Storage of medicines and medical products. Rules for the storage of medicines

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

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

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

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

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

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

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

physical chemical properties medicines;

pharmacological groups (for pharmacy and medical organizations);

method of application (internal, external);

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

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

9. Separately, in technically reinforced premises that meet the requirements federal law dated January 8, 1998 N 3-FZ "On narcotic drugs and psychotropic substances"(Collection of Legislation Russian Federation, 1998, N 2, Art. 219; 2002, No. 30, Art. 3033; 2003, N 2, art. 167, No. 27 (part I), art. 2700; 2005, N 19, Art. 1752; 2006, N 43, Art. 4412; 2007, N 30, Art. 3748, No. 31, art. 4011; 2008, N 52 (part I), art. 6233; 2009, N 29, Art. 3614; 2010, No. 21, Art. 2525, No. 31, art. 4192) are stored:

narcotic and psychotropic drugs;

potent and poisonous drugs under control in accordance with international legal regulations.

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

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

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

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

12. When identifying drugs with expired they must be stored separately from other groups of medicinal products in a specially designated and designated (quarantine) area.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

34. Freezing of insulin preparations is not allowed.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

49. Storage medicinal leeches carried out in a bright room without the smell of drugs, for which a constant temperature regime is set.

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

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

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

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

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

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

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

57. Joint storage of flammable medicinal products with mineral acids (especially sulfuric and nitric acids), compressed and liquefied gases, flammable substances ( vegetable oils, sulfur, dressing material), alkalis, as well as with inorganic salts, giving with organic matter explosive mixtures (potassium chlorate, potassium permanganate, potassium chromate, etc.).

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

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

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

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

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

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

65. Narcotic and psychotropic drugs are stored in organizations in isolated rooms, specially equipped with engineering and technical means protection, and in places of temporary storage, subject to the requirements in accordance with the Rules for the storage of narcotic drugs and psychotropic substances established by Decree of the Government of the Russian Federation of December 31, 2009 N 1148 (Collected Legislation of the Russian Federation, 2010, N 4, Art. 394; N 25, article 3178).

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

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

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

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

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

Answers on questions:

1. Does paragraph 35 of Order 647n (information regarding price tags) apply to dietary supplements?
- In this case, paragraph 35 of Order 647n refers specifically to over-the-counter drugs. As for price tags for dietary supplements, the requirements for them are regulated by Decree of the Government of the Russian Federation of January 19, 1998 No. 55 “On approval of the rules for the sale certain types 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, dimension, style, color or configuration."

2. Recent changes in legislation regarding the storage and accounting of narcotic drugs and psychotropic substances?
- Significant changes regarding the issue of storage of narcotic drugs and psychotropic substances in this moment no.
There will definitely be amendments regarding accounting. They will be spelled out in Decree of the Government of the Russian Federation of November 4, 2006 No. 644 "On the procedure for submitting information on activities related to the circulation of narcotic drugs and psychotropic substances, and registration of operations related to the circulation of narcotic drugs and psychotropic substances." This document is currently under development and as soon as it is released, we will hold a new webinar on this Resolution.

3. In the Rules of proper pharmacy practice the position appears - the head of the subject retail. Is this the director of the entire pharmacy chain or the head of one pharmacy in this chain?
- The head of the retail trade entity means the head legal entity, i.e. in this case, the director of the pharmacy chain.

4. Should prescription drugs be kept separate from OTC drugs?
- According to paragraph 36 of Order 647n, “prescription drugs are placed separately from non-prescription drugs in closed cabinets with a mark “by prescription for a drug applied to the shelf or cabinet in which such drugs are placed.”

