Conditions for storing medicines of the LPU. Accounting for medicines

  • Date: 29.06.2020

2.1. Responsible for the storage and rational use of drugs, as well as for the order of storage places, compliance with the rules for issuing drugs to the patient are the head of the department (Cabinet) and the senior nurse. The direct artist of the organization of storage and consumption of medicines is the senior nurse.

2.2. Responsibility for the complete set, the presence, and the expiration date of the sets for emergency assistance in procedural offices (etc. In the Cabinet, an endoscopic office in hospitals, women's consultation and adolescent office) are the heads of the department and senior nurse.

2.3. Storing medicines in branches (cabinets) must be organized in lockable cabinets. Mandatory division into groups "external," "internal," "Injection," "Eye drops." In addition, in each compartment of the cabinet, for example, "internal", there must be division on powders, medicine, ampoules, which are placed separately, and the powders are stored, as a rule, on the upper shelf, and solutions - on the bottom.

2.4. Storage of drugs in the operating, dressing, procedural is organized in instrumental glazed cabinets (darkened) or on surgical tables. Each bottle, bank, the drug containing medicines must have a corresponding label.

2.5. Narcotic drugs, psychotropic, poisonous, potent substances should be kept in safes or in metal cabinets attached to the wall or semi. On the inside of the door of the cabinet (safe) - a list of medicines indicating the highest one-time and daily doses.

2.6. Drugs (not subject to subject and quantitative accounting) should be stored in a separate (wooden) cabinet under the lock in compliance with the temperature and light mode,

2.7. In places of storage and at posts on duty doctors and nurses, there must be tables of higher one-time and daily doses of narcotic, psychotropic, poisonous and potent substances, as well as antidote tables in poisoning.



2.8. In places storage of medical drugs must be observed temperature and light mode specified by the manufacturer on the package.

In storage premises, a certain air and humidity temperature should be maintained, the frequency of checking which should be carried out at least 2 times a day. To monitor these parameters, the premises must provide hygrometers that are fixed on the inner walls of the storages away from the heating devices at an altitude of 1.5-1.7 m from the floor and at a distance of at least 3 meters from the door.

In each room where medicines are stored, a map of temperature and humidity card must be established.

2.9. Drugs requiring protection from the effects of high temperature should be stored at room (+ 15- + 25 degrees), cool (or cold - + 8- + 15 degrees) temperature. In some cases, a lower storage temperature is required (for example, for ATP - 3-5 degrees), which should be indicated on the label or in the instructions for the use of the drug. In refrigerators, thermometers must be certified and subjected to verification in the prescribed manner. Thermometers should be passports. For each refrigerator, the temperature regime is fixed in a special journal.

2.10. Antibioticsit should be stored in industrial packaging at room temperature if there are no other indications on the labels.

2.11. Organopreparats It should be stored in a light, cool and dry place at a temperature of 0 + 15 degrees, if there are no other indications on the labels or in the instructions for use.

2.12. Pills And dragee is stored isolated from other medicines in the factory package that protects them from external influences and designed for vacation by separate patients. Storage of tablets and dragee should be carried out in dry and, if necessary, in a dark place.

2.13. Drug forms for injection It should be stored in a cool (+ 8- + 15 degrees), protected from light place, which should be indicated on the label, in a separate cabinet and taking into account the features of the container (fragility), if there are no other instructions on the package.

2.14. Liquid dosage forms (syrups, tincture) Must be stored in hermetically visited, filled to the top tare in the cool (+ 8- + 15 degrees.), protected from light place.

2.15. Plasmo-substituting (and disintellation) solutions Store isolated at temperatures ranging from 0 degrees to 40 degrees (which should be indicated on the label) in the light-protected place. In some cases, the freezing of the solution is allowed if this is not reflected on the quality of the drug.

2.16. Ointment, linimes Store in the cool (+ 8- + 15 degrees), protected from light place in a tightly attached container. If necessary, the storage conditions are combined depending on the properties of incoming ingredients. For example, preparations containing volatile and thermolabile substances are stored at a temperature not higher than 10 grades.

2.17. Storage suppositories It should be carried out in a dry, cool (+ 8- + 15 degrees.), protected from light place.

2.18. Storage of most medicines in aerosol packages It should be carried out at a temperature of +3 to +20 degrees. In a dry place, protected from light, away from fire and heating devices. Aerosol packaging should be protected from shocks and mechanical damage.

2.19. Drugs requiring protection against volatilization and drying, (Alcohol tinctures, ammonia solutions, ethyl alcohol of various concentrations, hydrogen peroxide) should be stored in a cool place, in hermetically visited container from impenetrable materials for weathered substances (glass, metal, aluminum foil).

2.20. Storage flammable and combustible liquids must be carried out separately from other materials. The flammable liquids (alcohol and alcohol solutions, alcohol and essential tinctures, alcohol and essential extracts, ether) are stored in a tightly attached durable, glass container, in a cool and protected place.

A co-storage of flammable substances with light splashing substances (vegetable oil, dressing material) is not allowed.

2.21. Rubber products

Protection against light, especially direct sunlight, high (more than 20 degrees) and low (below 0 degrees) air temperature; fluid air (drafts, mechanical ventilation); mechanical damage (squeezing, bending, twisting, pulling, etc.);

To prevent drying, deformation and loss of their elasticity, relative humidity of at least 65%;

Insulation from the effects of aggressive substances (iodine, chloroform, ammonium chloride, lysol, formalin, acid, organic solvents, lubricants and alkalis, chlorine b, naphthalene);

Storage conditions away from heating devices (at least 1 m).

Rubber products can not be laid in several layers, since items located in the lower layers are squeezed and flattened.

Cabinets must have tightly closing doors. Inside the cabinets must have a completely smooth surface.

Storage of rubber products in a lying position (vest, catheters, ice bubbles, gloves, etc.), not allowing their folds, flattening, twisting, etc.;

Storage of products in suspended state (harnesses, probes, irrigator tubes) are equipped with hangers located under the lid of the cabinet.

Lining circles, Rubber heats, Ice bubbles are recommended to store slightly inflated, rubber tubes are stored with plugs inserted at the ends;

Removable rubber parts of the devices should be stored separately from parts made from another material;

2.22. Dressing agents Store in a dry ventilated room in cabinets, boxes, on racks and pallets, which should be painted from the inside of light oil paint and contained clean.

Sterile dressing material (bandages, gauze napkins, wool) are stored in the factory packaging. It is forbidden to keep them in the primary opened packaging.

The non-sterile dressing material (cotton march) is stored packed in dense paper or in bales (bags) on racks or pallets.

Dissense, solutions for technical purposes (hand processing, tools, furniture, linen, etc.) Store together with medical preparations intended for the treatment of patients.

In the departments and on posts to pack, hang, overflow, shift medications from one packaging to another, replace the labels.

2.24. The duration of the storage of drugs made in the pharmacy is limited by certain periods indicated on the vial label. The storage time of medicines manufactured in the pharmacy must be posted in the procedural office.

2.25. Allocate wardrobes for storing documents (accounting logs, requirements, invalid, receiving acts, etc.) for drugs to be subject to subject-quantitative accounting.

Appendix 2.

to the order of the music ""

Instruction

according to the accounting of medicines, dressings and medical products in departments (cabinets)

1. In pharmacies, branches (cabinets) subject-to-quantitative accounting:

Narcotic drugs, psychotropic substances and precursors of narcotic drugs and psychotropic substances, and other drugs to be subject to subject-quantitative accounting,

Ethanol,

Expensive medicines (by decision of the head of the institution),

Dressing agents.

2. Subject and quantitative accounting is carried out in the appropriately executed magazines:

Narcotic drugs, psychotropic substances and precursors of narcotic drugs and psychotropic substances in accordance with the Decree of the Government of the Russian Federation of 04.11.2007. № 644,

Pages of magazines must be numbered, magazines are laid and certified by the signature of the head of the institution.

3. For each name, packing, dosage form, the dosage of medicines to be subject to subject and quantitative accounting, a separate page opens.

4. The basis for the daily entry in journals of the received and issued drugs is the requirements of the comprehensive (at the main and older nurses, as a post), receiving-acts or other documents.

5. Drugs are released by offices (cabinets) in the size of the current need for them: narcotic and psychotropic drugs - a daily, 3-day (5-day), all other -10-day.

6. It is prohibited to obtain and storing medicines in offices (cabinets) over the current need, as well as discharge drugs from the pharmacy (main nurse) for general requirements - the factory for several offices (cabinets) and make the subsequent packaging, moving from one dish to another , replace labels, etc.

7. The issuance of drugs containing drugs containing drugs, psychotropic, poisonous and potent substances should be made separately from other medicines. Acceptance of patients with medicinal preparations is carried out in the presence of a medical worker. An exception can be drugs that are not related to narcotic, psychotropic, poisonous, potent, prescribed for diseases in need of continuous supporting treatment (ischemic heart disease with stress and resting angina, hypertensive disease with a resistant increase in blood pressure, diabetes, epilepsy and other similar diseases ).

Issue medicines without appointing a doctor, replace one drugs to others.

Disposable, draw up and store medications under conventional, abbreviated names, not approved by the pharmacopoeial committee (for example, cough medicine, solution for disinfection of hands, "Triple solution", etc.).

