Minnesota Administrative Rules

6800.6700 DRUGS FOR USE IN EMERGENCY KITS.

Subpart 1.

Authorization upon request.

A pharmacy may provide, upon a written or oral request from the quality assurance and assessment committee, limited supplies of drugs for use in an emergency kit. The drugs remain the property of the pharmacy.

Subp. 2.

Emergency drug supplies.

Only emergency drug supplies determined by the quality assurance and assessment committee necessary for patient care in life threatening emergencies may be made available. The drugs in the emergency kit are the responsibility of the pharmacist and, therefore, shall not be used or altered in any way except as outlined in this subpart. The emergency drug supplies shall comply with the following in items A to F.

A.

The drugs shall be limited to the extent possible to a 72-hour supply of any one emergency drug in either sealed ampules, vials, or prefilled syringes. If an emergency drug is not available in parenteral form, a supply in an alternate dosage form may be provided. Notwithstanding these restrictions, if the quality assurance and assessment committee considers it necessary, up to a 72-hour supply of each of a maximum of 15 different oral pharmaceuticals, not counting oral antibiotics, restricted to therapeutic categories related to symptomatic patient distress or emergencies may be stocked. An unlimited number of oral antibiotics may be stocked in 72-hour supplies of each. Inclusion of other oral legend drugs is permissible only through the granting of a variance by the board. Drugs in the supply shall be properly labeled, including beyond-use dates and lot numbers.

B.

The emergency drug supply shall be stored in a container which is sealed by the pharmacist or the pharmacist's agent with a tamperproof seal that must be broken to gain access to the drugs, and shall be placed in a locked area.

C.

The pharmacist shall be notified by the health care facility when drugs from the emergency kit have been used or when the seal has been broken.

D.

Drugs used from the kit shall be replaced by submitting a prescription drug order for the used item to the pharmacist within 72 hours and the supply shall be resealed by the pharmacist or the pharmacist's agent.

E.

The pharmacist shall see that the contents of the kit are accurately listed on the container and accounted for.

F.

The supply shall be checked and inventoried monthly by the pharmacist who is responsible for control of the kit.

Subp. 3.

Controlled substances.

Emergency kits may contain limited supplies of controlled substances only if:

A.

the controlled substances are supplied by a licensed pharmacy duly registered with the Federal Drug Enforcement Administration;

B.

the emergency kit is kept in a locked medicine room or medicine cabinet;

C.

access to the emergency kit is limited to the following individuals:

(1)

a licensed professional nurse who is employed by the facility and who has been directed by a physician to administer a drug from the kit;

(2)

a consultant pharmacist or other licensed pharmacist designated by the facility's pharmaceutical services committee; or

(3)

a licensed medical practitioner;

D.

the emergency kit does not contain more than six single doses of any controlled substance narcotic analgesic;

E.

the dispensing pharmacy keeps a complete record of each controlled substance stored in the emergency kit, including the name of the drug, the strength of the drug, and the number of doses provided;

F.

the facility keeps a complete record of the use of controlled substances from the kit for two years, including the patient's name, the date of use, the name of the drug used, the strength of the drug, the number of doses used, and the signature of the person administering the dose; and

G.

the controlled substances stored in the emergency kit are used only in a situation deemed an emergency by a licensed practitioner in conformity with the following provisions:

(1)

immediate administration of the controlled substance is necessary for the proper treatment of the intended ultimate user;

(2)

no appropriate alternative treatment is available, including administration of a drug which is not a controlled substance; and

(3)

it is not reasonably possible for the prescribing practitioner to provide prior to administration a written prescription drug order to be presented to a pharmacist for dispensing of the controlled substance.

Subp. 4.

Excluded controlled substances.

Controlled substance stimulants in oral dosage forms may not be included in emergency kits.

Subp. 5.

Penalty.

If any of the provisions of this part are violated, the board may suspend or revoke a pharmacy's privilege to maintain an emergency kit of drug supplies at the noncompliant facility.

Statutory Authority:

MS s 151.06; 151.102

History:

18 SR 1145; 23 SR 1597; 36 SR 237

Published Electronically:

October 11, 2013