N.Y. Education Law § 7101-a: Certification to use therapeutic drugs

§ 7101-a. Certification to use therapeutic drugs. 1. Definitions. As

used in this section, the following terms shall have the following

meanings:

(a) Clinical training. Clinical training shall mean the diagnosis,

treatment and management of patients with ocular disease and shall be

comparable to that acquired by a current graduate of the State

University College of Optometry.

(b) Consultation. Consultation shall mean a confirmation of the

diagnosis, a plan of co-management of the patient, and a periodic review

of the patient's progress.

(c) Education review committee. Education review committee shall mean

the committee established pursuant to subdivision nine of this section.

(d) Diagnostic pharmaceuticals. Diagnostic pharmaceuticals shall mean

those drugs which shall be limited to topical applications to the

surface of the eye for the purpose of diagnostic examination of the eye

and shall be limited to:

(i) Anesthetic agents;

(ii) Mydriatics;

(iii) Cycloplegics;

(iv) Miotics;

(v) Disclosing agents and other substances used in conjunction with

these drugs as part of a diagnostic procedure.

(e) Topical therapeutic pharmaceutical agents. Topical therapeutic

pharmaceutical agents shall mean those drugs which shall be limited to

topical application to the surface of the eye for therapeutic purposes

and shall be limited to:

(i) antibiotic/antimicrobials;

(ii) decongestants/anti-allergenics;

(iii) non-steroidal anti-inflammatory agents;

(iv) steroidal anti-inflammatory agents;

(v) antiviral agents;

(vi) hyperosmotic/hypertonic agents;

(vii) cycloplegics;

(viii) artificial tears and lubricants; and

(ix) immunosuppressive agents.

(e-1) Nasal sprays as topical therapeutic pharmaceutical agents.

Topical therapeutic pharmaceutical agents shall also include those drugs

listed in subparagraph (iii) of paragraph (f) of this subdivision that

are administered through a nasal spray for the treatment of dry eye

disease.

(f) Therapeutic pharmaceutical agents for treatment of glaucoma and

ocular hypertension. Therapeutic pharmaceutical agents for treatment of

glaucoma and ocular hypertension shall mean those drugs which shall be

limited to topical application to the surface of the eye and shall be

limited to:

(i) beta blockers;

(ii) alpha agonists;

(iii) direct acting cholinergic agents;

(iv) prostaglandin analogs; and

(v) carbonic anhydrase inhibitors.

(g) Oral therapeutic pharmaceutical agents. Oral therapeutic

pharmaceutical agents shall mean those orally administered drugs used

for therapeutic purposes solely for the treatment of diseases of the eye

and adnexa and shall be limited to:

(i) the following antibiotics:

(1) amoxicillin/clavulanate potassium;

(2) cephalexin;

(3) azithromycin;

(4) sulfamethoxazole/trimethoprim;

(5) doxycycline; and

(6) tetracycline;

(ii) the following antiglaucoma agents used for the management of

acute increases in intraocular pressure; provided, however, an

optometrist may use or prescribe a maximum of one twenty-four hour

prescription and shall immediately refer the patient to a licensed

physician specializing in diseases of the eye:

(1) acetazolamide; and

(2) methazolamide; and

(iii) the following antiviral agents used for herpes zoster

ophthalmicus; provided an optometrist shall use or prescribe in maximum,

one seven-day prescription; provided, however, if a patient is diagnosed

with herpes zoster ophthalmicus and has not already been examined by a

primary care physician or other appropriate physician for such viral

condition, an optometrist shall refer the patient to a licensed primary

care physician, licensed physician specializing in diseases of the eye,

or other appropriate physician within three days of such diagnosis:

(1) valacyclovir; and

(2) acyclovir.

2. Standard of care. An optometrist authorized to use pharmaceutical

agents for use in the diagnosis, treatment or prevention of ocular

disease shall be held to the same standard of care in diagnosis, use of

such agents, and treatment as that degree of skill and proficiency

commonly exercised by a physician in the same community.

3. Certificate. The commissioner shall issue appropriate certificates

to use therapeutic pharmaceutical agents in accordance with the

provisions of this section to those optometrists who have satisfactorily

completed a curriculum in general and ocular pharmacology at a college

of optometry with didactic and supervised clinical programs approved by

the department are eligible to apply for the certificate issued pursuant

to this section.

4. Topical therapeutic pharmaceutical agents. (a) Before using or

prescribing topical therapeutic pharmaceutical agents, each optometrist

shall have completed at least three hundred hours of clinical training

in the diagnosis, treatment and management of patients with ocular

disease other than glaucoma and ocular hypertension, not fewer than

twenty-five hours of such training shall have been completed subsequent

to June thirtieth, nineteen hundred ninety-three and additionally shall

either have taken and successfully passed the treatment and management

of ocular diseases portion of the National Board of Examiners in

Optometry test or have taken and successfully passed an examination

acceptable to the board.

