BILL ANALYSIS
SB 1169
Page 1
Date of Hearing: July 10, 2001
ASSEMBLY COMMITTEE ON HEALTH
Helen Thomson, Chair
SB 1169 (Alpert) - As Amended: July 3, 2001
SENATE VOTE : 24-10
POLICY QUESTION :
Should a pharmacist be permitted to initiate emergency
contraception drug therapy in accordance with standardized
procedures or protocols developed by the pharmacist and an
authorized prescriber?
SUBJECT : Pharmacy: emergency contraception.
SUMMARY : Permits a pharmacist to initiate emergency
contraception drug therapy in accordance with standardized
procedures or protocols developed by the pharmacist and an
authorized prescriber. Specifically, this bill :
1)Permits a pharmacist to initiate emergency contraception drug
therapy in accordance with standardized procedures or
protocols developed by the pharmacist and an authorized
prescriber who is acting within his or her scope of practice.
2)Requires a pharmacist, prior to initiating emergency
contraception drug therapy, to complete a training program on
emergency contraception, which includes, but is not limited
to, conduct of sensitive communications, quality assurance,
referral to additional services, and documentation.
3)Requires a pharmacist, for each emergency contraception drug
therapy initiated, to provide the recipient of the emergency
contraception drugs with a standardized fact sheet that
includes, but is not limited to, the indications for use of
the drug, the appropriate method for using the drug, the need
for medical follow-up, and other appropriate information.
4)Requires the Board of Pharmacy to develop the fact sheet
required in #3 above in consultation with the Department of
Health Services, the American College of Obstetricians and
Gynecologists, the California Pharmacists Association, and
other health care organizations. Specifies that this bill
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does not preclude the use of existing publications developed
by nationally recognized medical organizations.
EXISTING LAW :
1)Licenses and regulates pharmacists through the Board of
Pharmacy, and generally permits pharmacists to dispense
prescription drugs and devices only upon a prescription issued
by a physician, dentist, optometrist, podiatrist, or
veterinarian, or, if a drug order is issued pursuant to
specified provisions of law, by a physician assistant or nurse
practitioner.
2)Permits a pharmacist, among other things, to perform certain
procedures and functions in a licensed health care facility in
accordance with procedures or protocols developed by health
professionals with the concurrence of the facility
administrator, including initiating or adjusting the drug
regimen of a patient pursuant to an order or authorization
made by the patient's prescriber.
3)Permits a pharmacist, among other things, to perform certain
procedures and functions as part of the care provided by a
health care facility, a licensed home health agency, a
licensed clinic in which there is physician oversight, a
health care service plan, or an individual physician, in
accordance with procedures or protocols, including adjusting
the drug regimen of a patient pursuant to a specific written
order or authorization made by the patient's prescriber.
FISCAL EFFECT : Unknown
COMMENTS :
1)PURPOSE OF THIS BILL . According to the author, this bill
seeks to make emergency contraception available to women who
are at risk of an unwanted pregnancy. The author states that
making emergency contraception available to women will reduce
the number of abortions. The author notes that emergency
contraception differs from RU-486 in that it does not cause an
abortion, but rather prevents a pregnancy. Under this bill,
the author states that women who have had unprotected
intercourse and do not want to risk becoming pregnant will be
able to obtain emergency contraception in a pharmacy provided
the pharmacy has a collaborative physician protocol. The net
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effect of this bill is to make emergency contraception
available in a pharmacy, without first having to make an
appointment with your physician to obtain a prescription.
This bill is sponsored by the Public Health Institute (PHI),
which states that more than 3 million unplanned pregnancies
occur each year in the United States. Making emergency
contraception easily accessible to women can dramatically
reduce unintended pregnancies and abortions. PHI states that
several medical organizations representing physicians have
developed resolutions supporting emergency contraception pills
being made available to women on an over-the-counter basis.
While the federal Food and Drug Administration has stated that
emergency contraception pills are safe and effective, there is
no indication it will change the class of these products from
prescription to over-the-counter. PHI states that California
has no authority to grant drugs over-the-counter status, but
there are significant steps California can take to broaden
access to emergency contraception pills. PHI states that
under current law, pursuant to recent legislation, consumers
can receive services such as emergency contraception in
pharmacies, under limited protocols. The current protocol
requirements must be patient-specific for a condition for
which that patient has seen their physician. PHI states that
while programs utilizing this authority to provide emergency
contraception have been developed in several counties, these
programs have found a significant limitation in the ability to
provide service under the narrow protocol requirements of
current law. For instance, women who do not have a physician
cannot currently access this safe and effective service in a
pharmacy. PHI states that this bill will broaden current law
by allowing all women in need to obtain emergency
contraception services in a pharmacy, provided the pharmacy
has a collaborative physician protocol.
2)WHAT IS EMERGENCY CONTRACEPTION ? According to the Office of
Population Research at Princeton University, which operates
the Emergency Contraception World Wide Web server, emergency
contraceptives are methods of preventing pregnancy after
unprotected sexual intercourse. There are two types of
emergency contraceptive pills. One type uses hormones that
are the same type and dose as hormones used in some kinds of
ordinary birth control pills. These hormones are called
estrogen and progestin, and one brand name called Preven is
especially packaged and labeled for emergency use, although
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other brands packaged for ongoing contraception can be used
for emergency use as well. Use of this type of contraception
cuts the chance of pregnancy by 75% The other type of
emergency contraceptive pill contains only the hormone called
progestin, and is specially packaged and labeled for use as
the brand name Plan B . Plan B reduces the risk of pregnancy
by 89%. Women can start the pills right away or up to three
days after unprotected sex. Therapy is more effective the
earlier it is initiated within the 72 hour window.
Depending on the time during the menstrual cycle that the
emergency contraception pills are taken, emergency
contraception pills may inhibit or delay ovulation, inhibit
tubal transport of the egg or sperm, interfere with
fertilization, or alter the endometrium (the lining of the
uterus), thereby inhibiting implantation of a fertilized egg.
Emergency contraception does not cause an abortion. Emergency
contraception prevents pregnancy and thereby reduces the need
for induced abortion. Medical science defines the beginning
of pregnancy as the implantation of a fertilized egg in the
lining of a woman's uterus. Implantation begins five to seven
days after fertilization (and is completed several days
later). Emergency contraceptives work before implantation and
not after a woman is already pregnant. When a woman is already
pregnant, emergency contraception does not work. Emergency
contraception is also harmless to the fetus and the mother.
3)PHARMACY ACCESS PARTNERSHIP . According to information
provided by the author, the Pharmacy Access Partnership, which
is based in Oakland, California and foundation supported, has
developed the 72 Hr. Emergency Contraception Pharmacy Program.
The Pharmacy Access Partnership has set up demonstration
sites with approximately 50 pharmacies in San Diego, Los
Angeles, San Luis Obispo, Santa Cruz, San Francisco, Marin and
San Joaquin Counties. The program matches pharmacies with
clinics, and sets up the proper authorizations for patients to
purchase the emergency contraception pills from the
participating pharmacies whenever they need it. It is modeled
after a program in Washington state, where more than 30,000
women have received emergency contraception pills directly
from local pharmacies. However, unlike Washington state,
California law requires the pharmacy to have a
patient-specific protocol with a physician in order to
dispense the emergency contraception pill.
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4)SUPPORT . The American College of Obstetricians and
Gynecologists, District IX (ACOG), states that it supports
changing emergency contraception pills from prescription drugs
to over-the-counter drugs, because these drugs have a
consistently high record of safety. Until that happens, ACOG
states that this bill provides an interim solution by making
these drugs available through pharmacies that have protocol
agreements with prescribers who are acting within their scope
of practice. The California Medical Association also supports
obtaining over-the-counter status for these drugs, but short
of that, argues that this bill makes positive strides in
dealing with the current prescription status. The California
Society of Health-System Pharmacists assert that pharmacists
are highly trained medication experts, and that by expanding
access to this medication through pharmacies, women will gain
timely access, a non-stigmatizing environment, and the
counseling of a knowledgeable and trustworthy pharmacist.
The Santa Cruz Women's Health Center states that it has been
participating in the successful pilot project for increased
access to emergency contraception pills, and supports this
bill to allow women much greater access to emergency
contraception pills in California.
Planned Parenthood Affiliates of California (PPAC) and the
California Family Health Council (CFHC) argue in support that
emergency contraception is designed to prevent pregnancy after
unprotected intercourse by preventing ovulation,
fertilization, or implantation, and that it will not cause an
abortion. PPAC and CFHC assert that for several decades,
emergency contraception has been prescribed to women in cases
of unanticipated sexual activity, contraceptive failure, or
sexual assault, and that millions of women around the world
have used emergency contraception safely and effectively.
PPAC and CFHC estimate that widespread use of emergency
contraception could prevent an estimated 1.7 million
unintended pregnancies and 800,000 abortions each year.
5)OPPOSITION . The California Right to Life Committee, Inc.,
opposes this bill as another vehicle for the promotion of
abortion under the euphemism of "emergency contraception drug
therapy." California Right to Life argues that this bill
promotes the use of abortifacients, or chemicals that destroy
the lining of the womb which creates a hostile environment
prohibiting the embryo from implanting in the wall of the
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uterus. California Right to Life asserts that using the term
"fertilized egg" to redefine the beginning of a pregnancy will
not change the scientific evidence, and that this entity is a
tiny living human which will not be able to continue life
because of the altered womb lining. California Right to Life
also states that this bill requires the Board of Pharmacy to
provide a standardized fact sheet, developed in conjunction
with health care organizations, which could have a vested
interest in the promotion of emergency contraceptives.
6)COMMENT . This bill requires a pharmacist, prior to initiating
emergency contraception under the provisions of this bill, to
complete a training program on emergency contraception, which
includes specified topics. However, this bill does not
specify the entity responsible for developing the length and
content of the training program, or who will be providing the
training program. The author may wish to consider an
amendment that would specify whether the Medical Board of
California, or the Board of Pharmacy, or both working in
conjunction, or some other entity, would be responsible for
this training program.
REGISTERED SUPPORT / OPPOSITION :
Support
Public Health Institute (sponsor)
American College of Obstetricians and Gynecologists, District IX
California Coalition of Nurse Practitioners
California Conference of Local Health Officers
California Family Health Council
California Medical Association
California Pharmacists Association
California Society of Health-System Pharmacists
Delta Health Care
Planned Parenthood Affiliates of California
Santa Cruz Women's Health Center
Vista Community Clinic
YWCA of the Harbor Area
One individual
Opposition
California Right to Life Committee
SB 1169
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Analysis Prepared by : Vincent D. Marchand / HEALTH / (916)
319-2097