INN codes for medicines. Medicines - Pavlova I.I.

Each medicine can have 3 names:

· Full chemical name – description of the structure of the molecule according to the international chemical nomenclature;

· Nonproprietary name, international nonproprietary name (INN, INN) – a name that is issued to a medicinal product by a special WHO committee or a national pharmacopoeial committee. This name is not anyone's intellectual property and can be used by any drug manufacturer. When choosing an INN, 3 principles should be taken into account:

· The name must have a distinct sound and spelling;

· The name should not be similar to existing drug names;

· The name must reflect the generic relationship of the medicines. For example, the suffix -olol for b-adrenergic receptor blockers, -pril for ACE inhibitors, -sartan for angiotensin AT1 receptor antagonists, prefixcefa- for cephalosporin antibiotics.

· Patented (brand) names are a trademark that is assigned to a specific drug by the manufacturer. Without the permission of the rights owner, no company can produce a medicine under this brand. The patented name is an a priori guarantee of a certain level of quality of the drug. Proprietary names are not subject to the same requirements as INNs. Typically, a proprietary name includes part of the name of the manufacturer. For example, mebendazole from Pharmacar is called Vermacar®.

In principle, it is believed that if a doctor prescribes a medicine under its brand name, he wants that particular medicine to be given to the patient. If the pharmacist for any reason cannot do this and dispenses a medicine produced by another manufacturer, he is not only obliged to inform the patient about this, but also explain to him that he must contact the doctor and clarify how the replacement will affect the treatment plan.
If a doctor prescribes a medicine under his INN, then he leaves the right to choose the manufacturer of the medicine to the pharmacist and leaves at his discretion the possibility of the so-called. generic substitution (i.e. dispensing a drug under any of its trade names).
Depending on the manufacturer, branded and generic medicines are distinguished:

· Brands (original medicines) – medicines that are produced by the developer company, i.e. pharmaceutical concern that discovered this medicine and carried out all stages of its study. All branded drugs, after their discovery, are under patent protection (the patent period in most countries is 15 years). The production of new drugs is a very expensive process; according to 1994 data in the United States, the cost of developing a new drug ranged from 200 to 300 million dollars. According to a report published by the largest French corporation Servier in 2002, in 30 years it managed to register only 30 new drugs (the corporation's research department employs 2,400 people).

· Generics (generic drugs) - produced by a pharmaceutical concern under a license from the owner company or after the patent for the drug has expired. Generics do not require a full research program; to register them, the company sometimes only needs to provide data on the absorption of the drug in comparison with the brand-name drug. Thus, generic drugs are always cheaper than their branded counterparts, because the company does not spend money on 10-15 years of drug research, but uses ready-made data. Currently, a large pharmaceutical company is capable of launching an average of 30 new generic drugs per year.

To summarize the above, it should be noted that any medicine can be presented on the market in 3 versions:

· A branded drug with a trade name. For 15 years after the discovery of the drug, it was the only one on the market.

· Generic drug under a trade (brand) name;

· Generic drug under INN.

A study carried out in Great Britain in the 90s of the 20th century showed that about 41% of prescriptions prescribed by doctors contained INN drugs.

The costs of creating drugs are so high that the well-known Bayer concern, which created aspirin (acetylsalicylic acid), still cannot cover the primary costs (taking into account inflation) associated with the development of this drug.

Rules for dispensing medications from pharmacies

Medicines can be dispensed from pharmacies either with a prescription or without a prescription. The list of medicines approved for sale without a prescription has been approved by the USSR Ministry of Health. All other medicines are dispensed from pharmacies only according to prescribed prescription forms.

Recipe (from the Latin word “gearege” - to take or gesertum - taken)- a written instruction from a medical professional to a pharmacy regarding the preparation and dispensing of a medicine, indicating the method of its use.
Doctors working in medical institutions and research institutes and treating outpatients, as well as hospital doctors, as an exception, have the right to write prescriptions only when a patient is discharged if it is necessary to continue the course of treatment that has been started.
The right to write a prescription is also granted to authorized medical workers (paramedics, obstetricians), who are allowed to independently issue a prescription in accordance with the established procedure.
General rules for writing prescriptions and dispensing drugs according to them are approved by the USSR Ministry of Health. It is not allowed to write prescriptions for patients undergoing inpatient treatment, as well as for drugs not included in the USSR medicinal register.
The prescription must be written out indicating the position and title of the person giving the prescription, with his signature and personal seal, as well as taking into account the age of the patient, the procedure for paying for the medicines and the effect of the incoming ingredients.
Prescriptions are written clearly and legibly in ink or ballpoint pen on approved and printed forms. Corrections to recipes are not allowed.

A prescription is a written request from a doctor or other authorized person (dental technician, paramedic, midwife) to a pharmacist about the preparation and dispensing of a medicinal product to a patient, indicating how this medicinal product should be used.

· A prescription is a legal document and is carried out in accordance with the rules established by Order of the Ministry of Health of the Russian Federation No. 328 of August 23, 1999 “On the rational prescription of drugs, the rules for writing prescriptions for them and the procedure for their dispensing by pharmacies.”

