Medicines - what are they? Their classification into groups. B (list of potent drugs) List of storage of drugs

B (list of potent medicines) - a group of medicines, the prescription, use, dosage and storage of which must be exercised with caution.

List B includes medicinal raw materials, galenic (tinctures, extracts) and novogalenic preparations, as well as finished drugs (in tablets and ampoules) containing alkaloids and their salts, hypnotics, antipyretics, analgesics, anesthetics and cardiac drugs, sulfonamides, sex hormone preparations , some vitamins, etc.

In pharmacies, medicines of list B and ready-made products, containing them, are stored in separate cabinets, locked with a padlock, with the inscription “B - Heroica” (potent); in medical institutions - in special cabinets under lock and key. In control and analytical laboratories, drugs from List B can be stored together with non-potent drugs, and stocks of reagents belonging to List B can only be locked up. In pharmacy warehouses and pharmaceutical industry enterprises, potent substances are stored in separate rooms or in locked cabinets.

List B drugs are dispensed with a doctor’s prescription with the seal of a medical institution or a personal doctor’s seal, always indicating the method of use. When prescribing potent substances in doses exceeding the highest, be sure to indicate the amount of the substance in words with exclamation point. Paramedics and midwives can prescribe potent drugs in accordance with the range approved for them. Dispensing medicines containing potent substances from pharmacy stores, kiosks and pharmacies of the 2nd group is permitted within the approved range.

The rules for prescribing, dispensing and storing potent drugs are set out in the order of the Minister of Health of the USSR No. 523 of July 3, 1968 and in the appendices to the order.

List B is included in the State Pharmacopoeia; all additions and changes to the list are made on the basis of directives of the USSR Ministry of Health.

For a list of potent drugs, as well as highest or average therapeutic doses, see tables 1, 2.

Table 1

LIST OF POTENT MEDICINES AND HIGH OR MEDIUM THERAPEUTIC DOSES (CONCENTRATIONS) FOR ADULTS BY VARIOUS ROUTES OF ADMINISTRATION in grams or (where indicated) in milliliters, drops or units of action (U) *1 (according to State Pharmacopoeia X)

