Medicines

Medicines (medicines, drugs)- substances or combinations thereof that come into contact with the human or animal body, penetrate the organs, tissues of the human or animal body, used for prevention, diagnosis (except for substances or their combinations that do not come into contact with the human or animal body), treatment of disease, rehabilitation, for the preservation, prevention or termination of pregnancy and obtained from blood, blood plasma, organs, tissues of the human or animal body, plants, minerals by synthesis methods or using biological technologies. Medicines include pharmaceutical substances and drugs.

Original medicine- a medicinal product containing a pharmaceutical substance obtained for the first time or a new combination of pharmaceutical substances, the effectiveness and safety of which are confirmed by the results of preclinical studies of drugs and clinical studies of drugs

Source: Federal Law of the Russian Federation of April 12, 2010 N 61-FZ

Medicine, medicinal product, medicine, medicine(novolat. praeparatum medicinale, praeparatum pharmaceuticum, medicamentum;) - a substance or mixture of substances of synthetic or natural origin in the form of a dosage form (tablets, capsules, solution, ointment, etc.) used for the prevention, diagnosis and treatment of diseases.

Before being used in medical practice, medicines must undergo clinical trials and receive permission for use.

Original medicines and generics

An original medicine is a drug that was previously unknown and was first released onto the market by the developer or patent holder. As a rule, the development and marketing of a new drug is a very expensive and lengthy process. From a variety of known compounds, as well as newly synthesized ones, substances with maximum target activity are identified and synthesized using the brute force method, based on databases of their properties and computer modeling of their expected biological activity. After animal experiments, in case of a positive result, limited clinical trials are carried out on groups of volunteers. If the effectiveness is confirmed and the side effects are insignificant, the medicine goes into production, and based on the results of additional tests, possible features of the action are clarified and undesirable effects are identified. Often the most harmful side effects are revealed during clinical use. Currently, almost all new drugs are patented. The patent legislation of most countries provides patent protection not only for the method of obtaining a new drug, but also for patent protection of the drug itself.

In the Russian Federation, the validity period of a patent for an invention related to a medicinal product, the use of which requires obtaining permission in accordance with the procedure established by law, is extended by the federal executive body for intellectual property at the request of the patent holder for a period calculated from the date of filing the application for the invention until the date of receipt of the first such permits for use, minus five years. In this case, the period for which the validity of a patent for an invention is extended cannot exceed five years. After the patent expires, other manufacturers can reproduce and put on the market a similar drug (the so-called generic) if they prove the bioequivalence of the reproduced and original drugs. At the same time, the technology for producing a generic drug can be any, but not subject to the existing patent protection in the country. Of course, the generic manufacturer cannot use the brand name for this medicine, but only the international non-proprietary name (INN), or some new one patented by him (synonym). Despite the new name, the drugs may be similar or very close in their medicinal effect.

Are original drugs and generics completely equivalent? From a chemical point of view, the active substance is the same. But the production technology is different, and different degrees of purification are possible. There are other factors too. For example, it is known that for a long time different companies could not achieve the same effectiveness of acetylsalicylic acid (for generics) as Bayer AG, the manufacturer of the original drug “aspirin”. It turned out that the matter is not only in the purity of the raw materials, but also in the special method of crystallization, which results in special, smaller crystals of acetylsalicylic acid. There can be many such nuances. The opposite result is also possible, when the generic drug turns out to be more successful than the original medicine.

What does the word medicine mean?

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The site provides reference information for informational purposes only. Diagnosis and treatment of diseases must be carried out under the supervision of a specialist. All drugs have contraindications. Consultation with a specialist is required!

Definition of the concept

Historical facts

Our ancestors tried to heal from various ailments using various substances of exclusively natural origin. In most cases these were plant extracts.
Some ancient healers also invented drugs that could be obtained from animal waste, raw meat or yeast. Even then, people realized that in many living organisms there is an accumulation of certain components that can help overcome various pathologies. A little later, scientists were able to establish that the effect of such components lies in the selective effect of various chemical compounds on the human body. A few years later, they learned how to obtain such compounds in laboratories by synthesis. Already in 1891, the German chemist and bacteriologist Paul Ehrlich developed the theory of using such compounds to treat infectious diseases.

Existing classifications

• pharmacological action: in this case we are talking about the therapeutic effects that certain drugs tend to have. So, for example, analgesics help reduce pain irritation, but vasodilators tend to dilate blood vessels;
• nosological principle: a list of various medicines that are used to treat a strictly defined disease. This can be either bronchial asthma or myocardial infarction, angina pectoris, etc.;
• therapeutic use: let's say drugs for the treatment of malignant neoplasms, antimicrobial agents or medications to lower blood pressure;
• chemical structure: This group includes medications that are similar in structure. These are salicylates, the main component of which is acetylsalicylic acid. The list of salicylates includes both aspirin and methyl salicylate, as well as salicylamide, etc.

• synthetic: they are obtained by chemical synthesis;
• mineral: they are obtained from mineral compounds such as silver nitrate and magnesium sulfate;
• natural: They are made from plant extracts, as well as animal tissues and organs.

Dose and concentration

Routes of administration

The list of enteral routes includes:

• oral ( inside);
• rectal ( into the rectum);
• sublingual ( under the tongue);
• buccal ( by the cheek);
• through a probe into the duodenum.

• subcutaneous;
• inhalation;
• intravenous;
• subarachnoid ( under the membranes of the brain);
• intramuscular;
• intraperitoneal;
• intra-arterial;
• intranasal ( through the nose);
• intrasternal ( into the sternum);
• transdermal ( into the pleural cavity, into the body, urethra, cervix, etc.).

