A Scoping Review of Published Literature on the Contributions of the Natural Health Products (NHPs) Industry to Pharmacovigilance for NHPs.

Background: The natural health products (NHPs) industry is a key stakeholder in pharmacovigilance for NHPs. However, the specific contributions that the NHPs industry makes to pharmacovigilance for NHPs are not well-understood.

Objective: This scoping review aimed to identify and map published literature describing the contributions of the NHPs industry to pharmacovigilance activities for NHPs. Assessment of benefit-harm balance for individual NHPs/natural ingredients is outside the scope of this review.

Methods: Using predetermined keywords and Medical Subject Headings, seven international electronic biomedical journal databases were searched to identify articles describing the contributions of the NHPs industry to pharmacovigilance for NHPs in relation to product surveillance and stakeholders' views on the NHPs industry and its pharmacovigilance activities.

Results: Of the 2285 records identified, 40 articles (representing 40 studies) met the inclusion criteria for this review. Among these, 33 described post-marketing surveillance activities and seven explored stakeholders' views. Of the articles describing post-marketing surveillance studies, 22 were authored and/or sponsored by the industry; the remaining 11 involved contributions from the NHPs industry in the form of safety data submitted as spontaneous reports to a national or state pharmacovigilance database. Contributions of the NHPs industry were primarily through passive surveillance via spontaneous reporting. In total, 13 active surveillance studies were undertaken by the NHPs industry, mainly in clinical care settings such as medical centres, hospitals, and private practices, and were focused on single products. There were limited findings relating to stakeholders' views on pharmacovigilance and the NHPs industry's involvement.

Conclusions: The NHPs industry contributes to pharmacovigilance for NHPs primarily through passive surveillance measures. Active surveillance involving the NHPs industry was typically undertaken in non-community settings. Additional research exploring stakeholders' views on and preparedness for participating in active surveillance involving the industry, focusing particularly on models based on the consumer-industry reporting pathway, could identify new strategies for strengthening post-marketing safety monitoring for NHPs.