22 Tex. Admin. Code § 280.10

Current through Reg. 49, No. 49; December 6, 2024
Section 280.10 - Optometric Glaucoma Specialist: Administration and Prescribing of Oral Medications and Anti-Glaucoma Drugs
(a) An optometric glaucoma specialist may administer and prescribe any drug authorized by the Texas Optometry Act, §351.358 and §351.3581, in addition to those drugs that may be administered and prescribed by a therapeutic optometrist.
(b) The requirements of § 280.5 of this chapter (relating to Prescription and Diagnostic Drugs for Therapeutic Optometry) and the statutes cited in the rule apply to the optometric glaucoma specialist's prescription orders, the administration of drugs in the optometric office and the labeling of drugs supplied to patients. The requirements for a prescription order for a Controlled Substance are listed in subsection (f) of this section.
(c) An optometric glaucoma specialist may administer and prescribe appropriate medications in accordance with the Texas Optometry Act Section 351.3581, in addition to those drugs authorized by § 280.5 of this chapter:
(1) appropriate oral and topical pharmaceutical agents used for diagnosing and treating visual defects, abnormal conditions, or diseases of the human vision system, including the eye and adnexa;
(2) appropriate medication by parenteral means and purpose pursuant to Section 351.3581 of the Texas Optometry Act; and
(3) antiglaucoma drugs.
(d) An optometric glaucoma specialist may inject appropriate medications to treat a patient who has an anaphylactic reaction in order to counteract the anaphylaxis. The optometric glaucoma specialist shall immediately refer the patient to a physician.
(e) An optometric glaucoma specialist may independently administer oral carbonic anhydrase inhibitors for emergency purposes only and shall immediately refer the patient to an ophthalmologist.
(f) Controlled Substances
(1) The following paragraphs apply to an optometric glaucoma specialist possessing, administering or prescribing a Schedule III, IV or V analgesic Controlled Substance. The paragraphs also apply to an optometric glaucoma specialist who has obtained the registrations necessary to possess, administer, or prescribe a Schedule III, IV or V Controlled Substance.
(2) An optometric glaucoma specialist must possess a current Controlled Substances Registration from the United States Drug Enforcement Administration (DEA) in order to procure, possess, administer or prescribe a Schedule III, IV or V analgesic Controlled Substance. A licensee applying for or possessing a Controlled Substances Registration must observe all requirements of the Texas Controlled Substances Act, the Health and Safety Code, Chapter 481, and applicable federal law.
(3) All prescriptions for a Schedule III, IV or V Controlled Substance shall contain the following information (Licensees telephoning or communicating the prescription orally to a pharmacist shall supply the information in this subsection to the pharmacist, except for the signature of the optometric glaucoma specialist.):
(A) date of issuance;
(B) name, address and date of birth of the patient for whom the controlled substance is prescribed;
(C) name, strength, and quantity (written as both a number and as a word) of the controlled substance prescribed;
(D) direction for use of the controlled substance;
(E) intended use of the controlled substance prescribed unless the optometric glaucoma specialist determines the furnishing of this information is not in the best interest of the patient;
(F) printed or stamped name, address and business telephone number of the optometric glaucoma specialist;
(G) written signature of the prescribing optometric glaucoma specialist;
(H) complete license number of the prescribing optometric glaucoma specialist; and
(I) DEA registration number.
(4) An optometric glaucoma specialist shall maintain a complete and accurate record of purchases (to include samples received from pharmaceutical manufacturer representatives) and administrations of Schedule III, IV or V analgesic Controlled Substances.
(5) The record keeping listed in this section shall be subject to inspection at all times by the Texas Department of Public Safety, the U.S. Drug Enforcement Administration, and the Texas Optometry Board and any officer or employee of the governmental agencies shall have the right to inspect and copy records, reports, and other documents, and inspect security controls, inventory and premises where Schedule III, IV, and V analgesic controlled substances are possessed or administered.
(6) Minimum security controls shall be established to include but not limited to:
(A) establishing adequate security to prevent unauthorized access and diversion of the controlled substance;
(B) during the course of business activities, not allowing any individual access to the storage area for controlled substances except those authorized by the optometric glaucoma specialist;
(C) storing the controlled substance in a securely locked, substantially constructed cabinet or security cabinet which shall meet the requirements under the DPS Drug Rules; and
(D) not employ in any manner an individual that would have access to controlled substances who has had a federal or state application for controlled substances denied or revoked, or have been convicted of a felony offense under any state or federal law relating to controlled substances or been convicted of any other felony, or have been a licensee of a health regulatory agency whose license has been revoked, canceled, or suspended.
(7) Failure of the optometric glaucoma specialist to maintain strict security and proper accountability of controlled substance shall be deemed to be a violation of the Texas Optometry Act, §351.501 and §351.551.