5. How many work instructions / SOPs should a pharmacy have, guided by the requirements of Order 647n?
- The basic information regarding SOPs is spelled out in paragraphs 37, 47, 66 and 68 of Order 647n. Order 647n does not give an exact figure of how many SOPs should be in a pharmacy organization, but special attention should be paid to paragraph 68:
“Standard operating procedures should describe the procedures for:
a) analysis of complaints and suggestions of buyers and making decisions on them;
b) establishing the reasons for the violation of the requirements of these Rules and other requirements of regulatory legal acts regulating the circulation of pharmacy goods;
c) assessing the need and feasibility of adopting appropriate ones in order to avoid the recurrence of a similar violation;
d) definitions and implementation necessary action in order to prevent the ingress of falsified, poor-quality, counterfeit goods of the pharmacy assortment to the buyer;
e) analyzing the effectiveness of the preventive and corrective actions taken.”
Referring to this paragraph, you will be able to form SOPs on the Rules of Good Pharmacy Practice yourself.

6. A medical organization has a structural unit - a pharmacy. Do the requirements of Order 646n regarding the storage of medicines apply to the posts of the middle medical personnel, treatment rooms and other rooms?
- Clause 2 of Order 646n states that its requirements apply to both pharmacy and medical organizations. But as already discussed above, attributing violations of Order 646n to a specific article of the Code of Administrative Offenses of the Russian Federation is a rather complicated issue. In this case, it is necessary to wait for the first court decisions on these violations, because there is a possibility that violations of Order 646n will not be related to medical and pharmacy organizations.
Nevertheless, based on clause 2 of this Order, it is still worthwhile for medical organizations to comply with its requirements.

Order N 646n in paragraph 3 gives the head of the subject of medicines circulation (hereinafter referred to as the MD) the obligation to provide a set of measures for employees to comply with the rules for storing and (or) transporting the MD. In this case, the subject of treatment means any of the organizations that are subject to the said order, including a medical organization and its separate divisions(outpatient clinics, feldsher and feldsher-obstetric stations, centers (departments) of general medical (family) practice) located in rural settlements where there are no pharmacy organizations. It follows from the above that every medical organization involved in the storage of medicines must, from 2017, comply with the “new” rules of good practice for their storage.

A set of managerial measures medical organization is called the quality system and includes a wide variety of activities to ensure compliance with the Storage and Transportation Rules. In particular, for the implementation of a quality system for the storage of medicinal products of a medical organization, it is required:

Approve the regulations for employees to take actions during the storage and transportation of medicines.
Approve the procedures for servicing and checking measuring instruments and equipment.
Approve the order of keeping records in journals, reporting procedures.
Ensure compliance with standard operating procedures.

At the same time, the new rules for the storage and transportation of medicines require the head of a medical organization to additionally approve documents regulating the procedure for receiving, transporting, and placing medicines. These actions are referred to as standard operating procedures.

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

To introduce a quality system and perform standard operating procedures, the head of a medical organization issues an order and instructs the responsible person to develop and submit for approval the regulations (instructions) for committing various activities during storage of drugs. A specific list of such instructions has not been established by the Rules of Good Storage Practice. Taking into account the “breakdown” of standard operating procedures for the reception, transportation and placement of medicines, it is advisable to divide the process of storing medicines 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 medicines from the carrier

The instruction on the procedure for taking medicines from the carrier (transport organization) should fix the 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 find out when drawing up documents for each batch of medicines. Thus, the employee should be aware that, in accordance with the Good Practices for Storage and Transportation, drugs with a shorter expiration date are first dispensed for transportation. The remaining shelf life is agreed with the recipient of the medicinal product in preparation for transportation. If the residual shelf life of the medicinal product is not long, it is better for the medical organization, when agreeing to receive the medicinal product, to refuse such a supply in order to avoid the subsequent write-off of the entire received batch.

When accepting a medicinal product, the employee must check the compliance of the received drug with the accompanying documentation for the assortment, quantity and quality (checks the name, quantity of drugs with the consignment note or waybill and appearance containers).

As part of standard operating procedures, a medical organization, before taking medicines, must plan the transportation of medicines with an analysis and assessment of possible risks. In particular, before delivery, the carrier finds out whether the medicinal product has special storage conditions and whether the carrier can provide them during transportation. Despite the fact that this is the responsibility of the carrier, and not the medical organization, the latter also has an interest in the knowledge of the transport company about the conditions for transporting a particular drug in order to get it suitable for use. In this connection, it is recommended, at the request of the carrier, to provide full information about the qualitative features of medicinal products, the conditions for their storage and transportation, including temperature, illumination, requirements for containers and packaging.

