BILL ANALYSIS �
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|Hearing Date:August 26, 2014 |Bill No:SB |
| |204 |
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SENATE COMMITTEE ON BUSINESS, PROFESSIONS
AND ECONOMIC DEVELOPMENT
Senator Ted. W. Lieu, Chair
Bill No: SB 204Author:Corbett
As Amended:June 10, 2014 Fiscal: Yes
SUBJECT: Prescription drugs: labeling.
SUMMARY: Requires the Board of Pharmacy to conduct a survey of
pharmacists and vendors of electronic health records to gather
information about the utilization of, and the obstacles to, the use of
the Board's standardized directions for use on prescription drug
labels.
NOTE : The Assembly amendments create a new bill and this measure has
been referred to the Committee pursuant to Senate Rule 29.10 (d) for
consideration. The Committee may, by a vote of the majority, either:
(1) hold the bill, or (2) return the bill to the Senate floor for
consideration of the bill as amended in the Assembly.
Existing law:
1) Provides for the practice of pharmacy and the licensing and
regulation of pharmacies and pharmacists by the Board of Pharmacy
(Board) within the Department of Consumer Affairs (DCA).
2) Specifies certain requirements regarding the dispensing and
furnishing of dangerous drugs and devices, and prohibits a person
from furnishing any dangerous drug or device except upon the
prescription of a physician, dentist, podiatrist, optometrist,
veterinarian or naturopathic doctor. (BPC � 4059)
1) Requires that each prescription dispensed by a pharmacist must be
in a container complying with state and federal law and correctly
labeled as specified, including: (BPC � 4076)
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a) Unless otherwise ordered by the prescriber, the manufacturer's
trade name of the drug or the generic name and the name of the
manufacturer, as specified.
b) The directions for the use of the drug.
c) The name of the patient or patients.
d) The name of the prescriber, as specified.
e) The date of issue.
f) The name and address of the pharmacy, and prescription number
or other means of identifying the prescription.
g) The strength of the drug or drugs dispensed.
h) The quantity of the drug or drugs dispensed.
i) The expiration date of the effectiveness of the drug
dispensed.
j) The condition for which the drug was prescribed if requested
by the patient and the condition is indicated on the
prescription.
aa) The physical description of the dispensed medication,
including its color, shape, and any identification code that
appears on the tablets or capsules.
2) Requires the Board to promulgate regulations on or before January
1, 2011, for a standardized, patient-centered, prescription drug
label on all prescription medication dispensed in the state. (BPC �
4076.5 (a))
3) Requires the Board to hold public meetings statewide in order to
seek information on a standardized label from groups representing
consumers, seniors, pharmacists, the practice of pharmacy, other
health care professionals, and other interested parties. (BPC �
4076.5 (b))
4) Requires the Board, when considering the requirements for
prescription labels, to consider: (BPC � 4076.5 (c))
a) Medical literacy research.
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b) Improved directions for use.
c) Improved font types and sizes.
d) Placement of information that is patient-centered.
e) The needs of patients with limited English proficiency.
f) The needs of senior citizens.
g) Technology requirements necessary to implement the standards.
This bill:
1)Requires the Board to conduct a survey of a representative sample of
licensed pharmacists to determine the utilization of the
standardized directions in current law.
2)Requires the survey to address, but not be limited to, the
following:
a) Whether the pharmacist utilizes the standardized directions;
b) How often the pharmacist utilizes the standardized directions;
c) Challenges or barriers to utilizing the standardized
directions; and,
d) Other directions utilized by the pharmacist.
1)Requires the Board to conduct a survey of vendors that provide
electronic health records (EHRs) to pharmacies and prescribers to
determine the type of directions included in the vendor's EHR
programming.
2)Requires the survey to address, but not be limited to, the
following:
a) Whether California's standardized directions are included in
the vendor's EHR programming;
b) Challenges or barriers to utilizing the standardized
directions in the vendor's EHR programming; and,
c) Other directions utilized by the vendor in its EHR
programming.
