[Drug packaging and context of use as a cause of intoxication].
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Biomedical subjects
Publications and source records attributed to G Lagier.
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All the requests (162) from the 1st to the 31th of december 1988 (a period of one month) are analysed by the Paris Fernand-Widal ADR Monitoring Centre. The requests are classified as following: 74 pharmacological consults (39 about pregnancy, 9 for breast-feeding, 3 neonates or children, 2 about G6PD deficiency, 3 guide-lines after a therapeutic error, 3 requests for treatment of ADR, and 15 miscellaneous). 5 ADRs notified and reported to an other nearest Centre to the caller and 3 diagnosed latter as an ADR 49 ADRs registered turn to a request because of lack of information (age: 15; sex: 18; name: 1; address: 31,) or faithfullness (4) or several reasons (18). 31 general information about drugs. Usually, physicians request the Monitoring Centre but recently patients request directly the Centre; specially during pregnancy. The progressive number of the questions makes computerization necessary. A single system appears to be essential for all the Regional Centres to improve the quality of the answer and for the new ADR's alert.
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In France, the use of an official drug adverse reaction assessment method is mandatory since 1984. The method proposes various qualifications for chronologic and semiologic criteria without clear limits. The definitions could vary with the nature of the side-effect. We report here the results of a consensus meeting on drug-induced photosensitivity. Dermatologists and experts in pharmacovigilance studied together how the "French method" could apply to the two variances of drug-induced photosensitivity: phototoxicity and photoallergy.
Since 1984, the use of the official method for determining the responsibility of drugs in side-effects has been compulsory in France. This method offers, but does not define, different qualificatives for chronological and semeiological criteria. Consensus workshops have been set up to define the undesirable side-effects themselves and the different qualificatives in each of the principal fields of pathology. As regards drug-induced interstitial pneumonia, chest specialists from university hospitals, members of the national system of pharmacovigilance and representatives of the Roussel-Uclaf central department of pharmaco-vigilance have determined: the limits of time elapsed between the beginning and end of drug administration and the occurrence of the adverse reaction; how to interpret various courses of the side-effect with and without temporary discontinuation of the drug, and how to interpret a possible readministration. A list of investigations aimed at excluding the main possible causes of interstitial pneumonia has been drawn up.
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The use of an official drug adverse reaction assessment procedure became compulsory in France in 1984. The method proposes various qualifications for chronologic and semiologic criteria but does not define them. Consensus meetings have been organized in order to define, in the main pathologic fields, the adverse reactions themselves and the various qualifications of the criteria. This paper reports the results of meetings attended by hepatologists from university hospitals, members of the National Network of pharmacovigilance and representatives of Roussel Uclaf Drug Monitoring Department for drug-induced acute hepatitis. Participants studied (a) the limits of the time interval between the appearance of the adverse reaction and the beginning or the end of the treatment with the suspected drug; (b) the interpretation of the course of disease with or without cessation of treatment; (c) the interpretation of a possible rechallenge; (d) the signs evoking a drug-induced origin and the risk factors, as well as the investigations to be performed in order to eliminate other possible causes.
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