Reporting natural health product related adverse drug reactions: is it the pharmacist’s responsibility? Rishma Walji a , Heather Boon b , Joanne Barnes c , Sandy Welsh d , Zubin Austin b and G. Ross Baker e a Department of Pediatrics, Faculty of Health Sciences, McMaster University, Hamilton, b Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada, c School of Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand, d Department of Sociology, Faculty of Arts and Science and e Department of Health Policy, Management and Evaluation, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada Keywords adverse drug reaction reporting; alternative medicines; pharmacist role; pharmacy practice Correspondence Dr Heather Boon, Leslie Dan Faculty of Pharmacy, University of Toronto, 144 College Street, Toronto, ON, Canada M5S 3M2. E-mail: heather.boon@utoronto.ca Received March 24, 2011 Accepted June 22, 2011 doi: 10.1111/j.2042-7174.2011.00150.x Author’s contributions: RW and HB conceptualized and designed the study. RW carried out the interviews, coded the transcripts and wrote the first draft of the paper. HB supervised the project, coded the transcripts and edited the drafts of the paper. JB, ZA, SW and GRB participated in the design of the study and commented on drafts of the paper. All authors read and approved the final manuscript Abstract Objectives Herbal medicines and other natural health products (NHPs) are sold in Canadian pharmacies as over-the-counter products, yet there is limited information on their safety and adverse effect profile. Signals of safety concerns associated with medicines can arise through analysis of reports of suspected adverse drug reactions (ADRs) submitted to national pharmacovigilance centres by health professionals, including pharmacists and the public. However, typically such systems experience substantial under-reporting for NHPs. The objective of this paper is to explore phar- macists’ experiences with and responses to receiving or identifying reports of suspected ADRs associated with NHPs from pharmacy customers. Methods A qualitative study in which in-depth, semi-structured interviews were conducted with 12 community pharmacists in Toronto, Canada. Key findings Pharmacists generally did not submit reports of adverse events associ- ated with NHPs to the national ADR reporting system and cited several barriers, including lack of time, complexity of the reporting process and lack of knowledge about NHPs. Pharmacists who accepted responsibility for adverse event reporting appeared to have different perceptions of their professional role: they saw themselves as‘knowledge generators’, contributing to overall healthcare knowledge. Conclusions Reporting behaviour for suspected ADRs associated with NHPs may be explained by a pharmacist’s perception of his/her professional role and percep- tions of the relative importance of generating knowledge to share in the wider system of health care. Introduction The importance of safety monitoring for herbal medicines and other natural health products (NHPs) has acquired a new importance in recent years. In part, this is because of increased utilization of these products by consumers. [1,2] and because there have been several high-profile safety concerns associated with herbal medicines in particular, but also with other NHPs. [3,4] As a result, there is increasing recognition of the potential for serious adverse drug reactions (ADRs) 1 associated with the use of certain NHPs. Since NHPs are widely available to the public in community pharmacies, pharmacists are well placed to facilitate and/or undertake NHP-ADR reporting. [5] In addition, pharmacists already undertake this role with respect to conventional medicines as part of their professional practice. However, the current safety monitoring system in Canada experiences under-reporting by health care professionals, including pharmacists. [6] Health Canada collects suspected ADR reports associated with use of all medicines, including NHPs, through the Canada Vigilance Program, formerly known as the Canadian Drug Reaction Monitoring Program. [7] In Canada, as in many other countries, the ADR reporting system is a spontaneous, 1 Adverse drug reaction (ADR): Defined as noxious and unintended responses to particular medicinal products. A reaction is defined as an ADR when there is a reasonable possibility that there is a causal relationship between a given product and the reaction. Research Paper © 2011 The Authors. IJPP © 2011 Royal Pharmaceutical Society 2011 International Journal of Pharmacy Practice, 19, pp. 383–391 383 Downloaded from https://academic.oup.com/ijpp/article/19/6/383/6130370 by guest on 29 July 2022