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5)Authorizes the two surveys to be conducted with other routine
surveys conducted by the Board during its regular course of
business.
6)Requires the Board to report the findings of the two surveys at its
July 2016 meeting and publish the findings on its Internet Web site,
as specified.
7)Repeals the above provisions on January 1, 2020.
FISCAL EFFECT: This bill is keyed "fiscal" by Legislative Counsel.
According to the Assembly Committee on Appropriations analysis dated
July 2, 2014, this bill will result in $50,000 in estimated costs to
the Contingent Fund of the Board to contract for the mandated surveys.
COMMENTS:
1. Purpose. This bill is sponsored by the California Pan-Ethnic
Health Network (CPEHN) . The Author states that according to the
U.S. Pharmacopeial Convention, the main cause for medication errors
and patient misunderstanding is a lack of universal standards. The
Author notes that in 2010, the Board of Pharmacy adopted
regulations to develop a patient-centered prescription label and
standardized directions for use and that despite taking this very
important step towards reducing dosage errors, the Board does not
know how many pharmacies are using these standardized directions,
nor do they have any method for determining whether or not
pharmacies are utilizing them. The Author adds that the Board also
does not know, nor does it have a method for determining, if the
vendors of electronic health records are using the standardized
directions for use in the products that they market to prescribers
and pharmacies.
The Author states that this bill directs the Board to gather this
important information to determine if the standardized directions
are being used and what the barriers there are to using the them in
prescriptions and electronic health records for prescribers and
pharmacists. The Author believes that these surveys will provide
the Board with the necessary data to determine how to better ensure
the use of this important aspect of the patient-centered
regulations.
2. Background.
a) Medication Errors and Legislative Response. According to
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the Journal of the American Medical Association, 46 percent
of adults cannot understand the information listed on their
prescription drug labels. Furthermore, the Institute of
Medicine of the National Academies indicates that medication
errors are among the most common medical errors, harming at
least 1.5 million people annually. Families USA reports that
90 percent of Medicare patients take medications for chronic
conditions with nearly half of them taking five or more
medications a day. Given the large numbers of prescriptions
that may be prescribed, it is not easily discernable what the
purpose for each of these medications is. This increases the
chances that a patient may take the wrong medication
increasing the likelihood of serious injury or death.
SCR 49 (Speier, Resolution Chapter 123, Statutes of 2005)
established the Medication Errors Panel (Panel) which
published a report in March 2007 entitled, "Prescription for
Improving Patient Safety: Addressing Medication Errors." The
report listed six general goals to reduce medication errors.
Under each goal were recommendations (12 in all) and methods
to accomplish each recommendation. The Panel report states
that "the information that consumers need to know about
regarding their medication is often complex and may include
unfamiliar language or concepts. Expecting a consumer to
retain all the pertinent knowledge from a brief verbal
encounter may not be reasonable in many instances." Although
the Panel did not come to consensus on the most important
subset of consumers that are at "high risk" for medication
errors, it did acknowledge that there are a variety of
factors which may increase an individual's risk for
experiencing a medication error. These include: i) low
health literacy; ii) limited English proficiency; iii)
cultural incongruence with healthcare providers; iv)
physical, cognitive and/or other impairments that make
understanding and/or complying with medication instructions
difficult; v) age at either end of the age spectrum (the
variability of a medication's response, metabolism and dose
increases in children and seniors);
vi) multiple medications; vii) multiple prescribers; viii)
non-prescription medication use (including herbals, dietary
supplements, alcohol, and tobacco); and,
ix) medication procurement from more than one pharmacy
including mail-order. The Panel did state that these factors
must be taken into consideration in the development of any
consumer education efforts.
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One bill was pursued in response to the Panel report. SB
472 , The California Patient Medication Safety Act, (Corbett,
Chapter 470, Statutes 2007) sought to deal with the lack of
uniformity in prescription drug labels throughout the state
and the resulting confusion and medication errors that may
arise. Much of the conversation during the SB 472 debate
focused on the fact that individual pharmacies design and
format their own labels, resulting in a lack of standards
across all pharmacies which adversely affects medication
users who are elderly, suffer from poor vision, have
difficulty reading and understanding instructions on labels
or have limited English proficiency.
The bill required the Board to promulgate regulations on or
before January 1, 2011, that require a standardized,
patient-centered, prescription drug label on all prescription
medicine dispensed to patients. Additionally, the Board was
required to report to the Legislature by January 1, 2010, on
its progress in implementing these regulations.
This measure is a follow-up to the Author's SB 472 which
created the patient-centered label standard.
b) Affordable Care Act (ACA). The passage of the federal
Patient Protection and Affordable Care Act has the potential
to require greater numbers of health professionals throughout
the nation and state, particularly pharmacists who are well
placed in communities, to provide medication therapy
management services. The Author also provided background
information highlighting the impact of implementation of the
federal ACA. As a result of the ACA, anywhere from
4 to 7 million more Californians will be eligible for health
insurance.
1. Implementation of a Standardized Prescription Drug Label by the
Board of Pharmacy. California is the first state to require
redesigned prescription container labels to emphasize
information most important to consumers offering an element of
safety and consistency since prescription labels are the key
source of patients' reference for information when taking
medications in their homes. Part of this current requirement
also ensures that oral interpreter services are available to
limited English speaking patients in pharmacies, to insure such
patients have access to information about how to take their
medications.
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The Board was charged with promulgating regulations that
require a standardized, patient-centered prescription drug
container label for all prescription drugs dispensed to
patients in California. The Board reported on its efforts in a
January 2010 report to the Legislature. The Board established
a "SB 472 Medication Label Subcommittee" in January of 2008, to
conduct public forums and to work with organizations and
individuals to develop recommendations to implement the
provisions of the law to establish a patient-centered
prescription drug label. In May 2008, the Board developed an
open-ended prescription label survey for distribution at public
outreach events. A total of 606 consumers completed the
surveys.
When asked what to change on the prescription label, the top
responses were:
1. Print should be larger or darker = 30.1%
2. Nothing needs to be changed on the label =24.6%
3. Include purpose of drug = 12%
The Board concluded that most consumers participating in the
survey requested larger and bolder type font on prescription
labels to increase readability. Many participants suggested
that if a generic drug is provided, the prescription label
should state the name of the generic drug name and the
brand-name it is generic for. They also noted that color
printing and highlighting on labels brings attention to
important information. Some participants suggested that the
labels themselves be color-coded to help differentiate between
multiple medications and family members. Many consumers
responded that they want to know "what the drug is for" and
suggested that "the purpose of drug" be printed directly on
prescription labels.
The Board approved a regulation per the requirements set forth
in SB 472 after engaging in a lengthy process. The Board
conducted outreach, hearings and information gathering sessions
throughout 2008, to collect data from the public on
prescription labels and standards for those labels. The Board
considered testimony and information provided from the public,
the pharmaceutical industry, pharmacy professionals and
literacy subject matter experts on medical literacy research,
improved directions for use, improved font types and sizes, the
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placement of information that is patient-centered, the needs of
patients with limited English proficiency, the needs of senior
citizens, and technology requirements necessary to implement
the standards developed. Board members were also provided with
research articles on designing patient-centered labels. In
2009, the Board discussed the requirements of the regulation at
regularly scheduled meetings.
Throughout early 2010, the Board held regulation hearings to
adopt the proposed regulation, a new section at Title 16
California Code of Regulations Section 1707.5 - "Requirements
For Patient-Centered Prescription Container Labels." The
regulation outlines that the following items must be clustered
into one area of the label that comprises at least 50 percent
of the label, using at least 10-point font using sans serif
typeface, listing these items in the following order:
Name of the patient.