Types of action

2. resorptive effect: observed after absorption of the drug into the blood and is characterized by the interaction of its components with tissues and organs;
3. direct action: represents the direct effect of a chemical on a target organ. This action is primary in all cases. A manifestation of the direct action of drugs is considered to be a selective action, during which the therapeutic effect is exerted on a limited group of cells or organs;
4. reversible and irreversible actions: if the changes resulting from the action of the drug disappear without a trace after a certain period of time, then we are talking about a reversible effect. If this does not happen, then the effect on the face is irreversible. An irreversible effect in most cases is observed when dosages or concentrations are exceeded, in case of individual intolerance to the drug by the body, as well as with prolonged use.

Prescription and over-the-counter drugs

The list of medicines that are allowed to be dispensed without a prescription is established by order of the Ministry of Health. This is done for a reason. The thing is that both irrational use and uncontrolled use of certain drugs can have a detrimental effect on the general health of people. Dispensing some drugs without a prescription can lead to distribution and addiction.

Best before date

Storage Features

Concerning drugs of the first group, which are represented by poisonous and narcotic drugs, they must be stored in a safe locked with a separate lock.

Drugs of the second group containing potent medications should be stored in locked medical cabinets.

Medical drugs of the third group, which can be dispensed without a prescription, may be stored in open cabinets.

The patient's course of therapy depends on the correct storage of medications. If the rules are violated for any reason, this may lead to a decrease in the therapeutic effect of a particular drug. In some cases, improper storage causes a person to feel even worse after a course of therapy with one or another drug.

First Aid Medicines

And here is a list of well-known medicines that must be present in every home medicine cabinet:

• Suprastin: taken for allergic reactions;
• Loperamide: treats acute and chronic diarrhea;
• Validol: used for hysteria, neurosis and angina;
• Paracetamol or Aspirin: has antipyretic, analgesic and anti-inflammatory effects;
• Analgin or Pentalgin: taken for headaches, toothaches, fever, pain syndrome, pain from injuries or burns;
• Valocordin: neuroses with increased irritability, tachycardia and insomnia;
• Donormil or Phenazepam: sleeping pills;
• Activated carbon: used for food intoxication, diarrhea, allergic diseases, poisoning with chemical compounds or salts of heavy metals, alcohol withdrawal syndrome. It is recommended to take this drug at the rate of 1 tablet per 5 – 10 kg of weight;
• Albucid: 20% eye drops endowed with bacteriostatic and antimicrobial effects, which can be used to treat both conjunctivitis and blepharitis ( inflammation of the eyelid margins), as well as some other eye pathologies. They can also be instilled as a preventive measure when a foreign body such as dirt or sand gets into the eyes;
• Phthalazole: an antimicrobial drug used for the treatment of enterocolitis, dysentery, gastroenteritis, colitis and other pathologies of the gastrointestinal tract of an infectious-inflammatory nature.

Free drugs for pregnant women

How to get such medicines?
First of all, you need to make an appointment with an obstetrician-gynecologist, who will examine you and write a prescription for free medications. With this prescription, you go to a pharmacy that has an agreement with a medical institution to provide free services to expectant mothers, and receive the medicine you need. Everything is quite easy and simple.

Free medications for children under 1 year of age

This same drug can also cause Reye's syndrome, which is characterized by acute hepatic encephalopathy.
Against the background of this pathology, damage occurs to both internal organs and the central nervous system. This syndrome is very rare in medical practice, but no parent can know in advance whether their child is predisposed to it or not. Given this fact, it is best not to give aspirin to children under 12 years of age. The list of drugs that are strictly prohibited for use at elevated temperatures includes phenazone, analgin, and pyramidon. These drugs are best replaced with ibuprofen or paracetamol. Other prohibited drugs for children are considered to be boric alcohol and chloramphenicol, which are intended for the treatment of otitis media. Some mothers still treat ear diseases with alcohol preparations. In fact, such treatment is at least unwise, since these drugs can provoke the development of a burn.

Various painkillers for abdominal pain are also contraindicated for children. Complaints of abdominal pain may indicate both the most common indigestion and appendicitis. Self-medication in such cases is unacceptable. By giving your baby a painkiller, you will only eliminate the pain, but the problem will still remain unresolved. In such cases, the best way out of the situation is to call emergency doctors to your home. In case of diarrhea, it is strictly forbidden to give fixative medications. If diarrhea occurs due to infection, taking such drugs will only worsen the general situation.

Antibiotics, which are used without the prescription of a specialist, are also considered prohibited drugs for children. Each antibiotic is a strong medicine, the irrational use of which can cause the development of various side effects and complications. Hormonal pills and homeopathic medicines are also prohibited from being given to children, since all these drugs can have an unpredictable effect on the growing body.

Remember once and for all - never treat your child with strong pharmaceuticals yourself and do not use the methods that your neighbor used. If this or that medicine helped your neighbor’s child, it is not a fact that your baby’s body will react to it the same way.

Allergy to drugs

With the development of a drug allergy, the patient may complain of diarrhea, difficulty breathing, vomiting, nausea, runny nose, conjunctivitis, tissue swelling, burning, etc. Repeated use of the drug that provoked the development of such a reaction will only increase the severity of its manifestation. Drug allergies are often classified as side effects that develop extremely rarely. Patients often confuse the side effects of the drug, which most often manifest themselves in a mild form, with an allergic reaction, which can even result in the death of the patient.

Diagnosis and treatment of drug allergies

To diagnose such immediate reactions, skin tests are often taken from patients. As for the direct treatment of drug allergies, it most often involves the treatment of pain and itching. If the medicine that causes an allergic reaction is vital and cannot be stopped, then patients will have to put up with all the unpleasant symptoms that they experience.

Weight loss medications and their side effects

If we talk directly about the medications that are used in the fight against obesity, then all of them involve, first of all, appetite suppression. Such medications are sold both in tablet and capsule form. By influencing the body, they seem to deceive it, as a result of which a person does not experience hunger. They also tend to reduce appetite by increasing the amount of catecholamines - chemical components of the brain that have a direct effect on both appetite and mood. Fat absorption inhibitors, which are part of such pharmaceuticals, prevent the absorption of fats that enter the body along with food. Undigested fat is, in turn, excreted from the body through feces.

