Regulations 

Medicines from the list of poisonous and potent drugs. Documentation

Among pharmaceutical preparations there is a group 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 lethal outcome. These drugs are included in the List of poisonous and potent drugs and are subject to special accounting and storage rules. The instructions for the use of medicines always indicate the belonging of the drug to a particular group. 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 observance of the doctor's instructions to avoid accidents by negligence or intentional injury to health.

Main provisions of the List of Poisonous and Potent Substances

The list of toxic and potent substances is approved by the Standing Committee on Drug Control (PCKN), 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;
  • existing international legislative acts and protocols preventing the illegal distribution of narcotic drugs;
  • information from criminal practice on the effect 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 the treatment various diseases, but also substances not included in the State Register of Medicines (prohibited for use in health authorities).

All substances on the SCCB Lists are listed according to their international non-proprietary names, and all known synonyms are also indicated.

Lists of toxic substances and drugs


The List of Poisonous 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:

  • snake;
  • bee;
  • arsenic;
  • potassium cyanide (calcium, cadmium, sodium, copper);
  • Mercury;
  • hydrocyanic acid;
  • aconite;
  • the amount of belladonna alkaloids and other substances.

List A drugs (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 RKKN. These include following groups funds:

  • antitumor (Bleomycin, Vincristine, Imiphos);
  • cardiac glycosides (Digotoxin, Cordigit, Methyldigoxin);
  • anesthetics (Ketamine, Butorphanol, Tetracoin);
  • psychostimulant (Methylphenidate)
  • immunosuppressive (Azathioprine);
  • muscle relaxants (Alcuronium chloride, Mivacurium chloride, Pipecuromia bromide);
  • m-anticholinergics (Atropine, Metocinium iodide, Platifillin) and others.

Such medicines are dispensed from the pharmacy strictly according to the prescription with the stamp of the medical institution that issued it. It is impossible to find drugs in the public domain.

On the label of all poisonous pharmaceutical preparations, the following must be indicated:

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

Preparations 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 drugs and have 126 items.

Based on this list, List B (Heroica) was compiled of 326 finished drugs in different form(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, Metralindol);
  • hormone-containing agents (clomiphene, mestranol, testosterone);
  • vitamins (Hydroxocobalamin, Calcium pantothenate, Nicotinic acid) and other groups of drugs.

All potent finished drugs, like poisonous ones, must be sold by 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 network. This is their danger to the population in self-treatment.

How poisonous and potent drugs are stored

To prevent poisoning or abuse for personal or criminal purposes, the Ministry of Health provides for the Rules for the storage of poisons, drugs and strong drugs from Lists A and B. For these groups of drugs, special storage conditions must be observed to ensure 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 with a multi-level alarm system connected to the round-the-clock monitoring console of a licensed security organization. A fire alarm is required.
  2. The storage should be equipped with an iron front door or wooden, but upholstered with metal (thickness of which is not less than 40 mm) with a doorway made of steel profile.
  3. All pharmacy windows are provided with finely patterned steel bars.

Storage of potent and poisonous medicines is carried out on the basis of the order of the Ministry of Health of the Russian Federation of 1997. In the pharmacy, special cabinets and safes are allocated for this. Particularly toxic substances are stored separately from other poisons and drugs in an internal lockable compartment of the safe.

Narcotic and poisonous medicines are stored in a safe with a mark: "A.Venena" indicating the names of all drugs stored in it and their quantity. Also in this cabinet they store the necessary devices and tools used for the preparation of prescription drugs. The safe must be closed during the day (it is opened only if necessary by an authorized pharmacy employee or manager who keeps 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 issued with the permission of the Internal Affairs Directorate only for people whose work is directly related to the preparation of medicines from poisonous, psychotropic and narcotic substances.

The doors of a safe that contains strong drugs are marked: “B. heroica. Be sure to indicate the number and name of the drugs contained in it. There are no such strict requirements as when storing toxic substances - authorized pharmacists have access to the cabinet, the safe is locked only at night.

Precautions for handling poisonous and potent substances

Handling toxic substances requires extra care. It is important to follow and observe the following rules.

  1. Work with strong, narcotic and poisonous drugs can only be 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.
  2. It is forbidden to work with poisons and narcotic substances for pregnant and lactating women.
  3. Poisonous drugs are issued to the population or a medical institution only according to a specially established form of the form - a prescription. It is written out in legible handwriting without errors and corrections by a qualified specialist indicating his last name and initials. Inaccuracies or mistakes made in the recipe can cause an accident.
  4. Equipment used to prepare prescription drugs must be constantly checked and adjusted, tools and fixtures should 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 forbidden to exceed 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 the medical center as soon as possible (minutes count). medical institution to provide emergency assistance. Without resuscitation (connection to the device artificial ventilation lungs, hemodialysis, intravenous administration of solutions and diuretics) the life of a person poisoned by poisons cannot be saved.

Potent drugs, when the recommended single or daily dose is exceeded, cause symptoms of severe poisoning. At long-term use of these drugs, there may be changes in the functioning internal organs and body systems, a syndrome of addiction and withdrawal, sometimes leading to death.

Poisonous and potent drugs in small doses have a therapeutic effect, but even their slight excess and abuse cause extremely Negative consequences health, resulting in disability and death. When handling any medication ( a large number of potent drugs used by man in Everyday life to alleviate the symptoms of various diseases and is prescribed independently) you need to be careful and be careful.

The abuse of poisonous, narcotic or psychotropic drugs always ends tragically.

CHAPTER 7. CLASSIFICATION OF MEDICINES (PHARMACEUTICAL SUBSTANCES). DOSES

CHAPTER 7. CLASSIFICATION OF MEDICINES (PHARMACEUTICAL SUBSTANCES). DOSES

The active substances are diverse in strength of pharmacological activity and composition. In terms of composition, pharmaceutical substances can be in the form of individual medicinal substances, medicinal plant or animal raw materials, or the sum of active substances. Among the drugs, depending on the pharmacological activity, 3 groups are distinguished: substances of list A (poisonous), substances of list B (strong) and non-strong.

This separation is important to prevent the risk of overdose in the process of manufacturing drugs and their use.

7.1. CLASSIFICATION OF MEDICINES (PHARMACEUTICAL

SUBSTANCES) BY THE NATURE OF ORIGIN

By nature of origin medicines are classified into mineral and organic (obtained by chemical or biological synthesis, including from animal or vegetable raw materials).

7.2. CLASSIFICATION OF MEDICINES DEPENDING ON

FROM PHARMACEUTICAL ACTIVITY

Active substances and pharmaceutical preparations are divided into 3 types:

1) medicines (List A);

2) medicines (list B);

3) non-potent.

List A funds - medicines, the dosing and use of which requires special care due to their high toxicity. These lists also include drugs that can cause addiction.

List B funds - medicinal products for which therapeutic, higher single and daily doses have been established and which are stored with caution in order to avoid possible complications.

Non-strong means - an extensive group of drugs, relatively safe, used in various therapeutic doses.

To poisonous (venena) and potent (heroica) include those drugs that are included in lists A and B, established by order of December 31, 1999? 472 "On the list of medicines of lists A and B".

7.3. CLASSIFICATION OF MEDICINES FROM THE POSITION OF ORDERS OF THE MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION IN REGARD TO

PRESCRIPTION

From the standpoint of the orders of the Ministry of Health of the Russian Federation regarding prescriptions medicines divided into 3 types:

Included in the list of medicines dispensed by prescription of a doctor (paramedic) when providing additional free medical care certain categories of citizens who have the right to receive state social assistance, approved by order of the Ministry of Health and social development Russian Federation from

September 28, 2005? 601;

Included in the list of medicines dispensed without a doctor's prescription, approved by order of the Ministry of Health of the Russian Federation No.

September 13, 2005? 578;

Included in the list of medicines subject to quantitative accounting, approved by order of the Ministry of Health of the Russian Federation of December 14, 2005 785 "On the order of leave ...".

7.4. CLASSIFICATION FROM THE POSITION OF THE ORDER OF THE MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION IN REGARD TO

STORAGE ORGANIZATIONS

From the standpoint of the order of the Ministry of Health? 377 11/13/1996 "On approval of requirements for the organization of storage ..." all medicines depending on the physical and physical and chemical properties, impact on them various factors external environment divided into 8 types:

Requiring protection from light;

Requiring protection from moisture;

Requiring protection from volatilization and drying;

Requiring protection from exposure to elevated temperatures;

Requiring protection from exposure to low temperatures;

Requiring protection from exposure to gases contained in the environment;

odorous, coloring;

Disinfectants.

7.5. CLASSIFICATION FROM THE POSITION OF THE FEDERAL CONTROL SERVICE

FOR DRUG TRAFFIC

From the standpoint of the Federal Drug Control Service, medicinal funds are divided into 3 classes:

1. Narcotics(NS) - substances of synthetic or natural origin, preparations, plants included in the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation, in accordance with the legislation of the Russian Federation, international treaties of the Russian Federation, including the United Convention on Narcotic Drugs 1961

2. Psychotropic substances(PV) - substances of synthetic or natural origin, preparations, natural materials included in the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation, in accordance with the legislation of the Russian Federation, international treaties of the Russian Federation, including the 1971 Convention on Psychotropic Substances.

