STATE OF NEW YORK
________________________________________________________________________
7440--A
IN SENATE
May 2, 2016
___________
Introduced by Sens. FUNKE, ADDABBO, ESPAILLAT, GALLIVAN, LITTLE,
MARCHIONE, O'MARA, ORTT, RITCHIE, SERINO, SEWARD, VALESKY, YOUNG --
read twice and ordered printed, and when printed to be committed to
the Committee on Higher Education -- committee discharged, bill
amended, ordered reprinted as amended and recommitted to said commit-
tee
AN ACT to amend the education law, in relation to the use of oral medi-
cations by optometrists; and providing for the repeal of certain
provisions upon expiration thereof
The People of the State of New York, represented in Senate and Assem-bly, do enact as follows:
1 Section 1. Paragraph (e) of subdivision 1 of section 7101-a of the
2 education law, as added by chapter 517 of the laws of 1995, is amended
3 to read as follows:
4 (e) [Phase one] Topical therapeutic pharmaceutical agents. [Phase one]
5 Topical therapeutic pharmaceutical agents shall mean those drugs which
6 shall be limited to topical application to the surface of the eye for
7 therapeutic purposes and shall be limited to:
8 (i) antibiotic/antimicrobials;
9 (ii) decongestants/anti-allergenics;
10 (iii) non-steroidal anti-inflammatory agents;
11 (iv) steroidal anti-inflammatory agents;
12 (v) antiviral agents;
13 (vi) hyperosmotic/hypertonic agents;
14 (vii) cycloplegics;
15 (viii) artificial tears and lubricants; and
16 (ix) immunosuppressive agents.
17 § 2. Paragraph (f) of subdivision 1 of section 7101-a of the education
18 law, as added by chapter 517 of the laws of 1995, is amended to read as
19 follows:
20 (f) [Phase two therapeutic] Therapeutic pharmaceutical agents for
21 treatment of glaucoma and ocular hypertension. [Phase two] Therapeutic
22 pharmaceutical agents for treatment of glaucoma and ocular hypertension
23 shall mean those drugs which shall be limited to topical application to
24 the surface of the eye and shall be limited to:
25 (i) beta blockers;
26 (ii) alpha agonists;
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[] is old law to be omitted.
LBD15035-09-6
S. 7440--A 2
1 (iii) direct acting cholinergic agents;
2 (iv) prostaglandin analogs; and
3 (v) carbonic anhydrase inhibitors.
4 § 3. Subdivision 1 of section 7101-a of the education law is amended
5 by adding a new paragraph (g) to read as follows:
6 (g) Oral therapeutic pharmaceutical agents. Oral therapeutic pharma-
7 ceutical agents shall mean those orally administered drugs used for
8 therapeutic purposes solely for the treatment of diseases of the eye and
9 adnexa and shall be limited to:
10 (i) the following antibiotics, including, where applicable, the gener-
11 ic equivalent of any of the listed drugs:
12 (1) augmentin;
13 (2) keflex;
14 (3) azithromycin;
15 (4) bactrim;
16 (5) doxycycline; and
17 (6) tetracycline;
18 (ii) the following decongestants/anti-allergenic/antihistamines,
19 including the generic equivalents of the listed drugs:
20 (1) clarinex;
21 (2) xyzal; and
22 (3) singulair;
23 (iii) the following antiglaucoma agents, including the generic equiv-
24 alents of such agents, used for the management of acute increases in
25 intraocular pressure; provided, however, an optometrist may use or
26 prescribe a maximum of one twenty-four hour prescription and shall imme-
27 diately refer the patient to a licensed physician specializing in
28 diseases of the eye:
29 (1) diamox; and
30 (2) neptazane;
31 (iv) the following antiviral agents for herpes zoster ophthalmicus;
32 provided an optometrist shall use or prescribe in maximum, seven-day
33 prescriptions; provided, however, if a patient is diagnosed with herpes
34 zoster ophthalmicus and has not already been examined by a primary care
35 physician or other appropriate physician for such viral condition, an
36 optometrist shall refer the patient to a licensed primary care physi-
37 cian, licensed physician specializing in diseases of the eye, or other
38 appropriate physician within three days of such diagnosis:
39 (1) valacyclovir; and
40 (2) acyclovir; and
41 (v) the following non-steroidal anti-inflammatory agents:
42 (1) cox-2 inhibitors;
43 (2) ibuprofen; and
44 (3) naproxen.
