Pharmacovigilance:
New challenges for WHO
Dr Shanthi Pal
Group Lead, Medicines Safety
Essential Medicines and
Health Products (EMP)
Director/EMP
K. De Joncheere
Policy, Access and Use
(PAU)
Public Health, Innovation
and Intellectual Property
Regulation of Medicines
and other Health
Technologies (RHT)
Coordinator PAU
G. Forte
(PHI)
Head/RHT
L.Rago
Coordinator/PHI
M Zafar
Prequalification
Team (PQT)
Regulatory Systems
Strengthening (RSS)
Safety and Vigilance
(SAV)
Technologies
Standard and Norms
(TSN)
Coordinator /PQT
Coordinator RSS
N Dellepiane
Coordinator /SAV
C Ondari
Coordinator /TSN
D Wood
Medicines
Vaccines
SSFFC
Group Lead
S Pal
Group Lead
Group Lead
M Deats
P Zuber
Scope of SAV work
• Develop policies, norms, standards, and methods for medical
product vigilance, post market surveillance and safe use
• Support countries to adapt and implement policies, norms and
standards
• Build global capacity, esp, through NRA strengthening activities
• Promote contribution to and effective use of the global safety data
base
• Facilitate exchange of information and global learning
• Promote new approaches to medical product vigilance activities
• Promote and collaborate on vigilance activities with public health
programmes
• Respond to safety concerns and crises of international importance
• Encourage the systematic and structured reporting of incidents
involving SSFFC medical products
Pharmacovigilance in WHO….
Mandate and Framework set
by WHA Resolution 16.36:
'….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'.
• Establish PV systems and centres in
every country in the world
• Maintain the network of PV centres
worldwide
• Provide a platform for data sharing
and exchange of information
• Develop methods, norms and
standards for PV in LMIC, PHPs
• Bring capacity, resources
• Provide 'PV service' to all
programmes that use medicinal
products in WHO
WHO Collaborating Centres
• UMC




PV database
PV tools, training
Signal detection
Research
• Oslo (ATC DDD, training)
• Ghana (2009)
 Toolkit
 African outreach
 PV in public health
programmes
• Morocco (2010)
 Francophone/Arabic countries
 PV for preventing ADRs: rational
use of medicines
 Cross cutting service across health
interventions
• Netherlands (2012)
 Training: patient reporting &
patient reporting systems
 Integrate PV in curriculum
Key SAV Priorities in 2014 - 2018
WHO Advisory Committees: Safety of Medicinal Products (ACSoMP),
Global Advisory Committee on Vaccine Safety GACVS (GACVS)
20 years of growth of the WHO
Pharmacovigilance Programme
1993
2013
PV in LMIC: Challenges Remain
WHO survey of PV systems in 55 countries
•
•
•
Lack of resources, political support
Lack of competence
Lack of PV systems and/
or inadequate function
• Lack of communication and
information exchange
Capacity to detect significant
vaccine safety issue
Europe
North America
Group of
countries
Number
of
Countrie
s
Number of
Countries
with data
available
Number of
Countries
with Indicator
Implemented
%
Implemente
d (of those
with data
available)
%
Implemente
d out of the
total
countries in
the region
A. Industrialized
48
48
45
94
94
B. Upper middle
income
39
13
5
38
13
C1.Lower middle
income
57
17
5
29
9
C2.Low income
49
17
2
12
4
Why is this a problem?
Ebola: 30 years later, still no capacity to
develop, assess, manage treatments in these
settings
Inadequate or no reference to PV
The case of new drugs and MDR TB
• new TB drugs in 40
years
• accelerated approval;
phase 2b data
• Early introduction
countries have no or
limited PV and
infrastructure
To be relevant: are we doing everything we can?
• 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)
• By investing in PV,
countries will benefit
multifold:
– Benefit harm
assessment of medicines
– Track quality issues
– Track irrational use
– Track medication errors
• Do we have all the
stakeholders: patients?
10
WHO's strategy: When we need more
Denominator and
numerator data:
ADR Frequencies
Patient reporting
Patient
reporting
Medication errors
1.
2.
3.
Targeted spontaneous reporting: to quantify a known ADR
Cohort Event Monitoring: to quantify all events with new medicines in a short period
of time
Guidelines: Consumer reporting; preventable ADR detection
PV Training in Public Health Programme
can improve overall PV awareness
CEM training
Impact on Spontaneous
reporting
Pharmacovigilance is effective / sustained if well integrated with Regulatory Function.
PV centres and PHPs need to collaborate better.
POLICIES
DRUG REGULATORY
AUTHORITY
KNOWLEDGE
HIV / AIDS
Tuberculosis
Expert Safety Review Panel
PV Coordinator
National PV centre
Malaria
Immunization
DISTRICT
INVESTIGATION TEAM
PATIENTS
DATA
Health workers
Ref: Safety monitoring in public health programmes:
pharmacovigilance an essential tool, WHO, 2002
Staircase Model for PV & NRA
Programmes
Assessment, Guidelines, Education &
Basic Capacity Building
SAV Programmes
Vaccines


Global vaccines
Safety Initiative
Basic and
advanced
capacity for AEFI
monitoring
Medicines
• WHO Programme
for International
Drug Monitoring
(PIDM)
• Support to Global
databases of
Individual Case
Safety Reports
(ICSRs)
• Drug Statistics
Methodology (ATC
DDD)
SSFFC
PV centres
in
reporting
network
www.who.int/medicines/areas/quality_safety/safety_efficacy/en/index.html
email: [email protected]