85R30089 JSC-D
By: Hinojosa, et al. S.B. No. 316
(Gonzales of Williamson, Coleman)
Substitute the following for S.B. No. 316: No.
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,
481.0751, 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, 481.0751, 481.076, [and] 481.0761,
481.0762, 481.0763, 481.0764, and 481.0765.
SECTION 2. Sections 481.074(k) and (q), Health and Safety
Code, are amended to read as follows:
(k) A prescription for a controlled substance must show:
(1) the quantity of the substance prescribed:
(A) numerically, followed by the number written
as a word, if the prescription is written;
(B) numerically, if the prescription is
electronic; or
(C) if the prescription is communicated orally or
telephonically, as transcribed by the receiving pharmacist;
(2) the date of issue;
(2-a) if the prescription is issued for a Schedule II
controlled substance to be filled at a later date under Subsection
(d-1), the earliest date on which a pharmacy may fill the
prescription;
(3) the name, address, and date of birth or age of the
patient or:
(A) [,] if the controlled substance is prescribed
for an individual animal:
(i) [,] the name, species, and actual or
estimated date of birth of the animal; and
(ii) the name and address of the animal's
[its] owner; or
(B) if the controlled substance is prescribed for
a group or herd of animals:
(i) an identifier for the group or herd and
the species of the group or herd; and
(ii) the name and address of the owner of
the group or herd or, if the group or herd is not owned by a person,
the name and address of the client to whom the controlled substance
is to be dispensed;
(4) the name and strength of the controlled substance
prescribed;
(5) the directions for use of the controlled
substance;
(6) the intended use of the substance prescribed
unless the practitioner determines the furnishing of this
information is not in the best interest of the patient;
(7) the name, address, Federal Drug Enforcement
Administration number, and telephone number of the practitioner at
the practitioner's usual place of business, which must be legibly
printed or stamped on a written prescription; and
(8) if the prescription is handwritten, the signature
of the prescribing practitioner.
(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. Subchapter C, Chapter 481, Health and Safety
Code, is amended by adding Section 481.0751 to read as follows:
Sec. 481.0751. DISPENSING VETERINARIANS. (a) This section
applies to a veterinarian who holds a registration issued by the
Federal Drug Enforcement Administration and dispenses Schedule II,
III, IV, or V controlled substances directly to the owner or handler
of an animal.
(b) Not later than the seventh day after the date the
veterinarian dispenses a controlled substance, the veterinarian
shall submit to the board:
(1) the name, strength, and quantity of the substance
dispensed;
(2) the date the substance was dispensed;
(3) the name of the individual animal or if the
substance is dispensed for a group or herd of animals, an identifier
for the group or herd;
(4) the species of the animal or group or herd of
animals;
(5) if the controlled substance is dispensed for an
individual animal, the actual or estimated date of birth of the
animal;
(6) as applicable, the name and address of:
(A) the owner of the individual animal;
(B) the owner of the group or herd; or
(C) if the controlled substance is dispensed for
a group or herd that is not owned by a person, the name and address
of the client to whom the controlled substance is dispensed; and
(7) the name, address, Federal Drug Enforcement
Administration number, and telephone number of the veterinarian at
the veterinarian's usual place of business.
(c) A veterinarian shall retain a record of the information
submitted to the board under Subsection (b) for a period of not less
than two years after the date the substance is dispensed.
(d) Failure to comply with this section is grounds for
disciplinary action by the State Board of Veterinary Medical
Examiners.
SECTION 5. Sections 481.076(a), (a-3), (a-4), (c), (d),
(i), and (j), 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, or 481.0751 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).
(a-3) The board shall ensure that the department has
unrestricted access at all times to information submitted to the
board under Sections 481.074(q), [and] 481.075, and 481.0751. The
department's access to the information shall be provided through a
secure electronic portal under the exclusive control of the
department. The department shall pay all expenses associated with
the electronic portal.
(a-4) A law enforcement or prosecutorial official described
by Subsection (a)(3) may obtain information submitted to the board
under Section 481.074(q), [or] 481.075, or 481.0751 only if the
official submits a request to the department. If the department
finds that the official has shown proper need for the information,
the department shall provide access to the relevant information.
(c) The board by rule shall design and implement a system
for submission of information to the board by electronic or other
means and for retrieval of information submitted to the board under
this section and Sections 481.074, [and] 481.075, and 481.0751.
