What is mibp in medicine. V. Accounting for mibp in pharmacies. VI. Vacation organization

Let's look at the turnover of immunobiological drugs using the example of the pharmacy of LLC "Rifarm" in Chelyabinsk.

Immunobiological drugs of domestic and foreign production, registered in accordance with the legislation of the Russian Federation, are sold through pharmacies. The largest sales volume are vaccines.

Examples of attenuated vaccines:

· Live dry anthrax vaccine STI (STI is an abbreviation for the name of the Sanitary Technical Institute where the vaccine was developed). The finished product consists of a dried suspension of live spores of the vaccine strain variant. The vaccine is indicated for subcutaneous and scarification use.

· Plague vaccine live, dry. Prepared from live bacteria of the vaccine strain of the plague microbe.

· Dry live plague vaccine for oral use. It is prepared from a lyophilized live culture of a vaccine strain of plague microbes with a filler and is available in the form of tablets. The vaccine is suitable for the prevention of plague in persons aged 14 to 60 years. The tablet must be chewed; swallowing the tablet whole is prohibited. Post-vaccination immunity lasts for a year.

· Live dry concentrated tularemia vaccine. The vaccine strain is obtained from virulent pathogens by attenuation. The vaccine is administered cutaneously.

· Oral polio vaccine (OPV - oral polio vaccine) is a trivalent preparation from attenuated Seibin strains of polio virus types I, II, III, obtained from a primary culture of African green monkey kidney cells. In Russia, in addition to the domestic one, 2 more vaccines against polio are registered: the Imovax Polio vaccine (inactivated polio vaccine - IPV) and Polio Seibin VERO.

· Vaccine E typhus combined live dry. It is a suspension of Provacek rickettsia of the avirulent Madrid E strain grown in the tissue of the yolk sacs of chicken embryos in combination with the soluble antigen of Provacek rickettsia of the virulent Breinl strain. Available in lyophilized form. It is used for epidemic indications in outbreaks or possible outbreaks of typhus. It is administered subcutaneously. Post-vaccination immunity lasts for 3 years.

· Live measles culture vaccine (LCV). Prepared from a vaccine strain of measles virus grown in a fibroblast culture of Japanese quail embryos. In Russia, in addition to the domestic one, several more vaccines are registered for the prevention of measles:

Ruvax is a live vaccine for the prevention of measles (France).

MMR II is an associated vaccine for the prevention of measles, mumps and rubella (USA).

Priorix is ​​an associated vaccine against measles, rubella and mumps (Belgium).

· Live mumps vaccine based on an attenuated strain of the mumps virus grown in Japanese quail embryonic cell culture. There is no domestic rubella vaccine in Russia. Foreign drugs are used to prevent the disease:

Rubella vaccine Rudivax - is a lyophilisate (France);

Rubella-mumps-measles vaccines (MMR II and Priorix).

· Live vaccine against chickenpox - was created in 1974, by successive passages on cell cultures from the OKA virus strain. The most commonly used vaccines abroad are OKA Vax (France) and Varilrix (SmithKline Beecham). There are no recommendations for mass use yet.

Examples of divergent vaccines:

· BCG vaccine (BCG - Baccille Calmette-Guerin). A virulent strain of M. bovis isolated from a sick cow was obtained by long-term cultivation (for 13 years) on potato-glycerin agar with the addition of ox bile. In our country, a special drug has been developed - the BCG-M vaccine, intended for gentle immunization. This vaccine is used to vaccinate newborns who have contraindications to the administration of the BCG vaccine. In the BCG-M vaccine, the content of bacterial mass in the vaccination dose is reduced by 2 times.

· Brucellosis live dry vaccine (BZV). It is a lyophilized culture of live microbes of the B.abortus vaccine strain. Post-vaccination immunity for 1 year.

The following live influenza vaccines have been registered and approved for use in Russia:

· Influenza vaccine live allantoic intranasal for children over 7 years old, adolescents and adults (Irkutsk);

· Influenza vaccine live allantoic intranasal for children 3-14 years old (St. Petersburg);

· Purified live influenza vaccine for adolescents and adults (St. Petersburg).

Live influenza vaccines are made from attenuated, safe for humans, strains of influenza virus types A and B, cultivated in the allantoic fluid of chicken embryos.

· Vaccine against human smallpox. Created on the basis of the cowpox virus, which is non-pathogenic to humans.

Example of recombinant vaccines:

· Recombinant yeast vaccine against hepatitis B (Russia). Obtained by inserting the gene of the hepatitis B virus, responsible for the production of a specific gene, into yeast (or other) cells. After completion of the yeast cultivation process, the produced protein, HBsAg, is thoroughly processed to remove yeast proteins. Available in 1 ml containing 20 µg HBsAg (adult dose) and 0.5 ml containing 10 µg HBsAg (child dose).

Foreign analogues:

· Engerix V (Great Britain);

· HB-VAX II (USA);

· Euvax (South Korea);

· DNA recombinant vaccine against hepatitis B (Republic of Cuba).

Examples of corpuscular vaccines:

· Leptospirosis concentrated inactivated liquid vaccine - whole cell. It is a mixture of leptospira cultures killed by formaldehyde of four main serogroups: icterohaemorrhagiae, grippotyphosa, romona, sesroe. It is used for the prevention of leptospirosis for epidemic indications, as well as for immunization of donors in order to obtain anti-leptospirosis human immunoglobulin.

· Cholera (El-Tor) inactivated. Contains Vibrio cholerae - whole cell. Vaccination is carried out according to epidemiological indications for both adults and children from 2 years of age. The Choleric Pasteur vaccine (France) is practically an analogue of the domestic inactivated cholera vaccine (El-Tor).

In our country, 2 vaccines are used to prevent rabies:

· Rabies vaccine, culture purified inactivated dry (Rabivak);

· Rabies vaccine, culture inactivated concentrated.

Both vaccines are whole-virion - they represent a weakened rabies virus grown in a culture of Syrian hamster kidney cells, inactivated by UV rays.

· Inactivated whole virion influenza vaccine for adults over 18 years of age (St. Petersburg) - represents concentrated influenza viruses of subtypes A(H1N1) and A(H3N2) inactivated by UV irradiation and purified by ultracentrifugation. Virus cultivation is carried out on chicken embryos. Persons over 60 years of age, schoolchildren, students, medical workers, workers in the service sector, transport, and educational institutions are subject to vaccination. Vaccinations are carried out in the fall. The vaccine is administered subcutaneously and intranasally.

· Influvac is a trivalent subunit inactivated influenza vaccine containing purified surface antigens, hemagglutinin and neuraminidase, obtained from current influenza virus strains recommended by WHO, taking into account the variability of the virus.

· Meningococcal vaccine of groups A and C, dry polysaccharide - subcellular. Represents purified capsular specific polysaccharides of N.meningitidis serogroups A and C. Polysaccharides are isolated from a broth culture of meningococci. The drug is intended for the prevention of meningococcal infection for epidemic indications. Immunize children over 1 year of age, adolescents and adults in areas of meningococcal infection caused by serogroups A or C.

Foreign vaccines registered in Russia:

· meningococcal vaccine A+C (Meningo A+C) (France);

· meningococcal vaccine B+C (VA-MENGOC-BC) (Cuba); Post-vaccination immunity in children lasts for at least 2 years, and in adults - up to 10 years.

Examples of molecular vaccines:

· Pertussis-diphtheria-tetanus vaccine adsorbed liquid (DTP vaccine) - associated vaccine. It is a mixture consisting of a suspension of killed pertussis microbes and purified diphtheria and tetanus toxoids.

