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.

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Some case-control studies have been conducted to study the relationship between a drug and adverse events in Japan. However, most such studies adopted hospital controls and rarely adopted community controls. Here, we describe the methodological issues of performing a case-control study using Japanese community controls to illustrate the association between upper gastrointestinal bleeding and nonsteroidal anti-inflammatory drugs.
To ensure efficient and accurate case identification, all candidate patients admitted to the participating hospitals with target conditions (upper gastrointestinal bleeding etc.) were listed by doctors/research coordinators. Summary tables with the candidates information on eligibility and whether or not the patient gave informed consent were reported back to the study office weekly. Using the summary tables, the fraction eligible and the participation rate for cases were estimated as 24% and 76%, respectively.
To select controls, residents matched with each case according to age, gender and district of residence were randomly sampled from the population registries in the municipal office. To achieve a satisfactory participation rate for residents (47%), we used envelopes with prestigious university letterhead and made phone calls in a timely manner rather than waiting for their replies, both of which yielded favorable results.
By telephone interview, a large amount of information was obtained in approximately 30 minutes. To help subjects' recall, a brochure displaying pictures of analgesics and a calendar for recent 4 weeks were sent in advance, and in the interview, questions using 6 kinds of “prompts” that might enhance recall were employed.

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