Bill Text: NY A09961 | 2015-2016 | General Assembly | Amended


Bill Title: Relates to the use of oral medications by optometrists.

Spectrum: Slight Partisan Bill (Democrat 27-11)

Status: (Introduced - Dead) 2016-06-12 - print number 9961a [A09961 Detail]

Download: New_York-2015-A09961-Amended.html


                STATE OF NEW YORK
        ________________________________________________________________________
                                         9961--A
                   IN ASSEMBLY
                                       May 2, 2016
                                       ___________
        Introduced  by  M.  of  A.  PAULIN, COOK, CYMBROWITZ, ABINANTI, GUNTHER,
          FARRELL, WEPRIN, HEVESI, RYAN, TITUS, STIRPE, SKOUFIS, BUCHWALD, GOLD-
          FEDER, DiPIETRO, BRABENEC, GRAF, BLAKE, FAHY, ORTIZ, COLTON, WALTER --
          Multi-Sponsored by -- M. of A. BARCLAY, BLANKENBUSH,  CAHILL,  CROUCH,
          FRIEND,  GALEF,  GOODELL,  GOTTFRIED,  HIKIND, KEARNS, LUPARDO, MAGEE,
          PALMESANO, RIVERA, SKARTADOS, STEC, WOERNER -- read once and  referred
          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:
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD15035-08-6

        A. 9961--A                          2
     1    (f)  [Phase  two  therapeutic]  Therapeutic  pharmaceutical agents for
     2  treatment of glaucoma and ocular hypertension.  [Phase two]  Therapeutic
     3  pharmaceutical  agents for treatment of glaucoma and ocular hypertension
     4  shall mean those drugs which shall be limited to topical application  to
     5  the surface of the eye and shall be limited to:
     6    (i) beta blockers;
     7    (ii) alpha agonists;
     8    (iii) direct acting cholinergic agents;
     9    (iv) prostaglandin analogs; and
    10    (v) carbonic anhydrase inhibitors.
    11    §  3.  Subdivision 1 of section 7101-a of the education law is amended
    12  by adding a new paragraph (g) to read as follows:
    13    (g) Oral therapeutic pharmaceutical agents. Oral  therapeutic  pharma-
    14  ceutical  agents  shall  mean  those  orally administered drugs used for
    15  therapeutic purposes solely for the treatment of diseases of the eye and
    16  adnexa and shall be limited to:
    17    (i) the following antibiotics, including, where applicable, the gener-
    18  ic equivalent of any of the listed drugs:
    19    (1) augmentin;
    20    (2) keflex;
    21    (3) azithromycin;
    22    (4) bactrim;
    23    (5) doxycycline; and
    24    (6) tetracycline;
    25    (ii)   the   following   decongestants/anti-allergenic/antihistamines,
    26  including the generic equivalents of the listed drugs:
    27    (1) clarinex;
    28    (2) xyzal; and
    29    (3) singulair;
    30    (iii)  the following antiglaucoma agents, including the generic equiv-
    31  alents of such agents, used for the management  of  acute  increases  in
    32  intraocular  pressure;  provided,  however,  an  optometrist  may use or
    33  prescribe a maximum of one twenty-four hour prescription and shall imme-
    34  diately refer the  patient  to  a  licensed  physician  specializing  in
    35  diseases of the eye:
    36    (1) diamox; and
    37    (2) neptazane;
    38    (iv)  the  following  antiviral agents for herpes zoster ophthalmicus;
    39  provided an optometrist shall use or  prescribe  in  maximum,  seven-day
    40  prescriptions;  provided, however, if a patient is diagnosed with herpes
    41  zoster ophthalmicus and has not already been examined by a primary  care
    42  physician  or  other  appropriate physician for such viral condition, an
    43  optometrist shall refer the patient to a licensed  primary  care  physi-
    44  cian,  licensed  physician specializing in diseases of the eye, or other
    45  appropriate physician within three days of such diagnosis:
    46    (1) valacyclovir; and
    47    (2) acyclovir; and
    48    (v) the following non-steroidal anti-inflammatory agents:
    49    (1) cox-2 inhibitors;
    50    (2) ibuprofen; and
    51    (3) naproxen.
    52    § 4. The subdivision heading and paragraph (a)  of  subdivision  4  of
    53  section 7101-a of the education law, as added by chapter 517 of the laws
    54  of 1995, is amended to read as follows:
    55    [Phase  one]  Topical  therapeutic  pharmaceutical  agents. (a) Before
    56  using or prescribing  [phase  one]  topical  therapeutic  pharmaceutical

        A. 9961--A                          3
     1  agents,  each  optometrist  shall  have completed at least three hundred
     2  hours of clinical training in the diagnosis, treatment and management of
     3  patients with ocular disease other than glaucoma  and  ocular  hyperten-
     4  sion,  not fewer than twenty-five hours of such training shall have been
     5  completed subsequent to June thirtieth,  nineteen  hundred  ninety-three
     6  and  additionally  shall  either  have taken and successfully passed the
     7  treatment and management of ocular  diseases  portion  of  the  National
     8  Board  of  Examiners  in  Optometry  test or have taken and successfully
     9  passed an examination acceptable to the board.
    10    § 5. Paragraph (b) of subdivision 4 of section 7101-a of the education
    11  law, as added by chapter 517 of the laws of 1995, is amended to read  as
    12  follows:
    13    (b) Before using or prescribing [phase two] therapeutic pharmaceutical
    14  agents for treatment of glaucoma and ocular hypertension, an optometrist
    15  must  be  certified  for  diagnostic and [phase one] topical therapeutic
    16  agents and have completed an additional one hundred  hours  of  clinical
    17  training  in  the  diagnosis,  treatment and management of patients with
    18  glaucoma and ocular hypertension, not fewer than  twenty-five  hours  of
    19  such  training shall have been completed subsequent to July first, nine-
    20  teen hundred ninety-four, and shall have taken and  successfully  passed
    21  an oral or written examination acceptable by the board.
    22    §  6. Paragraphs (c) and (d) of subdivision 4 of section 7101-a of the
    23  education law are relettered paragraphs (d) and (e) and a new  paragraph
    24  (c) is added to read as follows:
    25    (c)  Before  using  or  prescribing  oral  therapeutic  pharmaceutical
    26  agents, an optometrist must be certified to prescribe diagnostic pharma-
    27  ceutical agents and topical therapeutic and  therapeutic  pharmaceutical
    28  agents for treatment of glaucoma and ocular hypertension, have completed
    29  an  oral  therapeutic pharmaceutical agent certification course and have
    30  passed an examination, with a curriculum and  examination  developed  by
    31  academic  faculty  representatives approved by the department from a New
    32  York state  accredited  college  of  optometry,  from  a  department  of
    33  ophthalmology  at  a  New  York state accredited medical school upon the
    34  recommendation of a statewide professional  organization  consisting  of
    35  ophthalmologists,  and  from  a department of pharmacology at a New York
    36  state accredited medical school.
    37    (i) The curriculum shall include, but not be limited  to,  instruction
    38  in  pharmacology  and drug interaction in treating ocular disease and be
    39  taught through clinical case scenarios and emphasize  clinical  decision
    40  making  and  shall  be  no  less than forty hours, of which no less than
    41  twenty-four hours shall be live instruction.
    42    (ii) Such course shall qualify towards meeting the  continuing  educa-
    43  tion  per  triennial  registration  requirement  pursuant to subdivision
    44  seven of this section.
    45    (iii) The examination shall test the knowledge  of  materials  in  the
    46  curriculum.
    47    (iv) If an optometrist fails to pass the examination, such optometrist
    48  may  retake  the  examination  following completion of the certification
    49  course, and may retake the  examination  a  maximum  of  two  additional
    50  times,  provided  that  an  optometrist  may be authorized to retake the
    51  examination beyond such maximum number upon application by  the  optome-
    52  trist and a determination of good cause shown by the commissioner.
    53    (v)  The initial, and any subsequent, curriculum and examination shall
    54  be subject to review and approval by the department.
    55    (vi) The requirement for the  oral  therapeutic  pharmaceutical  agent
    56  certification  course  and  examination shall not apply to those optome-

        A. 9961--A                          4
     1  trists who graduated from an accredited college of optometry  subsequent
     2  to  January  first,  two  thousand  six  and have taken and successfully
     3  passed the National Board of Examiners in Optometry test or an  examina-
     4  tion acceptable to the board.
     5    § 7. Subdivision 5 of section 7101-a of the education law, as added by
     6  chapter 517 of the laws of 1995, is amended to read as follows:
     7    5.  Suspension  of  certification.  The  department  shall suspend the
     8  certification for the use and prescribing of [phase one] topical  thera-
     9  peutic  agents of any optometrist who fails to receive certification for
    10  [phase two] therapeutic pharmaceutical agents for treatment of  glaucoma
    11  and  ocular hypertension within three years of having been certified for
    12  [phase one] topical therapeutic pharmaceutical agents.
    13    § 8. The subdivision heading of subdivision 6 of section 7101-a of the
    14  education law, as added by chapter 517 of the laws of 1995,  is  amended
    15  to read as follows:
    16    Consultation  with  use  of certain topical therapeutic pharmaceutical
    17  agents for treatment of glaucoma and ocular hypertension.
    18    § 9. Subdivision 7 of section 7101-a of the education law, as added by
    19  chapter 517 of the laws of 1995, is amended to read as follows:
    20    7. Continuing education. Each optometrist certified to use [phase  one
    21  or  phase two] topical therapeutic pharmaceutical agents and therapeutic
    22  pharmaceutical agents for treatment of glaucoma and ocular hypertension,
    23  shall complete a minimum of thirty-six hours of continuing education  in
    24  the  area  of ocular disease and pharmacology per triennial registration
    25  period. [The education shall be in the area of ocular disease and  phar-
    26  macology  and  may  include both didactic and clinical components.] Each
    27  optometrist certified to  use  oral  therapeutic  pharmaceutical  agents
    28  shall,  in addition to the minimum thirty-six hours of continuing educa-
    29  tion provided for in this subdivision, complete an additional minimum of
    30  thirty-nine hours of continuing education related  to  systemic  disease
    31  and therapeutic treatment per triennial registration period. Such educa-
    32  tional  programs  may  include both didactic and clinical components and
    33  shall be approved in advance by  the  department  and  evidence  of  the
    34  completion  of this requirement shall be submitted with each application
    35  for license renewal as required by section  sixty-five  hundred  two  of
    36  this chapter.
    37    § 10. The subdivision heading and subparagraph (i) of paragraph (a) of
    38  subdivision  8 of section 7101-a of the education law, as added by chap-
    39  ter 517 of the laws of 1995, are amended to read as follows:
    40    Notice to patient with the use or prescription of topical  therapeutic
    41  pharmaceutical  agents  and therapeutic pharmaceutical agents for treat-
    42  ment of glaucoma and ocular hypertension.
    43    (i) An optometrist prescribing topical steroids or  antiviral  medica-
    44  tion  shall inform each patient that in the event the condition does not
    45  improve within five days, a physician of the patient's  choice  will  be
    46  notified.
    47    §  11. Subdivision 10 of section 7101-a of the education law, as added
    48  by chapter 517 of the laws of 1995, is amended to read as follows:
    49    10. Pharmaceutical agents. Optometrists who  have  been  approved  and
    50  certified  by  the  department  shall  be permitted to use the following
    51  drugs:
    52    (a) Diagnostic pharmaceuticals.
    53    (b) Those optometrists having been certified for [phase  one]  topical
    54  therapeutic  pharmaceutical  agents  shall be authorized [(i) to use and
    55  recommend all nonprescription medications appropriate for ocular disease
    56  whether intended for topical or oral use; and (ii)] to use and prescribe

