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PA Bulletin, Doc. No. 02-1247

RULES AND REGULATIONS

Title 28--HEALTH
AND SAFETY

DEPARTMENT OF HEALTH

[28 PA. CODE CH. 6]

Drugs Which May be Used by Certain Optometrists

[32 Pa.B. 3484]

   The Department of Health (Department) adopts amendments to § 6.1 (relating to approved drugs).

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 set forth 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 shown with the generic name in parentheses. Currently, the regulations identify drugs only by the generic name. The added drugs will also be listed by the generic name only. The Secretary 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 did not approve the request to add these agents. As broad-spectrum oral antibiotics, ciproflaxacin, zyvox and levofloxacin 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. The FDA has recommended that alternatives should be considered before initiating treatment with these antibiotics 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, it is advisable that periodic assessment of organ system functions, including renal, hepatic and hematopoietic functions, be done during prolonged therapy.

   For these reasons, the antibiotics 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.  Summary

   The Department has not changed the proposed rulemaking. Section 6.1 is amended by adding the following drugs to the approved drugs listed in subsection (b):

   1.  Levofloxacin.

   2.  Tramadol.

   3.  Pemirolast potassium.

   4.  Emedastine difumarate.

   5.  Azelastine hydrochloride.

   6.  Ketotifen fumerate.

   The Department received two comments, one from the Pennsylvania College of Optometry and one from the Pennsylvania Optometric Association (POA). Both comments supported the proposed rulemaking. The POA requested copies of the final-form regulation and comment and response documents.

C.  Affected Persons

   Optometrists will be able to use, administer and prescribe additional drugs and their patients will be able to receive them for therapeutic purposes. The patients will benefit in that they will have a wider range of agents available to them, thus potentially enhancing their care and treatment.

D.  Fiscal Impact

   This final-form rulemaking has no measurable fiscal impact on the Commonwealth, local government, the private sector or the general public. The final-form rulemaking merely enhances the availability of therapeutic agents to patients of certain optometrists.

E.  Paperwork Requirements

   The addition of these drugs to the list of approved drugs under the act will not result in additional costs or paperwork.

F.  Effective Date/Sunset Date

   The amendment will become effective immediately upon publication as final-form rulemaking. The final-form regulation will continually be monitored and updated as needed. There is no sunset date.

G.  Statutory Authority

   The amendment to the list of drugs which certain 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 drugs for therapeutic purposes. The amendment is also authorized under section 2102 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 30, 2002, the Department submitted a copy of the notice of proposed rulemaking published at 32 Pa.B. 796 (February 9, 2002) to the Independent Regulatory Review Commission (IRRC) and to the Chairpersons of the House Health and Human Services Committee and the Senate Public Health and Welfare Committee for review and comment.

   In compliance with section 5(c) of the Regulatory Review Act, the Department also provided IRRC and the Committees with copies of all comments received, as well as other documentation. In compliance with section 5.1(a) of the Regulatory Review Act (71 P. S. § 745a(a)), the Department submitted a copy of the final-form regulation to IRRC and the Committees on May 14, 2002. In addition, the Department provided IRRC and the Committees with a copy of the 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.

   This final-form regulation was deemed approved by the House Health and Human Services Committee and the Senate Public Health Welfare Committee on June 3, 2002. The amendment was deemed approved by IRRC under section 5(g) of the Regulatory Review Act effective June 4, 2002. The Office of Attorney General approved the final-form regulation on June 17, 2002.

I.  Contact Person

   Questions regarding this final-form may be submitted 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. Persons with a disability may submit questions regarding the regulations by using V/TT (717) 783-6514 for speech or hearing, or both, impaired persons or the Pennsylvania AT&T Relay Service at (800) 654-5984 [TT]. Persons who require an alternative format of this document should contact John Hair so that necessary arrangements may be made.

J.  Findings

   The Department finds that:

   (1)  Public notice of intention to amend the regulation adopted by this order has been given under sections 201 and 202 of the act of July 31, 1968 (P. L. 769, No. 240) (45 P. S. §§ 1201 and 1202), and the regulations thereunder, 1 Pa. Code §§ 7.1 and 7.2.

   (2)  A public comment period was provided as required by law.

   (3)  The adoption of the final-form regulation is necessary and appropriate.

K.   Order

   The Department, acting under the authorizing statutes, orders that:

   (a)  The regulations of the Department, 28 Pa. Code Chapter 6, are amended by amending § 6.1 to read as set forth at 32 Pa.B. 796.

   (b)  The Secretary of Health shall submit this order and 32 Pa.B. 769 to the Office of General Counsel and the Office of Attorney General for approval as required by law.

   (c)  The Secretary of Health shall submit this order, 32 Pa.B. 769 and a Regulatory Analysis Form to IRRC, the House Committee on Health and Human Services and the Senate Committee on Public Health and Welfare for their review and action as required by law.

   (d)  The Secretary of Health shall certify this order and 32 Pa.B. 769 and deposit them with the Legislative Reference Bureau as required by law.

   (e)  This order shall take effect upon publication in the Pennsylvania Bulletin.

ROBERT S. ZIMMERMAN, Jr.,   
Secretary

   (Editor's Note: For the text of the order of the Independent Regulatory Review Commission relating to this document, see 32 Pa.B. 3183 (June 29, 2002).)

   Fiscal Note: Fiscal Note 10-167 remains valid for the final adoption of the subject regulation.

[Pa.B. Doc. No. 02-1247. Filed for public inspection July 19, 2002, 9:00 a.m.]


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