BILL ANALYSIS �
SENATE COMMITTEE ON PUBLIC SAFETY
Senator Loni Hancock, Chair S
2011-2012 Regular Session B
4
1
SB 41 (Yee)
As Introduced December 7, 2010
Hearing date: April 26, 2011
Business and Professions and Health and Safety Codes
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HYPODERMIC NEEDLES AND SYRINGES
HISTORY
Source: San Francisco Aids Foundation; Drug Policy Alliance
Prior Legislation: AB 1701 (Chesbro) - Ch. 667, Stats. 2010
AB 1858 (Blumenfield) - 2010 Vetoed
AB 110 (Laird) - Ch. 707, Stats. 2007
SB 1305 (Figueroa) - Ch. 64, Stats. 2006
AB 547 (Berg and Richman) - Ch. 692, Stats. 2005
SB 1159 (Vasconcellos) - Ch.608, Stats.
2004
SB 774 (Vasconcellos) - 2003, Vetoed
SB 1785 (Vasconcellos) - 2002, Vetoed
AB 136 (Mazzoni) - Ch. 762, Stats. 1999
Support: Health Officers Association of California;
California Public Defenders Association; AIDS Project
Los Angeles; City and County of San Francisco; Alameda
County Board of Supervisors; American Civil Liberties
Union; American Federation of State County and
Municipal Employees; California Communities United
Institute; California Family Health Council;
California Nurses Association; California Pharmacists
Association; California Psychiatric Association; City
and County of San Francisco; County Alcohol and Drug
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Program Administrators Association of California;
California Medical Association; California Opioid
Maintenance Providers; California Retailers
Association; County of Santa Clara Board of
Supervisors; Friends Committee on Legislation of
California; Planned Parenthood Affiliates of
California, Inc.; Rite Aid; San Francisco Hepatitis C
Task Force; California Association of Alcohol and Drug
Programs Executives, Inc.; Equality California; Los
Angeles County Solid Waste Management
Committee/Integrated Waste Management Task Force
(support if amended)
Opposition:California District Attorneys Association; Peace
Officers Research Association; California State
Sheriffs' Association; Chief Probation Officers of
California
(SEE COMMENT # 7 FOR A DESCRIPTION OF AMENDMENTS TO BE OFFERED
BY THE AUTHOR IN COMMITTEE.)
KEY ISSUES
SHOULD A PHARMACY BE AUTHORIZED TO PROVIDE A PERSON WITH UP TO 30
HYPODERMIC NEEDLES OR SYRINGES PER DAY FOR PERSONAL USE WITHOUT A
PRESCRIPTION?
SHOULD PHARMACIES THAT PROVIDE NON-PRESCRIPTION HYPODERMIC NEEDLES
BE REQUIRED TO 1) ALLOW ONLY AUTHORIZED PERSONNEL ACCESS TO NEEDLES
AND SYRINGES; 2) GIVE CUSTOMERS NEEDLE AND SYRINGE DISPOSAL OPTIONS;
AND 3) PROVIDE CUSTOMERS WITH COUNSELING OR INFORMATION ON DRUG
TREATMENT, HIV AND HEPATITIS C TESTING, AND SAFE SHARPS DISPOSAL?
SHOULD THE EXISTING PROGRAM THAT REQUIRES LOCAL GOVERNMENT ENTITIES
TO APPROVE LIMITED NON-PRESCRIPTION HYPODERMIC NEEDLES SALES BY
PHARMACIES BE ELIMINATED?
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PURPOSE
The purposes of this bill are to 1) state legislative intent to
improve access to needles and syringes to reduce the spread of
communicable diseases; 2) allow a person to obtain from a
pharmacist or physician up to 30 hypodermic needles for personal
use; 3) eliminate the requirement that a local government entity
authorize pharmacists to provide hypodermic needles or syringes
without a prescription; and 4) require pharmacies that
distribute non-prescription needles and syringes to do the
following: a) allow access to needles and syringes only by
authorized personnel; b) give customers needle and syringe
collection and disposal options; and c) provide written
information or oral counseling to customers on drug treatment,
HIV and Hepatitis C testing, and safe sharps disposal.
Existing law prohibits possession of a hypodermic needle or
syringe except by prescription, unless otherwise authorized by
law. (Bus. & Prof. Code � 4140-4141.)
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. (Bus. & Prof.
Code � 4145, subd. (a)(1).)
Existing law 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 and
if the pharmacy complies with other specified provisions. (Bus.
& Prof. Code � 4145, subd. (a)(2).)
Existing law establishes the Disease Prevention Demonstration
Project (DPDP)<1> as a collaboration between pharmacies and
local and state health officials for the purpose of evaluating
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<1> SB 1159 (Vasconcellos) Ch. 608, Stats. 2004 and AB 1701
(Chesbro) Ch. 667, Stats. 2010
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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. (Health & Saf. Code �121285.)
The DPDP includes the following:
Participating pharmacies must 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.
Needles and syringes must be securely stored in
pharmacies.
Pharmacies must make safe disposal options available to
users.
The California Department of Public Health (CDPH) shall
evaluate non-prescription distribution by pharmacists of
hypodermic needles or syringes; and CDPH shall report its
findings to the Governor and the Legislature on or before
January 15, 2010.
Existing law 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. (Health &
Saf. Code � 121349.)
Existing 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.
(Health & Saf. Code � 121349.1.)
This bill repeals the Disease Prevention Demonstration Project.
This bill 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.
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This bill removes the requirement for local government
authorization of pharmacists' distribution of needles or
syringes.
This bill increases the cap from 10 to 30 needles or syringes
that a pharmacist may distribute to any one person without a
prescription.
This bill 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.
This bill 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. The bill also requires the State Board of Pharmacy to
also post this information on its website.
This bill states legislative intent to improve access to needles
and syringes to reduce the spread of communicable diseases.
RECEIVERSHIP/OVERCROWDING CRISIS AGGRAVATION
For the last several years, severe overcrowding in California's
prisons has been the focus of evolving and expensive litigation.
As these cases have progressed, prison conditions have
continued to be assailed, and the scrutiny of the federal courts
over California's prisons has intensified.
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On June 30, 2005, in a class action lawsuit filed four years
earlier, the United States District Court for the Northern
District of California established a Receivership to take
control of the delivery of medical services to all California
state prisoners confined by the California Department of
Corrections and Rehabilitation ("CDCR"). In December of 2006,
plaintiffs in two federal lawsuits against CDCR sought a
court-ordered limit on the prison population pursuant to the
federal Prison Litigation Reform Act. On January 12, 2010, a
three-judge federal panel issued an order requiring California
to reduce its inmate population to 137.5 percent of design
capacity -- a reduction at that time of roughly 40,000 inmates
-- within two years. The court stayed implementation of its
ruling pending the state's appeal to the U.S. Supreme Court.
On Monday, June 14, 2010, the U.S. Supreme Court agreed to hear
the state's appeal of this order and, on Tuesday, November 30,
2010, the Court heard oral arguments. A decision is expected as
early as this spring.
In response to the unresolved prison capacity crisis, in early
2007 the Senate Committee on Public Safety began holding
legislative proposals which could further exacerbate prison
overcrowding through new or expanded felony prosecutions.
This bill does not appear to aggravate the prison overcrowding
crisis described above.
COMMENTS
1.Need for This Bill
According to the author:
This bill will improve access to syringes and hypodermic
needles and thus remove barriers for persons seeking to
protect their health and the health of others. The bill also
removes barriers for programs or businesses to provide sterile
injection equipment and education to adults, thereby reducing
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the spread of communicable diseases and protecting the public
health. While many states allow an unlimited number of
syringes to be sold to an adult, this bill is an incremental
move away from complete prohibition of sale and possession of
syringes, allowing an adult to purchase and possess 30 or
fewer syringes for personal use.
California has an unnecessarily high rate of HIV and viral
hepatitis due to syringe scarcity. Sharing of used syringes
is the most common cause of new hepatitis C infections in the
state (approx. 3,000 per year) and the second most common
cause of HIV infections (approx.. 750 per year). Many women
were infected by sexual contact with a person who had shared a
dirty syringe.
A study published in the American Journal of Public Health
compared rates of injection drug use and rates of HIV in 96
U.S. cities. Sixty cites did not require a prescription for
the sale of syringes and 36 did require a prescription. There
was no statistically significant difference in the prevalence
of injection drug use between the two groups of cities.
However, the rate of HIV among injection drug users was twice
as high in the cities that prohibited sale of syringes (13.8%
versus 6.7%). (Friedman, SR, Perlis, T, Des Jarlais DC. Laws
Prohibiting Over-the-Counter Syringe Sale to Injection Drug
users: Relations to Population Density, HIV Prevalence, and
HIV Incidence. American Journal of Public Health
2001;91:791-793.)
Last year, the Department of Public Health (CDPH) published a
positive report on the existing California pilot project that
allows local government entities to approve limited
non-prescription sales of needles and syringes. The success
of SB 1159 in reducing syringe sharing was only limited by
costs and procedural barriers created by the "dual opt-in"
process whereby local health departments had to expend time
and effort to seek an authorizing vote, the county board city
council had to approve the recommendation, and then the local
health department had sign-up local pharmacies and provide
them with educational materials. The next step in the "dual
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opt-in" was that the pharmacies had to provide written
registration and certification to the local health department.