7.2. To avoid mistakes before opening the ampoule, packaging, it is necessary to read the name of the drug, dosage, check with the assignment and then release the patient.

8. Head of the Department (Cabinet) is obliged to constantly monitor:

The validity of the prescription of medicines,

Strict implementation of appointments in accordance with the history of the disease,

The number of the actual presence of medicines in the office (office),

Take decisive measures to prevent the creation of their stocks over the current need.

9. The pharmacy is responsible for the quality of the medicine made and released in the separation and accurate compliance with its requirement, subject to the preservation of the packaging integrity (in the unborn state) and the content of the medication in conditions determined by the storage rules. After opening the packaging and the first use of the drug in the department, the staff of the department headed by the head of the institution is further responsible for its quality.

10. The representative of the pharmacy at least once a quarter checks the state of storage, accounting and consumption of medicines in the hospital offices; Narcotic, psychotropic and potent drugs are-going.

11. Senior nurses of all divisions of drug accounting magazines for expiration time. In the presence of drugs with an expired shelf life (before transmission to destruction), separately from another product in the quarantine zone. Preparations with an expired expiration date to destroy the organization with an appropriate license (except for narcotic drugs and psychotropic substances).

12. Continue in departments personalized accounting of medicines.

General Pharmacopoeia article

POSSORY OF PRESSIONS OFF.1.1.0010.15
Entered for the first time

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

The storage of medicinal vegetable raw materials and medicinal plant preparations is carried out in accordance with the Office "Storage of medicinal plant materials and medicinal plant preparations".

Storage is the process of storing medicines until they are used within the established expiration date, which is an integral part of the treatment of medicines.

General Requirements for Storage Premises

medicines and their storage organizations

Medicinal storage should be carried out in the premises intended for these purposes. The device, composition, size of the area of \u200b\u200bstorage premises, their operation and equipment should ensure proper storage conditions for various groups of medicines.

The set of storage premises should include:

Acceptance room (zone) of acceptance intended for unpacking and receiving packaging with medicines and their preliminary inspection;

Room (zone) for sampling of drugs of medicines in accordance with the requirements of the Sampling Sampling;

Premises (zone) for quarantine storage of medicines;

Premises for medicines requiring special storage conditions;

Premises (zone) for storing rejected, returned, withdrawn and / or drugs with an expired shelf life. These drugs and storage locations should be clearly designated.

The storage area is highlighted in a shared storage room in the absence of a separate insulated room.

The finishing of drug storage premises must meet the current sanitary and hygienic requirements, the inner surfaces of the walls and the ceilings must be smooth, allowing wet cleaning.

In each storage room, it is necessary to maintain a climatic mode, by observing the temperature and humidity of the air established by the pharmacopoeia article or regulatory documentation for drugs. The necessary air exchange in storage premises is created using air conditioners, supply and exhaust ventilation or other equipment. Natural and artificial lighting in storage premises should ensure accurate and safe implementation of all operations performed in the room. If necessary, the protection of drugs from solar radiation should be provided.

Premises for storage of medicines must be equipped with the necessary number of indicators in the prescribed manner of measurement tools (thermometers, hygrometers, psychrometers, etc.) to control and register temperature and humidity carried out at least once a day. Measurement facilities are located at a distance of at least 3 meters from the doors, windows and heating devices in an accessible place to read, at an altitude of 1.5 - 1.7 m from the floor. At the same time, they are recommended to be placed in places where there is the greatest probability of temperature and humidity oscillations or deviations from the required parameters are most often observed.

Registration recordings should demonstrate the temperature and humidity modes installed for the premises, and when they are inconsistencies, corrective actions.

Storage premises must be equipped with a sufficient number of cabinets, safes, racks, sublinks, pallets. The equipment must be in good condition and be clean.

Racks, cabinets and other equipment should be established in such a way as to provide access to drugs, the free passage of personnel and, if necessary, the availability of loading and unloading works, as well as the availability of equipment, walls, flooring facilities.

In the premises for storing medicines should be maintained proper sanitary regime. The frequency and methods of cleaning premises must comply with the requirements of regulatory documents. Sanitary-disinfectants used should be safe, the risk of contamination by these means of storage drugs should be excluded.

Special instructions for cleaning spilled or scattered medicines should be developed to fully eliminate and prevent contamination of other drugs.

When performing work in premises for storing medicines, employees must wear special clothes and shoes, follow personal hygiene rules.

Persons for storage drugs are placed in accordance with the storage conditions specified in the pharmacopoeial article or regulatory documentation for drugs, taking into account their physicochemical and hazardous properties, pharmacological and toxicological action, the type of dosage form of the drug and the method of its use, aggregate Medicinal states. When using computer technology, drugs are allowed using the alphabetic principle, according to codes.

