From the first stages of human history, people have used medicines derived from plants and animals to prevent and treat illnesses. Substances that help fight illnesses and cheer up are almost as important for a person as food and shelter. Many drugs of plant and animal origin retain their medicinal value today, but most of the drugs used in modern medicine have appeared as a result of the progress made in synthetic organic chemistry and biotechnology since the end of World War II.
Medicines (medicines) are substances used for the diagnosis, prophylaxis, or treatment of diseases and allowed for use by an authorized health authority (in Russia it is the Pharmacological Committee of the Ministry of Health of the Russian Federation). Medications can affect the systems and functions of the body (for example, contraceptives for oral administration) or change the course of the disease (for example, drugs for treating bronchial asthma, hypertension or epilepsy).
Prescription and over-the-counter medicines
Medicines fall into two categories: prescription and over-the-counter. Prescription drugs are believed to be safe to use only under the supervision of a physician, so they are sold only by written prescription. OTC drugs can be used without medical supervision, so you can buy such drugs freely.
In different countries, the group of OTC drugs includes various drugs. In Russia, the list of over-the-counter drugs is regulated by order of the Ministry of Health of the Russian Federation (No. 287 of 09/19/99). Inclusion in this list is determined primarily by the scope of the drug. For example, drugs for the treatment of diseases of the cardiovascular or central nervous system are sold only by prescription, and drugs for the treatment of colds or skin lesions can be bought without a prescription. When assigning a medicine to a group of OTC drugs, its dose and dosage form are also taken into account.
The inventor of a new medicine receives a patent that grants him (the company) exclusive rights to this medicine for 17 years, although by the time it is approved for sale, most of this time usually passes. During the validity of the patent, the medicine after the expiration of the patent is the property of the inventor. After the patent expires, it may be legally sold under a different name, but the original owner continues to control the rights to its original trade name. Produced drugs (generic or generic) are not patented and are usually cheaper than the original drug. Licensed drugs are called licensed.
Each drug has several names: 1) chemical, 2) international, and 3) commercial (commercial).
The chemical name indicates which atoms the medicine consists of or reflects its molecular structure. It accurately describes the drug, but is usually too complicated for widespread use, with the exception of the names of some simple inorganic compounds, such as sodium bicarbonate.
The international name is approved by official bodies and is used in national and international reference literature.
Trade (commercial) names can be divided into names assigned by the inventor and manufacturing company and being their property. The brand name should be short, simple and easy to remember so that consumers can immediately find a medicine after it is prescribed by a doctor. Therefore, trade names sometimes indicate the use of a drug, for example, diabetes (for the treatment of diabetes) or rhythmylene (for the treatment of cardiac arrhythmias).
International standards require that reproduced versions of the drug have the same active components as the original, and their effect on the body appears with the same speed and strength. The manufacturer of the reproduced version may give the drug its trade name if it believes that with the new name the drug will sell better.
As a rule, the packaging of a medicine indicates its trade and international name. If a medicine includes several components, then usually on the packaging instead of the international name its ingredients are written. For example, acetylsalicylic acid, paracetamol and caffeine are indicated on the packaging of a medicine with the trade name Citramon, and paracetamol, phenylephrine, caffeine, terpinghydrate and ascorbic acid are shown on the packaging of a medicine under the trade name Coldrex.
Pharmacodynamics and pharmacokinetics
The choice and use of the drug are affected by its two most important properties: pharmacodynamics (what effect does it have on the body) and pharmacokinetics (what happens to it in the body). In addition to which the drug has an effect (for example, relieves pain, lowers blood pressure, reduces blood cholesterol), pharmacodynamics reflect, Where (coverage area) and as (mechanism) it works in the body. Although the effect of the drug is often obvious, the exact place and mechanism of its action may not be fully understood for many years after it has proven to be effective. For example, morphine has been used to reduce pain and anxiety for centuries, but only recently have brain structures and chemical processes been found involved in the mechanism of pain relief and the euphoria that this medicine causes.
In order for the drug to have its effect, it must reach the place in the body where there is a violation, and remain there in sufficient quantity. Excessive concentration of the drug can lead to serious side effects or toxic reactions. Every doctor knows that to choose the right dose you need to find a "middle ground". That is why the study of pharmacokinetics is important.
Many drugs enter their bloodstream. How long they should work and how long their effect actually manifests depends on how much they enter the bloodstream, how quickly they reach the target tissues, how actively they are destroyed (metabolized) by the liver and how quickly they are excreted through the kidneys or intestines .
The halo of mystery surrounding the effects of drugs will dissipate if it is understood that they only affect speed the implementation of biological functions, but do not change the basic nature of existing processes and do not lead to the emergence of new ones. For example, drugs can accelerate or slow down biochemical reactions that cause muscle contractions, cause kidney cells to regulate the amount of water and salts stored or removed from the body, affect the secretion by glands of various substances (acids in the stomach, mucus, or insulin) and the transmission of nerve impulses . The effectiveness of the drug depends on how the processes that its action is directed to change. For example, some antiepileptic drugs reduce the frequency of seizures by sending signals to the brain that slow down the production of specific substances. However, drugs cannot repair systems that are already irreversibly damaged. This is due to the disappointment that befell scientists in attempts to cure diseases, which are based on the death or degenerative tissue changes. Such diseases include, for example, heart failure, arthritis, muscular dystrophy, multiple sclerosis, and Alzheimer's disease.
People react to drugs differently. To achieve the same effect, a person with a large complexion, as a rule, needs more medicine than a person with a lower weight. In newborns and the elderly, drugs are included in the metabolism more slowly than in adolescents and young people. In patients suffering from diseases of the liver or kidneys, the removal of drugs requires more time.
The standard, or average, dose is determined for each new drug as a result of laboratory studies on animals and clinical trials. But the concept of a medium dose is similar to dimensionless clothes: it fits almost everyone, but certainly almost no one.
In the early 1900s, the German scientist Paul Erlich formulated the main requirement for an ideal medicine: it should be aimed precisely at the sore spot and not harm healthy organs and tissues. Although many new drugs are more selective in their action than their predecessors, a perfect drug has not yet been created. Most medicines are close in accuracy to the ideal Ehrlich medicine, but, curing the disease, they also cause some unwanted reactions.
The undesirable effect of the drug is called a side effect. If the content of the medicine in the body could be adjusted in accordance with the need for it, this would automatically extend the desired therapeutic effect. For example, drugs could constantly maintain normal blood pressure in a person with hypertension or a normal blood sugar concentration in a patient with diabetes. However, for most drugs this is not possible. On the contrary, the drug may have too much effect, excessively lowering blood pressure or lowering blood sugar. With good contact between the patient and the doctor, the number of undesirable effects can be reduced or not prevented from occurring at all: the patient must tell the doctor how the medicine acts on him, and the doctor will change the dose of the drug.
Often, a drug affects several body functions, although only one is prescribed for correction. For example, antihistamines reduce allergy symptoms (nasal congestion, lacrimation, and sneezing), but since most of them affect the nervous system, they can also cause drowsiness, confusion, blurred vision, dry mouth, constipation, and difficulty urinating.
The effect of the drug is evaluated as a side effect or as the desired effect, depending on why it is taken. For example, the antiallergic drug diphenhydramine has a hypnotic effect, so if it is prescribed for this purpose, then its ability to cause sleep will be the expected result, and not an undesirable side effect.
Efficiency and safety
When developing a new drug, there are two goals - to achieve its effectiveness and safety. Since any medicine can both harm and help, the concept of "safety" is very relative. The wider the therapeutic safety zone (therapeutic window) - the range between the usual effective treatment dose and the dose leading to severe or life-threatening adverse reactions - the safer the medicine. If the usual effective dose of the drug is practically equal to the toxic, doctors use it only in especially difficult situations, when there is no other, more suitable means.
