BILL ANALYSIS
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|Hearing Date: April 19, 2010 |Bill No:SB |
| |1029 |
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SENATE COMMITTEE ON BUSINESS, PROFESSIONS
AND ECONOMIC DEVELOPMENT
Senator Gloria Negrete McLeod, Chair
Bill No: SB 1029Author:Yee
As Amended:April 7, 2010 Fiscal: Yes
SUBJECT: Hypodermic needles and syringes.
SUMMARY: Allows pharmacies in California the discretion to sell up to
30 sterile syringes to an adult without a prescription.
NOTE : This bill was heard in the Senate Committee on Health on March
24, 2010 and passed as amended with a 6-3 vote.
Existing law:
1)Provides for the licensure and regulation of pharmacies, pharmacists
and wholesalers of dangerous drugs or devices by the California
State Board of Pharmacy (Board) in the Department of Consumer
Affairs (DCA).
2)Specifies certain requirements regarding the dispensing and
furnishing of dangerous drugs and devices, and prohibits a person
from furnishing any dangerous drug or device except upon the
prescription of a physician, dentist, podiatrist, optometrist, or
veterinarian.
3)Requires that no person shall possess a hypodermic needle or syringe
except when acquired in accordance with specified provisions of the
law.
4)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.
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Page 2
5)Allows a pharmacist, veterinarian or person licensed by the Board to
furnish hypodermic needles or syringes for animal use without a
prescription or permit if the person is known to the furnisher and
able to properly establish his or her identity.
6)Allows counties to authorize pharmacists to furnish or sell 10 or
fewer hypodermic needles or syringes to adults 18 years of age or
older, for the period commencing January 1, 2005 and ending December
31, 2010, if the pharmacy is registered for the Disease Prevention
Demonstration Project (DPDP) and if the pharmacy complies with other
specific provisions.
7)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.
8)Requires, as part of the DPDP, that participating pharmacies
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 point of
sale.
9)Proscribes, as part of the DPDP, requirements for the secure storage
of needles and syringes in pharmacies, and requires pharmacies to
make safe disposal options available to users.
10)Requires, as part of the DPDP, 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 a prescription, and to provide a report to the Governor and
the Legislature on or before January 15, 2010.
11)Creates the Office of Aids (OA) within CDPH as the lead agency
within the state responsible for coordinating state programs,
services, and activities relating to the human immunodeficiency
virus (HIV), acquired immune deficiency syndrome (AIDS), and AIDS
related conditions (ARC).
12)Authorizes clean needle exchange programs in a 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.
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Page 3
13)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 projects authorized by law.
This bill:
1) Declares legislative intent to improve access to syringes and
hypodermic needles for the purpose of protecting public health,
providing sterile injection equipment and allowing for education to
reduce the spread of communicable diseases.
2) Deletes the December 31, 2010 sunset date for the DPDP pilot
program and authorizes its provisions in a statewide program until
December 31, 2018.
3) 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.
4) Allows a pharmacist, veterinarian or person licensed by the Board
to furnish hypodermic needles or syringes for animal use without a
prescription or permit if the person is known to the furnisher and
able to properly establish his or her identity.
5) Allows a physician or pharmacist anywhere in the state the
discretion to furnish 30 or fewer hypodermic needles or syringes to
adults 18 years of age or older without a prescription or permit
solely for personal use. Specifies that this provision is for the
purpose of preventing the transmission of HIV, viral hepatitis,
other blood-borne diseases and subsequent infection of sexual
partners, newborn children, or other persons.
6) Removes the requirement for local authorization through a vote of a
Board of Supervisors or City Council.
7) Allows individuals to possess 30 or fewer syringes solely for
personal use if acquired from a pharmacy, physician or syringe
exchange program.
8) Requires pharmacies to store hypodermic needles and syringes in a
manner that ensures that they are available only to authorized
personnel, and are not accessible to other persons.
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9) Requires all pharmacies that furnish nonprescription syringes to
provide for safe disposal of syringe and sharps waste, by providing
one or more of the following options:
a) The pharmacy participate in a syringe take-back program.
b) The pharmacy furnish or make available mail-back containers
approved by the US Postal Service for the transportation and
destruction of sharps waste.
c) The pharmacy furnishes or makes available sharps containers
that meet applicable state or federal standards for disposal of
sharps waste.