Racks, cabinets, shelves, designed to store medicines, must be identified. It is also necessary to identify the stored drugs using a shelving card when using computer technologies - using codes and electronic devices.

With a manual method of unloading loading work, the height of the installation of drugs should not exceed 1.5 m. When using mechanized devices during unloading and loading work, drugs should be stored in several tiers. At the same time, the overall height of the placement of drugs on racks should not exceed the possibility of loading and unloading mechanisms.

Drugs in storage premises should be placed in cabinets, racks, sublinks, pallets, etc. It is not allowed to place medicines on the floor without pallet. Pallets can be located on the floor in one row or on racks in several tiers, depending on the height of the rack. Pallets with drugs with drugs in several rows in height without the use of racks are not allowed.

When creating storage conditions of a separate medicinal product, it is necessary to be guided by the requirements specified in the pharmacopoeial article or regulatory documentation for this drug established by the manufacturer of the drug based on the results of the stability study in accordance with the Office of the shelf life of drugs.

Medicinal storage is carried out in packaging (consumer, group), which meets the requirements of the regulatory documentation for this drug.

The storage of medicines is carried out at a relative humidity of no 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.

Drugs should be stored so as to prevent their pollution, mixing and cross-contamination. It is necessary to avoid foreign odors in storage premises.

Must be implemented in the organization, the system of accounting for drugs with a limited shelf life. If there are several series of one drug name on the storage, then for use, the drug must be taken first, whose shelf life has expired earlier than others.

Rejected drugs must be identified and stored in the appropriate room (zone) in conditions that do not allow them unauthorized use.

Features of storage of individual groups of medicines

Drugs with hazardous properties (flammable, explosive, radiopharmaceutical, caustic, corrosion, gases are compressed and liquefied, etc.) should be stored in specially arranged rooms equipped with additional safety and security facilities. When stored, it is necessary to ensure the safety and declared quality of drugs, prevent the possibility of manifestation of their dangerous properties and create safe working conditions of employees working with such drugs.

In the device of premises and the organization of storage of hazardous drugs, it is necessary to be guided by the requirements of federal laws and regulatory legal acts of the Russian Federation.

Storage of narcotic and psychotropic drugs should be carried out in accordance with federal laws and regulatory legal acts of the Russian Federation.

When storing medicines requiring protection against the influence of the external environmental factors (light, temperature, atmospheric composition of air, etc.), the storage mode specified in the pharmacopoeial article or regulatory documentation is necessary. Deviations from regulated conditions are allowed once only on the short-term period (no more than 24 hours), if the special conditions, for example, constant storage in a cold place, are not specified separately.

Drugs that under the action of light energy can change their properties (oxidize, restore, decompose, change their color, etc.), are photo or photosensitive; Drugs, resistant to the action of light, - photostable. The effect of light energy can manifest itself in the effects of direct sunlight, scattered light of the visible region of the light spectrum and radiation of the ultraviolet region.

Marking of photosensitive drugs, as a rule, contains an indication: "Store in the place protected from light." Drugs requiring protection against the action of light should be stored in rooms or specially equipped areas providing protection against natural and artificial lighting. Pharmaceutical substances requiring protection against the action of light should be stored either in a package of light-protective materials or in a dark room or cabinets. If the Pharmaceutical Substanties are used as a packaging of high-speed pharmaceutical substances for medicines, it is necessary to accumulate the container with black light-tight paper.

The photosensitive drugs should be packed in light-protective secondary (consumer) packaging and / or should be stored in light-protected place.

Drugs that, when in contact with water, can be separated by gases, etc., are moisture sensitive. Marking of moisture-sensitive drugs, as a rule, contains an indication: "Store in a dry place". When storing such medicines, you need to create conditions, so that relative air humidity does not exceed 50% at room temperature (under normal storage conditions) or equivalent vapor pressure at a different temperature. The fulfillment of the requirement also provides for the storage of a well-sensitive drug in airtight (moisture-proof) consumer packaging, providing the specified protection and compliance with the storage conditions when treating a medicine.

To maintain the low moisture content during the storage of drugs in the established cases, drying agents are used, subject to the exclusion of their direct contact with the drug.

Medicinal products with hygroscopic properties must be stored at relative humidity no more than 50% in the package, which is a glass container for medicines, hermetically evacued, or in packing with additional protection, for example, in a bag of polyethylene film, in accordance with the requirements of a pharmacopoeia article or regulatory documentation.

Some groups of drugs change their properties under the influence of atmospheric air gases, such as oxygen or carbon dioxide. To ensure the protection of drugs from the exposure to gases, the storage of drugs is recommended to be carried out in a hermetic packaging from materials that are not permeable for gases. Packaging, if possible, must be filled with top and evacuated hermetically.

