GENERAL GOVERNMENT CABINET
Kentucky Board of Pharmacy
(As Amended at ARRS, May 14, 2013)
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[
requires] 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
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
compounding robotics] from which
medications are prepared for final distribution that require the approval of a
pharmacy" means that portion of an acute care hospital licensed pursuant
under] 902 KAR 20:016 or a pharmacy serving an other[ another]
organized health care facility [ which is]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.
"Investigational drug" means a drug that[ any drug
which] has not been approved for use in the United States, but for
which an investigational drug application has been approved by the FDA.
organized health care facility" means a facility:
(a) With a primary purpose[
primary purpose is] to provide medical care and treatment to
(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[
under] 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.
(4)] "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[ they]
Section 2. Pharmacy Administration. (1) General.
(a) The pharmacy,
organized as a separate department or service, shall be directed by a [
competent, legally qualified]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.
(2) Director of
pharmacy services. (a) The director of pharmacy
services shall be thoroughly knowledgeable about institutional pharmacy
practice and management. (b)] If the director of pharmacy services
is not employed full time, the institution shall establish an ongoing
arrangement in writing with a[ an appropriately qualified]
pharmacist to provide services required by this administrative regulation and
The director of
pharmacy services shall be responsible to the chief executive officer of the
institution or his designee. (c)] 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.
(a) The institutional pharmacy shall
maintain additional pharmacists in cooperation with the institution's
administration, either full time or part time, as [
to operate safely and effectively to meet the needs of the patients.
(b) If nonpharmacist personnel are
employed, nonpharmacist personnel[
perform all duties under the supervision of a pharmacist and [ they]shall
not be assigned and shall not perform[ , nor shall they perform,]
duties that are to be performed only by a pharmacist[ pharmacists].
(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.
(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.
(a) The services of a pharmacist shall
be available continuously.[
at all times. However,]
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[
key] 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;
(c) Drug interactions;
(d) Parenteral drug compatibility; and
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[ e.g.], 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[
licensees] shall comply with U.S.P. Standards established pursuant to
federal law and all state and federal laws and regulations regarding labeling
(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.
(a) Drugs shall be administered only upon order of a licensed medical practitioner.
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[
regarding] 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[
is still in date].
(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
e.g.], 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[
documentation maintained to insure that no unusable items are present and that
all stock items are] 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[
drugs subjected to a recall].
(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 [
(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[
insure] 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:
(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[
robotics] 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
the hospital licensed under]
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
(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:
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[
robotics] 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.
JOEL THORNBURY, President
APPROVED BY AGENCY: March 27, 2013
FILED WITH LRC: April 15, 2013 at noon
CONTACT PERSON: Michael Burleson, Executive Director, Kentucky Board of Pharmacy, State Office Building Annex, Suite 300, 125 Holmes Street, Frankfort, Kentucky 40601, phone (502) 564-7910, fax (502) 696-3806.