Emergency Oral Schedule II and the Missing Follow-Up Prescription
At 8:45 p.m. on a Saturday, a dentist calls a Montana pharmacy and gives an oral prescription for hydrocodone/acetaminophen 5/325 mg, quantity 20, for a patient with an acute periapical abscess. The dentist says the patient cannot reach the office until Monday and promises to send a written prescription then. The pharmacist verifies the dentist's DEA registration, confirms the patient's identity, and dispenses 20 tablets that evening. The pharmacist reduces the oral prescription to writing and files it. Monday passes with no written prescription; Tuesday and Wednesday also pass. On the following Saturday, the pharmacist reviews the file and realizes the written prescription has not arrived. The pharmacist has made one documented call to the dentist's office on Tuesday and left a message. The patient has not requested a refill.
1. Was the pharmacist legally permitted to dispense a Schedule II drug on an oral prescription? Explain the conditions.
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Yes, if the emergency exception is satisfied. Under 21 CFR 1306.11(d), a pharmacist may dispense a Schedule II controlled substance pursuant to an oral prescription in a bona fide emergency. The quantity must be limited to the amount needed to treat the patient during the emergency period; the pharmacist must reduce the oral prescription to writing immediately; and the prescriber must deliver a written or electronic prescription to the pharmacy within 7 days. The dentist's call described an acute abscess, an emergency dental condition, and the quantity of 20 tablets is consistent with a short-term supply. The pharmacist verified the dentist's DEA registration and the patient's identity, which supports the emergency finding. The pharmacist should document the emergency, the date and time of the call, the prescriber's name and DEA number, the quantity, and the fact that the prescriber promised to send a written prescription.
2. What must the pharmacist do now that seven days have passed without the written or electronic prescription?
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If the written or electronic prescription is not received within 7 days, the pharmacist must notify the DEA field office and document the notification. The regulation requires the pharmacist to notify the local DEA office; the pharmacist should also check Montana Board requirements for reporting a prescriber's failure to follow the CII rules. The pharmacist should not simply keep the oral order on file as though it were a valid prescription, and should not dispense more on the same authorization. The pharmacist should continue to document attempts to reach the prescriber and the date the 7-day period expired. The patient should be advised to contact the prescriber or seek care elsewhere if more medication is needed; a new prescription would be required.
3. Could the pharmacist dispense another 20 tablets on the same oral authorization if the patient calls?
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No. A Schedule II prescription cannot be refilled. The emergency oral authorization covered only the emergency period and the quantity dispensed. If the patient needs more hydrocodone/acetaminophen, the dentist must issue a new prescription, and the pharmacist must independently determine that it is valid and issued for a legitimate medical purpose. The pharmacist cannot use the original oral call as a standing authorization, and cannot dispense a second 20 tablets on a verbal "okay" from the dentist unless the new oral order itself qualifies as a new emergency. At that point the 7-day written follow-up would apply again. The pharmacist should also assess whether the patient needs urgent dental care rather than another opioid supply.