It is possible, but it is not possible. V. Features of organizing the storage of medicines in warehouses

This document obliges to ensure the implementation of a set of measures aimed at creating a system for ensuring the quality of storage and transportation of medicines. What this system is and how it should be implemented in a pharmacy organization, she explained during the online seminar NataliaZolotareva,PhD, Associate Professor, Department of Management and Economics of Pharmacy, St. Petersburg State Chemical-Pharmaceutical Academy.

In accordance with current legislation, namely the Federal Law "On the Circulation of Medicines", pharmaceutical activities include wholesale and retail trade in medicines, storage , transportation, dispensing and manufacturing of medicines. In Decree of the Government of the Russian Federation dated December 22, 2011 No. 1081, for the first time, the set of works and services that includes pharmaceutical activities was legally specified. Also, in accordance with the current regulations on licensing of pharmaceutical activities, a certain set of requirements and conditions has been established that pharmaceutical organizations must fulfill without fail when applying for a license or having one and carrying out the relevant types of activities.

I would like to draw attention to one of the subparagraphs of paragraph 5 regarding licensing requirements and conditions regarding the storage of drugs in a pharmacy organization. Sub-clause h states that a licensee storing drugs for medical use must comply with the relevant storage rules. This subclause is included in the range of licensing requirements and conditions, the violation of which is considered gross and liability for which is established by current legislation.

TERMINOLOGY

One of the articles of the State Pharmacopoeia of the XII edition is separately devoted to the process of storing drugs, and it clearly states that this is a separate process that is an integral part of the circulation of drugs and is associated with the storage of drugs until they are used within the established expiration date.

The process of storing drugs involves solving several global problems, incl. and in connection with the introduction of new regulatory documents, therefore, when organizing the storage process, it is necessary to create a quality assurance system that will allow the storage process to be carried out in accordance with the requirements of regulatory documents. It is also necessary, when organizing storage, to ensure the physical safety of the goods. And an important point is related to the fact that drugs are goods, most of which require special storage conditions. In this regard, another important task arises - creating conditions that ensure the stability of the properties of the product declared by the manufacturer. In order to solve these problems, three areas of activity emerge for those directly involved in the storage process.

First— taking into account the requirements of new regulatory documents, develop a quality assurance system, and it involves a number of instructions and provisions, the so-called SOPs, and the documents provide a specific list of standard procedures that need to be developed at the organization level and approved.

Second- provide the storage process with the necessary premises and equipment that must meet the requirements established for them.

Third - creating the necessary storage regime and organizing the placement of goods during storage (systematization).

LEGISLATION ON THE PROCESS OF STORAGE OF DRUGS

Let's start with the regulatory framework of federal significance, with Decree of the Government of the Russian Federation No. 1148 of December 31, 2009 "On the procedure for storing narcotic drugs and psychotropic substances." This document has been supplemented and updated several times.

Of course, noteworthy are the “Rules of Good Practice for the Storage and Transportation of Medicines for Medical Use,” approved by Order of the Russian Ministry of Health dated August 31, 2016 No. 646n and which came into force on March 1, 2017.

Also among the documents is the current order of the Ministry of Health of Russia dated August 23, 2010 No. 706n “On approval of the rules for storing medicines”; Order of the Ministry of Health dated July 24, 2015 No. 484n, concerning the organization of storage and the creation of special regimes for narcotic drugs and psychotropic substances; the procedure for transportation and storage of immunobiological drugs dated 2016 is determined by the corresponding resolution of the Chief State Sanitary Doctor of the Russian Federation dated February 17, 2016 No. 19; Order of the Ministry of Health of the Russian Federation dated October 21, 1997 No. 309 approves the instructions on the sanitary regime of pharmacy organizations (it received a second life in connection with the entry into force of the Rules of Good Pharmacy Practice, where special attention is paid to the procedure for cleaning premises, for which appropriate standard procedures must be developed). How to write them? The answer is obvious: based on the requirements of regulatory documents. Apart from Order No. 309, it is hardly possible to name instructions at the level of the Ministry of Health of the Russian Federation that would answer the question of how the sanitary regime should be properly organized.

