| (II) provide for access to the automated pharmacy dispensing
system for stocking and retrieval of medications which is limited
to licensed healthcare professionals or pharmacy technicians acting
under the supervision of a pharmacist;
(III) require prior to use, that a pharmacist checks,
verifies, and documents that the automated pharmacy dispensing system
has been accurately filled each time the system is stocked;
(IV) provide for an accountability record to be maintained
which documents all transactions relative to stocking and removing
medications from the automated pharmacy dispensing system;
(V) require a prospective drug regimen review is conducted
as specified in subsection (c)(2) of this section; and
(VI) establish and make provisions for documentation
of a preventative maintenance program for the automated pharmacy dispensing
system.
(ii) A pharmacy which uses an automated pharmacy dispensing
system to fill prescription drug orders shall, at least annually,
review its written policies and procedures, revise them if necessary,
and document the review.
(D) Recovery Plan. A pharmacy which uses an automated
pharmacy dispensing system to fill prescription drug orders shall
maintain a written plan for recovery from a disaster or any other
situation which interrupts the ability of the automated pharmacy dispensing
system to provide services necessary for the operation of the pharmacy.
The written plan for recovery shall include:
(i) planning and preparation for maintaining pharmacy
services when an automated pharmacy dispensing system is experiencing
downtime;
(ii) procedures for response when an automated pharmacy
dispensing system is experiencing downtime; and
(iii) procedures for the maintenance and testing of
the written plan for recovery.
(E) Final check of prescriptions dispensed using an
automated pharmacy dispensing system. For the purpose of §291.32(c)(2)(D)
of this title (relating to Personnel), a pharmacist must perform the
final check of all prescriptions prior to delivery to the patient
to ensure that the prescription is dispensed accurately as prescribed.
(i) This final check shall be considered accomplished
if:
(I) a check of the final product is conducted by a
pharmacist after the automated pharmacy dispensing system has completed
the prescription and prior to delivery to the patient; or
(II) the following checks are conducted by a pharmacist:
(-a-) if the automated pharmacy dispensing system contains
bulk stock drugs, a pharmacist verifies that those drugs have been
accurately stocked as specified in subparagraph (C)(i)(III) of this
paragraph; and
(-b-) a pharmacist checks the accuracy of the data
entry of each original or new prescription drug order entered into
the automated pharmacy dispensing system.
(ii) If the final check is accomplished as specified
in clause (i)(II) of this subparagraph, the following additional requirements
must be met.
(I) The dispensing process must be fully automated
from the time the pharmacist releases the prescription to the automated
pharmacy dispensing system until a completed, labeled prescription
ready for delivery to the patient is produced.
(II) The pharmacy has conducted initial testing and
has a continuous quality assurance program which documents that the
automated pharmacy dispensing system dispenses accurately as specified
in subparagraphs (A) and (B) of this paragraph.
(III) The automated pharmacy dispensing system documents
and maintains:
(-a-) the name(s), initials, or identification code(s)
of each pharmacist responsible for the checks outlined in clause (i)(II)
of this subparagraph; and
(-b-) the name(s), initials, or identification code(s)
and specific activity(ies) of each pharmacist, pharmacy technician,
or pharmacy technician trainee who performs any other portion of the
dispensing process.
(IV) The pharmacy establishes mechanisms and procedures
to test the accuracy of the automated pharmacy dispensing system at
least every month rather than every six months as specified in subparagraph
(B) of this paragraph.
(3) Automated checking device.
(A) For the purpose of §291.32(c)(2)(D) of this
title, the final check of a dispensed prescription shall be considered
accomplished using an automated checking device provided:
(i) a check of the final product is conducted by a
pharmacist prior to delivery to the patient or the following checks
are performed by a pharmacist:
(I) the prepackaged drug used to fill the order is
checked by a pharmacist who verifies that the drug is labeled and
packaged accurately; and
(II) a pharmacist checks the accuracy of each original
or new prescription drug order.
(ii) the prescription is dispensed, labeled, and made
ready for delivery to the patient in compliance with Class A (Community)
Pharmacy rules; and
(iii) prior to delivery to the patient:
(I) the automated checking device confirms that the
correct drug and strength has been labeled with the correct label
for the correct patient; and
(II) a pharmacist performs all other duties required
to ensure that the prescription has been dispensed safely and accurately
as prescribed.
(B) If the final check is accomplished as specified
in subparagraph (A) of this paragraph, the following additional requirements
must be met.
(i) The pharmacy has conducted initial testing of the
automated checking device and has a continuous quality assurance program
which documents that the automated checking device accurately confirms
that the correct drug and strength has been labeled with the correct
label for the correct patient.
(ii) The pharmacy documents and maintains:
(I) the name(s), initials, or identification code(s)
of each pharmacist responsible for the checks outlined in subparagraph
(A)(i) of this paragraph; and
(II) the name(s) initials, or identification code(s)
and specific activity(ies) of each pharmacist or pharmacy technician
who perform any other portion of the dispensing process.
