public health programmes & pharmacovigilance shanthi pal quality assurance and safety: medicines...
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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?
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.