Monitoring adverse drug reactions (ADRs) through pharmacovigilance is vital to health consumer safety. Health Canada accepts ADR reports from physicians, health consumers, lawyers and manufacturer. This study uses a multi-methods approach to evaluate health consumers ADR reporting to pharmacovigilance programs. Methods: Guided by Risk Perception Theory, this study involved three phases. 1) A systematic review to identify factors influencing health consumer ADR reporting 2) An observational study to compare health consumer and physician ADR reports received by Health Canada from 2000-2014 to determine differences in seriousness, system organ class, and anatomical therapeutic class. 3) A qualitative study to explore health consumers’ experiences with ADR reporting and usability of the Canadian Vigilance ADR system. Results: 1) Of 1435 citations identified, 22 studies were eligible. Common barriers for health consumers to report ADRs were poor awareness and confusion on who should report. Common motives were preventing ADRs in others and wanting feedback. 2) Of 198,781 ADR reports, 57,078 (29.0 %) were from health consumers and 52,843 (27.0%) from physicians. Compared to physicians, health consumers reported significantly more ADRs (serious and non-serious) (p<0.0001) and reported differently for organ systems affected and by types of medication. 3) Interviews from 15 adult health consumers revealed barriers (e.g., poor awareness about the available reporting systems) and motives for reporting ADRs (e.g., intolerable side effect impacting daily activities). Few were aware of the Canadian Vigilance reporting system and usability was limited by the number and complexity of questions. Conclusion: Health consumer role in directly reporting ADRs is influenced by several factors. In Canada, most were unaware of the Canadian Vigilance System and unclear about their role in reporting ADRs. Quarters of Canadian ADRs are reported by health consumers and their ADRs had different characteristics from physicians. These findings are relevant to policymakers, public health officials, and regulatory agencies for improving medication safety in Canada and worldwide.

Consumer Operated Service Providers (COSPs) are programs that are directed and administratively controlled by mental health consumers for their peers. As such, many mental health consumers have been placed in the position of serving on a COSP and often with unclear descriptions and no training. As a result, there is often a disconnect between the will of the board and the vision of the executive director, leading to tension and the possibility of failed mission. Using servant leadership as the guide, the goal of this case study was to explore the experiences of executive directors who operate Consumer Operated Service Providers (COSPs) in Texas that specialize in mental health recovery support services to better understand how they work with mental health consumers serving as their governing board members. Data were collected through semi-structured interviews with 7 executive directors of COSPs in Texas. Interview data were inductively coded, then subjected to a thematic analysis procedure. Findings revealed that the concept of servant leadership is commonly used to empower board members and create healthy working relationships between boards and executive directors, particularly around the area of motivating board members to engage with the organization. It was also revealed that the existence of COSPs, in conjunction with traditional governing boards, provides a good balance and perspective relative to strategic planning activities and fundraising. Positive social change implications include recommendations to executives of COSPs to more adequately mobilize and train consumer board members in order to achieve organizational goals that often include consumer focused care and treatment for a wide range of mental health issues.

Health Studies / M. P. H.