Intensive monitoring methods are used in pharmacovigilance for prescription medicines but have not yet been implemented for natural health products (NHPs).
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.
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.
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.
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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Barnes J. Pharmacovigilance of herbal medicines: a UK perspective. Drug Saf. 2003;26(12):829–51.
World Health Organisation. WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems. World Health Organisation, Geneva. 2004. https://apps.who.int/medicinedocs/documents/s7148e/s7148e.pdf. Accessed 16 Mar 2020.
Dauncey EA, Irving JTW, Allkin R. A review of issues of nomenclature and taxonomy of Hypericum perforatum L. and Kew’s Medicinal Plant Names Services. J Pharm Pharmacol. 2019;71(1):4–14.
University of Otago and Ministry of Health. A focus on nutrition: key findings from the 2008/09 New Zealand Adult Nutrition Survey. Ministry of Health, Wellington. 2011. https://www.health.govt.nz/publication/focus-nutrition-key-findings-2008-09-nz-adult-nutrition-survey. Accessed 16 Mar 2020.
Barnes PM, Bloom B, Nahin RL. Complementary and alternative medicine use among adults and children: United States, 2007. Natl Health Stat Rep. 2008;12:1–23.
Thomas KJ, Nicholl JP, Coleman P. Use and expenditure on complementary medicine in England: a population based survey. Compl Ther Med. 2001;9(1):2–11.
Smith T, Lynch ME, Johnson J, Kawa K, Bauman H, Blumenthal M. Herbal dietary supplement sales in US increase 6.8% in 2014. HerbalGram J Am Bot Council. 2015;(107):52–9.
Smith T, Kawa K, Eckl V, Morton C, Stredney R. Herbal supplement sales in US increase 7.7% in 2016 Consumer preferences shifting toward ingredients with general wellness benefits, driving growth of adaptogens and digestive health products. HerbalGram J Am Bot Council. 2017;115:56–65.
World Health Organisation. WHO traditional medicine strategy: 2014–2023. World Health Organisation, Geneva. 2013. https://www.who.int/medicines/publications/traditional/trm_strategy14_23/en/. Accessed 16 Mar 2020.
Barnes J, Dong C. Professional practices and experiences with complementary medicines: a cross-sectional study involving community pharmacists in New Zealand. 15th International Social Pharmacy Workshop; 8–11 July 2008; Queenstown, New Zealand: Int J Pharm Pract; 2008.
Barnes J, McLachlan AJ, Sherwin CMT, Enioutina EY. Herbal medicines: challenges in the modern world. Part 1. Australia and New Zealand. Expert Rev Clin Pharmacol. 2016;9(7):905–15.
Demystifying rongoā Māori: traditional Māori healing. Best Pract J. 2008;13:32–6.
Fan X, Lee KS, Frazier SK, Lennie TA, Moser DK. The use of, and perceptions about, dietary supplements among patients with heart failure. Eur J Cardiovasc Nurs. 2014;13(4):311–9.
Barnes J, Anderson LA, Phillipson JD. Herbal medicines. A guide for health-care professionals, 3rd ed. London: Pharmaceutical Press; 2007.
Barnes J. Adverse drug reactions and pharmacovigilance of herbal medicines. In: Talbot J, Aronson J, editors. Stephens’ detection and evaluation of adverse drug reactions. 6th ed. Chichester: Wiley; 2012. p. 645–83.
Ko RJ. Adulterants in Asian patent medicines. N Engl J Med. 1998;339(12):847.
Koh HL, Woo SO. Chinese proprietary medicine in Singapore: regulatory control of toxic heavy metals and undeclared drugs. Drug Saf. 2000;23(5):351–62.
Botanical Adulterants Prevention Program. American Botanical Council. http://cms.herbalgram.org/BAP/index.html. Accessed 16 Mar 2020.
Xu M, Huang B, Gao F, Zhai C, Yang Y, Li L, et al. Assesment of adulterated traditional Chinese medicines in China: 2003–2017. Front Pharmacol. 2019;10:1446.
Commission of the European Communities. Proposal for amending the directive 2001/83/EC as regards traditional herbal medicinal products. 2002/0008 (COD). Brussels: European Commission; 2002.
