Traditional Chinese Herbal Medicine (TCHM)

Mild Adverse Event (AE) Database Reporting Tool

Reporting Information

Serious Adverse Event (SAE) FDA Reporting Guidelines: 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, must be used to report an SAE to the FDA.  

“The submission of a SAER is not construed as an admission that the dietary supplement product involved caused or even contributed to the adverse event. 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.”

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.

ADVERSE  EVENT  DEFINITIONS

according to: Dietary Supplement and Non-prescription Drug Consumer Protection Act PUBLIC LAW 109–462—DEC. 22, 2006

SERIOUS ADVERSE EVENT

The term ‘serious adverse event’ is an adverse event that:
—‘‘(A) results in—

  1. death;
  2. a life-threatening experience;
  3. inpatient hospitalization;
  4. a persistent or significant disability or incapacity;
  5. a congenital anomaly or birth defect; or

—‘‘(B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described under subparagraph (A).

ADVERSE EVENT

.—The term ‘adverse event’ means any health-related event associated with the use of a nonprescription drug that is adverse, including—

‘‘(A) an event occurring from an overdose of the drug, whether accidental or intentional;

‘‘(B) an event occurring from abuse of the drug;

‘‘(C) an event occurring from withdrawal from the drug;

‘‘(D) any failure of the expected pharmacological action of the drug.

References:

  1. FDA. Finding and Learning about Side Effects (adverse reactions)
  2. 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. J Evid Based Med. 2010 Feb;3(1):11-7. doi: 10.1111/j.1756-5391.2010.01056.x. PMID: 21349035.
  3. Chang, HH., Chiang, SY., Chen, PC. et al. A system for reporting and evaluating adverse drug reactions of herbal medicine in Taiwan from 1998 to 2016. Sci Rep 11, 21476 (2021). https://doi.org/10.1038/s41598-021-00704-w
  4. Chan, K.Zhang, H., and Lin, Z.-X. (2015An overview on adverse drug reactions to traditional Chinese medicines. Br J Clin Pharmacol80834– 843. doi: 10.1111/bcp.12598.
  5. Cheng CW, Bian ZX, Li YP, Moher D, Wu TX, Dagenais S, Li J, Li TQ. Transparently reporting adverse effects of traditional Chinese medicine interventions in randomized controlled trials. Zhong Xi Yi Jie He Xue Bao. 2008 Sep;6(9):881-6. doi: 10.3736/jcim20080901. PMID: 18782527.
  6. Hu J, Zhang H, Feng S, Ha Y, Wei C, Wang X, Zhang R, Li B. The safety of Chinese herbal medicine: a systematic review of adverse events in randomized controlled trials. Longhua Chin Med 2020;3:7.
  7. Bensoussan A, Myers SP, Carlton AL. Risks associated with the practice of traditional Chinese medicine: an Australian study. Arch Fam Med. 2000 Nov-Dec;9(10):1071-8. doi: 10.1001/archfami.9.10.1071. PMID: 11115210.
  8. Chiba T, Sato Y, Kobayashi E, Ide K, Yamada H, Umegaki K. Behaviors of consumers, physicians and pharmacists in response to adverse events associated with dietary supplement use. Nutr J. 2017 Mar 18;16(1):18. doi: 10.1186/s12937-017-0239-4. PMID: 28315635; PMCID: PMC5357328.
  9. Gardiner P, Sarma DN, Low Dog T, Barrett ML, Chavez ML, Ko R, Mahady GB, Marles RJ, Pellicore LS, Giancaspro GI. The state of dietary supplement adverse event reporting in the United States. Pharmacoepidemiol Drug Saf. 2008 Oct;17(10):962-70. doi: 10.1002/pds.1627. PMID: 18613260.
  10. Ide K, Yamada H, Kitagawa M, Kawasaki Y, Buno Y, Matsushita K, Kaji M, Fujimoto K, Waki M, Nakashima M, Umegaki K. Methods for estimating causal relationships of adverse events with dietary supplements. BMJ Open. 2015 Nov 25;5(11):e009038. doi: 10.1136/bmjopen-2015-009038. PMID: 26608636; PMCID: PMC4663420.
  11. Parida S. Clinical causality assessment for adverse drug reactionsIndian J Anaesth. 2013;57(3):325-326. doi:10.4103/0019-5049.115608
  12. Naranjo Algorithm – ADR Probability Scale
  13. WHO-UMC system for standardised case causality assessment
  14. Seger D, Barker K, McNaughton C. Misuse of the Naranjo Adverse Drug Reaction Probability Scale in toxicology. Clin Toxicol (Phila). 2013 Jul;51(6):461-6. doi: 10.3109/15563650.2013.811588. Epub 2013 Jun 18. PMID: 23777343; PMCID: PMC3887443.
  15. Chen J. Recognition and Prevention of Herb-Drug Interaction
  16. KPC. Do Chinese Herbs Have Side Effects?

AE Reporting Tool

This NON-reportable to FDA mild Adverse Events (AE) – reporting tool is intended for interprofessional data collection purposes.

3. Patient gender(Required)
4. Race(Required)
6. Adverse Reaction (AR) observed(Required)
13. Product acquisition source(Required)
21. Form of the preparation(Required)
I hereby agree that the data entered will be stored electronically, and will be processed and used for reference & research purposes. All Adverse Event data is HIPAA compliant and will not be used for any commercial reason.(Required)
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