Name of the drug		Method of administration	Higher or average (indicated*3) therapeutic doses (concentrations)
Russian*2	Latin			daily allowance
Adonizide - see Adonis				120 drops
Adrenaline hydrotartrate - see. Adrenalin	Adrenalini hydrotartras
Adrenaline hydrochloride - see Adrenalin	Adrenalini hydrochloridum
Amidopyrine
Amyl nitrite		For inhalation	0.1 ml (6 drops)	0.5 ml (30 drops)
Aminazine
		Intramuscularly
Analgin
		Subcutaneously, intramuscularly and intravenously
Anestezin
Antipyrine
Apressin
		Subcutaneously and intramuscularly
Barbamil
Barbital
Barbital sodium	Barbitalum-natrium	subcutaneously and intramuscularly
Benzylpenicillin potassium salt- see Penicillins (semi-synthetic)	Benzylpenicillinum-kalium	Intramuscularly and subcutaneously		1,500,000 units*3
Benzylpenicillin sodium salt- see Penicillins (semi-synthetic)	Benzylpenicillinum-sodium	Intramuscularly and subcutaneously	50,000 -300,000 units*3	200,000-1,500,000 units*3
Benzylpenicillin novocaine salt - see Penicillins (semi-synthetic)	Benzylpenicillinum-novocainum	Intramuscularly
Benzohexonium
Benzonal
Bigumal
Bromized
Butadion
		Intramuscularly
Gangleron
		Subcutaneously and intramuscularly
Hexamidine
Hexenal
Hexobarbital
Griseofulvin
Deoxycorticosterone acetate. Deoxycorticosterone	Desoxycorticosteroni acetas	Intramuscularly
Diazolin
Digalen-neo - see Foxglove			0.65 ml (20 drops)	1.95 ml (60 drops)
Diiodotyrosine - see Iodotyrosines
		Subcutaneously and intramuscularly
Diphenhydramine
		Intramuscularly
Diprazine
		Intramuscularly
Diprophylline
		Into a vein and intramuscularly
Ditrazine citrate - see Ditrazine	Ditrazini citras
Diethylstilbestrol	Diaethylstilboestrolum	Inside and intramuscularly
Diethylstilbestrol propionate - see Diethylstilbestrol	Diaethylstilboestroli propionas	Intramuscularly	0.05 (once every 3-4 days)**
Isoniazid - see Isonicotinic acid hydrazide
		Intramuscularly
Kanamycin monosulfate - see Kanamycin	Kanamycini monosulfas
Narbromal
Quateron
Nicotinic acid - see A nicotinic acid	Acidum nicotinicum
		Into a vein (as sodium salt)
Diluted hydrochloric acid	Acidum hydrochloricum dilutum		(40 drops)	(120 drops)
Codeine phosphate - see Codeine	Codeini phosphas
		Inside, under the skin and into a vein
Korglykon - see Lily of the Valley
Cordiamine		Inside and under the skin
		Under the skin and into a vein for drug poisoning
Cortisone acetate - see Cortisone	Cortisoni acetas
Corticotropin for injection - see Adrenocorticotropic hormone	Corticotropinum pro injectionibus	Intramuscularly
Cotarnine chloride - see Kotarnin	Cotarnini chloridum
Caffeine sodium benzoate - see Caffeine	Coffeinum-natrii benzoas
Lantoside - see Digitalis			0.5 ml (25 drops)	1.5 ml (75 drops)
Levomycetin
Henbane leaf - see Henbane	Folium Hyoscyami
Datura leaf - see Medicinal plants	Folium Stramonii
Belladonna leaf - see Belladonna	Folium Belladonnae
Foxglove leaf - see Foxglove	Folium digitalis
Copper, sulfate - see Copper			0.5 (single dose as an emetic)
		Subcutaneously and intramuscularly
Meprotane
Mercazolil
Methandrostenolone	Methandrostenolonum
Methylandrostenediol - see Anabolic steroids	Methylandrostendiolum	Inside and SINGING THE TONGUE
Methyltestosterone	Methyltestosteronum
Methylthiouracil	Methylthiouracilum
Methicillin sodium salt. Methicillin	Methicillinum-sodium	Intramuscularly
Belladonna tincture - see Belladonna	Tinctura Belladonnae		0.5 ml (23 drops)	1.5 ml (70 drops)
Opium-benzoin tincture	Tinctura Opii benzoica
Chilibukha tincture	Tinctura Strychni		0.3 ml (15 drops)	0.6 ml (30 drops)
