§ 7101-A — Certification to use therapeutic drugs

§ 7101-a. Certification to use therapeutic drugs. 1. Definitions. As\nused in this section, the following terms shall have the following\nmeanings:\n (a) Clinical training. Clinical training shall mean the diagnosis,\ntreatment and management of patients with ocular disease and shall be\ncomparable to that acquired by a current graduate of the State\nUniversity College of Optometry.\n (b) Consultation. Consultation shall mean a confirmation of the\ndiagnosis, a plan of co-management of the patient, and a periodic review\nof the patient's progress.\n (c) Education review committee. Education review committee shall mean\nthe committee established pursuant to subdivision nine of this section.\n (d) Diagnostic pharmaceuticals. Diagnostic pharmaceuticals shall mean\nthose drugs which shall be limited to topical applications to the\nsurface of the eye for the purpose of diagnostic examination of the eye\nand shall be limited to:\n (i) Anesthetic agents;\n (ii) Mydriatics;\n (iii) Cycloplegics;\n (iv) Miotics;\n (v) Disclosing agents and other substances used in conjunction with\nthese drugs as part of a diagnostic procedure.\n (e) Topical therapeutic pharmaceutical agents. Topical therapeutic\npharmaceutical agents shall mean those drugs which shall be limited to\ntopical application to the surface of the eye for therapeutic purposes\nand shall be limited to:\n (i) antibiotic/antimicrobials;\n (ii) decongestants/anti-allergenics;\n (iii) non-steroidal anti-inflammatory agents;\n (iv) steroidal anti-inflammatory agents;\n (v) antiviral agents;\n (vi) hyperosmotic/hypertonic agents;\n (vii) cycloplegics;\n (viii) artificial tears and lubricants; and\n (ix) immunosuppressive agents.\n (e-1) Nasal sprays as topical therapeutic pharmaceutical agents.\nTopical therapeutic pharmaceutical agents shall also include those drugs\nlisted in subparagraph (iii) of paragraph (f) of this subdivision that\nare administered through a nasal spray for the treatment of dry eye\ndisease.\n (f) Therapeutic pharmaceutical agents for treatment of glaucoma and\nocular hypertension. Therapeutic pharmaceutical agents for treatment of\nglaucoma and ocular hypertension shall mean those drugs which shall be\nlimited to topical application to the surface of the eye and shall be\nlimited to:\n (i) beta blockers;\n (ii) alpha agonists;\n (iii) direct acting cholinergic agents;\n (iv) prostaglandin analogs; and\n (v) carbonic anhydrase inhibitors.\n (g) Oral therapeutic pharmaceutical agents. Oral therapeutic\npharmaceutical agents shall mean those orally administered drugs used\nfor therapeutic purposes solely for the treatment of diseases of the eye\nand adnexa and shall be limited to:\n (i) the following antibiotics:\n (1) amoxicillin/clavulanate potassium;\n (2) cephalexin;\n (3) azithromycin;\n (4) sulfamethoxazole/trimethoprim;\n (5) doxycycline; and\n (6) tetracycline;\n (ii) the following antiglaucoma agents used for the management of\nacute increases in intraocular pressure; provided, however, an\noptometrist may use or prescribe a maximum of one twenty-four hour\nprescription and shall immediately refer the patient to a licensed\nphysician specializing in diseases of the eye:\n (1) acetazolamide; and\n (2) methazolamide; and\n (iii) the following antiviral agents used for herpes zoster\nophthalmicus; provided an optometrist shall use or prescribe in maximum,\none seven-day prescription; provided, however, if a patient is diagnosed\nwith herpes zoster ophthalmicus and has not already been examined by a\nprimary care physician or other appropriate physician for such viral\ncondition, an optometrist shall refer the patient to a licensed primary\ncare physician, licensed physician specializing in diseases of the eye,\nor other appropriate physician within three days of such diagnosis:\n (1) valacyclovir; and\n (2) acyclovir.\n 2. Standard of care. An optometrist authorized to use pharmaceutical\nagents for use in the diagnosis, treatment or prevention of ocular\ndisease shall be held to the same standard of care in diagnosis, use of\nsuch agents, and treatment as that degree of skill and proficiency\ncommonly exercised by a physician in the same community.\n 3. Certificate. The commissioner shall issue appropriate certificates\nto use therapeutic pharmaceutical agents in accordance with the\nprovisions of this section to those optometrists who have satisfactorily\ncompleted a curriculum in general and ocular pharmacology at a college\nof optometry with didactic and supervised clinical programs approved by\nthe department are eligible to apply for the certificate issued pursuant\nto this section.