1996 No. 377.

Compliance with the approved Instructions allows us to ensure the preservation of the high quality of drugs and create safe working conditions for pharmacists when working with them.

Particular attention is paid to the storage, prescribing, recording and dispensing of poisonous and narcotic drugs.

Proper storage of medicines is based on the correct and rational organization of storage, strict recording of its movement, and regular monitoring of the expiration dates of medicines.

It is also very important to maintain optimal temperature and humidity, and protect certain drugs from light.

Violation of the rules for storing medications can lead not only to a decrease in the effectiveness of their action, but also cause harm to health.

Excessively long-term storage of drugs (even if the rules are followed) is unacceptable, since the pharmacological activity of the drugs changes.

An important condition for storage is the systematization of drugs by groups, types and dosage forms.

This allows you to avoid possible errors due to the similarity of drug names, simplify the search for drugs and control their expiration dates.

Narcotic drugs (list A) must be stored in safes or iron cabinets with secure locking. A printed list of toxic drugs is kept in the cabinet, indicating the highest single daily doses.

Rooms and safes with narcotic and especially poisonous drugs must have an alarm system, and there must be metal bars on the windows.

The stock of poisonous and narcotic drugs should not exceed the general inventory standard established for a given pharmacy.

Medicines from list B are stored in locked cabinets indicating the list of drugs and the highest single and daily doses.

Instructions for organizing the storage of medicines and medical products apply to all pharmacies and pharmaceutical warehouses.

The equipment of storage rooms must ensure the safety of medicines. These rooms are provided with fire-fighting equipment, and the required temperature and humidity are maintained. Humidity and temperature parameters are checked once a day. Thermometers and hygrometers are fixed on internal walls away from heating devices at a distance of 3 m from the doors and 1.5 m from the floor.

To record temperature and relative humidity parameters, an accounting card is created in each department.

The cleanliness of the air in drug storage rooms plays an important role; for this, they must be equipped with supply and exhaust ventilation or, in extreme cases, vents, transoms, and grill doors.

Heating of the room should be carried out by central heating devices; the use of gas appliances with an open flame or electrical appliances with an open spiral is excluded.

If pharmacies are located in climatic zones with sharp fluctuations in temperature and humidity, they are equipped with air conditioning. Medicine storage areas must have a sufficient number of cabinets, racks, pallets, etc. Racks should be located at a distance of 0.5-0.7 m from the external walls, at least 0.25 m from the floor and 0.5 m from the ceiling. The distance between the racks must be at least 0.75 m, the aisles must be well lit. The cleanliness of pharmacies and warehouses is ensured by wet cleaning at least once a day using approved detergents.

Medicines are placed according to toxicological groups.

Poisonous, narcotic drugs - list A. This is a group of highly toxic drugs.

Their storage and use require special care. Poisonous drugs and drugs that cause drug addiction are stored in a safe. Particularly toxic substances are stored in the inner compartment of the safe, which is locked with a padlock.

List B - potent drugs.

Medicines of list B and ready-made products containing them are stored in separate cabinets, locked with a padlock, marked “B”.

Storage of medications depends on the method of their use (internal, external); these products are stored separately.

Medicines are stored in accordance with their state of aggregation: liquids are kept separately from bulk, gaseous, etc.

Products made of plastic, rubber, dressings, and medical equipment must be stored separately in groups.

At least once a month it is necessary to monitor external changes in medicines and the condition of the container. If the container is damaged, its contents must be transferred to another package.

In the territory of a pharmacy or warehouse, if necessary, measures are taken to combat insects and rodents.