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It is run by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Commission on Human Medicines. It was extended to hospital pharmacists in 1997, and to community pharmacists in 1999. [2] The Yellow Card Centre Scotland is a joint venture between MHRA and the Scottish Government. [3]
The MHRA and the US Food and Drug Administration were criticised in the 2012 book Bad Pharma, [43] and in 2004 by David Healy in evidence to the House of Commons Health Committee, [44] for having undergone regulatory capture, i.e. advancing the interests of the drug companies rather than the interests of the public.
SHOT was established in 1996. [5] During the first ten years, it collected more than 2,000 confidential reports about transfusion safety problems or near misses. [5] During the first two years of voluntary reports, about half of these errors involved giving the wrong type of blood or blood component to a patient. [6]
The following list encompasses notable medicine contamination and adulteration incidents. 1937 Elixir sulfanilamide incident: S. E. Massengill Company used diethylene glycol as the solvent for the antibacterial sulfanilamide, leading to the 1938 passage of the Federal Food, Drug, and Cosmetic Act. [2] [3]
Type A: augmented pharmacological effects, which are dose-dependent and predictable [5]; Type A reactions, which constitute approximately 80% of adverse drug reactions, are usually a consequence of the drug's primary pharmacological effect (e.g., bleeding when using the anticoagulant warfarin) or a low therapeutic index of the drug (e.g., nausea from digoxin), and they are therefore predictable.
Theralizumab (also known as TGN1412, CD28-SuperMAB, and TAB08) is an immunomodulatory drug developed by immunologist Thomas Hünig of the University of Würzburg.It was withdrawn from development after inducing severe inflammatory reactions as well as chronic organ failure in the first-in-human study by Parexel in London in March 2006. [1]
Unlike direct side effects, an adverse event does not necessarily mean the medication directly caused the problem. These events can include any unfavorable symptoms, signs , or medical conditions that appear during medical treatment, regardless of whether they are definitively linked to the specific medication being studied.
VAERS is a postmarketing surveillance program, collecting information about adverse events (possible harmful side effects) that occur after administration of vaccines to ascertain whether the risk–benefit ratio is high enough to justify continued use of any particular vaccine.