The best medicines are both effective and safe. Such drugs include penicillin. It is practically non-toxic, even in large doses, and only in rare cases causes allergic reactions. On the contrary, barbiturates, which used to be widely used as sleeping pills, can depress breathing, disrupt the heart rhythm, and even lead to death if taken in a large dose. New generation hypnotics, such as nitrazepam (radedorm) and imovan, have a wider therapeutic safety zone.
Some drugs have to be used despite their narrow therapeutic window. For example, phenylin, which is prescribed to reduce blood coagulation, can cause bleeding. People taking it often have to do blood tests so that the doctor can change the dose of the drug in time if it has too strong or, conversely, insufficient effect.
Another example is clozapine (leponex, azaleptin). It helps many people with schizophrenia that are not affected by other medicines, but it can suppress the formation of white blood cells, which are necessary to protect the body from diseases caused by infection. Therefore, while patients use this drug, they should do repeated blood tests.
Knowing what you can expect from a medicine (both good and bad), it is easier to understand whether it has its therapeutic effect or if potentially dangerous complications develop. Any person should not hesitate to ask a doctor or a nurse questions in order to understand the goals of treatment, to learn about possible side effects and other surprises that may occur when taking medications - this will ensure therapeutic success. In addition, the patient should always inform the doctor about the history of his disease, the medications taken and any circumstances that could affect the treatment.
With the simultaneous administration of two or more drugs, they can interact with each other, which leads to both favorable and unfavorable consequences for the patient. For example, together they are more effective in treating the disease than individually, but they can also mutually increase the number or intensity of adverse reactions. Such an undesirable interaction often occurs while taking a non-prescription drug and a drug prescribed by a doctor. If the patient is being treated by several doctors, each of them should be aware of all the medicines prescribed by other specialists. When choosing over-the-counter drugs (e.g., mild laxatives, antacids, cough medicines, or colds), patients should also consult a doctor, especially if they are already taking prescription drugs.
Many people do not know that alcohol affects the processes in the body and the effect of various drugs. You can learn about the possible interaction of alcohol and a specific medicine by asking questions to a doctor or pharmacist (a specialist with a pharmaceutical education working in a pharmacy).
The ability of drugs to interact with each other does not always lead to poor results. For example, some drugs used to lower high blood pressure are specifically prescribed in a specific combination to reduce side effects that might develop with a single drug, but at a higher dose.
For many centuries, medicines have been of great benefit to people, reducing their suffering, preventing disease and getting rid of it. However, some people are interested in drugs primarily as substances that can give pleasure by changing the activity of the brain.The discovery and use of drugs has always had a dark side, especially for agents that reduce anxiety or change a person’s mood and behavior, satisfying certain emotional needs. Unfortunately, along with the use of drugs according to relevant indications, there is always an abuse of drugs, that is, excessive and constant use of substances that change the activity of the central nervous system without medical need. Psychoactive drugs such as alcohol, barbiturates, benzodiazepines, and also marijuana, cocaine, heroin, amphetamines, LSD (lysergic acid diethylamide) and other drugs are most often abused.
The tactics of combating the disease should not be chosen independently. The doctor prescribes medicines based on a set of examinations and the clinical picture of the disease. The list of drugs for cerebral stroke includes drugs of various groups. They are aimed at the links of the pathological chain leading to the development of cerebrovascular insufficiency. Medicines act both directly on the cause of the disease, and help to cope with the changes caused by the disease. Each stroke medicine must be taken strictly according to the schedule prescribed by the doctor and according to the instructions.
Drugs in this group indirectly affect the hormone produced by the kidneys - angiotensin. Its allocation causes a strong rise in blood pressure. ACE inhibitors block the action of the enzyme, which converts the protein into an active form, which is one of the mechanisms of hypertension that causes stroke. The drugs in this group include such drugs as Enap, Diroton and Prestarium. They can be used for atherosclerotic vascular changes. As a rule, these medicines are used constantly.
