International Journal of Pharmaceutical Science and Research

International Journal of Pharmaceutical Science and Research


International Journal of Pharmaceutical Science and Research
International Journal of Pharmaceutical Science and Research
Vol. 1, Issue 7 (2016)

Adverse drug reaction reporting: A comparative analysis of five countries


Mohit Hans, SK Gupta

Information on drug reactions is the main input into the ADR monitoring system. The information may come from various sources, and by various means. Generally, health professionals - particularly physicians and pharmacists - are key persons in the discovery and preliminary identification of adverse reactions resulting from use of a drug. The marketing authorization holder, who possesses information on the ingredients of a product and the processes of manufacturing, packaging, storage and distribution, is another key source. In addition, multinational corporations should also have mechanisms for collecting information on the use of their products in the countries where they are marketed. Consumers can be considered another important source of information, since they experience any adverse effects at first hand. However, it can be difficult for consumers to identify an adverse reaction, and their accuracy of reporting may be doubtful, owing to the technical nature of pharmaceuticals. ADR reporting may be either voluntary or obligatory. Spontaneous reporting by health professionals is often favored, since it is very difficult to make reporting compulsory. But in many countries, considerations of ethical responsibility and/or technical expediency have inclined governments to make reporting mandatory for the holders of marketing authorizations
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How to cite this article:
Mohit Hans, SK Gupta. Adverse drug reaction reporting: A comparative analysis of five countries. International Journal of Pharmaceutical Science and Research, Volume 1, Issue 7, 2016, Pages 06-11
International Journal of Pharmaceutical Science and Research International Journal of Pharmaceutical Science and Research