\n 4. Topical therapeutic pharmaceutical agents. (a) Before using or\nprescribing topical therapeutic pharmaceutical agents, each optometrist\nshall have completed at least three hundred hours of clinical training\nin the diagnosis, treatment and management of patients with ocular\ndisease other than glaucoma and ocular hypertension, not fewer than\ntwenty-five hours of such training shall have been completed subsequent\nto June thirtieth, nineteen hundred ninety-three and additionally shall\neither have taken and successfully passed the treatment and management\nof ocular diseases portion of the National Board of Examiners in\nOptometry test or have taken and successfully passed an examination\nacceptable to the board.\n (b) Before using or prescribing therapeutic pharmaceutical agents for\ntreatment of glaucoma and ocular hypertension, an optometrist must be\ncertified for diagnostic and topical therapeutic agents and have\ncompleted an additional one hundred hours of clinical training in the\ndiagnosis, treatment and management of patients with glaucoma and ocular\nhypertension, not fewer than twenty-five hours of such training shall\nhave been completed subsequent to July first, nineteen hundred\nninety-four, and shall have taken and successfully passed an oral or\nwritten examination acceptable by the board.\n (c) Before using or prescribing oral therapeutic pharmaceutical\nagents, an optometrist must be certified to prescribe diagnostic\npharmaceutical agents and topical therapeutic and therapeutic\npharmaceutical agents for treatment of glaucoma and ocular hypertension,\nhave completed an oral therapeutic pharmaceutical agent certification\ncourse and have passed an examination within five years of the\ndepartment's approval of the initial certification course or the initial\nexamination, whichever is later provided, however, an optometrist who\nhas commenced the oral therapeutic pharmaceutical agent certification\ncourse within the five year time period but has not yet passed an\nexamination shall be allowed to take such examination and become\ncertified after the five year time period provided for in this paragraph\nhas ended.\n (i) The curriculum for the oral therapeutic pharmaceutical agent\ncertification course shall include, but not be limited to, instruction\nin pharmacology and drug interaction in treating ocular disease and be\ntaught through clinical case scenarios and emphasize clinical decision\nmaking and shall be no less than forty hours, of which no less than\ntwenty-four hours shall be live instruction.\n (ii) Such course shall qualify towards meeting the continuing\neducation per triennial registration requirement pursuant to subdivision\nseven of this section.\n (iii) The examination shall assess the knowledge of materials in the\ncurriculum and reflect the oral therapeutic pharmaceutical agents\ndescribed in paragraph (g) of subdivision one of this section, and shall\nbe acceptable to the department.\n (iv) The initial, and any subsequent, curriculum and examination shall\nbe subject to review and approval by the department.\n (v) The requirement for the oral therapeutic pharmaceutical agent\ncertification course and examination shall not apply to those\noptometrists who graduated from an accredited college of optometry\nsubsequent to January first, two thousand twenty-two and have taken and\nsuccessfully passed the National Board of Examiners in Optometry\nexamination or an examination acceptable to the department.\n (d) The clinical training required by this section may have been\nacquired prior to the enactment of this section not inconsistent with\nparagraphs (a) and (b) of this subdivision. Approval of the pre-acquired\nclinical training shall be in accordance with subdivision nine-a of this\nsection.\n (e) The provisions of paragraphs (a) and (b) of this subdivision shall\nnot apply to (i) graduates of an appropriate program approved by the\ndepartment who have successfully passed the examination on the use of\ndiagnostic and therapeutic drugs and who graduated subsequent to January\nfirst, nineteen hundred ninety-three; or (ii) optometrists who have been\ncertified for at least five years to use phase one and phase two drugs\nin another jurisdiction, have demonstrated such use in independently\nmanaged patients, and have been licensed in accordance with section\nseventy-one hundred four of this chapter. Provided, however, no\noptometrist exempt under this paragraph shall be permitted to use phase\none therapeutic pharmaceutical agents or phase two therapeutic\npharmaceutical agents prior to the general authorization provided to\noptometrists licensed in this state.