(iii) The pharmacy establishes mechanisms and procedures
to test the accuracy of the automated checking device at least monthly.
(4) Automated storage and distribution device. A pharmacy
may use an automated storage and distribution device to deliver a
previously verified prescription to a patient or patient's agent when
the pharmacy is open or when the pharmacy is closed as specified in
subsection (b)(3)(B)(iii) of this section, provided:
(A) the device is used to deliver refills of prescription
drug orders and shall not be used to deliver new prescriptions as
defined by §291.31(29) of this title (relating to Definitions);
(B) the automated storage and distribution device may
not be used to deliver a controlled substance;
(C) drugs stored in the automated storage and distribution
device are stored at proper temperatures;
(D) the patient or patient's agent is given the option
to use the system;
(E) the patient or patient's agent has access to a
pharmacist for questions regarding the prescription at the pharmacy
where the automated storage and distribution device is located, by
a telephone available at the pharmacy that connects directly to another
pharmacy, or by a telephone available at the pharmacy and a posted
telephone number to reach another pharmacy;
(F) the pharmacist-in-charge is responsible for the
supervision of the operation of the system;
(G) the automated storage and distribution device has
been tested by the pharmacy and found to dispense prescriptions accurately.
The pharmacy shall make the results of such testing available to the
board upon request;
(H) the automated storage and distribution device may
be loaded with previously verified prescriptions only by a pharmacist
or by pharmacy technicians or pharmacy technician trainees under the
direction and direct supervision of a pharmacist;
(I) the pharmacy will make the automated storage and
distribution device available for inspection by the board;
(J) the automated storage and distribution device is
located within the pharmacy building whereby pharmacy staff has access
to the device from within the prescription department and patients
have access to the device from outside the prescription department.
The device may not be located on an outside wall of the pharmacy and
may not be accessible from a drive-thru;
(K) the automated storage and distribution device is
secure from access and removal of prescription drug orders by unauthorized
individuals;
(L) the automated storage and distribution device has
adequate security system to prevent unauthorized access and to maintain
patient confidentiality; and
(M) the automated storage and distribution device records
a digital image of the individual accessing the device to pick-up
a prescription and such record is maintained by the pharmacy for two
years.
|
| Source Note: The provisions of this §291.33 adopted to be effective September 14, 1988, 13 TexReg 4306; amended to be effective February 1, 1989, 14 TexReg 453; amended to be effective September 5, 1990, 15 TexReg 4807; amended to be effective January 29, 1992, 17 TexReg 323; amended to be effective January 1, 1993, 17 TexReg 9116; amended to be effective January 4, 1994, 18 TexReg 9853; amended to be effective June 1, 1994, 19 TexReg 3921; amended to be effective December 1, 1994, 19 TexReg 9179; amended to be effective March 21, 1996, 21 TexReg 2227; amended to be effective April 7, 1997, 22 TexReg 3106; amended to be effective March 29, 2000, 25 TexReg 2575; amended to beeffective June 4, 2000, 25 TexReg 4778; amended to be effective August 31, 2000, 25 TexReg 8405; amended to be effective December 27, 2000, 25 TexReg 12690; amended to be effective June 20, 2001, 26 TexReg 4478; amended to be effective December 19, 2001, 26 TexReg 10311; amended to be effective June 1, 2002, 27 TexReg 1736; amended to be effective December 15, 2002, 27 TexReg 11537; amended to be effective June 23, 2003, 28 TexReg 4637; amended to be effective March 4, 2004, 29 TexReg 1951; amended to be effective June 6, 2004, 29 TexReg 5361; amended to be effective June 12, 2005, 30 TexReg 3208; amended to be effective June 11, 2006, 31 TexReg 4629; amended to be effective March 6, 2008, 33 TexReg 1784; amended to be effective September 7, 2008, 33 TexReg 7218; amended to be effective December 14, 2008, 33 TexReg 10027; amended to be effective March 12, 2009, 34 TexReg 1593; amendedto be effective June 7, 2009, 34 TexReg 3391; amended to be effective December 6, 2009, 34 TexReg 8691; amended to be effective May 30, 2010, 35 TexReg 4165; amended to be effective December 8, 2010, 35 TexReg 10690; amended to be effective March 10, 2011, 36 TexReg 1517; amended to be effective September 12, 2011, 36 TexReg 5847; amended to be effective June 7, 2012, 37 TexReg 4046; amended to be effective June 12, 2013, 38 TexReg 3592; amended to be effective December 10, 2013, 38 TexReg 8835; amended to be effective September 11, 2014, 39 TexReg 7094; amended to be effective December 7, 2014, 39 TexReg 9345; amended to be effective December 6, 2015, 40 TexReg 8766 |
