Evaluation of patient reporting of adverse drug reactions to the UK ‘Yellow Card Scheme’: literature review, descriptive and qualitative analyses, and questionnaire surveys

Avery, A.J. 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. (2011) 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: DOI: 10.3310/hta15200. NIHR HTA, Southampton.

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Abstract

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

suspected ADRs.

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

Great Britain.

Interventions: None.

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

in 2009.

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.

Item Type: Monograph (Technical Report)
Additional Information: Published as: Health Technology Assessment, 2011; 15(20). ISSN 1366-5278 (Print); 2046-4924 (Online)
Schools/Departments: University of Nottingham UK Campus > Faculty of Science > School of Pharmacy
Depositing User: Anderson, Prof Claire
Date Deposited: 12 Aug 2011 15:06
Last Modified: 12 Aug 2011 17:36
URI: http://eprints.nottingham.ac.uk/id/eprint/1514

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