It is also important to note the fact that these medications tend to cause the development of various side effects.

The list of adverse reactions can include:

• insomnia;
• anxiety;
• headache;
• increased sweating;
• increased heart rate;
• dry mouth;
• increased blood pressure;
• nasal congestion;
• excessive thirst;
• drowsiness;
• cramping abdominal pain;

Drugs for the treatment of psoriasis

Biologics are another group of medications that are increasingly used in the fight against this disease. Biologics are medications that resemble or are identical to proteins produced by the human body. The list of such drugs includes etanercept and alefacept, which tend to block the negative reaction of the human immune system, which causes signs of this pathology.

If topical medications do not have the desired therapeutic effect, then patients are prescribed medications that should be taken orally. These drugs include methotrexate, cyclosporine and retinoids such as acitretin.

Drug treatment of gout

Arcoxia is a non-steroidal anti-inflammatory drug that can also be used to treat this disease. This drug also has analgesic and antipyretic effects.

Ambene - this drug is intended for short-term treatment of critical situations with gout.

Drugs for the treatment of spinal osteochondrosis

• reduce the severity of pain in the back;
• eliminate inflammation;
• restore regeneration of cartilage and connective tissue of the intervertebral disc;
• prevent further development of the disease;
• functionally rehabilitate the patient.

Often, the course of therapy includes the use of antidepressants, such as fluoxetine or amitriptyline. The thing is that such drugs tend not only to balance the psyche, but also to have a fairly pronounced analgesic effect. Studies have shown that it is with the help of antidepressants that it is possible to achieve better control over pain and significantly shorten the course of therapy.

Medicines to improve memory

Another fairly well-known drug that is used directly to improve memory is a medication called glycine. This drug is available only in tablet form, but in terms of effectiveness it is in no way inferior to nootropil. With its help, it is possible to reduce irritability and aggressiveness, normalize sleep, make it easier to fall asleep, as well as increase performance and significantly improve memory. As for side effects, only allergic reactions can develop against the background of its use.

Akatinol memantine is also considered to be a very effective means of improving memory, which tends to improve the process of nerve impulse transmission, normalize membrane potential and increase learning ability. This medicine is produced in the form of tablets, the active components of which are absorbed into the blood in a fairly short period of time.

Medicines to relieve alcohol addiction

Veritrol is one of the newest drugs that helps even when previous treatment for alcoholism, for one reason or another, did not have the desired therapeutic effect. This drug is recommended to be administered in two doses, the interval between which is about half an hour. After such a procedure, the patient will need to take Finlepsin and Lucetam for a month. This approach makes it possible to enhance the effectiveness of encoding and minimize the craving for alcoholic beverages.

All of the above drugs have one common property. If a patient coded with one of these drugs begins to drink alcohol, then the drug forms a toxic compound with alcohol, which endangers both the organs and systems of the body, and sometimes even the life of the patient.

Many people believe that a drug is a substance taken to reduce pain or as a sleep aid. The composition of a particular medicine usually includes many different substances. The preparation of medicines and healing with their help have been known since ancient times. The ancient priests, who had the right to heal, prepared their potions from plants. The ancient Greeks also used plants to prepare medicines a thousand years ago. To this day, most medicines are prepared from plants.

Morphine and opium are prepared from poppy juice. Cocaine is used as a painkiller during surgery and is prepared from the coca plant. Quinine is obtained from the bark of the cinchona tree. Castor oil is obtained from castor beans. A large number of medicines we use are obtained from minerals - for example, salts, bromides, phosphorus. Did you know that animal organs can also produce beneficial medicinal substances for humans? These include the thyroid gland, adrenal glands, and pancreas.

Another group of drugs are vaccines, toxins and antitoxins. The vaccine contains dead or weakened pathogens. Placed in the body, they create antibodies that enter the bloodstream and protect against the disease itself. Toxins work in the same way, but they contain inactive poisons produced by disease-causing microbes. Antitoxins contain a large amount of antibodies, which when introduced into the body increases its resistance to infection. With the development of science, man was able to obtain artificial medicines. They are not created by plants or animals, but in laboratories through chemical research.

Now the number of artificial drugs is becoming more and more, and their production is becoming cheaper. Probably everyone is well aware of such an artificial medicine as aspirin. Relatively recently, science discovered another medicine - antibiotics. These chemicals are obtained from mold fungi.

Antibiotics have the ability to stop the growth of many pathogenic bacteria. The two most well-known antibiotics are penicillin and streptomycin.

In addition, there is also Nosological classification.

Prescription and over-the-counter drugs

In world practice, there is the concept of “over-the-counter” and “prescription” drugs. The latter suggest a greater potential danger of use without a doctor's prescription. There is a constant struggle between the “pharmaceutical” and “medical” lobbies (respectively, for the expansion of the 1st or 2nd group of drugs and the corresponding business).

State regulation is designed to take into account the interests of the population (the dilemma of “availability” and/or “safety” of medicines) - without bias towards the interests of the pharmaceutical or medical business.

Homeopathic medicines

In a number of countries, these products are regulated differently - either as the category “Medicines”, or as “Food products and supplements”, or as “alternative medicine”. Currently, there is no established opinion of international organizations on this matter, agreed upon with national health authorities.

In the Russian Federation, homeopathic medicines are subject to the same legislative regulation as conventional medicines.

Legislative regulation

The circulation of medicines is regulated by law and by-laws, including the regularly updated list of Vital and Essential Medicines (VED), List of Narcotic Drugs, etc.

Economic consequences of legislative regulation

In Ukraine, there is a practice of refunding excise duty for the use of alcohol in the production of medicines - only after their sale.

