22 Tex. Admin. Code § 291.73 - Personnel
(a) Requirements for pharmacist services.
(1) A Class C pharmacy in a facility with 101
beds or more shall be under the continuous on-site supervision of a pharmacist
during the time it is open for pharmacy services; provided, however, that
pharmacy technicians and pharmacy technician trainees may distribute
prepackaged and prelabeled drugs from a drug storage area of the facility
(e.g., a surgery suite), in the absence of physical supervision of a
pharmacist, under the following conditions:
(A) the distribution is under the control of
a pharmacist; and
(B) a pharmacist
is on duty in the facility.
(2) A Class C pharmacy in a facility with 100
beds or less shall have the services of a pharmacist at least on a part-time or
consulting basis according to the needs of the facility except that a
pharmacist shall be on-site at least once every seven days.
(3) A pharmacist shall be accessible at all
times to respond to other health professional's questions and needs. Such
access may be through a telephone which is answered 24 hours a day, e.g.,
answering or paging service, a list of phone numbers where the pharmacist may
be reached, or any other system which accomplishes this purpose.
(b) Pharmacist-in-charge.
(1) General.
(A) Each institutional pharmacy in a facility
with 101 beds or more shall have one full-time pharmacist-in-charge, who may be
pharmacist-in-charge for only one such pharmacy except as specified in
subparagraph (C) of this paragraph.
(B) Each institutional pharmacy in a facility
with 100 beds or less shall have one pharmacist-in-charge who is employed or
under contract, at least on a consulting or part-time basis, but may be
employed on a full-time basis, if desired, and who may be pharmacist-in-charge
for no more than three facilities or 150 beds.
(C) A pharmacist-in-charge may be in charge
of one facility with 101 beds or more and one facility with 100 beds or less,
including a rural hospital, provided the total number of beds does not exceed
150 beds.
(D) The
pharmacist-in-charge shall be assisted by additional pharmacists, pharmacy
technicians and pharmacy technician trainees commensurate with the scope of
services provided.
(E) If the
pharmacist-in-charge is employed on a part-time or consulting basis, a written
agreement shall exist between the facility and the pharmacist, and a copy of
the written agreement shall be made available to the board upon
request.
(F) The
pharmacist-in-charge of a Class C pharmacy with 101 beds or more, may not serve
as the pharmacist-in-charge of a Class A pharmacy or a Class B
pharmacy.
(2)
Responsibilities. The pharmacist-in-charge shall have the responsibility for,
at a minimum, the following:
(A) providing the
appropriate level of pharmaceutical care services to patients of the
facility;
(B) ensuring that drugs
and/or devices are prepared for distribution safely, and accurately as
prescribed;
(C) supervising a
system to assure maintenance of effective controls against the theft or
diversion of prescription drugs, and records for such drugs;
(D) providing written guidelines and approval
of the procedure to assure that all pharmaceutical requirements are met when
any part of preparing, sterilizing, and labeling of sterile preparations is not
performed under direct pharmacy supervision;
(E) participating in the development of a
formulary for the facility, subject to approval of the appropriate committee of
the facility;
(F) developing a
system to assure that drugs to be administered to patients are distributed
pursuant to an original or direct copy of the practitioner's medication
order;
(G) developing a system for
the filling and labeling of all containers from which drugs are to be
distributed or dispensed;
(H)
assuring that the pharmacy maintains and makes available a sufficient inventory
of antidotes and other emergency drugs as well as current antidote information,
telephone numbers of regional poison control center and other emergency
assistance organizations, and such other materials and information as may be
deemed necessary by the appropriate committee of the facility;
(I) maintaining records of all transactions
of the institutional pharmacy as may be required by applicable law, state and
federal, and as may be necessary to maintain accurate control over and
accountability for all pharmaceutical materials including pharmaceuticals,
components used in the compounding of preparations, and participate in policy
decisions regarding prescription drug delivery devices;
(J) participating in those aspects of the
facility's patient care evaluation program which relate to pharmaceutical
utilization and effectiveness;
(K)
participating in teaching and/or research programs in the facility;
(L) implementing the policies and decisions
of the appropriate committee(s) relating to pharmaceutical services of the
facility;
(M) providing effective
and efficient messenger or delivery service to connect the institutional
pharmacy with appropriate areas of the facility on a regular basis throughout
the normal workday of the facility;
(N) developing a system for the labeling,
storage, and distribution of investigational new drugs, including access to
related drug information for healthcare personnel in the pharmacy and nursing
station where such drugs are being administered, concerning the dosage form,
route of administration, strength, actions, uses, side effects, adverse
effects, interactions and symptoms of toxicity of investigational new
drugs;
(O) assuring that records in
a data processing system are maintained such that the data processing system is
in compliance with Class C (Institutional) pharmacy requirements;
(P) assuring that a reasonable effort is made
to obtain, record, and maintain patient medication records;
(Q) assuring the legal operation of the
pharmacy, including meeting all inspection and other requirements of all state
and federal laws or rules governing the practice of pharmacy; and
(R) if the pharmacy uses an automated
medication supply system, shall be responsible for the following:
(i) reviewing and approving all policies and
procedures for system operation, safety, security, accuracy and access, patient
confidentiality, prevention of unauthorized access, and malfunction;
(ii) inspecting medications in the automated
medication supply system, at least monthly, for expiration date, misbranding,
physical integrity, security, and accountability; except that inspection of
medications in the automated medication supply system may be performed
quarterly if:
(I) the facility uses automated
medication supply systems that monitors expiration dates of prescription drugs;
and
(II) security of the system is
checked at regularly defined intervals (e.g., daily or weekly);
(iii) assigning, discontinuing, or
changing personnel access to the automated medication supply system;
(iv) ensuring that pharmacy technicians,
pharmacy technician trainees, and licensed healthcare professionals performing
any services in connection with an automated medication supply system have been
properly trained on the use of the system and can demonstrate comprehensive
knowledge of the written policies and procedures for operation of the system;
and
(v) ensuring that the automated
medication supply system is stocked accurately and an accountability record is
maintained in accordance with the written policies and procedures of
operation.
