Assessment of suspected adverse drug reaction report

ASSESSMENT OF SUSPECTED ADVERSE DRUG REACTION REPORT

(To be filled out by Pharmacy)


Medication(s) suspected:
Date/Time reaction noted:
Date/Time drug administered:


Reaction first noted after drug was started.
Reaction ceased/diminished when drug stopped.
Reaction recurred when drug readministered.
Reaction is known to be associated with the drug.


Reports in the literature of reactions associated with the drug:



Classification of reaction:
Confirmed or definite - The reaction occurred or was noted after administering the drug (patient challenged), caused or deminished (patient improved) when the drug was stopped (patient rechallenged), and reacured when the drug was readministered (patient rechallenged). A known association of the reaxtion with the drug (eg. reports in the literature) supports this classification
Likely - Same as confirmed but the patient was not rechallenged
Possible - The reaction appeared to be due to the drug (eg. most other causes have been ruled out) and is known to be associated with the drug (i.e. the reaction is listed in the package insert or has been reported in the literature...
Unlikely or doubtful- There is reason to believe that another drug or cause is responsible for the reaction or there is no support for associating the reaction with the suspected drug.

Severity of reaction:
Serious - The reaction required immediate stoppage of the drug and initiation of supportive treatment ( i.e. generally life-threatening or harmful) or continued to death or disability
Moderate - The reaction required a significant reduction in dosage, required stoppage of the drug, or caused an extension of stay at the facility.
Negligible - The reaction required little or no treatment and no change in therapy, did not require stoppage of the drug, and did not extend the stay in the facility.


Factors associated with reaction:
Self medication   Error in administration Error in dosage Accidental Exposure
Drug mislabeled   Drug outdated Decomposition_of_drug Drug interaction
Unavoidable side effect   Intolerance Idiosyncrasy Allergy
Other 

Outcome of case:
No apparent harm Recovered  Still receiving treatment Increased langth of stay
Permanent disability Expired (not due to reaction)  Expired (due to reaction);
Alive with consequences 
Unknown (eg. discharged or transferred) 

Pharmacy and Therapeutics Action:
None required  Reason:
System changes  Explain:
Education  Explain:
Restriction  Explain:
Other  Explain:

Sent report to Mfr.: Yes  No  Date 
Sent report to FDA: Yes  No  Date 

Pharmacist:     Date:



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