GENERAL GOVERNMENT

Board of Optometric Examiners

(Amendment)

 

††††† 201 KAR 5:130. Controlled substances.

 

††††† RELATES TO: KRS 218A.172, 218A.202, 218A.205(3)

††††† STATUTORY AUTHORITY: KRS 218A.205(3)

††††† NECESSITY, FUNCTION, AND CONFORMITY: KRS 218A.205(3) requires the board to promulgate administrative regulations on: prescribing standards for controlled substances; a procedure to temporarily suspend, limit, or restrict a license if unrestricted practice poses a danger to the health, welfare, or safety of patients or the public; a procedure for the expedited review of complaints pertaining to controlled substances; and penalties for convictions of offenses related to controlled substances. This administrative regulation establishes the requirements relating to controlled substances in the practice of optometry.

 

††††† Section 1. Authorization to Prescribe Controlled Substances.[Prescribing Standards. (1)] A Kentucky licensed optometrist authorized to prescribe controlled substances for humans shall:

††††† (1)[(a)] Have a current and valid DEA number;

††††† (2) Have submitted to the board a fingerprint-supported criminal record check by the Department of Kentucky State Police and Federal Bureau of Investigation for initial licensure to practice; and

††††† (3)[(b)] Register and maintain such registration with Kentucky All Schedule Prescription Electronic Reporting (KASPER).[;]

 

††††† Section 2. Professional Standards for Prescribing Controlled Substances. (1) A Kentucky licensed optometrist authorized to prescribe controlled substances for humans shall:

††††† (a)[(c)] Prescribe controlled substances only for the examination or treatment [or relief of pain] for a condition of the eye and its appendages;

††††† (b)[(d)] Prescribe only Schedule II limited to hydrocodone combination products as defined in KRS 218A.010, Schedule III, IV, or V controlled substances; and

††††† (c)[(e)] Prescribe controlled substances for a quantity therapeutically sufficient, up to seventy-two (72) hours. [;]

††††† (2) Prior to prescribing any controlled substance, a Kentucky licensed optometrist shall:

††††† (a)[(f)] Examine the patient face-to-face and in-person [prior to prescribing a controlled substance];

††††† (b) Obtain a medical history and conduct a physical examination of the patient, as appropriate to the patientís medical complaint, and document the information in the patientís medical record;

††††† (c)[(g)] Verify the fact that the patient that is prescribed a controlled substance is who the patient claims to be; and

††††† (d)[(h)] Establish a documented diagnosis through the use of accepted medical practices.[; and]

††††† (3) Prior to prescribing a Schedule II controlled substance, a Kentucky licensed optometrist shall also:

††††† (a) Query the electronic monitoring system established in KRS 218A.202 for all available data on the patient for the twelve (12) month period immediately preceding the patient encounter and appropriately utilize that data in the evaluation and treatment of the patient;

††††† (b) Discuss the risks and benefits of the use of controlled substances with the patient, the patientís parent if the patient is an unemancipated minor child, or the patientís legal guardian or health care surrogate, including the risk of tolerance and drug dependence;

††††† (c) Discuss treatment objectives and further diagnostic examinations required; and

††††† (d) Obtain written consent for the treatment.

††††† (4) The requirements set forth within subsection (3) shall not apply when:

††††† (a) A licensed Kentucky optometrist prescribes or administers a controlled substance immediately prior to, during, or within the fourteen (14) days following an operative or invasive procedure, if the prescribing or administering is medically related to the operative or invasive procedure and the medication usage does not extend beyond the fourteen (14) days;

††††† (b) A licensed Kentucky optometrist prescribes or administers a controlled substance necessary to treat a patient in an emergency situation; or

††††† (c) A licensed Kentucky optometrist prescribes or administers a controlled substance for the following:

††††† 1. Administration in a hospital or long-term-care facility if the hospital or long-term-care facility with an institutional account, or a practitioner in those hospitals or facilities where no institutional account exists, queries the electronic monitoring system established in KRS 218A.202 for all available data on the patient or resident for the twelve (12) month period immediately preceding the query within the twelve (12) hours of the patientís or residentís admission and places a copy of the query in the patientís or residentís medical records during the duration of the patientís stay at the facility;

††††† 2. In a single dose to relieve the anxiety, pain, or discomfort experienced by a patient submitting to a diagnostic test or procedure;

††††† 3. To a research subject enrolled in a research protocol approved by an institutional review board that has an active federalwide assurance number from the United States Department of Health and Human Services, Office for Human Research Protections, where the research involves single, double, or triple blind drug administration or is additionally covered by a certificate of confidentiality from the National Institutes of Health; or

††††† 4. Within seven (7) days of an initial prescribing or dispensing as set forth within this section if the prescribing or dispensing:

††††† a. Is done as a substitute for the initial prescribing or dispensing; and

††††† b. Requires the patient to dispose of any remaining unconsumed medication.[(i) Keep accurate, readily accessible medical records which shall include:

††††† 1. History and eye examination;

††††† 2. Diagnostic, therapeutic, and laboratory results;

††††† 3. Evaluations and consultations;

††††† 4. Treatment objectives;

††††† 5. Discussions of risk, benefits, and limitations of treatments;

††††† 6. Treatments;

††††† 7. Medication including date, type, dosage, and quantity prescribed; and

††††† 8. Instructions and agreements.]

††††† (5)[(2)] A Kentucky licensed optometrist authorized to prescribe controlled substances for humans shall not:

††††† (a) Dispense any controlled substances;

††††† (b) Write a prescription for a controlled substance that is refillable; and

††††† (c) Prescribe:

††††† 1. With the intent or knowledge that a medication will be used, or is likely to be used, for other than a medicinal or an accepted therapeutic purpose; or

††††† 2. With the intent to evade any law with respect to sale, use, or disposition of the medication.

 

††††† Section 3. Professional Standards for Documentation. A Kentucky licensed optometrist authorized to prescribe controlled substances shall keep accurate, readily accessible, and complete medical records which include:

††††† (1) Medical history and eye examination;

††††† (2) Diagnostic, therapeutic, and laboratory results;

††††† (3) Evaluations and consultations;

††††† (4) A written plan stating treatment objectives and further diagnostic examinations required;

††††† (5) Discussion of risk, benefits, and limitations of treatments;

††††† (6) Treatments;

††††† (7) Medications, including date, type, dosage, and quantity prescribed;

††††† (8) Instructions and agreements; and

††††† (9) Written consent for treatment if the patient is prescribed a Schedule II controlled substance.

 

††††† Section 4[2]. Temporary Suspension, Limit, or Restriction of License. (1) The board may, without benefit of a hearing, temporarily suspend, limit, or restrict the license of an optometrist authorized to prescribe controlled substances if the board finds on the basis of reasonable evidence that the licensee has violated a statute or administrative regulation the board is empowered to enforce, or[and] continued unrestricted practice by the licensee would constitute the substantial likelihood of[a] danger to the health, welfare, or safety of the licenseeís patients or of the general public.

††††† (2) The temporary suspension, limit, or restriction of a license shall take effect upon receipt by the licensee of written notice, delivered by certified mail or in person, specifying the statute or administrative regulation violated. At the time the temporary suspension, limit, or restriction order issues, the board shall schedule a disciplinary hearing to be held in accordance with the provisions of KRS Chapter 13B within ten (10) days.

 

††††† Section 5[3]. Complaints. (1) The board shall consider all written complaints and sufficient anonymous complaints pertaining to the improper, inappropriate, or illegal prescribing of controlled substances. An anonymous complaint shall be considered sufficient if it is accompanied by sufficient corroborating evidence as would allow the board to believe, based upon a totality of the circumstances, that a reasonable probability exists that the complaint is meritorious.

††††† (2) Upon receipt of a complaint pertaining to the improper, inappropriate, or illegal prescribing of controlled substances, the board[shall]:

††††† (a) May send a copy of the complaint to the Office of the Attorney General, the Department of the Kentucky State Police, and the Cabinet for Health and Family Services within three (3) business days to the extent otherwise allowed by law;

††††† (b) Shall commence an investigation within seven (7) business days of the complaint;[and]

††††† (c) Shall produce a charging decision within 120 days of the complaint, unless an extension for a definite time period is requested in writing by a law enforcement agency due to an ongoing criminal investigation; and[.]

††††† (d) Shall obtain the services of a specialist in the treatment of pain and a specialist in drug addiction to evaluate information received regarding a licenseeís prescribing practices related to controlled substances if the board or its staff does not possess such expertise to ascertain if the licensee under investigation is engaging in improper, inappropriate or illegal practices.

 

††††† Section 6[4]. Penalties. (1) Pursuant to the provisions of KRS 218A.205 (3):

††††† (a) A licensee or applicant convicted of a felony offense in any state related to[prescribing] a controlled substance after July 20, 2012 shall, at a minimum, have a permanent ban[lifetime revocation] on prescribing any and all controlled substances;

††††† (b)[The board shall impose restrictions short of a permanent ban from prescribing controlled substances on a licensee convicted of a misdemeanor offense related to the prescribing of controlled substances.] A licensee or applicant who has been convicted of any misdemeanor offense[after July 20, 2012] relating to prescribing or dispensing controlled substances in any state shall have his or her authority to prescribe controlled substances suspended for at least three (3) months, and shall be further restricted as determined by the board; and

††††† (c) A licensee or applicant disciplined by a licensing board of another state related to the improper, inappropriate, or illegal prescribing or dispensing of controlled substances shall, at a minimum, have the same disciplinary action imposed by the licensing board of the other state.