Regulatory documents relevant to pharmacy organizations, wholesalers, and healthcare institutions are:

Order of the Ministry of Health and Social Development of Russia dated 01/09/07 No. 2 “On approval of norms of natural loss during storage of medicines in pharmacies, drug wholesale trade organizations and healthcare institutions.” This document is relevant only for those organizations that are related to substances. Natural loss presupposes the presence of a corresponding type of work;
Order of the Ministry of Health of Russia dated November 13, 1996 No. 377 “On approval of instructions for organizing storage in pharmacies of various groups of drugs and medical devices”;
Order of the Ministry of Health of Russia dated July 16, 1997 No. 214 of Russia “On quality control of medicines manufactured in pharmacies”;
general pharmacopoeial article OFS.1.1.0010.15 “On the storage of medicines.”

QUALITY ASSURANCE SYSTEM

Let's start with document No. 646n, which came into force on March 1, 2017. It contains certain innovations that require clarification. This document applies to a fairly large number of participants in the sphere of drug circulation. The first paragraph of the document states that the executors of this order are manufacturers, wholesale trade organizations of drugs, pharmacy organizations, individual entrepreneurs engaged in pharmaceutical activities, as well as medical organizations, including first aid stations, outpatient clinics, centers of various kinds located in those populated areas points where there are no pharmacy organizations, and which were vested with Federal Law-61 in 2010 with part of the powers to carry out a certain type of work and services of pharmaceutical activities.

The second section of this document attracts special attention - this is the system for ensuring the quality of storage and transportation of drugs. Speaking about the organization of storage, I would like to start with the requirements that are presented today in terms of creating a quality assurance system.

The document clearly states that this is a wide range of responsibilities. The quality assurance system requires a very serious resource in terms of time, money, and personnel, because SOPs will have to be written by the owners of the processes, i.e. those who directly carry out certain processes of storing, receiving, dispensing drugs. At the same time, no one relieves the manager of responsibility for organizing a whole set of measures that will maintain the appropriate quality of drugs in connection with their storage.

A quality assurance system is a set of measures that is associated with the development and approval of a number of issues. Firstly, you must clearly state in a separate local regulatory act of the organization how you work with suppliers, by what criteria they are selected, since this is an outpost of the procurement process and the associated reception and storage of drugs.

Order No. 646n states that standard operating procedures, so-called SOPs, must be developed for the process of receiving, transporting, and disposing of drugs. This could be either a document that outlines all of these processes together, or a document that could describe individual standard operating procedures. As you wish. Today, regulatory documents do not describe in any way whether you should register everything together or separately. Forms of documents in which you record the progress of processes must be prescribed. You must record all this in your instructions and regulations related to the drug storage process. It must also be clearly stated how counterfeit, substandard, and counterfeit drugs are identified. Maintenance and testing of measuring instruments and equipment that should be present during the storage of drugs is carried out, and it is important how to monitor compliance with standard operating procedures. They are not created to be written once on paper and forgotten. There is a certain positive aspect to standard operating procedures. This is a document that, to a certain extent, formalizes the procedure for personnel actions, excluding the subjective factor, errors during reception, transportation, placement and any other process related to pharmaceutical activities. The regulatory document assumes that standard operating procedures should live the life of a pharmacy organization and should change when there are objective reasons. The reason for making changes to the standard operating procedure may be control measures and internal audits, which must also be clearly defined at the organizational level. All activities related to the functioning of quality assurance, storage and transportation systems are carried out by the responsible person - the quality officer. It is necessary to systematize all processes, document them, familiarize employees and calmly work according to the developed documents.

SOP - STANDARD OPERATING PROCEDURE

An SOP is an algorithm of certain actions for various processes, a document that describes step by step the set of actions that an employee of a pharmacy organization must carry out in order to perform a particular procedure.

In terms of the type of standard operating procedures, there are two important regulatory documents - orders No. 646n and No. 647n. They specify, verbatim, what specific standard operating procedures must be developed. But there is no clear classification of SOPs, and each organization systematizes them independently. Large companies, as a rule, separate into separate groups of SOPs everything related to equipment and its inspection; SOPs related to room cleaning, risk management, and even SOPs for managing SOPs can be separated into a separate group. This is the document that will describe who is taking part in the development of documents, what kind of documents they are taking part in, how many copies and copies of these documents there are, where they will be stored, updated and agreed upon. This is a huge amount of work. Therefore, where there are many standard operating procedures, SOPs are needed to manage the SOPs.

