Adverse Drug Reaction Reports of Patients and Healthcare Professionals: How Different Are They?

Background: Changes in the European pharmacovigilance
legislation make it possible for patients of all
European member states to report concerns regarding
drugs directly to the national reporting centre for
adverse drug reactions (ADRs). Despite a number of
studies that have been conducted on patients as reporters
in pharmacovigilance, typical characteristics of
patients’ ADR reports compared to those of healthcare
professionals (HCPs) are unclear.

Objectives: To explore the differences in reported information
between patients’ and HCPs’ ADR reports.
Methods: A retrospective study among 200 anonymised
patients’ and HCPs’ ADR reports. Reports were
rendered anonymous and rated using a list of objective
(for example start date of the ADR) and subjective
(for example the impact of the ADR) elements of information that could be important considering ADR
reporting. A two-side Pearson’s Chi-square test
(p < 0.05) was used to detect statistically significant
differences in the number of reported elements of
information.

Results: The reported information between patients’
and HCPs’ reports is broadly consistent. However, differences
were found in both objective and subjective
elements of information; HCPs had a higher score for
objective and patients for subjective elements. Elements
of information that were more often reported
by patients: outcome ADR, detailed description,
course of ADR, impact the ADR on the patient’s daily
of life, severity, patient’s weight and height, patient’s
thoughts about causality, and contact with or between
HCPs. Elements of information that were more often
reported by HCPs: seriousness, registration number
for drugs, dosage, route of administration, pharmaceutical
form, other suspect drugs, medical history, and
diagnosis confirmed with test results.

Conclusions: Although the reported information is generally
comparable, patients’ reports are more focused
on the impact of the reported ADRs, whereas reports
from HCPs provide more diagnosis related information.