BILL ANALYSIS �
-----------------------------------------------------------------------
|Hearing Date:July 2, 2012 |Bill No:AB |
| |2348 |
-----------------------------------------------------------------------
SENATE COMMITTEE ON BUSINESS, PROFESSIONS
AND ECONOMIC DEVELOPMENT
Senator Curren D. Price, Jr., Chair
Bill No: AB 2348Author:Mitchell
As Amended:June 27, 2012 Fiscal: No
SUBJECT: Registered nurses: dispensing of drugs.
SUMMARY: 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. 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.
Existing law, the Business and Professions Code (BPC):
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. (BPC � 2725.1
(a))
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
AB 2348
Page 2
not include controlled substances except that a NP or CNM who
functions pursuant to standardized procedures or protocols may
dispense controlled substances. (BPC � 2725.1 (b))
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. (BPC � 2242 (a))
5)Defines "dangerous drug" or "dangerous device" as any drug or device
unsafe for self-use in humans or animals, and includes the
following: (BPC � 4022)
a) Any drug that bears the legend: "Caution: federal law
prohibits dispensing without prescription," "Rx only," or words
of similar import.
b) Any device that bears the statement: "Caution: federal law
restricts this device to sale or on the order of a __," "Rx
only," or words of similar import, the blank to be filled in with
the designation of the practitioner licensed to use or order use
of the device.
c) Any other drug or devices that by federal or state law can be
lawfully dispensed only on prescription or furnished pursuant to
regulations of the Board of Pharmacy.
6)Defines "dispense" as follows: (BPC � 4024)
a) The furnishing of drugs or devices upon a prescription from a
physician, dentist, optometrist, podiatrist, veterinarian, or
naturopathic doctor, or upon an order to furnish drugs or
transmit a prescription from a certified nurse-midwife, nurse
practitioner, physician assistant, naturopathic doctor, or
pharmacist acting within their scope of practice.
b) The furnishing of drugs or devices directly to a patient by a
physician, dentist, optometrist, podiatrist, or veterinarian, or
by a certified nurse-midwife, nurse practitioner, physician
assistant, naturopathic doctor, or pharmacist acting within their
scope of practice.
7)Specifies under the Pharmacy Law that dispensing of drugs in a
non-profit community clinic or primary care clinic, as defined,
shall be performed only by a physician, a pharmacist, or other
person lawfully authorized to dispense drugs, and only in compliance
AB 2348
Page 3
with all applicable laws and regulations. (BPC � 4181)
8)Provides that the practice of nursing includes direct and indirect
patient services, including but not limited to, the administration
of medications and therapeutic agents necessary to implement a
treatment, disease prevention, or rehabilitative regimen ordered by
and within the scope of licensure of a physician, dentist,
podiatrist, or clinical psychologist.
(BPC � 2735 (b) (2))
9)Provides that the practice of nursing may be performed under
"standardized procedures," as defined, for specified functions,
treatments and procedures. Standardized procedures usually involve
policies, procedures, protocols and/or guidelines developed through
collaboration of administrators and health professionals including
(supervising) physicians and nurses.
(BPC � 2725)
10)Provides that a certified nurse-midwife may furnish or order drugs
or devices, including controlled substances, if furnished or ordered
incidentally to the provision of family planning services, routine
health care or perinatal care, or care rendered consistent with the
certified nurse-midwife's practice; occurs under physician and
surgeon supervision; and is in accordance with standardized
procedures or protocols as specified. (BPC � 2746.51)
11)Provides that a nurse practitioner may furnish or order drugs or
devices, including controlled substances, if it is consistent with a
nurse practitioner's educational preparation or for which clinical
competency has been established and maintained; occurs under
physician and surgeon supervision; and is in accordance with
standardized procedures or protocols as specified. (BPC � 2836.1)
12)Defines the furnishing or ordering of drugs or devices by nurse
practitioners to mean the act of making a pharmaceutical agent or
agents available to the patient in strict accordance with a
standardized procedure. (BPC � 2836.2)
13)Establishes the Physician Assistant Practice Act which provides for
the licensure of physician assistants (PAs) by the Physician
Assistant Committee within the Department of Consumer Affairs.
