BILL ANALYSIS
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Sheila J. Kuehl, Chair
BILL NO: AB 501
A
AUTHOR: Swanson
B
AMENDED: May 6, 2008
HEARING DATE: June 11, 2008
5
FISCAL: Keyed Nonfiscal
0
CONSULTANT:
1
Hansel/sh
SUBJECT
Pharmaceutical devices
SUMMARY
Requires pharmaceutical manufacturers, upon request, to
arrange to provide consumers who are prescribed pre-filled
syringes, pre-filled pens, or other pre-filled injection
devices, with a postage prepaid mail-back sharps container,
or other approved sharps container. Requires such
manufacturers to also provide information on safe disposal
alternatives and options for sharps.
CHANGES TO EXISTING LAW
Existing law:
Existing law, the Medical Waste Management Act (Act),
establishes a comprehensive regulatory system for the
generation, handling, storage, transport, treatment, and
disposal of medical waste, as defined, which is overseen by
the Department of Public Health (DPH) and designated local
agencies.
Existing law allows DPH to approve home-generated sharps
waste consolidation locations, to which persons may
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transport home-generated sharps waste, and also allows
medical facilities which generate and handle medical waste
to collect such waste. Existing law additionally allows
city and county household hazardous waste plans to include
programs for the safe collection, treatment, and disposal
of home-generated sharps waste, as specified.
Effective September 1, 2008, existing law prohibits a
person from knowingly placing home-generated sharps waste
in any container used for the commercial and residential
collection of solid waste, recyclable materials, or green
waste. Existing law also provides that, after September 1,
2008, home-generated sharps waste may only be transported
in sharps containers, as defined, or other containers that
are approved by DPH or a local enforcement agency, and may
only be managed at a household hazardous waste facility, as
defined, a home-generated sharps consolidation point, as
defined, a medical waste generator's facility, or a waste
treatment facility through the use of an approved medical
waste mail-back container, as specified. "Home-generated
sharps waste" is defined in existing law as hypodermic
needles, pen needles, intravenous needles, lancets, and
other devices that are used to penetrate the skin for the
delivery of medications, that are derived from a household,
including a multifamily residence or household.
This bill:
This bill would require pharmaceutical manufacturers, upon
request, to provide consumers who are prescribed pre-filled
syringes, pre-filled pens, or other pre-filled injection
devices, with either a postage prepaid mail-back sharps
container that has been approved by the U.S. Postal Service
and DPH, or an approved sharps container that will
facilitate the safe storage of the sharps waste, and safe
transport to a sharps consolidation location that is
approved by DPH, or to a clinic, physician, or pharmacy
that accepts home-generated sharps waste. The manufacturer
would also be required to provide information on safe
disposal alternatives and options for sharps.
FISCAL IMPACT
According to the Assembly Floor analysis, this bill would
have no direct fiscal impact.
STAFF ANALYSIS OF ASSEMBLY BILL 501 (Swanson) Page
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BACKGROUND AND DISCUSSION
According to the author, the unsafe disposal of needles and
syringes into non-medical waste management systems is a
major and unnecessary public health risk. The author
states that AB 501 will make it easier for patients who use
self-injection devices for the treatment of conditions such
as diabetes, hepatitis, HIV, arthritis, allergies, and
multiple sclerosis, to safely and efficiently dispose of
their used sharps, by requiring pharmaceutical
manufacturers to provide a means for patients to receive
either a postage prepaid mail-back container or other
approved container for the sharps. The author cites
statistics indicating that at least two billion lawful
injections of medications occur yearly outside of health
care settings in California. Most of these used needles
end up in household trash and pose a significant risk of
injury and/or infection to children, sanitation workers,
and solid waste collection employees. The author states
that the Legislature has already authorized sharps
mail-back programs, utilizing containers and packaging
approved by the postal service, as a means of collecting
and destroying home-generated sharps, and has made previous
findings and declarations that the cooperative efforts of
the pharmaceutical industry are needed as part of the
development of a safe needle disposal system for
California.
Pre-filled syringes, pens and self- injection devices
Pre-filled syringes and pen injectors were developed,
beginning in the 1980s, for the reliable and accurate
injection at home of medications that must be taken
frequently. While use of the devices was initially limited
to insulin and human growth hormone, applications have more
recently been developed for drugs used to treat multiple
sclerosis, cancer, and infertility, as well as hormone
replacement drugs, blood factors, and vaccines. Use of the
devices has, in part, been accelerated by efforts made by
managed care plans to control costs by eliminating, for
certain medications, the use of a health care professional
to administer the medication. Pre-filled syringes can be
used directly, or in conjunction with various
auto-injectors, which automatically insert the needle and
administer the injection, by means of a spring-loaded
STAFF ANALYSIS OF ASSEMBLY BILL 501 (Swanson) Page
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device. Pen injectors are cartridge devices that
accommodate a single or multiple doses of a medication.
Many patients find these devices to be a more user-friendly
means of administering injection medications than standard
syringes. In the case of multiple-dose pen injectors, the
patient must remove and dispose of the needle upon
completion of the injection.
The Medical Waste Management Act
The Medical Waste Management Act, which became effective in
1991, and which is administered by DPH and designated local
entities, establishes a comprehensive system for regulating
the collection, transport, and treatment of medical waste.
The Act provides for the registration of medical waste
generators and transporters, requires operating permits for
treatment facilities such as incinerators and steam
sterilization units, and specifies methods for storing
medical waste and treating it so it may be handled as solid
waste. In 1995 the Act was amended to recognize
home-generated sharps waste as a type of medical waste and
to establish consolidation points for such waste, including
at health care facilities. Further amendments in 2004
allowed city and county household hazardous waste programs
to accept home-generated sharps waste. SB 1305 (Figueroa)
of 2006 amended the Act to prohibit, effective September 1,
2008, persons from knowingly placing home-generated sharps
waste in residential or commercial waste stream containers,
and to require these wastes to be transported in sharps
containers to approved medical waste collection sites or
household hazardous waste facilities, or to be sent to
approved medical waste treatment facilities through
approved mail-back systems.
Producer responsibility initiatives
A number of environmental organizations are promoting
initiatives to encourage producers and distributors of
certain products, particularly those requiring special
handling such as batteries, paints, electronic components,
and medical devices, to shoulder greater responsibility for
the proper disposal of the products. A number of
organizations support the concept of "Extended Producer
Responsibility" (EPR), which encompasses incentives and
mandates to make producers, and other entities which handle
their products, responsible for the disposal and management
of the products, and to encourage producers to make changes
STAFF ANALYSIS OF ASSEMBLY BILL 501 (Swanson) Page
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to their products to minimize their impact on human health
and the environment. The California Integrated Waste
Management Board recently developed a policy framework
intended to guide proposals to promote EPR.
Prior legislation:
SB 372 (Wright), Chapter 877, Statues of 1995, amended the
Medical Waste Management Act to allow hospitals and other
healthcare facilities to accept home-generated sharps waste
for consolidation with their own medical waste, and to
provide for the establishment of "home-generated sharps
consolidation points" such as pharmacies, fire stations,
and other facilities where home-generated sharps may be
collected.
SB 1362 (Figueroa), Chapter 157, Statues of 2004, allows
city and county household hazardous waste programs to
operate as home-generated sharps consolidation points.
SB 1305 (Figueroa), Chapter 64, Statutes of 2006, effective
September 1, 2008, prohibits any person from knowingly
placing home-generated sharps in residential, commercial or
construction site waste streams, and requires such wastes
to be transported in approved sharps containers and managed
at approved sites and facilities, or through approved
mail-back programs. Excludes home-generated sharps waste
from the definition of medical waste under the Medical
Waste Act, making it a separate type of waste under the
Act.
Arguments in support
Alameda County, one of the sponsors of AB 501, writes that
one million people in California must self-inject
prescription medications. Without a convenient mechanism
to safely dispose of sharps, many are disposed of in trash
and recycling bins, a practice which jeopardizes the health
and safety of workers and potentially increases exposure to
diseases such as hepatitis C and HIV/AIDS.
