Bill Text: CA SB1390 | 2009-2010 | Regular Session | Amended
Bill Title: Prescription drug labels.
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Engrossed - Dead) 2010-06-29 - Set, first hearing. Failed passage in committee. [SB1390 Detail]
Download: California-2009-SB1390-Amended.html
BILL NUMBER: SB 1390 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY JUNE 15, 2010
AMENDED IN SENATE APRIL 26, 2010
AMENDED IN SENATE APRIL 5, 2010
INTRODUCED BY Senator Corbett
FEBRUARY 19, 2010
An act to amend add Sections 4076.7 and
4076.9 to, and to repeal and add Section 4076.5 of ,
the Business and Professions Code, relating to pharmacy.
LEGISLATIVE COUNSEL'S DIGEST
SB 1390, as amended, Corbett. Prescription drug labels.
Existing law, the Pharmacy Law, provides for the licensure and
regulation of the practice of pharmacy by the California State Board
of Pharmacy. Existing law requires 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. A
knowing violation of the Pharmacy Law is a crime.
This bill would authorize the board to exempt from these
regulatory requirements certain prescriptions dispensed to patients
in a health facility, as defined. repeal
that provision and would instead, on and after January 1, 2012,
require prescription drug labels on all prescription drugs dispensed
to patients in California to conform to a specified standardized,
patient-centered format including that certain elements of the label
be printed in a specified typeface and that, when applicable,
directions for use utilize certain phrases and be translated into
non-English languages, as specified. The bill would exempt from these
requirements certain prescription drugs dispensed to patients in a
health facility, as defined.
The bill would require the board, by January 1, 2012, to develop,
collect, and publish on its Internet Web site (1) translations of the
directions for use into certain languages and (2) examples of labels
meeting the standardized, patient-centered format requirements.
The bill would require a pharmacy, by January 1, 2012, during its
hours of operation, to provide interpreter services, as specified, to
non-English-speaking patients at no charge to help the patient
understand the information on his or her prescription drug label. The
bill would also, by January 1, 2013, require a pharmacy to provide
these non-English patients with any other written information
relevant to the prescription drug in the patient's language. The bill
would require these pharmacies to develop written policies and
procedures by certain specified dates in order to carry out these
requirements.
Because a knowing violation of these requirements would be 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.
State-mandated local program: no yes .
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. The Legislature hereby finds and
declares all of the following:
(a) Health care costs and spending in the United States are rising
dramatically and are expected to continue to rise. Overall, national
health care spending grew an estimated 5.7 percent in 2009, reaching
$2.5 trillion and accounting for 17.3 percent of the nation's gross
domestic product.
(b) In 2009, spending on prescription drugs in the United States
totaled over $300 billion dollars, a 5-percent increase from the
previous year.
(c) The cost of prescription drugs 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 drugs.
(g) Ninety percent of Medicare patients take medications for
chronic conditions and nearly one-half of them take five or more
different medications each day.
(h) Nearly six out of 10 adults in the United States have taken
prescription medications incorrectly.
(i) According to the 2006 American Community Survey of the United
States Census Bureau, over 42 percent of Californians speak a
language other than English at home, which is significantly above the
national figure of 19.7 percent. Of these, 47 percent could be
considered limited-English proficient and represents just over 20
percent of all Californians.
(j) Numerous articles and studies, including a study by the
Institute of Medicine entitled Unequal Treatment: Confronting Racial
and Ethnic Disparities in Health (2002), highlight the language
barriers faced by patients who do not speak English and show that
providing adequate language services improves health outcomes and
patient satisfaction, comports with existing federal and state
requirements, and achieves long-term cost savings.
(k) Title VI of the Federal Civil Rights Act of 1964 (42 U.S.C.
Sec. 1981 et seq.) prohibits recipients of federal financial
assistance from discriminating against persons based on race, color,
or national origin. This has been interpreted to mean that a
limited-English proficient (LEP) individual is entitled to meaningful
access and participation in federally funded programs through the
provision of language assistance services. Any recipient of federal
funding, including a pharmacy operating in California that
participates in the Medi-Cal, Healthy Families, or Medicare programs,
is subject to the Title VI requirements.
(l) According to the Policy Guidance on the Prohibition Against
National Origin Discrimination as it Affects Persons with Limited
English Proficiency published by the Office for Civil Rights within
the United States Department of Health and Human Services on August
8, 2003 (68 Ded. Rdg. 47311-23), providers of health care and social
services that receive federal financial assistance, including
pharmacies, must take adequate steps to ensure that LEP persons
receive language assistance free of charge necessary to afford them
meaningful access to the provider's services.
(m) Current regulations of the California State Board of Pharmacy
(16 Cal Code Regs. 1707.2), require pharmacists to provide oral
consultation to all patients in all care settings where the patient
is present in the pharmacy for a new prescription and a prescription
of the same dosage, form, strength, or with the same directions has
not been previously dispensed to the patient.
(n) The people of the State 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.