Separately, it is worth dwelling on the packaging. An employee who takes medicines should pay attention to the quality of the packaging, as well as the presence on the packaging of information about the name, series of transported drugs, their release date, number of packages, name and location of the drug manufacturer, their expiration date and storage conditions, transportation . The absence of this information may indirectly indicate possible violations conditions of transportation or even about counterfeit. If discrepancies are found, or damage to the container, the drugs should not be taken - they must be returned to the supplier with the preparation of an appropriate act and the implementation of the return procedure provided for by the contract. An employee of a medical organization must be instructed on the procedure for processing the procedure for returning such goods.

According to the new Rules of Good Practice for Storage and Transportation, 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 ice packs. In addition to the new transport regulations, they must take into account the instructions for the preparations, as well as the transport conditions mentioned in other regulations. For example, the conditions for the transportation of immunobiological medicinal products are contained in SP 3.3.2.3332-16, approved. Decree of the Chief State Sanitary Doctor of the Russian Federation of February 17, 2016 N 19, which, among other things, categorically prohibits the use of cold chain equipment for the joint transportation of these drugs and food, other medicines, raw materials, materials, equipment and items that may affect the quality of the transported drugs or damage their packaging. When transporting the ILS, the readings of each thermoindicator should be monitored when loading and unloading preparations, the readings are recorded in a special register for the movement of the ILS 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, the journal should record the facts of planned or emergency shutdown of refrigeration equipment, breakdowns and violations of the temperature regime.

In real life, of course, one cannot rely on the carrier's strict observance of 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 that entails a violation of the conditions of transportation - in order to save money, faulty ice packs are used several times, food and other raw materials are placed along with medicines, the temperature is entered in the log "as you like", 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 an arriving car technical specifications or due to the laid route, obviously could not meet the requirements of the temperature regime, but was released by the transport company on a flight.

Although the rules of transportation require that information be communicated to the sender and recipient of medicinal products about cases of violation of the temperature regime of storage and damage to the package detected during the transportation of the medicinal product, in practice, of course, this requirement is not always observed. Carriers are unwilling to accept the risk of compensation for damages due to non-compliance with the rules of carriage and may seek to conceal this information.

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

2. Instructions on the placement (transportation) of medicinal products in the storage area

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

The instructions should describe the rules for the placement of medicinal products, taking into account the Rules of Good Storage Practice. It is worth noting, and conveying to the employee what should not be done: for example, place medicines on the floor without a pallet, place pallets on the floor in several rows, store with medicines food products, tobacco products etc.

Since, in accordance with the Rules of Good Storage Practice, shelves (cabinets) for storing medicinal products must be labeled, must have shelf cards located in a visible zone, and ensure the identification of medicinal products in accordance with the accounting system used by the Subject of Medicines Circulation, in the instructions for storage drugs and in job description the employee should reflect the obligation to label racks (cabinets) and fill out rack cards.

If a medical organization uses an electronic data processing system instead of rack cards, it is the responsibility of the employee to fill in the 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 one or another value and approve the code correspondence table, which greatly simplifies office work.

Because storage conditions and humidity must be maintained in rooms and areas that correspond to the storage conditions specified in the registration dossier of the medicinal product, the instructions for medical use and on the packaging, the instructions for the storage of medicinal products should mention the placement of drugs in accordance with the indicated modes and the obligation track changes in temperature and humidity by an employee.

In the same instruction, it is permissible to reflect the procedures for cleaning the premises (zones) for storing medicines - they are carried out in accordance with standard operating procedures that are the same for all subjects of medicines storage. 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 carrying out medical activity»- these measures are the same in relation to all premises of a medical organization (with some exceptions): processing at least 2 times a day, general cleaning at least once a month, washing windows at least 2 times a year, etc. In the instructions for storage, you can simply make a reference to the instructions for wet cleaning of the premises of a medical organization, so as not to clutter up the document with unnecessary information.

An employee of a medical organization should be instructed that persons who do not have access rights defined by standard operating procedures are not allowed into the premises (zones) for storing medicines, i.e. face, official duties which are not related to the reception, transportation, placement and use of medicines.

3. Instructions on the storage of medicinal products requiring special storage conditions

This document should analyze the points of storage of various categories of drugs, for example, note that the storage of flammable and explosive drugs is carried out away from fire and heating devices, and workers need to exclude mechanical impact on such drugs. It should be fixed in the instructions that medicinal products subject to quantitative accounting, with the exception of narcotic, psychotropic, potent and poisonous drugs, 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 should know this list and be able to sort medicines according to the specified list.

Medicinal preparations 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 the 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 worker who was given the keys to the safe must be identified. Typically, such an employee is a financially responsible person and receives a key “under signature”. In the instructions, it is worth noting the inadmissibility of handing over keys strangers, the procedure for handing over the key to the post and the ban on taking the keys home.

The specified order also indicates that after the end of the working day, narcotic and psychotropic drugs must be returned to the place of main storage of narcotic and psychotropic drugs - the medical worker should be charged with checking compliance with this requirement and reflect the procedure for detecting a shortage.

In medical organizations, on the inner sides of the doors of safes or metal cabinets where these medicines are stored, lists of stored medicines should be posted indicating their highest single and highest daily doses. Additionally, tables of antidotes for poisoning with these agents are placed in storage places in medical organizations. It would be correct to assign to a specific employee the obligation to generate these lists and monitor the relevance of the information contained in them.

Medical organizations should store narcotic and psychotropic drugs manufactured by drug manufacturers or a pharmacy organization, so the instructions may indicate the inadmissibility self-manufacturing an employee of such drugs. The safe or cabinet with the indicated drugs is sealed or sealed at the end of the working day - the sealing procedure should also be reflected in the instructions.

Storage of medicinal products containing potent and toxic substances, which are under control in accordance with international legal norms, is carried out in premises equipped with engineering and technical security equipment similar to those provided for the storage of narcotic and psychotropic medicinal products. 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 burglar alarm, familiarize employees with the principles of its operation, appoint an employee responsible for maintaining this system (personal service or with the help of a third-party contract organizations).

Depending on the physical and chemical properties of drugs, the impact of factors on them external environment they are divided into drugs that require protection from moisture, light, drying, high and low temperatures, coloring and odorous, disinfectants.

Medicines stored in a place protected from light - antibiotics, tinctures, extracts, vitamins, corticosteroids, plant materials, nitro compounds, amino and amido compounds, phenol derivatives, phenothiazine.

The above funds are stored in containers made of light-protective materials. These are metal containers, aluminum foil, orange glass containers, packaging made of materials painted in black, orange or brown colors. The room for storing such medicines should be dark or with tight-closing doors. These products can be stored in well-knit boxes with well-fitting lids.

Particularly light-sensitive preparations (prozurin, silver nitrate, etc.) are stored in glass containers lined with black opaque paper.

Protection of medicines from moisture is needed for such hygroscopic substances and preparations as dry extracts, plant materials, salts of nitrous, nitric, phosphoric acids, antibiotics, enzymes.

These medicines are stored in a dry place in a tight container made of glass, metal, aluminum foil, plastic. If the hygroscopic properties are pronounced, the container must be hermetically sealed, filled with paraffin on top. Preparations such as burnt gypsum and mustard powder require special storage, since at high humidity they lose their properties and may be unsuitable for use. Burnt gypsum is stored in a tightly closed container (it is advisable to lay out a plastic film from the inside).

Mustard plasters are stored in packs wrapped in plastic wrap or parchment paper. These packs are placed in carton boxes lined with polymer film on the inside.

Volatile substances such as alcohol tinctures, thick extracts, liquid alcohol concentrates, essential oils, solutions of ammonia, hydrogen chloride, formaldehyde, carbolic acid, ethyl alcohol, hydrogen peroxide, sodium bicarbonate, chloramine B need protection from drying out and volatilization.

In order to protect against drying and volatilization, medicinal products should be stored in airtight containers made of glass, metal, aluminum foil in a cool place. Crystalline hydrates are stored in a cool place in a hermetically sealed container made of glass, metal or thick-walled plastic at an air humidity of 50-65%.

Many medicines (antibiotics, hormonal preparations, glycosides, vitamins, fat-based ointments, immunobiological preparations) need protection from the effects of elevated temperature. The instructions for use of the drug indicate the storage temperature: room (+18-20 °C), cool (+12-15 °C). Sometimes required low temperature storage (for example, for ATP - + 3-5 ° С).

Immunobiological preparations are stored separately by name, series, taking into account their expiration date. The storage temperature of these products is indicated in the instructions. At least once a month, immunobiological preparations are subjected to visual control.

Storage of antibiotics is usually carried out at room temperature in industrial packaging, unless otherwise indicated in the instructions.

Organic preparations are stored in a dry, cool and dark place at a temperature of 0 to ±15 °C (unless otherwise indicated on the label).

Insulin solutions, 40% formaldehyde solution, etc. need protection from the action of low temperature.

Formalin should be stored at a temperature not lower than +9 °C. Ice acetic acid stored at a temperature not lower than +9 °C. Medical fixed oils it is required to store at + 4-12 ° С (if a precipitate appears, the oil is not used in medicine). Insulin preparations are destroyed when frozen.

Drugs affected by air gases include morphine and its derivative enzymes, sulfur-containing compounds, organ preparations and enzymes, alkali metal salts, aminophylline, caustic soda and caustic potash, magnesium oxide, etc.

These products are stored in airtight, if possible filled to the top containers made of gas-impervious materials in a dry room.

Salts of barbituric acid require special storage conditions; they are stored in sealed containers made of materials impervious to water vapor and carbon dioxide.

Coloring and odorous drugs and parapharmaceutical products (such as brilliant green, indigo carmine, methylene blue) are stored in a special cabinet in a tightly closed container separately by name. To work with substances of each name, separate scales, a spatula, a mortar and other equipment are distinguished.

Storage of finished medicinal products is carried out taking into account the properties of their constituent ingredients.

Ready-made products are packaged with the label facing out. A rack card is attached to cabinets and shelves, which reflects the name of the medicine, series and expiration date.

Such a card is entered for each newly received series, which allows you to control its timely implementation.

The department should have a file on the expiration dates of drugs.

Expired medicinal products are stored separately and are subject to re-control (after receiving the results of the analysis).

Tablets and dragees must be stored separately from other products in their original packaging in a dry and, if necessary, protected from light place.

Injectable preparations are stored in a cool, dark place in a closet or in an isolated room.

Liquid dosage forms (tinctures, syrups, etc.) are stored in sealed containers filled to the top in a dark and cool place. When precipitation occurs, the tincture can be filtered. It is considered suitable for use after checking its quality.

Plasma replacement and detoxification solutions are stored separately at temperatures from 0 to +14 ° C in a dark place.

Extracts should be stored in a glass container with a screw cap and a cork with a gasket in a dark place at a temperature of +12-15 °C.

Liniments and ointments should be stored in a dark and cool place in a well-closed container.

Storage temperature is individual.

Suppositories are stored in a dark and cool place.

Means in aerosol packages are stored mainly at a temperature of +3 to 20 ° C in a dry and dark place, away from heating devices.

These preparations must be protected from shock and mechanical damage.

Medicinal plant materials are stored in a dry, well-ventilated area in a well-closed container.

Cut raw materials should be in fabric bags, powders - in double bags (multilayer paper - inner, fabric - outer), in cardboard packaging. Sometimes packaging made of polymeric materials is allowed.

Digitalis leaves, kidney tea and other hygroscopic herbs and fruits are stored in glass or metal tightly closed containers.

Herbal medicinal raw materials are periodically controlled in accordance with the requirements of the State Pharmalogy.

If the raw material is affected by mold, pests, or loses its normal color and smell, it is either rejected or (after processing) used.

More stringent are the terms of storage and control of plant materials containing cardiac glycosides.

