2.1. Responsible for the storage and rational use of medicines, as well as for the order at the places of storage, compliance with the rules for the distribution of medicines to the patient are the head of the department (office) and the head nurse. The direct executor of the organization of storage and consumption of medicines is a senior nurse.
2.2. Responsibility for the complete set, availability, and shelf life of emergency kits in treatment rooms (etc. in the X-ray room, endoscopic room in hospitals, maternity welfare and adolescent rooms) rests with the department head and the senior nurse.
2.3. Storage of medicines in departments (offices) should be organized in lockers. Mandatory division into groups of "External," "Internal," "Injection," "Eye Drops." In addition, in each compartment of the cabinet, for example, "Internal", there should be a division into powders, potions, ampoules, which are placed separately, with the powders stored, as a rule, on the top shelf, and solutions on the bottom.
2.4. Storage of drugs in the operating room, dressing room, and treatment room is organized in instrumental glazed cabinets (darkened) or on surgical tables. Each bottle, jar, barbell containing medicines must have an appropriate label.
2.5. Narcotic drugs, psychotropic, toxic, potent substances should be stored in safes or in metal cabinets attached to a wall or floor. On the inside of the cabinet doors (safe) - a list of medicines with the indication of the highest single and daily doses.
2.6. Medicines (not subject to quantitative accounting) must be stored in a separate (wooden) cabinet under lock and key, subject to temperature and light conditions,
2.7. In the places of storage and at the posts of doctors on duty and nurses there should be tables of the highest single and daily doses of narcotic, psychotropic, toxic and potent substances, as well as tables of antidotes for poisoning.
2.8. In storage areas for medicinal products must be observed temperature and light conditions indicated by the manufacturer on the package.
A certain temperature of air and humidity should be maintained in the storage premises, the frequency of verification of which should be carried out at least 2 times a day. To monitor these parameters, the premises must be provided with hygrometers that are fixed on the internal walls of the store far from heating appliances at a height of 1.5-1.7 m from the floor and at a distance of at least 3 m from the doors.
In each room where medicines are stored, a temperature and humidity metering card must be established.
2.9. Medicines requiring protection from exposure to elevated temperatures should be stored at room temperature (+ 15- + 25 degrees C), cool (or cold - + 8- + 15 degrees C) temperature. In some cases, a lower storage temperature is required (for example, for ATP - 3-5 degrees C.), which should be indicated on the label or in the instructions for use of the drug. In refrigerators, thermometers must be certified and verified in the prescribed manner. Thermometers must have passports. For each refrigerator, the temperature regime is recorded in a special journal.
2.10. Antibioticsstore in industrial packaging at room temperature unless otherwise indicated on labels.
2.11. Organizational preparations should be stored in a dark, cool and dry place at a temperature of 0 + 15 degrees C, unless otherwise indicated on the labels or in the instructions for use.
2.12. Pills and dragees are stored in isolation from other medicines in the original packaging, protecting them from external influences and designed for leave to individual patients. Storage of tablets and dragees should be carried out in a dry place and, if necessary, in a dark place.
2.13. Injection Dosage Forms should be stored in a cool (+ 8- + 15 deg.), dark place, which should be indicated on the label, in a separate cabinet and taking into account the peculiarities of packaging (fragility), unless otherwise indicated on the packaging.
2.14. Liquid dosage forms (syrups, tinctures) must be stored in a hermetically sealed container filled to the top in a cool (+ 8- + 15 deg.), dark place.
2.15. Plasma substituting (and detoxifying) solutions stored in isolation at temperatures ranging from 0 degrees C to 40 degrees C (which should be indicated on the label) in a dark place. In some cases, freezing of the solution is allowed, if this does not affect the quality of the drug.
2.16. Ointments, liniment Store in a cool (+ 8- + 15 deg), dark place in a tightly sealed container. If necessary, storage conditions are combined depending on the properties of the incoming ingredients. For example, preparations containing volatile and thermolabile substances are stored at a temperature not exceeding 10 degrees C.
2.17. Storage suppository should be carried out in a dry, cool (+ 8- + 15 deg.), protected from light place.
2.18. Storage of most drugs in aerosol containers should be carried out at a temperature of +3 to +20 degrees Celsius in a dry, dark place, away from fire and heating appliances. Aerosol containers should be protected from shock and mechanical damage.
2.19. Medicines requiring protection against volatilization and drying out, (alcohol tinctures, ammonia solutions, ethanol of various concentrations, hydrogen peroxide) should be stored in a cool place, in a hermetically sealed container made of materials impervious to volatiles (glass, metal, aluminum foil).
2.20. Storage flammable and flammable liquids should be carried out separately from other materials. Flammable liquids (alcohol and alcohol solutions, alcohol and ether tinctures, alcohol and ether extracts, ether) are stored in tightly sealed strong, glass containers in a cool and dark place.
The joint storage of flammable substances with flammable substances (vegetable oil, dressings) is not allowed.
2.21. Rubber products
Protection from light, especially in direct sunlight, high (more than 20 degrees C) and low (below 0 degrees C) air temperature; fluid air (drafts, mechanical ventilation); mechanical damage (squeezing, bending, twisting, pulling, etc.);
To prevent drying, deformation and loss of elasticity, relative humidity of at least 65%;
Isolation from aggressive substances (iodine, chloroform, ammonium chloride, lysol, formalin, acids, organic solvents, lubricating oils and alkalis, chloramine B, naphthalene);
Storage conditions away from heating appliances (at least 1 m).
Rubber products can not be stacked in several layers, as objects located in the lower layers are compressed and caked.
Cabinets must have tight-fitting doors. Inside the cabinets should have a completely smooth surface.
Storage of rubber products in a lying position (bougie, catheters, ice bubbles, gloves, etc.), preventing their bending, flattening, twisting, etc .;
Storage of products in suspension (harnesses, probes, irrigation tube) are equipped with hangers located under the cabinet lid.
Lining circles, rubber warmers, ice bubbles are recommended to be stored slightly inflated, rubber tubes are stored with corks inserted at the ends;
Removable rubber parts of devices should be stored separately from parts made of other material;
2.22. Dressings stored in a dry, ventilated room in cabinets, drawers, on racks and pallets, which should be painted from the inside with light oil paint and kept clean.
Sterile dressings (bandages, gauze, cotton) are stored in their original packaging. It is forbidden to store them in their original opened packaging.
Non-sterile dressings (cotton, gauze) are stored packed in thick paper or in bales (bags) on shelves or pallets.
Disinfectants, solutions for technical purposes (processing of hands, tools, furniture, linen, etc.) should be stored together with medical preparations intended for the treatment of patients.
To pack, hang, transfer, transfer drugs from one package to another in the departments and at the checkpoints, replace labels.
2.24. The duration of storage of drugs manufactured in a pharmacy is limited to certain periods indicated on the label of the bottle. The shelf life of medicines manufactured in the pharmacy should be posted in the treatment room.
2.25. Allocate cabinets for storing documents (accounting books, requirements-invoices, acts of acceptance, etc.) for medicines subject to subject-quantitative accounting.
Appendix 2
to the order of the MUZ ""
INSTRUCTION
on the accounting of medicines, dressings and medical devices in departments (offices)
1. In pharmacies, departments (offices) subject-quantitative accounting shall be subject to:
Narcotic drugs, psychotropic substances and precursors of narcotic drugs and psychotropic substances, and other drugs subject to quantitative registration,
Ethanol,
Expensive medicines (by decision of the head of the institution),
Dressings.
2. The subject-quantitative accounting is conducted in appropriately designed journals:
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. No. 644,
Pages of magazines should be numbered, magazines are laced and certified by the signature of the head of the institution.
3. A separate page is opened for each name, packaging, dosage form, dosage of drugs subject to quantitative accounting.
4. The basis for a daily entry in the journals of received and issued medicines is the requirements-invoices (at the head and senior nurses, at the post), acceptance certificates or other documents.
5. Medicines are dispensed to departments (offices) in the amount of their current need: narcotic and psychotropic medicines - daily, 3-day (5-day), all the rest - 10-day.
6. It is forbidden to receive and store medicines in departments (offices) in excess of current needs, as well as to prescribe medicines from a pharmacy (head nurse) according to the general requirements - invoices for several departments (offices) and to make subsequent packaging, moving from one dish to another , replacement labels, etc.
7. The issuance to patients of medicines containing narcotic, psychotropic, toxic and potent substances should be carried out separately from other medicines. Reception of medicines by patients is carried out in the presence of a medical professional. An exception may be drugs that are not related to narcotic, psychotropic, poisonous, potent drugs prescribed for diseases requiring continuous support treatment (coronary heart disease with angina pectoris of tension and rest, hypertension with persistent increase in blood pressure, diabetes mellitus, epilepsy and other similar diseases )
Issue medicines without a doctor’s prescription, replace some drugs with others.
Prescribe, fill out and store medicines under conditional, abbreviated names not approved by the Pharmacopoeia Committee (for example, cough syrup, hand sanitizer, “triple solution”, etc.).
7.2. In order to avoid errors, before opening the ampoule, packaging, read the name of the drug, dosage, check with the appointment and then release the patient.
8. The head of the department (office) must constantly monitor:
The rationale for prescribing drugs,
Strict implementation of appointments in accordance with the medical history,
The amount of actual availability of drugs in the department (office),
Take decisive measures to prevent the creation of their stocks in excess of current needs.
9. The pharmacy is responsible for the quality of the medicine manufactured and dispensed to the department and exact compliance with its requirements, provided that the integrity of the package (in the unopened state) is maintained and the medicine is kept under conditions determined by storage rules. After opening the packaging and the first use of the medicine in the department, further responsibility for its quality lies with the staff of the department, headed by the heads.
10. The representative of the pharmacy at least once a quarter checks in the hospital departments the state of storage, recording and consumption of medicines; narcotic, psychotropic and potent drugs - monthly.
11. To senior nurses of all divisions to keep registers of medicines by expiration dates. If there are expired products, store them (until they are transferred for destruction) separately from other goods in the “quarantine zone”. Expired drugs should be sent for destruction to an organization that has an appropriate license (except for narcotic drugs and psychotropic substances).
12. Continue the personalized registration of medicines in the departments.
Memoapproved by Order of the Ministry of Health of the RSFSR of September 17, 1976 N 471
1. The procedure for obtaining medicines from pharmacies
1.1. Medicines intended for the treatment of patients in stationary conditions are dispensed by pharmacies to the duty paramedic or nurse only in the original factory or pharmacy packaging.
1.2. The representative of the department, receiving the medicine, is obliged to check its compliance with the words in the requirement.
2. Rules for storing drugs in the departments
2.1. Responsibility for the storage and consumption of drugs, as well as for the order at the places of storage, compliance with the rules for issuing and prescribing drugs rests with the head of the department (office). The direct executor of the organization of storage and consumption of medicines is a senior nurse.
2.2. Storage of medicines in departments (offices) should be organized in lockers. Mandatory division into groups of "External", "Internal", "Injection", "Eye drops." In addition, in each compartment of the cabinet, for example, “Internal”, there should be a division into powders, medicines, ampoules, which are placed separately, with the powders stored, as a rule, on the top shelf, and solutions on the bottom.
2.3. Odorous and coloring matter should be separated in a separate cabinet.
2.4. Storage of drugs in the operating room, dressing room, and treatment room is organized in instrumental glazed cabinets or on surgical tables. Each bottle, jar, barbell containing medicines must have an appropriate label.
2.5. Poisonous medicines should be stored in a separate cabinet under lock and key.
Narcotic drugs should be stored in safes or in iron cabinets. On the inner side of the cabinet doors (safe) should be the inscription "A" and a list of toxic agents indicating the highest single and daily doses.
Stocks of poisonous and narcotic drugs should not exceed 5-day need for them.
2.6. Potent drugs (list B) should be stored in a separate (wooden) cabinet under lock and key.
Stocks of potent drugs should not exceed 10-day requirements.
2.7. The keys to the cabinets "A" and "B" are stored only at the persons appointed by order of the medical institution, responsible for the storage and delivery of poisonous and potent drugs, and at night these keys are transferred to the doctor on duty, about which an appropriate entry is made in a special journal and put Signatures of the sender and receiver of the keys and the specified medicines.
2.8. In the places of storage and at the posts of doctors on duty and nurses there should be tables of the highest single and daily doses of toxic, narcotic and potent drugs, as well as tables of antidotes for poisoning.
2.9. The following material values \u200b\u200bare subject to quantitative accounting in departments (offices) of institutions:
a) toxic drugs in accordance with the rules approved by the Order of the Ministry of Health of the USSR of 03.07.68 N 523;
b) narcotic drugs in accordance with the rules approved by the Order of the Ministry of Health of the USSR dated 30.12.82 N 1311;
c) ethyl alcohol (Order of the Ministry of Health of the USSR of 08.30.91 N 245);
d) new drugs for clinical trials and studies in accordance with the current guidelines of the Ministry of Health;
e) scarce and expensive medicines and dressings in accordance with the list approved by order of the head of the medical institution.
The subject-quantitative accounting of the above material values \u200b\u200bis carried out in the form approved by Order of the Ministry of Health of the USSR of 03.07.68 N 523, with the exception of narcotic drugs, which are recorded in the book of narcotic drugs in offices and offices in form 60-AP, approved by Order of the USSR Ministry of Health from 12.30.82 N 1311. Pages of books should be laced, numbered, books must be certified by the signature of the head of the institution.
The form of accounting for material assets listed in subparagraphs a, c, d, d.
Name of product _________________________________________
Drug Accounting Book funds in offices and offices
Name of product __________________________________________
Unit of measurement______________________________________________
2.10. In places of storage of medicines, the temperature and light conditions must be observed. Infusions, decoctions, emulsions, penicillin, serums, vaccines, organ preparations, solutions containing glucose, etc. should be stored only in refrigerators (temperature 2 - 10 degrees C).
3. Forbidden:
3.1. Disinfectants, solutions for technical purposes (processing of hands, tools, furniture, linen, etc.) should be stored together with medical preparations intended for the treatment of patients.
3.2. To pack, hang, transfer, transfer drugs from one package to another in the departments and at the checkpoints, replace labels.
3.3. Give medicines without a doctor’s prescription, replace some drugs with others.
3.4. Prescribe, fill out and store drugs under conditional, abbreviated names not approved by the Pharmacopoeia Committee (for example, cough syrup, hand sanitizer, triple solution, etc.).
4. The dispensation of drugs containing poisonous and narcotic drugs to patients should be carried out only separately from other medicines.
5. In order to avoid mistakes before opening the ampoule, packaging, read the name of the drug, dosage, verify it with the appointment and then release the patient.
6. The duration of storage of drugs manufactured in a pharmacy is limited to certain periods. To determine the expiration date, you need to know the release date. Medicines of factory, factory production have a digital designation of the series, where the last two digits indicate the year, and the two preceding them indicate the month of release.
In accordance with the Order of the Ministry of Health of the USSR dated 29.10.68 N 768 for drugs manufactured in a pharmacy, the following storage periods are established:
6.1. For aqueous solutions containing benzylpenicillin, glucose - 1 day.
6.2. For injection solutions - 2 days, for solutions of sodium chloride 0.9%, novocaine 0.25%, 0.5% in bottles, sealed without break-in - 7 days. After opening, they are used immediately.
6.3. For eye drops - 2 days.
6.4. For infusions, decoctions, mucus - 2 days.
6.5. For emulsions, suspensions - 3 days.
6.6. For other drugs - 10 days.
7. The head of the department (office) is obliged at least once a month to personally check the storage, recording and consumption of medicines, expiration dates, paying particular attention to the medicines of list “A”.
8. The pharmacy is responsible for the quality of the medicine manufactured and delivered to the department and its exact prescription (requirements), provided that the integrity of the package (in the unopened condition) and the contents of the medicine are maintained under the conditions specified by the storage rules. After opening the package and the first use of the medicine in the department, further responsibility for its quality lies with the staff of the department, headed by the head.
An important role in the provision of high-quality and effective medical care is played by the correct storage of medicines in healthcare facilities. In a medical organization, stocks of medicines that provide a 5–10-day need are located in offices and rooms under the supervision of a senior (main) nurse, and stocks of medicines that provide a daily need are located in departments and at nurses' posts. It is necessary to create the right conditions for the storage of drugs, taking into account their quantity and physico-chemical properties, as well as to ensure safety from unwanted or illegal use of drugs, especially potent, toxic and narcotic drugs, psychotropic substances and their precursors.
The main regulatory documents on the rules for storing medicines in the Russian Federation are:
§ order of the Ministry of Health and Social Development of Russia dated 08.23.2009 No. 706n “On approval of the rules for storage of medicines” (hereinafter - order of the Ministry of Health and Social Development of Russia dated 08.23.2010 No. 706n);
§ order of the Ministry of Health and Social Development of Russia dated 05.16.2011 No. 397n “On approval of special requirements for storage conditions for narcotic drugs and psychotropic substances registered in the established manner in the Russian Federation as medicines intended for medical use in pharmacies, medical institutions, and scientific - research, educational organizations and wholesale drug trade organizations ”;
§ Decree of the Government of the Russian Federation dated December 31, 2009 No. 1148 “On the procedure for the storage of narcotic drugs, psychotropic substances and their precursors”.
To store medicines at the nurse's post there are cabinets that must be locked.
1. Medicines for external and internal use are stored at the nurse's post in a locked cabinet on different shelves, labeled “For external use”, “For internal use”.
2. The nurse groups the medicinal substances for internal use: they put drugs that lower blood pressure in one cell of the cabinet, diuretics in the other, and antibiotics in the third.
3. Strongly smelling medicines (Vishnevsky liniment, Finalgon ointment) are stored separately so that the smell does not spread to other medicines. Flammable substances (alcohol, ether) are also stored separately.
4. Alcohol tinctures and extracts are stored in bottles with tightly ground or well-screwed caps, because due to the evaporation of alcohol they can become more concentrated over time and cause an overdose. The preparations are stored in a cool place at a temperature of + 8 to + 15 ° C in the primary and secondary (consumer) packaging of the manufacturer.
5. Preparations requiring protection from the action of light (for example, proserin, silver nitrate) should be stored in a dark place. In order to avoid direct sunlight or other bright directing light, as well as ultraviolet rays, on these medications, you need to use reflective film, blinds, visors, etc.
6. Perishable products (water infusions, decoctions, medicines, serums, vaccines, rectal suppositories) are stored in a refrigerator at a temperature of + 2 ... + 10 ° С. The shelf life of infusions, decoctions, potions in the refrigerator is no more than 2 days.
7. All sterile solutions in ampoules and vials are stored in the treatment room.
8. Separately, in technically fortified premises that meet the requirements of the Federal Law of January 8, 1998 No. 3-FZ "On Narcotic Drugs and Psychotropic Substances", the following are stored:
§ narcotic and psychotropic drugs;
§ potent and toxic drugs that are controlled in accordance with international legal standards.
9. The shelf life of sterile solutions made in a pharmacy under parchment run-in is three days, and metal run-in is 30 days. If during this time they are not implemented, they should be returned to the senior nurse.
10. Signs of unsuitability are:
ü in sterile solutions- change in color, transparency, the presence of flakes;
ü at infusions, decoctions - turbidity, discoloration, the appearance of an unpleasant odor;
ü ointments - discoloration, exfoliation, rancid odor;
ü in powders, tablets - color change.
11. The nurse has no right:
ü change the form of medicines and their packaging;
ü combine the same drugs from different packages into one;
ü replace and correct labels on medicines;
ü store medicinal substances without labels.
Premises or storage areas for medicines must be equipped with air conditioning, refrigerators, window leaves, transoms, second lattice doors - all this is necessary to create temperature conditions.
In the premises where medicines are stored, it is necessary to have devices for recording air parameters: thermometers, hygrometers, psychrometers. The nurse of the department during the shift once a day should record in the places of storage of medicines the readings of these devices in a special journal.
At home, a separate place should be allocated for the storage of medicines, inaccessible to children and people with mental disorders. But at the same time, medicines that a person takes for pain in the heart or asphyxiation should be available at any time.
To treat many diseases, people buy many medicines, herbs, decoctions, etc. every day. A thousand pills, capsules, tablets and solutions help a person to feel healthy in the most critical days.
But the effect of the pills occurs only when the drugs are stored correctly, and the terms of their implementation are observed.
Acquiring unfamiliar medicines, people quite often do not know how to properly store them. To read the regulatory guidelines and find out answers to questions regarding storage and sale, it is enough to open an order of the Ministry of Health and Social Development of the Russian Federation, which sets out the general requirements for the premises for organizing the storage of medicines with different compositions. There you can find basic information about the rules for storing drugs at home, about temperature conditions, etc.
Medicines (psychotropic, explosive, volatile, narcotic, corrosive) should be stored separately from other drugs. A special place should be allocated for them, protected from light, moisture, etc. As a rule, such drugs are dispensed either by prescription or contain instructions. To store this separate group of drugs, it is necessary to ensure the temperature and humidity conditions in accordance with the requirements of the pharmacopeia article.
The places in which the preparations are stored should be regulated by a thermometer. Please note that the temperature in the refrigerator is different. As a rule, the temperature on the upper shelves of the refrigerator is lower than on the lower shelves.
Temperature conditions
Not all medicines should be stored in boxes, boxes, many drugs should only be stored in the refrigerator. Often, consumers do not know how to provide a dry place to store medicine. The temperature regimes for medicines today have a standardized look. It is worth highlighting several ranges of temperature conditions:
- room temperature (usually + 20- + 22 degrees Celsius);
- cold place for storage (storage in the refrigerator +5 C);
- cool place for storing medicines at a temperature of + 8- + 11 C;
- room temperature for storing medicines + 18- + 21 C;
- warm mode + 35- + 40 C;
- hot mode + 75- + 80 C.
Do not leave drugs in the bathroom, since excess moisture can change their composition and make tablets unsuitable for further use.
A dry place for storing medicines should be equipped with air conditioning or ventilation hoods. Evaporation products must not be placed near flammable substances. Essential medicines should be located nearby or separately from other medicines.
The humidity in the room is regulated using a psychrometer. Each drug needs its own level of air humidity.
