Orders for the storage of medicines. V. Features of the organization of storage of medicines in warehouses

Order N 646n in paragraph 3 gives the head of the subject of medicines circulation (hereinafter referred to as the MD) the obligation to ensure 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 areas. settlements in which there are no pharmacy organizations. It follows from the above that every medical organization involved in the storage of medicines must comply with the “new” rules of good practice for their storage from 2017.

A set of measures for the head of a medical organization is called a quality system and includes a wide variety of actions 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:

1. Approve the regulations for employees to take actions during the storage and transportation of medicines.
2. Approve the procedures for servicing and checking measuring instruments and equipment.
3. Approve the order of keeping records in journals, reporting procedures.
4. 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 the medical organization issues an order and instructs the responsible person to develop and submit for approval the regulations (instructions) for performing various actions during the storage of the medicinal product. 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 short, 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 consignment note and invoice, checks the appearance of the container).

As part of the 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. Although 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 of the conditions of transportation or even counterfeit goods. 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 leads to 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 journal "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 the arrived car, due to technical characteristics 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 food products, tobacco products with medicines, 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 the employee's job description 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 every 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 placement 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 SanPin 2.1.3.2630-10 "Sanitary and epidemiological requirements for organizations engaged in medical activities" - these measures are the same in relation to all premises of a medical organization (with some exceptions): at least 2 times a day, general cleaning at least once a month, window washing 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 must 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. persons whose official duties 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 must know this list and be able to sort drugs based on 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 the keys to 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 shortages.

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 must store narcotic and psychotropic drugs manufactured by drug manufacturers or a pharmacy organization, therefore, the instructions may indicate the inadmissibility of self-manufacturing of such drugs by an employee. 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 security 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).

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 told NataliaZolotareva, Ph.D., Associate Professor of the Department of Management and Economics of Pharmacy, St. Petersburg State Chemical Pharmaceutical Academy.

In accordance with the 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 (PM). In Decree of the Government of the Russian Federation of December 22, 2011 No. 1081, for the first time, a set of works and services was specified by law, which includes pharmaceutical activities. Also, in accordance with the current regulation on licensing pharmaceutical activities, a certain set of requirements and conditions has been established that pharmaceutical organizations must comply with without fail when applying for a license or having one and carrying out relevant activities.

I would like to draw attention to one of the subparagraphs of paragraph 5 concerning licensing requirements and conditions for the storage of drugs in a pharmacy organization. Subparagraph h states that a licensee storing drugs for medical use must comply with the relevant storage rules. This subparagraph is included in the range of license requirements and conditions, violation of which is considered gross and liability for which is established by applicable law.

TERMINOLOGY

One of the articles of the State Pharmacopoeia of the 12th edition is dedicated 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 medicines involves solving several global problems, incl. and in connection with the introduction of new regulatory documents, therefore, 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 a product, most of which require special storage conditions. In this regard, another important task arises - the creation of conditions that ensure the stability of those properties of the goods that are declared by the manufacturer. In order to solve these problems, three areas of activity of those who are directly involved in the storage process emerge.

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, equipment that must meet the requirements established for them.

Third - creation of the necessary storage mode and organization of the placement of goods during storage (systematization).

LEGISLATION ON THE PROCESS OF STORAGE OF MEDICINES

Let's start with the regulatory framework of federal significance, with the 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 repeatedly supplemented and updated.

Of course, attention is drawn to the "Rules of good practice for the storage and transportation of drugs for medical use", approved by order of the Ministry of Health of Russia dated August 31, 2016 No. 646n and entered 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 of July 24, 2015 No. 484n concerning the organization of storage and the creation of special regimes for narcotic drugs and psychotropic substances; the order of transportation and storage of immunobiological drugs of 2016 is determined by the relevant resolution of the Chief State Sanitary Doctor of the Russian Federation of February 17, 2016 No. 19; order of the Ministry of Health of the Russian Federation of October 21, 1997 No. 309 approves the instructions for 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 should be developed). How to write them? The answer is obvious: based on the requirements of regulatory documents. In addition to 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 related to pharmacy organizations, wholesalers, and healthcare institutions are:

• order of the Ministry of Health and Social Development of Russia dated 09.01.07 No. 2 "On approval of the norms of natural loss during storage of medicines in pharmacy organizations, drug wholesalers and healthcare institutions". This document is relevant only for those organizations that are related to substances. Natural loss implies the presence of the corresponding type of work;
• order of the Ministry of Health of Russia dated 11/13/96 No. 377 "On approval of instructions for organizing storage in pharmacy organizations 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 entered 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 field of drug circulation. The first paragraph of the document states that the executors of this order are manufacturers, drug wholesalers, pharmacy organizations, individual entrepreneurs engaged in pharmaceutical activities, as well as medical organizations, including FAPs, outpatient clinics, centers of various kinds located in those settlements. points where there are no pharmacy organizations, and which are endowed with FZ-61 in 2010 with part of the authority to carry out a separate type of work and services of pharmaceutical activities.

The second section of this document attracts special attention - this is a system for ensuring the quality of storage and transportation of medicines. Speaking about the organization of storage, I would like to start with the requirements that are imposed 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 process owners, i.e. those who directly carry out certain processes of storing, receiving, dispensing medicines. At the same time, no one relieves the manager of responsibility for organizing a whole range of measures, which will maintain the appropriate quality of drugs in connection with their storage.

The quality assurance system is a set of measures that is associated with the development and approval of a number of issues. First, you must clearly state in a separate local regulatory act of the organization how you work with suppliers, according to what criteria they are selected, since this is an outpost of the procurement process and the related receipt and storage of medicines.

Order No. 646n says that standard operating procedures, the so-called SOPs, should be developed for the process of receiving, transporting, and placing medicines. This can either be a document that sets out all of these processes as a whole, or a document that can describe individual standard operating procedures. As you wish. Today, regulatory documents do not describe in any way whether you should issue everything together or separately. The forms of documents in which you record the progress of the processes should be prescribed. You must record all this in your instructions and provisions related to the drug storage process. It should also be clearly spelled out how counterfeit, substandard, counterfeit drugs are detected. Maintenance and checks of measuring instruments and equipment that should be in the storage of medicines are carried out, and it is important how to monitor compliance with standard operating procedures. They are not created in order to write and forget once on paper. There is a certain positive moment in the standard operating procedures. This is a document that, to a certain extent, formalizes the procedure for personnel actions, excluding the subjective factor, errors in the reception, transportation, placement and any other process related to pharmaceutical activities. The regulatory document suggests that standard operating procedures should live the life of a pharmacy organization, should change when there are objective reasons. The reason for making a change in the standard operating procedure may be control activities, internal audits, which should also be clearly spelled out at the organization level. All activities related to the functioning of quality assurance, storage and transportation systems are carried out by a responsible person - a quality officer. All processes must be systematized, documented, familiarized with employees and calmly work according to the developed documents.

SOP - STANDARD OPERATING PROCEDURE

SOP is an algorithm of certain actions for different processes, a document that describes step by step the set of actions that an employee of a pharmacy organization must perform 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 are to be developed. But there is no clear classification of SOPs, and each organization systematizes them independently. Large companies, as a rule, allocate everything related to equipment, its verification into separate groups of SOPs, SOPs related to cleaning the premises, risk management, and even SOPs for managing SOPs can be allocated as a separate block. This is the document that will describe who is involved in the development of documents, what kind of documents they participate in, how many copies and copies of these documents, where they will be stored, updated and agreed upon. This is a huge piece of work. Therefore, where there are many standard operating procedures, SOPs are needed to manage SOPs.

SOPs are not the only document that forms the quality system documentation. The main document is the quality manual. Order No. 647n says that such a document should be developed, it provides the tactics of the organization in terms of ensuring the quality of the relevant goods, meeting consumer requirements in the implementation and implementation of one or another type of work or service. The documents of the second level are SOPs, which indicate who, what, when, with the help of what resources carries out job descriptions, etc. (including quality records).

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

Process description scheme, i.e. a standard operating procedure should typically 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 of actions itself and quality records.

