BILL ANALYSIS �
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Ed Hernandez, O.D., Chair
BILL NO: SB 41
S
AUTHOR: Yee
B
AMENDED: As Introduced
HEARING DATE: April 6, 2011
4
REFERRAL: Public Safety
1
CONSULTANT:
Orr
SUBJECT
Hypodermic needles and syringes
SUMMARY
Repeals 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, allows individuals to obtain up to
30 needles or syringes for personal use without a
prescription from a pharmacy, and authorizes pharmacists
and physicians to distribute up to 30 needles or syringes
to an individual solely for personal use without a
prescription.
CHANGES TO EXISTING LAW
Existing law:
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
Continued---
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years of age or older, for the period commencing January 1,
2005 and ending December 31, 2018, if the pharmacy is
registered for the 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 non-prescription hypodermic
needles or syringes to prevent the spread of bloodborne
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.
Also as part of the DPDP, prescribes requirements for the
secure storage of needles and syringes in pharmacies, and
requires pharmacies to make safe disposal options available
to users.
Also as part of the DPDP, requires the California
Department of Public Health (CDPH) to evaluate the effects
of allowing pharmacists to furnish or sell a limited number
of hypodermic needles or syringes without prescription, and
to provide a report to the Governor and the Legislature on
or before January 15, 2010.
Authorizes clean needle exchange programs in any city
and/or county upon the action of a county board of
supervisors and the local health officer or health
commission of that 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.
Requires that no person shall possess a hypodermic needle
or syringe except when acquired in accordance with
specified provisions of law.
Stipulates that no public entity, its agents, or employees
will be subject to criminal prosecution for the
distribution of hypodermic needles or syringes to
participants in clean needle and syringe exchange programs
authorized by law.
STAFF ANALYSIS OF SENATE BILL 41 (Yee) Page
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This bill:
Repeals the Disease Prevention Demonstration Project.
Repeals the prohibition on individual possession of a
hypodermic needle or syringe except under specified
circumstances, and instead allows individuals to obtain
from a physician or pharmacist up to 30 hypodermic needles
or syringes for personal use.
As a public health measure, allows a physician or
pharmacist to furnish up to 30 hypodermic needles or
syringes to an adult without a prescription or permit for
personal use.
Removes the requirement for local government authorization
of pharmacists' distribution of needles or syringes.
Increases the cap from 10 to 30 needles or syringes that a
pharmacist may distribute to any one person without a
prescription.
Requires pharmacies that furnish non-prescription needles
and syringes to:
Store needles and syringes so that they are only
available to authorized personnel,
Provide consumers with needle and syringe
collection and disposal options, and
Provide written information or verbal counseling on
accessing drug treatment, HIV and Hepatitis C testing,
and safe sharps waste disposal to consumers at the
point of sale.
Requires the Office of AIDS (OA), within CDPH to develop
and maintain information for consumers on its website
regarding access to drug treatment, testing and treatment
for viral hepatitis and HIV, and the safe disposal of
needles and syringes. Requires the State Board of Pharmacy
to also post this information on its website.
States the intent of the Legislature to improve access to
needles and syringes to reduce the spread of communicable
diseases.
FISCAL IMPACT
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This bill has not yet been analyzed by a fiscal committee.
BACKGROUND AND DISCUSSION
According to the author, the intent of the bill is to
improve access to hypodermic needles and syringes in order
to remove significant barriers for persons seeking to
protect their health and the health of other persons. The
author also seeks to remove barriers for programs or
businesses to provide sterile injection equipment and
education to adults.
The author claims that allowing adults to purchase a
sterile needle or syringe at their own cost will
significantly reduce the number of new HIV and hepatitis
infections, providing for significant cost savings from the
prevention of infections. As many of these infections
occur among the indigent, and as other infections occur
among those who will be made medically indigent by the high
cost of HIV and/or hepatitis care, the author believes the
prevention of infections could save the state hundreds of
millions of dollars in General Fund expenditures from
Medi-Cal and other programs that provide medical and
prescription care to persons with HIV/AIDS and hepatitis B
& C.
Injection drug use and disease prevalence
According to the CDPH/OA, injection drug use is the second
leading cause of HIV transmission and the leading cause of
hepatitis C virus (HCV) infection in California. Sharing of
contaminated syringes and other injection equipment is
linked to 19 percent of all reported AIDS cases in the
state. The shared use of needles and syringes was
recognized as being associated with HIV transmission among
injection drug users at the onset of the HIV/AIDS pandemic.
