Transcript Pharmacovigilance in Public Health Programmes (PHP)

PUBLIC HEALTH PROGRAMMES
&
PHARMACOVIGILANCE
Shanthi Pal
Quality Assurance and Safety: Medicines
Essential Medicines and Pharmaceutical Policies
World Health Organization
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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
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Education
Environmental modifications
Nutrition intervention
Lifestyle and behavioural changes
Mass free distribution of drugs
PHP characteristics
Vertical and intensive programmes
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Prophylaxis : vaccination, preventive treatment
(ivermectine, albendazole, antibiotic and antiparasitic
prophylaxis…)
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Treatment (artemisinine derivatives against malaria,
ARVs, Tuberculosis, Schistosomiasis...)
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Eradication (lymphatic filariasis, Trachomatis, Leprosy,
poliomyelitis elimination programmes…)
Involve drugs and vaccines
PHP sponsors
Government
WHO
Other non-governmental organizations:
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UNICEF - private associations
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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
SPONSORS
WHO
OTHERS
Others
Trachomatis
H.I.V
LEVE
Tuberculosis
Malaria, filariasis
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Vaccines
PROGRAMME MANAGERS
LOCAL COORDINATOR FOR
HEALTH PROGRAMMES
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PUBLIC
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HEALTH
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PROGRAMMES
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HEALTH WORKERS
PATIENTS
PHP monitoring
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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
No mention of:
 ADRs
 Pharmacovigilance
 Reports
(WHO, National)
1- DISEASES
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Tropical diseases
Not well diagnosed (Exposed not always
suffering from the disease)
Comorbid conditions
Insufficient follow-up
2. POPULATION
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Low living standards (Malnutrition)
Cultural specificities (Traditional
medicines)
Unlabelled and off-label indications
(pregnant or breast feeding women, small
children, elderly people)
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Food habits
3. DRUGS
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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
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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:
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Harm
Acceptance and tolerance
Misuse
Dependence
Effect on pregnancy and children
Therapeutic failures (resistance, quality defects,
counterfeits)
In most developing countries
PV
PHP
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Crucial and critical
Long standing
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Seen as a luxury discipline
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Not fully established
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Technically performed
Good financial support
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No spontaneous reporting
culture, no PV competence
Poor support
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
HIV / AIDS
Filariasis
Tuberculosis
Malaria
Vaccines
WHO-PV
(UMC)
WHO
PROGRAMMES
EXISTING SYSTEMS
HIV/AIDS
Filariasis
Tuberculosis
Malaria
Vaccines
NATIONAL PUBLIC
HEALTH
PROGRAMMES
PV Coordinator
National PV centre
Health
workers
Health
workers
PATIENTS
PATIENTS
HIV / AIDS
Filariasis
Tuberculosis
Malaria
Vaccines
INTEGRATING PHP AND PV
FUNCTIONAL AND STRUCTURAL RELATIONSHIP
WHO
PROGRAMMES
WHO ADVISORY
COMMITEE
WHO-PV
(UMC)
DRUG REGULATORY
AUTHORITY
HIV / AIDS
Filariasis
Tuberculosis
Malaria
Vaccines
NATIONAL PUBLIC
HEALTH
PROGRAMMES
Expert Safety Review
Panel
PV Coordinator
National PV centre
DISTRICT
INVESTIGATION
TEAM
PATIENTS
PATIENTS
Health workers
RESPONSIBILITIES
Health Authority
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Promote National PV activity
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Develop a risk management plan
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Integrate PHP and PV
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Promote policies for best practice
RESPONSIBILITIES
NATIONAL PHP MANAGER
Promote best practice; PV
While starting the programme:
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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?
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
DISTRICT
INVESTIGATION
TEAM
•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
RESPONSIBILITIES
PV Coordinator
National PV centre
•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
RESPONSIBILITIES
Expert Safety Review
Panel
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Review ADRs
Check and finalise causality assessment
Generate possible signals
Submit conclusions and recommendations to:
Public health programmes
National PV centre
Drug regulatory authority
HIV / AIDS
Filariasis
Tuberculosis
Malaria
Vaccines
RESPONSIBILITIES
WHO
PROGRAMMES
WHO-PV
(UMC)
Initiating, organizing, carrying out, advising and
guiding a number of clinical programmes
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Supporting member states in assuring the safe use of
medicinal products
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Encouraging all clusters within WHO to advise member
states on how to monitor the safe use of these products
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Encouraging initiatives to conduct operational research
on PV
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Addressing the needs of public health
programs
Neutropenia with ACTs in malaria-HIV co-infected ?
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Result of repeated treatment with ACTs?
Dystonia with As-Aq? SJS susceptibility
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Malaria
HIV/AIDS
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
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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