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Pharmacovigilance: New challenges for WHO
Dr Shanthi Pal Group Lead, Medicines Safety
Medicines Vaccines SSFFC
Prequalification Team (PQT)
Regulatory Systems Strengthening (RSS)
Safety and Vigilance (SAV)
Technologies Standard and Norms
(TSN)
Essential Medicines and Health Products (EMP)
Policy, Access and Use(PAU)
Regulation of Medicines and other Health
Technologies (RHT)
Public Health, Innovation and Intellectual Property
(PHI)
Director/EMP K. De Joncheere
Coordinator PAUG. Forte
Head/RHTL.Rago
Coordinator/PHIM Zafar
Coordinator /PQT Coordinator RSSN Dellepiane
Coordinator /SAVC Ondari
Coordinator /TSND Wood
Group LeadP Zuber
Group LeadS Pal
Group LeadM Deats
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
• Lack of resources, political support• Lack of competence• Lack of PV systems and/ or inadequate function• Lack 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 vaccine safety issue
WHO survey of PV systems in 55 countries
North America
Europe
Why is this a problem?
• new TB drugs in 40 years
• accelerated approval; phase 2b data
• Early introduction countries have no or limited PV and infrastructure
Inadequate or no reference to PV
The case of new drugs and MDR TBEbola: 30 years later, still no capacity to develop, assess, manage treatments in these settings
10
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?
Patient reporting
WHO's strategy: When we need more
Denominator and numerator data :
ADR Frequencies
1. Targeted spontaneous reporting: to quantify a known ADR2. Cohort Event Monitoring: to quantify all events with new medicines in a short period
of time3. Guidelines: Consumer reporting; preventable ADR detection
Patient reporting
Medication errors
PV Training in Public Health Programme can improve overall PV awareness
CEM training
Impact on Spontaneous reporting
Ref: Safety monitoring in public health programmes:
pharmacovigilance an essential tool, WHO, 2002
Expert Safety Review Panel
PV CoordinatorNational 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
DATAPATIENTS
KNOWLEDGE
POLICIES
Pharmacovigilance is effective / sustained if well integrated with Regulatory Function.PV centres and PHPs need to collaborate better.
Staircase Model for PV & NRA Programmes
Re-assess, improve, scale up
Twinning, mentorship, T3 forAdvanced Capacity Building
Assessment, Guidelines, Education &Basic Capacity Building
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