The formation of a first-aid kit
It is not surprising that a first-aid kit should be formed not only based on the characteristics of your body, but also based on the season of the year. In the summer, you should keep closer to the anti-burn and cooling ointments, bandages, tows, iodine, zelenka, hydrogen peroxide, painkillers, etc. Antibiotics, antiviral and warming preparations are suitable for the autumn and winter periods.
Do not overfill the medicine cabinet with unnecessary drugs. This will only take up a lot of space and increase the search for the right medicine. So that in case of emergency, do not look for the right among the pile of drugs, it is necessary to fold them compactly.
It is recommended to store everything in different containers. You can select several sealed boxes and divide the medicine depending on their composition. In one container, tablets may lie, in another - gels, ointments, anti-burn agents, etc. The instructions can be put in a separate file, tablets in another place, and the packaging from the tablets should be discarded so that it does not take up much space.
If you suddenly needed to leave for a long time, and medications must be taken every day, then a cooler bag will come to the rescue, which will ensure the safety of all medicines. You can put anything in your bag: from bandages, scissors, iodine, tows to medicines that are sensitive to temperature changes. To store tablets, you can purchase a special box with a timer, which is divided into 4 parts: morning, day, evening, night. Such containers are very convenient and compact.
Thus, the proper storage and use of medicines will ensure safety in taking medications, as well as eliminate negative consequences for the body.
Attention, only TODAY!
The Minister
T. Golikova
Registered
in the Ministry of Justice
Russian Federation
October 4, 2010
registration N 18608
Application. Rules for the storage of medicines
application
to the order of the Ministry
health and social
development of the Russian Federation
dated August 23, 2010 N 706n
I. General Provisions
1. These Rules establish the requirements for storage facilities for medicines for medical use (hereinafter referred to as medicines), regulate the storage conditions of these medicines and apply to pharmaceutical manufacturers, wholesale drug companies, pharmacy organizations, medical and other organizations implementing activity in the circulation of medicines, individual entrepreneurs licensed for pharmaceutical activities spine or a license for medical activities (hereinafter respectively - organizations, individual entrepreneurs).
II. General requirements for the arrangement and operation of drug storage facilities
2. The device, composition, size of the area (for manufacturers of medicines, organizations of wholesale trade in medicines), operation and equipment of premises for storing medicines must ensure their safety (paragraph as amended, effective from February 22, 2011.
3. Certain temperature and humidity of the air must be maintained in the premises for storing medicines in order to ensure the storage of medicines in accordance with the requirements of the manufacturers of medicines indicated on the primary and secondary (consumer) packaging.
4. Premises for storing medicines must be equipped with air conditioning and other equipment that allows storing medicines in accordance with the requirements of the manufacturers of medicines indicated on the primary and secondary (consumer) packaging, or it is recommended that the premises be equipped with windows, transoms, and second lattice doors.
5. Storage facilities for medicines must be provided with shelves, cabinets, pallets, and merchandise.
6. The decoration of the rooms for storing medicines (internal surfaces of walls, ceilings) should be smooth and allow the possibility of wet cleaning.
III. General requirements for storage facilities for medicines and storage arrangements
7. Storage facilities for medicines should be equipped with devices for recording air parameters (thermometers, hygrometers (electronic hygrometers) or psychrometers). The measuring parts of these devices should be placed at a distance of at least 3 m from doors, windows and heating appliances. Devices and (or) parts of devices from which visual readings are made should be located in a place accessible to personnel at a height of 1.5-1.7 m from the floor.
The readings of these devices should be recorded daily in a special journal (card) of registration on paper or in electronic form with archiving (for electronic hygrometers), which is maintained by the responsible person. The registration journal (card) is stored for one year, not counting the current one. Monitoring devices must be certified, calibrated and verified in the prescribed manner.
8. In storage rooms, medicinal products shall be placed in accordance with the requirements of regulatory documents indicated on the packaging of the medicinal product, taking into account:
physico-chemical properties of drugs;
pharmacological groups (for pharmacy and medical organizations);
method of application (internal, external);
state of aggregation of pharmaceutical substances (liquid, granular, gaseous).
When placing medicines, the use of computer technology is allowed (alphabetically, by codes).
9. Separately, in technically fortified premises that meet the requirements of the Federal Law of January 8, 1998 N 3-ФЗ "On Narcotic Drugs and Psychotropic Substances" (Collection of Legislation of the Russian Federation, 1998, N 2, Art. 219; 2002, N 30, Art. 3033, 2003, N 2, Art. 167, N 27 (Part I), Art. 2700; 2005, N 19, Art. 1752; 2006, N 43, Art. 4412; 2007, N 30, Art. 3748, N 31, Art. 4011; 2008, N 52 (part 1), Art. 6233; 2009, N 29, Art. 3614; 2010, N 21,
st.2525, N 31, st.4192) are stored:
narcotic and psychotropic drugs;
potent and toxic drugs that are controlled in accordance with international legal standards.
10. Racks (cabinets) for storing medicines in storage rooms for medicines must be installed in such a way as to provide access to medicines, free passage of personnel and, if necessary, loading devices, as well as the availability of shelving, walls, floor for cleaning .
Shelvings, cabinets, shelves intended for storing medicines must be identified (paragraph as amended, entered into force on February 22, 2011 by order of the Ministry of Health and Social Development of Russia of December 28, 2010 N 1221н.
Stored drugs must also be identified using a rack card containing information about the stored drug (name, release form and dosage, batch number, shelf life, manufacturer of the drug). When using computer technology, identification using codes and electronic devices is allowed.
