Abstract
The problem of counterfeit drugs was first discussed at international level in 1985 at the World Health Organization Conference of Experts on the Rational Use of Drugs in Nairobi. Nowadays it is estimated that counterfeit arc up to 10% of allmarketed drugs in the world. In Russia the first fake drug was reported in 1997 but definition of the term «counterfeit drug»and other amendments concerning this problem were added to the Federal Law «On Medicines» only in 2004. The survey conducted by Association of the International Pharmaceutical Manufacturers and the Coalition for Intellectual Property Rights showed that counterfeit medicines total 12% of those marketed in Russia and damage to pharmaceutical companies more than $250 mollion annually. The most commonly (47%) counterfeited medicines are antibiotics. According to WHO, the most common counterfeit medications in the world are antibiotics, antiTB, antimalarial and antiretroviral drugs. The most frequently counterfeited drug in the world is amoxicillin. Counterfeit antimicrobials area cause of reported deaths and contribute to antimicrobial resistance.
-
1.
Department of essential drugs and other medicines. Guidelines for the development of measures to combat counterfeit drugs. Geneva, Switzerland: World Health Organization; 1999. WHO/EDM/QSM/99.1.
-
2.
Шейнин Э.Б. Контрафакция в фармацевтике. Семинар по фармацевтическим системам и стандартам качества. Москва, июнь 2003 г.
-
3.
Cт. 101 ФЗ № 122-ФЗ от 22.08.2004 “О внесении изменений в Федеральный закон “О лекарственных средствах”. СЗ РФ. 2004. №35. Ст. 3607.
-
4.
Wertheimer A.I., Chaney N.M., Santella T. Counterfeit pharmaceuticals: current status and future projections. J Am Pharm Assoc 2003; 43:710--5. Ассоциация международных фармацевтических производителей, Коалиция в защиту прав интеллектуальной собственности. Отчет о ходе реализации плана действий по борьбе с фальсифицированными лекарственными средствами в России. Июнь 2002 г.
-
5.
Rudolf P.M., Bernstein I.B. Counterfeit Drugs. New Engl J Med 2004; 350:1384-6.
-
6.
Фальсификат в аптеках (пресс-конференция директора Северо-Западного центра испытаний и сертификации лекарств С. Некрасова.). Торговая газета от 05.03.2005. с. 207-8.
-
7.
Хабриев Р.У., Ягудина Р.И. Качество лекарственных средств, поступающих на российский фармацевтический рынок. Фармация 2003; 5.
-
8.
Институт фармацевтической безопасности. Мошенничество в сфере фармацевтики. Семинар по фармацевтическим системам и стандартам качества. Москва, июнь 2003 г.
-
9.
Коледа Ю. Минздрав России разработал формулировку понятия фальсифицированного лекарства. 27/10/2003. http://www.recipe.ru/news/3/1154_1. shtml.
-
10.
Фальсификаты обнаружены у половины из проверенных фармпредприятий России. Mednovosti.Ru 08-04-2005.
-
11.
Drug industry says 1-2 pct of medicines are fakes. LONDON, Nov 29 (Reuters).
-
12.
Pharmaceutical counterfeiting, tampering and diversion. Prepared by American bank note holographics, Inc. December 2002.
-
13.
World Health Organization steps up action against substandard and counterfeit medicines Asian and African countries move to improve the quality of their medicines. November 11, 2003. http://www.who. int/mediacentre/releases/2003/pr85/en/print.html
-
14.
WHO launches drive to stamp out fake drugs FT.COM, 2003 November, 12.
-
15.
Okeke I., Lamikanra A. Quality and bioavailability of tetracycline capsules in a Nigerian semi-urban community. Int J Antimicrob Agents 1995; 5:245-50.
-
16.
Taylor R.B., Shakoor O., Behrens R.H. Drug quality, a contributor to drug resistance? Lancet 1995; 346:122.
-
17.
Shakoor O., Taylor R.B., Behrens R.H. Assessment of the incidence of substandard drugs in developing countries. Trop Med Int Health 1997; 2:839-45.
-
18.
Рязанов В.В. Разработка стандарта и формуляра противобактериальных средств с целью оптимизации применения антибиотиков в хирургическом стационаре. Автореф. дис. … канд. мед. наук. – М. – 2002, 24 с.
-
19.
Carpenter J.P., 2003. Drug quality report matrix of USAID-assisted countries by the USP DQI Program, www.uspdqi.org.
-
20.
Nullis C. Fake medicine problems highlighted. http://www.stopgettingsick.com/templates/news_template.cfm/6259.
-
21.
Huitt G. Challenges to Treating MDR-TB. http://www.tballiance.org/2_1_2_MDR_TB.asp
-
22.
Combating counterfeit drugs. A Report of the Food and Drug Administration. February 2004. http://www.fda. gov/oc/initiatives/counterfeit/report02_04.html