Expedited Partner Therapy (EPT) for
Chlamydia trachomatis and Neisseria gonorrhoeae:

Guidance for Medical Providers in Minnesota

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Developed by: Minnesota Department of Health (MDH) in consultation with: California Department of Public Health Sexually Transmitted Diseases (STD) Control Branch; New Mexico Department of Health; and the Centers for Disease Control and Prevention who allowed MDH to use their EPT guidances.

Introduction
- Brief Description of Expedited Partner Therapy
- Expedited Partner Therapy for Chlamydia and Gonorrhea: Guidelines Summary
Background and Rationale
- Public Health Significance of Chlamydia and Gonorrhea in Minnesota
- Consequences of Untreated Infection
- Economic Burden
- Disease Trends in Minnesota
Importance of Partner Management
- For Patients
- For Population Disease Prevention
- Medical Provider Role and Responsibilities for Partner Management
Traditional Methods of Partner Management and Barriers to Effectiveness
- Patient Referral
- Health Care Provider Referral
- Public Health Department Notification and Referral
- Electronic Notification and Referral
EPT as an Alternative Partner Notification Method in Minnesota
- Legal Status of EPT in Minnesota
- EPT as a Standard of Care
Implementation of EPT
Selecting Appropriate Patients
Recommended Treatment Regimens
Options for Delivery of Drugs to Partners
- Dispense Medication Directly to the Patient for Delivery to Partner(s)
- Dispense Prescription to the Patient for Partner(s)
Patient Education
- Partner Notification Coaching
- Post-Treatment Testing/Rescreening
Special Issues
Medicolegal-Medical Provider Liability
Payment for Partner Drugs
STD Co-Morbidity in Partners
Missed Opportunities for Prevention of Future Partner Morbidity
Antimicrobial Resistance
Special Considerations When Caring for Adolescents

Appendices

  1. Minnesota Statute 2008 151.37 Legend Drugs, Who May Prescribe, Possess
  2. Directions for Sex Partners of Persons with Chlamydia
  3. Directions for Sex Partners of Persons with Gonorrhea and Directions for Sex Partners of Persons with Gonorrhea and Chlamydia
  4. Directions for Sex Partners of Persons with Chlamydia (Spanish)
  5. Directions for Sex Partners of Persons with Gonorrhea and Directions for Sex Partners of Persons with Gonorrhea and Chlamydia (Spanish)
  6. Information for Patients
  7. Coaching patients about Partner Notification

EPT References
Acknowledgements

Introduction

Expedited partner therapy (EPT) is the general term for the practice of treating sexual partners of patients diagnosed with a sexually transmitted disease (STD) without an intervening medical evaluation. EPT is an alternative strategy for ensuring that sex partners get needed medication thus reducing the likelihood of re-infection of the original patient.

In May 2008, Minnesota pharmacy statutes were amended removing the only known legal barrier to implementing EPT in Minnesota. This document was created to assist medical providers in Minnesota to utilize EPT as a tool in the management of partners of persons with Chlamydia trachomatis and Neisseria gonorrheae infection.

The following guidelines are focused on EPT strategies and provide information on the most appropriate patients, medications, and counseling procedures recommended to maximize patient and public health benefit while minimizing risk.

Brief Description of Expedited Partner Therapy
Expedited partner therapy (EPT) is the practice of treating the sex partners of persons with sexually transmitted diseases (STDs) without any intervening medical evaluation or professional prevention counseling. The usual implementation of EPT is through patient delivered partner therapy, whereby the index patient delivers medication or a prescription to their sexual partner(s).1

This option allowing providers to use EPT is not intended as the first and optimal choice of treatment for partners of individuals diagnosed with gonorrhea and chlamydia. However, this strategy can serve as a useful alternative when the partner is unable or unlikely to seek care. Providers should use their best judgment to determine whether partners will or will not come in for treatment, and to decide whether or not to dispense or prescribe additional medication to the index patient.

The best approach for treating STDs is for the partner(s) of a patient diagnosed with any STD to undergo testing, clinical evaluation and counseling by a clinician (their own primary care provider or at a public health clinic).2 When this is not feasible, EPT may be used to facilitate the treatment of these partners.

The U.S. Centers for Disease Control and Prevention (CDC) has concluded that EPT is a useful option to facilitate partner management, particularly for treatment of male partners of women with chlamydia or gonorrhea.3

Expedited Partner Therapy (EPT)
for Chlamydia trachomatis and Neisseria gonorrhoeae:
Guidance for Medical Providers in Minnesota

Expedited Partner Therapy (EPT) : EPT is the practice of treating sex partners of persons with STDs in the absence of medical evaluation. EPT is implemented through the delivery of medication or a prescription by the patient to their partners. While the best way to treat STDs is for partners to receive testing, treatment and counseling from a primary care provider, EPT is useful when the partners is unable or unlikely to seek care.
Index patient’s diagnosis: Clinical diagnosis of Chlamydia trachomatis or Neisseria gonorrhoeae
Most appropriate patients: Those with partners who are unable or unlikely to seek timely clinical services.
Recommended EPT drug regimens:
  Partners of patients diagnosed with chlamydia Azithromycin (Zithromax) 1 gram orally x1
 

Partners of patients diagnosed with gonorrhea*
OR
Partners of patients diagnosed with chlamydia and gonorrhea

* Presumptively treat for chlamydia due to high incidence of chlamydia/gonorrhea co-infection among patients with gonorrhea.