SOPs are not the only document that forms the documentation of the quality system. The main document is the quality manual. Order No. 647n states that such a document must be developed; it provides the organization’s tactics from the point of view of ensuring the quality of relevant goods, meeting consumer requirements when selling and carrying out one or another type of work or service. Second-level documents are SOPs, which indicate who, what, when, with what resources carries out job descriptions, etc. (including quality records).

Unfortunately, today there are no clear instructions on how this document should be compiled and in what format. But, one way or another, when describing the process, you must answer at least several questions: who carries out this process, with the help of what equipment, what resources are involved, what procedures are used, what methods and how this process can be assessed or measured . There is nothing complicated, you just need to systematize the huge volume of documents and present them in a logical sequence.

Process description diagram, i.e. a standard operating procedure should generally include the following sections: the purpose of the process, its scope, responsibility, references to the documents you used to develop it, terminology, if necessary, and a key section - the algorithm itself and quality records.

Order No. 646n requires the development of a number of standard operating procedures, incl. to receive the goods.

EXAMPLE SOP - DRUG ADMINISTRATION IN A PHARMACY ORGANIZATION

It is advisable to start the SOP with an SOP identifier, which should indicate the type of document or number the procedures. According to the regulatory documents of the quality assurance system, you must continuously improve, take corrective and preventive measures and actions. How will you prove that they were carried out? This includes changing the standard operating procedure. The second improved version will be reflected in the ID. This will show the reviewer that your versions are working and they are changing.

Preparatory activities - preparation of places for the receipt of drugs (refrigeration equipment, safes, shelving cabinets, depending on the type of drugs).
Unloading. Upon receipt of the medicine, the correctness of transportation is checked.
Placement of drugs. Narcotic drugs require immediate transfer to safes and metal cabinets. At the next stage, the person responsible for receiving checks the accompanying documents, then the delivery note is filled out, an acceptance stamp is affixed, and the documents are transferred to the supplier.
Acceptance control. There are two possible scenarios for the development of events: if everything is satisfactory during the acceptance control or there are questions in terms of quality and quantity during acceptance and then certain actions are required on the part of the person in charge. In the first case, if you agree with the delivery, a corresponding entry is made in the accompanying documents (invoice, acceptance stamp, pharmacy seal, full name and signature of the responsible person on the approval protocol) and then follows the process of registering the received goods in the acceptance control registration log, the form of which is not determined by current regulatory documents. It is determined by the head of the pharmacy organization. If medications are received for subject-quantitative accounting, entries are made in the appropriate journal.

In the second case, if you do not agree either in terms of quantity or quality of the medicine. In this case, the responsible employee draws up a letter of claim, and the commission, based on it, draws up an act on identifying discrepancies in quantity and quality when accepting drugs. Such goods must be placed in a quarantine zone until the circumstances are clarified. Completion of SOP - if acceptance control does not reveal any non-compliance with quality requirements, the drugs should be placed in storage areas taking into account a separate SOP. Next, we deal with the reusable returnable packaging and move it to a designated area, specifying responsibility. The document should include such items as how and who developed it (direct participant and controller), who approved it. The manager approves the standard procedure.

The golden rule of GMP: what is not documented does not exist.

PREMISES REQUIREMENTS

Space requirements are very important in terms of storage organization. They are determined by two regulatory documents: orders of the Ministry of Health No. 706n and No. 646n. The design, composition, operation and equipment of premises for storing drugs must correspond to the volume and type of work performed and, of course, ensure the safety of drugs. For pharmacy organizations there are no requirements for the composition of premises or space, unlike manufacturers and wholesalers. Only wet cleaning of premises is allowed, and in accordance with the requirements of Order No. 646n, the cleaning procedure must be recorded in the SOP.

Traditionally, storage facilities must be provided with equipment in the form of racks, cabinets, pallets, and they must be identified and labeled. In storage rooms, a certain temperature and humidity are fixed and must be maintained. The premises are equipped with instruments for recording temperature and humidity parameters. Devices must be maintained in good condition. A separate document must record the process of putting equipment into operation and testing it. This may be a separate SOP.

Order No. 706n speaks of the need to take into account drugs with a limited shelf life.

