Menu

A+ A A-

Download article

Kugach V.V., Tarasova E.N.
The comparative characteristic of the criteria for classification of drugs in the Republic of Belarus and abroad

Abstract.
In this article the results of the comparative analysis of the developed criteria for classifying drugs as OTC in the Republic of Belarus with the criteria used for the classification of drugs in the European Union, the World Health Organization American Region and the CIS is made. A comparison was carried out according to the following parameters: the possibility of harm to the health of a patient on self-medication for medical reasons in accordance with instructions for use; the use of drugs not medically indicated; experience of a wide variety of drug users and the parenteral route of drugs administration. The developed criteria differ from those in other countries in specified requirements for adverse reactions, pharmacological and toxicological properties of drugs.
Key words: criteria, OTC drugs, classification of drugs.

References

1. Moshkova LV, Brutko KV. Sistema samopomoshchi i rol' v nei farmatsevtov, vrachei i patsientov [System of a self-care and role in it of druggists, doctors and patients]. V: Farmatsevticheskaia nauka i praktika v novykh sotsial'no-ekonomicheskikh usloviiakh: nauch. trudy NIIF. Moscow, RF; 1997. T. XXXVI, ch. I. р. 53-59.
2. Bond KM, Orru MP, Leder ZhM, Buvi M. Rynok bezretsepturnykh sredstv [Market of OTC medicines]. V: Regulirovanie farmatsevticheskogo sektora v Evrope: radi effektivnosti, kachestva i ravenstva. Copenhagen, Denmark: Evropeiskaia observatoriia po sistemam i politike zdravookhraneniia; 2006. Gl. 15. р. 271-289.
3. Kugach VV, Tarasova EN. Optimizatsiia perechnia lekarstvennykh sredstv, realizuemykh bez retsepta vracha [Optimization of the list of the medicines realized without prescription of the doctor]. Vestnik farmatsii. 2008;(3):63-73.
4. Kugach VV, Tarasova EN. Kriterii otneseniia lekarstvennykh sredstv k otpusku bez retsepta vracha [Criteria of reference of medicines to holiday without prescription of the doctor]. Vestnik VGMU. 2008;7(3):127-34.
5. Tarasova EN, Kugach VV. Poriadok otneseniia lekarstvennykh sredstv k perechniu realizuemykh iz aptek bez retsepta vracha [Order of reference of medicines to the list realized from drugstores without prescription of the doctor]. V: Materialy VIII s"ezda farmatsevticheskikh rabotnikov Respubliki Belarus'. Vitebsk, RB; 2010. р. 394–397.
6. Ob utverzhdenii perechnia lekarstvennykh sredstv, realizuemykh bez retsepta vracha [About the approval of the list of the medicines realized without prescription of the doctor]: postanovlenie Ministerstva zdravookhraneniia Respubliki Belarus' ot 3 fevralia 2010 g. № 15. Natsional'nyi reestr pravovykh aktov Respubliki Belarus'. 2010;(57 (8/21986)).
7. Ob utverzhdenii Instruktsii o provedenii ekspertizy dokumentov registratsionnogo dos'e na lekarstvennoe sredstvo, farmatsevticheskuiu substantsiiu i dokumentov, predstavliaemykh dlia vneseniia izmenenii v registratsionnoe dos'e ranee zaregistrirovannogo lekarstvennogo sredstva, farmatsevticheskoi substantsii [About the approval of the Instruction about carrying out examination of documents of the registration file on medicine, pharmaceutical substance and the documents submitted for modification of the registration file of earlier registered medicine, pharmaceutical substance]: prikaz ministerstva zdravookhraneniia Respubliki Belarus' ot 23 iiunia 2009 g. № 610.
