Abstract
Many pharmacovigilance centres worldwide receive spontaneous reports for herbal medicines (including unapproved/unlicensed products) in addition to reports for conventional medicines. Reports involving herbal medicines are stored in pharmacovigilance databases that are mainly developed for storing, coding, assessing, analysing and transferring data to other databases in the context of conventional medicines. Using correct nomenclature for herbal medicinal products and their ingredients is essential to overcome confusion about the plant substances that are described in reports in pharmacovigilance databases. Binomial names for plants are recommended to be used in addition to naming the part of the plant and preparation method in the reports in the database. For pharmacovigilance centres using the WHODrug Global® dictionary, the Herbal-ATC (HATC) coding system is available. The HATC classification provides a scientific framework for a harmonized, global nomenclature and therapeutic classification of herbal substances and combinations of them used as ingredients in herbal medicines. However, the HATC also has some limitations, and is not universally used. Other coding methods using binominal names for plants are described in this chapter together with a description of how the pharmacovigilance centres in Morocco and the Netherlands code adverse reaction reports for herbal medicines.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
World Health Organization (2004) WHO guidelines on safety monitoring of herbal medicines
Norwegian Institute of Public Health—WHO Collaborating Centre for Drug Statistics Metodology (2011) ATC structure and principles. https://www.whocc.no/atc/structure_and_principles/. Accessed 1 Jun 2020
Farah MH, Olsson S, Bate J et al (2006) Botanical nomenclature in pharmacovigilance and a recommendation for standardisation. Drug Saf 29(11):1023–1029. https://doi.org/10.2165/00002018-200629110-00002
Zhao Z, Liang Z, Chan K et al (2010) A unique issue in the standardization of Chinese materia medica: processing. Planta Med 76(17):1975–1986. https://doi.org/10.1055/s-0030-1250522
Skalli S, Jordan SA (2017) Herbal and traditional medicines, now and future. In: Edwards R, Lindquist M (eds) . Springer International Publishing, Pharmacovigilance critique and ways forward, pp 145–159
Wu KM, Farrelly JG, Upton R, Chen J (2007) Complexities of the herbal nomenclature system in traditional Chinese medicine (TCM): lessons learned from the misuse of Aristolochia-related species and the importance of the pharmaceutical name during botanical drug product development. Phytomedicine 14(4):273–279. https://doi.org/10.1016/j.phymed.2006.05.009
Jordan SA, Cunningham DG, Marles RJ (2010) Assessment of herbal medicinal products: challenges, and opportunities to increase the knowledge base for safety assessment. Toxicol Appl Pharmacol 243(2):198–216. https://doi.org/10.1016/j.taap.2009.12.005
Wu X, Wang S, Lu J et al (2008) Seeing the unseen of Chinese herbal medicine processing (Paozhi): advances in new perspectives. Chin Med 13:4. https://doi.org/10.1186/s13020-018-0163-3
Reeuwijk NM, Venhuis BJ, de Kaste D, Hoogenboom RL, Rietjens IM, Martena MJ (2014) Active pharmaceutical ingredients detected in herbal food supplements for weight loss sampled on the Dutch market. Food Addit Contam Part A Chem Anal Control Expo Risk Assess 31(11):1783–1793. https://doi.org/10.1080/19440049.2014.958574
Centre for Australian National Biodiversity Research and Australian National Herbarium. https://www.anbg.gov.au/cpbr/databases/names.html. Accessed 16 Jun 2017
Bergman U (2006) The history of the drug utilization research group in Europe. Pharmacoepidemiol Drug Saf 15(2):95–98. https://doi.org/10.1002/pds.1171
Farah HM, Edwards R, Linquist M, Leon C, Shaw D (2000) International monitoring of adverse health effects associated with herbal medicines. Pharmacoepidemiol Drug Saf 9(2):105–112. https://doi.org/10.1002/(SICI)1099-1557(200003/04)9:2<105::AID-PDS486>3.0.CO;2-2
De Smet PA (1993) An introduction to herbal pharmacoepidemiology. J Ethnopharmacol 38(2–3):197–208. https://doi.org/10.1016/0378-8741(93)90016-x
The Uppsala Monitoring Centre (2019) The herbal anatomical therapeutic chemical classification system. https://www.who-umc.org/whodrug/whodrug-portfolio/whodrug-global/herbal-atc/. Accessed 11 Nov 2019
Dighe NS, Nirmal SA, Musmade SA, Dhasade VV (2010) Herbal database management. Syst Rev Pharm 2(1):152–157
Gurel E, Ustunova S, Ergin B et al (2013) Herbal haemorrhoidal cream for haemorrhoids. Chin J Physiol 56(5):253–262. https://doi.org/10.4103/0975-8453.75067
Stepantschitz G, Kresbach E (1954) Treatment of rheumatism with horse chestnut extracts (venostasin). Z Rheumaforsch 13(9–10):266–275
the Uppsala Monitoring Centre (2004) Guidelines for herbal ATC classification. The Uppsala Monitoring Centre, Sweden
Yi YD, Chang IM (2004) An overview of traditional Chinese herbal formulae and a proposal of a new code system for expressing the formula titles. Evid Based Complement Alternat Med 1(2):125–132. https://doi.org/10.1093/ecam/neh019
Shetti S, Kumar CD, Sriwastava NK, Sharma IP (2011) Pharmacovigilance of herbal medicines: current state and future directions. Pharmacogn Mag 7(25):69–73. https://doi.org/10.4103/0973-1296.75905
Skalli S, Bencheikh RS (2015) Pharmacovigilance of herbal medicines in Africa: questionnaire study. J Ethnopharmacol 171:99–108. https://doi.org/10.1016/j.jep.2015.05.033
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) (2019) Welcome to MedDRA. https://www.meddra.org/. Accessed 16 Jun 2017
Barnes J (2003) Pharmacovigilance of herbal medicines: a UK perspective. Drug Saf 26(12):829–851. https://doi.org/10.2165/00002018-200326120-00001
van Hunsel F, van de Koppel S, Skalli S et al (2019) Analysis of hepatobiliary disorder reports associated with the use of herbal medicines in the global suspected ADR database Vigibase. Front Pharmacol 10:1326. https://doi.org/10.3389/fphar.2019.01326
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2022 Springer Nature Switzerland AG
About this chapter
Cite this chapter
van Hunsel, F., Skalli, S. (2022). Coding Reports Involving Herbal Medicines in a Pharmacovigilance Database. In: Barnes, J. (eds) Pharmacovigilance for Herbal and Traditional Medicines. Adis, Cham. https://doi.org/10.1007/978-3-031-07275-8_9
Download citation
DOI: https://doi.org/10.1007/978-3-031-07275-8_9
Published:
Publisher Name: Adis, Cham
Print ISBN: 978-3-031-07273-4
Online ISBN: 978-3-031-07275-8
eBook Packages: Biomedical and Life SciencesBiomedical and Life Sciences (R0)