Transcript Slide 1

Expedited Partner Therapy:
A Legal Tool to Advance Women’s Health
Amy Pulver, MBA, MA
Division of STD Prevention
Healthy States Forum for State Legislators
Boston, Massachusetts
August 25, 2006
The findings and conclusions in this presentation are those of the author and do not
necessarily represent the views of the Centers for Disease Control and Prevention.
Overview
 Women’s health issue: STI-related infertility
Chlamydia and gonorrhea
 Impact on women

 CDC guidance
Annual screening recommendations
 Expedited Partner Therapy (EPT)

 Legal barriers/facilitators project
STI-related Infertility
 Chlamydia



Most commonly-reported infectious disease in U.S.
Bacterial infection, easily treated, asymptomatic
929,462 cases reported to CDC in 2004
 Gonorrhea



Second most commonly-reported infectious disease
Bacterial infection, easily treated, asymptomatic
330,132 cases reported to CDC in 2004
Chlamydia — Age- and sex-specific rates:
United States, 2004*
Men
3,000
Rate (per 100,000 population)
2,400
1,800
1,200
600
0
10.8
458.3
744.7
402.9
185.2
99.3
56.1
23.0
7.4
2.2
147.5
* 2004 STD Surveillance Report
Age
10-14
15-19
20-24
25-29
30-34
35-39
40-44
45-54
55-64
65+
Total
0
Women
600
1,200
1,800
2,400
3,000
132.0
2,761.5
2,630.7
1,039.5
364.8
148.3
62.6
22.4
6.2
2.0
486.2
Gonorrhea — Age- and sex-specific rates
United States, 2004*
Men
750
Rate (per 100,000 population)
600
450
300
150
0
5.8
252.9
430.6
302.1
178.6
124.5
89.6
48.1
17.0
4.1
110.2
* 2004 STD Surveillance Report
Age
10-14
15-19
20-24
25-29
30-34
35-39
40-44
45-54
55-64
65+
Total
0
Women
150
300
450
600
750
36.9
610.9
569.1
269.7
114.2
60.3
32.9
11.7
2.5
0.6
116.7
Women’s Health Consequences
infertility
chlamydia
pelvic
inflammatory
disease
9%
ectopic
pregnancy
gonorrhea
chronic
pelvic
pain
• Infectious complications
– Neonatal pneumonia (CT) or eye infections (CT & GC) in 6070% of infants born to untreated mothers
– At least 2-5 fold increased risk of HIV infection
CDC Guidance
 Annual chlamydia screening recommended for
sexually-active women ≤ 25 years of age
 Infertility Prevention Program
Partnership with HHS Office of Population
Affairs
 Screen low-income, sexually-active women in
publicly-funded clinics

Partner Services
 Treating partners of patients with STD is critical


Halt spread of infection
Prevent re-infection of those treated
 Provider or provider-assisted referral is optimal
strategy


Not available to most with chlamydia or gonorrhea
diagnoses because of resources
Usual alternative is advising patients to refer partners for
treatment
Expedited Partner Therapy
 Partners are treated without an intervening clinical
assessment
 Patients deliver either medications or prescriptions to
their partners
 2005 CDC supports EPT as a useful option to facilitate
partner management for treatment of male partners of
female patients with chlamydial or gonorrheal infection
 2006 CDC’s STD Treatment Guidelines include
guidance on EPT
http://www.cdc.gov/std/treatment/EPTFinalReport2006.pdf
Guidance
“The evidence indicates that EPT should be available
to clinicians as an option for partner management…
EPT represents an additional strategy for partner
management that does not replace other strategies,
such as standard patient referral or provider-assisted
referral, when available. Along with medication, EPT
should be accompanied by information that advises
recipients to seek personal health care in addition to
EPT. This is particularly important when EPT is
provided to male patients for their female partners, and
for male partners with symptoms.”
Centers for Disease Control and Prevention. Expedited partner therapy in the management of sexually transmitted diseases.
Atlanta, GA: US Department of Health and Human Services, 2006
http://www.cdc.gov/std/treatment/default.htm
Guidance
“When medical evaluation, counseling, and treatment of partners
cannot be done because of the particular circumstances of a
patient or partner or because of resource limitations, other partner
management options can be considered…. Patient-delivered
therapy (i.e., via medications or prescriptions) can prevent
reinfection of index case and has been associated with a higher
likelihood of partner notification, compared with unassisted patient
referral of partners. Medications and prescriptions for patientdelivered therapy should be accompanied by treatment
instructions, appropriate warnings about taking medications if
pregnant, general health counseling, and advice that partners
should seek personal medical evaluations, particularly women
with symptoms of STDs or PID.”
Centers for Disease Control and Prevention. Sexually Transmitted Diseases Treatment Guidelines, 2006. MMWR 2006;55 (no.
RR-11):6
AMA Policy Support
 The following statements, recommended by the
Council on Science and Public Health, were adopted
as by the AMA House of Delegates as AMA policy and
directive at the 2006 AMA Annual Meeting:
1. The AMA supports the Centers for Disease Control and
Prevention’s (CDC) guidance on expedited partner therapy
(EPT) that was published in its 2006 white paper, Expedited
Partner Therapy in the Management of Sexually Transmitted
Diseases. (Policy)
2. The AMA will continue to work with the CDC as it implements
EPT, such as through the development of tools for local health
departments and health care professionals to facilitate the
appropriate use of this therapy. (Directive)
http://www.ama-assn.org/ama/pub/category/16410.html
Legal Status
 Uncertainty about legal status consistently
identified as barrier to implementation
Published papers
 CDC guidance and reports
 AMA statements

 Perceived legal status is as important as actual
legal status
Legal Status
 “The legal status of EPT, whether real or perceived, will
affect implementation.” *
 “Most of the EPT implementation issues carry their own
implications for research. For example, the only
available data on the legality of EPT is based on the
personal opinions of survey respondents, and
refinement is desirable.” *
 “Currently, EPT is not feasible in many settings
because of operational barriers, including the lack of
clear legal status of EPT in some states.” **
* Centers for Disease Control and Prevention. Expedited partner therapy in the management of
sexually transmitted diseases. Atlanta, GA: US Department of Health and Human Services, 2006.
** Centers for Disease Control and Prevention. Sexually Transmitted Diseases Treatment
Guidelines, 2006. MMWR 2006;55 (no. RR-11
Assessing Legal and Policy Issues
Concerning Expedited Partner Therapies
for Sexually Transmitted Diseases
James G. Hodge, Jr., J.D., LL.M.,
Associate Professor, Johns Hopkins Bloomberg School of Public Health
Executive Director, Center for Law and the Public’s Health
Project Goals
 Joint effort of the Center for Law and the Public’s
Health and CDC’s National Center for HIV, STD, and
TB Prevention (NCHSTP), Division of STD Prevention
 Assess the legal environment underlying the practice
of EPT
 identify major legal issues
 clarify relevant laws, ethics, and policies that
facilitate or impede EPT
 offer legal interpretations, strategies, or proposals
for reform to accomplish EPT across jurisdictions
consistent with public health laws and policies
The Center for Law & the Public’s Health
at Georgetown & Johns Hopkins Universities
CDC Collaborating Center Promoting Health through Law
WHO/PAHO Collaborating Center on Public Health Law and Human Rights
Project Outcomes
 Comprehensive table of legal authorities at the state
and territorial levels to assist law- and policy-makers,
STD prevention professionals, and health care workers
assess the legality of EPT (but not to provide specific
legal advice)
 Web posting of comprehensive table is forthcoming
 National input from federal, state, local, and tribal
partners is anticipated
 Assessment report and scholarship analyzing results of
comprehensive table is in development
The Center for Law & the Public’s Health
at Georgetown & Johns Hopkins Universities
CDC Collaborating Center Promoting Health through Law
WHO/PAHO Collaborating Center on Public Health Law and Human Rights
Methodology

Examine statutes, bills, regulations, cases, opinions, and other
laws and policies in each jurisdiction in 4 key areas:
1.
2.
3.
4.
Laws concerning the ability of physicians to provide a
prescription to a patient’s partner without prior evaluation of
the partner
Laws concerning the ability of other health care personnel
(nurses, physicians’ assistants, pharmacists) to provide a
prescription to a patient’s partner without prior evaluation of
the partner
Laws concerning prescription requirements (e.g., patientspecific information requirements)
Laws concerning public health authorization for EPT (via
incorporation by reference or other techniques)
The Center for Law & the Public’s Health
at Georgetown & Johns Hopkins Universities
CDC Collaborating Center Promoting Health through Law
WHO/PAHO Collaborating Center on Public Health Law and Human Rights
Table of Key Legal Provisions Implicating EPT
Jurisdiction
I. Statutes/
regs on
health care
providers
authority to
prescribe
for STDs to a
patient’s
partner(s)
w/out prior
evaluation
Alabama
Results with
II. Specific
judicial
decisions
concerning EPT
(or like
practices)
hot links to
citations
↓
Wyoming
Summary
Totals
The Center for Law & the Public’s Health
at Georgetown & Johns Hopkins Universities
CDC Collaborating Center Promoting Health through Law
WHO/PAHO Collaborating Center on Public Health Law and Human Rights
III. Specific
administrative
opinions by
the AG, or
medical or
pharmacy
boards
concerning
EPT (or like
practices)
IV. Legislative
bills or
prospective regs
concerni
ng EPT
(or like
practices
)
V. Laws
that
incorporate
via
reference
guidelines
as
acceptable
practices
(including
EPT)
VI. Prescription
requirements
VII.
Assessment of
EPT’s
legal
status
with brief
comments
Select Example - California
Jurisdiction
I. Existing
statutes/regs
II. Specific
judicial
decisions
California
(+) EPT
authorized for
Chlamydia. May
be conducted by
physicians, nurse
practitioners,
certified nurse
midwives and
physicians
assistants.
Cal. Health &
Safety Code §
120582.
(-)
Suspension of
physician’s
license
upheld
because
the Board
established
that
physician
prescribed
to persons
who were
not his
patients.
Leslie v.
Bd. of
Medical
Quality
Assurance,
234 Cal.
App. 3d
117
(-) EPT not
allowed for all
diseases or
conditions except
Chlamydia.
Cal. Bus. & Prof.
Code §§ 2242(4),
4170.
The Center for Law & the Public’s Health
at Georgetown & Johns Hopkins Universities
CDC Collaborating Center Promoting Health through Law
WHO/PAHO Collaborating Center on Public Health Law and Human Rights
III. Specific
administrative
opinions
IV.
Legislative
bills or
prospective
regulations
(+) AB 2280
allows
medical
providers to
offer patientdelivered
therapy to
partners of
individuals
diagnosed
with
gonorrhea or
other STDs.
(introduced
June 21,
2006).
V. Legal
provisions that
incorporate via
reference
guidelines
VI.
Prescription
law
requirements
VII.
Assessment
of EPT’s
legal status
(-)
Prescription
label must
bear patient’s
name. Cal.
Bus. & Prof.
Code § 4076.
 EPT is
permissible.
Statutory
authority
expressly
authorizes
EPT for the
treatment of
chlamydia.
Preliminary Conclusions
 As of August 16, 2006, our initial assessment
of the various laws and policies across the 50
states and other jurisdictions is categorized
into three conclusions:
1.
2.
3.
EPT is permissible for certain practitioners
and conditions
EPT is possible subject to additional actions
or policies
EPT is likely prohibited
The Center for Law & the Public’s Health
at Georgetown & Johns Hopkins Universities
CDC Collaborating Center Promoting Health through Law
WHO/PAHO Collaborating Center on Public Health Law and Human Rights
Jurisdictions Where EPT is
Permissible
WA
HI
VT NH
AK
MT
ME
ND
MN
OR
MA
RI
CT
ID
SD
WI
WY
NE
NV
CA
UT
AZ
NM
KS
OK
EPT is Permissible
PA
NJ
DE
WV VA
MD
OH
IN
MO
KY
DC
NC
TN
AR
SC
MS
TX
MI
IA
IL
CO
NY
AL
GA
LA
FL
PR - (Puerto Rico)
The Center for Law & the Public’s Health
at Georgetown & Johns Hopkins Universities
CDC Collaborating Center Promoting Health through Law
WHO/PAHO Collaborating Center on Public Health Law and Human Rights
Jurisdictions Where EPT is
Possible
WA
HI
VT NH
AK
MT
ME
ND
MN
OR
MA
RI
CT
ID
SD
WI
WY
NE
NV
CA
UT
AZ
NM
KS
OK
PA
NJ
DE
WV VA
MD
OH
IN
MO
KY
DC
NC
TN
AR
SC
MS
TX
MI
IA
IL
CO
NY
AL
GA
LA
EPT is Possible
FL
PR - (Puerto Rico)
The Center for Law & the Public’s Health
at Georgetown & Johns Hopkins Universities
CDC Collaborating Center Promoting Health through Law
WHO/PAHO Collaborating Center on Public Health Law and Human Rights
Jurisdictions Where EPT is Likely
Prohibited
WA
HI
VT NH
AK
MT
ME
ND
MN
OR
MA
RI
CT
ID
SD
WI
WY
NE
NV
CA
UT
AZ
NM
KS
OK
PA
NJ
DE
WV VA
MD
OH
IN
MO
KY
DC
NC
TN
AR
SC
MS
TX
MI
IA
IL
CO
NY
AL
GA
LA
EPT is Likely Prohibited
FL
PR - (Puerto Rico)
The Center for Law & the Public’s Health
at Georgetown & Johns Hopkins Universities
CDC Collaborating Center Promoting Health through Law
WHO/PAHO Collaborating Center on Public Health Law and Human Rights
Comprehensive Assessment of
EPT’s Legal Status
WA
HI
VT NH
AK
MT
ME
ND
MN
OR
MA
RI
CT
ID
SD
WI
WY
NE
NV
CA
UT
AZ
NM
KS
OK
TX
PA
NJ
DE
WV VA
MD
OH
IN
MO
KY
DC
NC
TN
AR
SC
MS
EPT is Permissible
MI
IA
IL
CO
NY
AL
GA
LA
FL
EPT is Possible
EPT is Likely Prohibited
The Center for Law & the Public’s Health
at Georgetown & Johns Hopkins Universities
CDC Collaborating Center Promoting Health through Law
WHO/PAHO Collaborating Center on Public Health Law and Human Rights
PR - (Puerto Rico)
The Legality of EPT Across
Jurisdictions
 - EPT is permissible for certain practitioners
and conditions in 10 jurisdictions (CA, CO,
MN, MS, NV, PA, TN, UT, WA, WY).
~ - EPT is possible subject to additional actions
or policies in 29 jurisdictions.
 - EPT is likely prohibited in 13 jurisdictions
(AZ, AR, FL, IL, LA, KY, MI, ND, OH, OK, SC,
VT, WV).
The Center for Law & the Public’s Health
at Georgetown & Johns Hopkins Universities
CDC Collaborating Center Promoting Health through Law
WHO/PAHO Collaborating Center on Public Health Law and Human Rights
The Legality of EPT Across
Jurisdictions
30
29
Jurisdictions
25
20
15
10
13
10
5
0
Permissible
The Center for Law & the Public’s Health
at Georgetown & Johns Hopkins Universities
CDC Collaborating Center Promoting Health through Law
WHO/PAHO Collaborating Center on Public Health Law and Human Rights
Possible
Prohibited
Conclusions



These initial assessments challenge the perception
that laws may be impede the practice of EPT
In states where EPT is assessed as prohibited or
possible, simple legislative, regulatory, or
administrative fixes could permit its practice
Specific legal reforms may include statutory bills (in a
few jurisdictions), administrative regulations,
incorporation by reference of CDC STD Treatment
Guidelines (2006), or favorable medical or
pharmaceutical board interpretations
The Center for Law & the Public’s Health
at Georgetown & Johns Hopkins Universities
CDC Collaborating Center Promoting Health through Law
WHO/PAHO Collaborating Center on Public Health Law and Human Rights
Limitations




Reviews are systematic and comprehensive, but not
exhaustive
Interpreting non-binding legal sources, such as policy
guidance documents or administrative decisions, is
complicated
Comparative snapshot of legal provisions that may
highlight laws concerning EPT in a given jurisdiction
based on currently available information
Research is ongoing with additional opportunities for
jurisdiction-specific feedback
The Center for Law & the Public’s Health
at Georgetown & Johns Hopkins Universities
CDC Collaborating Center Promoting Health through Law
WHO/PAHO Collaborating Center on Public Health Law and Human Rights
Acknowledgements



Hunter Handsfield, MD, University of Washington
CDC Colleagues

Susan Bradley

Matthew Hogben, PhD

Karen McKie, JD, MLS

Steven Shapiro, BS

Jill Wasserman, MPH

Rachel Wynn, MPH
Center for Law and the Public’s Health Colleagues

Erin Fusé Brown, J.D., M.P.H.

Dhrubajyoti Bhattacharya, J.D., M.P.H.