Abstract / Description of output
Objective: The aim was to assess patterns in reporting of adverse drug reactions (ADRs) via the Yellow Card (YC) Scheme following a Scottish community pharmacy patient YC promotional campaign (January–February 2011). Methods: YC data were obtained from the Medicines and Healthcare Products Regulatory Agency (MHRA) [January 2009–February 2012]. The impact of the campaign on YC reporting rates was assessed by comparing YC submission rates before and after the intervention, using the segmented regression of interrupted time-series analysis. Results: The mean weekly reported ADRs [excluding general practitioner (GP) reports] before, during, and after the campaign were 0.029, 0.019, and 0.023 (per 10,000 inhabitants), respectively. In relation to patients’ YC reporting, the mean weekly patient-reported ADRs before, during, and after the campaign in Scotland were 0.005, 0.002, and 0.004 (per 10,000 inhabitants), respectively. The time-series analysis for monthly reported ADRs in Scotland (excluding GP reports) demonstrated no statistically significant level change (p = 0.706) and no significant trend change (p = 0.509) post-campaign. Similarly, there was no statistically significant level change (p = 0.983) and no significant trend change (p = 0.591) in patient YC reporting. Conclusions: The campaign had no statistically significant impact on influencing the reporting of ADRs. This study adds to a growing body of required information in this area, and suggests improvements if future patient ADR-reporting promotional campaigns are to be considered; the cost-effectiveness of such efforts requires further research. It is recommended that any similar future campaigns should include qualitative attitudinal data collection and evaluation to help further explore this more robustly.