· Purified adsorbed diphtheria-tetanus toxoid (ADS-anatoxin) - is a mixture of purified diphtheria and tetanus toxoids.

Vaccinal prevention of cancer:

· Currently, a vaccine against HPV (human papillomavirus) produced by GSK has been developed and introduced to prevent cervical cancer. Indications: active immunization of women over 10 years of age.

Examples of heterologous immunoglobulins:

· Immunoglobulin against tick-borne encephalitis (equine antiencephalitis gamma globulin) is obtained from the blood serum of horses hyperimmunized with the tick-borne encephalitis virus. The drug contains a high titer of antibodies, mainly the gamma globulin fraction. It is used for the treatment and prevention of tick-borne encephalitis, and is also prescribed to people in endemic areas in case of tick bites.

· Anti-anthrax immunoglobulin (globulin) is an active beta- and gamma-globulin fraction isolated from hyperimmune sera of horses (AT against the anthrax microbe). Used for prophylactic purposes no later than 5 days after eating infected meat and 10 days after contact infection of the skin. For therapeutic purposes, administration of the drug begins after the diagnosis is established.

Examples of homologous immunoglobulins (human immunoglobulins):

· Human immunoglobulin against hepatitis B (Neohepatect, made in Germany) - a solution of a purified fraction of immunoglobulins isolated by ethanol fractionation from donor serum. Contains antibodies to the Hbs antigen of the hepatitis B virus. Administered to individuals from the “high risk” group.

· Human immunoglobulin antipertussis antitoxic. Obtained from the serum of donors vaccinated with pertussis toxoid.

· Anti-tetanus immunoglobulin donor is a solution of the gamma-globulin fraction of the blood of human donors revaccinated with purified sorbed tetanus toxoid. The drug is used for the purpose of passive emergency prevention of tetanus in unvaccinated children and adults, and, if necessary, for therapeutic purposes. Indications for the use of immunoglobulin are wounds and injuries with violations of the integrity of the skin and mucous membranes, burns and frostbite of the 2nd and 3rd degree, animal bites. The administration of immunoglobulin is also indicated for newborns and women giving birth at home, in addition - for women after out-of-hospital abortions. It is used alone or in combination with anti-tetanus toxoid to persons who have not been vaccinated against tetanus and who are hypersensitive to horse protein.

The following immunobiological preparations are available in the pharmacy of Rifarm LLC in Chelyabinsk:

1) Pentaxim - lyophilisate for preparing a suspension for intramuscular administration; bottle complete with suspension for intramuscular administration (syringes) 0.5 ml 1 piece - vaccine for the prevention of diphtheria, whooping cough, polio, tetanus and infections caused by Haemophilus influenzae type b.

2) Human immunoglobulin against tick-borne encephalitis - solution for intramuscular administration 1:160 ampoule 1 ml No. 10.

3) Immunoglobulin complex preparation for enteral use (IIP) - lyophilisate for the preparation of an oral solution 300 mg/dose, 5 ml bottle No. 5. The active ingredient is normal human immunoglobulin. Increases specific immunity, increases the content of immunoglobulins and antibodies to enterobacteria (Shigella, Salmonella, Escherichia, etc.).

4) Infanrix Hexa - a vaccine for the prevention of diphtheria, tetanus, whooping cough (acellular), polio (inactivated), hepatitis B combined, adsorbed along with a vaccine for the prevention of infection caused by Haemophilus influenzae type b - suspension for intramuscular administration 0.5 ml/ dose No. 1; syringe with a bottle and 2 needles.

5) Menactra - meningococcal polysaccharide vaccine (serogroups A, C, Y and W-135), conjugated with diphtheria toxoid - solution for intramuscular administration 0.5 ml/dose bottle No. 1.

Questions on special microbiology

First semester

1. Medical microbiology as the science of microorganisms and their relationships with the human body. The influence of Louis Pasteur's work on the development of medical microbiology. Problems of medical microbiology.

2. Discovery of microbes by A. Leeuwenhoek. Basic microscopy methods. Staining of bacteria. Morphology of bacteria.

3. Systematics, classification, nomenclature of microorganisms. Species as the basic taxonomic unit. The works of R. Koch and their significance in microbiology and medicine.

4. Ultrastructure of a bacterial cell. Features of the cell wall of gram-positive and gram-negative bacteria. Protoplasts, spheroplasts, L-forms of bacteria.

5. Disputes. Capsules. Flagella. They drank. Chemical composition and significance of these structures for bacteria.

6. Types and mechanisms of bacterial nutrition. Transport of nutrients into the cell. Bacterial enzymes are constitutive, inducible, exo- and endoenzymes. Practical use of the biochemical activity of bacteria.

7. Respiration of bacteria: aerobes, anaerobes, facultative anaerobes, microaerophiles. Growth and reproduction. Phases of bacterial reproduction under stationary conditions. Batch and continuous cultivation, its significance in biotechnology.

8. Factors affecting the growth and reproduction of bacteria. Nutrient media. Classification. Requirements for nutrient media. Bacteriological research method, its stages.

9. Isolation of pure cultures of aerobic bacteria. Key features in species identification.

10. Isolation of pure cultures of anaerobic bacteria. Key features in species identification.

11. D. I. Ivanovsky – founder of virology. Properties of viruses. Classification, morphology, structure of virions. Prions.

12. Interaction of viruses with cells of the host body (productive, abortive, integrative types of viral infection).

13. Cultivation of viruses in the body of laboratory animals, in chicken embryos, cell cultures. Purpose of nutrient media No. 199, Needle.

14. Bacteriophages are bacterial viruses. Interaction of virulent and temperate phages with bacterial cells. Lysogeny. Phage conversion. Application of phages in medical practice.

15. Mutations, their classification. Mutagens. Molecular mechanism of mutation. The role of mutation in evolution.

16. Transfer of genetic material in bacteria: transformation, transduction, conjugation, The significance of genetic recombinations in evolution.

17. Antibiotics. Discovery of antibiotics (A. Fleming). Classification of antibiotics by origin, chemical composition, nature of antimicrobial action. Units of measurement of their activity. Mechanisms of acquisition of drug resistance. Determination of bacterial sensitivity to antibiotics.

18. Structure of the bacterial genome. Plasmids and other extrachromosomal elements of bacteria. Islands of pathogenicity.

19. Application of molecular biological methods in the diagnosis of infectious diseases: molecular hybridization, polymerase chain reaction, restriction analysis, ribotyping.

20. Microflora of soil, water, air. Determination of microbial contamination of environmental objects. Sanitary indicator microorganisms.

21. Microflora of the human body, its functions. Microorganisms of various biotopes. Disturbances in the qualitative and quantitative composition of the normal microflora of the human body, the causes of their occurrence.

22. Basic physiological functions of the natural microflora of the human body, its participation in colonization resistance. Gnotobiology.

23. Destruction of microbes in the environment. Disinfection. Sterilization. Asepsis and antiseptics.

24. Infection. Infectious process. Classification of infectious processes according to the etiological principle, origin (exo- and endogenous), localization of pathogens in the host body, the number of pathogens that have entered the body, duration of the course.

25. Dynamics of development, microbiological and immunological characteristics of periods of infectious disease.

26. The role of the pathogen in the infectious process. Pathogenicity, virulence, units of measurement of virulence (DLM, LD50), infectious dose.

27. Structural components of a bacterial cell - virulence factors: capsules, pili, peptidoglycan, outer membrane proteins, LPS of gram-negative bacteria.

