BILL ANALYSIS Ó
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Ed Hernandez, O.D., Chair
BILL NO: AB 604
A
AUTHOR: Skinner
B
AMENDED: April 5, 2011
HEARING DATE: June 22, 2011
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CONSULTANT:
0
Orr
4
SUBJECT
Needle exchange programs
SUMMARY
Allows the California Department of Public Health (CDPH) to
authorize entities meeting specified criteria to provide
clean hypodermic needle and syringe exchange programs
(SEPs) in any location where the department determines
conditions exist for the rapid spread of deadly or
disabling disease spread through the sharing of unclean
hypodermic needles and syringes.
CHANGES TO EXISTING LAW
Existing law:
Requires that no person shall possess a hypodermic needle
or syringe except when acquired in accordance with
specified provisions of law.
Authorizes an SEP in any city, county, or city and county
upon action by the county board of supervisors and the
local health officer or health commission as applicable, or
action of the city council, mayor and local health officer
as applicable. The programs are to be authorized using
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recommendations from the United States Secretary of Health
and Human Services, subject to availability of funding, and
are to be offered as part of a comprehensive network of
services.
Requires health officers of jurisdictions that participate
in SEPs to annually report the status of those programs and
at an open meeting of the board of supervisors or city
council.
Allows local governments, public health officials, and law
enforcement agencies the opportunity to comment on SEPs on
an annual basis to address potential adverse impacts to the
public.
Allows a pharmacist or physician to furnish hypodermic
needles or syringes for human use without a prescription or
permit if the person is known to the furnisher and the
furnisher has been previously provided with a prescription
or proof of legitimate medical need.
Allows counties to authorize pharmacists to furnish or sell
10 or fewer hypodermic needles or syringes to persons 18
years of age or older, for the period commencing January 1,
2005 and ending December 31, 2018, if the pharmacy is
registered for the Disease Prevention Demonstration Project
(DPDP) and if the pharmacy complies with other specified
provisions.
Establishes the DPDP as a collaboration between pharmacies
and local and state health officials, for the purpose of
evaluating the long-term desirability of allowing licensed
pharmacists to furnish or sell nonprescription hypodermic
needles or syringes to prevent the spread of blood-borne
pathogens, including HIV and hepatitis C.
As part of the DPDP, requires participating pharmacies to
register with their local health department, and certify
that they will provide written or verbal information on
drug treatment, testing services, and safe sharps disposal
practices at the point of sale. Describes requirements for
the secure storage of needles and syringes in pharmacies,
and requires pharmacies to make safe disposal options
available to users. Requires CDPH to evaluate the DPDP and
provide a report to the Governor and the Legislature on or
before January 15, 2010.
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Requires that no public entity, its agents, or employees be
subject to criminal prosecution for the distribution of
hypodermic needles or syringes to participants in clean
needle and syringe exchange projects authorized by law.
Finds and declares that needle exchange programs have been
shown to serve as a bridge to treatment and recovery from
drug abuse, curtail the spread of HIV infection through the
IDU population, and do not increase drug use.
This bill:
Authorizes CDPH to allow entities meeting specified
criteria to apply for authorization to provide hypodermic
needles and syringe exchange services in any location where
CDPH determines that conditions exist for the rapid spread
of HIV, viral hepatitis, or any other potentially deadly or
disabling infectious disease, spread through the sharing of
unclean hypodermic needles and syringes. The entity must
have sufficient staff, capacity and funding to provide
these services, and must demonstrate the ability to do the
following:
1) Provide specified services for drug treatment and
disease testing,
2) Begin the SEP within 3 months of CDPH's
authorization, and
3) Collect specified evaluative data to assess the
program's impact.
Requires CDPH to provide for a public comment period at
least 45 days prior to the approval of an application by
posting a notice on its website and notifying the health
officer of the jurisdiction where the entity submitting the
application is located. Requires CDPH to post addresses
and contact information of all SEPs on its website.
Requires CDPH to provide biennial reports to local health
officers in jurisdictions where CDPH has authorized needle
exchange services.
Provides that staff, volunteers and participants in an
authorized exchange project will not be subject to criminal
prosecution for violation of any law related to the
possession, furnishing, or transfer of hypodermic needles
in an exchange project.
Changes the frequency with which local governments, public
health officials, law enforcement agencies, and the public
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may comment on local SEPs from once per year to once every
two years. Also changes the requirement for local health
officials to report to the board of supervisors or city
council on the status of such programs from once per year
to once every two years.
Replaces a reference to recommendations by the US Secretary
of Health and Human Services, with the US Public Health
Service.
FISCAL IMPACT
The Assembly Appropriations Committee analysis estimates
annual costs to the CDPH of $30,000 to $40,000 in 2011-12
through 2013-14 to establish regulations. CDPH indicates
that the department could absorb the additional workload
with no new funding by redirecting existing federal monies
for HIV prevention. The analysis also estimates ongoing,
likely absorbable costs for CDPH to continue oversight of
needle exchange projects after 2014, and unknown but
potentially significant savings to the extent this bill
reduces medical costs associated with infectious diseases
such as HIV and hepatitis.
BACKGROUND AND DISCUSSION
The author believes SEPs are a highly cost-effective
component of a comprehensive HIV and hepatitis control
strategy, endorsed by every major national, state, and
international health and medical association. The author
asserts that local governments have had the authority to
allow these programs since 1999, but some have failed to do
so due to neglect, lack of knowledge, or lack of political
will. The author claims that there are thousands of new
hepatitis cases and hundreds of HIV cases occurring in the
state every year, including the inland empire and the
central valley where there are no authorized SEPs. The
author contends that federal funding is now available to
California to support SEPs and to prevent costly and deadly
infections, but the lack of SEPs in some of these areas
means that taxpayers statewide get stuck with paying the
bill.
Clean needle and syringe exchange programs (SEPs)
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Clean needle exchange programs make sterile needles
available to injection drug users (IDUs), in order to
mitigate the transmission of bloodborne diseases such as
HIV and HCV. SEPs provide a safe and accessible method for
IDUs to exchange used syringes for sterile ones. Often,
SEPs also provide other public health services, such as HIV
testing, risk-reduction education, and referrals for
substance-abuse treatment. For some California residents, a
SEP is the only accessible provider of medical or social
services.
SEPs have been shown to be effective in reducing the
sharing of syringes and the transmission of blood-borne
infections among drug users, without increasing drug use.
SEPs can help lower the number of contaminated syringes
circulating in communities by decreasing syringe scarcity,
and in the case of an accidental needlestick, can lower the
likelihood of a needle being contaminated with a
potentially deadly disease. Since the implementation of
these programs in the late 1980s, new HIV infections among
IDUs have declined overall by 80 percent. One study
published in 2001 found that the mean HIV prevalence rate
among IDUs in metropolitan areas that banned
over-the-counter sales or purchases of needles and syringes
was twice as high as the mean HIV prevalence rate in metro
areas that allow over-the-counter sales (13.8 percent vs.
6.7 percent respectively).
According to the Center for Health Improvement, there were
41 authorized SEPs in California as of March 2009. Cities
and counties are enabled to authorize an SEP as part of a
comprehensive network of services. Local government, local
public health officials, law enforcement personnel, and the
public are supposed to be given the opportunity to provide
comments on local SEPs annually. The local health officers
are required to annually report to the boards of
supervisors or city councils, and to include a detailed
report on the status of local SEPs including, but not
limited to, relevant statistics on blood-borne infections
associated with needle-sharing activities and the use of
public funds for these programs. According to CDPH/OA,
seventeen county boards of supervisors and four city
councils have authorized SEPs, and several other counties
and cities are currently considering them.
Funding for syringe exchange
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According to CDPH Office of AIDS (CDPH/OA), CDPH considers
syringe exchange to be "unquestionably vital in the
struggle to reduce the spread of HIV, HCV and other
bloodborne infections among injection drug users, their
partners, and their children." In the past, CDPH has
distributed millions of dollars in state funding to
authorized SEPs across the state to provide syringe
exchange, HIV and HCV testing, counseling and referral to
needed services. Recent cuts in state General Funds for HIV
prevention have resulted in elimination of all state
funding of SEPs; HIV prevention in the state is now solely
funded by federal dollars, which had precluded the funding
of SEPs.
On December 16, 2009, President Obama signed the
Consolidated Appropriations Act of
2010, which began the process of lifting the 1989 ban on
the use of federal funds for SEPs. This action allowed the
CDC and its partners to more fully implement a
comprehensive, evidence-based approach for reducing HIV
infection among injecting drug users. The U.S. Surgeon
General, Regina Benjamin, M.D. also announced on February
23, 2011 in the Federal Register that federal Substance
Abuse Prevention and Treatment Block Grant funds could now
be used to support syringe services programs. This
determination permitted states and territories to use their
Substance Abuse Prevention and Treatment Block Grant funds
for needle exchange.
Pharmacy sale of syringes
Until the 2004 signing of SB 1159 (Vasconcellos), which
started the Disease Prevention Demonstration Project,
California was one of only five states that required a
prescription in order to purchase a syringe. In the early
80s, insulin and allergy syringes could be bought in any
drugstore without a prescription. In spite of the available
supply, some drug users chose to reuse and share needles,
and are believed to be partly responsible for the early
spread of the AIDS epidemic. In the 90s, some states began
requiring needles to be stored behind the pharmacy counter
and began requiring a prescription, in hopes of cutting
down on illegal drug use by making syringes more scarce.
