BILL ANALYSIS Ó
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|Hearing Date:April 23, 2012 |Bill No:SB |
| |1237 |
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SENATE COMMITTEE ON BUSINESS, PROFESSIONS
AND ECONOMIC DEVELOPMENT
Senator Curren D. Price, Jr., Chair
Bill No: SB 1237Author:Price
As Amended:April 16, 2012 Fiscal:Yes
SUBJECT: Professions: pharmacists and court reporters: sunset dates.
SUMMARY: Extends the sunset date of the Pharmacy Board of California
(Board) to January 1, 2017. Extends the sunset date for the Court
Reporters Board (CRB) to January 1, 2017 and makes other programmatic
changes.
Existing law:
1) Licenses and regulates some 130,000 pharmacists by the Board within
the Department of Consumer Affairs (DCA), establishes the Board
which consists of 13 members, seven pharmacists and six public
members. All seven professional members and four public members
are appointed by the Governor. One public member of the Board is
appointed by the Senate Pro Tem and one public member is appointed
by the Speaker of the Assembly. (Business and Professions Code
(BPC) § 4001)
2) Makes the Board inoperative and repealed on January 1, 2013, unless
a statute is enacted to extend the Board. (BPC § 4001)
3) Authorizes the Board to appoint an executive officer, and makes
that authority inoperative and repealed on January 1, 2013. (BPC §
4003)
4) Provides that protection of the public shall be the highest
priority for the Board in exercising its licensing, regulatory, and
disciplinary functions, and whenever the protection of the public
is inconsistent with other interests sought to be promoted, the
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protection of the public shall be paramount. (BPC § 4001.1)
5) Licenses and regulates some 7,600 shorthand reporters by the CRB
within the DCA, establishes the CRB which consists of five members,
three of whom are public members and two of whom are holders of
certificates as shorthand reporters. (BPC § 8000).
6) Established the CRB and makes it inoperative and repealed on
January 1, 2013. (BPC § 8000)
7) Authorizes the CRB to appoint an executive officer, and makes that
authority inoperative and repealed on January 1, 2013. (BPC §
8005)
8) Provides that protection of the public shall be the highest
priority for the CRB in exercising its licensing, regulatory, and
disciplinary functions, and whenever the protection of the public
is inconsistent with other interests sought to be promoted, the
protection of the public shall be paramount. (BPC § 8005.1)
9) Authorizes the CRB to provide shorthand reporting services to low
income litigants in civil cases. The Transcript Reimbursement Fund
shall be repealed and inoperative on January, 1, 2013. (BPC §
8030.2)
10)Authorizes the CRB to provide shorthand reporting services to low
income litigants in civil cases to individuals who represent
themselves. The Transcript Reimbursement Fund for Pro Se Litigants
shall be repealed and inoperative on January, 1, 2013. (BPC §
8030.5)
This bill:
1) Extends the inoperative and repeal date for the Board to January 1,
2017.
2) Extends the authority for the Board to appoint an executive officer
to January 1, 2017.
3) Extends the inoperative and repeal date of the CRB to January 1,
2017.
4) Extends the authority for the CRB to appoint an executive officer
to January 1, 2017.
5) Extends the inoperative and repeal date for the CRB Transcript
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Reimbursement Fund to January 1, 2017.
6) Extends the inoperative and repeal date for the CRB Transcript
Reimbursement Fund for Pro Se Litigants to January 1, 2017.
7) Makes technical corrections and conforming changes.
FISCAL EFFECT: Unknown. This bill has been keyed "fiscal" by
Legislative Counsel.
COMMENTS:
1. Purpose. The Author is the Sponsor of this measure. According to
the Author, in 2012, this Committee conducted oversight hearings to
review 7 regulatory boards within the DCA: the Acupuncture Board,
the Board of Podiatric Medicine, the Physician Assistant Committee,
the Board of Pharmacy, the Court Reporters Board, the Board of
Behavioral Sciences and the Board of Psychology. The Committee
began its review of these licensing agencies in March and conducted
two days of hearings. This bill, and the accompanying sunset
bills, is intended to implement legislative changes as recommended
in the Committee's Background/Issue Papers for all of the agencies
reviewed by the Committee this year.
This bill is one of the four "sunset bills" authored by Senator Price,
the Chair of this Committee. According to the Author, this bill is
necessary to extend the sunset date of the Board and the CRB in
order to continue the regulation of pharmacists and court reporters
in California. The continued regulation will help to ensure that
the Board's and the CRB's mission, which is to protect the public,
is in place for an additional four years. Additionally, the Author
points out that is imperative to continue the funding of the
transcript reimbursement fund which provides valuable court
reporting transcripts to low income. Moreover, there is a need to
ensure the continued regulation of licensure for pharmacists as
their profession is expected to be grow after the enactment of
federal health care reform.
2. Background on the State Board of Pharmacy (Board). The Board was
created by the California Legislature in 1891. The Board is
responsible for enforcing federal and state laws pertaining to the
acquisition, storage, distribution and dispensing of dangerous
drugs; including controlled substances and dangerous devices. The
Board has approximately 130,000 licensees in 17 license categories
that include both personal and business licenses. As an agency
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that regulates the individuals and businesses that dispense,
compound, provide, store and distribute prescription drugs and
devices and pharmaceutical services to the public, or to other
health care practitioners in compliance with state and federal law,
the licensing of pharmacists, pharmacies, and pharmacy technicians
is the primary focus of Board activity, with consumer protection at
the core of the Board's operations. The Board's regulatory
authority, as described in the Pharmacy Law, extends over
individuals and firms located both within and outside California,
if they provide services into California
The Board's vision, "Healthy Californians through quality pharmacists
care," helps guide Board activities and initiatives. The Board
ensures that only those who possess specified requirements are
licensed, seeks removal of licenses for those who don't comply with
laws or maintain qualifications for licensure, investigates
consumer complaints as well as provides a focused effort to ensure
consumer education and awareness.
