Current through Reg. 49, No. 38; September 20, 2024
(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.