BILL NUMBER: SB 632	AMENDED
	BILL TEXT

	AMENDED IN SENATE  JANUARY 4, 2012
	AMENDED IN SENATE  MARCH 24, 2011

INTRODUCED BY   Senator Emmerson

                        FEBRUARY 18, 2011

   An act to  add   amend  Section 
4052.6   to   4980.42 of  the
Business and Professions Code, relating to  pharmacy.
  marriage and family therapists. 


	LEGISLATIVE COUNSEL'S DIGEST


   SB 632, as amended, Emmerson.  Pharmacy.  
Marriage and family therapists.  
   Existing law provides for the licensing and regulation of marriage
and family therapists by the Board of Behavioral Sciences. Existing
law specifies the education required for licensure, which includes,
for specified applicants, a requirement for a practicum that involves
direct client contact and hours of experience relating to
client-centered advocacy, as defined. Existing law authorizes
trainees to perform activities and services in certain work settings
provided that these constitute part of the trainee's supervised
course of study and the person is designated as a trainee. Existing
law also authorizes trainees to gain hours of experience outside the
required practicum under certain conditions, but requires trainees
who gain experience outside the required practicum to be enrolled in
a practicum in order to counsel clients, except that trainees may
counsel clients while not enrolled in a practicum if the period of
lapsed enrollment is less than 90 calendar days, and if that period
is immediately preceded and immediately followed by enrollment in a
practicum course.  
   This bill would provide that the exception described above applies
to specified trainees.  
   Existing law, the Pharmacy Law, provides for the licensure and
regulation of pharmacists and pharmacies by the California State
Board of Pharmacy. A violation of the law is a crime. Existing law
authorizes a pharmacist filling a prescription order for a drug
product prescribed by the trade or brand name to substitute a generic
drug product, subject to specified requirements. Existing law also
authorizes a pharmacist filling a prescription order for a drug
product to select a different form of medication with the same active
chemical ingredients, as specified, if certain requirements are met.
 
   This bill would prohibit a pharmacist from interchanging or
substituting an opioid analgesic drug, as defined, for an opioid
analgesic drug incorporating a tamper resistant technology, as
defined, unless the opioid analgesic drug to be interchanged or
substituted is described on a list to be prepared by the board. In
those situations where the drug is not on the board's list, the bill
would require the pharmacist to obtain consent from the prescriber
prior to an interchange or substitution. The bill would make findings
and declarations in that regard. Because a violation of these
requirements by a pharmacist would constitute a crime, the bill would
impose a state-mandated local program.  
   The California Constitution requires the state to reimburse local
agencies and school districts for certain costs mandated by the
state. Statutory provisions establish procedures for making that
reimbursement.  
   This bill would provide that no reimbursement is required by this
act for a specified reason. 
   Vote: majority. Appropriation: no. Fiscal committee:  yes
  no  . State-mandated local program:  yes
  no  .


THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:

   SECTION 1.    Section 4980.42 of the  
Business and Professions Code   is amended to read: 
   4980.42.  (a) Trainees performing services in any work setting
specified in subdivision (e) of Section 4980.43 may perform those
activities and services as a trainee, provided that the activities
and services constitute part of the trainee's supervised course of
study and that the person is designated by the title "trainee."
   (b) Trainees may gain hours of experience outside the required
practicum but must be enrolled in a practicum course to counsel
clients, as set forth in clause (iii) of subparagraph (B) of
paragraph (1) of subdivision (d) of Section 4980.36, except as
provided in subdivision (c).
   (c) Trainees  subject to clause (iii) of subparagraph (B) of
paragraph (1) of subdivision (d) of Section 4980.36  may counsel
clients while not enrolled in a practicum course if the period of
lapsed enrollment is less than 90 calendar days, and if that period
is immediately preceded and immediately followed by enrollment in a
practicum course.
   (d) All hours of experience gained pursuant to subdivisions (b)
and (c) shall be subject to the requirements of subdivision (b) and
to the other requirements of this chapter.
   (e)  On and after January 1, 1995, all   All
 hours of experience gained as a trainee shall be coordinated
between the school and the site where the hours are being accrued.
The school shall approve each site and shall have a written agreement
with each site that details each party's responsibilities, including
the methods by which supervision shall be provided. The agreement
shall provide for regular progress reports and evaluations of the
student's performance at the site. If an applicant has gained hours
of experience while enrolled in an institution other than the one
that confers the qualifying degree, it shall be the applicant's
responsibility to provide to the board satisfactory evidence that
those hours of trainee experience were gained in compliance with this
section. 
  SECTION 1.    The Legislature finds and declares
all of the following:
   (a) Opioid use and abuse has increased greatly in the United
States since the 1990s and continues to rise. While the benefits of
these products in treating and managing pain are widely recognized,
the potential for misuse and abuse of these products has long been a
concern of manufacturers, federal and state law enforcement, health
care providers, legislators, and regulators.
   (b) Studies show that addicts tend to crush or otherwise break
down time-released products into a form that can be snorted or
injected for a more intense high. Thus, formulations that make it
more difficult to crush or otherwise manipulate those products may
mitigate the potential for abuse.
   (c) Pharmaceutical manufacturers have invested enormous research
and development resources in both creating novel technologies that
may help deter the inappropriate use of opioid medications and
testing those products against other opioid formulations.
   (d) The United States Food and Drug Administration (FDA) has
afforded priority review to new drug applications for opioids
incorporating tamper resistant technologies. However, the FDA has
been reluctant to permit claims that those products actually mitigate
the potential for abuse without additional research. Companies
continue to develop post approval data in the overall patient
population; however, that effort will take many years. Products
incorporating tamper resistant technologies can play an important
role today in offering health care providers the opportunity to
prescribe products incorporating tamper resistant technologies that
provide advantages in reducing the potential for misuse and abuse of
opioids.
   (e) Given the critically important public health and law
enforcement goals of preventing the abuse and misuse of opioids, the
Legislature should approve policies that encourage manufacturers to
develop opioid products with tamper resistant technologies and
promote efficient use of scarce health care resources.
   (f) Health care providers should have the ability to write
prescriptions for opioid products incorporating tamper resistant
technologies when, in their medical judgment, those prescriptions are
medically necessary.  
  SEC. 2.    Section 4052.6 is added to the Business
and Professions Code, to read:
   4052.6.  (a) For the purposes of this section, the following
definitions shall apply:
   (1) "Opioid analgesic drug" means a drug in the opioid analgesic
drug class prescribed to treat moderate to severe pain or other
conditions, whether in immediate release or extended release form and
whether or not combined with other drug substances to form a single
tablet or other dosage form.
   (2) "Opioid analgesic drug incorporating a tamper resistant
technology" means an opioid analgesic drug listed as such by the
board pursuant to subdivision (b).
   (b) (1) For the purposes of carrying out the provisions described
in subdivision (c), the board shall create a list of opioid analgesic
drugs that incorporate a tamper resistant technology. A drug shall
not be included on the list unless the following requirements are
satisfied:
   (A)  The drug manufacturer or distributor submits evidence to the
board that the opioid analgesic drug incorporates a tamper resistant
technology.
   (B) The opioid analgesic drug has been approved by the United
States Food and Drug Administration (FDA) pursuant to an application
that includes at least one human tampering or abuse potential study
or a laboratory study comparing the tamper or abuse resistant
properties of the drug to one or more opioid analgesic drugs that
have been approved by the FDA and serve as a positive control.
   (2) The list shall include a determination by the board as to
which opioid analgesic drugs incorporating tamper resistant
technologies provide substantially similar tamper resistant
properties, based solely upon studies submitted by the drug
manufacturer.
   (3) Nothing in this subdivision shall be construed to require that
a drug included on the list bear a labeling claim with respect to
reduction of tampering, abuse, or abuse potential at the time of
listing.
   (c) (1) Notwithstanding Sections 4052.5 and 4073, a pharmacist
shall not interchange or substitute an opioid analgesic drug, brand,
or generic, for an opioid analgesic drug incorporating a tamper
resistant technology unless the opioid analgesic drug that is
interchanged or substituted is included on the list described in
subdivision (b).
   (2) If the opioid analgesic drug is not on the list described in
subdivision (b), the pharmacist shall obtain consent from the
prescribing physician and surgeon prior to an interchange or
substitution. The consent may be obtained by telephone or through any
other electronic communication.  
  SEC. 3.    No reimbursement is required by this
act pursuant to Section 6 of Article XIII B of the California
Constitution because the only costs that may be incurred by a local
agency or school district will be incurred because this act creates a
new crime or infraction, eliminates a crime or infraction, or
changes the penalty for a crime or infraction, within the meaning of
Section 17556 of the Government Code, or changes the definition of a
crime within the meaning of Section 6 of Article XIII B of the
California Constitution.