(1) The facility must have an organized system for drug administration that identifies each drug up to the point of administration. The system must assure that:

(a) all drugs are administered in compliance with the physician's orders;

(b) all drugs, including those that are self-administered, are administered without error;

(c) each client is taught how to administer their own medications if the interdisciplinary team determines that self-administration of medications is an appropriate objective, and if the physician does not specify otherwise;

(d) the client's physician is informed of the interdisciplinary team's decision that self-administration of medications is an objective for the client;

(e) no client self-administers medications until he or she demonstrates the competency to do so;

(f) drugs used by any client while not under the direct care of the facility are packaged and labeled in accordance with Montana law; and

(g) drug administration errors and adverse drug reactions are recorded and reported immediately to a physician.

(2) The facility must:

(a) store drugs under proper conditions of sanitation, temperature, light, humidity, and security;

(b) keep all drugs and biologicals locked except when being prepared for administration, and only permit authorized persons to have access to the keys to the drug storage area, except that any client who has been trained to self-administer drugs may have access to keys to their individual drug supply;

(c) maintain records of the receipt and disposition of all controlled drugs;

(d) on a sample basis, periodically reconcile the receipt and disposition of all controlled drugs in schedules II through IV of the Comprehensive Drug Abuse Prevention and Control Act of 1970, 21 U.S.C . 801 et seq., as implemented by 21 CFR part 308; and

(e) comply with the regulations of controlled drugs if the facility maintains a licensed pharmacy.

(3) Labeling of drugs and biologicals must:

(a) be based on currently accepted professional principles and practices; and

(b) include the appropriate accessory and cautionary instructions, as well as the expiration date, if applicable.

(4) The facility must remove from use:

(a) outdated drugs; and

(b) drug containers with worn, illegible, or missing labels.

(5) Drugs and biologicals packaged in containers designated for a particular client must be immediately removed from the client's current medication supply if discontinued by the physician.

History: Sec. 50-5-103 and 50-5-238, MCA; IMP, Sec. 53-5-103, 50-5-201 and 50-5-238, MCA; NEW, 2003 MAR p. 1322, Eff. 7/1/03.