        A. 9961--A                          5
     1  all [phase one] topical therapeutic pharmaceutical agents  specified  in
     2  paragraph (e) of subdivision one of this section, which are FDA approved
     3  and commercially available for topical use.
     4    In the event an optometrist treats a patient with topical antiviral or
     5  steroidal  drugs  and the patient's condition either fails to improve or
     6  worsens within five days,  the  optometrist  shall  notify  a  physician
     7  designated by the patient or, if none, by the treating optometrist.
     8    (c) Those optometrists having been certified for [phase two] therapeu-
     9  tic pharmaceutical agents for treatment of glaucoma and ocular hyperten-
    10  sion  shall  be  authorized to use and prescribe [phase two] therapeutic
    11  pharmaceutical agents for treatment of glaucoma and ocular  hypertension
    12  specified in paragraph (f) of subdivision one of this section, which are
    13  FDA approved and commercially available.
    14    (d)  Those  optometrists  having  been  certified for oral therapeutic
    15  pharmaceutical agents shall be authorized  to  use  and  prescribe  oral
    16  therapeutic pharmaceutical agents specified in paragraph (g) of subdivi-
    17  sion one of this section, which are FDA approved and commercially avail-
    18  able  and  shall  comply with all safety information and side-effect and
    19  warning advisories contained in the most current physicians' desk refer-
    20  ence.
    21    (e) Those optometrists having been certified for  topical  therapeutic
    22  pharmaceutical  agents,  therapeutic pharmaceutical agents for treatment
    23  of glaucoma and ocular hypertension or oral  therapeutic  pharmaceutical
    24  agents  shall  be  authorized  to  use and recommend all nonprescription
    25  medications, whether intended for topical or oral use,  appropriate  for
    26  the treatment of the eye and adnexa.
    27    §  12.  Section 7101-a of the education law is amended by adding a new
    28  subdivision 13 to read as follows:
    29    13. Oral therapeutic pharmaceutical agent implementation  review.  (a)
    30  Each optometrist certified to use oral therapeutic pharmaceutical agents
    31  pursuant  to  paragraph  (c)  of  subdivision four of this section shall
    32  provide the department with information, on a  form  prescribed  by  the
    33  commissioner,  related  to  the  prescription or use of oral therapeutic
    34  pharmaceutical agents provided for in this section.    Such  information
    35  shall  include  the  optometrist's name, license number, whether no oral
    36  prescriptions have been issued and in the event that oral  prescriptions
    37  have been issued, then the following information shall be required:  the
    38  prescribed  or used oral therapeutic pharmaceutical agent, the dosage of
    39  such agent, the date of the prescription, the diagnosis of  the  patient
    40  for  which  the agent was prescribed or used, and whether a referral was
    41  made in accordance  with  paragraph  (g)  of  subdivision  one  of  this
    42  section.    Such  information  shall not include any patient identifying
    43  information and must otherwise be  in  compliance  with  all  state  and
    44  federal  requirements related to protected health information. Each form
    45  shall be submitted by mail or electronic means to the  department  on  a
    46  quarterly  basis.   If a database of all oral therapeutic pharmaceutical
    47  agents prescribed or used by optometrists is, or becomes,  available  to
    48  the  committee  provided for in this subdivision, then optometrists will
    49  be advised by the commissioner that quarterly reporting  forms  will  no
    50  longer  be required.  The requirements of this paragraph shall remain in
    51  effect for five years  following  approval  by  the  department  of  the
    52  initial  oral  therapeutic pharmaceutical agent certification course and
    53  examination pursuant to  paragraph  (c)  of  subdivision  four  of  this
    54  section,  after which time these requirements shall expire and no longer
    55  have effect.

        A. 9961--A                          6
     1    (b) The commissioner shall appoint a committee to  advise  and  assist
     2  the  commissioner  in  evaluating compliance with the provisions of this
     3  section and to identify any necessary  enhancements  to  the  curriculum
     4  provided  for  in  this  section  and other educational materials and to
     5  assist  in  ensuring  patient safety. The committee shall consist of one
     6  pharmacist, one optometrist  upon  the  recommendation  of  a  statewide
     7  professional  organization  consisting of optometrists, one ophthalmolo-
     8  gist upon the recommendation of a  statewide  professional  organization
     9  consisting  of  ophthalmologists,  and one expert in the field of public
    10  health who shall be designated as chair by the commissioner in consulta-
    11  tion with the commissioner of the department of health and who shall  be
    12  neither an ophthalmologist nor an optometrist.
    13    (c)  The commissioner shall submit each form received pursuant to this
    14  subdivision to the committee.  The committee shall review the forms  and
    15  shall randomly cross-check such submissions with a publicly available or
    16  other  database  containing  electronic prescriber information. Should a
    17  database of all oral therapeutic  pharmaceutical  agents  prescribed  or
    18  used  by optometrists become available pursuant to this section, and the
    19  commissioner determines and advises optometrists that quarterly  reports
    20  are  no  longer  necessary, then the committee shall review the database
    21  and ascertain the prescribing information for all optometrists  consist-
    22  ent  with  this section.  The committee shall advise the commissioner as
    23  to compliance with the provisions of this section  for  the  purpose  of
    24  evaluating  compliance with the provisions of this section including the
    25  applicable referrals and dosing limitations and to identify  any  neces-
    26  sary  enhancements  to  the  curriculum provided for in this section and
    27  other educational materials and to assist in  ensuring  patient  safety.
    28  Upon  finding evidence of non-compliance by any optometrist, the commit-
    29  tee shall refer such information to the commissioner and to  the  office
    30  of  professions  for  investigation  and,  if  applicable,  disciplinary
    31  action.
    32    § 13. Subdivision 8 of section 7104 of the education law,  as  amended
    33  by chapter 517 of the laws of 1995, is amended to read as follows:
    34    (8)  Fees:  pay  a fee of two hundred twenty dollars to the department
    35  for admission to a department conducted examination and for  an  initial
    36  license,  a fee of one hundred fifteen dollars for each reexamination, a
    37  fee of one hundred  thirty-five  dollars  for  an  initial  license  for
    38  persons  not  requiring admission to a department conducted examination,
    39  [and] a fee of two hundred ten dollars for each  triennial  registration
    40  period,  [and] for additional authorization for the purpose of utilizing
    41  diagnostic pharmaceutical agents,  a  fee  of  sixty  dollars,  and  for
    42  certification  to  use  or  prescribe  oral  therapeutic  pharmaceutical
    43  agents, a fee of one hundred dollars.
    44    § 14. This act shall take effect one year after it shall have become a
    45  law; provided that:
    46    (a) subdivision 13 of section 7101-a of the  education  law  added  by
    47  section  twelve  of  this  act  shall expire and be deemed repealed five
    48  years following the approval by  the  department  of  education  of  the
    49  initial  certification  course and examination pursuant to paragraph (c)
    50  of subdivision 4 of section 7101-a of the  education  law  as  added  by
    51  section six of this act;
    52    (b)  the  commissioner  of education shall notify the legislative bill
    53  drafting commission upon approval of the  initial  certification  course
    54  and  examination  required  in section six of this act in order that the
    55  commission may maintain an accurate and timely effective  data  base  of
    56  the official text of the laws of the state of New York in furtherance of

        A. 9961--A                          7
     1  effectuating  the  provisions  of  section 44 of the legislative law and
     2  section 70-b of the public officers law; and
     3    (c)  any rule or regulation necessary for the timely implementation of
     4  this act on its effective date shall be promulgated on  or  before  such
     5  effective date.
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