NEW JERSEY REGISTER
VOLUME 38, ISSUE 24
ISSUE DATE: DECEMBER 18, 2006
LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS
New Jersey State Board of Optometrists
Requirements for Issuing Prescriptions and Dispensing of Medications; Requirements for Applications
for Licensure; Therapeutic Pharmaceutical Agents (TPA) Certification; Fee Schedule; Continuing Education
Adopted Amendments: N.J.A.C. 13:38-2.4, 3.5, 4.1 through 4.4, 5.1, 7.3 and 7.4
Adopted Repeal and New Rule: N.J.A.C. 13:38-4.5
Proposed: July 3, 2006 at 38 N.J.R. 2788(a).
Adopted: September 20, 2006 by the New Jersey State Board of Optometrists, Mitchell Fink, President.
Filed: November 22, 2006 as R.2006 d.450, with a technical change not requiring additional public notice and comment (see N.J.A.C. 1:30-6.3).
Authority: N.J.S.A. 45:12-4.
Effective Date: December 18, 2006.
Expiration Date: March 7, 2011.
Federal Standards Statement
A Federal standards analysis is not required because the amendments, repeal and new rule do not involve any Federal standards or requirements.
Full text of the adoption follows (addition to proposal indicated in boldface with asterisks *thus*; deletion from proposal indicated in brackets with asterisks *[thus]*):
13:38-2.4 Requirements for issuing prescriptions and dispensing of medications
(a)-(b) (No change.)
(c) In addition to the provisions of (a) and (b) above, optometrists certified to prescribe pharmaceutical agents pursuant to the provisions of N.J.A.C. 13:38-4 and N.J.S.A. 45:12-9.8 through 9.13 shall comply with the following:
1. The optometrist shall advise all patients by sign or pamphlet or similar notice available in a conspicuous location in the optometrist's office that the patient may request that the optometrist substitute a generic drug, when available, for any prescribed medication.
2.-3. (No change.)
(d) (No change.)
(e) Written prescriptions shall be issued only on New Jersey Prescription Blanks (NJPB), secured from an approved vendor and subject to the required security mandates of the prescription blank program pursuant to N.J.S.A. 45:14-14 and N.J.A.C. 13:45A-27.
(f) All licensees who are certified to prescribe therapeutic pharmaceutical agents on a topical level only, shall include the following language on the prescription blank:
"NOT VALID FOR CONTROLLED SUBSTANCES. VALID FOR TOPICAL PHARMACEUTICAL AGENTS (IF TPA CERTIFIED) AND PRESCRIPTION EYEWEAR ONLY."
(g) Any licensee who practices outside his or her scope of practice, as defined in N.J.S.A. 45:12-1, will be deemed to have engaged in professional misconduct pursuant to N.J.S.A. 45:1-21(e).
(h) Each prescription for a controlled dangerous substance shall be written on a separate NJPB.
1. An NJPB that contains prescriptions for two or more controlled dangerous substances shall be invalid.
2. An NJPB that contains a prescription for only one controlled dangerous substance and contains other prescriptions(s) other than another controlled substance shall be valid.
(i) All licensees are prohibited from prescribing controlled dangerous substances as outlined in N.J.S.A. 24:21-5, Schedule I, and 24:21-6, Schedule II.
(j) Each prescription for a pharmaceutical agent shall be for the purpose of diagnosing and treating deficiencies, deformities, diseases, or abnormalities of the human eye and adnexae.
13:38-3.5 Requirements for application for licensure
(a) (No change.)
(b) An applicant seeking licensure shall submit the following to the Board:
1. (No change.)
2. A non-refundable application fee as set forth in N.J.A.C. 13:38-5.1;
3.-5. (No change.)
(c) When an applicant is seeking licensure and is also seeking therapeutic pharmaceutical agents (TPA) certification at the same time, the licensee shall comply with (b) above and the TPA certification requirements set forth at N.J.A.C. 13:38-4.2, except that the applicant shall only be required to pay one application fee.
SUBCHAPTER 4. THERAPEUTIC PHARMACEUTICAL AGENTS (TPA) CERTIFICATION
13:38-4.1 Purpose and scope
(a) The rules of this subchapter implement the provisions of the Consumer Access to Eye Care Act of 1991, N.J.S.A. 45:12-9.8 through 9.13.
(b) This subchapter shall apply to a licensed optometrist utilizing therapeutic pharmaceutical agents, as defined and limited in N.J.S.A. 45:12-9.8 through 9.13.
13:38-4.2 Application for therapeutic pharmaceutical agents (TPA) certification; general requirements
(a) An optometrist licensed in this State who wishes to use therapeutic pharmaceutical agents for treatment purposes as permitted by N.J.S.A. 45:12-9.8 through 9.13 shall be certified by the Board prior to prescribing or dispensing such agents.
(b) Any applicant applying for initial TPA certification on or after *[(the date of promulgation)]* *December 18, 2006* shall submit the following to the Board:
1. (No change.)
2. A non-refundable application fee as set forth in N.J.A.C. 13:38-5.1;
3. Verification that the applicant has successfully completed the educational requirements set forth in N.J.A.C. 13:38-4.3(a) and (b). The applicant shall obtain the required verification from the school where the applicant completed the educational requirements; and
4. Verification of test scores that the applicant has successfully passed the examination requirements as set forth in N.J.A.C. 13:38-4.3 and 4.4.
(c) An applicant who satisfies all of the requirements set forth in (b) above shall, upon payment of the initial certification fee set forth in N.J.A.C. 13:38-5.1, be certified by the Board to use therapeutic pharmaceutical agents as defined and limited in N.J.S.A. 45:12-9.8 through 9.13.
(d) Any applicant certified by the Board prior to August 7, 2005 to use or prescribe topical TPA may choose to renew his or her certification every biennial period at the topical TPA level. The applicant shall certify in the renewal application that he or she has completed the continuing professional optometric education requirements as outlined in N.J.A.C. 13:38-7.3. If such applicant wishes to obtain the oral TPA certification, then he or she shall comply with the requirements set forth in (b) above.
(e) Any applicant who is applying for initial TPA certification and has graduated from a college of optometry on or after August 7, 2005 does not have to complete the credentialing course(s) requirement of N.J.A.C. 13:38-4.3(b)2 since this coursework is required to earn the degree.
13:38-4.3 Educational requirements for TPA certification
(a) Each applicant seeking TPA certification shall be required to successfully complete all educational requirements in ocular pharmacology at a school duly accredited by the United States Department of Education and the Council on Postsecondary Accreditation. This education shall be no less than that required of currently enrolled students as part of their requirements for graduation from that school. If an applicant attends a school other than a college of optometry, the education necessary to satisfy the ocular pharmacology educational requirement shall be substantially equivalent to that of a college of optometry.
(b) Each applicant seeking TPA certification shall be required to successfully complete credentialing courses consisting of the following:
1. All educational requirements as outlined in (a) above; and
2. A minimum of 30 hours distributed amongst the following credentialing course(s), with successful completion of an examination covering the following topics:
i. General pharmacology of appropriate agents;
ii. Pharmacokinetics, which includes drug absorption, distribution, metabolism, and elimination;
iii. Special populations including pediatrics and geriatrics;
iv. Prescription writing and appropriate dosages;
v. Appropriate and ethical uses of off-label medications;
vi. Safety issues, adverse drug reactions and interactions; recognition of systemic side-effects; awareness of medication errors (look-alike, sound-alike names), inappropriate use of medical abbreviations, proper notification of FDA MedWatch, and prevention of errors;
vii. Addiction recognition of patient, self and impaired practitioner;
viii. Recordkeeping; and
(c) The credentialing course(s) as set forth in (b) above shall be offered by a school that is accredited by the U.S. Department of Education and the Council on Postsecondary Accreditation and approved by the New Jersey State Board of Optometrists to ensure that the credentialing course(s) cover the topics in (b) above.
13:38-4.4 Examination requirements for TPA certification
Each applicant for TPA certification shall be required to successfully pass the Treatment and Management of Ocular Disease Examination, or any successive examination, administered by the National Board of Examiners in Optometry, prior to certification by the New Jersey State Board of Optometrists.
13:38-4.5 Biennial TPA certification renewal
An application for certification renewal shall be submitted to the Board every biennial period. The applicant shall certify in the renewal application that he or she has completed the continuing education requirements as outlined in N.J.A.C. 13:38-7.3.
13:38-5.1 Fee schedule
(a) The following fees shall be charged by the Board:
1.-6. (No change.)
7. Initial certification fee:
i. If paid during the first year of a biennial $ 250.00
ii. If paid during the second year of a $ 125.00
biennial renewal period:
8. Biennial renewal fee--certification to $ 250.00
9.-17. (No change.)
SUBCHAPTER 7. CONTINUING PROFESSIONAL OPTOMETRIC EDUCATION
13:38-7.3 Credit hour requirements
(a) An applicant for an active registration renewal certificate shall complete, during the preceding biennial period, a minimum of 50 credits of continuing professional optometric education. At least 30 of the 50 credits shall consist of courses or programs classified as therapeutic pharmaceutical agents (TPA) credits and shall be primarily devoted to the diagnosis, treatment and management of ocular disease, ocular pathology or the ocular manifestation of systemic disease, of which 10 of the 30 continuing professional optometric education credits shall be in oral TPA. The remaining 20 general continuing professional optometric education credits shall be in content areas set forth in N.J.A.C. 13:38-7.4.
(b) An applicant who initially obtains a certificate within the first year of a biennial period shall complete at least 25 of the minimum required credits of continuing professional optometric education. At least 15 of the 25 credits shall consist of courses or programs classified as TPA credits and shall be devoted to the subject matter set forth in (a) above.
(c) (No change.)
(d) A licensee who completes more than the required 50 credits in any biennial period may carry up to 20 credits into any succeeding biennial period. Any credits to be carried over shall be earned in the last one year of the biennial renewal period and shall be applied to the general continuing professional optometric education requirements and shall not be applied to the TPA requirements.
(e) (No change.)
13:38-7.4 Approved course offerings
(a)-(c) (No change.)
(d) A continuing professional optometric education program or course pre-approved by the Board pursuant to (c) above shall only be acceptable for the biennial period in which it was approved. In order to continue to offer a pre-approved continuing professional optometric education program or course, the sponsor shall re-apply and receive an approval by the Board. If a pre-approved continuing professional optometric education program or course is given in multiple locations during the then current biennial period, the course or program shall be identical in course titles speaker and content as that pre-approved by the Board. The sponsor shall notify the Board, in writing, of any change in course or program venue.
(e) The Board shall grant a maximum of 20 of the mandatory 50 continuing professional optometric education credits, including a maximum of 10 of the mandatory 30 TPA credits required, from any or all of the following:
1.-5. (No change.)
6. Preparation of an educational or scientific article authored and published in a professional refereed journal. TPA credits may be obtained from preparing an educational or scientific article authored and published in a professional refereed journal that is primarily devoted to the diagnosis, treatment and management of ocular disease, ocular pathology or the ocular manifestation of systemic disease;
7. The Board shall grant a maximum of 10 continuing professional optometric education credits per biennial renewal period for optometric practice management or managed care courses or programs relating to the practice of optometry. Continuing professional optometric education credit shall not be granted in courses or programs taken in the following subjects: estate planning, financial or investment/tax planning, personal health, the selling of ophthalmic materials, or other similar subjects; or
8. The Board shall grant a maximum of six continuing professional optometric education credits per biennial renewal period for CPR certification.