RULES AND REGULATIONS
Title 49--PROFESSIONAL AND VOCATIONAL AFFAIRS
STATE BOARD OF OPTOMETRY
[49 PA. CODE CH. 23]
Therapeutic Drugs
[28 Pa.B. 2586] The State Board of Optometry (Board) amends 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 §§ 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 amendments will be effective upon publication in the Pennsylvania Bulletin.
B. Statutory Authority
The amendments are authorized under sections 3(b)(14) and 4.1 of the Optometric Practice and Licensure Act (act) (63 P. S. §§ 244.3(b)(14) and 244.4a).
C. Background and Purpose
The amendments implement the act of October 30, 1996 (P. L. 719, No. 129) (Act 130). Act 130 amends the act (63 P. S. §§ 244.1--244.12), to require the certification and regulation of the prescription and administration by optometrists 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.
New provisions also require optometrists to obtain 30 hours of approved continuing optometric education every 2 years beginning with license renewals in 1998. For optometrists certified in therapeutic drugs, 6 of those hours must concern the prescription and administration of these drugs. Prior law required a minimum of 24 hours of continuing education every 2 years.
Finally, Act 130 empowers the Secretary of Health to approve the drugs which a Board-certified optometrist may use. The approved therapeutic drug list will be established in separate rulemaking by the Department of Health.
D. Summary of Comments on Proposed Rulemaking and Board Responses
Notice of proposed rulemaking was published at 27 Pa. B. 4466 (August 30, 1997). The Board received comments from 97 public commentators, including the Pennsylvania Optometric Association, the Pennsylvania College of Optometry, individual optometrists, Legislators, a physician and an attorney. The House Professional Licensure Committee and the Independent Regulatory Review Commission (IRRC) also provided comments and recommendations which the Board has considered in preparing final rulemaking.
The vast majority of commentators expressed concern that the proposed amendments treated optometrists who graduated from optometric school prior to April of 1993 differently from those who graduated after April of 1993. In particular, the commentators objected to the requirement that those who graduated prior to April of 1993 take a 100-hour course in therapeutic drugs offered subsequent to October 30, 1996, as well as passing the Treatment and Management of Ocular Disease (TMOD) examination subsequent to completing the course. Both the House Committee and IRRC suggested that the Legislative intent of mandating current training and testing would be achieved by requiring optometrists who graduated prior to April of 1993 to have completed a 100-hour course in therapeutic drugs and passed the TMOD after April of 1993. Additionally, IRRC recommended that a date certain, that is, April 1, 1993, be used as the transition date.
In response to these comments and recommendations, the Board has in final rulemaking applied the April 1, 1993, transition date to all applicants for certification. Accordingly, optometrists who graduated on or after April 1, 1993, will be certified to prescribe and administer therapeutic drugs upon proof of graduation 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 successful passage of a licensure examination to practice optometry which included therapeutic drugs. Optometrists who graduated prior to April 1, 1993, will be required to complete a Board-approved course of 100 hours in therapeutic drugs offered on or after April 1, 1993, and pass the TMOD on or after April 1, 1993. The foregoing would apply to applicants for licensure by examination or by reciprocity.
In this final rulemaking, the Board has also removed the language requiring that the TMOD be passed after completion of the 100-hour course. In this way, the Board has resolved the concerns expressed by certain commentators that they would be required to retake the TMOD examination which they had already passed on or after April 1, 1993.
A number of commentators suggested that optometrists in neighboring states who were authorized by those states' licensure laws and who have been prescribing and administering therapeutic drugs in those states should be certified in this Commonwealth without having to meet additional requirements. IRRC also suggested that section 6(c) of the act (63 P. S. § 244.6(c)) provides the necessary statutory authority for the Board to issue therapeutic drug certification based on the licensure and experience of optometrists in other states.
In reviewing this suggestion, the Board carefully examined Act 130's amendments to its licensure law. The Board observed that section 6(c) of the act authorizes the Board to issue a license without examination to an applicant who has practiced in another state for a minimum of 4 years preceding application. The section does not, the Board observed, reference therapeutic drug certification, which the act identifies as a separate certification obtainable by licensed optometrists who have fulfilled the further requirements of section 4.1 of the act.
The Board further noted that IRRC's suggestion appears to run counter to the Legislative intent expressed by the House Committee. Likewise, permitting out-of-State optometrists to avoid the certification requirements of section 4.1 of the act imposed on in-State practitioners may implicate constitutional equal protection concerns.
