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What has been the impact of the Traditional Herbal Registration (THR) scheme in the UK on information provided with herbal products bought over the counter?

BACKGROUND: In 2011 there was a strengthening of European Union (EU) legislation on the licencing of herbal products which, in the UK, resulted in the introduction of the Traditional Herbal Registration (THR) scheme. This scheme sets out standards for the safety and quality of herbal medicines and i...

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Autores principales: Dickinson, R., Kennedy, M. C., Raynor, D. K., Knapp, P., Thomas, M., Adami, E.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6460666/
https://www.ncbi.nlm.nih.gov/pubmed/30975140
http://dx.doi.org/10.1186/s12906-019-2494-8
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author Dickinson, R.
Kennedy, M. C.
Raynor, D. K.
Knapp, P.
Thomas, M.
Adami, E.
author_facet Dickinson, R.
Kennedy, M. C.
Raynor, D. K.
Knapp, P.
Thomas, M.
Adami, E.
author_sort Dickinson, R.
collection PubMed
description BACKGROUND: In 2011 there was a strengthening of European Union (EU) legislation on the licencing of herbal products which, in the UK, resulted in the introduction of the Traditional Herbal Registration (THR) scheme. This scheme sets out standards for the safety and quality of herbal medicines and includes the provision of information to the customer on the safe use of the product. The aim of this study is to replicate a survey undertaken in 2011, prior to the implementation of the THR scheme, and evaluate the impact of this scheme on the information provided with herbal products bought over-the-counter. METHODS: We undertook a survey on 5 herbal products commonly available over-the-counter (St John’s wort, echinacea, Ginkgo biloba, Asian ginseng, garlic). The information was searched for key safety messages identified by the National Center for Complementary and Integrative Health (NCCIH). We also explored the presence of risk of harm information. RESULTS: We recorded a rise in the number of products registered with the THR scheme (37% in 2016 compared to 7% in 2011). We also identified a reduction in the number of products that did not contain key safety information (75% in 2011 compared to 20% of products obtained in 2016). Risk of harm information was only communicated in products containing a PIL. We identified more products containing frequency of risk of harm information but this was not statistically significant. CONCLUSION: The introduction of the THR scheme appears to be associated with an increase in the provision of information about key safety messages on the safe use of herbal products. However, it is important to note that at least half of the products on the market that are not included in the THR scheme do not contain any information about their safe use; this includes information about precautions, interactions and side effects. The use of NCCIH herbal monographs replicated the methods used in the previous study; we recognise that the use of a different resource might effect the appraisal of the information provided. We also acknowledge that surveying presence of information does not assure that the latter is effectively communicated to patients, for which a close textual analysis would be required. While it is promising that more information is available after the introduction of the THR scheme, the public needs to be informed about ways to optimise safe use of all herbal products.
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spelling pubmed-64606662019-04-22 What has been the impact of the Traditional Herbal Registration (THR) scheme in the UK on information provided with herbal products bought over the counter? Dickinson, R. Kennedy, M. C. Raynor, D. K. Knapp, P. Thomas, M. Adami, E. BMC Complement Altern Med Research Article BACKGROUND: In 2011 there was a strengthening of European Union (EU) legislation on the licencing of herbal products which, in the UK, resulted in the introduction of the Traditional Herbal Registration (THR) scheme. This scheme sets out standards for the safety and quality of herbal medicines and includes the provision of information to the customer on the safe use of the product. The aim of this study is to replicate a survey undertaken in 2011, prior to the implementation of the THR scheme, and evaluate the impact of this scheme on the information provided with herbal products bought over-the-counter. METHODS: We undertook a survey on 5 herbal products commonly available over-the-counter (St John’s wort, echinacea, Ginkgo biloba, Asian ginseng, garlic). The information was searched for key safety messages identified by the National Center for Complementary and Integrative Health (NCCIH). We also explored the presence of risk of harm information. RESULTS: We recorded a rise in the number of products registered with the THR scheme (37% in 2016 compared to 7% in 2011). We also identified a reduction in the number of products that did not contain key safety information (75% in 2011 compared to 20% of products obtained in 2016). Risk of harm information was only communicated in products containing a PIL. We identified more products containing frequency of risk of harm information but this was not statistically significant. CONCLUSION: The introduction of the THR scheme appears to be associated with an increase in the provision of information about key safety messages on the safe use of herbal products. However, it is important to note that at least half of the products on the market that are not included in the THR scheme do not contain any information about their safe use; this includes information about precautions, interactions and side effects. The use of NCCIH herbal monographs replicated the methods used in the previous study; we recognise that the use of a different resource might effect the appraisal of the information provided. We also acknowledge that surveying presence of information does not assure that the latter is effectively communicated to patients, for which a close textual analysis would be required. While it is promising that more information is available after the introduction of the THR scheme, the public needs to be informed about ways to optimise safe use of all herbal products. BioMed Central 2019-04-11 /pmc/articles/PMC6460666/ /pubmed/30975140 http://dx.doi.org/10.1186/s12906-019-2494-8 Text en © The Author(s). 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research Article
Dickinson, R.
Kennedy, M. C.
Raynor, D. K.
Knapp, P.
Thomas, M.
Adami, E.
What has been the impact of the Traditional Herbal Registration (THR) scheme in the UK on information provided with herbal products bought over the counter?
title What has been the impact of the Traditional Herbal Registration (THR) scheme in the UK on information provided with herbal products bought over the counter?
title_full What has been the impact of the Traditional Herbal Registration (THR) scheme in the UK on information provided with herbal products bought over the counter?
title_fullStr What has been the impact of the Traditional Herbal Registration (THR) scheme in the UK on information provided with herbal products bought over the counter?
title_full_unstemmed What has been the impact of the Traditional Herbal Registration (THR) scheme in the UK on information provided with herbal products bought over the counter?
title_short What has been the impact of the Traditional Herbal Registration (THR) scheme in the UK on information provided with herbal products bought over the counter?
title_sort what has been the impact of the traditional herbal registration (thr) scheme in the uk on information provided with herbal products bought over the counter?
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6460666/
https://www.ncbi.nlm.nih.gov/pubmed/30975140
http://dx.doi.org/10.1186/s12906-019-2494-8
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