(c) Consultant pharmacist.
(1) The consultant pharmacist may be the
pharmacist-in-charge.
(2) A written
agreement shall exist between the facility and any consultant pharmacist, and a
copy of the written agreement shall be made available to the board upon
request.
(d) Pharmacists.
(1) General.
(A) The pharmacist-in-charge shall be
assisted by a sufficient number of additional licensed pharmacists as may be
required to operate the institutional pharmacy competently, safely, and
adequately to meet the needs of the patients of the facility.
(B) All pharmacists shall assist the
pharmacist-in-charge in meeting the responsibilities as outlined in subsection
(b)(2) of this section and in ordering, administering, and accounting for
pharmaceutical materials.
(C) All
pharmacists shall be responsible for any delegated act performed by pharmacy
technicians or pharmacy technician trainees under his or her
supervision.
(D) All pharmacists
while on duty, shall be responsible for complying with all state and federal
laws or rules governing the practice of pharmacy.
(E) A distributing pharmacist shall be
responsible for and ensure that the drug is prepared for distribution safely,
and accurately as prescribed unless the pharmacy's data processing system can
record the identity of each pharmacist involved in a specific portion of the
preparation of medication orders for distribution, in which case each
pharmacist involved in the preparation of medication orders shall be
responsible for and ensure that the portion of the process the pharmacist is
performing results in the safe and accurate distribution and delivery of the
drug as ordered. The preparation and distribution process for medication orders
shall include, but not be limited to, drug regimen review, and verification of
accurate medication order data entry, preparation, and distribution, and
performance of the final check of the prepared medication.
(2) Duties. Duties of the
pharmacist-in-charge and all other pharmacists shall include, but need not be
limited to the following:
(A) providing those
acts or services necessary to provide pharmaceutical care;
(B) receiving, interpreting, and evaluating
prescription drug orders, and reducing verbal medication orders to writing
either manually or electronically;
(C) participating in drug and/or device
selection as authorized by law, drug and/or device supplier selection, drug
administration, drug regimen review, or drug or drug-related
research;
(D) performing a specific
act of drug therapy management for a patient delegated to a pharmacist by a
written protocol from a physician licensed in this state in compliance with the
Medical Practice Act Subtitle B, Chapter 157, Occupations Code;
(E) accepting the responsibility for:
(i) distributing prescription drugs and
devices with drug components pursuant to medication orders;
(ii) compounding and labeling of prescription
drugs and devices with drug components;
(iii) proper and safe storage of prescription
drugs and devices with drug components; and
(iv) maintaining proper records for
prescription drugs and devices with drug components.
(3) Special requirements for
compounding. All pharmacists engaged in compounding non-sterile preparations
shall meet the training requirements specified in §
291.131 of this title (relating to
Pharmacies Compounding Non-sterile Preparations).
(e) Pharmacy technicians and pharmacy
technician trainees.
(1) General.
(A) All pharmacy technicians and pharmacy
technician trainees shall meet the training requirements specified in §
297.6 of this title (relating to
Pharmacy Technician and Pharmacy Technician Trainee Training).
(B) A pharmacy technician performing the
duties specified in paragraph (2)(C) of this subsection shall complete training
regarding:
(i) procedures for one pharmacy
technician to verify the accuracy of actions performed by another pharmacy
technician including required documentation; and
(ii) the duties that may be performed by one
pharmacy technician and checked by another pharmacy technician.