Bodies of state control over the quality of medicines

The quality of medicines in Russia is controlled by the Federal Service for Surveillance in Healthcare and Social Development (Roszdravnadzor), subordinate to the Ministry of Health and Social Development of the Russian Federation.

In most large cities of Russia there are Centers for Quality Control of Medicines. Their main task is to check organizations selling medicines (compliance with numerous standards for the storage and sale of medicines), as well as selective (and in some regions, total) control of medicines. Based on data from regional centers, Roszdravnadzor will make decisions on rejecting a particular drug.

This is how it should be ideally. In practice, everything looks a little different.

Firstly, the vast majority of drug quality control centers are poorly equipped, and they are not able to conduct a complex chemical analysis of a modern drug. An even more complex situation arises with microbiological research, which is either not carried out at all or is carried out in a very reduced volume. As a result, all, so to speak, studies are often limited to assessing the appearance of the medicine (whether there is an unacceptable sediment, whether the tablets are cracked, whether the packaging is correctly designed, a crooked label, etc.).

Secondly, according to the current legislation in Russia, it is unacceptable to require additional analysis from the seller if the medicinal product already has a valid certificate (declaration) of conformity. Thus, all additional studies must be carried out at the expense of the Centers for Quality Control of Medicines. In reality, this results in additional costs for the seller.

Thirdly, the Centers for Quality Control of Medicines must produce selective drug control. In many regions of Russia (for example, Stavropol, Tver region, Tatarstan), repeated inspection is of a total nature. This is generally illegal, and due to the lack of equipment in laboratories, it is simply pointless, which leads to significant difficulties in the sale of not only counterfeit and low-quality medicines, but also medicines in general.

As a result of the above, we can say that the majority of regional Centers for Quality Control of Medicines today do not fulfill their tasks, only creating the ground for bribes and unfair competition.

Rejected and falsified medicines are subject to withdrawal from the pharmacy network; information about them is posted on the following websites:

Original medicines and generics

An original medicine is a drug that was first released by the developer. As a rule, the development and marketing of a new drug is a very expensive and lengthy process. From a variety of known compounds, as well as newly synthesized ones, substances with maximum target activity are identified and synthesized using the brute force method, based on databases of their properties and computer modeling of their expected biological activity. After animal experiments, in case of a positive result, limited clinical trials are carried out on groups of volunteers. If the effectiveness is confirmed and the side effects are insignificant, the medicine goes into production, and based on the results of additional tests, possible features of the action are clarified and undesirable effects are identified. Often the most harmful side effects are revealed during clinical use.

In this case, the manufacturer patents this new drug. All other firms can produce synonyms (the so-called generics), but using our own technology, if the bioequivalence of the drugs is proven. Of course, they cannot use the brand name for this medicine, but only the INN, or any new one patented by them. Despite the new name, such drugs may be similar or very close in their effects.

Are original drugs and generics completely equivalent? From a chemical point of view, the active substance is the same. But the production technology is different, and different degrees of purification are possible. There are other factors too. For example, it is known that for a long time different companies could not achieve the same effectiveness of acetylsalicylic acid (generic) as that of Bayer AG, the manufacturer of the original drug “aspirin”. It turned out that the matter is not only in the purity of the raw materials, but also in the special method of crystallization, which results in special, smaller crystals of acetylsalicylic acid. There can be many such nuances. The opposite result is also possible, when the generic drug turns out to be more successful than the original medicine.

In modern drugs, only one of the isomers (enantiomers) may be biologically active; the other may be weakly active, inactive, or even harmful (see Bioavailability).

Illegal actions in the production and circulation of medicines

Falsification of medicines, counterfeit medicines

The pharmaceutical business is considered the third most profitable, after the arms and drug trade. This attracts unscrupulous entrepreneurs to him.

In Russia, until 1991, the problem of drug counterfeiting was practically absent.

Falsification

Counterfeiting is a deliberate change in the recipe for the production of a medicinal product. Replacing expensive components with cheaper ones, or reducing the content (or in the worst case, completely eliminating) 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, low-quality packaging materials, etc.

Counterfeit

Counterfeit medicines are medicines produced without the permission of the patent holder - the developer company.

The effectiveness of a drug is primarily determined by the active substance (but not only by it, see bioequivalence). According to international law, the formula or composition of the active substance cannot be a company secret. But this information is closed for some time (about several years) to other manufacturing companies, which, even under a different name, cannot produce this medicine without the permission of the patent holder.

Even after the end of the allotted period, other companies cannot use the name of the medicinal product (Brand) registered by the company - the patent holder (the so-called patented form).

Drug manufacturers are tempted, knowing the formula, to produce drugs bypassing the patent owner. An example is the drug No-Shpa® (registered brand name). In fact, it is a fairly simply synthesized drug, the active substance of which has the non-proprietary name “drotaverine”. However, several generations of people have used No-Spa and don’t know anything about some drotaverine. Accordingly, the price of a branded drug is 10(!) times higher than the price of the drug drotaverine, which is exactly the same in composition, manufacturing technology and action. It is not surprising that in some factories that produce cheap domestic drugs during the day, at night the same drugs are packaged in foreign, branded packaging. It should be added that this usually does not affect the quality of the medicine, since the counterfeit manufacturer is afraid to arouse even the slightest suspicion on the part of the inspection authorities.

Illicit drug trafficking

Narcotic substances are subject to more stringent handling rules than other drugs. However, due to the increased demand for them, situations arise in which officials neglect the proper performance of official duties.

• The flip side of tightening the requirements for the circulation of narcotic drugs is that it is unreasonably difficult for persons with direct indications for use (cancer diseases, etc.) to obtain them.

see also

Links

Wikimedia Foundation. 2010.

