Pharmacovigilance of Herbal and Traditional Medicines

eHealth technologies assisting in identifying potential adverse interactions with complementary and alternative medicine (CAM) or standalone CAM adverse events or side effects: a scoping review

“…We identified that the majority of adverse drug/event surveillance eHealth technologies including CAM identified were government initiated, and found across the following countries: China, India, the Republic of Korea, and the United States. These eHealth technologies are equipped with detection [ 34 ] and reporting systems [ 27 , 31 , 34 , 74 ] and safety alerts [ 74 , 75 ]. The countries with such government initiatives outside of the United States are unsurprising, given that a very large proportion of traditional and indigenous medical systems originate from these parts of the world, notably traditional Chinese and Korean medicine and Ayurvedic medicine [ 76 ].…”

“… Available for Anyone to Use? Developer of eHealth Technology Type of Developer Purpose of eHealth Technology Intended User(s) of eHealth Technology Adverse Drug/Event Alerting, Reporting and/or Signal Detection Systems ( n = 11) Center for Food Safety and Applied Nutrition Jackson et al 2001 [ 25 ] https://www.fda.gov/about-fda/office-foods-and-veterinary-medicine/center-food-safety-and-applied-nutrition-cfsan Adverse event reporting tool and safety alerts Website 1984 Yes Yes Yes, entirely free U.S. Food and Drug Administration Government Website containing safety alert publications, guide documents and a reporting tool for dietary supplement adverse events Healthcare providers, researchers, patients/public Guangdong Quantitative Signal Detection System (GDQSDS) Li et al 2009 [ 26 ]; Zhang 2018 [ 27 ] No Adverse drug reaction signal detection and spontaneous reporting system Web-based Unclear Unclear Yes Unclear Authors Researchers (authors) “A web-based system comprising three software modules that prepare data, detect associations, and generate reports, was developed based on the Guangdong ADR monitoring platform” p. 730 Researchers Institute for Safe Medication Practices (ISMP) Motl et al 2004 [ 28 ] https://www.ismp.org Adverse event reporting system Website 1995 (website) Yes Yes Yes, entirely free The Institute for Safe Medication Practices (ISMP) Not-for-Profit Contains a medication error reporting program, and publishes newsletters, reports and safety alerts based on information received Healthcare providers, patients/public INVDOCK Chen et al 2002 [ 29 ]; Chen et al 2006 [ 30 ] ...…”

“…Includes side-effects and has a search tool Healthcare providers, researchers Traditional Chinese Medicine Information Database (TCM-ID) Chen et al 2006 [ 30 ]; Lee et al 2015 [ 40 ]; Xu et al 2019 [ 47 ] http://bidd.nus.edu.sg/group/TCMsite/ Database Unclear 2005 Yes Yes Yes, entirely free Authors Researchers (authors) Provides information about traditional Chinese medicines including prescriptions, constituent herbs, herbal ingredients, molecular structure and functional properties of active ingredients, therapeutic and side effects, and clinical indications Healthcare providers, researchers Vigibase (includes Vigilyze) Ye et al 2009 [ 34 ]; Zhang 2018 [ 27 ] https://www.who-umc.org/vigibase/vigibase/ Database Website 1971 Yes Yes Yes, but only with a subscription WHO Uppsala Monitoring Center, World Health Organization Government A global pharmacovigilance database of individual case safety reports, with over 20 million reports of suspected adverse effects of medicines Healthcare providers (including physicians, dentists, nurses, and pharmacists) Factsheets/Healthcare Information ( n = 13) About Herbs Boddy et al 2008 [ 52 ]; Molassiotis et al 2004 [ 58 ]; Yap et al 2012 [ 39 ] https://www.mskcc.org/cancer-care/diagnosis-treatment/symptom-management/integrative-medicine Factsheets/healthcare information Website and mobile app Unclear Yes Yes Yes, entirely free Memorial Sloan-KetteringCancer Center Researchers Resources on herbs, botanicals and other CAM drugs. Includes information on CAM interactions Healthcare providers, researchers, patients ALMEKO ...…”

Traditional medicine regulation status and challenges in Malawi and Nigeria

“…This is consistent with other studies (28). Zhang (2018) reported that it is di cult to promote rational use of traditional medicines (29). It is also di cult to safeguard public health safety in traditional medicines where tools for enforcement of laws are not available.…”