The Board is comprised of 13 members, seven pharmacists and six public
members. All seven professional members and four public members
are appointed by the Governor. One public member of the Board is
appointed by the Senate Pro Tem and one public member is appointed
by the Speaker of the Assembly. Current law requires that at least
five of the seven pharmacist appointees must be actively engaged in
the practice of pharmacy and the Board must include at least one
practicing pharmacist from each of the following settings: an
acute care hospital; an independent community pharmacy; a chain
community pharmacy; a pharmacist member of a labor union that
represents pharmacists and; a long-term care or skilled nursing
facility. The Board meets about four times per year. All
Committee meetings are subject to the Bagley-Keene Open Meetings
Act.
The Board is a special fund agency, with funding coming from licensing
(87%), collected fines from citations (9%) and collected cost
recovery (3%). Of the fee revenue collected by the Board, 77%
comes from renewals while 22% comes from initial applications. The
Board has continuous renewal cycles for all of its license
categories except for intern licenses which are not renewable. The
renewal cycle is annual for facilities and designated
representatives. Licenses issued to pharmacists and pharmacy
technicians are renewed biennially. The Board currently licenses
close to 130,000 licensees.
Much of the Board's work is done in committees. Some committees are
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standing committees, others are task force or ad-hoc committees
formed to examine a specific topic, and then disbanded following
completion of the task. The Board also has one specialized
standing committee, the Competency Committee, which is responsible
for developing the California pharmacist licensing examination.
The Board's strategic plan establishes five standing committees. Each
committee typically meets quarterly prior to each Board meeting and
provides a report and minutes of the committee meeting during each
Board meeting. However, during the past several years, to curtail
travel expenses and in response to staffing challenges created by
furloughs, the Board has reduced the number of committee meetings
each year.
The Competency Committee develops and grades the Board's pharmacist
licensure examination, the California Practice Standards and
Jurisprudence Examination for Pharmacists. According to the Board,
membership on this committee is highly selective, professionally
challenging, and time-consuming. Members meet seven times annually
in two-day meetings. The Competency Committee is a stand-alone
committee within the auspices of the Board's Licensing Committee;
one Board member attends committee meetings and provides updates on
the status of the Board's pharmacist examination during Board
meetings. This Board member also serves as a liaison to the
committee.
In 2008, the Board raised all of its fees to the statutory maximums
via the regulation process. Following that, the Board commissioned
an independent fee audit to secure recommendations on a new fee
schedule that would ensure the financial viability of the Board for
the next five years. The audit found that the Board's expenditures
were exceeding its revenues and that its fee structure was
insufficient to maintain the required 12 month reserve. In 2009,
the Board sponsored legislation (AB 1071, Emmerson, Chapter 270,
Statutes of 2009) to reset the statutory minimum and maximum fee
levels according the recommendations in the audit. According to
the Board, this was the first time such legislation was needed
since 1987. The Board spends approximately 59% of its budget on
its enforcement program, 18% on its licensing program, 15% on
administration, 3% on its diversion program and four percent
administering examinations.
3. Prior Review of the Pharmacy Board. The Board was last reviewed in
2002-03 by the Joint Legislative Sunset Review Committee (JLSRC).
During the previous sunset review, the JLSRC raised 31 issues. The
final recommendations from JLSRC contained a set of recommendations
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to address those issues. Below are actions which the Board and the
Legislature took over the past 9 years to address many of the
issues and recommendations made, as well as significant changes to
the Board's functions.
In November, 2011, the Board submitted its required sunset report to
this Committee. In this report, the Board described actions it has
taken since its prior review to address the recommendations of the
Joint Legislative Sunset Review Committee (JLSRC). According to
the Board, the following are some of the more important
programmatic and operational changes, enhancements and other
important policy decisions or regulatory changes made:
Electronic Pedigree allows patients and prescribers to have
greater trust that they are receiving quality medication from
California pharmacies and wholesalers.
The Board took part in recognizing and identifying the failure
of a recall system intended to ensure removal of recalled
medications from hospitals. The Board cited and fined the
hospitals and then worked with the California Department of
Public Health (DPH), federal Food and Drug Administration (FDA),
associations, hospitals and pharmacists to ensure that drug
delivery systems in hospitals were improved to prevent recalled
drugs from remaining in patient care areas.
Through the Board, California was the first state to partner
with the federal Drug Enforcement Administration (DEA) to co-host
day-long seminars for pharmacists on knowledge they need to stop
drug diversion of controlled substances from California
pharmacies.
The Board led the way for California to become the first state
to aggressively deal with the unlawful purchase of prescription
medication via the Internet by using its statutory authority to
fine pharmacies $25,000 per prescription for supplying drugs
without a prescriber-patient relationship.
California became the first state to mandate that pharmacists
complete a structured 22 hour ethics counseling program for
violations involving ethical lapses as one provision of their
discipline.
The JLSRC asked what the Board does to educate the public of
its existence and role. Today the Board's Website has grown as a
way to better communicate with the public and the profession on
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important issues and contains substantially more information than
ever before on information and public meeting schedules and
agendas.
Over the years the Board has expanded its use of the citation
and fine program to address compliance issues involving the
Board's licensees.
In response to a purchasing restriction several years ago, the
Board transitioned to paperless meeting packets for its members
as a way to conserve resource and established a service to notify
anyone who is interested in receiving e-mail alerts about major
updates to the Board's Website.