(o) The Legislature affirms the importance of identifying
deficiencies in, and opportunities for improving, patient
prescription drug safety systems in order to identify and encourage
the adoption of structural safeguards related to prescription drug
container labels.
SEC. 2. Section 4076.5 of the Business
and Professions Code is repealed.
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. 3. Section 4076.5 is added to the
Business and Professions Code , to read:
4076.5. (a) The board shall promulgate any regulations necessary
to clarify the provisions in this section and in Sections 4076.7 and
4076.9.
(b) On or before January 1, 2012, the board shall develop,
collect, and publish on its Internet Web site the following:
(1) Translations for the directions for use described in
subparagraphs (A) to (P), inclusive, in a minimum of 14 languages, to
include all of the non-English languages identified by the Medi-Cal
Managed Care Division within the State Department of Health Care
Services for translation in vital documents, as well as any other
primary languages for groups of 10,000 or more with
limited-English-proficient persons in California, to facilitate the
use of those directions for use by pharmacies in California.
(A) Take 1 [insert appropriate dosage form] at bedtime.
(B) Take 2 [insert appropriate dosage form] at bedtime.
(C) Take 3 [insert appropriate dosage form] at bedtime.
(D) Take 1 [insert appropriate dosage form] in the morning.
(E) Take 2 [insert appropriate dosage form] in the morning.
(F) Take 3 [insert appropriate dosage form] in the morning.
(G) Take 1 [insert appropriate dosage form] in the morning, and 1
[insert appropriate dosage form] at bedtime.
(H) Take 2 [insert appropriate dosage form] in the morning, and 2
[insert appropriate dosage form] at bedtime.
(I) Take 3 [insert appropriate dosage form] in the morning, and 3
[insert appropriate dosage form] at bedtime.
(J) Take 1 [insert appropriate dosage form] in the morning, 1
[insert appropriate dosage form] at noon, and 1 [insert appropriate
dosage form] in the evening.
(K) Take 2 [insert appropriate dosage form] in the morning, 2
[insert appropriate dosage form] at noon, and 2 [insert appropriate
dosage form] in the evening.
(L) Take 3 [insert appropriate dosage form] in the morning, 3
[insert appropriate dosage form] at noon, and 3 [insert appropriate
dosage form] in the evening.
(M) Take 1 [insert appropriate dosage form] in the morning, 1
[insert appropriate dosage form] at noon, 1 [insert appropriate
dosage form] in the evening, and 1 [insert appropriate dosage form]
at bedtime.
(N) Take 2 [insert appropriate dosage form] in the morning, 2
[insert appropriate dosage form] at noon, 2 [insert appropriate
dosage form] in the evening, and 2 [insert appropriate dosage form]
at bedtime.
(O) Take 3 [insert appropriate dosage form] in the morning, 3
[insert appropriate dosage form] at noon, 3 [insert appropriate
dosage form] in the evening, and 3 [insert appropriate dosage form]
at bedtime.
(P) If you have pain, take [insert appropriate dosage form] at a
time. Wait at least __ hours before taking again. Do not take more
than [appropriate dosage form] in one day.
(2) Examples of labels conforming to the requirements described in
Section 4076.7 to aid pharmacies in label design and compliance.
SEC. 4. Section 4076.7 is added to the
Business and Professions Code , to read:
4076.7. (a) On and after January 1, 2012, all prescription drug
labels on all prescription drugs dispensed to patients in California
shall conform to the following standardized, patient-centered format:
(1) Each of the following elements shall be clustered into one
area of the label that comprises at least 50 percent of the label.
Each item shall be printed in at least a 12-point sans serif
typeface, and listed in the following order:
(A) Name of the patient.
(B) Name of the drug and strength of the drug. For the purposes of
this section, "name of the drug" means the generic name of the drug
and, if applicable, the manufacturer's trade name.
(C) Directions for use.
(D) Purpose or condition, if entered on the prescription by the
prescriber or otherwise known to the pharmacy.
(2) For added emphasis, the label shall also highlight in bold
typeface or color, or use a blank space to set off, the items listed
in paragraph (1).
(3) The remaining elements required for the label as described in
Section 4076, as well as any other items of information appearing on
the label or the container, shall be printed so as not to interfere
with the legibility or emphasis of the primary elements specified in
paragraph (1). These remaining elements may appear in any style,
font, and size typeface.
(4) When applicable, directions for use shall utilize one of the
following phrases and, when appropriate shall be in the language of
the patient as translated pursuant to Section 4076.5:
(A) Take 1 [insert appropriate dosage form] at bedtime.
(B) Take 2 [insert appropriate dosage form] at bedtime.
(C) Take 3 [insert appropriate dosage form] at bedtime.
(D) Take 1 [insert appropriate dosage form] in the morning.
(E) Take 2 [insert appropriate dosage form] in the morning.
(F) Take 3 [insert appropriate dosage form] in the morning.
(G) Take 1 [insert appropriate dosage form] in the morning, and 1
[insert appropriate dosage form] at bedtime.