Drugs that are actually volatile drugs or drugs containing a volatile solvent; solutions and mixtures of volatile substances; Drugs decomposing with the formation of volatile products require the creation of storage conditions that protect them from volatilization and drying. It is recommended to store drugs in a cool place, in hermetically soldered packaging from impermeable substances of materials or in primary and secondary (consumer) packaging in accordance with the requirements specified in the pharmacopoeial article or regulatory documentation.

Drugs, which are pharmaceutical substances containing crystallization water (crystallohydrates), exhibit the properties of hygroscopic substances. Storage of crystallohydrates is recommended to be carried out in hermetically visited packaging in accordance with the requirements specified in the pharmacopoeial article or regulatory documentation. Usually, crystal hydrates are stored at temperatures from 8 to 15 ° C and relative air humidity not more than 60%.

Drugs that change their properties under the action of ambient temperature are thermally sensitive. Drugs can change their properties under the influence of room and higher temperatures (thermolabile drugs) or under the influence of reduced temperature, including during freezing.

When storing heat-sensitive drugs, it is necessary to ensure the temperature regime regulated by the requirements of the pharmacopoeia article or the regulatory documentation specified on the primary and / or secondary (consumer) packaging of the drug.

Thermolabile drugs should be stored in specially equipped rooms (refrigeration chambers) or in storage rooms equipped with a sufficient amount of refrigerated cabinets, refrigerators. For storage of thermolabile drugs, pharmaceutical refrigerators or blood refrigerators and its preparations should be used.

The proper quality of immunobiological drugs, safety and efficiency of their application is provided by the "cold chain" system, which should be performed at all four levels.

In refrigerators (cameras, cabinets), the temperature corresponding to the temperature regime of the storage of drugs in them should be set. Storage of immunobiological drugs should be carried out at a temperature not higher than 8 ° C. Each packaging of the immunobiological drug in the refrigerator must be provided with cooled air access. Co-storage in the refrigerator of immunobiological drugs with other drugs is not allowed.

To monitor the temperature regime of storage of thermolabile drugs, all refrigerators (cameras, cabinets) must be provided with thermometers. Continuous temperature control control is carried out using the readings of which are recorded at least two times a day.

Temperature regime on the shelves of the refrigerator is different: the temperature is below the freezer, above - near the open door panel.

Ensuring a cold place involves storing medicines in the refrigerator at a temperature of from 2 to 8 ° C, not allowing freezing. Storage in a cool place implies storage of medicines at a temperature of from 8 to 15 ° C. In this case, the storage of drugs in the refrigerator is allowed, with the exception of drugs, which, when stored under the temperature of the temperature mode, the refrigerator below 8 ° C can change their physicochemical characteristics, such as tincture, liquid extracts, etc.Storage at room temperature implies temperature range from 15 to 25 ° C or, depending on climatic conditions, up to 30 ° C. Storage in the freezer provides temperature regimen from -5 to -18 ° C. Storage under deep freezing provides temperature regime below -18 ° C.

Drugs are advisable to place in areas and on the shelves of the refrigerator corresponding to their temperature storage mode. It is not allowed to store immunobiological drugs on the door panel of the refrigerator.

In storage premises, it is necessary to ensure the storage conditions of drugs requiring protection from the effects of reduced temperature, for which the lower limit of the temperature regime of storage is installed in the pharmacopoeial article or regulatory documentation.

It is not allowed to freeze drugs that have relevant requirements in the pharmacopoeial article or regulatory documentation and indicated on the primary or secondary packaging, including insulin preparations, adsorbed immunobiological preparations, etc.

It is not allowed to freeze drugs placed in packaging capable of collapse during freezing, for example, drugs in ampoules, glass bottles, etc.

The definitions used in the pharmacopoeix characterizing the temperature regimes of drug storage are shown in the table.

It is necessary to ensure compliance with the conditions for storing medicines and preserve their integrity during transportation.

For medicines that are particularly sensitive to temperature regime (vaccines, serums and other immunobiological drugs, insulin drugs, etc.), during transportation, the regulated by the pharmacopoeial article or regulatory documentation is temperature regime.

