Ept talk texas 5 10r

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Ept talk texas 5 10r

  1. 1. Expedited Partner Therapy for Gonorrhea & Chlamydia Matthew R. Golden MD, MPH Center for AIDS & STD, University of WA Public Health – Seattle & King County
  2. 2. Overview • Clinical issues and barriers to EPT • Experience with EPT rollout in Washington State
  3. 3. Barriers • Is this legal, and what is my liability? • Is this an acceptable standard of medical care? • Will EPT promote antimicrobial resistance? • Is this ethical?
  4. 4. Liability • You can always be sued • Are you acting in a manner that is consistent with standards of care in your community? • Can you be sued for not providing EPT?
  5. 5. Is EPT a Good Standard of Care? • A complete evaluation of all partners would be best • Are we missing concurrent diagnoses? • Are we placing partners at significant risk of adverse drug reactions?
  6. 6. STD diagnoses in persons presenting as contacts to gonorrhea, chlamydia or NGU/MPC Seattle, Baltimore, Birmingham and Denver Women Heterosexual Men Men who Have (n=2507) (n=3511) Sex with Men (n=460) Gonorrhea* 3.9% 3.1% 6.1% PID 3.7% NA NA New HIV 0 0.2% 5.5% Early Syphilis <0.1% 0 0.4% * GC excludes contacts to GC. Source: CID 2005;40:787
  7. 7. Adverse Drug Reactions • Anaphylaxis to macrolides is very rare • PCN – Anaphylaxis with cephalosporins is rare (0.1-0.0001%) – ~10% of people report having a PCN allergy – Cross reactivity to 3rd gen cephalosporins 1-3% – Only avertable reactions are those occurring in persons with a known allergy who take meds despite written warnings • No cases anaphylaxis to date in CA and WA
  8. 8. Antimicrobial Resistance • No known chlamydial resistance to azithro • Cephalosporin resistant GC – Some evidence rising MICs in Japan – No true resistance in U.S., though some isolates have decreased susceptibility • Standard of care is to treat contacts to GC & chlamydia without awaiting test results – EPT primarily increases antimicrobial use by increasing appropriate treatment of partners • In 2005, 55 million prescriptions for Azithro; 3 million cases of chlamydia in U.S.
  9. 9. Ethics Respect for Patient Autonomy Beneficence Nonmaleficence Justice • Insofar as RCTs show decreased reinfection in index cases given EPT, EPT is a superior standard of care • Is EPT better for the partner? Can partners make an informed decision?
  10. 10. History of EPT in Washington State Year WA State Pharmacy Board Rules that EPT is 1997 Legal King County EPT Randomized Trial 1998-2003 Washington State & Public Health – Seattle & 2003 King County Recommend Routine Use of EPT in Heterosexuals PHSKC makes free medication available to all 2004 medical providers for EPT Start State-wide Community-level Trial of EPT 2007
  11. 11. Washington State Community-level Randomized Trial of EPT • $2.5 million NIH funded study • Goal - to define whether an EPT program can decrease the prevalence of chlamydia and/or the incidence of gonorrhea in the population • No intervention to control STD has been shown to do this • Design – stepped-wedge community-level randomized trial • Order in which LHJs start intervention randomly assigned • Comparison of trends in places with and without the intervention • Outcome • CT prevalence in Infertility Prevention Planning clinics • Reported incidence of gonorrhea
  12. 12. EPT System • Case-report based triage of DIS services • Widespread access to prepacked medication for EPT
  13. 13. Proportion of Patients with Untreated Partners at Time of Study Interview 100 Percent with untreated partner 80 60 40 20 + Risk Factor No Risk Factor 0 0 2 4 6 8 10 12 14 Days Between Treatment & Interview Source: STD 2001;28:658 Risk factors: > 1 sex partner 60 days or pt does not anticipate sex with partner in future
  14. 14. PN CT & GC: where do we go from here?
  15. 15. WA State EPT Program: Prescription Pad
  16. 16. PDPT Distribution • Medication prepackaged to meet requirements of state pharmacy board – Allergy warning, info on STDs, complications & where to seek care, condoms • Stocked in high-volume clinics and in 157 pharmacies, statewide – Pharmacies paid $2-5 dispensing fee • Preprinted prescriptions on case-report form and on faxable forms
  17. 17. WA State Local Health Jurisdictions Participating in A Community- Level Trial of EPT Whatcom Okanogan San Juan Pend Ferry Skagit Oreille Stevens Island Clallam Snohomish Chelan Jefferson p Douglas King Lincoln Spokane tsa King * Ki Grays Mason Harbor Kittitas Grant Pierce Adams Whitman Thurston Lewis Pacific Yakima Franklin Garfield Columbia * Cowlitz Benton * * Asotin Asotin Skamania Walla Walla Wahkiakum 5 Klickitat Clark Wave 1 – 10/07 Wave 2 – 6/08 Wave 3 – 1/09 Ferry, Stevens, Pend-Orielle elected not to participate Wave 4 – 8/09
