Medication safety, pharmacovigilance and risk management: ADRs, errors, hygiene, cytotoxic safety
This domain tests whether you can distinguish an adverse drug reaction from a medication error, report each through the correct channel, and fix the system rather than the person.
Definitions that carry marks
An ADR is a noxious and unintended response to a drug, at normal doses; it may or may not be preventable. A medication error is a preventable failure in the treatment process, whether or not harm occurred; a near miss is an error intercepted before reaching the patient. Adverse events that are not drug-related are not ADRs.
Reporting channels
Serious and unexpected ADRs, suspected new signals, quality defects and counterfeit products go to Swissmedic's vigilance portal; internal and regional error reporting uses CIRS, which is anonymous, non-punitive and feeds local learning. Vaccination errors follow a separate pathway. Reports need drug, dose, timing, outcome, comedication and a causality assessment (WHO-UMC scale).
High-alert medication and error traps
Concentrated potassium chloride, insulin, heparin, opioids, chemotherapy and paediatric doses; look-alike/sound-alike packaging; decimal-point and unit errors (mg vs µg, mmol vs mg); infusion-pump programming; verbal orders. Controls: standard concentrations, double checks, barcode scanning, tall-man lettering, independent second calculation for cytotoxics.
Hygiene and cytotoxic safety
WHO five moments for hand hygiene, cleanroom behaviour, dedicated cytotoxic gowning with double gloves, closed system transfer devices, spill kits, patient excreta precautions for roughly 48–72 h after administration, and disposal as hazardous waste.
Risk management
Prospective tools (FMEA, risk matrix) versus retrospective tools (root cause analysis after a serious event); a just culture distinguishes system failure from reckless behaviour; safety climate surveys and audit close the loop.
Worked example
A 10-fold insulin overdose is discovered after administration. Immediate action: glucose monitoring, intravenous glucose, treat hypokalaemia, inform the patient. Then: ADR report to Swissmedic, CIRS entry, root cause analysis showing two insulin concentrations stored side by side, and corrective action - single concentration, segregated storage, barcode-verified administration, staff briefing. Blaming the nurse earns nothing.
Traps
- Labelling every ADR as preventable, or every error as an ADR.
- Using CIRS as a disciplinary tool - it destroys reporting.
- Confusing FMEA (prospective) with RCA (retrospective).
- Forgetting biological monitoring and safe waste handling in cytotoxic safety.