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; oral antivirals to be prescribed for more than ten days; or oral carbonic anhydrase inhibitors to be prescribed or administered 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. Wisconsin requires 30 hours of continuing education. 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 amending SPS 10 in order to fully enact 2005 Wisconsin Act 297. The Optometry Examining Board and the Department have opened Opt 6 and SPS 10, respectively, concurrently to accurately and consistently implement this legislative shift. Revisions were reviewed by the Optometry Examining Board and Department staff to ensure accuracy. The Pharmacy Examining Board and Medical Examining Board were informed of the rule project. 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:
Dale Kleven, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Policy Development, 4822 Madison Yards Way, P.O. Box 8366, Madison, Wisconsin 53708; telephone 608-261-4472; email at DSPSAdminRules@wisconsin.gov. Place where comments are to be submitted and deadline for submission:
The deadline for submitting comments was 8:45am on May 30, 2019.
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TEXT OF RULE
Section 1. Chapter SPS 10 is repealed and recreated to read:
USE OF PHARMACEUTICAL AGENTS BY LICENSED OPTOMETRISTS
SPS 10.01 Authority. The rules in ch. SPS 10 are adopted under the authority in ss. 449.17 (1), 449.18 (6) (cm), and 961.39, Stats., to authorize the pharmaceutical agents for use by licensed optometrists in Wisconsin. Note: To determine whether a licensed optometrist is eligible to use pharmaceutical agents under this chapter, refer to ch. Opt 6, relating to diagnostic and therapeutic pharmaceutical agents and removal of superficial foreign bodies from any eye or from an appendage to the eye. SPS 10.02 Diagnostic pharmaceutical agents. (1) A licensed optometrist, authorized in accordance with ch. Opt 6, may use topical ocular diagnostic pharmaceutical agents to determine the visual efficiency of the human visual system, including refractive and functional abilities, or to diagnose the presence of ocular disease or ocular manifestations of system disease and other departures from normal. (2) Diagnostic pharmaceutical agents include:
(a) Mydriatics.
1. Phenylephrine 2.5%.
2. Hydroxyamphetamine 1%.
(b) Cycloplegics.
1. Tropicamide 1%.
2. Cyclopentolate 1%.
(c) Topical anesthetics.
1. Benoxinate 0.4%.
2. Proparacaine 0.5%.
3. Tetracaine 0.5%.
4. Benoxinate 0.4% - Fluorescein 0.25% Combination.
(d) Dyes.
1. Fluorescein 0.25% - Benoxinate 0.4% Combination.
2. Rose Bengal.
(e) Miotics.
1. Dapiprazole HCl.
2. Pilocarpine .125%.
(f) Any drug or device that is used for an ophthalmic diagnostic purpose and that is the subject of a new drug application approved by the food and drug administration under section 505 (c) (1) of the federal food, drug and cosmetic act, 21 USC 355, as amended. (g) Any drug or device that is used for an ophthalmic diagnostic purpose and that is generally exempt from the new drug application approval requirement contained in section 505 of the federal food, drug and cosmetic act, 21 USC 355, as amended. SPS 10.03 Therapeutic pharmaceutical agents. (1) A licensed optometrist, authorized in accordance with ch. Opt 6, may prescribe or administer a drug, as specified in sub. (2), for ocular therapeutic purposes. (2) For the purposes of this chapter, therapeutic pharmaceutical agents are limited to:
(a) Oral analgesics.
1. Acetaminophen.
2. Aspirin.
3. Salicylates.
4. Schedule III, IV and V narcotic analgesics.
(b) Controlled substances in schedule II with limitations, as specified in s. 961.39 (2m), Stats. (c) Topical decongestant agents and decongestant combinations.
1. Epinephrine HCl.
2. Hydroxyamphetamine HBr.
3. Naphazoline HCl.
4. Oxymetazoline HCl.
5. Phenylephrine HCl.
6. Tetrahydrozoline HCl.
7. Combinations of the above agents with antihistamines or zinc sulfate.
(d) Antiallergy agents.
1. Topical and oral antihistamine agents in the following drug categories:
b. Ethanolamines
c. Ethylenediamines.
d. Phenothiazines.
e. Piperazines.
f. Piperidines.
g. Terfenadines.
2. Cromolyn sodium, a mast cell stabilizing agent.
(e) Artificial tear solutions, ophthalmic irrigants and ocular lubricants.
(f) Hypertonic sodium chloride, a topical hyperosmotic agent.
(g) Yellow mercuric oxide, a miscellaneous preparation and product.
(h) Topical anesthetics.
1. Benoxinate HCl.
