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

North Carolina Obstetric Quality InitiativesFebruary 22, 2008Marvin Hage, MD

Perinatal Consultingmhage@ec.rr.com

ObjectivesObjectives

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.

A Short History of Perinatal HIVA Short History of Perinatal HIVMedical/Provider

1980’s1981 – First description of AIDS1983 – Identification of HIV retrovirus

Perinatal transmission1987 – First prenatal testing1988 – 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

Public Health 1980’s

1988 – First NC rules 1990’s

1991 – IOM recommendations1995 - CDC – Counseling & Testing

2000’s

2001 – NC Partnership

2002 - CDC - Opt-out evaluation

2006 - CDC Recommendations

2007 – State Regulations

HIV Children/USAHIV Children/USA

076 Trial

New “Guidelines”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

ResponsesResponses

Universal vs. Risk-based screeningLegal/Ethical challenges

– Public/Private – Who is involved?– Protecting the patient?– Protecting children?– Legal concerns

Operational changes

Building/Defining a Perinatal Building/Defining a Perinatal PartnershipPartnership

GoalsProcess

– Stakeholders– Methods

Outcomes

GoalsGoals

Reduction of the burden of disease with increased testing and treatment.

Identify/Evaluate new strategies for reduction or prevention of STD’s.

ProcessProcess

Identify stakeholders– Physicians – Obstetricians, Pediatricians,

Infectious disease responses– Hospitals

Infrastructure – Policies, Committees, ProceduresRisk management/ComplianceLaboratory

– Community “Voices” – Payors

Translational MethodsTranslational Methods

Identify Methods– Best practices– “Hard wiring” – Quality improvement / Patient safety

Identify Tools

OutcomesOutcomes

Measures– Burden of disease– Costs – testing/treatment

IndividualDisease

SummarySummary

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.

ACOG ReferencesACOG 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

ACOG References(continued)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

Public Health ReferencesPublic 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) - DiscriminationNorth Carolina Administrative Code: 10A NCAC 41A.0202

Medical Literature ReferencesMedical 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

ReferencesReferences

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.