PROPOSED RULEMAKING
STATE BOARD OF OPTOMETRY
[49 PA. CODE CH. 23]
Therapeutic Drugs
[27 Pa.B. 4466] The State Board of Optometry (Board) proposes to amend its regulations in Chapter 23 (relating to State Board of Optometry) by: (1) adding a new definition in § 23.1 (relating to definitions); (2) amending § 23.82 (relating to continuing education hour requirements); and (3) adding new §§ 23.201 and 23.202 (relating to qualifications for certification; and application procedure), to read as set forth in Annex A.
A. Effective Date
The proposed amendments will be effective upon publication of the final-form regulations in the Pennsylvania Bulletin.
B. Statutory Authority
The proposed amendments are authorized under sections 3(b)(14) and 4.1 of the Optometric Practice and Licensure Act (63 P. S. §§ 244.3(b)(14) and 244.4a).
C. Background and Purpose
The purpose of the proposal is to implement the act of October 30, 1996 (P. L. 719, No. 129) (Act 130) effective October 30, 1996. Act 130 amended the Optometric Practice and Licensure Act (act) (63 P. S. §§ 244.1--244.12), to require, inter alia, the certification and regulation of the prescription and administration by opto- metrists of pharmaceutical agents for therapeutic purposes (therapeutic drugs). The Board is required to certify eligible optometrists in two categories. The first requires an applicant to have: (1) graduated from an accredited school of optometry where a condition for graduation is or was the successful completion of a minimum of 100 hours in therapeutic drugs; and (2) passed a licensure examination to practice optometry which included therapeutic drugs. The second requires an applicant to have: (1) completed a Board-approved course of a minimum of 100 hours in therapeutic drugs; and (2) passed an examination in therapeutic drugs prepared and administered by a qualified and approved professional testing organization.
The proposed amendments also require that therapeutic drugs which will be used by optometrists approved by the Secretary of Health.
Likewise, optometrists will be required by newly added sections to obtain 30 hours of approved continuing optometric education every 2 years beginning with license renewals in 1998. For optometrists certified to prescribe and administer therapeutic drugs, 6 of those hours must concern the prescription and administration of therapeutic drugs. Prior law required a minimum of 24 hours of continuing professional education during each biennial renewal period.
D. Description of Proposed Amendments
The ''Treatment and Management of Ocular Disease Examination'' (TMOD) is proposed to be defined in § 23.1 as the examination adopted by the Board as a prerequisite to therapeutic drug certification. The TMOD is a Nationally recognized examination in therapeutic drugs developed and administered by the National Board of Examiners in Optometry. It was first administered as a stand-alone examination in 1985, and as an integral part of the National Board Examination since April of 1993.
The minimum number of hours of required continuing education prerequisite to biennial renewal of an optometric license would be increased from 24 to 30 hours in § 23.82. The new language would also provide that for licensees certified in therapeutic drugs, at least 6 of the required 30 hours must concern the prescription and administration of pharmaceutical agents for therapeutic purposes. The new language would also clarify that completion of the 100-hour course in therapeutic drugs will satisfy the continuing education requirement for the biennial renewal period in which it is completed.
Proposed qualifications for certification in therapeutic drugs are outlined in § 23.201. The section establishes two categories of certification consistent with Act 130. Category 1 applies to applicants licensed by examination to practice optometry in this Commonwealth on or after April 1993. Those persons would be required to: (1) have graduated from an accredited optometric educational institution where a condition for graduation at the time the applicant graduated was the successful completion of a minimum of 100 hours in therapeutic drugs; and (2) have obtained a passing score on one of the following examinations taken on or after April 1993: the TMOD portion of Part II (Clinical Sciences) of the National Board Examination, the TMOD standing alone or an examination for licensure in another jurisdiction which required a passing score on therapeutic drugs. Category 2 certification is available to applicants who were licensed by examination to practice optometry in this Commonwealth before April 1993 or licensed by reciprocity. Those applicants would be required to: (1) successfully complete a course offered subsequent to October 30, 1996, by an accredited optometric educational institution in the United States or Canada, consisting of a minimum of 100 hours in the prescription and administration of pharmaceutical agents for therapeutic purposes; and (2) obtain a passing score on the TMOD taken subsequent to completion of the 100-hour course.
Proposed § 23.202 would set forth the application procedure under each category. It will also provide that applicants for licensure as optometrists by examination in this Commonwealth after the effective date of these proposed amendments will automatically qualify for certification in therapeutic drugs.
During the course of its predrafting deliberations on the implementation of Act 130, the Board received input from various interested parties, including the Chairperson of the House Professional Licensure Committee, Honorable Mario J. Civera, Jr.. Chairperson Civera advised that the legislative intent behind Act 130 would permit recent graduates, for example, those who graduated from optometric college and who took and passed the National licensure examination which included therapeutic drugs as a standard component in the early 1990's, to be certified in therapeutic drugs without further training. The Legislature further intended, he noted, that current training programs and examination would be required for all others seeking certification in therapeutic drugs. An interpretation of Act 130 to the contrary he opined would not implement the duty of both the Legislature and the Board to serve the public's best interest.
Although the TMOD was first given as a freestanding examination in April of 1985, it did not become a component part of the National Board Examination until April 1993. Consistent with the legislative intent expressed by Representative Civera, the Board will delineate April 1993 as the operative date subsequent to which candidates for certification in therapeutic drugs will be eligible for certification under Category 1 without completing an additional 100-hour course in therapeutic drugs. With respect to Category 2, those persons ineligible to be certified as recent graduates would be required to successfully complete a 100-hour course offered subsequent to October 30, 1996, the effective date of Act 130. Prior to that date, the Board had no authority to approve programs. The Board is satisfied that a sufficient number of 100-hour courses in therapeutic drugs are offered by the various accredited optometric educational institutions in the United States and Canada to accommodate those persons wishing certification. Those applicants would also be required to pass the TMOD subsequent to the conclusion of the course. Having passed the TMOD prior to the required current training would appear to defeat the purpose of Act 130 in assuring up-to-date competency in therapeutic pharmaceuticals.
The Board believes that these educational and examination requirements are consistent with the legislative intent to permit qualified optometrists to prescribe and administer therapeutic drugs in a safe manner.
E. Compliance with Executive Order 1996-1
In accordance with Executive Order 1996-1 (February 1, 1996), in drafting and promulgating the proposed amendments the Board solicited input from the regulated community as well as the Secretary of Health, the Pennsylvania Optometric Association, the Pennsylvania College of Optometry and the Pennsylvania Academy of Ophthalmology. The Board reviewed and incorporated many of the comments of the various individuals and professional organizations in the proposed amendments.
F. Fiscal Impact and Paperwork Requirements
The proposed amendments will have no fiscal impact on the Commonwealth or its political subdivisions. Applicants for certification in therapeutic drugs will be required to pay a small fee to cover the costs of certification. Similarly, applicants may be required to pay additional costs for specified therapeutic drug training and examinations. The public may benefit from reduced costs of health care in that optometrists will be permitted to treat minor eye diseases and conditions without multiple examinations by various health care providers.
G. Sunset Date
The Board continually monitors its regulations. Therefore, no sunset date has been assigned.
H. Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on August 14, 1997, the Board submitted a copy of these proposed amendments to the Independent Regulatory Review Commission (IRRC) and the Chairpersons of the House Professional Licensure Committee and the Senate Consumer Protection and Professional Licensure Committee. In addition to submitting the proposed amendments, the Board has provided IRRC and the Committees with a copy of a detailed Regulatory Analysis Form prepared by the Board in compliance with Executive Order 1996-1, ''Regulatory Review and Promulgation.'' A copy of this material is available to the public upon request.
If IRRC has objections to any portion of the proposed amendments, it will notify the Board within 10 days of the close of the Committees' comment period. The notification shall specify the regulatory review criteria which have not been met by that portion. The Regulatory Review Act specifies detailed procedures for review, prior to final publication of the amendments, by the Board, the General Assembly and the Governor of objections raised.
I. Public Comment
Interested persons are invited to submit written comments, suggestions or objections regarding the proposed amendments to April L. McClaine, Board Counsel, State Board of Optometry, P. O. Box 2649, 116 Pine Street, Harrisburg, PA 17105-2649, within 30 days of publication of this proposed rulemaking. Reference No. 16A-525 (Therapeutic Drugs), when submitting comments.
ROBERT A. GINSBURG, O.D.,
ChairpersonFiscal Note: 16A-525. No fiscal impact; (8) recommends adoption.
Annex A
TITLE 49. PROFESSIONAL AND VOCATIONAL STANDARDS
PART I. DEPARTMENT OF STATE
SUBPART A. PROFESSIONAL AND OCCUPATIONAL AFFAIRS
CHAPTER 23. STATE BOARD OF OPTOMETRY GENERAL PROVISIONS § 23.1. Definitions.