14)Provides that a PA may perform those medical services as set forth
by the regulations of the Medical Board of California when the
services are rendered under the supervision of a licensed physician
and surgeon, and provides that the PA and the supervising physician
AB 2348
Page 4
and surgeon shall establish written guidelines or protocols, as
specified, for some or all of the tasks performed by the PA. (BPC �
3502)
15)Provides that a PA while under the supervision of a physician and
surgeon may administer or provide medication to a patient, or
transmit orally or in writing a drug order under specified
conditions and protocols adopted by the supervising physician and
surgeon.
(BPC � 3502.1)
Existing law, the Health and Safety Code (HSC):
1)Defines "clinic" as an organized outpatient health facility that
provides direct medical, surgical, dental, optometric, or podiatric
advice services or treatment to patients who remain less than 24
hours, and that may also provide diagnostic or therapeutic services
to patients in the home as an incident to care provided at the
clinic facility. (HSC � 1200 (a))
2)Defines "primary care clinics" as all types of clinics as specified,
including community clinics and free clinics. (HSC � 1200 (b) (1))
3)Defines a "community clinic" as a clinic operated by a tax-exempt
non-profit corporation that is supported and maintained in whole or
in part by donations, bequests, gifts, grants, government funds or
contributions, that may be in the form of money, goods, or services
and the clinic provides that any charges to the patient shall be
based on the patient's ability to pay, utilizing a sliding fee
scale. (HSC � 1204 (a) (1) (A))
4)Defines "free clinic" as a clinic operated by a tax-exempt,
non-profit corporation supported in whole or in part by voluntary
donations, bequests, gift, grants, government funds or
contributions, that may be in the form of money, goods, or services
and the clinic provides there shall be no charges directly to the
patient for services rendered or for drugs, medicines, appliances,
or apparatuses furnished. (HSC � 1204 (a) (1) (B))
5)Provides that primary care clinics are eligible for licensure by the
State Department of Public Health (DPH).
6)Specifies other clinics which may operate in California but are not
subject to licensure by DPH, include:
a) Any clinic directly conducted, maintained or operated by the
AB 2348
Page 5
United States or by any of its departments, officers, or agencies
and any primary clinic that is directly conducted, maintained, or
operated by this state or by any of its political subdivisions or
districts, or by any city. (HSC � 1206 (b))
b) Any clinic conducted, maintained, or operated by a federally
recognized Indian tribe or tribal organization, as defined, which
is located on land that is recognized as tribal land by the
federal government. (HSC � 1206 (c))
c) An intermittent clinic that is operated by a primary care
community or free clinic and that is operated on separate
premises from the licensed clinic and is only open for limited
services of no more than 20 hours per week. (HSC � 1206 (h))
d) Student health centers operated by public institutions of
higher education.
(HSC � 1206 (j))
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 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
AB 2348
Page 6
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
patient examination comprised of checking blood pressure,
temperature, 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 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
supervising physician and surgeon.
f) The extent of physician and surgeon supervision required;
g) The method of periodic review of the RN's competence; and,
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.
5)Provides that for purposes of Item # 4 above, in compliance with the
provision under the Medical Practices Act which requires a prior
appropriate examination by a physician, an "appropriate patient
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 State Medical Eligibility
Criteria for Contraceptive Use.
6)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.
AB 2348
Page 7
FISCAL EFFECT: None. This bill has been keyed "non-fiscal" by
Legislative Counsel.
COMMENTS:
1.Purpose. This measure is co-sponsored by Planned Parenthood
Affiliates of California and the California Family Health Council .
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 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."
The sponsors 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.
The sponsors 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.
The sponsors state that the Nurse Practice Act specifies that a
standardized procedure must be developed collaboratively by the
nurses, physician, and administration of a health center. Because
of this interdisciplinary collaboration, there is accountability on
several levels for the activities to be performed by the registered
nurse. Utilizing a standardized procedure would allow the RN to
provide hormonal contraceptives to patients after the RN conducts a
patient assessment based on approved medical guidelines. This
AB 2348
Page 8
includes reviewing basic health indicators like age and blood
pressure and analyzing the patient's health history including
history of smoking and relevant cancers in order to dispense the
appropriate birth control for the patient.