Sodium nitrite
Naftamon
Neomycin sulfate - see Neomycins	Neomycini sulfas
Nitranol
Nitroglycerine			4 drops (1.5 tablets)	16 drops (6 tablets)
Novobiocin sodium salt - see Novobiocin	Novobiocinum-natrium
Novocaine
		Intramuscularly (2% solution)
		Into a vein (0.25% solution)
		For infiltration anesthesia	First single dose at the beginning of the operation, not more than 1.25 when using a 0.25% solution and 0.75 when using a 0.5% solution. In the future, for each hour of operation no more than 2.5 when using a 0.25% solution and 2.0 when using a 0.5% solution
Novocainamide	Novocain amid u m
Norsulfazole
Norsulfazole sodium - see.	Norsulfazolum-natrium
Norsulfazole			0.5-2.0 (10-20 ml 5 - 10% solution)*"
Oxacillin sodium salt. Oxacillin	Oxacillinum-sodium
Oxylidine		Inside, under the skin and intramuscularly
Oxytetracycline hydrochloride - see Oxytetracycline	Oxytetracyclini hydrochloridum
Oxytetracycline dihydrate - see Oxytetracycline	Oxytetracyclini dihydras
Octestrol - see Synthetic non-steroidal estrogens
Papaverine hydrochloride - see Papaverine	Papaverini hydrochloridum
		Under the skin, into a vein and intramuscularly
Paracetamol
Pachycarpine hydroiodide - see Pahicarpine	Pachycarpini hydroiodidum
Pentamin		Intramuscularly
Prednisolone
Prednisone
Progesterone		Intramuscularly
Propazine
		Intramuscularly
Alcohol iodine solution 5%	Solutio Iodi spirituosa 5%
Alcohol iodine solution 10%	Solutio Iodi spirituosa 10%
Salsolina hydrochloride - see Salsolin	Salsolini hydrochloridum
Sinestrol
		Intramuscularly at malignant neoplasms
Ergot
Streptomycin sulfate - see-Streptomycins	Streptomycini sulfas	Intramuscularly
Streptocide
Sulfadimezin
Sulfacyl sodium - see Sulfacyl	Sulfacylum-natrium
Spherophysin benzoate - see Spherophysin	Sphaerophysini benzoas
		Subcutaneously and intramuscularly
Theobromine
Theophylline		Orally and rectally
Testosterone propionate - see Testosterone	Testosteroni propionas	Intramuscularly
Tetracycline - See Tetracyclines
Tetracycline hydrochloride - see Tetracyclines	Tetracyclini hydrochloridum
		Intramuscularly
Thiopental sodium	Thiopentalum-natrium
Thyroidin
Adonis grass - see. Adonis	Herba Adonidis vernalis
Lily of the valley grass - see Lily of the valley	Herba Convallariae
Thermopsis grass - see Thermopsis	Herba Thermopsidis
Trimethine
Triftazin
Trichomonacid
Urosulfan
Phenacetin
Phenobarbital
Phenoxymethylpenicillin	Phenoxymethylpenicillinum
Phthalazole
Ftivazid
Furadonin
Furazolidone
Furacilin
Hingamin
Hiniophone
Chloral hydrate	Chloralum hydratum	Inside and in an enema
Chloracysin
Chloroform
Chlorpropamide
Chlortetracycline hydrochloride - see Chlortetracycline	Chlortetracyclini hydrochloridum
Chlorotrianisene	Chlortrianisenum
Belladonna extract thick - see. Belladonna	Extractum Belladonnae spissum
Dry belladonna extract - see. Belladonna	Extractum Belladonnae siccum
Male fern extract thick - see male fern	Extractum Filicis maris spissum		8.0 (one time)
Emetine hydrochloride - see Emetine	Emetini hydrochloridum	Subcutaneously and intramuscularly
Ergotal - see Ergot
				0 ,0005- 0,001**
Erythromycin
Etazol sodium - see Etazol	Aethazolum-natrium
			0.5-2.0 (5-10 ml of 10-20% solution)**
Ethacridine lactate - see Ethacridine	Aethacridini lactas
Etaminal sodium	Aethaminalum-natrium
Ethinyl estradiol	Aethinyloestradiolum
Eufillin		Orally, intramuscularly and rectally
Ephedrine hydrochloride - see Ephedrine	Ephedrini hydrochloridum	Inside and under the skin
Medical ether - see Ethyl ether	Aether medicinalis		0.33 ml (20 drops)	(60 drops)

