Pharmacovigilance for evaluating adverse drug reactions: value, organization, and methods.
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Biomedical subjects
Publications and source records attributed to Agnès Sommet.
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OBJECTIVES: To analyse trends in antibiotic exposure of the French population from 1992 to 2000. METHODS: The analysis used data provided by a representative annual nationwide survey of health care consumption in the community. RESULTS: The frequency of antibiotic use increased from 4.7 per 100 person-months in 1992 to 7.3 in 1995, and remained stable from 1998 to 2000. Children under 7 years of age were three times more strongly exposed to antibiotics than older subjects. Respiratory tract infections of probable viral aetiology and sore throat accounted for >50% of antibacterial prescriptions. CONCLUSIONS: We identified two major priorities for campaigns designed to reduce antibiotic exposure of the French population in the community, namely respiratory tract infections of presumed viral origin, and children under 7 years of age.
OBJECTIVE: The aim of this article is to present and compare the different methods used to study drug consumption. METHODS: Particular attention is given to one method, the defined daily dose (DDD), for antibiotic dispensation data in Toulouse University Hospital Centre between 2001 and 2003. RESULTS: Data, expressed in units of packaging, were converted into grams of active substance and then to number of DDD. The number of hospitalization days was used to calculate the penetration index (ratio of number of DDD to the number of hospitalization days). Penetration indexes were similar for each year of study period: 60.6 for 100 patient-days in 2001, 67.7 in 2002 and 66.6 in 2003 (p = 0.37). The most prescribed class was penicillin, most often amoxicillin. CONCLUSION: Use of DDD methodology and penetration index is an accessible and simple tool for monitoring consumption of antibiotics as well as other drugs.
This paper reviews recent data on the pharmacovigilance of antiparkinsonian drugs and drugs inducing parkinsonian syndroms. Sudden sleep attacks were first described in 1999 with dopamine agonists. In fact, they can be induced by all the dopaminergic antiparkinsonian drugs. Favorising factors are duration of the disease, dose of dopaminergic drugs, daytime somnolence or dysautonomia. This adverse drug reaction can be serious leading, for example, to road accidents. Cardiac valvulopathies were more recently (end of 2002) described with pergolide. Thus, this dopamine agonist should now be prescribed as a last choice among dopamine agonists. Dopamine drugs (levodopa as well as dopamine agonists) can induce hypersexual behaviours or pathological gambling. Among the long list of drugs inducing parkinsonian syndroms, recent data suggest the involvement of serotoninergic antidepressants, valproic acid and trimetazidine. Finally, these data on pharmacovigilance allow to precise the physiological role of dopamine: beside its motor and psychic effects, dopamine is also involved in the sleep-arousal control. It is also an important mediator for pleasure, hedonic regulations and sexual behaviour. This review also underlines the major role of spontaneous reports to the pharmacovigilance systems to identify new adverse drug reactions.
In 1999, The Regional Center of Pharmacogilance and the Department of Infectious Disease of the Toulouse University Hospital set up a system to improve the data collection about antiretroviral-induced adverse reactionss (ADRs). From November 1999 to April 2003, a resident of pharmacovigilance collected ADRs reported with antiretroviral drugs during 2 weekly medical consultations. A total of 613 ADRs corresponding to 428 patients were reported, classified as "non serious" in 88.6% of cases and required the withdrawal of suspected drugs in 57% of cases. Our data show an improvement of antiretroviral drug-induced ADRs reporting.