(b) Before using or prescribing therapeutic pharmaceutical agents for

treatment of glaucoma and ocular hypertension, an optometrist must be

certified for diagnostic and topical therapeutic agents and have

completed an additional one hundred hours of clinical training in the

diagnosis, treatment and management of patients with glaucoma and ocular

hypertension, not fewer than twenty-five hours of such training shall

have been completed subsequent to July first, nineteen hundred

ninety-four, and shall have taken and successfully passed an oral or

written examination acceptable by the board.

(c) Before using or prescribing oral therapeutic pharmaceutical

agents, an optometrist must be certified to prescribe diagnostic

pharmaceutical agents and topical therapeutic and therapeutic

pharmaceutical agents for treatment of glaucoma and ocular hypertension,

have completed an oral therapeutic pharmaceutical agent certification

course and have passed an examination within five years of the

department's approval of the initial certification course or the initial

examination, whichever is later provided, however, an optometrist who

has commenced the oral therapeutic pharmaceutical agent certification

course within the five year time period but has not yet passed an

examination shall be allowed to take such examination and become

certified after the five year time period provided for in this paragraph

has ended.

(i) The curriculum for the oral therapeutic pharmaceutical agent

certification course shall include, but not be limited to, instruction

in pharmacology and drug interaction in treating ocular disease and be

taught through clinical case scenarios and emphasize clinical decision

making and shall be no less than forty hours, of which no less than

twenty-four hours shall be live instruction.

(ii) Such course shall qualify towards meeting the continuing

education per triennial registration requirement pursuant to subdivision

seven of this section.

(iii) The examination shall assess the knowledge of materials in the

curriculum and reflect the oral therapeutic pharmaceutical agents

described in paragraph (g) of subdivision one of this section, and shall

be acceptable to the department.

(iv) The initial, and any subsequent, curriculum and examination shall

be subject to review and approval by the department.

(v) The requirement for the oral therapeutic pharmaceutical agent

certification course and examination shall not apply to those

optometrists who graduated from an accredited college of optometry

subsequent to January first, two thousand twenty-two and have taken and

successfully passed the National Board of Examiners in Optometry

examination or an examination acceptable to the department.

(d) The clinical training required by this section may have been

acquired prior to the enactment of this section not inconsistent with

paragraphs (a) and (b) of this subdivision. Approval of the pre-acquired

clinical training shall be in accordance with subdivision nine-a of this

section.

(e) The provisions of paragraphs (a) and (b) of this subdivision shall

not apply to (i) graduates of an appropriate program approved by the

department who have successfully passed the examination on the use of

diagnostic and therapeutic drugs and who graduated subsequent to January

first, nineteen hundred ninety-three; or (ii) optometrists who have been

certified for at least five years to use phase one and phase two drugs

in another jurisdiction, have demonstrated such use in independently

managed patients, and have been licensed in accordance with section

seventy-one hundred four of this chapter. Provided, however, no

optometrist exempt under this paragraph shall be permitted to use phase

one therapeutic pharmaceutical agents or phase two therapeutic

pharmaceutical agents prior to the general authorization provided to

optometrists licensed in this state.

5. Suspension of certification. The department shall suspend the

certification for the use and prescribing of topical therapeutic agents

of any optometrist who fails to receive certification for therapeutic

pharmaceutical agents for treatment of glaucoma and ocular hypertension

within three years of having been certified for topical therapeutic

pharmaceutical agents.

6. Consultation with use of certain topical therapeutic pharmaceutical

agents for treatment of glaucoma and ocular hypertension. (a) After the

initial diagnosis of glaucoma or ocular hypertension and before

initiating treatment of any patient, an optometrist shall engage in a

written consultation with a licensed physician specializing in diseases

of the eye.

(b) A consultation shall be required for a period of three years or

until the optometrist has examined and diagnosed seventy-five patients

having glaucoma or ocular hypertension which examinations require a

written consultation in accordance with paragraph (a) of this

subdivision, whichever occurs later.

(c) The consultation provisions shall not apply to a graduate of an

appropriate program approved by the department who successfully passed

an examination in the use of diagnostic and therapeutic pharmaceutical

agents approved by the department and graduated such school subsequent

to January first, nineteen hundred ninety-nine and who has had at least

seventy-five documented examinations and diagnosis of patients with

glaucoma or ocular hypertension which examinations were part of their

training and were under physician supervision.