8. Usenko VA, Spasokukotskii AL. Ob opredelenii kategorii lekarstvennykh preparatov dlia cheloveka [About definition of categories of medicinal preparations for the person]: direktiva Soveta ES ot 31 marta 1992 g. V: Litsenzirovanie v Evropeiskom Soiuze: farmatsevticheskii sektor. – Kiev, Ukraina: Morion Ltd; 1998. р. 290-293.
9. Direktiva 2001/83/ES Evropeiskogo Parlamenta i Soveta ES ot 6 noiabria 2001 g. O svode zakonov Soobshchestva v otnoshenii lekarstvennykh preparatov dlia cheloveka [About the code of laws of Community concerning medicinal preparations for the person] [Elektronnyi resurs]. Rezhim dostupa: http://www.webapteka.ru/expert_docs/pub59/. Data dostupa: 10.06.2014.
10. Usenko VA, Grinevich AI. Rukovodstvo po izmeneniiu kategorii otpuska lekarstvennykh preparatov dlia cheloveka [The guide to change of category of holiday of medicinal preparations for the person]. Farmateka. 1999;(1):5-10.
11. Pro zatverdzhennia kriterіїv viznachennia kategorіi vіdpusku lіkars'kikh zasobіv [Approval criteria for categories of supply of medicines]: nakaz Mіnіsterstva okhoroni zdorov'ia ukraїni № 185 vіd 17.05.200 [Elektronnyi resurs]. Rezhim dostupa: http://zakon4.rada.gov.ua/laws/show/z0464-01.
12. Ob utverzhdenii Pravil otneseniia lekarstvennykh sredstv k retsepturnomu ili bezretsepturnomu otpusku [About the approval of Rules of reference of medicines to prescription or non-prescription dispensing]: prikaz Ministra zdravookhraneniia Respubliki Kazakhstan ot 5 dekabria 2011 goda № 1460 [Elektronnyi resurs]. Rezhim dostupa: http://adilet.zan.kz/rus/docs/P1100001460.
13. Ob utverzhdenii kriteriev opredeleniia kategorii otpuska lekarstvennykh sredstv iz aptek [About the statement of criteria of definition of categories of holiday of medicines from drugstores]: prikaz Ministerstva zdravookhraneniia Respubliki Moldova № 21 ot 12.01.2006 [Elektronnyi resurs]. Rezhim dostupa: http://lex.justice.md/viewdoc.php?action=view&view=doc&id=315707&lang=2.
14. Kartavtsova TV, Gildeeva GN. Zarubezhnyi opyt klassifikatsii lekarstvennykh sredstv [Foreign experience of classification of medicines] [Elektronnyi resurs]. Medical Developemant Agency. Rezhim dostupa: http://mda-cro.com/rus/news/70.html. Data dostupa: 10.06.2014.
15. A Pharmacist-Only Class of Drugs: An Idea Whose Time Has Come? [Elektronnyi resurs]. Pharmacist. 2012. Rezhim dostupa: https://www.uspharmacist.com/. Data dostupa: 15.06.2014.
16. Jacobs LR, Pharm D. Prescription to Over-the-Counter Drug Reclassification [Elektronnyi resurs]. American Family Physician. Rezhim dostupa: http://www.aafp.org/afp/1998/0501/p2209.html. Data dostupa: 15.06.2014.
17. Sabitov RA. Osnovy nauchnykh issledovanii [Bases of scientific researches]: ucheb. posobie. Chelyabinsk, RF: Cheliab. gos. un-t; 2002. 138 р.
18. Goriachev DV, Gavrishina EV, Niiazov RR, Adonin VK. Perevod lekarstvennykh preparatov v bezretsepturnyi otpusk. Nauchno-obosnovannyi podkhod [Transfer of medicinal preparations to non-prescription dispensing. Scientifically based approach] [Elektronnyi resurs]. V: Razrabotka i registratsiia lekarstvennykh sredstv. 2013;(5). Rezhim dostupa: http://www.pharmjournal.ru/articles/stati/perevod-lekarstvennyix-preparatov-v-bezreczepturnyij-otpusk.nauchno-obosnovannyij-podxod-5-noyabr-2013. Data dostupa: 15.06.2014.
