Evidence map›Paper›PMID 32596765›Full record

ArticleDrug safety2020

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.

Joanne Barnes, Jane L Sheridan, Christine Yang Dong, Linda Härmark, Sunita Vohra, Mira Harrison-Woolrych

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Article in Drug safety, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

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Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

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4 · The record

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PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Joanne BarnesSchool of Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, Private Bag 92019, Auckland, New Zealand. j.barnes@auckland.ac.nz.ORCID 0000-0002-1522-8433
Jane L SheridanSchool of Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, Private Bag 92019, Auckland, New Zealand.ORCID 0000-0002-0312-3095
Christine Yang DongMercury, Mercury Building, 33 Broadway, Auckland, New Zealand.
Linda HärmarkNetherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH, 'S-Hertogenbosch, The Netherlands.ORCID 0000-0002-9314-9298
Sunita VohraDepartments of Pediatrics and Psychiatry, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.
Mira Harrison-WoolrychInternational Society of Pharmacovigilance, London, UK.

Funding

University of Auckland 3706858
6 · The paper itself

Abstract

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

objectivesOur 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.

methodsFor 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.

resultsFew 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.

conclusionsThese 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.

Indexed as

PhytotherapyAdverse Drug Reaction Reporting SystemsBiological ProductsCommunity Pharmacy ServicesDrug-Related Side Effects and Adverse ReactionsHumansInternetNew ZealandPharmacovigilanceSurveys and QuestionnairesBiological Products

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.