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Causality_Assessment_Form

The Causality Assessment Form is designed to evaluate adverse drug reactions (ADRs) by collecting patient and event details, including drug information and medical history. It employs various causality assessment methodologies such as the WHO-UMC scale, Naranjo Algorithm, and Karch and Lasagna criteria to classify the relationship between the drug and the ADR. The form also includes sections for recommendations, follow-up actions, and reviewer comments to ensure thorough evaluation and documentation.

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12 views

Causality_Assessment_Form

The Causality Assessment Form is designed to evaluate adverse drug reactions (ADRs) by collecting patient and event details, including drug information and medical history. It employs various causality assessment methodologies such as the WHO-UMC scale, Naranjo Algorithm, and Karch and Lasagna criteria to classify the relationship between the drug and the ADR. The form also includes sections for recommendations, follow-up actions, and reviewer comments to ensure thorough evaluation and documentation.

Uploaded by

DADA TOLUWASE
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Causality Assessment Form

Adverse Drug Reaction (ADR) Report Number: [Insert Report Number]

Patient ID: [Insert Patient ID]

Date of Report: [Insert Date]

Medicinal Product(s) Involved: [Insert Product Name(s)]

Suspect Drug(s): [Insert Drug(s)]

Date of Onset of ADR: [Insert Date]

Date of Recovery (If Applicable): [Insert Date]

Gender: [Male/Female]

Age: [Insert Age]

Reporter Information: [Insert Name & Contact Information]

1. Adverse Event Details


Description of Adverse Event(s): [Provide a detailed description of the adverse event(s)
including symptoms, severity, and timeline.]

Other Relevant Medical History: [Insert information such as pre-existing conditions, co-
morbidities, or any other factors relevant to the assessment.]

Concomitant Medications: [List any other medications the patient is taking, along with
dosage and administration details.]

2. Causality Assessment Methodology


Select the causality assessment method used (tick as appropriate):

[ ] WHO-UMC Causality Assessment Scale

[ ] Naranjo Algorithm

[ ] Karch and Lasagna Criteria


3. Assessment Criteria

WHO-UMC Causality Assessment Scale


Certain: [ ] Yes [ ] No

Probable/Likely: [ ] Yes [ ] No

Possible: [ ] Yes [ ] No

Unlikely: [ ] Yes [ ] No

Unrelated: [ ] Yes [ ] No

Naranjo Algorithm
Complete the Naranjo Algorithm (Score each question from 0-2, with 2 being most
suggestive of a causal relationship).

Question 1: Was there an increase in the frequency of the adverse event after the suspected
drug was administered? [ ] Yes [ ] No [ ] Don’t Know

Question 2: Did the adverse event improve when the drug was discontinued or the dose was
reduced? [ ] Yes [ ] No [ ] Don’t Know

(Continue with all Naranjo questions as required)

Total Score: [Insert Total Score]

Interpretation of Score:

9 or more: Certain

5-8: Probable

1-4: Possible

0 or less: Unlikely

Karch and Lasagna Criteria


Criteria 1: There is a temporal relationship between the drug and the ADR [ ] Yes [ ] No

Criteria 2: The adverse event resolved upon discontinuation of the drug [ ] Yes [ ] No

Criteria 3: The reaction reappeared upon rechallenge with the drug [ ] Yes [ ] No

Criteria 4: The adverse event is known to be associated with the drug class or active
ingredient [ ] Yes [ ] No

(Continue with other criteria as required)


Conclusion: [ ] Certain [ ] Probable [ ] Possible [ ] Unlikely

4. Final Causality Classification


Based on the criteria used and the findings, select the final causality classification:

[ ] Certain

[ ] Probable/Likely

[ ] Possible

[ ] Unlikely

[ ] Unrelated

5. Supporting Evidence and Rationale


[Insert rationale and any supporting information.]

6. Recommendations and Follow-up Actions


Recommendations: [Insert recommendations such as further clinical evaluation, changes in
dosage, or discontinuation of the drug.]

Follow-up Actions: [Specify any follow-up actions, such as contacting the reporter for
additional information or notifying regulatory authorities.]

7. Medical Reviewer Comments


[Insert any additional comments from the medical reviewer, if applicable.]

8. Causality Assessor Information


Name of Assessor: [Insert Name]

Signature: [Insert Signature]

Date: [Insert Date]

9. Approval Section
Reviewed and Approved by: [Insert Name of Approving Personnel]

Signature: [Insert Signature]

Date: [Insert Date]

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