Angiotensin II receptor blockers
They act directly on the active form of the hormone, preventing its reaction to an increase in ACE concentration. Drugs are also aimed at lowering blood pressure. The funds of this group include Lozap, Diocor and Candesar. They have fewer side effects than ACE inhibitors. Available in tablet form.
Diuretic drugs increase the excretion of fluid from the body. This leads to a decrease in pressure, as well as the removal of edema of the nervous tissue. The most modern, not causing serious side effects with proper use, are tools such as "Torasemide" and "Veroshpiron." Their use is limited for diabetes.
Drugs in this group also have a hypotensive effect. It is achieved by influencing specific nerve receptors located in the cardiovascular system. The most widely used products are Corvitol and Bisoprolol. Prescribed as medications for oral administration.
Drugs are able to normalize blood pressure by acting on specific receptors. They block the entry of trace elements into the myocardium and blood vessels, which contributes to their expansion. The funds of this group include “Phenigidin”, “Amlodipine” and “Verapamil”. Used in tablet form.
Adrenergic receptor blockers
The drugs have a pronounced vasodilating effect due to a decrease in the resistance of arteries and microvasculature. Their plus is that adrenergic receptor blockers are not contraindicated in patients with endocrinopathies and kidney diseases. Representatives are Coriol and Doxazosin, available in tablets.
Central action drugs
Means affect the functional centers of the brain that control blood pressure, which makes the drugs very effective. They also have a sedative and hypnotic effect, but can cause dizziness. However, medicines from this group, for example, “Klofelin”, are addictive, because of which their use is limited in time.
These funds are often used in inpatient departments in the form of injections and droppers. They contribute to the activation of blood circulation and restoration processes in damaged brain tissues. Vascular agents, such as Cortexon and Actovegin, when used in the early stages of a stroke, provide prophylaxis for complications such as paresis and paralysis.
Medicines of this group contribute to the stimulation of cerebral circulation and enhance the regenerative abilities of tissues, which improves the prognosis for stroke. Used funds based on piracetam and gamma-aminobutyric acid. Vinpocetine, also available as a powder for the preparation of a solution for intravenous injection, is also an effective drug.
Therapy aimed at improving the rheological properties of blood and preventing the formation of clots is recommended for hemorrhagic stroke. Acetylsalicylic acid, heparin and streptokinase-based drugs are used. They prevent the adhesion of platelets, and also contribute to the dissolution of the already formed formation.
Medicinal appointments for recovery
Drugs after a stroke are prescribed to accelerate the rehabilitation of the patient, as well as to combat the complications of the disease. The most commonly used drugs are nootropic drugs such as Cortexin and Glycine, which stimulate the repair of nerve tissue. The list of medicines after a stroke also includes homeopathic remedies that help accelerate the regeneration of nerve tissue and normalize blood pressure. An integrated approach to rehabilitation after cerebral infarction improves memory, reduces the risk of developing long-term complications, and also prevents a possible relapse. Medications for recovery from a stroke should be selected by a doctor.
The start time of the use of medicines for patient rehabilitation is determined individually, because it depends on the clinical picture. With a mild course of the disease, they can be used almost immediately after the onset of symptoms. At the same time, there are a number of contraindications to the early use of drugs that lower blood pressure. If the stroke is complicated by cardiological problems, such as atrial fibrillation, you should also carefully consider the need for anticoagulant therapy, since there is a risk of intracerebral bleeding in case of damage to the large cerebral artery. In such cases, treatment with acetylsalicylic acid and heparin preparations should be postponed until a later stage, when the patient's condition is stabilized. Moreover, according to statistics, a stroke is not prone to early relapse: only 2% of patients suffer from repeated cerebrovascular disease within 14 days after the initial one.
During the period of post-infarction recovery of the brain, it is required to refrain from using estrogen preparations, which include female oral contraceptives, as well as completely stop smoking.
