By: Hinojosa, et al. S.B. No. 316
A BILL TO BE ENTITLED
AN ACT
relating to powers and duties of certain prescribers and dispensers
of controlled substances and the regulatory agencies that issue a
license, certification, or registration to the prescriber or
dispenser; following the recommendations of the Sunset Advisory
Commission.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Section 481.003(a), Health and Safety Code, is
amended to read as follows:
(a) The director may adopt rules to administer and enforce
this chapter, other than Sections 481.073, 481.074, 481.075,
481.076, [and] 481.0761, 481.0762, 481.0763, 481.0764, and
481.0765. The board may adopt rules to administer Sections
481.073, 481.074, 481.075, 481.076, [and] 481.0761, 481.0762,
481.0763, 481.0764, and 481.0765.
SECTION 2. Section 481.074(q), Health and Safety Code, is
amended to read as follows:
(q) Each dispensing pharmacist shall send all required
information, including any information required to complete the
Schedule III through V prescription forms, to the board by
electronic transfer or another form approved by the board not later
than the next business [seventh] day after the date the
prescription is completely filled.
SECTION 3. Section 481.075(i), Health and Safety Code, is
amended to read as follows:
(i) Each dispensing pharmacist shall:
(1) fill in on the official prescription form or note
in the electronic prescription record each item of information
given orally to the dispensing pharmacy under Subsection (h) and
the date the prescription is filled, and:
(A) for a written prescription, fill in the
dispensing pharmacist's signature; or
(B) for an electronic prescription,
appropriately record the identity of the dispensing pharmacist in
the electronic prescription record;
(2) retain with the records of the pharmacy for at
least two years:
(A) the official prescription form or the
electronic prescription record, as applicable; and
(B) the name or other patient identification
required by Section 481.074(m) or (n); and
(3) send all required information, including any
information required to complete an official prescription form or
electronic prescription record, to the board by electronic transfer
or another form approved by the board not later than the next
business [seventh] day after the date the prescription is
completely filled.
SECTION 4. Sections 481.076(a) and (d), Health and Safety
Code, are amended to read as follows:
(a) The board may not permit any person to have access to
information submitted to the board under Section 481.074(q) or
481.075 except:
(1) [an investigator for] the board, the Texas Medical
Board, the Texas State Board of Podiatric Medical Examiners, the
State Board of Dental Examiners, the State Board of Veterinary
Medical Examiners, the Texas Board of Nursing, or the Texas
Optometry Board for the purpose of:
(A) investigating a specific license holder; or
(B) monitoring for potentially harmful
prescribing or dispensing patterns or practices under Section
481.0762;
(2) an authorized officer or member of the department
or authorized employee of the board engaged in the administration,
investigation, or enforcement of this chapter or another law
governing illicit drugs in this state or another state;
(3) the department on behalf of a law enforcement or
prosecutorial official engaged in the administration,
investigation, or enforcement of this chapter or another law
governing illicit drugs in this state or another state;
(4) a medical examiner conducting an investigation;
(5) provided that accessing the information is
authorized under the Health Insurance Portability and
Accountability Act of 1996 (Pub. L. No. 104-191) and regulations
adopted under that Act:
(A) a pharmacist or a pharmacy technician, as
defined by Section 551.003, Occupations Code, acting at the
direction of a pharmacist; or
(B) a practitioner who:
(i) is a physician, dentist, veterinarian,
podiatrist, optometrist, or advanced practice nurse or is a
physician assistant described by Section 481.002(39)(D) or an
employee or other agent of a practitioner acting at the direction of
a practitioner; and
(ii) is inquiring about a recent Schedule
II, III, IV, or V prescription history of a particular patient of
the practitioner[, provided that the person accessing the
information is authorized to do so under the Health Insurance
Portability and Accountability Act of 1996 (Pub. L. No. 104-191)
and rules adopted under that Act];
(6) a pharmacist or practitioner who is inquiring
about the person's own dispensing or prescribing activity; or
(7) one or more states or an association of states with
which the board has an interoperability agreement, as provided by
Subsection (j).
