What patient, clinician, policy and socio-cultural factors are associated with the rise in off-label prescribing of domperidone in British Columbia when used to treat low milk supply?

This research used a case study approach to study the off-label use of domperidone when it is used to treat low breastmilk supply (LMS) in British Columbia (BC). Off-label prescribing occurs when an approved drug is prescribed for a use for which it has not been approved. Off-label prescribing is prevalent in Canada and many drugs prescribed off-label lack strong evidence of effectiveness. My research objective was to identify the clinician, patient, socio-cultural and policy factors that are contributing to domperidone’s increasing use among breastfeeding mothers in BC. Results from my research were intended to increase the overall understanding of contributors to off-label prescribing in general in order to improve its transparency, safety and effectiveness. My four methodologies included online surveys with BC midwives and family physicians, interviews with breastfeeding mothers who had used domperidone to increase their breastmilk supply and an analysis of Health Canada’s policy response to off-label prescribing. The conceptual framework for the research was a socio-ecological model incorporating patient, clinician, community/institutional, socio-cultural and policy levels of analysis. I concluded that multiple factors at all of these levels have contributed to the rise in the off-label prescribing of domperidone to treat LMS in BC. Main drivers included clinician prescribing practices, knowledge and views of domperidone, patient needs and beliefs and the medicalization of breastfeeding. Policy-related factors appeared to have significant influence on off-label prescribing. Health Canada does not explicitly consider potential off-label uses in drug approval documents such as product monographs nor does it systematically collect and analyse adverse drug reactions from off-label uses to identify safety concerns. Off-label uses with safety concerns are not included in post-market surveillance activities such as Health Canada safety warnings for healthcare providers and the public. I concluded that when a drug is considered for an off-label use it should be subjected to additional scrutiny by prescribers to determine its real need and risk/benefit balance. Health Canada should systematically include off-label uses in all ADR reporting and analysis so that safety issues can be identified and responded to through post-market surveillance activities. Graduate and Postdoctoral StudiesGraduat