Methodologies for the detection of adverse drug reactions: comparison of hospital databases, chart review and spontaneous reporting

被引：31
|
作者：
Miguel, Ana [1 ,2 ]
Azevedo, Luis Filipe [1 ]
Lopes, Fernando [1 ]
Freitas, Alberto [1 ]
Pereira, Altamiro Costa [1 ]
机构：
[1] Univ Porto, Fac Med, Ctr Res Hlth Technol & Informat Syst CINTESIS, P-4200 Oporto, Portugal
[2] Hosp Univ Ctr Coimbra, Dept Ophthalmol, Coimbra, Portugal
来源：
PHARMACOEPIDEMIOLOGY AND DRUG SAFETY | 2013年 / 22卷 / 01期
关键词：
adverse drug reactions; hospital; prevalence; databases; pharmacovigilance; pharmacoepidemiology; EVENTS; SURVEILLANCE;
D O I：
10.1002/pds.3348
中图分类号：
R1 [预防医学、卫生学];
学科分类号：
1004 ; 120402 ;
摘要：
Purpose To evaluate a methodology for adverse drug reactions (ADRs) detection through hospital databases. Methods A retrospective analysis was conducted to identify ADRs using diagnostic codes from databases, later validated by chart review. An independent chart review was performed for comparison, as well as assessment of spontaneous reports. Results 325 ADRs were identified (prevalence of 2.41%, positive predictive value of 87.6%). Independent chart review identified 9% of ADRs at a cost of 35 person-hours (versus two person-hours in databases). There were seven spontaneous reports of ADRs. Conclusions Although not frequently used, the detection of ADRs through databases is a relatively less expensive, fast and effective methodology that can improve current pharmacovigilance systems. Copyright (C) 2012 John Wiley & Sons, Ltd.
引用
收藏
页码：98 / 102
页数：5
相关论文
共 50 条
  • [31] Pattern of adverse drug reactions notified by spontaneous reporting in an Indian tertiary care teaching hospital
    Jose, Jimmy
    Rao, Padma G. M.
    PHARMACOLOGICAL RESEARCH, 2006, 54 (03) : 226 - 233
  • [32] Factors associated with spontaneous reporting of adverse drug reactions in Japan
    Yamada, Toru
    Watanabe, Yuka
    Kusama, Makiko
    Sugiyama, Yuichi
    Ono, Shunsuke
    PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2013, 22 (05) : 468 - 476
  • [33] Assessment of suspected adverse drug reactions in elderly patients with diabetes mellitus based on a Portuguese spontaneous reporting database: analysis of reporting from 2008 to 2018
    Monteiro, Cristina
    Silvestre, Samuel
    Duarte, Ana Paula
    Alves, Gilberto
    EXPERT OPINION ON DRUG SAFETY, 2021, 20 (07) : 845 - 853
  • [34] Comparison of Statistical Signal Detection Methods Within and Across Spontaneous Reporting Databases
    Candore, Gianmario
    Juhlin, Kristina
    Manlik, Katrin
    Thakrar, Bharat
    Quarcoo, Naashika
    Seabroke, Suzie
    Wisniewski, Antoni
    Slattery, Jim
    DRUG SAFETY, 2015, 38 (06) : 577 - 587
  • [35] Adverse Drug Reactions in Hospitalized Patients: Results of the FORWARD (Facilitation of Reporting in Hospital Ward) Study
    Giardina, Claudia
    Cutroneo, Paola M.
    Mocciaro, Eleonora
    Russo, Giuseppina T.
    Mandraffino, Giuseppe
    Basile, Giorgio
    Rapisarda, Franco
    Ferrara, Rosarita
    Spina, Edoardo
    Arcoraci, Vincenzo
    FRONTIERS IN PHARMACOLOGY, 2018, 9
  • [36] Under-reporting of adverse drug reactions -: Estimate based on a spontaneous reporting scheme and a sentinel system
    Alvarez-Requejo, A
    Carvajal, A
    Bégaud, B
    Moride, Y
    Vega, T
    Arias, LHM
    EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY, 1998, 54 (06) : 483 - 488
  • [37] Reporting of adverse drug reactions by hospital doctors and the response to intervention
    McGettigan, P
    Golden, J
    Conroy, RM
    Arthur, N
    Feely, J
    BRITISH JOURNAL OF CLINICAL PHARMACOLOGY, 1997, 44 (01) : 98 - 100
  • [38] Adverse reactions to oncologic drugs: spontaneous reporting and signal detection
    Tuccori, Marco
    Montagnani, Sabrina
    Capogrosso-Sansone, Alice
    Mantarro, Stefania
    Antonioli, Luca
    Fornai, Matteo
    Blandizzi, Corrado
    EXPERT REVIEW OF CLINICAL PHARMACOLOGY, 2015, 8 (01) : 61 - 75
  • [39] Toward multimodal signal detection of adverse drug reactions
    Harpaz, Rave
    DuMouchel, William
    Schuemie, Martijn
    Bodenreider, Olivier
    Friedman, Carol
    Horvitz, Eric
    Ripple, Anna
    Sorbello, Alfred
    White, Ryen W.
    Winnenburg, Rainer
    Shah, Nigam H.
    JOURNAL OF BIOMEDICAL INFORMATICS, 2017, 76 : 41 - 49
  • [40] Adverse drug reactions in adolescents: a review of reporting to a national pharmacovigilance system
    Rebelo Gomes, Eva
    Ribeiro-Vaz, Ines
    Santos, Cristina Costa
    Herdeiro, Maria Teresa
    EXPERT OPINION ON DRUG SAFETY, 2020, 19 (07) : 915 - 922
12345