PUBLIC HEALTH PROGRAMMES&

PHARMACOVIGILANCE

Shanthi PalQuality Assurance and Safety: Medicines

Essential Medicines and Pharmaceutical PoliciesWorld Health Organization

Why the use of drugs in Public HealthProgrammes (PHP) could carry some risk of harm

Proposals regarding synergy between PHP and Pharmacovigilance (PV)

WHO GUIDELINE « PHARMACOVIGILANCE AND PUBLIC HEALTH

PROGRAMMES »

Clinical Practice vs PHP

Clinical practice

PHYSICIAN

Improve patient health

Public Health Programmes

HEALTHAUTHORITIES

Improve population health(Prevent disease)

Public Health or community health

Science and art of preventing disease, prolonging life and promoting healthand efficiency through organized community efforts.

PHP

EducationEnvironmental modificationsNutrition interventionLifestyle and behavioural changesMass free distribution of drugs

PHP characteristics

Vertical and intensive programmes

Prophylaxis : vaccination, preventive treatment(ivermectine, albendazole, antibiotic and antiparasiticprophylaxis…)

Treatment (artemisinine derivatives against malaria, ARVs, Tuberculosis, Schistosomiasis...)

Eradication (lymphatic filariasis, Trachomatis, Leprosy, poliomyelitis elimination programmes…)

Involve drugs and vaccines

PHP sponsors

GovernmentWHO Other non-governmental organizations:

UNICEF - private associations

Private sector:Onchocerciasis eradication /Merck, - Leprosis eradication/Novartis, Filariasis eradication/GSK, Trachoma eradication /Pfizer, ARV Access initiatives/ Merck, GSK, Roche, Boeringer Ingelheim, Abbot

PHP ORGANIZATION

LEVEL

INTERNATIONAL

NATIONAL

LOCAL

SPONSORSWHO

OTHERS

MALARIAPROGRAMME MANAGERS

HEALTH WORKERS

PATIENTS

V a c c i n e sMalaria, filariasisTuberculosisH.I.V

T r a c h o m a t i s

PUBLIC HEALTH

PROGRAMMES

LOCAL COORDINATOR FOR HEALTH PROGRAMMES

Others

PHP monitoring

Incidence and prevalence of the diseaseMorbidity and mortality ratesNumber of patients treatedNumber of drug units delivered

What about the risk / effectiveness of drugs used?

PHP guidelines (WHO, National)

No mention of:ADRsPharmacovigilanceReports

1- DISEASES

Tropical diseasesNot well diagnosed (Exposed not alwayssuffering from the disease)Comorbid conditionsInsufficient follow-up

2. POPULATIONLow living standards (Malnutrition)Cultural specificities (Traditionalmedicines)Unlabelled and off-label indications

(pregnant or breast feeding women, smallchildren, elderly people)Food habits

3. DRUGS

Distribution of huge amounts of drugsPoor quality standards or counterfeitsNew drugs with little clinical experienceOrphan drugs, donated drugsImproperly stored, delivered and usedLack of established manufacturers

4. HEALTH CARE SYSTEM

Under developed public health systemUnder developed drug regulatory systemNo pharmacovigilance programmeUnqualified health workersPoor medical servicesFinancial shortages

Need to monitor PHPs…

To detect, evaluate and prevent ADRsrelated to:

HarmAcceptance and toleranceMisuse DependenceEffect on pregnancy and childrenTherapeutic failures (resistance, quality defects, counterfeits)

PHPCrucial and critical

Long standing

Technically performed

Good financial support

PVSeen as a luxury discipline

Not fully established

No spontaneous reporting culture, no PV competence

Poor support

In most developing countries

In those countries

PHPs could provide:Opportunity to implement PV activities Offer a cohort of patients under controlled conditions to be monitored for safety over a period of time

PV willDetect , evaluate, and prevent adverse eventsPromote rational use of drugs in mass treatment programmesEvaluate the impact of the programmesImprove acceptability of the programme

EXISTING SYSTEMS

WHOPROGRAMMES

WHOPROGRAMMES

V a c c i n e sMalaria

TuberculosisFilariasis

HIV / AIDS

WHO-PV(UMC)

PV CoordinatorNational PV centre

PATIENTS

NATIONAL PUBLIC HEALTH

PROGRAMMES

VaccinesMalaria

TuberculosisFilariasis

HIV/AIDS

Healthworkers

Healthworkers

PATIENTS

Expert Safety ReviewPanel

INTEGRATING PHP AND PVFUNCTIONAL AND STRUCTURAL RELATIONSHIP

WHOPROGRAMMES

WHOPROGRAMMES

V a c c i n e sM a l a r i a

T u b e r c u l o s i sF i l a r i a s i s

HIV / AIDS

WHO ADVISORYCOMMITEE

WHO-PV(UMC)

PV CoordinatorNational PV centre

Health workers

NATIONAL PUBLIC HEALTH

PROGRAMMES

V a c c i n e sM a l a r i a

T u b e r c u l o s i sF i l a r i a s i s

HIV / AIDS

DISTRICT INVESTIGATION

TEAM

DRUG REGULATORY AUTHORITY

PATIENTSPATIENTS

RESPONSIBILITIES

Promote National PV activity

Develop a risk management plan

Integrate PHP and PV

Promote policies for best practice

Health Authority

RESPONSIBILITIES

Promote best practice; PV While starting the programme:

Is the medicine well known?Is the company represented in the country?Is the safety profile of the drug established?Is the dosage in use authorised by marketing authorisation?In case of generic product: what about bioequivalence test?

NATIONAL PHP MANAGER

RESPONSIBILITIES

Health workers

•Diagnose ADRs•Manage ADRs•Take action•Educate patients•Attend meetings•Promote rational use of drugs•Report ADRs to the district Investigation team

RESPONSIBILITIES

•Assess causality •Investigate and manage ADRs•Take action•Educate patients•Train health workers•Promote rational use of drugs•Report ADRs to the national pharmacovigilance coordinator

DISTRICT INVESTIGATION

TEAM

RESPONSIBILITIES

•Coordinate the national PV programmefor P.H.P

•Collect ADR reports•Develop and adapt procedures•Develop training modules•Liaison with all the actors•Submit recommendations•Be the secretary for expert safety review panel

PV CoordinatorNational PV centre

RESPONSIBILITIES

• Review ADRs• Check and finalise causality assessment• Generate possible signals• Submit conclusions and recommendations to:1. Public health programmes2. National PV centre3. Drug regulatory authority

Expert Safety ReviewPanel

WHOPROGRAMMES

WHOPROGRAMMES

V a c c i n e sM a l a r i a

T u b e r c u l o s i sF i l a r i a s i s

HIV / AIDS

WHO-PV(UMC)

RESPONSIBILITIES

Initiating, organizing, carrying out, advising and guiding a number of clinical programmes

Supporting member states in assuring the safe use of medicinal products

Encouraging all clusters within WHO to advise member states on how to monitor the safe use of these products

Encouraging initiatives to conduct operational research on PV

Addressing the needs of public health programs

MalariaHIV/AIDS

Neutropenia with ACTs in malaria-HIV co-infected ? • Result of repeated treatment with ACTs?

Dystonia with As-Aq? SJS susceptibility

Delete d4t? NVP in women? Can we use TDF without renal monitoring?

Risk of severe anaemia in children with AZT?Use NVP & rifampicin concomitantly in HIV/TB patients?

CONCLUSION

The success of PHP is largely dependent on the participation of society and the acceptance that drugs are safePV should be an integral part of every PHPPV is essential to promote the rational and safe use of medicines and the acceptability of mass treatment programmes.

Complementary functions for a common goal

PHP

Reducing morbidity and mortality

Pharmacovigilance

Evaluating drug effectiveness, harm and

cost

IMPROVE PATIENT HEALTH