N.D. Admin. Code 61-02-09-01

Current through Supplement No. 394, October, 2024

Section 61-02-09-01 - Definitions

In this chapter, unless the context or subject matter otherwise requires:

1. "Actively reports" means reporting all dispensing errors and analysis of such errors to a patient safety organization as soon as practical or at least within thirty days of identifying the error.

2. "Analysis" means a review of the findings collected and documented on each dispensing error, assessment of the cause and any factors contributing to the dispensing error, and any recommendation for remedial action to improve pharmacy systems and workflow processes to prevent or reduce future errors.

3. "Dispensing error" means one or more of the following discovered after the final verification by the pharmacist:

a. Variation from the prescriber's prescription drug order, including:

(1) Incorrect drug;

(2) Incorrect drug strength;

(3) Incorrect dosage form;

(4) Incorrect patient; or

(5) Inadequate or incorrect packaging, labeling, or directions.

b. Failure to exercise professional judgments in identifying and managing:

(1) Therapeutic duplication;

(2) Drug-disease contraindications, if known;

(3) Drug-drug interactions, if known;

(4) Incorrect drug dosage or duration of drug treatment, interactions;

(5) A clinically significant, avoidable delay in therapy; or

(6) Any other significant, actual or potential problem with a patient's drug therapy.

c. Deliver of a drug to incorrect patient.

d. Variation in bulk repackaging or filling of automated devices, including:

(1) Incorrect drug;

(2) Incorrect drug strength;

(3) Incorrect dosage form; or

(4) Inadequate or incorrect packaging or labeling.

4. "Incident" means a patient safety event that reached the patient, whether or not the patient is harmed.

5. "Near miss" means a patient safety event that did not or could not have reached the patient.

6. "Patient safety organization" means an organization that has as its primary mission continuous quality improvement under the Patient Safety and Quality Improvement Act of 2005 ( P.L. 109-41 ) and is credentialed by the agency for healthcare research and quality.

7. "Unsafe condition" means any circumstance that increases the probability of a patient safety event.

N.D. Admin Code 61-02-09-01

Adopted by Administrative Rules Supplement 2016-360, April 2016, effective 4/1/2016.

General Authority: NDCC 28-32-02, 43-15-10, 23-34

Law Implemented: NDCC 28-32-03, 43-15-10, 23-34