28. Secreted factors of pathogenicity of bacteria: bacteriocins, toxins, enzymes of aggression.

29. Comparative characteristics of bacterial exo- and endotoxins, mechanisms of action of exotoxins.

30. Virus pathogenicity factors: nucleic acids, proteins, enzymes. Acute, chronic and persistent viral infection.

Second term

1. Staphylococci. Classification. Pathogenicity factors. The role of staphylococci in the development of purulent-inflammatory diseases and nosocomial infections. Microbiological diagnosis of diseases caused by them. Principles of treatment and prevention of diseases caused by staphylococci.

2. Streptococci. Classification. Pathogenicity factors. The role of streptococci in the etiology of purulent-inflammatory and non-suppurative diseases. Microbiological diagnostics. Principles of treatment and prevention of diseases caused by streptococci.

3. Neisseria are the causative agents of meningococcal infection. Basic properties, pathogenicity factors. Pathogenesis, microbiological diagnosis, principles of treatment and prevention of meningococcal meningitis.

4. Gonococci are the causative agents of gonorrhea and blenorrhea. Pathogenicity factors. Pathogenesis of caused diseases. Microbiological diagnosis, principles of treatment and prevention of gonorrhea.

5. Enterobacteriaceae family. Diarrheagenic Escherichia. Classification. Pathogenicity factors. Microbiological diagnosis of escherichiosis. Principles of treatment and prevention of escherichiosis.

6. Shigella. Classification. Properties. Pathogenicity factors. Pathogenesis of dysentery. Microbiological diagnostics. Principles of treatment and prevention.

7. Salmonella genus. Classification. Properties. Pathogenicity factors. Pathogenesis of typhoid fever and acute gastroenteritis. Microbiological diagnostics. Immunity. Principles of treatment and prevention of typhoid fever. The role of Salmonella in the development of nosocomial infections.

8. Yersinia – causative agents of plague, pseudotuberculosis, intestinal yersiniosis. Pathogenicity factors of the plague pathogen. Pathogenesis of the disease. Microbiological diagnostics. Principles of treatment and prevention of plague.

9. Vibrio cholerae. Biovars. Pathogenicity factors. Pathogenesis of cholera. Microbiological diagnostics. Principles of treatment, general and specific prevention of cholera.

10. Spore-forming bacteria of the genus Clostridium are the causative agents of tetanus and botulism. Characteristics of toxins. Pathogenesis of diseases. Features of immunity. Principles of treatment. Specific prevention of tetanus and botulism.

11. Corynebacterium diphtheria. Pathogenicity factors. The significance of the tox gene for the production of diphtheria toxin. Pathogenesis of diphtheria. Microbiological diagnostics. Specific therapy and prevention.

12. Mycobacterium tuberculosis. Pathogenicity factors. Pathogenesis of the disease. Features of immunity. Microbiological diagnostics. Tuberculin diagnostics. Treatment. Specific prevention of tuberculosis.

13. Pathogenic spirochetes. The causative agent of syphilis. Pathogenicity factors. Pathogenesis of the disease. Microbiological diagnostics. Principles of treatment and prevention of syphilis.

14. Pathogenic spirochetes. The causative agent of Lyme disease. Pathogenicity factors. Pathogenesis of the disease. Microbiological diagnostics. Principles of treatment and prevention of disease.

15. Causative agents of candidiasis. Morphological features. Pathogenicity factors. Pathogenesis of the disease. Immunity. Microbiological diagnostics. Principles of treatment and prevention of candidiasis.

16. Picornaviruses. Polio viruses. Pathogenesis of the disease. Microbiological diagnostics. Immunity. Specific prevention of polio.

17. Enteral hepatitis viruses A and E. Features of pathogenesis. Microbiological diagnostics. Immunoprophylaxis of hepatitis A.

18. Filoviruses. Causative agents of hemorrhagic fevers Marburg and Ebola. Pathogenesis of diseases. Microbiological diagnostics. Principles of treatment and prevention of filovirus fevers.

19. Orthomyxoviruses. Influenza virus. Antigenic resistance. Pathogenesis of influenza. Microbiological diagnostics. Immunity. Principles of treatment and prevention of influenza.

20. Togaviruses. Rubella virus. Pathogenesis of acquired and congenital rubella. Principles of treatment. Specific prevention of rubella.

21. Parenteral hepatitis viruses B, D, C, G. Pathogenesis of diseases. Microbiological diagnostics. Principles of treatment and prevention. Specific prevention of hepatitis B and D.

22. Herpes viruses. HSV-1, HSV-2, Varicella-zoster. Pathogenesis of diseases. Microbiological diagnostics. Antiviral drugs. Specific prevention of caused diseases.

23. Herpes viruses. Cytomegalovirus. Pathogenesis of cytomegalovirus infection. Virus persistence. Microbiological diagnostics. Principles of treatment and prevention of cytomegalovirus infection.

24. Herpes viruses. EBV, HHV-8 type. Lymphotropicity of EBV. Persistence and oncogenicity of viruses. Microbiological diagnosis of infectious mononucleosis. Principles of treatment and prevention of diseases caused by EBV.

25. Retroviruses. AIDS virus. Genome structure. Pathogenesis of the disease. Microbiological diagnostics. Principles of treatment and prevention of HIV infection.

26. Slow viral infections. Conditions conducive to the persistence of viruses. Subacute sclerosing panencephalitis, progressive rubella panencephalitis, subacute herpetic encephalitis. Microbiological diagnostics.

27. Slow viral infections caused by prions. Causes of development of prion diseases. Pathogenesis of Kuru, Creutzfeldt-Jakob disease, etc. Laboratory diagnostics. Prevention.

28. Rhabdoviruses. Rabies virus. Pathogenesis of the disease. Microbiological diagnostics. Specific and nonspecific prevention of rabies.

29. Paramyxoviruses. Pathogenesis of measles, SSPE, mumps. Microbiological diagnostics. Principles of treatment and prevention of diseases.

30. Paramyxoviruses. Pathogenesis of parainfluenza and respiratory syncytial infection. Laboratory diagnosis of parainfluenza and RSV infection. Principles for the prevention of these diseases.

Additional questions for the exam.

1. RNA and DNA – containing oncogenic viruses. Classification. Molecular genetic mechanisms of viral oncogenesis.

2. General characteristics of the families Togaviridae, Flaviviridae, Bunyaviridae, members of the ecological group of arboviruses. Flaviviruses– causative agents of tick-borne encephalitis and Zika fever. Morphology and structure of virions. Cultivation and reproduction. Natural foci (hosts, vectors of viruses). Pathogenesis of tick-borne encephalitis and Zika fever. Laboratory diagnostics. General prevention. Active and passive immunoprophylaxis.

3. Coronaviruses. The causative agent of acute respiratory syndrome is SARS. Morphology and structure of the virion. Pathogenesis and clinical manifestations of the disease. Laboratory diagnostics. Express diagnostic methods. Prevention.

4. Adenoviruses. Morphology and ultrastructure of the virion. Pathogenesis and clinical manifestations of adenoviral infections. Laboratory diagnostics. General and specific prevention.

5. Leptospira. Properties. Pathogenicity factors. Pathogenesis of leptospirosis. Laboratory diagnostics. Prevention.

6. Chlamydia. Properties. Development cycle. Cultivation methods. Chlamydophila psittaci and Chlamydophila pneumoniae, their participation in the development of chlamydial acute respiratory infections and pneumonia. Chlamydia trachomatis: the role of certain serovars in the pathogenesis of urogenital chlamydia and infections of newborns. Laboratory diagnostic methods. Prevention.

8. Clostridia are causative agents of anaerobic wound infection (traumatic clostriosis). Kinds. Properties. Pathogenicity factors. Pathogenesis of the disease. Laboratory diagnostics. Specific therapy. Prevention.

9. Helicobacter. Properties of Helicobacter pylori. Pathogenicity factors. Pathogenesis of lesions of the gastric and duodenal mucosa. Laboratory diagnostics.