(C) In addition to the training
requirements specified in subparagraph (A) of this paragraph, pharmacy
technicians working in a rural hospital and performing the duties specified in
paragraph (2)(D)(ii) of this subsection shall complete the following. Training
on the:
(i) procedures for verification of the
accuracy of actions performed by pharmacy technicians including required
documentation;
(ii) duties which
may and may not be performed by pharmacy technicians in the absence of a
pharmacist; and
(iii) pharmacy
technician's role in preventing dispensing and distribution errors.
(2) Duties. Duties may
include, but need not be limited to, the following functions under the
supervision of and responsible to a pharmacist:
(A) Facilities with 101 beds or more. The
following functions must be performed under the physically present supervision
of a pharmacist:
(i) pre-packing and labeling
unit and multiple dose packages, provided a pharmacist supervises and conducts
a final check and affixes his or her name, initials or electronic signature to
the appropriate quality control records prior to distribution;
(ii) preparing, packaging, compounding, or
labeling prescription drugs pursuant to medication orders, provided a
pharmacist supervises and checks the preparation prior to
distribution;
(iii) bulk
compounding or batch preparation provided a pharmacist supervises and conducts
in-process and final checks and affixes his or her name, initials, or
electronic signature to the appropriate quality control records prior to
distribution;
(iv) distributing
routine orders for stock supplies to patient care areas;
(v) entering medication order and drug
distribution information into a data processing system, provided judgmental
decisions are not required and a pharmacist checks the accuracy of the
information entered into the system prior to releasing the order;
(vi) loading unlabeled drugs into an
automated compounding or counting device provided a pharmacist supervises,
verifies that the system was properly loaded prior to use, and affixes his or
her name, initials or electronic signature to the appropriate quality control
records;
(vii) accessing automated
medication supply systems after proper training on the use of the automated
medication supply system and demonstration of comprehensive knowledge of the
written policies and procedures for its operation; and
(viii) compounding non-sterile preparations
pursuant to medication orders provided the pharmacy technicians or pharmacy
technician trainees have completed the training specified in §
291.131 of this
title.
(B) Facilities
with 100 beds or less.
(i) Physically present
supervision. The following functions must be performed under the physically
present supervision of a pharmacist unless the pharmacy meets the requirements
for a rural hospital and has been approved by the board to allow pharmacy
technicians to perform the duties specified in §562.1011 of the Texas
Pharmacy Act and subparagraph (D)(ii) of this paragraph:
(I) pre-packing and labeling unit and
multiple dose packages, provided a pharmacist supervises and conducts a final
check and affixes his or her name, initials or electronic signature to the
appropriate quality control records prior to distribution;
(II) bulk compounding or batch preparation
provided a pharmacist supervises and conducts in-process and final checks and
affixes his or her name, initials, or electronic signature to the appropriate
quality control records prior to distribution;
(III) loading unlabeled drugs into an
automated compounding or counting device provided a pharmacist supervises,
verifies that the system was properly loaded prior to use, and affixes his or
her name, initials, or electronic signature to the appropriate quality control
records; and
(IV) compounding
medium-risk and high-risk sterile preparations pursuant to medication orders
provided the pharmacy technicians or pharmacy technician trainees:
(-a-) have completed the training specified
in §
291.133 of this title (relating to
Pharmacies Compounding Sterile Preparations); and
(-b-) are supervised by a pharmacist who has
completed the training specified in §
291.133 of this title and who
conducts in-process and final checks, and affixes his or her name, initials, or
electronic signature to the label or if batch prepared, to the appropriate
quality control records. (The name, initials, or electronic signature are not
required on the label if it is maintained in a permanent record of the
pharmacy.)
(ii)
Electronic supervision or physically present supervision. The following
functions may be performed under the electronic supervision or physically
present supervision of a pharmacist:
(I)
preparing, packaging, or labeling prescription drugs pursuant to medication
orders, provided a pharmacist checks the preparation prior to
distribution;
(II) distributing
routine orders for stock supplies to patient care areas;
(III) entering medication order and drug
distribution information into a data processing system, provided judgmental
decisions are not required and a pharmacist checks the accuracy of the
information entered into the system prior to releasing the order;
(IV) accessing automated medication supply
systems after proper training on the use of the automated medication supply
system and demonstration of comprehensive knowledge of the written polices and
procedures for its operation;
(V)
compounding non-sterile preparations pursuant to medication orders provided the
pharmacy technicians or pharmacy technician trainees have completed the
training specified in §
291.131 of this title;
and
(VI) compounding low-risk
sterile preparations pursuant to medication orders provided the pharmacy
technicians or pharmacy technician trainees:
(-a-) have completed the training specified
in §
291.133 of this title;
and
(-b-) are supervised by a
pharmacist who has completed the training specified in §
291.133 of this title, and who
conducts in-process and final checks, and affixes his or her name, initials, or
electronic signature to the label or if batch prepared, to the appropriate
quality control records. (The name, initials, or electronic signature are not
required on the label if it is maintained in a permanent record of the
pharmacy.)
