CHAPTER 7HOSPITAL PHARMACY PRACTICE[Prior to 2/10/88, see Pharmacy Examiners[620] Ch 12]6577.1(155A) Purpose and scope. Hospital pharmacy means and includes a pharmacy licensed by the board and located within any hospital, health system, institution, or establishment which maintains and operates organized facilities for the diagnosis, care, and treatment of illnesses to which patients may or may not be admitted for overnight stay at the facility. A hospital is a facility licensed pursuant to Iowa Code chapter 135B. This chapter does not apply to a pharmacy located within such a facility for the purpose of providing outpatient prescriptions. A pharmacy providing outpatient prescriptions is and shall be licensed as a general pharmacy subject to the requirements of 657—Chapter 6. The requirements of these rules for hospital pharmacy practice apply to all hospitals, regardless of size or type, and are in addition to the requirements of 657—Chapter 8 and other rules of the board relating to services provided by the pharmacy.Related ARC(s): 9911B6577.2(155A) Pharmacist in charge. One professionally competent, legally qualified pharmacist in charge in each pharmacy shall be responsible for, at a minimum, the responsibilities identified in rule 657—8.3(155A). Where 24-hour operation of the pharmacy is not feasible, a pharmacist shall be available on an “on call” basis.Related ARC(s): 8673B, 1961C6577.3(155A) Reference library. A pharmacy shall maintain a reference library which is either printed or computer-accessed and which adequately meets the needs of the services provided and patients served. Examples of such references include:
- A reference including all pertinent Iowa laws, rules, and regulations that impact the pharmacy’s practice.
- A patient information reference that includes or provides patient information in compliance with rule 657—6.14(155A).
- A reference on drug interactions.
- A drug information reference.
- A drug equivalency reference.
- An injectable-drug compatibility reference.
- A drug identification reference to enable identification of drugs brought into the facility by patients.
- The readily accessible telephone number of a poison control center that serves the area.
- Additional references relating to specific patient populations served, such as pediatrics or geriatrics, or disease states treated, such as oncology or infectious disease.
"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.
7.11(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. 7.11(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.Related ARC(s): 8909B, 0243C, 1961C, 3345C, 4267C6577.12(124, 126, 155A) Drugs in the emergency department. Drugs maintained in the emergency department are kept for use by or at the direction of prescribers in the emergency department. Drugs shall be administered or dispensed only to emergency department patients. For the purposes of this rule, “emergency department patient” means a patient who is examined and evaluated in the emergency department and includes the partner or partners of a patient treated pursuant to Iowa Code section 139A.41. 7.12(1) Accountability. Established policies and procedures shall include a system of drug control and accountability in the emergency department. The system shall identify drugs of the nature and type to meet the emergency needs of patients. Drugs shall be administered or dispensed only in accordance with the system. 7.12(2) Controlled substances. Controlled substances maintained in the emergency department are kept for use by or at the direction of prescribers in the emergency department. a. In order to receive a controlled substance, a patient shall be examined in the emergency department by a prescriber who shall determine the need for the drug. It is not permissible under state and federal regulations for a prescriber to see a patient outside the emergency department setting, or talk to the patient on the telephone, and then proceed to call the emergency department and order the administration of a stocked controlled substance upon the patient’s arrival at the emergency department except as provided in paragraph 7.12(2)“c” or “d.” b. A prescriber may authorize, without again examining the patient, the administration of additional doses of a previously authorized drug to a patient presenting to the emergency department within 24 hours of the patient’s examination and treatment in the emergency department. c. In an emergency situation when a health care practitioner authorized to prescribe controlled substances is not available on site, and regardless of the provisions of paragraph 7.12(2)“a,” the emergency department nurse may examine the patient in the emergency department and contact the on-call prescriber. The on-call prescriber may then authorize the nurse to administer a controlled substance to the patient pending the arrival of the prescriber at the emergency department. As soon as possible, the prescriber shall examine the patient in the emergency department and determine the patient’s further treatment needs. d. In an emergency situation when a health care practitioner authorized to prescribe controlled substances examines a patient in the prescriber’s office and determines a need for the administration of a controlled substance, and regardless of the provisions of paragraph 7.12(2)“a,” the prescriber may direct the patient to present to the emergency department for the administration of a controlled substance for which the prescriber has issued a prescription in compliance with federal regulation and board rules. As soon as possible, the prescriber shall examine the patient in the emergency department and determine the patient’s further treatment needs. 7.12(3) Drug dispensing. Only a pharmacist or prescriber may dispense any drugs to an emergency department patient pursuant to the provisions of this rule. a. Responsibility. Pursuant to rule 657—8.3(155A), policies and procedures shall be established to ensure the accuracy and labeling of prepackaged drugs and accurate records of dispensing of drugs from the emergency department shall be maintained. (1) Except as provided in subrule 7.12(4), drugs dispensed to an emergency department patient may be dispensed in quantities not to exceed a 72-hour supply or the minimum quantity in suitable containers, except that an authorized supply of a drug provided through the department of public health may be dispensed for the treatment of a victim of sexual assault. Prepackaged drugs shall be prepared pursuant to the requirements of rule 657—22.3(126). (2) Drugs dispensed pursuant to this paragraph shall be appropriately labeled as required in paragraph 7.12(3)“b,” including necessary auxiliary labels. b. Prescriber responsibility. Except as provided in subrule 7.12(4), a prescriber who authorizes the dispensing of a prescription drug to an emergency department patient is responsible for the accuracy of the dispensed drug and for the accurate completion of label information pursuant to this paragraph, including when any portion of the dispensing process is delegated to a licensed nurse under the supervision of the prescriber. (1) Except as provided in subrule 7.12(4), at the time of delivery of the drug the prescriber shall be responsible for ensuring that the dispensing container bears a label with at least the following information:- Name and address of the hospital;
- Date dispensed;
- Name of prescriber;
- Name of patient, except when the drug is dispensed for one or more unnamed partners receiving expedited partner therapy pursuant to Iowa Code section 139A.41;
- Directions for use; and
- Name, quantity, and strength of drug.