The Board proposes the rule amendment to clarify and update the requirements for seeking approval of CE courses.

 

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 and update the requirements for seeking approval of CE courses.

SUMMARY: The requirements for seeking approval of CE courses will be clarified and updated.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COST AND LEGISLATIVE RATIFICATION:

During discussion of the economic impact of the rule at its Board meeting, the Board, based upon the expertise and experience of its members, determined that a Statement of Estimated Regulatory Cost (SERC) was not necessary and that the rule amendment will not require ratification by the Legislature. No person or interested party submitted additional information regarding the economic impact at that time. The Board has determined that this rule will not have an adverse impact on small business, or likely increase regulatory costs in excess of $200,000 in the aggregate within 1 year after implementation of the rule.

Any person who wishes to provide information regarding the statement of estimated costs, or to provide a proposal for a lower regulatory cost alternative must do so in writing within 21 days of this notice.

RULEMAKING 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 THE FAW.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Mark Whitten, Executive Director, Board of Pharmacy/MQA, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3254

 

THE FULL TEXT OF THE PROPOSED RULE IS:

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

(1) Providers seeking board approval for General Continuing Education courses shall meet each of the following:

(a) Complete the approved application form DOH/MQA/PH109, (Rev. 02/09), entitled Board of Pharmacy Provider Approval application, which is incorporated by reference, and which can be obtained from the Board of Pharmacy, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3254, or from the website located at http://www.doh.state.fl.us/mqa/pharmacy 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 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 Section 456.025(7), F.S.

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

(a) Complete the application DOH/MQA/PH111, (Rev. 02/09), entitled Individual Request for Approval of Continuing Education, which is incorporated by reference, and which may be obtained from the Board of Pharmacy, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3254 or from the website located at http://www.doh.state.fl.us/mqa/pharmacy.

(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 experience.

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

(d) 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.

(e) All approved continuing education offerings under this section are valid for one biennium.

(3)(1) Each continuing education offering shall proposal for program or course approval submitted by a qualified provider must contain a detailed outline of the content of said program or course on forms which will be provided by the Board of Pharmacy upon request, and shall must 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.

(2) All offerings shall must meet the following standards:

(a) Education Content Development.

1. No change.

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

3. Continuing education offerings for registered pharmacy technicians shall be designed to reflect the educational needs of the pharmacy technician and build on the standards for practice and courses in the curricula of Board-approved training programs for registered pharmacy technicians,

4.3. No change.

(b) Methods of Delivery.

1. through 2. No change.

(c) Program Faculty Qualifications.

1. through 3. No change.

(d) Facilities.

1. No change.

(e) Evaluation. The provider must 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).

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

2.3. The provider shall develop and employ an evaluation mechanism that will 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. The CEU 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 individual 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. No change.

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

(3) Providers seeking board approval shall meet each of the standards outlined herein:

(a) All continuing education offerings conducted by the provider shall meet the standards for continuing education offerings as outlined in these rules.

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

(4) All programs approved by the Accreditation Council on Pharmacy Education (ACPE) are for continuing education for pharmacists may be deemed approved by this Board for general continuing education hours for pharmacists.

(5) Entities or individuals who wish to become Aapproved providers of continuing education must submit an initial approval fee of $150 and provide information to demonstrate compliance with the requirements of this rule. A provider seeking to renew approved provider status shall pay a renewal fee of $150. The renewal period for approved providers shall run concurrent with the pharmacist licensure renewal period. Approved providers will be subject to the audit provided for in Rule 64B16-26.600, F.A.C. and must maintain compliance with these audit requirements.

(6) Entities or individuals applying for approval of an individual program shall submit a fee of $50 and the individual program shall only be approved for one biennium and provide information to demonstrate compliance with this rule.

Rulemaking 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 AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Board of Pharmacy

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: December 14, 2010

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: October 14, 2011