Dr Shanthi Pal Group Lead Medicines Safety DirectorEMP K De Joncheere Coordinator PAU G Forte HeadRHT LRago CoordinatorPHI M Zafar Coordinator PQT Coordinator RSS N Dellepiane ID: 746129
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Slide1
Pharmacovigilance:
New challenges for WHO
Dr Shanthi Pal
Group Lead, Medicines Safety Slide2
Director/EMP
K. De
Joncheere
Coordinator PAU
G. Forte
Head/RHT
L.Rago
Coordinator/PHI
M Zafar
Coordinator /PQT
Coordinator RSS
N Dellepiane
Coordinator /SAV
C Ondari
Coordinator /TSND Wood
Group LeadP Zuber
Group LeadS Pal
Group LeadM DeatsSlide3
Scope of SAV work
Develop policies, norms, standards, and methods for medical
product vigilance, post market surveillance and safe useSupport countries to adapt and implement policies, norms and standardsBuild global capacity, esp
, through NRA strengthening activities Promote contribution to and effective use of the global safety data baseFacilitate exchange of information and global learning
Promote new approaches to medical product vigilance activitiesPromote 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 productsSlide4
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 worldwideProvide
a platform for data sharing and exchange of informationDevelop methods, norms and standards for PV in LMIC, PHPsBring capacity, resources
Provide 'PV service' to all programmes that use medicinal products in WHOSlide5
WHO
Collaborating Centres
UMC PV databasePV tools, training
Signal detection ResearchOslo (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 medicinesCross cutting service across health interventions
Netherlands (2012)Training: patient reporting & patient reporting systems
Integrate PV in curriculum Slide6
Key SAV Priorities in 2014 - 2018
WHO Advisory Committees: Safety of Medicinal Products (ACSoMP),
Global Advisory Committee on Vaccine Safety GACVS (GACVS)Slide7
20 years of growth of the WHO Pharmacovigilance Programme
1993
2013Slide8
PV in LMIC: Challenges Remain
Lack of resources, political support
Lack of competenceLack of PV systems and/ or inadequate functionLack of communication and information exchange
% Implemented out of the total countries in the region
% Implemented (of those with data available)
Number of Countries with Indicator Implemented
Number of Countries with data available
Number of Countries
Group of countries
94
94
45
48
48
A. Industrialized
13
38
5
13
39
B. Upper middle income
9
29
5
17
57
C1.Lower middle income
4
12
2
17
49
C2.Low income
Capacity to detect significant
v
accine safety issue
WHO survey of PV systems in 55 countries
North America
EuropeSlide9
Why is this a problem?
new TB drugs in 40 years
accelerated approval; phase 2b dataEarly introduction countries have no or limited PV and infrastructure
Inadequate or no reference to PV
The case of new drugs and MDR TB
Ebola: 30 years later, still no capacity to develop, assess, manage treatments in these settings Slide10
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 medicinesTrack quality issues
Track irrational useTrack medication errorsDo we have all the stakeholders: patients?
10Slide11
Patient reporting
WHO's strategy: When we need more
Denominator and numerator data:
ADR Frequencies
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
Patient reporting
Medication errorsSlide12
PV Training in Public Health Programme can improve overall PV awareness
CEM training
Impact on Spontaneous reportingSlide13
Ref
:
Safety
monitoring in public
health
programmes: pharmacovigilance an essential
tool, WHO, 2002
Expert Safety Review Panel
PV Coordinator
National PV centre
Health
workers
Immunization
M a l a r i a
T u b e r c u l o s i s
HIV / AIDS
DISTRICT INVESTIGATION TEAM
DRUG REGULATORY AUTHORITY
DATA
PATIENTS
KNOWLEDGE
POLICIES
Pharmacovigilance is effective / sustained if well integrated with Regulatory Function.
PV centres and PHPs need to collaborate better. Slide14
Staircase Model for PV & NRA ProgrammesSlide15
SAV Programmes
Medicines
WHO Programme for International Drug Monitoring (PIDM)
Support to Global databases of Individual Case Safety Reports (ICSRs)
Drug Statistics Methodology (ATC DDD)
Vaccines
Global vaccines Safety Initiative
Basic and advanced capacity for AEFI monitoring
SSFFC
PV centres
in reporting
network Slide16
www.who.int/medicines/areas/quality_safety/safety_efficacy/en/index.html
email: pvsupport@who.int