Cefixime (Suprax) 400 mg orally x1
OR
Cefpodoxime (Vantin) 400 mg orally x1
PLUS
Azithromycin (Zithromax) 1 gram orally x1
Number of doses is limited to the number of known sex partners in previous 60 days (or most recent sex partner if none in the previous 60 days).
Informational materials must accompany medication and must include clear instructions, warnings, and referrals.
Patient counseling: Abstinence until seven days after treatment and until seven days after partners have been treated.
Patient re-testing for gonorrhea and chlamydia is recommended three months after treatment to check for possible re-infection.

For treatment of index patients, see 2006 CDC STD Treatment Guidelines at www.cdc.gov/std/treatment.

Reporting: In Minnesota, clinicians are required to report laboratory-confirmed chlamydia and gonorrhea infections to MDH. To report cases, complete the MDH STD Confidential Case Report Form available at www.health.state.mn.us/std or call (651) 201-5414.

Adapted from Patient-Delivered Partner Therapy for Chlamydia trachomatis and Neisseria gonorrhoeae: Guidance for Medical Providers in California, California Department of Public Health Sexually Transmitted Diseases (STD) Control Branch in collaboration with California STD Controllers Association March 27, 2007


Background and Rationale

Public Health Significance of Chlamydia and Gonorrhea in Minnesota

  1. Consequences of untreated infections

Genital infections caused by chlamydia and gonorrhea, if left untreated, can lead to pelvic inflammatory disease (PID), chronic pelvic pain, ectopic pregnancy, and preventable infertility in women.4  Approximately 40 % of women with untreated chlamydia or gonorrhea develop PID and a prior episode of PID increases the risk of another episode due to the damage caused by the initial infection. Women with repeated episodes of PID are more likely to suffer serious complications. About one in ten women with PID becomes infertile, and if a woman has multiple episodes of PID, her chances of becoming infertile increase.5  Pregnant women with chlamydia or gonorrhea can pass the infections on to their newborn babies during the birthing process, causing pneumonia, ocular or other infections. Complications among men are rare. Infection sometimes spreads to the epididymis, causing discharge, pain, fever, and rarely sterility.

Patients with chlamydia or gonorrhea are at increased risk of acquiring or transmitting HIV during sex.6  Repeat infections, which increase the risk of complications, occur in nearly 11 % of patients within six months of treatment.7,8  To prevent repeat infections, reduce complications in individuals, and reduce further transmission of infection in the community, sex partners of infected patients must be provided timely and appropriate antibiotic treatment. However, because infected partners, and indeed most patients, are generally asymptomatic, they are unlikely to seek medical treatment. Even when health care providers counsel patients about the need for partner treatment, some partners have limited or no access to medical care or choose not to seek care.

  1. Economic Burden

Sexually transmitted diseases (STDs) impose a substantial economic burden on the U.S. The direct cost of STDs, including HIV, among all age groups was estimated to be $9.3-15.5 billion in the U.S. in the mid-1990s, adjusted to within the health care system treating STDs and their complications. These estimates do not include nonmedical costs, out-of-pocket costs, costs incurred when STDs are transmitted to infants, and the cost of STD prevention and screening. By far the greatest costs associated with bacterial STDs such as chlamydia and gonorrhea result from complications of untreated infections, which can lead to pelvic inflammatory disease and other serious sequelae. In a study done by the Kaiser Family Foundation in 1997, the average estimated annual total medical costs of chlamydia and gonorrhea per year are $374.6 million and $56 million respectively. 10,11

  1. Disease Trends in Minnesota

Under Minnesota law, chlamydia and gonorrhea infections that are confirmed by a laboratory test must be reported to the Minnesota Department of Health (MDH). Reports are received from diagnosing physicians as well as the laboratories conducting the testing. These reports are the basis for the MDH STD surveillance system, which tracks STD incidence in Minnesota over time by key demographic characteristics (i.e., sex, race, age, and geography). Of the nearly 100 infectious diseases that are reportable to MDH, chlamydia and gonorrhea are the most common. In 2007, MDH received 13,412 reports of chlamydia infection and 3,459 reports of gonorrhea, accounting for two thirds of all infectious diseases reported to MDH in that year.

