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Substandard and Falsified Medical Products
World Health Organization
.
Technical Briefing Seminar
2019
• You are a local small pharmaceutical wholesaler who is licensed by the National Regulatory Authority. You
have been licensed for 10 years, but due to a downturn in the economy your business is under financial
pressure.
• You have a large consignment of 1000 packs (28 tablets per pack) of an Anti-psychotic medicine which
you were supplied by a reputable manufacturer at a reduced price to due short expiry date. It formed part
of a larger consignment of medicines, the rest of which have been sold.
• The shelf life of the medicine is due to expire in 2 months.
How will you seek to sell these medicines without incurring a financial loss. Examine all options and
possibilities
Exercise
Democratic Republic of Congo
Remote rural area
Low literacy levels
Poor access to medicines
Civil unrest
▪ 3 medical centres and 100 medical staff dealt with over 1000 hospitalizations and at least 11 deaths
▪ Containers labelled Diazepam containing high dosage of anti-psychotic medicine - Haloperidol
▪ Irrational use of Diazepam
▪ Limited Access in the region
▪ Illegal cross border supply
▪ Unethical / Criminal practice by distributors
▪ Little regulatory oversight
FALSIFIED MEDICAL PRODUCT
SUBSTANDARD
Also called ‘out of specification’, these are authorized medical products that fail to meet either their quality standards or their specifications, or both. e.g. Manufacturing error, expired or degraded
FALSIFIED
Medical products that deliberately/fraudulently misrepresent their identity, composition or source.
UNREGISTERED / UNLICENSED
Medical products that have not undergone evaluation and/or approval by the NRRA for the market in which they are marketed/distributed or used, subject to conditions under national or regional regulation and legislation.
A common global understanding is necessary for coordinated action
Source: http://www.who.int/medicines/regulation/ssffc/mechanism/A70_23-en33-36.pdf
WHO and Member States agreed definitions
• The role of WHO
• Member State Mechanism
• Global Surveillance and Monitoring System
• Causes, Consequences and Solutions
• Prevention, Detection and Response
• Ongoing projects
• Challenges
OUTLINE
7
UN Sustainable Development Goals Goals
Substandard and Falsified medical products significantly undermine development efforts
Access to quality, safe, affordable and efficacious medical products
WHO’s triple billion
- UHC- Health emergencies- Healthier populations
2030 Agenda for Sustainable Development
- Goal 3
- Ensure healthy lives and promote well-being for all at all ages
1 billion more people
enjoying better health and well-being
1 billion more people
better protected from health emergencies
1 billion more people
benefitting from universal health
coverage
8
WHO Access to medicines roadmap
Objective
Improved prevention, detection and response to SF medical products
Action
Support strengthening national capacity to ensure the quality, safety and efficacy of health products
Strategic Area
Ensuring the quality, safety and efficacy of health products
Deliverables
• GSMS and focal point network maintained
• Medicine Quality Alerts issued
• Medicine Quality Surveys conducted
• Smartphone reporting Apps launched
• Regulatory systems strengthening to prevent, detect and respond
Member State Mechanism Prioritized Activities
The United Nations specialized agency on International Health
The Role of the World Health Organization
▪ Responsible for the surveillance and monitoring
of substandard and falsified medical products
▪ Providing technical assistance to Member States to
Prevent, Detect and Respond to SF medical products
▪ Issue Global alerts of SF medical products
▪ Lead projects and research in relation to SF
medical products
▪ Facilitate global collaboration amongst Member States to
Prevent, Detect and Respond to SF medical products
through the Member State Mechanism
Chaired by Member State
Governed by Steering
Committee of Member States
Secretariat Provided by
WHO
Open to all Member States
* www.who.int/medicines/regulation/ssffc/mechanism/en/
Member State Mechanism*
Prevention of SF Medical Products
Response to SF Medical Products
Detection of SF Medical Products
GovernanceObjectives Activities
A. Regulatory tools and
guidance
B. Global Regulatory Focal
Point Network
C. Technology
D. Access to Medical
Products
E. Education and
Awareness
F. Advocacy
G. Medicines in Transit
H. Medicines on the
Internet
Member State Mechanism Steering Committee 2019/20
African Region
Benin Kenya
Americas Region
Brazil United States
Eastern Mediterranean Region
Iran Iraq
European Region
Spain Russia
South East Asia Region
India (Chair) Indonesia
Western Pacific Region
China Malaysia
GovernanceGovernance
Commissioned by the WHO Member State
mechanism, with objectives focused on:
➢ Estimated prevalence of SF medical products
globally
➢ Estimated economic impact of SF medical
products
➢ Advocacy document for increased Political will
and investment
PUBLIC HEALTH AND SOCIO-ECONOMIC IMPACT OF SF MEDICAL PRODUCTS
www.who.int/medicines/regulation/ssffc/publications/se-study-sf/en/
METHODOLOGY
Expert technical group representing all regions convened
1. Need for
Evidence
Literature review covering 10-years of
publications
100 publications that matched inclusion
criteria
2. Assess the
Extent of the
Problem
Over 48,000 samples analysed
Quality surveys in 88 countries
Aggregation of observed failure rates
3. Making the Case
for Attention and
Investment
Multiplier method to estimate spending based
on country pharmaceutical sales
Results grouped by income level of World
Bank country classification
Estimations Impact models
Observed failure rate on medicines samples
in low and middle income countries
10.5%
US$ 30.5 billionEstimated spending on SF medicines in low and
middle income countries,based on wholesale level
sales
Caused by SF antibiotics in children under 5 suffering
from pneumonia**
72,430-169,271 deaths
31,000 -116,000 deaths
US$ 38.5 Million
caused by SF antimalarials in sub-Saharan Africa**
estimated spending on SF antimalarials in sub-
Saharan Africa***
* https://www.who.int/medicines/regulation/ssffc/publications/se-study-sf/en/
** University of Edinburgh
*** London School of Hygiene and Tropical Medicine
WHO Estimates on Substandard and falsified medical products
Public health and socioeconomic impact study 2017*
Lost Income
Lost Productivity
Lack of
Social Mobility
Economic Loss
Wasted Resources
Increased
Out-of-pocket Spending
Higher Disease
Prevalence
Progression of Antimicrobial
ResistanceIncreased Mortality and Morbidity
(Adverse Effects)
Loss of Confidence
SUBSTANDARD
AND
FALSIFIED
PRODUCTSIncreased Poverty
Consequences of SF Medical Products
▪ SYSTEMATIC REPORTING of incidents involving SF
medical products to WHO by National Medicine
Regulatory Authorities (NMRA’s)
▪ SEARCHABLE DATABASE accessible to NMRA’s
focal points
▪ TECHNICAL SUPPORT provided where necessary:
laboratory assistance, deployment of experts,
etc.
▪ Capacity building and regulatory strengthening
through REGIONAL AND NATIONAL WORKSHOPS
▪ Issues GLOBAL ALERTS
▪ VALIDATION AND ANALYSIS OF DATA
▪ Identification of medicines most at RISK,
VULNERABILITIES in health systems and
WEAKNESSES in the supply chain
▪ More accurate ESTIMATION OF THE SCOPE, SCALE
AND HARM CAUSED
▪ Data informs the Member State Mechanism and
policy makers, supporting EVIDENCE BASED
POLICY, more DIRECTED INVESTMENT and
TARGETED CAPACITY BUILDING
Technical Support Strategic Support
WHO Global Surveillance and Monitoring System for Substandard and falsified medical products
Global System – Regional Networks
SURVEILLANCE AND ALERTNETWORKS
Global System
Regional
Network
National
Focal Point
National risk based post
market surveillance and
reporting systems
Regional Rapid Alert Systems
WHO Global Surveillance and
monitoring system for
substandard and falsified
medical products
December 2012, Pakistan
50 deaths
September 2013, Paraguay
44 children hospitalised
WHO International Alert
WHO International Alert
Colombia and Peru
trace the API before
reaching patients
Global Impact
8 Countries
4 Continents
18
Globalization =Globalized Vigilance
2018 Syria.
6 Adverse drug reactions
Same batch of API
WHO Global Surveillance and Monitoring System forSubstandard and falsified medical products
170 700 18
2000+111 34
training workshopsin all regions
WHO Technical Assistance in
large procurement agencies sensitized
regulatory personnel trained
countriesreported incidents
Global Drug alerts (+ warnings and regional bulletins)
languages for reporting and
response
3
150+
member States trained
26
reports of suspect products
Landmark report in 2017*
cases
*https://www.who.int/medicines/regulation/ssffc/publications/gsms-report-sf/en/
WHO Global Surveillance and Monitoring Data
SF Medicines and Vaccines Reported to WHO byTherapeutic Categories
Antibiotics Other
Antimalarials Other
0 50 100 150 200 250 300 350 400 450
Antiinfectives for systemic use
Antiparasitic products, insecticides and repellents
Nervous system
Antineoplastic and immunomodulating agents
Alimentary tract and metabolism
Genito-urinary system and sex hormones
Musculo-skeletal system
Cardiovascular system
Various
Respiratory system
Blood and blood forming organs
Systemic hormonal preparations, excluding sex hormones…
Dermatologicals
Sensory organs
Importance of sub- regional networks
African Customs Seizure Angola
Coartem – Anti malarial
1.383,528 packs
Postinor 2 – Emergency Contraceptive
4930 packs
Vermox – Worming treatment
1534 packs
Clomid – Fertility treatment
36,550 packs
Clamoxyl - Antibiotic
744 packs
ANTI-MICROBIAL RESISTANCE
✓ First or second choice
antibiotics
✓ Should be widely available,
affordable and quality-assured
Most frequently reported API:
amoxicillin, penicillin,
sulfamethoxazole, cloxacillin…
Key Access
✓ Have higher resistance
potential
✓ Key targets of stewardship
programs and monitoring
Most frequently reported API:
ciprofloxacin, ceftriaxone,
clarithromycin, ceftazidime…
Watch Group
✓ Should be treated as “last
resort” options
✓ Tailored to highly specific
patients and settings, when all
alternatives have failed
Reported products: Linezolid
Reserve
WHO Essential Medicines List
• Misdeclaration of consignment: Only one medicine declared on Customs documentation
• Second medicine- 10million doses of falsified anti biotic also found in container
• Laboratory analyses indicates very low levels of AMPICILLIN and no CLOXACILLIN detected in the antibiotic
(both API’s are on key access list)
Falsified Antibiotics 2018
Immunization Programme - Indonesia
Diphtheria
Pertussis
Tetanus
Polio
HIB Vaccine
Hep B
Snake Venom
Sera
TB diagnostic
Test kit
26
Date Falsified
Medical
Product
Countries in which discovered
Jan Rabies
Vaccine
Philippines
Jan/
Feb
Leukemia
Medicine
Switzerland, Argentina, Colombia,
Malaysia
Mar Cholera
Vaccine
Bangladesh
Mar Meningitis
Vaccine
Niger
Apr Anti
Hypertensive
Cameroon
Apr Leishmaniosis Iran and Pakistan
July Rabies
Vaccine
Philippines
Aug Antibiotic Kenya, Uganda, Tanzania
Oct Antimalarial Chad, Central African Republic
Oct Antibiotic Haiti
WHO Medical Product Alerts 2019
Constrained access to medicines
Weak technical capacity
Poor governance
practices
SF Medical Products
SF Medical Products
▪ Availability▪ Affordability▪ Acceptability
▪ Poor procurement▪ Unethical practice▪ Corruption
▪ Poor oversight▪ Lack of resources▪ Limited awareness
Causes of SF
WHO and Member States holistic strategy
Prevent – Detect – Respond
Capacity Building
Data collection
Updated technology
Appropriate tools
WHO SF Related Projects 2019
▪ Field surveys on medicines
quality
▪ Database for, and automation
of, surveys
▪ Smart phone application to
design, guide and implement
sample collection and analysis
▪ Develop Risk-based post market
surveillance and targeted
inspections programme
▪ GSMS National and regional
workshops for regulators and
stakeholders
▪ African Pharmacy School Pilot
▪ Software update and
upgrade GSMS
▪ Link GSMS to other
databases and systems
▪ Screening devices
▪ Smartphone reporting application for Healthcare professionals
KEY MESSAGES
POLITICAL WILL is required to translate policy agreed at the global level to SUSTAINABLE ACTIONS
on the ground with APPROPRIATE FINANCIAL AND
HUMAN RESOURCES
From global policy to local
impact
STRENGTHENING REGULATORY CAPACITY AND
SYSTEMS is a key step and SOUND INVESTMENT to safeguard the manufacture, distribution and supply of medical products
Sound investment strategies
Improved REPORTING SYSTEMS and greater TRANSPARENCY within and between countries is required, together with wide and EFFECTIVE MULTI
STAKEHOLDER ENGAGEMENT
Cooperation and
coordination
Further Information
www.who.int/medicines/regulation/ssffc/en/
WHO Alerts
Thank you
Michael Deats
Acting coordinator, Safety and Vigilance,
WHO