Medicines are also created by chemical synthesis, not using biological technologies, but using the activity of microorganisms. Humanity has been using medicines since time immemorial, but in the history of pharmacotherapy there are periods (from the 19th to the early 20th centuries) when the positive role of medicines was denied, and this was considered a sign of an advanced way of thinking. The denial of pharmacotherapy was expressed in a punning saying: “Treat with your mind, not with medicine.”

Medicines are dosed medicines, ready for use. They are divided into poisonous, potent and general purpose. When taking it, it is important to strictly follow the dose.

A single dose is the amount of drug calculated for one dose. If the drug is dispensed by prescription, the doctor determines the single dose. When using medications on your own, it is important to correctly determine their dose (for example, if you need to take 500 mg of the drug, and the tablet contains 1000 mg, then you need to take 1/2 of the tablet).

The highest single dose is the maximum amount of the drug calculated for one dose.

The highest daily dose is the maximum amount of the drug that can be taken per day.

Medicine is usually called tablets, mixtures, powders, etc. However, these are only medicinal forms of certain medications.

Each drug contains an active substance that determines its medicinal properties.

An ordinary tablet may consist entirely of the active substance, but much more often it is a mixture of it with auxiliary, non-medicinal substances. The fact is that medicinal doses of a particular substance are often milligrams and even fractions of a milligram, and therefore a tablet entirely consisting of such a substance would have microscopic dimensions. Filler substances, in addition, can slow down or, conversely, accelerate the effect of the drug. Therefore, even medications with the same active ingredient sometimes cause different effects. You should remember this and take the product only under the supervision of a doctor.

To date, more than 7 thousand drugs have been developed in the world, and most of them have appeared in the last 25 years.

Before starting treatment, consult your doctor.

Medicines

Medicines are substances or mixtures of substances used for the prevention, diagnosis, treatment of diseases, as well as for the regulation of other conditions (for example, preventing pregnancy, etc.). Medicines are obtained from a wide variety of substances by synthesis, through various chemical reactions, extraction, using biotechnology and other methods (including from blood, blood plasma, as well as organs, human or animal tissues, plants, minerals).

Thus, medicinal products include substances of plant, animal or synthetic origin that have pharmacological activity and are intended for the production and manufacture of dosage forms.

Classification of drugs

Prescription and over-the-counter drugs

In world practice, there is the concept of “over-the-counter” and “prescription” drugs. The latter suggest a greater potential danger of use without medical advice. There is a constant struggle between the “pharmaceutical” and “medical” lobbies (respectively, for the expansion of the 1st or 2nd group of drugs and the corresponding business).

State regulation is designed to take into account the interests of the population (the dilemma of “availability” and/or “safety” of medicines) - without bias towards the interests of the pharmaceutical or medical business.

Homeopathic medicines

In a number of countries, these products are regulated differently - either as “Medicines”, or as “Foods and Supplements”, or as “Alternative Medicines”. Currently, there is no established opinion of international organizations on this matter, agreed upon with national health authorities.

In the Russian Federation, homeopathic medicines are subject to the same legislative regulation as conventional medicines.

Legislative regulation

From the point of view of Russian legislation, at the moment (2006), a medicinal product is a drug included in the state register of medicinal products.

The production of approved medicines must comply with the international requirements of the GMP standard, however, the introduction of this requirement in a number of CIS countries is carried out gradually, as the equipment of the main operating enterprises is updated.

The sale of medicines (as opposed to dietary supplements) is carried out only by specialized stores (pharmacies, pharmacy kiosks) that have the appropriate license.

The circulation of medicines is regulated by law and by-laws, including the regularly updated list of Vital and Essential Medicines (VED), List of Narcotic Drugs, etc.

Economic consequences of legislative regulation

VAT on the sale of medicines (Russia, 2006) corresponds to 10% (in contrast to dietary supplements - 18%).

In Ukraine, there is a practice of refunding excise duty for the use of alcohol in the production of medicines - only after their sale.

Bodies of state control over the quality of medicines

The quality of medicines in Russia is controlled by the Federal Service for Surveillance in Healthcare and Social Development (Roszdravnadzor), subordinate to the Ministry of Health and Social Development of the Russian Federation.

In most large cities of Russia there are Centers for Quality Control of Medicines. Their main task is to check organizations selling medicines (compliance with numerous standards for the storage and sale of medicines), as well as selective (and in some regions, total) control of medicines. Based on data from regional centers, Roszdravnadzor will make decisions on rejecting a particular drug.

This is how it should be ideally. In practice, everything looks a little different.

Firstly, the vast majority of drug quality control centers are poorly equipped, and they are not able to conduct a complex chemical analysis of a modern drug. An even more complex situation arises with microbiological research, which is either not carried out at all or is carried out in a very reduced volume. As a result, all, so to speak, studies are often limited to assessing the appearance of the medicine (whether there is an unacceptable sediment, whether the tablets are cracked, whether the packaging is properly designed, a crooked label, etc.).

Secondly, according to the current legislation in Russia, it is unacceptable to require additional analysis from the seller if the medicinal product already has a valid certificate (declaration) of conformity. Thus, all additional studies must be carried out at the expense of the Centers for Quality Control of Medicines. In reality, this results in additional costs for the seller.

Thirdly, the Centers for Quality Control of Medicines must produce selective drug control. In many regions of Russia (for example, Stavropol, Tver region, Tatarstan), repeated inspection is of a total nature. This is generally illegal, and due to the lack of equipment in laboratories, it is simply pointless, which leads to significant difficulties in the sale of not only counterfeit and low-quality medicines, but also medicines in general.

As a result of the above, we can say that the majority of regional Centers for Quality Control of Medicines today do not fulfill their tasks, only creating the ground for bribes and unfair competition.