*1 When calculating higher doses for people over 60 years of age, individual sensitivity to different groups medicines:

a) doses of drugs that depress the central nervous system(hypnotics, bromides), as well as cardiac glycosides, diuretics are reduced to 1/2 the dose indicated in the table;

b) doses of other potent drugs should be 2/3 of the dose indicated in the table;

c) doses of antibiotics, sulfa drugs and vitamins are usually the same for all adults.

*2 Typed in italics are published as independent articles.

*3 Average therapeutic doses are indicated.

V. P. Kalashnikov.

Among pharmaceutical drugs There is a group of medicines, small doses of which already have a significant effect on the body. A small overdose of such drugs leads to irreversible processes in the body and death. These drugs are included in the List of Poisonous and Potent Medicines and are subject to special accounting and storage rules. In the instructions for use medical supplies The drug's belonging to a specific group is always indicated. Poisonous and potent drugs belong to Lists A and B, which are approved by the Ministry of Health of the Russian Federation. They require careful handling and careful adherence to doctor's instructions in order to avoid accidents due to negligence or intentional harm to health.

Basic provisions of the List of toxic and potent substances

The list of poisonous and potent substances is approved by the Standing Committee on Narcotics Control (PCDN) and is periodically reviewed and updated.

It is compiled taking into account:

• physiological effects of natural or chemical substances per person;
• recommendations of the World Health Organization;
• current international legislative acts and protocols preventing the illegal distribution of narcotic drugs;
• information from criminal practice about the effects of substances on the body.

The lists of potent and toxic substances differ from Lists A and B, approved by the Ministry of Health of the Russian Federation, since they include not only drugs used in medical institutions for treatment various diseases, but also substances not included in the State Register of Medicines (prohibited for use by health authorities).

All substances listed in the PKKN Lists are listed in accordance with their international generic names, all known synonyms are also indicated.