45 § 4. The subdivision heading and paragraph (a) of subdivision 4 of
46 section 7101-a of the education law, as added by chapter 517 of the laws
47 of 1995, is amended to read as follows:
48 [Phase one] Topical therapeutic pharmaceutical agents. (a) Before
49 using or prescribing [phase one] topical therapeutic pharmaceutical
50 agents, each optometrist shall have completed at least three hundred
51 hours of clinical training in the diagnosis, treatment and management of
52 patients with ocular disease other than glaucoma and ocular hyperten-
53 sion, not fewer than twenty-five hours of such training shall have been
54 completed subsequent to June thirtieth, nineteen hundred ninety-three
55 and additionally shall either have taken and successfully passed the
56 treatment and management of ocular diseases portion of the National
S. 7440--A 3
1 Board of Examiners in Optometry test or have taken and successfully
2 passed an examination acceptable to the board.
3 § 5. Paragraph (b) of subdivision 4 of section 7101-a of the education
4 law, as added by chapter 517 of the laws of 1995, is amended to read as
5 follows:
6 (b) Before using or prescribing [phase two] therapeutic pharmaceutical
7 agents for treatment of glaucoma and ocular hypertension, an optometrist
8 must be certified for diagnostic and [phase one] topical therapeutic
9 agents and have completed an additional one hundred hours of clinical
10 training in the diagnosis, treatment and management of patients with
11 glaucoma and ocular hypertension, not fewer than twenty-five hours of
12 such training shall have been completed subsequent to July first, nine-
13 teen hundred ninety-four, and shall have taken and successfully passed
14 an oral or written examination acceptable by the board.
15 § 6. Paragraphs (c) and (d) of subdivision 4 of section 7101-a of the
16 education law are relettered paragraphs (d) and (e) and a new paragraph
17 (c) is added to read as follows:
18 (c) Before using or prescribing oral therapeutic pharmaceutical
19 agents, an optometrist must be certified to prescribe diagnostic pharma-
20 ceutical agents and topical therapeutic and therapeutic pharmaceutical
21 agents for treatment of glaucoma and ocular hypertension, have completed
22 an oral therapeutic pharmaceutical agent certification course and have
23 passed an examination, with a curriculum and examination developed by
24 academic faculty representatives approved by the department from a New
25 York state accredited college of optometry, from a department of
26 ophthalmology at a New York state accredited medical school upon the
27 recommendation of a statewide professional organization consisting of
28 ophthalmologists, and from a department of pharmacology at a New York
29 state accredited medical school.
30 (i) The curriculum shall include, but not be limited to, instruction
31 in pharmacology and drug interaction in treating ocular disease and be
32 taught through clinical case scenarios and emphasize clinical decision
33 making and shall be no less than forty hours, of which no less than
34 twenty-four hours shall be live instruction.
35 (ii) Such course shall qualify towards meeting the continuing educa-
36 tion per triennial registration requirement pursuant to subdivision
37 seven of this section.
38 (iii) The examination shall test the knowledge of materials in the
39 curriculum.
40 (iv) If an optometrist fails to pass the examination, such optometrist
41 may retake the examination following completion of the certification
42 course, and may retake the examination a maximum of two additional
43 times, provided that an optometrist may be authorized to retake the
44 examination beyond such maximum number upon application by the optome-
45 trist and a determination of good cause shown by the commissioner.
46 (v) The initial, and any subsequent, curriculum and examination shall
47 be subject to review and approval by the department.
48 (vi) The requirement for the oral therapeutic pharmaceutical agent
49 certification course and examination shall not apply to those optome-
50 trists who graduated from an accredited college of optometry subsequent
51 to January first, two thousand six and have taken and successfully
52 passed the National Board of Examiners in Optometry test or an examina-
53 tion acceptable to the board.
54 § 7. Subdivision 5 of section 7101-a of the education law, as added by
55 chapter 517 of the laws of 1995, is amended to read as follows:
S. 7440--A 4
1 5. Suspension of certification. The department shall suspend the
2 certification for the use and prescribing of [phase one] topical thera-
3 peutic agents of any optometrist who fails to receive certification for
4 [phase two] therapeutic pharmaceutical agents for treatment of glaucoma
5 and ocular hypertension within three years of having been certified for
6 [phase one] topical therapeutic pharmaceutical agents.
7 § 8. The subdivision heading of subdivision 6 of section 7101-a of the
8 education law, as added by chapter 517 of the laws of 1995, is amended
9 to read as follows:
10 Consultation with use of certain topical therapeutic pharmaceutical
11 agents for treatment of glaucoma and ocular hypertension.
12 § 9. Subdivision 7 of section 7101-a of the education law, as added by
13 chapter 517 of the laws of 1995, is amended to read as follows:
14 7. Continuing education. Each optometrist certified to use [phase one
15 or phase two] topical therapeutic pharmaceutical agents and therapeutic
16 pharmaceutical agents for treatment of glaucoma and ocular hypertension,
17 shall complete a minimum of thirty-six hours of continuing education in
18 the area of ocular disease and pharmacology per triennial registration
19 period. [The education shall be in the area of ocular disease and phar-
20 macology and may include both didactic and clinical components.] Each
21 optometrist certified to use oral therapeutic pharmaceutical agents
22 shall, in addition to the minimum thirty-six hours of continuing educa-
23 tion provided for in this subdivision, complete an additional minimum of
24 thirty-nine hours of continuing education related to systemic disease
25 and therapeutic treatment per triennial registration period. Such educa-
26 tional programs may include both didactic and clinical components and
27 shall be approved in advance by the department and evidence of the
28 completion of this requirement shall be submitted with each application
29 for license renewal as required by section sixty-five hundred two of
30 this chapter.
31 § 10. The subdivision heading and subparagraph (i) of paragraph (a) of
32 subdivision 8 of section 7101-a of the education law, as added by chap-
33 ter 517 of the laws of 1995, are amended to read as follows:
34 Notice to patient with the use or prescription of topical therapeutic
35 pharmaceutical agents and therapeutic pharmaceutical agents for treat-
36 ment of glaucoma and ocular hypertension.
37 (i) An optometrist prescribing topical steroids or antiviral medica-
38 tion shall inform each patient that in the event the condition does not
39 improve within five days, a physician of the patient's choice will be
40 notified.
41 § 11. Subdivision 10 of section 7101-a of the education law, as added
42 by chapter 517 of the laws of 1995, is amended to read as follows:
43 10. Pharmaceutical agents. Optometrists who have been approved and
44 certified by the department shall be permitted to use the following
45 drugs:
46 (a) Diagnostic pharmaceuticals.
47 (b) Those optometrists having been certified for [phase one] topical
48 therapeutic pharmaceutical agents shall be authorized [(i) to use and
49 recommend all nonprescription medications appropriate for ocular disease
50 whether intended for topical or oral use; and (ii)] to use and prescribe
51 all [phase one] topical therapeutic pharmaceutical agents specified in
52 paragraph (e) of subdivision one of this section, which are FDA approved
53 and commercially available for topical use.
54 In the event an optometrist treats a patient with topical antiviral or
55 steroidal drugs and the patient's condition either fails to improve or
S. 7440--A 5
1 worsens within five days, the optometrist shall notify a physician
2 designated by the patient or, if none, by the treating optometrist.
3 (c) Those optometrists having been certified for [phase two] therapeu-
4 tic pharmaceutical agents for treatment of glaucoma and ocular hyperten-
5 sion shall be authorized to use and prescribe [phase two] therapeutic
6 pharmaceutical agents for treatment of glaucoma and ocular hypertension
7 specified in paragraph (f) of subdivision one of this section, which are
8 FDA approved and commercially available.
9 (d) Those optometrists having been certified for oral therapeutic
10 pharmaceutical agents shall be authorized to use and prescribe oral
11 therapeutic pharmaceutical agents specified in paragraph (g) of subdivi-
12 sion one of this section, which are FDA approved and commercially avail-
13 able and shall comply with all safety information and side-effect and
14 warning advisories contained in the most current physicians' desk refer-
15 ence.
16 (e) Those optometrists having been certified for topical therapeutic
17 pharmaceutical agents, therapeutic pharmaceutical agents for treatment
18 of glaucoma and ocular hypertension or oral therapeutic pharmaceutical
19 agents shall be authorized to use and recommend all nonprescription
20 medications, whether intended for topical or oral use, appropriate for
21 the treatment of the eye and adnexa.