The board shall use automated information security techniques and
devices to preclude improper access to the information. The board
shall submit the system design to the director and the Texas Medical
Board for review and comment a reasonable time before
implementation of the system and shall comply with the comments of
those agencies unless it is unreasonable to do so.
(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.
(i) Information submitted to the board under Section
481.074(q), [or] 481.075, or 481.0751 is confidential and remains
confidential regardless of whether the board permits access to the
information under this section.
(j) The board may enter into an interoperability agreement
with one or more states or an association of states authorizing the
board to access prescription monitoring information maintained or
collected by the other state or states or the association,
including information maintained on a central database such as the
National Association of Boards of Pharmacy Prescription Monitoring
Program InterConnect. Pursuant to an interoperability agreement,
the board may authorize the prescription monitoring program of one
or more states or an association of states to access information
submitted to the board under Sections 481.074(q), [and] 481.075,
and 481.0751, including by submitting or sharing information
through a central database such as the National Association of
Boards of Pharmacy Prescription Monitoring Program InterConnect.
SECTION 6. Section 481.0761, Health and Safety Code, is
amended by amending Subsections (a) and (c) and adding Subsections
(h), (i), (j), (k), and (l) to read as follows:
(a) The board shall by rule establish and revise as
necessary a standardized database format that may be used by a
pharmacy to transmit the information required by Sections
481.074(q), [and] 481.075(i), and 481.0751 to the board
electronically or to deliver the information on storage media,
including disks, tapes, and cassettes.
(c) The board by rule may:
(1) permit more than one prescription to be
administered or dispensed and recorded on one prescription form for
a Schedule III through V controlled substance;
(1-a) establish a procedure for the issuance of
multiple prescriptions of a Schedule II controlled substance under
Section 481.074(d-1);
(2) remove from or return to the official prescription
program any aspect of a practitioner's or pharmacist's hospital
practice, including administering or dispensing;
(3) waive or delay any requirement relating to the
time or manner of reporting;
(4) establish compatibility protocols for electronic
data transfer hardware, software, or format, including any
necessary modifications for participation in a database described
by Section 481.076(j);
(5) establish a procedure to control the release of
information under Sections 481.074, 481.075, 481.0751, and
481.076; and
(6) establish a minimum level of prescription activity
below which a reporting activity may be modified or deleted.
(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), 481.075, and 481.0751 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
diversion or drug abuse. 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 diversion or drug abuse.
(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.
(l) If the board finds that the electronic system used by
the board in maintaining the information under Section 481.076
requires data elements that cannot be provided for a prescription
or dispensation of a controlled substance to a group or herd of
animals, the board, in consultation with the State Board of
Veterinary Medical Examiners, shall adopt rules relating to the
specific format in which a person may enter or submit those data
elements with respect to the group or herd.
SECTION 7. 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), 481.075, and 481.0751 to determine whether a prescriber
is engaging in potentially harmful prescribing patterns or
practices.
(c) The State Board of Veterinary Medical Examiners shall
periodically access the information submitted to the board under
Sections 481.074(q), 481.075, and 481.0751 to determine whether a
veterinarian is engaging in potentially harmful prescribing or
dispensing patterns or practices.
(d) If the board sends a prescriber or dispensing
veterinarian an electronic notification authorized under Section
481.0761(i), the board shall immediately send an electronic
notification to the appropriate regulatory agency.
(e) In determining whether a potentially harmful
prescribing or dispensing pattern or practice is occurring, the
appropriate regulatory agency, at a minimum, shall consider:
(1) the number of times a prescriber prescribes or a
veterinarian dispenses opioids, benzodiazepines, barbiturates, or
carisoprodol; and
(2) for prescriptions and dispensations described by
Subdivision (1), patterns of prescribing or dispensing
combinations of those drugs and other dangerous combinations of
drugs identified by the board.
(f) If, during a periodic check under this section, the
regulatory agency finds evidence that a prescriber may be engaging
in potentially harmful prescribing or dispensing patterns or
practices, the regulatory agency may notify that prescriber.
(g) 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) 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 subject to this section is required to
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 is not subject to the requirements of
Section 481.0764(a) if:
(1) the prescription is for a controlled substance in
a quantity not to exceed a five-day supply;
(2) the prescription does not authorize any refills;
(3) the prescription is issued:
(A) pursuant to a patient's emergency medical
condition; or
(B) following the patient's surgical procedure;
and
(4) the prescriber clearly notes in the prescription
record that the prescription was issued pursuant to the patient's
emergency medical condition or following the patient's surgical
procedure, as applicable.
