BG C.S.H.B. 2319 75(R)    BILL ANALYSIS


PUBLIC HEALTH
C.S.H.B. 2319
By: Van de Putte
4-17-97
Committee Report (Substituted)


BACKGROUND 

Currently, the Controlled Substances Act, Chapter 481 of the Health and
Safety Code requires that prescriptions written for Schedule II Controlled
Substances be issued on a special, serially numbered triplicate
prescription form.  When a prescription is issued one copy is sent to the
Department of Public Safety (DPS), one is kept by the doctor, and one kept
by the pharmacist. At DPS the information is entered by data clerks into
an electronic monitoring system.  In 1988, there were 626,105
prescriptions entered into the system.  That number increases annually and
in 1996 there were 1,347,086 prescriptions entered into the program with a
115% increase.  Today, however, there are technological advances that make
it possible for that information to be collected electronically
eliminating the need for data entry clerks and others to manually enter
and track the information. 

A second aspect to the Triplicate Prescription Program is the enforcement
of laws relating to the use and abuse of Controlled Substances that are in
Schedule II.  When passed the law strictly limited the dissemination of
any information collected through this program, even the release of
statistical information is prohibited.   For DPS to enforce drug diversion
laws and other abuse laws, they were required to request permission from
the practitioner board prior to reviewing the data collected by the
prescription monitoring program. 

PURPOSE

C.S.H.B. 2319 changes the triplicate prescription form to a sequentially
numbered nontransferable sticker that attaches to a normal prescription
form. C.S.H.B. 2319 also establishes an electronic reporting mechanism for
Schedule II prescription information to DPS and increases the amount of
the fee paid to fund the program. Additionally, the bill broadens the
ability of DPS to access prescription program information for law
enforcement purposes. 

RULEMAKING AUTHORITY

It is the committee's opinion that this bill expressly grants additional
rulemaking authority to the Director of the Department of Public Safety in
SECTION 2 ( Subchapter A, Chapter 481, Sec. 481.003, Health and Safety
Code) and in SECTION 3 (Sec. 481.064(a) Health and Safety Code). In
SECTION 5 (Sec. 481.075, Health and Safety Code) rulemaking authority is
granted to the director of DPS in Subsection (g); new rulemaking is
referenced in Subsections (a),(f), and (l). Additional rulemaking
authority is also granted to the DPS director in SECTION 6 (Sec.
481.076(c), Health and Safety Code) and in SECTION 7 (Subchapter C,
Chapter 481, Sec. 481.0761(a),(b),(c),(d), and (e), Health and Safety
Code). 

SECTION BY SECTION ANALYSIS

SECTION 1.  Amends Section 481.002, Health and Safety Code, as follows:

Subdivision (47) replaces "Triplicate" in the name of the prescription
form with "Official" and redefines that official form as a prescription
form "that contains the prescription information required by Section
481.075 with an attached prescription sticker as specified. Removes
language regarding DPS and uses involving administering, dispensing,
prescribing, or delivering a controlled substance. 

 Subdivision (50) is added to define "patient identification number" as
specified.   

Subdivision (51) is added to define "department" as DPS.

Subdivision (52) is added to define "drivers licence" as referenced in the
Transportation Code, Section 521.001. 

Subdivision (53) is added to define "personal identification certificate"
as specified. 

Subdivision (54) is added to define "prescription sticker" as specified.

SECTION 2. Amends Subchapter A, Chapter 481, Health and Safety Code, by
adding Section 481.003, entitled " RULES," to allow the director to adopt
rules to administer and enforce this Chapter. 

SECTION 3.  Amends Section 481.064, Health and Safety Code, by revising
the heading title and subsections as follows: 

Sec. 481.064.  REGISTRATION FEES.  

Subsection (a) removes language regarding the adoption of reasonable rules
by the director. Revises the amount the director is allowed to charge for
an annual registration fee to be no more than $25, instead of $5. Requires
the director, to set the fee amount, by rule, at an amount necessary to
cover administration and enforcement costs as specified. Replaces the
reference to the "chapter" with "subchapter." Makes conforming changes.  

Subsection (b) replaces the reference to "DPS" with the "department" and
makes a conforming change. 

Subsection (c) removes "in the state treasury" in reference to where
collected fees are deposited. Revises language to establish that fees are
to the credit of the operator's and chauffeur's license "account in the
general revenue" fund. Makes conforming changes. 

SECTION 4.  Amends Section 481.074, Health and Safety Code, as follows:

Subsection (a)(4) removes language pertaining to a person without
identification and the pharmacist's determination of a substance being
needed for immediate well-being. Adds language to specifically state
"except as provided by Subsection (n)." 

Subsection (b) replaces reference to Section 481.075(g) with 481.075(j).
Adds language to clarify that the form is "an official prescription" form.
Adds to clarify circumstances and obligations concerning the person who is
a prescribing practitioner or pharmacist, and promptly complies with
Subsection (c); or if the person is not a prescribing practitioner or
pharmacist, and as required, promptly writes the oral or telephonically
communicated prescription as specified. Revises the section references as
specified, removes the requirement that the person send a copy of the
written record to DPS and makes nonsubstantive language changes.  

