Medicines safety in WHO: promoting best
practices in Pharmacovigilance
Dr Shanthi Pal
Quality and Safety of Medicines
WHO
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What is pharmacovigilance
 The science and activities relating to the detection,
assessment, understanding and prevention of adverse
effects or any other drug-related problems.
(The Importance of Pharmacovigilance, WHO 2002)
 A tool for generating evidence to inform policies
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Birth of modern pharmacovigilance
Thalidomide – Phocomelia 1961
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16th World Health Assembly 1963
Assembly Resolution 16.36 - Clinical and
Pharmacological Evaluation of Drugs
INVITES Member States to arrange for a systematic
collection of information on serious adverse drug
reactions observed during the development of a
drug and, in particular, after its release for general
use.
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WHO Programme
for
140
International National
Drug Monitoring
Centres
WHO
Collaborating
Centre, Uppsala
WHO
WHO
Collaborating
Centre, Ghana
WHO
Collaborating
Centre, Morocco
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Roles and Responsibilities
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WHO
Policies and strategies for PV
Guidelines, norms and
standards
Exchange of information
Systems strengthening
Training and capacity
building
Dialogue with donors &
public health programmes
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WHO Collaborating Centres
Tools and technologies
Research and Innovation
Implementation / proof of
concept
Everyday technical support
Training and capacity
building
Exchange of information
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 Policies (WHO)
 Implementation
WHO
WHO CCs
 ADR Data
Country  Analysis
 Signals
 Communication
Based on spontaneous
reporting
Database
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Advisory Committee on Safety of Medicinal
Products (ACSoMP)
The Advisory Committee on Safety of Medicinal Products shall
provide advice on pharmacovigilance policy and issues related
to the safety and effectiveness of medicinal products
 to the relevant Assistant Director-General in WHO and through him /
her
 to the Collaborating Centre for International Drug Monitoring (the
Uppsala Monitoring Centre), and
 to the Member States of WHO.
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The WHO PV strategy
What defines it
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Putting the horse in front of the cart
AFRICA
If there are no systems, there will
be no evidence
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Morbidity profile (Clinical case mix)
 Distinct from developed countries
 Infectious diseases – 90% of global burden
 Determines the pharmaceutical characteristics
 Determines the Adverse event profile
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Characteristics of the Pharmaceutical Setting
 Inefficient pharmaceutical procurement; inadequate
storage facilities and distribution practices
 Few functional reputable or local pharmaceutical
companies
 Lax border controls and customs entry points
 Weak regulatory systems
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Diethylene glycol tragedy in Nigeria
NAFDAC Nigeria
 Paracetamol 1989
> 100 deaths (children)
 Paracetamol + Chlorpheniramine
2009
(teething mixture – ‘My Pikin’)
~100 deaths (children)
~110 Acute renal failure
 PV scope needs to be expanded to address quality issues
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Up to 50% of ADRs are preventable
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Pharmacovigilance system that
 Records errors
 Analyses
 Learns
 Implements checks
 Prevents errors
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Spontaneous reporting: Bedrock of
PV these forty years.
But: Lack of denominator data
Public health programmes need to
 address key safety questions, quickly
 provide rates of AEs
 monitor AEs in special populations (children..)
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Addressing the PV needs of public health
programmes
Dystonia with ACTs ?
Result of malnutrition / repeated treatment with ACTs?
 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?
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Methodological development
Additional data sources
 Cohort Event Monitoring
 recording patients exposed (cohort, target 10 000)
 active and systematic follow-up for adverse events
 provides incidence rates and risk profile
 identification of sub-groups at risk
 piloted in Tanzania and Nigeria for malaria treatment
 supported by CemFlow ™ management tool
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WHO
 has developed a protocol for
cohort event monitoring (CEM)
of
 antimalarials and
 ARVs
 is implementing CEM of
antimalarials in Africa
 has developed 'Pregnancy
register' protocol
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Understanding what's available
and what's needed in countries
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Challenges to Pharmacovigilance
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Type of assistance needed
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PV consultants for
AFRICA: PVSF
WHO CC for advocacy and
training in PV, Accra, Ghana
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Technical Solutions for Africa
 VigiFlow: tool for national ICSR
management and submission to
WHO/UMC
 Provides country with a national
database
 E2b compliant
 Incorporates MEDRA
 Free software update and maintenance
by UMC
Challenge: access to
broadband internet
Solution: Silverlite
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Joint WHO/Global Fund
pharmacovigilance strategy
 Establish basic functions and minimum requirements of
national pharmacovigilance system
Min PV req
 pharmacovigilance toolkit to support training and development
www.pvafrica.org/toolkit
 Strong wording in Round 10 requesting countries to include PV
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http://www.who.int/medicines/areas/quality_safety/
safety_efficacy/saf_pub/en/
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What gets measured, gets done
 Success indicators
 Outcomes
 Impact
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Additional stakeholders: the full
picture
 Direct patient reporting
 WHO guidelines
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Our strategy
 Understanding the local needs
 Making a 'deal' with public health programmes
 Bringing in additional stakeholders
 Expanding the scope of PV
 More patient centred
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A systems approach
 We need to install systems and structures in place
 To promote PV as 'best practice'
 That aim to improve quality of care
 While addressing the safety, effectiveness and quality
of medicines
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Maintain as the cheapest,
easiest, most sustainable
method
3 tiers-approach for WHO
1. As before
(Spontaneous reporting)
Methods, additional use (errors,
quality issues, resistance), more
2. More than before
centres, patient focused
 Tools
 Handbooks
New partners,
 Pilot
3. As never before
 Public
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
Measure,
Resources
Indicators
Fundraising (EuropeAid; BMGF; FP7)
Networks of excellence (PVSF)
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Thank you
 The impossible: we are on it
 For miracles: expect some delay
 Website
 www.who.int/medicines/areas/quality_safety/safety_efficacy/en
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