| (viii) unique identification number.
(E) The practitioner, or a licensed nurse under the
supervision of the practitioner, shall give the appropriately labeled,
prepackaged drug to the patient and explain the correct use of the
drug.
(F) A perpetual record of dangerous drugs and/or controlled
substances supplied from the emergency room shall be maintained in
the emergency room. Such record shall include the following:
(i) date supplied;
(ii) practitioner's name;
(iii) patient's name;
(iv) brand name and strength of the dangerous drug
or controlled substance; or if no brand name, then the generic name,
strength, and the name of the manufacturer or distributor of the dangerous
drug or controlled substance;
(v) quantity supplied; and
(vi) unique identification number.
(G) The pharmacist-in-charge, or staff pharmacist designated
by the pharmacist-in-charge, shall verify the correctness of this
record at least once every seven days.
(i) Radiology departments.
(1) During the times a pharmacist is on duty, any prescription
drugs dispensed to an outpatient, including radiology department patients,
may only be dispensed by a pharmacist.
(2) When a pharmacist is not on duty, the following
procedures shall be observed in supplying prescription drugs from
the radiology department.
(A) Prescription drugs may only be supplied to patients
who have been scheduled for an x-ray examination at the facility.
(B) Prescription drugs may only be supplied in accordance
with the system of control and accountability for prescription drugs
administered or supplied from the radiology department and supervised
by the pharmacist-in-charge or staff pharmacist designated by the
pharmacist-in-charge.
(C) Only prescription drugs listed on the radiology
drug list may be supplied; such list shall be developed by the pharmacist-in-charge
and the facility's radiology committee (or like group or persons responsible
for policy in that department) and shall consist of drugs for the
preparation of a patient for a radiological procedure.
(D) Prescription drugs may only be supplied in prepackaged
quantities in suitable containers and prelabeled by the institutional
pharmacy with the following information:
(i) name and address of the facility;
(ii) directions for use;
(iii) name and strength of the prescription drug--if
generic name, the name of the manufacturer or distributor of the prescription
drug;
(iv) quantity;
(v) facility's lot number and expiration date; and
(vi) appropriate ancillary label(s).
(E) At the time of delivery of the prescription drug,
the practitioner or practitioner's agent shall complete the label
with the following information:
(i) date supplied;
(ii) name of physician;
(iii) name of patient; and
(iv) unique identification number.
(F) The practitioner or practitioner's agent shall
give the appropriately labeled, prepackaged prescription drug to the
patient.
(G) A perpetual record of prescription drugs supplied
from the radiology department shall be maintained in the radiology
department. Such records shall include the following:
(i) date supplied;
(ii) practitioner's name;
(iii) patient's name;
(iv) brand name and strength of the prescription drug;
or if no brand name, then the generic name, strength, dosage form,
and the name of the manufacturer or distributor of the prescription
drug;
(v) quantity supplied; and
(vi) unique identification number.
(H) The pharmacist-in-charge, or a pharmacist designated
by the pharmacist-in-charge, shall verify the correctness of this
record at least once every seven days.
(j) Automated devices and systems.
(1) Automated compounding or counting devices. If a
pharmacy uses automated compounding or counting devices:
(A) the pharmacy shall have a method to calibrate and
verify the accuracy of the automated compounding or counting device
and document the calibration and verification on a routine basis;
(B) the devices may be loaded with unlabeled drugs
only by a pharmacist or by pharmacy technicians or pharmacy technician
trainees under the direction and direct supervision of a pharmacist;
(C) the label of an automated compounding or counting
device container shall indicate the brand name and strength of the
drug; or if no brand name, then the generic name, strength, and name
of the manufacturer or distributor;
(D) records of loading unlabeled drugs into an automated
compounding or counting device shall be maintained to show:
(i) name of the drug, strength, and dosage form;
(ii) manufacturer or distributor;
(iii) manufacturer's lot number;
(iv) expiration date;
(v) date of loading;
(vi) name, initials, or electronic signature of the
person loading the automated compounding or counting device; and
(vii) signature or electronic signature of the responsible
pharmacist; and
(E) the automated compounding or counting device shall
not be used until a pharmacist verifies that the system is properly
loaded and affixes his or her signature to the record specified in
subparagraph (D) of this paragraph.
(2) Automated medication supply systems.
(A) Authority to use automated medication supply systems.
A pharmacy may use an automated medication supply system to fill medication
orders provided that:
(i) the pharmacist-in-charge is responsible for the
supervision of the operation of the system;
(ii) the automated medication supply system has been
tested by the pharmacy and found to dispense accurately. The pharmacy
shall make the results of such testing available to the Board upon
request; and
(iii) the pharmacy will make the automated medication
supply system available for inspection by the board for the purpose
of validating the accuracy of the system.
(B) Quality assurance program. A pharmacy which uses
an automated medication supply system to fill medication orders shall
operate according to a written program for quality assurance of the
automated medication supply system which:
(i) requires continuous monitoring of the automated
medication supply system; and
(ii) establishes mechanisms and procedures to test
the accuracy of the automated medication supply system at least every
six months and whenever any upgrade or change is made to the system
and documents each such activity.
(C) Policies and procedures of operation.
(i) When an automated medication supply system is used
to store or distribute medications for administration pursuant to
medication orders, it shall be operated according to written policies
and procedures of operation. The policies and procedures of operation
shall establish requirements for operation of the automated medication
supply system and shall describe policies and procedures that:
(I) include a description of the policies and procedures
of operation;
(II) provide for a pharmacist's review and approval
of each original or new medication order prior to withdrawal from
the automated medication supply system:
(-a-) before the order is filled when a pharmacist
is on duty except for an emergency order;
(-b-) retrospectively within 72 hours in a facility
with a full-time pharmacist when a pharmacist is not on duty at the
time the order is made; or
(-c-) retrospectively within 7 days in a facility with
a part-time or consultant pharmacist when a pharmacist is not on duty
at the time the order is made;
(III) provide for access to the automated medication
supply system for stocking and retrieval of medications which is limited
to licensed healthcare professionals, pharmacy technicians, or pharmacy
technician trainees acting under the supervision of a pharmacist;
(IV) provide that a pharmacist is responsible for the
accuracy of the restocking of the system. The actual restocking may
be performed by a pharmacy technician or pharmacy technician trainee;
(V) provide for an accountability record to be maintained
which documents all transactions relative to stocking and removing
medications from the automated medication supply system;
(VI) require a prospective or retrospective drug regimen
review is conducted as specified in subsection (g) of this section;
and
Cont'd... |
