PHARMACOVIGILANCE Thérapie 2012 Septembre-Octobre; 67 (5): 471–476 DOI: 10.2515/therapie/2012059 © 2012 Société Française de Pharmacologie et de Thérapeutique Adverse Drug Reactions in Older Adults: a Retrospective Study from Pharmacovigilance Rim Charfi 1,2 , Sihem El Aïdli 1,2 , Ahmed Zaïem 1,2 , Sarah Kastalli 1,2 , Samia Sraïri 1 , Riadh Daghfous 1,2 and Mohamed Lakhal 1,2 1 Tunisian National Centre of Pharmacovigilance, Tunis, Tunisia 2 Faculty of Medicine, University of Tunis El Manar, Tunis, Tunisia Text received February 14 th , 2012; accepted April 12 th , 2012 Abstract – Purpose. To assess the adverse drug reactions notified in older adults to pharmacovigilance and to identify the incriminated drugs in their genesis. Methods. A retrospective study including 688 notifications of adverse drug reactions to pharmacovigilance in patients aged of 65 years and more, over a period of 16 years and where the responsibility of one drug or more was incriminated in the genesis of the adverse reaction. Imputation was established according to the French method and seriousness according to the World Health Organization (WHO) criteria. Results. Sex-ratio W/M was 1.2. Average age was 71.3 years. The average number of administered drugs was 3.64 and polymedication was noted in 30% of cases. Adverse drug reactions were essentially cutaneous and systemic. Incriminated drugs were mainly antibiotics and cardio-vascular drugs. Serious adverse drug reactions were noted in 26%. Conclusion. In older adults, adverse drug reactions’ notification to phar- macovigilance is necessary and allows assessing large scale epidemiologic studies to identify iatrogenic risk factors. Résumé – Effets indésirables médicamenteux chez les sujets âgés : étude rétrospective en pharmacovigilance. Objec- tifs. Rapporter les effets indésirables survenus chez les sujets âgés, notifiés en pharmacovigilance et identifier les médicaments incriminés dans leur genèse. Méthodes. Étude rétrospective incluant 688 cas d’effets indésirables notifiés en pharmacovi- gilance chez des sujets âgés de 65 ans et plus sur une période de 16 ans. L’imputabilité a été établie selon la méthode française et la gravité définie selon les critères de l’Organisation mondiale de la santé. Résultats. Le sex-ratio femme/homme était de 1,2 et la moyenne d’âge était de 71,3 ans. Le nombre moyen de médicaments administrés était de 3,64 et 30 % des sujets étaient polymédiqués. Les effets indésirables étaient essentiellement cutanés et systémiques et les médicaments incriminés étaient surtout les antibiotiques et les médicaments à visée cardio-vasculaire. Les effets indésirables étaient graves dans 26 %. Conclusion. La notification des effets indésirables en pharmacovigilance chez les sujets âgés est nécessaire afin de permettre des études épidémiologiques à large échelle et de mieux cerner les facteurs de risque iatrogène. * For the list of participants, see end of article. 1. Introduction In 2006, the elderly or the group of persons aged of 65 years or more, represented, respectively 6% of the tunisian population and 7% of the world population. [1,2] Special attention is generally focused on adverse drug reactions (ADRs) occurring in this partic- ular category of people. The polypathology exposes older adults to a drug overconsumption. In fact, in 2001, in France, 39% of pre- scribed drugs were administered to older adults. [3] In older adults, the specific functions of vital organs, in partic- ular the liver and the kidney, are not more quickly altered than the young and middle-aged adults, nevertheless, deficits appear more frequently. [4] Some of these changes may be pharmacokinetic ones getting all the stages of the drug course in the body or pharmaco- dynamic leading to a modification of the sensitivity to numerous drugs. [5-7] The drug overconsumption, pharmacokinetic and pharmacody- namic modifications are at the origin of an increased incidence of ADR occurrence at this age. Indeed, most of the studies showed that the incidence of ADR was twice as frequent after 65 years. Among these ADR, 10 to 20% were serious and led to a hospitalization. [3] One of the aims searched in pharmacovigilance is to identify risk factors of drug use. So, many studies concerned the epidemiol- ogy of the ADR in older adults. In general, the published studies Keywords: adverse reaction; drug; elderly; pharmacovigilance Mots clés : effet indésirable ; médicament ; sujet âgé ; pharmacovigilance Article publié par EDP Sciences