Mich. Admin. Code R. 338.590

Current through Vol. 24-21, December 1, 2024

Section R. 338.590 - Hospice emergency drug box

Rule 90.

(1) A pharmacy that establishes a medication box exchange program for hospice emergency care services rendered in patients' homes under section 17746 of the code, MCL 333.17746, shall establish drug boxes that comply with this rule. Before providing drug boxes for a hospice emergency care system, the pharmacist in charge shall ensure that the hospice has developed policies and procedures that require all of the following:

(a) Maintenance by the hospice of a drug box exchange log that accounts for the hospice's receipt of the boxes from the pharmacy, assignment of the boxes to registered nurses or physicians' assistants, and return of the boxes to the pharmacy for restocking.

(b) A procedure to ensure that the drug boxes are inspected not less than weekly to determine if they have expired or have been opened.

(c) Procedures for the storage and control of a drug box while it is assigned to, and being used by, the prescriber, a registered nurse, or a physician's assistant.

(d) A procedure for implementing the hospice medical director's responsibility for ensuring that prescriptions for drugs removed from the drug boxes are obtained from an appropriate prescriber.

(2) A pharmacy shall stock drug boxes for a hospice emergency care system in accordance with the policies and procedures developed by the hospice and approved by the hospice medical director.

(3) The drugs contained in each drug box must be listed inside the front cover of the box. Each box must be equipped with only 1 nonreusable, tamper-evident seal or sealing system that is a color that designates that the box has not been opened and several nonreusable, tamper-evident seals or sealing systems that are a different color that designates that the box has been opened.

(4) A drug box must be numbered. A permanent record of all drug boxes must be maintained at the pharmacy.

(5) A label that contains all of the following information must be attached to the drug box so that it is visible from the outside of the box:

(a) The name and address of the pharmacy.

(b) The name and address of the hospice.

(c) The name of the pharmacist who last inspected and restocked the drug box.

(d) The date the drug box was last restocked.

(e) The date the drug box must be returned to the pharmacy for the replacement of expired drugs.

(f) The number of the drug box.

(6) After the drug box has been stocked and labeled, the pharmacist shall seal it with the nonreusable, tamper-evident seal or sealing system that is the color that designates that the box has not been opened.

(7) A drug box must be maintained in a substantially constructed, securely locked storage compartment when not under the direct control of the pharmacist, prescriber, registered nurse, or physician's assistant. The box must be stored under conditions that maintain the stability, integrity, and effectiveness of the drugs. Access to the storage compartment and to the drug box must be limited to individuals who are authorized to stock the drug box or to dispense drugs from the drug box on the order of an appropriate prescriber.

(8) The drug box must remain sealed at all times, except when in use. All drugs removed from the box must be recorded on a medication use form. After completing the form, the physician, registered nurse, or physician's assistant who removed the drug must place the form in the drug box and seal the box with a nonreusable, tamper-evident seal or sealing system that is a color that designates that the box has been opened.

(9) Each drug box under the control of the pharmacy must be examined not less than weekly to ensure that the seal, which designates that the box has not been opened is still intact and the expiration date, has not been exceeded. If the expiration date has been exceeded or the box has been opened, the box must be returned to the pharmacy. The written prescription for all drugs that have been administered from the drug box must accompany the drug box when it is returned to the pharmacy after opening.

(10) The pharmacy shall maintain a permanent record of drug box exchanges on a drug box exchange log. The record must contain all of the following information:

(a) The number of the box.

(b) The name of the hospice to which the box is released.

(c) The date the box is released to the hospice.

(d) The name and signature of the pharmacist who releases the box to the hospice.

(e) The expiration date assigned.

(f) The date the box is returned to the pharmacy for restocking.

(g) The name and signature of the pharmacist who received the box for restocking.

(11) On the return of the drug box to the pharmacy, the pharmacist shall reconcile the drugs dispensed from the drug box with the prescriptions of the appropriate prescriber or medical director of the hospice. The pharmacist shall note that the prescriptions were dispensed from the hospice drug box on the back of the prescriptions. The prescriptions must be filed in the same manner as other prescriptions are maintained at the pharmacy.

Mich. Admin. Code R. 338.590

2020 AACS; 2024 MR 5, Eff. 2/29/2024