10. The causative agent of anthrax. Properties. Pathogenicity factors. Pathogenesis of the disease. Clinical forms of the disease. Immunity. Laboratory diagnostics. Specific therapy. General and specific prevention.

List of immunobiological drugs

1. BCG vaccine

2. Sabin polio vaccine (OPV)

3. Salka polio vaccine (IPV)

4. Measles vaccine

5. Rubella vaccine

6. Mumps vaccine

7. Diphtheria toxoid

8. Tetanus toxoid

9. DPT vaccine

10. Vaccine “Pneumo 23” (Pneumorrhagic cancer)

11. Meningococcal serogroup AB vaccines

12. Hib vaccine (from H. influenzae serovar b)

13. Pentaxim vaccine

14. Subunit influenza vaccine (“Grippol”, “Influvac”)

15. Hepatitis B vaccine

16. Tetanus antitoxic serum

17. Antidiphtheria antitoxic serum

18. Antibotulinum antitoxic serum

19. Antistaphylococcal immunoglobulin

20. Donor immunoglobulin

21. Tuberculin

22. Vaccine against tick-borne encephalitis

23. Rabies vaccine

24. Anti-rabies immunoglobulin

25. Anti-influenza immunoglobulin

26. Leptospirosis vaccine

In accordance with Article 55 of the Federal Law of April 12, 2010 No. 61-FZ “On the Circulation of Medicines” (Collection of Legislation of the Russian Federation, 2010, No. 16, Art. 1815; No. 31, Art. 4161; 2013; No. 48, Art. immunoprophylaxis of infectious diseases" (Collected Legislation of the Russian Federation, 1998, No. 38, Art. 4736; 2009, No. 1, Art. 21; 2013, No. 48, Art. 6165) and subparagraphs 5.2.169, 5.2.183 of the Regulations on the Ministry of Health of the Russian Federation, approved by Decree of the Government of the Russian Federation of June 19, 2012 No. 608 (Collected Legislation of the Russian Federation, 2012, No. 26, Art. 3526; 2013, No. 16, Art. 1970; No. 20, Art. 2477; No. 22, Art. 2812; No. 33, Art. 4386; No. 45, Art. 5822; 2014, No. 12, Art. 1296; No. 26, Art. 3577; No. 30, Art. 4307; No. 37, Art. 4969; 2015, No. 2, Art. 491; No. 12, Art. 1763; No. 23, Art. 3333; 2016, No. 2, Art. 325; No. 9, art. 1268; No. 27, art. 4497; No. 28, art. 4741; No. 34, art. 5255; No. 49, art. 6922; 2017, No. 7, Art. 1066), I order:

1. Approve the rules for the dispensing of medicinal products for medical use, including immunobiological medicinal products, by pharmacy organizations and individual entrepreneurs with a license for pharmaceutical activities, in accordance with.

2. To recognize as invalid:

Order of the Ministry of Health and Social Development of the Russian Federation dated December 14, 2005 No. 785 “On the Procedure for Dispensing Medicines” (registered by the Ministry of Justice of the Russian Federation on January 16, 2006, registration No. 7353);

Order of the Ministry of Health and Social Development of the Russian Federation dated April 24, 2006 No. 302 “On amendments to the order of the Ministry of Health and Social Development of the Russian Federation dated December 14, 2005 No. 785” (registered by the Ministry of Justice of the Russian Federation on May 16, 2006, registration number 7842);

order of the Ministry of Health and Social Development of the Russian Federation dated February 12, 2007 No. 109 “On amendments to the Procedure for the dispensing of medicines, approved by order of the Ministry of Health and Social Development of the Russian Federation dated December 14, 2005 No. 785” (registered by the Ministry of Justice of the Russian Federation March 30, 2007, registration No. 9198);

order of the Ministry of Health and Social Development of the Russian Federation dated August 6, 2007 No. 521 “On amendments to the Procedure for the dispensing of medicines, approved by order of the Ministry of Health and Social Development of the Russian Federation dated December 14, 2005 No. 785” (registered by the Ministry of Justice of the Russian Federation August 29, 2007, registration No. 10063).

psychotropic medicinal products included in the List of psychotropic substances, the circulation of which is limited in the Russian Federation and in respect of which certain control measures may be excluded in accordance with the legislation of the Russian Federation and international treaties of the Russian Federation (List III), the List (hereinafter referred to as psychotropic medicinal products of List III );

narcotic and psychotropic drugs of list II in the form of transdermal therapeutic systems;

medicines included in the list of medicines for medical use subject to subject-quantitative accounting, with the exception of medicines specified in this paragraph and over-the-counter medicines (hereinafter referred to as medicines subject to subject-quantitative accounting);

drugs with anabolic activity (in accordance with the main pharmacological action) and classified according to the anatomical-therapeutic-chemical classification recommended by the World Health Organization (hereinafter - ATC) as anabolic steroids (code A14A) (hereinafter - drugs with anabolic activity );

medicinal products specified in paragraph 5 of the Procedure for dispensing medicinal products to individuals for medical use, containing, in addition to small quantities of narcotic drugs, psychotropic substances and their precursors, other pharmacological active substances, approved by order of the Ministry of Health and Social Development of the Russian Federation dated May 17, 2012 No. 562n;

medicinal products manufactured according to a prescription for a medicinal product and containing a narcotic drug or psychotropic substance included in List II of the List, and other pharmacological active substances in a dose not exceeding the highest single dose, and provided that this combined medicinal product is not a narcotic or psychotropic drug of schedule II.

According to prescriptions written on prescription forms No. 148-1/u-04 (l) or form No. 148-1/u-06 (l), medications are dispensed and prescribed to citizens who have the right to receive medicines free of charge or to receive medicines. drugs at a discount (hereinafter referred to as drugs sold free of charge or at a discount).

According to prescriptions written out on prescription forms No. 107-1/u, other medications not specified in this paragraph are dispensed, with the exception of over-the-counter medications.

5. The dispensing of medications not specified in these Rules, in accordance with the instructions for their medical use, is carried out without prescriptions.

6. Medicines are dispensed during the validity period specified in the prescription when a person contacts a retail trade entity.

If a retail trade entity does not have the medicinal product specified in the prescription, when the person contacts the retail trade entity, the prescription is accepted for servicing within the following terms (hereinafter referred to as deferred servicing):

a prescription marked “statim” (immediately) is served within one business day from the date the person contacts the retail trade entity;

a prescription marked “cito” (urgent) is served within two working days from the date the person contacts the retail trade entity;

a prescription for a medicinal product included in the minimum range of medicinal products for medical use necessary for the provision of medical care is serviced within five working days from the date of the person’s application to the retail trade entity;

a prescription for a medicinal product that is dispensed free of charge or at a discount and is not included in the minimum range of medicinal products for medical use required for the provision of medical care is serviced within ten working days from the date the person contacts the retail trade entity;

prescriptions for medications prescribed by decision of the medical commission are serviced within fifteen working days from the date the person contacts the retail trade entity.

Do not fill expired prescriptions unless the prescription expired while it was on deferred maintenance.

If a prescription expires while it is under deferred servicing, the medicinal product for such a prescription is dispensed without reissuing it.

7. Medicines are dispensed in the quantity specified in the prescription, except for cases where the maximum permissible or recommended quantity for prescribing per prescription is established for the medicine.

When a prescription is presented that exceeds the maximum permissible or recommended amount of a medicinal product for prescribing per prescription, the pharmacist informs the person who submitted the prescription about this to the head of the relevant medical organization and releases to the specified person the correspondingly established maximum permissible or recommended amount of the medicinal product for prescribing per prescription. by putting the appropriate mark in the recipe.

