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AL MPJE: Pharmacy Operations, Personnel, and Quality Assurance

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Pharmacy Operations, Personnel, and Quality Assurance

The pharmacist-in-charge owns the operation

Alabama requires each pharmacy to have a PIC responsible for compliance, personnel supervision, records, security, and quality. Operations include staffing and workflow that allow unhurried verification; written policies and procedures; training and competency assessment for technicians and interns; equipment maintenance and calibration; and a clean, secure, properly permitted physical plant.

Quality assurance means a continuous quality improvement program that captures medication errors and near misses, analyzes root causes, and implements change without punishing reporting. Error-prevention tools: separation of look-alike/sound-alike products, barcode verification, independent double checks, tall-man lettering, and counseling as a final check. Document interventions.

Other duties: managing shortages and recalls, REMS compliance, current references and labeling, prescription-file confidentiality consistent with HIPAA and Alabama law, complaint handling, and reporting theft or loss. Changes in ownership, location, or PIC require Board notification; closure requires inventory and records disposition.

Traps: treating QA as a binder rather than a running process; failing to document a PIC change; assuming HIPAA permits any disclosure to law enforcement when state law may be stricter; letting technicians work without active supervision; keeping records unavailable for inspection.

Rule of thumb: if it is not written, trained, and documented, it did not happen - and the PIC is accountable.