The CII That Arrived Without a Diagnosis Code
A community pharmacy in Sacramento receives a faxed prescription for oxycodone 30 mg, #120, one tablet every 8 hours as needed for pain, written by a physician in Nevada. The prescription is dated today and contains the patient's name, address, drug, strength, quantity, directions, prescriber's name, DEA number, and signature, but no diagnosis or ICD-10 code. The patient arrives the same afternoon and asks to pay cash because he does not want to use insurance. The pharmacist also notices the patient received a similar quantity of oxycodone 30 mg from a different prescriber 11 days ago at the same pharmacy and paid cash then too. The prescriber's office confirms the prescription is authentic when called.
1. Is the prescription valid on its face under California law, and what must the pharmacist do about the missing diagnosis?
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The prescription is valid on its face for federal and California purposes: it contains all required elements for a Schedule II prescription (patient name and address, drug, strength, quantity, directions, prescriber name, DEA number, and signature). California does not require a diagnosis code as a condition of validity for a CII prescription.
However, California law requires a pharmacist to exercise corresponding responsibility and to resolve red flags before dispensing. The missing diagnosis is not automatically disqualifying, but combined with the other facts it is a red flag the pharmacist must resolve. The pharmacist should contact the prescriber, document the conversation, and confirm the medical purpose and expected duration. If the prescriber cannot provide a satisfactory explanation, the pharmacist should decline to fill.
2. The pharmacist decides the cash payment and the recent fill from another prescriber are concerning. What are the pharmacist's obligations, and what is the legal basis for refusing to fill?
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The pharmacist has a professional and legal duty to resolve red flags before dispensing a controlled substance. The relevant concerns are: (1) cash payment for a high-strength CII, (2) a recent fill of the same drug from a different prescriber, and (3) no documented diagnosis. Under California law and DEA corresponding responsibility, the pharmacist may refuse to fill if the red flags cannot be resolved, and the pharmacist is not required to dispense a prescription the pharmacist believes is not for a legitimate medical purpose.
The pharmacist should: check CURES for the patient's controlled-substance history; contact the prescriber to discuss the overlapping prescriptions and confirm the medical need; document all findings and the decision; and, if the pharmacist still cannot resolve the concerns, decline to fill and inform the patient without accusation. The pharmacist should not simply fill because the prescription is technically valid.
3. If the pharmacist refuses to fill, what are the pharmacist's obligations regarding the prescription and the patient's records?
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The pharmacist should return the original prescription to the patient (or, if the patient prefers, keep it on file with a notation) and document the refusal, the reasons, the CURES review, and any prescriber contact in the patient's profile. The pharmacist should not alter the prescription. The pharmacist should treat the patient respectfully and explain that the pharmacist cannot fill it at this time. If the pharmacist suspects diversion or forgery, the pharmacist may report to the appropriate authorities, but a good-faith refusal to fill is not itself a reportable event. The pharmacist should also consider whether the patient needs a referral for pain management or a substance-use evaluation.