Investigation into the factors affecting community pharmacists’ engagement with spontaneous reporting of adverse drug reactions

Lead researcher
Dr Louise Hughes, Cardiff University

Research question
What factors affect the engagement of community pharmacists in Wales with the spontaneous reporting scheme for adverse drug reactions (ADRs) i.e. the ‘yellow card scheme’?

To investigate community pharmacists’ experiences of ADR reporting and explore barriers and facilitators to reporting.

  • To interview a purposive sample of community pharmacists in Wales in order to explore their reasons for reporting / non-reporting of ADRs through the yellow card scheme
  • To develop and pilot a postal questionnaire for community pharmacists based on a review of the literature and the results of the preliminary interviews.
  • To administer the postal questionnaire to a sample of working community pharmacists across Wales in order to investigate these issues in a wider population.
  • Through the results of this pilot investigation, to identify targets for future strategies to increase ADR reporting rates by community pharmacists.
Although pharmaceutical companies are required to demonstrate the efficacy and safety of new medicines through clinical trials before coming to market, the number of patients involved in these trials is limited. As such, many ADRs are not observed until the drug reaches the wider marketplace and is used in a wider range of patients1. ADRs are therefore a major cause of morbidity and mortality: they rank among the leading causes of death in many countries2 and account for significant numbers of hospital admissions1. In the UK it has been suggested that 6.5% of hospital admissions are due to adverse drug reactions and that the subsequent costs of dealing with these events are significant and can be approximated to the equivalent of seven, 800-bed hospitals being filled for one year3. However, many of these ADRs are potentially avoidable3; by understanding the specific risks associated with each medicine, its administration can be carefully managed to minimise these risks. Gathering information about ADRs through spontaneous reports leads to increased knowledge about ADRs4 and could therefore reduce the incidence of ADRs and the associated costs, resulting in benefits for both individual patients and the National Health Service1.

Study design summary
Semi-structured interviews will investigate the interviewee’s prior experiences of ADRs and ADR reporting, including exploration of the reasons for reporting or non-reporting. A questionnaire will be developed to further investigate amongst community pharmacists the roles played by the barriers and facilitators to reporting suggested in the interviews. In addition, background data such as prior identification and / or reporting of ADRs will be sought.

Total awarded