(d) Information submitted to the board under this section
may be used only for:
(1) the administration, investigation, or enforcement
of this chapter or another law governing illicit drugs in this state
or another state;
(2) investigatory, [or] evidentiary, or monitoring
purposes in connection with the functions of an agency listed in
Subsection (a)(1);
(3) the prescribing and dispensing of controlled
substances by a person listed in Subsection (a)(5); or
(4) [(3)] dissemination by the board to the public in
the form of a statistical tabulation or report if all information
reasonably likely to reveal the identity of each patient,
practitioner, or other person who is a subject of the information
has been removed.
SECTION 5. Section 481.0761, Health and Safety Code, is
amended by adding Subsections (h), (i), (j), and (k) to read as
follows:
(h) The board, in consultation with the department and the
regulatory agencies listed in Section 481.076(a)(1), shall
identify potentially harmful prescribing or dispensing patterns or
practices that may suggest drug diversion or drug abuse. The board
shall develop indicators for levels of prescriber or patient
activity that suggest that a potentially harmful prescribing or
dispensing pattern or practice may be occurring or that drug
diversion or drug abuse may be occurring.
(i) The board may, based on the indicators developed under
Subsection (h), send a prescriber or dispenser an electronic
notification if the information submitted under Sections
481.074(q) and 481.075 indicates that a potentially harmful
prescribing or dispensing pattern or practice may be occurring or
that drug diversion or drug abuse may be occurring.
(j) The board by rule may develop guidelines identifying
patterns that may indicate that a particular patient to whom a
controlled substance is prescribed or dispensed is engaging in drug
abuse or drug diversion. These guidelines may be based on the
frequency of prescriptions issued to and filled by the patient, the
types of controlled substances prescribed, and the number of
prescribers who prescribe controlled substances to the patient.
The board may, based on the guidelines developed under this
subsection, send a prescriber or dispenser an electronic
notification if there is reason to believe that a particular
patient is engaging in drug abuse or drug diversion.
(k) The board by rule may develop guidelines identifying
additional behavior that would suggest that drug diversion or drug
abuse is occurring. A person described by Section 481.076(a)(5)(A)
who observes that behavior by a person to whom a controlled
substance is to be dispensed shall access the information under
Section 481.076(a)(5) regarding the patient for whom the
prescription for the controlled substance was issued.
SECTION 6. Subchapter C, Chapter 481, Health and Safety
Code, is amended by adding Sections 481.0762, 481.0763, 481.0764,
and 481.0765 to read as follows:
Sec. 481.0762. MONITORING BY REGULATORY AGENCY. (a) Each
regulatory agency that issues a license, certification, or
registration to a prescriber shall promulgate specific guidelines
for prescribers regulated by that agency for the responsible
prescribing of opioids, benzodiazepines, barbiturates, or
carisoprodol.
(b) A regulatory agency that issues a license,
certification, or registration to a prescriber shall periodically
access the information submitted to the board under Sections
481.074(q) and 481.075 to determine whether a prescriber is
engaging in potentially harmful prescribing patterns or practices.
(c) If the board sends a prescriber an electronic
notification authorized under Section 481.0761(i), the board shall
simultaneously send an electronic notification to the appropriate
regulatory agency.
(d) In determining whether a potentially harmful
prescribing pattern or practice is occurring, the appropriate
regulatory agency, at a minimum, shall consider:
(1) the number of times a prescriber prescribes
opioids, benzodiazepines, barbiturates, or carisoprodol; and
(2) for prescriptions described by Subdivision (1),
patterns of prescribing combinations of those drugs and other
dangerous combinations of drugs identified by the board.
(e) If, during a periodic check under this section, the
regulatory agency finds evidence that a prescriber may be engaging
in potentially harmful prescribing patterns or practices, the
regulatory agency may notify that prescriber.
(f) A regulatory agency may open a complaint against a
prescriber if the agency finds evidence during a periodic check
under this section that the prescriber is engaging in conduct that
violates this subchapter or any other statute or rule.
Sec. 481.0763. REGISTRATION BY REGULATORY AGENCY. A
regulatory agency that issues a license, certification, or
registration to a prescriber or dispenser shall provide the board
with any necessary information for each prescriber or dispenser,
including contact information for the notifications described by
Sections 481.0761(i) and (j), to register the prescriber or
dispenser with the system by which the prescriber or dispenser
receives information as authorized under Section 481.076(a)(5).
