Kentucky State Profile
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EC PHARMACY UPDATE
HB 346, a bill to expand access to EC, was introduced in 2005. One of its provisions will allow a practitioner to authorize a pharmacist, under protocol, to provide emergency contraception directly to women who are not patients of the practitioner. While this bill died in the house in 2005, the same sponsor, Representative Thomas Burch (D), introduced HB 353 in January 2006 to similarly allow a practitioner to authorize a pharmacist, under protocol, to provide emergency contraception directly to women who are not patients of the practitioner.
Despite the fact that there is no state refusal clause for emergency contraception (EC) on the books, 37 percent of Kentucky pharmacists, according to a recent survey, would refuse to fill a prescription for EC, while nearly half of Kentucky pharmacies (just over 300) do not carry EC at all (Source: Planned Parenthood Federation of America, June 22, 2006).
From 2002 to 2004, earlier versions of the bill were introduced in the House relating to dispensing EC. HB
597 in 2002, HB
457 in 2003, and HB
87 in 2004 would have revised KRS 217.182 to permit pharmacists to dispense EC under collaborative practice with a prescriber. In 2002, the bill received a hearing but it never came to the floor for a vote. In 2003, the bill did not receive a hearing. In 2004, the bill died upon the legislature’s adjournment.
For more information, read the ACLU of Kentucky Reproductive Freedom Project’s Fall 2005 survey (PDF-12K) on EC access in Kentucky pharmacies. Advocates for Youth has provided training on EC in two parts of the State, and some pharmacists attended.
CONTACTS
Amanda Kreps-Long
Reproductive Freedom Projcet
ACLU of Kentucky
315 Guthrie Street Suite 300
Louisville, KY 40202
502-581-9746
Fax: 502-589-9687
rfp@aclu-ky.org
www.aclu-ky.org
Brad Hall
Executive Director
Kentucky Pharmacists Association
1228 U.S. 127 South
Frankfort, KY 40601-4330
502-227-2303
Fax: 502-227-2258
bradhall@kphanet.org
www.kphanet.org
Teresa Scott
Bluegrass Planned Parenthood
508 W. Second St.
Lexington, KY 40508
859-255-0385
teresa.scott@ppff.org
Director of Public Affairs
Planned Parenthood of Louisville
1025 South Second Street
Louisville, KY 40203
502-584-2471
Fax 502-584-2476
USEFUL LINKS
Kentucky Board of Pharmacy
www.state.ky.us/boards/pharmacy
Kentucky Pharmacists Association
www.kphanet.org
Kentucky Legislature
www.lrc.state.ky.us
Mountain Maternal Health League Planned Parenthood
www.mountainmaternal.org
Planned Parenthood of the Bluegrass
www.ppbg.org
PROTOCOL ENVIRONMENT
Possible Environment: Revision to Existing Authority Required
This state permits collaborative practice agreements or a similar agreement between physicians and pharmacists. However, some modification of existing statutes and/or regulations is required to allow pharmacists to initiate EC for the general community.
Pharmacist initiation of EC would require:
- Modifying the requirement for patient-specific protocols
PHARMACY PRACTICE ACT
Pharmacy Practice Act Regulatory and Statutory Authority
Note: The text presented below has been prepared by the American Pharmacists Association for the Pharmacy Access Partnership and reflects legislation or regulation promulgated as of June 15, 2003.
KENTUCKY
Pharmacists in any practice setting may administer any drug, but only pursuant to an individual prescription order written for an individual patient. No more than one pharmacist in any practice setting may enter into a collaborative care agreement with no more than one practitioner governing a specific patient that allows for initiating, adjusting, managing and discontinuing drug therapy and stipulates conditions which warrant modifications to dose, dosage regimen, dosage form, or route of administration. This agreement requires no external review, although a hospital or other health facility operated by a hospital may require review and approval of the protocol.
