Medication
It should be borne in mind that the terms "drug" and "drug" (pharmaceutical, "drug") are full synonyms:
- A drug is a drug in a specific dose in the form of a specific dosage form, ready for use. In addition to the active ingredient, medicinal products often contain excipients formers, solvents, stabilizers, preservatives, dyes, flavors, etc.). Analogues of medicinal products with the same medicinal products, but differing depending on the manufacturer in the composition of excipients and (or) the form of release, appearance (for example, tablets), or only a patented name, are called generics. Medicines, depending on patent protection, can be original and reproduced. trade names can be the same as the name of the drug (INN) or have a different commercial name protected by copyright. Drugs belonging to the same pharmacological group, but having a different composition of the drug, are called analogues.
The term medicine can be applied to any of them and more colloquially.
Before being used in medical practice, medicinal products must undergo clinical trials and obtain permission for use.
History
Already in ancient times, people tried to save their lives by using various natural medicines. Most often these were plant extracts, but preparations were also used that were obtained from raw meat, yeast and animal excrement. 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 beans, opium, sea onions, known in ancient Egypt; mercury, known to the ancient Hindus; foxglove, lily of the valley, redflower and many others, widely used in folk medicine). It was only with the development of chemistry that people became convinced that the therapeutic effect of such substances consisted in the selective effect of certain chemical compounds on the body. Later, such compounds began to be obtained in laboratories by synthesis.
In the second half of the 19th century, advances in technology and the development of a number of scientific disciplines (anatomy, physiology, and especially chemistry) made it possible to synthesize a significant number of substances that did not exist in a given combination or form, but had a therapeutic effect (antipyrine, pyramidone, plasmocide, aspirin and hundreds of others), and, secondly, made it possible to make scientific experiment the basis for the study of the effects of drugs, as well as the search for new drugs. Experiment replaced the various theories that had hitherto prevailed in treatment and medicine (Paracelsus, Hahnemann, and others).
Paul Ehrlich, a German bacteriologist and chemist, is considered the founder of modern chemotherapy. In 1891, he developed a theory of the use of chemical compounds to combat infectious diseases.
Classification
There are several classifications based on different characteristics of medicines:
- by chemical structure (e.g., compounds-derivatives of furfural, imidazole, pyrimidine, etc.);
- by origin – natural, synthetic, mineral;
- nosological classification – classification according to the diseases for the treatment of which the drug is used;
- Anatomical-therapeutic-chemical classification (ATC) is an international classification that takes into account the pharmacological group of a drug, its chemical nature and the nosology of the disease for the treatment of which the drug is intended.
The raw materials for the production of medicines are:
- plants (leaves, grasses, 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 wool fat, etc.;
- fossil organic raw materials — oil and its distillation products, coal distillation products;
- 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-scale chemical industry.
Study
The study of drugs is carried out by means of chemical analysis, pharmacological studies, and clinical observations (see PHARMACOLOGY); At the same time, the active principles of the substance and its main qualitative indicators are determined: organotropy or parasitotropy of the drug, that is, its predominant effect on certain organs of the patient or on pathogens of the disease (bacteria, parasites, etc.); the presence of a "side" (undesirable) effect; The ability of a drug to make some individuals particularly sensitive (e.g., a runny nose and nausea from minute amounts of ipecacuana).
Quantitative indicators for a medicinal product are established: lethal dose (usually calculated per 1 kg of live weight of an animal or person), tolerated (tolerated) dose and therapeutic dose. Tolerated doses (or slightly less for caution) for many medications are legitimized as maximum doses. The ratio of lethal to therapeutic dose is called the "therapeutic index" of a drug, since the higher the ratio, the more freely the drug can be prescribed.
Action
The action of drugs is carried out mainly by changing the physical and chemical properties of the environment in which the cellular elements of the body are located; At the same time, the action can have the character of a chemical combination 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 drug is either excitation or inhibition of the vital activity of cellular elements; At the same time, the dose of the drug 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.
An essential point is the phase of action of drugs: some drugs can manifest their effect at the moment of penetration into the body (Kravkow's entry phase), others — most — during the period of maximum concentration in the body (saturation phase), still others — at the moment of concentration drop (exit phase); At the same time, the ability of some drugs to accumulate is extremely important, which manifests itself in a sharp increase and sometimes distortion of their action when repeated administration, which is explained by the accumulation of the drug in the body and the accumulation of its effect.
The effect of the drug depends on the age, gender, state of health and individual characteristics of the body of the person taking it. A number of drugs in a correspondingly reduced dose have a much stronger effect on children than on adults (often poisonous); Women during menstruation, pregnancy, lactation respond to medications differently than usual; In some individuals, the drug has an abnormally strong effect, which is explained by the body's increased sensitivity to certain substances (see: Idiosyncrasy).