European Medicines Agency. Traditional herbal medicine products and simplified registrations for homeopathic medicinal products: pharmacovigilance requirements and EudraVigilance access. Note for clarification. EMA/80556/2017. London: Inspections, Human Medicines, Pharmacovigilance and Committees Division; 2017.
Schmitz SM, Lopez HL, MacKay D. Nutravigilance: principles and practices to enhance adverse event reporting in the dietary supplement and natural products industry. Int J Food Sci Nutr. 2014;65(2):129–34.
Barnes J, Tatley M. Scant reporting on CAMs safety in NZ. Pharmacy Today. 2007:6.
Farah MH, Edwards R, Lindquist M, Leon C, Shaw D. International monitoring of adverse health effects associated with herbal medicines. Pharmacoepidemiol Drug Saf. 2000;9(2):105–12.
Aronson J. Adverse drug reactions: history, terminology, classification, causality, frequency, preventability. In: Talbot J, Aronson J, editors. Stephens’ detection and evaluation of adverse drug reactions. 6th ed. Chichester: Wiley; 2011.
Barnes J, Mills SY, Abbot NC, Willoughby M, Ernst E. Different standards for reporting ADRs to herbal remedies and conventional OTC medicines: face-to-face interviews with 515 users of herbal remedies. Br J Clin Pharmacol. 1998;45(5):496–500.
Harrison-Woolrych M, Coulter DM. PEM in New Zealand. In: Mann R, Andrews EB, editors. Pharmacovigilance. 2nd ed. Chichester: Wiley; 2007. p. 317–32.
New Zealand Pharmacovigilance Centre: About—IMMP. New Zealand Pharmacovigilance Centre. https://nzphvc.otago.ac.nz/about/. Accessed 16 Mar 2020.
Härmark L, van Grootheest K. Web-based intensive monitoring: from passive to active drug surveillance. Expert Opin Drug Saf. 2012;11(1):45–51.
Borden EK, Lee JG. A methodologic study of post-marketing drug evaluation using a pharmacy-based approach. J Chron Dis. 1982;35(10):803–16.
Gauld NJ, Shaw JP, Emmerton LM, Pethica BD. Surveillance of a recently switched non-prescription medicine (Diclofenac) using a pharmacy-based approach. Pharmacoepidemiol Drug Saf. 2000;9(3):207–14.
Sinclair HK, Bond CM, Hannaford PC. Over-the-counter ibuprofen: how and why is it used? Int J Pharm Pract. 2000;8(2):121–7.
Layton D, Sinclair HK, Bond CM, Hannaford PC, Shakir SAW. Pharmacovigilance of over-the-counter products based in community pharmacy: methodological issues from pilot work conducted in Hampshire and Grampian. UK. Pharmacoepidemiol Drug Saf. 2002;11(6):503–13.
Bond C, Hannaford P. Issues related to monitoring the safety of over-the-counter (OTC) medicines. Drug Saf. 2003;26(15):1065–74.
Aggarwal AM, Barnes J. A pilot study of community-pharmacy-based pharmacovigilance of an over-the-counter herbal medicine ginkgo (ginkgo biloba): methodological issues from work in progress. Drug Saf. 2006;29(4):358.
Ingredients. Natural Health Products New Zealand. https://www.naturalhealthproducts.nz/ingredients/. Accessed 16 Mar 2020.
Coriolis. Food & beverage information project 2011—depth sector stream—nutraceuticals & foods for health. Final report. Auckland, New Zealand. 2011.
Ginkgo. In: Stockley’s herbal medicines interactions. Pharmaceutical Press, London. http://www.medicinescomplete.com.ezproxy.auckland.ac.nz/. Accessed 16 Mar 2020.
Qualtrics XM. https://www.qualtrics.com/. Accessed 16 Mar 2020.
Green Cross Health. https://www.greencrosshealth.co.nz/. Accessed 16 Mar 2020.
MedDRA. Medical Dictionary for Regulatory Activities. https://www.meddra.org/. Accessed 16 Mar 2020.
Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981;30(2):239–45.
