STATE OF WISCONSIN
DEPARTMENT OF SAFETY AND PROFESSIONAL SERVICES
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IN THE MATTER OF RULEMAKING : ORDER OF THE
PROCEEDINGS BEFORE THE : DEPARTMENT OF SAFETY AND
DEPARTMENT OF SAFETY AND : PROFESSIONAL SERVICES
PROFESSIONAL SERVICES : ADOPTING RULES
: (CLEARINGHOUSE RULE 19-028)
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ORDER
An order of the Department of Safety and Professional Services to repeal and recreate ch. SPS 10, relating to use of pharmaceutical agents by licensed optometrists. Analysis prepared by the Department of Safety and Professional Services.
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ANALYSIS
Statutes interpreted:
Statutory authority:
Explanation of agency authority:
Section 448.17 (5), Stats., provides that the department, “shall, after consultation with the examining board, the medical examining board and the pharmacy examining board, promulgate rules specifying the topical ocular diagnostic pharmaceutical agents which optometrists may utilize in this state.” Section 449.18 (6) (cm), Stats., provides that the department, “shall, after consultation with the examining board, the medical examining board and the pharmacy examining board, promulgate rules specifying those therapeutic pharmaceutical agents that may or may not be prescribed or administered.” Related statute or rule:
Chapter Opt 6, relating to use of diagnostic and therapeutic pharmaceutical agents and removal of superficial foreign bodies from eye or from an appendage to the eye Plain language analysis:
The definitions for “adverse drug reaction,” “adverse drug reaction referral plan,” “approved institution,” “classroom hour,” and “course of study in pharmacology” have been removed from ch. SPS 10 and inserted into the proposed order for ch. Opt 6. In order to conform the chapter to drafting standards, the definitions for “diagnostic pharmaceutical agent” and “therapeutic pharmaceutical agent” were repealed and recreated as substantive provisions.
The specific continuing education provisions, formerly included in s. SPS 10.02 (1) (a), have been repealed. Continuing education requirements have been consolidated into ch. Opt 8.
The content formerly included in ss. SPS 10.02 (1) (b) and SPS 10.02 (2) has been inserted in the proposed order for ch. Opt 6. The requirements of s. SPS 10.03 are addressed in the proposed order for ch. Opt 6. Since the authority for issuing DPA certificates has shifted from the Department to the Optometry Examining Board, s. SPS 10.04 has been repealed. 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.
Illinois designates Optometrists to meet specific requirements to prescribe or distribute each type of pharmaceutical agents, depending on when they graduated from an approved school, including Diagnostic Ocular Pharmaceuticals (TN-D-OPT), Topical Therapeutics (TN-T-OPT) and Oral Therapeutic Medications (TN-T-OPT Oral Therapeutics). Illinois also requires a separate Controlled Substance license to prescribe controlled substances, and it must be renewed annually. 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 requirements are very similar to those in Wisconsin. 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. In addition, 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. Wisconsin requires 30 hours of continuing education. 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).
