Detection of adverse drug reactions through the minimum basic data set
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Objective To analyze adverse drug reaction (ADR) detection using the Minimum Basic Data Set (MBDS) at hospital discharge and to compare the ADR reporting rate to the Pharmacovigilance Referral Centre with other similar hospitals that do not use this reporting system. Setting 650-bed University Hospital serving a population of 294,000 inhabitants in Spain. Method: A retrospective descriptive study was conducted between January 2006 and December 2007. All reports of ADRs gathered in MBDS (a tool that encodes all administrative and clinical information generated for each patient during a hospitalization episode) with International Classification Disease codes between E930 and E949.9 were analyzed to assess the appropriateness of their referral to the pharmacovigilance centre. Finally, we compared our reporting rate with other hospitals that do not use this system for ADR identification. Main outcome measure The incidence of ADRs detected in hospitalized patients and the reporting rate (per thousand inhabitants) to the referral pharmacovigilance centre using the Yellow Card system. Results: Out of 43,282 hospital discharges, 386 ADR were recorded (0.89% of hospitalized patients). The mean (±SD) age of patients with reported ADR was 61.9 years (±19.2), median age was 65 years, and 55.2% were female. The Department of Pharmacy reported 276 (71.5%) of ADR using the Yellow Card system. The most frequently reported drugs were anti-cancer agents (42.5%) and cardiovascular drugs (23.8%), with a high frequency of digitalis glycosides (18.4%). ADR were most frequently recorded by the Departments of Oncology (41.7%) and Internal Medicine (17.9%). Conclusion The MBDS is a useful and accessible instrument to determine the incidence of ADR in a hospital, resulting in the notification of severe events that might otherwise not be reported. Its use also improves identification of the main drugs responsible for ADR and of the patient populations at greatest risk, facilitating the implementation of alert systems and the development of prevention and detection strategies.
KeywordsAdverse drug reactions ADR-reporting systems Drug surveillance systems Hospital Minimum basic data set Pharmacovigilance Spain
The authors would like to thank the Hospital Pharmacy Units of Reina Sofia University Hospital, Nuestra Señora de Valme University Hospital and Costa del Sol Hospital for kindly providing us with their notification rates.
This research did not receive any specific grant from any funding agency in the public, commercial or not-for-profit sector.
Conflicts of interest
The authors declare that there is no conflict of interest that would prejudice the impartiality of this scientific work.
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