Drug safety: reporting systems for the general public

BMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e4916 (Published 07 August 2012) Cite this as: BMJ 2012;345:e4916
  1. June Munro Raine, director of vigilance and risk management of medicines
  1. 1Medicines and Healthcare Products Regulatory Agency, London SW1W 9SZ, UK
  1. june.raine{at}mhra.gsi.gov.uk

WHO’s latest guidance is relevant to developed and developing countries

Harms from drugs are an important cause of morbidity, mortality, and extra costs to healthcare.1 Such costs are high in developed countries—the average treatment costs of a single adverse drug reaction in Germany were recently estimated to be €2250 (£1766; $2762).2 The costs to healthcare delivery in developing countries could be even greater, because real harm to even a few patients can destroy the credibility and success of an important public health programme. Public concern about adverse effects of drugs can spread rapidly and is difficult to refute in the absence of good data.3 4 The latest guidance on monitoring the safety of drugs from the World Health Organization focuses on planning and implementing adverse drug reaction systems for the general public and will probably make an important contribution to pharmacovigilance strategies.5

Spontaneous reporting systems remain a core element of pharmacovigilance—the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug related problem. But is the WHO report relevant to countries with an existing …

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