Pharmacy Operations, Recordkeeping, and Quality Assurance
Records and security
Pharmacies must maintain prescription records, controlled substance records, purchasing records, inventories, and compounding records, and make them available to the Board and DEA. Federal controlled substance records are generally kept for two years; follow the longer applicable state retention period. Schedule II drugs require biennial inventory (or more often if required) and accurate receiving and dispensing records. Theft or significant loss must be reported to DEA and the Board as required. Prescription files must be readily retrievable and preserve refill and transfer information.
Quality assurance
A quality program should include error detection and prevention, root-cause analysis, workflow checks, staff training, and periodic audits. Continuous quality improvement (CQI) programs are expected, and errors should be documented and reviewed without discouraging reporting. Security includes restricted access, alarm systems, and controlled substance storage. Recalls must be handled promptly, with quarantining and patient notification when necessary.
Traps
Questions test retention periods, inventory frequency, and reporting duties. A common error is assuming that only paper records count, or that a loss need not be reported because it was small. Another trap is failing to document a recall or an override in the CQI process.
Worked example
A technician discovers 10 tablets of a Schedule II drug missing. Secure the area, recount, review records, and report the loss per DEA and Board requirements; document corrective action. Rule of thumb: if a controlled substance cannot be accounted for, investigate and report; do not adjust inventory without a record.