Name of the drug and strength of the drug. ("Name
of the drug" means either the manufacturer's trade name,
or the generic name and the name of the manufacturer.)
Directions for use.
Purpose or condition, if entered onto the
prescription by the prescriber, or otherwise known to the
pharmacy, and its inclusion on the label is requested by
the patient.
The regulation also requires pharmacies to have policies and
procedures in place to help patients with limited or no English
proficiency, understand the information on the label in the
patient's language. The pharmacy's policies and procedures
must be specified in writing, and must include, at minimum, the
selected means to identify the patient's language, and to
provide interpretive services in the patient's language.
Pharmacies must provide, at minimum, interpretive services in
the patient's language, if interpretive services in such
language are available, during all hours that the pharmacy is
open, either in person by pharmacy staff or by use of a
third-party interpretive service available by telephone at or
adjacent to the pharmacy counter.
Since the adoption of the regulation, the Board has continued to
evaluate the implementation of the requirements provided under SB
472. When the Board initially promulgated the regulation, a
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requirement was included for the Board to reevaluate the regulation
by December 2013. In April 2013, the Board's Public Education
subcommittee began its review of the regulation. As a result of
discussions at these subcommittee meetings (which are presented to
the full Board for further discussion at Board meetings), in April
2014 the Board initiated a new rulemaking request to change the
font size to a minimum of 12-point, rather than the current
10-point. Additionally, the new rulemaking request requires that
only four items be clustered into one area of the label that
comprises at least 50 percent of the label. The Board continues to
discuss the directions for the use component of the standardized
label at its Public Education subcommittee meetings.
1. Related Legislation. SB 205 (Corbett) of 2013 would have required
the information on the prescription label to be printed in at least
a 12-point sans serif typeface. ( Status: The bill was vetoed by
Governor Brown who indicated in his veto message that "the Board of
Pharmacy is required to provide an update of its 2010 labeling
guidelines to the Legislature next month. I prefer to wait for
their findings before mandating such a change.")
AB 396 (Fox) of 2013 would have required every prescription to
include a legible, clear notice of the condition or purpose for
which the drug is prescribed, unless the patient or prescriber
requests that this information be omitted. Also, would have
required that every prescription container be correctly labeled to
include that information, if indicated on the prescription, unless
the patient or prescriber requests that this information be
omitted. ( Status: The bill was never heard in a policy
committee.)
AB 1136 (Levine, Chapter 304, Statutes of 2013) required a
pharmacist to include a written label on the drug container
indicating that the drug may impair a person's ability to operate a
vehicle or vessel.
SB 1390 (Corbett) of 2010 would have repealed the requirement that
the Board promulgate regulations requiring a standardized,
patient-centered, prescription drug label on all prescription
medications dispensed to patients in California on or before
January 1, 2011, and instead established statutory requirements for
standardized, patient centered prescription drug labels. ( Status:
The bill failed passage in the Assembly Committee on Business,
Professions and Consumer Protection.)
SB 470 (Corbett, Chapter 590, Statutes of 2009) permitted, if
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requested by patients, the purpose of the prescribed medication to
be listed on prescription drug labels.
SB 472 (Corbett, Chapter 470, Statutes of 2007), the California
Patient Medication Safety Act, required the Pharmacy Board to
promulgate regulations that require a standardized,
patient-centered, prescription drug label on all prescription
medication dispensed to patients in California. Additionally, the
Board was required to report to the Legislature by January 1, 2010,
on its progress in implementing these regulations.
AB 1276 (Karnette, 2007) would have required medication prescribers
to ask a patient if they wanted the intended use on the
prescription label. ( Status: The measure failed passage in the
Assembly Committee on Business and Professions.)