\n 5. Suspension of certification. The department shall suspend the\ncertification for the use and prescribing of topical therapeutic agents\nof any optometrist who fails to receive certification for therapeutic\npharmaceutical agents for treatment of glaucoma and ocular hypertension\nwithin three years of having been certified for topical therapeutic\npharmaceutical agents.\n 6. Consultation with use of certain topical therapeutic pharmaceutical\nagents for treatment of glaucoma and ocular hypertension. (a) After the\ninitial diagnosis of glaucoma or ocular hypertension and before\ninitiating treatment of any patient, an optometrist shall engage in a\nwritten consultation with a licensed physician specializing in diseases\nof the eye.\n (b) A consultation shall be required for a period of three years or\nuntil the optometrist has examined and diagnosed seventy-five patients\nhaving glaucoma or ocular hypertension which examinations require a\nwritten consultation in accordance with paragraph (a) of this\nsubdivision, whichever occurs later.\n (c) The consultation provisions shall not apply to a graduate of an\nappropriate program approved by the department who successfully passed\nan examination in the use of diagnostic and therapeutic pharmaceutical\nagents approved by the department and graduated such school subsequent\nto January first, nineteen hundred ninety-nine and who has had at least\nseventy-five documented examinations and diagnosis of patients with\nglaucoma or ocular hypertension which examinations were part of their\ntraining and were under physician supervision.\n 7. Continuing education. (a) Each optometrist certified to use topical\ntherapeutic pharmaceutical agents and therapeutic pharmaceutical agents\nfor treatment of glaucoma and ocular hypertension, shall complete a\nminimum of thirty-six hours of continuing education in the area of\nocular disease and pharmacology per triennial registration period. Each\noptometrist certified to use oral therapeutic pharmaceutical agents\nshall, in addition to the minimum thirty-six hours of continuing\neducation provided for in this subdivision, complete an additional\nminimum of eighteen hours of continuing education related to systemic\ndisease and therapeutic treatment per triennial registration period.\nSuch educational programs may include both didactic and clinical\ncomponents and shall be approved in advance by the department. Beginning\non January first, two thousand twenty-three, all sponsors of continuing\neducation courses seeking advanced approval from the department shall\nfile an application and pay a fee determined by the department in\naccordance with the regulations of the commissioner. An optometrist\nsubject to the provisions of this subdivision whose first registration\ndate following the effective date of this section occurs less than three\nyears from such effective date, but on or after January first, two\nthousand twenty-three, shall complete continuing education hours on a\nprorated basis at the rate of one hour per month for the period\nbeginning January first, two thousand twenty-three up to the first\nregistration date thereafter. An optometrist who has not satisfied the\nmandatory continuing education requirement pursuant to this subdivision\nshall not be issued a triennial registration certificate by the\ndepartment and shall not practice unless and until a conditional\nregistration is issued as provided for in paragraph (b) of this\nsubdivision. Continuing education hours taken during one triennium may\nnot be transferred to the subsequent triennium.\n (b) The department, in its discretion, may issue a conditional\nregistration to an optometrist who fails to meet the continuing\neducation requirements established in paragraph (a) of this subdivision,\nbut who agrees to make up any deficiencies and complete any additional\neducation which the department may require. The fee for such a\nconditional registration shall be the same as, and in addition to, the\nfee for the triennial registration. The duration of such conditional\nregistration shall be determined by the department, but shall not exceed\none year. Any optometrist who is notified of the denial of registration\nfor failure to submit evidence, satisfactory to the department, of\nrequired continuing education and who practices without such\nregistration may be subject to disciplinary proceedings pursuant to\nsection sixty-five hundred ten of this title.