Medication Safety and Quality
Systems, not scapegoats
Modern safety practice treats errors as system failures. Know the vocabulary: medication error, adverse drug event, near miss, root cause analysis, failure mode and effects analysis, and just culture. Exam answers that single out one employee for blame, while ignoring workflow and staffing, are usually wrong.
High-risk areas
High-alert medications (anticoagulants, insulin, opioids, concentrated electrolytes, chemotherapy), look-alike/sound-alike names, pediatric dosing, and sterile compounding. Controls include independent double checks, barcode verification, standardized concentrations, smart-pump libraries, segregation of look-alikes, and clear labeling.
External reporting - know the channel
FDA MedWatch handles adverse events and product problems (defects, packaging confusion). ISMP collects error reports nationally. The Board handles conduct and practice violations. Confusing these channels is a favorite trap: an adverse drug reaction is not automatically an error, and a product defect is not automatically a Board matter.
Recalls: a Class I recall means stop dispensing immediately, quarantine, and notify patients already served if the risk warrants.
Compounding quality
USP <797> governs sterile compounding (environment, garb, verification, beyond-use dates); <800> governs hazardous drugs; <795> governs nonsterile compounding. Documentation of competency and environmental monitoring is part of the standard.
Rule of thumb: when a question asks what to do first after an error, the answer is almost always protect the patient, then document and report - not assign blame.