Pharmacological Research, Vol. 22, Supplement 2,1990 POST-MARKETING DRUG SURVEILLANCE: PREUMINARY DATA OF AN EXPERIENCE IN HOSPITALIZED PATIENTS. Sturiale Y., Rotondo S., Princi P., Spina E., Costa G., Meo M., Carlostella R., Turiano G., Valvo E., Stornello M., Ancione M., Caputi AP. Centro Interdipartimentale di Informazioni Farmaco Tossicologiche (C.I.I.F.T.), Istituto di Farmacologia e Clinica Psichiatrica dell'Universita di Messina; Servizio di salute mentale USL 41 (ME); Divisione di Endocrinologia USL 42 (ME); Centro Ipertensione Ospedale Umberto I (SR). Post-marketing drug surveillance is a scientific discipline in which the clinical experience is closely associated with the application of modern technologies for data processing. Our experience is based upon an experimental protocol involving the C.I.I.F.T. of the University of Messina and different local hospitals. Our investigation concerns the methodology of automated data entry and analysis of informations related to a sample of around 700 inpatients mainly treated with antipsychotic drugs or ACE-inhibitors over the period feb.'89-mar.'90. Adverse reactions, defined according to W.H.O. and reported on a specific form, have been classified into "severe" and "not-severe" on the basis of an analytical algorithm and their prevalence as been calculated. Particular interest has been focused on the prevalence and quality of adverse effects in relationship to the number and class of given drugs, to the lenght of treatment and to drug interactions. We have also taken into consideration changes in the prevalence of the adverse effects due to their specific therapy. Statistical analysis have been performed on data matching results. 471 I043-6618j90j22110471---{)1 j$03.00jO © 1990The Italian Pharmacological Society

Post-marketing drug surveillance: Preliminary data of an experience in hospitalized patients

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Page 1: Post-marketing drug surveillance: Preliminary data of an experience in hospitalized patients

Pharmacological Research, Vol. 22, Supplement 2,1990

POST-MARKETING DRUG SURVEILLANCE: PREUMINARY DATAOF AN EXPERIENCE IN HOSPITALIZED PATIENTS.Sturiale Y., Rotondo S., Princi P., Spina E., Costa G., Meo M., Carlostella R.,Turiano G., Valvo E., Stornello M., Ancione M., Caputi AP.Centro Interdipartimentale di Informazioni Farmaco Tossicologiche(C.I.I.F.T.), Istituto di Farmacologia e Clinica Psichiatrica dell'Universita diMessina; Servizio di salute mentale USL 41 (ME); Divisione diEndocrinologia USL 42 (ME); Centro Ipertensione Ospedale Umberto I(SR).

Post-marketing drug surveillance is a scientific discipline in which the clinicalexperience is closely associated with the application of modern technologiesfor data processing. Our experience is based upon an experimental protocolinvolving the C.I.I.F.T. of the University of Messina and different localhospitals. Our investigation concerns the methodology of automated dataentry and analysis of informations related to a sample of around 700 inpatientsmainly treated with antipsychotic drugs or ACE-inhibitors over the periodfeb.'89-mar.'90. Adverse reactions, defined according to W.H.O. and reportedon a specific form, have been classified into "severe" and "not-severe" on thebasis of an analytical algorithm and their prevalence as been calculated.Particular interest has been focused on the prevalence and quality of adverseeffects in relationship to the number and class of given drugs, to the lenght oftreatment and to drug interactions. We have also taken into considerationchanges in the prevalence of the adverse effects due to their specific therapy.Statistical analysis have been performed on data matching results.

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