201 KAR 2:074. Pharmacy services in hospitals or other organized
health care facilities.
RELATES TO: KRS 315.010, 315.020,
315.030, 315.121
STATUTORY AUTHORITY: 315.002, 315.005, KRS
315.191(1)
NECESSITY, FUNCTION, AND CONFORMITY: KRS
315.191(1) authorizes the Kentucky Board of Pharmacy to establish requirements
to regulate and control pharmacies. KRS 315.002 and 315.005 require standards
of practice in all settings where drugs are handled and requires the board to
insure the safety of all drug products provided to the citizens of Kentucky.
This administrative regulation establishes requirements for pharmacy services
in hospitals or other organized health care facilities.
Section 1. Definitions. (1) "Automated
pharmacy system" means a mechanical system that performs operations or
activities, other than compounding or administration, relative to the storage,
packaging, counting, labeling, and dispensing of medications, and which
collects, controls, and maintains all transaction information and shall be either:
(a) A decentralized automated pharmacy
system that is located outside the pharmacy department, but within the same
institution, and under the supervision of a pharmacist; or
(b) A centralized automated pharmacy system
from which medications are prepared for final distribution that require the
approval of a pharmacist.
(2) "Institutional pharmacy"
means that portion of an acute care hospital licensed pursuant to 902 KAR
20:016 or a pharmacy serving an other organized health care facility engaged in
the manufacture, production, sale, or distribution of drugs, medications,
devices, or other materials used in the diagnosis or treatment of injury, illness,
or disease.
(3) "Investigational drug"
means a drug that has not been approved for use in the United States, but for
which an investigational drug application has been approved by the FDA.
(4) "Other organized health care
facility" means a facility:
(a) With a primary purpose to provide
medical care and treatment to inpatients; and
(b) That is:
1. An intermediate care facility;
2. A skilled nursing facility;
3. A hospital other than an acute care
hospital licensed pursuant to 902 KAR 20:016;
4. A licensed personal care home;
5. A licensed family care home;
6. A nursing home;
7. A nursing facility;
8. An intermediate care facility for
mental retardation; or
9. An Alzheimer's nursing home.
(5) "Unit dose distribution"
means a system in which drug therapy profiles are maintained in the pharmacy
and doses are scheduled, prepared, and delivered in a ready-to-administer form
to the patient care area as the doses are needed.
Section 2. Pharmacy Administration. (1)
General.
(a) The pharmacy, organized as a separate
department or service, shall be directed by a pharmacist, who shall be
thoroughly knowledgeable about institutional pharmacy practice and management.
(b) The director of pharmacy services
shall be responsible for departmental management and the development and
implementation of goals and objectives to meet the needs of the institution and
shall be responsible to the chief executive officer of the institution or the
chief executive officer’s designee.
(c) If the director of pharmacy services
is not employed full time, the institution shall establish an ongoing
arrangement in writing with a pharmacist to provide services required by this
administrative regulation and KRS 315.020(1).
(d) If a hospital pharmacy is
decentralized, each decentralized section or separate organizational element
shall be under the immediate supervision of a pharmacist responsible to the
director of pharmacy services.
(2) Pharmacy personnel.
(a) The institutional pharmacy shall
maintain additional pharmacists in cooperation with the institution's
administration, either full time or part time, as required to operate safely
and effectively to meet the needs of the patients.
(b) If nonpharmacist personnel are
employed, nonpharmacist personnel shall perform all duties under the
supervision of a pharmacist and shall not be assigned and shall not perform
duties that are to be performed only by a pharmacist.
(3) Responsibilities.
(a)1. Lines of authority and areas of
responsibility within the pharmacy shall be clearly defined.
2. Written job descriptions for all
categories of pharmacy personnel shall be prepared and revised as necessary.
(b)1. There shall be policies and
procedures to provide for selection of drugs as well as a distribution system
to serve the needs of the patient.