Minnesota has seen substantial increases in STD morbidity over the past decade. From 1997 to 2007, the chlamydia rate nearly doubled (from 143 to 273 per 100,000) while the gonorrhea rate increased by 37 % (from 51 to 70 cases per 100,000). The impact of these diseases is evident in all areas of the state. In 2007, 85 of 87 Minnesota counties had at least one case of chlamydia and one-third of all reported cases were from greater Minnesota. Gonorrhea is somewhat more concentrated in the Twin Cities metropolitan area, but there was a large (34 %) increase in cases from greater Minnesota from 2006 to 2007.

A consistent, yet unfortunate feature of Minnesota’s STD epidemiology is the unequal distribution of disease across the population. Adolescents and young adults (15-24 year-olds) account for 14% of the state’s population but 65 % of all chlamydia and gonorrhea infections reported in 2007. Some of this disparity may be due to higher STD screening rates in young people, but this population remains at high risk for STDs for many other reasons. STD rates are also higher in Minnesota’s communities of color, who represent 11 % of the state’s population but 60 % of all chlamydia and gonorrhea cases reported in 2007. African Americans are especially impacted, having chlamydia and gonorrhea rates that were 15 and 40 times higher than Whites, respectively, in 2007.

About 10-12 % of people reported to MDH with chlamydia or gonorrhea have “repeat” infections, meaning they had at least one other infection reported in the previous year. Many of these episodes are thought to be re-infections, where the patient acquires the infection again from an untreated sexual partner. In Minnesota, the prevalence of repeat chlamydia and gonorrhea infections is especially high in females, African Americans, and adolescents.

Importance of Partner Management

  1. For Patients

Proper management of sexual partners of persons with chlamydia and gonorrhea has important benefits for the patient, their sexual partners, and the populations of which they are a part. Partner management begins with the notification of a sexual partner that s/he has been sexually exposed to one of these infections. According to the CDC’s Sexually Transmitted Diseases Treatment Guidelines, 2006: “Many persons individually benefit from partner notification. When partners are treated, index patients have reduced risk for re-infection.”

  1. For Population Disease Prevention

As described in the CDC publication Sexually Transmitted Diseases Treatment Guidelines, 2006: “At a population level, partner notification can disrupt networks of STD transmission and reduce disease incidence. Therefore, providers should encourage their patients with STDs to notify their sex partners and urge them to seek medical evaluation and treatment, regardless of whether assistance is available from health agencies.”

  1. Medical Provider Role and Responsibilities for Partner Management

The importance of partner management is further affirmed in the requirements for physicians in Minnesota Department of Health rules governing communicable diseases: “Notwithstanding any previous report, physicians who treat persons infected with chlamydia infection, syphilis, gonorrhea, or chancroid shall ensure that contacts are treated or provide the names and addresses of contacts who may also be infected to the (Minnesota) commissioner (of health).” Minnesota Rule 4605.7700, subpart B.

Traditional Methods of Partner Management and Barriers to Effectiveness

  1. Patient Referral

For this strategy, the patient accepts and is given the full responsibility to inform the partner that s/he has exposed him/her to chlamydia infection and/or gonorrhea and to refer the partner for medical evaluation and treatment. While this strategy is the least intensive with respect to public health and medical personnel resources, it is also the least effective for assuring that all relevant partners are notified. Several actions by clinicians can, however, mitigate or remove the barriers to the effectiveness of this strategy. First, to reduce the natural reluctance of a patient to disclose to another person sensitive and potentially embarrassing health information, the clinician can counsel the patient to identify and reduce the barriers the patient perceives will make notification of the partner difficult. Second, the practice can develop an instruction sheet that clinicians can give to their patients for them to deliver to their partners. The instruction sheet can include 1) a statement that the partner has been exposed to and may unknowingly be infected with chlamydia and/or gonorrhea; 2) information about the disease(s); and 3) specific information about where the partner can seek care. Employing EPT for the medical management of partners is dependent on the basic premise of patient notification.

  1. Health Care Provider Referral

This strategy involves the clinician locating, notifying, and referring for medical care the partners of patients who they have diagnosed. Little or nothing is known about this strategy with respect to its feasibility, effectiveness, and acceptability to patients, clinicians, or partners.

  1. Public Health Department Notification and Referral

This strategy involves partners being notified of their exposure by a health department specialist specifically trained to locate and notify partners and then facilitating their medical evaluation. Such notification and referral depends on the ability and willingness of the patient to disclose sufficient identifying and locating information about their partners. Partner information is disclosed by the patient directly to the health department specialist or to the patient’s treating health care provider who, in turn, reports the information to the health department. Additional advantages of this strategy include: 1) the protection of the patient’s confidentiality, because the health department specialist reveals nothing to partners about the patient; 2) the protection of the partner’s confidentiality; 3) immediate risk reduction counseling of the partner; 4) immediate resources for medical care referrals; and 5) verification of partner completing the referral and receiving medical evaluation and treatment.

