BILL ANALYSIS
SB 1169
Page 1
SENATE THIRD READING
SB 1169 (Alpert)
As Amended September 4, 2001
Majority vote
SENATE VOTE :24-10
HEALTH 13-1 APPROPRIATIONS 16-2
-----------------------------------------------------------------
|Ayes:|Thomson, Chan, Cohn, Chu, |Ayes:|Migden, Alquist, Aroner, |
| |Frommer, Koretz, Negrete | |Cedillo, Corbett, Correa, |
| |McLeod, Richman, Salinas, | |Daucher, Goldberg, Papan, |
| |Steinberg, Wayne, Wesson, | |Pavley, Simitian, |
| |Zettel | |Thomson, Wesson, Wiggins, |
| | | |Wright, Zettel |
|-----+--------------------------+-----+--------------------------|
|Nays:|Runner |Nays:|Ashburn, Robert Pacheco |
| | | | |
-----------------------------------------------------------------
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, delivered by an American Council on
Pharmaceutical Education provider or another training program
approved by the Board of Pharmacy (Board). Requires this
training program to include, but not be 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.
SB 1169
Page 2
4)Requires the Board to develop the fact sheet required in #3
above in consultation with the Department of Health Services,
the American College of Obstetricians and Gynecologists
(ACOG), the California Pharmacists Association, and other
health care organizations. Specifies that this bill does not
preclude the use of existing publications developed by
nationally recognized medical organizations.
5)Incorporates changes proposed by AB 826 (Cohn), pending the
Governor's signature, to avoid chaptering out if both bills
are enacted and become law.
EXISTING LAW :
1)Licenses and regulates pharmacists through the Board, 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 : According to the Assembly Appropriations
Committee analysis, minor, absorbable costs to the Board to
develop the required fact sheet on emergency contraception.
COMMENTS :
SB 1169
Page 3
1)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 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 three 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
SB 1169
Page 4
has a collaborative physician protocol.
2)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 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 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
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, and it 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.
3)ACOG, District IX, 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
SB 1169
Page 5
timely access, a non-stigmatizing environment, and the
counseling of a knowledgeable pharmacist.
4)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 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 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.
Analysis Prepared by : Vincent D. Marchand / HEALTH / (916)
319-2097 FN: 0002800