Table - Definitions characterizing drug storage regimens

Storage mode

Temperature interval, ° С

Store at a temperature not higher than 30 ° C

from 2 to 30 ° C

Store at a temperature not higher than 25 ° C

from 2 to 25 ° C

Store at a temperature not higher than 15 ° C

from 2 to 15 ° C

Store at a temperature not higher than 8 ° C

from 2 to 8 ° C

Store at a temperature not lower than 8 ° C

from 8 to 25 ° C

Store at a temperature of from 15 to 25 ° C

from 15 to 25 ° C

Store at temperatures from 8 to 15 ° C

from 8 to 15 ° C

Store at temperatures from -5 to -18 ° C

from -5 to -18 ° С

Store at temperatures below -18 ° C

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    Samvel Grigoryan about whether it is possible to place medicines and badges on one showcase shelf

    Employees of pharmacy organizations often have issues related to the calculation of drugs and other pharmacy assortment products to showcases. Many of these issues relate to the rules for storing the BAA in the pharmacy. "Explain whether it is possible to put a bad badge with medicines on one shelf?" - Such a laconic letter from the pharmacist from Bryansk was found in the editorial mail "Katren-Style". It would seem, well, it may be supervised in ordering windows. However, the problem is that this topic is not properly regulated.

    After March 2, 2014, the sectoral standard "Rules of vacation (implementation) of drugs in pharmacy institutions has lost its strength. Basic provisions (Order of the Ministry of Health of the Russian Federation No. 80 dated 04.03.2003) "- which contained very vague, but at least some regulation of showcase placement - on this topic, the legislation was formed if not a vacuum, then a very rarefied space. As a result, the pharmacy workers do not have clear rules from the regulator, how to spread out correctly, and inspecting, on the contrary, have the ability to prevent or punish at their discretion. And yet we will try to highlight this topic.

    Showcase - this is also storage

    Any product adopted by a pharmacy can only be two states - it is either stored or released. And the presence of packaging on the pharmacy showcase - whether it is a cure for a non-prescription vacation or dietary supplement - this is one of the storage options, during which consumers are informed of this product, its availability in a pharmacy, price, dosage, dosage form, etc. maybe Therefore, regulators do not consider it necessary or urgently adjusted to the show-case question - because the topic of storage is adjusted in the appropriate regulatory act.

    It is understood Order of the Ministry of Health and Social Development of the Russian Federation of August 23, 2010 No. 706n "On Approval of the Rules of Drug Storage". What concerns "Instructions on the organization of storage in pharmacy institutions of various groups of medicines and medical products" (Order of the Ministry of Health of the Russian Federation of November 13, 1996 No. 377), Most of her articles have lost strength. There are only its norms concerning medical products and medical equipment, dressings and auxiliary material, plastic and rubber products.

    In order No. 706n, even the words "showcase" and "laying" are absent. But, probably, there is not a single pharmacy or pharmacy point, in which part of the drugs would not be kept in the predictrous and display part of the pharmacy hall. In this way, Drug storage rules Order No. 706n is naturally distributed to the pharmacy hall.

    What follows from the order number 706n

    Pay attention to the name of the order - it really concerns almost exclusively medicines. Paragraph 8 of Section III of the order, it was determined that they were placed in storage premises - we have already mentioned above that there are also predictrous and display parts of pharmacy halls - taking into account:

    • pharmacological groups;
    • physicochemical properties;
    • method of use (internal, outdoor);
    • aggregate state of farmsubstation (liquid, bulk, gaseous);

    and in accordance with the requirements of the regulatory and technical documentation indicated on the packaging of the drug.

    No individual indications, as needed to be stored in the pharmacy - including the showcase - dietary supplements, medical products, personal hygiene products, mineral water, cosmetics, etc. relative to medicinal products, the order No. 706 does not contain. There are no them in "Hygienic requirements for the organization of production and turnover of biologically active additives to food" (SanPine 2.3.2. 1290-03). Therefore, from a formal point of view, some interpret it so that the dietary supplement can be placed with the medications "one of the orientation" on one showcase shelf.

    However, this conclusion is doubtful. First, the dietary supplements can not be with the medicines of the "one orient way", for they are not drugs (the impact on the same organism systems does not mean anything).

    Secondly, the "focus" does not mean belonging to one pharmacological group, which, by the way, cannot contain medicines, and non-good, that is, dietary supplements. And since in order No. 706n and in the above item we are talking about streamlining the storage of drugs and precisely on pharmacological groups, it is obvious that none of the places of storage - including on the showcase - drugs can not be placed together with the BD .

    So as not to mislead

    There is another side of the topic. We should not forget about Article 10 of the Law "On Consumer Rights Protection" (from 07.02.1992 No. 2300-1), which prescribes to provide customers with the necessary and reliable information about goods, ensuring the possibility of their correct choice.

    Imagine, the consumer is suitable for a showcase, where not only the drugs of one pharmacological group, but also the dietary supplements "with them of the orientation" are placed. The phrase "is not a medicine", of course, according to paragraph 4.4 Sanpin 2.3.2. 1290-03, present on the packaging of dietary supplements, but, as a rule, it is shallow font, and in afar, it does not rush.