(d) A dispenser is not subject to the requirements of
Section 481.0764(a) if:
(1) the prescription is for a controlled substance in
a quantity not to exceed a five-day supply;
(2) the prescription does not authorize any refills;
and
(3) it is clearly noted in the prescription record
that the prescription was issued pursuant to a patient's emergency
medical condition or following a patient's surgical procedure, as
applicable.
(e) 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 8. Section 481.127(a), Health and Safety Code, is
amended to read as follows:
(a) A person commits an offense if the person knowingly
gives, permits, or obtains unauthorized access to information
submitted to the board under Section 481.074(q), [or] 481.075, or
481.0751.
SECTION 9. 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, 481.0751, 481.076, [and] 481.0761,
481.0762, 481.0763, 481.0764, and 481.0765, Health and Safety Code.
SECTION 10. (a) A joint interim committee is created to
conduct an interim study on the monitoring of the prescribing and
dispensing of controlled substances in this state.
(b) The joint interim committee shall be composed of three
senators appointed by the lieutenant governor and three members of
the house of representatives appointed by the speaker of the house
of representatives.
(c) The lieutenant governor and speaker of the house of
representatives shall each designate a co-chair from among the
joint interim committee members.
(d) The joint interim committee shall convene at the joint
call of the co-chairs.
(e) The joint interim committee has all other powers and
duties provided to a special or select committee by the rules of the
senate and house of representatives, by Subchapter B, Chapter 301,
Government Code, and by policies of the senate and house committees
on administration.
(f) The interim study conducted by the joint interim
committee 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 use and effectiveness of electronic
notifications sent to prescribers and dispensers under Sections
481.0761(i) and (j), Health and Safety Code, as added by this Act;
(6) evaluate the use and effectiveness of identifying
geographic anomalies in comparing delivery and dispensing data;
(7) evaluate the integration of any new data elements
required to be reported under this Act, including information from
veterinarians regarding controlled substances prescribed or
dispensed for animals;
(8) evaluate the existence and scope of diversion of
controlled substances by animal owners to whom the substances are
dispensed by veterinarians;
(9) explore the best methods for preventing the
diversion of controlled substances by animal owners, including
veterinary reporting under Section 481.0751, Health and Safety
Code, as added by this Act; and
(10) determine how mandated reporting by
veterinarians under Section 481.0751, Health and Safety Code, as
added by this Act, might best be tailored to fit the practice of
veterinary medicine.
(g) The committee shall solicit feedback from regulatory
agencies, prescribers, dispensers, and patients affected by the
passage of this Act.
(h) 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.
(i) Subject to available resources, the Texas Legislative
Council shall provide legal and policy research, drafts of proposed
legislation, and statistical analysis services to the joint interim
committee for the purpose of the study required under this section.
(j) Notwithstanding Section 481.076, Health and Safety
Code, as amended by this Act, or any other law relating to access to
or disclosure of prescription drug information maintained by the
Texas State Board of Pharmacy, the Texas State Board of Pharmacy
shall disclose any information maintained by the board under
Section 481.076, Health and Safety Code, to the Texas Legislative
Council on request of the council for the purpose of assisting with
the study required under this section.
(k) Not later than November 1, 2017, the lieutenant governor
and speaker of the house of representatives shall appoint the
members of the joint interim committee in accordance with this
section.
(l) The joint interim committee created under this section
is abolished and this section expires January 2, 2019.
SECTION 11. (a) Notwithstanding Section 481.0751(b),
Health and Safety Code, as added by this Act:
(1) a veterinarian who dispenses a controlled
substance before January 1, 2018, is not required to submit the
information under that subsection to the Texas State Board of
Pharmacy; and
(2) a veterinarian who dispenses a controlled
substance on or after January 1, 2018, but before September 1, 2019,
is required to submit the information under that subsection to the
Texas State Board of Pharmacy not later than the 30th day after the
date the veterinarian dispenses the controlled substance.
(b) A veterinarian who dispenses a controlled substance on
or after September 1, 2019, is required to comply with Section
481.0751(b), Health and Safety Code, as added by this Act.
SECTION 12. A person is not required to comply with Section
481.0761(k), Health and Safety Code, as added by this Act, before
September 1, 2019.
SECTION 13. 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
controlled substance on or after September 1, 2019; or
(2) a person authorized by law to dispense a
controlled substance who dispenses a controlled substance on or
after September 1, 2019.
SECTION 14. This Act takes effect September 1, 2017.