The Uppsala Monitoring Centre. The use of the WHO-UMC system for standardised case causality assessment. https://www.who.int/medicines/areas/quality_safety/safety_efficacy/WHOcausality_assessment.pdf. Accessed 16 Mar 2020.
Aggarwal AM. An examination of the role of the community pharmacist in the pharmacovigilance of herbal medicines. PhD [dissertation]. London: University of London; 2008.
Vohra S, Cvijovic K, Boon H, Foster BC, Jaeger W, LeGatt D, et al. Study of natural health product adverse reactions (SONAR): active surveillance of adverse events following concurrent natural health product and prescription drug use in community pharmacies. PLoS One. 2012;7(9):e45196.
Walji R, Boon H, Barnes J, Welsh S, Austin Z, Baker GR. Reporting natural health product related adverse drug reactions: is it the pharmacist’s responsibility? Int J Pharm Pract. 2011;19(6):383–91.
Shaw JP, Ferry DG, Pethica D, Brenner D, Tucker IG. Usage patterns of transdermal nicotine when purchased as a non-prescription medicine from pharmacies. Tob Control. 1998;7(2):161–7.
Sinclair HK, Bond CM, Hannaford PC, Grampian Pharmacy Network. Pharmacovigilance of over-the-counter products based in community pharmacy: a feasible option? Pharmacoepidemiol Drug Saf. 1999;8(7):479–91.
Sinclair HK, Bond CM, Hannaford PC. Long term follow-up studies of users of nonprescription medicines purchased from community pharmacies: some methodological issues. Drug Saf. 2001;24(12):929–38.
Rosenbloom K, Taylor K, Harding G. Community pharmacists’ attitudes towards research. Int J Pharm Pract. 2000;8(2):103–10.
Saini B, Brillant M, Filipovska J, Gelgor L, Mitchell B, Rose G, et al. Factors influencing Australian community pharmacists’ willingness to participate in research projects—an exploratory study. Int J Pharm Pract. 2006;14(3):179–88.
Cvijovic K, Boon H, Jaeger W, Vohra S. Pharmacists’ participation in research: a case of trying to find the time. Int J Pharm Pract. 2010;18(6):377–83.
Awaisu A, Alsalimy N. Pharmacists’ involvement in and attitudes toward pharmacy practice research: a systematic review of the literature. Res Social Adm Pharm. 2015;11(6):725–48.
Harrison-Woolrych M, Jamieson S, Malik M, Holt A, Herbison P. Electronic capture of dispensing data by the New Zealand Intensive Medicines Monitoring Programme: a consultation study of community and hospital pharmacists. Int J Pharm Pract. 2011;19(2):136–9.
Pharmacy Council of New Zealand. Code of ethics 2018 safe effective pharmacy practice. Pharmacy Council of New Zealand. 2018. https://www.pharmacycouncil.org.nz/dnn_uploads/Documents/standardsguidelines/Code%20of%20Ethics%202018%20FINAL.pdf?ver=2018-03-04-215933-993. Accessed 16 Mar 2020.
van Grootheest K, Olsson S, Couper M, de Jong-van den Berg L. Pharmacists’ role in reporting adverse drug reactions in an international perspective. Pharmacoepidemiol Drug Saf. 2004;13(7):457–64.
Rutter P, Brown D, Howard J, Randall C. Pharmacists in pharmacovigilance: can increased diagnostic opportunity in community settings translate to better vigilance? Drug Saf. 2014;37(7):465–9.
Härmark L, van Puijenbroek E, Straus S, van Grootheest K. Intensive monitoring of pregabalin: results from an observational, web-based, prospective cohort study in the Netherlands using patients as a source of information. Drug Saf. 2011;34(3):221–31.
Härmark L, van Puijenbroek E, van Grootheest K. Intensive monitoring of duloxetine: results of a web-based intensive monitoring study. Eur J Clin Pharmacol. 2013;69(2):209–15.
Inflation calculator. Reserve Bank of New Zealand. https://www.rbnz.govt.nz/monetary-policy/inflation-calculator. Accessed 16 Mar 2020.
