Adverse Drug Reaction Definition And Process
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.
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
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