1) Requires all pharmacies to furnish information to purchasers of
nonprescription syringes about accessing drug treatment, accessing
HIV and hepatitis screenings and safe disposal of syringe and
sharps waste.
2) Requires OA to develop and maintain information on its website
about accessing drug treatment, accessing HIV and hepatitis
screenings and safe disposal of syringe and sharps waste; requires
the Board to either post or maintain a link to the same information
on its website.
FISCAL EFFECT: Unknown. This bill is keyed "fiscal" by Legislative
Counsel.
COMMENTS:
1. Purpose. This bill is co-sponsored by the Drug Policy Alliance and
San Francisco AIDS Foundation . According to the Author, "This bill
is needed because California is suffering an unnecessarily high
rate of HIV and viral hepatitis due to syringe scarcity. 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."
The Author also cites syringe scarcity as contributing to the
state's high rate of HIV and viral hepatitis, considering the role
that sharing of used syringes play in cases of new infections of
both diseases. According to the Author, "these conditions are
costly and potentially deadly. Hospitalizations for hepatitis B
and C cost the state $2 billion in 2007, according to a recent
report of California Research Bureau based on data provided by the
California Department of Public Health (CDPH.)"
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Further, the Author states that "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. Background. It is estimated that each year, over 8 million people
across the country use more than 3 billion needles, syringes and
sharps to manage a variety of medical conditions at home, including
allergies, arthritis, cancer, diabetes, hepatitis, HIV/AIDS,
infertility, migraines, Multiple Sclerosis, osteoporosis and
psoriasis. In California alone, over 2 million people currently
live with diabetes, many of whom take insulin to manage their
disease. Most of these Californians who take insulin use a needle
and syringe to inject it under the skin. Yet many people do not
always know the safest means of disposal, increasing the risk of
needle-stick injuries and exposure to other diseases.
HIV and other blood-borne pathogens are transmitted among injection
drug users (IDUs) through the reuse and sharing of contaminated
needles. According to OA, "injection drug use is the second
leading cause of HIV transmission and the leading cause of
hepatitis C virus infection in California. IDUs continue to be at
high risk for HIV and hepatitis infection in California. Sharing
of contaminated syringes and other injection equipment is linked to
19 percent of all reported AIDS cases in the state. California
data suggests that over 1,500 new syringe-sharing HIV infections
occur annually. The link between injection drug use and HIV in
California is particularly strong for women and people of color.
Among adult/adolescent women in California, injection drug
use-related risk factors account for 35 percent of cumulative AIDS
cases. Forty-six percent of AIDS cases among African American
women and 55 percent of AIDS cases among Native American women are
associated with injection drug use, compared to 40 percent of AIDS
cases among White women."
Studies throughout the nation and state, and recommendations from
government agencies, professional associations and non-profits look
to pharmacies as key partners in the effort to combat further
spread of disease and complications arising from use of
contaminated needles and syringes and to improve access to sterile
needles and syringes. Pharmacies and pharmacists are seen as a
reliable source for sterile needles and syringes because of their
location in neighborhoods, extended hours of operation, presence of
trained and licensed professionals, existing infrastructure to
offer sales of needles and syringes, and availability of safe
disposal options.
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As early as July 1991, the National Commission on AIDS recommended
removing legal barriers to the purchase and possession of needles
and syringes as part of a strategy for reducing the spread of HIV
among IDUs unable or unwilling to enter drug treatment. In a joint
letter, the American Medical Association (AMA), the American
Pharmaceutical Association (APhA), the Association of State and
Territorial Health Officials (ASTHO), the National Alliance of
State and Territorial AIDS Directors (NASTAD) and the National
Association of Boards of Pharmacy (NABP) also stated that
"coordinated efforts of state leaders in pharmacy, public health,
and medicine are needed to address access to sterile syringes as a
means of preventing further transmission of blood-borne diseases."
3. Effectiveness of the DPDP. CDPH was required to report to the
Governor and the Legislature by January 15th of this year on the
impact of allowing pharmacists to furnish or sell nonprescription
hypodermic needles or syringes, specifically focusing on: rates of
disease infection to syringe sharing; rates of crime in the
vicinity of pharmacies that participate in the program; rates of
drug use; rates of needle stick injury to law enforcement officers
and waste management employees, and rates of safe or unsafe discard
of syringes, and syringe sharing practice among IDUs.. CDPH was
also required to convene an uncompensated evaluation panel.
While the evaluation of DPDP is not yet available, CDPH in January
of this year released recommendations contained in the California
Adult Viral Hepatitis Prevention Strategic Plan for 2010-2014 that
are similar to provisions in this bill. In 2008, CDPH convened a
group of stakeholders, including state and local health officials,
service providers, community leaders, and individuals living with
or affected by viral hepatitis to outline an approach to prevent
transmission of the disease. Recommendations and actions contained
in the report's strategic direction section for "Targeting and
Integrating Services and Building Infrastructure" promote increased
access to syringe exchange programs, and other strategies, such as
encouraging pharmacists to participate in pharmacy syringe sales
programs, and removing structural barriers to accessing syringes
and other sage drug-using equipment for IDUs.
4. What Are Other States Doing And Do The Programs Work? Currently,
there are only three states, including California, that still
require a prescription to purchase a sterile syringe. Most states
allow between ten and thirty sterile syringes to be purchased,
although Washington state, for example, allows for unlimited sales
and possession of sterile syringes.
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A recent report by the New York Aids Institute, evaluating the of
first five years of that state's Expanded Syringe Access Program
(ESAP), which permits over-the-counter sale of syringes by
registered pharmacies, found that more than 90% of participants
reported no problems or very few problems administering the
program. The report concluded that "pharmacy-based syringe access
is a viable harm-reduction alternative in the fight against
blood-borne diseases?".
In reviewing efforts in Connecticut to allow pharmacists to furnish
needles and syringes without a prescription, the Centers for
Disease Control (CDC) reported findings (based primarily on focus
group conversations with IDUs) within the first five months of the
program that IDUs purchased syringes from pharmacies, syringe
sharing decreased, and police reported fewer needle-stick injuries.
A May 2001 study published in the American Journal of Public Health
reviewed 96 metropolitan areas in the U.S. to determine the
relationship between laws restricting access to syringes and
prevalence of IDUs and HIV. The study concluded that these laws
against over-the-counter sales of syringes do not actually prevent
illicit drug injection but rather result in higher instances of HIV
- that "laws restricting syringe access are statistically
associated and should be repealed".
The first international review of U.S. governmental reports and
international studies on syringe access, including pharmacy access
and syringe exchanges, "Do Needle Syringe Programs Reduce HIV
Infection Among Injecting Drug Users: A Comprehensive Review of
the International Evidence," was published in 2006 in the journal
Substance Use & Misuse. Researchers found that "there is
compelling evidence of effectiveness, safety, and
cost-effectiveness, consistent with seven previous reviews
conducted by or on behalf of U.S. government agencies. Authorities
in countries affected or threatened by HIV infection among
injecting drug users should carefully consider this convincing
evidence now available for needle syringe programs with a view to
establishing or expanding needle syringe programs to scale."
5. Related and Previous Legislation.
AB 1701 (Chesbro) deletes the sunset date for the DPDP and continues
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the program indefinitely. This measure passed the Assembly Health
Committee on March 23, 2010 with a 14-4 vote and is currently on
Assembly Third Reading.
AB 1858 (Blumenfield) allows CDPH to authorize clinics, health
services organizations, community-based organizations or other
entities to provide hypodermic needle and syringe exchange services
in locations the Department determines conditions exist for the
rapid spread of HIV or other diseases. This measure is set for
hearing in the Assembly Health Committee on April 6, 2010.
AB 110 (Laird) Chapter 707, Statutes of 2007, permitted 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, prohibited a person
from knowingly placing home-generated sharps waste in 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 1597 was held at the Assembly Desk.
AB 547 (Berg and Richman) Chapter 692, Statutes of 2005, authorized
clean needle exchange programs 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, created the
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, authorized
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.
