Development of instrument to report and asses causality of adverse events related to herbal medicines
Background: The use of herbal medicines is justified empirically using ethnopharmacological knowledge, which has limitations. Reports of adverse events (AE) may contribute for safety, quality, and effectiveness assessment. Objectives: This study aimed to develop an instrument to allow detection and evaluation of the causal likelihood of AE related to herbal medicines. Methods: A quantitative methodological development research intervention was performed with primary care health professionals. Two cases were distributed in an interval of one week in order to allow for completion of the proposal form. The within-rater reliability was calculated and classified into satisfactory, regular, and unsatisfactory, according to essential, necessary, and recommended items reported. Results: Fifty-seven professionals were enrolled. A high degree of the within-rater reliability was observed for the most essential, necessary, and recommended fields. The instrument contributed to assessment of definite causal association, once the duration of reactions including evolution, withdrawal, and reposition items showed high reliability. Most fields poor and weak filled were related to quality defects, such as popular name and appearance. Conclusions: Data suggest the instrument is adequate to report AE arising from herbal medicines. Owing to information regarding to organoleptic characteristics, the instrument is different from drug instruments. Therefore, it is intended to improve AE reports related to herbal medicines and contribute for appropriate use.
Rodrigues E, Barnes J. Pharmacovigilance of herbal medicines. The potentioal contributions of ethnobotanical and ethnopharmacological studies. Drug Saf ety. 2013; 36:1-12.
Balbino EE, Dias MF. Farmacovigilância: um passo em direção ao uso racional de plantas medicinais e fitorápicos. Revista Brasileira de Farmacognosia. 2010; 20(6): 992-1000.
Menniti-Ippolito F, Mazzanti G, Santuccio C, Moro PA, Calapai G, Firenzuoli F, et al. Surveillance of suspected adverse reactions to natural health products in Italy. Pharmacoepidemiology and Drug Safety. 2008; 17: 626-635.
Barnes J, Mills SY, Abbot NC, Willoughby M, Ernst E. Different standards for reporting ADRs to herbal remedies and conventional OTC medicines: face-to-face interviews with 515 users of herbal remedies. British Journal of Clinical Pharmacology. 1998; 45: 496-500.
Hopf Y, Watson M, Williams D. Adverse Drug Reaction related admissions to a hospital in Scotland. Pharmacy World and Science. 2008; 30: 854-862.
Lanini J, Duarte-Almeida JM, Nappo S, Carlini EA. O que vêm da terra não faz mal. Relatos de problemas relacionados ao uso de plantas medicinais por raizeiros de Diadema/SP. Revista Brasileira de Farmacognosia. 2009; 19(1A): 121-129.}
Shaw D. Toxicological risks of Chinese herbs. Planta Medica. 2010; 76: 2012-2010.
Soares-Neto JAR, Galduróz JCF, Rodrigues E. A rede de comércio popular de drogas psicoativas na cidade de Diadema e o seu interesse para a Saúde Pública. Saúde Soc. 2010, 19: 310-319.
Soares-Neto JAR, Kato EM, Bugno A, Galduróz JCF, Marques LC, Macrini T, et al. Informal trade of psychoactive
herbal products in the city of Diadema, SP, Brazil: quality and potential risks. J Evid Based Complem Altern Med, 2013. doi: 10.1155/2013/894834
Adusumilli PS, Lee B, Parekh K, Farrelly PA. Acalculuos eosinophilic cholecystitis from herbal medicine: a review of adverse effects of herbal medicine in surgical patients. Surgery. 2002; 131: 352-356.
Van Hunsel FP, van Grootheest AC. Adverse reactions to herbal remedies: analysis of reported adverse reactions in the Nerthelands. Nederlands Tijdschrift voor Geneeskunde 2013; 157(47):A6615.
Pagotto C, Varallo FR, Mastroianni PC. Impact of Educational Interventions on Adverse Drug Events Reporting. International Journal of Technology Assessment of Health Care. 2013; 29 (4) 410-417.
Gonzalez-Gonzalez C, Lopez-Gonzalez E, Herdeiro MT, Figueira A. Strategies to improve adverse drug reaction reporting: a critical and systematic review. Drug Saf. 2013; 36(5):317-328.
Tabach R, De Santi D, Movilla J, Mattos P, Carlini EA. Boletim PLANFAVI 1ª edição. Sistema de Farmacovigilância de Plantas Medicinais. CEBRID, 2007.
Soares-Neto JA, Galduróz JC, Marques LC, Kato ET, Macrini T, Rodrigues E. Possible adverse reactions to herbal products: a study with individuals who report to popular medicine in the city of Diadema, SP, Brazil. Phytother Res. 2014, 28: 405-11.
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