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Evaluation of a Web-Based, ‘Purchase Event’ Intensive Monitoring Method for Pharmacovigilance of Natural Health Products: Lessons and Insights from Development Work in New Zealand

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Abstract

Introduction

Intensive monitoring methods are used in pharmacovigilance for prescription medicines but have not yet been implemented for natural health products (NHPs).

Objectives

Our objective was to assess feasibility issues with a new ‘purchase event’ intensive monitoring method for pharmacovigilance of NHPs, including pharmacy and NHP purchaser recruitment rates, collection of NHP purchaser key patient identifier information for data linkage and quality and completeness of data.

Methods

For the Ginkgo study, 213 community pharmacies in the Auckland (Aotearoa New Zealand) District Health Board area were invited to participate. Staff in participating pharmacies (n = 3 [1.4%]) recorded ginkgo product sales and gave purchasers a study invitation card (October 2015–January 2016). Ginkgo purchaser participants were emailed links to web-based baseline and follow-up questionnaires about adverse events occurring during/after taking ginkgo. Participating pharmacists and consumers were invited to provide qualitative feedback about the study. For the NHP-Lite study, all NHPs were included for monitoring. Community pharmacies in the Green Cross Health network were invited to participate. Participating pharmacy staff gave all NHP purchasers a study invitation card over a 2-week period (May 2016). NHP purchaser participants were emailed links to web-based baseline, follow-up and feedback questionnaires.

Results

Few community pharmacists (Ginkgo study, n = 3; NHP-Lite study, n = 18) and NHP purchasers (Ginkgo study, n = 0; NHP-Lite study, n = 4) participated. Pharmacists (Ginkgo study, 3/3; NHP-Lite study, 11/18) described several reasons for participating and suggested ways to increase consumer recruitment, including simplifying study procedures.

Conclusions

These web-based, purchase event, intensive monitoring studies, with cohorts built through NHP purchases in pharmacies, identified substantial issues with recruiting pharmacists/pharmacies and NHP purchasers that, at present, render such studies unfeasible. Future studies need to consider other methods of recruiting NHP purchasers and develop a simple method for recording NHP purchases.

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Acknowledgements

Research assistants Rosalind Smart (development work, ethics application), Aleks Antevska (building online questionnaires and distribution sequence, ginkgo study administration, interviews data collection) and Jo Bishop (NHP-Lite study administration, qualitative analysis) also contributed to some aspects of the work. We acknowledge the assistance of Alison van Wyk, Green Cross Health Ltd, and all the pharmacists and NHP purchasers who participated in these studies.

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Authors and Affiliations

  1. School of Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, Private Bag 92019, Auckland, New Zealand

    Joanne Barnes & Jane L. Sheridan

  2. Mercury, Mercury Building, 33 Broadway, Auckland, New Zealand

    Christine Yang Dong

  3. Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH, ‘S-Hertogenbosch, The Netherlands

    Linda Härmark

  4. Departments of Pediatrics and Psychiatry, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada

    Sunita Vohra

  5. International Society of Pharmacovigilance, London, UK

    Mira Harrison-Woolrych

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  1. Joanne Barnes
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Correspondence to Joanne Barnes.

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Author Contributions

JB was the principal investigator for this research, conceived and designed the study and its tools and processes, wrote the grant application, obtained ethics approval, contributed to data analysis, supervised and had overall responsibility for all aspects of the work and wrote the paper. JLS assisted with study design, qualitative data analysis and project supervision. MH-W contributed to writing an earlier version of the grant application, study and tools design and advised on MAAC criteria. SV and LH contributed to tools design. CYD undertook quantitative data cleaning, validation and analysis and contributed to data interpretation. All authors contributed to writing the paper.

Funding

This work was supported by a University of Auckland Faculty Research Development Fund grant (number: 3706858) to JB (principal investigator) and JLS (co-investigator).

Conflicts of interest

JB has received fees, honoraria and travel expenses from the Pharmaceutical Society of New Zealand for preparation and delivery of continuing education material on CMs for pharmacists (2013, 2015); has provided consultancy to the Pharmacy Council of New Zealand on Code of Ethics statements on CMs (unpaid) and competence standards (paid); was a member of the New Zealand Ministry of Health Natural Health Products (NHPs) Regulations Subcommittee on the Permitted Substances List (2016–2017); and leads the Herbal and Traditional Medicines Special Interest Group, and the Western Pacific region chapter, of the International Society of Pharmacovigilance. JB is a registered pharmacist (academic) in NZ and has a personal viewpoint that supports regulation for CMs. JB has undertaken other research exploring pharmacists’ views on and experiences with CMs, supported by the Royal Pharmaceutical Society of Great Britain (RPSGB), the New Zealand Pharmacy Education and Research Fund and the University of Auckland. JB and JLS are senior members of staff at the University of Auckland School of Pharmacy, are members of a School of Pharmacy committee alongside a member of the Pharmacy Council of New Zealand and have other interactions with individuals in senior positions in the pharmacy profession. The School of Pharmacy has strategic relationships with several pharmacy organisations and receives support in various forms, such as sponsorship of student events and guest lectures given by individuals from those organisations. JB has received assistance (non-financial) from Green Cross Health Ltd in contacting its pharmacies and customers with respect to invitations to participate in research studies. JB was the principal author of a reference textbook on CMs and, at that time, received royalties in respect of sales of that publication from Pharmaceutical Press, the publishing arm of the RPSGB. JLS is a registered pharmacist (non-practising) in NZ and has a personal viewpoint that supports regulation for CMs. JLS has been involved in other research exploring pharmacists’ views on and experiences with CMs, supported by the University of Auckland. JLS has or has had personal investment portfolios that may include shares, stock and/or bonds in online general retailers and retail outlets that sell NHPs. She may have or have had indirect exposure to NHP investments through managed bundle financial investment funds and the university superannuation scheme, over which she has no control. CYD, LH, SV and MH-W have no conflicts of interest that are directly relevant to the content of this article.

Availability of data and material

The datasets generated and/or analysed during the current study are not publicly available as this is outside the terms of the ethics approval.

Ethics approval

The University of Auckland Human Participants Ethics Committee approved the Ginkgo and NHP-Lite studies for 3 years on 18 April 2015 (reference number: 013654) and 7 March 2016 (reference number: 016743), respectively.

Consent to participate

Informed consent was obtained from all individual participants included in the study.

Consent to publish

All authors consent to publication of this paper.

Code availability

Not applicable.

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Barnes, J., Sheridan, J.L., Dong, C.Y. et al. Evaluation of a Web-Based, ‘Purchase Event’ Intensive Monitoring Method for Pharmacovigilance of Natural Health Products: Lessons and Insights from Development Work in New Zealand. Drug Saf 43, 981–998 (2020). https://doi.org/10.1007/s40264-020-00963-y

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