A pharmacy organization must have quarantine zones: one for drugs for which a decision has been made to suspend sales, another for counterfeit drugs, expired drugs, and another zone for other products in the pharmacy range. Each pharmacological group of drugs is stored in accordance with its specifics: for example, drugs that are subject to subject-quantitative accounting require separate storage, etc.

Based on materials from an online seminar organized by the St. Petersburg Union of Doctors

In accordance with Article 58 of the Federal Law of April 12, 2010 “On the Circulation of Medicines” (Collected Legislation of the Russian Federation, 2010, N 16, Art. 1815; N 31, Art. 4161) I order:

1. Approve the Rules for the storage of medicines in accordance with the appendix.

2. To recognize as invalid:

sections 1 and 2, clauses 3.1 - 3.4, 3.6 and 3.7 section 3, sections 4 - 7, 12 and 13 Instructions for organizing storage in pharmacies of various groups of medicines and medical products, approved by order of the Ministry of Health of the Russian Federation dated November 13, 1996 N 377 “On approval of requirements for organizing storage in pharmacies of various groups of medicines and medical products” (registered by the Ministry of Justice of Russia on November 22, 1996 N 1202).

Minister T. Golikova

Application

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 manufacturers of medicines, wholesale trade organizations of medicines, pharmacies, medical and other organizations carrying out activities in the circulation of medicines, individual entrepreneurs with a license for pharmaceutical activities or a license for medical activities (hereinafter referred to as organizations, individual entrepreneurs, respectively).

II. General requirements for the device

and operation of premises

storage of medicines

2. The design, composition, size of areas (for wholesale trade organizations of medicines), operation and equipment of premises for storing medicines must ensure their safety.

3. In the premises for storing medicines, certain temperatures and air humidity must be maintained to ensure 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 with air conditioners and other equipment that allows for storage of medicines in accordance with the requirements of the manufacturers of medicines specified on 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 with racks, cabinets, pallets, and 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 instruments for recording 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 devices must be recorded daily in a special log book (card) on paper or in electronic form 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 No. 3-FZ of January 8, 1998 “On Narcotic Drugs and Psychotropic Substances” (Collected Legislation of the Russian Federation, 1998, No. 2, Art. 219; 2002, No. 30 , Article 3033, 2003, No. 2, Article 167, No. 27 (Part I), Article 2700; 2005, No. 19, Article 1752; 2006, No. 43, Article 4412; 2007, No. 30, Art. 3748, No. 31, Article 4011; 2008, No. 52 (part 1), Article 6233; 2009, No. 29, Article 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, and shelves intended for storing medicines must be numbered.

Stored medicinal products must also be identified using a shelf 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. Organizations and individual entrepreneurs must 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 logs. The procedure for maintaining records of these medicines is established by the head of the organization or individual entrepreneur.

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

IV. Premises requirements

for storing flammable

and explosive drugs

and organizing their storage

13. Premises for storing flammable and explosive medicines must fully comply with current regulatory documents.

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 a fire resistance limit of building structures of at least 1 hour.

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

16. The floors of warehouses and unloading areas must have a hard, even surface. 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 with fireproof and stable 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, pharmacies and individual entrepreneurs are allocated isolated premises equipped with automatic fire protection and alarm systems (hereinafter referred to as premises for storing flammable and explosive medicines).

19. In pharmacy organizations and individual entrepreneurs, it is allowed to store pharmaceutical substances with flammable and combustible properties in an amount of up to 10 kg outside the premises for storing flammable and explosive drugs 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 medicinal products for medical use (in secondary (consumer) packaging) for use for one work shift in metal cabinets outside the premises for storing flammable and explosive medicinal products.

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 form.

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

21. It is prohibited to enter premises for storing flammable and explosive medicines with open sources of fire.

V. Features of organizing storage of medicines

in warehouses

22. Medicines stored in warehouses must be placed on racks or on racks (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. Features of storage of individual groups of drugs depending on

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 natural and artificial light.

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, proserine), glass containers are covered with black light-proof 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 shelves, provided that measures are taken to prevent these medicines from being exposed to direct sunlight or other bright directional light (use of reflective film, blinds, visors, etc.).

