Iowa Admin. Code r. 657-7.11

Current through Register Vol. 47, No. 8, October 30, 2024

Rule 657-7.11 - Outpatient services

No prescription drugs shall be dispensed from the hospital pharmacy to patients treated in a hospital outpatient setting. If a need is established for the dispensing of a prescription drug to an outpatient, a prescription shall be issued to be filled at a pharmacy of the patient's choice.

(1)Definitions. For the purposes of this rule, the following definitions shall apply:

"Emergency department patient" means a patient who is examined and evaluated in the emergency department.

"Outpatient" means a patient who was examined and evaluated by a prescriber who determined the patient's need for the administration of a drug or device, when the patient presents to the hospital outpatient setting with a prescription or order for administration of a drug or device. "Outpatient" does not include an emergency department patient.

"Outpatient medication order" means an order issued by a prescriber pursuant to rules of the board for administration of a drug or device. An outpatient medication order may authorize continued or periodic administration of a drug or device for a period of time and frequency determined by the prescriber or by hospital policy, not to exceed legal limits for the refilling of a prescription drug order.

(2)Administration in the outpatient setting. Drugs shall be administered only to outpatients who have been examined and evaluated by a prescriber who determined the patient's need for the drug therapy ordered.

a.Accountability. Established policies and procedures shall include a system of drug control and accountability in the outpatient setting. The system shall ensure accountability of drugs incidental to outpatient nonemergency therapy or treatment. Drugs shall be administered only in accordance with the system.

b.Controlled substances. Controlled substances maintained in the outpatient setting are kept for use by or at the direction of prescribers for the nonemergency therapy or treatment of outpatients. In order to have a controlled substance administered, a patient shall be examined in the outpatient setting or in an alternate practice setting or office by a prescriber who shall determine the patient's need for the drug. If the patient is examined in a setting other than the outpatient setting, the prescriber shall issue a prescription or order for administration of the drug in the hospital outpatient setting.

c.Outpatient medication orders. A prescriber may authorize, by outpatient medication order, the periodic administration of a drug to an outpatient.

(1) Schedule II controlled substance. An outpatient medication order for administration of a Schedule II controlled substance shall be issued pursuant to federal regulation and board rules and, except as provided in rule 657-10.29 (124) regarding the issuance of multiple Schedule II prescriptions, may authorize the administration of an appropriate amount of the prescribed substance for a period not to exceed 90 days from the date ordered.

(2) Schedule III, IV, or V controlled substance. An outpatient medication order for administration of a Schedule III, IV, or V controlled substance shall be issued pursuant to federal regulation and board rules and may be authorized for a period not to exceed six months from the date ordered.

(3) Noncontrolled substance. An outpatient medication order for administration of a noncontrolled prescription drug may be authorized for a period not to exceed 18 months from the date ordered.

(3)Samples. If the use of drug samples is permitted for hospital outpatients, that use of samples shall be controlled and the samples shall be distributed through the pharmacy or through a process developed in cooperation with the pharmacy and the facility's appropriate patient care committee, subject to oversight by the pharmacy.

Iowa Admin. Code r. 657-7.11

ARC 8909B, IAB 6/30/10, effective 8/4/10; ARC 0243C, IAB 8/8/12, effective 9/12/12

Amended by IAB April 15, 2015/Volume XXXVII, Number 21, effective 5/20/2015

Amended by IAB September 27, 2017/Volume XL, Number 7, effective 11/1/2017

Amended by IAB January 30, 2019/Volume XLI, Number 16, effective 3/6/2019