Rejected and falsified medicines are subject to withdrawal from the pharmacy network; information about them is posted on the following websites:

Original medicines and generics

An original medicine is a drug that was first released by the developer. Typically, developing a new drug is a very expensive and lengthy process. From a variety of known compounds, as well as newly synthesized ones, substances with maximum target activity are identified and synthesized using the brute force method, based on databases of their properties and computer modeling of their expected biological activity. After animal experiments, in case of a positive result, limited clinical trials are carried out on groups of volunteers. If the effectiveness is confirmed and the side effects are insignificant, the medicine goes into production, and based on the results of additional tests, possible features of the action are clarified and undesirable effects are identified.

In this case, the manufacturer patents this new drug. All other firms can produce synonyms (the so-called generics), but using our own technology, if the bioequivalence of the drugs is proven. Of course, they cannot use the brand name for this medicine, but only the INN, or any new one patented by them. Despite the new name, such drugs may be similar or very close in their effects.

Are original drugs and generics completely equivalent? From a chemical point of view, the active substance is the same. But the production technology is different, and different degrees of purification are possible. There are other factors too. For example, it is known that for a long time different companies could not achieve the same effectiveness of acetylsalicylic acid (generic) as that of Bayer AG, the manufacturer of the original drug “aspirin”. It turned out that the matter is not only in the purity of the raw materials, but also in the special method of crystallization, which results in special, smaller crystals of acetylsalicylic acid. There can be many such nuances. The opposite result is also possible, when the generic drug turns out to be more successful than the original medicine.

In modern drugs, only one of the isomers (enantiomers) may be biologically active; the other may be weakly active, inactive, or even harmful (see Bioavailability).

Illegal actions in the production and circulation of medicines

Falsification of medicines, counterfeit medicines

The pharmaceutical business is considered the third most profitable, after the arms and drug trade. This attracts unscrupulous entrepreneurs to him.

In Russia, until 1991, the problem of drug counterfeiting was practically absent.

After the collapse of the USSR, which was caused by a decrease in the production of our own drugs and a sharp increase in imports, the problem became urgent. About a tenth of all drugs sold on the world market are fake or counterfeit.

• 1998 The first official case of detection of counterfeit drugs in Russia was registered
• 2004 Introduction of the concept of “falsified medicines” into Russian legislation

In the Russian history of drug falsification, 3 stages can be roughly distinguished:

It is necessary to distinguish between falsification of a medicine and counterfeit medicines.

Falsification

Counterfeiting is a deliberate change in the recipe for the production of a medicinal product. Replacing expensive components with cheaper ones, or reducing the content (or in the worst case, completely eliminating) 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, low-quality packaging materials, etc.

Counterfeit

Counterfeit medicines are medicines produced without the permission of the patent holder - the developer company.

The effectiveness of a drug is primarily determined by the active substance (but not only by it, see bioequivalence). According to international law, the formula or composition of the active substance cannot be a company secret. But this information is closed for some time (about several years) to other manufacturing companies, which, even under a different name, cannot produce this medicine without the permission of the patent holder.

Even after the end of the allotted period, other companies cannot use the name of the medicinal product (Brand) registered by the company - the patent holder (the so-called patented form).

Drug manufacturers are tempted, knowing the formula, to produce drugs bypassing the patent owner. An example is the drug No-Shpa® (registered brand name). In fact, it is a fairly simply synthesized drug, the active substance of which has the non-proprietary name “drotaverine”. However, several generations of people have used No-Spa and don’t know anything about some drotaverine. Accordingly, the price of a branded drug is 10(!) times higher than the price of the drug drotaverine, which is exactly the same in composition, manufacturing technology and action. It is not surprising that in some factories that produce cheap domestic drugs during the day, at night the same drugs are packaged in foreign, branded packaging. It should be added that this usually does not affect the quality of the medicine, since the counterfeit manufacturer is afraid to arouse even the slightest suspicion on the part of the inspection authorities.

Illicit drug trafficking

Narcotic substances are subject to more stringent handling rules than other drugs. However, due to the increased demand for them, situations arise in which officials neglect the proper performance of official duties.

• The flip side of tightening the requirements for the circulation of narcotic drugs is that it is unreasonably difficult for persons with direct indications for use (cancer diseases, etc.) to obtain them.

5. Drug substance, drug, drug, dosage form

Drug – any substance or product used to modify or study physiological systems or pathological conditions for the benefit of the recipient (according to WHO, 1966); individual substances, mixtures of substances or compositions of unknown composition that have proven medicinal properties.

A medicinal substance is an individual chemical compound used as a medicine.

Dosage form is a form convenient for practical use, given to a medicinal product to obtain the necessary therapeutic or prophylactic effect.

A medicinal product is a medicinal product in a specific dosage form approved by a government agency.

6. Names of drugs, generic drugs.

a) full chemical name: para-acetaminophenol

b) international (non-proprietary, officially approved in the pharmacopoeia): “Paracetamol”

c) trade (patented): “Panadol”

Generic drugs (generic drugs) are drugs that have chemical, biological and clinical equivalence with known drugs whose patent protection has expired.

7. Concepts about pharmacokinetics and pharmacodynamics.

Pharmacokinetics is everything that the body does with a drug: it studies the absorption, distribution, metabolism (biotransformation), interaction with proteins in plasma and other tissues, and elimination of the drug.

Pharmacodynamics is everything that a drug does to the body: it studies the localization, mechanism of action, biochemical, physiological, side, toxic effects of drugs, their strength and duration.

8. Main components of pharmacokinetics:

Communication with plasma proteins and other tissues

Metabolism (biotransformation) of drugs

Elimination of drugs from the body

9. Ways of introducing drugs into the body. Presystemic elimination of drugs.

Routes of administration of drugs into the body:

1. For systemic action

A. Enteral route of administration:

Inside (peros) - orally

Through a probe (for example, into the duodenum)

b. Parenteral route of administration: intravenous, subcutaneous, intramuscular, inhalation, subarachnoid, transdermal.

2. For local exposure:

In the cavity (abdominal, pleural, articular)

In tissue (infiltration)

Presystemic elimination of drugs - loss of drugs before entering the general circulation system (i.e., into the systemic bloodstream) - losses during the first passage (through the liver).

10. Transport of drugs across biological barriers: basic mechanisms and determinants.

The main mechanisms of drug transfer:

a) filtration through water channels of membranes (pore diameter about 4 Ắ), typical for water, some ions, small hydrophilic molecules (urea).

b) diffusion in lipids is the main mechanism of drug transfer; drugs diffuse passively along a concentration gradient.

2) active (i.e. occurring with energy consumption):

a) active transfer - the transfer of drugs, regardless of the concentration gradient, using the energy of ATP, typical for hydrophilic polar molecules, a number of inorganic ions, sugars, amino acids, pyrimidines.

b) microvesicular transport (pinocytosis) - invagination of the cell membrane and subsequent capture of drugs with the formation of a vacuole (absorption of vitamin B 12 in combination with the intrinsic factor of Castle and some protein molecules).

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What is a drug

A medicinal product (MD) is a special substance or a combination of several substances of natural, synthetic or biotechnological origin, possessing pharmacological activity and in a certain dosage form used for the prevention and diagnosis of diseases, treatment and medical rehabilitation of patients, and prevention of pregnancy through internal or external use.

Classification of drugs (main criteria):

1. By physical state (dosage form):

Solid (tablets, dragees, granules, powders, preparations, hard gelatin capsules, films);

Soft (ointments, gels, creams, suppositories, soft gelatin capsules);

Liquid (solutions, tinctures, extracts, suspensions, emulsions, syrups);

2.According to dosing method:

Dosed (powders, solutions, tablets, capsules and others, divided into individual doses);

Undosed (ointments, gels, powders, bath powders, etc.);

3. According to the method and route of administration into the body:

Enteral - introduced into the body through the gastrointestinal tract (through the mouth - orally, under the tongue - sublingually, through the rectum - rectally);

Parenteral - administered, bypassing the gastrointestinal tract (by injection into the vascular bed (artery, vein), under the skin or into the muscle, by application to the skin and mucous membranes of the body, by inhalation).

4. By anatomical-therapeutic-chemical groups (international classification):

According to the nosology of the disease for which the drug is intended to treat

According to the pharmacological action of drugs,

Its chemical structure

Group L: Antineoplastic drugs and immunomodulators

L 01 Antineoplastic drugs

L 01 C Alkaloids of plant origin

L 01 CA Vinca alkaloids and its analogues

L 01 CA01 Vinblastine

L 01 CA02 Vincristine

L 01 CA04 Vinorelbine

L 01 CD Taxoids

L 01 CD01 Paclitaxel

L 01 CD02 Docetaxel

Dosage form is the form given to a medicinal product, which determines its condition, dosage, packaging and method of administration.

Types of dosage forms of drugs:

Solid (tablets, hard gelatin capsules, powders, granules);

Liquid (solutions, suspensions, emulsions);

Soft (ointments, creams, gels, suppositories, soft gelatin capsules);

2. Pharmacy and pharmaceuticals: history of origin and development. « | » 4. Composition of medicines | pharmaceutical substance, excipient.

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Medicines - what are they? Classifications

Pharmacology is the science that studies how drugs act on the human body and how new drugs are obtained. Even the ancient Greeks and Indians, the inhabitants of the tundra and the southern edge of Africa tried to defeat diseases and looked for ways to combat them. People have always strived for this, making their obsession their main dream.

A little about pharmacological terminology

Medicines are substances or combinations of substances used by people to treat diseases or for preventive purposes.

Medicines are medicines that are ready for use. Medicines can have different forms, which makes their use convenient and creates the opportunity to individually approach the treatment of each patient. The variety of drug release forms allows them to be delivered to the body in different ways, which helps to work with patients who are unconscious and treat patients who have suffered injuries or burns.

Concept of lists: A and B

There is a division of all drugs into three main groups:

• List A includes drugs containing poisons.
• List B includes potent drugs and analgesics.
• Medicines available without a doctor's prescription include all others.

To obtain drugs of classes A and B from pharmacy chains, you must have a special prescription. They require that they be treated with increased attention: they know how to take them correctly, as well as the conditions for proper storage of these medications. Some are degraded by sunlight or become toxic if kept in light.

In addition, there is strict reporting on the use of certain drugs (such drugs include morphine). In this case, the drugs are handed over in ampoules by nurses after the shift, which must be confirmed by a corresponding entry in the journal. Medicines considered to be antipsychotics, vaccines, and anesthesia drugs are also subject to registration.

What is a recipe?

A prescription is a special note from a doctor to pharmacists or pharmacists, which contains a request to allow the patient to purchase a medicine. The prescription specifies the form, dose, method and frequency of use of the medicine.

The prescription form is at the same time a medical, legal and monetary document in the case when the medicine is issued free of charge and at a discount. Based on the existing legislation regulating the rules for issuing prescriptions, this can be done by a doctor of any specialty and position.

Medicines can not only eliminate or prevent diseases. It can also be poisonous, so the doctor must be careful when writing a prescription: the dosage indication must be precise and correct.

Concept of drug dosage

When filling out a prescription form, the doctor writes down, using Arabic numerals, the amount of the medicinal substance, indicating mass or volume units in the decimal system, separating grams with a comma (1.5). The drops that make up the medicinal substance are designated using Roman numerals. The composition of some antibiotics is calculated only in international or biological units, designated IU or ED.

There are various forms of medicinal substances: solid, liquid, gaseous. Milliliters are used to indicate the amount of liquids and gases in a prescription, and for inhalations, doctors sometimes mark the doses of dry medicinal substance. At the bottom of the prescription, the doctor puts his signature and personal seal. Also in the prescription it is necessary to indicate the surname, initials, age of the patient, put the date and expiration date of the prescription.

Prescriptions are issued on special forms for the purchase of subsidized medications, narcotic substances, sleeping pills, antipsychotics and painkillers. Such prescriptions are signed by the attending physician, the chief physician of the hospital, and certified with a seal. A round seal of the medical institution is also affixed.

It is prohibited to prescribe ether for anesthesia, fentanyl, chloroethane, ketamine and other sedatives in outpatient clinics. Doctors in most countries use Latin to write prescriptions. Medication recommendations are made in language that patients can understand.

Permission to sell narcotic and poisonous drugs is issued for five days, medical alcohol - for ten days, and prescriptions for other medications are valid for two months after issue.

What is the general classification?

Today there are many unusual medicines, so they need to be classified for proper orientation. There are the following conditional classification guidelines:

1. Therapeutic action is a group of drugs that are used to treat one disease.
2. Pharmacological action - the effect produced by a drug.
3. Chemical structure.
4. Nosological principle, which is similar to the therapeutic one, but with a narrow distinction.

Dividing drugs into groups

The development of medicine led to the fact that doctors had to begin systematizing medicines. The classification was made by chemists and pharmacists using the principle of application point. It consisted of the following categories:

1. Psychotropic drugs and drugs that have a therapeutic effect on the cells of the central nervous system (tranxylizers, antipsychotics, sedatives, antidepressants, antiepileptics, anti-inflammatory drugs).
2. Medicines for the treatment of the peripheral nervous system (ganglionic blockers, anticholinergics).
3. Local anesthetics.
4. Drugs that change vascular tone.
5. Diuretics and choleretic agents.
6. Medicines for the treatment of internal secretion and metabolic organs.
7. Antibiotics and antiseptics.
8. Antitumor drugs.
9. Means that allow diagnostics (dyes, contrast agents, radionuclides).

With the help of this and similar divisions, young doctors are studying the drugs that exist today. Using classification into groups, doctors intuitively understand how a particular drug works and remember the doses.

Medicines are classified according to their chemical structure

Antiseptic and antimicrobial drugs are classified according to this criterion. Medicinal substances are bactericidal and bacteriostatic, and differ in their chemical structure, which underlies the mechanism of action of the drug on the body and their names.

• Halides. They are based on elements belonging to the halogen group (chlorine, fluorine, bromine, iodine).
• Oxidizing agents. The mechanism of their action is the ability to form free oxygen in large quantities (hydrogen peroxide, potassium permanganate, hydroperite).
• Acids. Various acids are used for medical purposes, but the most commonly used are salicylic and boric acids.
• Alkalis. These include sodium borate and ammonia.
• Aldehydes that remove fluid from tissues (formalin, ethyl alcohol and others).
• Salts of heavy metals.
• Phenols characterized by having an irritating and cauterizing effect on the body (carbolic acid, Lysol).
• Dyes. Used for diagnostics, as well as as a local irritant and antibacterial agent (methylene blue, brilliant green and others).
• Tars and resins in the form of Vishnevsky balsam, Wilkinson ointment, ichthyol and others. Used to improve local blood supply to tissues.

Solid medicines are drugs produced in the form of:

• Tablets obtained by pressing into a powder form, which contains active and auxiliary substances.
• Dragees - arranged in layers of active and auxiliary substances that are compressed around granules.
• Powder. They are used as powders for wounds, for intramuscular or intravenous injections (saline solution is used to dilute the powder). Powders come in non-dosed and dosed forms, simple and complex.
• The gelatin-coated capsule contains the medicine, which can be liquid, granular, powder or paste.
• Granules, most often used for the manufacture of homeopathic medicines, are small particles whose size does not exceed half a millimeter.

Medicines are available in liquid form

This method is used for preparing solutions, galenic and new galenic preparations, balms, collodions and other liquid and semi-liquid preparations.

• To form solutions, the drug is mixed with a solvent.
• To obtain herbal preparations, plant extracts are heated.
• Dry medicinal plants are used to prepare infusions and decoctions. Their composition is indicated in the prescription, and the solvent and its quantity are also indicated so that the pharmacist correctly prepares the medicine.
• Infusions and extracts are liquids that contain alcohol. They can be prepared in pure form, and can also be alcohol-based or alcohol-ether.
• To prepare novogalenic preparations, raw materials and the finished product are subjected to a high degree of purification.

Medicines of special forms

These include balms. Balm is an oily liquid with deodorizing and antiseptic properties.

Collodion is obtained by dissolving nitrocellulose in alcohol and ether. A one to six combination. Used for external use.

Any cream has a semi-liquid consistency and consists of plant extracts that are mixed with a base in the form of glycerin, wax, and paraffin.

It is better to give medicines to children in the form of lemonades and syrups. Young patients take them with pleasure and enjoy this treatment process.

Injections are made with sterile aqueous and oil solutions, which can be simple or complex. When writing a prescription, the doctor must indicate the dose of the drug and its volume, which one ampoule contains, and recommend the site of administration of the drug.

Soft medicines

The soft form of the medicine is obtained by using a fatty or fat-like substance as a base. They are defined, classified, manufactured by chemists and pharmacists. The doctor must only indicate the dose and indication for use in the prescription.

Medicinal ointments must contain at least twenty-five percent dry matter. The appropriate consistency can be achieved by mixing the powder and animal fat, wax, vegetable oils, petroleum jelly or polyethylene glycol.

The same conditions are used when making pastes, with the difference that they are more viscous. The consistency of liniments, on the contrary, should be more liquid. In addition, they are shaken before use in order to allow the settled powder to be evenly distributed in the solvent.

Candles or suppositories have a solid form, but when they enter the human body, they quickly melt and turn into liquid.

The patches remain solid while they are in a room at room temperature. Once on the skin, they melt and stick to it, which contributes to the formation of tight contact.

Most medicines are substances of plant origin, to which chemical or physical treatment is applied for better absorption by the body of an unhealthy person.