Different standards for reporting ADRs to herbal remedies and conventional OTC medicines: face‐to‐face interviews with 515 users of herbal remedies

TLDR

The study aims to assess whether users report adverse drug reactions to herbal remedies differently than to conventional OTC medicines. The authors conducted structured face‑to‑face interviews with 515 herbal‑remedy users across 12 UK stores to capture their actions following adverse drug reactions to herbal and conventional OTC medicines. Results show that while 30.3 % of respondents would consult a GP for a serious ADR regardless of type, a larger proportion (42.9 %) would not, and significant differences exist in reporting patterns for serious and minor ADRs between herbal and conventional OTC medicines, highlighting challenges for herbal pharmacovigilance.

Abstract

Aims To determine whether adverse drug reactions (ADRs) to herbal remedies would be reported differently from similar ADRs to conventional over‐the‐counter (OTC) medicines by herbal‐remedy users. Methods Face‐to‐face interviews (using a structured questionnaire) with 515 users of herbal remedies were conducted in six pharmacy stores and six healthfood stores in the UK. The questionnaire focused on the likely course of action taken by herbal‐remedy users after experiencing an ADR associated with a conventional OTC medicine and a herbal remedy. Results Following a ‘serious’ suspected ADR, 156 respondents (30.3%) would consult their GP irrespective of whether the ADR was associated with the use of a herbal remedy or a conventional OTC medicine, whereas 221 respondents (42.9%) would not consult their GP for a serious ADR associated with either type of preparation. One hundred and thirty‐four respondents (26.0%) would consult their GP for a serious ADR to a conventional OTC medicine, but not for a similar ADR to a herbal remedy, whereas four respondents (0.8%) would consult their GP for a serious ADR to a herbal remedy, but not for a similar ADR to a conventional OTC medicine. Similar differences were found in attitudes towards reporting ‘minor’ suspected ADRs. Conclusions Consumers of herbal remedies would act differently with regard to reporting an ADR (serious or minor) to their GP depending on whether it was associated with a herbal remedy or a conventional OTC medicine. This has implications for herbal pharmacovigilance, particularly given the increasing use of OTC herbal remedies. The finding that a high proportion of respondents would not consult their GP or pharmacist following ADRs to conventional OTC medicines is also of concern.