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Introduction of the new PMTCT Policy and Guidelines

Parliamentary Portfolio Committee on Health

4 March 2008

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Purpose

Policy and Guidelines in brief

Recommended approach to implementation

Conclusion

Recommendations

Outline

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Purpose To provide an update to the Health

Portfolio Committee on progress with the introduction of dual therapy for PMTCT, for Information, Discussion, and Advice

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Guidelines in brief Approved by the Minister on the 12

February 2008 Policy approach addresses four

stages of intervention Primary prevention

Especially among women of child bearing age Antenatal care activities Activities during labour and delivery Postnatal care including safe infant

feeding

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Guidelines in brief

Early booking Routine offer of HIV testing

Approach and algorithm outlined Repeat test at 34 weeks if HIV

negative Counselling on safe infant feeding

Affordable, Feasible, Acceptable, Safe, Sustainable (AFASS) criteria emphasised

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Guidelines in brief Dual therapy – AZT + sdNVP

AZT from 28 weeks (or as soon as possible thereafter but before the onset of labour) and through labour + sdNVP at labour

Baby – sdNVP + AZT (7 OR 28 days)

Cotrimoxazole – mothers and babies

Nutrition interventions Supplements – HIV positive pregnant women, and or Food supplements

Other social security interventions

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Guidelines in brief CD4 count at HIV positive diagnosis OR earliest

afterwards HAART if < 200 and/or WHO stage 4

Comprehensive plan guideline Prioritisation of pregnant women at service points

O&G units to consider providing HAART Safe obstetric procedures Intensive infant feeding education and support Early testing - PCR for babies Data management and reporting Document is on the Departmental website

Being prepared for printing and distribution with training

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Guidelines in brief Major developments relate to

Addition of AZT to sdNVP Infant feeding policy

Implications Longer course of therapy Require more complex health systems support Drug adherence support is critical for the realisation of health

outcomes Especially for safe infant feeding

Expected improvement in efficacy > 90% in clinical trials (sdNVP was 50% in clinical trials)

Reduction in risk of resistance development Challenges

Access Monitoring Budgets Communication

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Approach to implementation Considerations for readiness to

provide the service may include: A facility manager Trained team on site Adequate physical space Other relevant services- BANC, FP, basic

HIV & AIDS services Reasonable access to laboratory services

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Approach to implementation Efficient Information management systems Good record of adherence to drug dispensing

SOPs for OI Management & ARVs Reasonable demand, utilisation & supply

numbers on the current PMTCT Programme Maximise access and efficiency

Patient/treatment tracking system in place Efficient links with district & province Efficient links with community-based

organisations

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Approach to implementation The following health facilities may be

considered during the introduction phase: Comprehensive Plan (CCMT) service points Non-CCMT hospitals with O & G units & ANC

services CHCs with Maternal and Obstetric Units &

established comprehensive HIV & AIDS and MCWH programmes

Other PHC facilities that fulfill the criteria above

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Approach to implementation

District-based approach District manager

Mapping of current PMTCT services in each sub district Identification of facilities for implementation of full package

new PMTCT guideline Establishment of effective referral systems in each sub

district Seamless information management

Identify elements for the different levels with minimal negative impact on access

Work closely with local municipality health services Supporting coordination of implementation

PMTCT and MCWH coordinators Sub district “complexes” of facilities to inform

provincial implementation plans

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Approach to implementation “Medicine Act” of 1965 and the “Nursing Act” of 1978

provide regulatory framework for the handling of medicines

All ARVs are Schedule 4 drugs Require a prescription by a Doctor (Medicines Act) Nursing Act, 1978

Handling of medicines by nurses (Section 38A) Examine, diagnose illness or defect Authorisation

DG, HOD, Medical Officer of Health in Local Authority, medical officer of an organisation – DG designated after consultation with pharmacy Council

Consultation with Nursing Council Only whenever the services of a medical practitioner or

pharmacist are not available Adhere to regulations GN R2418 of 1984

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Approach to implementation Small clinics and PHC centres with ANC services

VCT Infant feeding counselling and support CD4 testing TB screening Nutrition support Social support PCR testing Haemoglobin monitoring

Larger centres with easy access to a doctor should be considered for prescription of dual therapy

Clients may be referred to these centres for the original prescription AZT could be delivered to the smaller clinics on patient-name

Consider invoking the regulatory provisions in order to increase access

Quality assurance will be critical

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Laboratory services Haemoglobin monitoring

Point-of-care, hand held devices used Laboratory tests may be required in complicated cases More training to be done