22 § 12. Section 7101-a of the education law is amended by adding a new
23 subdivision 13 to read as follows:
24 13. Oral therapeutic pharmaceutical agent implementation review. (a)
25 Each optometrist certified to use oral therapeutic pharmaceutical agents
26 pursuant to paragraph (c) of subdivision four of this section shall
27 provide the department with information, on a form prescribed by the
28 commissioner, related to the prescription or use of oral therapeutic
29 pharmaceutical agents provided for in this section. Such information
30 shall include the optometrist's name, license number, whether no oral
31 prescriptions have been issued and in the event that oral prescriptions
32 have been issued, then the following information shall be required: the
33 prescribed or used oral therapeutic pharmaceutical agent, the dosage of
34 such agent, the date of the prescription, the diagnosis of the patient
35 for which the agent was prescribed or used, and whether a referral was
36 made in accordance with paragraph (g) of subdivision one of this
37 section. Such information shall not include any patient identifying
38 information and must otherwise be in compliance with all state and
39 federal requirements related to protected health information. Each form
40 shall be submitted by mail or electronic means to the department on a
41 quarterly basis. If a database of all oral therapeutic pharmaceutical
42 agents prescribed or used by optometrists is, or becomes, available to
43 the committee provided for in this subdivision, then optometrists will
44 be advised by the commissioner that quarterly reporting forms will no
45 longer be required. The requirements of this paragraph shall remain in
46 effect for five years following approval by the department of the
47 initial oral therapeutic pharmaceutical agent certification course and
48 examination pursuant to paragraph (c) of subdivision four of this
49 section, after which time these requirements shall expire and no longer
50 have effect.
51 (b) The commissioner shall appoint a committee to advise and assist
52 the commissioner in evaluating compliance with the provisions of this
53 section and to identify any necessary enhancements to the curriculum
54 provided for in this section and other educational materials and to
55 assist in ensuring patient safety. The committee shall consist of one
56 pharmacist, one optometrist upon the recommendation of a statewide
S. 7440--A 6
1 professional organization consisting of optometrists, one ophthalmolo-
2 gist upon the recommendation of a statewide professional organization
3 consisting of ophthalmologists, and one expert in the field of public
4 health who shall be designated as chair by the commissioner in consulta-
5 tion with the commissioner of the department of health and who shall be
6 neither an ophthalmologist nor an optometrist.
7 (c) The commissioner shall submit each form received pursuant to this
8 subdivision to the committee. The committee shall review the forms and
9 shall randomly cross-check such submissions with a publicly available or
10 other database containing electronic prescriber information. Should a
11 database of all oral therapeutic pharmaceutical agents prescribed or
12 used by optometrists become available pursuant to this section, and the
13 commissioner determines and advises optometrists that quarterly reports
14 are no longer necessary, then the committee shall review the database
15 and ascertain the prescribing information for all optometrists consist-
16 ent with this section. The committee shall advise the commissioner as
17 to compliance with the provisions of this section for the purpose of
18 evaluating compliance with the provisions of this section including the
19 applicable referrals and dosing limitations and to identify any neces-
20 sary enhancements to the curriculum provided for in this section and
21 other educational materials and to assist in ensuring patient safety.
22 Upon finding evidence of non-compliance by any optometrist, the commit-
23 tee shall refer such information to the commissioner and to the office
24 of professions for investigation and, if applicable, disciplinary
25 action.
26 § 13. Subdivision 8 of section 7104 of the education law, as amended
27 by chapter 517 of the laws of 1995, is amended to read as follows:
28 (8) Fees: pay a fee of two hundred twenty dollars to the department
29 for admission to a department conducted examination and for an initial
30 license, a fee of one hundred fifteen dollars for each reexamination, a
31 fee of one hundred thirty-five dollars for an initial license for
32 persons not requiring admission to a department conducted examination,
33 [and] a fee of two hundred ten dollars for each triennial registration
34 period, [and] for additional authorization for the purpose of utilizing
35 diagnostic pharmaceutical agents, a fee of sixty dollars, and for
36 certification to use or prescribe oral therapeutic pharmaceutical
37 agents, a fee of one hundred dollars.
38 § 14. This act shall take effect one year after it shall have become a
39 law; provided that:
40 (a) subdivision 13 of section 7101-a of the education law added by
41 section twelve of this act shall expire and be deemed repealed five
42 years following the approval by the department of education of the
43 initial certification course and examination pursuant to paragraph (c)
44 of subdivision 4 of section 7101-a of the education law as added by
45 section six of this act;
46 (b) the commissioner of education shall notify the legislative bill
47 drafting commission upon approval of the initial certification course
48 and examination required in section six of this act in order that the
49 commission may maintain an accurate and timely effective data base of
50 the official text of the laws of the state of New York in furtherance of
51 effectuating the provisions of section 44 of the legislative law and
52 section 70-b of the public officers law; and
53 (c) any rule or regulation necessary for the timely implementation of
54 this act on its effective date shall be promulgated on or before such
55 effective date.