BILL ANALYSIS �
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THIRD READING
Bill No: AB 2348
Author: Mitchell (D)
Amended: 8/20/12 in Senate
Vote: 21
SENATE BUSINESS, PROF. & ECON. DEVELOP. COMM. : 6-2, 7/2/12
AYES: Price, Corbett, Correa, Hernandez, Negrete McLeod,
Vargas
NOES: Strickland, Wyland
NO VOTE RECORDED: Emmerson
ASSEMBLY FLOOR : 44-28, 5/31/12 - See last page for vote
SUBJECT : Registered nurses: dispensation of drugs
SOURCE : California Family Health Council
Planned Parenthood Affiliates of California
DIGEST : This bill allows registered nurses to dispense
drugs or devices, except controlled substances, within a
primary care clinic and other clinics, as defined, upon an
order issued pursuant to standardized procedures, as
defined, developed by physicians and surgeons with
certified nurse-midwives, nurse practitioners, or physician
assistants. This bill also allows for a registered nurse
to dispense self-administered hormonal contraceptives and
to administer injections of hormonal contraceptives in
strict adherence to standardized procedures, as specified.
Senate Floor Amendments of 8/20/12 provide that if a
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patient has been seen exclusively be a registered nurse for
three consecutive years, the patient shall be evaluated by
a physician and surgeon, nurse practitioner, certified
nurse-midwife, or physician assistant prior to continuing
the dispensation or administration of hormonal
contraceptives, and make other technical and clarifying
changes.
ANALYSIS : Existing law:
1.Establishes the Nursing Practice Act which provides for
the certification and regulation of registered nurses
(RNs), nurse practitioners (NPs) and certified
nurse-midwives (CNMs) by the Board of Registered Nursing
within the Department of Consumer Affairs.
2.Provides that a RN may dispense drugs or devices upon an
order by a licensed physician and surgeon if the nurse is
functioning within a licensed primary clinic or within
other clinics as defined under Sections1204 and 1206 of
the Health and Safety Code.
3.Provides that no clinic shall employ a RN to perform
dispensing duties exclusively and that no RN shall
dispense drugs in a pharmacy, keep a pharmacy, open shop,
or drugstore for the retailing of drugs or poisons and
that no RN shall compound drugs. Specifies that
dispensing of drugs by an RN shall not include controlled
substances except that a NP or CNM who functions pursuant
to standardized procedures or protocols may dispense
controlled substances.
4.Specifies under the Medical Practice Act that
prescribing, dispensing of furnishing dangerous drugs, as
defined, without an appropriate prior examination and a
medical indication, constitutes unprofessional conduct.
This bill:
1.Allows RNs to dispense drugs or devices, except
controlled substances, upon an order by a licensed
physician and surgeon or any order by a CNM, NP, or PA
issued pursuant to standardized procedures, as defined
within the respective practice acts of the CNM, NP, or
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PA, if the registered nurse is functioning within a
licensed primary care clinic or other clinics, as
defined.
2.Provides that nothing in Item #1 above shall be construed
to limit any other authority granted to a certified
nurse-midwife, a nurse practitioner, or to a physician
assistant under their respective practice acts.
3.Provides that nothing in Item #1 above shall be construed
to affect the sites or health care facilities at which
drugs or devices are authorized to be dispensed pursuant
to the Pharmacy Law.
4.Provides that notwithstanding any other provision of law,
a RN may dispense self-administered hormonal
contraceptives approved by the federal Food and Drug
Administration (FDA) and may administer injections of
hormonal contraceptives approved by the FDA in strict
adherence to standardized procedures developed in
compliance with the Nurses Practice Act. The
standardized procedure shall specify all of the
following:
A. Which nurse, based on successful completion of
training and competency assessment, may dispense or
administer the hormonal contraceptives.
B. Minimum training requirements regarding educating
patients on medical standards for ongoing women's
preventive health, contraception options education and
counseling, properly eliciting, documenting, and
assessing patient and family health history, and
utilization of the United States Medical Eligibility
Criteria for Contraceptive Use.
C. Demonstration of competency in providing the
appropriate prior examination comprised of checking
blood pressure, weight, and patient and family health
history, including medications taken by a patient.
D. Which hormonal contraceptives may be dispensed or
administered under specified circumstances, utilizing
the most recent version of the United States Medical
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Eligibility Criteria for Contraceptive Use.
E. Criteria and procedure for identification,
documentation, and referral of patients with
contraindications for hormonal contraceptive and
patients in need of a follow-up visit to a physician
and surgeon, nurse practitioner, certified
nurse-midwife, or physical assistant.
F. The extent of physician and surgeon supervision
required.
G. The method of periodic review of the RN's
competence.
H. The method of periodic review of the standardized
procedure, including, but not limited to, the required
frequency of review and the person conducting that
review.
I. Adherence to the Medical Practices Act in a manner
developed through collaboration with health care
providers and the appropriate prior examination shall
be consistent with the evidence-based practice
guidelines adopted by the federal Centers for Disease
Control and Prevention in conjunction with the United
States Medical Eligibility Criteria for Contraceptive
Use.
J. If a patient has been seen exclusively by a
registered nurse for three consecutive years, the
patient shall be evaluated by a physician and surgeon,
nurse practitioner, certified nurse-midwife, or
physician assistant prior to continuing the
dispensation or administration of hormonal
contraceptives.
1.Provides that nothing in Item # 4 above shall be
construed to affect the sites or types of health care
facilities at which drugs or devices are authorized to be
dispensed pursuant to the Pharmacy Law.
Background
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Lack of Access and Unmet Needs to Birth Control . According
to the sponsors, access to birth control is a critical
public health issue and an essential component of women's
health care. Unfortunately, there are thousands of women
in California who lack access to contraception, leaving
them at significant risk of unintended pregnancy. The
sponsors state that, "While the Family PACT program serves
1.82 million women annually, overall only 71% of the women
in need of family planning received services through Family
PACT or Medi-Cal. Unmet need for family planning varies
widely by county, of the 10 counties with the highest need,
the proportion that accessed services ranged from 46% in
San Bernardino to 75% in San Diego, with the greatest need
in rural areas.
"Need for the program has increased 12% since FY 2005-06,
yet the percentage of patients in need who accessed
services has dropped 6% (Family PACT Program Report,
2009-10). This gap is likely to become increasingly acute
with the addition of the estimated 5-6 million California
residents to be insured under national health reform.
"Women with unintended pregnancies are more likely to
receive late or no prenatal care, smoke, and consume
alcohol during pregnancy (Contraception, 2009), to be
depressed during pregnancy, experience domestic violence
during pregnancy, and have a higher rate of maternal death.
The health consequences for a newborn are dire as pre-term
birth and low birth weight, are associated with infant
mortality.
"An essential component of comprehensive reproductive
health care for women, hormonal contraceptives, are among
the safest medications available today. Many respected
medical institutions, including the World Health
Organization (WHO), the American College of Obstetricians
and Gynecologists (ACOG) and Planned Parenthood Federation
of America (PPFA), have developed evidence-based guidelines
for hormonal contraceptive use based on a self-reported
medical history and measurement of blood pressure. All of
these guidelines acknowledge that hormonal contraception
can be safely provided and utilized without requiring a
pelvic examination.
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"The Institute of Medicine Committee (IOM) on Women's
Health Research recently reported a universal need for
making contraceptives more available, accessible, and
acceptable (IOM, 2010b). They indicate the several
barriers that women often face that keep them from being
able to successfully and correctly utilize their birth
control method. Among these are expensive co-pays,
insurance coverage limitations on prescriptions, and the
difficulty or delay when scheduling an office visit."
Hormonal Methods of Birth Control . Hormonal contraceptives
are made up of female sex hormones: estrogen or progestin
(a synthetic form of progesterone). The most popular
hormonal contraceptive is the combination pill, or oral
contraceptive. Other hormonal contraceptions include
injected progestins, subdermal implants that release
progestins, transdermal patch, vaginal ring, and emergency
contraception.
1.The Birth Control Pill . Four out of five women in the
United States use oral contraceptives (commonly called
"the pill") during their lifetime. The pill is the most
popular form of reversible contraception (can be
discontinued to restore fertility). Recent studies have
alleviated safety concerns about the pill.
2.Injectable Hormones . The most common injectable hormonal
contraceptive is Depo-Provera, a synthetic hormonal
substance also known as DMPA (depot-medroxyprogesterone
acetate) that is injected into the muscle in the upper
arm or buttocks every 3 months. Another, shorter-acting
injectable hormone, norethdrone enanthate, is injected at
a higher dose every 2 months. Injectable hormones
prevent pregnancy by suppressing ovulation; by making it
more difficult for the sperm to swim through the cervical
mucus; and by destroying the endometrial lining of the
uterus, keeping fertilized eggs from implanting.