VCT Rapid test kits used Quality assurance system in place – provinces to improve adherence to

programme Access to CD4, Viral load, and PCR has improved considerably over the

comprehensive plan period Turn-around-times to be improved Courier services to be expanded to meet demand

Resistance surveillance Annual antenatal survey Virologic failure amongst comprehensive plan clients

Opportunity to improve technology for better efficiency Especially in remote areas

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Information management and research Cover core indicators outlined in guideline

document Starting with 13 (currently 7 reported on) Facility to District to Province to National

Feedback to all who need information To be expanded after twelve months

Cover all indicators in the guideline Operational research and questions

Awareness and knowledge, uptake, health systems issues, quality, access

Outcomes Part of training programme

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Communication and Social Mobilisation

Provincial EXCOs Provincial Councils on AIDS

District AIDS Councils General public

By the NDOH By the Provinces

Communities Mass media, Province and District-based

Indaba’s, etc

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Communication and Social Mobilisation What to communicate

The PMTCT package Primary HIV Prevention Early ANC booking Benefits of VCT Male and partner involvement Community involvement & support Safe infant feeding Adherence and support Where to access all relevant services Importance of follow up

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Approach to training Update current PMTCT manual – MCWH &

HIV and AIDS Clusters Manual to be printed by 25 March 2008 Training to start on 31 March 2008

Short term in-service information updates Course is envisaged to be 7 days

Counselling, haemoglobin monitoring, other drug toxicities, PCR, safe infant feeding, nutrition for the mother, dual therapy, programme monitoring and evaluation, and other relevant aspects

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Approach to training Master trainers and course directors - 10 per

province – critical mass Over three weeks in April Train-the-trainer

Down-cascade Prioritise identified service points Facility managers, hospital CEOs, all participating staff,

support services staff District managers and local health municipal services All relevant units in province

Health service providers to be trained by midMay in all nine provinces

Pre-service through the relevant institutions

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Provincial support NDOH

Printing and distribution of all relevant materials Information dissemination and provincial workshops Monthly provincial support visits for the first 12

months MCWH and Nutrition, HIV & AIDS, QA units

Implementation of the training programme Quarterly progress review meetings Information management and updating the DHIS Development and monitoring of conditional grant

business plans – DORA Ensure adequate resources for the MTEF period

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Estimated cost (NSP targets) 281.42m (2008); 323.18m (2009); 363.03m (2010) 378.84m (2011).

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Proposed PMTCT - MTEF Budget

Province 2007/08 2008/09 2009/10 2010/11

EC11,933

m 43.871 m 50.381 m 56.593m FS 7,721m 28,386m 32,598m 36,617m GP 10,921m 40,150m 46,108m 51,794 mKZN 7,320m 26,911m 30,905m 34,716m LP 9,466m 34,801m 39,965m 44,893 mMP 2,757m 10,136m 11,640m 13,075 mNC 4,293m 15,783m 18,125m 20,360m NW 6,721m 24,709 m 28,376m 31,875 mWC 15,415m 56,672m 65,082 m 73,107m

Total76,547

m 281,420m

323,180m

363,030m

Current budget (projections) 3.8%

84,946m

101,695m

107,797m

Projected shortfall   -196,474m

-221,485 m

-255,233m

Approved Addit. Budget 350,000m

650,000m

1,100,000m

PMTCT new proposal vs. additional budget   56.1% 34.0% 23.2%PMTCT new proposal vs. Total HIV and AIDS budget   10.9% 9.9% 9.1%

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RESOURCE IMPLICATIONS Items to consider for 2007/08 (the next six

weeks) Printing and distribution

Guidelines, IEC, Training manual, facility register, support visit tool

Training of trainers Stakeholder meetings Budgets available from NDOH

Provinces to submit business plans to the DG by 14 March 2008

Service points identified Patient target numbers 12 month plans

Indicating starting date

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Progress HODs have been briefed

Detail of policy and guideline discussed with provincial HAST managers

Approaches to implementation discussed with provinces

Developing provincial business plans NHC Council briefed

Commitment to support implementation of the policy and guideline

Local municipalities keen to contribute

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Conclusion The new policy and guidelines for PMTCT has been

approved National operational plan to be informed by

provincial business plans Some provinces may be more ready than others All nine provinces should have started by end of May

2008 NHLS to ensure support to implementation NDOH to ensure allocation of budgets during the

adjustment bid process Monitoring and evaluation essential

Pharmacovigilance Resistance surveillance Conclusion of current programme evaluation

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Recommendations It is recommended that the

Parliamentary Portfolio Committee on Health; Takes note of the progress towards

the implementation of the new PMTCT policy and guidelines

Supports successful implementation of these guidelines