If a retail trade entity has a medicinal product with a dosage different from the dosage of the medicinal product specified in the prescription, dispensing of the existing medicinal product is allowed if the dosage of such medicinal product is less than the dosage specified in the prescription. In this case, the amount of the drug is recalculated taking into account the course of treatment specified in the prescription.

If the dosage of a medicinal product available to a retail trade entity exceeds the dosage of the medicinal product specified in the prescription, the decision to dispense the medicinal product with such dosage is made by the medical professional who wrote the prescription.

8. Dispensing of a medicinal product is carried out in primary and secondary (consumer) packaging, the labeling of which must meet the requirements of Article 46 of the Federal Law of April 12, 2010 No. 61-FZ “On the Circulation of Medicines”, and packaging for narcotic and psychotropic medicinal products of the list II - the requirements of paragraph 3 of Article 27 of the Federal Law of January 8, 1998 No. 3-FZ “On Narcotic Drugs and Psychotropic Substances”.

Tampering with the primary packaging of the medicinal product when dispensing it is prohibited.

Violation of the secondary (consumer) packaging of the medicinal product and dispensing of the medicinal product in the primary packaging is permitted if the amount of the medicinal product indicated in the prescription or required by the person purchasing the medicinal product (for over-the-counter dispensing) is less than the amount of the medicinal product contained in the secondary (consumer) packaging. ) packaging. In this case, when dispensing a medicinal product, the person purchasing the medicinal product is provided with instructions (a copy of the instructions) for the use of the dispensed medicinal product.

9. When dispensing drugs according to a prescription, the pharmacist puts a mark on the prescription about the dispensing of the drug indicating:

name of the pharmacy organization (last name, first name, patronymic (if any) of the individual entrepreneur);

trade name, dosage and quantity of the drug dispensed;

last name, first name, patronymic (if any) of the medical worker in the cases specified in these Rules;

details of the identity document of the person who received the medicinal product in the case specified in these Rules;

surname, name, patronymic (if any) of the pharmaceutical worker who dispensed the medicinal product, and his signature;

date of release of the drug.

10. When dispensing medicinal products according to a prescription written on the prescription form No. 107-1/u, which is valid for one year, and which indicates the periods and quantity of dispensing of the medicinal product (in each period), the prescription is returned to the person purchasing the medicinal product. drug, with a mark containing the information specified in these Rules.

The next time a person contacts a retail trade entity with this prescription, the notes on the previous dispensing of the medicinal product according to such a prescription are taken into account and in the event that the person purchased a quantity of the medicinal product corresponding to the maximum quantity specified by the medical professional in the prescription, as well as after the expiration of the prescription, on the prescription a stamp “The drug has been dispensed” is affixed and the prescription is returned to the person.

A one-time dispensing of a medicinal product according to a prescription written out on prescription form Form No. 107-1/u, which is valid for one year, and which indicates the periods and quantity of dispensing of the medicinal product (in each period), is allowed only in agreement with a medical professional, who wrote the prescription.

11. When dispensing medicinal products according to a prescription written out on a prescription form, form No. 148-1/u-04 (l) or form No. 148-1/u-06 (l), the completed counterfoil of such a prescription is handed over by the pharmacist to the person purchasing ( receiving) medications.

12. When dispensing a narcotic and psychotropic drug of List II, a seal of the pharmacy or pharmacy point is affixed to the prescription for the dispensing of the drug, which indicates their full name (if there is a seal).

13. When dispensing an immunobiological medicinal product, the exact time (in hours and minutes) of dispensing the medicinal product is indicated on the prescription or prescription counterfoil, which remains with the person purchasing (receiving) the medicinal product.

The release of an immunobiological medicinal product is carried out to the person purchasing (receiving) the medicinal product, if he has a special thermal container in which the medicinal product is placed, with an explanation of the need to deliver this medicinal product to a medical organization, subject to storage in a special thermal container for a period not exceeding 48 hours after its acquisition.

14. Recipes (with the mark “The medicinal product is dispensed”) remain and are stored by the retail trade entity for:

narcotic and psychotropic drugs of list II, psychotropic drugs of list III - for five years;

medicines dispensed free of charge or at a discount - for three years;

combined medicinal products containing narcotic drugs or psychotropic substances included in lists II and III of the List, manufactured in a pharmacy, medicinal products with anabolic activity, medicinal products subject to subject-quantitative accounting - for three years;

medicinal products in liquid dosage form containing more than 15% ethyl alcohol by volume of the finished product, other medicinal products classified by ATC as antipsychotics (code N05A), anxiolytics (code N05B), hypnotics and sedatives (code N05C), antidepressants ( code N06A) and not subject to subject-quantitative accounting - within three months.

18. Dispensing counterfeit, substandard and counterfeit medicines is prohibited.

II. Requirements for the dispensing of narcotic and psychotropic drugs, drugs with anabolic activity, and other drugs subject to subject-quantitative accounting

19. The dispensing of narcotic and psychotropic drugs, drugs with anabolic activity, drugs subject to subject-quantitative accounting is carried out by pharmaceutical workers holding positions included in the list of positions of pharmaceutical and medical workers in organizations that are granted the right to dispense narcotic drugs and psychotropic medications to individuals, approved by order of the Ministry of Health of the Russian Federation dated September 7, 2016 No. 681n (registered by the Ministry of Justice of the Russian Federation on September 21, 2016, registration No. 43748).

20. Narcotic and psychotropic drugs of List II, with the exception of drugs in the form of transdermal therapeutic systems, are dispensed upon presentation of an identification document to the person indicated in the prescription, his legal representative or a person who has a power of attorney issued in accordance with the legislation of the Russian Federation the right to receive such narcotic and psychotropic medications.

21. Narcotic and psychotropic drugs of List II (with the exception of drugs in the form of transdermal therapeutic systems), intended for citizens entitled to receive free drugs or receive drugs at a discount, are dispensed upon presentation of a prescription written out on prescription form Form No. 107/u-NP, and a prescription written out on a prescription form, form No. 148-1/u-04 (l) or form No. 148-1/u-06 (l).

The medicines specified in these Rules, intended for citizens entitled to receive medicines dispensed free of charge or at a discount, are dispensed upon presentation of a prescription written on the prescription form form No. 148-1/u-88, and a prescription written on the prescription form No. 148-1/u-04 (l) or form No. 148-1/u-06 (l).

22. After dispensing narcotic and psychotropic drugs of List II, including in the form of transdermal therapeutic systems, psychotropic drugs of List III, the person who received the drug is given a signature with a yellow stripe at the top and the inscription “Signature” on it in black font, which indicates:

name and address of the pharmacy or pharmacy;

number and date of the prescription;

last name, first name, patronymic (if any) of the person for whom the drug is intended, his age;

medical record number of the patient receiving medical care on an outpatient basis for whom the drug is intended;

last name, first name, patronymic (if any) of the medical worker who wrote the prescription, his contact phone number or the phone number of the medical organization;

last name, first name, patronymic (if available) and signature of the pharmaceutical worker who dispensed the drug;

date of release of the drug.

23. Ethyl alcohol is dispensed according to a prescription, taking into account the established requirements for the volume of containers, packaging and completeness of medicines.

Medicines containing ethyl alcohol, including those manufactured according to a prescription by a retail trade entity that has a license for pharmaceutical activities with the right to manufacture medicines, are dispensed taking into account the established requirements for the volume of containers, packaging and completeness of medicines.

24. Separate dispensing of medicinal products included in a medicinal product manufactured by a retail trade entity is prohibited.

25. It is prohibited for a retail trade entity to dispense medicinal products specified in these Rules according to prescriptions from veterinary organizations.

