Be Audit Ready! Clinical Notes and Annotations: What Documentation is Essential for Audit?

• Date (and preferably time)
• Name and title of who you spoke with (some PBMs do not accept “per MD” or “per nurse”)
• The details of the clarification/conversation
• Your name or initials

This documentation should either be noted directly on the prescription or within your dispensing software. For clinical notes on controlled substance prescriptions received electronically, the clinical note must be made and retained electronically per 21 CFR 1311.200(f). Any notations made must be visible to the auditor at the time of audit.

Clarifications to a prescription should be made prior to dispensing. PAAS National^® has seen clinical notes invalidated when the pharmacy prints an image of a prescription for audit that shows the printed date, then proceeds to hand-write a clinical note on the prescription with a date prior to the printed date of that prescription. The auditor assumes the pharmacy “made up” the clinical note after the audit notice was issued and will expect the pharmacy to prove the clinical note was valid on appeal.

PAAS Tips:

• Remember to always document the When, Who You Spoke With, What Was Discussed, and Who Documented elements of a clinical note
  • A custom ink stamp containing these elements may be made to help ensure pharmacy staff documentation is complete
• Documentation should be included on the original prescription or electronically
• Documentation should be visible to the auditor at the time of audit
• Any notations made on previous prescriptions that are still valid should be carried forward to the new prescription
• Submission clarification codes and Drug Utilization Reviews must be clearly documented with details to support the override given
• Professional service code “M0” requires consultation with the prescriber and documentation to support the conversation
• If the patient directions are clarified, ensure the patient label is updated prior to dispensing to reflect the new directions
• Verbal clarifications do not change the origin code of the prescription
• See our March 2021 Newsline article, Are You Documenting DUR and Submission Clarification Codes?
• See our October 2021 Newsline article, Prescriber Statements Requested to Validate Incomplete Clinical Notes