††††† (2) A licensee or applicant who is authorized to prescribe controlled substances shall be subject to discipline by the board if:

††††† (a) A licensee who is required to register for an account with KASPER fails to do so or does not maintain continuous registration[during the licenseeís term of licensure]; or

††††† (b) A licensee or applicant fails to report to the board, within thirty (30) days of the action:

††††† 1. Any conviction involving controlled substances; or

††††† 2. Disciplinary action taken by another licensure board involving controlled substances.

††††† (3) For purposes of this section, a conviction of a misdemeanor or felony offense relating to a controlled substance means any conviction or plea to a criminal charge, regardless of adjudication or the title of the offense named in the plea or judgment of conviction, that is determined from all available facts to have been based upon or resulted from, in whole or part, an allegation of conduct involving the improper, inappropriate, or illegal prescribing, dispensing, distribution, possession, or use of a controlled substance.

††††† (4) Any violation of the professional standards established in this administrative regulation shall constitute a violation of KRS 218A.205, which may result in the imposition of disciplinary sanctions by the board pursuant to KRS 320.310.

††††† (5) Pursuant to the provisions of KRS 218A.205(3)(g)[(f)], the board shall submit all disciplinary actions to the National Practitioner Data Bank of the United States Department of Health and Human Services either directly or through a reporting agent.

 

JONATHON L. SHREWSBURY, O.D., President

††††† APPROVED BY AGENCY: May 9, 2018

††††† FILED WITH LRC: May 10, 2018 at 3 p.m.

††††† PUBLIC HEARING AND PUBLIC COMMENT PERIOD: A public hearing on this administrative regulation shall be held on June 21, 2018 at 9:30 a.m. in the Board office, 2365 Harrodsburg Road, Suite A240, Lexington, Kentucky 40504. Individuals interested in attending this hearing shall notify the agency in writing by five (5) workdays prior to the hearing of their intent to attend. If no notification of intent to attend the hearing is received by that date, the hearing may be canceled. This hearing is open to the public. Any person who attends, will be given an opportunity to comment on the proposed administrative regulation. A transcript of the public hearing will not be made unless a written request for a transcript is made. If you do not wish to attend the public hearing, you may submit written comments on the proposed administrative regulation. Written comments shall be accepted until the end of day on June 30, 2018. Send written notification of intent to attend the public hearing or submit written comments on the proposed administrative regulation to:

††††† CONTACT PERSON: Connie Calvert, Kentucky Board of Optometric Examiners, 2365 Harrodsburg Road, Suite A240, Lexington, Kentucky 40504, phone 859-246-2744, fax 859-246-2746, email connie.calvert@ky.gov.

 

REGULATORY IMPACT ANALYSIS AND TIERING STATEMENT

 

Contact person: Connie Calvert

††††† (1) Provide a brief summary of

††††† (a) What this administrative regulation does: This administrative regulation establishes the requirements relating to controlled substances in the practice of optometry.

††††† (b) The necessity of this administrative regulation: This regulation is necessary to establish the professional standards for controlled substances in the practice of optometry.

††††† (c) How this administrative regulation conforms to the content of the authorizing statutes: Pursuant to KRS 218A.205(3), the Board is required to promulgate administrative regulations which establish the mandatory prescribing and dispensing standards related to controlled substances. The regulation is also required to include the diagnostic, treatment, review and other protocols and standards. This administrative regulation complies with these statutory requirements.

††††† (d) How this administrative regulation will assist in the effective administration of the statutes: This administrative regulation sets forth the specific requirements and standards relating to controlled substances in the practice of optometry. It clarifies the handling of complaints, provides specific requirements, and establishes clear guidelines for potential violations that do not otherwise exist within the enabling statutes.

††††† (2) If this is an amendment to an existing administrative regulation, provide a brief summary of:

††††† (a) How the amendment will change this existing administrative regulation: These amendments are necessary so that the administrative regulation is now consistent with the statutory requirements set forth in KRS Chapter 218A as it relates to controlled substances. The amendments now include the authority of an optometrist to prescribe Schedule II-combination controlled substances, which is in light of amendments made during the 2016 legislative session. Other amendments include the listing of what must be done before an optometrist is authorized to prescribe controlled substances, the written standards that must be met before a prescription is written by an optometrist, and the handling of violations of these standards.