Kennedy E, Krska J, John D, Hansford D. Effect of incentives on recruitment and response rate in a community-based pharmacy practice study. Int J Pharm Pract. 1999;7(2):80–5.
Krska J, John DN, Hansford D, Kennedy E. Drug utilization evaluation of nonprescription H2-receptor antagonists and alginate-containing preparations for dyspepsia. Br J Clin Pharmacol. 2000;49(4):363–8.
Härmark L, Lie-Kwie M, Berm L, de Gier H, van Grootheest K. Patients’ motives for participating in active post-marketing surveillance. Pharmacoepidemiol Drug Saf. 2013;22(1):70–6.
Castillon G, Salvo F, Moride Y. The social impact of suspected adverse drug reactions: an analysis of the Canada vigilance spontaneous reporting database. Drug Saf. 2019;42(1):27–34.
Kingi TKR, Durie MH. Hua Oranga: a Māori mental health outcome measure. A report prepared for the Ministry of Health. Massey University. 2000. https://www.moh.govt.nz/NoteBook/nbbooks.nsf/0/2E3845581DC2CF9DCC257F070007CD17/$file/Hua%20Oranga%20Kingi%20&%20Durie%202000.pdf. Accessed 16 Mar 2020.
Harwood M, Weatherall M, Talemaitoga A, Barber PA, Gommans J, Taylor W, et al. An assessment of the Hua Oranga outcome instrument and comparison to other outcome measures in an intervention study with Māori and Pacific people following stroke. N Z Med J. 2012;125(1364):57–67.
MacPherson H, Liu B. The safety of Chinese herbal medicine: a pilot study for a national survey. J Altern Compl Med. 2005;11(4):617–26.
Bensoussan A, Myers SP, Carlton AL. Risks associated with the practice of traditional Chinese medicine: an Australian study. Arch Fam Med. 2000;9(10):1071–8.
Teng L, Shaw D, Barnes J. Practice of traditional Chinese herbal medicine shops in central London. Phytochem Lett. 2008;1(2):94–8.
Walji R, Boon H, Barnes J, Austin Z, Welsh S, Baker GR. Consumers of natural health products: natural-born pharmacovigilantes? BMC Compl Altern Med. 2010;10:8.
Klein K, Hazell L, Stolk P, Shakir S. The UK BIO-TRAC study: a cross-sectional study of product and batch traceability for biologics in clinical practice and electronic adverse drug reaction reporting in the UK. Drug Saf. 2020;43(3):255–63.
Booker A, Johnston D, Heinrich M. Value chains of herbal medicines—ethnopharmacological and analytical challenges in a globalizing world. In: Mukherjee PK, editor. Evidence-based validation of herbal medicine. Elsevier; 2015. pp. 29–44.
Heinrich M, Scotti F, Booker A, Fitzgerald M, Kum KY, Lobel K. Unblocking high-value botanical value chains: is there a role for blockchain systems? Front Pharmacol. 2019;10:396.
Coutinho Moraes DF, Still DW, Lum MR, Hirsch AM. DNA-based authentication of botanicals and plant-derived dietary supplements: where have we been and where are we going? Planta Med. 2015;81(9):687–95.
de Vries ST, Harrison J, Revelle P, Ptaszynska-Neophytou A, Radecka A, Ragunathan G, et al. Use of a patient-friendly terms list in the adverse drug reaction report form: a database study. Drug Saf. 2019;42(7):881–6.
Rodrigues E, Barnes J. Pharmacovigilance of herbal medicines: the potential contributions of ethnobotanical and ethnopharmacological studies. Drug Saf. 2013;36(1):1–12.
Green G, Bradby H, Chan A, Lee M. “We are not completely Westernised”: dual medical systems and pathways to health care among Chinese migrant women in England. Soc Sci Med. 2006;62(6):1498–509.
de Vries ST, Wong L, Sutcliffe A, Houÿez F, Lasheras Ruiz C, Mol PGM, et al. Factors influencing the use of a mobile app for reporting adverse drug reactions and receiving safety information: a qualitative study. Drug Saf. 2017;40(5):443–55.
