| (i) Drugs in the emergency medication kit shall be
accessed for administration to meet the emergency medication needs
of a resident of the remote site pursuant to an order from a practitioner.
The prescription drug order for the drugs used from the emergency
medication kit shall be forwarded to the provider pharmacy in a manner
authorized by §291.34(b) of this title.
(ii) The remote site shall notify the provider pharmacy
of each entry into an emergency medication kit. Such notification
shall meet the requirements of paragraph (5)(D)(ii) of this subsection.
(E) Drugs.
(i) The contents of an emergency medication kit:
(I) may consist of dangerous drugs and controlled substances;
and
(II) shall be determined by the consultant pharmacist,
pharmacist-in-charge of the provider pharmacy, medical director, and
the director of nurses and limited to those drugs necessary to meet
the resident's emergency medication needs. For the purpose of this
subsection, this shall mean a situation in which a drug cannot be
supplied by a pharmacy within a reasonable time period.
(ii) When deciding on the drugs to be placed in the
emergency medication kit, the consultant pharmacist, pharmacist-in-charge
of the provider pharmacy, medical director, and the director of nurses
must determine, select, and record a prudent number of drugs for potential
emergency incidents based on:
(I) clinical criteria applicable to each facility's
demographics;
(II) the facility's census; and
(III) the facility's healthcare environment.
(iii) A current list of the drugs stored in each remote
site's emergency medication kit shall be maintained by the provider
pharmacy and a copy kept with the emergency medication kit.
(iv) An automated pharmacy system may be used as an
emergency medication kit provided the system limits emergency access
to only those drugs approved for the emergency medication kit.
(v) Drugs for use in an emergency medication kit shall
be packaged in the original manufacturer's container or prepackaged
in the provider pharmacy and labeled in compliance with the board's
prepackaging requirements for the class of pharmacy.
(F) Stocking emergency medication kits.
(i) Stocking of drugs in an emergency medication kit
shall be completed at the provider pharmacy or remote site by a pharmacist,
pharmacy technician, or pharmacy technician trainee under the direct
supervision of a pharmacist, except as provided in clause (ii) of
this subparagraph.
(ii) If the emergency medication kit is an automated
pharmacy system which uses bar-coding, microchip, or other technologies
to ensure that the containers or unit dose drugs are accurately loaded,
the prepackaging of the containers or unit dose drugs shall occur
at the provider pharmacy unless provided by an FDA approved repackager.
The prepackaged containers or unit dose drugs may be sent to the remote
site to be loaded into the machine by personnel designated by the
pharmacist-in-charge provided:
(I) a pharmacist verifies the container or unit dose
drug has been properly filled and labeled;
(II) the individual containers or unit dose drugs are
transported to the remote site in a secure, tamper-evident container;
and
(III) the automated pharmacy system uses bar-coding,
microchip, or other technologies to ensure that the containers or
unit dose drugs are accurately loaded in the automated pharmacy system.
(iii) All drugs to be stocked in the emergency medication
kit shall be delivered to the remote site by the provider pharmacy.
(G) Policies and procedures of operation.
(i) A provider pharmacy that provides pharmacy services
through an emergency medication kit at a remote site shall operate
according to written policies and procedures. The policy and procedure
manual shall include, but not be limited to, the following:
(I) duties which may only be performed by a pharmacist;
(II) a copy of the written contract or agreement between
the pharmacy and the facility which outlines the services to be provided
and the responsibilities and accountabilities of each party in fulfilling
the terms of the contract in compliance with federal and state laws
and regulations;
(III) date of last review/revision of the policy and
procedure manual; and
(IV) policies and procedures for:
(-a-) security;
(-b-) operation of the emergency medication kit;
(-c-) preventative maintenance of the automated pharmacy
system if the emergency medication kit is an automated pharmacy system;
(-d-) sanitation;
(-e-) storage of drugs;
(-f-) dispensing;
(-g-) supervision;
(-h-) drug procurement;
(-i-) receiving of drugs;
(-j-) delivery of drugs; and
(-k-) recordkeeping.
(ii) A pharmacy that provides pharmacy services through
an emergency medication kit at a remote site shall, at least annually,
review its written policies and procedures, revise them if necessary,
and document the review.
(iii) A pharmacy providing remote pharmacy services
using an emergency medication kit which is an automated pharmacy system
shall maintain a written plan for recovery from an event which interrupts
the ability of the automated pharmacy system to provide emergency
medications. The written plan for recovery shall include:
(I) planning and preparation for maintaining pharmacy
services when an automated pharmacy system is experiencing downtime;
(II) procedures for response when an automated pharmacy
system is experiencing downtime; and
(III) procedures for the maintenance and testing of
the written plan for recovery.
(5) Records.
(A) Maintenance of records.
(i) Every record required under this section must be:
(I) kept by the provider pharmacy and be available,
for at least two years, for inspecting and copying by the board or
its representative and to other authorized local, state, or federal
law enforcement agencies; and
(II) supplied by the provider pharmacy within 72 hours,
if requested by an authorized agent of the Texas State Board of Pharmacy.
If the pharmacy maintains the records in an electronic format, the
requested records must be provided in an electronic format if specifically
requested by the board or its representative. Failure to provide the
records set out in this section, either on site or within 72 hours,
constitutes prima facie evidence of failure to keep and maintain records
in violation of the Act.
(ii) The provider pharmacy shall maintain original
prescription drug orders for drugs dispensed from an emergency medication
kit in compliance with §291.34(b) of this title.
(B) Prescriptions. Prescription drug orders shall meet
the requirements of §291.34(b) of this title.
(C) Records of dispensing. Dispensing records for a
prescription drug order shall be maintained by the provider pharmacy
in the manner required by §291.34(d) or (e) of this title.
(D) Transaction information.
(i) A prescription drug order shall be maintained by
the provider pharmacy as the record of removal of a drug from an emergency
medication kit for administration to a patient.
(ii) The remote site shall notify the provider pharmacy
electronically or in writing of each entry into an emergency medication
kit. Such notification may be included on the prescription drug order
or a separate document and shall include the name, strength, and quantity
of the drug removed, the time of removal, and the name of the person
removing the drug.
(iii) A separate record of stocking, removal, or dispensing
for administration from an emergency medication kit shall be maintained
by the pharmacy and include the:
(I) date;
(II) name, strength, dosage form, and quantity of drug
stocked, removed, or dispensed for administration;
(III) name, initials, or identification code of the
person stocking, removing, or dispensing for administration, drugs
from the system;
(IV) name, initials, or identification code of the
pharmacist who checks and verifies that the system has been accurately
filled; and
(V) unique prescription number assigned to the prescription
drug order when the drug is administered to the patient.
(E) Inventory.
(i) A provider pharmacy shall:
(I) keep a record of all drugs sent to and returned
from a remote site separate from the records of the provider pharmacy
and from any other remote site's records; and
Cont'd... |