(g) Prescribing a Controlled Substances Schedule III, IV or V analgesic.
(1) If permitted by the generally accepted standard of care, an optometric glaucoma specialist may prescribe a Schedule III, IV or V analgesic if the following minimum requirements have been met:
(A) Evaluation of the patient.
(i) An optometric glaucoma specialist is responsible for obtaining a medical history and a physical examination that includes a problem-focused exam specific to the chief presenting complaint of the patient.
(ii) Should the optometric glaucoma specialist prescribe a Schedule III, IV or V analgesic, the medical record shall document the medical history and physical examination, including:
(I) the nature and intensity of the presenting pain;
(II) current and past treatments for the presenting pain;
(III) underlying or coexisting diseases and conditions;
(IV) any history and potential for substance abuse or diversion; and
(V) the presence of one or more recognized medical indications for the use of a dangerous or scheduled drug.
(B) Prior to prescribing a Schedule III, IV or V analgesic, an optometric glaucoma specialist must review the prescription data and history related to the patient, if any, contained in the Prescription Drug Monitoring Program set out in §§ 481.075, 481.076, and 481.0761 of the Texas Health and Safety Code, unless:
(i) the patient has been diagnosed with cancer or the patient is receiving hospice care and the optometric glaucoma specialist clearly notes in the prescription record that the patient was diagnosed with cancer or is receiving hospice care, as applicable; or
(ii) the optometric glaucoma specialist makes a good faith attempt to comply but is unable to access the information under § 481.076(a)(5) of the Texas Health and Safety Code because of circumstances outside the control of the prescriber or dispenser.
(C) Informed consent. It is the responsibility of the optometric glaucoma specialist to discuss the risks and benefits of the use of a Schedule III, IV or V analgesic with the patient, persons designated by the patient, or with the patient's surrogate or guardian if the patient is without medical decision-making capacity. This discussion must be documented by a contemporaneous notation included in the medical records. Discussion of risks and benefits must include an explanation of the:
(i) diagnosis;
(ii) treatment plan;
(iii) anticipated therapeutic results, including the realistic expectations for sustained pain relief and improved functioning and possibilities for lack of pain relief;
(iv) therapies in addition to or instead of drug therapy, including physical therapy or psychological techniques;
(v) potential side effects and how to manage them;
(vi) adverse effects, including the potential for dependence, addiction, tolerance, and withdrawal; and
(vii) potential for impairment of judgment and motor skills.
(D) Patients who are at-risk for abuse or addiction require special attention. Patients with chronic pain and histories of substance abuse or with comorbid psychiatric disorders require even more care. A referral to an expert in the management of such patients must be considered in their treatment.
(E) Medical records. The medical records shall document the rationale of the treatment plan and the rationale for prescribing a Schedule III, IV or V analgesic. The medical records must be sufficient to document compliance with this rule, including but not limited to containing:
(i) the medical history and the physical examination;
(ii) diagnostic, therapeutic and laboratory results;
(iii) evaluations and consultations;
(iv) treatment objectives;
(v) discussion of risks and benefits;
(vi) informed consent;
(vii) treatments;
(viii) medications (including date, type, dosage and quantity prescribed); and
(ix) instructions and agreements.
(2) The Board may open a complaint against an optometric glaucoma specialist if the Board finds evidence that the optometric glaucoma specialist is engaging in potentially harmful prescribing patterns or practices may be occurring. A potentially harmful prescribing pattern or practice may be determined from:
(A) the number of times a optometric glaucoma specialist prescribes a Schedule III, IV or V analgesic;
(B) patterns of prescribing combinations of Schedule III, IV or V analgesics and other dangerous combinations of drugs;
(C) data from the Prescription Monitoring Program indicating that the volume of prescribing places the optometric glaucoma specialist in the top prescribers in the state at any time in the preceding 12 months for prescriptions of Schedule III, IV or V analgesics, except for an optometric glaucoma specialist prescribing the drugs to treat cancer patients or patients in hospice facilities;
(D) complaints and/or information, from non-anonymous complainants related to inappropriate prescribing practices, including those from law enforcement agencies or health care regulators;
(E) A patient overdose death related to Schedule III, IV or V analgesics, prescribed by a optometric glaucoma specialist; or
(F) arrest of an optometric glaucoma specialist related to improper or fraudulent prescribing of controlled substances.
(3) Language in this section regarding the prescribing of a Schedule III, IV or V analgesic is not intended to expand the classes of drugs that may be prescribed by an optometric glaucoma specialist under subsections (a) - (e) of this section.

22 Tex. Admin. Code § 280.10

The provisions of this §280.10 adopted to be effective August 3, 2000, 25 TexReg 7176; amended to be effective March 9, 2009, 34 TexReg 1591; Amended by Texas Register, Volume 43, Number 52, December 28, 2018, TexReg 8596, eff. 1/2/2019; Amended by Texas Register, Volume 48, Number 20, May 19, 2023, TexReg 2576, eff. 5/22/2023