Alexey, 58 years old, St. Petersburg
He suffered an ischemic stroke. He lay under the droppers in the hospital for two weeks. At home, Mexidol drank, went to Cortexin injections. The doctor said that they help restore nerve tissue. My motor skills were impaired, so I took medication and did special exercises. A month after discharge, everything returned to normal.
Inna, 61 years old, Voronezh
I got to the hospital with a hemorrhagic stroke. I spent a week in a hospital, I was given injections of Heparin, a dropper, and I took Enap. When more or less came to, they were discharged home. I still take pills to reduce pressure, I feel much better with them. In addition, I drink Glycine, it helps to maintain good health.
Ilya Vladimirovich: Experience in the treatment of prostatitis for more than three years. Painful urination is very familiar.
Svetlana: A year ago they gave me moderate hypertension. The doctor warned that the treatment.
Catherine: My two-month-old daughter died after the introduction of the Prevenar 13 vaccine.
Selintseva: Diarrhea is mainly due to bacteria, you need to take something against them. I chose between StopDiar.
Already in ancient times, people tried to save their lives using various natural medicinal substances. Most often, these were plant extracts, but drugs that were obtained from raw meat, yeast, and animal excrement were also used. Some medicinal substances are available in readily available form in plant or animal raw materials, in connection with which medicine has successfully used since ancient times a large number of medicines of plant and animal origin (for example, castor oil plant, opium, sea onions, known in ancient Egypt, mercury, known to ancient Indians, digitalis, lily of the valley, adonis and many others, widely used by traditional medicine). It was only with the development of chemistry that people became convinced that the therapeutic effect of such substances lies in the selective effect of certain chemical compounds on the body. Later, such compounds began to be obtained in laboratories by synthesis.
Advances in technology and the development of a number of scientific disciplines (anatomy, physiology, and especially chemistry) in the second half of the 19th century, firstly, made it possible to synthesize a significant amount of substances that did not exist in this combination or form, but which had a therapeutic effect (antipyrine, pyramidone, plasmocide , aspirin and hundreds of others), and, secondly, made it possible to make a scientific experiment the basis for studying the effects of drugs, as well as finding new drugs. The experiment replaced the prevailing until that time in treatment and drug science various unreasonable scientific theories (Paracelsus, Hahnemann and others).
Paul Erlich, a German bacteriologist and chemist, is considered the founder of modern chemotherapy. In 1891, he developed the theory of the use of chemical compounds to combat infectious diseases.
There are several classifications based on various signs of drugs:
- chemical structure (for example, compounds-derivatives of furfural, imidazole, pyrimidine, etc.),
- by origin - natural, synthetic, mineral,
- according to the pharmacological group - the most common classification in Russia is based on the effect of the drug on the human body,
- nosological classification - classification by disease for the treatment of which a drug is used,
- Anatomical-therapeutic-chemical classification (ATX) - an international classification that takes into account the pharmacological group of the drug, its chemical nature and the nosology of the disease for which the drug is intended to be treated.
Raw materials for medicines are:
- plants (leaves, grass, flowers, seeds, fruits, bark, roots) and products of their processing (fatty and essential oils, juices, gums, resins),
- animals - glands and organs of animals, lard, wax, cod liver, sheep’s fat and more,
- fossil organic raw materials - oil and products of its distillation, products of distillation of coal,
- inorganic minerals - mineral rocks and products of their processing by the chemical industry and metallurgy (metals),
- all kinds of organic compounds are products of the large chemical industry.
The study of drugs is carried out by chemical analysis, pharmacological studies and clinical observations (see Pharmacology), while determining the active principles of the substance and its main qualitative indicators: organotropy or parasitotropy of the drug, that is, its predominant effect on those or other organs of the patient or pathogens of the disease (on bacteria, parasites, etc.), the presence of "side" (undesirable) effects, the ability of the drug to cause in some people a special feeling for themselves activity (for example, a runny nose and the appearance of nausea from negligible amounts of Ipecac).
