Spontaneous monitoring of adverse reactions to drugs by Italian dermatologists: A pilot study

L. Naldi, C. Ferri, T. Cainelli, G. Tognoni, M. G. Franzosi, A. Rebora, F. Locati, L. Marchesi, F. Mari, P. Lisi, G. Zina, F. Grimaldi-Filioli, P. A. Villano, C. Moscariello, P. Turco, M. Pisani, P. Puiatti, M. Tomidei, M. Fassino

Research output: Contribution to journalArticlepeer-review

Abstract

During 1988, the Gruppo Italiano Studi Epidemiologici in Dermatologia (GISED) coordinated a pilot study aimed at evaluating the feasibility of a system for spontaneous monitoring of adverse drug reactions in dermatological practice in Italy. Approximately 400 dermatologists were asked to collaborate, and 141 agreed to the study. Procedures similar to those well established in other surveillance programs (including the use of standard forms and standardized assessment procedure) were adopted. In a 2-month period 775 reports were collected, of which 711 were maintained after careful evaluation. The general profile of the adverse reactions reported was in accordance with the experience derived by other spontaneous surveillance programs. The main purpose of spontaneous reporting systems is the identification of new reactions, and a model analysis was proposed, in our study, with reference to skin reactions to bamifylline. The demonstration of the feasibility of a drug-monitoring program in Italy, where little tradition exists in the area, is the most important result of our study.

Original languageEnglish
Pages (from-to)12-17
Number of pages6
JournalDermatologica
Volume182
Issue number1
Publication statusPublished - 1991

Keywords

  • adverse drug reactions
  • bamifylline
  • dermatological spontaneous reporting system
  • exanthema
  • postmarketing surveillance

ASJC Scopus subject areas

  • Dermatology

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