A significant barrier to employing this strategy for chlamydia infection and gonorrhea is that cases of these infections are too numerous to permit the small number of health department specialists to interview all diagnosed patients to elicit partner information. Although required by State Communicable Disease Rules, clinicians who diagnose and treat cases may have insufficient time to elicit, and record, partner identifying and locating information sufficient for a health department specialist to initiate locating attempts. However, when such information is reported, health department specialists will work to locate, notify, and refer partners for medical evaluation and treatment.

  1. Electronic Notification and Referral

In 2004, Internet Sexuality Information Services (ISIS), a non-profit organization, developed inSPOT, a peer-to-peer, Web-based, STD partner notification system. To use this method of partner notification, a patient need only have access to the Internet and go to www.inSPOT.org. The user can then select a city or state nearest him or her and click on “Tell Them.” At this screen, the patient chooses from the assortment of cards to send to a partner, enters the e-mail address(es) of each partner, selects the STD to which the partner has been exposed, enters their own e-mail address (or can send anonymously), and types an optional personal message. Upon receipt of the e-card, the partner clicks on it and is linked to a page containing disease-specific information.

While this strategy of notification can have the advantage of anonymity for the patient and a reasonable level of message credibility, there are cautions for its use. First, if a patient chooses to send a card from the Minnesota inSPOT site to a partner outside of the state, the partner may deduce the identity of the patient. Second, to preserve the privacy of the partner, it is important that the patient not use this method if there’s a possibility that others share or have access to the partner’s e-mail account.

Currently, there are no data that speak to the effectiveness of this strategy. Data are limited to the number of people who have sent cards, the number of cards that have been sent, and the number of cards opened.

EPT as an Alternative Partner Notification Method in Minnesota

1.   There are no legal barriers to implementing EPT in Minnesota. The 2008 Minnesota legislature revised existing pharmacy practice laws by incorporating the Centers for Disease Control EPT Guidance by reference:

“Nothing in this chapter prohibits a licensed practitioner from issuing a prescription or dispensing a legend drug in accordance with the Expedited Partner Therapy in the Management of Sexually Transmitted Diseases guidance document issued by the United States Centers for Disease Control.” See Appendix A.

This removed the last legal barrier to EPT implementation in Minnesota.

2.   EPT as a Standard of Care
In 2006 CDC issued an EPT guidance (http://www.cdc.gov/std/treatment/EPTFinalReport2006.pdf). CDC recommends EPT as a partner management option when other management strategies are impractical or unsuccessful for heterosexually acquired gonorrhea and chlamydia infections in both males and females.
The American Medical Association (AMA) supports the CDC recommendations (Report 7 of the Council on Science and Public Health (A-06), echoing CDC’s position.

The AMA specific recommendations are:

  • 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)
  • 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)

Implementation of EPT

Selecting Appropriate Patients

The most appropriate patients for EPT are those with partners who are unable or unlikely to seek prompt clinical services.  When EPT is provided partners should be encouraged to be tested soon for other STDs because people with chlamydia and gonorrhea are at risk for having other infections.  It is important to remember that partners may: a) lack health insurance.  Younger persons and people from communities of color are over represented in this category, b) lack a primary care provider, c) be unwilling to seek medical care for an STD, and d) have other barriers to accessing clinical services.

EPT is clinically indicated for the following patients:         

  • Patients with a clinical diagnosis of sexually transmitted chlamydia and/or gonorrhea, confirmed by a positive laboratory test; and
  • Patients without laboratory confirmation when the provider has a high clinical suspicion for chlamydia and/or gonorrhea based on symptoms and is concerned about loss of follow-up.

Note: EPT may be used in adolescents, but there are limited data evaluating its effectiveness in this population.

Routine EPT for the following patients is not recommended by the CDC:
In these situations EPT should only be used selectively, and with caution, when other partner management strategies are impractical or unsuccessful:

  • Men who have sex with men (MSM) with chlamydia or gonorrhea infections, due to the high prevalence of co-morbidities (e.g. syphilis and HIV) in MSM and a lack of data regarding EPT efficacy in this population.
  • Women with trichomoniasis, because of a high risk of STD co-morbidity (especially chlamydia and gonorrhea) in partners.

EPT should not be used for the following patients:

  • Patients with syphilis.
  • Pregnant partners. They should not be considered for EPT and must be referred to their prenatal care provider or to another medical provider.

Recommended Treatment Regimens

For Chlamydia:

  • Azithromycin (Zithromax) 1 gram by mouth (once).

Common side effects include headache, abdominal pain, diarrhea and vomiting.
Note: Seven day doxycycline is not recommended due to patient compliance issues.

