Medicine Quality and Public Health · •You are a local small pharmaceutical wholesaler who is...
Transcript of Medicine Quality and Public Health · •You are a local small pharmaceutical wholesaler who is...
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Medicine Quality and Public Health
Substandard and Falsified Medical Products
• 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 1
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 an overdose 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
• The role of WHO
• Member State Mechanism
• Global Surveillance and Monitoring System
• Causes, Consequences and Solutions
• Prevention, Detection and Response
• Ongoing projects
• Challenges
OUTLINE
THE ROLE of WHO
• Member State Mechanism
• Global Surveillance and Monitoring System
WHO MEMBER STATE MECHANISM
World Health Assembly 65.19 ; 2012
Recognised as an unacceptable threat to public
health
MANDATE
• Steering Committee
• 1 Chair (Spain)
• 11 Vice Chairs
• Regional Rotation
GOVERNANCE
International collaboration from a public health
perspective on substandard and falsified medical
products
PURPOSE
Member State Mechanism Steering Committee
African Region
Tanzania Togo
Americas Region
Brazil USA
Eastern Mediterranean Region
Iran Morocco
European Region
Spain (Chair) United Kingdom
South East Asia Region
India Indonesia
Western Pacific Region
China Malaysia
GOVERNANCE
MS MECHANISM WORK PLAN 2018/19
• Develop training material and guidance for Member States
• Expand and maintain the global regulatory focal point
network
• Detection technologies, authentication and track and trace
models
• Identify links between access and SF medical products
• Risk communication and awareness raising campaigns
• Understand and address the supply of medical products via
the internet and social media
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A common global understanding
WHO DEFINITIONS (World Health Assembly 2017)
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.
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
WHO ESTIMATES 2017
Observed failure rate of analysed medical product samples from low
and middle-income countries
10.5%
US$ 30.5 Billion Estimated spending on SF medical products in low
and middle-income countries based on un-weighted
estimates of pharmaceutical sales
SOCIO ECONOMIC STUDY – IMPACT MODELS
Estimated deaths caused by SF antibiotics
used by children under 5 with childhood
pneumonia*
72,430-169,271 Deaths
31,000 -116,000 Deaths
US$ 38.5 Million
Estimated deaths caused by SF products
used by patients suffering from malaria in
sub-Saharan Africa**
Estimated spending on SF anti-malarials
in sub-Saharan Africa
* University of Edinburgh
** London School of Hygiene and Tropical Medicine
SOCIO ECONOMIC STUDY - LIMITATIONS
Variation across studies
Definitions
Sample sizes
Sampling & testing methodologies
Uneven Distribution
Geographic representation
Therapeutic categories
Available pharmaceutical sales data
GLOBAL SURVEILLANCE and MONITORING SYSTEM
• Systematic reporting and search portal
• Photograph library of SF medical products
• Launched in West Africa in 2013
• Expanded to 150 Countries
• Global Regulatory Network of Focal Points
• 2000 Medical Products Reported from 110
countries
SURVEILLANCE AND ALERT NETWORKS
Global
Regional
National 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
GLOBALIZATION = INCREASED VIGILANCE
December 2012, Pakistan
50 deaths
September 2013, Paraguay
46 patients hospitalised
WHO International Alert
WHO International Alert
Colombia and Peru
trace the API
Global Impact
8 Countries
4 Continents
0 50 100 150 200 250 300 350
Sensory organs
Dermatologicals
Systemic hormonal preparations
Blood and blood forming organs
Respiratory system
Various
Cardiovascular system
Musculo-skeletal system
Antineoplastics and immunomodulators
Genito-urinary
Alimentary tract and metabolism
Nervous system
Antiparasitics
Antiinfectives
WHO GSMS data; 2013-2017
MEDICAL PRODUCTS REPORTED BY THERAPEUTIC CATEGORY
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
* WHO Essential Medicines List Data extracted 11 January 2018
ANTI-MICROBIAL RESISTANCE*
First or second choice
antibiotics
Should be widely
available, affordable
and quality-assured
Most frequently reported
API: amoxicillin, penicillin,
sulfamethoxazole,
cloxacillin…
77% of antibiotics in the
database are Key Access
antibiotics
Key Access
Have higher resistance
potential
Key targets of
stewardship programs
and monitoring
Most frequently reported
API: ciprofloxacin,
ceftriaxone,
clarithromycin,
ceftazidime…
18% of antibiotics in the
database are on the Watch
Group
Watch Group
Should be treated as
“last resort” options
Tailored to highly
specific patients and
settings, when all
alternatives have failed
Reported products:
Linezolid
2 reports in the GSMS
database of reserve group
antibiotics
Reserve
Source: National Ministries of Health Alerts and Govt Press releases
Falsified vaccines around the world
2010 Cameroon
Meningitis
High prices
Stock Shortage
2016 Indonesia
Hepatitis B, Tuberculosis,
Polio, Tetanus
23 Arrests
2015-2017
Meningitis
Shortage
Public Supply
1995 Niger
Meningitis
2500 Deaths
2013-2016
Tetanus
Rabies
Vaccine Clinics
2009 Philippines
Influenza
2013
Rabies
10,800 Doses
17 Arrests
2010 China
Rabies
1 Death
8 Arrests
2016 Bangladesh
Yellow Fever
Public procurement
Falsified Yellow Fever Vaccine
Falsified vaccines discovered in Bangladesh
Local wholesaler supplied by a bogus employee pretending to work for the genuine manufacturer
No antigens present
Global WHO Alert Issued
Immunization Programme Indonesia
Diptheria
Pertussis
Tetanus
Polio
HIB Vaccine
Hep B
Snake Venom
Sera
TB diagnostic
Test kit
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GLOBAL SURVEILLANCE and MONITORING SYSTEM (November 2017)
www.who.int/medicines/regulation/ssffc/publications/gsms-report-sf/en/
• Data from the GSMS
• Case Studies
• Evidence v Anecdote
• Medicines most at risk
• Weaknesses in Health
Systems
• Vulnerabilities in
supply chains
SF Medical Products
Constrained access to
medicines
Weak
Technical
Capacity practices
Poor governance
SF Medical Products
Availability Affordability Acceptability
Poor oversight Lack of resources Limited awareness
Poor procurement Unethical practice Corruption
CAUSES
Lost Income
Lost Productivity
Lack of
Social Mobility
Economic Loss
Wasted Resources
Increased
Out-of-pocket Spending
Higher Disease
Prevalence
Progression of
Antimicrobial Resistance
Increased Mortality and
Morbidity (Adverse Effects)
Loss of Confidence
SUBSTANDARD
AND
FALSIFIED
PRODUCTS
Increased Poverty
CONSEQUENCES
SOLUTIONS
PREVENTION, DETECTION, RESPONSE
• Medicine Quality Surveys
24 Countries over 4years
• Smartphone Application for Healthcare
professional reporting
2 Pilot studies underway in Africa and South East Asia
• Pharmacy School Curriculum
4 African Pharmacy schools (2 Francophone, 2 Anglophone)
• Insight Studies on Communication campaigns
4 African Countries
WHO PROJECTS
• Risk Based Post Market Surveillance concept
3 Countries
• Upgrade of WHO Global Surveillance and
Monitoring System
Increased languages and functionality, linking to other systems
• Upgraded systems and database for Medicine
Quality surveys
• Streamlined collection protocol, tracking of samples and linking to
laboratory results
WHO PROJECTS
• Political will and leadership
• Transparency
• Investment in National Medicine Regulatory Agency
• Access to accredited laboratories and field detection technology
• Implementation of risk based post market surveillance
• Laboratory methods to differentiate between poor manufacturing and poor
distribution
• Better knowledge of degradation of products
• Links between SF medical products and anti microbial resistance
• More effective education and awareness campaigns, patient behaviours
CHALLENGES
Prevalence of SF medical products, including:
Product type
Geographic distribution
Level of active ingredient
Burden of Disease and health service
utilization
Geographic distribution
Effect of sub-therapeutic dosing, including:
Morbidity
Mortality
Antimicrobial resistance
Improved analytical techniques
Better data on stability of medicines
Differentiate between poor
manufacture and degradation
Reliable and affordable field detection
equipment
Out-of-pocket and health system spending
on health care:
Disaggregated by disease and
geographic region
Income lost, due to:
Death
Increased morbidity
Economic impact of increased antimicrobial
resistance on health systems
Costs to regulators and industry:
Product recalls
Other expenses
Health Impact Estimation Economic Impact Estimation
WHAT DO WE NEED TO KNOW?
KEY MESSAGESNeeds
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
Thank you
08/10/2018 35
Michael Deats
WHO Group Lead SF Medical Products