VigiCarib Reporting Form

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.

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

DayMonthYear

Type of Report*

ADR: Suspected Adverse Drug ReactionSFU: 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; 5mg/mL

Manufacturer name*

Batch / Lot Number, if available

Expiry Date, if available (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 at time of event (number only)

Age unit

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

DayMonthYear

Stop Date

DayMonthYear

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

Enter as much information as possible based on availability

Reaction Onset Date

DayMonthYear

Reaction End Date

DayMonthYear

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

DayMonthYear

If patient died, please indicate date of death

DayMonthYear

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

DayMonthYear

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, or QPPV

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*

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: Health Professionals, PV Officers