Expedited Partner Therapy in Wisconsin

1. Expedited Partner Therapy in Wisconsin STD Control Section Wisconsin Division of Public Health June 2010

2. Overview Epidemiology of trichomoniasis, gonorrhea and Chlamydia trachomatis infections Partner Services Expedited partner therapy (EPT) EPT legislation in Wisconsin

3. Sexually Transmitted Diseases In the Nation: More than 1.5 million cases of gonorrhea and Chlamydia trachomatis infections were reported to the CDC in 2008 Approximately 50% of new gonorrhea and Chlamydia trachomatis infections occurring each year remain undiagnosed and unreported Trichomoniasis is the most common curable STD in young, sexually active women in the U.S., and an estimated 7.4 million new cases occur each year in both men & women STDs are increasing at an alarming rate in both Wisconsin and the nation. STDs are increasing at an alarming rate in both Wisconsin and the nation.

4. Reported STD cases, by diseaseWisconsin, 2008 In Wisconsin there are more bacterial sexually transmitted diseases (STDs) reported than all other reportable communicable diseases combined. When we talk about STDs � we mean bacterial STDs.� HIV is not included.� There are five reportable, bacterial STDs:� chancroid, Chlamydia trachomatis infection, gonorrhea, sexually transmitted PID, and syphilis. When we talk about STDs � we mean bacterial STDs.� HIV is not included.� There are five reportable, bacterial STDs:� chancroid, Chlamydia trachomatis infection, gonorrhea, sexually transmitted PID, and syphilis.

5. Approximately 47% of Chlamydia cases and 67% of gonorrhea cases in 2008 were from Milwaukee County. Milwaukee ranked second highest for rates of both Chlamydia and gonorrhea in 2006 and 2007 of the 50 largest metropolitan areas in the U.S. which include Chicago, Minneapolis, and Detroit. Approximately 47% of Chlamydia cases and 67% of gonorrhea cases in 2008 were from Milwaukee County. Milwaukee ranked second highest for rates of both Chlamydia and gonorrhea in 2006 and 2007 of the 50 largest metropolitan areas in the U.S. which include Chicago, Minneapolis, and Detroit.

6. Disproportionate Impact of STDs For Example: Adolescents In Milwaukee, among adolescents 15-19 years of age, 1 in 18 were reported with a Chlamydia trachomatis infection and 1 in 50 with gonorrhea in 2008 Communities of Color The rate of reported STDs among black adolescents 15-19 years of age is 18 times that of whites in Wisconsin Adolescents are disproportionately impacted by STDs. In Milwaukee, among adolescents 15-19 years of age, 1 in 18 were reported with a Chlamydia infection and 1 in 50 with gonorrhea in 2008 alone; and TDs disproportionately impact communities of color and the rate of reported STDs among black adolescents 15-19 years of age is eighteen times that of whites in Wisconsin Adolescents are disproportionately impacted by STDs. In Milwaukee, among adolescents 15-19 years of age, 1 in 18 were reported with a Chlamydia infection and 1 in 50 with gonorrhea in 2008 alone; and TDs disproportionately impact communities of color and the rate of reported STDs among black adolescents 15-19 years of age is eighteen times that of whites in Wisconsin

7. Complications of STDs STDs cause at least 24,000 women in the U.S. each year to become infertile Untreated trichomoniasis, gonorrhea and Chlamydia trachomatis infections can lead to: Pelvic inflammatory disease (PID) Ectopic pregnancy leading to fetal death Infertility Systemic infection of gonorrhea causing arthritis Perinatal transmission leading to pneumonia or conjunctivitis Increased risk of acquiring and transmitting HIV Continued spread of infection Chlamydia infections and gonorrhea are often asymptomatic. When left untreated, 10 to 20% of these infections in women result in pelvic inflammatory disease (PID), an infection of the reproductive organs that can lead to infertility. Undiagnosed and untreated STDs cause at least 24,000 women in the U.S. each year to become infertile. In addition, untreated STDs can lead to premature labor and low birth weight infants, neonatal pneumonia and blindness, ectopic pregnancies and fetal and maternal death. Chlamydia infections and gonorrhea are often asymptomatic. When left untreated, 10 to 20% of these infections in women result in pelvic inflammatory disease (PID), an infection of the reproductive organs that can lead to infertility. Undiagnosed and untreated STDs cause at least 24,000 women in the U.S. each year to become infertile. In addition, untreated STDs can lead to premature labor and low birth weight infants, neonatal pneumonia and blindness, ectopic pregnancies and fetal and maternal death.

8. Cost of STDs STDs cost the U.S. health care system an estimated $15.9 billion annually A single oral pill for treatment of Chlamydia trachomatis infection costs $30/patient while treatment for infertility can cost thousands of dollars per patient A single oral pill for treatment of gonorrhea costs $19/patient while treating PID costs over $1000 per patient EPT is a cost-saving and cost effective partner management strategyEPT is a cost-saving and cost effective partner management strategy

9. STD Re-infection is Common Re-infection rates among women treated for CT1: 15% re-infected within 6 months 30% re-infected within 12 months Re-infection rates among women treated for GC2: 14% re-infected within 6 months 27% re-infected within 12 months Re-infection rates among men with CT & GC3: 15% re-infected at 6 months 21% re-infected at 8 months Re-infection increases the likelihood of complications. Effectively treating a patient with an STD requires treatment of the patient�s current sex partners to prevent re-infection. Studies have shown that between 14%-26% of young women become re-infected with Chlamydia within 12 months of their initial infection. The main underlying cause is that re-infections result from continued sexual contact with an infected partner.Re-infection increases the likelihood of complications. Effectively treating a patient with an STD requires treatment of the patient�s current sex partners to prevent re-infection. Studies have shown that between 14%-26% of young women become re-infected with Chlamydia within 12 months of their initial infection. The main underlying cause is that re-infections result from continued sexual contact with an infected partner.

10. Partner Services in Wisconsin Local Health Officers are required to perform interviewing and investigation for cases of reportable STDs A universally difficult task, sex partners are not always being notified and treated for STDs Funding/staffing Overwhelming burden of disease Accuracy of sex partner information Compliance of sex partners to seek medical attention This is where EPT comes in . . . Funding: STD Control Section funds have decreased in recent years: 95% of the budget is from CDC, only 5% from the state Overwhelming number of cases: In Milwaukee County, the majority of the staff resources are directed at eliminating syphilis infections and the vast majority of gonorrhea and Chlamydia trachomatis infection cases do not receive public health follow-up due to the large number of cases. Accuracy of partner information and partner compliance: In Dane County, public health staff are able to reach less than 50% of the partners of persons with STDs via traditional provider referral strategies Funding: STD Control Section funds have decreased in recent years: 95% of the budget is from CDC, only 5% from the state Overwhelming number of cases: In Milwaukee County, the majority of the staff resources are directed at eliminating syphilis infections and the vast majority of gonorrhea and Chlamydia trachomatis infection cases do not receive public health follow-up due to the large number of cases. Accuracy of partner information and partner compliance: In Dane County, public health staff are able to reach less than 50% of the partners of persons with STDs via traditional provider referral strategies

11. Expedited Partner Therapy EPT is a treatment alternative for partners of a patient diagnosed with sexually transmitted diseases (STDs) without a medical evaluation of the partner EPT allows the patient to deliver oral medication or prescriptions to their sexual partner who might not otherwise seek care EPT prevents re-infection to the original patient, thus reducing the burden of STDs in the community Ideally, sexual partners would be receive a medical evaluation but when the probability of this happening seems unlikely or has not happened in the past, EPT is the next best alternative. EPT can supplement statutorily required partner services not supplant statutory requirements in Wisconsin Ideally, sexual partners would be receive a medical evaluation but when the probability of this happening seems unlikely or has not happened in the past, EPT is the next best alternative. EPT can supplement statutorily required partner services not supplant statutory requirements in Wisconsin

12. Summary of CDC�s Guidance for Expedited Partner Therapy in the Management of Sexually Transmitted Diseases EPT was effective in reducing persistent or recurrent infections due to chlamydia and gonorrhea EPT was associated with higher likelihood of partner notification and partner treatment Preliminary economic analysis suggest that EPT is a cost-saving and cost-effective partner management strategy EPT represents an additional strategy for partner management that does not replace other strategies EPT is safe and effectiveEPT is safe and effective

13. EPT is supported by: Nationally: CDC American Medical Association Society of Adolescent Medicine National Association of County and City Health Officials The Council of State Governments The National Bar Association 22 states including Minnesota, Illinois, and Iowa In Wisconsin: The Department of Health Services Medical Examining Board Medical Society of WI WI Academy of Family Physicians American College of Nurse-Midwives WI Nurses Association Wisconsin Public Health Association Planned Parenthood

14. 2009 EPT Legislation in Wisconsin Explicitly allows medical providers to dispense medication or prescribe EPT and pharmacists to dispense medication Limits liability for all providers as long as EPT is provided in accordance with the Act Allows the prescription to be written for �EPT� when the patient does not know or is unwilling to give the partner�s name Requires written materials be developed by DHS and be provided with EPT prescription about trichomoniasis, gonorrhea and Chlamydia trachomatis infections, their treatment and the risk of drug allergies Dr. Wasserman has been introducing EPT legislation since 1999. Current legislation was introduced by Rep. Sandy Pasch and Sen. Robson. Ideally the index patient would give their partner�s name, but some patients are unwilling or do not know their partner�s name. Providing the patient with a prescription for �EPT,� STD counseling and written materials for the partner increases the chances that the partner will receive treatment and the index patient will not be re-infected. Other states allow prescriptions to be written for partners without a name including Utah, Washington, Pennsylvania, Mississippi, and Tennessee. Dr. Wasserman has been introducing EPT legislation since 1999. Current legislation was introduced by Rep. Sandy Pasch and Sen. Robson. Ideally the index patient would give their partner�s name, but some patients are unwilling or do not know their partner�s name. Providing the patient with a prescription for �EPT,� STD counseling and written materials for the partner increases the chances that the partner will receive treatment and the index patient will not be re-infected. Other states allow prescriptions to be written for partners without a name including Utah, Washington, Pennsylvania, Mississippi, and Tennessee.

