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:
(a) Red eye.
(b) Painful eye.
(c) Decrease in vision.
(d) Pale or red swelling of the periocular or periorbital tissues.
(e) Nausea.
(f) Vomiting.
(g) Fainting.
(h) Mental confusion.
(i) Cessation of respiration.
Section 5. Opt 6.02 (1m) is repealed.
Section 6. Opt 6.02 (1e), (1n), and (1s) are created to read:
(1e) “Approved institution” means an institution approved by the board and accredited by a regional or professional accrediting organization which is recognized by the Council for Higher Education Accreditation or its successor or the federal department of education, in accordance with ss. 449.17 (1m) (b) and 449.18 (2) (a) 2., Stats. (1n) “Classroom hour" means a minimum of 50 minutes of lecture, group discussion, or laboratory. “Classroom hour” does not include time spent working in a clinic other than as part of a laboratory directly associated with a course in pharmacology.
(1s) “Course of study in pharmacology" means a course of study completed in an approved institution after 1973 in general and clinical pharmacology as it relates to optometry with the characteristics described in s. 449.17 (1m) (b), Stats. For a course, such as a continuing education course, that does not lead to a degree in optometry to qualify as part of a course of study in pharmacology, the course must include at least one examination on course content. Section 7. Opt 6.02 (3) is amended to read:
(3) “DPA" or “diagnostical diagnostic pharmaceutical agent" has the meaning given under s. SPS 10.01. means an agent authorized under s. SPS 10.02. Section 8. Opt 6.02 (4) is repealed.
Section 9. Opt 6.02 (6) is amended to read:
(6) “TPA" or “therapeutic pharmaceutical agent" has the meaning given under s. SPS 10.01. means an agent authorized under s. SPS 10.03. Section 10. Opt 6.025 and Opt 6.025 (Note) are created to read:
Opt 6.025 Adverse drug reaction referral plan. (1) An optometrist who wants to use diagnostic pharmaceutical agents authorized under s. SPS 10.02 or therapeutic pharmaceutical agents authorized under s. SPS 10.03 shall submit an adverse drug reaction referral plan prior to providing pharmaceutical agents. The plan shall be submitted to the department on an approved form in which the optometrist agrees to do all of the following: (a) Refer any patient who notifies the optometrist of an adverse drug reaction to appropriate medical specialists or facilities.
(b) Routinely advise all patients to immediately contact the optometrist if the patient experiences adverse reactions.
(c) Place in a patient's permanent record information describing any adverse drug reactions experienced by the patient and the date and time that any referral was made.
(2) The plan shall include the names of at least 3 physicians, physician clinics, or hospitals to whom the optometrist agrees to refer patients who experience an adverse drug reaction. At least one of these physicians shall be skilled in the diagnosis and treatment of diseases of the eye.
(3) An optometrist authorized to use diagnostic or therapeutic pharmaceutical agents shall file a revised adverse drug reaction referral plan with the department within 10 working days after the optometrist designates a new physician, physician clinic, or hospital to which the optometrist agrees to refer patients who experience adverse drug reactions.
(4) An optometrist authorized to use therapeutic pharmaceutical agents shall file with the department within 10 working days of its occurrence a report on any adverse drug reaction resulting from the optometrist's administration of the agents. This report shall include all of the following:
(a) The optometrist's name, address, and license number.
(b) The patient's name, address, and age.
(c) The patient's presenting problem, the diagnosis, the agent administered and the method of administration, the reaction, and the subsequent action taken.
Note: The TPA Adverse Reaction Report (Form #1728) and DPA/TPA Certification Application are available on the department’s website at dsps.wi.gov, or by request from the Department of Safety and Professional Services, P.O. Box 8935, Madison, Wisconsin 53708, or call (608) 266-2112.
Section 11. Opt 6.03 and Opt 6.04 are repealed and recreated to read:
Opt 6.03. Certificate to use diagnostic pharmaceutical agents. (1) A licensed optometrist who has submitted an adverse drug reaction referral plan in accordance with s. Opt 6.025 is authorized to use diagnostic pharmaceutical agents if any of the following applies: (a) The board initially issued a license to practice optometry to the optometrist on or after August 1, 2006.
(b) The department issued a certificate to the optometrist under s. 449.17, 2003 Stats. (c) The board issued a certificate under sub. (2) to an optometrist issued a license to practice optometry before August 1, 2006.
(2) An optometrist licensed prior to August 1, 2006 shall be certified by the board to use diagnostic pharmaceutical agents if all of the following are completed:
(a) The optometrist submits an application to the department.
(b) The optometrist submits satisfactory evidence of 60 classroom hours of a course of study that is in accordance with sub. (3) and that was completed prior to entering the examination required in par. (c).
(c) The optometrist submits satisfactory evidence of passing one of the following:
1. Section 9, ocular pharmacology, National Board of Examiners in Optometry administered only after 1981.
2. Parts I and II, National Board of Examiners in Optometry administered only after 1986.
3. An exam administered as part of the course of study under par. (b) that, as determined by the board, satisfactorily assesses competency in the subject matter described in sub. (3). The board may require additional evidence to approve the exam.
(3) A satisfactory course of study under par. (2) (b) at an approved institution shall include at least 30 classroom hours of a course of study in pharmacology and emphasizes the systemic effects of and reactions to pharmaceutical agents, including the treatment of any adverse reactions that may occur, in accordance with s. 449.17 (1m) (b), Stats. Opt 6.04. Certificate to use therapeutic pharmaceutical agents and remove foreign bodies from eyes. (1) A licensed optometrist who has submitted an adverse drug reaction referral plan in accordance with s. Opt 6.025 is authorized to use therapeutic pharmaceutical agents and remove foreign bodies from an eye or from an appendage to the eye if any of the following applies:
