Current through Register Vol. 18, September 20, 2024
(1) In an institutional facility , drugs may
be provided for use by authorized personnel through drug kits prepared by the
registered pharmacist providing pharmaceutical services to the facility. Such
drug kits must meet all of the following requirements:
(a) a registered pharmacist shall prepare and
seal the drug kit for a supplying pharmacy;
(b) the supplying pharmacy and the designated
practitioner or appropriate committee of the institutional facility shall
jointly determine the identity and quantity of drugs to be included in the drug
kit;
(c) the drug kit must be
locked and stored in a secure area to prevent unauthorized access and to ensure
a proper storage environment for the drugs contained therein;
(d) all drugs in the drug kit must be
properly labeled, including lot number and expiration date, and shall possess
any additional information that may be required to prevent risk of harm to the
patient;
(e) the exterior of the
drug kit must be clearly labeled to indicate:
(i) expiration date of the drug kit. The
expiration date of a drug kit must be the earliest date of expiration of any
drug supplied in the drug kit. On or before the expiration date, the supplying
pharmacy shall replace the expired drug;
(ii) the name, address, and telephone number
of the supplying pharmacy; and
(iii) a statement indicating that the drug
kit is to be used in situations only pursuant to a valid drug order;
(f) if a drug kit is being
utilized for an emergency drug cart or crash cart in an inpatient setting, as
defined in ARM
24.174.301(15):
(i) the pharmacist-in-charge must maintain
policies and procedures for access to the cart; and
(ii) a pharmacist must review access to the
cart within 72 hours of drug removal.
(2) Except as provided for in (1)(f), drugs
shall be removed from drug kits in compliance with the following:
(a) by authorized licensed personnel pursuant
to policies and procedures referenced in (4); and
(b) a pharmacist must:
(i) review the drug order prior to removal of
a controlled substance; or
(ii)
review the drug order within 72 hours of removal of a non-controlled
substance.
(3) Removal of any drug from a drug kit by
authorized personnel must be recorded in an electronic record or on a suitable
form showing the following information:
(a)
patient name;
(b) name, strength,
and quantity of drug removed;
(c)
date and time the drug was removed;
(d) signature of the authorized personnel
removing the drug; and
(e)
documentation of pharmacy review.
(4) The supplying pharmacy shall, in
conjunction with the appropriate institutional committee, be responsible for
development and annual review of policies and procedures for safe and
appropriate use, access by authorized licensed personnel, restocking, and
maintenance of drug kits.
(5)
Documentation for all drugs that have been removed from the drug kit shall be
kept at the institutional facility and at the supplying pharmacy for two years
and be available upon inspection.
(6) The drug kit, policies and procedures,
and related records shall be available upon inspection.
(7) The supplying pharmacy and appropriate
designated practitioner of a licensed facility will provide adequate controls
to prevent drug diversion.
(8) The
supplying pharmacy shall submit to the board and have available for inspection:
(a) an application for a drug kit
endorsement;
(b) a list of drug
kit locations; and
(c) any change
to drug kit locations at the time of such change.
AUTH:
37-7-201,
MCA IMP:
37-7-201,
MCA
