| (ii) at an institution licensed under Chapter 242,
Health and Safety Code and that is a veterans home as defined by the §164.002,
Natural Resources Code, if the provider pharmacy is a United States
Department of Veterans Affairs pharmacy or another federally operated
pharmacy.
(C) Prepackaging--The act of repackaging and relabeling
quantities of drug products from a manufacturer's original commercial
container, or quantities of unit dosed drugs, into another cartridge
or container for dispensing by a pharmacist using an emergency medication
kit.
(D) Provider pharmacy--The community pharmacy (Class
A), the institutional pharmacy (Class C), the non-resident pharmacy
(Class E) located not more than 20 miles from an institution licensed
under Chapter 242 or 252, Health and Safety Code, or the United States
Department of Veterans Affairs pharmacy or another federally operated
pharmacy providing remote pharmacy services.
(E) Remote pharmacy service--The provision of pharmacy
services, including the storage and dispensing of prescription drugs,
in remote sites.
(F) Remote site--A facility not located at the same
location as a Class A, Class C, Class E pharmacy or a United States
Department of Veterans Affairs pharmacy or another federally operated
pharmacy, at which remote pharmacy services are provided using an
emergency medication kit.
(3) General requirements.
(A) A provider pharmacy may provide remote pharmacy
services using an emergency medication kit to an institution regulated
under Chapter 242, or 252, Health and Safety Code.
(B) A provider pharmacy may provide remote pharmacy
services at more than one remote site.
(C) A provider pharmacy shall not place an emergency
medication kit in a remote site which already has a kit from another
provider pharmacy except as provided by paragraph (4)(B)(iii) of this
subsection.
(D) A provider pharmacy which is licensed as an institutional
(Class C) or a non-resident (Class E) pharmacy is required to comply
with the provisions of §§291.31 - 291.34 of this title and
this section.
(E) The pharmacist-in-charge of the provider pharmacy
is responsible for all pharmacy operations involving the emergency
medication kit located at the remote site including supervision of
the emergency medication kit and compliance with this section.
(4) Operational standards.
(A) Application for permission to provide pharmacy
services using an emergency medication kit.
(i) A Class A, Class C, or Class E pharmacy shall file
a completed application containing all information required by the
board to provide remote pharmacy services using an emergency medication
kit and pay the application fee specified in §291.6(e)(2) of
this title.
(ii) Such application shall be resubmitted every two
years in conjunction with the application for renewal of the provider
pharmacy's license.
(iii) Upon approval of the application, the provider
pharmacy will be issued a certificate which must be displayed at the
remote site.
(B) Notification requirements.
(i) A provider pharmacy shall notify the board in writing
within ten days of a discontinuance of service, or closure of:
(I) a remote site where an emergency medication kit
is operated by the pharmacy; or
(II) a remote pharmacy service at a remote site.
(ii) A provider pharmacy shall comply with appropriate
federal and state controlled substance registrations for each remote
site if controlled substances are maintained within an emergency medication
kit at the facility.
(iii) If more than one provider pharmacy provides an
emergency kit to a remote site, the provider pharmacies must enter
into a written agreement as to the emergency medications supplied
by each pharmacy. The written agreement shall include reasons why
an additional pharmacy is required to meet the emergency medication
needs of the residents of the institution.
(iv) A provider pharmacy shall file a change of location
and/or name of a remote site as specified in §291.3 of this title.
(C) Environment/Security.
(i) Emergency medication kits shall have adequate security
and procedures to:
(I) prohibit unauthorized access;
(II) comply with federal and state laws and regulations;
and
(III) maintain patient confidentiality.
(ii) Access to the emergency medication kit shall be
limited to pharmacists and licensed healthcare personnel employed
by the facility.
(iii) Drugs shall be stored in compliance with the
provisions of §291.15 and §291.33(f)(2) of this title including
the requirements for temperature and handling outdated drugs.
(D) Prescription dispensing and delivery.
(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;
Cont'd... |