Storing medications that require protection from moisture

28. Pharmaceutical substances with pronounced hygroscopic properties should be stored in glass containers with an airtight 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 requiring protection

from volatilization and drying out

30. Pharmaceutical substances that require protection from volatilization and drying (volatile drugs themselves; drugs containing a volatile solvent (alcohol tinctures, liquid alcohol concentrates, thick extracts); solutions and mixtures of volatile substances (essential oils, solutions of ammonia, formaldehyde, chloride hydrogen over 13%, carbolic acid, ethyl alcohol of various concentrations, etc.); medicinal plant materials containing essential oils; medicines containing water of crystallization - crystal hydrates; medicines that decompose to form volatile products (iodoform, hydrogen peroxide, sodium bicarbonate ); medicines with a certain lower limit of moisture content (magnesium sulfate, sodium para-aminosalicylate, sodium sulfate) should be stored in a cool place, in hermetically sealed containers made of materials impenetrable to volatile substances (glass, metal, aluminum foil) or in primary and secondary ( consumer) manufacturer's packaging. 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 - crystal 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 medicines.

Storage of medicines requiring protection from exposure to elevated temperatures

32. Organizations and individual entrepreneurs must store medicines that require protection from exposure to elevated temperatures (heat-labile medicines) in accordance with the temperature conditions indicated on the primary and secondary (consumer) packaging of the medicine in accordance with the requirements of regulatory documentation.

Storage of medicines requiring protection from exposure to low temperatures

33. Storage of medicines that require protection from exposure to low temperatures (medicines whose physical and chemical state changes after freezing and is not restored upon subsequent warming to room temperature (40% formaldehyde solution, insulin solutions) organizations and individual entrepreneurs must carry out in accordance with with the temperature conditions 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.

Storage of medicines requiring protection from gases contained in the environment

35. Pharmaceutical substances that require protection from 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 carbon dioxide in the air: salts of alkali metals and weak organic acids (sodium barbital, hexenal), drugs containing polyhydric amines (aminophylline), magnesium oxide and peroxide, sodium hydroxide, caustic potassium), should be stored in hermetically sealed containers made of materials impermeable to gases, filled to the top if possible.

Storage of odorous and coloring medicines

36. Odorous medicines (pharmaceutical substances, both volatile and practically non-volatile, but with a strong odor) should be stored in hermetically sealed containers that are impenetrable to odor.

37. Coloring medicinal products (pharmaceutical substances that leave a colored mark that is not washed off by normal sanitary and hygienic treatment on containers, closures, equipment and inventory (diamond 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.

Storage of disinfectant medicines

39. Disinfectant 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 medicines

for medical use

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) facing out.

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

Storage of medicinal

vegetable raw materials

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 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 those affected by mold and 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 monitoring of 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 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-sized 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. Packaged 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.

Storage of flammable

medicines

52. Flammable medications are stored in tightly closed, durable glass or metal containers to prevent evaporation of liquids from the containers.

53. Bottles, cylinders and other large containers with flammable and highly combustible 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.

Storing these medications near heating appliances is not allowed. 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 pharmacies and individual entrepreneurs, flammable and combustible medicines can be stored in quantities not exceeding shift requirements. 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 degree of filling should be no more than 90% of the 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 compounds with organic substances. mixtures (potassium chlorate, potassium permanganate, potassium chromate, etc.).

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

Storage of explosives

medicines

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

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

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

62. Bulk solution of nitro glycerin is stored in small well-closed flasks 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, impact, and friction are not allowed.

Drug storage

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 the 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, Art. 3178).

Storage of potent and toxic drugs,

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. The 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.

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:

Approve regulations for employees to perform actions during storage and transportation of medicines.
Approve procedures for servicing and checking measuring instruments and equipment.
Approve the procedure for maintaining entries in journals and reporting procedures.
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 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 the transportation process. 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 obliged 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).

Topic: Drug treatment in nursing practice

Prepared by teacher

Aforkina A.N.

Chairman of the Central Committee

Osmirko E.K.

Orenburg -2015

I. Routes and methods of introducing drugs into the body.

Drug therapy is the most important component of the entire treatment process.

Medicinal substances have both local and general (resorptive) effects on the body.

Medicines are introduced into the human body in various ways. The way the drug is introduced into the body depends on:

1) speed of onset of effect,

2) effect size,

3) duration of action.

Tab.1 Routes and methods of drug administration

II. Rules for prescribing, receiving, storing, recording and distributing medicines.

Rules for prescribing medications for the department.