SCR 49 (Speier, Resolution Chapter 123, Statutes of 2005) created a
panel to study the causes of medication errors and recommend
changes in the health care system that reduces errors associated
with the delivery of prescription and over the counter medication
to consumers. This resolution required the panel to convene by
October 1, 2005, and to submit to the Assembly Committee on Health
and the Senate Committee on Health, a report on its finding by June
1, 2006.
AB 657 (Karnette, 2005) would have required prescription drug
labels to include the intended purpose of the drug, if indicated on
the prescription, and required prescribers to ask the patient or
the patient's authorized representative, if the patient is either
incapacitated or a minor who cannot provide informed consent,
whether to indicate the intended purpose of the prescription on the
label. ( Status: The bill was held in this Committee at the
request of the Author.)
AB 288 (Mountjoy, 2005) would have amended the prescription
labeling requirement to include the condition for which the drug is
prescribed unless the patient, physician or legal guardian
requested that the information be omitted. ( Status: The measure
was held in the Assembly Committee on Business and Professions at
the request of the Author.)
AB 2125 (Levine, 2004) would have required a physician and surgeon
to indicate the patient's diagnosis on each prescription written,
unless directed otherwise by the patient and amended the
prescription labeling requirement to require that the condition be
included on the label unless otherwise directed by the patient.
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( Status: The bill was held in the Assembly Committee on Business
and Professions at the request of the Author.)
SB 292 (Speier, Chapter 544, Statutes of 2003) required
prescription labels to include a physical description of the drug,
including the color, shape, and any identification code that
appears on the tablet or capsule.
AB 2099 (Epple, Chapter 397, Statutes of 1993) required that the
condition for which the drug is being prescribed must be included
on the label if the patient requests that information on the label.
2. Arguments in Support. The AllCare Alliance writes in support of
this bill, stating that it represents an important step toward
quality - and linguistically competent - health care.
According to the California Alliance for Retired Americans (CARA),
"with an estimated
7 million limited English proficient Californians and studies
showing that only about 2/3 of California pharmacies are providing
translated directions on prescription labels upon request, it is
unlikely that limited English proficient patients can properly read
and follow their medication directions." CARA believes this bill
will help this population of Californians so they can read and
understand the directions on their prescriptions medication labels.
The California Pan-Ethnic Health Network (CPEHN) asserts that "a
patient's first and best source of information about their
medication is the prescription container label." CPEHN believes
that the data provided through this bill about how pharmacists and
vendors of electronic health records utilize standardized
instructions for use, as well as barriers that may impede their
use, will help ensure the needs of California consumers are being
met while also preventing cost and health risks associated with
adverse drug events.
According to the Latino Coalition for A Healthy California , studies
show that a large percentage of patients misunderstand dosage
instructions on their labels and that simple, explicit and specific
instructions can help with patients' misunderstanding.
The Western Center on Law and Poverty believes that the information
collected through surveys provided under this bill will be
especially useful in determining a streamlined way to provide
translated medication instructions to meet the needs of
California's limited English proficient patients.
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3. Arguments in Opposition. The Board of Pharmacy writes in
opposition to this bill, stating that it would require the Board to
perform two surveys: one on pharmacies' use of the standardized
directions for use as specified in Board regulations, and another
of electronic health record vendors to determine the types of
standardized directions included in software. The Board states that
it is unable to absorb the cost of conducting these surveys,
estimated to be approximately $50,000. According to the Board,
"while the Board opposes Senate Bill 204, the Board has directed
staff to collect information during its compliance inspections from
pharmacies on the use of the standardized directions for use."
Additionally, the Board writes that it "has committed to continue
its work to determine ways that drug labels can be improved so that
patients can have better health outcomes through medication
adherence."
SUPPORT AND OPPOSITION:
Support:
California Pan-Ethnic Health Network (Sponsor)
AllCare Alliance
California Alliance for Retired Americans
Latino Coalition for a Healthy California
Western Center on Law and Poverty
Opposition:
Board of Pharmacy
Consultant: Sarah Mason