Subsection (c) adds language to the provision concerning the requirements
for actions within 72 hours after authorizing an emergency prescription to
clarify that "all information required by the director, including
information as specified, to be sent electronically or on a universal
claim form or other approved form" to the director. 

Subsection (f) revises language to clarify that the prescription the
pharmacist records must be "on an official prescription form and must
indicate on the form" if the patient is on terminally ill or long term
care status as specified. Omits a reference to "copy 1 and copy 2" and
makes conforming change. 

Subsection (m) is added. Allows a pharmacist to permit delivery of a
controlled substance  by a person known to the pharmacist, by an
authorized person as specified, or by mail as specified. Requires that
records as specified be retained by the pharmacist for at least two years. 

Subsection (n) is added to allow a pharmacist to permit the delivery of a
controlled substance to a person not known to the pharmacist, an intern,
or authorized individual without first requiring identification as
specified, if the pharmacist determines it to be an emergency as
specified. Requires the pharmacist to retain records of such a delivery in
the pharmacy for at least two years. Requires the records to contain
identifying information as specified.  

SECTION 5.  Amends Section 481.075, Health and Safety Code, as follows:

Sec. 481.075.  OFFICIAL PRESCRIPTION PROGRAM. 

Subsection (a)  adds the exception to the requirement concerning Schedule
II controlled substances as provided by rule adopted under Section
481.0761. Adds language to clarify that the prescription form include
required information as specified and have an issued sticker affixed as
specified. Omits language to conform. 

Subsection (b)  establishes that each sticker be sequentially numbered and
produced as specified.  

Subsection (c) replaces DPS with the "director" and "the forms" with
"prescription stickers" in regards to the requirement that they be issued
to practitioners as specified. Revises language to require that before
mailing or otherwise delivering sticker packages as specified, the
director print on each sticker the number and any other information
determined necessary. Makes conforming changes. 

Subsection (d)  makes conforming changes and adds reference to the
definition in Section 481.002(39)(A). 

Subsection (e) makes conforming changes, removes language pertaining to
triplicate forms, and adds "schedule II" to clarify which controlled
substances are being addressed.  Revises language to establish the
information, as specified, provided by the prescribing practitioner. 

Subsection (f) makes conforming changes, adds language to clarify the form
to be "an official" prescription form, adds language to provide an
exception as specified.  

Subsection (g)  makes conforming changes. Revises language to state that
each item of information required to be provided by the prescribing
practitioner under subsection (e)(1) be on the  official prescription form
and as specified, unless the practitioner determines under rule adopted by
the director, that it is unnecessary or determines that it is not in the
best interest of the patient as specified. 

Subsection (h) makes a conforming change.

Subsection (i) makes conforming changes. Adds language to clarify that
each item of information given orally to the dispensing pharmacy as
specified, the date filled, and the dispensing pharmacist's signature is
to be filled in on the official prescription form and retained with
records of the pharmacy as specified; and sent as specified to the
director by electronic transfer, or as specified. 

Subsection (j)  is relettered to conform.

Subsection (k) makes conforming changes. Replaces "seventh" with "30th" in
reference to the maximum number of days after which all prescription
stickers are to be returned to the department.  

Subsection (l)  is added to specify that the prescribing practitioner may
only use the prescription sticker to prescribe a controlled substance.
Requires each prescribing practitioner to date or sign an official
prescription form only on the date the prescription is issued, and to take
reasonable precautionary measures as specified.  

Subsection (m)  is added to allow dispensing pharmacists in this state to
fill a prescription issued in another state as specified. Requires a
dispensing pharmacist to send information as specified to the director. 

Subsection (n) is added to establish expiration of this section expires
9/1/03. Omits the provision which allowed the director to adopt
implementation rules. 

SECTION 6.  Amends Section 481.076, Health and Safety Code, as follows:

Sec. 481.076. OFFICIAL PRESCRIPTION INFORMATION. 

Subsection (a) makes conforming and nonsubstantive language changes. Adds
language in clarification of the exceptions on the prohibition to permit
someone access to submitted information as specified.  

Subsection (b) establishes that this section does not prohibit the
director from creating, using, or disclosing statistical dat as specified.
Removes language concerning an investigator and cooperation requirements. 

Subsection (c) revises language to require that the director, by rule,
design and implement a system for the submission of information, as
specified. Replaces "department" with "director" and adds reference to
Sec. 481.075.  

Subsection (d) makes conforming changes and adds language to specify that
information submitted may be used only for "the administration,
investigation and enforcement of this chapter and laws governing illicit
drugs", for investigatory purposes as was in the existing language, or for
dissemination in the form of a statistical tabulation as specified. 

Subsection (e) makes conforming changes, revises the time schedule by
which the record of the identity or a patient is made irretrievable to be
36 calendar months, rather than 12. Adds "the 30th day after" the end of
the month in reference to the provision for a specific ongoing
investigation. 