  18. 18. Evaluation of System • Random sample of cases defined at time case is entered into Internet case registry • Outcomes: 1) Association of provider’s partner notification plan as indicated on the case report form and a) Outcomes at time of initial index patient interview: partner notified, treated, receipt of PDPT from diagnosing provider b) Acceptance of PDPT or assistance from DIS 2) Use of PDPT by Providers • Statistics – Associations defined using GEE to adjust for correlated data
  19. 19. Provider’s Partner Management Plan as Indicated on the Case Report Form (n=26,051) 25% 89% of Forms Completed with a Partner 54% Management Plan 21% Health Department Provider All Partners Treated
  20. 20. Process Outcome Evaluation: WA State EPT Trial 31,399 Cases GC/CT in Heterosexuals 1/1/07-12/31/09 6650 (21%) Random Sample 3931 (59%) Interviewed 2719 (41%) Not Interviewed Not located 1446 (53%) Late report 506 (19%) 4304 Partners with Dispositions Patient refused 360 (13%) Language barrier or out of area 141 (5%) Provider refused 120 (4%) Missing 146 (5%)
  21. 21. Association of PN Plan on Case Report Form with PN Outcomes All partners already treated Provider to assure PN Health dept. assistance requested 100 P<.0001 All Comparisons Health Dept. 91 Assistance vs. No Health Dept Assistance 80 88 72 Percent 64 60 48 60 40 89 56 26 20 10 29 22 0 Partner Notified at Time Partner Supplied PDPT from Partner Untreated at Time Initial Interview Clinician Initial Interview
  22. 22. Association of PN Plan on Case Report Form with PN Outcomes All partners already treated Provider to assure PN 50 Health dept. assistance requested 40 P<.0001 All Comparisons Health Dept. Percent Assistance vs. No Health Dept Assistance 30 25 20 5 7 17 10 8 4 6 6 0 Partners Supplied PDPT by Health Dept. DIS Assistance Accepted
  23. 23. Partner Receiving PDPT from the Diagnosing Provider, WA State EPT Community-Level Trial Wave 1 Wave 2 Wave 3 Wave 4 50 Intervention Intervention Begins Begins 40 Percent Intervention Begins 30 20 10 Intervention Begins 0 May-Aug Sep-Dec Jan-Apr May-Aug Sep-Dec Jan-Apri May-Aug Sep-Dec Jan-Apr 2007 2007 2008 2008 2008 2009 2009 2009 2010
  24. 24. Medication Delivery • ~25,000 cases of GC and CT annually in WA State • ~ 15,000 medication packets distributed per year • 77% chlamydial infection • 75% direct to providers – 25% via pharmacies • 56% of heterosexuals with GC/CT offered PDPT • 34% of all heterosexual receive PDPT from their provider • 60% of those not referred to public health • Total cost of meds including distribution = $105,000/year
  25. 25. Proportion of Partners Treated at Time of Initial Partner Notification Interview, Before and After Program Initiation 100 Preintervention p<.0001 80 Intervention Percent 60 56 40 48 20 0 Partners Treated
  26. 26. Impact of DIS Services Among Persons Referred to Receive Partner Services 3/09-3/10 100 82 Initial Interview • 1290 partners provided Final Interview 80 72 PDPT 66 • 1147 partners treated 60 after receipt of DIS 40 34 services • Cost per partner treated 20 ~$500 0 • Probably roughly Notified Treated comparable to the cost per case treated via screening
  27. 27. DIS Services • ~11,000 cases assigned and ~8000 interviews annually • Driven by high proportion of cases referred by case- reports to receive DIS services • 1290 partners received PDPT via DIS • ~750 partners notified by DIS • 10-12 DIS state-wide • Assigned 1000 cases each per year • Interview 50-60% • Total cost of DIS = ~$600,000/year
  28. 28. Cost-Effectiveness of EPT Health Care QALYs Lost Cost- System effectiveness Costs ratio Index Men EPT $379 .0272 Cost-saving Standard $445 .0308 Index Women EPT $150 0.004 Cost-saving Standard $186 0.005
  29. 29. EPT is cost saving to the system ~$50 per male index and $20 per female From payer’s perspective, it is only cost saving if at least 40% of partners receive care from the payer
  30. 30. Tragedy of the Commons • Each person despoils a common resource because they as an individual pay little of the cost, and acting conscientiously does not benefit them • Two solutions • Regulation – all insurance companies have to pay • Pay in common – we buy the meds as a group
  31. 31. Summary Community-level EPT Trial • Ongoing • Triage via case report form successful in directing DIS services to those most likely to benefit • Cost of these services remains high • Publicly financed free medication can promote widespread use of PDPT • Cost of medications, if purchased using 340b pricing, is relatively modest
  32. 32. Conclusion • Routinely offering patients medication for their partners is a superior standard of care for the index case • Most heterosexual patients should be offered PDPT • Public Health programs should seek to make sure that provider have the tools to offer their patients PDPT in a way that is legal and the maximizes the likelihood that partners receiving information about STD & meds • Publicly financed partner medication is relatively inexpensive and can increase PDPT use • Assures legal compliance • Highest priority for funding in this area

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