Abstract
Introduction
Pharmacovigilance (safety monitoring) for natural health products (NHPs) is essential for consumer health protection. However, pharmacovigilance for NHPs is under-researched, especially regarding consumer involvement and the contributions of the NHPs industry.Objectives
This qualitative study aimed to explore consumers' views, experiences, and awareness of the NHPs industry's contributions to pharmacovigilance for NHPs in New Zealand.Methods
One-on-one online interviews were conducted with NHP consumers (n = 19) using a semi-structured interview schedule with the following domains: (1) meaning of terms (NHPs and pharmacovigilance); (2) pharmacovigilance for NHPs (including experiences with reporting adverse drug reactions (ADRs) to the NHPs industry); (3) views on NHP regulations and pharmacovigilance regulatory requirements for the NHPs industry; (4) a proposed active surveillance study for NHPs. Interviews were recorded, transcribed verbatim, and analysed inductively.Results
Five main themes were identified: (1) right to choose; (2) trust enables engagement; (3) considering information; (4) rationalising consumer protection; (5) perceiving and navigating risk. Participants exercised autonomy to self-select NHPs. Participants had limited experience with ADRs (associated with NHP use) and with reporting ADRs to the NHPs industry. Despite acknowledging that ethical standards varied across companies, participants expressed distrust of the industry's handling of ADRs, due to perceived conflicts of interest and a lack of transparency. Participants' self-responsibility, underscored by autonomy and lack of trust in the industry, appeared to be significant barriers to the industry's involvement in pharmacovigilance for NHPs. Despite low awareness of NHP regulations, participants held expectations for regulatory requirements that balance product accessibility and safety controls.Conclusion
Participants (consumers of NHPs) had minimal engagement with the NHPs industry regarding pharmacovigilance. Raising awareness of the potential harms associated with NHP use, improving knowledge of channels for reporting ADRs, and fostering trust in the industry's handling of ADR reports could empower consumers and enable the industry to assume a more active and significant role in pharmacovigilance for NHPs. Quantitative studies involving larger samples of NHP consumers are necessary to corroborate these findings.