Adverse Drug Events (ADEs)

Luv N. Pineda, RPh Faculty of Pharmacy University of Santo Tomas

ADEs
1) Adverse Drug Reaction 2) Medication Errors 3) Other Sentinel Events

Adverse Drug Reaction (ADR)

Any unexpected, unintended, or excessive response to a drug (but not blood or blood products) occurring at dose normally used in man.

Effects of ADR
Discontinuation of drug (therapeutic/diagnostic) Changing the drug therapy Modification of dose (except for minor dose adjustments) Admission to a hospital Prolonged hospitalization Supportive treatment Significant complication of diagnosis Results from drug interaction Birth defects Temporary or permanent harm, disability or death

Serious ADR
Drug reactions whereby the patient outcome is either/or:
Death Life-threatening (real risk or dying) Hospitalization (initial or prolonged) Disability (significant, persistent or permanent) Congenital anomaly Required intervention to prevent permanent impairment or damage

Reporting & Monitoring of ADR

Roles of PTC
Develops, promotes and maintains a program to monitor and report ADRs Maintains a database of reported non-serious and serious ADRs Investigates every reported SADR for its nature, probability and severity Enlists the continued support of health professionals (HP) in this program

Reporting & Monitoring of ADR

Regular monitoring by ALL HPs. Documentation by prescribing MD in patients chart (i.e., problem/physicians notes on DOS) Documentation by resident/fellow of SADRs Submission to the PTC within 24 hours after detection Quarterly report by PTC to ADR Monitoring Program of Philippine FDA.

PTC: Review & Evaluation of ADR Reports

Rationale
To differentiate between obvious medication errors, iatrogenic, and other causes To distinguish between serious and non-serious ADRs

Naranjo algorithm: determines validity of SADR Report Feedback: PTC and/or concerned HP to HC team, patient and family members

Medication Errors

Medication Errors
Any preventable event that may cause or lead to inappropriate medication use or patient harm, while the medication is in control of healthcare professionals or the patient.

Taxonomy of Medication Errors

(National Coordinating Council for Medication Error Reporting & Prevention)

1. 2. 3. 4. 5. 6. 7. 8.

Patient Information Medication Error Event Patient Outcome Product Information Personnel Involved Type of Medication Error Causes Contributing Factors

Category of Medication Errors

(National Coordinating Council for Medication Error Reporting & Prevention)

A Events that has the capacity to cause error. B An error occurred but it did not reach the patient (Near Miss). C An error occurred that reached the patient, but did not cause harm. D An error occurred that reached the patient, but requires monitoring or intention to preclude harm. E An error occurred that may have contributed to or resulted in temporary harm to the patient and required intervention. F An error occurred that may have contributed to or resulted in temporary harm to the patient and required initial or prolonged hospitalization. G An error occurred that may have contributed to or resulted in permanent patient harm. H An error occurred that required intervention necessary to sustain life. I An error occurred that may have contributed to or resulted in the patients death.

Types of Medication Errors

(National Coordinating Council for Medication Error Reporting & Prevention)

Dose of Omission Improper Dose (Overdose, Underdose, Extra Dose) Wrong Strength/Concentration Wrong Drug Wrong Dosage Form Wrong Technique Wrong Route of Administration Wrong Rate Wrong Duration Wrong Time Wrong Patient Monitoring Error (Interactions, Clinical Labs) Deteriorated Drug Error Others

Other Sentinel Events

Other Sentinel Events

Any adverse events experienced by the patient while he/she is on a medication, where the adverse event may or may not be related to the medication.

Thank You!