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SB 774 (Vasconcellos) of 2003, which was vetoed by the Governor, was
almost identical to SB 1159 but allowed a maximum of 30 hypodermic
needles or syringes.
SB 1785 (Vasconcellos) of 2002, which was vetoed by the Governor,
was nearly identical to SB 744, 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 school, vocational, junior high, or high school.
AB 1292 (Aroner) of 2001 was similar to SB 1785 and SB 744. The
measure would have authorized pharmacists in a licensed pharmacy to
furnish or sell at retail hypodermic needles or syringes for human
use without a prescription. This measure did not move through the
legislative process.
AB 136 (Mazzoni), Chapter 762, Statutes of 1999, exempted public
entities and their agents and employees from criminal prosecution
for distributing hypodermic needles or syringes to participants in
clean needle and syringe exchange projects authorized by the public
entity, pursuant to a declaration of a local emergency due to the
existence of a critical local public health crisis.
6. Arguments in Support.
The Sponsors of this measure, Drug Policy Alliance and San
Francisco AIDS Foundation, state that "Preventing the spread of
infectious disease will save California taxpayers hundreds of
millions of dollars in healthcare costs." They further state that
"The current California pilot project has been successful?and no
adverse events have been reported and pharmacists are enthusiastic
about participating."
In its support, the California Medical Association states that HIV
and hepatitis can easily be prevented by providing access to
sterile syringes.
The California Nurses Association (CNA) notes that it supported
previous legislative efforts to establish programs for statewide
access to sterile syringes at pharmacies and that they continue to
support "this life-protecting policy".
The California Pharmacists Association (CPHA) writes that it
"supports access to hypodermic needles as a matter of public
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health" and cites the effectiveness of these efforts in fighting
disease.
The California Psychiatric Association states that needle exchange
programs "save lives, prevent disease and ultimately save money and
prevent needless suffering and human and economic costs."
According to the California Retailers Association , "Preventing
disease before it spreads is sound fiscal policy, particularly in
light of California's current recession and budget cuts.
Additionally, CRA believes all communities throughout the state
benefit from this highly effective, no-cost approach and supports
the statewide solution established by this legislation."
7. Arguments in Opposition.
The California Narcotic Officers' Association argues that "there is
very good reason to allow local option with respect to needle
furnishing programs, and each community should retain sovereignty
concerning these important matters" in its opposition to this
measure's removal of local authorization for a needle furnishing
program.
The California Peace Officers' Association and California Police
Chiefs' Association echoes the same sentiment in arguing that
"there have been too many instances of needle users irresponsibly
dumping their needles in ways that jeopardize others."
8. Policy Issue : The Role of the Pharmacy Board. The Board is
charged with enforcement of the state's Pharmacy Law through its 13
major regulatory programs that regulate both the individuals and
firms that procure, ship, store and dispense prescription drugs and
devices to the state's health care providers and patients, both
from within and outside California. As such, the Board collects
data on and performs inspections of its licensees. Should the
Board be provided notification through a registration process or on
licensing applications when a pharmacy or pharmacist participates
in the program to furnish needles or syringes without a
prescription to ensure accountability and effectiveness of the
program?
SUPPORT AND OPPOSITION:
Support:
Drug Policy Alliance (Co-sponsor)
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San Francisco Aids Foundation (Co-sponsor)
AIDS Project Los Angeles
American Civil Liberties Union
California Association of Alcohol and Drug Program Executives, Inc.
California Communities United Institute
California Hepatitis Alliance
California Nurses Association/National Nurses Organizing Committee
California Medical Association
California Opioid Maintenance Providers
California Pharmacists Association
California Psychiatric Association
California Retailers Association
California Society of Addiction Medicine
City and County of San Francisco
City of West Hollywood
County Alcohol & Drug Program Administrators Association of California
County of Alameda
Equality California
Health Officers Association of California
Planned Parenthood
Planned Parenthood Advocacy Project of Los Angeles County
Planned Parenthood of Orange and San Bernardino Counties
Project Inform
Rite Aid
San Francisco Mayor's Hepatitis C Task Force
Walgreens
Opposition:
California Narcotic Officers' Association
California Peace Officers' Association
California Police Chiefs' Association
Consultant:Sarah Mason