7. Continuing education. (a) Each optometrist certified to use topical

therapeutic pharmaceutical agents and therapeutic pharmaceutical agents

for treatment of glaucoma and ocular hypertension, shall complete a

minimum of thirty-six hours of continuing education in the area of

ocular disease and pharmacology per triennial registration period. Each

optometrist certified to use oral therapeutic pharmaceutical agents

shall, in addition to the minimum thirty-six hours of continuing

education provided for in this subdivision, complete an additional

minimum of eighteen hours of continuing education related to systemic

disease and therapeutic treatment per triennial registration period.

Such educational programs may include both didactic and clinical

components and shall be approved in advance by the department. Beginning

on January first, two thousand twenty-three, all sponsors of continuing

education courses seeking advanced approval from the department shall

file an application and pay a fee determined by the department in

accordance with the regulations of the commissioner. An optometrist

subject to the provisions of this subdivision whose first registration

date following the effective date of this section occurs less than three

years from such effective date, but on or after January first, two

thousand twenty-three, shall complete continuing education hours on a

prorated basis at the rate of one hour per month for the period

beginning January first, two thousand twenty-three up to the first

registration date thereafter. An optometrist who has not satisfied the

mandatory continuing education requirement pursuant to this subdivision

shall not be issued a triennial registration certificate by the

department and shall not practice unless and until a conditional

registration is issued as provided for in paragraph (b) of this

subdivision. Continuing education hours taken during one triennium may

not be transferred to the subsequent triennium.

(b) The department, in its discretion, may issue a conditional

registration to an optometrist who fails to meet the continuing

education requirements established in paragraph (a) of this subdivision,

but who agrees to make up any deficiencies and complete any additional

education which the department may require. The fee for such a

conditional registration shall be the same as, and in addition to, the

fee for the triennial registration. The duration of such conditional

registration shall be determined by the department, but shall not exceed

one year. Any optometrist who is notified of the denial of registration

for failure to submit evidence, satisfactory to the department, of

required continuing education and who practices without such

registration may be subject to disciplinary proceedings pursuant to

section sixty-five hundred ten of this title.

(c) In accordance with the intent of this section, adjustment to the

mandatory continuing education requirement may be granted by the

department for reasons of health that are certified by an appropriate

health care professional, for extended active duty with the armed forces

of the United States, or for other good cause acceptable to the

department which may prevent compliance.

(d) An optometrist not engaged in practice, as determined by the

department, shall be exempt from the mandatory continuing education

requirement upon the filing of a statement with the department declaring

such status. Any licensee who returns to the practice of optometry

during the triennial registration period shall notify the department

prior to reentering the profession and shall meet such continuing

education requirements as shall be prescribed by regulations of the

commissioner.

(e) Optometrists subject to the provisions of this subdivision shall

maintain adequate documentation of completion of acceptable continuing

education credits and shall provide such documentation at the request of

the department. Failure to provide such documentation upon the request

of the department shall be an act of misconduct subject to disciplinary

proceedings pursuant to section sixty-five hundred ten of this title.

(f) The mandatory continuing education fee shall be determined by the

department. Such fee shall be payable on or before the first day of each

triennial registration period, and shall be paid in addition to the

triennial registration fee required by subdivision eight of section

seventy-one hundred four of this article.

8. Notice to patient with the use or prescription of topical

therapeutic pharmaceutical agents and therapeutic pharmaceutical agents

for treatment of glaucoma and ocular hypertension. (a) (i) An

optometrist prescribing topical steroids or antiviral medication shall

inform each patient that in the event the condition does not improve

within five days, a physician of the patient's choice will be notified.

(ii) An optometrist engaged in a written consultation with an

ophthalmologist shall inform a patient diagnosed with glaucoma that the

optometrist will have the diagnosis confirmed and co-managed with an

ophthalmologist of the patient's choice, or one selected by the

optometrist.

(b) In addition, each optometrist certified to prescribe and use

therapeutic drugs shall have posted conspicuously in the office

reception area the following notice:

"Dr. (Name), O.D. is certified by New York State to use drugs to

diagnose and treat diseases of the eye. In the event your condition

requires the use of steroids or antiviral medication and your condition

does not improve within five days, a physician of your choice will be

notified.

In the event you are diagnosed with glaucoma, the optometrist will

have your diagnosis confirmed and treatment co-managed with an

ophthalmologist (MD) of your choice, or if you wish, one selected by Dr.

(Name)."

The second paragraph of such notice shall only be required to be

included during the period when the optometrist is engaged in a written

consultation pursuant to subdivision six of this section.