3. Precursors of narcotic drugs and psychotropic substances

(hereinafter - precursors) - substances frequently used in the production, manufacture, processing of narcotic drugs and psychotropic substances, included in the list of narcotic drugs, psychotropic substances and their precursors, subject to control in the Russian Federation, in accordance with the legislation of the Russian Federation, international treaties of the Russian Federation, including the 1988 United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances.

7.6. CLASSIFICATION UNDER THE NARCOTIC DRUGS ACT

According to federal law? 3-FZ "On narcotic drugs and psychotropic substances" all narcotic substances, depending on the control measures applied by the state, are included in the following lists:

2. List of narcotic drugs and psychotropic substances, the circulation of which in the Russian Federation is limited and in respect of which control measures are established in accordance with the legislation of the Russian Federation and international treaties of the Russian Federation (List II).

4. List of precursors whose circulation in the Russian Federation is limited and for which control measures are established in accordance with the legislation of the Russian Federation and international treaties of the Russian Federation (List IV).

Circulation of substances whose names are included in the List of Narcotic Drugs, Psychotropic Substances and Their Precursors Subject to Control in the Russian Federation, approved

Decree of the Government of the Russian Federation of June 30, 1998? 681 is considered from the standpoint of Art. 234 of the Criminal Code of the Russian Federation.

7.7. DOSES OF DRUGS

Dose- a certain amount of the drug ( active substance) introduced into the body.

toxic (dosis toxica);

Lethal (dosis letalis);

Therapeutic or curative (dosis curativa).Therapeutic or curative doses are divided into 3 types (dosis cu-

rativa):

1) threshold (cause the initial action of the substance);

2) maximum - higher (cause the greatest or limiting action);

3) medium (determine the pharmacological action medium degree). The average dose is about 1/3 or 1/2 of the maximum (highest) dose. It is usually contained in a unit dosage form (tablet, ampoule, capsule).

For substances included in lists A and B, government bodies(Pharmacological, Pharmacopoeial committees) establish the highest (maximum) and therapeutic doses:

single dose ( pro dose) for children, adults and animals;

Daily intake (pro die) for children and adults (hereinafter

VRD and VSD).

7.8. RULES FOR CALCULATION OF DOSE ACCORDING TO AGE

Rule 1

Therapeutic doses are established based on the intake of drugs by an adult of middle age and weight

70 kg.

Rule 2

For patients older than 60 years, the dose of medicinal substances is reduced by 1/2-1/3 of the adult dose.

Rule 3

Children are prescribed a dose:

According to the table of GF doses by age;

Recalculated for 1 kg of body weight according to the formula:

7.9. DOSE RULES

IN SPEECH IN THE RECIPE

Worker pharmacy institution is obliged to give the patient a medicinal product in the amount and dose prescribed by the doctor.

By order of the Ministry of Health and the SR? 110 dated February 12, 2007, it was established that single, daily and course doses when prescribing medicines are determined by the attending physician based on the age of the patient, the severity and nature of the disease in accordance with the standards of medical care. When prescribing a narcotic drug or psychotropic substance of lists II and III, other medicinal products subject to quantitative accounting, the dose of which exceeds the highest single dose, the doctor must write the dose of this drug or substance in words and put an exclamation mark. Recipe not responding this requirement, is considered invalid.

If it is possible to clarify the dosage and compatibility with the doctor who wrote the prescription, the pharmacy worker can release the drug to the patient.

Rule 4

Changes in the composition of dosage forms (if necessary) should be made only with the consent of the doctor, with the exception of cases established by the current State Pharmacopoeia, orders and instructions of the Ministry of Health of Russia, and should be noted on the requirement, prescription (copy of the prescription, label).

In the absence of the indicated mark on the requirement, prescription (copy of the prescription, label), the manufacturing quality of the dosage form is assessed as "Unsatisfactory". Changes in the quantity of the dispensed medicinal product or the dispensing of tablets instead of powders should also be noted on the requirement, prescription (copy of the prescription, label).

Rule 5

When issuing medicines of the NA, PV, A and B lists in the written control passport and on reverse side prescription of the person who issued and received the substance, sign, date, indicate the name, mass or volume received in words.

Issued by: Atropini sulfatis 0.9 (nine decigrams) Date... Signature... Received by: Atropini sulfatis 0.9 (nine decigrams) Date... Signature...

