title: [Use of Nadis(®) software to improve adverse drug reaction reporting of antiretroviral drugs: experience in south west of France (midi-pyrénées)].
abstract: OBJECTIVE
  To study the value of the module of pharmacovigilance in Nadis® to improve the antiretroviral (ARV) drugs-induced adverse drug reactions (ADRs) reporting.
  
  
  METHODS
  We collected the ADRs reported for 17 months from November 2010 until April 2012. Following data were recorded: characteristics of patients, ADRs, ARV drugs. The number of ADRs was compared to those collected in the same period (17 months) before use of Nadis®.
  
  
  RESULTS
  The 119 ADRs reported (an increase of 183%) for 109 patients ADRs were mainly gastrointestinal (21.8%) followed by renal (20.2%), neuro-psychiatric (16.8%), hepatic (13.5%), cutaneous (8.4%), metabolic (6.7%) and others (12.6%). The repartition of ARV drugs was: nucleoside (31.8%), nucleotide (13.6%) reverse transcriptase inhibitors respectively, non-nucleoside reverse transcriptase inhibitors (13.1%), protease inhibitors (36.4%), and integrase inhibitors (5.1%).
  
  
  CONCLUSIONS
  Our results show the improvement of ARV-induced ADRs reporting by Nadis® which could be used to reduce the rate of under-reporting in patients exposed to these drugs.
authors.affiliation: Service de Pharmacologie médicale et clinique, Centre Midi-Pyrénées de Pharmacovigilance, de Pharmacoépidémiologie et d'Information sur le Médicament, CHU Toulouse, Inserm U1027, Université Toulouse III, Toulouse, France.
authors.forename: Liselotte
authors.initials: L
authors.lastname: Pochard
authors.affiliation: Service de Pharmacologie médicale et clinique, Centre Midi-Pyrénées de Pharmacovigilance, de Pharmacoépidémiologie et d'Information sur le Médicament, CHU Toulouse, Inserm U1027, Université Toulouse III, Toulouse, France.
authors.forename: Laurent
authors.initials: L
authors.lastname: Hauviller
authors.affiliation: Service de Maladies infectieuses, Centre d'Information et de Soins de l'Immuno-déficience Humaine (CISIH), CHU Toulouse, Toulouse, France.
authors.forename: Lise
authors.initials: L
authors.lastname: Cuzin
authors.affiliation: Service de Pharmacologie médicale et clinique, Centre Midi-Pyrénées de Pharmacovigilance, de Pharmacoépidémiologie et d'Information sur le Médicament, CHU Toulouse, Inserm U1027, Université Toulouse III, Toulouse, France.
authors.forename: Fréderic
authors.initials: F
authors.lastname: Eyvrard
authors.affiliation: Service de Pharmacologie médicale et clinique, Centre Midi-Pyrénées de Pharmacovigilance, de Pharmacoépidémiologie et d'Information sur le Médicament, CHU Toulouse, Inserm U1027, Université Toulouse III, Toulouse, France.
authors.forename: Agnès
authors.initials: A
authors.lastname: Sommet
authors.affiliation: Service de Pharmacologie médicale et clinique, Centre Midi-Pyrénées de Pharmacovigilance, de Pharmacoépidémiologie et d'Information sur le Médicament, CHU Toulouse, Inserm U1027, Université Toulouse III, Toulouse, France.
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Montastruc
authors.affiliation: Service de Pharmacologie médicale et clinique, Centre Midi-Pyrénées de Pharmacovigilance, de Pharmacoépidémiologie et d'Information sur le Médicament, CHU Toulouse, Inserm U1027, Université Toulouse III, Toulouse, France.
authors.forename: Haleh
authors.initials: H
authors.lastname: Bagheri
mesh_terms: D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D000369:Aged, 80 and over; D044966:Anti-Retroviral Agents / Q000009:adverse effects*; D016208:Databases, Factual; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005260:Female; D005602:France; D006801:Humans; D008297:Male; D008875:Middle Aged; D060735:Pharmacovigilance; D015995:Prevalence; D012984:Software
chemical_list: D044966:Anti-Retroviral Agents