Skip to main content

Coding Reports Involving Herbal Medicines in a Pharmacovigilance Database

  • Chapter
  • First Online:
Pharmacovigilance for Herbal and Traditional Medicines

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.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 109.00
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Hardcover Book
USD 139.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

References

  1. World Health Organization (2004) WHO guidelines on safety monitoring of herbal medicines

    Google Scholar 

  2. 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

  3. 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

    Article  PubMed  Google Scholar 

  4. 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

    Article  CAS  PubMed  Google Scholar 

  5. 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

    Google Scholar 

  6. 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

    Article  CAS  PubMed  Google Scholar 

  7. 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

    Article  CAS  PubMed  Google Scholar 

  8. 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

    Article  CAS  Google Scholar 

  9. 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

    Article  CAS  PubMed  Google Scholar 

  10. Centre for Australian National Biodiversity Research and Australian National Herbarium. https://www.anbg.gov.au/cpbr/databases/names.html. Accessed 16 Jun 2017

  11. 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

    Article  PubMed  Google Scholar 

  12. 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

    Article  CAS  PubMed  Google Scholar 

  13. 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

    Article  PubMed  Google Scholar 

  14. 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

  15. Dighe NS, Nirmal SA, Musmade SA, Dhasade VV (2010) Herbal database management. Syst Rev Pharm 2(1):152–157

    Article  Google Scholar 

  16. 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

    Article  PubMed  Google Scholar 

  17. Stepantschitz G, Kresbach E (1954) Treatment of rheumatism with horse chestnut extracts (venostasin). Z Rheumaforsch 13(9–10):266–275

    CAS  PubMed  Google Scholar 

  18. the Uppsala Monitoring Centre (2004) Guidelines for herbal ATC classification. The Uppsala Monitoring Centre, Sweden

    Google Scholar 

  19. 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

    Article  PubMed  PubMed Central  Google Scholar 

  20. 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

    Article  PubMed  PubMed Central  Google Scholar 

  21. 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

    Article  PubMed  Google Scholar 

  22. 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

  23. Barnes J (2003) Pharmacovigilance of herbal medicines: a UK perspective. Drug Saf 26(12):829–851. https://doi.org/10.2165/00002018-200326120-00001

    Article  PubMed  Google Scholar 

  24. 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

    Article  PubMed  PubMed Central  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Florence van Hunsel .

Editor information

Editors and Affiliations

Rights and permissions

Reprints and permissions

Copyright information

© 2022 Springer Nature Switzerland AG

About this chapter

Check for updates. Verify currency and authenticity via CrossMark

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

Publish with us

Policies and ethics