Orders on medicines in the hospital. V. Features of the organization of storage of medicines in warehouses. Storage of medicinal plant materials

Storage order medicines and medical devices is regulated by the Order of the Ministry of Health of the Russian Federation dated November 13, 1996 No. 377.

Compliance with the approved Instructions makes it possible to ensure the preservation of the high quality of medicines and create safe working conditions for pharmacists when working with them.

Particular attention is paid to the storage, prescribing, recording and dispensing of poisonous and narcotic drugs.

Proper storage of medicines is based on the correct and rational organization of storage, strict accounting of its movement, regular monitoring of the expiration dates of medicines.

It is also very important to maintain the optimum temperature and humidity of the air, to observe the protection of certain preparations from light.

Violation of the rules for storing medicines can lead not only to a decrease in the effectiveness of their action, but also to harm health.

Excessively long storage of drugs (even if the rules are observed) is unacceptable, as the pharmacological activity of the drugs changes.

An important condition for storage is the systematization of drugs by groups, types and dosage forms.

This allows you to avoid possible errors due to the similarity of drug names, simplify the search for drugs and control their expiration date.

Narcotic drugs (List A) should be stored in safes or iron cabinets with secure locks. A printed list of poisonous drugs is kept in a cabinet with the indication of the highest single daily doses.

Rooms and safes with narcotic and especially poisonous drugs must have an alarm system, there must be metal bars on the windows.

The stock of poisonous and narcotic medicines should not exceed the general standard of commodity stocks established for this pharmacy.

Drugs from list B are stored in lockers with a list of drugs and higher single and daily doses.

Instructions for organizing the storage of medicines and medical products apply to all pharmacies and pharmacy warehouses.

The equipment of storage rooms should ensure the safety of medicines. These rooms are provided with fire-fighting equipment, they maintain the necessary temperature and humidity. Checking the parameters of humidity and temperature is carried out 1 time per day. Thermometers and hygrometers are fixed on internal walls away from heaters at a distance of 3 m from doors and 1.5 m from the floor.

To register the parameters of temperature and relative humidity, an accounting card is created in each department.

An important role is played by the cleanliness of the air in the premises for storing medicines; for this, they must be equipped with forced-air ventilation or, in extreme cases, vents, transoms, and lattice doors.

Heating of the room should be carried out by central heating devices, the use of gas appliances with an open flame or electrical appliances with an open coil is excluded.

If pharmacies are located in climatic zones with sharp fluctuations in temperature and humidity, they are equipped with air conditioners. There should be a sufficient number of cabinets, racks, pallets, etc. in the drug storage rooms. Racks should be at a distance of 0.5-0.7 m from the outer walls, at least 0.25 m from the floor and 0.5 m from the ceiling. The distance between the racks should be at least 0.75 m, the aisles should be well lit. The cleanliness of the premises of pharmacies and warehouses is ensured by wet cleaning at least once a day using approved detergents.

Medicines are placed according to toxicological groups.

Poisonous, narcotic drugs - list A. This is a group of highly toxic drugs.

Their storage and use require special care. Poisonous and addictive drugs are kept in a safe. Particularly toxic agents are stored in the inner compartment of the safe, which is locked with a lock.

List B - potent drugs.

Medicines of list B and ready-made products containing them are stored in separate lockers with the inscription “B”.

Storage of drugs depends on the method of their use (internal, external), these funds are stored separately.

Medicines are stored in accordance with the state of aggregation: liquid ones are separated from loose, gaseous, etc.

It is necessary to store separately in groups products made of plastic, rubber, dressings, medical equipment products.

At least once a month, it is necessary to monitor external changes in medicines, the state of the container. If the container is damaged, its contents must be transferred to another package.

On the territory of a pharmacy or a warehouse, if necessary, measures are taken to combat insects and rodents.

Send your good work in the knowledge base is simple. Use the form below

Students, graduate students, young scientists who use the knowledge base in their studies and work will be very grateful to you.

General requirements for the storage of medicines and medical devices

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Answers on questions:

1. Does paragraph 35 of Order 647n (information regarding price tags) apply to dietary supplements?
- In this case, in paragraph 35 of Order 647n we are talking about over-the-counter drugs. As for price tags for dietary supplements, the requirements for them are regulated by Decree of the Government of the Russian Federation of January 19, 1998 No. 55 “On approval of the rules for the sale of certain types of goods, a list of durable goods that are not subject to the buyer’s requirement to provide him free of charge for the period of repair or replacement a similar product, and a list of non-food products of good quality that are not subject to return or exchange for a similar product of a different size, shape, size, style, color or configuration.

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

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

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

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

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

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

READ THE INSTRUCTIONS!

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

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

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

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

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

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

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

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

EVERYONE HAS A PLACE!

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

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

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

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

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

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

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

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

WE FILL OUT THE JOURNAL CORRECTLY!

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

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

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

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

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

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

"DRY" IS HOW?

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

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

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

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

Seal

Also interesting:

Pebble cactus

Antique icon: how to evaluate and sell dearly

Black roses - a gift from breeders

We recommend reading:

2023-02-01 11:45:45

Why do little kittens dream of a woman?

2023-01-07 23:50:19

The unique diary of Joseph Ilyin during the First World War Ilyin wanderings of a Russian officer read

2022-12-05 16:35:41

Conjugation of the verb to be (am, is, are) in the present tense

Continuing the topic:

Products

Is it allowed for a mother who is breastfeeding a baby to enjoy tangerines?

Tangerines are incredibly tasty fruits that combine pleasant sweetness and the benefits of citrus fruits. Their appearance on store shelves in late autumn comes in handy in ...