III. Requirements for the dispensing of medicinal products according to the invoice requirements of medical organizations and individual entrepreneurs with a license for medical activities

26. The demand-invoice for the dispensing of medicines is drawn up in accordance with the Instructions on the procedure for prescribing medicines and issuing prescriptions and demands-invoices, approved by order of the Ministry of Health and Social Development of the Russian Federation dated February 12, 2007 No. 110 “On the procedure for prescribing and prescribing medicines, medical products and specialized medical nutrition products" (registered by the Ministry of Justice of the Russian Federation on April 27, 2007, registration No. 9364).

It is allowed to dispense medicines according to the requirements of invoices of medical organizations and individual entrepreneurs with a license for medical activities, issued in electronic form, if the medical organization, an individual entrepreneur with a license for medical activities, and a retail trade entity are respectively participants in the information exchange exchange system information.

27. Dispensing of narcotic and psychotropic drugs of list II, psychotropic drugs of list III, other drugs subject to subject-quantitative accounting, including those sold without a prescription, is carried out according to separate invoice requirements.

28. It is prohibited to dispense narcotic and psychotropic drugs of List II, including in the form of transdermal therapeutic systems, psychotropic drugs of List III according to the invoice requirements of an individual entrepreneur who has a license for medical activities.

29. When dispensing medicines, the pharmacist checks the proper execution of the demand invoice and puts a note on it about the quantity and cost of the medicines dispensed.

30. All invoice requirements for which medications are dispensed must be left and stored with the retail trade entity:

for narcotic and psychotropic drugs of list II, psychotropic drugs of list III (in relation to pharmacies and pharmacy points) - for five years;

for medicinal products subject to subject-quantitative accounting - for three years;

for other drugs - for one year.

31. Violation of the primary packaging of a medicinal product when dispensing it upon request-invoice is permitted by a retail trade entity that has a license for pharmaceutical activities with the right to manufacture medicinal products. In this case, the medicinal product is dispensed in a package prepared in accordance with the established procedure, with instructions (copies of instructions) for the use of the dispensed medicinal product provided.

______________________________

*(1) Subparagraph “h” of paragraph 5 of part 4 of Article 18, subparagraph “k” of paragraph 1 of part 1 of Article 33 of the Federal Law of April 12, 2010 No. 61-FZ “On the Circulation of Medicines” (Collected Legislation of the Russian Federation, 2010 , No. 16, Art. 1815; No. 42, Art. 5293; No. 49, Art. 6409; 2014, No. 52, Art. 7540).

*(2) Orders of the Ministry of Health of the Russian Federation:

dated December 20, 2012 No. 1175n “On approval of the procedure for prescribing and prescribing medicines, as well as forms of prescription forms for medicines, the procedure for completing these forms, their accounting and storage” (registered by the Ministry of Justice of the Russian Federation on June 25, 2013, registration No. 28883), as amended by orders of the Ministry of Health of the Russian Federation dated December 2, 2013 No. 886n (registered by the Ministry of Justice of the Russian Federation on December 23, 2013, registration No. 30714), dated June 30, 2015 No. 386n (registered by the Ministry of Justice August 6, 2015, registration No. 38379) and dated April 21, 2016 No. 254n (registered by the Ministry of Justice of the Russian Federation on July 18, 2016, registration No. 42887) (hereinafter referred to as order No. 1175n);

dated August 1, 2012 No. 54n “On approval of the form of prescription forms containing the prescription of narcotic drugs and psychotropic substances, the procedure for their production, distribution, registration, accounting and storage, as well as registration rules” (registered by the Ministry of Justice of the Russian Federation on August 15, 2012 ., registration No. 25190), as amended by orders of the Ministry of Health of the Russian Federation dated June 30, 2015 No. 385n (registered by the Ministry of Justice of the Russian Federation on November 27, 2015, registration No. 39868) and dated April 21, 2016 No. 254n ( registered by the Ministry of Justice of the Russian Federation on July 18, 2016, registration No. 42887) (hereinafter referred to as order No. 54n).

*(3) Collection of legislation of the Russian Federation, 1998, No. 27, art. 3198; 2004, No. 8, art. 663; No. 47, art. 4666; 2006, No. 29, art. 3253; 2007, No. 28, Art. 3439; 2009, No. 26, Art. 3183; No. 52, art. 6572; 2010, No. 3, art. 314; No. 17, art. 2100; No. 24, art. 3035; No. 28, art. 3703; No. 31, art. 4271; No. 45, art. 5864; No. 50, art. 6696, 6720; 2011, No. 10, Art. 1390; No. 12, art. 1635; No. 29, art. 4466, 4473; No. 42, art. 5921; No. 51, art. 7534; 2012, No. 10, Art. 1232; No. 11, art. 1295; No. 19, art. 2400; No. 22, art. 2864; No. 37, art. 5002; No. 48, art. 6686; No. 49, art. 6861; 2013, No. 9, art. 953; No. 25, art. 3159; No. 29, art. 3962; No. 37, art. 4706; No. 46, art. 5943; No. 51, art. 6869; 2014, No. 14, art. 1626; No. 23, art. 2987; No. 27, art. 3763; No. 44, art. 6068; No. 51, art. 7430; 2015, No. 11, Art. 1593; No. 16, art. 2368; No. 20, art. 2914; No. 28, art. 4232; No. 42, art. 5805; 2016, No. 15, Art. 2088; 2017, No. 4, Art. 671; No. 10, art. 1481.

*(4) Appendices No. 1 and 2 to order No. 54n.

*(5) Clause 9 of the procedure for prescribing and prescribing medications, approved by Order No. 1175n.

*(6) Order of the Ministry of Health of the Russian Federation dated April 22, 2014 No. 183n “On approval of the list of medicines for medical use subject to subject-quantitative accounting” (registered by the Ministry of Justice of the Russian Federation on July 22, 2014, registration No. 33210) with amendments made by order of the Ministry of Health of the Russian Federation dated September 10, 2015 No. 634n (registered by the Ministry of Justice of the Russian Federation on September 30, 2015, registration No. 39063).

*(7) Subclause 3 of clause 9 of the procedure for prescribing and prescribing medications, approved by order No. 1175n.

*(8) Registered by the Ministry of Justice of the Russian Federation on June 1, 2012, registration No. 24438, as amended by orders of the Ministry of Health of the Russian Federation dated June 10, 2013 No. 369n (registered by the Ministry of Justice of the Russian Federation on July 15, 2013, registration No. 29064), dated August 21, 2014 No. 465n (registered by the Ministry of Justice of the Russian Federation on September 10, 2014, registration No. 34024), dated September 10, 2015 No. 634n (registered by the Ministry of Justice of the Russian Federation on September 30, 2015, registration No. 39063).

*(9) Order of the Government of the Russian Federation of December 26, 2015 No. 2724-r (Collected Legislation of the Russian Federation, 2016, No. 2, Art. 413).

*(10) Appendices No. 1 and No. 2 to the procedure for prescribing and prescribing medications, approved by Order No. 1175n.

*(11) Collection of legislation of the Russian Federation, 2010, No. 16, art. 1815; No. 42, art. 5293; 2014, No. 52, art. 7540.

*(12) Collection of legislation of the Russian Federation, 1998, No. 2, art. 219; 2012, No. 53, Art. 7630; 2013, No. 48, art. 6165; 2015, No. 1, Art. 54.

*(13) Appendix No. 2 to the procedure for prescribing and prescribing medications, approved by Order No. 1175n.

*(14) Order No. 1175n and order No. 54n.