Prescriptions must be written on forms measuring 105*148 mm, printed using forms approved by the Ministry of Health of the Russian Federation, indicating the full name, age of the patient, the procedure for paying for the medicine, as well as the ingredients included in the medicine. When specifying the payment procedure, what is necessary is underlined, what is unnecessary is crossed out. The order of the Ministry of Health of the Russian Federation approves 3 forms of prescription forms: No. 148-1/u-88, No. 107-u and a special prescription form for NLS.

Prescription forms of form No. 148-1/u-88 are intended for prescribing and dispensing drugs:

· included in the list of substances of list III (list III is the “List of NS, substances and their precursors subject to control in the Russian Federation”);

· potent and toxic substances (these substances are approved by the Standing Committee on Drug Control), drugs: apomorphine hydrochloride, atropine sulfate, homatropine hydrobromide, dicaine, silver nitrate, pachycarpine hydroiodide, anabolic steroids, as well as those sold free of charge and with a 50% discount.

All other drugs, including lists A and B, as well as those containing ethyl alcohol, are prescribed on form No. 107-u.

Medicines are divided into official And main:

* Official(from Latin officina - pharmacy) are medicines produced by industry, having a standard composition given in pharmacopoeial monographs. They are approved for use by the Ministry of Health. For example, cephalexin tablets, Lorinden ointment. Such funds can be issued under trade or international non-proprietary names.

* Mainline (extemporaneous) (from lat. magister – teacher, ex tempore – as needed) refer to medications formulated at the discretion of the physician. They are prepared in a pharmacy according to a prescription for a specific consumer.

Accordingly, they distinguish official and main prescriptions of medicines:

· Official copybooks– prescriptions of finished medicinal products approved by the Ministry of Health of the Republic of Belarus, recommended for medical use.

· Main (extemporaneous) prescriptions are compiled at the discretion of the doctor.

Exist abbreviated, expanded and semi-abbreviated forms of recipes.

1. B abbreviated form at the beginning of the copybook indicate dosage form, then the name of the drug, its concentration and dose. As a rule, official drugs are prescribed in an abbreviated form. Commercial names of drugs with complex compositions are usually prescribed in the same form.

Titles official medicines in the abbreviated copybook, after the names of the dosage forms, they are placed in the singular genitive case. For example:

Recipe: Solutiōnis Gentamycini sulfātis 4% – 2 ml

Da tales doses numĕro 10 in ampūllis

Signa: 2 ml intramuscularly

Commercial names of drugs with complex composition in the abbreviated copybook, after the names of the dosage forms, they are written in quotation marks and placed in the nominative singular case. For example:

Recipe: Tabulettas "Quamatel" number 28

Yes. Signa: 1 tablet 2 times a day

2. B expanded form at the beginning of the prescription, the names of the ingredients included in the medicinal product are listed, then the dosage form is indicated. For example:

Recipe: Extracti Belladonnae 0.015

Olei Cacao quantum satis, ut fiat suppositorium rectale

Yes. Signa: 1 suppository per night into the rectum

3. Semi-short form used to prescribe medications that can be presented as a mixture of several dosage forms. This example is a mixture of solution and powders:

Recipe: Solutionis Procaini 1%-100 ml

Ephedrini hydrochloride 3.0

Diphenhydramini 1.0

Acĭdi ascorbinĭci 2.0

Misce. Yes. Signa: 10 ml per inhalation 1 time per day

This form is more compact and convenient than the unfolded one. It is used most often when prescribing medicines. Components can be registered under both international and trade names.

Doses of drugs in R. are indicated in the decimal measurement system. The unit of mass is 1 g. When dosing drugs, smaller values are also used, for example 0.01 g - one centigram; 0.001 g - one milligram. Hard (tablets, powders, dragees) and soft (ointments, pastes and suppositories) dosage forms are dosed in grams. The amount of liquid substances (solutions, infusions, decoctions, tinctures, etc.) is indicated in milliliters, grams or drops. To prescribe a medicine in drops, guttas (drops) are written after its name and their quantity is indicated in Roman numerals. Usually the word guttas is abbreviated, for example, to indicate 5 drops, it is enough to write gtts V. When prescribing medications dosed in units of action (AU), the number of units is indicated in the prescription instead of weight or volume (for example, 40 units).

Sometimes the amount of constitiens is not given in R. (for example, in suppositories), giving the pharmacist the right to take the required amount himself; in this case they write quantum satis (as much as required). However, this applies only to indifferent substances.

The number of medicinal substances included in the prescription is indicated on the right side of the prescription form next to the name of the medicinal product (or one line below). In cases where the maximum dose of toxic or potent substances is deliberately exceeded, it is necessary to specify their quantity in words, put an exclamation mark and a signature to confirm that this dose was not prescribed by chance. If the correctness of the prescribed dose is not confirmed, the pharmacist reduces the dose of the substance to 50% of the highest single dose specified in the pharmacopoeia.

Each drug can have 3 names:

full chemical name – description of the structure of the molecule according to the international chemical nomenclature;

nonproprietary name, international nonproprietary name (INN, INN) - the name that is issued to the drug by a special WHO committee or national pharmaceutical committee. This name is not anyone's intellectual property and can be used by any drug manufacturer. When choosing an MMM, 3 principles should be taken into account:

The name must have a distinct sound and spelling;

The name should not be similar to existing drug names;

The name should reflect the generic connection of the drug. For example, the suffix -olol for beta-adrenergic receptor blockers, -pril for ACE inhibitors, -sartan for angiotensin AT 1 receptor antagonists, and the prefix cefa for cephalosporin antibiotics.

If a doctor prescribes a medicine under his INN, then he leaves the right to choose the manufacturer of the medicine to the pharmacist and leaves at his discretion the possibility of generic replacement (i.e. dispensing the medicine under any of its trade names).

4. Clinical and pharmacological characteristics of antiallergic drugs.

Allergy is a pathological process that is a consequence of hypersensitization (increased sensitivity) of the body to various substances and manifestations of a hyperimmune reaction. There are 2 types of hypersensitivity reactions: immediate and delayed. Allergic reactions of the immediate type are associated with humoral immunity, appearing after a few minutes or hours: urticaria, bronchospasm, rhinitis, conjunctivitis, Quincke's edema, anaphylactic shock, etc. Allergic reactions of the delayed type are formed over 1-2 days or more, they are associated with cellular immunity, (presence of T-lymphocytes). These are tuberculin reaction, contact dermatitis, transplant rejection reaction, bacterial allergy, autoimmune diseases, etc. In this case, immunosuppressants, corticosteroids, NSAIDs are used to reduce tissue damage. For the treatment of immediate allergic reactions, use:

Glucocorticoids

H1-histamine receptor blockers

Mast cell membrane stabilizers

Functional antagonists of allergy mediators.

Glucocorticoid hormones inhibit the development of all stages of allergies. They suppress the formation of immune cells and reduce the production of antibodies, prevent the destruction of mast cells, have an effect opposite to allergy mediators, and inhibit exudation and tissue swelling.

Histamine receptor blockers

Histamine is the main pathophysiological agent, the action of which is associated with an acute allergic reaction that develops as a result of the release of mediators from mast cells and basophils. Histamine itself is used only for diagnostic purposes when studying the state of the secretory function of the stomach. Histamine antagonists, which block the H1 and H2 histamine receptors, are often used.

(H2 histamine receptor blockers - cimetidine, ranitidine, famotidine, etc.).

H1 histamine receptor blockers have the following effects: antihistamine, sedative-hypnotic, anticholinergic, antiemetic, local anesthetic, etc. The drugs prevent and relieve bronchospasm, stabilize the permeability of the vascular wall, relieve itching, and eliminate spasms of the intestines and uterus caused by histamine. These medications are used for urticaria, allergic rhinitis, hay fever, skin itching, allergic rash, neurodermatitis, dermatitis, eczema, bronchial asthma, and 1st generation drugs for difficulty falling asleep, for premedication before anesthesia, for pain. Undesirable side effects of H1 histamine receptor blockers are associated with their M-cholinolytic properties (dry mouth, constipation and difficulty urinating, tachycardia, increased intraocular pressure) or hypnotic effects: drowsiness, deterioration of attention, performance, contraindicated for drivers, operators, etc. ) All drugs in this group are contraindicated during pregnancy; they are prescribed with caution for glaucoma, peptic ulcers, kidney and liver diseases.

1st generation drugs are lipophilic, penetrate the BBB, in addition to histamine receptors, they can block M-cholinergic receptors, alpha-adrenergic receptors, serotonin receptors and exhibit the following effects: sedative-hypnotic, anticholinergic, antiemetic and anti-motion sickness. With long-term use for 2-3 weeks, antihistamine activity decreases (tachyphylaxis).

Diphenylhydramine (diphenhydramine) – duration of action is 3-5 hours, strong sedative effect.

Promethazine (diprazine, pipolphen) - duration of action is 6-8 hours, strong sedative effect, enhances the effect of narcotic, analgesic, local anesthetic agents.

Chloropyramine (suprastin, allergozic) - similar to diprazine, duration of action is 4-6 hours.

Clemastine (tavegil) – duration of action is 6-12 hours, moderate sedative effect, more active than diphenhydramine.

Dimetindine (fenistil) – has a sedative, anticholinergic effect, duration of action is 12 hours, unwanted side effects are rare.

Quifenadine (fenkarol) is highly active, has almost no sedative, anticholinergic effect, and is not irritating.

Mebhydrolin (diazolin) - without sedative effect, moderately active, duration of action up to 24 hours.

Antihistamines 2nd generation.

Terfenadine, loratadine (Claritin, Erolin), astemizole (Gistalong), cetirizine (Zyrtec, Parlazin, Allercaps, Zodak), ebastine (Kestin) are effective, long-acting drugs. Apply once a day, sometimes arrhythmias are possible.

Antihistamines 3rd generation.

Fexofenadine (Telfast, Fexomax), desloratodine (Erius) are long-acting, highly effective drugs without significant side effects. Contraindicated for children under 12 years of age.

Mast cell membrane stabilizers.

They block the entry of calcium ions into mast cells and stabilize the membrane of mast cells and their granules, as a result of which the process of degranulation and the release of allergy mediators are inhibited.

Sodium cromoglycate (intal) – reduces and alleviates attacks of bronchial asthma. They are used prophylactically for the treatment of br. Asthma (but not for relieving attacks) by inhalation using the Spinhaler inhaler. Effect after several weeks of regular use. Used to treat allergic rhinitis (nasal spray), conjunctivitis (eye drops).

Ketotifen (zaditen, ketasma) - used to prevent asthma attacks, allergic rhinitis, etc. Lasting effect - after 10-12 weeks of daily use, well tolerated, sometimes drowsiness due to central nervous system depression.

Nedocromil sodium (Tylet) – effect for the prevention of inflammatory reactions of allergic origin. Effect – by the end of 1 week of use.

Functional antagonists of allergy mediators– activate a physiological reaction opposite to that caused by this mediator. For gastrointestinal spasms - M-anticholinergics (atropine, etc.) and myotropic antispasmodics (no-spa, etc.), for bronchial asthma - beta-adrenergic agonists (salbutamol, etc.), antispasmodics (aminophylline, etc.), for allergic rhinitis in the form of drops, ointments. Alpha adrenergic agonists (galazolin, etc.). They have only a temporary symptomatic effect.

Rosa Ismailovna Yagudina, Doctor of Pharmaceutical Sciences, Professor, Head. Department of Organization of Drug Supply and Pharmacoeconomics, Head. laboratory of pharmacoeconomic research of the First Moscow State Medical University named after. THEM. Sechenova (Moscow), editor-in-chief of the journal “Pharmacoeconomics. Modern pharmacoeconomics and pharmacoepidemiology.”

Information about medications: facets of one phenomenon

Medicines are a whole world, and each medicine has several information fields associated with it. First of all, this is information about the pharmacological properties of the drug. This is what is most interesting to consumers. This information includes data on pharmacological properties, pharmacodynamics, pharmacokinetics.

In addition, each drug is associated with information about its storage conditions, its physicochemical properties, and stability. Another aspect is the vacation policy. Drugs may belong to controlled groups that are available only by prescription. There is also information related to the legislative regulation of the circulation of medicines. In addition, there is information related to economic aspects, the price of the drug, and the pharmacoeconomic characteristics of the drug. There is information related to the history of the development and use of drugs.

Of course, for pharmacy workers involved in the dispensing of drugs to the population, the pharmacological properties of the drug are of utmost importance - the mechanism of action, contraindications, drug safety, interaction with drugs, with food, dosage regimen, chronopharmacology, and so on.

Secrets of the name

The life of a drug begins with its name. Medicines, like humans, have several names.

Chemical name

This name is assigned in accordance with the requirements of the International Union of Pure and Applied Chemistry (IUPAC). It is important for chemists, for example, for those who control the quality of drugs. This information is also needed by drug developers; it allows them to reproduce the structure of the active substance.

International Nonproprietary Name (INN)

This is one of the most important titles for specialists in the field of medicine and pharmacy. It is assigned to the active substance in a medicinal product, has worldwide recognition and is public property. The INN reflects the essence of the drug’s action and is assigned by a special commission of the World Health Organization in accordance with a special procedure. In 1953, the first list of INNs for pharmaceutical products was published. Now WHO regularly publishes the journal “WHO Drug Information” and the reference book “International Nonproprietary Names for Pharmaceutical Substance. Cumulative List" with a list of INNs.

A number of countries also have national generic names, for example, in countries with innovative pharmaceutical industries - Japan, the USA, and the UK. Russia does not have a system of national names.

The INN is necessary so that we can unambiguously understand which drug we are dealing with in all the variety of drugs that appear after the expiration of the patent for the original drug. The fact is that, in addition to the international nonproprietary name, many drugs also have trade names. For example, there are 52 trade names for the INN diclofenac, 38 trade names for the INN ciprofloxacin, 33 trade names for the INN paracetamol, and so on. In addition, different medicinal products (MDs) are created based on the same pharmaceutical substances. For example:

nitroglycerin - 25 LP;

penicillin - 55 LP;

paracetamol - 125 LP;

diclofenac - 205 LP.

Total: 410 drugs were created based on four pharmaceutical substances.

Currently, the total number of INNs reaches approximately 8,000 and continues to increase annually by 100-120 new names.

INNs belonging to substances of the same pharmacological group must have “common stems”, based on which doctors and pharmacists can determine their belonging to a specific group of drugs that have similar pharmacological properties. Most often, ancient Greek and Latin roots are used in the names of medicines, but recently there has been a tendency to also use roots from European languages.

Tradename

This is the name under which the drug is registered and sold on the pharmaceutical market. Trade names can be brand names (proprietary names, trademarks), or they can simply be a generic name - in this case, the drug is called by its INN. Brand names are registered as trademarks and are protected by legislation in the field of intellectual property protection.

Sometimes a brand, due to its wide popularity, can cost even more than the drug itself. For example, everyone knows the drug “No-shpa”, but not everyone knows drotaverine. Brand promotion is the main goal of a company's advertising activity. However, now the situation will change, since from July 1, 2013, an order of the Russian Ministry of Health will come into force, which establishes the need to issue prescriptions using international nonproprietary names (Order of the Russian Ministry of Health dated December 20, 2012 No. 1175n “On approval of the procedure for prescribing and prescribing medications, as well as prescription forms for medications, the procedure for completing these forms, their recording and storage”).

Example

Deadly mistake in title

The name of the drug can be considered an element that ensures the safety of its use. In the United States, a study was conducted on the causes of errors in the use of medications that led to the death of a patient. In 10% of cases, the cause of the error was a confusion of drug names! (Source: Analysis of 469 reports of fatal errors in the United States over 6 years. Phillips J. et all. JAMA, 1998, 279, 1200-5.) If another drug with a similar name is used instead of one drug, it can be fatal. That is why special attention is paid to the choice of drug names.

In Russia, the examination is carried out in accordance with the requirements of the Federal Law “On the Circulation of Medicines”. It is impossible to come up with any name for a drug that you want and release it on the market. There are special rules for compiling names that promote the safety of their use.

There is another problem that is often not taken seriously, but it can lead to serious errors - the illegibility of the doctor's handwriting on the prescription. During the Soviet Union, they even specifically fought this problem: they collected illegible prescriptions in pharmacies, and then held meetings in clinics about this. Now, of course, such methods are no longer relevant. This problem will probably be solved by issuing a prescription using a computer.

What will the issuing of prescriptions using INN change?

From July 1, 2013, only INN will be indicated in all recipes. What does this mean for pharmacy professionals? Of course, there will be even greater responsibility than before, since mass issuance of prescriptions using INN will begin and patients will have to be consulted much more often when choosing drugs within the framework of one INN. But you should not be afraid of this responsibility, since even today, in accordance with current legislation, a pharmacy worker can carry out synonymous substitutions within the framework of one INN. Computer databases and reference books help him navigate the large assortment. However, the pharmacy employee must also keep in mind information about the peculiarities of dosing, drug interactions, and the characteristics of different dosage forms.

A list of interchangeable drugs will soon be developed at the legislative level, which should make the work of a pharmacy specialist easier. The need for this list is due to the fact that not all drugs released under the same INN can be considered completely interchangeable. For example, biosimilars are not always interchangeable (more information about these drugs can be read in KS No. 3, 2013 “Biosimilars: a new group of drugs and the problem of identity,” editor’s note). The pharmacy specialist must be very careful during the consultation. He must examine the prescription, clarify whether there is an allergy to the drug, what concomitant diseases there are, and so on - there are entire consultation algorithms for this. Also, the pharmacy specialist must carefully consider the choice of dosage form, since not all dosage forms are interchangeable. In the absence of a drug with the required dose of the active substance, it is not always possible to replace it with a synonym, since, for example, film-coated tablets often cannot be divided into parts, otherwise the active substance will be inactivated or its prolonged action will not be ensured. The tasks facing a pharmacy specialist are very complex, so the requirements for the pharmacological training of pharmacy workers will constantly increase.

Instructions for use

An important issue with drug information is how it is distributed and where it can be found. The most widespread source of information about medicines is the instructions for medical use, which is an integral part of the drug dossier.

It is very important that the instructions contain the most complete information about the drug. For example, in the 90s, instructions for the use of medicinal products released within the framework of one INN could differ so greatly in the amount of information they provided about contraindications and side effects that an uninitiated consumer might think that a synonym with fewer side effects more secure. In fact, it's the other way around. The more detailed the manufacturer's instructions for use are, the higher the degree of evidence of the effectiveness and safety of this drug. Why else do serious reputable companies pay so much attention to information about the drug? Because if the company does not indicate any side effect or contraindication in the instructions for use and this becomes apparent during use, the patient may sue. There are examples of similar claims against companies abroad. For example, in 2010, one of the largest multinational pharmaceutical companies paid 400 thousand US dollars to the family of a person who died from the use of one of the drugs. As it turned out, the drug was not fully tested.

Until 2000 in Russia, very different information could be found in the instructions for use of drugs within the same INN. That is why in 2001, the requirement was legislated that, with regard to contraindications and side effects, instructions for the use of drugs within the framework of one INN should be comparable with a standard clinical and pharmacological article (OST “State Information Standard for Medicines. Basic Provisions”, OST 91500.05.0002-2001). This is an official document containing information about the basic properties of the drug that determine its effectiveness and safety.

Today in practice one can find examples of differences in the instructions for use of drugs released under the same INN. For example, the instructions for use of “Analgin” (INN metamizole sodium) list “aspirin asthma”, blood diseases, and diseases accompanied by bronchospasm as contraindications. But the instructions for use of the drug with the trade name “Metamizole sodium” do not indicate these contraindications. The lists of side effects also differ slightly. The instructions for use of Analgin indicate side effects not described for Metamizole sodium: decreased blood pressure, impaired renal function and other side effects. And the instructions for Metamizole Sodium describe side effects not mentioned for Analgin - granulocytopenia, hemorrhages.

What should the instructions for use contain?

The draft instructions for use of the medicinal product must contain the information provided for in paragraph 16, paragraph 3, article 18 of the Federal Law “On the Circulation of Medicines” No. 61 of 04/12/2010:

a) name of the medicinal product (international nonproprietary or chemical and trade names);

b) dosage form indicating the names and quantitative content (activity) of pharmaceutical substances and excipients;

c) pharmacotherapeutic group of the drug;

d) indications for use;

e) contraindications for use;

f) dosage regimen, route of administration, if necessary, time of taking the drug, duration of treatment (including in children before and after one year);

g) precautions for use;

h) symptoms of overdose, measures to provide assistance in case of overdose;

i) an indication, if necessary, of the characteristics of the action of the drug upon first administration or upon its withdrawal;

j) a description, if necessary, of the actions of the doctor (paramedic) or patient when one or more doses of the drug are missed;

k) possible side effects when using the drug;

l) interaction with other drugs and (or) food products;

m) indication of the possibility and features of medical use of the drug by pregnant women, women during breastfeeding, children, adults with chronic diseases;

o) information about the possible effect of a medicinal product for medical use on the ability to drive vehicles and machinery;

o) expiration date and an indication of the prohibition of using the medicinal product after the expiration date;

p) storage conditions;

c) an indication of the need to store the medicinal product in places inaccessible to children;

r) indication, if necessary, of special precautions when destroying unused medicinal products;

t) name, address of the manufacturer of the medicinal product and address of the place of production of the medicinal product;

x) vacation conditions.

Other sources of information

There are a huge number of sources of information about medicines, for example, reference books, some of which are official and unofficial. The latter have primarily advertising purposes. Which sources of information are primarily important for a pharmacy specialist?

State register of medicines is the main official document that contains information about medicines and is published in Russia annually. This register determines the range of drugs, which is the most important characteristic of the national pharmaceutical market and healthcare of any country.

Unofficial directories. For example, VIDAL, RLS, “Great Russian Encyclopedia of Medicines”, “Synonyms of Medicines”, “Pharmacological Directory”, “Directory of Medicines” and others. It is important to pay attention to the fact that the quality of information placed in drug reference books is not regulated in any way by law. In this regard, information about the same drugs in different reference books may be presented differently. And you cannot rely only on unofficial reference books. They may be of high quality, but they have their own specific task - to provide basic, rather than exhaustive, information. When comparing articles in different reference books about drugs released within the same INN under different trade names, it turns out that the list of contraindications, indications, and side effects may differ.

Remembering everything is the task of a pharmacy specialist

Sometimes both specialists and people far from medicine and pharmacy underestimate the danger of drugs and pay much more attention to their safety in other areas of life. Meanwhile, according to statistics, the probability of an accident due to a plane crash is only 1 in 3 million. But the risk of an accident as a result of treatment is 1 in 300. In the United States, more than 100 thousand people die per year from adverse reactions to medications, which is twice as many as from transport injuries (46 thousand people per year). The doctor is primarily responsible for the correctness of drug therapy, but the pharmacy specialist who dispenses the drugs also bears no less responsibility.

What information should a pharmacy specialist first pay attention to when dispensing a drug? There is a whole list of information - this includes pharmacokinetics, pharmacodynamics, dosage regimen, and drug interactions. The pharmacist must not only dispense the drug, he must carry out a whole range of procedures related to the examination of the prescription and informing the patient. This is the essence of our profession. The patient is often unable to correctly understand the contents of the instructions for use. And if the pharmacy specialist does not explain all the important points to him, then the patient may end up using or storing the medicine incorrectly.

In order to constantly develop as a professional, a pharmacy employee must constantly study - read instructions, study the drug database. You cannot take advanced training courses every five years. You need to develop constantly. That is why the practice of a credit system is being introduced all over the world, when a person gains “credits” over the course of five years by participating in conferences and various events. These credits count in lieu of a portion of the time he would otherwise have to spend in formal courses every five years. Of course, the manager plays a big role in organizing the training of pharmacy staff. He must understand that qualified personnel are the most important competitive advantage of a pharmacy!

The names of medicines are presented in three versions: chemical, international nonproprietary and commercial.

Chemical name- reflecting the composition and structure of the medicinal substance. Chemical names are rarely used in practical healthcare, but are often given in annotations for medications and contained in special reference publications, for example: 1,3-dimethylxanthine, 5-ethyl-5-phenylbarbituric acid, etc.

International nonproprietary name (INN, International Nonpro-prietary Name, INN) - This is the name of the drug substance recommended by the World Health Organization (WHO), adopted for use throughout the world in educational and scientific literature for the purpose of convenient identification of the drug by belonging to a specific pharmacological group and in order to avoid bias and errors. A synonym for INN is the term generic or generic name. Sometimes the INN reflects the chemical structure of the drug, for example: acetylsalicylic acid, acetaminophen.

Trade name of the drug- name of the medicinal product assigned by its developer;

Patented commercial name (Brand name) - o but is assigned by pharmaceutical companies producing this particular original drug and is their commercial property (trademark), protected by a patent. For example, the trade name of acetylsalicylic acid is aspirin, furosemide is Lasix, and diclofenac is Voltaren. Trade names are used by manufacturing companies for marketing purposes, to promote and compete drugs on the market.

The concept of bioequivalence of drugs

An important concept is bioavailability, which is understood as “the speed and extent with which the active substance or its active component is absorbed (absorbed) from the dosage form and becomes available at the site of action (systemic circulation).” Considering that when administered intravenously, the drug almost completely enters the systemic circulation, we can assume that its bioavailability absolute.

The drug whose bioavailability is being studied is test takers. As a rule, the drug being tested is a generic. It is compared to bioavailability reference drug (original or innovative).

Bioavailability is a key concept for understanding bioequivalence. If, after administration of the same molar concentration of the reference and test drug, their bioavailability is similar to the extent that guarantees the same therapeutic effect and toxic effect, then such drugs can be considered bioequivalent.

Also distinguished pharmaceutical equivalence, by which we mean that the tested drug contains an equal amount of active substance (substances) with the reference one, the same dosage form and meets comparable standards (production and quality). It is clear from the definition that if a company produces a dosage form with other excipients that significantly change bioavailability, then such a drug will be pharmaceutically equivalent to the original one, but not bioequivalent. A similar situation can occur if the manufacturer uses components that slow down absorption to create prolonged forms. Therefore, despite the same dosage form, they will have completely different pharmacokinetic curves in the blood serum.

A generic drug must exhibit a therapeutic effect equivalent to the original one. If, in clinical trials, drugs exhibit a comparable therapeutic effect, then such drugs are considered therapeutically equivalent. It is generally accepted that the therapeutic effect depends on the concentration of the active substance in the blood plasma. Based on this principle, drugs that have the same pharmacokinetic curve will exhibit comparable therapeutic effects.

A bioequivalence study is a clinical study and must comply with GCP requirements. This is one of the guarantees of the quality and evidence of the research.

During the study, individual pharmacokinetic parameters of the substance are determined for each subject (area under the curve, C max - maximum concentration, time to reach maximum concentration, etc.). The methodology and principles for calculating these parameters are widely covered in the scientific literature.

Good Clinical Practice (GCP)- a standard of clinical research, covering the planning, conduct, completion, verification, analysis of results, reporting and documentation, which ensures the scientific significance of the research, its ethical acceptability and full documentation of the clinical characteristics of the drug being studied. As has been repeatedly noted in domestic and foreign literature, as well as in WHO documents, the consumer properties of drugs - effectiveness, safety and pharmaceutical aspects of quality - are ensured through compliance with the most important industry rules, in other words, GLP, GCP and GMP standards or codes during their development , testing and production.

GLP (GoodLaboratoryPractice, Good Laboratory Practice)- a system of norms, rules and guidelines aimed at ensuring consistency and reliability of laboratory research results. The system has been an approved national standard of the Russian Federation since March 1, 2010 - GOST R-53434-2009. The main goal of GLP is to ensure that the entire progress of a study can be fully traced and reconstructed. Quality control is called upon to be carried out by special bodies that periodically inspect laboratories for compliance with GLP standards. GLP sets very strict requirements for the maintenance and storage of records - significantly more stringent than the European standards of the EN 45000 series. The scope of application of GLP standards is established by law. This primarily applies to the development of new chemicals, the production and use of toxic substances, and healthcare.

GMP(“Good Manufacturing Practice”, Good Manufacturing Practice)- a system of norms, rules and guidelines regarding the production of: medicines, medical devices, diagnostic products, food products, food additives, active ingredients

In contrast to the quality control procedure of examining samples of such products, which ensures the suitability of only the samples themselves (and possibly the batches manufactured closest to the given batch), the GMP standard takes a holistic approach and regulates and evaluates the production parameters themselves. and laboratory testing.

To standardize the quality of medical care for the population, it is used together with the standards: GLP (Good Laboratory Practice), GCP (Good Clinical Practice, GDP (Good Distribution Practice).

Pharmacovigilance- a type of continuous monitoring of adverse events and others related to the safety aspects of medicines that are already on the market. In practice, pharmacovigilance relies solely on spontaneous reporting systems that allow healthcare professionals and others to report adverse drug reactions to a central unit. Said central unit then combines reports from multiple sources to create a drug safety information profile based on one or more reports from one or more healthcare professionals.

Toxicity – the property of a substance, when it enters the human body in certain quantities in animals or plants, to cause their poisoning or death.

Embryotoxicity – the ability of a medicinal substance to have a toxic effect on developing embryos; embryotoxicity can manifest itself in three main forms: embryo-lethal effect, teratogenic effect, general developmental delay.

Embryoletal effect– increase in the overall level of embryonic mortality, both preimplantation and postimplantation.

Teratogenic effect– anatomical, histological, cytological, biochemical, neurophysiological and other abnormalities that appear before or after birth.

Generaldelaydevelopment– changes in body weight, craniocaudal size, delayed ossification of skeletal bones.

Carcinogenicity b – the effect of a substance that can cause the development of tumors.

Mutagenicity - the action of a substance that can cause changes in the genetic apparatus of a cell and leading to changes in hereditary properties.

The life of any medicine begins with a name, of which there may be several - chemical, trade, national non-proprietary, generic or international non-proprietary name of the drug (abbreviated INN). The latter is considered particularly important for all medical and pharmaceutical workers. This name is assigned to the active substance of the drug, has worldwide recognition and is considered public property.

