Avery, Anthony and Anderson, Claire and Bond, C.M. and Fortnum, H. and Gifford, A. and Hannaford, P.C. and Hazell, L. and Krska, J. and Lee, A.J. and McLernon, D.J. and Murphy, Elizabeth and Shakir, S. and Watson, M.C.
Evaluation of patient reporting of adverse drug
reactions to the UK ‘Yellow Card Scheme’:
literature review, descriptive and qualitative
analyses, and questionnaire surveys.
Technical Report: https://doi.org/10.3310/hta15200.
NIHR HTA, Southampton.
Background: The monitoring of adverse drug reactions (ADRs) through pharmacovigilance
is vital to patient safety. Spontaneous reporting of ADRs is one method of
pharmacovigilance, and in the UK this is undertaken through the Yellow Card Scheme
(YCS). Yellow Card reports are submitted to the Medicines and Healthcare products
Regulatory Agency (MHRA) by post, telephone or via the internet. The MHRA electronically
records and reviews information submitted so that important safety issues can be
detected. While previous studies have shown differences between patient and healthcare
professional (HCP) reports for the types of drugs and reactions reported, relatively
little is known about the pharmacovigilance impact of patient reports. There have also
been few studies on the views and experiences of patients/consumers on the reporting of
Objectives: To evaluate the pharmacovigilance impact of patient reporting of ADRs by
analysing reports of suspected ADRs from the UK YCS and comparing reports from
patients and HCPs. To elicit the views and experiences of patients and the public about
patient reporting of ADRs.
Design: (1) Literature review and survey of international experiences of consumer reporting
of ADRs; (2) descriptive analysis of Yellow Card reports; (3) signal generation analysis of
Yellow Card reports; (4) qualitative analysis of Yellow Card reports; (5) questionnaire survey
of patients reporting on Yellow Cards; (6) qualitative analysis of telephone interviews with
patient reporters to the scheme; (7) qualitative analysis of focus groups and usability
testing of the patient YCS; and (8) national omnibus telephone survey of public awareness
of the YCS.
Participants: Patients (n = 5180) and HCPs (n = 20,949) submitting Yellow Card reports
from October 2005 to September 2007. Respondents to questionnaire survey (n = 1362).
Participants at focus groups and usability testing sessions (n = 40). National omnibus
telephone survey (n = 2028).
Setting: The literature review included studies in English from across the world. All other
components included populations from the UK; the omnibus survey was restricted to
Main outcome measures: Characteristics of patient reports: types of drug and suspected
ADR reported; seriousness of reports; and content of reports. The relative contributions of
patient reports and of HCP reports to signal generation. Views and experiences of patient
reporters. Views of members of the public about the YCS, including user-friendliness and
usability of different ways of patient reporting. Public awareness of the YCS. Suggestions
for improving patient reporting to the YCS.
Results: Compared with HCPs, patient reports to the YCS contained a higher median
number of suspected ADRs per report, and described reactions in more detail. The
proportions of reports categorised as ‘serious’ were similar; the patterns of drugs and
reactions reported differed. Patient reports were richer in their descriptions of reactions
than those from HCPs, and more often noted the effects of ADRs on patients’ lives.
Combining patient and HCP reports generated more potential signals than HCP reports
alone; some potential signals in the ‘HCP-only’ data set were lost when combined with
patient reports, but fewer than those gained; the addition of patient reports to HCP reports
identified 47 new ‘serious’ reactions not previously included in ‘Summaries of Product
Characteristics’. Most patient reporters found it fairly easy to make reports, although
improvements to the scheme were suggested, including greater publicity and the redesign
of web- and paper-based reporting systems. Of the public, 8.5% were aware of the YCS
Conclusions: Patient reporting of suspected ADRs has the potential to add value to
pharmacovigilance by: reporting different types of drugs and reactions than those reported
by HCPs; generating new potential signals; and describing suspected ADRs in enough
detail to provide useful information on likely causality and impact on patients’ lives. These
findings suggest that further promotion of patient reporting to the YCS is justified, along
with improvements to existing reporting systems.
In order of priority, future work should include further investigation of: (1) the
pharmacovigilance impact of patient reporting in a longer-term study; (2) the optimum
approach to signal generation analysis of patient and HCP reports; (3) the burden of ADRs
in terms of impact on patients’ lives; (4) the knowledge and attitudes of HCPs towards
patient reporting of ADRs; (5) the value of using patient reports of ADRs to help other
patients and HCPs who are seeking information on patient experiences of ADRs; and
(6) the impact of increasing publicity and/or enhancements to reporting systems on the
numbers and types of Yellow Card reports from patients.
Actions (Archive Staff Only)