The attitudes of pharmacists toward adverse drug reaction reporting

Abstract

The aim of this study was to determine community and hospital pharmacists' as well as pharmacy students' attitudes towards their perceived role in the reporting of ADRs and to determine which factors might encourage or discourage reporting of ADRs. Key researchers who have worked in this area include C. F. Green. et al. (1997, 1999, 2000) J. Houghton et al. (1999) and Swedis D. et al. (2000) in the United Kingdom, and A.C. van Grootheest et al. (2003) in the Netherlands. The Medicines Authority in Malta launched an official adverse drug reaction reporting system on the 4th of May 2004 (Medicines Regulatory Unit Web site, 2001) in order to fulfill the legal requirements set in Article 101 and Article 102 of the European Union Directive 2001/83/EC concernmg medicinal products for human use (Eudralex Web site, 2001). The main criticism of ADR reporting systems is the phenomenon of 'under-reporting'. Even at established centres the reported proportion of serious reactions reported by healthcare professionals may not be more than 10%. (Uppsala Monitoring Centre, 2000, p.10) Greater participation by pharmacists in ADR reporting could be an important tool to counter under-reporting of ADRs. (Van Grootheest, 2002, p.267) A quantitative study was performed through the use of a questionnaire survey. A structured questionnaire was personally delivered to a convenience sample of community pharmacists, to all hospital pharmacists at St.Luke's Hospital and 3rd year pharmacy students. The questionnaire items were formulated through an extensive literature review and by taking into consideration the theory of reasoned action and planned behaviour. Prior to the survey the questionnaire was piloted with ten pharmacists. The data was analysed through the use of the statistical computer programme SPSS. ANOVA and t-tests were used to determine statistically significant differences and Factor Analysis was used for data reduction. Hypothesis was tested through the use of Linear Regression Analysis. Pharmacists had a positive attitude towards reporting which compared well with that of pharmacists in other countries. Factors identified that might encourage or discourage pharmacists' reporting included knowledge relating to ADRs and their reporting, the reporting procedure and fears related to the effects of reporting AD Rs on doctors, patients and the pharmacist, including issues of legal liability and confidentiality. Although making reporting forms available, receiving feedback after reporting and making reporting obligatory emerged as possible factors for encouraging reporting, no correlation between these and the intention to report was observed. Community and hospital pharmacists' and pharmacy students' attitudes towards their perceived role in the reporting of ADRs did not differ in many respects. It is suggested that the factors identified in this study be taken into consideration by the Medicines Authority when promoting the ADR reporting system and that further research as regards measuring antecedents to reporting attitude, further methods for promoting ADR reporting and measurements of the effects of these activities on reporting behaviour be undertaken.