STDs and NC State Law – A Provider / Public Health Partnership

1. STDs and NC State Law – A Provider / Public Health Partnership North Carolina Obstetric Quality Initiatives February 22, 2008 Marvin Hage, MD Perinatal Consulting mhage@ec.rr.com

2. Objectives • A brief history of perinatal HIV • United States and North Carolina • Identify the initial responses to recent North Carolina regulations regarding STD’s – Nov 1, 2007. • Proposal for the continued provider public health partnership responses to STD’s.

3. A Short History of Perinatal HIV Medical/Provider Public Health 1980’s 1988 – First NC rules 1990’s 1991 – IOM recommendations 1995 - CDC – Counseling & Testing 2000’s 2001 – NC Partnership 2002 - CDC - Opt-out evaluation 2006 - CDC Recommendations 2007 – State Regulations • 1980’s 1981 – First description of AIDS 1983 – Identification of HIV retrovirus Perinatal transmission 1987 – First prenatal testing 1988 – ACOG Bulletin #123 • 1990’s 1992 – ACOG Bulletin #165, #169 1994 – ACTG 076 Trial 1997 – HIV in Pregnancy #23 1999 – ACOG/AAP statement • 2000’s 2004 – Expanded testing 2007 – Expanded recommendations

4. HIV Children/USA 076 Trial

5. New “Guidelines” • Recommends “Routine screening for all women…. • regardless of risk. • (13-64 – CDC 19-64 - ACOG) • Rescreening annually for those at high risk – ACOG • Repeat testing of low risk – clinical judgment – ACOG • Follow state requirements • Communication of results • Rapid test use • Unethical conduct of physicians – denial of care • Universal precautions From Women’s Health Care, 3td edition 2007

6. Responses • Universal vs. Risk-based screening • Legal/Ethical challenges • Public/Private • Who is involved? • Protecting the patient? • Protecting children? • Legal concerns • Operational changes

7. Building/Defining a Perinatal Partnership • Goals • Process • Stakeholders • Methods • Outcomes

8. Goals • Reduction of the burden of disease with increased testing and treatment. • Identify/Evaluate new strategies for reduction or prevention of STD’s.

9. Process Identify stakeholders • Physicians – Obstetricians, Pediatricians, Infectious disease responses • Hospitals • Infrastructure – Policies, Committees, Procedures • Risk management/Compliance • Laboratory • Community “Voices” • Payors

10. Translational Methods • Identify Methods • Best practices • “Hard wiring” • Quality improvement / Patient safety • Identify Tools

11. Outcomes Measures • Burden of disease • Costs – testing/treatment • Individual • Disease

12. Summary • The public/provider partnership has reduced the burden of perinatal HIV through testing and treatment subsequent to the ACTG 076 trial in 1994. • The expansion of perinatal testing has raised important ethical issues primarily around the doctrine of “informed consent”. • The public/provider partnership needs to be expanded to: • Increase breadth of stakeholders • Monitor outcomes of changes in our prevention, testing and treatment. • Address other preventable perinatally transmitted STD’s • Develop new treatment/prevention responses.

13. ACOG References ACOG Technical Bulletin, Human Immune Deficiency Virus Infections, #123, Dec, 1988 ACOG Committee Opinion, Human Immunodeficiency Virus Infection: Physicians’ Responsibilities, #85, Sept, 1990 ACOG Technical Bulletin, Human Immunodeficiency Virus Infections, #165, March, 1992 ACOG Technical Bulletin, Human Immunodeficiency Virus Infections, #169, June, 1992 ACOG Committee Opinion, Human Immunodeficiency Virus Infection: Physicians’ Responsibilities, #130, November, 1993 ACOG Educational Bulletin, Human Immunodeficiency Infections in Pregnancy, #232, January 1997

14. ACOG References(continued) AAP/ACOG Joint Statement of Policy, Joint Statement on Human Immunodeficiency Virus Screening. Approved by the ACOG Executive Board, May 1999 , Approved by the AAP Executive Board, May 1999; Reaffirmed by the AAP Executive Board, September 2005, Reaffirmed by the ACOG Executive Board, July 2006 ACOG Committee Opinion, Prenatal and Perinatal Human Immunodeficiency Virus Testing: Expanded Recommendations, #304, November 2004 ACOG Committee Opinion, Human Immunodeficiency Virus, #389, December 2007

15. Public Health References Institute of Medicine HIV Screening of Pregnant Women and Newborns. Washington, DC: National Academy Press, 1991. MMWR, July 7, 1995 U.S. Public Health Service Recommendations for Human Immunodeficiency Virus Counseling and Voluntary Testing for Pregnant Women. MMWR, November 15, 2002 HIV Testing among Pregnant Women – United States and Canada, 1998-2001 North Carolina General Statutes: 2007 130A-148(h) – HIV testing 130A-143 – Confidentiality of records 130A-25 – Misdemeanor 130A-148(i) - Discrimination North Carolina Administrative Code: 10A NCAC 41A.0202

16. Medical Literature References Simpson WM. Johnstone FD. Goldberg DJ. Gormley SM. Hart GJ. Antenatal HIV testing: Assessment of a routine voluntary approach. BMJ 318;1660-1661,1999 Polaneczky, M. Cadogan, M. McGuinness, K. Waterstone, M. State-mandated voluntary newborn human immunodeficiency virus screening in a New York City Hospital. Obstetrics & Gynecology. 94(5 Pt 1):647-52, 1999 Nov. Henderson, S L. Lindsay, M K. Higgins, J E. Clark, W S. Bulterys, M. Nesheim, S R. Experience with routine voluntary perinatal human immunodeficiency virus testing in an inner city hospital. Pediatric Infectious Disease Journal. 20(11):1090-2, 2001 Nov. Troccoli K. Pollard H 3rd. McMahon M. Foust E. Erickson K. Schulkin J. Human immunodeficiency virus counseling and testing practices among North Carolina providers. Obstetrics & Gynecology. 100(3):420-7, 2002

17. References Sansom SL. Jamieson DJ. Farnham PG. Bulterys M. Fowler MG. Human immunodeficiency virus retesting during pregnancy: costs and effectiveness in preventing perinatal transmission. Obstetrics & Gynecology. 102(4):782-90, 2003 Oct.  Chou R. Smits AK. Huffman LH. Fu R. Korthuis PT. US Preventive Services Task Force. Prenatal screening for HIV: A review of the evidence for the U.S. Preventive Services Task Force. [Review] [154 refs] Annals of Internal Medicine. 143(1):38-54, 2005 Jul 5. Peeling RW. Holmes KK. Mabey D. Ronald A. Rapid tests for sexually transmitted infections (STIs): the way forward. Sexually Transmitted Infections. 82 Suppl 5:v1-6, 2006 Dec.