(a) Purpose.
(1) The purpose of this section is to provide standards
for centralized prescription drug or medication order processing by
a Class A (Community), Class C (Institutional), or Class E (Non-Resident)
pharmacy.
(2) Any facility established for the purpose of processing
prescription drug or medication drug orders shall be licensed as a
Class A, Class C, or Class E pharmacy under the Act. However, nothing
in this subsection shall prohibit an individual pharmacist employee,
individual pharmacy technician employee, or individual pharmacy technician
trainee employee who is licensed in Texas from remotely accessing
the pharmacy's electronic data base from outside the pharmacy in order
to process prescription or medication drug orders, provided the pharmacy
establishes controls to protect the privacy and security of confidential
records.
(b) Definitions. The following words and terms, when
used in this section, shall have the following meanings, unless the
context clearly indicates otherwise. Any term not defined in this
section shall have the definition set out in the Act. Centralized
prescription drug or medication order processing--the processing of
a prescription drug or medication orders by a Class A, Class C, or
Class E pharmacy on behalf of another pharmacy, a health care provider,
or a payor. Centralized prescription drug or medication order processing
does not include the dispensing of a prescription drug order but includes
any of the following:
(1) receiving, interpreting, or clarifying prescription
drug or medication drug orders;
(2) data entering and transferring of prescription
drug or medication order information;
(3) performing drug regimen review;
(4) obtaining refill and substitution authorizations;
(5) interpreting clinical data for prior authorization
for dispensing;
(6) performing therapeutic interventions; and
(7) providing drug information concerning a patient's
prescription.
(c) Operational Standards.
(1) General requirements.
(A) A Class A, Class C, or Class E Pharmacy may outsource
prescription drug or medication order processing to another Class
A, Class C, or Class E pharmacy provided the pharmacies:
(i) have:
(I) the same owner; or
(II) entered into a written contract or agreement which
outlines the services to be provided and the responsibilities and
accountabilities of each pharmacy in compliance with federal and state
laws and regulations; and
(ii) share a common electronic file or have appropriate
technology to allow access to sufficient information necessary or
required to process a non-dispensing function.
(B) A pharmacy that performs centralized prescription
drug or medication order processing shall comply with the provisions
applicable to the class of pharmacy contained in either §§291.31
- 291.35 of this title (relating to Definitions, Personnel, Operational
Standards, Records, and Official Prescription Requirements in Class
A (Community) Pharmacies), or §§291.72 - 291.75 of this
title (relating to Definitions, Personnel, Operational Standards,
and Records in a Class C (Institutional) Pharmacy), or §§291.102
- 291.105 of this title (relating to Definitions, Personnel, Operational
Standards, and Records in a Class E (Non-Resident) Pharmacy) to the
extent applicable for the specific processing activity and this section
including:
(i) duties which must be performed by a pharmacist;
and
(ii) supervision requirements for pharmacy technicians
and pharmacy technician trainees.
(2) Notifications to patients.
(A) A pharmacy that outsources prescription drug or
medication order processing to another pharmacy shall prior to outsourcing
their prescription:
(i) notify patients that prescription processing may
be outsourced to another pharmacy; and
(ii) give the name of that pharmacy; or if the pharmacy
is part of a network of pharmacies under common ownership and any
of the network pharmacies may process the prescription, the patient
shall be notified of this fact. Such notification may be provided
through a one-time written notice to the patient or through use of
a sign in the pharmacy.
(B) The provisions of this paragraph do not apply to
patients in facilities where drugs are administered to patients by
a person required to do so by the laws of the state (i.e., hospitals
or nursing homes).
(3) Policy and Procedures. A policy and procedure manual
as it relates to central processing shall be maintained at all pharmacies
involved in central processing and be available for inspection. Each
pharmacy is required to maintain only those portions of the policy
and procedure manual that relate to that pharmacy's operations. The
manual shall:
(A) outline the responsibilities of each of the pharmacies;
(B) include a list of the name, address, telephone
numbers, and all license/registration numbers of the pharmacies involved
in centralized prescription drug or medication order processing; and
(C) include policies and procedures for:
(i) protecting the confidentiality and integrity of
patient information;
(ii) maintenance of appropriate records to identify
the name(s), initials, or identification code(s) and specific activity(ies)
of each pharmacist or pharmacy technician who performed any processing;
(iii) complying with federal and state laws and regulations;
(iv) operating a continuous quality improvement program
for pharmacy services designed to objectively and systematically monitor
and evaluate the quality and appropriateness of patient care, pursue
opportunities to improve patient care, and resolve identified problems;
and
(v) annually reviewing the written policies and procedures
and documenting such review.
(d) Records. All pharmacies shall maintain appropriate
records which identify, by prescription drug or medication order,
the name(s), initials, or identification code(s) of each pharmacist,
pharmacy technician, or pharmacy technician trainee who performs a
processing function for a prescription drug or medication order. Such
records may be maintained:
(1) separately by each pharmacy and pharmacist; or
(2) in a common electronic file as long as the records
are maintained in such a manner that the data processing system can
produce a printout which lists the functions performed by each pharmacy
and pharmacist.
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