11. In organizations and individual entrepreneurs, it is necessary to keep records of medicines with a limited shelf life on paper or in electronic form with archiving. Monitoring the timely sale of medicines with a limited shelf life should be carried out using computer technology, rack cards indicating the name of the drug, series, shelf life or shelf life logs. The procedure for accounting for these drugs is established by the head of the organization or individual entrepreneur.
12. When identifying expired medicines, they must be stored separately from other groups of medicines in a specially allocated and designated (quarantine) zone.
IV. Requirements for premises for storage of flammable and explosive medicines and organization of their storage
13. Storage facilities for flammable and explosive medicines must fully comply with applicable regulatory documents.
14. Storage facilities for medicines in wholesale drug companies and pharmaceutical manufacturers (hereinafter referred to as storage facilities) are divided into separate rooms (compartments) with a fire resistance limit of building structures of at least 1 hour in order to ensure storage of flammable and explosive medicines for the principle of homogeneity in accordance with their physico-chemical, fire hazard properties and the nature of the packaging (paragraph as amended, entered into force on February 22, 2011 rikazom Health Ministry of Russia from December 28, 2010 N 1221n.
15. The amount of flammable medicinal products required for filling and manufacturing medicinal products for medical use per work shift may be kept in production and other premises. The remaining amount of flammable drugs at the end of work at the end of the shift is transferred to the next shift or returned to the place of main storage.
16. The floors of storage rooms and unloading areas should have a hard, even coating. It is forbidden to use boards and iron sheets for leveling floors. The floors should provide convenient and safe movement of people, goods and vehicles, have sufficient strength and withstand the loads of stored materials, ensure the simplicity and ease of cleaning the warehouse.
17. Warehouses for storing flammable and explosive medicines must be equipped with fireproof and stable shelving and pallets designed for the appropriate load. The racks are installed at a distance of 0.25 m from the floor and walls, the width of the racks should not exceed 1 m and have, in the case of storage of pharmaceutical substances, a flange of at least 0.25 m. The longitudinal passages between the racks should be at least 1.35 m.
18. In pharmacy organizations and individual entrepreneurs, isolated rooms are allocated, equipped with automatic fire protection and alarm systems, for storing flammable pharmaceutical substances and explosive medicinal products (item in the wording entered into force on February 22, 2011 by order of the Ministry of Health and Social Development of Russia of December 28, 2010 years N 1221n.
19. Pharmacy organizations and individual entrepreneurs may store pharmaceutical substances with flammable and combustible properties in the amount of up to 10 kg outdoors for storing flammable pharmaceutical substances and explosive medicines in built-in fireproof cabinets. Cabinets should be removed from heat-conducting surfaces and walkways, with doors at least 0.7 m wide and at least 1.2 m high. They should be freely accessible (the paragraph was supplemented on February 22, 2011 by order of the Russian Ministry of Health and Social Development of December 28, 2010 years N 1221n.
It is allowed to store explosive medicinal products for medical use (in secondary (consumer) packaging) for use per shift in metal cabinets outdoors for storage of flammable pharmaceutical substances and explosive medicines (the paragraph was supplemented from February 22, 2011 by order of the Ministry of Health and Social Development of Russia of December 28 2010 N 1221n.
20. The quantity of flammable pharmaceutical substances allowed for storage in premises for storage of flammable pharmaceutical substances and explosive medicines located in buildings for other purposes should not exceed 100 kg in bulk.
Storage rooms for flammable pharmaceutical substances and explosive medicines used to store flammable pharmaceutical substances in quantities of over 100 kg must be in a separate building, and the storage itself must be carried out in glass or metal containers isolated from the storage rooms for other groups of flammable pharmaceutical substances .
(Clause as amended, entered into force on February 22, 2011 by order of the Ministry of Health and Social Development of Russia of December 28, 2010 N 1221н.
21. It is forbidden to enter the premises for storing flammable pharmaceutical substances and explosive medicines with open sources of fire (the item was supplemented on February 22, 2011 by order of the Ministry of Health and Social Development of Russia of December 28, 2010 N 1221н.
V. Features of the organization of storage of medicines in warehouses
22. Medicines stored in warehouses should be placed on shelves or on shelves (pallets). Do not place drugs on the floor without a pallet.
Pallets can be placed on the floor in one row or on racks in several tiers, depending on the height of the rack. It is not allowed to place pallets with medicines in several rows in height without using racks.
23. With the manual method of loading and unloading, the height of the laying of medicines should not exceed 1.5 m.
When using mechanized devices for unloading and loading operations, medicines must be stored in several tiers. At the same time, the total height of the placement of medicines on the shelves should not exceed the capabilities of mechanized loading and unloading means (lifts, trucks, hoists).
23_1. The area of \u200b\u200bthe warehouse should correspond to the volume of stored medicines, but not less than 150 sq.m, including:
drug acceptance area;
zone for the main storage of medicines;
expedition area;
premises for medicines requiring special storage conditions.
(The item was additionally included on February 22, 2011 by order of the Ministry of Health and Social Development of Russia of December 28, 2010 N 1221н)
VI. Features of storage of certain groups of drugs depending on the physical and physico-chemical properties, exposure to various environmental factors
Storage of medicines requiring protection from light
24. Medicines requiring protection against the effects of light are stored in rooms or specially equipped places that provide protection from natural and artificial lighting.
25. Pharmaceutical substances requiring protection against the effects of light should be stored in containers made of light-protective materials (orange glass containers, metal containers, aluminum foil packaging or plastic materials painted in black, brown or orange), in a dark room or cabinets .
To store pharmaceutical substances that are especially sensitive to light (silver nitrate, proserin), glass containers are glued with black opaque paper.
26. Medicinal products for medical use that require protection against the effects of light, packaged in primary and secondary (consumer) packaging, should be stored in cabinets or racks, provided that measures are taken to prevent direct sunlight or other bright directional light from entering these medicines (use of reflective film, blinds, peaks, etc.).
