Adverse Drug Reaction Definition And Process

POLICY:
 
An Adverse Drug Reaction (ADR) is defined as a detrimental 
response to a medication which is undesired, unintended or 
unexpected in doses accepted as the community standard and 
that results in a complication of the disease state or drug 
discontinuation, a change of therapy (including dosage 
reduction), or initiation of supportive treatment.
 
PROCEDURE:
 
The physician is immediately notified of the adverse drug 
reaction by the clinical staff.  The reaction is documented 
on the patient's chart and an incident report is completed.  
There will be verification that the medication that was 
administered was the correct medication based on the order 
and product label; given via the correct route, correct dose 
and proper time.  The medication was stable based on visual 
examination for particulates or discoloration and the 
medication had not expired.  
 
The ordering physician, when available or other senior 
clinical staff will discuss the adverse reaction with the 
patient and when appropriate the patient's family.
 
The adverse drug reaction will be tracked and trended 
utilizing the sequella monitoring record.  
 
Every adverse drug reaction is reviewed by the Medical 
Director and clinical staff; following their review, the 
matter will be turned over to the Safety Committee.  The 
Committee will identify opportunities for improvement and 
make recommendations pertaining to continuing education for 


 
all levels of the facility staff involved with drug delivery.
 
Any adverse drug reaction meeting the following criteria will 
be reported to the FDA:
 
1.  Reaction directly or indirectly led to the death of a
    patient, or was life threatening or permanently 
    disabling;
 
2.  Reaction was attributed to an investigational drug;
 
3.  Reaction was not listed in the package insert; or
 
4.  Suspected drug causing the reaction has been on the
    market for less than two years.
 
If the adverse drug reaction was due to a prescribing error, 
this will become part of the providers peer review process 
for the quarter in which it occurred.
 
Approved By Governing Board    
MP.10    
Control #253.4
GUPTA GASTRO