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

EXAMPLE OF SOP - RECEPTION OF MEDICINES BY A PHARMACY ORGANIZATION

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

1. Preparatory measures - preparation of places for the receipt of drugs (refrigeration equipment, safes, cabinets, racks, depending on the type of drugs).
2. Unloading. Upon receipt of drugs, the correctness of transportation is checked.
3. Placement of drugs. Narcotic drugs require instant transfer to safes and metal cabinets. At the next stage, the person responsible for receiving checks the accompanying documents, then the consignment note is filled in, the acceptance stamp is put, the documents are transferred to the supplier.
4. Acceptance control. There are two possible scenarios for the development of events: if everything suits 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 responsible person. 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 the process of registering the received goods in the acceptance control log, the form of which is not determined by the current regulations. It is determined by the head of the pharmacy organization. If subject-quantitative medications are received, entries are made in the appropriate journal.

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

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

REQUIREMENTS FOR PREMISES

Premises 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 device, composition, operation and equipment of premises for storing medicines must correspond to the volume and type of work performed and, of course, ensure the safety of medicines. For pharmacy organizations, there are no requirements for the composition of premises, areas, unlike manufacturers and wholesalers. Only wet cleaning of the premises is allowed, and in accordance with the requirements of Order No. 646n, the cleaning procedure must be recorded in the SOP.

Traditionally, storage rooms should be provided with equipment in the form of racks, cabinets, pallets, and they should be identified and marked. Storage rooms are fixed and must be maintained at a certain temperature and humidity. The premises are equipped with devices for recording temperature and humidity parameters. Instruments must be maintained in good condition. A separate document should record the process of putting the equipment into operation, its verification. This may be a separate SOP.

Order No. 706n speaks of the need to account for 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 products, drugs with an expired shelf life, and another zone for other pharmacy products. Each pharmacological group of drugs is stored in accordance with its specifics: for example, drugs subject to subject-quantitative accounting require separate storage, etc.

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

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

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

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

Refrigerators for storage of thermolabile medicines;

· Devices for recording air parameters (thermometers, hygrometers or psychrometers), which are placed on the inner wall of the room away from heating devices at a height of 1.5-1.7 m from the floor and at a distance of at least 3 m from the doors;

· Detergents and disinfectants to ensure sanitary conditions.

Equipment must be resistant to wet cleaning with the use of disinfectants and meet sanitary and hygienic, fire safety and labor protection requirements.

General requirements for the storage of medicines and medical devices

Medicines and medical products in departments should be stored in lockable cabinets, with the obligatory division into groups: “External”, “Internal”, “Injectable”, “Eye drops”, etc. In addition, in each compartment of the cabinet (for example, “ Internal”) there should be a division of medicines into tablets, medicines, etc.; powders and tablets are stored, as a rule, on the top shelf, and solutions - on the bottom.

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

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

Dosage forms for injection should be stored in a cool, dark place in a separate cabinet (or cabinet compartment).

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

Plasma-substituting solutions are stored in isolation in a cool, dark place. Ointments, liniments are stored in a cool, dark place, in a tightly closed container. Preparations containing volatile and thermolabile substances are stored at a temperature not exceeding +10 C.

Suppositories are stored in a dry, cool, dark place.

Storage of most medicines in aerosol packages should be carried out at a temperature of +3 to +20 C in a dry, dark place, away from heating devices. Aerosol packages should be protected from shock and mechanical damage.

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

Immunobiological preparations should be stored separately by name at the temperature indicated for each name on the label or in the instructions for use. Immunobiological preparations of the same name are stored in batches, taking into account the expiration date.

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

Medicines with a strong odor (iodoform, lysol, ammonia, etc.) and flammable (ether, ethyl alcohol) are stored in a separate cabinet. Coloring medicines (iodine, brilliant green, etc.) are also stored separately.

Storage of medicines in the operating room, dressing room, procedural room is organized in glassed instrument cabinets or on surgical tables. Each vial, jar, package containing a medicinal product must have an appropriate label.

Narcotic drugs and psychotropic substances, potent and poisonous substances must be kept in safes. It is allowed to store narcotic drugs and psychotropic substances in metal cabinets in technically fortified premises. Safes (metal cabinets) must be kept closed. After the end of the working day, they must be sealed or sealed. Keys to safes, seals and ice-cream should be kept by financially responsible persons authorized to do so by order of the head physician of the healthcare institution.

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

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

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

In order for the enterprise to bring only profit, one must be on the alert literally in everything. Otherwise, the pharmacy will face either serious fines, or confiscation of goods, or suspension of activities for three months, or closure ...

READ THE INSTRUCTIONS!

So, in order for the pharmacy to work quietly, without spending money on fines, and for the business to be profitable, the first-desk workers must strictly comply with all the rules and regulations prescribed for pharmacy staff. The same can be said about pharmacy equipment. Meanwhile, not everything and not everywhere goes as it should. And representatives of regulatory authorities at this time come with checks. And what happens? Here is just one real example from practice. Once in Moscow, near the Paveletsky railway station, a young entrepreneur opened a pharmacy. And the process, as they say, has begun. But only before the first check. The group of inspectors who came to him first of all inquired about the presence and indicators of thermometers and hygrometers. To which the owner of the pharmacy business, not without surprise, asked: "Why are they? We have air conditioners. The climate is comfortable. Everything is fine!" The entrepreneur had nothing to prove that everything was really good in the pharmacy. As a result, this pharmacy was sealed up within an hour, and the inventory for 9 million rubles was closed. seized and destroyed.

Of course, the described example is almost a rarity. But more local troubles happen almost regularly. What's happening? The fact is that the staff of any pharmacy works with people, most of them work in a state of stress, because pharmacy visitors are most often sick people who already carry negativity in communication. Imagine that the worker of the first table must take a vacation, listen carefully to the buyer, give a qualified answer, while not forgetting about goodwill. And yet (a modern pharmacy is still a business) I want to sell and resell, there are also terms and goods of the day. But at the same time, the pharmacy worker must accept, disassemble, decompose the goods that arrive at the pharmacy once or twice daily ...

What is the result? Time goes by, and carts with goods keep growing and growing. The work of laying out the goods comes to automatism - they don’t think, they don’t look, they don’t read, just stuffing the incoming goods, while also keeping in mind the fear of some unscheduled check (pharmacies know about comprehensive checks).

After all, the inspectors can come to the pharmacy, take a picture, ask an unexpected, sometimes tricky question "for backfilling", open any cabinet and refrigerator, check appliances. Fear of them literally paralyzes the worker of the first table, and even experienced managers sometimes cannot say their names for several minutes. Here is what the pharmaceutical inspector of the SoyuzPharma Association of Pharmacy Institutions says Olga Afanasyevna Pozdnyakova:

- I go to the pharmacy, take a package of drug N and ask the pharmacist: "What is this?" The pharmacist begins to retell the entire instruction literally by heart, like an excellent schoolgirl. After listening carefully, I say: "Fine. 40 thousand." She says: "For what? I told everything!" Yes, I just forgot about the storage conditions! This is perhaps the most important information that manufacturers of drugs or dietary supplements want to convey to pharmacies. After all, what is a drug - it is a substance, a chemical, molecular compound obtained under certain conditions and influences, tested, dated and studied. The manufacturer guarantees the stability of this substance if it is stored in pharmacies under certain conditions specified by him. Often a deviation from the required temperature, humidity level, or other factors leads to the fact that the medicine, at best, will not have the desired effect, and at worst, will cause irreparable harm to the health of the consumer.

Pharmacy managers, first-desk workers are required to know the standards regarding the storage of medicines. You can get acquainted with them by reading the State Pharmacopoeia of the 13th edition (Article 1.1.10 OFS 1.1.0010.15), the pharmacopoeial article describes in detail that when storing medicines that require protection from the influence of environmental factors (light, temperature, atmospheric composition of air and etc.), it is necessary to ensure the storage mode specified in the pharmacopoeial monograph or regulatory documentation.

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

Let's get back to the checks. The pharmaceutical inspector checks the refrigerator, and there the temperature does not correspond to the concept of a "cool place", i.e. 8-15°C! Is it possible to guarantee the stability of substances if they are stored incorrectly? The required parameters of humidity, temperature, illumination are not observed. But people trust pharmacies. But, unfortunately, we have to admit that the storage of medicines is the weakest point in our pharmacies. The inspectors know about this and fine heavily.