\n (c) In accordance with the intent of this section, adjustment to the\nmandatory continuing education requirement may be granted by the\ndepartment for reasons of health that are certified by an appropriate\nhealth care professional, for extended active duty with the armed forces\nof the United States, or for other good cause acceptable to the\ndepartment which may prevent compliance.\n (d) An optometrist not engaged in practice, as determined by the\ndepartment, shall be exempt from the mandatory continuing education\nrequirement upon the filing of a statement with the department declaring\nsuch status. Any licensee who returns to the practice of optometry\nduring the triennial registration period shall notify the department\nprior to reentering the profession and shall meet such continuing\neducation requirements as shall be prescribed by regulations of the\ncommissioner.\n (e) Optometrists subject to the provisions of this subdivision shall\nmaintain adequate documentation of completion of acceptable continuing\neducation credits and shall provide such documentation at the request of\nthe department. Failure to provide such documentation upon the request\nof the department shall be an act of misconduct subject to disciplinary\nproceedings pursuant to section sixty-five hundred ten of this title.\n (f) The mandatory continuing education fee shall be determined by the\ndepartment. Such fee shall be payable on or before the first day of each\ntriennial registration period, and shall be paid in addition to the\ntriennial registration fee required by subdivision eight of section\nseventy-one hundred four of this article.\n 8. Notice to patient with the use or prescription of topical\ntherapeutic pharmaceutical agents and therapeutic pharmaceutical agents\nfor treatment of glaucoma and ocular hypertension. (a) (i) An\noptometrist prescribing topical steroids or antiviral medication shall\ninform each patient that in the event the condition does not improve\nwithin five days, a physician of the patient's choice will be notified.\n (ii) An optometrist engaged in a written consultation with an\nophthalmologist shall inform a patient diagnosed with glaucoma that the\noptometrist will have the diagnosis confirmed and co-managed with an\nophthalmologist of the patient's choice, or one selected by the\noptometrist.\n (b) In addition, each optometrist certified to prescribe and use\ntherapeutic drugs shall have posted conspicuously in the office\nreception area the following notice:\n "Dr. (Name), O.D. is certified by New York State to use drugs to\ndiagnose and treat diseases of the eye. In the event your condition\nrequires the use of steroids or antiviral medication and your condition\ndoes not improve within five days, a physician of your choice will be\nnotified.\n In the event you are diagnosed with glaucoma, the optometrist will\nhave your diagnosis confirmed and treatment co-managed with an\nophthalmologist (MD) of your choice, or if you wish, one selected by Dr.\n(Name)."\n The second paragraph of such notice shall only be required to be\nincluded during the period when the optometrist is engaged in a written\nconsultation pursuant to subdivision six of this section.\n 9. Education review committee. An education review committee is hereby\ncreated to advise and assist the commissioner in evaluating pre-acquired\nclinical training. The members of the committee shall be appointed by\nthe commissioner in consultation with the chancellor of the state\nuniversity of New York. The committee shall consist of five members, two\nof whom shall be optometrists on the faculty of the SUNY college of\noptometry, two of whom shall be ophthalmologists who, in addition to\nbeing members of the faculty of any approved medical school in this\nstate and not also faculty members of SUNY college of optometry, have\nsurgical privileges at a New York state hospital. The fifth member who\nshall be designated as chair shall be an expert in the field of public\nhealth and shall be neither an ophthalmologist nor an optometrist.\n The commissioner shall submit each application to the committee for\nits review and recommendation. In making such recommendation, the\ncommittee shall advise as to the number of hours of pre-acquired\nclinical training, if any, to be approved, based upon the information\nsubmitted with the application. In evaluating such training, the\ncommittee shall be authorized to require the submission of such\nreasonable documentation needed to facilitate the committee's review of\nthe adequacy and relevance of such training.