Temperature regime of storage of medicines. Storage of medicines in the department
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The order of storage of medicines and medical devices is regulated by the Order of the Ministry of Health of the Russian Federation of 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.
The room for the storage of basic stocks of medicines and medical products at the head nurse of the health facility unit must meet the technical, sanitary, fire and other licensing requirements and conditions, be isolated from other premises of the unit. The internal surfaces of walls and ceilings must be smooth, allowing the possibility of wet cleaning. The floor of the room must have a dust-free coating that is resistant to the effects of mechanization and wet cleaning using disinfectants. The use of wooden unpainted surfaces is not allowed. Materials for interior decoration must meet the requirements of the relevant regulatory documents.
The storage room for medicines and medical products must be equipped with special equipment to ensure their storage and proper preservation, taking into account the physicochemical, pharmacological and toxicological properties, as well as the requirements of quality standards for medicines and the State Pharmacopoeia of the Russian Federation, namely:
· Cabinets, racks, trays for storing medicines and medical products, as well as lockable metal cabinets and safes for storing certain groups of medicines;
Refrigerators for storage of thermolabile medicines;
· Devices for recording air parameters (thermometers, hygrometers or psychrometers), which are placed on the inner wall of the room away from heating devices at a height of 1.5-1.7 m from the floor and at a distance of at least 3 m from the doors;
· Detergents and disinfectants to ensure sanitary conditions.
The equipment must be resistant to the effects of wet cleaning with the use of disinfectants and meet the sanitary and hygienic, fire safety and labor protection requirements.
General requirements for the storage of medicines and medical devices
Medicines and medical devices in departments should be stored in lockable cabinets, with the obligatory division into groups: “External”, “Internal”, “Injectable”, “Eye drops”, etc. In addition, in each compartment of the cabinet (for example, “ Internal”) there should be a division of medicines into tablets, medicines, etc.; powders and tablets are stored, as a rule, on the top shelf, and solutions - on the bottom.
Storage of finished medicinal products should be carried out in compliance with the external conditions (temperature, humidity, light conditions) specified by the manufacturer in the instructions for the drug, and general requirements. All finished medicinal products must be packed and installed in the original industrial or pharmacy packaging with the label (marking) facing out.
Tablets and dragees are stored separately from other medicines in a dry and, if necessary, protected from light place.
Dosage forms for injection should be stored in a cool, dark place in a separate cabinet (or cabinet compartment).
Liquid dosage forms (syrups, tinctures) should be stored in a place protected from light.
Plasma-substituting solutions are stored in isolation in a cool, dark place. Ointments, liniments are stored in a cool, dark place, in a tightly closed container. Preparations containing volatile and thermolabile substances are stored at a temperature not exceeding +10 C.
Suppositories are stored in a dry, cool, dark place.
Storage of most medicines in aerosol packages should be carried out at a temperature of +3 to +20 C in a dry, dark place, away from heating devices. Aerosol packages should be protected from shock and mechanical damage.
Infusions, decoctions, emulsions, serums, vaccines, organ preparations, solutions containing benzylpenicillin, glucose, etc., are stored only in refrigerators (+2 - +10 C).
Immunobiological preparations should be stored separately by name at the temperature indicated for each name on the label or in the instructions for use. Immunobiological preparations of the same name are stored in batches, taking into account the expiration date.
Medicinal plant materials should be stored in a dry, well-ventilated area.
Medicines with a strong odor (iodoform, lysol, ammonia, etc.) and flammable (ether, ethyl alcohol) are stored in a separate cabinet. Coloring medicines (iodine, brilliant green, etc.) are also stored separately.
Storage of medicines in the operating room, dressing room, procedural room is organized in glassed instrument cabinets or on surgical tables. Each vial, jar, package containing a medicinal product must have an appropriate label.
Narcotic drugs and psychotropic substances, potent and poisonous substances must be kept in safes. It is allowed to store narcotic drugs and psychotropic substances in metal cabinets in technically fortified premises. Safes (metal cabinets) must be kept closed. After the end of the working day, they must be sealed or sealed. Keys to safes, seals and ice-cream should be kept by financially responsible persons authorized to do so by order of the head physician of the healthcare institution.
Narcotic drugs and psychotropic substances, potent and poisonous substances received by shift medical personnel must be stored in a closed and sealed safe attached to the floor or wall in a specially designated room. On the inside of the safe door there is a list of narcotic drugs and psychotropic substances indicating the highest single and daily doses. Narcotic drugs and psychotropic substances for parenteral, internal and external use should be stored separately.