Lists of toxic substances and medications

The List of Toxic Substances (Sheet 2 of the PKKN List) includes 65 names of substances of plant, animal or synthesized origin, which, when exposed to a living organism, cause acute or chronic poisoning, often leading to death. These are mainly poisons of natural or chemical origin, for example:

• serpentine;
• bee;
• arsenic;
• potassium cyanide (calcium, cadmium, sodium, copper);
• mercury;
• hydrocyanic acid;
• aconite;
• sum of belladonna alkaloids and other substances.

List A of medicines (Venena) includes 116 medicines produced on the basis of toxic and narcotic substances included in the List of Narcotic and Psychotropic Substances or the List of Poisonous Substances of the PKKN. These include the following groups of funds:

• antitumor (Bleomycin, Vincristine, Imiphos);
• cardiac glycosides (Digotoxin, Cordigit, Methyldigoxin);
• anesthetics (Ketamine, Butorphanol, Tetracoin);
• psychostimulants (Methylphenidate)
• immunosuppressive (Azathioprine);
• muscle relaxants (Alcuronium chloride, Mivacurium chloride, Pipecuromium bromide);
• m-anticholinergic agents (Atropine, Metocinium iodide, Platiphylline) and others.

Such medications are dispensed from pharmacies strictly according to a prescription with a stamp from the medical institution that prescribed it. IN free access drugs cannot be found.

The label of all toxic pharmaceutical drugs must indicate:

• mode of application;
• composition of the drug;
• date of manufacture;
• best before date;
• place of manufacture;
• signatures of persons who took part in the process of its preparation.

Drugs containing poisons psychotropic substances or drugs, must be stamped on the label with the warning "Poison".

Lists of potent substances and medicines

Substances of natural or synthetic origin, small doses of which have a noticeable effect on the body, are called potent substances. They are included in Sheet 1 of the List of Poisonous and Potent Medicines and number 126 items.

Based on this list, List B (Heroica) was compiled of 326 ready-made medicines V various forms(tinctures, tablets, dietary supplements, ampoules, suppositories, etc.) These include, for example:

• NSAIDs (Diclofenac, Ibuprofen, Indomethacin);
• antibiotics (Azithromycin, Gentamicin, Oxacillin);
• sleeping pills (Zolpidem tartrate, Zopiclone);
• glucocorticosteroids (Hydrocortisone, Dexamethasone, Prednisolone);
• antidepressants (Clomipramine, Maprotiline, Metralindole);
• hormone-containing drugs (Clomiphene, Mestranol, Testosterone);
• vitamins (Hydroxocobalamin, Calcium pantothenate, Nicotinic acid) and other groups of drugs.

All potent ready-made medicines, like poisonous ones, must be sold with a doctor’s prescription, but in practice, most often pharmacists do not require a prescription when selling most of them; they can be freely purchased at any pharmacy chain. This is their danger to the population during self-medication.

How to store poisonous and potent drugs

To prevent poisoning or abuse for personal or criminal purposes, the Ministry of Health has established Rules for the storage of poisons, drugs and potent drugs from Lists A and B. For these groups of drugs, the following must be observed: special conditions storage, ensuring their quality and safety when used as prescribed by a doctor.

When storing poisonous and potent drugs in a pharmacy, the organization must have the necessary premises, equipment and inventory that meet all legal requirements.

1. Pharmacy storage with medicines is equipped multi-level system alarm system connected to the 24-hour monitoring console of a licensed security organization. A fire alarm is required.
2. The storage facility must be equipped with iron front door or wooden, but upholstered in metal (the thickness of which is at least 40 mm) with a doorway made of steel profile.
3. All pharmacy windows are equipped with finely patterned steel bars.

The storage of potent and toxic drugs is carried out on the basis of the order of the Ministry of Health of the Russian Federation in 1997. The pharmacy has special cabinets and safes for this purpose. Particularly toxic substances are stored separately from other poisons and drugs in the inner, locked compartment of the safe.

Narcotic and poisonous drugs are stored in a safe marked: “A.Venena” indicating the names of all drugs stored in it and their quantity. Also in this cabinet they store the necessary equipment and tools used for preparing prescription medications. The safe must be closed during the day (it is opened only if necessary by a pharmacy employee authorized by order or by the manager who holds the key). At night the safe is sealed and sealed.

Entrance to the room in which this safe is located is restricted. Access to it is granted with the permission of the Internal Affairs Directorate only for people whose work is directly related to the preparation of medicines from toxic, psychotropic and narcotic substances.

The doors of the safe in which potent drugs are stored are marked: “B. Heroica." The quantity and name of the drugs contained in it must be indicated. There are no such strict requirements as for storing toxic substances - authorized pharmacists have access to the cabinet, and the safe is locked with a key only at night.

