PROPOSED RULEMAKING
DEPARTMENT OF HEALTH
[28 PA. CODE CH. 6]
Drugs Which May be Used by Cetain Optometrists
[32 Pa.B. 796] The Secretary of Health (Secretary) proposes to amend the list of drugs which may be used by certain optometrists in § 6.1 (relating to approved drugs), to read as set forth in Annex A.
A. Purpose of the Amendment
Under section 2 of the Optometric Practice and Licensure Act (act) (63 P. S. § 244.2), optometrists may use pharmaceutical agents for diagnostic purposes, and for certain therapeutic purposes, only as approved by the Secretary. The pharmaceutical agents, and the purposes for which they may be used by optometrists are in § 6.1. The drugs included on the list must be approved by the Secretary. The State Board of Optometry (Board) requested that the Secretary approve certain additional therapeutic drugs. In its request to the Secretary, the Board identified the drugs by brand name and generic name, which are listed in this paragraph with the generic name in parentheses. Currently, the regulations identify drugs only by the generic name. It is proposed that any added drugs will also be listed by the generic name only. The Secretary has approved a request from the Board to add antibacterial agent Quixin (levofloxacin); oral analgesic Ultram (tramadol); and topical analgesics Alamast (pemirolast potassium), Emadine (emedastine difumarate), Optivar (azelastine hydrochloride) and Zaditor (ketotifen fumerate) to the list of approved drugs. Antibacterial agents destroy bacteria. Analgesic drugs are used as pain relievers.
The Board also requested that certain oral antibiotics [Cipro (ciprofloxacin), Lenezolid (zyvox) and Levaquin (levofloxacin)] be added to the list. The Secretary declined the request to add these agents. As broad-spectrum oral antibiotics, Cipro, zyvox and Levaquin should be limited to treating resistant or serious infections only. Further, the Federal Food and Drug Administration (FDA) has expressed concerns about inappropriate use of antibiotics leading to increase in resistant organisms; thereby recommending that alternatives should be considered before initiating treatment with antibiotics such as zyvox in the outpatient setting.
Using broad-spectrum antibiotics also creates a higher risk of certain side effects, such as the development of pseudomembranous colitis and superinfections. Also, due to the pharmacological profile of these antibiotics, periodic assessment of organ system functions, including renal, hepatic and hematopoietic functions, is advisable during prolonged therapy.
For these reasons, the antibiotic drugs rejected for inclusion in the list of drugs that optometrists may use in their practice should only be prescribed by a licensed health professional with extended pharmacological, diagnostic and treatment education.
B. Requirements of the Amendment
The Secretary proposes to add the following pharmaceutical agents to the approved drug products listed in § 6.1(b):
1. Levofloxacin
2. Tramadol
3. Pemirolast potassium
4. Emedastine difumarate
5. Azelastine hydrochloride
6. Ketotifen fumerate
C. Affected Persons
Optometrists will be able to use, administer and prescribe additional pharmaceutical agents and their patients will be able to receive them for therapeutic purposes. The patients would potentially benefit in that they would have a wider range of agents available to them, thus potentially enhancing their care and treatment.
D. Fiscal Impact
This proposed rulemaking will have no measurable fiscal impact on the Commonwealth, local government, the private sector or the general public. This proposed rulemaking merely enhances the availability of therapeutic agents to patients of certain optometrists.
E. Paperwork Requirements
The addition of these agents to the list of approved drugs will not result in additional costs or paperwork.
F. Effective Date/Sunset Date
This proposed rulemaking will become effective immediately upon publication as a final-form regulation. This regulation is continually monitored and updated as needed. There is no sunset date.
G. Statutory Authority
The proposed amendment to the list of drugs which optometrists may use in the course of their practice is made under section 2 of the act which defines the ''practice of optometry'' to include the administration and prescription of legend and nonlegend drugs as approved by the Secretary for treatment. Treatment may include the prescription or administration of pharmaceutical agents for therapeutic purposes. The proposed amendment is also authorized under section 2101 of The Administrative Code of 1929 (71 P. S. § 532(g)), which provides the Department with general authority to adopt its regulations.
H. Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on January 31, 2002, the Department submitted a copy of the proposed rulemaking to the Independent Regulatory Review Commission (IRRC) and to the Chairpersons of the House Committee on Health and Human Services and the Senate Committee on Public Health and Welfare. In addition to submitting the proposed rulemaking, the Department has provided IRRC and the Committees with a copy of a detailed Regulatory Analysis Form prepared by the Department in compliance with Executive Order 1996-1, ''Regulatory Review and Promulgation.'' A copy of this material is available to the public upon request.
Under section 5(g) of the Regulatory Review Act, if IRRC has any objections to any portion of the proposed rulemaking, it will notify the Department by March 11, 2002. The notification shall specify the regulatory review criteria which have not been met by the portion. The Regulatory Review Act specifies detailed procedures for review, prior to final publication of the amendment, by the Department, the General Assembly and the Governor, of objections raised.
I. Contact Person
Interested persons are invited to submit all questions, comments, suggestions or objections regarding the proposal to John C. Hair, Director, Bureau of Community Program Licensure and Certification, Department of Health, 132 Kline Plaza, Suite A, Harrisburg, PA 17104, (717) 783-8665, within 30 days after publication of this notice in the Pennsylvania Bulletin. Persons with a disability who wish to submit comments, suggestions or objections regarding the proposed rulemaking may do so by using V/TT (717) 783-6514 for speech and/or hearing impaired persons or the Pennsylvania AT&T Relay Service at (800) 654-5984 [TT]. Persons who require an alternative format of this document may contact John Hair so that necessary arrangements may be made.
ROBERT S. ZIMMERMAN, Jr.,
SecretaryFiscal Note: 10-167. No fiscal impact; (8) recommends adoption.
Annex A
TITLE 28. HEALTH AND SAFETY
PART I. GENERAL HEALTH
CHAPTER 6. DRUGS WHICH MAY BE USED BY CERTAIN OPTOMETRISTS § 6.1. Approved drugs.
* * * * * (b) Allowable pharmaceutical products. Optometrists may prescribe and administer the following pharmaceutical products or the A-rated generic therapeutically equivalent drug:
* * * * * (7) Antimicrobial agents.
(i) Antibacterial--topical use only.
* * * * * (D) DNA synthesis inhibitors.
* * * * * (IV) Levofloxacin.
* * * * * (8) Analgesic drugs--oral and topical.
(i) Analgesic drugs--oral.
* * * * * (E) Tramadol.
(ii) Antihistamines and mast cell stabilizers--topical only.
* * * * * (I) Pemirolast potassium.
(J) Emedastine difumarate.
(K) Azelastine hydrochloride.
(L) Ketotifen fumerate.
[Pa.B. Doc. No. 02-214. Filed for public inspection February 8, 2002, 9:00 a.m.]
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