PUBLIC HEALTH PROGRAMMES & PHARMACOVIGILANCE Shanthi Pal Quality Assurance and Safety: Medicines Essential Medicines and Pharmaceutical Policies World.

PUBLIC HEALTH PROGRAMMES&

PHARMACOVIGILANCE

Shanthi PalQuality Assurance and Safety: Medicines

Essential Medicines and Pharmaceutical PoliciesWorld Health Organization

Why the use of drugs in Public Health Programmes (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

HEALTH AUTHORITIES

Improve population health(Prevent disease)

Public Health or community health

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

PHP Education Environmental modifications Nutrition intervention Lifestyle and behavioural changes Mass free distribution of drugs

PHP characteristics

Vertical and intensive programmes

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

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

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

Involve drugs and vaccines

PHP sponsorsGovernmentWHO 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

MALARIA

PROGRAMME MANAGERS

HEALTH WORKERS

PATIENTS

V a c c i n e sMalaria, filariasis

Tuberculosis H.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 disease Morbidity and mortality rates Number of patients treated Number of drug units delivered

What about the risk / effectiveness of drugs used?

PHP guidelines (WHO, National)

No mention of: ADRs Pharmacovigilance Reports

1- DISEASES

Tropical diseases Not well diagnosed (Exposed not

always suffering from the disease) Comorbid conditions Insufficient follow-up

2. POPULATION Low living standards (Malnutrition) Cultural specificities (Traditional

medicines) Unlabelled and off-label indications (pregnant or breast feeding women, small

children, elderly people) Food habits

3. DRUGS

Distribution of huge amounts of drugs Poor quality standards or counterfeits New drugs with little clinical experience  Orphan drugs, donated drugs Improperly stored, delivered and used Lack of established manufacturers

4. HEALTH CARE SYSTEM

Under developed public health system Under developed drug regulatory

system No pharmacovigilance programme Unqualified health workers Poor medical services Financial shortages

Need to monitor PHPs…

To detect, evaluate and prevent ADRs related to:

Harm Acceptance and tolerance Misuse Dependence Effect on pregnancy and children Therapeutic failures (resistance, quality defects,

counterfeits)

PHP Crucial and critical

Long standing

Technically performed

Good financial support

PV Seen 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 will Detect , evaluate, and prevent adverse events Promote rational use of drugs in mass

treatment programmes Evaluate the impact of the programmes Improve acceptability of the programme

EXISTING SYSTEMS

WHOPROGRAMME

S

WHOPROGRAMME

S

V a c c i n e sMalaria

TuberculosisFilariasis

HIV / AIDS

WHO-PV(UMC)

PV CoordinatorNational PV centre

PATIENTS

NATIONAL PUBLIC HEALTH PROGRAMMES

VaccinesMalaria

Tuberculosis Filariasis

HIV/AIDS

Health workers

Health workers

PATIENTS

Expert Safety Review Panel

INTEGRATING PHP AND PVFUNCTIONAL AND STRUCTURAL RELATIONSHIP

WHOPROGRAMME

S

WHOPROGRAMME

S

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

PATIENTS

PATIENTS

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 programme

for 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 programmes

2. National PV centre

3. Drug regulatory authority

Expert Safety Review Panel

WHOPROGRAMME

S

WHOPROGRAMME

S

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)

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

RESPONSIBILITIES

Addressing the needs of public health programs

Malaria HIV/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 safe

PV should be an integral part of every PHP PV 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