Iowa Admin. Code r. 657-7.8

Current through Register Vol. 47, No. 11, December 11, 2024

Rule 657-7.8 - Drug distribution and control

Policies and procedures governing drug distribution and control shall be established pursuant to rule 657-8.3 (155A) with input from other involved hospital staff such as physicians and nurses, from committees such as the pharmacy and therapeutics committee or its equivalent, and from any related patient care committee. It is essential that the pharmacist in charge or designee routinely be available to or on all patient care areas to establish rapport with the personnel and to become familiar with and contribute to medical and nursing procedures relating to drugs.

(1)Drug preparation. Control and adequate quality assurance procedures needed to ensure that patients receive the correct drugs at the proper times shall be established pursuant to rule 657-8.3 (155A).

a. Hospitals shall utilize a unit dose dispensing system pursuant to rule 657-22.1 (155A). All drugs dispensed by the pharmacy for administration to patients shall be in single unit or unit dose packages if practicable unless the dosage form or drug delivery device makes it impracticable to package the drug in a unit dose or single unit package.

(1) Established policies and procedures shall identify situations when drugs may be dispensed in other than unit dose or single unit packages outside the unit dose dispensing system.

(2) The need for nurses to manipulate drugs prior to their administration shall be minimized.

b. All sterile and nonsterile compounded products shall be prepared in conformance with 657-Chapter 20.

(2)Medication orders. Except to meet the emergent needs of a patient, no drug or device shall be dispensed or made available for patient administration prior to the issuance of a valid medication order and appropriate pharmacist review.

a.Verbal order. The use of verbal orders shall be minimized. All verbal orders shall be read back to the prescriber, and the read back shall be documented with or on the order.

b.Written order not entered by prescriber. If an individual other than the prescriber enters a medication order into an electronic medical record system from an original written medication order, a pharmacist shall review and verify the entry against the original written order before the drug is dispensed or made available for administration except for emergency use, when the pharmacy is closed, or as provided in rule 657-7.7 (155A).

c.Order entered when pharmacy closed. When the pharmacy is closed and remote pharmacist services are not available, a registered nurse or pharmacist may enter a medication order into an electronic medical record system for the purpose of creating an electronic medication administration record and, except when a pharmacist entered the order, a pharmacist shall verify the entry against the original written medication order, if such written order exists, as soon as practicable.

d.Abbreviations and chemical symbols on orders. The use of abbreviations and chemical symbols on medication orders shall be discouraged but, if used, shall be limited to abbreviations and chemical symbols approved by the appropriate patient care committee.

(3)Stop order. A policy concerning stop orders shall be established to ensure that medication orders are not inappropriately continued.

(4)Emergency drug supplies and floor stock. Pursuant to policies and procedures, supplies of drugs for use in medical emergencies shall be immediately available. All drug storage areas within the facility shall be routinely inspected to ensure that no outdated or unusable items are available for administration and that all stock items are properly labeled and stored.

(5)Disaster services. The pharmacy shall be prepared to provide drugs and pharmaceutical services in the event of a disaster affecting the availability of drugs or internal access to drugs or access to the pharmacy.

(6)Drugs brought into the facility. Established policies and procedures shall determine those circumstances when patient-owned drugs brought into the facility may be administered to the patient and shall identify procedures governing the use and security of drugs brought into the facility. Procedures shall address identification of the drug and methods for ensuring the integrity of the product prior to permitting its use. The use of patient-owned drugs shall be minimized to the greatest extent possible.

(7)Samples. The use of drug samples within the institution shall be eliminated to the extent possible. Sample use is prohibited for hospital inpatient use. For the purposes of this subrule, "samples" shall not include initiation doses provided by a manufacturer's long-acting antipsychotic medication initiation program.

(8)Investigational drugs. If investigational drugs are used in the facility:

a. A pharmacist shall be a member of the institutional review board or its equivalent.

b. The pharmacy shall be responsible, in cooperation with the principal investigator, for providing information about investigational drugs used in the facility and for the distribution and control of those drugs.

(9)Hazardous drugs and chemicals. Policies and procedures for handling drugs and chemicals that are known occupational hazards shall be established pursuant to rule 657-8.3 (155A). The procedures shall maintain the integrity of the drug or chemical and protect facility personnel.

(10)Leave and discharge meds. Labeling of medications for a patient on leave from the facility for a period in excess of 24 hours or being discharged from the facility shall comply with 657-subrule 6.10(1).

(11)Own-use outpatient prescriptions. If the hospital pharmacy dispenses own-use outpatient prescriptions, the pharmacist shall comply with all requirements of 657-Chapter 6 except rule 657-6.1 (155A).

(12)Influenza and pneumococcal vaccines. As authorized by federal law, a patient-specific medication order shall not be required prior to administration to an adult patient of influenza and pneumococcal vaccines pursuant to physician-approved facility policy and after the patient has been assessed for contraindications. Administration shall be recorded in the patient's medical record.

(13)Accountability of stock supply. An individual who administers a controlled substance from a non-patient-specific stock supply in a facility shall personally document on a separate readily retrievable record system each dose administered, wasted, or returned to the pharmacy. Such documentation shall not be delegated to another individual. Wastage documentation shall include the signature or unique electronic signature or identification of a witnessing licensed health care practitioner. Distribution records for non-patient-specific floor-stocked controlled substances shall include the following information:

a. Patient's name;

b. Prescriber who ordered the drug;

c. Drug name, strength, dosage form, and quantity;

d. Date and time of administration;

e. Signature or unique electronic signature of the individual administering the controlled substance;

f. Returns to the pharmacy;

g. Waste, which is required to be witnessed and cosigned by another licensed health care practitioner.

Iowa Admin. Code r. 657-7.8

ARC 8170B, IAB 9/23/09, effective 10/28/09; ARC 9911B, IAB 12/14/11, effective 1/18/12

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

Amended by IAB October 14, 2015/Volume XXXVIII, Number 08, effective 11/18/2015

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