The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:
* * * * * TMOD--Treatment and Management of Ocular Disease Examination--An examination developed, prepared, administered and scored by the NBEO, which the Board adopts as the examination for certification in pharmaceutical agents for therapeutic purposes.
CONTINUING EDUCATION § 23.82. Continuing education hour requirements.
(a) An applicant for biennial license renewal or reactivation of license is required to complete, during the 2 years preceding renewal or reactivation, a minimum of [24] 30 hours of continuing education. For licensees certified in accordance with section 4.1 of the act (63 P.S. § 244.4a) and §§ 23.201 and 23.202 (relating to qualifications for certification; and application procedure), at least 6 of the required 30 hours shall concern the prescription and administration of pharmaceutical agents for therapeutic purposes. Completion of a course described in § 23.201(b)(1) (relating to qualification for certification) shall satisfy the continuing education requirement for the biennial renewal period in which it is completed.
* * * * *
CERTIFICATION IN PHARMACEUTICAL AGENTS FOR THERAPEUTIC PURPOSES
§ 23.201. Qualifications for certification.
(a) Category 1. To obtain certification to prescribe and administer pharmaceutical agents for therapeutic purposes, an applicant licensed by examination to practice optometry in this Commonwealth on or after April 1993, shall meet the following requirements:
(1) Graduation from an accredited optometric educational institution in the United States or Canada where a condition for graduation at the time the applicant graduated was the successful completion of a minimum of 100 hours in the prescription and administration of pharmaceutical agents for therapeutic purposes.
(2) A passing score on one of the following examinations taken on or after April 1993:
(i) The TMOD portion of Part II (Clinical Sciences) of the National Board Examination.
(ii) The TMOD.
(iii) An examination for licensure in another jurisdiction which required passing scores on the prescription and administration of pharmaceutical agents for therapeutic purposes.
(b) Category 2. To obtain certification to prescribe and administer pharmaceutical agents for therapeutic purposes, an applicant licensed by examination to practice optometry in this Commonwealth before April 1993, or licensed by reciprocity, shall meet the following requirements:
(1) Successful completion of a course offered subsequent to October 30, 1996, consisting of a minimum of 100 hours in the prescription and administration of pharmaceutical agents for therapeutic purposes offered by an accredited optometric educational institution in the United States or Canada.
(2) A passing score as determined by the NBEO on the TMOD taken subsequent to completion of the course required in paragraph (1).
§ 23.202. Application procedure.
(a) An applicant for certification under Category 1 shall submit the following to the Board:
(1) A completed application obtained from the Board together with the certification fee required by § 23.91 (relating to fees).
(2) Certification on a form provided by the Board from an accredited optometric educational institution in the United States or Canada that the applicant graduated from the institution and that a condition for the applicant's graduation was the successful completion of a minimum of 100 hours in the prescription and administration of pharmaceutical agents for therapeutic purposes.
(3) Certification from the NBEO that the applicant obtained a passing score on the TMOD portion of Part II (Clinical Sciences) of the National Board Examination taken on or after April 1993 or a passing score on the TMOD taken on or after April 1993, or certification on a form provided by the Board from the appropriate licensing authority of another jurisdiction that the applicant obtained a passing score on a licensing examination in that jurisdiction taken on or after April 1993 which required a passing score on the prescription and administration of pharmaceutical agents for therapeutic purposes at the time the applicant passed the examination.
(b) An applicant for certification under Category 2 shall submit the following to the Board:
(1) A completed application obtained from the Board together with the certification fee required by § 23.91.
(2) Certification on a form provided by the Board from an accredited optometric educational institution in the United States or Canada that the applicant has successfully completed its course offered subsequent to October 30, 1996, consisting of a minimum of 100 hours in the prescription and administration of pharmaceutical agents for therapeutic purposes.
(3) Certification from the NBEO that the applicant has obtained a passing score on the TMOD taken after completion of the course.
(c) On and after ____ (Editor's Note: The blank refers to the effective date of adoption of this proposal), applicants for licensure as optometrists by examination who meet the qualifications, including a passing score on the TMOD portion of Part II (Clinical Sciences) of the National Board Examination and graduation from an accredited optometric educational institution in the United States or Canada shall be certified to prescribe and administer pharmaceutical agents for therapeutic purposes without further application.
[Pa.B. Doc. No. 97-1400. Filed for public inspection August 29, 1997, 9:00 a.m.]
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