The Spontaneous reporting structure is the voluntary and the most common way through which the regulatory bodies collect ADR information for medicines once they are on the market.

ADR reporting is an important aspect of an efficient and effective pharmacovigilance program. Although Medwatch, Yellow Card, CDSCO form, etc. are the protocol forms of ADR collection and reports, a number of countries design and use their respective ADR forms.

Patient initials, age at onset of reaction, reaction term(s), date of onset of reaction, suspected medication(s) & reporter information.

Use one of the methods below to submit voluntary adverse event reports to the FDA: Report Online. Consumer Reporting Form FDA 3500B. ... Call FDA at 1-800-FDA-1088 to report by telephone. Reporting Form FDA 3500 commonly used by health professionals.

You can usually report side effects by filling in a form online or from your doctor or local pharmacy. For more details, and to report online, please check the website of your national authority (use these links to ensure you are reporting to the appropriate website).

Following are the mandatory fields for a valid case report: Suspected Adverse Reaction: Description of the reaction (reaction terms), reaction date. Suspected Medication(s): Name (brand/generic) of the medication. Reporter Details: Name, address, contact details, qualification, and date of the report.

The ADR reporting forms are completed by our inpatient nurses immediately after an unwanted drug reaction has been detected.