Minn. R. agency 164, ch. 6800, OPERATION OF PARENTERAL-ENTERAL/HOME HEALTH CARE PHARMACIES, pt. 6800.8007

Current through Register Vol. 49, No. 24, December 9, 2024

Part 6800.8007 - PATIENT CARE GUIDELINES

Subpart 1.Primary provider.

The pharmacist who assumes the responsibilities under this part must ensure that there is a designated practitioner primarily responsible for the patient's medical care and that there is a clear understanding between the practitioner, licensed home care agency, if any, the patient, and the pharmacist of the responsibilities of each in the areas of the delivery of care and the monitoring of the patient. Compliance with this subpart shall be documented in the patient's profile.

Subp. 2.Patient training.

The pharmacy must demonstrate or document the patient's training and competency in managing this type of therapy in the home environment. A pharmacist must be involved in the patient training process in any area that relates to drug compounding, labeling, storage, stability, or incompatibility.

Subp. 3.Patient monitoring.

The pharmacist shall request access to clinical and laboratory data concerning each patient and, if the data is obtained, monitor each patient's response to drug therapy. Any unexpected or untoward response shall be reported to the prescribing practitioner. If the data is not obtained and the pharmacist is not doing the monitoring, the identity of the health care provider who has assumed the responsibility shall be documented in the patient's profile.

Subp. 4.Emergency kit.

The pharmacy may provide emergency medications and supplies to be used by designated, registered nurses, employed in the hospice or home health care setting.

The minimum requirements relating to the establishment of an emergency kit are described in items A to C.

A. The pharmacy must have ownership of and assume the responsibility for the emergency supply.

B. Appropriate and agreed-to policies and procedures for the use of the kit must be developed by hospice and home health agencies in conjunction with the supplying pharmacy. Copies of the policies and procedures must be kept at the supplying pharmacy and a copy submitted to the board. The policies and procedures must address the following:

(1) the signed prescriber's protocols stating the drugs to be used, under what medical circumstances they are to be used, who can administer these drugs, how the prescriber is notified of the use of drugs from the kit, and how the prescription covering the drugs that were used is transmitted to the pharmacy;

(2) the storage, temperature, stability, humidity, and proper transportation of the portable container of drugs;

(3) security and who has access to the drugs. An acceptable method is assigning responsibility by a numbering system for each separate box, designated to each separate registered nurse;

(4) replacement of the medications used from the container within 72 hours and the application of tamperproof seals;

(5) the method by which a pharmacy would be furnished with a copy of each prescriber's prescription drug order or approved protocol reference which will be used as a hard copy prescription drug order and will trigger drug replacement; and

(6) a system whereby the supplying pharmacy inspects the contents of the emergency box at least every 60 days for expiration dates of the medications, the tamperproof seal, and the correctness of the contents list; and documents and retains records of the inspection.

C. The pharmacy having ownership and responsibility shall ensure that each portable emergency supply is:

(1) sealed with a tamperproof seal to ascertain entry into the kit;

(2) delivered to and kept under the control of a registered nurse;

(3) labeled on the outside of the container with a list of drugs and quantities contained in the kit; and

(4) limited to drugs that are not controlled substances.

Minn. R. agency 164, ch. 6800, OPERATION OF PARENTERAL-ENTERAL/HOME HEALTH CARE PHARMACIES, pt. 6800.8007

18 SR 1145; 23 SR 1597; 36 SR 237

Statutory Authority: MS s 151.06; 151.102