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SECTION 7101-A
Certification to use therapeutic drugs
Education (EDN) CHAPTER 16, TITLE 8, ARTICLE 143
§ 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.