Chapter SPS 10
USE OF PHARMACEUTICAL AGENTS BY LICENSED OPTOMETRISTS
SPS 10.02 Restrictions and reports.
SPS 10.03 Statement of approval required.
SPS 10.04 Application for certificate.
SPS 10.01
SPS 10.01
Definitions. As used in the rules in this chapter:
SPS 10.01(1)
(1) "Adverse drug reaction" means an adverse, physical or psychological reaction experienced by a person resulting from diagnostic or therapeutic pharmaceutical agents administered by an optometrist which occurs within 24 hours after the drug is administered. An adverse drug reaction may be indicated by symptoms which include, but are not limited to, the following: red eye, painful eye, decrease in vision, pale or red swelling of the periocular or periorbital tissues, nausea, vomiting, fainting, mental confusion or cessation of respiration.
SPS 10.01(2)
(2) "Adverse drug reaction referral plan" means a plan submitted to the department on an approved form in which the optometrist agrees to: a) refer patients who notify the optometrist of an adverse drug reaction to appropriate medical specialists or facilities; b) routinely advise the patient to immediately contact the optometrist if the patient experiences adverse reactions; and 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. Such 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.
SPS 10.01(3)
(3) "Approved institution" means a college of optometry accredited by the American council on optometric education approved by the optometry examining board which offers a course of study in general and ocular pharmacology meeting the requirements of s.
449.17 (1m) (b), Stats., or a course of study relating to the use of therapeutic pharmaceutical agents and the removal of superficial foreign bodies from an eye or from an appendage to the eye meeting the requirements of s.
449.18 (2), Stats.
SPS 10.01 Note
Note: The optometry examining board annually reviews for approval the colleges of optometry accredited by the council on optometry education of the American optometric association or other accrediting bodies. A list of board approved colleges of optometry is available from the board upon request.
SPS 10.01(4)
(4) "Classroom hour": For the purpose of determining whether a course of study meets the requirements of s.
449.17 (1m) (b), Stats., "classroom hour" means a 50-60 minute period of lecture, group discussion or laboratory directly associated with a course in pharmacology; time spent working in a clinic other than as part of a laboratory directly associated with a course in pharmacology does not qualify as a "classroom hour".
SPS 10.01(5)
(5) "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 courses, such as continuing education courses, which do not lead to a degree in optometry to qualify as part of a course of study in pharmacology, the courses must include at least one examination on course content.
SPS 10.01(6)
(6) "DPA certificate" means a certificate issued by the department to an optometrist approving an adverse reaction referral plan submitted by the optometrist and as evidence that the optometrist has completed all requirements in
s. SPS 10.03 and is entitled to use diagnostic pharmaceutical agents in accordance with ss.
449.17 and
449.19, Stats.
SPS 10.01(8)
(8) "Diagnostic pharmaceutical agent" means any topical ocular diagnostic pharmaceutical agent which is an optometric means used 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 systemic disease and other departures from normal. "Diagnostic pharmaceutical agents" include but are not limited to:
SPS 10.01(8)(f)
(f) Any drug which is used for an ophthalmic diagnostic purpose and which 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.
SPS 10.01(8)(g)
(g) Any drug which is used for an ophthalmic diagnostic purpose and which 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 10.01(9)
(9) "TPA certificate" means a certificate granted by the optometry examining board to an optometrist as evidence that the optometrist is certified to use therapeutic pharmaceutical agents in accordance with s.
449.18, Stats.
SPS 10.01(10)
(10) "Therapeutic pharmaceutical agent" means a drug which is prescribed or administered for ocular therapeutic purposes. Therapeutic pharmaceutical agents include but are not limited to:
SPS 10.01(10)(b)7.
7. Combinations of the above agents with antihistamines or zinc sulfate.
SPS 10.01(10)(c)1.
1. Topical and oral antihistamine agents in the following drug categories.