Progress on implementation of Progress on implementation of PharmacovigilancePharmacovigilance

in the in the NATIONAL ARV PROGRAMME NATIONAL ARV PROGRAMME

November 2009 November 2009

Dr Mwango ADr Mwango A

National ARV Programme National ARV Programme Coordinator,Coordinator,

Ministry of Health, ZAMBIA Ministry of Health, ZAMBIA

Republic of Zambia

Dr Sunkutu K Dr Sunkutu K

HIV & AIDS Advisor WHO Zambia Country Office Lusaka, Zambia

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OUTLINE OUTLINE of presentationof presentation BackgroundBackground ART ImplementationART Implementation Legal mandate of PRA Legal mandate of PRA ImplementationImplementation Current AnalysisCurrent Analysis ChallengesChallenges The way forward The way forward

Background StatisticsBackground Statistics

Year Patients on ART

Disease Burden

2002 143 236,000

2003 2,000 242,151

2004 15,325 248,638

2005 51,764 256,653

2006 78,683 273,642

2007 164,435 295,540

2008 228,050 338,315

2009 q2

245,382 359,391

2009287,445(Target)

359,391

ART programme ART programme ImplementationImplementation

2003-Pilot phase2003-Pilot phase Two sites –UTH and NCHTwo sites –UTH and NCH

2004- Development Phase2004- Development Phase Building capacity-human, systems and infrastructure Building capacity-human, systems and infrastructure Added 8 provincial hospitalsAdded 8 provincial hospitals

2005- Expansion Phase2005- Expansion Phase More patients and facilities More patients and facilities 322 (target is 350 centers by mid 2008)322 (target is 350 centers by mid 2008) Total number accessing ARVs 156,753 (December 31 Total number accessing ARVs 156,753 (December 31

2007)2007) 2006-2008 Further Expansion Phase2006-2008 Further Expansion Phase

Continued expansion at health center level (65% access)Continued expansion at health center level (65% access) 2009-2010 “Reaching out to remote communities” 2009-2010 “Reaching out to remote communities”

PhasePhase Continued expansion at rural health center levelContinued expansion at rural health center level 363 ART sites to date363 ART sites to date

Policy Change SupportPolicy Change Support

Enabling Enabling political willpolitical will to allow to allow commencement of PV activity for commencement of PV activity for Antiretroviral TherapyAntiretroviral Therapy

Provision of Provision of initial funds for PV initial funds for PV activityactivity

Specific Specific objective to address PV objective to address PV activities in the MOH strategic plan activities in the MOH strategic plan 2006-2008 (rolling plan to 2009) for ART2006-2008 (rolling plan to 2009) for ART

Legal and regulatory framework Legal and regulatory framework adoptedadopted

ORGANISATIONAL ORGANISATIONAL STRUCTURE OF PVUSTRUCTURE OF PVU

Ministry of health

PRA ------------------------

National Pharmaco-vigilance unit

ProvincialPharmacovigilance

District Pharmacovigilance

Public and Private Health Centres/

Hospitals

Professional Bodies

Investigation teams(HIV/AIDS, TB,EPI

MALARIA & others)

Reference Laboratories

PeripheralLaboratories

PatientAnd

Public

Manufacturers/Distributors

UNZA / TDRC

Expert ReviewPanel

World HealthOrganisation

-----------------------------Uppsala Monitoring

Centre

KeyReporting/ info flow Lab work & reporting info flow

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Legal frameworkLegal framework

One of the functions of the One of the functions of the Pharmaceutical Regulatory Authority Pharmaceutical Regulatory Authority (PRA) in the new legislation which came (PRA) in the new legislation which came into effect in November 2004, is post-into effect in November 2004, is post-marketing surveillance and monitoring of marketing surveillance and monitoring of ADRs. ADRs.

The PRA is coordinating all PV activities. The PRA is coordinating all PV activities. Pharmacovigilance Unit (PVU) was on 16Pharmacovigilance Unit (PVU) was on 16thth June 2006 and is set up at PRA.June 2006 and is set up at PRA.

Implementation-TWGImplementation-TWG

TWG to set up the PV systemTWG to set up the PV system Developed training package, ADR Developed training package, ADR

reporting tools, system design, reporting tools, system design, coordinating trainingscoordinating trainings

HIVDRSS incorporated in the PV HIVDRSS incorporated in the PV systemsystem

Supervisory visits to monitor Supervisory visits to monitor implementationimplementation

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Implementation -PlanningImplementation -Planning

Original plan was centered on Anti-Original plan was centered on Anti-malarials at the National Malaria malarials at the National Malaria Control Centre.Control Centre.

