Notice of Proposed Rule

DEPARTMENT OF HEALTH
Board of Pharmacy
RULE NO: RULE TITLE
64B16-26.601: Standards for Approval of Courses and Providers
PURPOSE AND EFFECT: The Board proposes the rule amendment to clarify the standards for approval of continuing education courses and providers.
SUMMARY: The rule amendment will clarify the standards for approval of continuing education courses and providers.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared.
Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.
SPECIFIC AUTHORITY: 465.005, 465.009 FS.
LAW IMPLEMENTED: 456.025(7), 465.009 FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN FAW.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Rebecca R. Poston, Executive Director, Board of Pharmacy/MQA, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3253

THE FULL TEXT OF THE PROPOSED RULE IS:

(Substantial rewording of Rule 64B16-26.601 follows. See Florida Administrative Code for present text.)

64B16-26.601 Standards for Approval of Continuing Education Courses and Providers.

(1) Providers seeking board approval shall meet each of the following:

(a) Complete the application (DOH/MQA/PH109) and submit a fee of $150.00.

(b) There shall be a visible, continuous, and identifiable authority charged with the administration of continuing education programs. The person or persons in whom the administrative function is vested shall be qualified by virtue of background, education, training and/or experience.

(c) All continuing education offerings conducted by the provider shall meet the standards outlined in subsection (3).

(d) Submit licensee continuing education course completion credits in the electronic continuing education tracking system in accordance with Florida Statute 456.025(7).

(2) Organizations or individuals seeking approval of a single course or program shall meet each of the following:

(a) Complete the application (DOH/MQA/PH 111) and submit a fee of $50.00.

(b)   All continuing education offerings under this section shall meet the standards outlined in subsection (3).

(c)   All continuing education offerings shall be submitted to the Tripartite Committee for review and approval at least 45 days in advance of the program or course.

(3) Each continuing education offering shall contain a detailed outline of the content and shall build upon Standards of Practice and a basic course or courses offered in the curricula of accredited colleges or schools of pharmacy. Continuing education may consist of post-baccalaureate degree programs offered by accredited colleges or schools of pharmacy, post-graduate studies, institutes, seminars, lectures, conferences, workshops, correspondence courses, or other such committee-approved educational methods. All offerings shall meet the following standards:

(a) Education Content Development.

1. Continuing education offerings shall involve advance planning that includes a statement of measurable educational goals and behavioral objectives.

2. Continuing education offerings shall be designed to reflect the educational needs of the pharmacist and build on the standards of practice and courses in the curricula of accredited colleges or schools of pharmacy.

3. Each continuing education offering shall be designed to explore one subject or a group of closely related subjects or standards.

(b) Methods of Delivery.

1. The method of delivery of a course shall be determined by giving appropriate consideration to such factors as educational content, objectives, and composition of the audience.

2. The method of delivery shall encourage active participation and involvement on the part of the pharmacist.

(c) Program Faculty Qualifications.

1. The program faculty for a particular continuing education offering shall be competent in the subject matter and qualified by experience.

2. An appropriate number of program faculty for each activity shall be utilized.

3. There shall be adequate personnel to assist with administrative matters and personnel with competencies outside content areas in cases where the method of delivery requires technical or other special expertise.

(d) Facilities. The facilities to be utilized shall be appropriate and adequate to the content, method of delivery, size of the audience and promote the attainment of the objectives of the offering.

(e) Evaluation.

1. The provider shall make provision for evaluation of the participants’ attainment of the stated learner objectives through in-process activities that provide a measurable demonstration of the learner’s achievement(s).

2. The provider shall develop and employ an evaluation mechanism for the purpose of allowing the participant to assess his/her achievement of personal objectives.

3. The provider shall develop and employ an evaluation mechanism that shall assess the effectiveness of the learning experiences, instructional methods, facilities, and resources used for the offering.

(f) Contact Hour Criteria.

1.The number of contact hours or Continuing Education Units (CEU) shall be determined by the provider in advance of the offering subject to approval by the committee and awarded upon the successful completion of the entire planned education experience.

2. Providers shall adhere to a uniform quantitative system of measurement for continuing education credit based on the contact hour which is defined as 50-60 minutes of participation or its equivalent and the CEU which is defined as 10 contact hours in an organized continuing pharmacy education activity under responsible sponsorship, capable direction and qualified instruction.

(g) Record Keeping.

1. Records of single course offerings shall be maintained by the provider for inspection by the Board. The records shall be adequate to serve the needs of the participants and to permit the Board to monitor for adherence to the standards for continuing education offerings as outlined in the rules.

2. An individual certificate of attendance specifying title of offering, provider number, date of offering, and number of contact hours earned shall be furnished to each participant by the provider.

3. Records shall be maintained by the provider for a minimum of four (4) years.

(4) All programs issued an Accreditation Council for Pharmacy Education (ACPE) Universal Program number from an ACPE approved provider may be deemed approved by this Board for general continuing education hours for pharmacists.

(5) Approved providers shall pay a renewal fee of $150 which shall run concurrent with the pharmacist licensure renewal period.

Specific Authority 465.005, 465.009 FS. Law Implemented 456.025(7), 465.009 FS. History–New 10-17-79, Amended 7-29-81, Formerly 21S-13.02, 21S-13.002, Amended 1-10-93, Formerly 21S-26.601, 61F10-26.601, 59X-26.601, Amended 1-29-03,_________.


NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Pharmacy
NAME OF SUPERVISOR OR PERSON WHO APPROVED THE PROPOSED RULE: Board of Pharmacy
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: February 6, 2007
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: April 13, 2007