Quantitative indicators for the drug are: lethal dose (usually calculated per 1 kg of live weight of an animal or person), tolerated (tolerated) dose and therapeutic dose. The tolerated doses (or slightly lower for caution) for many drugs are legalized as maximum doses. The ratio of the lethal dose to the therapeutic one is called the “therapeutic index” of the drug, since the larger the ratio, the more freely the medicine can be prescribed.
The action of drugs is carried out mainly by changing the physicochemical properties of the environment in which the cellular elements of the body are located, while the action may have the character of a chemical compound of the drug with the elements of the body and, in some cases, with a direct effect on the protoplasm of cells, be accompanied by their complete destruction. The physiological effect of the action of the drug is either the excitation or inhibition of the vital activity of cellular elements, while the dose of the drug substance plays an important role, since the same drug in different doses can cause different effects - excite in small doses and inhibit (up to paralysis) in large doses.
The essential point is the phase of action of drugs: some drugs can exert their effect at the time of penetration into the body (Kravkov entry phase), others - most - at the time of maximum concentration in the body (saturation phase), and others - at the time of concentration drop (exit phase ), while the ability of some drugs to cumulate, manifested in a sharp increase, and sometimes a distortion of their action upon repeated administration, is extremely important, which is explained by the accumulation of the drug in the body change and accumulate the effect of his action.
The effect of the drug depends on the age, gender, health status and individual characteristics of the body of the person taking it. A number of drugs in a correspondingly reduced dose has a much stronger effect on children than on adults (often poisonous), women during menstruation, pregnancy, and lactation react to drugs differently than usual, for some people the drug acts abnormally strongly, which is explained by increased body sensitivity to certain substances (see: Idiosyncrasy).
Ways of introducing drugs into the body are very diverse. Most often, oral medication is used. In order to avoid rapid decomposition of the drug, irritation of the gastrointestinal canal, or to achieve the greatest speed of action, the drug is administered using a syringe subcutaneously, intramuscularly or intravenously. Some drugs are administered through the rectum or by inhalation.
The external use of drugs is their application to the skin and mucous membranes of the eye, nose, ears, oral cavity, genitourinary tract (to the place of entry into the bladder and to the cervical canal of the uterus), to the mucous membrane of the rectum (to the location of the internal sphincter) .
In the body, drugs are destroyed, altered and, entering into chemical compounds with its salts and fluids, lose their poisonous properties (and sometimes, on the contrary, acquire them) and in one form or another are excreted from the body through the intestines, kidneys, respiratory tract, sweat glands, etc.
Prescription and OTC Medicines
Prescription for a medicinal product is a written prescription of a medicinal product in the prescribed form issued by a medical or veterinarian authorized to do so for the purpose of dispensing a finished medicinal product or manufacturing and dispensing it. Accordingly, a prescription drug is a drug dispensed from a pharmacy institution only by prescription. An OTC drug is a drug that is officially allowed to be dispensed from a pharmacy without a doctor’s prescription. The list of drugs allowed for over-the-counter leave is approved by order of the Ministry of Health. However, this regulatory document ceased to be valid in August 2011, and to date there is no document or legislatively approved procedure for classifying a drug as a non-prescription drug. In this regard, pharmacy workers have to be guided only by the manufacturer's instructions on the packaging of the drug.
The percentage of over-the-counter and prescription drugs in a pharmacy looks about 30 to 70. However, at present in Russia there is a crisis of the “doctor-pharmacist-sick” system, which is expressed in the release of officially prescribed drugs (antibiotics, hormonal contraceptives, drugs for the treatment of the cardiovascular system, etc.) without a properly prescribed prescription, or (which occurs much more often) without it at all. In fact, this leads to the free sale of drugs. Uncontrolled intake and irrational use of drugs endanger not only patients, but also leads to the appearance of antibiotic-resistant strains of microorganisms, the spread of substance abuse, drug addiction and many other similar consequences.
