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Adverse drug reactions in hospitalized patients: An operational procedure to improve reporting and investigate underreporting
Author(s) -
Maistrello Italo,
Morgutti Marina,
Maltempi Maura,
Dantes Marcello
Publication year - 1995
Publication title -
pharmacoepidemiology and drug safety
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.023
H-Index - 96
eISSN - 1099-1557
pISSN - 1053-8569
DOI - 10.1002/pds.2630040206
Subject(s) - medicine , adverse effect , under reporting , emergency medicine , drug , medical emergency , pharmacoepidemiology , medical record , adverse drug event , adverse event reporting system , drug reaction , family medicine , pediatrics , pharmacology , medical prescription , statistics , mathematics
Background — Adverse event (AE) underreporting is a serious obstacle to drug safety monitoring in hospitalized patients, and it is necessary to find new approaches for improving the situation. The aim of the present study was to try to improve reporting and to evaluate the difference between actual and expected reporting. Methods — The drug surveillance programme was implemented in a 72‐bed internal medicine ward. A simple algorithm was printed on each page of the progress notes of the patients' medical record, which the physicians were asked to use in choosing the AEs to be reported to the drug surveillance system. The actual reporting was evaluated for a period of 12 months (1203 patients). Using the same algorithm, two reviewing doctors evaluated expected reporting by analysing all of the AEs deduced from the records of 120 randomly selected patients. Results — Actual reporting: over a period of 12 months, the doctors reported 89 AEs (7.4 per 100 patients), whereas no event had been reported to the national drug surveillance system in the twelve months preceding the introduction of the project. Actual versus expected reporting: in 120 randomly selected patients, 22 AEs were considered by the reviewers as constituting the expected reporting; nine were actually reported. Conclusions — The described drug surveillance programme led to a substantial improvement in adverse event reporting, although a considerable difference still remains between expected and actual reporting.