Nationwide, injection drug use accounted for 17 percent of
new HIV/AIDS diagnoses in adults and adolescents in 2007,
according to the Centers for Disease Control and Prevention
(CDC). California data suggests that over 1,500 new
syringe-sharing HIV infections occur annually. The link
between injection drug use and HIV/AIDS is particularly
strong for women and people of color. In California, 37
percent of cumulative AIDS cases among women, 24.3 percent
of cases among African American men and women, and 22.4
percent of cases among Latinas are directly attributable to
syringe-sharing.
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In addition, there are an estimated 500,000 to 600,000
Californians currently infected with HCV with an estimated
5,000 new infections annually due to injection drug use.
Viral hepatitis is a major cause of liver cancer and the
leading cause of liver transplants nationwide. In the
United States, there are more than 5 million people living
with chronic hepatitis B virus (HBV) or chronic HCV. In
2007 alone, HBV- and HCV-related hospitalization costs in
California totaled $2 billion. Over the next 20 years,
annual medical costs for people with HCV nationwide are
expected to increase more than 2.5 times, from $30 billion
to more than $85 billion.
Clean needle and syringe exchange programs (SEPs)
SEPs make sterile needles available to intravenous drug
users (IDUs) in order to avoid acquiring and transmitting
bloodborne diseases such as HIV, HBV and HCV. SEPs provide
a safe and accessible method for IDUs to exchange used
syringes for sterile ones. SEPs use special puncture-proof
containers to collect used syringes, which are then
collected and safely disposed of according to special
procedures designated for hazardous waste.
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. According to the National Institutes of Health,
individuals in areas with SEPs have an increased likelihood
of entering drug treatment programs.
SEPs have been shown to be effective in reducing the
sharing of syringes and the transmission of bloodborne
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 needle stick, 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 (OTC) sales or purchases of needles and
syringes was twice as high as the mean HIV prevalence rate
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in metropolitan areas that allow over-the-counter sales
(13.8 percent versus 6.7 percent respectively).
CDPH has awarded over $3.5 million in state General Fund
money to authorized SEPs across the state to provide
syringe exchange, HIV and HCV testing, counseling and
referral to needed services. Recent cuts in the state
General Fund 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
precluded the funding of SEPs.
Local SEP implementation
According to the Center for Health Improvement, there were
41 authorized SEPs in California as of March 2009.
Currently, a public entity that receives state General Fund
money from CDPH for the purpose of HIV education and
prevention and, as part of an authorized SEP, can use those
funds for the purchase of sterile hypodermic needles and
syringes. Cities and counties are enabled to authorize a
SEP as part of a comprehensive network of services. Under
current law, no public entity, its agents, or employees
will be subject to criminal prosecution for the
distribution of hypodermic needles or syringes to
participants in SEPs.
Local government, local public health officials, law
enforcement personnel and the public are supposed to be
given the opportunity to provide comments on the 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 bloodborne infections associated with
needle-sharing activities and the use of public funds for
these programs. According to the CDPH/OA, 17 county boards
of supervisors and four city councils so far have
authorized SEPs, and several other counties and cities are
currently planning for authorization.
Pharmacy sale of syringes
Until the 2004 signing of SB 1159 (Vasconcellos) that
started the DPDP, California was one of only five states
that still required a prescription in order to purchase a
syringe. In the early 1980s insulin and allergy syringes
could be bought in any drugstore without a prescription. In
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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 1990s, some states began requiring needles to be stored
behind the pharmacy counter and began requiring
prescriptions 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.
To address and prevent the spread of bloodborne infectious
diseases among IDUs in California, the DPDP was established
to allow the sale of up to ten hypodermic needles or
syringes at pharmacies without a prescription. 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, the sale and possession of syringes without a
prescription remains illegal in California.
Under current law, pharmacies that participate in the DPDP
are required to register with their local health department
and certify that they will provide information to adult
purchasers of needles or syringes about drug treatment
programs, testing and treatment programs for HIV and HCV,
and safe disposal of sharps waste. They are also required
to store needles and syringes such that only authorized
pharmacy personnel may have access, provide on-site
collection and disposal options for used needles, and make
mail-back and personal sharps disposal containers available
to purchasers. Participating local health departments are
required to maintain a list of all pharmacies registered
under the DPDP and make available to pharmacies written
information that can be provided at the time of furnishing
or selling non-prescription needles and syringes.
Needlestick injuries
Access to sterile syringes can affect the occupational
health and safety of peace officers and waste management
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employees because they are at risk of accidental
needlestick injuries. 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. 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 two
or more needlestick injuries. Research has shown that
accidental needlestick injuries 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.
CDPH evaluation of SB 1159
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
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
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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 �OTC] 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.
