VigiCarib Reporting Form

This form is intended for health professionals, 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.

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.

The Caribbean Public Health Agency is committed to protecting your privacy and developing technology that gives you the most powerful and safe online experience. The information submitted here is subject to CARPHA privacy policy at: https://carpha.org/Privacy.

Questions about this form may be sent to vigicarib@carpha.org.

Today's Date

Day Month Year

Type of Report *

ADR: Suspected Adverse Drug Reaction SFU: Substandard / Falsified / Unregistered (SF) medical product

Non-proprietary name *

E.g. Acetaminophen

Brand name (where applicable)

E.g. Panadol

Dosage form *

Strength (include units)

E.g. 800mg

Anatomic-Therapeutic-Chemical Classification

Manufacturer name *

Batch / Lot Number and Expiry Date (mm-yyyy) *

Description of Adverse Reaction or Product Quality Issue and Sector *

Please indicate if the event or issue was identified in Public or Private sector; and where the product is usually distributed

Patient Initials *

If you are reporting a suspected SF product where a patient has been harmed, create a new report for the ADR and patient details.

Patient Sex *

Patient Age (in years) *

Age Group

Race / Ethnicity

Weight (kg)

To convert from pounds (lbs) to kilograms, multiply by 0.4536

Height (cm)

To convert from inches to centimeters, multiply by 2.54

Dosage Regimen of suspected medicine

Indication

Start Date

Day Month Year

Stop Date

Day Month Year

Other Medicines used within 3 months of reported medicine - indication for each

Enter as much information as possible based on availability

Reaction Onset Date

Day Month Year

Reaction End Date

Day Month Year

Was Treatment Given or Action Taken?

If treatment was given, or Action taken, briefly describe here:

Action may include contacting the manufacturer, product seizure, market suspension / withdrawal.

Seriousness of Adverse Reaction

Outcome of Adverse Reaction

If patient recovered, please provide the Recovery Date

Day Month Year

If patient died, please indicate date of death

Day Month Year

Did event subside after stopping the medicine or reducing dosage?

Did event reappear after reintroducing the medicine or dosage?

Other Relevant Information

Country where product was used or discovered *

Local Report Date

Day Month Year

Please insert any photos of the substandard / falsified / unregistered product, and its label

If only the packaging / label is available, please upload the photos here.

PV Record Number

Record number used by national or regional PV centre

Status of Case

SFU Category (primary)

Report has been submitted to:

Please indicate if the report has been submitted to any of the WHO international monitoring systems or the national regulatory authority.

Reporter Name or Alias *

Your Role

Institution or Company Name *

For additional information, we ask that you provide a contact (name & email or phone)

For VigiCarib staff: Record number

Format: CountryYear_### (ADR) or CountryYear_SF### (SFU) e.g. TTO2020_005, or TTO2020_SF002.

VigiCarib Reporting Form for suspected Adverse Drug Reactions or Substandard / Falsified / Unregistered Medical Products