6.4 Emergency Dispensing: Oral Schedule II Orders & Schedule VI Emergency Supplies

Emergency Dispensing

Two quite different emergency mechanisms exist, and they are easy to confuse because both are called "emergency." One lets a pharmacist dispense a Schedule II drug on a prescriber's spoken word. The other lets a pharmacist dispense a Schedule VI drug when there is no prescriber to speak to at all.

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1. Oral Schedule II Prescriptions in an Emergency — 21 CFR 1306.11

When an emergency exists

All three conditions must be satisfied, and it is the dispensing pharmacist who determines that they are:

1. Immediate administration of the controlled substance is necessary for the proper treatment of the ultimate user;
2. No appropriate alternative treatment is available, including a non-Schedule II drug; and
3. It is not reasonably possible for the prescriber to provide a written or electronic prescription before dispensing.

What the pharmacist must do

• Limit the quantity to the amount adequate to treat the patient during the emergency period only. This is the operative restriction, and it is deliberately not expressed in days.
• Immediately reduce the oral order to writing, containing every element required of a Schedule II prescription except the prescriber's signature.
• Make a reasonable effort to verify the prescriber's identity where the prescriber is not known — for example by calling back on a number obtained from a directory or the practitioner's registry entry, rather than a number supplied by the caller.

The seven-day follow-up

Within seven days after authorising an emergency oral prescription, the prescribing practitioner must deliver a written or electronic prescription to the dispensing pharmacy. It must:

• bear on its face the words "Authorization for Emergency Dispensing"; and
• state the date of the oral order.

The pharmacist attaches it to the oral-order record already reduced to writing.

[!CAUTION] The pharmacist has a mandatory duty when it does not arrive. If the follow-up prescription is not delivered within seven days, the pharmacist must notify the nearest office of the Drug Enforcement Administration. Failure to do so voids the authority to dispense without a written or electronic prescription, and renders the pharmacist subject to the ordinary penalties for dispensing a Schedule II without a valid prescription.

[!IMPORTANT] Do not embroider the notification duty. The federal rule names the DEA. A Massachusetts pharmacist will in practice also be dealing with the Board and the DPH Drug Control Program if the incident reveals a broader problem, but the specific consequence written into 21 CFR 1306.11 for a missing follow-up prescription is notification of the nearest DEA office.

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2. Emergency Supply of a Schedule VI Drug — 247 CMR 9.04(12)

This is the provision that answers the Saturday-afternoon problem: a chronic maintenance medicine has run out, the prescription has expired or has no refills, and the prescribing office is closed.

Under 247 CMR 9.04(12), where a Schedule VI prescription has expired or has no remaining refills and the pharmacist is unable to obtain prescriber authorisation in a timely manner, the pharmacist in his or her professional judgement may dispense a quantity not to exceed 14 days or the smallest available unit-of-use packaging.

[!WARNING] 14 days, not 72 hours and not 30 days. Both of those figures circulate in secondary material about Massachusetts and neither is what 247 CMR 9.04(12) says. Note also the unit-of-use alternative: for an inhaler, an insulin pen or an ophthalmic bottle, the smallest available package is the measure, because those products cannot be split into a 14-day quantity.

There is no controlled substance equivalent

The 247 CMR 9.04(12) authority reaches Schedule VI only. A pharmacist faced with an expired Schedule II, III, IV or V prescription and an unreachable prescriber has no state emergency-refill authority — the options are the federal emergency oral prescription route (which requires an actual prescriber on the telephone) or waiting for the prescriber.

Good practice around an emergency supply

Document in the pharmacy system: the reason the prescriber could not be reached, the attempts made, the clinical basis for continuing therapy, the quantity supplied, and the notification sent to the prescriber as soon as practicable.

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Comparing the Two Mechanisms

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Worked Traps

• A hospice physician telephones an oral order for a 30-day supply of morphine solution. The quantity is wrong. An emergency oral Schedule II order is limited to the amount needed for the emergency period, not a full course.
• The written follow-up arrives on day nine. It is late. The pharmacist's duty to notify the nearest DEA office arose at day seven.
• A patient's metformin prescription expired yesterday; the office is shut for a public holiday. 247 CMR 9.04(12) permits up to a 14-day supply in the pharmacist's professional judgement.
• The same patient's alprazolam prescription expired yesterday. No emergency supply authority exists for Schedule IV in Massachusetts.