Аннотация
Today, drugs effectively fight with wide varieties of diseases. Although, despite of its benefit, there are increased cases of the diseases, invalidity and sometimes - lethal outcome, because the side effects of the medicines. In some countries, the side effects of drug are in the first ten causes of the mortality. In each individual case, to line up the effective and safe medicines, it mainly depends on the knowledge and skills of the physician, to evaluate the situation properly. Moreover, the most important aim of pharmacotherapy is to determine and monitor the drug safety, during the use in medical practice. In real life, to realize this idea is possible just with wellestablished and developed system of pharmacovigilance as in state institutes as in private structures or companies. In Georgia, at this stage, the main goal is to develop strong legislation base for medicine side effect monitoring - Pharmacovigilance. The realization of this goal is just possible only if it will be inseparable part of the State healthcare politics and make a significant contribution in safe pharmacotherapy of population, and respectively will be commercially profitable for products’ Marketing Authorization Holders and distributor companies.
Библиографические ссылки
2. European Commission. Assessment of the European Community System of Pharmacovigilance: Final Report e Final version, January 25. Submitted by Fraunhofer Institute Systems and Innovation Research, Karlsruhe, Germany, to the European Commission Enterprise and Industry Directorate- General, Unit F2, Pharmaceuticals, http://ec.europa.eu/enterprise/pharmaceuticals/pharmacovigilance/docs/acs_consultation_final.pdf; 2006.
3. Nwokike J. Technical Assistance for the Establishment of a Pharmacovigilance and Medicine Safety System in Rwanda. Submitted to the US Agency for International Development by the Strengthening Pharmaceutical Systems (SPS) Program. Arlington, VA: Management Sciences for Health; 2009.
4. Kranish, M. New use is found for thalidomide: Fighting cancer. Boston Globe Online, October 20, 2002
5. 40 years after the thalidomide holocaust. Available: www.thalidomide.org/FfdN/Grun en/Grunthl.html
6. Castilla EE et al. Thalidomide, a current teratogen in South America. Teratology1996, 54: 273.
7. US Food and Drug Administration. 21 CFR Parts 312 and 320, Final Rule: Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans, http://www.fda.gov/ Drugs/ Development Approval Process/ How Drugs are Developed andApproved/ApprovalApplications/ Investigational NewDrug INDApplication/ucm226358.htm
8. Gaukler SM1, Ruff JS2, Galland T2, Underwood TK2, Kandaris KA2, Liu NM2, Morrison LC2, Veranth JM3, Potts WK2. Quantification of cerivastatin toxicity sup ports organismal performance assays as an effective tool during pharmaceutical safety assessment. Evol Appl. 2016 Apr 15;9(5):685-96. 2016.
9. SAFETY MONITORING of MEDICINAL PRODUCTS. World Health Organization 2012
10. Marie Lindquist, Malin Stahl, Andrew Bate I., Ralph Edwards, Ronald H.B. Meyboom. A Retrospective Evaluation of a Data Mining Approach to Aid Finding New Adverse Drug Reaction Signals in the WHO International Database. Drug Safety, December 2000, Volume 23, Issue 6, pp 533–542.