Herbal drug leaflets: are they in compliance with standards?

Abstract

Leaflets inside pharmaceutical packages should include focal points about medicines being used by patients. The current study was designed to assess the compliance of information cited in herbal medicine leaflets with the standards released by the Ministry of Health and Medical Education of Iran (MHMEI). Leaflets of commonly used herbal pharmaceutical products sold in pharmacies of Iran were collected. Standards for herbal drug leaflets were obtained from the MHMEI, Drug Administration Office. These standards are classified into two main groups of criteria: 1. information for health professionals and 2. information for patients. First group is summarized as 14 principles consisting of: official name of plant, therapeutic category, components, pharmacokinetics, pharmacological action (s), indication (s), contraindication (s), side effects, precaution and interactions, usage in pregnancy, usage in lactation, dosage, administration method and finally dosage form. This information should be in English. Information for patients included 3 main benchmarks of dose and administration method, side effects and storage instructions. This information should be in Persian. Data obtained from the leaflets was entered into the Excel spreadsheet and their compliance with the standard criteria was analyzed. 35 leaflets from 10 pharmaceutical companies were analyzed of which 23 (66.7%) had group 1 information in Persian and only 12 (34.3%) of them were in English. None of those written in English had the whole of the itemized standard information. None of them had pharmacokinetics data either. Overall, these 12 leaflets contained 123/168 (73.2%) of the criteria recommended by the MHMEI. Regarding the information for patients, all leaflets included dose and usage method advice. However, both side effects and storage conditions were not quoted in 11/35 (31.4%) of them. 16/35 (45.7%) of the leaflets had all-inclusive information for patients complying with MHMEI standards. Overall, 83/105 (79.1%) of the principles recommended by the MHMEI were followed. Taking standards as points of reference which should be abided by pharmaceutical companies, results of this study discloses that a significant proportion of the herbal product leaflets need to be revised and re-written in accordance with the criteria recommended by the MHMEI. MHMEI should have a higher level of controlling on these products since they are easily available for public sale.