Storage of drugs requiring protection against moisture
27. Pharmaceutical substances requiring protection against moisture should be stored in a cool place at temperatures up to + 15 degrees. C (hereinafter referred to as a cool place), in tightly corked containers made of materials impervious to water vapor (glass, metal, aluminum foil, thick-walled plastic containers) or in the manufacturer’s primary and secondary (consumer) packaging.
28. Pharmaceutical substances with pronounced hygroscopic properties should be stored in a glass container with an airtight closure filled with paraffin on top.
29. In order to avoid damage and loss of quality, the storage of medicines should be organized in accordance with the requirements in the form of warning labels on the secondary (consumer) packaging of the medicine.
Storage of medicines requiring protection against volatilization and drying out
30. Pharmaceutical substances that require protection against volatilization and drying out (actually volatile medicines; medicines containing a volatile solvent (alcohol tinctures, liquid alcohol concentrates, thick extracts); solutions and mixtures of volatile substances (essential oils, ammonia, formaldehyde, chloride solutions hydrogen over 13%, carbolic acid, ethyl alcohol of various concentrations, etc.); medicinal plant materials containing essential oils; medicines containing crystallization in ode - crystalline hydrates; drugs that decompose with the formation of volatile products (iodoform, hydrogen peroxide, sodium bicarbonate); drugs with a certain lower moisture limit (magnesium sulfate, sodium paraaminosalicylate, sodium sulfate) should be stored in a cool place in a hermetically sealed container from materials impervious to volatiles (glass, metal, aluminum foil) or in the manufacturer’s primary and secondary (consumer) packaging. The use of polymer packaging, packaging and capping is allowed in accordance with the requirements of the state pharmacopoeia and regulatory documentation.
31. Pharmaceutical substances - crystalline hydrates should be stored in hermetically sealed glass, metal and thick-walled plastic containers or in the primary and secondary (consumer) packaging of the manufacturer under conditions that meet the requirements of regulatory documents for these drugs.
Storage of medicines requiring protection from exposure to elevated temperatures
32. Organizations and individual entrepreneurs should carry out the storage of medicines requiring protection from exposure to elevated temperatures (thermolabile drugs) in accordance with the temperature regime indicated on the primary and secondary (consumer) packaging of the medicine in accordance with the requirements of regulatory documents.
Storage of medicines requiring protection against exposure to low temperature
33. Storage of medicines requiring protection from exposure to low temperatures (medicines whose physical and chemical state after freezing changes and is not restored upon subsequent warming to room temperature (40% formaldehyde solution, insulin solutions) must be carried out by organizations and individual entrepreneurs in accordance with with the temperature regime indicated on the primary and secondary (consumer) packaging of the medicinal product in accordance with the requirements of regulatory d kumentatsii.
34. Freezing of insulin preparations is not allowed.
Storage of medicines requiring protection against exposure to gases contained in the environment
35. Pharmaceutical substances that require protection against gases (substances that react with air oxygen: various compounds of the aliphatic series with unsaturated carbon bonds, cyclic with side aliphatic groups with unsaturated carbon bonds, phenolic and polyphenolic, morphine and its derivatives with unsubstituted hydroxyl groups; sulfur-containing heterogeneous and heterocyclic compounds, enzymes and organic preparations; substances that react with carbon dioxide of the air: alkali metal salts c and weak organic acids (barbital sodium, hexenal), drugs containing polyhydric amines (aminophylline), magnesium oxide and peroxide, sodium hydroxide, potassium hydroxide) should be stored in a hermetically sealed container made of gas impermeable materials, filled to the maximum possible .
Storage of odorous and coloring medicines
36. Odorous medicines (pharmaceutical substances, both volatile and practically non-volatile, but with a strong odor) should be stored in a hermetically sealed container, impermeable to smell.
37. Coloring medicines (pharmaceutical substances that leave a stained trace that cannot be washed off by normal sanitary treatment on containers, closures, equipment and implements (diamond green, methylene blue, indigo carmine) should be stored in a special cabinet in a tightly sealed container.
38. To work with coloring drugs for each item, it is necessary to allocate special scales, a mortar, spatula and other necessary equipment.
Disinfectant drug storage
39. Disinfectant medicines should be stored in hermetically sealed containers in an isolated room away from the storage rooms of plastic, rubber and metal products and distilled water production facilities.
Medical drug storage
40. Storage of medicines for medical use is carried out in accordance with the requirements of the State Pharmacopoeia and regulatory documents, as well as taking into account the properties of the substances included in them.
41. When stored in cabinets, on racks or shelves, medicines for medical use in secondary (consumer) packaging must be placed with the label (labeling) out.
42. Organizations and individual entrepreneurs should store medicines for medical use in accordance with the requirements for their storage indicated on the secondary (consumer) packaging of the specified medicinal product.
Storage of medicinal plant materials
43. Bulk medicinal plant materials should be stored in a dry (not more than 50% humidity), well-ventilated room in a tightly closed container.
44. Bulk medicinal plant material containing essential oils is stored in isolation in a well-closed container.
45. Bulk medicinal plant materials should be periodically monitored in accordance with the requirements of the State Pharmacopoeia. Grass, roots, rhizomes, seeds, fruits that have lost their normal color, smell and the required amount of active substances, as well as those affected by mold, barn pests are rejected.
46. \u200b\u200bStorage of medicinal plant materials containing cardiac glycosides is carried out in compliance with the requirements of the State Pharmacopoeia, in particular, the requirement for re-monitoring of biological activity.
47. Bulk medicinal plant material included in the lists of potent and toxic substances approved by the Decree of the Government of the Russian Federation of December 29, 2007 N 964 "On the approval of lists of potent and toxic substances for the purposes of Article 234 and other articles of the Criminal Code of the Russian Federation, as well as large size of potent substances for the purposes of Article 234 of the Criminal Code of the Russian Federation "(Collection of Legislation of the Russian Federation, 2008, N 2, Art. 89; 2010, N 28, Art. 3703), is stored in the department nom indoors or in a separate cabinet under lock and key.
48. Prepackaged medicinal plant materials are stored on shelves or in cabinets.
Storage of medical leeches
49. Storage of medical leeches is carried out in a bright room without the smell of drugs, for which a constant temperature regime is established.
Flammable Medicines Storage
51. Storage of flammable drugs (drugs with flammable properties (alcohol and alcohol solutions, alcohol and ether tinctures, alcohol and ether extracts, ether, turpentine, lactic acid, chloroethyl, collodion, cleol, Novikov liquid, organic oils); drugs with readily combustible properties (sulfur, glycerin, vegetable oils, bulk medicinal plant materials) should be carried out separately from other medicines (paragraph in the wording, enter effective from February 22, 2011 by order of the Ministry of Health and Social Development of Russia dated December 28, 2010 N 1221н.
52. Flammable medicines are stored in tightly sealed strong, glass or metal containers to prevent evaporation of liquids from the vessels.
53. Bottles, cylinders and other large containers with flammable and combustible medicines should be stored on shelves in racks in a row in height. It is forbidden to store them in several rows in height using various cushioning materials.
It is not allowed to store these medicines with heating devices. The distance from the rack or stack to the heating element must be at least 1 m.
54. Storage of bottles with flammable and easily combustible pharmaceutical substances should be carried out in containers that protect against shocks, or in bottle tippers in a row.
55. At the workplaces of industrial premises allocated by pharmacy organizations and individual entrepreneurs, flammable and combustible medicines may be stored in quantities not exceeding the shift requirement. At the same time, the containers in which they are stored must be tightly closed.
56. It is not allowed to store flammable and combustible medicines in a fully filled container. The degree of filling should be no more than 90% of the volume. Alcohols in large quantities are stored in metal containers filled not more than 75% of the volume.
57. The joint storage of flammable medicinal products with mineral acids (especially sulfuric and nitric acids), compressed and liquefied gases, easily combustible substances (vegetable oils, sulfur, dressings), alkalis, and also with inorganic salts giving explosive with organic substances is not allowed mixtures (potassium chlorate, potassium permanganate, potassium chromate, etc.).
58. Medical ether and ether for anesthesia are stored in industrial packaging in a cool, dark place, away from fire and heating devices.
Explosive Medicines Storage
59. When storing explosive drugs (drugs with explosive properties (nitroglycerin); drugs with explosive properties (potassium permanganate, silver nitrate), measures should be taken against dust contamination.
60. Tanks with explosive medicinal products (booms, tin drums, flasks, etc.) must be tightly closed to prevent the vapors of these products from getting into the air.
61. Storage of bulk potassium permanganate is allowed in a special compartment of the warehouse (where it is stored in tin drums), in barrels with ground stoppers separately from other organic substances - in drugstores and individual entrepreneurs.
62. The bulk solution of nitroglycerin is stored in small, well-sealed bottles or metal vessels in a cool, dark place, observing fire precautions. To move the dishes with nitroglycerin and weigh this drug should be in conditions that exclude the spillage and evaporation of nitroglycerin, as well as its contact with the skin.
63. When working with diethyl ether, shaking, shock, and friction are not allowed.
Storage of narcotic and psychotropic drugs
65. Narcotic and psychotropic medicines are stored in organizations in isolated rooms specially equipped with engineering and technical security equipment, and in temporary storage places, subject to the requirements in accordance with the Rules for the Storage of Narcotic Drugs and Psychotropic Substances established by Decree of the Government of the Russian Federation of December 31, 2009 N 1148 (Meeting of the legislation of the Russian Federation, 2010, N 4, Art. 394; N 25, Art. 3178).
Storage of potent and toxic drugs, drugs subject to quantitative registration
66. In accordance with the Decree of the Government of the Russian Federation of December 29, 2007 N 964 "On approval of the lists of potent and toxic substances for the purposes of Article 234 and other articles of the Criminal Code of the Russian Federation, as well as large amounts of potent substances for the purposes of Article 234 of the Criminal Code of the Russian Federation "potent and toxic drugs include medicines containing potent and toxic substances included in the lists of potent substances and toxic s substances.
67. Storage of potent and poisonous drugs controlled under international legal standards (hereinafter referred to as potent and poisonous drugs controlled internationally) is carried out in rooms equipped with engineering and technical protection equipment similar to those provided for the storage of narcotic and psychotropic drugs.
68. It is allowed to store in one technically fortified room strong and toxic drugs under international control, and narcotic and psychotropic drugs.
At the same time, storage of potent and toxic drugs should be carried out (depending on the volume of stocks) on different shelves of the safe (metal cabinet) or in different safes (metal cabinets).
69. Storage of potent and toxic drugs that are not under international control is carried out in metal cabinets that are sealed or sealed at the end of the working day.
70. Medicines subject to quantitative accounting in accordance with the order of the Ministry of Health and Social Development of the Russian Federation dated December 14, 2005 N 785 "On the procedure for dispensing medicines" (registered with the Ministry of Justice of the Russian Federation on January 16, 2006 N 7353), with the exception of narcotic, psychotropic, potent and toxic drugs, are stored in metal or wooden cabinets, sealed or sealed at the end of the working day.
Edition of the document taking into account
changes and additions prepared
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