19. Tsentr ekspertiz i ispytanii v zdravookhranenii MZ RB. Rukovodstvo po vyiavleniiu i predostavleniiu informatsii o pobochnykh reaktsiiakh na lekarstvennye sredstva [Guide to identification and providing information on collateral reactions to medicines]. Sovremennaia stomatologiia. 2010;(2):106.
20. Kukes VG, red. Klinicheskaia farmakologiia [Clinical pharmacology]: ucheb. dlia med. vuzov. Moscow, RF: GEOTAR-Media; 2009. 1056 р.
21. Sychev DA, Dmitriev VA, Tsvetov VM, Tashenova AI, Zaeva VV, Ruvinov YuV, Kukes VG. Znachenie dlia klinitsista informatsii iz razdela «Pobochnoe deistvie» instruktsii po meditsinskomu primeneniiu lekarstvennogo sredstva [Value for the clinician of information from the section "Side effect" of the instruction on medical use of medicine]. Retsept. 2010;(5):21-7.
22. O trebovaniiakh k dokumentam na lekarstvennye sredstva, farmatsevticheskie substantsii, zaiavliaemye na gosudarstvennuiu registratsiiu (pereregistratsiiu), dokumentam, predstavliaemym dlia vneseniia izmenenii v registratsionnoe dos'e na lekarstvennoe sredstvo (farmatsevticheskuiu substantsiiu) ranee zaregistrirovannoe v Respublike Belarus', i o priznanii utrativshim silu postanovleniia Ministerstva zdravookhraneniia Respubliki Belarus' ot 21 noiabria 2008 g. № 199 [About demands to documents of the medicines, pharmaceutical substances declared on the state registration (re-registration), to the documents submitted for modification of the registration file on the medicine (pharmaceutical substance) which is earlier registered in Republic of Belarus and about recognition No . 199 which became invalid for the resolution of Ministry of Health of Republic of Belarus of November 21, 2008]: postanovlenie Ministerstva zdravookhraneniia Respubliki Belarus' ot 8 maia 2009 g. № 52. Natsional'nyi reestr pravovykh aktov Respubliki Belarus'. 2009;(134 (8/20954)).
23. Ob utverzhdenii Nadlezhashchei aptechnoi praktiki [About the adoption of Appropriate pharmaceutical practice]: postanovlenie Ministerstva zdravookhraneniia Respubliki Belarus' ot 27 dekabria 2006 g. № 120. Natsional'nyi reestr pravovykh aktov Respubliki Belarus'. 2014;(28 (8/28606)).
24. Gala LO, Natsіon. farmatsevt. akademіia Ukraїni. Rozrobka osnovnikh printsipіv ta pіdkhodіv do bezretsepturnogo vіdpusku lіkars'kikh zasobіv naselenniu v Ukraїnі [Development of the basic principles and approaches to non-prescription dispensing of medicines to the population in Ukraine]: avtoref. dis. … kand. farm. nauk: 15.00.01. Kharkov, Ukraine; 2002. 25 р.
25. Nois PR. Perevod lekarstv v bezretsepturnyi status [Translation medicines OTC status]. V: Lekarstvennye sredstva i den'gi: tseny, dostupnost' i sderzhivanie zatrat. Moscow, RF; 2006. р. 143-146.
26. Pro zatverdzhennia kriterіїv vіdnesennia lіkars'kikh zasobіv, shcho mіstiat' malu kіl'kіst' narkotichnikh zasobіv abo psikhotropnikh rechovin і prekursorіv, do kategorії lіkars'kikh zasobіv, iakі vіdpuskaiut'sia bez retseptіv [About the statement of criteria of reference of the medicines containing small amount of drugs or psychotropic substances and precursors to category of the medicines provided without prescriptions]: nakaz Mіnіsterstva okhoroni zdorov'ia ukraїni № 210 vіd 14.05.2003: iz zmіnami, vnesenimi zgіdno z Nakazami Mіnіsterstva okhoroni zdorov'ia № 441 vіd 02.09.2005, № 708 vіd 07.09.2012. Rezhim dostupa: http://zakon1.rada.gov.ua/laws/show/z1012-03.

Поиск по сайту