Uses
The ways in which the drug is administered into the body are very diverse. Most often, oral medication is used. To avoid rapid degradation of the drug, irritation of the gastrointestinal tract, or to achieve the greatest rapidity of action, the drug is administered with a syringe subcutaneously, intramuscularly, or intravenously. Some medications are given through the rectum or by inhalation.
External application of drugs is considered to be 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, changed, and, entering into chemical compounds with its salts and liquids, lose their poisonous properties (and sometimes, on the contrary, acquire them) and are excreted from the body in one form or another through the intestines, kidneys, respiratory tract, sweat glands, etc.
Original medicines, synonyms, "generics" and analogues
The World Health Organization (WHO) considers a substance with an international nonproprietary name (INN) to be a medicine. In total, there were about 10 thousand substances with INN in the world by the beginning of 2019.
An original drug is a drug that was previously unknown and first placed on the market by a developer or patent holder. The development and marketing of a new drug is usually a very expensive and time-consuming process. From a variety of known compounds, as well as newly synthesized ones, substances with maximum target activity are identified and synthesized on the basis of databases on their properties and computer modeling of the expected biological activity. After animal experiments, in case of a positive result, limited clinical trials are conducted on groups of volunteers. If the efficacy is confirmed, and the side effects are insignificant, the drug goes into production, and based on the results of additional tests, the possible features of the action are clarified, and undesirable effects are identified. Often, the most harmful side effects are found out during clinical use.
At the same time, the period for which the 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 can prove the bioequivalence of the reproduced and original drugs. At the same time, the technology for the production of a generic drug can be any, but does not fall under the existing patent protection in the country. The manufacturer of a generic drug cannot use the brand name for this drug, but only the International Nonproprietary Name (INN) or some new one patented by it (synonym).
From the point of view of chemistry, the active ingredient of the original drug and the generic is the same, but the production technology is different, and different degrees of purification are possible. There are other factors that affect the efficacy of the drug. For example, for a long time, different companies could not achieve the same effectiveness of acetylsalicylic acid for generics as Bayer, the manufacturer of the original drug aspirin. It turned out that the matter was not only in the purity of the raw material, but also in a special method of crystallization, which resulted in special, smaller, crystals. The opposite result is also possible, when the generic drug turns out to be more successful than the original drug.
Analogue is a medicinal product based on a substance other than that used in the matched original and, therefore, with a different INN. Therefore, if the selection of a synonym or generic is the prerogative of the pharmacist, then the qualification of a doctor is required to prescribe an analogue (sometimes generics are also called similar drugs, which creates a certain confusion).
Falsification and counterfeiting
A distinction should be made between falsification of medicines and counterfeit medicines.
Falsification is a deliberate change in the formulation of the production of a drug. Replacing expensive components with cheaper ones or reducing the content (or in the worst case, no content at all) of the necessary component of the drug. For example, replacing the more expensive cefazolin with the 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 cleaning, low-quality packaging materials, etc.
Counterfeit medicines are medicines that are produced without the permission of the patent holder.
The efficacy of a drug is primarily determined by the active ingredient (but not only, see bioequivalence). According to the norms of international law, the formula or composition of the active ingredient cannot be a secret of the company. However, for a certain period of time, other companies are not allowed to produce this drug without the permission of the patent holder. Even at the end of the allotted period, other companies cannot use the original name of the drug (registered brand).
Prescription and over-the-counter medicines
A prescription for a medicinal product is a written prescription of a medicinal product in the prescribed form, issued by a medical or veterinary professional who has the right to do so, for the purpose of dispensing a finished medicinal product or its manufacture and dispensing. Accordingly, a prescription drug is a drug that is dispensed from a pharmacy only by prescription. An over-the-counter 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 prescription is approved by the order of the Ministry of Health However, this regulatory document became invalid in August 2011 and today there is no document or legally approved procedure for classifying a drug as over-the-counter. In this regard, pharmacy employees 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 is about 30 to. without a properly issued prescription, or (which is much more common) without it at all. In fact, this leads to the free sale of medicines. Uncontrolled intake and irrational use of drugs endanger not only patients, but also lead to the emergence of antibiotic-resistant strains of microorganisms, the spread of substance abuse, drug addiction and many other similar consequences.
Homeopathic medicines
In a number of countries, homeopathic medicines are regulated in different ways, either as "medicines," as "foods and supplements," or as "alternative medicine." At present, there is no well-established opinion of international organizations on this matter, coordinated with national health authorities.