Traditional Chinese Herbal Medicine (TCHM)<\/p>\n
Mild Adverse Event (AE) Database Reporting Tool<\/p>\n<\/div><\/div>
Reporting Information<\/em><\/strong><\/h3>\n<\/div><\/div>Serious Adverse Event (SAE) FDA Reporting Guidelines:<\/strong> In the United States, SERIOUS adverse events must be reported to the FDA no later than 15 business days after the responsible person receives the report. New information concerning the AE received within one year of the initial report must also be submitted to the agency. The MedWatch form, Form 3500<\/span><\/a>, must be used to report an SAE to the FDA. \u00a0<\/em><\/strong><\/p>\n\u201cThe submission of a SAER is not construed as an admission that the dietary supplement product involved caused or even contributed to the adverse event.<\/em><\/strong> Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer or product caused or contributed to the event.”<\/em><\/strong><\/p>\nThe responsible party for submitting an adverse event report for a TCHM to the FDA is the manufacturer, packer, or distributor whose name appears on the label of a dietary supplement marketed in the United States. TCHM practitioners compounding and dispensing TCHM from their office are the responsible party for reporting AE.<\/p>\n<\/div><\/div>
ADVERSE\u00a0 EVENT\u00a0 DEFINITIONS<\/strong><\/h3>\naccording to: Dietary Supplement and Non-prescription Drug Consumer Protection Act<\/em> PUBLIC LAW 109\u2013462\u2014DEC. 22, 2006<\/p>\nSERIOUS ADVERSE EVENT<\/strong><\/p>\nThe term \u2018serious adverse event\u2019 is an adverse event that:
\n\u0097\u2018\u2018(A) results in\u2014<\/p>\n
\n- death;<\/li>\n
- a life-threatening experience;<\/li>\n
- inpatient hospitalization;<\/li>\n
- a persistent or significant disability or incapacity;<\/li>\n
- a congenital anomaly or birth defect; or<\/li>\n<\/ol>\n
\u0097\u2018\u2018(B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described under subparagraph (A).<\/p>\n<\/div><\/div>
To report to FDA click here<\/span><\/a><\/div><\/div>ADVERSE EVENT<\/strong><\/p>\n.\u2014The term \u2018adverse event\u2019 means any health-related event associated with the use of a nonprescription drug that is adverse, including\u2014<\/p>\n
\u2018\u2018(A) an event occurring from an overdose of the drug, whether accidental or intentional;<\/p>\n
\u2018\u2018(B) an event occurring from abuse of the drug;<\/p>\n
\u2018\u2018(C) an event occurring from withdrawal from the drug;<\/p>\n
\u2018\u2018(D) any failure of the expected pharmacological action of the drug.<\/p>\n<\/div><\/div>
To report use the form on the right<\/span><\/a><\/div><\/div>Click here to go to the below AE reports portal<\/a><\/span><\/p>\n<\/div><\/div><\/div><\/div><\/div>References:<\/p>\n
\n- FDA. Finding and Learning about Side Effects<\/strong><\/em> (adverse reactions)<\/span><\/a><\/li>\n
- Wu T, Shang H, Bian Z, Zhang J, Li T, Li Y, Zhang B. Recommendations for reporting adverse drug reactions and adverse events of traditional Chinese medicine<\/span>.<\/strong><\/em><\/a> J Evid Based Med. 2010 Feb;3(1):11-7. doi: 10.1111\/j.1756-5391.2010.01056.x. PMID: 21349035.<\/li>\n
- Chang, HH., Chiang, SY., Chen, PC.\u00a0et al.<\/i>\u00a0A system for reporting and evaluating adverse drug reactions of herbal medicine in Taiwan from 1998 to 2016.<\/span><\/strong><\/em><\/a>\u00a0Sci Rep<\/i>\u00a011,\u00a0<\/b>21476 (2021). https:\/\/doi.org\/10.1038\/s41598-021-00704-w<\/li>\n
Serious Adverse Event (SAE) FDA Reporting Guidelines:<\/strong> In the United States, SERIOUS adverse events must be reported to the FDA no later than 15 business days after the responsible person receives the report. New information concerning the AE received within one year of the initial report must also be submitted to the agency. The MedWatch form, Form 3500<\/span><\/a>, must be used to report an SAE to the FDA. \u00a0<\/em><\/strong><\/p>\n \u201cThe submission of a SAER is not construed as an admission that the dietary supplement product involved caused or even contributed to the adverse event.<\/em><\/strong> Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer or product caused or contributed to the event.”<\/em><\/strong><\/p>\n The responsible party for submitting an adverse event report for a TCHM to the FDA is the manufacturer, packer, or distributor whose name appears on the label of a dietary supplement marketed in the United States. TCHM practitioners compounding and dispensing TCHM from their office are the responsible party for reporting AE.<\/p>\n<\/div><\/div> according to: Dietary Supplement and Non-prescription Drug Consumer Protection Act<\/em> PUBLIC LAW 109\u2013462\u2014DEC. 22, 2006<\/p>\n SERIOUS ADVERSE EVENT<\/strong><\/p>\n The term \u2018serious adverse event\u2019 is an adverse event that: \u0097\u2018\u2018(B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described under subparagraph (A).<\/p>\n<\/div><\/div> ADVERSE EVENT<\/strong><\/p>\n .\u2014The term \u2018adverse event\u2019 means any health-related event associated with the use of a nonprescription drug that is adverse, including\u2014<\/p>\n \u2018\u2018(A) an event occurring from an overdose of the drug, whether accidental or intentional;<\/p>\n \u2018\u2018(B) an event occurring from abuse of the drug;<\/p>\n \u2018\u2018(C) an event occurring from withdrawal from the drug;<\/p>\n \u2018\u2018(D) any failure of the expected pharmacological action of the drug.<\/p>\n<\/div><\/div> Click here to go to the below AE reports portal<\/a><\/span><\/p>\n<\/div><\/div> References:<\/p>\nADVERSE\u00a0 EVENT\u00a0 DEFINITIONS<\/strong><\/h3>\n
\n\u0097\u2018\u2018(A) results in\u2014<\/p>\n\n
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