Responsible for organizing the storage and issuance of narcotic drugs and psychotropic substances to patients are the head of the health facility or his deputies, as well as persons authorized to do so by order of the health facility.
Units of healthcare facilities should have tables of higher single and daily doses of narcotic drugs and psychotropic substances, as well as tables of antidotes for poisoning by them, in places of storage and at the posts of doctors and nurses on duty. Medical products should be stored separately from medicines and in groups: rubber products, plastic products, dressings and auxiliary materials, medical equipment products.
In order for the enterprise to bring only profit, one must be on the alert literally in everything. Otherwise, the pharmacy will face either serious fines, or confiscation of goods, or suspension of activities for three months, or closure ...
READ THE INSTRUCTIONS!
So, in order for the pharmacy to work quietly, without spending money on fines, and for the business to be profitable, 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 finished dosage forms. In general, light can be both natural (sunny) and artificial, pharmacy workers sometimes consider only the first one to be “forbidden”. In fact, we are talking about any kind of lighting.
There are also contradictions. For example, it may be written on the packaging (in the instructions) " store in a cool place at a temperature not exceeding 6° FROM", this information from the manufacturer should be guided by, even if it does not correspond to those indicated in the Pharmacopoeia for a "cool place" of 8-15 ° C.
By the way, for dietary supplements, standards have not yet been developed that determine what is considered a cool storage place, and what is cold.
Be sure to read the instructions, paying attention to the following.
WE FILL OUT THE JOURNAL CORRECTLY!
It is also important who and how fills in the mandatory accounting (control) logs in the pharmacy. Everything is very beautiful, but not always right. The inspector, together with the council, opens the refrigerator, and there, instead of 2-8 ° C, all three thermometers show 15 ° C. They check with the magazine, and there the morning record is + 6 ° С. All violations are immediately photographed and recorded. The verdict of the inspector is a refrigerator full of medicines for immediate destruction and suspension of the license for 90 days. It must be remembered that proper storage of medicines is the life and health of their consumers. The filling of the journal must be approached extremely responsibly. Sometimes, especially on New Year's holidays, a pharmacy employee who keeps a journal combines several days with one curly bracket and sets, for example, 12 ° C. All. Fine. Indications each day must be filled in a separate line. If a pharmacy employee gives an incorrect or even simply inaccurate answer to the question of the inspector, this is a fine. It also happens that they open a storage place, and in the refrigerator -6 ° C, everything is frozen! Sometimes the magazine says - in the morning + 4 ° C, and in the evening + 8 ° C. This is an unacceptable temperature fluctuation. According to the regulations, it can only be 1 ° C! Otherwise, this means that the refrigerator needs repair and cannot be used.
Now there are so-called pharmaceutical refrigerators, in which the entire cooling element goes throughout the chamber. In such a refrigerator, the temperature is the same in all its places. At the same time, there is no official term "pharmaceutical refrigerator" yet, but I know that in Voronezh, for example, pharmacies are licensed only if such a refrigerator is available. But this is a "local" exception. Usually in drugstores there are household refrigerators. They often have glass doors, which is already a violation for drugs that are prescribed to be stored in a place protected from light. The cooling element is either only at the top, or only up to half of the refrigerator. Naturally, the temperature in different parts of such a refrigerator is different. Closer to the cooling element - below. In other areas - higher. Therefore, in such refrigerators, three thermometers must be installed. If we are talking about the storage of insulin and other biological preparations, then in this case a thermometer is needed on each shelf of the refrigerator.
Important! Let us turn again to the 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:
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"
Topic: Drug treatment in nursing practice
Prepared by the teacher
Aforkina A.N.
Chairman of the Central Committee
Osmirko E.K.
Orenburg -2015
I. Ways and means of introducing drugs into the body.
Drug therapy is an essential part of the entire treatment process.
Medicinal substances have both local and general (resorptive) effects on the body.
Drugs are introduced into the human body in various ways. How the drug is introduced into the body depends on:
1) the speed of the onset of the effect,
2) effect size,
3) duration of action.
Tab.1 Ways and means of drug administration
II. Rules for prescribing, receiving, storing, recording and distributing medicines.
Rules for prescribing medicines for the department.
1. The doctor, conducting a daily examination of patients in the department, writes down in the medical history or prescription list the medicines necessary for this patient, their doses, frequency of administration and routes of administration.
2. The ward nurse makes a daily selection of prescriptions, copying the prescribed drugs into the "Book of prescriptions" separately for each patient. Information about the injections is transmitted to the procedural nurse who performs them.
3. The list of prescribed drugs that are not at the post or in the treatment room is submitted to the head nurse of the department.
4. The head nurse (if necessary) writes out, in a certain form, an invoice (requirement) for receiving medicines from a pharmacy in several copies, which is signed by the head. department. The first copy remains in the pharmacy, the second is returned to the financially responsible person. The invoice f. No. 434 must indicate the full name of medicines, their sizes, packaging, dosage form, dosage, packaging, quantity.
Order of the Ministry of Health of the Russian Federation of August 23, 1999 N 328 "On the rational prescription of medicines, the rules for writing prescriptions for them and the procedure for their dispensing by pharmacies (organizations)", as amended on January 9, 2001, May 16, 2003
Medicines are dispensed by the pharmacy to departments in the amount of the current need for them: poisonous - 5 day supply, narcotic - 3 day supply (in the intensive care unit), all others - 10 day supply.
Order of the Ministry of Health of the Russian Federation No. 330 dated November 12, 1997 “On measures to improve the accounting, storage, prescribing and use of NLS”.
5. Requirements for poisonous (for example, strophanthin, atropine, prozerin, etc.) and narcotic drugs (for example, for promedol, omnopon, morphine, etc.), as well as for ethyl alcohol, are written out on separate forms of the senior m / s in Latin language. These requirements are stamped and signed by the chief physician of the health facility or his deputy for the medical unit, indicating the route of administration, the concentration of ethyl alcohol.
6. In the requirements for acutely scarce and expensive medicines, indicate the full name. patient, case history number, diagnosis.
7. Receiving medicines from the pharmacy, the head nurse checks their compliance with the order. When issuing ampoules with narcotic drugs from a pharmacy, the integrity of the ampoules is checked.
On dosage forms made in a pharmacy, there must be a certain color of the label:
for external use - yellow;
for internal use - white;
For parenteral administration - blue (on vials with sterile solutions).
The labels should contain clear names of drugs, designations of concentration, dose, dates of manufacture and the signature of the pharmacist (manufacturer's details) who manufactured these dosage forms.
Rules for the storage of medicines in the department.
1. To store medicines at the nurse's station, there are cabinets that must be locked with a key.
2. In the cabinet, medicinal substances are placed in groups (sterile, internal, external) on separate shelves or in separate cabinets. Each shelf should have a corresponding indication ("For external use", "For internal use", etc.).
3. Medicinal substances for parenteral and enteral administration should be placed on the shelves according to their intended purpose (antibiotics, vitamins, antihypertensives, etc.).
4. Larger dishes and packages are placed behind, and smaller ones in front. This makes it possible to read any label and quickly take the right medicine.
6. Medicinal substances included in List A, as well as expensive and acutely scarce drugs are stored in a safe. On the inner surface of the safe there should be a list of them indicating the highest daily and single doses, as well as a table of antidote therapy. Inside any cabinet (safe), medicines are divided into groups: external, internal, eye drops, injections.
7. Preparations that decompose in the light (therefore they are produced in dark vials) are stored in a place protected from light.
8. Strong-smelling drugs (iodoform, Vishnevsky ointment, etc.) are stored separately so that the smell does not spread to other drugs.
9. Perishable drugs (infusions, decoctions, potions), as well as ointments, vaccines, serums, rectal suppositories and other drugs are stored in the refrigerator.
10. Alcoholic extracts, tinctures are stored in bottles with tightly ground stoppers, as due to the evaporation of alcohol, they can become more concentrated over time and cause an overdose.
11. The shelf life of sterile solutions made in a pharmacy is indicated on the bottle. If during this time they are not sold, they must be poured out, even if there are no signs of unsuitability.
Temperature and light conditions must be observed. Infusions, decoctions, emulsions, serums, vaccines, organ preparations should be stored only in the refrigerator.
Signs of unsuitability are:
In sterile solutions - a change in color, transparency, the presence of flakes;
Infusions, decoctions - turbidity, discoloration, the appearance of an unpleasant odor;
In ointments - discoloration, delamination, rancid smell;
In powders, tablets - discoloration.
The nurse is not allowed to:
Change the form of medicines and their packaging;
Combine the same medicines from different packages into one;
Replacing and correcting labels on medicines:
Store medicinal substances without labels.