Disinfectants are stored in a cool dark place, in a hermetically sealed container, away from the storage of plastic, metal and rubber products, from premises for obtaining distilled water.

There are features in the storage of products medical purpose. So, rubber products must be stored in a dark place at a temperature of 0 to +20 ° C, protected from mechanical damage, aggressive substances (formalin, lysol, etc.). Ammonium carbonate contributes to the preservation of rubber elasticity, the vessels with which are recommended to be placed in cabinets and rooms for storing rubber products. To prevent products from being squeezed, they cannot be stacked in cabinets in several layers.

Cabinets for rubber products and parapharmaceutical products should have tightly closing doors, smooth inner surface. Harnesses, probes are stored in a suspended state on removable hangers located under the cabinet cover. Rubber heating pads, overhead circles, ice packs are stored slightly inflated. Removable rubber parts of appliances must be stored separately. Elastic catheters, gloves, bougie, rubber bandages, fingertips are stored in tightly closed boxes, sprinkled with talc. Rubber bandages are sprinkled with talc over the entire surface and stored rolled up.

Separately store rubberized fabric in rolls, horizontally suspended on racks. You can store it on shelves stacked in no more than 5 rows. Elastic lacquer bougie, catheters, probes are stored in a dry place. Products are rejected if their stickiness and softening appear.

When hardening rubber gloves they are placed in a warm 5% ammonia solution for 15 minutes, then they are kneaded and kept for 15 minutes in a 5% water-glycerin solution at a temperature of + 40-50 ° C.

Plastic products are stored in a dark, ventilated room at a distance of at least 1 m from heating devices, with a relative humidity of no higher than 65%. Switches and electrical appliances must be fireproof.

Dressings and auxiliary materials must be stored in a dry, ventilated area. Cabinets, racks and storage trays should be painted on the inside with light oil paint. Periodically, they should be wiped with disinfectant solutions (for example, 0.2% chloramine solution).

Sterile bandages, wipes and cotton wool are stored in their original packaging. Non-sterile dressings are stored on racks packed in thick paper or in bags.

Auxiliary material (paper capsules, filter paper) is stored in its original packaging in separate cabinets under strictly hygienic conditions. After opening the package, the material is stored in paper or polyethylene bags or in kraft paper bags.

Hardware medical technology, including surgical instruments, are stored in dry rooms at room temperature.

Sharp fluctuations in temperature and humidity in the storage room are unacceptable. Relative humidity should not exceed 60% (rarely 70%).

Metal products that do not have anti-corrosion grease must be treated with a thin layer of petroleum jelly. Such instruments should be stored wrapped in paraffin paper. Take tools with a gauze cloth or tweezers. Scalpels and knives are stored in special cases of boxes to avoid blunting.

Store surgical instruments by name. This is convenient for their vacation and control.

Copper (brass), tin products do not require lubrication.

If rust appears on painted iron products, it is removed and the product is repainted.

Silver items and nickel silver tools should not be stored together with sulfur, rubber items, as their surface may turn black.

Medicinal leeches should be stored in a bright and clean room without the smell of medicines and perfumes. Leeches can die due to a sharp fluctuation in temperature. They are kept in wide-mouthed glass jars (50-100 leeches require about 3 liters of water). From above, the jar is covered with a thick calico napkin or a double layer of gauze and tied tightly, otherwise the leeches will spread.

Leeches must be kept in clean water without chlorine, peroxide compounds, salts of heavy metals. Water must be changed daily, harvesting it 2 days before use.

Before changing the water, rinse the inside of the jar, then drain the water through gauze. The jar is poured clean water by 1/3. If the leeches become lethargic, the water should be changed twice a day.

The storage of medicines and medical devices with flammable and explosive properties is regulated by Order No. 318 of November 5, 1997.

Compliance with this Order helps prevent fires and accidents, creates safe conditions labor. This Instruction must be observed by all pharmacy organizations.

