The Need for Clarification on Prescription Labels

1. Date/time of clarification
2. Name and title of who you spoke with
3. What information was clarified
4. Initials of pharmacy staff that made the call

This proactive approach not only enhances accuracy but also mitigates audit risk.

PBMs like OptumRx^® and Caremark^® are very particular that any clarification relating to instructions for use be included on the patient’s label. Auditors that determine information is missing from the patient label have flagged these as “misfilled” prescriptions – which can be very difficult to overturn. Pharmacy staff must be diligent in updating patient labels to include any supplemental instructions that were clarified.

Additionally, OptumRx^® has been flagging prescriptions that include a numeric value at the end of the instructions. Some e-prescribing systems will drop the days’ supply value at the end of the instructions for use (e.g., Take 1 tablet daily. 90). Auditors claim they cannot accurately calculate the days’ supply based off “unclear information included in the instructions”. As time consuming (and absurd) as it may seem, auditors will only be satisfied if the pharmacy took the time to contact the prescriber’s office to clarify the directions and remove the erroneous days’ supply number at the end of the directions.

PAAS National^® analysts frequently see the following items flagged on audit when the clarifying clinical note does not make it on the patient label:

• Max daily dose for insulin prescriptions with sliding scale or titration
• Area of use for topical medications or max number of grams per application
• Number of meals and snacks for pancreatic enzyme prescriptions

PAAS also sees issues where the backtag or label do not reflect the entire instructions for use due to an expanded sig and limit of characters being printed.

PAAS Tips:

• Ensure all staff know the four elements of a clinical notation
• Clarification of instructions for use MUST be reflected on the patient label
• Be sure clinical notations are included on the prescription, or electronic notations provided to the auditor for review
• Self-audit prescriptions frequently to ensure patient labels include supplemental information clarified