Rule 6

If the prescription exceeds the dispensing rate, the pharmacy must reduce the number of doses of the dosed medicinal product or the volume (mass) of the undosed drug in order to maintain the dispensing rate.

The norms for dispensing medicines are presented in the order

MOH? 110.

Rule 7

Pharmaceutical substances are dosed in units by mass (gram, milligram, microgram), volume units (milliliter, drops) and in the form of activity units (IU - international or IE - international units).

The definition of units of action for various medicinal substances is indicated in the relevant articles of the pharmacopoeia. When dosing by weight, doses of medicinal substances are indicated in the decimal system of measurement (the unit of mass is 1 g). When dosing substances weighing less than 1 g (1.0), the following designations are used:

0.1 - 1 decigram;

0.01 - 1 centigram;

0.001 - 1 milligram;

0.0001 - 1 decimilligram;

0.00001-1 centi-milligram;

0.000001 - 1 microgram.

7.10. DOSE VERIFICATION

7.10.1. The masses of substances in the prescription are written out in a distributive way

Check algorithm:

1. Find the highest single dose (WFD) and the highest daily dose (VD) according to the GF, respectively. The highest single and daily doses for adults, children and animals are established in the Global Fund X, p. 1021, 1037, 1045 respectively.

2. Compare the found WFD with a single dose (RD) prescribed in the prescription.

3. Compare the found IRR with the daily dose (DM) prescribed in the prescription.

4. In case of exceeding the RD and DM without an appropriate prescription compared to the WFD and VVD, the pharmacy employee contacts the doctor and clarifies the dose and conditions of admission; correct RD and SD. It is recommended in this case to accept the RD equal to half of the GF WFD.

Rule 8

Order M3 and SR RF? 110 dated February 12, 2007, it was established: “If it is possible to clarify with a doctor or other medical worker who wrote the prescription, the name of the medicinal product, its dosage, compatibility, etc., the employee of the pharmacy institution (organization) may dispense the medicinal product to the patient.

Example 1

Rp.: Atropini sulphatis 0.002 Sacchari 0.25

M. ut f. pulv. D.t.d. ? 10

1. WFD of atropine sulfate under the skin and inside is 0.001.

2. The IRR of atropine sulfate is 0.003.

3. The RD of atropine sulfate is 0.002.

4. SD of atropine sulfate is 0.002. 3 = 0.006.

5. Single and daily doses are too high (without a proper prescription by a doctor).

As a result of a consultation between the pharmacist and the doctor, it was decided to give the patient atropine sulfate at a dose equal to half the highest single dose.

6. The corrected RD is equal to: WFD:2 = 0.00:2 = 0.0005.

7. The corrected SD is: 0.0005. 3 = 0.0015.

Rp.: Atropini sulphatis 0.0005 Sacchari 0.25 M. utf. pulv. D.t.d. ? 10

S. 1 powder 3 times a day.

7.10.2. The masses of substances in the prescription are written out in a separating way

A. Dosing per single dosage form

Solution algorithm:

1. Find the highest single dose (WFD) and the highest daily dose (VD) according to the GF, respectively.

2. Determine the RD for one reception. To do this, divide the prescribed amount of the medicinal substance by the number of prescribed doses (powders, suppositories, pills, etc.).

3. SD is determined. For this, the RD is multiplied by the number of doses per day.

4. Compare RD and SD with WFD and VSD.

5. In case of excess of RD and SD in comparison with WFD and VVD, agree on the dose with the doctor; correct RD and DM and calculate the mass of the medicinal substance that must be taken to prepare the dosage form. To do this, multiply the corrected RD by the number of prescribed doses (powders, suppositories, pills, etc.).

Example 2

Rp.: Novocain 6.0

Ol. cocoa 60.0

M. ut f. supp.

Div. in p. aeq. ? twenty

1. The WFD of novocaine is 0.2.

2. The IRR of novocaine is 0.6.

3. RD is 6.0:20 = 0 3.

4. SD is 0.3. 2 = 0.6.

5. RD is overestimated compared to the pharmacopoeial, SD is not overestimated.

6. The RD corrected in agreement with the doctor is equal to half

WFD: 0.2:2 = 0.1.

To prepare candles, you need to take novocaine 0.1. 20 = 2.0.

Recipe view after correction:

Rp.: Novocaini 2.0

Ol. cocoa 60.0

M. ut f. supp.

Div. in p. aeq. ? twenty

D.S. 1 candle in the morning and evening.

B. Dose testing in liquid non-dosage dosage forms taken with spoons

Solution algorithm:

1. Find WFD and VSD by GF.

2. Determine the RD of the medicinal substance for 1 dose. To do this, set the number of doses of the drug (NPLS) by dividing the volume of the dosage form by the volume of the spoon (the volume of a tablespoon is 15 ml, the volume of a dessert spoon is 10 ml, the volume of a teaspoon is 5 ml); find the RD of the medicinal substance by dividing its mass (volume) by the number of doses.

3. Determine the SD of the medicinal substance. For this, the RD is multiplied by the number of doses per day.

4. Compare the found RD and SD with tabular values

VRD and VSD.

5. In case of excess of RD and SD in comparison with WFD and VVD, the dose is agreed with the doctor. Accordingly, the RD and SD are corrected. Calculate the amount of medicinal substance (pharmacist-

tic substance), which must be taken to prepare the dosage form. To do this, multiply the RD of the drug by the number of doses of the drug.

Example 3

Rp.: Apomorphini hydrochloridi 2.5 Aq. pur. 100 ml

Solution algorithm:

1. WFD of apomorphine hydrochloride is 0.01.

2. VSD - 0.03.

3. The number of doses of the drug (NPLS) is 100 ml / 10 ml = 10 dessert spoons (10 ml in 1 spoon of water).

4. The RD of apomorphine hydrochloride is 2.5:10 = 0.25>0.01 (WRD).

5. The SD of apomorphine hydrochloride is 0.25. 3 = 0.25>0.03 (VSD).

6. RD and DD are overestimated without proper prescription.

By agreement with the doctor, take a single dose equal to half the highest single dose; correct RD and SD.

7. The corrected RD (corr.) for apomorphine hydrochloride is 0.01/2 = 0.005.

8. The corrected SD is 0.005. 3 = 0.015.

9. Calculation of the corrected mass of the medicinal product:

to prepare the dosage form, you need to take apomorphine hydrochloride:

RD (correct) x number of doses of the drug: 0.005. 10 = 0.05.

Recipe view after correction: Rp.: Apomorphini hydrochloridi 0.05 Aq. pur. 100 ml

M.D.S. 1 dessert spoon 3 times a day.

B. Checking doses of liquid potent or poisonous substances prescribed in a mixture with other liquids and taken in drops

Solution algorithm:

1. Find WFD and VSD by GF.

2. Determine the number of drops in 1 ml of the drug according to the table of drops (see Table 6.3).

3. Determine the total number of drops in the dosage form.

4. Determine the number of doses of the drug (NPLS) by dividing the number of drops in the entire dosage form by the number of drops of 1 dose.

5. Find the RD of the drug by dividing its amount in drops by the number of doses of the drug.

6. Determine the SD of the medicinal substance. For this, the RD is multiplied by the number of doses per day.

7. Compare the found RD and SD with WFD and VSD.

8. In case of excess of RD and DM in comparison with the WFD, the ERR, in agreement with the doctor, correct the RD and DM.

9. Calculate the amount of the medicinal substance that must be taken to manufacture the dosage form.

Rule 9

The number of drops in the entire dosage form is equal to the sum of the drops of each ingredient.

Example 4

Rp.: Tinct. conv. Tinct.

Val. ana 10 ml Tinct.

Belladonnae 40 ml Mentholi 0.2 M .D.S.

40 drops 3 times a day.

1. WFD of belladonna tincture is 23 drops, VSD is 70 drops.

2. According to the drop table (see Table 6.3), determine: 1 ml of lily of the valley tincture - 50 drops; 10 ml of lily of the valley tincture - 500 drops; 1 ml of valerian tincture - 51 drops; 10 ml of valerian tincture - 510 drops; 1 ml of belladonna tincture - 44 drops; 40 ml belladonna tincture - 1760 drops. The total number of drops is: 500+510+ +1760 = 2770 drops.

3. The number of doses of the drug is: 2770:40 = 69.

4. RD of belladonna tincture is (40.44): 69 = 1760:69 = 25 drops.

5. SD of belladonna tincture is 25. 3 = 75 drops.

6. SD and RD are overestimated compared to WFD and VSD.

7. A modified dose was agreed with the doctor (S from the highest single dose). The corrected RD is 23:2 = 11.5 drops.

8. Corrected SD is 13. 3 = 39 drops.

9. Then you need to change the total amount of belladonna tincture so that for 1 dose it was 11.5 drops, i.e. 11.5. 69/44 = 18 ml.

The single dose dosage form contains:

belladonna tinctures - 12 drops (see above);

Lily of the valley tinctures - 500/69 = 7.3 drops;

Valerian tinctures - 510/69 = 7.4 drops.

Thus, a mixture of tinctures of belladonna, valerian and lily of the valley for 1 dose should be prescribed: 11.5 + 7.3 + 7.4 = 26.2 drops.

Recipe view after correction: Rp.: Tinct. conv. Tinct. Val. ana 10 ml Tinct. Belladonnae 20 ml Mentholi 0.2

M.D.S. 26 drops 3 times a day.

7.11. REQUIREMENTS FOR THE DESIGN OF INDICATIONS ON STANDLASSES

In pharmacy, it is customary to store medicines in glass, tightly closed containers (shtanglas). On the side of the barbell, an inscription with the designation of the contents is pasted or engraved.

Rule 10

On rods with poisonous medicinal substances(list A) must be written in white on a black background. Be sure to indicate the highest single and daily doses.

On barbells with potent substances (list B), the inscriptions are made in red on a white background. Indicate single and daily doses of the substance.

Rule 11

In the storage rooms of a pharmacy, on all barbells with medicines, the following must be indicated: the serial number of the manufacturer, the analysis number of the control and analytical laboratory (the center for quality control of medicines), the expiration date, the date of filling and the signature of the person who filled out the barbell. The number of units of action in 1 g of medicinal plant material or in 1 ml of the medicinal product should be indicated on the barbells with medicinal products containing cardiac glycosides.

In the assistant's rooms on all the barbells with medicinal substances must be indicated: the date of filling, the signature of the person who filled out the barbell and verified the authenticity of the medicinal substance. The highest single and daily doses must be indicated on the A&B lists of medicinal substances, and the warning label “For sterile dosage forms” must be on the medicinal substances on the shelves intended for the manufacture of sterile dosage forms.

Barrels with solutions, tinctures and liquid semi-finished products should be provided with normal dropmers or empirical pipettes. The number of drops in a certain volume must be determined by weighing 5 times a mass of 20 drops and indicated on the label.

Control questions

1. What is the need for classification of medicines?

2. For what purpose is the classification of medicines used in terms of accounting and storage?

3. What is the significance of the classification of medicines from the point of view of the PKKN?

4. What groups are medicines divided into depending on the strength of action?

5. How are medicines stored and what inscriptions should be on the barbells?

Tests

1. By nature of origin, drugs are classified into:

1. Mineral.

2. Synthetic.

3. Organic (obtained by chemical or biological synthesis, including from animal or vegetable raw materials).

2. List A means are:

1. Medicines, dosing and use of which require special care due to their high toxicity.

2. These lists also include drugs that can cause addiction.

3. List B drugs are medicines:

1. For which therapeutic doses have been established.

2. For which higher single doses are established.

3. For which daily doses are established.

4. Stored with care to avoid possible complications.

5. Listed as potent substances.

4. Depending on the physical and physico-chemical properties, the impact on them of various environmental factors, drugs are classified into:

1. Requiring protection from light.

2. Requiring protection from moisture.

3. Requiring protection from volatilization and drying.

4. Requiring protection from exposure to elevated temperatures.

5. Requiring protection from low temperatures.

6. Requiring protection from exposure to gases contained in the environment.

7. Odorous, coloring.

8. Disinfectants.

5. According to federal law? 3-FZ "On Narcotic Drugs and Psychotropic Substances", all narcotic substances, depending on the control measures applied by the state, are included in the following lists:

1. List of narcotic drugs and psychotropic substances, the circulation of which is prohibited in the Russian Federation in accordance with the legislation of the Russian Federation and international treaties of the Russian Federation (List I).

2. List of narcotic drugs and psychotropic substances, the circulation of which in the Russian Federation is limited and for which control measures are established in accordance with the legislation of the Russian Federation and international treaties of the Russian Federation (List II).

3. List of psychotropic substances whose turnover in the Russian Federation is limited and for which the exclusion of certain control measures is allowed in accordance with the legislation of the Russian Federation and international treaties of the Russian Federation (List III).

4. List of psychotropic substances, the circulation of which is permitted in the Russian Federation and for which the exclusion of certain control measures is allowed in accordance with the legislation of the Russian Federation and international treaties of the Russian Federation (List III).

5. List of precursors whose turnover in the Russian Federation is limited and for which control measures are established in accordance with the legislation of the Russian Federation and international treaties of the Russian Federation (List IV).

6. Dose - a certain amount of a drug:

1. Introduced into the body.

2. Caller positive influence on the course of the disease.

7. Depending on the strength of the pharmacological action of the dose, there are:

1. Toxic (dosis toxica).

2. Lethal (dosis letalis).

3. Therapeutic or curative (dosis curativa).

4. For children and adults.

8. Therapeutic or therapeutic doses are divided into 3 types:

1. Threshold (cause the initial action of the substance).

2. Maximum - the highest (cause the greatest or limiting action).

3. Medium (cause the pharmacological action of an average degree).

9. Changes in the composition of dosage forms should be made only with the consent of:

1. Pharmacist-technologist.

2. Doctor.

10. All changes in the composition of the medicinal product should be noted on:

1. Requirements.

2. Prescription.

3. Copies of the prescription.

4. Label.

5. Passport of written control.

11. When issuing medicines of the NA, PV, A and B lists in the written control passport and on the back of the prescription l and those who issued and received the substance put:

1. Signature.

2. Date.

3. Specify the name.

4. The mass or volume of the funds received in words.

12. 0.00001 is:

1. 1 milligram.

2. 1 decimilligram.

3. 1 centigram.

13. In case of exceeding the dosage of the medicinal product without appropriate registration, the employee of the pharmacy institution:

1. May dispense the drug to the patient.

2. Cannot release the drug.

3. Can dispense a drug in a dose equal to 1/2 of the highest single dose.

14. The number of drops in the entire dosage form is:

1. The amount of drops of each ingredient.

2. The sum of the volumes of medicines divided by the sum of the drops of each ingredient.

15. In the assistant's rooms, on all barbells with medicinal substances, the following must be indicated:

1. Date of completion.

2. Signature of the person who completed the barbell.

3. Signature of the authenticator of the medicinal substance.

4. Number of analysis according to the packing work log.

16. On the barbells with medicinal substances of lists A and B, the following must be indicated:

1. Higher single and daily doses.

2. Name of the manufacturer and date of manufacture.

17. Barrels with medicinal substances intended for the manufacture of sterile dosage forms must have a warning inscription:

1. Sterile.

2. Non-pyrogenic.

3. For sterile dosage forms.

18. Barbells with poisonous medicinal substances (List A) must bear the following inscriptions:

19. Barbells with potent substances (List B) must have the following inscriptions:

1. Black color on a white background.

2. Red color on a white background.

3. white color on a black background.

4. Be sure to indicate the highest single and daily doses.

LISTS

POTENTIAL AND POISONOUS SUBSTANCES

Approved at the meeting of the Committee on February 2, 2007,

protocol N 1/106-2007 with additions and changes

(according to the protocols:

dated January 27, 2005, protocol N 1/97-2005,

dated 03.04.2005 protocol N 2/98-2005,

dated 08.12.2005 protocol N 5/101-2005,

dated March 16, 2006, protocol N 1/102-2006,

dated 12.10.2006 protocol N 3/104-2006,

dated 02.02.2007 protocol N 1/106-2007,

dated February 26, 2007, protocol N 2/107-2007)

With the publication of these Lists, they lost their legal force

Lists of potent and poisonous substances

DECISION No. 8

PLENUM OF THE SUPREME COURT OF THE USSR

ON THE APPLICATION OF DECISIONS BY THE COURTS OF THE RUSSIAN FEDERATION

OF THE PLENUM OF THE SUPREME COURT OF THE UNION OF THE SSR

In connection with questions coming from the courts about the possibility of applying the clarifications contained in the decisions of the Plenum of the Supreme Court of the USSR, when considering criminal and civil cases, the Plenum of the Supreme Court of the Russian Federation decides:

Based on paragraph 2 of the resolution of the Supreme Council of the RSFSR of December 12, 1991 "On the ratification of the Agreement on the establishment of the Commonwealth of Independent States", until the adoption of the relevant legislative acts of the Russian Federation, the norms former Union The SSR and the clarifications on their application contained in the decisions of the Plenum of the Supreme Court of the USSR may be applied by the courts insofar as they do not contradict the Constitution of the RSFSR, the legislation of the Russian Federation and the Agreement on the Establishment of the Commonwealth of Independent States.

Chairman

Supreme Court

Russian Federation

V.M.LEBEDEV

Secretary of the Plenum

Member of the Supreme Court

Russian Federation

V.V.DEMIDOV

NOTES TO THE LISTS OF POTENT AND

TOXIC SUBSTANCES

1. These Lists of potent and toxic substances are compiled taking into account:

Features of the pharmacological action of the relevant substances and drugs;

Data from the practice of judicial and investigative authorities related to illegal actions with substances and drugs that are not classified as narcotic and psychotropic;

Relevant provisions and requirements of international conventions and protocols in force within the UN, primarily the 1971 Convention on Psychotropic Substances and the 1988 UN Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances.

2. Lists A and B, published by the Ministry of Health of the Russian Federation, include only registered and approved medicinal products for medical use. In case of exclusion from the State Register of Medicines of a particular drug, it is also excluded from the next reissue of these Lists.

3. Lists A and B, published by the Ministry of Health of the Russian Federation, have purely professional purposes and set themselves only the tasks of determining the procedure for storing, extracting, monitoring and using medicines included in these Lists.

4. The lists of potent and poisonous substances issued by the Standing Committee on Drug Control (SCDC) include not only drugs, but also other substances that are not allowed as medicines. Potent and toxic substances remain on the PKKN Lists, despite the next revision by the Ministry of Health of the Russian Federation of the nomenclature of the State Register of Medicines.

5. Lists of potent and poisonous substances cover a wide range of synthetic and natural substances, including those excluded from the State Register of Medicines, which remain relevant for the prevention and fight against the illegal distribution of potentially dangerous compounds that cause addiction symptoms. These Lists are important both for health workers and for law enforcement agencies, as they solve problems arising from the disposition of Art. 234 of the Criminal Code of the Russian Federation.

The PKKN Lists of Potent and Poisonous Substances do not in any way duplicate Lists A and B, as each of these Lists has its own specific goals and different objectives.

6. In all cases when the question arises of classifying a particular substance as potent or toxic due to the fact that for the current period of time it is not included in the Lists of potent and toxic substances, the issue is resolved by obtaining an expert opinion from the Presidium of the Standing Committee on drug control.

7. As relevant information is accumulated, arising from the provisions of clause 6 of these notes, for substances that are not classified as potent and poisonous by the current SCCP Lists, changes will be made to them in the prescribed manner.

8. If the Standing Committee on Narcotics Control decides to include additional substances in the Lists of Potent and Poisonous Substances, they are included in these Lists in chronological order, and not in alphabetical order, since very often in the expert opinions of the SCCB there are references to specific substances, under the control of the specified Lists with the designation of the specific temporary dispositions they occupy. Adding additions in alphabetical order inevitably changes the temporal disposition of that particular substance in the Schedules for which the expert opinion was given, and this may cause undesirable consequences and a number of perplexing questions. In addition, if additional substances were included in the Lists in alphabetical order, their order would have to be changed in all sections of the Lists, and technical errors could occur.

9. The SCREC Lists provide international generic names and major synonyms for substances. If some synonyms of the listed substances are not given, the control extends to these substances, no matter what brand (trade) names they are designated.

10. The Lists of potent and poisonous substances do not include narcotic drugs and those psychotropic substances of the 1971 Convention on Psychotropic Substances that are listed in the current Lists of Narcotic and Psychotropic Substances approved by the Decree of the Government of the Russian Federation "On Approval of the List of Narcotic Drugs, Psychotropic Substances and Their Precursors" subject to control in the Russian Federation" dated June 30, 1998 N 681.

11. Potent and toxic substances include not only substances listed in these Lists, but also dosed dosage forms provided that the composition of the drug does not include other pharmacologically active substances that determine the specific activity of the drug.

If the composition of the combined drug includes, in addition to the main controlled substance, also other pharmacologically active substances, and they are not listed in the Lists, then the issue is resolved by an expert in accordance with paragraph 6 of these notes. This provision also applies to dosage forms in the form of suppositories (suppositories) and prolonged forms (long, retard).

If the Lists for a controlled substance do not specify the prescription composition of the combined drug or its dosage form (suppositories, long, retard), then such substances are not subject to the control of these Lists.

After the adoption of the expert opinion of the PCKN that one or another specific composition of the combined drug or the corresponding dosage form (suppositories, retard, long) is recognized as potent, these drugs or dosage forms are included in the next edition of the Lists of potent and toxic substances and, from a legal standpoint, they are potent and poisonous from the moment the published Lists come into force. Also, the Lists of potent and toxic substances include all solutions of substances listed in these Lists, regardless of their concentration.

12. K potent substances also includes salts of the substances listed in this List in all cases where the existence of such salts is possible.

13. Changes have also been made to the Lists arising from federal law"On narcotic drugs and psychotropic substances" dated January 8, 1998 N 3-FZ and, accordingly, the Decree of the Government of the Russian Federation on the approval of the List of narcotic drugs, psychotropic substances and their precursors.

14. These notes to the Lists have the same legal force as the Lists themselves.

15. Official interpretations and clarifications on these Lists are within the competence of the Standing Committee on Narcotics Control and its Presidium only.

After the publication of these Lists, the previously published Lists lose their legal force.

Chairman of the Standing Committee

drug control,

Doctor of Medical Sciences,

professor, academician