    Therefore, looking at the showcase, such a phrase is easy not to notice, skip. In addition, when laying it, it may be on the wrong side of the packaging side. As a result, the buyer can automatically calculate that this product, as well as located around the drugs, is a medicine, although, we emphasize, it is unlikely that it can be called a conscious introduction of his misleading from the pharmacy. However, the consumer can decide to acquire exactly this name, believing his medicinal. And only at home, looking for packaging or instructions, will find that it is not.

    Thus, the joint layout of drugs and dietary supplements on one showcase regiment creates the risk of unconscious disinformation of the consumer, violations of its rights defined by Article 10 of the Law "On Consumer Rights Protection". And therefore it should also be avoided.

    Conclusions are following. Medicines and any dietary supplements are not recommended to lay out one showcase shelf. For storage of dietary supplements in the pharmacy, it is better to provide separate display spaces that should be accompanied by the inscription "Biologically active additives for food". On the ordering of various dietary supplements within such a SanPine showcase 2.3.2. 1290-03 nothing reports. It only contains an indication that the dietary supplement should be stored taking into account their physicochemical properties, under the conditions specified by the manufacturer, observing the temperature, humidity and illumination modes.

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

    However, in practice, they are often violated. Recall the basic rules for storing medicines of various groups, consider typical errors of medical institutions when organizing storage processes. R

    azbrem who is responsible for improper storage of medicines.

    From the article you will learn:

    • Drug Storage Rules
    • Rules for storing drug groups
    • Requirements for the storage conditions of drugs


    Drug Storage Rules

    Medicinal storage is one of the basic processes of drug circulation. Order of the Ministry of Health and Social Development of the Russian Federation No. 706n of August 23, 2010 approved the list of rules for which medicines are organized in medical institutions of the Russian Federation. Order "On approval of the rules for storing medicines"

    This document provides a classification of medicines that require protection against environmental factors - light, temperature, moisture, etc. The following groups of drugs are allocated, for each of which there are different storage rules: a group of funds requiring protection against the impact of a wet environment and light; medicines that, with improper storage, can dry and disappear; medicines that should be stored at a certain temperature; Preparations that can be spoiled when exposed to gases contained in the medium.

    What documents approve drug storage rules

    As mentioned above, the rules for storing drugs are approved by Order No. 706n.

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

    1. Order of the Ministry of Health No. 771 of 29.10.2015 (list of pharmacopoeial articles).

    2. Order of the Ministry of Health No. 676N of August 31, 2016 (description of the proper practice of storage and transportation of medicines);

    3. Order of the Ministry of Health No. 770 of 28.10.2015 (changes in the list of pharmacopoeial articles).

    Drug storage rules are also fixed in local documentation of the medical organization. Such documents include cops - standard operational procedures that describe in detail the conditions for storing medicines, the actions of medical staff, etc. The maintenance of such standard documents includes the following sections: Requirements for the transportation of medicines; measures for the protection of drugs from the impact of the external environment; the rules of admission of health workers in the hospitals for the placement of medicines; rules for cleaning these premises; Procedure for conducting compliance checks and the results of these inspections; Responsibility of health workers who violated standard procedures.


    Rules for storing drug groups

    The rules for storing medicines must be respected taking into account the group to afford the specific drug.
    Medicinal preparations must be placed in specially dedicated places. These are cabinets, open shelves ,.

    If the drugs relate to narcotic or subject to PKU - the cabinet in which they are placed, should be sealed. It is advisable to use a safe-refrigerator with a class-resistance class.

    The rest of the drugs can be stored on racks so that their consumer packaging is visible.

    Medicinal storage conditions include equipping storage facilities with opening windows, pharmaceutical refrigerators and air conditioning.

    This allows you to provide a suitable temperature mode.

    Medicine Storage Conditions

    Consider some rules for storing drugs of different groups.

    1. Medicines that should be protected from light. The storage of group drugs is carried out in those places, light access to which is limited. For this, a reflective film is applied to the window or they are watched blinds, etc. In pharmaceutical refrigerators there must be a special glass in the door that does not miss ultraviolet rays or the door should be deaf.

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

    3. Prone to drying and volatile drugs. Special storage conditions are provided by maintaining the optimal air temperature - from 8 to 15. Hydrogen peroxide is inclined to volatile, iodine, etc.

    4. Storage of drugs in singular temperature conditions. There are preparations that can deteriorate under conditions of high or low temperatures. Recommendations for the storage temperature of a particular preparation indicates a manufacturer on primary or secondary packaging.

    5. Preparations that can be spoiled due to the effects of gases in the air. Packaging of drugs should not be damaged, there should be no intensive lighting and extraneous smells in the room. Complied with the recommended temperature mode in the office.

