GENERAL GOVERNMENT CABINET
KENTUCKY BOARD OF PHARMACY
(Amendment)
201 KAR 2:220. Collaborative care agreements.
RELATES TO: KRS 315.010(4), 315.040(4), 315.191(1)(a)
STATUTORY AUTHORITY: KRS 315.191(1)(a)
NECESSITY, FUNCTION, AND CONFORMITY: KRS 315.191(1)(a)
authorizes the Board of Pharmacy to promulgate administrative regulations to
regulate and control matters relating to pharmacists, pharmacist interns,
pharmacist technicians, pharmacies, wholesale distributors, and manufacturers.
This administrative regulation establishes[, consistent with the
requirements of KRS 315.191(1)(a),] minimum requirements for the
development and maintenance of collaborative care agreements between an
individual pharmacist and an individual practitioner.
Section 1. A collaborative care agreement shall:
(1) Be in writing;
(2) Be signed and dated by the:
(a) Individual practitioner;
(b) Individual pharmacist; and
(c) Patient or care giver;
(3) Provide that upon termination of the agreement the individual practitioner or individual pharmacist shall notify the patient in writing;
(4) State the method for termination of the agreement; and
(5) Contain the information specified by Section 2 of this administrative regulation.
Section 2. [Patient Information.] A collaborative
care agreement shall contain the following information [relating to the
patient]:
(1) Patient name;
(2) Patient address and telephone number;
(3) Protocol, criteria, standing orders, or other
method by which services are authorized[Emergency notification contact];
(4) The method established for the assessment of
patient outcomes, if appropriate; and[Date of birth, weight, height, and
gender;]
(5) Lab tests that may be ordered.[Prescription
regimen;
(6) Nonprescription regimen;
(7) Medical history, including:
(a) Known diseases;
(b) Known allergies;
(c) Reactions and conditions relating to:
1. Prescription regimens; and
2. Nonprescription regimens;
(8) Protocol, criteria, standing orders, or other
method by which services are authorized;
(9) The method established for the assessment of
patient outcomes, if appropriate; and
(10) Lab tests that may be ordered.]
Section 3. The following information relating to a collaborative care agreement shall be maintained by a pharmacist and shall be provided to the collaborating practitioner:
(1) Emergency notification contact;
(2) Date of birth, weight, height, and gender;
(3) Prescription regimen;
(4) Nonprescription regimen;
(5) Medical history; including:
(a) Known diseases;
(b) Known allergies; and
(c) Reactions and conditions relating to:
1. Prescription regimens; and
2. Nonprescription regimens;
(6) Lab tests ordered, including results of lab tests;
(7)[(2)] Assessments of patient
outcomes;
(8)[(3)] Notes relating to contacts
between the individual pharmacist and the individual practitioner concerning
the care and course of therapy of the patient; and
(9)[(4)] Documentation of the specific
counseling information provided to the patient or care giver.
Section 4. A collaborative care agreement, and information and records required by the provisions of this administrative regulation, shall be maintained:
(1) At the pharmacist's practice site; and
(2) For at least five (5) years after termination.
W. MICHAEL LEAKE, President
APPROVED BY AGENCY: April 9, 2008
FILED WITH LRC: April 14, 2008 at 11 a.m.
PUBLIC HEARING PUBLIC COMMENT PERIOD: A public hearing on this administrative regulation shall be held on Wednesday May 28, 2008 at 9 a.m. at the Board’s office, Spindletop Administration Building Suite 302, 2624 Research Park Drive, Lexington, Kentucky 40511. Individuals interested in attending this hearing shall notify this agency in writing by Wednesday May 21, 2008, five (5) workdays prior to this hearing, of their intent to attend. If no notification of intent to attend the hearing is received by that date, the hearing may be cancelled. This hearing is open to the public. Any person will be given an opportunity to comment on the proposed administrative regulation. A transcript of the public hearing will not be made unless a written request for a transcript is made. If you do not wish to attend the public hearing, you may submit written comments on the proposed administrative regulation. Written comments shall be accepted until 4:30p.m. Monday June 2, 2008. Send written notification of intent to attend the public hearing or written comments on the proposed administrative regulation to:
CONTACT PERSON: Michael Burleson, Executive Director, Kentucky Board of Pharmacy, Spindletop Administrative Building Suite 302, 2624 Research Park Drive, Lexington, Kentucky 40511, phone (859) 246-2820, fax (859) 246-2823.
REGULATORY IMPACT ANALYSIS AND TIERING STATEMENT
Contact person: Michael Burleson
(1) Provide a brief summary of:
(a) What this administrative regulation does: This administrative regulation allows pharmacists to provide optimal care in an efficient manner.
(b) The necessity of this administrative regulation: This regulation is necessary to comply with KRS 315.010(4), 315.040(4) and 315.191(1)(a).
(c) How this administrative regulation conforms to the content of the authorizing statues: The regulation is in conformity with the authorizing statute that requires the board to promulgate administrative regulations on all matters set forth in KRS Chapter 315.
(d) How this administrative regulation currently assists or will assist in the effective administration of the statutes: This regulation delineates the procedure utilized fro collaborative care agreements.
(2) If this is an amendment to an existing administrative regulation, provide a brief summary of:
(a) How the amendment will change this existing administrative regulation: This will allow the pharmacist to provide care with a collaborative care agreement in a more efficient manner.
(b) The necessity of the amendment to this administrative regulation: This regulation amendment will allow the pharmacist to provide care without delay.
(c) How the amendment conforms to the content of the authorizing statutes: The amendment delineates the procedure for collaborative care agreements authorized in KRS Chapter 315.
(d) How the amendment will assist in the effective administration of the statutes: It will clearly state the procedure for collaborative care agreements achieving optimal patient care and efficiency of process.
(3) List the type and number of individuals, businesses, organizations, or state and local governments affected by this administrative regulation: The board estimates that twenty (20) pharmacists that provide collaborative care agreements will be affected by this regulation and that additional pharmacists would be affected because of the improvement in efficiency provided by the amendment.
(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: The pharmacists will be able to intervene sooner with the therapy allowed pursuant to the collaborative care agreement.
(b) In complying with this administrative regulation or amendment, how much will it cost each of the entities identified in question (3): No costs.
(c) As a result of compliance, what benefits will accrue to the entities identified in question (3): This will allow pharmacists to more quickly intervene in the care of a patient pursuant to the collaborative care agreement.
(5) Provide an estimate of how much it will cost to implement this administrative regulation:
(a) Initially: No new costs will be incurred.
(b) On a continuing basis: No new costs will be incurred.
(6) What is the source of the funding to be used for the implementation and enforcement of this administrative regulation: No funding is required for implementation of this administrative regulation.
(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 to implement this regulation.
(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 increases any fees.
(9) TIERING: Is tiering applied? Tiering was not applied as the regulation is applicable to all pharmacists that utilize a collaborative care agreement.
FISCAL NOTE ON STATE OR LOCAL GOVERNMENT
1. Does this administrative regulation relate to any program, service, or requirements of a state or local government (including cities, counties, fire departments, or school districts)? Yes
2. 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.
3. Identify each state or federal statute or federal regulation that requires or authorizes the action taken by the administrative regulation. KRS 315.010(4), 315.040(4), and 315.191(1)(a) requires or authorizes the action taken by this administrative regulation.
4. 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? None
(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? None
(c) How much will it cost to administer this program for the first year? None
(d) How much will it cost to administer this program for subsequent years? None
Note: If specific dollar estimates cannot be determined, provide a brief narrative to explain the fiscal impact of the administrative regulation.
Revenues (+/-):
Expenditures (+/-):
Other Explanation: