Policy Name:
Adverse Drug Reactions
Approved Date:
Section:
Pharmacy
Review Date:
Policy #:
Revised Date:
Purpose:
To establish protocol
POLICY
Adverse drug reactions are unintended or untoward effect of medications or medication administration
techniques attributable to a medication which requires a change in the patient’s management. Adverse
drug reactions are reported immediately to the physician/practitioner on discovery and recorded in the
patient record. An Adverse Drug Reaction Report is completed and reviewed in Quality Assessment and
Performance Improvement committee.
Provide adverse drug reaction information for all medications utilized in the facility:
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Manufacturer’s literature
Reference texts
Current literature
Report suspected adverse drug reactions immediately:
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Stop the drug immediately, if possible.
Assess airway patency, level of consciousness, cardiac output and any other reactions, which may
contribute to death.
Notify the physician immediately of the type of drug, reaction and current status of the patient.
Document type and severity of reaction.
Monitor vital signs every five minutes until stable.
Notify Medical Director.
Prepare an incident report. Refer case to Consultant Pharmacist for review.
Present data to Quality Assessment and Performance Improvement Committee.
Notify the appropriate FDA regulatory agency, if warranted.
Carefully record in nurses’ notes:
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Time of reaction
Date of reaction
Patient status (symptoms, vital signs)
Indicated nursing follow-up
Complete an Adverse Drug Reaction Report (physician, nurse, or pharmacist). Include:
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Patient name
Patient age, sex, weight
Patient location at the time of reaction
Date and time of reaction
Date and time physician was notified
Drugs or other therapy administered as a result of the reaction
Patient symptoms during the reaction
Patient vital signs
Patient outcome
Drugs administered to the patient
Names of persons administering doses or observing and reporting the drug reaction
Contributing factor (reported allergy, surgery, etc.)
Maintain the adverse drug reaction file (not patient chart) in Clinical Director’s office:
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Send copy to the Administrator.
Review ADR reports at appropriate Center committee meetings.
Request recommendations, if applicable, from medical staff. The FDA or manufacturer will be
notified for any significant or unusual adverse reaction or if a trend develops, in accordance with
the ASHP-USP-FDA Drug Product Problem Reporting Program.