The California Nurses Association (CNA) states that the use
of pre-filled syringes, pens, and devices is an effective
method of administering injectible prescription drugs and
is expected to increase significantly in the future.
However, this increase will be associated with increased
disposal problems. CNA states that sharps mail-back
STAFF ANALYSIS OF ASSEMBLY BILL 501 (Swanson) Page
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programs offer one of the most convenient means of
collecting and destroying home-generated sharps, and that
expanding use of these programs requires greater
involvement of the pharmaceutical industry.
Taking a support if amended position, the California
Association of Environmental Health Administrators (CAEHA)
states that AB 501 would require manufacturers to provide
sharps containers only upon request from consumers, with no
requirement that manufacturers or retailers inform
consumers that it is illegal to place the sharps in their
household trash. CAEHA states that local governments are
expected to implement a ban on disposal of home-generated
sharps starting in September 2008, with no additional
resources for education, outreach, or program
implementation and that it is unreasonable to expect them
to do so without also creating incentives for manufacturers
to reduce the amount of waste and costs that local
governments must incur. CAEHA requests amendments to
ensure that producers and distributors of sharps are fully
responsible for the safe disposal of their products.
Taking a similar support if amended position on an earlier
version of the bill, the Regional Council of Rural Counties
states that it supports amendments to remove the "upon
request" provisions of the bill and to impose on the
manufacturer an unequivocal requirement to take back used
sharps through an automatic postage prepaid mail-back
program, rather than allowing them to direct consumers to
local disposal options.
Arguments in opposition
Sanofi-aventis states that, effective September 1, 2008,
current law already requires consumers to properly dispose
of needles, including those covered by AB 501, and provides
consumers with different methods of safely disposing of
home-generated sharps. Sanofi-aventis states that the duty
to ensure safe disposal rests with the consumer and that it
is unlikely that those who choose not to comply with the
law will change their behavior due to another law on the
books. Sanofi-aventis argues that patients who are
prescribed pre-filled syringes or pens are generally
educated on the safe use and disposal of these products by
health care professionals, and that product inserts for its
products state that used needles should be placed in an
appropriate sharps container. To add a requirement that it
STAFF ANALYSIS OF ASSEMBLY BILL 501 (Swanson) Page
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also provide a container on request is overly burdensome.
Sanofi-aventis also states that the bill excludes certain
devices that require needles, but are not sold with
needles, and that a more consistent approach would be to
exclude manufacturers of products that are sold without
needles from the bill. Sanofi-aventis also argues that the
bill does not address the disposal of regular syringes with
needles that are dispensed to administer medications that
come in vials.
Amgen states that the bill does not recognize the
difference between products intended to be injected at home
and products intended to be injected in a medical setting,
such as a doctor's office. Because the distinction is not
clear in the bill, many of Amgen's products would be
subject to the bill, even though they are not intended to
be used at home.
COMMENTS AND QUESTIONS
1. Assembly amendments reduce reliance on pre-paid
mail-back containers. As introduced, AB 501 would have
required a pharmaceutical company whose product is
dispensed in the form of a pre-filled syringe, pre-filled
pen, or other pre-filled injection device to make
available, at no cost and through an annually renewable
program, postage prepaid, mail-back sharps containers.
Under this approach, most sharps would be sent to an
approved hazardous waste facility in mail-back containers,
with the manufacturer bearing the cost of the container and
postage. Amendments taken in the Assembly allow
manufacturers to arrange to provide either a postage
prepaid mail-back container or other approved sharps
container, which the consumer would be required to
transport to an approved collection or consolidation
location. The bill does not require that the latter be
provided at no cost to the consumer. These changes are
likely to increase reliance on local hazardous waste
collection programs, as well as to require greater efforts
on the part of consumers to ensure the safe disposal of
home-generated sharps.
2. Scope of bill limited to pre-filled devices. As
introduced, and as currently drafted, AB 501 would apply
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only to pre-filled syringes, pens, or other devices, which
account for one-third of injectable medications designed or
provided for self-administration. Other types of devices
meeting the definition of home-generated sharps waste, such
as regular syringes and hypodermic needles, would be
excluded. The author should be asked his reasoning for
limiting the scope of the bill to pre-filled syringes,
pens, and devices.