A new employee entering work must be familiar with this Instruction, with the rules for storing compressed gases and explosive substances. He must comply with safety regulations, fire safety and be able to provide first aid in case of an accident. Checking the knowledge of employees on the above issues should be carried out at least once a year by a commission of 3 people. The test results are documented in a protocol.

In accordance with the requirements of the Rules fire safety RF 01-93 all pharmacies must have and store in right place primary means of extinguishing a fire. Fire safety instructions and evacuation plans should be in place for the storage of flammable substances.

Flammable and prone to spontaneous combustion in contact with air, water, sunbeams substances must be stored separately. The influence of high temperatures and mechanical influences should be completely excluded.

There should be separate storage or compartments for flammable products. The rooms must be well ventilated.

The floors of warehouses and unloading areas must be even and strong.

Racks and pallets for storing flammable and explosive substances must be made of non-combustible material, durable. The width of the racks should be no more than 1 m, the distance from the floor and walls - 0.25 m, the passages between them - at least 1.35 m.

Electrical installations are mounted in accordance with the regulations.

It is allowed to store in pharmacies no more than 10 kg of flammable liquids in fireproof cabinets. The closet must be freely accessible.

With special care and thoroughness, it is necessary to carry out the reception, packaging and dispensing of drugs with explosive properties.

It is necessary to distribute the goods to the place of main storage immediately upon receipt. The condition of the closure of the container deserves special attention.

It is forbidden to pack several explosive substances at the same time in one room. At the end of the working day, it is necessary to return the remaining substances to the premises of the main storage. Rooms are frequently and thoroughly ventilated.

On the doors of each storage and packaging room, bright indelible inscriptions should be placed: “Explosive”, “Flammable”, “Smoking is prohibited”, “In case of fire, call ...”.

Near the entrance, in a conspicuous place, a sign should be hung with the inscription: “Responsible for ensuring fire safety Full name.” Every day, the responsible person inspects the storage premises at the end of the working day.

Explosives include nitroglycerin.

Explosive substances include potassium permanganate, silver nitrate.

Flammable substances include alcohol, alcohol tinctures and solutions, turpentine, ether, chloroethyl, cleol, organic oils, x-ray films.

Flammable substances include glycerin, sulfur, dressings, vegetable raw materials, vegetable oils.

Store flammable and combustible liquids separately from other substances in well-closed glass or metal containers.

Heating should be carried out in water baths or on stoves with a closed spiral.

Large bottles, cylinders can be stored on racks in 1 row in height, at a distance of at least 1 m from heaters.

Fill containers with flammable liquid can be no more than 90% of the volume.

Alcohols are stored in large quantities in metal containers, filling no more than 75% of the volume.

Joint storage of flammable substances with acids (especially sulfuric and nitric), compressed gases, dressings, sulfur, potassium permanganate is prohibited.

Anesthesia ether and medical ether should be stored in their original packaging in a cool, dark place away from heating devices.

Particular care should be taken when loading, carrying and packaging flammable liquids, the tightness of the container is important.

A container freed from liquids must be left open for some time.

Explosive substances require special storage conditions. Containers with substances must be tightly closed.

Silver nitrate should be stored in isolation in a clean room no more than 50 g in a pharmacy and up to 5 kg in warehouses.

Potassium permanganate is explosive in contact with sulfur, dust, alcohol, ethers, glycerin, organic substances. It is stored in tin drums in a separate compartment (in warehouses), in barbells with ground stoppers.

A solution of nitroglycerin is stored in small vessels in a dark, cool place. Caution must be observed when moving dishes with nitroglycerin and hanging the drug. Skin contact with a small amount of nitroglycerin can cause poisoning (severe headaches).

It is forbidden to store explosive substances with acids and alkalis.

Cylinders with flammable liquids must be carried by two people in suitable baskets or crates with serviceable handles.

The storage of nitric and sulfuric acids requires special care: it is necessary to avoid contact with wood, straw and other organic substances.

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Storage of medicines and medical products. Rules for the storage of medicines

1. Instructions for accepting medicines from the carrier

2. Instructions on the placement (transportation) of medicinal products in the storage area

3. Instructions on the storage of medicinal products requiring special storage conditions

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