Related Bills
AB 604 (Skinner) would permit CDPH to authorize specified
entities to provide hypodermic needle and syringe exchange
services consistent with state and federal standards,
including those of the United States Public Health Service,
in any location where CDPH determines that the conditions
exist for the rapid spread of HIV, viral hepatitis, or any
other potentially deadly or disabling infections that are
spread through the sharing of used hypodermic needles and
syringes. Pending in the Assembly Health Committee.
Prior legislation
SB 1029 (Yee) of 2010 is substantially similar to this
bill, and would have allowed 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. This bill would have
repealed the 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
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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.
AB 110 (Laird) Chapter 707, Statutes of 2007, permits a
public entity that receives General Fund money for HIV
prevention and education from CDPH to use that money to
support clean needle and syringe exchange projects, as
specified.
SB 1305 (Figueroa) Chapter 64, Statutes of 2006, prohibits
a person from knowingly placing home-generated sharps waste
in the commercial and residential solid waste collection
containers after September 1, 2008.
AB 1597 (Laird) of 2005 and AB 2076 (Laird) of 2006
contained provisions substantially similar to AB 110.
Governor Schwarzenegger vetoed AB 1597, stating
"authorizing the use of state funds to purchase syringes,
without appropriate local controls, including mechanisms
for input from local law enforcement, and protections
against the use of state funds to supplant private or local
resources is not prudent." AB 2076 was held on the
Assembly Floor.
AB 547 (Berg and Richman) Chapter 692, Statutes of 2005,
authorized 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 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
established the DPDP to evaluate the long-term desirability
of allowing licensed pharmacies to sell or furnish
non-prescription hypodermic needles or syringes to prevent
the spread of bloodborne pathogens, authorized a licensed
pharmacist, until December 31, 2010 and subject to
authorization by a county or city, to sell or furnish ten
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.
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SB 774 (Vasconcellos) 2003 was almost identical to SB 1159,
however the needle and syringe limit was higher, permitting
a maximum of 30. Vetoed.
SB 1785 (Vasconcellos) 2002 was nearly identical to SB 774,
however the bill included an additional provision that
would have mandated criminal penalties for discarding or
disposing of hypodermic needles or syringes on a
playground, public beach, public park, or the grounds of an
elementary, vocational, junior high, or high school.
Vetoed.
AB 136 (Mazzoni) Chapter 762, Statutes of 1999, exempts
from criminal prosecution public entities and their agents
and employees who distribute hypodermic needles or syringes
to participants in SEPs authorized by the public entity
pursuant to a declaration of a local emergency due to the
existence of a critical local public health crisis.
Arguments in support
The Drug Policy Alliance and the San Francisco AIDS
Foundation are sponsoring this bill because they believe
legal access to sterile syringes for adults is a proven
method for reducing the transmission of HIV, hepatitis C
and other costly, deadly bloodborne diseases. They claim
that preventing disease transmission is sound fiscal policy
and believe expanding access to sterile syringes statewide
will reduce costs to California taxpayers.
Rite Aid and CVS/Caremark both support this bill and claim
their respective experiences in other states demonstrates
that allowing pharmacists to dispense needles without a
prescription enhances public health. They also support
creating a statewide policy on pharmacy sale of syringes,
in contrast to the current patchwork of county programs,
because it will decrease confusion for pharmacies which are
located in multiple jurisdictions. The California
Retailers Association also supports the statewide solution
established by this legislation and believes all
communities benefit from this highly effective, no-cost
approach to disease prevention.
Arguments in opposition
The Riverside Sheriffs Association and the Association of
Los Angeles Deputy Sheriffs oppose this measure due to the
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potential for needle dumping and for careless distribution
of the actual needles in the pharmacy and nearby areas.
They claim that SB 41 does not stop at its broad-based
approach to needle distribution but also makes changes
regarding additional drug implements as well. They believe
that needle furnishing programs should not harm public
safety, nor should a community lose its right to retain
control of such an important matter.
COMMENTS
1. Double referral. This bill is double referred to
the Public Safety Committee.
POSITIONS
Support: Drug Policy Alliance (sponsor)
San Francisco AIDS Foundation (co-sponsor)
ACLU
AFSCME
AIDS Project Los Angeles
Alameda County Board of Supervisors
California Hepatitis Alliance
California Medical Association
California Nurses Association
California Opioid Maintenance Providers
California Pharmacists Association
California Psychiatric Association
California Retailers Association
County Alcohol and Drug Program Administrators
Association of
California
CVS/Caremark
Drug Policy Alliance
Friends Committee on Legislation of California
Health Officers Association of California
Rite Aid
San Francisco Hepatitis C Task Force
Santa Clara County Board of Supervisors
Walgreens
Oppose: Association of Los Angeles Deputy Sheriffs
California District Attorneys Association
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California State Sheriffs' Association
Chief Probation Officers of California
Riverside Sheriffs' Association
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