"I don't know how the yellow card works": Issues with Pharmacovigilance

Yvonne Hopf, Christine Margaret Bond, John Andrew Francis Haughney, Peter Joseph Benedict Helms

Research output: Contribution to conferencePosterpeer-review


Pharmacovigilance is defined as the science relating to the detection, assessment, understanding, and prevention of adverse effects of medicines1. A programme of work is ongoing to develop a novel pharmacovigilance system using linked routinely collected NHS healthcare data. The aim of a qualitative component of the programme was to explore the views and opinions of Scottish healthcare professionals (HCP) about pharmacovigilance in the UK and the proposals to link data. The work reported here describes a sub set of the findings related to HCPs’ understanding of pharmacovigilance and the knowledge of current UK pharmacovigilance systems.
Methods were chosen by suitability to target group. In-depths interviews were conducted with a purposive sample of opinion leaders (n=40) including experts in pharmacovigilance, paediatrics, ethics and prescribing. Six profession specific focus groups (FG) (pharmacists n=11, nurses n=6 and doctors n=5, from primary and secondary care (n=6)) were conducted in different Scottish Health Boards to explore the views and opinions from front-line professionals. Convenience sampling was used because of recruitment challenges. Similar semi-structured schedules, reflecting the study aims, were used for interviews and focus groups. The question “What comes to your mind when you hear the term pharmacovigilance?” was used an ice-breaker for interviewees and a focussing exercise for FGs. Interactions were audio recorded and fully transcribed. Themes were identified via a framework approach. NHS ethical approval was obtained.
Six broad themes were identified one of which was views and understanding of pharmacovigilance. The definition of pharmacovigilance, current systems in the UK and their (dis-)advantages, perceived importance and problems of pharmacovigilance as well as ADR reporting were discussed in both interviews and focus groups. FG participants further discussed recognition of ADRs as well as available support for HCPs for pharmacovigilance. The main purposes of pharmacovigilance were described as monitoring and surveillance of drug usage, including screening for harm as well as benefit. Clinical interviewees focussed on ADRs whereas non-clinical interviewees defined pharmacovigilance by dissecting the term into ‘pharmaco’ and ‘vigilance’, translating it into surveillance related to medicine. FG participants had a more practical approach to pharmacovigilance, e.g. review and feedback of prescribing within a practice by using PRISMS data: FG participants also talked about pharmacovigilance as “not just [being] medication” (FG04, hospital pharmacist) but also includes providing additional instructions to parents, clinical governance –“[a] record of what was done [clinically]” (FG02, GP), and also education. Safety was highlighted in interviews and FGs, with FG participants, but whereas interviewees mentioned high-level monitoring of drug safety, FGs emphasised the “safety net” (FG02) aspect. The Yellow Card scheme was well known. Participants also considered the following as pharmacovigilance systems: clinical trials, local incidence reporting systems (Datix, Sentinel), post-marketing surveillance and disease registries.
FG participants had a wider more pragmatic understanding of pharmacovigilance than interviewees, conceptualising it around medication administration and physical checks, whereas interviewees correctly focussed more on adverse drug reactions. Inconsistent understanding of the importance of pharmacovigilance may limit HCP support for new initiatives.
1WHO, 2002. The Importance of Pharmacovigilance. Geneva: World Health Organization.

Original languageEnglish
Publication statusPublished - 2012
EventHealth Service Research and Pharmacy Practice - Cork, Ireland
Duration: 23 Apr 201224 Apr 2012


ConferenceHealth Service Research and Pharmacy Practice


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