EVERYONE HAS A PLACE!

What should the attention of a pharmacy worker be first of all drawn to when he picks up a package? For distribution by pharmaceutical groups - external and internal preparations separately! "I open the cabinets. And what do I see? Medicines, dietary supplements, ointments, cosmetics, massagers ... All in one box. I hear the answer to my question: "It's so convenient for us!" - Olga Pozdnyakova gives an example from her practice. And here is the State Pharmacopoeia with this disagrees: "All medicines - storage and display - separately by pharmaceutical groups, taking into account their external or internal use."

Some companies produce both medicines and biologically active additives (BAA), and pharmacy workers arrange them in a single line on the showcase. As a result, fines - 40 thousand rubles each. for each (!) violation. If a package falls into the hands of the inspector, on which there will be no inscription " Medicine" or " biologically active additive, then the internal filling can be considered a food product, it is generally prohibited for sale through a pharmacy. Again, fine! We remember display of the drug and dietary supplements cannot be together.

"Keep in a place protected from light at a temperature not exceeding 25 ° C!", i.e. secondary packaging cannot serve as light protection, even if there is dark glass in the cabinet or blackout packaging. The requirements of both Roszdravnadzor and Rospotrebnadzor confirm that it is necessary to remove the drug with the indicated information on the primary packaging in a cabinet without a glass door; otherwise, the pharmacy will again receive the same 40 thousand rubles. fine.

Some manufacturers write that their secondary packaging serves as protection from light. Then it's another matter. But it happens that the inspectors, examining the cabinet doors from the inside, notice that there is no dark coating on the glass, and issue a fine for violation, and this is already wrong. According to the new requirements, darkening the inside of the door must be done only for substances, and not finished dosage forms. In general, light can be both natural (sunny) and artificial, pharmacy workers sometimes consider only the first one to be “forbidden”. In fact, we are talking about any kind of lighting.

There are also contradictions. For example, it may be written on the packaging (in the instructions) " store in a cool place at a temperature not exceeding 6° FROM", this information from the manufacturer should be guided by, even if it does not correspond to those indicated in the Pharmacopoeia for a "cool place" of 8-15 ° C.

By the way, for dietary supplements, standards have not yet been developed that determine what is considered a cool storage place, and what is cold.

Be sure to read the instructions, paying attention to the following.

• What's in the package? Medicine, dietary supplement, medical product, hygiene product, etc. Lay everything out separately.
• Aggregate state of the drug. Coloring medicinal products, volatile, liquid must have a separate storage place; flammable - in a metal cabinet. Explosive, radiopharmaceutical, caustic, corrosive, liquefied, etc. medicinal products with hazardous properties must be stored in a specially arranged room equipped with additional safety and security equipment.

WE FILL OUT THE JOURNAL CORRECTLY!

It is also important who and how fills in the mandatory accounting (control) logs in the pharmacy. Everything is very beautiful, but not always right. The inspector, together with the council, opens the refrigerator, and there, instead of 2-8 ° C, all three thermometers show 15 ° C. They check with the magazine, and there the morning record is + 6 ° С. All violations are immediately photographed and recorded. The verdict of the inspector is a refrigerator full of medicines for immediate destruction and suspension of the license for 90 days. It must be remembered that proper storage of medicines is the life and health of their consumers. The filling of the journal must be approached extremely responsibly. Sometimes, especially on New Year's holidays, a pharmacy employee who keeps a journal combines several days with one curly bracket and sets, for example, 12 ° C. All. Fine. Indications each day must be filled in a separate line. If a pharmacy employee gives an incorrect or even simply inaccurate answer to the question of the inspector, this is a fine. It also happens that they open a storage place, and in the refrigerator -6 ° C, everything is frozen! Sometimes the magazine says - in the morning + 4 ° C, and in the evening + 8 ° C. This is an unacceptable temperature fluctuation. According to the regulations, it can only be 1 ° C! Otherwise, this means that the refrigerator needs repair and cannot be used.