2. Provision for procurement of drugs in
an emergency situation shall be provided for.
(4) Supportive personnel.
(a) Sufficient supportive personnel
(technical, clerical, and other) shall be available in order to optimize the
participation of pharmacists in activities requiring professional judgment.
(b) The training and supervision of
supportive personnel shall be the responsibility of the pharmacist.
(5) Availability.
(a) The services of a pharmacist shall be
available continuously. If around-the-clock operation of the pharmacy is not
feasible, the pharmacist shall be available on an on-call basis, and an
adequate night drug cabinet shall be established. The pharmacy itself shall not
be designated as the night drug cabinet.
(b) A hospital not having a full-time
pharmacist, but in which drugs are prepackaged or relabeled or transferred from
one (1) container to another, shall obtain a pharmacy permit and have at least
a part-time pharmacist designated to perform those functions or to provide
personal supervision of those functions.
Section 3. Physical Facility. (1) The
institutional pharmacy shall have adequate space, equipment, and supplies
sufficient to provide for safe and efficient drug storage, preparation, and
distribution, patient education and consultation, drug information services,
and proper management of the department.
(2) Legal requirements. The physical
facility shall meet state and federal regulations and shall be accessible by
authorized pharmacy personnel only.
(3)(a) A currently licensed hospital
shall be exempt from the provisions of subsection (2) of this section if it:
1. Is authorized by the Department for
Health and Human Services to provide pharmacy services; and
2. Does not currently possess a pharmacy
permit.
(b) A currently licensed hospital exempt
from the provisions of subsection (2) of this section shall permit access by
authorized personnel only.
(4) Location. Locked storage or locked
medication carts shall be provided for use in each nursing unit or service
area.
(5) Reference materials. The pharmacy
shall have current pharmaceutical reference materials in accordance with 201
KAR 2:090. References related to the following subjects shall also be
available:
(a) Drug identification;
(b) Toxicology;
(c) Drug interactions;
(d) Parenteral drug compatibility; and
(e) Microbiology.
Section 4. Drug Distribution and Control.
(1) General. The institutional pharmacy shall be responsible for the
procurement, distribution, and control of all drugs and parenteral solutions
used within the institution. Policies and procedures governing these functions
shall be developed by the pharmacist with input from other involved hospital or
other organized health care facility staff (for example, nurses) and committees
(for example, pharmacy and therapeutics committee and patient care committee).
(2) Dispensing. The pharmacist shall
dispense medications only on the order of a licensed medical practitioner.
(3) Prescriber's order. The pharmacist
shall review the medication order within a reasonable amount of time.
(4) Recordkeeping. The pharmacist shall
maintain appropriate records of each medication order. The records shall be
retained for the time and in the manner prescribed by state and federal law.
(5) Patient medication profile. A
medication profile shall be maintained for all inpatients and for those
ambulatory patients routinely receiving care at the institution. The pharmacist
shall utilize this profile to properly review, schedule, prepare, and
distribute medications except in an emergency situation.
(6) Labeling and packaging.
(a) Each licensee shall comply with
U.S.P. Standards established pursuant to federal law and all state and federal
laws and regulations regarding labeling and packaging.
(b) Labeling and packaging of medications
used for outpatients shall meet the requirements of state and federal law.
(7) Dispensing. The pharmacist shall
dispense medications by the unit dose distribution system if feasible. If the
unit dose distribution system is not utilized, adequate safeguards shall be in
place to protect patients.
(8) Stop orders. There shall be
established written stop order policies or other methods of assuring that drug
orders are not continued inappropriately in accordance with the status of the
patient.
(9) Administration.
(a) Drugs shall be administered only upon
order of a licensed medical practitioner.
(b) The institutional pharmacy shall
participate in the establishment of policies and procedures regarding the
administration of medications. Specific procedures shall be developed in
cooperation with appropriate hospital or other health care facility personnel
and shall include personnel authorized to schedule, prepare, and administer
medications.
