• Adverse Drug Event includes all medication errors and adverse drug reactions.
• A Medication Error is any preventable event that may cause or lead to inappropriate medication use or patient harm.
• A Reportable Adverse Drug Reaction (ADR) is an unintended drug reaction that:
• Prolongs hospital stay
• Results in admission or an Emergency Department visit
• Causes the postponement or cancellation of surgery
• Is unlabeled or rarely seen
• Results in death or permanent disability
• Is potentially life-threatening.

Identifying an ADR

• Staffs who suspects an ADR notifies prescriber- physician or resident doctor immediately if the event is significant or may alter the patient’s plan of care.
• Assess the patient.
• Implement adjustments in the patient’s treatment as ordered.
• Document the description of the ADR in incident form and ADR form

Reporting an ADR

• Staff completes the Suspected Adverse Reaction Notification form immediately or not later than 24 hours of the ADR identification.
• Forms are sent, confidentially to the PTC chairman, at the earliest.
• Evaluate the reaction and document it in the Suspected Adverse Reaction Documentation form.

Reports to include

• Describe the error or preventable adverse drug reaction. What went wrong?
• Was this an actual medication accident (reached the patient) or are you expressing concern about a potential error or writing about an error that was discovered before it reached the patient?
• Patient outcome.
• Where in the hospital did this occur?
• Generic name of all products involved.
• Brand name of all products involved.
• Dosage form, concentration or strength, etc.
• Where error was based on communication problem, is a sample of the order available? Are samples or pictures available if requested?
• Please state your recommendations for error prevention.
• Please include the name and contact info of reporter.

Reviewing ADRs

• PTC Committee chairman completes a timely evaluation of the circumstances surrounding the event.
• A copy of the ADR form and incident report is sent to the quality department after verification by the PTC Committee chairman
• Root cause analysis.
• ADR reports are categorized by location, severity, product information and therapeutic classification, type, causes and contributing factors.
• ADR’s are further evaluated to determine:
• Appropriateness of medication for the patient’s condition
• Any contraindications to medication
• Appropriate documentation of Allergies
• Appropriate management and monitoring of ADR
• The P & T Committee reviews the monthly report, significant events, and results of root cause analysis and makes recommendations for improvements to the medication use process.
• The policies on medication administration are reviewed and changed based on the analysis of Adverse Drug Reactions.

Exceptions

Adverse reactions that occur following the administration of investigational drugs are reported according to the specific protocol for that drug by contacting the principal investigator.

References: National Coordinating Council for Medication Error Reporting and Prevention

Categories of adverse drug reactions

Category A An error occurred that may have the capacity to cause error No Error

Category B An Error occurred but the error did not reach the patient Error, but No Harm

Category C An Error occurred that reached the patient but did not cause patient harm Error, but No Harm

Category D An error occurred that reached the patient and required monitoring to confirm that it resulted in no harm to the patient and / or required intervention to preclude harm Error, but No Harm

Category E An Error occurred that may have contributed to or resulted in temporary harm to the patient and required intervention Error + Harm

Category F An error occurred that may have contributed to or resulted in temporary harm to the patient and required initial or prolonged hospitalization Error + Harm

Category G An error occurred that may have contributed to or resulted in permanent patient harm Error + Harm

Category H An error occurred that required intervention necessary to sustain life Error + Harm

Category I An error occurred that may have contributed to or resulted in the patient’s death Error + Death