PROPOSED RULEMAKING
DEPARTMENT OF HEALTH
[28 PA. CODE CH. 6]
Drugs Which May Be Used By Qualified Optometrists
[28 Pa.B. 485] The Department of Health (Department) is proposing to amend Chapter 6 (relating to drugs which may be used by certain optometrists) by replacing the current list of drugs contained in that chapter with an updated list which may be used by certain optometrists under the stated conditions, to read as set forth in Annex A.
A. Statutory Authority
The definition of ''examination and diagnosis'' in section 2 of the Optometric Practice and Licensure Act (63 P. S. § 244.2) (act), permits optometrists to use pharmaceutical agents approved by the Department for certain diagnostic purposes. Amendments to the act's definition of ''practice of optometry,'' effective in 1996, permit optometrists to administer and prescribe legend and nonlegend drugs as approved by the Secretary of Health (Secretary) for certain treatment purposes. See section 1 of the act of October 30, 1996 (P. L. 721, No. 130) (Act 130), amending 63 P. S. § 244.2. These regulations are proposed under these provisions and section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)), which grants the Department authority to promulgate regulations.
B. Purpose of the Regulations
The 1996 amendments to the act redefined the practice of optometry to permit the administration and prescription of legend and nonlegend drugs as approved by the Secretary for the treatment of certain areas of the visual system, and under certain conditions. These changes not only permitted the Secretary to expand the list of drugs which optometrists may use in the course of their practices, but granted the Secretary the authority to establish standards under which optometrists could administer or prescribe those drugs. After discussions with various interested parties, including the Pennsylvania Academy of Ophthalmology, the Pennsylvania Optometric Association, the Pennsylvania Medical Society, the Pennsylvania College of Optometrists, and other interested State agencies, the Department has developed a list of drugs which may be used by optometrists, as well as conditions that must be satisfied, including Department of State licensure and certification standards as required by Act 130. See 63 P. S. § 244.4a. The Department is proposing to amend Chapter 6, by restructuring § 6.1 (relating to approved drugs) to include these conditions and the newly developed list of approved drugs.
C. Summary of the Regulations
Chapter 6 contains a very limited list of drugs which optometrists may use, restricted to three types: local anesthetics, miotics (for contracting the pupil) and mydriatics or cycloplegics (for dilating the pupil or stopping the movement of the eye). This list reflects the limits placed on the practice of optometry under the act prior to 1996. With the 1996 amendments to the act, the practice of optometry was expanded, requiring the Department to expand the list of drugs approved for use by optometrists. In doing so, the Department is proposing to create a list of categories of drugs approved for use by optometrists, rather than a simple list of acceptable drugs. The proposed list of categories of drugs includes categories beyond those drugs necessary for simple examination of the visual system, and reflects the expanded practice of optometry as envisioned by the 1996 amendments to the act. In developing the proposed categories and drugs, the Department has made every effort to balance that expansion with concern for the welfare of the patient.
Section 6.1(a) (relating to approved drugs).
In developing this expanded list, the Department has taken into account the conditions placed on the practice of optometry by the amendments to the act, and has included many of these conditions in proposed subsection (a). The Department has also proposed requirements which are intuitive, for example, the Department has proposed the requirement that drugs shall be approved by the Federal Drug Administration (FDA) and has proposed to permit optometrists to prescribe and administer over-the-counter medications. By allowing optometrists to prescribe and administer over-the-counter medications, the Department is recognizing the fact that an optometrist should not be precluded from providing to a patient a drug the patient could use on him or herself. In cases where the nature of individual categories of drugs warrant conditional use, the Department has included language in the specific subparagraph relating to that drug. The definition of the ''practice of optometry'' restricts the optometrist's use of over-the-counter drugs to the scope of optometric practice.
Section 6.1(b).
Proposed subsection (b) contains the list of categories and approved drugs under those categories. The Department has chosen not to include allowable potencies because this manner of approving drugs no longer makes sense medically. In some cases, the potencies originally listed were the only potencies available. In some cases, multiple potencies could be acceptable.
In choosing what categories of drug to approve, and whether to approve these drugs for oral use, or topical use only, the Department took into account the issue of whether or not the treatment would be systemic. The act only permits the Department to approve drugs used for therapeutic purposes, for ''the treatment of the anterior segment of the eye, the eyelids, the lacrimal system and conjunctiva and the removal of superficial foreign bodies from the ocular surface and adnexa . . . .'' See the definition of ''practice of optometry'' in 63 P. S. § 244.2. Drugs which, if used only topically, would treat the anterior of the eye with a minimal systemic effect, would be approved for treatment by the Department for topical use only (for example, autonomic drugs and nonsteroidal antiinflammatory drugs). The Department proposes, however, to approve certain drugs for oral use in cases in which failure of an optometrist to use these drugs could put the health and safety of the patient at risk. The Department proposes to list under these categories those drugs most likely to treat effectively the most common conditions seen by optometrists. Although there may be a systemic effect in these cases, treatment focuses on the limited area of the visual system permitted by the act, as amended.
To protect the patient, the Department proposes that, prior to the oral use of these categories of drugs, the treating optometrist shall obtain verbal or written concurrence from the patient's referring physician, usual primary care physician, or an ophthalmologist if the patient's condition so indicates. The Department further proposes to require that, if the patient has no continuing medical care provider, the patient shall be referred to a primary care physician or an ophthalmologist by the optometrist before the optometrist prescribes the drugs listed under these categories. It is the Department's position that this requirement, in connection with the statutory prohibition that no treatment be continued for longer than 6 weeks without the concurrence of a licensed physician, is sufficient protection for the health and safety of the patient.
In making these decisions, the Department recognizes that in some cases, patients are unaware of the differences between ophthalmologists and optometrists, or may, for other reasons, choose or find it necessary to see an optometrist rather than an ophthalmologist. To ensure that necessary treatment is begun, the Department proposes to allow the use of oral drugs. The Department, however, has included the prior concurrence requirement in all categories of oral drugs approved, including antibacterial drugs, and antiviral drugs. It is the Department's position that this requirement will permit physicians to make a decision whether or not the patient should be treated by the optometrist, or referred back to the physician, or to an ophthalmologist for further treatment. At the same time, it will remove a barrier to care.
The proposed amendment would also permit optometrists to prescribe a limited number of analgesic medications once per patient visit, for a period of no longer than 72 hours per prescription.
D. Cost and Paperwork Estimates
1. Cost
The addition of new drugs to the approved list contained in Chapter 6 will not affect the Commonwealth, local governments or the general public financially. It is possible that the expansion of the practice of optometry to include the administration and prescription of certain drugs under certain enumerated conditions may adversely affect the practice of some ophthalmologists, if individuals who would otherwise find it necessary to consult an ophthalmologist can, under the 1996 statutory amendments and the proposed amendment, consult an optometrist and chose to do so. It is not certain that this will be the case, however, and the statute does provide for consultation with a licensed physician after treatment for a 6-week period by an optometrist. See 63 P. S. § 244.2.
2. Paperwork
No changes to reporting, recordkeeping or other paperwork would be required, except to the extent that the number of drugs optometrists would be permitted to administer and prescribe under certain conditions would increase, which may require increased notations in patient records.
E. Effective Date/Sunset Date
The proposed amendment will be effective immediately upon final adoption. The regulation will be continually monitored and updated as needed. Therefore, no sunset date has been set.
G. Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on January 21, 1998, the Department submitted a copy of this proposed to the Independent Regulatory Review Commission (IRRC) and the Chairpersons of the House Health and Human Services Committee and the Senate Public Health and Welfare Committee. In addition to submitting the proposed amendment, 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.
If the Committees have objections to any portion of the proposed amendment, they will notify the Board within 20 days of the close of the public comment period.
If IRRC has objections to any portion of the proposed amendment, it will notify the Department within 10 days of the close of the Committees' review period. The notification shall specify the regulatory review criteria which have not been met by that 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.
H. Contact Person
Interested persons are invited to submit all comments, suggestions or objections regarding the proposed amendment to Lori Gerhard, Department of Health Policy Office, P. O. Box 90, Harrisburg, PA 17108 within 30 days of publication of this notice in the Pennsylvania Bulletin. Persons with a disability may submit comments, suggestions or objections regarding the proposed amendment to Lori Gerhard in an alternative format, such as by audio tape, braille or by using TDD: (717) 783-6514. Persons with a disability who require a copy of the proposed amendment in an alternative format (that is, large print, audio tape, braille) should contact the Department of Health's Policy Office at (717) 787-3488 so that the necessary arrangements may be made.
DANIEL F. HOFFMANN,
SecretaryFiscal Note: 10-152. 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 Sec.
6.1. Approved drugs. § 6.1. Approved drugs.
[(a) Optometrists who are appropriately qualified under the Optometric Practice and Licensure Act (63 P. S. §§ 244.1--244.12) are permitted to utilize the following drugs in their practice of optometry:
(1) Local anesthetics. Local anesthetics shall conform with the following:
(i) Benoxinate Hydrochloride--Ophthalmic Solution (0.4%)
(ii) Proparacaine Hydrochloride--Ophthalmic Solution (0.5%)
(iii) Tetracaine Hydrochloride--Ophthalmic Solution (0.5%)
(2) Miotics. Miotics shall conform with the following:
(i) Pilocarpine Nitrate Ophthalmic Solution U.S.P. (1.0%)
(ii) Pilocarpine Hydrochloride Ophthalmic Solution U.S.P. (1.0%)
(iii) Methacholine Chloride--Ophthalmic Solution (2.5%)
(iv) Dapiprazole HCL.
(3) Mydriatics or cycloplegics. Mydriatics or cycloplegics shall conform with the following:
(i) Eucatropine Hydrochloride U.S.P.--Ophthalmic Solution (5.0%)
(ii) Homatropine Hydrobromide Ophthalmic Solution U.S.P. (2.0%)
(iii) Homatropine Hydrobromide Ophthalmic Solution U.S.P. (5.0%)
(iv) Hydroxyamphetamine Hydrobromide Ophthalmic Solution U.S.P. (0.5%)
(v) Hydroxyamphetamine Hydrobromide Ophthalmic Solution U.S.P. (1.0%)
(vi) Tropicamide Ophthalmic Solution U.S.P. (1.0%)
(vii) Atropine Sulfate Ophthalmic Solution U.S.P. (1.0%) Ophthalmic Ointment (1.0%)
(viii) Cyclopentolate Hydrochloride--Ophthalmic Solution (1.0%)
(ix) Cyclopentolate Hydrochloride Ophthalmic Solution U.S.P. (2.0%)
(x) Cyclopentolate Hydrochloride (0.2%)/Phenylephrine Hydrochloride (1.0%) Ophthalmic solution
(xi) Phenylephrine Hydrochloride Ophthalmic Solution U.S.P. (10%)
(xii) Scopolamine Hydrobromide U.S.P. Ophthalmic Solution U.S.P. (0.25%)
(xiii) Ephedrine Sulfate U.S.P.--Ophthalmic Solution (5.0%)
(b) Potencies listed in this section are the maximum allowable potencies.]
(a) Administration of pharmaceutical agents. Optometrists who are certified to prescribe and administer pharmaceutical agents for therapeutic purposes under section 4.1 of the Optometric Practice and Licensure Act (35 P. S. § 244.4a), may prescribe and administer the drugs listed in subsection (b) in their practice of optometry under the following conditions:
(1) The drugs shall be approved by the Food and Drug Administration.
(2) Over-the-counter medications (per FDA listing) are fully authorized.
(3) An optometrist may not administer any drug parenterally.
(4) The treatment undertaken by an optometrist under this section:
(i) Shall be limited to 6 weeks duration.
(ii) May not include beta-blockers or steroids.
(iii) May not be prescribed for systemic conditions except as an adjunctive therapy and shall be limited to the anterior eye structures (and adnexa).
(5) An optometrist may not treat glaucoma.
(6) An optometrist may not prescribe or administer a Schedule I or II controlled substance.
(b) Allowable pharmaceutical products. Optometrists may prescribe and administer the following pharmaceutical products:
(1) Topical anesthetics.
(i) Proparacaine.
(ii) Benoxinate.
(iii) Tetracaine.
(2) Topical ocular lubricants.
(3) Topical opthalmic dyes and stains.
(i) Fluorescein.
(ii) Rose Bengal.
(iii) Fluorexen.
(4) Topical hyperosmotic agents.
(5) Autonomic drugs--topical only.
(i) Cholinergic agonists.
(A) Pilocarpine nitrate and pilocarpine hydrochloride-diagnostic use only.
(B) Physostigmine.
(C) DFP (diisopropylfluorophosphate).
(D) Echothiopate.
(ii) Cholinergic antagonists.
(A) Homatropine hydrobromide.
(B) Torpicamide.
(C) Atropine sulfate.
(D) Cyclopentolate hydrochloride.
(E) Scopolamine hydrobromide.
(iii) Adrenergic agonists.
(A) Hydroxyamphetamine hydrobromide.
(B) Phenylephrine hydrochloride.
(C) Tetrahydrazoline.
(D) Nefazoline.
(E) Oxymetazoline.
(iv) Adrenergic antagonists--diagnostic use only.
(A) Dapiprazole.
(B) Thymoxamine.
(6) Nonsteroidal antiinflammatory drugs--topical only.
(i) Diclofenac.
(ii) Ketorolac.
(iii) Flurbiprofen.
(iv) Suprofen.
(7) Antimicrobial agents--access to culture and sensitivity testing (as clinically indicated) is urged.
(i) Antibacterial--topical use only.
(A) Cell wall inhibitors.
(I) Bacitracin.
(II) Cephalosporins.
(III) Penicillins.
(IV) Vancomycin.
(B) Protein synthesis inhibitors.
(I) Aminoglycosides.
(II) Tetracycline.
(III) Erythromycin.
(IV) Chloramphenicol.
(C) Intermediary metabolism inhibitors.
(I) Sodium sulfacetamide and sulfisoxazole.
(II) Trimethoprim.
(D) DNA synthesis inhibitors.
(I) Ciprofloxacin.
(II) Norfloxacin.
(III) Ofloxacin.
(E) Cell membrane permeability.
(I) Polymyxin B.
(II) Gramicidin.
(ii) Antibacterial--oral. Prior to prescribing oral antibacterial agents, the optometrist shall obtain verbal or written concurrence from the patient's referring physician or usual primary care physician or from an ophthalmologist if the patient's condition so indicates. The optometrist shall record the concurrence in the patient's medical record and on the prescription form. If the patient has no continuing medical care provider, the optometrist shall refer the patient to a primary care physician or an ophthalmologist before prescribing these agents.
(A) Cell wall inhibitors.
(I) Penicillins--including in combination with clavulanic acid.
(II) Cephalosporins.
(1) First generation--cephalexin and cefadroxil.
(2) Second generation--cefaclor and cefuroxime.
(B) Protein synthesis inhibitors.
(I) Tetracycline.
(II) Doxycycline.
(III) Erythromycin.
(IV) Azithromycin.
(iii) Antivirals--topical only.
(A) Idoxurine.
(B) Vidarabine.
(C) Trifluridine.
(iv) Antivirals--oral. Prior to prescribing oral antiviral agents, the optometrist shall obtain verbal or written concurrence from the patient's referring physician or usual primary care physician or from an ophthalmologist if the patient's condition so indicates. The optometrist shall record the concurrence in the patient's medical record and on the prescription form. If the patient has no continuing medical care provider, the optometrist shall refer the patient to a primary care physician or an ophthalmologist before prescribing these agents.
(A) Acyclovir.
(B) Valacyclovir.
(C) Famcyclovir.
(v) Antifungal and antiparasitic--topical only.
(A) Amphotericin B, nystatin, natamycin.
(B) Miconazole, ketoconazole, clotrimazole.
(C) Thiabendazole.
(D) Neomycin and polymyxin B.
(E) Paromycin.
(8) Analgesic drugs--oral and topical.
(i) An optometrist shall only be permitted to prescribe the following drugs, either alone or in combination with acetaminophen or aspirin, for up to 72 hours per patient visit.
(A) Codeine.
(B) Hydrocodone.
(C) Pentazocine.
(D) Propoxyphene.
(ii) Antihistamines and mast cell stabilizers--topical only.
(A) Pheniramine.
(B) Pyrilamine.
(C) Antazoline.
(D) Levocarbastine.
(E) Cromolyn.
(F) Nedocromil.
(G) Lodoxamide.
(H) Olopatadine.
[Pa.B. Doc. No. 98-166. Filed for public inspection January 30, 1998, 9:00 a.m.]
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