BILL NUMBER: SB 472	CHAPTERED
	BILL TEXT

	CHAPTER  470
	FILED WITH SECRETARY OF STATE  OCTOBER 11, 2007
	APPROVED BY GOVERNOR  OCTOBER 11, 2007
	PASSED THE SENATE  SEPTEMBER 6, 2007
	PASSED THE ASSEMBLY  SEPTEMBER 5, 2007
	AMENDED IN ASSEMBLY  AUGUST 30, 2007
	AMENDED IN ASSEMBLY  JUNE 20, 2007
	AMENDED IN SENATE  MAY 21, 2007
	AMENDED IN SENATE  APRIL 30, 2007
	AMENDED IN SENATE  APRIL 16, 2007
	AMENDED IN SENATE  APRIL 9, 2007

INTRODUCED BY   Senator Corbett
   (Coauthors: Assembly Members Berg, Karnette, and Ma)

                        FEBRUARY 21, 2007

   An act to add Section 4076.5 to the Business and Professions Code,
relating to pharmacy.


	LEGISLATIVE COUNSEL'S DIGEST


   SB 472, Corbett. Prescription drugs: labeling requirements.
    Existing law, the Pharmacy Law, provides for the licensure and
regulation of the practice of pharmacy by the California State Board
of Pharmacy in the Department of Consumer Affairs. Existing law
prohibits a pharmacist from dispensing a prescription, except in a
container that meets certain labeling requirements.
   This bill would require the board to promulgate regulations that
require, on or before January 1, 2011, a standardized,
patient-centered, prescription drug label on all prescription
medication dispensed to patients in California. The bill would
require the board to hold special public meetings statewide in order
to seek information from certain groups, and would require the board
to consider specified factors in developing the label requirements.
The bill would require the board to report to the Legislature on or
before January 1, 2010, on its progress at the time of the report,
and to report to the Legislature on or before January 1, 2013, on the
status of implementation of the requirements.
   Because a knowing violation of the Pharmacy Law constitutes a
crime, and because the above-described provisions would impose
additional duties under that law, this 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.


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

  SECTION 1.  This act shall be known and may be cited as the
California Patient Medication Safety Act.
  SEC. 2.  The Legislature hereby finds and declares all of the
following:
   (a) Health care costs and spending in California are rising
dramatically and are expected to continue to increase.
   (b) In California, prescription drug spending totaled over $188
billion in 2004, a $14 billion dollar per year spending increase from
1984.
   (c) Prescription drug cost continues to be among the most
significant cost factors in California's overall spending on health
care.
   (d) According to the Institute of Medicine of the National
Academies, medication errors are among the most common medical
errors, harming at least 1.5 million people every year.
   (e) Up to one-half of all medications are taken incorrectly or
mixed with other medications that cause dangerous reactions that can
lead to injury and death.
   (f) Approximately 46 percent of American adults cannot understand
the label on their prescription medications.
   (g) Ninety percent of Medicare patients take medications for
chronic conditions and nearly one-half of them take five or more
different medications.
   (h) Nearly six out of 10 adults in the United States have taken
prescription medications incorrectly.
   (i) The people of California recognize the importance of reducing
medication-related errors and increasing health care literacy
regarding prescription drugs and prescription container labeling,
which can increase consumer protection and improve the health,
safety, and well-being of consumers.
   (j) The Legislature affirms the importance of identifying
deficiencies in, and opportunities for improving, patient medication
safety systems in order to identify and encourage the adoption of
structural safeguards related to prescription drug container labels.
   (k) It is the intent of the Legislature to adopt a standardized
prescription drug label that will be designed by the California State
Board of Pharmacy for use on any prescription drug dispensed to a
patient in California.
  SEC. 3.  Section 4076.5 is added to the Business and Professions
Code, to read:
   4076.5.  (a) The board shall promulgate regulations that require,
on or before January 1, 2011, a standardized, patient-centered,
prescription drug label on all prescription medicine dispensed to
patients in California.
   (b) To ensure maximum public comment, the board shall hold public
meetings statewide that are separate from its normally scheduled
hearings in order to seek information from groups representing
consumers, seniors, pharmacists or the practice of pharmacy, other
health care professionals, and other interested parties.
   (c) When developing the requirements for prescription drug labels,
the board shall consider all of the following factors:
   (1) Medical literacy research that points to increased
understandability of labels.
   (2) Improved directions for use.
   (3) Improved font types and sizes.
   (4) Placement of information that is patient-centered.
   (5) The needs of patients with limited English proficiency.
   (6) The needs of senior citizens.
   (7) Technology requirements necessary to implement the standards.
   (d) (1) On or before January 1, 2010, the board shall report to
the Legislature on its progress under this section as of the time of
the report.
   (2) On or before January 1, 2013, the board shall report to the
Legislature the status of implementation of the prescription drug
label requirements adopted pursuant to this section.
  SEC. 4.  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.