The sponsors believe that this measure would expand access to birth
control, as essential component of women's preventative health care,
by allowing RNs to dispense hormonal birth control under a
standardized procedure. Increasing access while maintaining the
safety of current medical guidelines will help address the
significant unmet need faced by many women across the state.
2.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
AB 2348
Page 9
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.
"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."
3.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 (OC). Other hormonal
contraceptions include injected progestins, subdermal implants that
release progestins, transdermal patch, vaginal ring, and emergency
contraception.
a) The Birth Control Pill. Four out of 5 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.
b) 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.
c) Subdermal Implants. Subdermal implants, also known as
contraceptive implants, are matchstick-sized, hollow, rubber rods
AB 2348
Page 10
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 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 5 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.
d) 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.
e) 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 2
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 pregnant. The ring is
inserted into the vagina, remains in place for 3 weeks, and is
AB 2348
Page 11
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.
f) 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 U.S. Food and Drug Administration (FDA)
has approved three ECPs:
i) Preven kits were approved in 1997. They include 4 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.
ii) An ECP containing only levonorgestrel was approved in
1999, and it is 85% effective at reducing pregnancy. Women
take 2 pills, 12 hours apart.
iii) 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.
4.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 Center for Disease Control and
Prevention (CDC) created the U.S. Medical Eligibility Criteria for
Contraceptive Use 2010 (USMEC) and finalized the recommendations
AB 2348
Page 12
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.
5.This Measure Grants Two Separate Authorities for RNs. Existing law
allows RNs working in primary care clinics to dispense drugs or
other devices only upon an order by a physician and surgeon. This
bill expands the number of practitioners under whose orders an RN
may dispense medications to including CNMs, NPs, and PAs, but only
in accordance with standardized procedures and protocols which are
adopted and only within primary care clinics or other clinics as
specified. The standardized procedures for CNMs, NPs, and PAs are
somewhat similar in their requirements for these advanced health
care practitioners to furnish and order drugs. For example, NPs can
only furnish or order drugs when all of the following conditions are
met:
a) The drugs of devices are furnished or ordered by a NP in
accordance with standardized procedures or protocols developed by
the NP and the supervising physicians and surgeon when the drugs
or devices furnished or ordered are consistent with the
practitioner's educational preparation or for which clinical
competency has been established and maintained.
b) The NP is functioning pursuant to standardized procedure, as
defined, or protocol. The standardized procedure or protocol
shall be developed and approved by the supervising physician and
surgeon, the NP and the facility administrator or the designee.
AB 2348
Page 13
c) The standardized procedure or protocol covering the furnishing
of drugs or devices shall specify which NPs may furnish or order
drugs or devices, which drugs or devices may be furnished or
ordered, under what circumstances, the extent of physician and
surgeon supervision, the method of periodic review of the NPs
competence, including peer review, and review of the provisions
of the standardized procedures.
d) There are additional and specific requirements for
standardized procedures and protocols which permit NPs to furnish
or order controlled substances.
e) The furnishing or ordering of drugs or devices by a NP occurs
under physician and surgeon supervision. Physician and surgeon
supervision shall not be construed to require the physical
presence of the physician, but does include 1) collaboration on
the development of the standardized procedure, 2) approval of the
standardized procedure, and 3) availability by telephonic contact
at the time of patient examination by the NP.
This bill also allows RNs to dispense hormonal contraceptives
pursuant to standardized procedures as that term is defined in
existing law governing RN's scope of practice. The standardized
procedures for RNs means either of the following:
a) Policies and protocols developed by a health facility, as
specified, through collaboration among administrators and health
professionals including physicians and surgeons.
b) Policies and protocols developed through collaboration among
administrators and health professionals, including physicians and
nurses, by an organized health care system which is not a health
facility, as specified.
The policies and protocols shall be subject to any guidelines for
standardized procedures that the Division of Licensing of the
Medical Board and the Board of Registered Nursing (BRN) may jointly
promulgate. If promulgated, the guidelines shall be administered by
the BRN.
6.Arguments in Support. ACCESS to Women's Health Justice (ACCESS) is
one of the many health organizations and groups in support of this
measure. According to ACCESS, this bill
will increase timely access to birth control for thousands of
California women, helping to prevent unintended pregnancies and
AB 2348
Page 14
reducing the need for abortion. "Increasing access while
maintaining the safety underscored in current medical guidelines
will help address the significant unmet need faced by women across
the state. While anti-choice leaders in Congress and elected
officials in state houses across the country are working over-time
to restrict access to basic women's health care like birth control,
by passing AB 2348, California lawmakers can defy this alarming
national trend and maintain our state's legacy of leadership in
expanding access to comprehensive reproductive health care.
California Latinas for Reproductive Justice (CLRJ) writes that access
to comprehensive reproductive health care is especially important in
the Latina/o community, which has among the lowest access to
reproductive health services and experiences higher reproductive
health disparities. While Latinas represent 37% of women in
California, they comprise 60% of uninsured women. At the same time,
about half of pregnancies among Latinas are unintended. Moreover,
CLRJ believe that access to contraception and birth control services
is one of the most important services to be available to everyone in
their communities. CLRJ further points out that Latinas often rely
solely on community clinics to seek preventative reproductive health
care they need to thrive. "By permitting women to receive
comprehensive reproductive health care from their local providers,
AB 2348 will provide much needed equity in access to comprehensive
reproductive health care for all women, particularly Latinas and
other low-income women of color experiencing limited access to
health care.
Other proponents and supporters of this measure generally make similar
comments and argue that access to birth control is a critical public
health issue and an essential component of women's health care, but
unfortunately there are thousands of women in California who lack
access to contraception, leaving them at significant risk of
unintended pregnancy. According to the proponents, this measure
will authorize RNs to dispense medication within a community clinic
based on a standardized procedure. Standardized procedures are
regularly used in a range of health care settings and are developed
collaboratively by the physicians, nurses and administration of an
organization, providing accountability on several levels. The
standardized procedure would outline a specific formulary,
supervision, protocols for complex or high risk patients, and
requirements for education and training to competency. The clinic
medical director would delegate authority to the RN to provide the
contraception to the patient through the standardized procedure.
Proponents further state that RNs are skilled professionals who are
trained and legally authorized to perform the required health
AB 2348
Page 15
assessments (medical history and blood pressure check) necessary to
safely dispense birth control. Concerns have been raised that
allowing RNs to dispense birth control provides a lower standard of
care and even that women should not receive their birth control
method until undergoing a physical exam from a physician.
Proponents argue that this perspective is outdated and is not
consistent with current medical guidelines. Due to the safety of
hormonal contraceptives and the importance of timely access,
guidelines from leading medical institutions recommend that birth
control be provided based on a self-reported medical history and
blood pressure check and have delinked �sic] requirements for annual
pelvic examinations.
The proponents point out that hormonal contraceptives are one of the
most widely studied medications available today and used safely by
millions of women every day. Ninety Four percent (94%) of women
have no complicating health factors that would keep them from safely
taking birth control. For these women, removing barriers such as
required pelvic exam and a limited number of providers is key to
expanding access and preventing unintended pregnancies.
The proponents further explain that there are shortages of health care
professionals in many parts of the state - rural and urban. For
example, Planned Parenthood health centers in the Central Valley
have ongoing staff vacancies, which, if filled, would result in
13,000 more patients receiving basic reproductive care each month.
For a woman in need of birth control, these staff shortages can mean
waiting long periods of time to schedule an appointment, sitting in
a waiting room for hours before being seen, or driving long
distances to see a provider. All of these delays put woman at risk
of unintended pregnancy.
The proponents strongly believe that this measure will increase access
to birth control for thousands of California women, helping to
prevent unintended pregnancies and reducing the need for abortion.
Increasing access while maintaining the safety of current medical
guidelines will help address the significant unmet need faced by
woman across the state.
7.Arguments in Opposition (Prior Version of the Measure). The
California Nurses Association (CNA) is opposed to this measure and
has several concerns. The CNA believes this bill expands the scope
of practice for any RN who is currently employed in or is hired into
a licensed primary, community of free clinic. As stated by CNA,
"this bill involves the expansion of the scope of practice of the
larger group of RNs represented by CNA into the area of practice of
AB 2348
Page 16
the smaller group of RNs also represented by CNA." The CNA argues
that this bill does not meet any of the recommended criteria for
this scope of practice change. Instead of a demonstration of
requisite training and competence to provide this new service
�dispensing of hormonal contraceptives by RNs], the sponsors of the
legislation state:
". . .evidence-based guidelines for use of hormonal
contraceptives that are based on patient assessment, medical
history, blood pressure, history of smoking and other basic
elements that are well within the skills, training and scope of
practice of RNs. And we trust that registered nurses can
dispense birth control without any diminution of safety or
quality of care." �Emphasis Added]
CNA states that as the largest representative of RNs in California
it also has "trust " in RNs. However, CNA's further states, "our
concern for patient protection, our understanding of the unique
architecture of the nursing education requirements in California and
our recognition that appropriate training and demonstrated
competency cannot be replaced by 'trust' in the nursing profession
which compels us as patient advocates to strongly oppose this
potentially unsafe and unwise scope expansion. Being poor and
female should not mean that you should be provided a lower standard
of care than other patients in the same or other settings. We
unabashedly advocate for a single standard of high quality care that
applies to all patents in all health care settings. This is an
exceedingly dangerous precedent in which an employer of health care
professionals believes that is appropriate to lower professional
standards to meet is own business plan...we firmly believe that his
legislation sets a dangerous precedent by reducing the quality of
family planning services for poor women in response to an employer's
'bottom line.'"
The California Association of Nurse Practitioners (CANP) are also
opposed and indicate that they are generally supportive of efforts
to expand access to care and the nursing scope of practice, but are
unable to support the measure because the bill remains limited to
community clinic settings rather than all settings where women
access health care. As explained by CANP, this bill would create a
new, condition-specific, standardized procedure that would allow a
RN to perform a medical assessment and then determine a form of
hormonal contraceptive for a new patient seen at a community clinic.
This bill would provide the RN with limited discretion in
determining which method of hormonal contraceptives to dispense to
the woman seeking medical care. The CANP believes that if the
AB 2348
Page 17
Legislature determines that this new approach is an appropriate
means to expand access to hormonal contraceptives, then this
approach should be available to all settings, not exclusively
community clinics.
CANP further believes that this bill could have unintended
consequences of limiting access in other settings, including other
settings that may be experiencing health care provider shortages.
Settings where women are seeking access to hormonal contraceptives,
other than a community clinic would not be able to use the approach
created in this bill. Additionally, CANP is concerned that the part
of the bill which clarifies that RNs may dispense upon an order by
an NP, but only in community clinics, other settings would no longer
be allowed to have an RN dispense on the order of an NP.
CANP comments that the health care delivery system in California is
expected to absorb approximately 4 million new patients in 2014,
with the implementation of federal health care reform. Given that
increase of patients seeking care, CANP believes that legislation
expanding the scope of practice of RNs, NPs, or other non-physician
providers should be applicable to all settings and not be limited to
certain settings only.
8.Arguments in Opposition (Recent Version of the Measure): This
measure was amended on June 27, 2012. Neither CNA nor CANP have had
an opportunity to respond to this amended version. However, the
American Congress of Obstetricians and Gynecologists (ACOG) have
written an "Oppose Unless Amended" letter and indicate that as
physicians with advanced training in the health care of women,
including the option of fellowship training in family planning;
ACOG's foremost concern is what is in the best interests of
patients. "Sponsors of AB 2348 state that as birth control is safe,
personnel with substantially less training than a physician or an
advance practice clinician (APC) are qualified to provide these
controlled medications to patients. Their reasoning is flawed. We
agree that hormonal birth control is safe, when provided by
professionals who have the capability of assessing and analyzing the
patient's medical condition for both suitability to be on hormonal
contraception at all, and if so, what is the most appropriate. We
have not seen evidence that RNs are adequately equipped to do so."
ACOG further states that there are risks with hormonal contraceptives
and when prescribed by highly trained medical professionals risks
are low and have not seen evidence showing that a lower level of
analysis is equally safe. ACOG is concerned that the type of
contraceptive provided by an RN may not be the most efficacious
AB 2348
Page 18
ones, potentially providing the patients seen by RNs with a lower
standard of care. "Failure to have the patient first assessed by a
physician could mean less effective birth control for the patient."
As ACOG further indicates there are other issues to be considered
with the initial visit than just birth control and that those are
within the purview of the physician and of APCs, but not of the RN.