9. Education review committee. An education review committee is hereby

created to advise and assist the commissioner in evaluating pre-acquired

clinical training. The members of the committee shall be appointed by

the commissioner in consultation with the chancellor of the state

university of New York. The committee shall consist of five members, two

of whom shall be optometrists on the faculty of the SUNY college of

optometry, two of whom shall be ophthalmologists who, in addition to

being members of the faculty of any approved medical school in this

state and not also faculty members of SUNY college of optometry, have

surgical privileges at a New York state hospital. The fifth member who

shall be designated as chair shall be an expert in the field of public

health and shall be neither an ophthalmologist nor an optometrist.

The commissioner shall submit each application to the committee for

its review and recommendation. In making such recommendation, the

committee shall advise as to the number of hours of pre-acquired

clinical training, if any, to be approved, based upon the information

submitted with the application. In evaluating such training, the

committee shall be authorized to require the submission of such

reasonable documentation needed to facilitate the committee's review of

the adequacy and relevance of such training.

9-a. Pre-acquired clinical training. (a) Each optometrist requesting

approval of pre-acquired clinical training shall submit a written

application to the department. The commissioner, in consultation with

the education review committee may provide credit for the following:

(i) clinical training acquired at an institution accredited by a

regional or professional accreditation organization which is recognized

or approved by the United States Department of Education, the department

and the Board of Regents of the University of the state of New York;

(ii) clinical training acquired at a facility licensed by the state of

New York in accordance with article twenty-eight of the public health

law or at a comparable facility located in another state or country

provided the licensing requirements or accreditation requirements of

such institution are comparable to those of New York state;

(iii) hospital affiliations, including rounds and patient management

for applicants having staff privileges at such facility;

(iv) consultation and co-management with ophthalmologists of patients

with ocular disease and post-surgery recovery;

(v) postdoctoral accredited residency or fellowship programs;

(vi) experience at an accredited educational institution as a faculty

instructor in clinical practice, ocular disease management and

pharmacology;

(vii) experience in other states in which the applicant has been

certified to use therapeutic pharmaceutical agents.

(b) Any optometrist disagreeing with the recommendation of the

education review committee shall have a right to appeal in writing to

the commissioner. The decision of the commissioner shall be final and

binding on all parties.

10. Pharmaceutical agents. Optometrists who have been approved and

certified by the department shall be permitted to use the following

drugs:

(a) Diagnostic pharmaceuticals.

(b) Those optometrists having been certified for topical therapeutic

pharmaceutical agents shall be authorized to use and prescribe all

topical therapeutic pharmaceutical agents specified in paragraph (e) of

subdivision one of this section, which are FDA approved and commercially

available for topical use.

In the event an optometrist treats a patient with topical antiviral or

steroidal drugs and the patient's condition either fails to improve or

worsens within five days, the optometrist shall notify a physician

designated by the patient or, if none, by the treating optometrist.

(c) Those optometrists having been certified for therapeutic

pharmaceutical agents for treatment of glaucoma and ocular hypertension

shall be authorized to use and prescribe therapeutic pharmaceutical

agents for treatment of glaucoma and ocular hypertension specified in

paragraph (f) of subdivision one of this section, which are FDA approved

and commercially available.

(d) Those optometrists having been certified for oral therapeutic

pharmaceutical agents shall be authorized to use and prescribe oral

therapeutic pharmaceutical agents specified in paragraph (g) of

subdivision one of this section, which are FDA approved and commercially

available and shall comply with all safety information and side-effect

and warning advisories contained in the most current physicians' desk

reference.

(e) Those optometrists having been certified for topical therapeutic

pharmaceutical agents, therapeutic pharmaceutical agents for treatment

of glaucoma and ocular hypertension or oral therapeutic pharmaceutical

agents shall be authorized to use and recommend all nonprescription

medications, whether intended for topical or oral use, appropriate for

the treatment of the eye and adnexa.

11. Responsibilities of the commissioner. The commissioner shall adopt

regulations (a) providing for the certification of graduates of an

appropriate program approved by the department who have successfully

passed the examination on the use of diagnostic and therapeutic

pharmaceutical agents and who have graduated subsequent to January

first, nineteen hundred ninety-three; and (b) providing for the

certification of optometrists who have graduated from other accredited

colleges of optometry or who are licensed to practice in other

jurisdictions, have demonstrated such use in independently managed

patients and are seeking licensure and certification in New York.

12. Responsibilities of the commissioner of health. The commissioner

of health may recommend to the commissioner additions or deletions to

the department's regulations relating to optometric use of drugs except

that such recommendations shall be limited only to additions which have

been determined to be equivalent to those drugs already authorized or

deletions based upon a finding that the drugs are no longer appropriate

for their current use or for other similar reasons.