REPORT OF THE COUNCIL ON SCIENTIFIC AFFAIRS
CSA Report 9-A-05
Subject:
Expedited Partner Therapy (Patient-Delivered Partner Therapy)
(Resolution 820, I-04)
Presented by:
Melvyn L. Sterling, MD, Chair
Referred to:
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
Reference Committee E
(Daniel W. van Heeckeren, MD, Chair)
--------------------------------------------------------------------------------------------------------------------Resolution 820 (I-04), introduced by the American Association of Public Health Physicians, the
American Medical Women’s Association, and the Washington Delegation at the 2004 Interim
Meeting and referred to the Board of Trustees, asks:
That our American Medical Association (AMA): (1) encourage state licensing boards,
medical societies, health and malpractice insurance carriers, and others to consider the
demonstrated benefits of Patient-Delivered Partner Therapy (PDPT) when evaluating the
appropriateness of this practice; (2) encourage continued research on expedited partner
treatment (EPT) and other innovative strategies for sexually transmitted infection (STI)
control; (3) encourage federal, state, and local governments to fully fund STI control
programs; (4) support and encourage efforts by the Centers for Disease Control and
Prevention to identify opportunities for increased use of PDPT; analyze existing and potential
barriers to PDPT use; encourage use of PDPT in all appropriate settings; and establish model
guidelines and recommendations for implementation of PDPT and other EPT strategies; and
(5) notify appropriate medical societies, federal and state agencies, and malpractice carriers
of its position on PDPT.
This Council on Scientific Affairs report briefly describes our AMA’s current collaborative efforts
with the Centers for Disease Control and Prevention (CDC) on the issue of expedited partner therapy
(EPT) and provides recommendations for consideration by the House of Delegates.
DATA SOURCES
Our AMA participated in a meeting, Expedited Partner Therapy Stakeholders Consultation, organized
by the CDC on March 2-3, 2005. This meeting presented a systematic review of the science of EPT
as well as significant background information on the issues that need to be considered when
implementing EPT.
INTRODUCTION
EPT has been discussed and used by health care professionals over the past decade.1,2 EPT involves
enabling treatment, without a prior examination, of sex partners of individuals diagnosed with a
sexually transmitted disease (STD). Patient-delivered partner therapy (PDPT) is an extension of EPT
in that the patient is asked to deliver the treatment to the sex partner. Currently, the focus of EPT is
on the sex partners of those persons infected with gonorrhea or Chlamydia because of the significant
public health burden of these diseases and the relative ease of treatment with antibiotics.
Thus, EPT can be carried out by physicians giving medication to patients for their partners, giving
prescriptions to patients for their partners, or providing “use as needed” prescriptions. Public health
CSA Rep. 9 -- A-05 — page 2
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
professionals can also deliver medication during partner follow-up interviews with or without
collecting morbidity data. The rationale for EPT arises from data indicating there is an inability to
provide public health staff the assistance and resources they need to contact, notify, and bring to
treatment many sex partners of persons infected with STDs. Indeed, in 1998 only 17% of gonorrhea
and 12% of Chlamydia patients received partner-notification services.3
CURRENT SCIENTIFIC DATA ON EXPEDITED PARTNER THERAPY
While limited, sufficient good-quality studies exist to indicate that EPT can not only reduce the
incidence of chlamydial infections,4 it can also significantly reduce the reinfection rates of patients
with chlamydial infection.5-7 EPT has been shown to be more effective than patient self-referral
(whereby the patient is asked to notify partners about exposure and encourage them to seek treatment)
in ensuring follow-up with the sex partner.8 Similarly, a randomized, controlled study by Schillinger
demonstrated reduced incidence of chlamydial infection in patients receiving EPT as compared to
patients in the self-referral arm.9 Studies also indicated significant reduction in gonorrheal
reinfections and significant reduction in symptomatic urethritis due to Neisseria gonorrhea following
EPT.5
Data also indicate that EPT improves the frequency at which the partner receives notification of
his/her potential exposure and the frequency of treatment.5,10 Additionally, those who received EPT
are more likely to ensure that their partner completes the treatment. Data also indicate that those
participating in EPT are more likely to improve sexual behaviors (eg, reduce frequency of
unprotected sex). Accordingly, it appears that with respect to medical science, EPT is indicated for
partners of those diagnosed with gonorrheal or chlamydial infections.
Since 2001, medical professionals in California have been allowed by law to provide patients
diagnosed with Chlamydia infection with antibiotics to deliver to their sex partners. While
preliminary, data emerging from California support published findings and indicate that most
participating physicians feel that EPT protects patients from reinfection and that EPT helps provide
better care for patients with Chlamydia. Consequently, the CDC is currently engaged in a major effort
to improve the use of EPT in the United States. As part of this process, the CDC has already
conducted a systematic review of the scientific evidence on EPT in order to produce an official
guidance on the implementation of EPT.
From a cost-effectiveness perspective, while the data are limited, it appears EPT is at least
comparable if not less costly than standard referral in terms of cost per index patient and cost per
partner treated; however, more research is indicated. A study by Postma suggests that partner therapy
reduces net costs per outcome averted by about 50% and sensitivity analyses indicate that even when
assumptions are varied, cost-effectiveness was demonstrated. 10
However, most participants in the stakeholders’ meeting agreed that while EPT should be an option
available to physicians in their “toolbox” for combating chlamydial and gonorrheal infections, the
primary goal is still to get the partner of the index patient to a physician for examination. This
reflects concerns about the potential loss of the partner to actual physician follow up due to EPT,
which may result in lost opportunities to identify potentially more serious medical conditions
associated with chlamydial and gonorrheal infections, such as pelvic inflammatory disease.
CSA Rep. 9 -- A-05 — page 3
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
BARRIERS TO THE IMPLEMETNATION OF EXPEDITED PARTNER THERAPY
A significant portion of the CDC meeting focused on discussing barriers that must be overcome to
facilitate EPT in the United States. These range from funding mechanisms to liability. Some of the
more important barriers are summarized below.
Funding Mechanisms
Some public health clinics and other similar providers will likely pay the direct and administrative
costs of providing EPT, especially if the treatment is delivered through the index patient. However,
the sustainability of such funding is uncertain as burdens on state public health funding continue to
increase. In the private care setting, the patient, the sex partner, or their insurers will be responsible
for the cost of EPT, potentially creating barriers in some situations. While the data indicating reduced
risk of persistent or recurrent gonorrhea and chlamydial infections and their accompanying
complications will prompt some health maintenance organizations to cover EPT, others will decline
to cover it for logistical and administrative reasons, or due to liability concerns.
Cost of EPT
Cost is of particular concern for already under-funded public health departments and in this situation,
the benefits derived from EPT will have to balanced by the trade-offs with other prevention strategies,
such as primary screening of women, expansion of screening to underserved populations of women,
screening programs for males, and rescreening of persons treated for either chlamydial or gonorrheal
infection.
However, it is likely that the actual expenses of EPT are modest relative to the total costs incurred in
the diagnosis and management of patients with treatable STDs, and in relation to the potential to
prevent complications and curtail the spread of infection.
Legality of EPT
For EPT to become reality in California, a specific exception to the state’s Medical Practice Act had
to be enacted by the state legislature. This reflects the fact that providing a prescription drug to a
patient with whom the clinician lacks an established physician-patient relationship may not be legal in
all settings and may be considered a breach of medical ethics.11 Regardless of the actual legal status
of EPT, perceived illegality is another significant barrier to its implementation. As is evidenced by
experience in California, Tennessee, and Washington state, changes may have to be made to grant
physicians the option of EPT for their patients diagnosed with Chlamydia or gonorrhea. As suggested
earlier, preliminary data from California indicate that the removal of legal barriers improves
utilization of EPT.
STD Co-morbidity in Partners
As noted above, EPT may involve missed opportunities for diagnosis and treatment of STDs that
would be detected by personal examination of the partners. It is clear that where traditional partner
management approaches are available to the physician, EPT should be deemphasized. However, this
risk of delayed diagnosis and undertreatment may be balanced by the improved rates of notification
and treatment of sex partners associated with EPT. Regardless, all physicians should be aware of
these caveats before considering EPT for their patients, and partners should be urged to seek followup examinations after EPT.
CSA Rep. 9 -- A-05 — page 4
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
Concern is also expressed about the potential missed opportunities for prevention counseling of
partners receiving EPT. However, there are no data to quantify the prevention efficacy of such
counseling, or to document that the prevention benefit of an interview outweighs that which would be
possible via the use of educational literature that can accompany EPT.
Liability Concerns
Physicians may encounter litigation in the event of adverse outcomes due to EPT. State law may also
prohibit prescribing to patients with whom a physician has no established relationship. However, as
the CDC continues to educate on the value of EPT as an additional tool to treat STDs, it is likely that
this concern will decrease as EPT becomes a legally acceptable community practice. On the reverse
side, liability concerns also exist should it be argued that a physician failed to prevent reinfection of
his/her patient by failing to offer EPT to the patient’s partner. The CDC acknowledges the value of
establishing EPT as an accepted community standard of care and intends to use its planned guidance
to accomplish this.
CURRENT STATUS OF THE CENTERS FOR DISEASE CONTROL AND PREVENTION
EXPEDITED PARTNER THERAPY GUIDANCE
The CDC has stated its intention to issue two documents on EPT. These documents will reflect the
extensive literature reviews and expert opinion/stakeholder consultations that have been conducted.
The first document will be a “white paper” highlighting the scientific data supporting EPT and the
associated risks and benefits of adding this tool to the physician’s options to reduce the incidence of
Chlamydia and gonorrhea.
A second, less scientific, “implementation guidance” will then follow the white paper to assist states
to implement the legislation, policies, and education necessary to establish EPT as an acceptable and
available practice.
At this time, the CDC anticipates that the first “white paper” will be available for stakeholder review
in Fall 2005.
CONCLUSIONS
The CDC has already expended significant effort in researching the scientific evidence for or against
a more widespread implementation of EPT. It appears from the presentations and discussions at the
CDC-sponsored EPT stakeholder meeting held in Atlanta on March 2-3, 2005, that the medical and
scientific evidence supports the use of EPT in treating the sex partners of patients who have been
diagnosed with either chlamydial or gonorrheal infections. However, numerous barriers remain to be
addressed for EPT be successfully implemented throughout the United States. Our AMA should
remain engaged with the CDC as it completes its guidance on the implementation of EPT. Following
official publication of the guidance, our AMA can review and offer its support for the guidance
recommendations at that time.
CSA Rep. 9 -- A-05 — page 5
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
RECOMMENDATIONS
The Council on Scientific Affairs recommends that the following statements be adopted in lieu of
Resolution 820 (I-04), and that the remainder of this report be filed:
1.
That our American Medical Association continue to work with the Centers for Disease
Control and Prevention (CDC) as it prepares its “white paper” on expedited partner therapy
(EPT) and its follow-up guidance on the implementation of EPT. (Directive to Take Action)
2.
That our AMA review and then support, as appropriate, the final documents on expedited
partner therapy as issued by the CDC. (Directive to Take Action)
3.
That our AMA encourage continued research into benefits and potential adverse outcomes
that might be associated with the use of EPT to treat sex partners of those diagnosed with
either chlamydial or gonorrheal infections. (Directive to Take Action)
Fiscal Note: $3,000, to continue to participate in CDC stakeholder meetings on EPT.
CSA Rep. 9 -- A-05 — page 6
REFERENCES
1. Golden MR, Whittington WL, Gorbach PM, Coronado N, Boyd MA, Holmes KK. Partner
notification for chlamydial infections among private sector clinicians in Seattle-King County:
a clinician and patient survey. Sex Transm.Dis. 1999;26:543-547.
2. Hogben M, McCree DH, Golden MR. Patient-delivered partner therapy for sexually
transmitted diseases as practiced by U.S. physicians. Sex Transm.Dis. 2005;32:101-105.
3. Golden MR, Hogben M, Handsfield HH, St Lawrence JS, Potterat JJ, Holmes KK. Partner
notification for HIV and STD in the United States: low coverage for gonorrhea, chlamydial
infection, and HIV. Sex Transm.Dis. 2003;30:490-496.
4. Klausner JD, Chaw JK. Patient-delivered therapy for chlamydia: putting research into
practice. Sex Transm.Dis. 2003;30:509-511.
5. Golden MR, Whittington WL, Handsfield HH, et al. Effect of expedited treatment of sex
partners on recurrent or persistent gonorrhea or chlamydial infection. N.Engl.J.Med.
2005;352:676-685.
6. Ramstedt K, Forssman L, Johannisson G. Contact tracing in the control of genital Chlamydia
trachomatis infection. Int.J.STD AIDS. 1991;2:116-118.
7. Kissinger P, Brown R, Reed K, et al. Effectiveness of patient delivered partner medication for
preventing recurrent Chlamydia trachomatis. Sex Transm.Infect. 1998;74:331-333.
8. Nuwaha F, Kambugu F, Nsubuga PS, Hojer B, Faxelid E. Efficacy of patient-delivered
partner medication in the treatment of sexual partners in Uganda. Sex Transm.Dis.
2001;28:105-110.
9. Schillinger JA, Kissinger P, Calvet H, et al. Patient-delivered partner treatment with
azithromycin to prevent repeated Chlamydia trachomatis infection among women: a
randomized, controlled trial. Sex Transm.Dis. 2003;30:49-56.
10. Postma MJ, Welte R, van den Hoek JA, van Doornum GJ, Jager HC, Coutinho RA. Costeffectiveness of partner pharmacotherapy in screening women for asymptomatic infection
with Chlamydia Trachomatis. Value.Health. 2001;4:266-275.
11. Golden MR, Anukam U, Williams DH, Handsfield HH. The legal status of patient-delivered
partner therapy for sexually transmitted infections in the United States: a national survey of
state medical and pharmacy boards. Sex Transm.Dis. 2005;32:112-114.