15. Potential Concerns Adverse drug and allergic reactions Paying for the medication Spread of antibiotic resistance Risk of undiagnosed disease in the partner Fortunately, serious adverse reactions are very rare with the CDC recommended Chlamydia, gonorrhea and trichomoniasis medications. If side effects do occur, they are typically transient gastrointestinal symptoms that rarely result in severe morbidity. The risk for anaphylaxis with these antibiotics is rare with estimates ranging from 0.0001 to 0.1 percent. In California and Washington States, which have implemented EPT since 2001, have documented no adverse events related to EPT medication allergies. EPT partner information to be given with EPT will contain explicit information about medication allergies and warnings of medication allergies such as those who are taking medication for epilepsy. In reality, the health risks to a patient and their partner from consequences of untreated STDs far exceed the small risk of adverse reactions to the antibiotics. Medication costs will have to be paid for by the person who picks up the prescription or by the partner�s insurance if the name is given. Guidance would strongly encourage the partner to seek treatment, and remember EPT is only recommended for partner�s that are unlikely to seek care so it at least eliminates one disease reducing the risk of complications and transmission of other diseases such as HIV. In this case the benefits of treatment out way the risks. Drug resistance most commonly occurs when a full course or dosage of treatment is not completed. The only drug dosage recommended for EPT is 1 dose orally which eliminates the chance of treatment not being completed.Fortunately, serious adverse reactions are very rare with the CDC recommended Chlamydia, gonorrhea and trichomoniasis medications. If side effects do occur, they are typically transient gastrointestinal symptoms that rarely result in severe morbidity. The risk for anaphylaxis with these antibiotics is rare with estimates ranging from 0.0001 to 0.1 percent. In California and Washington States, which have implemented EPT since 2001, have documented no adverse events related to EPT medication allergies. EPT partner information to be given with EPT will contain explicit information about medication allergies and warnings of medication allergies such as those who are taking medication for epilepsy. In reality, the health risks to a patient and their partner from consequences of untreated STDs far exceed the small risk of adverse reactions to the antibiotics. Medication costs will have to be paid for by the person who picks up the prescription or by the partner�s insurance if the name is given. Guidance would strongly encourage the partner to seek treatment, and remember EPT is only recommended for partner�s that are unlikely to seek care so it at least eliminates one disease reducing the risk of complications and transmission of other diseases such as HIV. In this case the benefits of treatment out way the risks. Drug resistance most commonly occurs when a full course or dosage of treatment is not completed. The only drug dosage recommended for EPT is 1 dose orally which eliminates the chance of treatment not being completed.

16. Current Status of Legislation in Wisconsin Act 280 was signed into law by Governor Doyle on May 11, 2010 Effective May 26, 2010 The Act requires written materials (an �information sheet�) be distributed to the patient by the medical provider, for use by the partner receiving EPT.

17. Information Sheet The Information Sheet distributed by the clinician to the patient, for the sex partner receiving treatment shall include: Information about STDs and their treatment The risk of drug allergies from the treatment A statement advising persons with questions to contact his/her physician, pharmacist, or local health department

18. Coming Soon . . . EPT Provider Guidance � specific information on EPT for medical providers FAQ sheet for local health departments, medical providers, and pharmacists

19. Letter announcing new legislation Guidance and Information Sheet EPT Website EPT Hotline EPT Surveillance Letter announcing new legislation Guidance and Information Sheet EPT Website EPT Hotline EPT Surveillance

20. Questions? For more information or questions regarding EPT legislation please contact Marisa Stanley at 608-266-0463 or marisa.stanley@wi.gov For questions regarding the STDs and implications of EPT for health departments please contact, Loriann Wunder at 608-266-7922 or loriann.wunder@wi.gov EPT is a safe and effective option for STD care among individuals with trichomoniasis, gonorrhea and Chlamydia trachomatis infections who are unlikely or have not sought treatment in the past EPT does not replace statutorily required partner services for STD case patients The high STD rates in Wisconsin are unacceptable and disproportionately impact youth and minority populations EPT is a safe and effective option for STD care among individuals with trichomoniasis, gonorrhea and Chlamydia trachomatis infections who are unlikely or have not sought treatment in the past EPT does not replace statutorily required partner services for STD case patients The high STD rates in Wisconsin are unacceptable and disproportionately impact youth and minority populations