3.Subdermal Implants . Subdermal implants, also known as
contraceptive implants, are matchstick-sized, hollow,
rubber rods filled with synthetic progestin that are
placed under the skin on the inside of the upper or lower
arm. Subdermal implants were FDA-approved for use in the
United States in 1991. Norplant is the most commonly
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used brand. The tubes provide a slow, constant release
of progestin into the bloodstream, maintaining hormone
levels. Subdermal implants are considered one of the
most effective methods of birth control and one of the
most cost-effective, but only 1.3% of women in the United
States use this form. The implants are effective for up
to five years and can be removed by a physician at any
time. Inserting and removing them requires local
anesthesia and a small incision. New capsules are being
developed to make insertion and removal easier.
4.Transdermal Administration (Birth Control Patch). The
birth control patch is a form of hormonal contraception
that delivers a steady level of the hormones
norelgestromin/ethinyl estradiol (progestin and estrogen)
into the bloodstream through the skin. Ortho Evra has
been shown in clinical trials to be 99% effective in
preventing pregnancy. The hormones in the patch prevent
pregnancy by suppressing ovulation and by thickening the
cervical mucus, making it difficult for sperm to enter
the uterus. Each square patch is less than 2 inches in
size and is thin enough to be unobtrusive under clothing.
The patch is worn directly on the skin and can be
applied on the upper torso (back or front, but not on the
breasts), abdomen, upper arm, or buttocks. It is changed
once a week, on the same day of the week, and is worn for
3 weeks per month. A new patch must be applied
immediately after removing the old one. It is worn
continuously, including while exercising, showering,
bathing, and swimming. If the patch loosens or becomes
detached, backup contraception (e.g., diaphragm, condom)
may be necessary and a health care professional should be
consulted.
5.Etonogestrel Ethinyl Estradiol Vaginal Ring . The vaginal
ring (NuvaRing) is a once-a-month form of hormonal
contraception that delivers steady levels of the
pregnancy-preventing hormones etonogestrel and ethinyl
estradiol into the body. The ring is made of a flexible,
transparent polymer and is approximately two inches in
diameter and about one-eighth inch thick. The ring is
self-inserted and does not require a visit to the
doctor's office. In clinical trials, 1 to 2 out of every
100 women who use the vaginal ring as directed becomes
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pregnant. The ring is inserted into the vagina, remains
in place for 3 weeks, and is removed for the fourth week.
Menstruation should begin a few days into week 4. A new
ring is inserted 1 week after removing the old one, at
about the same time of day. The ring must stay in place
continuously to be effective. If it slips out, the same
ring may be reinserted if fewer than 3 hours have
elapsed. If more than 3 hours have elapsed without the
ring in place, the ring can be reinserted, but backup
contraception (e.g., condom) is necessary.
6.Emergency Contraception . Emergency contraceptive pills
(ECP) have been marketed in the United States within the
past several years. ECPs must be taken within 72 hours
of unprotected intercourse to be effective. ECPs do not
disrupt pregnancy and are not considered abortifacients
(something that induces or causes an abortion). The FDA
has approved three ECPs:
Preven kits were approved in 1997. They include
four pills taken in pairs, 12 hours apart. They
contain 0.1 mg of ethinyl estradiol and 0.5 mg
levonorgestrel. Preven kits are 75% effective.
An ECP containing only levonorgestrel was approved
in 1999, and it is 85% effective at reducing
pregnancy. Women take 2 pills, 12 hours apart.
In 2006, the FDA approved Plan B emergency
contraceptive, a high-dose oral contraceptive (two
pills) that may reduce the risk for pregnancy by as
much as 89%, if taken within 72 hours (3 days) of
unprotected intercourse. This drug, which is
available over the counter for women aged 18 and
older, and by prescription for women under the age of
18, will not terminate an existing pregnancy. In July
2009, a single-pill version of Plan B was approved by
the FDA and over-the-counter access to this
contraceptive was expanded to women over 17 years of
age.
U.S. Medical Eligibility Criteria for Contraceptive Use .
Under the Department of Health and Human Services, and with
guidance from the World Health Organization (WHO), the
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Center for Disease Control and Prevention (CDC) created the
U.S. Medical Eligibility Criteria for Contraceptive Use
2010 and finalized the recommendations after consultation
with a group of health professionals who met in Atlanta,
Georgia, in February of 2009. The WHO's guidance includes
recommendations for the use of specific contraceptive
methods by women and men who have certain characteristics
or medical conditions. The majority of the U.S. guidance
does not differ from the WHO guidance and covers more than
60 characteristics or medical conditions. However, some
WHO recommendations were modified for use in the United
States, including recommendations about contraceptive use
for women with venous thromboembolism, valvular heart
disease, ovarian cancer, and uterine fibroids and for women
who experience postpartum depression or are breastfeeding.
Recommendations were added to the U.S. guidance for women
with rheumatoid arthritis, history of bariatric surgery,
peripartum cardiomyopathy, endometrial hyperplasia,
inflammatory bowel disease, and solid organ
transplantation. The recommendations are intended to
assist health-care providers when they counsel women, men,
and couples about contraceptive method choice. Although
the recommendations are meant to serve as a source of
clinical guidance, the CDC cautioned that health-care
providers should always consider the individual clinical
circumstances of each person seeking family planning
services.
FISCAL EFFECT : Appropriation: No Fiscal Com.: No
Local: No
SUPPORT : (Verified 8/7/12)
California Family Health Council (co-source)
Planned Parenthood Affiliates of California (co-source)
ACCESS Women's Health Justice
American Civil Liberties Union of California
American Nurses Association\California
Bay Area Communities for Health Education
Black Women for Wellness
California Black Women's Health Project
California Latinas for Reproductive Justice
California Maternal, Child and Adolescent Health Directors
California Primary Care Association
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California Women Lawyers
City of Berkeley
Coalition Advancing Multipurpose Innovations
Forward Together
Ibis Reproductive Health
Law Students for Reproductive Justice
Latino Health Alliance
Maternal and Child Health Access
National Center for Youth Law
National Council of Jewish Women, California
National Council of Jewish Women, Los Angeles Section
Nevada County Citizens for Choice
Physicians for Reproductive Choice and Health
Planned Parenthood Action Fund of the Pacific Southwest
Planned Parenthood Advocacy Project, Los Angeles County
Planned Parenthood Mar Monte
Planned Parenthood of Santa Barbara, Ventura and San Luis
Obispo
Counties, Inc.
Planned Parenthood Pasadena and San Gabriel Valley
Planned Parenthood Shasta Pacific Action Fund
Service Employees International Union (SEIU)
SisterSong Women of Color Reproductive Justice Collective
Six Rivers Planned Parenthood
United Nurses Associations of California/Union of Health
Care
Professionals
Women's Community Clinic
Women's Health Specialists
OPPOSITION : (Verified 8/7/12)
California Association for Nurse Practitioners
California Nurses Association
California Catholic Conference, Inc.
California Right to Life Committee, Inc.
ARGUMENTS IN SUPPORT : According to the sponsors:
"Across California, many women lack access to birth
control, leaving them at significant risk of unintended
pregnancy. In some parts of the state, patients of
community health clinics cannot access hormonal
contraceptives because of the limited supply of prescribers
and others who are legally authorized to order or furnish
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these medications. Lack of enough appropriate staff can
result in health centers closing or reducing hours,
compounding many communities' unmet family planning needs.
For a woman in need of birth control these types of
shortages can mean waiting long periods of time to schedule
a health center appointment, sitting in a waiting room for
hours before being seen, or driving long distances to see a
provider. All of these barriers place her at greater risk
of unintended pregnancy."
They indicate that current law allows for the �ordering] or
furnishing of drugs, including birth control, by physicians
and surgeons and by nurse practitioners, certified nurse
midwives, and physician assistants pursuant to standardized
procedures or protocols developed and approved by the
supervising physician and others as designated. RNs in
community clinics have the authority to dispense drugs
based on an order from a physician or surgeon, they
currently serve in this capacity by dispensing birth
control to community clinic patients.
They maintain that this bill would build on current law by
allowing RNs to dispense hormonal contraceptives, including
birth control pills, transdermal contraceptive patch, and
vaginal contraceptive ring, pursuant to a standardized
procedure.
ASSEMBLY FLOOR : 44-28, 5/31/12
AYES: Alejo, Ammiano, Atkins, Block, Blumenfield, Bonilla,
Bradford, Brownley, Buchanan, Butler, Charles Calderon,
Campos, Carter, Cedillo, Chesbro, Davis, Dickinson,
Feuer, Fletcher, Fong, Fuentes, Furutani, Gatto, Gordon,
Hall, Roger Hern�ndez, Hill, Huber, Hueso, Huffman, Lara,
Bonnie Lowenthal, Ma, Mitchell, Monning, Pan, Perea, V.
Manuel P�rez, Portantino, Skinner, Torres, Wieckowski,
Williams, John A. P�rez
NOES: Achadjian, Beall, Bill Berryhill, Conway, Cook,
Donnelly, Beth Gaines, Galgiani, Garrick, Gorell, Grove,
Hagman, Halderman, Harkey, Hayashi, Jeffries, Jones,
Knight, Logue, Miller, Morrell, Nestande, Nielsen, Olsen,
Silva, Smyth, Swanson, Wagner
NO VOTE RECORDED: Allen, Eng, Mansoor, Mendoza, Norby,
Solorio, Valadao, Yamada
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JJA:n 8/21/12 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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