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Adverse Drug Reactions: Definitions, Classifications and Regulatory Aspects

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Pharmacovigilance in Psychiatry

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Abstract

Adverse drug reactions (ADRs) are a common and important cause of morbidity and mortality that represent a major health problem worldwide, with high social costs for communities. Several studies have shown that ADR-related hospital admissions comprise up to 10 % of the total number of hospitalizations.

Owing to the well-known limitations of pre-marketing research, it is now generally accepted that part of the process of evaluating drug safety needs to take place in the post-marketing (approval) phase. Thus, once approval is granted, it becomes essential to detect and to evaluate unrecognized ADRs related to medicines for protecting the public health. This activity, known as post-marketing surveillance or “pharmacovigilance,” can lead to the identification of important safety problems, which may even result in the withdrawal of drugs from the market. The main goal of pharmacovigilance is the early detection of new, rare, or serious ADRs and the communication of these risks to the public.

ADRs occur by a number of mechanisms, some of which remain unclear. Besides the intrinsic danger associated with the drug, patients might have a particular, unpredictable hypersensitivity to certain drugs, which requires careful monitoring. Furthermore, several risk factors are important in determining susceptibility to ADRs. Knowledge and use of ADR classification systems can give the health professional greater clarity about an ADR and in some cases suggest ways of managing or avoiding a future event.

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Authors and Affiliations

  1. Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy

    Paola Maria Cutroneo & Giovanni Polimeni

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  1. Paola Maria Cutroneo
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  2. Giovanni Polimeni
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Correspondence to Paola Maria Cutroneo .

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Editors and Affiliations

  1. University of Messina, Department of Clinical and Experimental Medicine, Messina, Italy

    Edoardo Spina

  2. University of Messina, Department of Clinical and Experimental Medicine, Messina, Italy

    Gianluca Trifirò

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Cutroneo, P.M., Polimeni, G. (2016). Adverse Drug Reactions: Definitions, Classifications and Regulatory Aspects. In: Spina, E., Trifirò, G. (eds) Pharmacovigilance in Psychiatry. Adis, Cham. https://doi.org/10.1007/978-3-319-24741-0_2

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  • DOI: https://doi.org/10.1007/978-3-319-24741-0_2

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