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Development of a Natural Health Product Active Surveillance Method in Outpatient Centers in Canada

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Pharmacovigilance for Herbal and Traditional Medicines

Abstract

Natural health products (NHPs) are commonly used across the globe. Pre-market regulations for NHPs vary considerably by jurisdiction and little is known about clinically relevant interactions with other products. Enhanced pharmacovigilance is vital for a better understanding of NHP adverse events (AEs) and interactions with other NHPs and prescription drugs. Passive surveillance or spontaneous reporting systems are recognized for under-reporting and poor-quality AE reports, both of which are further exacerbated with regard to NHPs. A new approach to NHP AE active surveillance, including causality assessment, was developed and implemented. The main objective was to identify clinically relevant NHP adverse reactions (ARs). Methodology and major study results to date are discussed, as well as strengths, limitations, and future directions of this approach.

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Bharadia, M., Necyk, C., Vohra, S. (2022). Development of a Natural Health Product Active Surveillance Method in Outpatient Centers in Canada. In: Barnes, J. (eds) Pharmacovigilance for Herbal and Traditional Medicines. Adis, Cham. https://doi.org/10.1007/978-3-031-07275-8_12

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