Consumer opinions on adverse events associated with medical devices.

INTRODUCTION: Post-market surveillance of medical devices relies on compulsory and voluntary reports. Although direct consumer reporting of medical device-related adverse events (AEs) is available in Australia, the proportion of consumer reports has remained low. Limited qualitative research has previously explored consumer insights on AEs associated with medical devices and in particular, AE reporting. OBJECTIVE: To explore consumer opinions on AEs related to medical devices, and their knowledge of, experiences with, and views on, the reporting of medical device-related AEs. METHODS: Focus groups (n = 4; total of 29 participants) were conducted in metropolitan Sydney, Australia. Focus group discussions of approximately 1.5 h in length centred on consumers' understanding of AEs, opinions on AEs and their previous experiences, views on medical device benefits and harms, and actions taken (or potential actions) in response to AEs. With participant consent, discussions were audio-recorded, transcribed verbatim, and thematically analysed. RESULTS: Participants regarded medical device-related side effects to be unexpected AEs associated with their use. Where there was a clear need for the medical device itself, potential improvement in quality of life took precedence over potential harms. Most participants had not experienced negative issues with their medical device(s). There was poor awareness among participants of an existing direct consumer AE reporting system for medical devices. Despite this, the value of reporting was acknowledged. Severity of the AE was a key motivator for potential AE reporting. CONCLUSIONS: Further efforts are necessary to improve consumer awareness of available AE reporting systems to better support post-market surveillance and safe medical device use.

Consumer opinions on adverse events associated with medicines and vaccines.

INTRODUCTION: Despite the availability of an Australian consumer adverse event (AE) reporting system for over 50 years, reporting rates remain low. A comprehensive understanding of consumer perceptions and experiences regarding AEs is needed to further ascertain factors impacting their engagement in AE reporting. AIM: The aim of this study was to explore consumer opinions about AEs potentially associated with medicines and vaccines, and their experiences and understanding of managing and reporting AEs. METHODS: Six focus groups were conducted across metropolitan Sydney with a total of 48 adult participants. A semi-structured focus group topic guide was developed to explore consumers' understanding, experiences, and actions taken in relation to AEs; and perspectives on managing treatment benefits and harms. Discussions were audio-recorded with participant permission and transcribed verbatim. Transcripts were thematically analyzed. RESULTS: Consumers acknowledged the potential for side effects (SEs), however inaccurately estimated SE risk in response to verbal descriptors such as "common." Consumer appraisal of treatment benefits and harms was influenced by factors such as medical condition(s), previous experiences, and beliefs. Although many had experienced SEs, consumers only reported them if considered severe or troublesome. Minimal awareness of consumer AE reporting systems was evident. Doctors were the primary avenue for reporting; consumers preferred doctors to act as the intermediary in reporting AEs to an independent body. CONCLUSION: Consumers' lack of awareness of AE reporting systems was evident. With the complexities inherent in benefit/harm risk appraisal, information seeking, and AE reporting preferences, better consumer understanding of AEs and the systems available for reporting is needed.

Provision of a Medicines Information Service to Consumers on Facebook: An Australian Case Study.

BACKGROUND: Social networking sites (SNSs) have changed the way people communicate. They may also change the way people seek health advice. OBJECTIVE: This study describes the provision of a medicines information service on Facebook to individual consumers. It aimed to discuss the pros and cons, and inform health and pharmacy stakeholders and researchers about the opportunities and challenges of providing such a service. METHODS: We adopted an exploratory approach using a case study method. RESULTS: NPS MedicineWise, an independent, not-for-profit Australian organization, runs a public question-and-answer service on Facebook, dubbed Pharmacist Hour. Consumers following the organization's Facebook page are invited to post medication-related questions often with a suggested health topic. A wide range of questions and comments are posted related to medication usage. The pharmacist answers the queries, providing evidence-based medicines information and using consumer-friendly language, during the specific 1-hour period. The most popular questions in the past 12 months were related to adverse effects, treatment options for conditions, and drug interactions. The service had a mean number of engagements (defined as a like or share of the Pharmacy Hour post) of 38 (SD 19) people and a mean 5 (SD 3) questions per session. CONCLUSIONS: The Pharmacist Hour Facebook service addresses the medicines information needs of consumers and indirectly promotes other appropriate and relevant NPS MedicineWise products and services to further assist consumers. The service offers a new medium for a quality use of medicines organization committed to promoting awareness about the correct and safe use of medicines in Australia.