Chapter SPS 10, relating to the use of pharmaceutical agents by licensed optometrists Plain language analysis:
Section 1 is amended to include s. 961.39, Stats., which outlines the limitations on optometrists in the Uniform Controlled Substances Act. Section 2 adds two notes, one to clarify that Opt 6 is not a chapter for licensure and only applies to those already licensed by Wisconsin, and a second note to cross-reference ch. SPS 10, relating to the use of pharmaceutical agents by licensed optometrists. Sections 3 and 4 amend the definition of “adverse drug reaction,” amending to accommodate the revisions of ch. SPS 10, relating to the use of pharmaceutical agents by licensed optometrists, a concurrent rule project. The definition for “adverse drug reaction” is being repealed from ch. SPS 10, so the content is being moved to ch. Opt 6. Section 5 repeals the definition for “adverse drug reaction referral plan” because the content of the definition, which previously referenced ch. SPS 10, is being recreated as s. Opt 6.025. Section 6 moves three new definitions for “approved institution,” “classroom hour,” and “course of study in pharmacology” into ch. Opt 6, which was previously in ch. SPS 10. Sections 7 and 9 amend the definitions for “DPA” and “TPA” to correct the reference to the revised ch. SPS 10, a concurrent rule project. Section 8 repeals the definition for “100 hours of approved study.” This definition is unnecessary and the content has been directly incorporated into the recreated s. Opt 6.04. Section 10 creates a new section in ch. Opt 6 for the Adverse Drug Reaction Referral Plan, this information is moved from ch. SPS 10. It also adds a note to s. Opt 6.025 to state where a user can get the forms necessary to comply with s. Opt 6.025, Adverse Drug Reaction Referral Plan. Section 11 repeals ss. Opt 6.03 and Opt 6.04 and recreates them. Section Opt 6.03 was a repeat of s. 449.17, Stats. The recreated s. Opt 6.03 distills the statutory language to the process and procedure used by the Optometry Examining Board in certifying optometrists for DPA. Section Opt 6.04 was a repeat of s. 449.18, Stats. The recreated s. Opt 6.04 distills the statutory language to the process and procedure used by the Optometry Examining Board in certifying optometrists for TPA and to remove foreign bodies from eyes. Section 12 moves a section from ch. SPS 10 into ch. Opt 6 for Prescribing Therapeutic Pharmaceutical Agents. Summary of, and comparison with, existing or proposed federal regulation:
The federal government schedules therapeutic pharmaceutical agents through the Controlled Substances Act, which categorizes optometrists as mid-level practitioners under Title 21, Code of Federal Regulations, Section 1300.01.
Comparison with rules in adjacent states:
Illinois:
Under Illinois law, optometrists may prescribe Schedule II (hydrocodone products only), III, IV, and V controlled substances and ocular pharmaceutical agents to patients without consulting a physician unless the patient is under 5 years of age. Ocular pharmaceutical agents include topical anesthetics, topical mydriatics, topical cycloplegics, topical miotics and mydriatic reversing agents, anti-infective agents, anti-allergy agents, anti-glaucoma agents (except oral carbonic anhydrase inhibitors, which may be prescribed only in a quantity sufficient to provide treatment for up to 30 days), anti-inflammatory agents (except oral steroids, which may be prescribed only in a quantity sufficient to provide treatment for up to 7 days), over-the-counter agents, analgesic agents, anti-dry eye agents, and agents for the treatment of hypotrichosis. The authority to prescribe a Schedule III, IV, or V controlled substance shall include analgesic agents only in a quantity sufficient to provide treatment for up to 72 hours. The prescription of a Schedule II controlled substance is prohibited, except for Dihydrocodeinone (Hydrocodone) with one or more active, non-narcotic ingredients only in a quantity sufficient to provide treatment for up to 72 hours, and only if such formulations of Dihydrocodeinone are reclassified as Schedule II by federal regulation. The Illinois Optometric Licensing and Disciplinary Board may recommend additional pharmaceutical agents approved by the FDA to the Department of Financial and Professional Regulation, and the Department shall promulgate rules to allow for the prescribing or administering pharmaceutical agents. See 225 ILCS 80/15.1.
The requirements for licensure and certification to use diagnostic and therapeutic pharmaceutical agents in Illinois are substantially equivalent to the requirements in Wisconsin. Both Illinois and Wisconsin require applicants to complete specialized course work relating to the use of diagnostic and therapeutic pharmaceutical agents and to pass a qualifying examination. In reference to continuing education, Illinois requires licensees to complete 24 hours of continuing education. Optometrists who are certified to use therapeutic ocular pharmaceuticals are required to complete an additional 6 hours of continuing education in the treatment of ocular disease. Illinois’s administrative rules relating to the practice are found in Title 68: Professions and Occupations, Chapter VII: Department of Financial and Professional Regulation Part 1320, Optometric Practice Act of 1987.
Iowa:
Under Iowa law, the Board of Optometry Examiners is part of the Department of Public Health. An optometrist licensed by the Board of Optometry Examiners may employ all diagnostic and therapeutic pharmaceutical agents for the purpose of diagnosis and treatment of conditions of the human eye and adnexa, excluding the use of injections other than to counteract an anaphylactic reaction, and may without charge supply any of the above pharmaceuticals to commence a course of therapy. Iowa Code § 154.1 3. and 4. Optometrists can prescribe oral medications including antibiotics, antivirals, and DMARDs, prescribe Schedule II, III, IV, and V drugs, and prescribe oral steroids (for a maximum of 14 days) without consultation of a physician. The Board of Pharmacy reviews requests for additions to the controlled substances schedules, and the Board’s decision will amend Iowa Code section 124.201, subs. 4. 657-10.37, Iowa Admin. Code.
The requirements for licensure and certification to use diagnostic and therapeutic pharmaceutical agents in Iowa are substantially similar to the requirements in Wisconsin. Both Iowa and Wisconsin require applicants to complete specialized course work relating to the use of diagnostic and therapeutic pharmaceutical agents and to pass a qualifying examination. In reference to continuing education, Iowa and Wisconsin require licensees to complete course work every two years in order to renew their credentials. Iowa requires optometrists who are not certified to use therapeutic pharmaceutical agents to complete 30 hours of continuing education, and optometrists who are certified to use therapeutic pharmaceutical agents to complete 50 hours of continuing education. Iowa’s administrative rules relating to the practice of optometry are found in their chapters 179 to 183.
Michigan:
In Michigan, the Board of Optometry requires optometrists to be certified to administer topical ocular diagnostic pharmaceutical agents and to prescribe therapeutic pharmaceutical agents. R 338.315 and R 338.317. The authority to prescribe or administer pharmaceutical agents includes Schedule III, IV, and V drugs and dihydrocodeinone combination drugs. See 333.17401 (f), Michigan Stats. A controlled substances license is required to prescribe controlled substances. A management and emergency plan is also required. See Article 7 of Public Act 3.68 of 1978, as amended.
The requirements for licensure and certification to use diagnostic and therapeutic pharmaceutical agents in Michigan are substantially equivalent to the requirements in Wisconsin. Both Michigan and Wisconsin require applicants to complete specialized course work relating to the use of diagnostic and therapeutic pharmaceutical agents and to pass a qualifying examination. In reference to continuing education, Michigan and Wisconsin require licensees to complete course work every two years in order to renew their credentials. Michigan requires 40 hours of continuing education. Michigan’s administrative rules relating to the practice of Optometry are found in their sections R. 338.211 to 338.279 (General Rules) and R 338.291 (Ethical and Unprofessional Conduct).
Minnesota:
Optometrists may prescribe or administer FDA approved drugs to aid in the diagnosis, cure, mitigation, prevention, treatment, or management of disease, deficiency, deformity, or abnormality of the human eye and adnexa included in the curricula of accredited schools or colleges of optometry, and as limited by Minnesota statute and adopted rules by the Board of Optometry. § 148.56 (a), Minn. Stats. Optometrists may not prescribe or administer Schedule II and III oral FDA approved drugs and oral steroids; prescribe oral antivirals for more than ten days; or prescribe or administer oral carbonic anhydrase inhibitors for more than seven days. § 148.56 (b), Minn. Stats. The Board of Pharmacy schedules substances. § 152.02, Minn. Stats. The requirements for licensure and certification to use diagnostic and therapeutic pharmaceutical agents in Minnesota are substantially equivalent to the requirements in Wisconsin. Both states require applicants to be a graduate of an accredited college of optometry and to pass a qualifying examination in order to obtain a license. Both states allow for applicants holding equivalent licensure from another jurisdiction to apply for licensure. In addition, both Minnesota and Wisconsin require applicants to complete specialized course work relating to the use of diagnostic and therapeutic pharmaceutical agents and to pass a qualifying examination. In reference to experience required in order to obtain a certification to use therapeutic pharmaceutical agents, Minnesota requires 2 years of supervised clinical experience in differential diagnosis of eye disease or disorders as part of optometric training or one year of that experience and ten years of actual clinical experience as a licensed optometrist. Other than experience or training required in conjunction with an initial optometry degree program, Wisconsin does not require an applicant to complete experience in order to obtain a certificate to use therapeutic pharmaceutical agents. In reference to continuing education, Minnesota and Wisconsin require licensees to complete course work every two years in order to renew their credentials. Minnesota requires 40 hours of continuing education. Minnesota’s administrative rules relating to the practice of optometry are under their Chapter 6500.
Summary of factual data and analytical methodologies:
Opt 6, relating to the Use of Diagnostic and Therapeutic Pharmaceutical Agents and Removal of Superficial Foreign Bodies From an Eye or From an Appendage to the Eye, was amended in 2007 to implement 2005 Wisconsin Act 297. The legislation shifted to the Optometry Examining Board from the Department of Safety and Professional Services the authority to determine which licensed optometrists may use pharmaceutical agents. The Department is also amending SPS 10 in order to fully enact 2005 Wisconsin Act 297. Staff have opened Opt 6 and SPS 10 concurrently to accurately and consistently implement this legislative shift. Revisions were reviewed by the Optometry Examining Board and DSPS staff to ensure accuracy. Analysis and supporting documents used to determine effect on small business or in preparation of economic impact analysis:
The proposed rules were posted for a period of 14 days to solicit public comment on economic impact, including how the proposed rules may affect businesses, local government units, and individuals. No comments were received.
Fiscal Estimate and Economic Impact Analysis:
The Fiscal Estimate and Economic Impact Analysis document is attached.
Effect on small business:
These rules do not have an economic impact on small businesses, as defined in s. 227.114 (1), Stats. The Department’s Regulatory Review Coordinator may be contacted by email at Daniel.Hereth@wisconsin.gov, or by calling (608) 267-2435. Agency contact person:
Sharon Henes, Administrative Rule Coordinator, Department of Safety and Professional Services, Division of Policy Development, 4822 Madison Yards Way, P.O. Box 8366, Madison, Wisconsin 53708; telephone 608-261-2377; email at DSPSAdminRules@wisconsin.gov. ------------------------------------------------------------------------------------------------------------
TEXT OF RULE
Section 1. Opt 6.01 is amended to read:
Section 2. Opt 6.01 (Note 1) and (Note 2) are created to read:
Opt 6.01 Note: The rules in this chapter apply only to optometrists licensed by the State of Wisconsin in accordance with ch. Opt 3 or ch. Opt 4, as applicable. Note: To determine which pharmaceutical agents may be used by licensed optometrists, refer to ch. SPS 10, relating to the use of pharmaceutical agents by licensed optometrists. Section 3. Opt 6.02 (1) is renumbered Opt 6.02 (1) (intro.) and amended to read:
(1) “Adverse drug reaction" has the meaning given under s. SPS 10.01. means an adverse, physical or psychological reaction experienced by a person resulting from diagnostic or therapeutic pharmaceutical agents administered by an optometrist that occurs within 24 hours after the drug is administered. An adverse drug reaction may be indicated by symptoms that include any of the following: Section 4. Opt 6.02 (1) (a) to (i) are created to read:
