François Montastruc1, Haleh Bagheri1, Isabelle Lacroix1, Christine Damase-Michel1, Leila Chebane1, Vanessa Rousseau1, Emilie Jouanjus1, Maryse Lapeyre-Mestre1, Geneviève Durrieu1, Jean-Louis Montastruc2. 1. Service de Pharmacologie Médicale et Clinique, Centre de PharmacoVigilance, de Pharmacoépidémiologie et d'Informations sur le Médicament, Pharmacopôle, INSERM UMR 1027, CIC INSERM 1436, Faculté de Médecine, Centre Hospitalier Universitaire de Toulouse, Toulouse, France. 2. Service de Pharmacologie Médicale et Clinique, Centre de PharmacoVigilance, de Pharmacoépidémiologie et d'Informations sur le Médicament, Pharmacopôle, INSERM UMR 1027, CIC INSERM 1436, Faculté de Médecine, Centre Hospitalier Universitaire de Toulouse, Toulouse, France. jean-louis.montastruc@univ-tlse3.fr.
Abstract
INTRODUCTION: The use of mobile apps is increasing in medicine. In pharmacovigilance, mobile apps may help to increase adverse drug reaction reporting and improve the communication of safety issues. The Toulouse University Pharmacovigilance Center has developed VigiBIP®, a free smartphone app available on Android and Apple stores, for reporting adverse drug reactions and requesting drug safety information. OBJECTIVE: The present study was performed to compare the main characteristics of spontaneous adverse drug reaction reports received through VigiBIP® with classical methods of reporting (phone, e-mail, fax, letter, website) during 25 months (2015-17). METHODS: Using the Chi squared test, we compared the type of reporter, adverse drug reaction seriousness, drugs involved and reported ADRs using VigiBIP® and classical methods of reporting RESULTS: A total of 4102 reports were received by the Toulouse University Pharmacovigilance Center, including 4.7% through VigiBip®. Patients' reports were significantly more frequent with VigiBip® (6.7%) than with classical methods (3.4%) [p = 0.01]. Reported adverse drug reactions and involved drugs differed according to the method of reporting used. CONCLUSION: Our study shows that a mobile app is an additional tool used in pharmacovigilance. Types of reporters and adverse drug reactions in VigiBIP were different to those seen in classical methods of reporting.
INTRODUCTION: The use of mobile apps is increasing in medicine. In pharmacovigilance, mobile apps may help to increase adverse drug reaction reporting and improve the communication of safety issues. The Toulouse University Pharmacovigilance Center has developed VigiBIP®, a free smartphone app available on Android and Apple stores, for reporting adverse drug reactions and requesting drug safety information. OBJECTIVE: The present study was performed to compare the main characteristics of spontaneous adverse drug reaction reports received through VigiBIP® with classical methods of reporting (phone, e-mail, fax, letter, website) during 25 months (2015-17). METHODS: Using the Chi squared test, we compared the type of reporter, adverse drug reaction seriousness, drugs involved and reported ADRs using VigiBIP® and classical methods of reporting RESULTS: A total of 4102 reports were received by the Toulouse University Pharmacovigilance Center, including 4.7% through VigiBip®. Patients' reports were significantly more frequent with VigiBip® (6.7%) than with classical methods (3.4%) [p = 0.01]. Reported adverse drug reactions and involved drugs differed according to the method of reporting used. CONCLUSION: Our study shows that a mobile app is an additional tool used in pharmacovigilance. Types of reporters and adverse drug reactions in VigiBIP were different to those seen in classical methods of reporting.
Authors: Sieta T de Vries; Lisa Wong; Alastair Sutcliffe; François Houÿez; Carmen Lasheras Ruiz; Peter G M Mol Journal: Drug Saf Date: 2017-05 Impact factor: 5.606