VigiCarib Reporting Form - Confidential v2

Welcome

Welcome! Please fill out and submit this form to report either a (i) Suspected Adverse Medicine (Drug) Reaction, or a (ii) Quality Issue for suspected substandard, unregistered/unlicensed or falsified (SF) medical products to the CARPHA VigiCarib network. For biologics and suspected SF products, the brand or trade name and the manufacturer's name are needed. Patient details are not required for quality issues unless an adverse reaction has occurred. The submission of a report DOES NOT constitute an admission that health personnel caused or contributed to the adverse reaction or quality problem. For further information or assistance, contact us at vigicarib@carpha.org.

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Caribbean Network for Pharmacovigilance / Post-marketing Surveillance: VigiCaribComplete this form as best as possible. Patient and reaction details are not required for SF reports.
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Today's DateThis field will automatically populate. Format mm/dd/yyyy
Date
Month
Day
Year
Date
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Type of Report* This field is requiredPlease indicate if this is a report of an adverse medicine/ drug reaction or a quality issue with a medical product
Adverse Medicine (Drug) Reaction (AMR/ADR)
Substandard / Falsified / Unregistered (SF) medical product
Therapeutic Failure
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Name(s) of Medicine - strength - formulation* This field is requiredInternational Nonproprietary Name (generic) required; Brand name if available
E.g. acetaminophen (Tylenol)
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Manufacturer name* This field is requiredRequired for substandard / falsified product reports. For adverse reaction reports where this is unknown, enter 'UNK'
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Batch or Lot Number - Expiry Date* This field is requiredRequired for SF reports. For adverse reaction reports, if unknown enter 'UNK'
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Description of Adverse Reaction or Product Quality Issue* This field is required
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Patient Initials (& Record number, if available)* This field is requiredRequired for adverse reaction reports. Insert 'NIL' if reporting a SF product with no patient involvement.
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Patient Sex* This field is required
Female
Male
Not given
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Patient Age or Date of Birth* This field is requiredFor age, include units (e.g. wks, mo, mths, yrs). If SF report, enter 'NIL'
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Weight (kg)Numbers only
To convert from pounds (lbs) to kilograms, multiply by 0.4536
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Height (cm)Numbers only
To convert from inches to centimeters, multiply by 2.54
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Medicine Dosage - Frequency - Route
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Indication
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Start DateDate medicine was started. Leave blank if unknown
Date
Month
Day
Year
Date
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Stop DateDate medicine was stopped. Leave blank if unknown
Date
Month
Day
Year
Date
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Other Medicines used within 3 months of reported medicineName, Dosing regimen, Start/stop dates, Indication
Enter as much information as possible based on availability
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Reaction Onset DateDate adverse reaction started
Date
Month
Day
Year
Date
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Reaction End DateDate adverse reaction stopped
Date
Month
Day
Year
Date
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Was Treatment Given (AMR) or Action Taken (SF)?
Yes
No
Don't know
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If treatment was given (AMR), or action taken (SF product), briefly describe here:
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Seriousness of Adverse ReactionTick all that apply
Caused or prolonged hospitalization
Life-threatening
Congenital anomaly
Persistent disability or incapacity
Death (provide date in next block)
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If patient died, please indicate date of death
Date
Month
Day
Year
Date
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Outcome of Adverse Reaction
Fatal
Not Recovered
Recovering
Recovered (provide date below)
Unknown
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If patient recovered, please provide the Recovery Date
Date
Month
Day
Year
Date
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Did event subside after stopping the medicine or reducing dosage?Dechallenge
Yes
No
Unknown
Not Applicable (medicine continued)
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Did event reappear after reintroducing the medicine or dosage?Rechallenge
Yes
No
Unknown
Not applicable (not reintroduced)
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Other Relevant InformationE.g. medical history, additional narrative, pregnancy, lab results, allergies; action taken, sampling
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Please insert any photos of the SF product and/or label that you are reporting
Drag and drop files here
Select files to upload
Max. file size: 10.6MB
Browse Files
Cancelof
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Reporter Initials* This field is requiredReporter information will only be used by local centres to follow-up / verify information if needed. Reporters may request anonymity by contacting VigiCarib.
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Profession or RoleFor verification purposes, if needed, and data analyses
Focal point
Nurse
Pharmacist
Physician
Other health professional
Patient / caregiver
Other
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Health Institution* This field is requiredFor verification purposes, if needed and data analyses
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Country* This field is required
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For additional information, we ask that you provide a contact (name & email or phone)Contact information will be kept confidential and will not be shared with unauthorized persons or agencies
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Local Record NumberTo be completed by focal point or designee within national centre, where applicable
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Should be Empty: