GENERAL GOVERNMENT CABINET

Kentucky Board of Pharmacy

(Amended After Comments)

 

††††† 201 KAR 2:380. Board authorized protocols.

 

††††† RELATES TO: KRS 315.010(25)[(24)], 315.191(1)(a), (f)

††††† STATUTORY AUTHORITY: KRS 315.010(25)[(24)], 315.191(1)(a), (f)

††††† NECESSITY, FUNCTION, AND CONFORMITY: KRS 315.010(24) defines prescription drug order, which includes orders issued through protocols authorized by the board. KRS 315.191(1)(a) authorizes the board to promulgate administrative regulations necessary to regulate and control all matters pertaining to pharmacists, pharmacist interns, pharmacy technicians, and pharmacies. KRS 315.191(1)(f) authorizes the board to promulgate administrative regulations that are necessary to control the dispensing of prescription drug orders. This administrative regulation establishes procedures for board authorized protocols by which pharmacists may initiate the dispensing of non-controlled medications or other professional services.

 

††††† Section 1. Definition. (1) "Prescriber" means any individual authorized to prescribe a legend drug.

 

††††† Section 2. Procedures. (1) Pharmacists may initiate the dispensing of noncontrolled medications, over-the-counter medications, or other professional services under the following conditions:(a) A prescriber-approved protocol that meets the minimum requirements as set forth by the board is in place, and is dated and signed by the prescriber and pharmacists authorized to initiate the dispensing of noncontrolled medications, over-the-counter medications, or other professional services;

††††† (b) The protocol has been approved by the board; [and]

††††† (c) The pharmacist documents the dispensing event in the pharmacy management system, including:

††††† 1. Documentation as required by 201 KAR 2:170 for dispensing of prescription medication; and

††††† 2. Documentation that the individual receiving the medication or other professional service was provided with education pursuant to this administrative regulation; and[.]

††††† (d) Upon the request of an individual receiving care under a protocol, a pharmacist shall request the individualís primary care providerís information, provided one exists, and shall provide notification to the primary care provider within thirty (30) days of care.

 

††††† Section 3. Minimum Requirements of Protocol. (1) Protocols shall contain the following elements:

††††† (a) Criteria for identifying persons eligible to receive medication therapies or other professional services under the protocol, and referral to an appropriate prescriber if the patient is high-risk or treatment is contraindicated;

††††† (b) A list of the medications, including name, dose, route, frequency of administration, and refills authorized to be dispensed under the protocol;

††††† (c) Procedures for how the medications are to be initiated and monitored, including a care plan implemented in accordance with clinical guidelines;

††††† (d) Education to be provided to the person receiving the dispensed medications;

††††† (e) Procedures for documenting in the pharmacy management system all medications dispensed, including notification of the prescriber[physician] signing the protocol, if requested;

††††† (f) Length of time protocol is in effect;

††††† (g) Date and signature of prescriber approving the protocol; and

††††† (h) Dates and signatures of pharmacists authorized to initiate dispensing of medications or other professional services under the protocol.

 

††††† Section 4. Pharmacist Education and Training Required. A pharmacist who dispenses medication pursuant to a prescriber-approved protocol shall first receive education and training in the subject matter of the protocol from a provider accredited by the accreditation council for pharmacy education or by a comparable provider approved by the board.

 

SCOTT GREENWELL, R.PH., President

††††† APPROVED BY AGENCY: September 6, 2017

††††† FILED WITH LRC: October 12, 2017 at 4 p.m.

††††† CONTACT PERSON: Steve Hart, 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, email Steve.Hart@ky.gov

 

REGULATORY IMPACT ANALYSIS AND TIERING STATEMENT

 

Contact person: Steve Hart

††††† (1) Provide a brief summary of:

††††† (a) What this administrative regulation does: This administrative regulation establishes protocol procedures for pharmacists who dispense medication through protocols.

††††† (b) The necessity of this administrative regulation: KRS 315.010(25) defines a prescription drug order to include protocols authorized by the board. This administrative regulation establishes protocols that are authorized by the board.

††††† (c) How this administrative regulation conforms to the content of the authorizing statues: KRS 315.191(1)(a) authorizes the board to promulgate administrative regulations to regulate and control all matters pertaining to pharmacists and pharmacies. KRS 315.191(1)(f) authorizes the board to promulgate administrative regulations pertaining to prescription drug orders. KRS 315.010(25) defines a prescription drug order to include protocols authorized by the board. This administrative regulation establishes criteria for protocols to be authorized by the board.

††††† (d) How this administrative regulation currently assists or will assist in the effective administration of the statutes: Prescribers, pharmacists, pharmacies, patients, and the public will be able to ascertain what is required for pharmacist dispensing of medications pursuant to protocols.

††††† (2) If this is an amendment to an existing administrative regulation, provide a brief summary of:

††††† (a) How the amendments will change this existing administrative regulation: The amendments will specify that protocols do not apply to non-controlled substances; the term "prescriber" will be consistently applied throughout the administrative regulation; a pharmacist, upon patient request, shall notify the patientís primary care provider within 30 days of care; protocols will apply to over-the-counter medications; the reference to the definition for prescription drug order is corrected; and language will be added to the Necessity, Function, and Conformity clause so that it is clear board authorized protocols are not confused with immunization or naloxone protocols referenced elsewhere in KRS Chapter 315 and 201 KAR Chapter 2.

††††† (b) The necessity of the amendment to this administrative regulation: These amendments are responsive to concerns raised during the public hearing and comment period; they should address reservations about the breadth of the boardís protocol intentions, and foster a collaborative environment within the healthcare community.

††††† (c) How the amendment conforms to the content of the authorizing statutes: The amendments tighten parameters for protocols between prescribers and pharmacists; protocols are included within the definition of prescription drug orders in KRS 315.010(25). The statutory authority is broad, but this amendment tightens the parameters for protocols in an attempt to assuage some concerns raised by physicians.

††††† (d) How the amendment will assist in the effective administration of the statutes: The amendments eliminate the dispensing of non-controlled substances and permit a pharmacist to dispense over-the-counter medications pursuant to board approved protocols. A pharmacist shall notify the patientís primary care provider within 30 days of care, upon patient request Ė this should optimize continuity of care for patients. The amendments further clarify the limitations and responsibilities of a pharmacist in the prescriber-pharmacist protocol relationship.

††††† (3) List the type and number of individuals, businesses, organizations, or state and local governments affected by this administrative regulation: The board anticipates approximately 1000 protocols will be established with this regulation.

††††† (4) Provide an analysis of how the entities identified in question (3) will be impacted by either the implementation of this administrative regulation, if new, or by the change, if it is an amendment, including:

††††† (a) List the actions that each of the regulated entities identified in question (3) will have to take to comply with this administrative regulation or amendment: Pharmacists who dispense medications pursuant to a protocol will not dispense non-controlled substances, and will notify the patientís primary care provider within 30 days of care, assuming notification is authorized by the patient.

††††† (b) In complying with this administrative regulation or amendment, how much will it cost each of the entities identified in question (3): There are no expected costs for the identities identified in question (3).

††††† (c) As a result of compliance, what benefits will accrue to the entities identified in question (3): Pharmacists will dispense medications and professional services pursuant to physician-approved protocols with the benefits of increased convenience and accessibility to medications and professional services for patients.

††††† (5) Provide an estimate of how much it will cost to implement this administrative regulation:

††††† (a) Initially: No costs will be incurred.

††††† (b) On a continuing basis: No costs will be incurred.

††††† (6) What is the source of the funding to be used for the implementation and enforcement of this administrative regulation: Board revenues from fees will be used for implementation of this administrative regulation. Enforcement of this regulation shall be accomplished through normal and customary inspections.

††††† (7) Provide an assessment of whether an increase in fees or funding will be necessary to implement this administrative regulation, if new, or by the change if it is an amendment: No increase in fees or funding will be required because of the amendments.

††††† (8) State whether or not this administrative regulation establishes any fees or directly or indirectly increases any fees: This administrative regulation does not establish fees or directly or indirectly increase any fees.

††††† (9) TIERING: Is tiering applied? Tiering was not applied because the regulation is applicable to all pharmacists that enter into a protocol for the dispensing of medications and services.

 

FISCAL NOTE ON STATE OR LOCAL GOVERNMENT

 

††††† 1. What units, parts or divisions of state or local government (including cities, counties, fire departments, or school districts) will be impacted by this administrative regulation? The Kentucky Board of Pharmacy will be impacted by this administrative regulation.

††††† 2. Identify each state or federal statute or federal regulation that requires or authorizes the action taken by the administrative regulation. KRS 315.191(1)(a) and (f) authorize the board to promulgate administrative regulations to regulate and control pharmacies, pharmacists, and prescription drug orders. KRS 315.010(24) defines prescription drug orders to include orders issued through protocols authorized by the board.

††††† 3. Estimate the effect of this administrative regulation on the expenditures and revenues of a state or local government agency (including cities, counties, fire departments, or school districts) for the first full year the administrative regulation is to be in effect.

††††† (a) How much revenue will this administrative regulation generate for the state or local government (including cities, counties, fire departments, or school districts) for the first year? This administrative regulation will not generate revenue for the Kentucky Board of Pharmacy in the first year.

††††† (b) How much revenue will this administrative regulation generate for the state or local government (including cities, counties, fire departments, or school districts) for subsequent years? This administrative regulation will not generate revenue for the Kentucky Board of Pharmacy in subsequent years.

††††† (c) How much will it cost to administer this program for the first year? No costs are required to administer this program for the first year.

††††† (d) How much will it cost to administer this program for subsequent years? No costs are required to administer this program for subsequent years.

††††† Note: If specific dollar estimates cannot be determined, provide a brief narrative to explain the fiscal impact of the administrative regulation. N/A

††††† Revenues (+/-): 0

††††† Expenditures (+/-): 0

††††† Other Explanation: