Hospice Morphine Partial Fill and the 60-Day Window
On February 10, a hospice nurse brings a prescription to a Montana pharmacy for morphine sulfate oral solution 20 mg/mL, 120 mL, sig "1 mL every 4 hours as needed for pain." The prescription is dated January 3 and was written by the hospice medical director. The patient is a 72-year-old woman with metastatic pancreatic cancer enrolled in hospice at home. The pharmacy currently has only 40 mL in stock. The nurse explains that the patient cannot afford to pay for the full 120 mL at once and asks the pharmacist to dispense 40 mL now and the rest when the patient's daughter gets paid next week. The prescriber is reachable by phone. The pharmacy's wholesaler delivery is scheduled for February 14. The patient has no history of opioid misuse, and the hospice program has a written pain protocol on file.
1. May the pharmacist partially fill this Schedule II prescription? Identify the applicable federal rule and any Montana requirement.
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Yes. Under 21 CFR 1306.22, a pharmacist may partially fill a Schedule II prescription at the request of the patient or the prescriber. The general rule is that the remainder must be dispensed within 30 days of the date the prescription was written. There is a longer window for a patient who is terminally ill or who is in a long-term care facility: the remainder may be dispensed up to 60 days from the date of issue. This patient is enrolled in hospice with metastatic cancer, so she qualifies as terminally ill. Montana's Board rules adopt the federal controlled-substance requirements, so the 60-day window applies. The pharmacist should confirm the hospice status-the nurse's statement and the prescription's hospice notation are enough if consistent-and should not treat the request as an ordinary 30-day partial fill. The partial fill is not a refill and does not create a new prescription.
2. Calculate the last date the remainder may be dispensed and explain the documentation required.
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The prescription is dated January 3. Count 60 days from the date written; in a non-leap year the 60th day is March 4. The pharmacist should record on the prescription: the date of the partial fill, the quantity dispensed (40 mL), the quantity remaining (80 mL), the pharmacist's initials, and the fact that the patient is terminally ill. On the final fill, note "remainder of 60-day terminal-illness partial fill." If the remainder is not dispensed by the deadline, the pharmacist cannot dispense it on that prescription; a new prescription is required. The pharmacist should not use the February 14 wholesaler delivery as an automatic extension if it falls after the deadline, although here it does not. The partial fill must be documented in the pharmacy's controlled-substance records and must be retrievable for inspection.
3. How would the analysis change if the patient were not terminally ill and the pharmacy simply lacked stock?
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If the patient were not terminally ill and was not in a long-term care facility, the 60-day window would not apply. If the pharmacy simply lacked stock, 21 CFR 1306.22(a) permits a partial fill when the pharmacist is unable to supply the full quantity, but the remainder must be supplied within 72 hours. If the patient requested the partial fill for financial reasons, the remainder must be supplied within 30 days of the date written. The pharmacist should not use the 72-hour "out of stock" rule as an excuse to extend a patient-requested partial fill, and should document which basis applies. If the remainder is not supplied within the applicable period, the prescription expires and a new prescription is needed. The pharmacist should also consider whether a different strength or package size could avoid a partial fill altogether.