*(15) Article 74 of the Federal Law of November 21, 2011 No. 323-FZ “On the fundamentals of protecting the health of citizens in the Russian Federation” (Collected Legislation of the Russian Federation, 2011, No. 48, Art. 6724; 2013, No. 48, Art. 6165).

*(16) Article 57 of the Federal Law of April 12, 2010 No. 61-FZ “On the Circulation of Medicines”.

*(17) In relation to the person specified in Part 2 of Article 20 of the Federal Law of November 21, 2011 No. 323-FZ “On the fundamentals of protecting the health of citizens in the Russian Federation” (Collected Legislation of the Russian Federation, 2011, No. 48, Art. 6724 ; 2012, No. 26, Art. 3442, 3446; 2013, No. 27, Art. 3459, 3477; No. 30, Art. 4038; No. 39, Art. 4883; No. 48, Art. 6165; No. 52, Art. 6951 ; 2014, No. 23, Art. 2930; No. 30, Art. 4106, 4206, 4244, 4247, 4257; No. 43, Art. 5798; No. 49, Art. 6927, 6928; 2015, No. 1, Art. 72, 85; No. 10, Art. 1403, 1425; No. 14, Art. 2018; No. 27, Art. 3951; No. 29, Art. 4339, 4356, 4359, 4397; No. 51, Art. 7245; 2016, No. 1, Art. 9, 28; No. 15, Art. 2055; No. 18, Art. 2488; No. 27, Art. 4219).

*(18) Part 4.1 of Article 45 of the Federal Law of April 12, 2010 No. 61-FZ “On the Circulation of Medicines” (Collected Legislation of the Russian Federation, 2010, No. 16, Art. 1815; 2014, No. 52, Art. 7540; 2015, No. 51, Art. 7245), Decree of the Government of the Russian Federation dated July 23, 2016 No. 716 “On the procedure for creating a list of medicines for medical use, in respect of which requirements are established for the volume of containers, packaging and completeness, a list of medicines for veterinary use, in respect of which requirements are established for the volume of containers, and the definition of such requirements" (Collected Legislation of the Russian Federation, 2016, No. 31, Art. 5030).

*(19) As amended by orders of the Ministry of Health and Social Development of the Russian Federation dated August 27, 2007 No. 560 (registered by the Ministry of Justice of the Russian Federation on September 14, 2007, registration No. 10133), dated September 25, 2009 No. 794n ( registered by the Ministry of Justice of the Russian Federation on November 25, 2009, registration No. 15317), dated January 20, 2011 No. 13n (registered by the Ministry of Justice of the Russian Federation on March 15, 2011, registration No. 20103), by orders of the Ministry of Health of the Russian Federation dated August 1, 2012 No. 54n (registered by the Ministry of Justice of the Russian Federation on August 15, 2012, registration No. 25190), dated February 26, 2013 No. 94n (registered by the Ministry of Justice of the Russian Federation on June 25, 2013, registration No. 28881).

*(20) Clause 4 of Article 31 of the Federal Law of January 8, 1998 No. 3-FZ “On Narcotic Drugs and Psychotropic Substances” (Collected Legislation of the Russian Federation, 1998, No. 2, Art. 219; 2003, No. 27, Art. 2700; 2013, No. 48, Art. 6165; 2015, No. 1, Art. 54).

*(21) Order of the Ministry of Health of Russia dated October 26, 2015 No. 751n “On approval of the rules for the manufacture and dispensing of drugs for medical use by pharmacy organizations and individual entrepreneurs with a license for pharmaceutical activities” (registered by the Ministry of Justice of the Russian Federation on April 21, 2016 , registration number 41897).

Document overview

New rules for the dispensing of drugs for medical use, including immunobiological ones, by pharmacies and individual entrepreneurs with a pharmaceutical license have been approved.

Medicines are dispensed without a prescription, by prescription and according to the invoice requirements of medical organizations and individual entrepreneurs with a license for medical activities. The rules apply to pharmacies, pharmacy points, pharmacy kiosks and individual entrepreneurs with a license for pharmaceutical activities. Of these, only pharmacies and pharmacy points can dispense prescription drugs, as well as narcotic and psychotropic drugs. To release the latter, you must have an appropriate license.

As before, separate prescription forms are provided for psychotropic drugs; free medicines; for others. It is clarified what drugs are dispensed for them. Prescription service times have been kept the same.

The specifics of dispensing an immunobiological drug have been established. Thus, on the prescription or prescription stub, which remains with the purchaser, the exact time (in hours and minutes) of dispensing is indicated. In this case, the purchaser must have a special thermal container. The first receives clarification on the delivery time of the drug to the medical facility.

The shelf life of recipes has been clarified.

The requirements for the dispensing of narcotic and psychotropic, anabolic drugs, as well as drugs subject to subject-quantitative accounting, have been revised.

The order of the Russian Ministry of Health and Social Development on the procedure for dispensing medicines (taking into account the changes made) has become invalid.

Immunobiological are drugs that influence the immune system, act through the immune system, or the principle of action of which is based on immunological reactions, as well as drugs for normalizing the composition of automicroflora.

To date, immunobiotechnology has developed more than 1000 immunobiological drugs.

The following groups of medical immunobiological preparations (MIBPs) are distinguished:

Vaccines

Therapeutic serums and immunoglobulins

Preparations from living microorganisms or microbial products (phages, eubiotics, enzymes)

Immunomodulators

Diagnostic preparations (diagnostic sera, diagnosticums, allergens, bacteriophages).

The action of MIBP can be active and passive, specific and nonspecific.

Active leads to activation of the immune system to produce antibodies or cell-mediated reactions (for example, during vaccination).

Passive - to create immunity, bypassing the activation of the immune system (with the introduction of ready-made immunoglobulins).

Specific - if it is directed against a specific antigen (for example, influenza vaccine or diphtheria serum).

Nonspecific - leads to activation of the immune system and or natural resistance factors in general (for example, activation of phagocytosis or proliferation of immunocytes under the influence of immunomodulators).

Characteristics of vaccine preparations

Vaccine classification

Currently, the following vaccine preparations are used to prevent infectious diseases:

1) Live vaccines make up approximately half of all vaccines used in practice. Live vaccines, when introduced into the body (usually at a dose of 1 thousand-1 million cells), take root, multiply, cause the vaccination process and the formation of active immunity against the corresponding pathogen. Vaccines are obtained from attenuated vaccine strains or from natural (divergent) strains that are non-pathogenic to humans and have common antigenic properties with disease-causing pathogenic strains; they are suspensions of vaccine strains grown on various nutrient substrates. The main property of the live attenuated strain used in vaccine production is a persistent loss of virulence while maintaining the ability to induce an immune response similar to the natural one. The vaccine strain multiplies in the host's body and induces cellular, humoral, and secretory immunity, creating protection for all entry points of infection. The main advantages of live vaccines are:

High tension, strength and duration of the immunity they create;

Possibility of use not only by subcutaneous administration, but also by other, simpler routes (dermal, oral, intranasal).

Live vaccines have a number of disadvantages:

Difficult to combine and poorly dosed;

Cause vaccine-associated diseases

Relatively unstable;

Naturally circulating wild virus may inhibit vaccine virus replication and reduce vaccine effectiveness; This was noted for vaccine strains of poliovirus, the reproduction of which can be suppressed during infection with other enteroviruses.

During the production, transportation, storage and use of live vaccines, we must strictly observe measures that protect microorganisms from death and guarantee the preservation of the activity of the drugs (cold chain).

In the Russian Federation, live vaccines are widely used for the purpose of specific prevention of polio, measles, mumps, influenza, tuberculosis, plague, tularemia, brucellosis, and anthrax.

