Thai stakeholders' awareness and perceptions of the patient adverse event reporting system for herbal medicines: a qualitative study

Int J Clin Pharm. 2023 Apr;45(2):491-501. doi: 10.1007/s11096-022-01533-1. Epub 2023 Feb 6.

Abstract

Background: In Thailand, the consumption of herbal medicines has been increasing. Adverse events (AEs) of herbal medicines have been identified through the spontaneous reporting system. However, the number of patients reporting AEs of herbal medicines remains limited.

Aim: To explore the awareness and perceptions about the patient reporting system and to explore attitudes towards safety of herbal medicines, experiences, and intention to report AEs of herbal medicines.

Method: Semi-structured in-depth interviews were conducted with stakeholders (patients, community pharmacists, village health volunteers, and consumers who had experienced submitting a complaint about health products to the Consumers Foundation). Additionally, a focus group discussion was held with stakeholders (academics, herbal medicine manufacturers, healthcare professionals, policy maker who was responsible for promoting the use of herbal medicines, pharmacovigilance staff, patient, and representative from patient organisations). The data were audio recorded, transcribed verbatim and analysed using thematic analysis.

Results: Fifty participants were interviewed and the focus group discussion included 12 participants. Patients had positive attitudes towards the safety of herbal medicines. Lack of awareness of the patient reporting system was identified. Nevertheless, all stakeholders acknowledged the importance of the safety monitoring of herbal medicines and indicated a willingness to report AEs via the patient reporting system in the future. A simple reporting system, a variety of reporting channels, the provision of feedback, and providing rewards would motivate patients to report AEs.

Conclusion: Although there is a lack of awareness, this provides a great opportunity to improve patient AE reporting system for herbal medicines in Thailand.

Keywords: Herbal medicine; Patient adverse event reporting system; Pharmacovigilance; Safety monitoring system.

MeSH terms

  • Adverse Drug Reaction Reporting Systems*
  • Humans
  • Plant Extracts / adverse effects
  • Qualitative Research
  • Southeast Asian People*
  • Thailand / epidemiology

Substances

  • Plant Extracts