ABSTRACT
Spontaneous reporting system of adverse reactions (ADRs) is indispensable to secure drug safety. Although good systems of western countries are well-known in Japan, it seems that the French pharmacovigilance system is not familiar, as compared with the yellow-card system in the UK and the MEDWatch program in the US.<BR>This report outlines various features of the French system according to our information collected by a visit to the French medicines agency and one of the regional centers. The “good pharmacovigilance practices, ” enforced by the agency in 1995, is used as a reference.<BR>Notable features are summarized as follows : (1) decentralized activities by the 31 regional centers collecting spontaneous ADR reports from healthcare professionals, (2) centralized EDP-system retaining ADR data, (3) official decision-making process called “inquiry”, which opens when a signal of safety issues comes up, and synthesizes a consensus and proposal on necessary measures, (4) bidirectional communication between the regional centers and prescribers, reporting ADRs and providing safety information by Q & A, (5) collaboration of specialist committees and pharmaceutical companies with the above elements, and so forth.<BR>The system is characterized by these elements constructing collectively an effctive system to prevent ADRs and reduce the seriousness. These findings will be helpful, even in Japan, when subjects for improvement of a reporting system are discussed.
ABSTRACT
Objective : To examine antihypertensive drug use in major therapeutic categories and to compare with guidelines for antihypertensive therapy.<BR>Design : Cross-sectional drug utilization survey.<BR>Methods : Prescription data on antihypertensives, from 1985 to 1994, were extracted from electronic record accumulated in Bohsei Pharmacy. Repeated prescriptions were identified by patients' identification code. Patients using diuretics (DU), beta-blockers (BB), Ca-channel blockers (CCB), ACE-inhibitors (ACEI), and others were counted in each calender year. These data were compared with 1993 annual utilization data of antihypertensive drugs in Western countries obtained from a commercial database.<BR>Results : The use of CCB and ACEI increased to reach a high proportion of 43.0 % and 18.7 %, respectively, in 1994. On the other hand, the use of DU and BB showed a marked decrease and DU accounted for 16.3 %, BB for 13.5 % in 1994. The other categories were minor. These figures from Bohsei Pharmacy formed a contrast to those in Western countries. For instance, the use of DU waspredominant in the UK. In the US and Germany, CCB was widely used (≅30%) but DU was also used to a similar extent (30-40%).<BR>Conclusion : The pattern of antihypertensive drug use found in the record of Bohsei Pharmacy may be judged to be appropriate since the JNC and other guidelines recommend DU, BB, CCB, and ACEI as the first line drugs. However, the proportion of the use of CCB is an issue of concern and might be criticized to be too high in light of the fact mentioned by those guidelines that efficacy/safety of CCB's has not yet been proven sufficiently based on morbidity and mortality data.