Several commentators also suggested that the Board review individual credentials on a case-by-case basis to determine competency in the prescription and administration of therapeutic drugs. The act does not, however, provide exceptions to the certification requirements of section 4.1 of the act, nor does it authorize the Board to do case-by-case credentialing.
Additional commentators suggested that optometrist educators who have been teaching approved courses in therapeutic drugs at accredited optometric institutions be exempt from the certification requirements. The act does not, however, as the Board has noted, exempt educators or others who may otherwise be qualified to prescribe and administer therapeutic drugs.
Several commentators also suggested that prohibitions in Act 130 regarding the treatment of glaucoma and the use of steroids fail to recognize the education of optometrists in these areas. The Board cannot address these concerns because they relate solely to the Legislation and not to the Board's implementing regulations.
The Board does find merit in numerous commentators' contention that additional training and examination requirements are unnecessary for three groups of pre-1993 graduates. Those groups involve optometrists who have: (1) been prescribing therapeutic drugs in surrounding states where drug authorization is broader; (2) successfully completed more than 100 hours in therapeutic drugs both in school and through continuing education since the 1980's; or (3) passed the TMOD which has remained basically unchanged since its first administration in 1985. The final rulemaking, however, is designed to track the Legislative intent expressed by a unanimous House Committee.
E. Compliance with Executive Order 1996-1
In accordance with the requirements of Executive Order 1996-1 (February 6, 1996), in drafting and promulgating the 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 amendments.
F. Fiscal Impact and Paperwork Requirements
The 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, the 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 continuously 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 30, 1997, the Board submitted a copy of the notice of proposed rulemaking, published at 27 Pa.B. 4466 to IRRC and the Chairpersons of the House Professional Licensure Committee and the Senate Consumer Protection and Professional Licensure Committee for review and comment. In compliance with section 5(c) of the Regulatory Review Act, the Board also provided IRRC and the Committees with copies of all comments received, as well as other documentation.
In preparing these final-form regulations, the Board has considered all comments received from IRRC, the Committees and the public.
Under section 5.1(d) of the Regulatory Review Act (71 P. S. § 745.5a(d)), these final-form regulations were approved by the House Committee on April 22, 1998, and deemed approved by the Senate Committee on April 26, 1998. IRRC met on May 7, 1998, and approved the final-form regulations in accordance with section 5.1(e) of the Regulatory Review Act.
I. Public Information
Interested persons may obtain information regarding the amendments by writing to Deborah L. Smith, Board Administrator, State Board of Optometry, P. O. Box 2649, 116 Pine Street, Harrisburg, PA 17105-2649.
J. Findings
The Board finds that:
(1) Public notice of proposed rulemaking was given under sections 201 and 202 of the act of July 31, 1968 (P. L. 769, No. 240) 45 P. S. §§ 1201 and 1202) and the regulations promulgated thereunder at 1 Pa. Code §§ 7.1 and 7.2.
(2) A public comment period was provided as required by law and all comments were considered.
(3) These amendments do not enlarge the purpose of proposed rulemaking published at 27 Pa.B. 4466.
(4) These amendments are necessary and appropriate for administration and enforcement of the authorizing act identified in Part B of this Preamble.
K. Order
The Board, acting under its authorizing statute, orders that:
(a) The regulations of the Board, 49 Pa. Code Chapter 23, are amended by amending §§ 23.1 and 23.82 to read as set forth at 27 Pa.B. 4466 and by adding §§ 23.201 and 23.202 to read as set forth in Annex A.
(b) The Board shall submit this order, 27 Pa.B. 4466 and Annex A to the Office of General Counsel and to the Office of Attorney General as required by law.
(c) The Board shall certify this order, 27 Pa.B. 4466 and Annex A and deposit them with the Legislative Reference Bureau as required by law.
(d) This order shall take effect on publication in the Pennsylvania Bulletin.
JAY B. TANNER, O.D.,
Chairperson(Editor's Note: For the text of the order of the Independent Regulatory Review Commission relating to this document, see 28 Pa.B. 2463 (May 23, 1998).)
Fiscal Note: Fiscal Note 16A-525 remains valid for the final adoption of the subject regulations.
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
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 or another jurisdiction on or after April 1, 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 1, 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 or another jurisdiction before April 1, 1993, shall meet the following requirements:
(1) Successful completion of a course offered on or after April 1, 1993, 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 on or after April 1, 1993.
§ 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 1, 1993, or a passing score on the TMOD taken on or after April 1, 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 1, 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 (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 has successfully completed its course offered on or after April 1, 1993, 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 on or after April 1, 1993.
(c) On and after June 6, 1998, 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. 98-888. Filed for public inspection June 5, 1998, 9:00 a.m.]
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