As a result of these barriers, even jurisdictions that
allowed participation experienced significant delays in
implementation. Los Angeles County Public Health Department
did not sign up even one pharmacy until 18-months after the
Board of Supervisors authorized the program.
This bill appropriately provides the discretion to licensed
pharmacists to decide whether they wish to participate in
community based public health and preventatives services.
Pharmacists will decide whether it is appropriate to sell a
limited number of syringes to an adult.
2. Pharmacy Sale of Syringes in California Under the Disease
Prevention Demonstration Project
Until the 2004 enactment of the Disease Prevention Demonstration
Project (DPDP), California was one of only five states that
required a prescription for a syringe. To address and prevent
the spread of blood-borne diseases among intravenous drug user
in California, the DPDP was established to allow the
non-prescription sale of up to ten hypodermic needles or
syringes at pharmacies. To participate in the DPDP, pharmacies
must register with their local health department and agree to
provide 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.
3. July 2010 Department of Public Health Evaluation of
Non-Prescription Pharmacy Distribution of Needles and Syringes
Prior legislation required CDPH to report to the Governor and
Legislature by January 15, 2010, about how pharmacy distribution
of hypodermic needles and syringes affects rates of the
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following: 1) crime in the vicinity of pharmacies; 2) drug use;
3) needlestick injury to law enforcement officers and waste
management employees; 5) safe or unsafe discard of syringes; 6)
syringe-sharing practice among IDUs; and 7) disease infection
related to syringe sharing.
The report was released to the Legislature in July of 2010. It
made several key findings:
Injection-mediated risks were lower among IDUs in local
health jurisdictions (LHJ) that authorized DPDPs.
Reported needlestick injuries among law enforcement
officers remained rare.
Drug-related crime remained stable in the LHJs that
authorized DPDPs.
Levels of unsafe discard of hypodermic needles or
syringes around DPDPs were low.
Levels of injection of illegal drugs decreased among
publicly funded HIV testing clients since implementation of
SB 1159.
The report found that 40 to 45 percent of IDUs in
DPDP-authorizing counties reported never sharing syringes in the
past two years. In counties that did not authorize
over-the-counter sales, 22 to 32 percent if IDUs did not share
needles. The report stated that more time is needed to
accurately assess disease incidence rates due to limitations in
available data.
There were substantial differences in authorization and
implementation of local DPDPs. The report concluded that
requiring a two-step authorization process - government and then
pharmacy authorization - limited risk-reduction and recommended
elimination of this process.
4. Studies on Needles and Syringe Exchange Programs and
Over-the-Counter Sale
Over the past two decades various government entities across the
country and around the world have implemented programs to make
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needles and syringes available to drug users with the intention
of reducing the transmission of HIV, hepatitis C and other
bloodborne diseases. Many studies have been published on these
programs. A 2004 World Health Organization (WHO) review of more
than 200 studies concluded:
There is compelling evidence that increasing the
availability and utilization of sterile injection
equipment for both out-of-treatment and in-treatment
injecting drug users contributes substantially to
reductions in the rate of HIV transmission.
There is not convincing evidence of major unintended
consequences of programmes �sic] providing sterile
injecting equipment to injecting drug users, such as
initiation of injecting among people who have not
injected previously, or an increase in the duration or
frequency of drug use.
A May 2001 Study in the American Journal of Public Health
entitled, "Laws Prohibiting Over-the-Counter Syringe Sales to
Injection Drug Users: Relations to Population Density, HIV
Prevalence, and HIV Incidence" found the following:
Metropolitan area with anti OTC �over-the-counter
syringe sales] laws had a higher mean HIV prevalence
(13.8 vs. 6.7) than other metropolitan areas. ?
Population proportions of injection drug users did not
vary by presence of anti-OTC laws.
Anti-OTC laws are not associated with lower population
proportions of injection drug users. Laws restricting
syringe access are associated with HIV transmissions
and should be repealed.
5. 1997 Montreal Study often Cited by Opponents of
Over-the-Counter Distribution of Needles and Syringes -
Relatively Unique Participants; Reforms in Montreal Programs
Opponents of non-prescription access to syringes and needles
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often cite a 1997 study published in the American Journal of
Epidemiology by Dr. Julie Bruneau concerning a Montreal needle
exchange program by an entity called CACTUS that was used mostly
by cocaine IDUs. The study found that IDUs participating in the
program were more than twice as likely to become infected with
HIV than IDUs who did not participate in the program.