The scope of practice as outlined in the agreement must include:
- patient-related information;
- medical history including disease, allergies, reactions and conditions related to prescription and nonprescription regimens;
- the protocol, criteria, standing orders, or other method by which services are authorized;
- method of assessing patient outcomes;
- lab tests that may be ordered; and
- notification to patient upon termination of agreement.
The pharmacist is required to maintain documentation of lab tests ordered and results, assessments of patient outcomes, and notes relating to contacts between the pharmacist and practitioner concerning care and course of therapy. There are no limitations on disease state management opportunities.
Statutory authority: Provided in definitions of Pharmacy Practice and Collaborative Care Agreement, 26 Ky. Rev. Stat. Ann. § 315.010, § 315.040
Regulatory authority: Provided in Board of Pharmacy regulations, Ky. Admin. Reg. 201-2:074, 201-2:220
KENTUCKY STATUTES
Kentucky Statute
KRS Chapter 315.00
315.010 Definitions for chapter.
As used in this chapter, unless the context requires otherwise:
(1) Administer means the direct application of a drug to a patient or research subject by injection, inhalation, or ingestion, whether topically or by any other means;
(4) Collaborative care agreement means a written agreement between a specifically identified individual practitioner and a pharmacist who is specifically identified, whereby the practitioner outlines a plan of cooperative management of a specifically identified individual patient's drug-related health care needs that fall within the practitioner's statutory scope of practice. The agreement shall be limited to specification of the drug-related regimen to be provided and any tests which may be necessarily incident to its provisions; stipulated conditions for initiating, continuing, or discontinuing drug therapy; directions concerning the monitoring of drug therapy and stipulated conditions which warrant modifications to dose, dosage regimen, dosage form, or route of administration;
(10) Drug regimen review means retrospective, concurrent, and prospective review by a pharmacist of a patient's drug-related history, including but not limited to, the following areas:
- (a) Evaluation of prescription drug orders and patient records for:
- 1. Known allergies;
- 2. Rational therapy contraindications;
- 3. Appropriate dose and route of administration;
- 4. Appropriate directions for use; or
- 5. Duplicative therapies.
- (b) Evaluation of prescription drug orders and patient records for drug-drug, drug-food, drug-disease, and drug-clinical laboratory interactions;
- (c) Evaluation of prescription drug orders and patient records for adverse drug reactions; or
- (d) Evaluation of prescription drug orders and patient records for proper utilization and optimal therapeutic outcomes;
(13) Medical order means a lawful order of a specifically-identified practitioner for a specifically-identified patient for the patient's health care needs. Medical order may or may not include a prescription drug order;
(19) Practice of pharmacy means interpretation, evaluation, and implementation of medical orders and prescription drug orders; responsibility for dispensing prescription drug orders, including radioactive substances; participation in drug and drug-related device selection, administration of medication in the course of dispensing or maintaining a prescription drug order, and drug evaluation, utilization, or regimen review; maintenance of patient pharmacy records; and provision of patient counseling and those professional acts, professional decisions, or professional services necessary to maintain and manage all areas of a patient's pharmacy-related care, including pharmacy-related primary care as defined in this section;
(23) Pharmacy-related primary care means the pharmacists' activities in patient education, health promotion, assistance in the selection and use of over-the-counter drugs and appliances for the treatment of common diseases and injuries as well as those other activities falling within their statutory scope of practice;
KENTUCKY REGULATIONS
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: 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) Name;
- (2) Address and telephone number;
- (3) Emergency notification contact;
- (4) Date of birth, weight, height, and gender;
- (5) 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:
- (1) Lab tests ordered, including results of lab tests;
- (2) Assessments of patient outcomes;
- (3) Notes relating to contacts between the individual pharmacist and the individual practitioner concerning the care and course of therapy of the patient; and
- (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;
(2) For at least five (5) years after termination. (23 Ky.R. 3125; Am. 3807; 4109; eff. 6-16-97.)
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