(10)(a) Unused medication. The
institutional pharmacy shall establish policies and procedures for the
disposition of patients' unused medications.
(b) Medication in unit dose form may be
reissued if package integrity has been maintained and the product has not
expired.
(11) Hospital floor stocks.
(a) Floor stocks of drugs shall be kept
as small as possible. The pharmacist in charge shall be responsible for
authenticating the need for floor stock.
(b) A pharmacist shall review all orders
distributed through floor stock within a reasonable amount of time.
(c) The pharmacist in charge shall be
responsible for defining those areas of the hospital requiring floor stock (for
example, emergency room, surgery, critical care, or medical or surgical wards).
(d) All drug storage areas within the
hospital shall be routinely inspected by pharmacy personnel at least monthly,
and documentation shall be maintained to ensure that:
1. Unusable items shall not be present;
and
2. All stock items shall be properly labeled
and stored.
(e) This subsection shall not apply to
other organized health care facilities.
(12) Drug recall. There shall be a system
for removing from use a drug that has been recalled.
(13) Sample medications. The
institutional pharmacy shall establish policies and procedures regarding
medical representatives and the obtaining, storage, and dispensing of
complimentary packages of medications.
(14) Emergency drugs.
(a) The institutional pharmacy shall
establish policies and procedures for supplying emergency drugs.
(b) For expediency and efficiency,
emergency drugs shall be limited in number to include only those whose prompt
use and immediate availability are generally regarded by physicians as essential
in the proper treatment of sudden and unforeseen patient emergencies.
(c) Emergency stocks shall be routinely
inspected by pharmacy personnel on a monthly basis and documentation maintained
to determine if contents have become outdated and if the stocks are being
maintained at adequate levels.
(15) Investigational drugs.
(a) Policies and procedures controlling
the use of investigational drugs (if used in the institution) shall be developed
and followed.
(b) The pharmacy shall be responsible for
storing, packaging, labeling, distributing, maintaining inventory records
(including lot numbers and expiration date), and providing information about investigational
drugs (including proper disposal).
(16) Controlled substances. All permit
holders shall comply with state and federal laws regarding controlled
substances.
Section 5. Assuring Rational Drug
Therapy. (1) Appropriate clinical information about patients shall be available
and accessible to the pharmacist for use in daily practice activities.
(2) The pharmacist shall be a member of
the pharmacy and therapeutics committee and any other committees where input concerning
the use of drugs is required.
(3) The pharmacist shall provide a means
to ensure that patients receive adequate information about the drugs they receive.
Patient education activities shall be in coordination with the nursing and
medical staffs and patient education department, if any.
Section 6. Responsibility. The pharmacist-in-charge
of a pharmacy utilizing an automated pharmacy system shall be responsible for:
(1) An initial validation of system
accuracy prior to use for distribution to patients;
(2) Ensuring the system:
(a) Is properly maintained;
(b) Is in good working order;
(c) Accurately dispenses the correct
strength, dosage form, and quantity of drug prescribed; and
(d) Complies with the recordkeeping,
access, and security safeguards pursuant to all applicable state and federal
laws;
(3) Assuring medications are reviewed
prior to loading into an automated pharmacy system and distribution;
(4) Implementing an ongoing quality
assurance program that monitors performance of the pharmacy compounding
robotics, which is evidenced by written policies and procedures and requires a
continued documented validation of doses distributed on a routine basis and
annual review of the quality assurance program;
(5) Establishing policies and procedures if
there is a system failure of an automated pharmacy system;
(6) Providing the board with prior
written notice of installation or removal of an automated pharmacy system. This
notification shall include the:
(a) Name and address of the pharmacy; and
(b) Initial location of the automated
pharmacy system;
(7) Oversight for assigning,
discontinuing, or changing personnel access to the system, including
establishment of written policies and procedures for security and control;
(8) Reviewing personnel access on at
least an annual basis;
(9) Assuring that the decentralized automated
pharmacy system stock is checked at least monthly in accordance with
established policies and procedures, including checking for:
(a) Accuracy;
(b) Integrity of packaging; and
(c) Expiration dates;
(10) Maintaining in the pharmacy the
following documentation relating to an automated pharmacy system:
(a) The 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, serial number, and software version;
(c) A description of how the system is
used;
(d) Written quality assurance procedures
and accompanying documentation of use to determine continued appropriate use of
the system as established in subsections (7) and (8) of this section; and
(e) Written policies and procedures for
system operation, safety, security, accuracy, emergency medication access,
access, and malfunction which includes clearly defined down time and
procedures; and
(11) Maintaining adequate security
systems and procedures, evidenced by written policies and procedures to:
(a) Prevent unauthorized access;
(b) Maintain patient confidentiality;
(c) Allow user access modification; and
(d) Comply with federal and state laws.
Section 7. Standards. (1) (a) All events
involving the contents of the automated pharmacy system shall be recorded
electronically.
(b) Records shall be maintained by the
pharmacy and be available to the board and shall include the following:
1. The date, 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; and
5. Name of the patient for whom the drug
was ordered, if applicable.
(2) All medications to be stocked into the
centralized automated pharmacy system shall have been previously validated for
bar code accuracy by a pharmacist, pharmacist intern, or certified pharmacy
technician. Integrity and accuracy shall be validated by a pharmacist.
(3) The stocking of medications in a
decentralized automated pharmacy system utilizing bar code technology shall be
done by a pharmacist, pharmacist intern, or a certified pharmacy technician.
(4) The stocking of medications in a
decentralized automated pharmacy system without bar code technology shall be
done by a pharmacist, pharmacist intern, or a certified pharmacy technician.
Integrity and accuracy shall be validated by a pharmacist.
(5) If a hospital licensed pursuant to
902 KAR 20:016 utilizes technology that validates appropriate drug, dose,
dosage form, route of administration, time of administration, and patient at
the exact time of medication administration, the stocking of the decentralized
automated pharmacy system shall be done by a pharmacist, pharmacist intern, or
certified pharmacy technician.
(6) A record of medications stocked in an
automated pharmacy system shall be maintained for at least five (5) years and shall
include:
(a) The name of the person repacking the medications;
and
(b) Documentation of the pharmacist
checking the medications.
(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) All medications initially received in
the pharmacy for use in an automated pharmacy system shall be quarantined until
validation of bar code accuracy and existence of the item in the database
powering automated pharmacy system by a certified pharmacy technician, pharmacist
intern, or pharmacist.
(10) If a medication needs to be repackaged:
(a) A pharmacist, pharmacist intern, or
certified pharmacy technician shall:
1. Perform the repackaging and validate
the presence of an accurate bar code on the unit dose packaging; and
2. Document the repackaging process
including:
a. Manufacturer;
b. Date and time of repackaging;
c. The person repackaging;
d. The lot number or batch number;
e. The expiration date; and
f. The quantity repackaged; and
(b) A pharmacist shall:
1. Validate for accuracy and integrity
prior to the addition to the automated pharmacy system; and
2. Document the validation including:
a. The date and time of the validation;
b. The name of the pharmacist validating;
c. The lot number or batch number;
d. The expiration date; and
e. The quantity validated.
(11) A medication returned to the
pharmacy from a patient care area shall follow the processes established
pursuant to Section 4(10) of this administrative regulation.
(12) A medication distributed by the centralized
automated pharmacy system shall be distributed in the delivery device utilized
by that system.
(13) A medication distributed by an
automated pharmacy system shall be accessed and administered by a professional
licensed to administer medications. (16 Ky.R. 1713; Am. 2150; 17 Ky.R. 2175; eff.
12-13-90; 30 Ky.R. 75; 577; eff. 8-20-2003; 39 Ky.R. 1753; 2175; 2312; eff.
6-19-2013.)