Precautions when handling toxic and potent substances

Handling toxic substances requires increased caution. It is important to adhere to and comply with the following rules.

1. Only specially trained personnel over 18 years of age who are well aware of the effects of toxic substances on the body and the risks associated with such work can work with potent, narcotic and toxic drugs.
2. Pregnant and lactating women are prohibited from working with poisons and narcotic substances.
3. Poisonous drugs are issued to the public or medical institutions only on a specially established form - a prescription. It is written out in legible handwriting without errors or corrections by a qualified specialist indicating his surname and initial. Inaccuracies or errors made in the recipe may cause an accident.
4. Devices used to prepare prescription medications must be constantly checked and adjusted, instruments and devices must be thoroughly washed and disinfected.
5. Poisonous and narcotic substances are prescribed only in extreme cases, and the dose, which is accurately calculated by the doctor taking into account the age and weight of the patient, is strictly prohibited from being exceeded during treatment.
6. In case of accidental or intentional use of a high dose of drugs from List A, the victim should be taken to a medical facility as soon as possible (minutes count). medical institution to provide emergency assistance. Without resuscitation measures (connection to the device artificial ventilation lungs, hemodialysis, intravenous administration solutions and diuretics) the life of a person poisoned by poisons cannot be saved.

Potent medications when exceeding the recommended one-time or daily dose cause symptoms severe poisoning. At long-term use such drugs may cause changes in the functioning internal organs and body systems, addiction and withdrawal syndrome, sometimes leading to death.

Poisonous and potent drugs in small doses have therapeutic effect, but even their slight excess and abuse cause extremely Negative consequences for health, leading to disability and death. When handling any medications ( a large number of potent drugs used by humans in Everyday life to relieve the symptoms of various diseases and is prescribed independently) one must be careful and exercise caution.

Abuse of poisonous, narcotic or psychotropic drugs always ends tragically.

Storage of over-the-counter medicines is possible on open shelves

Medicines on list “a”

The list of medicines in lists “A” and “B” was approved by Order of the Ministry of Health of the Russian Federation No. 472 of December 31, 1999. In May 2010, this order was canceled, but the storage of medicines in lists “A” and “B” is not.

Latest list medicinal substances, assigned to lists “A” and “B” and the definitions of these concepts are given in the Global Fund, X ed. (1968) Order of the Ministry of Health of the Russian Federation No. 388 dated November 1, 2001 established that a pharmacopoeia is published once every 5 years and the validity of a pharmacopoeial article cannot exceed 5 years. In this case, can the Global Fund (1968) be considered valid? normative document- this is the question.

In GF XII ed. (2007) there are no concepts of lists “A” and “B”.

Therefore, it can be assumed that the belonging of medicines to these lists for pharmacies and wholesale organizations can only be determined by the instructions for use, since in accordance with Federal law No. 61 of April 12, 2010 “On the circulation of medicines” manufacturers

when labeling medicinal products, they are required to indicate the storage conditions and conditions for dispensing the medicinal product (“dispensed without a doctor’s prescription”, List “B”, List “A”)

 Medicines of list “A” are stored in isolation, in locked metal cabinets under lock and key

 There should be an inscription “A” on the inside of the cabinet doors.

(“Venena”) and a list of drugs on the list indicating the highest

single and daily doses

 The inscriptions on the shelves in which list “A” drugs are stored must be white on a black background and their highest single and daily doses should be indicated

 During working hours, the keys to the metal cabinet with medicines ( drugs) List "A" located in the assistant's room must be kept by an authorized employee of the pharmacy organization. After the end of the working day, the cabinets are sealed or sealed, and the keys to them, the seal and the seal must be kept by the head of the pharmacy organization or by persons authorized by order of the pharmacy organization

 In pharmacies on duty, drugs of list “A” are left overnight, which are kept by the pharmacist on duty in a separate locked cabinet, in quantities and assortment necessary to provide emergency medical care. After the end of duty, this cabinet is sealed or sealed.

 Reagents containing drugs of list “A” and located on the table of the pharmacist-analyst or pharmacist-technologist during work must be stored in a locked cabinet after completion of work.

Medicines from list “b”

List B drugs are stored isolated in wooden cabinets under lock and key.

