Assessing the usability of methods of public reporting of adverse drug reactions to the UK Yellow Card Scheme

Abstract

Objectives The aim of this study, which was part of the first independent evaluation of patient reporting of adverse drug reactions (ADRs) to the Yellow Card Scheme, was to observe the three reporting systems (paper, internet and telephone) Ôin useÕ in a simulated setting to identify aspects which facilitated or hindered reporting.Methods Forty adult participants were recruited from the general public using posters in pharmacies and a press article, and from a pool of volunteer simulated patients maintained by University of Nottingham medical and pharmacy schools. The participants, in seven groups that met at different times, were asked to Ôthink aloud,Õ as they were individually observed completing the reporting process for the paper and internet system, highlighting their thoughts and any issues encountered. They were asked to talk about their experience of reporting immediately after they had reported by telephone. Data from the field notes were analysed thematically and supplemented with relevant information from digital audio recordings.Conclusions Usability testing using the Ôthink aloudÕ approach worked well and identified areas of the Yellow Card reporting system which could be improved. Whilst the three methods of reporting available to the public are all reasonably Ôfit for purposeÕ, there were many suggestions identified for improving ease of completion and data quality, especially for the internet system.

ADRIC: Adverse Drug Reactions In Children – a programme of research using mixed methods

“…Altruistic motivations, such as a desire to contribute to the improving the safety of medicines at a population level, were particularly prominent in their accounts. This is similar to findings on other patient groups who have reported ADRs, to clinicians' motivations for submitting Yellow Cards 12,261,262 and it is also consistent with the goals of the MHRA. 223 Linked to their dissatisfaction with practitioners for not taking their concerns about suspected ADRs seriously, some parents experienced reporting as providing a form of redress or felt reassured, as others have also described, 12,261,262 by the availability of an independent vehicle for 'officially' recording ADRs.…”

“…This is similar to findings on other patient groups who have reported ADRs, to clinicians' motivations for submitting Yellow Cards 12,261,262 and it is also consistent with the goals of the MHRA. 223 Linked to their dissatisfaction with practitioners for not taking their concerns about suspected ADRs seriously, some parents experienced reporting as providing a form of redress or felt reassured, as others have also described, 12,261,262 by the availability of an independent vehicle for 'officially' recording ADRs. A few parents pointed to how submitting a Yellow Card had helped to resolve feelings of guilt (about the medicines they had given or allowed their child to take), a motivation that has not been previously described and may be unique to parents and others who care for vulnerable patients.…”

What can we learn from the public’s understanding of drug information and safety? A population survey

“…This option was published in a safety warning in January 2013 . Consumer reporting of ADR gives new perspectives on the public's own unfiltered experiences of the side effects of drugs in a way that is not otherwise available . The growing numbers of patient reports indicate European patients’ high motivation to report ADR and suggest that the new European Union pharmacovigilance legislation has made a positive impact by empowering patients …”

What can we learn from parents about enhancing participation in pharmacovigilance?

“…Research supports the development of patient participation in pharmacovigilance, with UK patients being positive about the aims of the Yellow Card Scheme and finding it ‘user friendly’ . However, public awareness and participation in the UK Yellow Card Scheme is low .…”