Pharmacy audit documentation checklist

Prescription records

• The original prescription, whether hard copy, fax, phone order or electronic prescription.
• Complete prescriber information as required for the claim.
• Documented clarifications: what was clarified, with whom, when, and by which staff member.
• Refill authorizations and the refill history for each prescription.
• Directions that support the days’ supply that was billed.

Dispensing and claims records

• Claims history showing the NDC, quantity, days’ supply and fill date for each claim.
• Records of reversals, with the reason for each one.
• The product selection (DAW) code used on each claim, and documentation supporting it where needed.
• Records showing which product, manufacturer and package size was actually dispensed.

Proof of pickup or delivery

• Signature logs or electronic signature records for pickups.
• Delivery manifests or signed delivery records.
• Shipping and tracking records for mailed prescriptions.

Purchase and inventory records

• Invoices from every wholesaler and secondary supplier for the full audit period.
• Credit memos and return records.
• Records of transfers to or from other pharmacies.
• Controlled substance records kept as the applicable requirements specify.

Pharmacy and staff records

On-site audits in particular may include questions about the pharmacy itself. Keep current licenses, permits and registrations, pharmacist and staff license information, and written policies and procedures where they can be produced quickly. Our guide on how to prepare for a PBM on-site audit covers the visit itself.

How to keep the checklist working

1. Name one person responsible for records and audit readiness.
2. File records so they can be found by prescription number and fill date.
3. Check the record retention requirements in your contracts and the rules that apply in your state, and keep records at least that long.
4. Spot-check a sample of recent claims on a regular schedule, using this checklist.
5. Reconcile purchases against dispensing for high-cost and frequently audited drugs, as explained in what is NDC reconciliation.
6. Fix gaps going forward. Never alter or backdate an existing record; if something needs correcting, add a dated note that explains the correction.

Frequently asked questions