The state is gradually tightening control over the circulation of medicines. In particular, in June 2012, Order No. 562n of the Ministry of Health and Social Development of May 17, 2012 on the approval of a new procedure for dispensing drugs containing precursors, including codeine-containing combined painkillers, which were popular with a large part of the population, entered into force. In order to combat drug addiction, since July 2012, the above drugs are dispensed in a 148-1 / y-88 prescription form.
In Russia, selling over-the-counter medicine is punishable by a fine of 1-2 thousand rubles. If the situation repeats, the inspectors have the right to draw up a protocol already for a legal entity, that is, for a pharmacy organization, and in this case, the amount of the fine increases many times - up to 40-50 thousand rubles.
In a number of countries, these funds are regulated in different ways - either as a category of “medicines”, or as “foods and additives”, or as “alternative medicine”. Currently, there is no established opinion of international organizations on this subject, agreed with national health authorities.
In the Russian Federation, homeopathic medicines are subject to the same legislative regulation as conventional medicines. In 2010, work was begun to review the status of certain types of drugs, in particular homeopathic medicines.
Legislative regulation in the Russian Federation
The state rather strictly regulates the circulation of medicines. The main document regulating the circulation of medicines for 2011 is Federal Law dated 12.04.2010 No. 61-FZ “On the Circulation of Medicines” (adopted by the State Duma of the Federal Assembly of the Russian Federation on March 24, 2010). In addition to the basic law, the subjects of drug circulation are subject to laws No. 3-FZ of 01/08/1998 "On Narcotic Drugs and Psychotropic Substances", No. 2300-1 "On the Protection of Consumer Rights", No. 122-FZ of 02.08.1995 "On Social Serving Elderly and Disabled Citizens ”, No. 128-ФЗ dated 08.08.2001“ On licensing of certain types of activities ”and others.
The Law on Medicines distinguishes between the concepts of “medicinal product” and “medicinal product”. According to the law, “medicine” is a more general concept; substances also include substances. Medicines - medicines in the form of dosage forms used for the prevention, diagnosis, treatment of a disease, rehabilitation, for the preservation, prevention or termination of pregnancy. All medicines used in Russia must be registered with the appropriate authorized federal executive body, Roszdravnadzor, which maintains the state register of medicines.
The production of permitted medicines must comply with the requirements of GOST adopted in 2010. This GOST complies with the international GMP standard. All pharmaceutical companies in Russia are obliged to switch to the requirements of this GOST by 2014.
Sale of medicines (in contrast to dietary supplements) is carried out only by pharmacy institutions (pharmacies, pharmacy kiosks) that have the appropriate license.
The circulation of medicines is regulated by law and by-laws, including regularly updating the list of vital and essential medicines, the list of narcotic drugs, etc.
State quality control bodies
The quality of medicines in Russia is controlled by the Federal Service for Supervision of Healthcare (Roszdravnadzor), subordinate to the Ministry of Health.
In most large cities of Russia, there are drug quality control centers. Their main task is to verify the drug-trading organizations (compliance with the numerous standards for the storage and sale of medicines), as well as selective (and in some regions total) drug control. Based on data from regional centers, Roszdravnadzor makes decisions on the rejection of a drug.
Defective and counterfeit medicines are subject to seizure from the pharmacy network; information about them is available on the Roszdravnadzor website.
According to regulatory documents, narcotic drugs are drugs and pharmaceutical substances containing narcotic drugs and included in the list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation, in accordance with the legislation of the Russian Federation, international treaties of the Russian Federation, including the 1961 Single Convention on Narcotic Drugs.
From the list of drugs to drugs are related:
- List II - 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 III - psychotropic substances whose circulation in the Russian Federation is limited and in respect of 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
The state reserves the monopoly on the production of drugs of Schedule II. All enterprises associated with the turnover of narcotic and psychotropic substances are subject to mandatory licensing. Pharmacies that have an assortment of medicines of lists II and III are required to have licenses for the implementation of each list.