1. The doctor, daily examining patients in the department, writes down in the medical history or prescription list the medications required for the patient, their doses, frequency of administration and routes of administration.

2. The ward nurse makes a selection of prescriptions daily, copying the prescribed drugs into the “Prescription Notebook” separately for each patient. Information about injections is transmitted to the procedural nurse who performs them.

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

4. The head nurse (if necessary) writes out an invoice (demand) in a certain form for receiving medicines from the pharmacy in several copies, which is signed by the manager. department. The first copy remains in the pharmacy, the second is returned to the financially responsible person. The invoice form No. 434 must indicate the full name of the medicines, their sizes, packaging, dosage form, dosage, packaging, quantity.

Order of the Ministry of Health of the Russian Federation dated August 23, 1999 N 328 “On the rational prescribing of medicines, the rules for writing prescriptions for them and the procedure for their dispensing by pharmacies (organizations)” as amended on January 9, 2001, May 16, 2003.

Medicines are dispensed by the pharmacy to the departments in the amount of the current need for them: poisonous - a 5-day supply, narcotic - a 3-day supply (in the intensive care unit), all others - a 10-day supply.

Order of the Ministry of Health of the Russian Federation No. 330 dated November 12, 1997 “On measures to improve the accounting, storage, issuance and use of NLS.”

5. Requirements for poisonous (for example, strophanthin, atropine, prozerin, etc.) and narcotic drugs (for example, promedol, omnopon, morphine, etc.), as well as for ethyl alcohol, are written out on separate forms of the senior m/s in Latin language. These requirements are stamped and signed by the head physician of the health care facility or his deputy for medical treatment, indicating the route of administration and the concentration of ethyl alcohol.

6. In the requirements for acutely scarce and expensive medicines, indicate the full name. patient, medical history number, diagnosis.

7. When receiving medications from the pharmacy, the head nurse checks that they comply with the order. When dispensing ampoules with narcotic drugs from a pharmacy, the integrity of the ampoules is checked.

Dosage forms manufactured in a pharmacy must have labels of a certain color:

for external use – yellow;

for internal use - white;

For parenteral administration - blue (on bottles with sterile solutions).

The labels must contain clear names of the drugs, indications of concentration, dose, date of manufacture and the signature of the pharmacist (manufacturer details) who prepared these dosage forms.

Rules for storing medicines in the department.

1. To store medications at the nurse’s station there are cabinets that must be locked.

2. In the cabinet, medicinal substances are arranged in groups (sterile, internal, external) on separate shelves or in separate cabinets. Each shelf must have an appropriate indication (“For external use”, “For internal use”, etc.).

3. It is advisable to place medicinal substances for parenteral and enteral administration on shelves according to their intended purpose (antibiotics, vitamins, antihypertensives, etc.).

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

6. Medicinal substances included in list A, as well as expensive and acutely scarce drugs are stored in a safe. On the inside of the safe there should be a list of them indicating the highest daily and single doses, as well as a table of antidote therapy. Inside any cabinet (safe), medications are divided into groups: external, internal, eye drops, injection.

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

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

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

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

11. The shelf life of sterile solutions prepared in a pharmacy is indicated on the bottle. If they are not sold within this time, they must be discarded, even if there are no signs of unsuitability.

Temperature and light conditions must be observed. Infusions, decoctions, emulsions, serums, vaccines, organ preparations should be stored only in the refrigerator.

Signs of unsuitability are:

For sterile solutions - changes in color, transparency, presence of flakes;

In infusions and decoctions - cloudiness, color change, and the appearance of an unpleasant odor;

In ointments - discoloration, delamination, rancid odor;

Powders and tablets show a change in color.

The nurse does not have the right:

Change the form of medicines and their packaging;

Combine identical medicines from different packages into one;

Replace and correct labels on medicines:

Store medications without labels.

22. Medicines stored in warehouses must be placed on racks or on racks (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). 23.1. The area of warehouse premises must correspond to the volume of stored medicines, but be at least 150 square meters. m, including: medicine reception area; area for the main storage of medicines; expedition zone; premises for medicines requiring special storage conditions. (as amended by the Order of the Ministry of Health and Social Development of the Russian Federation dated 12/28/2010 N 1221н)

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 natural and artificial light. 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, proserine), glass containers are covered with black light-proof 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 shelves, provided that measures are taken to prevent these medicines from being exposed to direct sunlight or other bright directional light (use of reflective film, blinds, visors, etc.).