The aim was to revise the initial plan The aim was to revise the initial plan to be more inclusive for all drugs to be more inclusive for all drugs including ARVs, TB, Malaria and including ARVs, TB, Malaria and VaccinesVaccines

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Implementation-DesignImplementation-Design

Design of PV and HIVDRSS systemsDesign of PV and HIVDRSS systems Manuals developed for training of Manuals developed for training of

trainers with financial help from trainers with financial help from Health Services Systems Project Health Services Systems Project (HSSP under PEPFAR) and WHO.(HSSP under PEPFAR) and WHO.

Different forms for resistance Different forms for resistance monitoring in HIV/AIDS, Malaria and monitoring in HIV/AIDS, Malaria and TB have been developed. TB have been developed.

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Implementation-Implementation-InfrastructureInfrastructure

Secured a building (needs Secured a building (needs rehabilitation) for conference, admin rehabilitation) for conference, admin offices, data center and utility roomsoffices, data center and utility rooms

Procure field vehiclesProcure field vehicles Procured office equipment for data Procured office equipment for data

analysis and training (laptop, analysis and training (laptop, computers, printers, LCD, screens, computers, printers, LCD, screens, etc)etc)

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Implementation-TrainingImplementation-Training

Trainers (63) have been trained which Trainers (63) have been trained which included doctors, pharmacists, nurses, included doctors, pharmacists, nurses, clinical officers, lab technicians from the clinical officers, lab technicians from the Public and Private SectorPublic and Private Sector Health workers in NGO’s e.g. CHAZ, CIDRZHealth workers in NGO’s e.g. CHAZ, CIDRZ Defense forces medical services and UNZA Defense forces medical services and UNZA Health workers (21) from the private sectorHealth workers (21) from the private sector

Total number trained is over 580 HCWsTotal number trained is over 580 HCWs

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Current AnalysisCurrent Analysis

Well established health programmes Well established health programmes such as TB, HIV/AIDS, Malariasuch as TB, HIV/AIDS, Malaria

Availability of Resources from Global Availability of Resources from Global Fund, PEPFAR (thru HSSP and CDC) Fund, PEPFAR (thru HSSP and CDC) and UN systemand UN system

Training conducted on cost sharing Training conducted on cost sharing basis with health facilities basis with health facilities

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Current AnalysisCurrent Analysis

Some ADR/ADE reports received Some ADR/ADE reports received (now approx. 130 reports annually) (now approx. 130 reports annually) and acknowledgement of receipt of and acknowledgement of receipt of reports is done almost immediately. reports is done almost immediately.

Causality assessments are yet to be Causality assessments are yet to be done.done.

Need to link system to SmartCare Need to link system to SmartCare system (Zambia’s Electronic Medical system (Zambia’s Electronic Medical Records System)Records System)

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ChallengesChallenges No full time secretariat and short listing No full time secretariat and short listing

for a coordinators for PVU and for for a coordinators for PVU and for HIVDRSS activities (funding yet to be HIVDRSS activities (funding yet to be secured)secured)

Mechanisms to encourage more Mechanisms to encourage more reporting by health workers reporting by health workers

Bring on board Bring on board allall National Health National Health programmes including the private sectorprogrammes including the private sector

Motivation of reporters especially health Motivation of reporters especially health care professionalscare professionals

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Way ForwardWay Forward

Provide support to the Provide support to the pharmacovigilance at provincial and pharmacovigilance at provincial and district levels.district levels.

Sensitization of members of Sensitization of members of professional bodies and associations professional bodies and associations e.g. MAZ, PSZ, Diabetes and Epilepsy e.g. MAZ, PSZ, Diabetes and Epilepsy associations associations

Fully operationalise NPV Secretariat Fully operationalise NPV Secretariat Publication of “Medicines Monitor”Publication of “Medicines Monitor”

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Way ForwardWay Forward

Incorporate pharmacovigilance in Incorporate pharmacovigilance in pre-service professional training pre-service professional training for medical, pharmacy, nursing for medical, pharmacy, nursing etc.etc.

Public sensitization on Public sensitization on pharmacovigilancepharmacovigilance

Secure funds for infrastructure Secure funds for infrastructure and causality assessments of and causality assessments of reportsreports

Thank you…Thank you…