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Many developed countries set up their pharmacovigilance programs following the Thalidomide scandal in the 1960s. [2] India set up its program in the 1980s. [2] This general concept of drug safety monitoring went through different forms, but the Central Drugs Standard Control Organisation established the present Pharmacovigilance Program of India in 2010. [2]
This event was linked to the death sentence of a former pharmaceuticals control officer in China, as the Costa Rican newspaper La Nación reported on its issue of May 30. [9] On June 4, 2007, a press release by the Chinese Foreign Ministry [ 10 ] cited an earlier study in China [ 11 ] which concluded that up to 15.6% diethylene glycol in ...
Worldwide Not approved in the US, withdrawn in France in 1994 [4] and the rest of the market in 1995 because of rare but serious hepatotoxicity. [3] [5] Alosetron (Lotronex) 2000 US Serious gastrointestinal adverse events; ischemic colitis; severe constipation. [2] Reintroduced 2002 with restricted indication and new controls. [6]
The principle of international collaboration in the field of pharmacovigilance is the basis for the WHO Programme for International Drug Monitoring, through which over 150 member nations have systems in place that encourage healthcare personnel to record and report adverse effects of drugs in their patients. [19]
Between 1998 and 2007, 33 serious adverse drug or device reactions have been reported by RADAR investigators. The toxicities involved multiple biological system and included thrombotic thrombocytopenic purpura (TTP) (ticlopidine and clopidogrel), thromboembolism (thalidomide and lenalidomide), liver failure (gemtuzumab and nevirapine), hypersensitivity (drug eluting coronary arterial stents ...
A study showed that 48% of patients had an adverse drug reaction to at least one drug, and pharmacist involvement helps to pick up adverse drug reactions. [44] In 2012, McKinsey & Company concluded that the cost of the 50-100 million preventable error-related adverse drug events would be between US$18–115 billion. [45]
The FDA provides a database for reporting of adverse medical device events called the Manufacturer and User Facility Device Experience Database (MAUDE)[1]. The data consist of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996, and is open for public view.
The World Drug Report is a United Nations Office on Drugs and Crime annual publication that analyzes market trends, compiling detailed statistics on drug markets.Using data, it helps draw conclusions about drugs as an issue needing intervention by government agencies around the world.