For Gonorrhea:

  1. Cefixime (Suprax) 400 mg by mouth (once). Common side effects include loss of appetite, nausea, diarrhea and vomiting.
    OR
  2. Cefpodoxime (Vantin) 400 mg by mouth (once) to treat gonorrhea. Common adverse effects include nausea and diarrhea.
    PLUS
  3. Presumptive treatment for chlamydia coinfection: Azithromycin (Zithromax) 1 gram by mouth (once).

      Common side effects include headache, abdominal pain, diarrhea and vomiting.

Notes: Fluoroquinolones (e.g., ciprofloxacin, ofloxacin, and levofloxacin) should not be used to treat gonorrhea.
Consult with the MDH for alternative cephalosporin treatments.
For partners of patients where EPT is clinically indicated, MDH recommends presumptive treatment for chlamydial co-infection as a partner management strategy in accordance to CDC recommendations.  See CDC Sexually Transmitted Diseases Treatment Guidelines, 2006, page 46.

Risk of Adverse Reactions to Medications:
Adverse reactions to single-dose cefpodoxime, cefixime and azithromycin, beyond mild to moderate side effects, are rare. This risk of allergy and adverse drug reactions may be best mitigated through educational materials that accompany the medication, which include explicit warnings and instructions for partners who may be allergic to penicillin, cephalosporins, or macrolides, to seek medical advice before taking the medication. Severe adverse reactions should be reported to the Minnesota Department of Health at (651) 201-5414. Known adverse reactions to cefpodoxime and azithromycin are as follows:

Azithromycin
Azithromycin is generally well tolerated.12  The most common side effects are related to the gastrointestinal system: diarrhea/loose stools (7 %), nausea (5 %), abdominal pain (5 %), vomiting (2 %), and dyspepsia (1 %). Vaginitis occurs in about 1 % of women taking azithromycin. No other side effects have been documented with a frequency greater than 1 %. Anaphylaxis or severe allergy to macrolides generally, and to azithromycin specifically, is very rare.

Cefpodoxime and Cefixime
Cefpodoxime is generally well tolerated. The most common side effects were related to the gastrointestinal system: nausea (1.4 %) and diarrhea/loose stools (1.2 %).13 No other side effects occurred with a frequency greater than 1 % depending on the molecular structure.14  Approximately 1 % to 3 % of patients have a primary hypersensitivity to cephalosporins; however, rates and cross-reactivity vary. The risk of anaphylaxis with cephalosporin in the general population is less than 1/1000 people (and maybe as small as 1 in a million).15-17  However, patients with IgE-mediated allergy to penicillin are at increased risk for severe allergic reactions to cephalosporins. Evidence of IgE-mediated allergy include anaphylaxis, hypotension, laryngeal edema, wheezing, angioedema, and/or uticaria.

Approximately 10 % of patients report penicillin allergy; however, more than 90 % of them are found not to be allergic and are able to tolerate the drug.18  Cephalosporins are less allergenic than penicillin.  Even among patients who report a penicillin allergy, the chance of anaphylaxis is not more than 1-3 % for third- and fourth-generation cephalosporins19 which include cefpodoxime and cefixime.

Options for Delivery of Drugs to Partners

  • Dispense medication directly to the patient for delivery to partner(s).
    • The patient should be given enough doses to treat each sex partner in the past 60 days whom the patient feels confident contacting. If the patient reports no sex partners in the past 60 days, provide one dose for the most recent sex partner.
    • Medication packets should contain drugs described above in “Recommended Treatment Regimens.”
  • Dispense prescription to the patient to be delivered to partner(s), who present the prescription to a pharmacy of their choice to be filled.
    • The patient should be given one prescription for each sex partner in the past 60 days whom the patient feels confident contacting. If the patient reports no sex partners in the past 60 days, provide one prescription for the most recent sex partner.
    • Clinicians may write a prescription for an “unnamed partner” or simply leave the name field blank if the patient can not identify sex partners by name. Before the EPT statute was passed in Minnesota, prescriptions were required to list the patient’s name.

In both situations, the patient should be given an information sheet (in an appropriate language) for each partner who will receive EPT. This sheet should include the following educational information:

  • Partners are encouraged to seek clinical evaluation.
  • Medication should NOT be taken if the partner is pregnant or has concurrent medical conditions; instead, seek clinical evaluation.
  • Side effects of the medication that require immediate evaluation.
  • Allergy information advising patient not to take the medication if allergic.
  • Symptoms of adverse drug reactions and common side effects.
  • Telephone numbers of providers to contact for answers to their questions.
  • Follow-up information especially in areas with high rates of re-infection. The CDC recommends that all women with gonorrhea or chlamydia be re-tested three months after treatment. Providers are also encouraged to retest males three months after treatment.

See Appendices B, C and D, E for example patient information sheets in English and Spanish.

