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Quality of clinical information in ADR reports

Date: 20 June 2017

Patients report clinical information at a similar level as their healthcare professionals. However, since patients and healthcare professionals report from their own perspective, both should be encouraged to report for an optimal pharmacovigilance.

Clinical information is needed to assess the causal relationship between a drug and an ADR. Studies that have compared information reported by patients and healthcare professionals have so far focused on the completeness of information. Little is known about the level of relevant clinical information about ADRs reported by patients. Lareb explored to what extent patients reported clinical information about an adverse drug reaction (ADR) compared to their healthcare professional.

To compare the level of clinical information in ADR reports by patients and healthcare professionals, all ADR reports in the Lareb database on the same case, i.e. duplicate reports from both a patient and a healthcare professional, were selected. The level of clinical information was analyzed using a structured tool. The following four domains were included: description of the ADR, chronology, suspected drug, and patient characteristics. For each domain, the proportion of reported information in relation to information deemed relevant was calculated. An average score of all relevant domains was determined and categorized as: poorly (≤45%), moderately (46 to 74%) and well (≥75%) quality.

A total of 197 cases were included. For 107 cases (54.3%) patients and healthcare professionals reported a similar level of clinical information. For the 90 cases were there was a difference in category, for most cases (87.8%) the reports differed only one category (well vs. moderately or moderately vs. poor).


To read the article:
Rolfes L, van Hunsel F, van der Linden L, Taxis K, van Puijenbroek E. The Quality of Clinical Information in Adverse Drug Reaction Reports by Patients and Healthcare Professionals: A Retrospective Comparative Analysis. Drug Saf. 2017 Apr 12.

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