Subsection (f) is added to require the director to notify and cooperate
with an agency as specified, regarding the disposition of a matter before
taking action against the person, unless the director finds that the
notification might interfere with or jeopardize an investigation or
prosecution.  

Subsection (g) is added. Requires the director to notify an agency as
specified of the disclosure of information not later than the 10th working
day after the date the information is released, if the director permits
access as specified. Provides exceptions for requests to withhold
notification as specified and determinations of interference with an
administrative or criminal action as specified.  

Subsection (h)  is added. Requires the director to notify the agency, as
specified, if notification is withheld under subsection (g). 

Subsection (i) is added to provide that information submitted to the
director under Sec. 481.075 is confidential and remains confidential
regardless of whether the  director permits access to the information
under this section. 

Subsection (j) is added to establish that this section expires 09/01/03.
Omits text regarding a departmental semiannual report requirement and
audits. 

SECTION 7.  Amends Subchapter C, Chapter 481, Health and Safety Code, by
adding Section 481.0761 as follows: 

Sec.  481.0761.  RULES; AUTHORITY TO CONTRACT.  (a) Requires the
Department to consult with the Board of Pharmacy to develop a standardized
database format for the electronic transfer of controlled substance
information as specified. 

Subsection (b) requires the director, to consult with the Department of
Health, State Board of Pharmacy and the Board of Medical Examiners and
allows, by rule, the removal of controlled substance listed in Schedule II
from the official prescription program as specified or return a substance
previously removed to the program as specified. 

Subsection (c) allows the director, by rule, to permit more than one
prescription to be on the official form; remove from or return to the
program any aspect of the practitioner's or pharmacist's professional
practice; waive or delay the reporting requirements; establish
compatibility protocols for the electronic system; permit the use of a
transitional period as specified; establish a procedure to control the
release of information as specified; and establish a minimum level of
prescription activity below which reporting may be modified. 

Subsection (d) requires the director, by rule, to authorize a prescribing
practitioner to determine whether it is necessary to obtain and record a
particular patient identification number as specified.  

Subsection (e) requires the director to consider the economic impact of a
rule relating to electronic transfer of information on practitioners and
pharmacists and act to minimize any negative impacts as specified.
Prohibits the adoption of a rule, as specified, that imposes an additional
fee than that authorized in Sec. 481.064. 

Subsection (f)  allows the director to authorize a contract between the
department and another state agency or private vendor as necessary to
ensure effective operation of the prescription program. 

Subsection (g) establishes that this section expires on September 1, 2003.

SECTION 8.   Amends Section 481.127(a), Health and Safety Code, by
deleting the word "intentionally" in regards to the commission of an
offense, and replacing "DPS" with "director." 

SECTION 9.  Amends Section 481.128(a), Health and Safety Code, by deleting
the word "intentionally" in regards to the commission of an offense, with
conforming and section references changes and removal of a reference to a
past date.  

SECTION 10.  Amends Section 481.129(a), Health and Safety Code, by
striking references to previous triplicate forms and other conforming
changes, including deletion of the word "intentional." 

SECTION 11.  Amends Section 552.118, Government Code, to conform in
heading title and language use in terms of "an official" prescription form
filed with the "director."   

SECTION 12.  Amends Section 3.06(d)(6)(J)(i), Medical Practice Act
(Article 4495b, Vernon's Texas Civil Statutes), by changing the language
concerning the prohibition of physician delegation of the prescription
form use from a restrictive "shall" to a permissive "may." Removes
references to the triplicate prescription program and adds language
pertaining to the  official prescription program. 

SECTION 13.  Establishes this Act takes effect September 1, 1999, except
for Section 7 which takes effect September 1, 1997.  

SECTION 14.  Establishes that the changes made by this this Act do not
affect retention, use,  or destruction requirements as specified relating
to prescriptions written under the triplicate prescription program prior
to September 1, 1999.  A provision, as specified, continues in effect for
those purposes.  

SECTION 15.  Provides that changes made by this Act apply only to an
offense committed on or after September 1, 1999. Previous sections of the
code remain in effect for offenses committed prior to that date. 

SECTION 16.  Provides that changes in law established by this measure does
not affect the dispensing of a Schedule II controlled substance by a
pharmacist to  a certified nurse anesthetist or a certified nurse midwife
or a physicians assistance as currently authorized by the Medical Practice
Act. 

SECTION 17. Emergency clause.

COMPARISON OF ORIGINAL TO SUBSTITUTE

C.S.H.B. 2319 first requires re-establishment of Sections 481.075 and
481.076 and 481.0761 in 2003.  Additionally, the measure changes the
definition of "official form" from a pre-printed numbered form to a normal
prescription form with a sequentially numbered non-transferable sticker
issued by DPS transferring the required information previously need on the
old printed form to the new stickered form and the liability for the old
form to the new sticker and makes conforming changes in the code for the
establishment of and regulation of the sticker in a manner similar to the
regulation of the form.  C.S.H.B. 2319 also clarifies the requirement for
out of state or mail order prescriptions and it clarifies that the measure
does not affect the prescribing practice of certain practitioners that
currently have the authority to prescribe  Schedule II drugs.