| Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems.
The Erice declaration provides framework of values and practice for collection, analysis and subsequent communication of drug safety issues (www.who-umc.org)
Why adverse events to be reported even after completion of Clinical Trial ? : Clinical Trials are done in controlled settings and are not the correct representation of the entire population. The rare but significant adverse events are therefore left undetected in a small sample of patients in a Clinical Trial.
Medwatch Form : download the form
CIOMS Form : download the form
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<<<<<<<<<<< PHARMACOVIGILANCE >>>>>>>>>> |
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Products in Clinical Development |
Marketed Drugs/products |
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<<<<<<<<<<<<< ADVERSE EVENT >>>>>>>>>>> |
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Seriousness |
Expectedness |
Causality |
Intensity |
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Serious / non serious |
expected / unexpected |
Related /unrelated |
Mild / moderate /severe |
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Causality assessment methods: various methods can be adopted for causality assessment:
1.
Naranjo’s scale
2. Karch and Lasagna’s scale
3 WHO assessment scale
| Naranjo Algorithm for ADR Causality Assessment |
Yes |
No |
Don't Know |
| 1. Are there previous conclusive reports of this reaction? |
1 |
0 |
0 |
| 2. Did the adverse event appear after the suspect drug was administered? |
2 |
-1 |
0 |
| 3. Did the adverse reaction improve when the drug was discontinued? |
1 |
0 |
0 |
| 4. Did the adverse reaction reappear when the drug was readministered? |
2 |
-1 |
0 |
| 5. Are there alternate causes that on their own could have caused the reaction? |
-1 |
2 |
0 |
| 6. Did the reaction appear when a placebo was given? |
-1 |
1 |
0 |
| 7. Was the drug detected in the blood (or other fluids) in concentrations known to be toxic? |
1 |
0 |
0 |
| 8. Was the reaction more severe when the dose was increased or less severe when decreased? |
1 |
0 |
0 |
| 9. Did the patient have a similar reaction to the same or similar drugs in any previous exposure? |
1 |
0 |
0 |
| 10. Was the adverse event confirmed by any objective evidence? |
1 |
0 |
0 |
| Total score =
Interpretation of the Total Score
Total scores of 9 or more mean that an ADR is highly probable.
Scores from 5 to 8 mean that an ADR is probable.
Scores from 1 to 4 that an ADR is possible.
Scores of zero or less mean that an ADR is doubtful |
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Links :
http://en.wikipedia.org/wiki/Pharmacovigilance
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