"However, we do understand the need to get contraception in the
hands of patients as soon as possible and want to work to make that
happen.
ACOG believes that at the core there must be an initial exam by and MD
or APC, with the RN able to provide refills (with qualifications)
once the prescription has expired, provided another exam is not
needed as determined by the standard of care. Also, ACOG suggests
that if clinics are finding challenges with MD access, they are open
and willing to work with them to find alternative, such as
telemedicine , before lowering the standard of care provided to lower
income women.
ACOG appears to be suggesting the following amendments:
(1) Delete subdivision (c) of Section 2725.2. This would keep
current law intact and require the prior appropriate
examination for a patient be done by an MD/APC.
(2) For the RN to provide refills under standardized
procedures without additional MD/APC patient contact require
the following:
(a) Exam at least every three years;
(b) Refills only for patients who meet the Center for
Disease Control Medical Eligibility Criteria Category 1 -
the ability to obtain hormonal contraception with no
limitations; and
(c) Provision of information to patients about all types
of birth control, sexually transmitted infections and health
behaviors.
9.Recent Amendments Possibly Addressing Concerns of CANP. There were
two basic concerns raised by the CANP. The first was the concern
about placing a limitation on the settings (such as within primary
care clinics only) in which a RN could dispense hormonal
contraceptives. The second was possibly placing a limitation on the
RNs ability to dispense a drug pursuant to an NPs order in other
health care settings.
The recent amendments appear to try and deal with the two concerns
AB 2348
Page 19
raised by the CANP. One of the amendments deletes the reference to
primary care clinics and other clinic settings. Hormonal
contraceptives would now be able to be dispensed by RNs in any heath
care setting. The other concern seems to be addressed by an
amendment which states that nothing in the amended section of the
law which allows RNs to dispense drugs pursuant to an order of a
CNM, NP or PA shall be construed to limit any other authority
granted to a CNM, NP or PA pursuant to the provisions which relate
to their scope of practice. Pursuant to this amendment, if current
authority exists in other settings pursuant to standardized
procedures or protocols which allow RNs to dispense pursuant to an
order of these advanced health care practitioners, then this
authority would not be affected by the changes in this bill. (It
should be noted that amendments also include a number of other
clinic settings.)
10.Recent Amendment Regarding Requirement for an "Appropriate Patient
Examination" is Unclear. The recent addition of subdivision (c) of
Section 2725.2, which speaks to the requirement of "an appropriate
patient examination," appears to be unclear. It mentions
"compliance with subdivision (a) of Section 2242" which requires a
physician and surgeon prior appropriate examination of a patient
before prescribing, dispensing, or furnishing dangerous drugs. It
is unclear whether this language would allow an RN, possibly
pursuant to standardized procedures, to provide an initial
examination as long as it is consistent with the USMEC guidelines,
or whether it now requires strict compliance with subdivision (a) of
Section 2242, and would require an examination by a physician and
surgeon under all circumstances. The Author may want to consider
the following amendment which would at least allow a physician and
surgeon to determine in collaboration with both APCs and RNs, and
under standardized procedures and protocols, and in compliance with
the USMEC guidelines, which health care provider would provide a
"prior appropriate examination" so as to comply with Section 2242 of
the Medical Practice Act.
Suggested Amendment:
On page 4, strike lines 7 through 12, inclusive and insert after line
6, the following:
(9) Adherence to subdivision (a) of Section 2242 developed through
collaboration among health professionals, including physicians and
surgeons, certified nurse-midwives, nurse practitioners, or
physician assistants and registered nurses and that the prior
appropriate examination shall be consistent with the evidence-based
AB 2348
Page 20
practice guidelines adopted by the federal Centers for Disease
Control and Prevention in conjunction with the United States Medical
Eligibility Criteria for Contraceptive Use.
SUPPORT AND OPPOSITION:
Support:
California Family Health Council (Sponsor)
Planned Parenthood Affiliates of California (Sponsor)
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
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
AB 2348
Page 21
Women's Health Specialists
Opposition:
California Association for Nurse Practitioners
California Nurses Association
California Catholic Conference, Inc.
California Right to Life Committee, Inc.
Consultant:Bill Gage