Pharmacological Research, Vol. 46, No. 5, 2002 doi:10.1016/S1043-6618(02)00210-4, available online at http://www.idealibrary.com on ADVERSE DRUG REACTIONS TO ANTIBIOTICS OBSERVED IN TWO PULMONOLOGY DIVISIONS OF CATANZARO, ITALY: A SIX-YEAR RETROSPECTIVE STUDY L. GALLELLI a , G. FERRERI a , M. COLOSIMO a , D. PIRRITANO a , L. GUADAGNINO a , G. PELAIA b , R. MASELLI b and G. B. DE SARRO a,∗ a Chair of Pharmacology, Department of Experimental and Clinical Medicine, University “Magna Graecia” of Catanzaro, Regional Pharmacovigilance Center, “Mater Domini” University Hospital, Via T. Campanella, 88100 Catanzaro, Italy, b Chair of Respiratory Diseases, Department of Experimental and Clinical Medicine, University “Magna Graecia” of Catanzaro, “Mater Domini” University Hospital, Via T. Campanella, 88100 Catanzaro, Italy Accepted 7 August 2002 We retrospectively analysed adverse drug reactions (ADRs) associated with antibiotic therapy and reported over a 6-year period, from January 1995 to December 2000, in clinical notes of two Pul- monology Units of “Mater Domini” University Hospital and “Pugliese-Ciaccio” Hospital, both lo- cated in Catanzaro, Italy. Antibiotics were responsible for 92 (44.9%) out of 205 episodes of ADRs. In particular, 22 episodes (23.9%) were observed after penicillin G administration, 19 episodes (20.7%) following ceftazidime and cefotaxime administration, 16 episodes (17.4%) after therapy with ampicillin, and 35 reac- tions (38%) were further reported during treatments with other antibiotics. We determined that the drug–ADR relationship was certain in 63% of the reports; withdrawal of the suspected drug led to re- covery in 95% of cases. In conclusion, this retrospective evaluation demonstrated that antibiotics are a common cause of ADRs in hospitalised patients and, therefore, drug surveillance can successfully identify targeted adverse events. © 2002 Elsevier Science Ltd. All rights reserved. Key words: antibiotics, adverse drug reactions, clinical records, pulmonology, hospitalised patients. INTRODUCTION Pharmacovigilance or post-marketing surveillance aims to identify and quantify the risks associated with the use of drugs [1], thus contributing to better understand the most important characteristics of adverse drug reactions (ADRs) and the pathogenic mechanisms involved. Indeed, ADRs represent a common clinical problem and can be responsible for an increased number and/or duration of hospitalisations [2,3]. An ADR is associated with a sig- nificantly prolonged length of stay, increased economic burden, morbidity, and an almost 2-fold increased risk of death [4]. Any drug can cause ADRs, which may range from mild skin rashes (hives) to a life-threatening allergic reaction. ∗ Corresponding author. Cattedra di Farmacologia, Dipartimento di Medicina Sperimentale e Clinica, Policlinico Universitario “Mater Domini”, Via T. Campanella, 88100 Catanzaro, Italy. E-mail: desarro@unicz.it Antibiotics are some of the major contributors to drug hypersensitivity and represent the most frequently used drugs in hospital practice [5,6]. Although spontaneous re- porting is, among the several different methods that can be used to detect ADRs, the only surveillance system capa- ble of routinely monitoring these events [7], it alone can- not provide sufficient guarantee that a particular adverse event is a true ADR. Therefore, this approach has to be integrated with other procedures using retrospective data based on clinical trials and medical reports, in order to de- fine ADRs which are either not time-related or associated with chronic drug administration [8]. These retrospective analysis carried out to investigate ADRs in hospital populations could be very useful to im- prove the health care system with regard to both financial aspects and cost–benefit evaluations. A better health care can be achieved by applying this knowledge to the indi- vidual patient, thus trying to avoid possible troubles. The magnitude of these problems implies the need of investing sufficient resources in order to implement programs aimed to identify, assess, and manage ADRs [9]. The purpose 1043-6618/02/$ – see front matter © 2002 Elsevier Science Ltd. All rights reserved.