Now there are so-called pharmaceutical refrigerators, in which the entire cooling element goes throughout the chamber. In such a refrigerator, the temperature is the same in all its places. At the same time, there is no official term "pharmaceutical refrigerator" yet, but I know that in Voronezh, for example, pharmacies are licensed only if such a refrigerator is available. But this is a "local" exception. Usually in drugstores there are household refrigerators. They often have glass doors, which is already a violation for drugs that are prescribed to be stored in a place protected from light. The cooling element is either only at the top, or only up to half of the refrigerator. Naturally, the temperature in different parts of such a refrigerator is different. Closer to the cooling element - below. In other areas - higher. Therefore, in such refrigerators, three thermometers must be installed. If we are talking about the storage of insulin and other biological preparations, then in this case a thermometer is needed on each shelf of the refrigerator.

Important! Let us turn again to the pharmacopoeia article: “The temperature regime on the shelves of the refrigerator is different: the temperature is lower near the freezer, higher near the door panel being opened.

Provision of a cold place implies storage of drugs in a refrigerator at a temperature of 2 to 8 ° C, avoiding freezing. Storage in a cool place means storing the drug in a refrigerator at a temperature of 8 to 15 ° C. In this case, storage of drugs in a refrigerator is allowed, with the exception of drugs that, when stored in a refrigerator at temperatures below 8 ° C, can change their physical and chemical characteristics, for example, tinctures, liquid extracts, etc.

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

It is not allowed to freeze drugs placed in packaging that can be destroyed by freezing, for example, drugs in ampoules, glass vials, etc.

"DRY" IS HOW?

Now for the humidity. In pharmacies, work is literally "boiling". Sometimes it is very difficult for staff to find time to take hygrometer readings. And this must be done daily, before 10 am, with an entry in the journal. It happens that a certain employee is responsible for this procedure, who works according to the "two days after two" schedule. As a result, she writes the hygrometer readings "forward". All inspectors know about this and ... fined. It is necessary to remember exactly the procedure for working with a hygrometer. The algorithm is:

1. Read dry and wet thermometer readings.
2. Calculate the temperature difference between dry and wet thermometers.
3. Determine the relative humidity of the air according to the psychrometric table. The desired relative humidity will be at the intersection of the lines of temperature according to the "dry" thermometer and the temperature difference according to the "dry" and "wet" thermometers.
4. Places where medicines are stored for more than 4 hours must be equipped with hygrometers without fail (Order of the Ministry of Health of the Russian Federation No. 377 of November 13, 1996 "On approval of requirements for organizing storage in pharmacies of various groups of medicines and medical products").
5. Storage of medicinal products is carried out at a relative humidity of not more than 60 ± 5%, depending on the corresponding climatic zone (I, II, III, IVA, IVB), if special storage conditions are not specified in the regulatory documentation.
6. Humidity when stored in a cool, dry place should be 50%. We don't have more humidity. But we have unconfigured hygrometers. And therein lies the problem. If it is dry, it is considered inoperative, and its performance is not taken into account.

A pharmacy worker should be responsible for the quality of products, medicines, which he dispenses to the consumer, and the quality primarily depends on the storage conditions of the medicinal product. If the pharmacy does everything right, works honestly, then it is not afraid of fines!

Based on the materials of the training seminar AAU "SoyuzPharma"

1. These Rules establish requirements for storage facilities for medicinal products for medical use (hereinafter referred to as medicinal products), regulate the storage conditions for these medicinal products and apply to drug manufacturers, drug wholesalers, pharmacies, medical and other organizations that carry out activities in the circulation of medicines, individual entrepreneurs holding a license for pharmaceutical activity or a license for medical activity (hereinafter, respectively - organizations, individual entrepreneurs).

Judicial practice and legislation - Order of the Ministry of Health and Social Development of the Russian Federation of August 23, 2010 N 706n (as amended on December 28, 2010) On approval of the Rules for the storage of medicines

Storage of medicines is carried out in accordance with the Rules for the storage of medicines, approved by order of the Ministry of Health and Social Development of the Russian Federation of August 23, 2010 N 706n (hereinafter - the Order).