Bill Text: TX SB316 | 2017-2018 | 85th Legislature | Comm Sub
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Bill Title: 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.
Spectrum: Bipartisan Bill
Status: (Engrossed - Dead) 2017-05-21 - Committee report sent to Calendars [SB316 Detail]
Download: Texas-2017-SB316-Comm_Sub.html
Bill Title: 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.
Spectrum: Bipartisan Bill
Status: (Engrossed - Dead) 2017-05-21 - Committee report sent to Calendars [SB316 Detail]
Download: Texas-2017-SB316-Comm_Sub.html
By: Hinojosa, et al. | S.B. No. 316 | |
(In the Senate - Filed March 7, 2017; March 9, 2017, read | ||
first time and referred to Committee on Health & Human Services; | ||
April 3, 2017, reported adversely, with favorable Committee | ||
Substitute by the following vote: Yeas 7, Nays 2; April 3, 2017, | ||
sent to printer.) | ||
COMMITTEE SUBSTITUTE FOR S.B. No. 316 | By: Uresti |
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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. 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, if the controlled substance is prescribed for an | ||
animal, the name, species, gender, and actual or estimated date of | ||
birth of the animal and the name and address of the animal's [ |
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owner; | ||
(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 [ |
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prescription is completely filled. | ||
SECTION 2. 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 [ |
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completely filled. | ||
SECTION 3. 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 next business 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 animal; | ||
(4) the species, gender, and actual or estimated date | ||
of birth of the animal; | ||
(5) the name and address of the animal's owner; and | ||
(6) 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 4. 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), [ |
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481.075, or 481.0751 except: | ||
(1) [ |
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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[ |
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(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), [ |
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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), [ |
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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, [ |
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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, [ |
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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) [ |
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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), [ |
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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), [ |
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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 5. Section 481.0761, Health and Safety Code, is | ||
amended by amending Subsections (a) and (c) and adding Subsections | ||
(h), (i), (j), and (k) 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), [ |
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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 | ||
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), 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 simultaneously 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 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. (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, including information from | ||
veterinarians regarding controlled substances prescribed or | ||
dispensed for animals; | ||
(6) evaluate the existence and scope of diversion of | ||
controlled substances by animal owners to whom the substances are | ||
dispensed by veterinarians; | ||
(7) 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 | ||
(8) 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. | ||
(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 8. (a) Notwithstanding Section 481.0751(b), Health | ||
and Safety Code, as added by this Act: | ||
(1) a veterinarian who dispenses a controlled | ||
substance before September 1, 2018, is not required to submit the | ||
information under that subsection to the Texas State Board of | ||
Pharmacy; | ||
(2) a veterinarian who dispenses a controlled | ||
substance on or after September 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; | ||
and | ||
(3) a veterinarian who dispenses a controlled | ||
substance on or after September 1, 2019, but before September 1, | ||
2020, is required to submit the information under that subsection | ||
to the Texas State Board of Pharmacy not later than the seventh day | ||
after the date the veterinarian dispenses the controlled substance. | ||
(b) A veterinarian who dispenses a controlled substance on | ||
or after September 1, 2020, is required to comply with Section | ||
481.0751(b), Health and Safety Code, as added by this Act. | ||
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. | ||
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