title: [Pharmacovigilance center --internal medicine interactions: A useful diagnostic tool].
abstract: OBJECTIVE
  Patients hospitalized in internal medicine often have unexplained clinical symptoms for which a drug origin can be considered. The prevalence of patients hospitalized for iatrogenic is estimated between 4-22%. We wanted to evaluate the diagnostic value of the regional center of pharmacovigilance to identify or confirm an iatrogenic disease in the department of internal medicine of Lille and characterize factors associated with drug-related side effect.
  
  
  METHODS
  This is a single-center prospective diagnostic study. We included all subsequent requests from the department of internal medicine with the Nord-Pas-de-Calais regional pharmacovigilance center between 2010 and 2012. The opinion of the regional pharmacovigilance centre was held on the record of the adverse drug reaction in the national pharmacovigilance database and analyzed according to the conclusion of iatrogenic used by clinicians in internal medicine (reference diagnosis) with a follow-up to June 2013. The variables relating to the patient, medication and adverse events were analyzed by binary logistic regression.
  
  
  RESULTS
  We analyzed 160 contacts: 118 concordant cases, 38 false-positives (drug-related side effect retained by the regional pharmacovigilance center only), 4 false negatives. Registration in the national pharmacovigilance database had a sensitivity of 96% (95% CI [0.92 to 0.99]), a specificity of 46% (95% CI [0.38 to 0.53]), a value positive predictive of 69% (95% CI [0.62 to 0.76]), a negative predictive value of 89% (95% CI [0.84 to 0.94]) and a negative likelihood ratio of 0.1. False-positive had chronological and semiological accountabilities questionable (adjusted RR=2.1, 95% CI [1.2 to 2.8]).
  
  
  CONCLUSIONS
  In our study, the regional pharmacovigilance center confirms the clinician's suspicion of drug-related side effects and helps to exclude drug-induced with a high negative predictive value.
authors.affiliation: Département de médecine générale, faculté de médecine pôle formation, université de Lille, 1, avenue Eugène-Avinée, 59120 Loos, France. Electronic address: michael.rochoy@gmail.com.
authors.forename: M
authors.initials: M
authors.lastname: Rochoy
authors.affiliation: Département de pharmacologie médicale, centre régional de pharmacovigilance, faculté de médecine pôle recherche, université de Lille, 1, place de Verdun, 59037 Lille cedex, France.
authors.forename: S
authors.initials: S
authors.lastname: Gautier
authors.affiliation: Département de pharmacologie médicale, centre régional de pharmacovigilance, faculté de médecine pôle recherche, université de Lille, 1, place de Verdun, 59037 Lille cedex, France.
authors.forename: R
authors.initials: R
authors.lastname: Bordet
authors.affiliation: Département de pharmacologie médicale, centre régional de pharmacovigilance, faculté de médecine pôle recherche, université de Lille, 1, place de Verdun, 59037 Lille cedex, France.
authors.forename: J
authors.initials: J
authors.lastname: Caron
authors.affiliation: Service de médecine interne, centre national de référence de la sclérodermie systémique, hôpital Claude-Huriez, université de Lille, CHRU de Lille, 59037 Lille cedex, France.
authors.forename: D
authors.initials: D
authors.lastname: Launay
authors.affiliation: Service de médecine interne, centre national de référence de la sclérodermie systémique, hôpital Claude-Huriez, université de Lille, CHRU de Lille, 59037 Lille cedex, France.
authors.forename: E
authors.initials: E
authors.lastname: Hachulla
authors.affiliation: Service de médecine interne, centre national de référence de la sclérodermie systémique, hôpital Claude-Huriez, université de Lille, CHRU de Lille, 59037 Lille cedex, France.
authors.forename: P-Y
authors.initials: PY
authors.lastname: Hatron
authors.affiliation: Service de médecine interne, centre national de référence de la sclérodermie systémique, hôpital Claude-Huriez, université de Lille, CHRU de Lille, 59037 Lille cedex, France.
authors.forename: M
authors.initials: M
authors.lastname: Lambert
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016208:Databases, Factual; D064420:Drug-Related Side Effects and Adverse Reactions / Q000175:diagnosis*; D005260:Female; D006801:Humans; D007049:Iatrogenic Disease; D007388:Internal Medicine; D008297:Male; D008875:Middle Aged; D060735:Pharmacovigilance; D011446:Prospective Studies; D055815:Young Adult
keywords: Decision support techniques; Drug-related side effects and adverse reactions; Effets secondaires indésirables des médicaments; Internal medicine; Médecine interne; Pharmacovigilance; Techniques d’aide à la décision