Pharmacovigilance as a New Discipline
10.3820/jjpe1996.11.43
- VernacularTitle:新しい理念としてのファルマコビジランス
- Author:
Shinji SUZUKI
- Publication Type:Journal Article
- Keywords:
drug monitoring;
PMS;
pharmacovigilance;
risk-benefit evaluation
- From:Japanese Journal of Pharmacoepidemiology
2006;11(2):43-51
- CountryJapan
- Language:Japanese
-
Abstract:
In last ten years or more, the term pharmacovigilance has been often used instead of post-marketing surveillance (PMS) or drug monitoring. However, this term, pharmacovigilance, is not just another term for PMS but should be understood as a new discipline, namely, science for the benefit-risk evaluation of medicinal products on humans with the final aim of individualization of medical therapy. It will be more clearly understood why nowadays this term pharmacovigilance has been used, when one considers the historical development of the safety issue of medicinal products. Pharmacovigilance as a new discipline should evaluate constantly safety and efficacy of medicinal products in daily practice considering all available data from non-clinical data, clinical data, pharmacoepidemiological data, post-marketing clinical data, risk-benefit evaluation and applied pharmacologies such as gender-specific pharmacology, pharmacogenetics, graviduspharmacology etc. in order to collect, evaluate and disseminate systematically necessary information and data on the safety and efficacy of medicinal products.
In addition, one should realize the presence of two different aspects of pharmacovigilance, namely obligatory duty of care and voluntary duty of care. The former aspect is defined by regulatory authorities and each pharmaceutical industry should carry out all necessary countermeasures and studies defined by regulatory authorities in order to keep the optimal standard on the efficacy, safety and effectiveness of the company's medicinal products. The latter aspect can also be considered as ethical duty of care for pharmaceutical industries, and refers to more detailed studies in particular patients such as children, pregnant women, aged patients, ethnically different patients, etc.