\n 9-a. Pre-acquired clinical training. (a) Each optometrist requesting\napproval of pre-acquired clinical training shall submit a written\napplication to the department. The commissioner, in consultation with\nthe education review committee may provide credit for the following:\n (i) clinical training acquired at an institution accredited by a\nregional or professional accreditation organization which is recognized\nor approved by the United States Department of Education, the department\nand the Board of Regents of the University of the state of New York;\n (ii) clinical training acquired at a facility licensed by the state of\nNew York in accordance with article twenty-eight of the public health\nlaw or at a comparable facility located in another state or country\nprovided the licensing requirements or accreditation requirements of\nsuch institution are comparable to those of New York state;\n (iii) hospital affiliations, including rounds and patient management\nfor applicants having staff privileges at such facility;\n (iv) consultation and co-management with ophthalmologists of patients\nwith ocular disease and post-surgery recovery;\n (v) postdoctoral accredited residency or fellowship programs;\n (vi) experience at an accredited educational institution as a faculty\ninstructor in clinical practice, ocular disease management and\npharmacology;\n (vii) experience in other states in which the applicant has been\ncertified to use therapeutic pharmaceutical agents.\n (b) Any optometrist disagreeing with the recommendation of the\neducation review committee shall have a right to appeal in writing to\nthe commissioner. The decision of the commissioner shall be final and\nbinding on all parties.\n 10. Pharmaceutical agents. Optometrists who have been approved and\ncertified by the department shall be permitted to use the following\ndrugs:\n (a) Diagnostic pharmaceuticals.\n (b) Those optometrists having been certified for topical therapeutic\npharmaceutical agents shall be authorized to use and prescribe all\ntopical therapeutic pharmaceutical agents specified in paragraph (e) of\nsubdivision one of this section, which are FDA approved and commercially\navailable for topical use.\n In the event an optometrist treats a patient with topical antiviral or\nsteroidal drugs and the patient's condition either fails to improve or\nworsens within five days, the optometrist shall notify a physician\ndesignated by the patient or, if none, by the treating optometrist.\n (c) Those optometrists having been certified for therapeutic\npharmaceutical agents for treatment of glaucoma and ocular hypertension\nshall be authorized to use and prescribe therapeutic pharmaceutical\nagents for treatment of glaucoma and ocular hypertension specified in\nparagraph (f) of subdivision one of this section, which are FDA approved\nand commercially available.\n (d) Those optometrists having been certified for oral therapeutic\npharmaceutical agents shall be authorized to use and prescribe oral\ntherapeutic pharmaceutical agents specified in paragraph (g) of\nsubdivision one of this section, which are FDA approved and commercially\navailable and shall comply with all safety information and side-effect\nand warning advisories contained in the most current physicians' desk\nreference.\n (e) Those optometrists having been certified for topical therapeutic\npharmaceutical agents, therapeutic pharmaceutical agents for treatment\nof glaucoma and ocular hypertension or oral therapeutic pharmaceutical\nagents shall be authorized to use and recommend all nonprescription\nmedications, whether intended for topical or oral use, appropriate for\nthe treatment of the eye and adnexa.\n 11. Responsibilities of the commissioner. The commissioner shall adopt\nregulations (a) providing for the certification of graduates of an\nappropriate program approved by the department who have successfully\npassed the examination on the use of diagnostic and therapeutic\npharmaceutical agents and who have graduated subsequent to January\nfirst, nineteen hundred ninety-three; and (b) providing for the\ncertification of optometrists who have graduated from other accredited\ncolleges of optometry or who are licensed to practice in other\njurisdictions, have demonstrated such use in independently managed\npatients and are seeking licensure and certification in New York.\n 12. Responsibilities of the commissioner of health. The commissioner\nof health may recommend to the commissioner additions or deletions to\nthe department's regulations relating to optometric use of drugs except\nthat such recommendations shall be limited only to additions which have\nbeen determined to be equivalent to those drugs already authorized or\ndeletions based upon a finding that the drugs are no longer appropriate\nfor their current use or for other similar reasons.\n