Patient Education

Partner Notification Coaching

At the time of diagnosis, providers should ask about sexual partners and what plans the patient has for notifying partners about their exposure and being sure that partners get treated.  See Appendix F for information about coaching patients about partner notification.

For patients who are willing to disclose partner information:

  • If a partner has accompanied the patient to the clinic, the provider should ensure that the partner is examined, tested and treated during that visit.
  • For partners who are not present at the time of the infected patient’s clinic visit, the provider should inform the patient that it would be best to have all partners who were exposed during the previous 60 days come into a clinic for examination, testing and treatment.
  • If the patient cannot assure that partners will go to a clinic for treatment, the patient may be supplied with a prescription or medication for each partner.
  • EPT may consist of either a prescription for antibiotics or provision of the appropriate antibiotic, along with relevant allergy and educational information for the patient to give to partners, including information about the clinical symptoms of STDs and PID. The information provided to partners should also specify that if they have symptoms of a more serious infection (such as fever, testicular or pelvic pain), they should seek medical care right away rather than take the EPT antibiotics. In the event they want to determine if they are infected, they must have a test for the disease before taking the treatment. They also need to be told they should be sexually abstinent for 7 days following taking the medication to avoid spreading the infection.
  • Many factors affect the ability and/or willingness of patients to discuss their test results and the need for treatment with their partners. Providers can coach patients on how to approach their partners when informing them of their positive test results and the need for taking medication by discussing possible scenarios with them and suggesting statements that might help them say what they need to say. Providers should stress the need to emphasize the importance of partners reading the educational materials provided.
  • Providers may attempt to make telephone contact with the sexual partner(s) whenever possible to explain the reason for providing EPT, to ask about allergies to medications, medical problems, medications being taken, to ask about other symptoms of STDs (such as whether there are sores, ulcers, discharge, testicular, or abdominal pains that need medical evaluation), and to answer questions. Female partners for EPT should be asked if they are pregnant or breastfeeding, and if they have any symptoms such as abdominal pain that will require immediate medical evaluation. Partners should be advised to abstain from intercourse for seven days after taking the medication.
  • Providers who are interested in learning more about eliciting partner information can contact MDH at (651) 201-5414 for assistance.
  • Documentation: A note in the index patient’s medical chart should document the number of partners who are being provided with EPT, the medication and dosage being provided, whether the partner is known to be allergic to any medications, and that educational information has been included. It is recommended that the names of partners receiving EPT not be written in the index patient’s chart. Sexual partners do not require a medical chart in order to be provided with EPT.

For patients who are willing to disclose partner information but who are unable to or do not want to assume the responsibility of assuring they are treated:

  • Providers may choose to make telephone contact with sexual partner(s) to let them know they have been exposed to chlamydia and gonorrhea and to encourage them to seek treatment at a clinic. Referral to a public health STD clinic can be made at that time.
  • If providers choose not to contact partners, the clinic may contact the MDH Partner Services at (651) 201-4031 to notify MDH that assistance is needed to notify partners.
  • Note: Clinics are encouraged to develop internal policies and procedures regarding telephone contact of sexual partners that include information such as who will make the calls, how many attempts will be made and the time period in which these calls must be made before MDH is contacted for assistance. Some clinics may decide that they will not make phone calls but instead will ask for assistance from MDH immediately.

For patients who are not willing to disclose partner information:

  • Fill in any information on partners that is learned at the time of the index patient’s diagnosis on the back side of the STD Case Report Form.

In all cases, available information on partners should be included on the back side of the STD Case Report Form in the event that MDH is needed to assist with partner notification.

Post-treatment Testing/Rescreening

Test-of-cure, or repeat testing 3-4 weeks after completion of drug therapy to determine the effectiveness of treatment, is not recommended by CDC for persons treated with recommended or alternative regimens, unless therapeutic compliance is in question, symptoms persist, or re-infection is suspected. The majority of post treatment infections result from re-infection, not treatment failure.  This is frequently because the patient’s sex partners were not treated or because the patient resumed sex with a new partner infected with chlamydia or gonorrhea.

The CDC recommends advising all women with chlamydia or gonorrhea to be retested approximately three months after treatment. Providers are also strongly encouraged to retest all women treated for chlamydia or gonorrhea whenever they next seek medical care within the following 3-12 months, regardless of whether or not the patient believes that her sex partners were treated.

Healthcare providers are also encouraged to retest males three months after treatment.

For pregnant women, repeat testing using a nucleic acid amplification test (NAAT) three weeks after completion of drug therapy is recommended by CDC to ensure that therapeutic cure occurs, because of the sequelae that might occur in the mother and/or neonate if the infection persists.

