(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.
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