A 1998 paper in the Journal AIDS<2> heavily criticized the
CACTUS program. CACTUS served cocaine addicts who often
injected the drug substantially more than 15 to 20 times per
day, in runs of five or six days at a time, while the exchange
provided 15 needles per day. The IDUs quickly ran through clean
needles and began to share. CACTUS did not require a true
exchange of dirty needles for clean, but simply provided the
needles. The program was only open from 9:00 p.m. until 4:00
a.m. (It appears that other IDUs could obtain needles from
pharmacies during regular business hours.) The late-night hours
of operation attracted IDUs who were engaged in other high-risk
activities. For example, the program was located in an area
especially known for prostitution. The participants were less
likely to be involved in drug treatment and counseling than
participants in other programs. The authors questioned whether
HIV rates would have been higher among the participants had
there not been the needle program.
Shortly after publication of the study, Dr. Bruneau stated that
Montreal should have had more needle exchange programs and that
by not expanding the program earlier "we may have created
problems as well.'' Without adequate supplies of needles from
other programs, IDUs were likely to be drawn to IDUs
participating in the study in order to share their supply of
scarce needles.<3>
It appears that needle exchange programs in Montreal were
substantially reformed after publication of the 1997 study. Dr.
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<2> Drucker, Lurie, et al, Measuring Harm Reduction: The
Effects of Needle and Syringe Exchange Programs and Methadone
Maintenance on the Ecology of HIV, AIDS, 1998, 12 (suppl
A):S217-5230.)
<3> See http://www.ndsn.org/jan98/harmred1.html.
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Bruneau and others published a long-term study of needle
exchange programs in Montreal between 1992 and 2008 that
reflected decreased HIV transmission among IDUs. The abstract
of the paper states: "In conclusion, HIV incidence has declined
in this cohort, with an acceleration of the reduction in HIV
transmission after 2000. (Italics added.)<4>
WAS THE CACTUS MONTREAL NEEDLE PROGRAM CONSIDERED BY DR.
BRUNEAU'S 1997 STUDY DEEPLY FLAWED, SUCH THAT IT MAY HAVE
ENCOURAGED HIGH-RISK ACTIVITY THAT SPREAD HIV?
HAVE MORE RECENT STUDIES IN MONTREAL REFLECTED REDUCED RATES OF
HIV IN IDUs PARTICIPATING IN NEEDLE EXCHANGE PROGRAMS?
6. Concerns About Needlestick Injuries to Law Enforcement and
Waste Disposal Personnel
Peace officers and waste management employees 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.<5> Research has shown that accidental needlestick
injuries to police officers have decreased significantly
following the implementation of SEPs (syringe exchange
programs). For instance, studies in Connecticut and
Massachusetts found that needlestick injuries to officers were
reduced 66 percent after syringe deregulation.<6> In 1998, San
Francisco Police Chief Lau reported that needles from exchange
programs were more likely to be capped and thus less likely to
produce accidental injuries to officers. A study of New York
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<4> Bruneau, Daniel, et al, Trends in Human Immunodeficiency
Virus Incidence and Risk Behavior among Injection Drug Users in
Montreal, Canada: A 16-Year Longitudinal Study, Amer. Jour. of
Epidemiology, March, 2011.)
<5> (Occupational Needlestick Injuries in a Metro. Police Force,
Amer. Journ. of Preventive Medicine, Feb. 2000.)
<6> Groseclose, Weinstein, et al. "Impact of Increased Legal
Access to Needles ? on ? Drug users and Police -Connecticut,
1992-1993. Journal of Acquired Immune Deficiency Syndromes &
Human Retrovirology; 1995;10(1):82-89.)
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City sanitation workers found that needlestick injuries dropped
from thirty three to eleven per year after enactment of a law
allowing non-prescription pharmacy sale of hypodermic
needles.<7>
7. Amendments to be Offered by Author in Committee
Senator Yee, in presenting the bill in Senate Health, agreed to
offer amendments to the bill in this Committee, as follows.
1) Evaluation of the Implementation of the Bill
This amendment would clarify that General Fund money will not be
used to pay for a study of the implementation of the bill.
Further, the amendment specifies that DPH shall consult with law
enforcement leaders in assisting independent researchers in the
study. This amendment reads as follows:
The California Department of Public Health shall, in
consultation with law enforcement leaders, assist
independent researchers complete an evaluation of the
effect of allowing adults to purchase and possesses a
limited amount of sterile syringes on rates of crime,
drug use and unsafe discard of syringes. No state
General Funds may be used for the completion of the
evaluation.
2) Three-Year Sunset
The bill will include a three-year sunset (until December 31,
2014).
3)Safe Disposal of Syringes
As currently drafted, the bill requires participating pharmacies
to provide for safe disposal or needles and syringes. This
amendment would require any hypodermic needle or syringe
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<7> Lawitts S: Needle sightings and... needlestick injuries
among New York City ?sanitation workers. J Am Pharm Assoc. 2002,
42(6 Suppl 2):S92-S93.
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exchange program to also provide for safe disposal of needles
and syringes.
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