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Make Healthcare Safer...Report an Adverse Reaction
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Frequently Asked Questions
- What is considered a "natural medicine"?
- What is an adverse event?
- Should all side effects related to natural medicines be reported?
- What happens after I submit a report?
- How is my personal information protected?
1. What is considered a "natural medicine"?
A natural medicine is an herb, extract, vitamin, mineral, dietary supplement, tea, medicinal food, or other natural product used for health.
2. What is an adverse event?
An adverse event is any event resulting in an unwanted or untoward outcome or side effect.
Adverse events include any side effect that causes discomfort,
illness, hospitalization, or other negative outcome.
3. Should all side effects related to natural medicines be reported?
Any type of side effect or adverse event related to a natural medicine can and should be
reported ranging from side effects that cause minor discomfort to those causing more serious adverse outcomes.
4. What happens after I submit a report?
Once a report is submitted to Natural Medicines Watch it is stored on a secure server with other adverse event data.
Selected researchers may be provided with access to de-identified data for specific research studies.
These studies are designed to identify potential safety issues related to therapeutic and diagnostic products and procedures.
No patient names or any other personal information about any patient is ever released or shared.
All research is done using data that is de-identified and does not include any patient name to prevent disclosure of any personal information.
Additionally, reports will be forwarded to the appropriate regulatory agency.
For example, reports originating from the United States submitted through Natural Medicines Watch are submitted to the US Food and Drug Administration (FDA).
Reports originating in countries other than the United States may be submitted to the appropriate health regulatory agency of that respective country,
if that country is participating in the Natural Medicines Watch program. Like the Natural Medicines Watch program,
these regulatory agencies monitor adverse event reports to identify potential problems.
By analyzing trends and specific data, Natural Medicines Watch, researchers and regulatory agencies are able to recognize specific safety
issues and make appropriate communications to health professionals, consumers and manufacturers.
5. How is my personal information protected?
The information collected through Natural Medicines Watch is used only for medical and public health research purposes.
The information will never be used for any marketing purpose whatsoever.
Many steps are taken to protect your information.
Only the information that you agree to provide in the Natural Medicines Watch adverse event reporting form is collected.
No other information provided on the Natural Medicines Watch website is tracked or included in the report.
Patient identifying information is not required and should not be included.
When your report is submitted, your information and all data are transmitted in a secure fashion.
Information is submitted to a protected database over secure connections. Reports forwarded to regulatory agencies,
such as the US Food and Drug Administration, are also submitted over secure connections.
When used for research purposes, all reports used are de-identified to prevent disclosure of any personal information.
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