3. Information about safe disposal options. While the
bill requires manufacturers of pre-filled devices to
provide information on safe disposal alternatives and
options, the bill does not specify how they must do that.
Additionally, the bill does not include in the information
to be provided to consumers notice that state law
prohibits, effective September 1, 2008, consumers from
disposing of home-generated sharps in conventional waste
streams. Suggested amendments would be to require
manufacturers of devices that are subject to the bill to
provide information on safe disposal options with the
device at the time the device is dispensed to the patient,
and to include notice of the prohibition of disposal in
containers used for residential or commercial collection of
solid waste, recyclable materials, or green waste.
Suggested amendment language:
On page 3, lines 17 - 20:
(b) In addition to providing an appropriate sharps
container, the manufacturer shall provide information on
safe disposal alternatives and options for sharps, and
notice to the consumer that, effective September 1, 2008,
California law prohibits disposal of sharps in any
container used for the residential or commercial collection
of solid waste, recyclable materials, or green waste. This
information shall be contained in a notice which is
prominently displayed and is easily readable, and which is
on, or is contained with, the device, at the time it is
dispensed.
4. Manufacturers' requirements and privacy concerns. The
bill requires manufacturers of pre-filled devices to
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arrange to provide consumers, upon request, with postage
prepaid mail-back sharps containers, or other approved
sharps containers. The author's intent is to allow
manufacturers to choose how to meet these requirements, and
the author believes that different manufacturers will
utilize different options: automatically arranging for
containers either to be provided or to be sent to the
patient, or providing toll-free numbers or websites with
the devices, which consumers can contact to be connected to
suppliers of containers and mail-back programs. However,
the language of the bill would allow manufacturers to do
less than this, for example, simply handle inquiries
through their general customer service number. In
addition, the bill does not preclude manufacturers from
obtaining confidential medical information in the process
of meeting the bill's requirements, and does not require
third parties, with whom the manufacturer contracts in
order to meet the requirements of the bill, to be subject
to medical privacy laws. Suggested amendments would be to
specify how manufacturers may meet the requirements, and to
preclude use of consumers' information for purposes
unrelated to providing containers.
Suggested amendment language:
On page 3, insert a new subdivision (d), as follows:
(d) (1) A manufacturer may satisfy its obligations under
(a) by arranging to provide and paying for a sharps
container that meets the requirements of (a) (1) or (a)
(2), or supplying a coupon that may be exchanged for a
sharps container that meets the requirements of (a) (1) or
(a) (2), which would either be delivered to the patient, or
included with the device at the time it is dispensed to a
patient or prescribed to the patient, or by providing a
toll-free number or website, which is noted on the
packaging containing the device, which directs the patient
to a supplier of sharps containers that meet the
requirements of (a) (1) or (a) (2).
(2) A manufacturer may not use or disclose any medical
information, as defined in Section 56.05 of the Civil Code,
that it receives in the course of meeting its requirements
under this section for any purposes unrelated to meeting
the requirements of the section, including for the purposes
of marketing, without the written consent of the consumer.
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This shall apply to any person or agent with which the
manufacturer contracts or otherwise makes arrangements to
carry out the requirements of this section.
PRIOR ACTIONS
Assembly Floor: 45-27
Assembly Health: 9-6
POSITIONS
Support: Alameda County Board of Supervisors (sponsor)
California Association of Sanitation Agencies
California Conference of Machinists
California Labor Federation
California Nurses Association
County of Santa Clara Board of Supervisors
Del Norte Solid Waste Management Authority
Engineers and Scientists of California
Los Angeles County Solid Waste Management Committee
National Multiple Sclerosis Society-California
Action Network
Planning and Conservation League
Regional Council of Rural Counties
San Mateo County Central Labor Council
Solid Waste Association of North America (SWANA)
United Food and Commercial Workers Union, Western
States Council
Oppose: Amgen
Sanofi-aventis
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