This form is intended for use by health professionals, representatives of market authorisation holders, and country focal points to submit case reports of suspected adverse drug reactions, or reports of substandard / falsified /unregistered medical products identified in CARPHA Member States. However, since patients or caregivers may want to use this form, we encourage them to consult with a physician or pharmacist before completing it.
If there are multiple suspected medicines, please complete a form for each one, and in the case narrative, you may simply refer to the first form submitted.
Reports from persons outside of the Ministy of Health will be forwarded to the focal points accordingly. Based on the seriousness of the reaction or the threat to public health, the national regulatory authorities will follow up with the reporter as needed. All reports are considered 'preliminary' or 'unconfirmed' until the national authority conducts its verification or investigation of the case.
For suspected adverse drug reactions, we understand that you may not have all the details at the time of making the report, but the most important details we need are:
- a way to identify the patient (e.g. initials, alias),
- the age and sex of the patient,
- a description of the reaction,
- the name of the medicine (include brand name only if the actual brand is suspected),
- the date the medicine was used,
- the date the reaction started
- your name and contact as the reporter, and
- the country where the medicine or product was used.
Of course, if you have more details, like other medicines taken recently, or if the person has recovered, please include them. Where you do not have the information for a field, you can state 'not available' or skip to the next field.
For substandard / falsified medical products, please include the brand name, the lot / batch number, and the name of the manufacturer. You may take a photo of the product label for reference.
Questions about this form may be sent to email@example.com.