A survey on factors that could affect adverse drug reaction reporting according to hospital pharmacists in Great Britain

Abstract

Introduction: Since April 1997, UK hospital pharmacists have been invited to submit reports of suspected adverse drug reactions (ADRs) to the Committee on Safety of Medicines (CSM) and Medicines Control Agency. Three studies have investigated the involvement of hospital pharmacists in ADR reporting; however, they did not investigate the possible factors that could affect ADR reporting. Objectives: (i) To analyse the extent to which hospital pharmacists think that specified factors could affect reporting ADRs; (ii) to identify any additional factors that could hinder reporting; and (iii) to recommend possible methods to improve reporting. Methods: Piloted questionnaires were sent to 548 hospital pharmacists in Great Britain randomly selected by the Royal Pharmaceutical Society of Great Britain (RPSGB) from their computer database. 346 questionnaires were returned and 280 were included in this study. Results: 46% of the pharmacists had identified ADRs that were considered to be reportable according to the CSM criteria in the 6 months prior to the survey. 39% did not report these ADRs either to the CSM or the manufacturers. Only 8.2% reported that their hospitals had a written policy; conversely, 73.7% agreed that such a policy could enhance ADR reporting. Although not statistically significant, the result showed an increasing tendency to report ADRs by pharmacists who had received training. Furthermore, there was an increasing tendency to report ADRs with increasing seniority. Discussion: The results show that hospital pharmacists say they are more likely to report serious and rare ADRs and ADRs associated with newly marketed drugs. Factors that could reduce ADR reporting included being busy at work, lack of confidence in recognising ADRs and the fear of breaching patient confidentiality. Most common suggestions on methods to improve ADR reporting were to provide ADR training and meetings (34%) and a hospital written policy (24%). Recommendations: ADR training and meetings would be a useful step in improving hospital pharmacist ADR reporting. Therefore, we recommend that the CSM and the RPSGB liaise with regional drug information centres and schools of pharmacy to provide more study days and training programmes for hospital pharmacists. Furthermore, the CSM should write to the 'Drugs and Therapeutics Committee' of each hospital and encourage them to develop a written local policy for pharmacist ADR reporting. Further studies should be conducted to test the recommendations noted here, assessing the response of the pharmacists in terms of absolute numbers of reports made. It would be particularly interesting to study the need for a written hospital policy and education.