4.2 Article

Adverse drug reaction reports of patients and healthcare professionals-differences in reported information

Journal

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY
Volume 24, Issue 2, Pages 152-158

Publisher

WILEY-BLACKWELL
DOI: 10.1002/pds.3687

Keywords

adverse drug reactions (ADRs); pharmacovigilance; patient reporting; pharmacoepidemiology

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PurposeThis study aims to explore the differences in reported information between adverse drug reaction (ADR) reports of patient and healthcare professionals (HCPs), and, in addition, to explore possible correlation between the reported elements of information. MethodsThis retrospective study compared the reported information between 200 ADR reports of patients and HCPs. Reports were rendered anonymous and scored for the presence or absence of predefined elements of information. These elements can be objective (e.g. start date of the ADR) or subjective (e.g. the impact or severity of the ADR). A two-sided Pearson's Chi-square test was used to detect statistically significant differences in the reported information. A Bonferroni correction was used to correct for multiple comparisons. Correlation between the elements of information was explored using categorical principal components analysis (CATPCA). ResultsOverall, HCPs had a higher score for the presence of objective and patients for subjective elements of information. Elements that were statistically significant more often reported by patients are the impact of the ADR and the patient's weight and height. HCPs statistically significant more often reported the medical history and the route of administration of the drug. CATPCA showed four clusters of elements of information that have fair correlation. ConclusionsThis study demonstrates the differences in reported information between ADR reports of patients and HCPs. Patient reports are more focused on patient-related information and the impact of the reported ADRs, whereas reports from HCPs provide more clinically related information. Copyright (c) 2014 John Wiley & Sons, Ltd.

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