Many states abandoned that policy once a correlation was
noted between syringe scarcity and increased infectious
disease rates in IDUs.
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To address and prevent the spread of blood-borne infectious
diseases among IDUs in California, the DPDP was established
to allow the sale of up to 10 hypodermic needles or
syringes without a prescription at pharmacies. In order to
participate in the DPDP, pharmacies must register with
their local health department and provide a contact name
and related information. They must also certify that they
will provide written or verbal counseling at the time of
furnishing or selling needles or syringes. Additionally,
pharmacies must properly store needles and syringes so that
they are only available to authorized personnel, provide
on-site safe disposal of needles and syringes, or furnish
or sell mail-back state or federal standard personal sharps
disposal containers. In the absence of local authorization
of a DPDP or a SEP, the sale and possession of syringes
without a prescription remains illegal in California.
CDPH evaluation of the DPDP
SB 1159 required CDPH to report to the Governor and to the
Legislature by January 15, 2010 on the impact of allowing
pharmacists to furnish or sell non-prescription hypodermic
needles or syringes on rates of crime in the vicinity of
pharmacies, rates of drug use, rates of needlestick injury
to law enforcement officers and waste management employees,
rates of safe or unsafe discard of syringes,
syringe-sharing practice among IDUs, and rates of disease
infection related to syringe sharing. CDPH was also
required to convene an uncompensated evaluation panel.
The report was released to the Legislature in July of 2010.
It made several key findings:
1) Injection-mediated risks were lower among IDUs in
local health jurisdictions (LHJ) that authorized
DPDPs.
2) Reported needlestick injuries among law enforcement
officers remained rare.
3) Drug-related crime remained stable in the LHJs that
authorized DPDPs.
4) Levels of unsafe discard of used hypodermic needles
or syringes around DPDPs were low.
5) Levels of injection of illegal drugs decreased
among publicly funded HIV testing clients since
implementation of SB 1159.
The report found that between 40 and 45 percent of IDUs in
DPDP-authorizing counties reported never sharing syringes
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during the past two years. In counties that did not
authorize OTC sale, never-sharing rates were lower, ranging
from 22 to 32 percent. The authors of the report claimed
that more time would be needed to accurately assess SB
1159's effect on disease incidence rates due to limitations
in available data.
The report found substantial differences in authorization
and implementation of local DPDPs across California LHJs
and claims that "the two-step authorization process for
legalizing ÝOTC] syringe sales (i.e., first on the county
or city level and second on the pharmacy level) limited
potential risk-reduction intentions of the legislation and
deletion of this stipulation from a future bill could
provide better access to this important prevention
intervention." The report points out that universal
authorization of OTC syringe sales could reduce costs to
LHJs by eliminating the need for staff time and resources
to support that local authorization process and suggests
broadening implementation among and within counties.
Needlestick injuries
Access to sterile syringes can affect the occupational
health and safety of peace officers and waste management
employees because they are at risk of accidental
needlestick injuries from improperly disposed needles. A
recent study found that 29.7 percent of San Diego Police
Officers surveyed had suffered a needlestick injury on
duty, usually during a pat-down or search incident to
arrest. A study of police officers in Rhode Island found
that nearly 30 percent had been stuck by a syringe at one
point in their career, with over 27 percent experiencing 2
or more needle stick injuries. Research has shown that
accidental needlesticks to police officers have decreased
significantly following the implementation of SEPs. For
instance, studies in Connecticut and Massachusetts found
that needlestick injuries to officers were reduced 66
percent after syringe deregulation.
Related bills
SB 41 (Yee) would repeal the Disease Prevention
Demonstration Project (DPDP) which authorizes local
jurisdictions to allow pharmacies to distribute up to 10
needles or syringes without a prescription. Instead, would
allow individuals to obtain up to 30 needles or syringes
for personal use without a prescription from a pharmacy,
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and would authorize pharmacists and physicians to
distribute up to 30 needles or syringes to an individual
solely for personal use without a prescription. Pending in
Assembly Rules Committee.
Prior legislation
SB 1029 (Yee) of 2010 would allow individuals to obtain,
and pharmacists and physicians to distribute up to 30
syringes or needles for personal use without a prescription
from a pharmacy until December 31, 2018. Repeals the
Disease Prevention Demonstration Project (DPDP), thereby
removing a requirement for local governments to first
authorize participation in the DPDP prior to a pharmacy's
registration in the program. Vetoed with the message: "SB
1029 would remove the ability of local officials to best
determine policies in their jurisdiction. Some counties
have not sought to implement this pilot program, citing
competing priorities, lack of pharmacy interest and law
enforcement opposition."
