Purpose: Andrographis paniculata is one of the commonly used herbal medicines worldwide. Nevertheless, evidences on adverse events (AEs) associated with Andrographis paniculata are very limited. This systematic review and meta-analysis was conducted to estimate and to compare the AE incidence of oral monotherapy Andrographis paniculata with others among patients with upper respiratory tract infection, noninfective diarrhea, and autoimmune disease.Methods: Systematic search was performed through six databases from inception until August 2018. Randomized controlled trial (RCT), cohort, or intensive monitoring of AEs was eligible for review if AE incidence was examined. The incidence of AEs was, then, pooled across studies using meta-analysis.Results: Ten RCTs and 3 intensive monitoring studies were included. Incidence of serious AEs was very rare with the pooled incidence (95% CI) from RCTs of 0.02 per 1000 patients (0.0-0.5). However, the incidence of nonserious AEs was considered very common with the pooled incidence (95% CI) from RCTs of 102.6 per 1000 patients (10.7-256.1), and the pooled incidence (95% CI) from intensive monitoring of 34.2 per 1000 patients (0.0-229.6). The most common nonserious AEs were related to gastrointestinal disorder, and skin and subcutaneous disorder system.Conclusions: Like other medicine, Andrographis paniculata can cause some AEs. However, it may be generally safe. Nevertheless, prospective patients who plan to use Andrographis paniculata should be thoroughly advised and closely monitored for common AEs. Due to the increasing use of Andrographis paniculata worldwide, larger studies with adequate methodological quality are warranted to monitor the safety of such product.

Patients are recognized as important players in the pharmacovigilance system. This study aims to describe and compare the characteristics of patient reporting systems, reporting forms, awareness raising-activities, and the statistics related to patient reporting in the selected countries. Fifteen countries (eight Western countries and seven Asian countries) were purposively selected. A questionnaire survey was distributed to national pharmacovigilance authorities in those countries. Nine countries (five Western countries and four Asian countries) returned the questionnaire. A review of the websites of national pharmacovigilance centres was conducted. The proportion of patient reports in the selected Western countries ranged from 57.83% to 14.37%, while it was accounted for less than 1% in the selected Asian countries. Currently, patients in all nine countries can report adverse drug reactions online via a website. The number of clicks from the national pharmacovigilance website to reach the online reporting form range from one to five clicks. Countries with higher patient reporting rates seemed to share the following characteristics; provision of feedback, engagement with patient organizations, and implementation of several activities to raise the awareness of the general public on the importance of pharmacovigilance. To increase the number of patient reports, the strengths of each country’s system should be adopted.

To date, many studies were conducted to examine knowledge, attitude, and practice of adverse drug reaction (ADR) reporting among health care practitioners. However, a very limited number of the studies were specific to traditional medicine related-ADR reporting. In addition, studies among traditional medicine practitioners, who are key persons for safety monitoring of traditional medicine are scarce. This study aimed to evaluate knowledge, attitude, and practice of traditional medicine-related ADR reporting among hospital pharmacists and traditional medicine practitioners in Thailand. Furthermore, factors associated with ever reported traditional medicine-related ADRs were investigated. A cross-sectional study using mail questionnaire survey was conducted. Samples were hospital pharmacists and traditional medicine practitioners, who were currently working at the selected 205 hospitals throughout the countries. Overall response rate of the survey was 47.56% (195/410). Of the total respondents, 107 (54.9%) were pharmacists while 87 (44.6%) were traditional medicine practitioner. We found that pharmacists had higher knowledge score than traditional medicine practitioners (15.47 + 3.25 VS 11.99 + 2.99, p < 0.001). Both pharmacists and traditional medicine practitioner had positive attitude towards ADR reporting. Both groups of practitioners agreed that ADRs reporting improved the safety of traditional medicine. Nevertheless, only one third of pharmacist and traditional medicine practitioner have ever reported traditional medicine related-ADRs (34.9% VS 26.4% p = 0.206). Factors associated with ever reported ADR related to traditional medicines were knowledge, education, and duration of work experiences. Improving knowledge through training program was essential in promoting traditional medicine-related ADR reporting in Thailand.