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PUBLIC HEALTH PROGRAMMES&
PHARMACOVIGILANCE
Shanthi PalQuality Assurance and Safety: Medicines
Essential Medicines and Pharmaceutical PoliciesWorld Health Organization
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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 »
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Clinical Practice vs PHP
Clinical practice
PHYSICIAN
Improve patient health
Public Health Programmes
HEALTHAUTHORITIES
Improve population health(Prevent disease)
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Public Health or community health
Science and art of preventing disease, prolonging life and promoting healthand efficiency through organized community efforts.
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PHP
EducationEnvironmental modificationsNutrition interventionLifestyle and behavioural changesMass free distribution of drugs
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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
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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
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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
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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?
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PHP guidelines (WHO, National)
No mention of:ADRsPharmacovigilanceReports
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1- DISEASES
Tropical diseasesNot well diagnosed (Exposed not alwayssuffering from the disease)Comorbid conditionsInsufficient follow-up
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2. POPULATIONLow living standards (Malnutrition)Cultural specificities (Traditionalmedicines)Unlabelled and off-label indications
(pregnant or breast feeding women, smallchildren, elderly people)Food habits
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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
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4. HEALTH CARE SYSTEM
Under developed public health systemUnder developed drug regulatory systemNo pharmacovigilance programmeUnqualified health workersPoor medical servicesFinancial shortages
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Need to monitor PHPs…
To detect, evaluate and prevent ADRsrelated to:
HarmAcceptance and toleranceMisuse DependenceEffect on pregnancy and childrenTherapeutic failures (resistance, quality defects, counterfeits)
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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
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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
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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
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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
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RESPONSIBILITIES
Promote National PV activity
Develop a risk management plan
Integrate PHP and PV
Promote policies for best practice
Health Authority
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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
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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
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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
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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
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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
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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
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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?
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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.
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Complementary functions for a common goal
PHP
Reducing morbidity and mortality
Pharmacovigilance
Evaluating drug effectiveness, harm and
cost
IMPROVE PATIENT HEALTH