The Board has completed comprehensive reviews in several areas
that impact the Board's operations or pharmaceutical care
including: A Job Analysis Study of California Pharmacist,
Emergency Response Policy Statement, Health Notes, The Scrip and
E-Prescribing of Controlled Substances - Guidelines for
Pharmacies and Prescribers.
The Board used DCA's Consumer Protection Enforcement
Initiative (CPEI) as an opportunity to evaluate its enforcement
systems to achieve time savings in its investigations making
several internal operational changes, such as assigning cases
online and conducting mail votes electronically. The Board now
requires pharmacies to report any evidence of a licensee's theft
or impairment within 14 days, submit information about drug loss
from the pharmacy within 30 days and prohibits a nonresident
pharmacy from allowing a pharmacist, whose license has been
revoked in California, from providing pharmacist-related services
to Californians.
The Board was previously comprised of 11 members, 7
professional members and 4 public members. In 2004, the Board
composition was changed to add 2 public members; both appointees
of the Governor.
The JLSRC was concerned about the establishment of the Board
standing subcommittees, the composition of these committees and
whether members of the public were provided opportunities to
comment at these meetings. The Board now has committees
comprised of at least four members, each of which holds public
meetings with multiple opportunities for public comment.
1. Current Issues and Problems Identified of the Pharmacy Board. The
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following are some of the major unresolved issues pertaining to the
Board, or areas of concern presented to the Committee for
consideration, along with background information concerning the
particular issue. Recommendations were made by Committee staff
regarding the particular issues or problem areas which needed to be
addressed. The Board has 30 days to submit a response to the issues
raised at the Sunset Review informational hearings on April 19,
2012.
a) Issue : Drug Diversion and Prescription Monitoring Program:
"CURES."
Background : For the past number of years, abuse of prescription
drugs (taking a prescription medication that is not prescribed
for you, or taking it for reasons or in dosages other than as
prescribed) to get high has become increasingly prevalent.
Federal data shows the past year abuse of prescription pain
killers now ranks second, just behind marijuana, as the nation's
most widespread illegal drug problem.
Abuse can stem from the fact that prescription drugs are legal and
potentially more easily accessible, as they can be found at home
in a medicine cabinet. Data shows that individuals who misuse
prescription drugs, particularly teens, believe these substances
are safer than illicit drugs because they are prescribed by a
health care professional and thus are safe to take under any
circumstances. National Institute on Drug Abuse (NIDA) data
states that in actuality, prescription drugs act directly or
indirectly on the same brain systems affected by illicit drugs,
thus, their abuse carries substantial addiction liability and can
lead to a variety of other adverse health effects.
Controlled substances are ranked according to their potential for
abuse, accepted medical use, and safety under medical
supervision. Schedule I substances (e.g. heroin and LSD) have
high potential for abuse, no currently accepted medical use, and
lack accepted safety for use. Schedule II drugs (e.g. morphine,
codeine, Demerol, and Percodan) have a high potential for abuse
and high potential for physical or psychological dependence if
used improperly, but have accepted medical value in treating
pain. Schedule III drugs (e.g. Vicodin, anabolic steroids,
codeine with aspirin or Tylenol), Schedule IV drugs (e.g. Darvon,
Valium, Halcyon, and Xanax), and Schedule V drugs (over the
counter cough medicines with codeine) generally have less
potential for abuse than Schedule I or II drugs, have accepted
medical use in treatment, and lower potential for physical or
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psychological dependence.
The three classes of prescription drugs that are most commonly
abused are opioids, which are most often prescribed to treat
pain, central nervous system (CNS) depressants, which are used to
treat anxiety and sleep disorders, and stimulants, which are
prescribed to treat the sleep disorder narcolepsy and
attention-deficit hyperactivity disorder (ADHD). Each class can
induce euphoria, and when administered by routes other than
recommended, such as snorting or dissolving into liquid to drink
or inject, can intensify that sensation. Opioids, in particular,
act on the same receptors as heroin and, therefore, can be highly
addictive. Common opioids are: hydrocodone (Vicodin), oxycodone
(OxyContin), propoxyphene (Darvon), hydromorphone (Dilaudid),
meperidine (Demerol), and diphenoxylate (Lomotil).
With rising levels of abuse, prescription drug monitoring programs
are a critical tool in assisting regulatory bodies with their
efforts to reduce drug diversion. In California, the Controlled
Substance Utilization Review and Evaluation System (CURES) is an
electronic tracking program that reports all pharmacy (and
specified types of prescriber) dispensing of controlled drugs by
drug name, quantity, prescriber, patient, and pharmacy. In 2009,
then Attorney General Brown launched an online CURES system at
DOJ to replace the previous system that required mailing or
faxing written requests for information, giving health
professionals (doctors, pharmacists, midwives, and registered
nurses), law enforcement agencies and medical profession
regulatory boards instant computer access to patients'
controlled-substance records.
Data from CURES is managed by DOJ to assist state law enforcement
and regulatory agencies in their efforts to reduce prescription
drug diversion. CURES provides invaluable information that
offers the ability to identify if a person is "doctor shopping"
(when a prescription-drug addict visits multiple doctors to
obtain multiple prescriptions for drugs, or uses multiple
pharmacies to obtain prescription drugs). Information tracked in
the system contains the patient name, prescriber name, pharmacy
name, drug name, amount and dosage, and is available to law
enforcement agencies, regulatory bodies and qualified
researchers. The system can also report on the top drugs
prescribed for a specific time period, drugs prescribed in a
particular county, doctor prescribing data, pharmacy dispensing
data and is a critical tool for assessing whether multiple
prescriptions for the same patient may exist. In addition to the
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Board, CURES data can be obtained by the Medical Board of
California, Dental Board of California, Board of Registered
Nursing, Osteopathic Medical Board of California and Veterinary
Medical Board.
