BACKGROUND: Adverse Drug Reactions (ADRs) are a major public health problem. Prompt reporting of suspected ADRs is fundamental in the post-marketing surveillance of medicines and helps in ensuring medicine safety. However, fewer ADRs are reported in general and in particular by community pharmacists. There is limited knowledge about the factors which are preventing community pharmacists in the UK from reporting an ADR.
OBJECTIVES: To identify the barriers to ADR reporting among community pharmacists practicing in the UK.
METHODS: A cross sectional study using a 25-items questionnaire (both online and paper based) including 10 barriers to ADR reporting was conducted from 1st April 2012 to September 2012. Community pharmacists practicing in the West Midlands, UK, were approached for the participation in this study. Chi-Square and regression were applied to identify covariates for the barriers to ADR reporting. A significant value of 0.05 was assigned for analysis.
RESULTS: Of the 230 invited community pharmacists, 138 pharmacists responded (response rate 60%). The median age of respondents was 31 years. All pharmacists reported that they would report both serious and mild ADRs from drugs with black triangle among children as well as adults. About 95% (n=131) of the pharmacists were familiar with the paper based ADR reporting system. Store-based pharmacists were more likely to be more confident about which ADRs to report [0.680, 95% Confidence Interval 0.43-3.59]. Lack of time 46.4% (n=64), and pharmacists perception that ADR is not serious enough to report (65.2%; n=90) were identified as barriers to ADR reporting. Majority 63.0% (n=87) of the pharmacists identified training and information about what to report and access to Information Technology (IT) (For example access to internet connection) 61.6% (n=85) as facilitators to ADR reporting process.
CONCLUSION: Lack of time and ADRs considered not serious enough by pharmacists to report were barriers to ADR reporting. Further training and education about the types of ADRs to be reported can help to improve the reporting of ADRs.
* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.