Sec. 481.0764. DUTIES OF PRESCRIBERS, PHARMACISTS, AND
RELATED HEALTH CARE PRACTITIONERS. (a) A person authorized to
receive information under Section 481.076(a)(5), other than a
veterinarian, shall access that information with respect to the
patient before prescribing or dispensing opioids, benzodiazepines,
barbiturates, or carisoprodol.
(b) A person authorized to receive information under
Section 481.076(a)(5) may access that information with respect to
the patient before prescribing or dispensing any controlled
substance.
(c) A veterinarian authorized to access information under
Subsection (b) regarding a controlled substance may access the
information for prescriptions dispensed only for the animals of an
owner and may not consider the personal prescription history of the
owner.
(d) A violation of Subsection (a) is grounds for
disciplinary action by the regulatory agency that issued a license,
certification, or registration to the person who committed the
violation.
(e) This section does not grant a person the authority to
issue prescriptions for or dispense controlled substances.
Sec. 481.0765. EXCEPTIONS. (a) A prescriber is not
subject to the requirements of Section 481.0764(a) if:
(1) the patient has been diagnosed with cancer or the
patient is receiving hospice care; and
(2) the prescriber clearly notes in the prescription
record that the patient was diagnosed with cancer or is receiving
hospice care, as applicable.
(b) A dispenser is not subject to the requirements of
Section 481.0764(a) if it is clearly noted in the prescription
record that the patient has been diagnosed with cancer or is
receiving hospice care.
(c) A prescriber or dispenser is not subject to the
requirements of Section 481.0764(a) and a dispenser is not subject
to a rule adopted under Section 481.0761(k) if the prescriber or
dispenser makes a good faith attempt to comply but is unable to
access the information under Section 481.076(a)(5) because of
circumstances outside the control of the prescriber or dispenser.
SECTION 7. Section 554.051(a-1), Occupations Code, is
amended to read as follows:
(a-1) The board may adopt rules to administer Sections
481.073, 481.074, 481.075, 481.076, [and] 481.0761, 481.0762,
481.0763, 481.0764, and 481.0765, Health and Safety Code.
SECTION 8. (a) The Senate Committee on Health and Human
Services shall conduct an interim study on the monitoring of the
prescribing and dispensing of controlled substances in this state.
(b) The interim study must:
(1) include the number of prescribers and dispensers
registered to receive information electronically under Section
481.076, Health and Safety Code, as amended by this Act;
(2) evaluate the accessing of information under
Section 481.076, Health and Safety Code, as amended by this Act, by
regulatory agencies to monitor persons issued a license,
certification, or registration by those agencies;
(3) address any complaints, technical difficulties,
or other issues with electronically accessing and receiving
information under Section 481.076, Health and Safety Code, as
amended by this Act;
(4) examine controlled substance prescribing and
dispensing trends that may be affected by the passage and
implementation of this Act;
(5) evaluate the integration of any new data elements
required to be reported under this Act;
(6) evaluate the existence and scope of diversion of
controlled substances by animal owners to whom the substances are
dispensed by veterinarians; and
(7) explore the best methods for preventing the
diversion of controlled substances by animal owners.
(c) The committee shall solicit feedback from regulatory
agencies, prescribers, dispensers, and patients affected by the
passage of this Act.
(d) The committee shall submit a report to the legislature
on the results of the interim study, including any legislative
recommendations for improvements to information access and
controlled substance prescription monitoring, not later than
January 1, 2019.
SECTION 9. A person is not required to comply with Section
481.0761(k), Health and Safety Code, as added by this Act, before
September 1, 2018.
SECTION 10. Section 481.0764(a), Health and Safety Code, as
added by this Act, applies only to:
(1) a prescriber who issues a prescription for a
Schedule II controlled substance on or after September 1, 2018;
(2) a prescriber who issues a prescription for a
controlled substance on any schedule on or after September 1, 2019;
(3) a person authorized by law to dispense a
controlled substance who dispenses a Schedule II controlled
substance on or after September 1, 2018; or
(4) a person authorized by law to dispense a
controlled substance who dispenses a controlled substance on any
schedule on or after September 1, 2019.
SECTION 11. This Act takes effect September 1, 2017.