Some historical facts about INN

The system of international nonproprietary names was initiated by a resolution of the World Health Assembly in 1950. The first list of INNs was published three years later.

From this period the system started working. Currently, this organization constantly publishes a directory of international nonproprietary names of medicines and a journal containing a list of INNs. The essence of the system is to help healthcare professionals, using an exclusive and at the same time common name throughout the world, identify each pharmaceutical substance. An international range of such substances in INN form is necessary for:

international information exchange between medical and pharmaceutical workers, as well as scientists;
safe prescribing and dispensing to patients;
identification of drugs.

Objectives of the INN system

The international nonproprietary name of a medicine is unique and should not be similar to other names so that it cannot be confused with other widely used names. In order for these names to be used throughout the world, they are non-proprietary, meaning they can be used without restrictions to identify pharmaceutical substances. One of the features of the INN system is that due to the use of common elements of words in the names of substances with similar pharmacological properties, their relationship can be traced.

As a result, any specialist in the field of pharmacy or medicine understands that substances belong to a certain group that have similar activity.

Using INN

INNs belonging to the same pharmacological group have similar properties. names of medicines are used:

when labeling;
in advertising publications;
in scientific literature;
in regulatory documents;
in information about the medicine;
in pharmacopoeias.

Their use is provided for by international or national legislation. To avoid confusion and to ensure that there is no threat to the health of individuals, it is prohibited to borrow trade names from the INN. There are countries that have a specific font size that allow a generic name to be printed under an advertisement or brand marking.

Why is INN assigned?

International nonproprietary names of medicines are assigned in accordance with a certain procedure by a specially created commission by the World Health Organization (WHO). A generic name helps specialists understand the variety of medications that appear on the pharmaceutical market after the patent for the original drug expires. Many drugs with the same INN have different trade names. For example, a medicine called “Ciprofloxacin” - this INN has about thirty-eight trade names, “Diclofenac” - fifty-two, and the well-known “Paracetamol” - thirty-three. Many drugs are produced based on one substance, for example:

55 drugs are created from penicillin;
from nitroglycerin - 25;
from diclofenac - 205.

Every year the total number of INNs increases by more than one hundred items. Currently there are more than eight and a half thousand of them.

How is the list of international nonproprietary names of medicinal products selected and published?

INN is assigned only to those substances that can be characterized by a chemical formula or nomenclature. In accordance with the policy followed by WHO, names are not selected for herbal and homeopathic preparations, as well as mixtures. In addition, names are not selected for substances that have been used for a long period of time for medical purposes under specific names and for some common chemical names, for example, acetic acid. The selection process itself is quite lengthy, lasting more than two years. After notifying the submitter, WHO publishes all names in a special journal. During the year, starting in 1997, the following lists of titles are issued:

proposed;
recommended.

Moreover, they are compiled in Spanish, English, French, and also contain the Latin name of each INN. In addition, a complete list of international nonproprietary drug names is printed. It is subject to regular updating. It lists names in six different languages, including Latin.

Application of INN

The growth in the number of non-proprietary names is also expanding the scope of their application. Thanks to the global recognition and active use of the INN system in practical medicine, most pharmaceutical substances are designated using an international nonproprietary name. When filling out clinical documents or conducting various studies, INN is used quite widely and has become quite commonplace. In addition, the importance of INN is increasingly increasing as a result of the active use of generic names for pharmaceutical products.

Use of INN in practical medicine

What is the international nonproprietary name of medicines? The Federal Law “On the Circulation of Medicines” deciphers this concept as follows - this is the name of the pharmaceutical substance proposed by WHO. As mentioned above, the INN system was invented to classify and record the names of active substances and their free use in the medical and pharmaceutical community. Since 2012, in practical medicine, all prescriptions and prescriptions of medications are carried out using INNs, and in their absence, using group names. When selecting a drug, doctors need to distinguish between the following concepts:

name of the active substance;
trade name of a medicine containing a pharmacologically active, i.e., active substance.

On the pharmaceutical market there are a huge number of trade names of drugs that are manufactured by different manufacturers, but have the same active ingredient. All official instructions for medical use of the drug, as well as on the packaging, contain the international nonproprietary name of the drug. Knowledge and use of INN allows doctors to effectively and efficiently prescribe medications, as well as economically use limited financial resources.

Search for analogues and synonyms

Analogues are drugs that have a similar pharmacological effect and mechanism of action. Such drugs may belong to different pharmacological groups, have different therapeutic effects, and have different contraindications and side effects. For example, “Remantadine”, “Kagocel”, “Ingavirin” are similar products. Synonyms are drugs with different trade names, but having the same INN. Let's look at a few examples of synonymous drugs. Listed below are medications with the international nonproprietary names “Drotaverine” and “Paracetamol”.

The first includes “No-shpa”, “Spazmol”, “Spakovin”, “Spazmoverin”, the second - “Kalpol”, “Ifimol”, “Prohodol”. Many people confuse these two concepts and often look for cheap analogues in pharmacies. It is important to understand that the analogues are not synonymous, and only a doctor can choose them correctly. And any patient can choose a synonym drug independently, depending on the preferences of a particular trade name and the country of origin of the drug.