AB 1701 (Chesbro) Chapter 667, Statutes of 2010, extended
the sunset date of the DPDP from December 31, 2010, to
December 31, 2018.
AB 1858 (Blumenfield) of 2010 is substantially similar to
AB 604 but included a sunset date of January 1, 2016.
Vetoed with the message: "I signed legislation in 2005 that
reflected a careful balance between good public health
policy and local decision-making authority. I remain
comfortable with that original decision and do not believe
it
is appropriate to change this balance and instead give
authority to the state Department of Public Health to
overrule local decisions regarding syringe exchange
programs."
AB 110 (Laird), Chapter 707, Statutes of 2007, permits a
public entity that receives General Fund (GF) money for
human immunodeficiency virus (HIV) prevention and education
from the Department of Public Health (DPH) to use that
money to support clean needle and syringe exchange projects
(NEPs), as specified.
AB 547 (Berg and Richman), Chapter 692, Statutes of 2005,
authorized clean SEPs in any city and county, county, or
city upon the action of a county board of supervisors and
the local health officer or health commission of that
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county; the city council, the mayor, and the local health
officer of a city with a health department; or, the city
council and the mayor of a city without a health
department.
SB 1159 (Vasconcellos), Chapter 608, Statutes of 2004,
authorizes the Disease Prevention Demonstration Project
(DPDP) to evaluate the long-term desirability of allowing
licensed pharmacies to sell or furnish nonprescription
hypodermic needles or syringes to prevent the spread of
blood-borne pathogens. Authorizes a licensed pharmacist,
until December 31, 2010 and subject to authorization by a
county or city, to sell or furnish 10 or fewer hypodermic
needles or syringes to a person for human use without a
prescription if the pharmacy is registered in the DPDP with
a local health department.
PRIOR ACTIONS
Assembly Health: 13- 6
Assembly Appropriations:12- 3
Assembly Floor: 52- 26
Arguments in support
AIDS Project Los Angeles asserts that expanding SEPs will
reduce the future costs of HIV and hepatitis C to
taxpayers. More than 600,000 Californians are living with
hepatitis C, and their health care costs are expected to
soar over the next decade. AB 604 will help to bring SEPs
to communities that currently have no access to sterile
syringes and thus are experiencing high rates of HIV and
hepatitis C infections. The California Hepatitis Alliance
asserts that sharing needles is the leading cause of
hepatitis C infections in the state, and the second most
common means of contracting HIV and hepatitis B. the
estimated lifetime cost to treat hepatitis C exceeds
$100,000 per person, and the lifetime cost to treat HIV
exceeds $600,000. Failure to prevent these infections
creates long-term burden on state General Fund-supported
health insurance and drug programs.
Arguments in opposition
The League of California Cities opposes the bill because
they believe the ultimate considerations for local health
and safety impacts should be made by the city that will
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directly bear the consequences, for better or for worse.
The League asserts that AB 604 overrides local authority
and allows health services organizations to act outside of
a city or county government's discretion. The
International Faith-Based Coalition believes this bill will
have a devastating impact on the neighborhoods that their
pastors shepherd. The coalition believes that having local
government bodies make these decisions is not only good
public safety and quality of life policy, it is good public
health policy.
COMMENTS
1. Local authority. AB 604 allows CDPH to determine where
to provide authorization for SEPs for the purpose of
addressing a public health problem, and circumvents the
existing local control over the authorization of such
programs. Given the concerns about bypassing local
authority, and that this change in policy would allow
additional unknown entities to engage in needle and syringe
exchanges, should this bill apply a sunset provision in
order to offer an opportunity for the legislature to
formally reevaluate its impact?
POSITIONS
Support: Drug Policy Alliance (sponsor)
AIDS Project Los Angeles
American Civil Liberties Union
American Nurses Association California
California Association of Alcohol and Drug
Program Executives, Inc.
California Hepatitis Alliance
California Nurses Association
California Opioid Maintenance Providers
California Society of Addiction Medicine
California State Board of Pharmacy
California Syringe Exchange Provider Network
Center for Health Justice
Clinica Monsenor Oscar A. Romero
Common Ground: The Westside HIV Community Center
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County Alcohol and Drug Program Administrators
Association of California
Harm Reduction Coalition
L.A. Gay and Lesbian Center
National Association of Social Workers
Redwood AIDS Information Network and Services
Saint James Infirmary
San Francisco AIDS Foundation
San Francisco Hepatitis C Task Force
Santa Clara County Board of Supervisors
Waste Management
Oppose: California Narcotic Officers' Association
California Police Chiefs Association
International Faith Based Coalition
League of California Cities
Los Angeles Division, League of California Cities
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