Pierce CE, de Vries ST, Bodin-Parssinen S, Härmark L, Tregunno P, Lewis DJ, et al. Recommendations on the use of mobile applications for the collection and communication of pharmaceutical product safety information: lessons from IMI WEB-RADR. Drug Saf. 2019;42(4):477–89.
Population. Stats NZ. https://www.stats.govt.nz/topics/population. Accessed 16 Mar 2020.
Coulter DM. PEM in New Zealand. In: Mann R, Andrews E, editors. Pharmacovigilance. Chichester: Wiley; 2002. p. 345–62.
Mann RD. Prescription-event monitoring. In: Strom BL, editor. Pharmacoepidemiology. Chichester: Wiley; 2002.
Kamin W, Kieser M. Pinimenthol ointment in patients suffering from upper respiratory tract infections—a post-marketing observational study. Phytomedicine. 2007;14(12):787–91.
Stauss-Grabo M, Atiye S, Warnke A, Wedemeyer RS, Donath F, Blume HH. Observational study on the tolerability and safety of film-coated tablets containing ivy extract (Prospan® Cough Tablets) in the treatment of colds accompanied by coughing. Phytomedicine. 2011;18(6):433–6.
Jeschke E, Ostermann T, Luke C, Tabali M, Kroz M, Bockelbrink A, et al. Remedies containing Asteraceae extracts: a prospective observational study of prescribing patterns and adverse drug reactions in German primary care. Drug Saf. 2009;32(8):691–706.
Baybutt J, Sheridan J, Barnes J. New Zealand community pharmacists’ views on pharmacovigilance for natural health products. Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists (ASCEPT) and Australasian Pharmaceutical Science Association (APSA) Joint Scientific Meeting; 29 Nov–2 Dec 2015; Tasmania, Australia: ASCEPT-APSA; 2015.
Brown P, Bahri P. ‘Engagement’ of patients and healthcare professionals in regulatory pharmacovigilance: establishing a conceptual and methodological framework. Eur J Clin Pharmacol. 2019;75(9):1181–92.
Precautionary recall—six batches of St John’s Wort tablets. UK: Medicines and Healthcare products Regulatory Agency; 2016.
Mazzanti G, Moro PA, Raschi E, Da Cas R, Menniti-Ippolito F. Adverse reactions to dietary supplements containing red yeast rice: assessment of cases from the Italian surveillance system. Br J Clin Pharmacol. 2017;83(4):894–908.
Savage RL, Hill GR, Barnes J, Kenyon SH, Tatley MV. Suspected hepatotoxicity with a supercritical carbon dioxide extract of Artemisia annua in grapeseed oil used in New Zealand. Front Pharmacol. 2019;10:1448.
The regulation of natural health products consultation. Ministry of Health, New Zealand. 2015. https://www.health.govt.nz/publication/regulation-natural-health-products-consultation. Accessed 16 Mar 2020.
Natural Health and Supplementary Products Bill. New Zealand Parliament. 2017. https://www.parliament.nz/en/pb/bills-and-laws/bills-proposed-laws/document/00DBHOH_BILL11034_1/natural-health-and-supplementary-products-bill. Accessed 16 Mar 2020.
Zoio N. Natural health products bill quietly killed off. Pharmacy Today 2017.
Therapeutic products regulatory regime. Ministry of Health, New Zealand. 2019. https://www.health.govt.nz/our-work/regulation-health-and-disability-system/therapeutic-products-regulatory-regime. Accessed 16 Mar 2020.
Natural health products. Ministry of Health, New Zealand. 2019. https://www.health.govt.nz/our-work/regulation-health-and-disability-system/natural-health-products. Accessed 16 Mar 2020.
Ministry of Health. The development of a Natural Health Products Bill: consultation paper. Ministry of Health, Wellington. 2010. https://www.moh.govt.nz/notebook/nbbooks.nsf/0/4ceccd294966aa9ccc2576f800015572/$FILE/development-natural-health-bill-consult-mar10.pdf. Accessed 16 Mar 2020.
Directive 2010/84/EU of the European parliament and of the council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use. Official Journal of the European Union; 2010.
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.
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.
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.
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.
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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 (2020). https://doi.org/10.1007/s40264-020-00963-y