Kentucky Administrative Regulations
Title 201 - GENERAL GOVERNMENT CABINET
Chapter 2 - Board of Pharmacy
Section 201 KAR 2:260 - Automated Pharmacy System in Residential Hospice Facilities
Universal Citation: 201 KY Admin Regs Service 2:260
Current through Register Vol. 51, No. 3, September 1, 2024
RELATES TO: KRS 315.010(9), 315.020, 315.035, 315.295, 315.300, 216B3195
NECESSITY, FUNCTION, AND CONFORMITY: KRS 335.020(1) requires that prescription drugs, medicines, and pharmaceuticals be dispensed or manufactured by a licensed pharmacist. KRS 315.295 authorizes the board to regulate an automated pharmacy system in a residential hospice facility. This administrative regulation establishes the standards for the operation of this type of system.
Section 1. Definitions.
(1) "Automated Pharmacy System"
is defined by
KRS
315.295(1)(a).
(2) "Residential Hospice Facility" is defined
by
KRS
315.295(1)(b).
Section 2. Responsibility. The pharmacist-in-charge of a pharmacy utilizing an automated pharmacy system shall be responsible for all of the following:
(1)
Assuring that the automated pharmacy system is in good working order and
accurately dispenses the correct strength, dosage form, and quantity of drug
prescribed and complying with the recordkeeping and security safeguards
pursuant to Section 3 of this administrative regulation;
(2) Assuring medications are reviewed by a
pharmacist prior to access;
(3)
Implementing an ongoing quality assurance program that monitors performance of
the automated system, which is evidenced by written policies and procedures;
and
(4) Notifying the board with
prior written notice of the installation or removal of an automated pharmacy
system. This notification shall include the following:
(a) Name and address of pharmacy;
(b) Initial location of the automated
pharmacy system. The automated pharmacy system may thereafter be relocated
within the pharmacy or health care facility without providing subsequent
notification to the board; and
(c)
Pharmacist-in-charge.
(5) Assigning, discontinuing or changing
personnel access to the system;
(6)
Assuring that access to the medications comply with state and federal laws;
and
(7) Assuring that the automated
pharmacy system is stocked accurately and that the automated pharmacy system
stock is checked monthly in accordance with established written policies and
procedures, including the following:
(a)
Accuracy;
(b) Integrity;
and
(c) Expiration date.
Section 3. Standards. An automated pharmacy system shall comply with the following provisions:
(1) A pharmacy shall maintain on-site the
following documentation relating to an automated pharmacy system:
(a) Name and address of the pharmacy or
inpatient health care facility where the system is being used;
(b) The automated pharmacy system
manufacturer's name, model, and serial number;
(c) Description of how the system is
used;
(d) Written quality assurance
procedures to determine continued appropriate use of the system; and
(e) Written policies and procedures for
system operation, safety, security, accuracy, access and malfunction.
(2) All written policies and
procedures shall be maintained in the pharmacy responsible for the automated
pharmacy system.
(3) An automated
pharmacy system shall maintain adequate security systems and procedures,
evidenced by written policies and procedures to prevent unauthorized access to
maintain patient confidentiality and to comply with federal and state
laws.
(4) Records and data kept by
the automated pharmacy system shall meet the following requirements:
(a) All events involving the contents of the
automated pharmacy system shall be recorded electronically; and
(b) Records shall be maintained by the
pharmacy and be available to the Board and shall include the following:
1. The time and location of the system
accessed;
2. Identification of the
individual accessing the system;
3.
Type of transaction;
4. Name,
strength, dosage form and quantity of drug accessed;
5. Name of the patient for whom the drug was
ordered;
6. The prescription
number;
7. The name of the
prescriber; and
8. All events
involving user database modifications shall be recorded electronically and
maintained.
(5) The stocking of all medications in the
automated pharmacy system shall be done by a pharmacist, pharmacist intern, or
pharmacy technician, who shall be under the general supervision of a pharmacist
on-site.
(6) A record of
medications stocked into an automated pharmacy system shall be maintained for
five (5) years and shall include identification of the person stocking and
pharmacist checking for accuracy.
(7) All containers of medications stored in
the automated pharmacy system shall be packaged and labeled in accordance with
federal and state laws.
(8) The
automated pharmacy system shall provide a mechanism for securing and accounting
for medications removed from and subsequently returned to the automated
pharmacy system, in accordance with federal and state laws.
(9) The automated pharmacy system shall
provide a mechanism for securing and accounting for medications returned to the
system and accounting for wasted medications in accordance with federal and
state laws.
STATUTORY AUTHORITY: KRS 315.035, 315.191(1)(a), 315.295
Disclaimer: These regulations may not be the most recent version. Kentucky may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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