Since 2009, more than 8,000 doctors and pharmacists have signed up
to use CURES, which has more than 100 million prescriptions. The
system also has been accessed more than 1 million times for
patient activity reports and has been key in investigations of
doctor shoppers and nefarious physicians. For the Board, this
data is critical in allowing for the identification of pharmacies
involved in massive dispensing of controlled substances, which
can be a potential sign of drug diversion, and serves as a
trigger for important investigations. According to the AG's
office, CURES assisted in targeting the top 50 doctor shoppers in
the state, who averaged more than 100 doctor and pharmacy visits
to collect massive quantities of addictive drugs and the
crackdown led to the arrest of dozens of suspects. The system
has also been successful in alerting law enforcement and licensed
medical professionals to signs of illegal drug diversions.
While California has the largest number of practitioners,
pharmacies and patients, the CURES program may not be stable in
terms of funding or location at DOJ. The 2011/12 state budget
eliminated the Bureau of Narcotic Enforcement at DOJ which had
been responsible for administering and maintaining the CURES
database and program. DOJ is still currently staffing the
program and the database remains accessible to registered
participants.
Recommendation : The Board should discuss its drug diversion
enforcement efforts and the role of CURES. The Board should
provide recommendations for the future success and viability of
this program, including efforts to increase utilization and
suggestions for stable funding and location.
b) Issue : Implementation of California's Electronic Pedigree
Law.
Background : The Food, Drug and Cosmetic Act (FDCA) was passed by
Congress to ensure public confidence in our drug distribution
system and to require that drugs are both safe and effective.
The FDCA requires FDA to regulate drug manufacturers and to
approve drugs for sale but also requires state governments to
regulate the drug distribution system by licensing and regulating
drug wholesalers. In California, the Board licenses wholesalers.
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In the simplest situation, a manufacturer sells drugs directly
to one of the major wholesalers who then sell the drugs to a
hospital or pharmacy. However, this simple distribution pattern
is not the only distribution route taken through the supply
chain. Typically, there is more than one wholesaler who receives
the drugs before they reach the pharmacy. These transactions
include transfers between separate facilities owned by major
wholesalers and transfers between the major wholesalers and the
large drug store chains that have their own wholesale facilities
in the company distribution system. Common carriers may
transport the drugs between licensed entities and in some cases
will store, select and then ship products to pharmacies at the
direction of manufacturers.
The distribution system is further complicated by the practice of
"repackaging." Unlike European countries and Canada, most drugs
in the United States are not packaged in a "unit of use" size by
the drug manufacturers. Instead, many drugs are sold by the
manufacturers in large bulk containers and then are repackaged by
additional companies into smaller containers for resale to the
pharmacy. And the distribution system is complicated yet again
by the existence of a "secondary" wholesale market. "Secondary"
wholesalers are smaller companies (often regional down to small
family owned companies) that focus their business on selling
drugs to other wholesalers and serving smaller niche clients that
are not routinely served by the major wholesalers (individual
practitioners, small clinics, rural locations, etc.).
Drugs routinely move between both primary and secondary wholesalers
and from pharmacies to secondary wholesalers as well. These
intermediate steps pose the greatest opportunities for
compromising the integrity of the drug distribution system. The
primary threat to system integrity is the introduction of
counterfeit products. Counterfeit drugs are most likely to be
introduced into a distribution system that involves multiple
wholesalers because drugs are largely untraceable unless they are
only handled by a major wholesaler who purchases directly from
the manufacturer. Without being able to trace a drug back, there
is no assurance to the consumer that the drug has been stored and
handled appropriately to preserve its potency and safety.
In response to a growing threat to the pharmaceutical supply chain
from counterfeit, misbranded, adulterated or diverted drugs,
California enacted SB 1307 (Figueroa, Chapter 857, Statutes of
2004) which made comprehensive changes to the drug distribution
system to protect the integrity of the pharmaceutical supply
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chain. That legislation enacted the nation's strongest
pharmaceutical consumer protection measure and included
provisions pertaining to the licensure and qualifications of
wholesalers, restrictions on furnishing and the requirement,
beginning January 1, 2007, of an electronic pedigree (e-pedigree)
to accompany and validate drug distributions for the purpose of
tracking each prescription drug at the saleable unit (item) level
through the distribution system. Subsequent Board sponsored
legislation, SB1476 (Figueroa, Chapter 658, Statutes of 2006)
delayed the implementation date for the e-pedigree component to
January 1, 2009 and granted the Board the authority to extend the
deadline an additional two years to allow the industry additional
time to implement technologies necessary for electronic
pedigrees. In 2008, the Board sponsored SB 1307 (Ridley-Thomas,
Chapter 713, Statutes of 2008), which amended the law to resolve
implementation issues, specifically staggering and extending the
implementation dates for e-pedigree compliance, establishing
grandfathering of existing stock in the supply chain, allowing
the Board to establish criteria for inference, and preempting
California's requirements in the event federal legislation is
enacted in this area. Per SB 1307, California's e-pedigree
requirements for prescription drugs will take effect on a
staggered basis from January 1, 2015 through July 1, 2017: 50
percent of a manufacturer's products by 2015 will have to have an
e-pedigree; the remaining 50 percent of the manufacturer's
products will have to have an e-pedigree by 2016; wholesalers and
repackagers must accept and forward products with the e-pedigree
by July 1, 2016 and; pharmacy and pharmacy warehouses must accept
and pass e-pedigrees by July 1, 2017.
Implementation of this legislation will impact all drug
manufacturers and wholesalers who sell and distribute drugs into
California. The Board states that it will spend considerable
effort over the next six years in securing regulations and
implementation of the requirement and it would be helpful for the
Committee to understand what that entails and what impediments
the Board anticipates to full, timely implementation.
Recommendation: The Board should provide the Committee with an
update on the status of e-pedigree implementation, including
timelines, Board activity, potential impediments and manufacturer
and industry efforts and response.
c) Issue : Implementation of a Prescription Label Standard.
Background : California is the first state to require redesigned
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prescription container labels to emphasize information most
important to consumers - offering an element of safety and
consistency since prescription labels are the key source
patients' reference for information when taking medications in
their homes. Part of this 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.
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 Board was charged 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. 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 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.
The Board approved a regulation per the requirements set forth in
SB 472 in 2010, 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. In 2009, the Board
discussed the requirements of the regulation at regularly
scheduled meetings. Throughout early 2010, the Board held
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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.
Recommendation: The Board should provide a status update on the
creation of a patient-centered label for all prescriptions
dispensed in California. The Board should describe what
additional public outreach it will undertake to ensure
compliance. The Board should explain impediments to compliance,
industry feedback or pushback, if any and anticipated changes
that may be made to the law or regulation.
d) Issue : Implementation of Drug Take-Back and Reuse Programs.
Background: There are growing concerns about the impact of drugs
and pharmaceutical waste based on improper disposal, which in
turn leads to contamination of water systems and inappropriate
access by potential abusers. The U.S. Geological Survey
conducted a study in 2002, sampling 139 streams across 30 states
and found that 80 percent had measurable concentrations of
prescription and nonprescription drugs, steroids, and
reproductive hormones. Exposure, even to low levels of
pharmaceuticals, has been shown to have negative effects on fish
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and other aquatic species and may have negative effects on human
health. Proper disposal is believed to decrease the threat of
these substances to the environment and waterways. Proper
disposal is also believed to decrease the availability of expired
and unused prescription drugs to abusers.
The guidelines for proper disposal of prescription drugs can be
confusing, lack uniformity throughout the state and nation, and
are cumbersome to the consumer. For example, the federal FDA
highlights certain very harmful drugs that should be flushed down
a toilet, but the organization also recommends a lengthy process
for proper disposal of the majority of prescriptions drugs,
including mixing whole tablets or capsules with an unpalatable
substance such as kitty litter or used coffee grounds then
placing that mixture in a sealed container before throwing it in
household trash. The Board's recommended process for disposal is
similarly extensive and requires even additional steps.
Take-back programs for medication disposal have risen in popularity
due to problems surrounding safe, accessible, easy disposal
options. These programs are seen as a good way to remove
expired, unwanted, or unused medicines from the home and reduce
the chance that others may accidentally take the medicine or it
ends up being flushed. In California, though, The Medical Waste
Management Act (MWMA) currently requires home generated
pharmaceutical waste to be managed as "medical waste" which
includes such material as infectious and biohazardous waste and
other types of waste that pose a potential harm to public health
and safety and the environment if not managed properly. The MWMA
establishes rigorous management and tracking requirements for
medical waste; including requiring the use of hazardous or
medical waste haulers and strict manifesting requirements.
Many pharmacies and other retail establishments have expressed an
interest in providing collection opportunities for their
customers and while they are willing and able to provide safe and
appropriate collection, they do not want to become licensed
medical waste collectors. Concerns have been raised regarding
the issue of theft of home generated pharmaceutical waste at
collection points, including pharmacies. As pharmacies have the
responsibility of keeping the drug supply safe, it is important
that assurances are in place for drugs taken back at a pharmacy
to remain secure and not diverted to unauthorized users.
Similarly, expired or unused medications that have been dispensed
to a consumer must not re-enter the drug supply, to ensure
quality of products.
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In 2007, the Legislature passed SB 966 (Simitian, Chapter 542,
Statutes of 2007) which required the California Integrated Waste
Management Board (CIWMB) to develop, in consultation with
appropriate state, local, and federal agencies, model programs
for the collection and proper disposal of pharmaceutical drug
waste. However, it does not appear that California has
implemented widespread take-back programs and consistent
opportunities throughout the state for consumers to properly
dispose of unwanted, expired or unused medication. It would be
helpful for the Committee to understand barriers to take-back
programs and the Board's role in implementing SB 966.
Access to affordable prescription drugs is also a growing problem
in California and in other states. Prescription drugs represent
one of the fastest growing health care expenditures as drug
prices continue to grow and the population is rapidly aging.
Many states have enacted prescription drug recycling or
repository programs for unused medications to provide access to
vulnerable populations. While details of these laws vary, most
allow return of prescription drugs in single use packaging from
state programs, nursing homes, and other medical facilities to be
redistributed to needy residents. In 2000, the American Medical
Association (AMA) looked at one such program in Oklahoma where
nursing homes directed unused and unopened medicines back to
pharmacies for distribution to indigent patients. According to
the AMA, there was an estimated $3 to $10 million dollars a year
in unused prescription drugs from such facilities in the state of
Oklahoma.
The Board may also have responsibility for assisting in the
implementation of prescription drug redistribution or reuse
programs. In 2005, the Legislature passed SB 798 (Simitian,
Chapter 444, Statutes of 2005) which allowed counties to
establish a voluntary drug redistribution program, allowed
skilled nursing facilities and drug manufacturers to donate
unused medications and allowed county pharmacies to dispense the
donated drugs to underserved populations free of charge, modeled
after the Oklahoma program. At the heart of the issue is the
large amount of surplus medication that goes unused, but may not
be expired and has never been distributed to the public, thus may
not face supply chain quality concerns. SB 798 specified that
the only medications eligible for recycling or repository are
those that have been maintained in specified settings under the
watch of a licensed pharmacist or manufacturer and have not been
distributed to consumers. Designed to combat both the issue of
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rampant improper disposal of medication and the rising costs of
prescription drugs for some of California's most vulnerable
patients, programs under SB 798 have only been established in two
counties, San Mateo and Santa Clara. It would be helpful for the
Committee to understand the Board's role in overseeing recycling
and redistribution programs.
Recommendation: The Board should explain the status of
implementation of drug take-back programs in California and what
barriers exist to successful implementation of these programs?
What role does the Board play in establishing safe, secure
methods for consumers to properly dispose of medication? What
steps has the Board taken to promote and create take-back
programs? What should be the role, if any, of board-licensed
reverse distributors in the drug take-back process? What role
does the Board play in drug redistribution and reuse programs,
whereby unused medication that has not been dispensed can be
donated to community clinics and organizations that can in turn
provide medication to vulnerable populations? What are the
barriers to successful redistribution and reuse programs?
1.Background on the Court Reporters Board. Established in 1951, the
Certified Shorthand Reporters Board, now known as the CRB, regulates
the court reporting profession through testing, licensing, and
disciplining of court reporters. In California, court reporters use
the title certified shorthand reporter (CSR), which is a designation
restricted by statute to those individuals who have a Board-issued
license.
In California, a person can be licensed to work as a court reporter
employed by state courts (official reporter) or to act as a
deposition officer (freelance reporter). Freelance reporters can be
hired as individual contractors or can be hired by court reporting
firms which, in turn, are hired by law firms or lawyers to provide
services in depositions. The laws governing deposition/freelance
reporters can be found in the Code of Civil Procedure Section 2025,
et seq. As of January 1, 2012, there are 7,316 licensed CSRs in
California.
According to the CRB, licensing of CSRs is critical to the proper
functioning of the courts. An accurate written record of who said
what in court is essential if the outcome of judicial proceeding is
to be accepted by the litigants and the public as non-arbitrary,
fair, and credible. In criminal cases, for example, courts of
appeal rely exclusively upon written briefs and a written transcript
to adjudicate the lawfulness of what occurred at trial. A
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conviction, and thus, in some instances the life or death of an
accused, can stand or fall based entirely upon what a witness said,
what a lawyer said, what a juror said, or what a judge said, as
solely reflected in the written transcript. In civil cases,
millions of dollars, life-long careers, and the fate of whole
business' enterprises can hinge on what was said or what was not
said in a deposition or at trial.
Moreover, as indicated by the CRB, the testimony in civil and criminal
cases is often thick with technical jargon. A medical malpractice
case, where experts from both sides contradict one another, can
involve complex technical medical terminology; criminal cases can
involve scientific language related to DNA identification;
anti-trust cases can involve diction from economic theory, and so
on. No matter how obscure or technical, such jargon must be
accurate to-the-word and be reflected in the written transcript.
Court reporters are highly trained professionals who transcribe the
words spoken in a wide variety of official legal settings such as
court hearings, trials, and other litigation and in related
proceedings such as depositions.
The CRB also has oversight of court reporting schools in addition to
having oversight over CSRs. Although CRB "recognizes" schools,
there is no statutory authority for licensure. Even so, only court
reporting schools "recognized" by the CRB can certify students to
qualify for the CSR examination. The CRB can also issue citations,
and fine schools not in compliance with their rules. Also in 1972,
the CRB's authority was expanded to give them the ability to
recognize court reporting schools and to set minimum curriculum
standards for court reporting programs. Additional authorization to
cite and fine schools was passed by the Legislature in 2002 (BPC §
8027.5). The CRB can discipline schools up to and including
removing recognition. There are currently 16 schools of court
reporting recognized by the CRB; 8 public schools and 8 private
schools. Since the last Sunset Review, one school has closed.
Until the 1960s, the CRB allowed only CSRs to own and operate companies
offering court reporting services. However, when no statutory
authority supporting that prohibition could be found, the practice
ceased, and in 1972, CRB began registering reporting corporations.
That process was rescinded by Assembly Bill 2743 (Chapter 1289,
Statutes of 1992) when the CRB decided that the registration
duplicated the filing required by the Secretary of State's Office,
provided no additional benefit or consumer protection, and was an
unnecessary expense for businesses.
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The CRB's average annual operating budget over the past four years has
been approximately $787,000. Of that, each year by statute,
$300,000 is assigned to the Transcript Reimbursement Fund (TRF); a
fund designated to reimburse transcript costs incurred by indigent
litigants. The greatest expenditure for the CRB is its enforcement
program, which on average represents 38% of expenditures. The
second highest expenditure is the examination at 30% of
expenditures.
The CRB is funded almost completely by examination and licensing fees
collected from applicants and licensees. License renewal is the
CRB's largest source of revenue, accounting for approximately 91% of
the operating fund. Another 3% comes from examination and license
application fees, and just under 3% is comprised of payments of
citations/fines. The remaining, just over 3%, is miscellaneous
revenue including delinquent fees and investment income. The CRB
receives no federal funding and no revenue from the State's General
Fund. There is no statutory mandatory reserve level for the CRB.
The rates charged by freelance reporters and the businesses that employ
them are not fixed by statute. That was not the case in the past
but in a compromise package with the profession, the Legislature and
the Governor, eliminated rate regulation in 1981 and created the
TRF, a special fund paid for by a portion of the court reporters'
licensing fees.
Prior to January 1, 1983, state courts had been allowed to use
noncertified reporters if they could demonstrate that a certified
reporter was not available. BPC Section 8016 now requires all state
court reporters to be licensed as CSRs. Court reporters hired prior
to 1983 can still maintain an exemption to the licensing
requirement.
The CRB is composed of five members, two of whom are licensed CSRs and
three of whom are public members. The Governor appoints, subject to
Senate confirmation, the two-licensed members and one public member.
The Assembly Speaker and the Senate Rules Committee each appoint a
public member.
