Patient Safety, Medication Errors, and Quality Assurance
CQI requirement
Minnesota pharmacies must maintain a written continuous quality improvement (CQI) program for medication errors. The program should detect errors and near misses, document them, analyze causes, and implement system changes. The focus is system improvement rather than individual blame, which encourages reporting. Records are kept for quality review and produced to the Board on request.
Error handling
When an error reaches a patient, the pharmacist assesses harm, contacts the prescriber and patient as appropriate, provides follow-up, and documents the event. Errors that constitute a violation of law may require reporting to the Board. Near misses are still recorded because they reveal workflow risks.
Compounding standards
Nonsterile compounding follows USP <795>, sterile compounding follows USP <797>, and hazardous drugs follow USP <800>. Requirements include trained personnel, suitable facilities and environmental monitoring, master formulation records, compounding records, and beyond-use dates consistent with the applicable USP chapter. Sterile preparations require validated processes and, where required, end-product testing.
Worked example
A wrong-strength tablet is discovered at final verification before the patient leaves. The pharmacist documents it as a near miss, reviews look-alike/sound-alike storage, and changes labeling or shelf placement. Because no patient received the drug, no prescriber notification is needed, but the CQI record is required.
Traps
Treating CQI as a blame exercise; failing to record near misses; extending a beyond-use date beyond USP limits; compounding sterile products without environmental monitoring.