On the inside of the cabinet doors in which they are stored medications(medicines) of list "B" there must be the inscription "B" ("Heroica") and a list of drugs indicating the highest single and daily doses

The inscriptions on the shelves in which drugs of list “B” are stored must be red on a white background and their highest single and daily doses must be indicated.

Wooden cabinets for storing medicines ( drugs) list "B" after the end of the working day must be locked

In the on-duty pharmacies, drugs of list “B” are left overnight, which are kept by the pharmacy employee on duty in a separate locked cabinet, in quantities and assortment necessary to provide emergency medical care. After the end of duty, this cabinet is sealed or sealed;

Nevolina Elena Viktorovna
Executive Director of the NP "Pharmacy Guild", Ph.D.

SALES OF NS and PV FOR PHARMACIES IS NOT PROFITABLE

A license for the right to sell potent drugs costs from 200 to 650 thousand rubles. depending on the region. The safe will need to be replaced, the doors strengthened, and the alarm system updated. The problem of storing DM medications has not yet been resolved. By imposing increased safety requirements for the storage of potent drugs, pharmaceutical companies create additional difficulties that are incomparable with real conditions their storage.

The owner of a pharmacy company needs to say “thank you” for the fact that he takes on the burdensome function of providing a certain category of patients with the necessary medications, but instead they are trying to crush him with the requirements of regulations to ensure the maintenance of logs, additional training of personnel and control over the discharge of diabetes by medical workers. drugs.

Example. Clause 3.4. Order of the Ministry of Health of Russia dated December 20, 2012 No. 1175 “On approval of the procedure for prescribing and prescribing medicines, as well as forms of prescription forms for medicines, the procedure for completing these forms, their recording and storage” (PR-1175) allows you to increase the dosage permissible for prescribing by twice. At the same time, no one canceled the order of the Russian Ministry of Health dated December 14, 2005. No. 785, paragraph 2.5 “On the procedure for dispensing drugs that are subject to subject-quantitative accounting...” says that “it is impossible to exceed the amount of dosage allowed for prescribing” (PR-785). According to PR-1175 patients with severe pain syndrome of any origin, both Schedule II and Schedule III drugs can be prescribed. The question arises, how is the supply of drugs from List II currently carried out? If the drug was prescribed urgently due to indications, how to attach it, what does the signature of the doctor who has the right to prescribe the drug look like, what does his personal seal look like? Despite the appearance of PR-1175, pharmacies continue to dispense drugs from Lists II and III by appointment.

MAJOR DISORDERS - DUE TO STORAGE CONDITIONS

The main violations that are revealed during inspections of pharmacy enterprises, both scheduled and extraordinary, are storage conditions. There are still incompetent employees of the inspection bodies who Special attention are given to drugs from Lists A and B, not taking into account the fact that by the corresponding order of the Ministry of Health of Russia No. 380 dated May 24, 2010, these lists... were cancelled!

Example. Violations of storage of List B drugs - and the pharmacy organization is ordered to provide sufficient quantity wooden cabinets with locks. How long will the pharmacy be responsible for the negligence of drug manufacturers who were obliged, in accordance with regulations, to make changes to the instructions for its use? At IP No. 851 there is a pharmacy at the address: st. Kastanaevskaya, 17, according to the inspection report dated 10/05/13, penalties in the amount of 40 thousand rubles were imposed. for improper storage of drugs from List B. I have one wish for pharmacies for the future: in order not to pay for someone else’s mistake, keep the following in mind. When a pharmacy accepts a drug for sale and sees a discrepancy regulations in the text of the instructions for use, she thereby shares responsibility with the dishonest manufacturer of this drug.

Unfortunately, the Ministry of Health does not have any measures of influence on negligent manufacturers, most of whom do what is easier for them. In turn, the pharmacy will show excessive adherence to principles and refuse to accept drugs from “Lists A and B” for sale, and the consumer may lose the necessary drug.

In accordance with clause 5.6 of the Industry Standard “Rules for the dispensing (sale) of medicines in pharmacy organizations. Basic provisions" OST 91500.05.0007-2003, approved by order of the Ministry of Health of Russia dated March 4, 2003 No. 80 (as amended on April 18, 2007), there are special requirements for the storage of drugs Lists A and B in pharmacies. IN in this case it is necessary to demand the repeal of the clauses of the above normative act.

