Section 7101-A. Certification to use therapeutic drugs  


Latest version.
  • 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)  Phase  one   therapeutic   pharmaceutical   agents.   Phase   one
      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.
        (f)   Phase   two   therapeutic   pharmaceutical   agents.  Phase  two
      pharmaceutical agents 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.
        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.  Phase  one  therapeutic pharmaceutical agents. (a) Before using or
      prescribing  phase   one   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 phase two  therapeutic  pharmaceutical
      agents,  an  optometrist  must be certified for diagnostic and phase one
      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)  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.
        (d) 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 phase one therapeutic
      agents of any optometrist who fails to receive certification  for  phase
      two  therapeutic pharmaceutical agents within three years of having been
      certified for phase one therapeutic pharmaceutical agents.
        6. Consultation. (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. Each optometrist certified to use phase one
      or phase two therapeutic pharmaceutical agents shall complete a  minimum
      of  thirty-six  hours of continuing education per triennial registration
      period. The education shall  be  in  the  area  of  ocular  disease  and
      pharmacology and may include both didactic and clinical components. Such
    
      educational  programs shall be approved in advance by the department and
      evidence of the completion of this requirement shall be  submitted  with
      each  application  for license renewal as required by section sixty-five
      hundred two of this chapter.
        8.  Notice  to patient. (a) (i) An optometrist prescribing 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 phase one therapeutic
      pharmaceutical  agents  shall be authorized (i) to use and recommend all
      nonprescription  medications  appropriate  for  ocular  disease  whether
      intended  for  topical  or  oral  use; and (ii) to use and prescribe all
      phase one therapeutic pharmaceutical agents which are FDA  approved  and
      commercially available.
        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 phase two therapeutic
      pharmaceutical agents shall be authorized to use and prescribe phase two
      therapeutic   pharmaceutical   agents   which   are   FDA  approved  and
      commercially available.
        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.