(H) Take 2 [insert appropriate dosage form] in the morning, and 2
[insert appropriate dosage form] at bedtime.
(I) Take 3 [insert appropriate dosage form] in the morning, and 3
[insert appropriate dosage form] at bedtime.
(J) Take 1 [insert appropriate dosage form] in the morning, 1
[insert appropriate dosage form] at noon, and 1 [insert appropriate
dosage form] in the evening.
(K) Take 2 [insert appropriate dosage form] in the morning, 2
[insert appropriate dosage form] at noon, and 2 [insert appropriate
dosage form] in the evening.
(L) Take 3 [insert appropriate dosage form] in the morning, 3
[insert appropriate dosage form] at noon, and 3 [insert appropriate
dosage form] in the evening.
(M) Take 1 [insert appropriate dosage form] in the morning, 1
[insert appropriate dosage form] at noon, 1 [insert appropriate
dosage form] in the evening, and 1 [insert appropriate dosage form]
at bedtime.
(N) Take 2 [insert appropriate dosage form] in the morning, 2
[insert appropriate dosage form] at noon, 2 [insert appropriate
dosage form] in the evening, and 2 [insert appropriate dosage form]
at bedtime.
(O) Take 3 [insert appropriate dosage form] in the morning, 3
[insert appropriate dosage form] at noon, 3 [insert appropriate
dosage form] in the evening, and 3 [insert appropriate dosage form]
at bedtime.
(P) If you have pain, take [insert appropriate dosage form] at a
time. Wait at least ____ hours before taking again. Do not take more
than [insert appropriate dosage form] in one day.
(b) As used in this section, "appropriate dosage form" means the
prescribed form of the prescription medication and includes a pill,
caplet, capsule, or tablet.
(c) This section shall not apply to prescriptions dispensed to a
patient in a health facility, as defined in Section 1250 of the
Health and Safety Code, if the prescriptions are administered by a
licensed health care professional. Prescriptions dispensed to a
patient in a health facility that will not be administered by a
licensed health care professional or that are provided to the patient
upon discharge from the facility shall be subject to the
requirements of this section. Nothing in this subdivision shall alter
or diminish existing statutory and regulatory informed consent,
patients' rights, or pharmaceutical labeling and storage
requirements, including, but not limited to, the requirements of
Section 1418.9 of the Health and Safety Code or Section 72357, 72527,
or 72528 of Title 22 of the California Code of Regulations.
SEC. 5. Section 4076.9 is added to the
Business and Professions Code , to read:
4076.9. (a) For the purposes of this section, "limited-English
proficient" or "LEP," means a person who does not speak English as
his or her primary language, and who has a limited ability to read,
write, speak, or understand English and who can read, speak, or
understand a language other than English.
(b) (1) On and after January 1, 2012, a pharmacy shall provide,
during all hours when the pharmacy is open, competent interpreter
services to each LEP patient in the LEP patient's language at no
charge in order to help an LEP understand the information on his or
her prescription drug label. The interpreter services may be provided
in person by pharmacy staff, in person by a third-party interpreter
service, or by telephone or video conference using a third-party
interpreter service.
(2) On or before January 1, 2012, each pharmacy shall develop
written policies and procedures to help an LEP patient orally
understand the information on his or her prescription drug label,
including the directions for use, as described in Section 4076.7. The
policies and procedures shall include, at a minimum, the means to
(A) identify and record the patient's oral and written language, (B)
provide language assistance services, including interpreter services
pursuant to paragraph (1) and translation services, (c) train
pharmacy staff on these policies and procedures, (d) provide clear
and prominent notice to LEP patients about the availability of free
language assistance services, and (e) monitor and update the relevant
policies and procedures.
(C) (1) On and after January 1, 2013, in addition to providing the
required information on the prescription drug label in the language
of an LEP patient a pharmacy shall provide an LEP patient with any
other written information relevant to the prescription drug in the
language of the LEP patient.
(2) On or before January 1, 2013, each pharmacy shall develop
written policies and procedures to carry out the requirement in
paragraph (1).
SEC. 6. 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.
SECTION 1. Section 4076.5 of the Business and
Professions Code is amended 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) The board may exempt from the requirements of regulations
promulgated pursuant to subdivision (a) prescriptions dispensed to a
patient in a health facility, as defined in Section 1250 of the
Health and Safety Code, if the prescriptions are administered by a
licensed health care professional. Prescriptions dispensed to a
patient in a health facility that will not be administered by a
licensed health care professional or that are provided to the patient
upon discharge from the facility shall be subject to the
requirements of this section and the associated regulations. Nothing
in this subdivision shall alter or diminish existing statutory and
regulatory informed consent, patients' rights, or pharmaceutical
labeling and storage requirements, including, but not limited to, the
requirements of Section 1418.9 of the Health and Safety Code or
Section 72357, 72527, or 72528 of Title 22 of the California Code of
Regulations.
(e) (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.