Special Issues

Medicolegal-Medical Provider Liability

The new legislation allowing EPT for sexually transmitted diseases does not protect healthcare providers from lawsuits resulting from adverse outcomes related to this practice. The risk of liability or litigation in the event of adverse outcomes is no different from the liability of any other action taken by a healthcare provider, including prescribing or dispensing medicine for any medical condition, in which the provider remains liable. However, these guidelines establish a standard of care, and standard of care is the primary medicolegal standard for appropriate practice.

Payment for Partner Drugs

The cost of EPT medication must be borne by the patient (either out-of-pocket or through insurance) or, when partner medications are given directly to the patient, by the patient’s clinic. The MDH does not provide medications for EPT, or reimbursements for these medications, to clinics practicing EPT in Minnesota.

A significant barrier to EPT in other states has turned out to be the inability to get Medicaid reimbursement. Because partners of Medicaid enrollees are generally not enrolled themselves, payment for their medication would be considered fraudulent under current Medicaid policy. This issue will need on-going discussion in upcoming months and years.

At this time, it is not known how many insurance providers in Minnesota would finance EPT for their enrollees’ sex partners. The potential for EPT to prevent re-infection of the enrollee by eliminating infection in his/her sexual partners may persuade some companies to provide such coverage.

Concerns surrounding the cost of EPT must be balanced by the adverse and costly health effects that may be averted by its use. EPT targets infected individuals who would otherwise not receive treatment. Therefore, widespread implementation of EPT would presumably reduce the number of infected persons in the population and lead to lower disease rates, thus reducing the number of women needing costly treatment for long-term sequelae (e.g. PID, infertility, and ectopic pregnancy).

Missed STD Co-Morbidity in Partners

If partners receiving EPT do not seek evaluation, this leads to missed opportunities for diagnosis and therapy of other STDs that would be detected by clinical evaluation of the partners. Therefore it is imperative that partners be encouraged to seek clinical evaluation.

Missed Opportunities for Prevention of Future Partner Morbidity

The lack of clinical evaluation in a healthcare setting due to the use of EPT presents missed opportunity for professional counseling of patients’ sex partners. However, there is broad consensus that partners who are willing and able to attend for personal care should be encouraged to do so. There is a lack of sufficient evidence to judge whether the prevention efficacy of such counseling, especially when provided by typical primary care providers, outweighs that which might accrue through educational literature that might accompany EPT or counseling by a pharmacist.

Antimicrobial Resistance

The recipients of EPT have indications for antimicrobial therapy. Nevertheless, a substantial increase in relatively unsupervised antibiotic usage might raise concerns about the effects on bacterial ecology and antimicrobial resistance. However, the incremental effect of EPT on overall antibiotic use likely would be small. For example, about 55 million prescriptions for azithromycin and other macrolide antibiotics are written in the US annually.20  Even if azithromycin could be successfully administered through EPT and other means to one sex partner for each of 3 million estimated annual cases of incident chlamydial infection, the increment in macrolide prescriptions would approximate 5%; the actual increment in macrolide use would be much smaller. Similar considerations apply to single-dose treatment with cephalosporins.
     
Special Considerations When Caring for Adolescents

Minnesota law stipulates that any minor under age 18 can independently consent to and receive confidential medical care for the diagnosis and treatment of STDs. Parental consent is not required. Healthcare providers seeing adolescent patients should provide assurance regarding the confidential nature of the visit, the testing for chlamydia and gonorrhea, and any treatment received. Providers can encourage adolescents to tell their parents/guardians about their medical condition when appropriate and help them determine how and what to say.

Adolescents are more likely to confide in providers if they know their conversations will be kept confidential. Arrangements within the healthcare facility should be made to ensure confidentiality for every aspect of the visit, including the billing, laboratory fee for the STD tests, notification of test results, and provision of treatment. Some Minnesota insurance companies send out Explanations of Benefits to insured clients – usually a parent or guardian in the case of adolescents – while others do not. Clinics should know the status of this practice for each insurance and managed care company with which they work since this procedure could impact the ability of the clinic to maintain an adolescent’s confidentiality.


References

1.   Golden, M.R., Expedited Partner Therapy for Sexually Transmitted Diseases.

2.   Bauer, H.M., Wohlfeiler, M.J., Klausner, J.D., Guerry, S., Gunn, R.A., Bolan, G., and The California STD Controllers Association, “California Guidelines for Expedited Partner Therapy for Chlamydia trachomatis and Neisseria gonorrhoeae.”

3.   U.S. Centers for Disease Control and Prevention, “Dear Colleague Letter 2005.” http://www.cdc.gov/std/DearColleagueEPT5-10-05.pdf 

4.   Hook, E.W., Handsfield, H.H., “Gonococcal Infections in the Adult.” In: Holmes, K.K., Sparling, P.F., Mardh, P.-A., et al., eds. Sexually Transmitted Diseases, 3rd Edition. New York, NY: McGraw-Hill, 1999: 451-466.

5.   U.S. Centers for Disease Control and Prevention.
http://www.cdc.gov/std/chlamydia/STDfact-chlamydia.htm

6.   Wasserheit, J.N., “Epidemiological Synergy. Interrelationships Between Human Immunodeficiency Virus Infection and Other Sexually Transmitted Diseases.” Sexually Transmitted Diseases, 1992; 19: 61-77.

7.   Mehta, S.D., Erbelding, E.J., Zenilman, J.M., and Rompala, A.M., “Gonorrhoea Re-infection in Heterosexual STD Clinic Attendees: Longitudinal Analysis of Risks for First Re-infection.” Sexually Transmitted Infections, 2003; 79: 124-128.

8.   Peterman, T.A., Tian, L.H., Metcalf, C.A., et al., “High Incidence of New Sexually Transmitted Infections in the Year Following a Sexually Transmitted Infection: A Case for Rescreening.” Annals of Internal Medicine, 2006; 145: 564-572.

9.   Chesson, Harrell W., Blandford, John M., Gift, Thomas L., Tao, Guoyu, and Irwin, Kathleen L., “The Estimated Direct Medical Cost of Sexually Transmitted Diseases Among American Youth, 2000.” Perspectives on Sexual and Reproductive Health 2004; 36(1), January/February 2004: 11-19.

10.  Washington, E., Johnson, R., Sanders, L., “Chlamydia trachomatis Infections in the United States: What are They Costing Us?” Journal of the American Medical Association (JAMA) 1987; 257: 2070-2072. In: Eng, T.R., and Butler, W.T., eds, The Hidden Epidemic: Confronting Sexually Transmitted Diseases, Washington, DC, National Academy Press, 1997, p 59.

11.  Begley, C.E., McGill, L., Smith, P.B., “The Incremental Cost of Screening, Diagnosis and Treatment of Gonorrhea and Chlamydia in a Family Planning Clinic.” Sexually Transmitted Diseases 1989; 16: 63-7. In Eng, T.R., and  Butler, W.T., eds, The Hidden Epidemic: Confronting Sexually Transmitted Diseases, Washington, DC, National Academy Press, 1997, p 59.

12. Rubinstein, E., “Comparative Safety of the Different Macrolides.” International Journal of Antimicrobial Agents 2001; 18; 571-576.

13. Pfizer Product Information. Vantin® Tablets and Oral Suspension cefpodoxime proxetil tablets and cefpodoxime proxetil for oral suspension, USP. Pfizer, 2006. (Accessed March 2007)

14. Romano, A., Torres, M.J., Namour, F., et al., “Immediate Hypersensitivity to Cephalosporins.” Allergy 2002; 52: 52-57.

15. Pichichero, M.E., “A Review of Evidence Supporting the American Academy of Pediatrics Recommendation for prescribing Cephalosporin Antibiotics for Penicillin-Allergic Patients.” Pediatrics 2005; 115: 1048-1057.

16. Pichichero, M.E., “Cephalosporins Can Be Prescribed Safely for Penicillin-Allergic Patients.” Journal of Family Practice 2006; 55: 106-112.

17. Kelkar, R.S., and Li, J.T.-C., “Cephalosporin Allergy.” New England Journal of Medicine 2001; 345: 804-809.

18. Solensky, R., “Drug Hypersensitivity.” Medical Clinics of North America 2006; 90: 233-260.

19. Greenberger, P.A., “Drug Allergy,” Journal of Allergy and Clinical Immunology 2006; 117:
5464-5470.

20. IMS, Inc. “Leading 20 Therapeutic Classes by Total U.S. Dispenses Prescriptions, 2004.”

(Accessed June 29, 2005)
 

Acknowledgments

Expedited Partner Therapy Work Group: Marisela Babcock, William Burleson, Peter Carr, MPH, Candy Hadsall, RN, MA, Summer Martins, MPH,  Nancy Petschauer, Amy Gust, Stephen Schletty, STD, HIV and TB Section, Infectious Disease Epidemiology, Prevention and Control Division, MDH; Delford Doherty, PharmD and MPH Candidate, University of Minnesota.

Internal Reviewers: Kristen Ehresmann, RN, MPH, Ruth Lynfield, MD, Infectious Disease Epidemiology, Prevention and Control Division; Douglas Schultz, Communications Office, MDH.

External Reviewers: David Aughey, MD, Children’s Hospitals and Clinics of Minnesota; Carol Ball, MD, Planned Parenthood of Minnesota, North Dakota, and South Dakota; Amy Gilbert, MD, Family Tree Clinic; William K. Henry, MD, St. Paul-Ramsey County Public Health Department; Ron Jankowski, MD, Fremont Community Clinics; Kevin Nelson, MD, Richfield Medical Group; Michelle Van Vranken, MD, Children’s Hospitals and Clinics of Minnesota.

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Updated Thursday, August 07, 2014 at 10:00AM