Based on materials from the section within the framework of the XV All-Russian Conference “PharmMedAppeal 2013”

"Moscow pharmacies", 2010, N 10
MEDICINES OF LIST A AND LIST B:
WHAT SHOULD WE KEEP TODAY
Back in 1922, the Instruction of the People's Commissariat of Health "On the right to open and conduct trade in medicines" established the rules for the circulation of potent and toxic substances (trade in such substances and their storage). The instructions, for example, stated that “poisonous and potent substances should be stored in special compartments under lock and key...”. In addition, a number of provisions of this document revealed the existing approaches to the definition of potent and toxic substances and the establishment of their lists.
To determine which specific substances are considered potent and toxic, the instructions also referred to the Russian Pharmacopoeia. In particular, § 4 of the instructions stated that “to record the arrival and release of poisons according to List “A” of the 6th edition of the Russian Pharmacopoeia, a special corded book must be kept in wholesale warehouses, certified by the health department.”
The inspector is always right?! This statement-question refers to the “ever-memorable” lists A and B, the list of which has become invalid since May 24, 2010 in accordance with the order of the Ministry of Health and Social Development N 380. But as for the conditions of their storage established by the order of the Ministry of Health of the Russian Federation dated 04.03.03 N 80 "On approval of the industry standard "Rules for the dispensing (sale) of medicines in pharmacies. Basic provisions", then they remain in force. Moreover, they are especially carefully checked by regional Ministries of Health and Departments of Health and are classified as "gross violations of licensing requirements and conditions" and entail administrative punishment in the form of a fine of 40 thousand rubles or suspension of the license for a period up to 90 days. Their argument is that the concept of lists A and B are given in the State Pharmacopoeia (SP), which is of a legislative nature. However, in arguing that they are right, the experts conducting the inspections do not mention in which issue of this very GF they found them. We decided to figure out what we should store today in accordance with the requirements for lists A and B. The definition of lists A and B is given in the State Pharmacopoeia X - edition of 1968, in the “Introduction” section:
“List A includes medicines, the prescription, use, dosing and storage of which, due to their high toxicity, must be carried out with extreme caution. This list also includes medicines that cause drug addiction.
List B includes medicines, the prescription, use, dosage and storage of which must be carried out with caution due to possible complications when used without medical supervision.
Storage and dispensing in pharmacies and in all other institutions of medicines according to lists A and B is carried out in compliance with the rules given in the special instructions approved by the Ministry of Health of the USSR." Here is a list of medicinal substances included in list A, which includes 121 items, and list B - 340 items, by the way, in the Global Fund VIII edition (1948) list A consisted of 36 medicinal substances, and list B - of 192. List A also included narcotic drugs, since they were considered not as an independent group, but as a type of toxic substances.
A deeper retrospective look into history showed that historically all “strong” medications were allocated to group B (list B), and “highly toxic” ones to group (list) A.
Medicines of group A are stored separately from other medicines in permanently closed safes or cabinets, on the inside of the door of which there must be the inscription “A. Venena” indicating the list of stored substances, their single and daily doses. After work, safes or cabinets are sealed. Group B medications are stored separately in special cabinets, which are closed at the end of the working day. On the inside of the door there must be the inscription "B. Heroica".
The fact that all poisonous and narcotic drugs in the Soviet period were identified with the concept of “drugs of List A”, and the concept of “potent drugs” with the concept of “drugs of List B” is confirmed by previously valid regulatory documents, for example, paragraph 3.3. "Instructions for organizing storage in pharmacies various groups medicines and medical products", approved by Order of the USSR Ministry of Health dated May 15, 1981 N 520 (by the way, in the Order of the Ministry of Health dated November 13, 1996 N 377, which replaced Order N 520, the concepts of "list "A" and "B" disappeared, and only “narcotic, psychotropic and potent drugs remain”), paragraphs 2 and 4 of the “Rules for the storage, accounting and dispensing of poisonous, narcotic and potent drugs in self-supporting pharmacies”, approved by Order of the USSR Ministry of Health dated 07/03/68 N 523, also give grounds to interpret list "A" - as poisonous and narcotic drugs, and list "B" as potent.
A study of documents showed that until 1991, lists A and B, given in the Global Fund, were the only professional lists defining groups of potent, poisonous drugs, along with lists of narcotic drugs, published by the PCKN in relation to drugs. They were a mandatory legal document that determined the activities of doctors, pharmacists and other medical specialists in prescribing, organizing the receipt, storage, accounting and dispensing of these medicines, they were mandatory in nature, they were a legal document that determined the activities of pharmacies regarding these medicines.
However, the Plenum of the Supreme Court of the Russian Federation, by its resolution dated April 27, 1993 N 2, indicated that in order to determine which drugs are classified as narcotic, potent, poisonous, it is necessary to use the lists published by the Standing Committee for Drug Control (PKKN). It goes without saying that such a solution to the issue fundamentally changed the legal status of lists A and B given in the Global Fund X (1968). The Lists published by the PCKN covered many medicines that were previously listed in parallel in both Lists A and B.
In connection with the above, there was a need, from a fundamental standpoint, to review the lists of medicines A and B, to develop criteria for their formation, since the nomenclature of medicines had changed significantly and, moreover, there were actually no clear criteria for classifying medicines as lists A and B. Before the Ministry of Health the task arose, based on all legal norms in the field of narcotic, toxic, potent substances and legal acts regulating the import and export of these drugs and the procedure for writing prescriptions for narcotic, potent, toxic substances, for the first time, develop clear criteria for the formation and classification of medicines to lists A and B, as well as find the appropriate place for lists A and B in the entire system of legal regulation and determine the legal boundaries and boundaries of competence. The rule-makers successfully dealt with this, and on December 31, 1999, Order No. 472 “On the list of lists A and B” was issued. In the preamble to the list it is noted that “medicines of list “A” and “B” do not have an alternative name of “potent drugs and toxic substances”, are not included in the list of ADD and toxic substances of the PCKN, are not in the List of narcotic drugs and psychotropic substances and their precursors. In the list, list “A” includes more than a hundred drugs according to INN, list “B” has gone far beyond 1000 INN. The list that existed since 1999 ceased to exist on May 24, 2010.
So, taking into account the above, we summarize that all drugs can be divided into the following control groups:
- narcotic drugs and psychotropic substances, the list was approved by the RF Government of June 30, 1998 N 681;
- potent drugs and toxic substances, the list is approved by the RF Government No. 964;
- medicines of lists A and B, the list was approved by order of the Ministry of Health of the Russian Federation dated December 31, 1999 N 472, canceled by order of the Ministry of Health of Russia dated May 24, 10 N 380;
- over-the-counter medicines, the list is approved by order of the Ministry of Health of the Russian Federation No. 578.
Now about the industry standard “Rules for the dispensing (sale) of medicines in pharmacies. Basic provisions” and the State Pharmacopoeia. So, in the Industry Standard in clause 5.6, which defines the storage conditions for drugs of lists A and B, we read: “the list of drugs (medicines) classified as lists “A” and “B” is determined in accordance with current regulatory documents" . The key word is "acting".
The latest List of medicinal substances included in lists A and B is given in the Global Fund X (1968). Order of the Ministry of Health of the Russian Federation dated November 1, 2001 N 388 established that a pharmacopoeia is published once every 5 years and the validity of a pharmacopoeial article cannot exceed 5 years. In this case, can GF X be considered a valid regulatory document? In addition, the current Federal Law N 86-FZ defines that the State Fund is “a collection of state standards for a medicinal product, containing a list of indicators and methods for monitoring the quality of a medicinal product.” The basic law does not say anything regarding the fact that this collection, which is of a legislative nature, establishes that medicinal substances belong to lists A and B! Moreover, in the Global Fund XII (2007) we did not find the concept of lists A and B at all, however, as in the Global Fund XI (1987).
It can be assumed that the “inspectors” establish whether a drug belongs to List B on the basis of the instructions for use, but formally they are not regulations mandatory for implementation by organizations of wholesale and retail trade in medicines. By the way, it is easier in this sense for wholesalers, for whom in their industry standard “requirements for the storage of medications of lists A and B are determined in accordance with the established procedure.” Since no one has ever established such an order, there are no requirements.
One good thing is that the Decree of the All-Russian Central Executive Committee of 1919 “On the Cheka” was canceled in time, which granted the right to “direct reprisal (up to execution..., including for illegal actions with poisonous (list A) and potent (list B) substances ..." Otherwise...
It is a pity that advanced training, at least once every 5 years, is not provided for “inspectors” serving in regional health authorities. Otherwise, maybe they would be smart enough to understand the regulatory framework and finally put things in order.
Executive Director
Non-profit partnership
promoting the development of the pharmacy industry
"Pharmacy Guild", Ph.D.
E.V.NEVOLINA
Signed for seal
25.10.2010