    The conditions in which medicines must be stored are usually described: on packaging or transportation containers; In the instructions for medical use medication; In the State Register of Medicines. These conditions must be readable. Instructions language - Russian. Information on the storage conditions of medicines is also placed on transportation containers in the form of manipulation and warning signs. For example: "Do not throw", "Bear from sunlight", etc.


    Requirements for the storage conditions of drugs

    Storage of medicines belonging to the group of poisonous and potent, is carried out in special premises. They must be equipped with security engineering and technical devices. In an additional fortified premises, both narcotic and other potent drugs can be stored at the same time.

    Depending on the available stock of drugs, they are stored on separate shelves or in different sections of the cabinet. The rules for storing drugs require that potent drugs that are not under international control are kept in metal cabinets that the responsible health workers seal at the end of the day. Actually use that protects against unauthorized access and allows for accurate temperature storage of drugs.

    What should be the storage premises of medicines

    The medical organization must be complied with the requirements for the premises that are planned to be used for storage of drugs. Severe several general rules: it is important that the room has sufficient capacity for convenient and separate storage of drugs of different groups; The zoning of the room involves the allocation of a common zone, a special zone and a quarantine zone. Separately stored drugs whose shelf life has expired; Storage zones should be well lit; Household premises are separated from the zones in which medicines are stored; Together with drugs, it is impossible to store personal stuffing workers, drinks and food; The room provides optimum temperature for individual groups of drugs; In separate cabinets, devices are stored for current and general cleaning of the room; In the room there must be no possibility of penetrating animals, rodents and insects; Near the drug racks are placed rack maps that allow you to quickly find the necessary drug; The room must be equipped with a security system; Operating rules are complied with the use of refrigerators, air conditioners and other systems of the room (fire-fighting, security, etc.); Preparations for temperature registration and other air indicators should pass periodic calibration and calibration.

    Medicinal preparations with special storage conditions

    Special conditions for storing medicines are observed for the following medicines: 1. Psychotropic and narcotic drugs. 2. Explosive and flammable. 3. Preparations whose properties affect the conditions of the external environment.

    For example, explosive medicines cannot be shaked and hit when moving. They are stored away from heating radiators and daylight.

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

    Storage of medicines relating to immunobiological requires special attention. We are talking about the principle of the "cold chain", which ensures the maintenance of the optimal temperature to preserve the beneficial properties of the drug at all stages of its transportation and displacements. Separately, from other drugs, spoiled drugs are stored, which will continue to be destroyed. Requirements for the storage of narcotic drugs are indicated in the FZ "On narcotic drugs and psychotropic substances". Premises for storage are equipped with additional protection measures in accordance with the requirements of the Order of the Federal Tax Service of Russia No. 370 dated September 11, 2012. Special requirements for storing such drugs are also contained in the departmental order of the Ministry of Health of the Russian Federation No. 484n dated July 24, 2015.

    The essence of these requirements is to storing narcotic drugs to be further strengthened. Drugs are placed in metal cabinets, pharmaceutical refrigerators, refrigerators safes that are subject to sealing at the end of the work shift of responsible health workers. Similar rules are established for medicines to be subject to substantive accounting.

    Errors when storing medicines

    The rules for the storage of drugs discussed above are often violated in medical institutions.

    Among the common errors, you can select the following:

    • medicines are stored in violation of the requirements that are indicated on their packaging from the manufacturer;
    • ordinary drugs are stored together with drugs, whose shelftics expired;
    • the medical institutions are not taken into account in the special journal the shelf life of medicines;
    • in medical institutions there are no instruments for tracking temperature indicators in drug storage rooms.

    Who is responsible for improper storage of drugs

    Accounting, storage and use of drugs is included in the duties of the nurse.

    This is indicated in the order of the Ministry of Health and Social Development of Russia of July 23, 2010 No. 541n. According to part 1 of article 14.43 of the Code of the Russian Federation on administrative offenses, violation of the requirements for the treatment of medicines is an administrative offense.

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

    The medical insurance can be fined in the amount of 100,000 to 300,000 rubles.

    Examples of violations and punishments that followed them

    Temperature violation - Resolution of the Supreme Court of the Russian Federation of December 8, 2014 No. 307-ad14-700
    100 000 rub.

    In the procedural offices there are no devices attornected by metrological control authorities - Resolution of the Supreme Court of the Russian Federation of February 3, 2016 No. 305-ad1518634
    100 000 rub.

    Daily accounting of temperature and humidity indicators; There is no device for registration of air humidity parameters (hygrometer); There is no specially dedicated and designated (quarantine) zone; Consideration of medicines with a limited expiration date - Resolution of the Supreme Court of the Russian Federation of January 19, 2015 No. 306-ad144327
    100 000 rub.