title: A comparison of active surveillance programs including a spontaneous reporting model for phamacovigilance of adverse drug events in a hospital.
abstract: OBJECTIVE
  Spontaneous reporting systems have several weak points, such as low reporting rates and insufficient clinical information. Active surveillance programs, such as ward rounds and a clinical data repository (CDR), may supplement the weak points of such systems. We developed active surveillance programs and compared them with existing spontaneous reporting.
  
  
  METHODS
  We collected adverse drug event (ADE) cases, which comprised 1,055 cases of spontaneous reporting, 309 reported by ward rounds, and 229 found using a CDR. The clinical features and causative drugs were evaluated.
  
  
  RESULTS
  Active surveillance programs detected additional serious ADEs compared to those of spontaneous reporting programs. The ADEs identified by CDR (22.9%) were more likely to be classified as "serious" than those reported spontaneously (5.2%) or identified during ward rounds (10.3%). Causative drugs also differed. Opioids, antibiotics, and contrast media were the most common drugs causing ADEs in the spontaneous reporting system, whereas the active surveillance programs identified antibiotics as the most common causative drug. Clinical features also differed. ADEs with gastrointestinal manifestations were reported most frequently by spontaneous reporting programs. ADEs reported from active surveillance more reliably identified events associated with changes in laboratory values, such as hepatobiliary toxicity, hematologic manifestations, and nephrologic manifestations, compared with spontaneous reporting programs.
  
  
  CONCLUSIONS
  Our findings suggest that active surveillance programs can supplement spontaneous reporting systems in hospitals. ADEs related to laboratory abnormalities were monitored more closely by active surveillance programs and may be useful for identification of serious ADEs.
authors.affiliation: Severance Hospital Regional Pharmacovigilance Center, Division of Allergy and Immunology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Il Seon
authors.initials: IS
authors.lastname: Yun
authors.forename: Myung Jin
authors.initials: MJ
authors.lastname: Koo
authors.forename: Eun Hye
authors.initials: EH
authors.lastname: Park
authors.forename: Sung-Eun
authors.initials: SE
authors.lastname: Kim
authors.forename: Jae-Hyun
authors.initials: JH
authors.lastname: Lee
authors.forename: Jung-Won
authors.initials: JW
authors.lastname: Park
authors.forename: Chein-Soo
authors.initials: CS
authors.lastname: Hong
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006784:Hospitals, Teaching; D006801:Humans; D008297:Male; D008875:Middle Aged; D060735:Pharmacovigilance; D056910:Republic of Korea; D012189:Retrospective Studies