The Need for Clarification on Prescription Labels
Pharmacy staff frequently receive prescriptions from prescribers that lack (or are missing) complete quantities or instructions for use. Clarifying these details before dispensing can help prevent audit discrepancies. Pharmacies must document these clarifications made with the prescriber’s office utilizing a clinical note that contains all four essential elements:
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- Date/time of clarification
- Name and title of who you spoke with
- What information was clarified
- 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
I attended Madison College in nearby Madison, WI (PAAS headquarters are in the Madison suburb of Stoughton). Prior to coming to work at PAAS, I worked as a Certified Pharmacy Technician in a retail setting for 25+ years. Pharmacy has been my life’s work.
Helping our members have a successful audit experience is very rewarding. Celebrating with them, when PAAS often helps generate positive post-audit results, is the best part of my work.
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