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©2014
3rd WHO Member State
Mechanism Meeting
Update on the WHO Surveillance and Monitoring System,
SSFFC Medical Products
©2014
WHO Member State Mechanism
• WHA Resolution 65.19
• Established Member State Mechanism
World Health Assembly
• 1st Meeting Argentina 2012
• 2nd Meeting Geneva 2013
• 3rd Meeting Geneva 2014
Member State Mechanism
• Rotating chair, Currently Americas
• 2 vice chairs from 6 WHO regions
Chair and Steering Committee
• 8 Point work plan adopted by WHA in May 2014
• Working groups have commenced Work Plan
©2014
Member State Mechanism – Work Plan
Capacity Strengthening, Regulators and
Laboratories
Co-operation and collaboration
amongst National Authorities
Communication, education and
awareness raising
Consult, cooperate and collaborate
with relevant stakeholders
Identify actions, activities and behaviours
resulting in SSFFC medical products
Strengthen national and regional capacities to
secure supply chains
Collaborate on surveillance and
monitoring of SSFFC medical
products
Collaborate on access to Quality, safe, efficacious and affordable
medicines
©2014
Programme Strategy
©2014
Rationale
Understand the GLOBAL PICTURE
through validated evidence
IDENTIFY VULNERABILITIES
in Health Systems and
influence change
Provide technical
support and guide CAPACITY
BUILDING
PROTECT PUBLIC HEALTH
©2014
SYSTEM OBJECTIVES
SCALE
• Quantity
• Value
SCOPE • Medicines • Vaccines • Diagnostics
EXTENT
• Geographic coverage
HARM
• Public Health
©2014
What to Report
1. Medical Products that are suspected or confirmed to be :
SSFFC , or
to have caused unexpected adverse reactions, including lack of efficacy
2. Genuine medical products that are suspected or confirmed to be intentionally manufactured in non-
compliance with National standards
3. Medical products which are confirmed as diverted
©2014
METHODOLOGY - RAPID ALERT FORM
Reporting Person
Details of and discovery of product
Public health Impact ; Lab Analysis
Communication ; Dissemination
Investigation; Regulation
©2014
METHODOLOGY - DATABASE
Incident
Classification
Health Impact
Supply route
Risk Assessment
Suspect Product(s)
Alert
©2014
SSFFC Incidents Reported Worldwide
as of 22 October 2014
80 Member States trained in 8 workshops 230 Regulatory personnel trained 18 large procurement agencies trained Over 500 Suspect Products Reported Incidents occurred in 62 countries
©2014
DATABASE STATISTICS AS OF 22 OCTOBER 2014
197 Incidents reported
504 Medical products reported
272 (54%) medical products reported
are on the WHO Essential Medicines
List
50 reports refer to WHO Pre Qualified
Medicines
10% of reports involved attributable
serious adverse reactions
8 WHO International Drug Alerts
issued
©2014
International Coordination and Alert Contaminated Active Pharmaceutical Ingredient (API)
DECEMBER 2012, PAKISTAN 50 deaths
WHO INTERVENTION
SEPTEMBER 2013, PARAGUAY 46 paediatric patients
WHO INTERVENTION
WHO INTERNATIONAL ALERT WHO INTERNATIONAL ALERT
COLOMBIA AND PERU trace the API at a
manufacturers
ZERO DEATHS
©2014
SUSPECT PRODUCTS REPORTED BY WHO REGION AS OF 22 OCT 2014
214; 42%
158; 31%
61; 12%
34; 7%
24; 5%
13; 3%
African region
European region
Western Pacific region
Region of the Americas
Eastern Mediterranean
South East Asia region
©2014
VULNERABILITIES
• Pharmacists and hospitals purchase products from unlicensed sources
• Poor procurement practice
Unregulated supply chains
• Stock shortages and Storage difficulties
• Price differentials
• Lack of awareness
Difficult access to quality and safe products
• Lack of deterrents
• Porous Borders
• High levels of corruption
Lack of effective law and criminal
justice system
©2014
Falsified products with Essential Drugs
programme WHO Logo
©2014
FALSIFIED EMERGENCY CONTRACEPTIVE
WHO Pre Qualified medicine
UN Agency procured
Emergency contraceptive
150,000 doses seized in Lagos
Commonly seized in Africa
©2014
Africa Seizure
Coartem – Anti malarial
• 1.383,528 packs
• Artemether /Lumefantrine
Postinor 2 – Emergency Contraceptive
• 4930 packs
• Levongestrel
Vermox – Worming treatment
• 1534 packs
• Mebendazole
Clomid – Fertility treatment
36,550 packs
Clomiphene
Clamoxyl - Antibiotic
744 packs
Amoxicillin
©2014
Thank You
Michael Deats
Group Lead
SSFFC, Safety and Vigilance
Essential Medicines and Health Products
