BILL ANALYSIS
SB 490
Page 1
Date of Hearing: July 1, 2003
ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS
Lou Correa, Chair
SB 490 (Alpert) - As Amended: April 24, 2003
SENATE VOTE : 24-13
SUBJECT : Pharmacy: emergency contraception drug therapy.
SUMMARY : Authorizes a licensed pharmacist to furnish emergency
contraception drug therapy (EC) in accordance with standardized
procedures and protocols developed by the Board of Pharmacy and
the Medical Board of California. Specifically, this bill :
1)Authorizes a pharmacist to furnish emergency contraception
drug therapy in accordance with a standardized procedure or
protocol developed and approved by both the Medical Board of
California and the Board of Pharmacy, in consultation with the
American College of Obstetricians and Gynecologists, the
California Pharmacist Association and other appropriate
entities.
2)Specifies that both the Board of Pharmacy and the Medical
Board of California shall have authority to ensure compliance,
and that each board is specifically charged with the
enforcement of this provision with respect to their own
licensees.
3)Deletes specified pharmacist training program requirements
related to EC, including the topics of sensitive
communications, quality assurance, referral to additional
services, and documentation.
4)Requires a pharmacist, prior to furnishing emergency
contraception, to receive training regarding the "appropriate
use and indications" for emergency contraception.
5)Clarifies that nothing in these provisions shall be construed
to expand the authority of a pharmacist to prescribe any
prescription medication.
EXISTING LAW authorizes a pharmacist to initiate emergency
contraception drug therapy in accordance with standardized
protocols developed by the pharmacist and an authorized
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prescriber acting within his or her scope of practice.
Existing law also 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.
FISCAL EFFECT : Unknown
COMMENTS :
Purpose of this bill . This bill intended to make it easier for
pharmacists to dispense emergency contraceptive drugs to
consumers by creating one statewide protocol with simpler
training and oversight requirements. Under current law,
individual pharmacists have to seek out physicians to arrange
"protocol" agreements, which can be difficult given the concerns
some physicians report about malpractice liability.
In practice, this bill would create one standard protocol, under
the direction of the Pharmacy and Medical Boards, and pharmacies
would simply need to follow the treatment protocol created by
the Board. This bill would also streamline the EC training
requirements, providing the boards with greater flexibility to
design the requirements.
Current practices in emergency contraception . Emergency
contraception therapy is a drug regimen that reduces the chance
of pregnancy significantly if administered within 72 hours of
unprotected intercourse. SB 1169 (Alpert), Chapter 900,
Statutes of 2001 created authority for a pharmacist to initiate
emergency contraception drug therapy in accordance with
standardized procedures or protocols developed by the pharmacist
and an authorized prescriber acting within their scope of
practice.
SB 1169 required a pharmacist, prior to initiating emergency
contraception drug therapy, to complete a training program on
emergency contraception that covers the conduct of sensitive
communications, quality assurance, referral to additional
services, and documentation. The pharmacist must provide each
recipient of the emergency contraception services with a
standardized fact sheet, developed by the Board of Pharmacy,
that includes the indications for the drug, the appropriate
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method for using the drug, the need for medical follow-up, and
other information. Pharmacists must also sign "protocol"
agreements with individual physicians so that the pharmacist can
dispense the drugs as directed.
According to the sponsor, four states other than California
provide direct public access to ECs in pharmacies: Washington,
New Mexico, Alaska and Hawaii. In fact, New Mexico currently
permits its Board of Pharmacy to develop a standard statewide
protocol for emergency contraception in much the same way as
this bill. They also note that the American Medical Association
and the American College of Obstetricians and Gynecologists have
recommended that emergency contraception be granted
over-the-counter status by the Food and Drug Administration.
Arguments in support . According to proponents, SB 490 will
further expand access to emergency contraception by making it
easier for pharmacists to dispense ECs to consumers under
appropriate protocols, thereby reducing unintended pregnancies
in California.
According to the author's office and proponents, although
existing law allows pharmacists to provide emergency
contraception to patients under a physician protocol, the
current system is cumbersome and presents significant barriers
to pharmacists. Moreover, few physicians have agreed to
participate in the development of protocols because of
malpractice concerns. As a result, supporters estimate that
only 14% of all retail pharmacies in the state currently provide
full access to emergency contraception.
By making it far easier for pharmacists to comply with protocol
requirements, proponents expect more pharmacists to offer the
product so that consumers have better access to ECs when needed.
Conflicting legislation . SB 545 (Speier), also in the Assembly
Business and Professions Committee and scheduled to be referred
to Assembly Health and Human Services Committee, would prohibit
pharmacists from charging a separate consultation fee if they
provide emergency contraception and limit the dispensing fee
charged for emergency contraception drugs to $10. SB 545 would
also completely remove the training requirement for pharmacists
who wish to provide emergency contraception, a requirement that
this bill only amends. This puts both bills and their
respective policies in direct conflict with the other, a problem
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magnified by the fact that both bills are amending the exact
same subsection. This means that the training issue will need
to be decided by the Committee, and the bills will require
amendment (see below) in order to sort out the changes so that
one does not chapter the other out if signed.
Given that training requirements are the policy in dispute, a
brief summary of the arguments for and against an EC training
requirement is provided below.
Is a training requirement for ECs still necessary ? There is
some disagreement among health providers as to whether or not
pharmacists should still be required to receive additional
training before furnishing EC's.
The California Pharmacists Association (CPA) argues that the
training requirement (and the proposed language of the current
SB 490) is necessary and appropriate. They note that training
was included in the original EC bill (SB 1169 in 2001) for good
reason and in agreement with all parties, including physicians.
California's current EC laws were based on the Washington model
- which required a similar pharmacist training regime for
similar reasons. More importantly, the furnishing of ECs is
"out of the ordinary" for pharmacists because they are providing
prescription drugs with minimal oversight, making training
important for addressing the legal and social implications of
furnishing EC's even if the pharmacological issues are well
known.
The American College of Obstetricians and Gynecologists (ACOG)
disagrees with CPA, arguing that additional training
requirements are unnecessary and burdensome. ACOG points out
that hospital and health system pharmacists already furnish ECs
under protocols without additional training. Furthermore, the
medications in ECs are "the same as those found in oral birth
control pills which pharmacists have been dispensing for
decades." Training requirements also impose costs on
pharmacists, which can be passed on to consumers as
'consultation fees' that indirectly impair access for consumers.
Voluntary training can still be offered or pursued by
pharmacists as needed even if the mandate were repealed. As
such, the training requirement is no longer necessary and should
be deleted.
Possible amendments . As noted above, this bill and SB 545 are
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directly in conflict, both in policy and in code sections.
However, as both bills also have separate, non-conflicting
elements, the solution is not necessarily as simple as choosing
one bill over the other. One approach is to address the
contentious issue of training requirements in one bill while
renumbering the relevant sections so that, regardless of the
outcome of the training issue, both bills could be voted on
without conflict between them.
This could be done by removing the training language from SB 490
and allowing its "appropriate use and indications" approach to
be discussed in the context of SB 545. At the same time, SB 545
should have its "protocol" language removed and its fee
restrictions and "no imposition of duty" language renumbered so
it does not conflict with SB 490. Then, training requirement
language could be incorporated, if necessary, in SB 545 as a new
subsection, thereby avoiding overlapping conflicts with the two
bills.
The Committee may wish to discuss with the author amending SB
490 to remove its training requirement subsection (page 4, lines
36-39). It also may make sense to subsequently double-join SB
490 with SB 545) .
Prior legislation . SB 1169 (Alpert), Chapter 900, Statutes of
2001, authorized a pharmacist to initiate emergency
contraception drug therapy in accordance with standardized
protocols developed by the pharmacist and an authorized
prescriber acting within his or her scope of practice.
AB 261 (Lempert) Chapter 375, Statutes of 1999, allows
pharmacists to dispense emergency contraception pills for
patients who have a written authorization by the patient's
physician.
REGISTERED SUPPORT / OPPOSITION :
Support
Public Health Institute (sponsor)
American Federation of State, County & Municipal Employees
California Abortion and Reproductive Rights Action League
California Commission on the Status of Women
California Family Health Council
California Medical Association
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California National Organization for Women
California Pharmacists Association
California State Board of Pharmacy
Children's Hospital Los Angeles
Health Offices Association of California
League of Women Voters of California
Medical Board of California
Napa County Office of Education
New Generation Health Center
Planned Parenthood Affiliates of California
Planned Parenthood, Los Angeles
Planned Parenthood, San Diego & Riverside
Planned Parenthood, Santa Barbara, Ventura & San Luis Obispo
Counties
San Francisco Health Plan
The Permanente Medical Group, Inc.
UCSF, Institute for Health Policy Studies, School of Medicine
Opposition
None on file.
Analysis Prepared by : Hank Dempsey / B. & P. / (916) 319-3301