2. Prior Review of the CRB. The CRB was last reviewed by the Joint
Committee on Boards, Commissions and Consumer Protection (Joint
Committee) in 2005. Several questions were raised during the last
sunset hearing including the CRB's relevance, fiscal surplus
concerns, continuing education requirements, instructional quality
at public court reporting schools, examination passage rates and
enforcement authority in regards to releasing public documents.
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Continuing education has been an issue as far back as in the 1996
Sunset Review Report and again in the 2005 review. Accordingly, in
2008, the CRB sponsored a mandatory continuing education bill, AB
2189 (Karnette), which ultimately was vetoed by the Governor. In
2011, SB 671 (Price), a similar mandatory continuing education
bill, was also vetoed. The CRB remains committed to this consumer
protection aim. While the Legislature has twice passed such
legislation, the CRB states that it will continue to work with the
Administration to address its concerns.
The Joint Committee made the following recommendations in the last
review:
The CRB should seek statutory clarification regarding
fraudulent acts that may amount to unprofessional conduct by the
court reporter. The CRB has continued oversight of the
profession as recommended, putting protection of the consumer at
the forefront of all activities. In response to this issue the
CRB sought clarification in the enactment of Title 16, California
Code of Regulations (CCR) § 2475.
The statute should be changed to make it explicit that the CRB
should disclose letters of reprimand. In response to this issue,
the CRB now publishes all action taken on the CRB's Website and
published in the CRB's biannual newsletter. The mere fact that a
complaint has been received is kept confidential, however,
pending outcome of the investigation.
The Joint Committee recommended that the court reporter
profession should continue to be regulated and that a board
structure be maintained.
1. Current Issues and Problems Identified of the Court Reporters
Board. The following are some of the major unresolved issues
pertaining to the Board, or areas of concern presented to the
Committee for consideration, along with background information
concerning the particular issue. Recommendations were made by
Committee staff regarding the particular issues or problem areas
which needed to be addressed.
a) Issue : Are professional corporations owned by non-CSRs
asserting lack of Board jurisdiction over their activities?
Background : In response to complaints about unethical gift giving
(violation of CCR Section 2475(a)(8)) and violations of the
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minimum transcript format standards (CCR Section 2473), a task
force was appointed by the CRB in 2007, to study the issue of
firm oversight. The members of the task force included small,
medium and large-firm owners. Ultimately the task force arrived
at language which was included in AB 1461 (Ruskin).
In 2010, via AB 1461 (Ruskin), the CRB sought legislative
clarification to Section 8046 of the BPC as it relates to firms
providing court reporting services. AB 1461 sought to clarify
that in addition to corporations, a firm, partnership, sole
proprietorship or other business entity providing or arranging
for shorthand reporting services (any entity offering or
providing the services of a shorthand reporter) was barred from
doing or failing to do any act that constitutes unprofessional
conduct under any statute, rule or regulation pertaining to
shorthand reporters or shorthand reporting. The bill died on
Suspense in Assembly Appropriations Committee.
Since that time, the CRB has issued a citation and fine against a
non-CSR-owned court reporting corporation that allegedly violated
the gift-giving regulations embraced in the Professional
Standards of Practice. As the corporation has refused to pay the
fine, a request for declaratory relief has been filed in Santa
Clara County, seeking judicial clarification.
Not only does the statute affirm that corporations providing court
reporting services are subject to the jurisdiction and rules of
CRB, it is also counterintuitive to have the activities of
corporately owned firms offering court reporting services be
outside the jurisdiction of CRB. The ultimate consumer of the
transcript is the litigant, and their need to have transcripts
that are lawful, honestly and accurately prepared is the same
regardless of the corporate form of the entity that arranged for
the proceeding.
If an attorney hires a firm because of a large gift, a direct
violation of Section 2475(a)(8), rather than competitive rates or
quality of service, the consumer, the lawyer, and the litigant
are the unknowing potential victims. Similarly, if there is a
violation of Section 2473, the minimum transcript format
standards, the litigant could end up paying hundreds or even
thousands of dollars more for transcripts.
It is noteworthy that the Corporations Code that exempts
professional corporations from having to register with the CRB is
the same Code that provides they are subject to its jurisdiction.
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If a corporation is not a professional corporation subject to
the CRB's jurisdiction, then they may have to indeed register
with the CRB.
Recommendation : BPC Section 8046 should be amended to clarify that
any entity offering or providing shorthand reporter services must
comply with the laws governing licensees of the CRB.
b) Issue : Is the TRF Underfunded?
Background : As indicated, in 2010, SB 1181 (Cedillo, Chapter 518,
Statutes of 2010) authorized a two-year pilot project, expanding
TRF to pro se litigants who are indigent. Historically TRF has
been underutilized by indigent litigants represented by pro bono
attorneys or qualified nonprofit entities, so this pilot project
was implemented in order to maximize the benefits of TRF,
expanding access to justice to those most in need. A cap of
$30,000 per each calendar year was set aside for this project,
with a case cap of $1,500.
The entire $30,000 cap was reached after processing an application
received July 15, 2011. Staff continues to process applications
as previously encumbered money becomes available, but clearly
demand exceeds resources.
According to the CRB, no legislative action is actually needed at
this point; however, CRB wants the Legislature to be aware there
is a potential issue. There could be staffing issues if the
pilot project were to become permanent or if the $30,000 cap were
to be increased.
An additional consideration is the increasing move toward
privatization of the courts. Some counties have decided not to
provide court reporters in civil matters, requiring litigants to
provide their own reporter. This additional cost to the litigant
may bring increased demand for assistance with costs associated
with obtaining a transcript.
