Original Notice.

     Preproposal statement of inquiry was filed as WSR 03-13-125.

     Title of Rule: Optometrist certification for oral drugs and injectable epinephrine, WAC 246-851-570 and 246-851-600.

     Purpose: In response to 2003 authorizing legislation, these rules ensure that practitioners are qualified to use and prescribe oral medication in the practice of optometry and are qualified to administer epinephrine by injection.

     Statutory Authority for Adoption: Chapter 142, Laws of 2003, RCW 18.54.070(2).

     Statute Being Implemented: Chapter 142, Laws of 2003.

     Summary: For certification to use or prescribe drugs orally, qualified licensees must have an additional minimum of sixteen hours of didactic and eight hours of supervised clinical instruction. For certification to administer epinephrine by injection for treatment of anaphylactic shock, qualified licensees must have a minimum of four hours of didactic and supervised clinical instruction.

     Name of Agency Personnel Responsible for Drafting, Implementation and Enforcement: Judy Haenke, P.O. Box 47870, Olympia, WA 98504-7870, (360) 236-4947.

     Name of Proponent: Optometric Physicians of Washington, private.

     Rule is not necessitated by federal law, federal or state court decision.

     Explanation of Rule, its Purpose, and Anticipated Effects: These rules are being proposed to implement 2003 legislation which authorizes qualified optometrists to use or prescribe drugs administered orally and to administer epinephrine by injection for anaphylactic shock. In response to 2003 authorizing legislation, these rules ensure that practitioners are qualified to use and prescribe oral medication in the practice of optometry and are qualified to administer epinephrine by injection.

     WAC 246-851-570 Certification required for use or prescription of drugs administered orally for diagnostic or therapeutic purposes. Sets specific course requirements for didactic and supervised clinical instruction required for certification.

     WAC 246-851-600 Certification required for administration of epinephrine by injection for treatment of anaphylactic shock. Sets forth specific course requirements for didactic and supervised clinical instruction required for certification.

     Proposal does not change existing rules.

     A small business economic impact statement has been prepared under chapter 19.85 RCW.

     Chapter 142, Laws of 2003 (SSB 5226), authorizes licensed optometrists to administer, dispense, or prescribe oral drugs for diagnostic or therapeutic purposes. In order to qualify for certification to use or prescribe drugs administered orally, an optometrist must have an additional minimum of sixteen hours of didactic and eight hours of supervised clinical instruction as established by the Washington State Board of Optometry by rule. The instruction must be through an accredited institution of higher learning.

     The chapter also authorizes qualified optometrists to administer epinephrine by injection for treatment of anaphylactic shock. To qualify to administer epinephrine, an optometrist must have an additional minimum of four hours of didactic and supervised clinical instruction as established by the Washington State Board of Optometry (the board) through rule. The instruction must be through an accredited institution of higher learning.

     This provision to provide oral medication or injectable epinephrine is voluntary and not required of the licensee. It does not amend any existing rules.

     2. The Following SIC Coded Industries are Affected by These Rules Because They Hire Staff That May Require Training:

SIC	Description	Total Units		Total Employment		Smallest 90%	Largest 10%
3827	Optical instruments/lenses	4		10		N/A*	N/A*
3851	Ophthalmic goods	17		269		1.5	6
8042	Offices and clinics of optometrists	379		1627		3.7	13.5
8099	Health and allied services	93		1484		143.3	64.3

     *There are only four companies with a total of ten employees.

     I. What Are The Costs:

     The average costs for tuition for the courses to each licensee are $1200. These costs are based on courses currently being proposed by the Optometric Physicians of Washington, a state professional organization.

TRAINING COURSE	LENGTH	TUITION COST
Didactic training for drugs administered orally.	16 hours	$460.00
Clinical training for drugs administered orally.	8 hours	$440.00
Didactic and supervised clinical instruction/ epinephrine.	4 hours	$300.00
Total	28 hours	$1200.00

     The Optometric Physicians of Washington estimate that five hundred licensees will obtain the voluntary endorsements to use and prescribe drugs administered orally and epinephrine administered by injection. In addition to the cost of tuition, licensees would incur additional costs for travel, loss of revenue or expense for hiring temporary staff replacement. A telephone survey of ten optometric physicians was conducted. Amounts below represent an average of the responses received by practice type. All those who responded to the survey indicated that they would seek all twenty-eight hours of training. All of those who responded to the survey indicated that they would not hire temporary staff during their absences. All of those who responded to the survey indicated that the costs would be significantly less if the training were held on the weekend or in the evening.

     The course will be given in sites in both Eastern and Western Washington.

PRACTICE TYPE	TRAVEL	REVENUE LOSS	TOTAL
Private Practice	$360	$3,340	$3,700*
Partnership/Clinic	$130	$3,920	$4,050*

     * Does not include the cost of the training course.

     Specific cost categories:

•	Reporting: There is no reporting requirement.
•	Recordkeeping: There is no record-keeping requirement.
•	Compliance Costs: Other than the initial training cost, there are no compliance costs. The rule is voluntary, however, and does not require compliance.
•	Professional Services: No special services are required.
•	Equipment: No equipment is required.
•	Supplies: There is a cost associated with maintaining a supply of pharmaceuticals. The rule is voluntary, however, and does not require compliance.
•	Labor

•	Increased Administrative Costs: No significant increase.
•	Lost Sales or Revenue: No lost sales or revenue.

     II. Is the Cost Disproportionate?

     The rule does not impose disproportionate costs. The costs involved in this voluntary certification are borne by the licensee. The cost per employee to comply with the rules is substantially the same for each licensed optometrist.

     III. Does DOH Have to Minimize the Costs?

     No.

     IV. How Did You Involve Small Business in the Rule Making?

     Business, public, and licensee involvement was solicited through mailing from the Board of Optometry. A mailing was sent to all licensed optometrists and other stakeholders including professional associations, and educators. Opportunity for written comments was provided during different stages of the development of the rules. This effort has produced rules that are the least burdensome to practitioners.

     A copy of the statement may be obtained by writing to Judy Haenke, Program Manager, P.O. Box 47870, Olympia, WA 98504-7870, Judy.Haenke@doh.wa.gov, phone (360) 236-4947, fax (360) 586-4359.

     RCW 34.05.328 applies to this rule adoption. This proposal is legislatively significant. The proposed rules represent a change in regulatory program.

     Hearing Location: CenterPoint Corporate Park, Creekside Building #3, 2nd Floor, 20437 72nd Avenue South, Kent, WA 98032, on January 28, 2004, at 9:00 a.m.

     Assistance for Persons with Disabilities: Contact Judy Haenke by January 15, 2004, TDD 1-800-833-6388.

     Submit Written Comments to: Judy Haenke, Program Manager, P.O. Box 47870, Olympia, WA 98504-7870, judy.haenke@doh.wa.gov, fax (360) 586-4359, by January 24, 2004.

     Date of Intended Adoption: January 28, 2004.

November 25, 2003

Donald Williams

Executive Director

OTS-6664.5

NEW SECTION
WAC 246-851-570   Certification required for use or prescription of drugs administered orally for diagnostic or therapeutic purposes.   (1) To qualify for certification to use or prescribe drugs administered orally for diagnostic or therapeutic purposes, licensed optometrists must provide documentation that he or she:

     (a) Are certified under RCW 18.53.010 (2)(b) to use or prescribe topical drugs for diagnostic and therapeutic purposes.

     (b) Have successfully completed a minimum of sixteen hours of didactic and eight hours of supervised clinical instruction from an institution of higher learning, accredited by those agencies recognized by the United States Office of Education or the Council on Postsecondary Accreditation.

     (2) The didactic instruction must include a minimum of sixteen hours in the following subject area:

     (a) Basic principles of systemic drug therapy;

     (b) Side effects, adverse reactions and drug interactions in systemic therapy;

     (c) Review of oral pharmaceuticals:

     (i) Prescription writing;

     (ii) Legal regulations in oral prescription writing;

     (iii) Systemic antibacterials in primary eye care;

     (iv) Systemic antivirals in eye care;

     (v) Systemic antifungal in eye care;

     (vi) Systemic antihistamines and decongestants and their uses in eye care;

     (vii) Oral dry eye agents;

     (viii) Anti-emetics and their use in eye care;

     (ix) Systemic diuretics and their management of elevated IOP;

     (x) Systemic epinephrine;

     (d) Review of systemic medication in ocular pain management:

     (i) Legal regulations with scheduled medication;

     (ii) Systemic nonsteroidal anti-inflammatory drugs (NSAIDS);

     (iii) Systemic noncontrolled analgesics;

     (iv) Systemic controlled substances;

     (e) Review of oral medications used for sedation and anti-anxiety properties in eye care:

     (i) Controlled anti-anxiety/sedative substances;

     (ii) Legal ramifications of prescribing anti-anxiety drugs;

     (f) Review of systemic medications used during pregnancy and in pediatric eye care:

     (i) Legal ramifications in prescribing to this population;

     (ii) Dosage equivalent with pregnancy and pediatrics;

     (iii) Medications to avoid with pregnancy and pediatrics;

     (g) Applied systemic pharmacology:

     (i) Eyelid and adnexal tissue;

     (ii) Lacrimal system and peri-orbital sinuses;

     (iii) Conjunctival and corneal disorders;

     (iv) Iris and anterior chamber disorders;

     (v) Posterior segment disorders;

     (vi) Optic nerve disease;

     (vii) Peripheral vascular disease and its relationship with ocular disease;

     (viii) Atherosclerotic disease;

     (ix) Other/course review.

     (3) The supervised clinical instruction must include at least eight hours in the following subject areas:

     (a) Vital signs;

     (b) Auscultation;

     (c) Ear, nose and throat;

     (d) Screening neurological exam.

     (4) Written examination to cover required curriculum.

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     (a) Are certified under RCW 18.53.010 (2)(b) to use or prescribe topical drugs for diagnostic and therapeutic purposes.

     (b) Have successfully completed a minimum of four hours of didactic and supervised clinical instruction from an institution of higher learning, accredited by those agencies recognized by the United States Office of Education or the Council on Postsecondary Accreditation to qualify for certification by the optometry board to administer epinephrine by injection.

     (2) The didactic instruction must include the following subject area:

     (a) Review of urgencies, emergencies and emergency-use agents;

     (b) Ocular urgencies:

     (i) Thermal burns-direct and photosensitivity-based ultraviolet burn;

     (ii) Electrical injury;

     (iii) Cryo-injury and frostbite;

     (iv) Insect stings and bites;

     (v) Punctures, perforations, and lacerations;

     (c) General urgencies and emergencies:

     (i) Anaphylaxis;

     (ii) Hypoglycemic crisis;

     (iii) Narcotic overdose.

     (3) The supervised clinical instruction must include the following subject areas:

     (a) Instrumentation;

     (b) Informed consent;

     (c) Preparation (patient and equipment);

     (d) All routes of injections.

     (4) With the exception of the administration of epinephrine by injection for treatment of anaphylactic shock, no injections or infusions may be administered by an optometrist.

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