2) Killed vaccines(inactivated) are obtained by inactivating grown strains using various methods in a manner that results in only minimal damage to the structural proteins. Most often, for this purpose, they resort to mild treatment with formalin, phenol, and alcohol. Inactivate by heating at a temperature of 56 C for 2 hours, with UV rays. The immunogenicity of inactivated vaccines is lower compared to live ones, immunity is less intense and short-lasting.

Killed vaccines have the following advantages:

1) are well combined and dosed;

2) do not cause vaccine-associated diseases

3) used in people suffering from immunodeficiencies

In the Russian Federation, killed vaccines are used (against typhoid fever, cholera, rabies, influenza, tick-borne encephalitis, lentosyrrosis, whooping cough.

Therapeutic killed vaccines against brucellosis, dysentery, gonorrhea, staphylococcal infections. The therapeutic effect is achieved by activating the immune system and natural resistance factors of the body. Therapeutic killed vaccines are used for chronic, indolent infections; administered intramuscularly, dosed under the control of the patient's condition.

The disadvantages of corpuscular vaccines (live and killed) include the presence in their composition of a large number of “ballast” antigens and other components that are not involved in the formation of specific protection; they can have a toxic and/or allergenic effect on the body.

3) Chemical vaccines contain individual components (with immunogenicity) extracted from microorganisms using various chemical methods Chemical vaccines have the following advantages:

- less reactogenic, suitable for preschool children

Chemical vaccines have a number of disadvantages:

The immunogenicity of chemical vaccines is lower compared to live ones, so an adjuvant (aluminum hydrate) is often added to such preparations.

In the Russian Federation, vaccines are used to prevent typhoid and typhus, meningococcal, influenza, etc.

4) Anatoxins, toxoids are obtained by neutralizing toxins with formaldehyde, which are a product of the metabolism of certain pathogenic microorganisms. They are intended for immunization of people, used in the form of purified, concentrated preparations adsorbed on aluminum oxide hydrate. To purify them from ballast substances, native toxoids are subjected to special treatment using various chemical methods, as a result of which the drugs are not only freed from ballast substances, but are also concentrated in volume, which makes it possible to administer the required dose of the drug in a much smaller volume. The human immune system is not able to respond effectively to the simultaneous introduction of several antigens. Adsorption of antigens dramatically increases the effectiveness of vaccination. This is explained by the fact that a “depot” of antigens is created at the injection site of the adsorbed drug, which is characterized by their slow absorption; the fractional supply of antigen from the injection site provides the effect of summation of antigenic irritation and sharply increases the immune effect.

Toxoids have the following benefits:

- the drugs are relatively heat stable, however
Toxoids have a number of disadvantages:

They induce only antitoxic immunity, which does not prevent bacterial carriage and localized forms of disease

Freezing of adsorbed drugs (ADS, AS, AD, ADS-m, etc.) is not allowed.

Repeated booster vaccinations are required

Synthetic and semi-synthetic vaccines, developed within the framework of the problem of increasing the effectiveness and reducing the side effects of vaccines, they consist of an antigen or its determinant in molecular form, a polymer carrier (to impart macromolecularity) and an adjuvant that nonspecifically increases the immunogenicity of antigens. Polyelectrolytes (vinylpyrrolidone, dextran) are used as a carrier, with which AG is combined. Synthetic vaccines against influenza, hepatitis B, etc. are being developed.

5) vector vaccines obtained by genetic engineering. Hundreds of recombinant strains of bacteria, viruses, yeasts carrying a specific antigen have been obtained (for example, Salmonella vaccine against hepatitis B)

6) molecular vaccines obtained by biosynthesis (anatoxins) or chemical synthesis (antigenic components of HIV, hepatitis); molecular genetically engineered vaccines are obtained from protective antigens that are produced by recombinant strains of microorganisms (yeast vaccine against hepatitis B, against malaria, etc.).

7) Associated vaccines (polyvaccines) include antigens of several microbes and often in different forms (killed cells, toxoids, etc.), which allows simultaneous immunization against several infections.

In the Russian Federation, one associated DTP vaccine is used (DTP vaccine contains killed pertussis bacteria and 2 toxoid - diphtheria and tetanus); Abroad, associated vaccines are widely used - tetracoccus (whooping cough, diphtheria, tetanus, polio); MMR vaccine (measles, mumps, rubella), etc.

Diphtheria toxoid(AD): contains antigen in the form of neutralized (0.4% formalin solution, at 37 0 C, for 1 month) diphtheria exotoxin combined with adjuvant; dosed V ml, 1 ml contains 10 LF (flocculating units) of diphtheria toxoid; used for planned specific prevention of diphtheria by parenteral (intramuscular or deep subcutaneous) administration: the action is based on the formation of artificial active antitoxic immunity to diphtheria toxin.

Methods of administering vaccines

1. Intramuscular method administration is the main one when using sorbed drugs (DPT vaccine, AD, ADS-m, AS, AD-m-anatoxins, etc.), since the local reaction is less pronounced than with subcutaneous administration. That is why the above drugs are administered to children only intramuscularly, while adults are also allowed the subcutaneous method of vaccination with toxoids. Sorbed vaccines must be thoroughly mixed by shaking the ampoules before administration.

For some drugs (hepatitis B vaccine), the intramuscular route of administration is used due to the fact that it produces a more intense immune response. To do this, the hepatitis B vaccine is injected into the deltoid muscle.

Due to the greater possibility of vascular damage with intramuscular administration, this method of immunization in patients with hemophilia should be replaced by subcutaneous administration.

It should also be pointed out that the recommendations of the USA and a number of other countries provide for pulling back the syringe plunger after the injection, and the vaccine can be administered only if there is no blood in the syringe. Otherwise, the entire procedure must be repeated.

2. Subcutaneous vaccination usually used when administering unsorbed drugs (measles, mumps, meningococcal and others polysaccharide vaccines). The injection site is the subscapular region or the area of ​​the surface of the shoulder (at the border of the upper and middle third). Intradermal administration of drugs is carried out in the area of ​​the outer surface of the shoulder (administration of the BCG vaccine) or when performing intradermal tests (Mantoux reaction, administration of horse serum diluted 1: 100, administration of allergens, etc.), in the area of ​​the flexor surface of the forearm. The intradermal method of administration requires particularly careful adherence to the technique: the vaccinator stretches the skin of the vaccinated person with his thumb and forefinger and with the other hand slowly inserts the needle (bevel upward) into the skin almost parallel to its surface by approximately 2 mm. When the drug is administered, carried out with a certain voltage, a lemon peel should appear.” When a volume of 0.1 ml is administered, its diameter is 6-7 mm.

It must be emphasized that violation of the technique of intradermal administration of the BCG vaccine (BCG-m) can lead to the formation of cold abscesses.

3. Cutaneous (scarification) vaccination used for vaccinations
live vaccines against particularly dangerous infections (plague, tularemia, etc.). In this case, a drop (drops) of the vaccine applied in the appropriate place on the surface of the skin (usually the outer surface at the border of the upper and middle third), with a dry smallpox vaccination pen, is applied to a regulated number of superficial shallow (the appearance of “dewdrops” of blood is allowed) incisions. When making incisions, it is recommended to stretch the skin as for intradermal injection.

When administering a particular drug, it is necessary to strictly adhere to the regulated dose (volume). It should be taken into account that dosage violations when using sorbed drugs, as well as BCG vaccines, may be the result of their mixing. In this regard, the requirement to “shake thoroughly before use” must be taken very conscientiously. The vaccination should be carried out in a lying or sitting position to avoid falling due to fainting, which was encountered, although extremely rarely, during the procedure in adolescents and adults. Observation of vaccinated people is carried out in accordance with the instructions for use of the drug during the first 30 minutes.