††††† (b) The necessity of the amendment to this administrative regulation: This amendment is necessary to comply with the statutory requirements established throughout KRS 218A.

††††† (c) How the amendment conforms to the content of the authorizing statutes: Pursuant to KRS 218A.205(3), the Board is required to promulgate administrative regulations which establish the mandatory prescribing and dispensing standards related to controlled substances. The regulation is also required to include the diagnostic, treatment, review and other protocols and standards. These amendments thereby bring the regulation into compliance with the authorizing statutes.

††††† (d) How the amendment will assist in the effective administration of the statutes: These amendments provide the necessary information to comply with KRS 218A.205. All standards and protocols relating to controlled substances and the practice of optometry are included within these amendments, which previously did not exist in the regulation.

††††† (3) List the type and number of individuals, businesses, organizations, or state and local governments affected by this administrative regulation: All licensed optometrists in Kentucky must comply with this regulation. As of May 2018, there are 841 optometrists who possess a license to practice in Kentucky. Additionally, there are additional requirements on the Kentucky Optometric Board of Examiners.

††††† (4) Provide an analysis of how the entities identified in question (3) will be impacted by either the implementation of this administrative regulation, if new, or by the change, if it is an amendment, including:

††††† (a) List the actions that each of the regulated entities identified in question (3) will have to take to comply with this administrative regulation or amendment: For those Kentucky licensed optometrists who prescribe controlled substances, additional action must be taken in order to comply with this regulation and the other requirements set forth within KRS 208A. Kentucky optometrists who prescribe Schedule II controlled substances must query KASPER, as well as have certain discussions and documentation within a patientís file. All Kentucky optometrists who prescribe controlled substances must submit an appropriate background check and maintain the adequate registration with KASPER. The Kentucky Optometric Board of Examiners will have to retain a specialist as it relates to controlled substances if the Board does not otherwise possess certain knowledge as it reviews a potential complaint. Additionally, the Board must now how certain standards to applicants for licensure.

††††† (b) In complying with this administrative regulation or amendment, how much will it cost each of the entities identified in question (3): There are no additional costs associated with these amendments to any impacted entity.

††††† (c) As a result of compliance, what benefits will accrue to the entities identified in question (3): Optometrists who comply with the regulation amendments will also remain in compliance with the statutory requirements set forth within KRS 208A. The Board of Examiners will have clear processes outlined for the handling of applicants and licensees as it relates to compliance with controlled substance protocols and standards, and the Board will also have clear directives with the handling of complaints against an optometrist that is received by the Board.

††††† (5) Provide an estimate of how much it will cost to implement this administrative regulation:

††††† (a) Initially: N/A

††††† (b) On a continuing basis: N/A

††††† (6) What is the source of the funding to be used for the implementation and enforcement of this administrative regulation: N/A

††††† (7) Provide an assessment of whether an increase in fees or funding will be necessary to implement this administrative regulation, if new, or by the change if it is an amendment: An increase in fees or funding will not be required to implement the changes made by these amendments.

††††† (8) State whether or not this administrative regulation establishes any fees or directly or indirectly increases any fees: This administrative regulation does not establish or increase fees.

††††† (9) TIERING: Is tiering applied? Tiering is not applied. All licensed optometrists are held to the same standards based upon their prescribing authority.

 

FISCAL NOTE ON STATE OR LOCAL GOVERNMENT

 

††††† 1. What units, parts or divisions of state or local government (including cities, counties, fire departments, or school districts) will be impacted by this administrative regulation? The Kentucky Board of Optometric Examiners

††††† 2. Identify each state or federal statute or federal regulation that requires or authorizes the action taken by the administrative regulation: KRS 218A.172, 218A.202, 218A.205(3)

††††† 3. Estimate the effect of this administrative regulation on the expenditures and revenues of a state or local government agency (including cities, counties, fire departments, or school districts) for the first full year the administrative regulation is to be in effect.

††††† (a) How much revenue will this administrative regulation generate for the state or local government (including cities, counties, fire departments, or school districts) for the first year? N/A

††††† (b) How much revenue will this administrative regulation generate for the state or local government (including cities, counties, fire departments, or school districts) for subsequent years? N/A

††††† (c) How much will it cost to administer this program for the first year? N/A

††††† (d) How much will it cost to administer this program for subsequent years? N/A

††††† Note: If specific dollar estimates cannot be determined, provide a brief narrative to explain the fiscal impact of the administrative regulation.

††††† Revenues (+/-):

††††† Expenditures (+/-):

††††† Other Explanation: