First Conference of Regulatory
Authorities in Sudan and Neighbouring
Countries
Khartoum, 6-8 December 2014
Dr Lembit Rägo
Head, Regulation of Medicines and other Health Technologies
Essential Medicines and Health Products
©2014
WHO Member State Mechanism
World Health
Assembly
Member State
Mechanism
Chair and Steering
Committee
Work Plan
©2014
• WHA Resolution 65.19
• Established Member State Mechanism
• 1st Meeting Argentina 2012
• 2nd Meeting Geneva 2013
• 3rd Meeting Geneva 2014
• Rotating chair, Currently Americas
• 2 vice chairs from 6 WHO regions
• 8 Point work plan adopted by WHA in May 2014
• Working groups have commenced
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
©2014
Collaborate on
access to Quality,
safe, efficacious
and affordable
medicines
A Global Issue
Contaminated Active Pharmaceutical Ingredient
(API) produced in one country
Exported to 6 other countries on three
continents
Used to manufacture finished medicines
Caused loss of life and hospitalizations in two
countries
International drug alerts issued, medicines and
API seized
©2014
African Customs Seizure 2012
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
Rationale
Global Picture
Identify
vulnerabilities
through
validated
evidence
in Health
Systems and
influence change
Understand the
Provide
technical
support and
build capacity
PROTECT PUBLIC HEALTH
©2014
WHO SURVEILLANCE AND MONITORING SYSTEM
OBJECTIVES
SCALE
• Quantity
• Value
EXTENT
• Geographic
coverage
©2014
SCOPE
• Medicines
• Vaccines
• Diagnostics
HARM
• Public Health
SSFFC INCIDENTS REPORTED TO WHO





©2014
90 Member States trained in 9 workshops
250 Regulatory personnel trained
18 large procurement agencies trained
Over 530 Suspect Products Reported
Incidents occurred in 65 countries
West Africa 2012-14
©2014
DATABASE HIGH LEVEL STATISTICS
 Over 530 medicines, vaccines and
devices reported
 285 (53%) medical products reported are
listed as WHO Essential Medicines
 Over 50 reports refer to WHO
PreQualified Medicines
 10% of reports involved attributable
serious adverse reactions
 8 WHO International Drug Alerts issued
©2014
SUSPECT PRODUCTS REPORTED BY WHO REGION
African region
61; 12%
34; 7%
158; 31%
24; 5%
European region
Western Pacific region
13; 3%
Region of the Americas
214; 42%
Eastern Mediterranean
South East Asia region
©2014
THERAPEUTIC CATEGORIES
BY SUSPECT RECORDS
Systemic hormonal preparations,… 4
Dermatologicals 5
9
Blood and blood forming organs
Musculo-skeletal system
Respiratory system
Various
Cardiovascular system
Antineoplastic and immunomodulating…
Alimentary tract and metabolism
Nervous system
Antiparasitic products, insecticides and…
Genito-urinary system and sex hormones
Antiinfectives for systemic use
0
©2014
20
21
27
33
37
46
48
70
82
97
20
40
60
80
100
FALSIFIED ANTIBIOTICS BY API
FOCUS ON AMOXICILLIN DISTRIBUTION BY REGION
Amoxicillin
Cloxacillin
Clarithromycin
3%
Ceftriaxone
Benzylpenicillin
2%
SEARO
3%
5%
Phenoxymethylpenicillin
Benzathine benzylpenicillin
Azithromycin Dihydrate
Doxycycline
Levofloxacin
Chloramphenicol
Ampicillin
Sulfanilamide
Cefuroxime axetil
©2014
Amoxicillin
40%
5%
AFRO
64%
EURO
3%
7%
WPRO
5%
10%
12%
PAHO
25%
PATIENT HARM
Minor reaction no medical care required
1
Unknown
1
Disability or permanent damage
3
Minor reaction requiring medical care
3
Medical intervention to prevent permanent damage
4
Other
5
Hospitalization
6
Death
9
Life Threatening
12
0
5
10
Does not include lack of efficacy of SSFFC medical products
©2014
CLASSIFICATION
PRODUCT RECORDS
Falsified
23
Suspect falsified
124
Diverted
233
2
8
Genuine
Intentional substandard manufacture
10
104
Pending
Substandard
©2014
Criteria for WHO Medical Product Alert
(Drug Alert)
Validated
Report
(eg. Lab analysis)
Product in
recent
circulation
©2014
Significant
threat to
public health
Extended
geographic
risk
GLOBAL VULNERABILITIES
Unregulated
supply chains
Difficult access
to quality and
safe products
Lack of effective
law and criminal
justice system
©2014
• Pharmacists and hospitals purchase
products from unlicensed sources
• Poor procurement practice
• Stock shortages and Storage difficulties
• Price differentials
• Lack of awareness
• Lack of deterrents
• Porous Borders
• High levels of corruption
Prevention, Detection and Response
©2014
Collaboration is the key!
Thank you
©2014