(C) Facilities with an ongoing clinical
pharmacy program. A Class C pharmacy with an ongoing clinical pharmacy program
may allow a pharmacy technician to verify the accuracy of the duties specified
in clause (ii) of this subparagraph when performed by another pharmacy
technician, under the following conditions:
(i) The pharmacy technician:
(I) is a registered pharmacy technician and
not a pharmacy technician trainee; and
(II) meets the training requirements
specified in §
297.6 of this title and the
training requirements specified in paragraph (1) of this
subsection.
(ii) If the
requirements of clause (i) of this subparagraph are met, a pharmacy technician
may verify the accuracy of the following duties performed by another pharmacy
technician:
(I) filling medication
carts;
(II) distributing routine
orders for stock supplies to patient care areas; and
(III) accessing and restocking automated
medication supply systems after proper training on the use of the automated
medication supply system and demonstration of comprehensive knowledge of the
written policies and procedures for its operation; and
(iii) The patient's orders have previously
been reviewed and approved by a pharmacist.
(iv) A pharmacist is on duty in the facility
at all times that the pharmacy is open for pharmacy services.
(D) Rural Hospitals.
(i) A rural hospital may allow a pharmacy
technician to perform the duties specified in clause (ii) of this subparagraph
when a pharmacist is not on duty, if:
(I) the
pharmacy technician:
(-a-) is a registered
pharmacy technician and not a pharmacy technician trainee; and
(-b-) meets the training requirements
specified in §
297.6 of this title and those
specified in paragraph (1) of this subsection;
(II) a pharmacist is accessible at all times
to respond to any questions and needs of the pharmacy technician or other
hospital employees, by telephone, answering or paging service, e-mail, or any
other system that makes a pharmacist immediately accessible;
(III) the pharmacy is appropriately staffed
to meet the needs of the pharmacy; and
(IV) a nurse or practitioner at the rural
hospital or a pharmacist through electronic supervision as specified in
paragraph (2)(B)(ii) of this subsection, verifies the accuracy of the actions
of the pharmacy technician.
(ii) If the requirements of clause (i) of
this subparagraph are met, the pharmacy technician may, during the hours that
the institutional pharmacy in the hospital is open, perform the following
duties in the pharmacy without the direct supervision of a pharmacist:
(I) enter medication order and drug
distribution information into a data processing system;
(II) prepare, package, or label a
prescription drug according to a medication order if a licensed nurse or
practitioner verifies the accuracy of the order before administration of the
drug to the patient;
(III) fill a
medication cart used in the rural hospital;
(IV) distribute routine orders for stock
supplies to patient care areas; and
(V) access and restock automated medication
supply cabinets.
(3) Procedures.
(A) Pharmacy technicians and pharmacy
technician trainees shall handle medication orders in accordance with standard,
written procedures and guidelines.
(B) Pharmacy technicians and pharmacy
technician trainees shall handle prescription drug orders in the same manner as
those working in a Class A pharmacy.
(f) Owner. The owner of a Class C pharmacy
shall have responsibility for all administrative and operational functions of
the pharmacy. The pharmacist-in-charge may advise the owner on administrative
and operational concerns. The owner shall have responsibility for, at a
minimum, the following, and if the owner is not a Texas licensed pharmacist,
the owner shall consult with the pharmacist-in-charge or another Texas licensed
pharmacist:
(1) establishing policies for
procurement of prescription drugs and devices and other products dispensed from
the Class C pharmacy;
(2)
establishing and maintaining effective controls against the theft or diversion
of prescription drugs;
(3) if the
pharmacy uses an automated pharmacy dispensing system, reviewing and approving
all policies and procedures for system operation, safety, security, accuracy
and access, patient confidentiality, prevention of unauthorized access, and
malfunction;
(4) providing the
pharmacy with the necessary equipment and resources commensurate with its level
and type of practice; and
(5)
establishing policies and procedures regarding maintenance, storage, and
retrieval of records in a data processing system such that the system is in
compliance with state and federal requirements.
(g) Identification of pharmacy personnel. All
pharmacy personnel shall be identified as follows.
(1) Pharmacy technicians. All pharmacy
technicians shall wear an identification tag or badge that bears the person's
name and identifies him or her as a pharmacy technician.
(2) Pharmacy technician trainees. All
pharmacy technician trainees shall wear an identification tag or badge that
bears the person's name and identifies him or her as a pharmacy technician
trainee.
(3) Pharmacist interns.
All pharmacist interns shall wear an identification tag or badge that bears the
person's name and identifies him or her as a pharmacist intern.
(4) Pharmacists. All pharmacists shall wear
an identification tag or badge that bears the person's name and identifies him
or her as a pharmacist.
Notes
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No prior version found.