Storing medications that require protection from moisture

27. Pharmaceutical substances that require protection from moisture should be stored in a cool place at temperatures up to +15 degrees. C (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 an airtight 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 (volatile drugs themselves; drugs containing a volatile solvent (alcohol tinctures, liquid alcohol concentrates, thick extracts); solutions and mixtures of volatile substances (essential oils, solutions of ammonia, formaldehyde, chloride hydrogen over 13%, carbolic acid, ethyl alcohol of various concentrations, etc.); medicinal plant materials containing essential oils; medicines containing water of crystallization - crystal hydrates; medicines that decompose to form volatile products (iodoform, hydrogen peroxide, bicarbonate sodium); medicines with a certain lower limit of moisture content (magnesium sulfate, sodium para-aminosalicylate, sodium sulfate)) should be stored in a cool place, in hermetically sealed containers made of materials impenetrable to volatile substances (glass, metal, aluminum foil) or in primary and manufacturer's secondary (consumer) packaging. 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 - crystal 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 medicines.

Storage of medicines requiring protection from exposure to elevated temperatures

Storage of medicines requiring protection from exposure to low temperatures

33. Storage of medicines that require protection from exposure to low temperatures (medicines whose physical and chemical state changes after freezing and is not restored upon subsequent warming to room temperature (40% formaldehyde solution, insulin solutions)), organizations and individual entrepreneurs must carry out in accordance with the temperature conditions 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.

Storage of medicines requiring protection from gases contained in the environment

Storage of odorous and coloring medicines

36. Odorous medicines (pharmaceutical substances, both volatile and practically non-volatile, but with a strong odor) should be stored in hermetically sealed containers that are impenetrable to odor. 37. Coloring medicinal products (pharmaceutical substances that leave a colored mark that is not washed off by normal sanitary and hygienic treatment on containers, closures, equipment and supplies (diamond 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.

Storage of disinfectant medicines

Storage of drugs for medical use

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

Storage of medicinal plant materials

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 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 those affected by mold and 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 monitoring of biological activity. 47. Bulk medicinal plant materials included in lists potent and toxic 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 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. Packaged 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 medicines (medicines with flammable properties (alcohol and alcohol solutions, alcohol and ether tinctures, alcohol and ether extracts, ether, turpentine, lactic acid, chloroethyl, collodion, cleol, Novikov liquid, organic oils); medicinal products with flammable properties (sulfur, glycerin, vegetable oils, bulk medicinal plant materials) should be carried separately from other medicines (as amended by the Order of the Ministry of Health and Social Development of the Russian Federation dated 12/28/2010 N 1221н) 52. Flammable medications are stored in tightly closed, durable glass or metal containers to prevent evaporation of liquids from the containers. 53. Bottles, cylinders and other large containers with flammable and highly combustible 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. Storing these medications near heating appliances is not allowed. The distance from the rack or stack to the heating element must be at least 1 m. 54. Bottles with flammable and highly combustible pharmaceutical substances must be stored in impact-resistant containers or in tipping containers in one row. 55. At workplaces of production premises allocated in pharmacies and individual entrepreneurs, flammable and combustible medicines can be stored in quantities not exceeding shift requirements. 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 degree of filling should be no more than 90% of the 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 compounds with organic substances. mixtures (potassium chlorate, potassium permanganate, potassium chromate, etc.). 58. Medical ether and ether for anesthesia are stored in industrial packaging, in a cool place, protected from light, away from fire and heating devices.

Storage of explosive drugs

59. When storing explosive drugs (medicines 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 (barbells, tin drums, bottles, etc.) must be tightly closed to prevent vapors of these drugs from entering the air. 61. Storage of bulk potassium permanganate is allowed in a special compartment of warehouses (where it is stored in tin drums), in containers with ground-in stoppers, separately from other organic substances - in pharmacy organizations and individual entrepreneurs. 62. Bulk nitroglycerin solution is stored in small well-closed flasks 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, impact, and friction are not allowed. 64. It is prohibited to store explosive drugs 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 compliance with the requirements according to Rules 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, Art. 3178).

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

66. In accordance with the Decree of the Government of the Russian Federation dated 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" 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. The 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.