The control state body of enterprises related to drug trafficking, except for Roszdravnadzor, is the Federal Drug Control Service of the Russian Federation. Since many doctors fear the development of drug dependence in patients and do not psychologically accept it, because of confused, and also because of conflicting and often changing laws, doctors are wary of prescribing drugs even to those people who need it.
Original medicines, synonyms, "generics" and analogues
Original A medicine is a drug that was previously unknown and was first introduced to the market by a developer or patent holder. As a rule, the development and marketing of a new drug is a very expensive and lengthy process. Of the many known compounds, as well as newly synthesized, by enumeration, on the basis of databases on their properties and computer modeling of the expected biological activity, substances having the maximum target activity are identified and synthesized. After animal experiments, in the case of a positive result, limited clinical trials are conducted on groups of volunteers. If the effectiveness is confirmed, and side effects are insignificant - the medicine goes into production, and on the basis of the results of additional tests, possible features of the action are clarified, undesirable effects are revealed. Often the most harmful side effects are clarified precisely with clinical use.
Almost all new drugs are currently patented. Patent law in most countries provides for patent protection not only of a method for producing a new drug, but also patent protection of the drug itself. In the Russian Federation, the validity of a patent for an invention relating to a medicinal product, the application of which requires obtaining permission in the manner prescribed by law, is extended by the federal executive authority for intellectual property at the request of the patent holder for a period from the date of filing the application for the invention to the date of receipt of the first such permission to use, net of five years. Moreover, the term for which the validity of a patent for an invention is extended may not exceed five years. After the patent expires, other manufacturers can reproduce and market a similar drug (the so-called generic), if they prove the bioequivalence of the reproduced and original drugs. Moreover, the technology for the production of generics can be any, but not subject to the existing patent protection in the country. The generic manufacturer cannot use the brand name for this medicine, but only the international nonproprietary name (INN) or any new patented name (synonym).
From the point of view of chemistry, the active substance of the original drug and the generic is the same, but the production technology is different, different degrees of purification are possible. There are other factors that affect the effectiveness of the drug. For example, for a long time different companies could not achieve the same efficacy of acetylsalicylic acid for generics as that of Bayer, the manufacturer of the original drug “aspirin”. It turned out that the matter was not only in the purity of the raw materials, but also in a special crystallization method, resulting in special, smaller crystals. The opposite result is also possible, when a generic is more successful than the original medicine.
Analogue - drug-based substance great from that used in the original being compared, and therefore with another INN. Therefore, if the selection of a synonym or generic is the prerogative of a pharmacist, then the appointment of an analogue requires the qualification of a doctor. (Sometimes generics are also referred to as similar drugs, which creates a certain amount of confusion.)
Counterfeiting and Counterfeiting
- 1998 - the first official case of detecting fake drugs in Russia was registered. source not specified 2383 days
- 2004 - introduction of the concept of “counterfeit medicines” into Russian law.
It is necessary to distinguish between falsification of drugs and counterfeit drugs.
Counterfeit - This is a conscious change in the formulation of the production of the drug. Replacing expensive components with cheaper ones or reducing the content (and in the worst case, completely lacking) of the necessary component of the drug. For example, replacing the more expensive cefazolin with cheaper (and less effective) penicillin. In addition, other violations during production are possible: violation of the time and sequence of the technological process, underestimation of the degree of purification, poor-quality packaging materials, etc.
Counterfeit Medicines are medicines manufactured without the permission of the patent holder.
The effectiveness of the drug is primarily determined by the active substance (but not only them, see bioequivalence). According to international law, the formula or composition of the active substance cannot be the secret of the company. However, for some time other companies are not entitled to produce this medicine without the permission of the patent holder. Even at the end of the allotted time, other companies cannot use the original name of the drug (registered brand).