Recommendation : In agreement with the CRB's recommendation, no
legislative changes need to be made at this point. However, the
CRB should notify the Committee if conditions occur which
necessitate changes related to the TRF Pilot Project.
c) Issue : CRB's Fund Decrease
Background: The CRB is funded almost completely by examination and
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licensing fees collected from applicants and licensees. The CRB
receives no federal funding and no revenue from the State's
General Fund. License renewal is the CRB's largest source of
revenue, accounting for approximately 91% of the operating fund.
Another 3% comes from examination and license application fees,
and just under 3% is comprised of payments of citations/fines.
The remaining just over 3% is miscellaneous revenue including
delinquent fees and investment income. For fiscal year 2010-11,
the CRB has a projection of 16.2 months in reserve. There is no
statutory mandatory reserve level for the CRB.
Recommendation: The CRB should discuss with the Committee the CRB's
fund condition, and identify any unusual expenditures or
shortfalls that are contributing to the diminishing fund
reserves. The CRB should also identify appropriate solutions,
including raising fees, controlling spending, or other steps that
might be taken in order to ensure a stable reserve level for the
Court Reporters Fund.
1.Responses regarding Issues Raised by the Committee. The CRB
responded to the issues raised by Committee staff on April 5, 2012.
In terms of whether BPC § 8046 should be amended to clarify that any
entity offering or providing shorthand reporter services must comply
with the laws governing licensees, the CRB indicates that there is
no question that there are professional corporations owned by
non-CSRs that are asserting lack of Board jurisdiction over their
activities. However there is ongoing litigation regarding this
specific issue, and the Board feels it prudent to defer any
legislative changes until the legal matter is completed.
Regarding whether the TRF is underfunded, the CRB indicates that there
could be staffing issues for the CRB if the pilot project were to
become permanent or if the $30,000 cap were to be increased. While
existing staff was able initially to absorb the workload, the
overall TRF workload increased by 70% in 2011 compared to prior
years. This resulted in the inability of staff to perform mandatory
oversight of recognized court reporting programs and to reach
significant strategic plan objectives. While CRB is supportive of
every effort to maximize the use of the TRF. In light of the
increased workload, however, and the pressure that decreasing
appropriations in recent years has placed upon staff resources, the
CRB does not feel the project can be sustained with existing staff.
Regarding the CRB's declining Fund reserve, the CRB indicates, that the
Board currently has a healthy fund condition with 19.3 months in
reserve for the current fiscal year. With the number of licensees
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remaining relatively stable, revenue remains fairly constant.
During the time period since the last review, expenditures have been
reduced by 3.4%. An analysis of the overall numbers reveals that
the decline in fund reserves is mainly due to a decrease in budget
authority, which has been reduced some 44.6 percent. Part of this
reduction is explained by exceptional expenditures that arise from
time to time, such as the cost of an occupational analysis , and
examination development. An additional impact on the fund condition
is the ongoing funding of the TRF. At this point, the CRB that the
decline when projected into the future, would hit a zero or negative
balance in fiscal year 2018/19.
2.This Measure Includes the Following Statutory Changes as Identified
by this Committee During Its Oversight Hearings of March, 2011:
a) Extends the Sunset Date of the Pharmacy Board and the Board's
Executive Officer. The health and safety of consumers are
protected by a well-regulated pharmacy profession. The Board
should be continued with a four year extension of its sunset date
so that this Committee may review it once again.
b) Extends the Sunset Date of the CRB and Its Executive Officer.
The health, safety and welfare of the public are better protected
by a well-regulated court reporter profession. Court reporters
provide an invaluable service to the legal community. The Board
should be continued with a four extension of its sunset date so
that this Committee may review it once again.
c) Extends the Sunset Date for the Transcript Reimbursement Fund.
Since its inception in 1981, the TRF was established with a
sunset date, which has been extended on an ongoing basis by
legislation until the current time. The TRF is currently
scheduled to be repealed on January 1, 2013, and unless
legislation is passed extending that date, all unencumbered funds
remaining in the TRF, as of that date, will be transferred to the
Court Reporters Fund. The Board should continue with a four year
sunset date for the TRF so that this Committee may review it once
again.
d) Extends the Sunset Date for the Transcript Reimbursement Fund
for Pro Se Litigant. SB 1181 (Cedillo, Chapter 518, Statutes of
2010) authorized a two-year pilot project, expanding TRF to pro
se litigants who are indigent. The pilot project runs for two
calendar years, January 1, 2011, through January 1, 2013. The
project is capped at $30,000 per calendar year and each case is
capped at $1,500. The TRF for Pro Se Litigants is currently
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scheduled to be repealed on January 1, 2013, and unless
legislation is passed extending that date, all unencumbered funds
remaining in the TRF, as of that date, will be transferred to the
Court Reporters Fund. However, due to limited funding, CRB
points out that the program should be extended until the TRF for
pro se litigants is maximized.
e) Makes a technical correction to BPC § 8027. On January 1,
2007, the Bureau for Private Postsecondary and Vocational
Education was allowed to sunset. In 2009 AB 48 (Portantino,
Chapter 310, and Statutes of 2009) established the Bureau for
Private Postsecondary Education. This bill makes a technical
change to correctly reference the name of the Bureau.
1. Related Legislation. Other sunset review bills to be presented
before the Senate Business and Professions Committee include:
SB 1236 which deals with the Board of Podiatric Medicine and the
Board of Physician Assistants.
SB 1238 which deals with the Board of Psychology and the Board of
Behavioral Sciences.
SB 1239 which deals with the Board of Acupuncture.
SUPPORT AND OPPOSITION:
Support :
Court Reporters Board (CRB) of California
California State Board of Pharmacy
Healthcare Distribution Management Association
Opposition : None received as of April 16, 2012
Consultant:Michael Lynch