WHO Global Surveillance and Monitoring System SSFFC Medical Products (Substandard, Spurious, Falsely labelled, Falsified and Counterfeit) TECHNICAL BRIEFING SEMINAR 2016
What does SSFFC mean? Counterfeit Medicine Falsificado Medicamento Falsified Medicine Counterfeit Medicine Spurious Medicine Counterfeit Medicine Fake/ Substandard Medicine Counterfeit Medicine Fraudulent, Falsely labelled, Forged, Copied, Adulterated, Pirated, Fake
Substandard Medical Product Registered medical product Sub Standard Out of specification due to degraded, expired, or manufacturing error Genuine Medical Product (manufactured in compliance with National Specifications)
Substandard Medical Product Isosorbide-5-Mononitrate Paracetamol Also called out of specification (OOS) products, are genuine medicines produced by manufacturers authorized by the National Medicines Regulatory Authority (NMRA) which do not meet quality specifications set for them by National standards.
Falsified Medical Product Unregistered medical product Falsified Deliberately Misrepresents its identity, composition or source
Falsified Medical Product Heart Disease Cancer Anti-malarial Medical Products which deliberately misrepresent either their identity, and /or composition, and/or source
Working Definitions Surveillance and Monitoring System Unregistered medical product Unregistered Not licensed or assessed for safety, quality and efficacy in Country of marketing
Unregistered medical Product Medical products which are not authorized by the competent medicines regulatory authority for marketing and distribution, and have not undergone evaluation of their safety, efficacy and quality for the market in which they are distributed
Working Definitions Surveillance and Monitoring System Registered medical product Unregistered medical product Sub Standard Falsified Unregistered Out of specification due to degraded, expired, or manufacturing error Deliberately Misrepresents its identity, composition or source Not licensed or assessed for safety, quality and efficacy in Country of marketing Genuine Medical Product (manufactured in compliance with National Specifications)
Democratic Republic of Congo 2015 1000 hospitalizations: up to 40 per week Acute dystonic reaction affecting face, neck upper limbs, particularly in young persons Limited access to medicines MSF investigate root cause and inform WHO Surveillance and Monitoring system
Democratic Republic of Congo 2015
Toxic Reactions Falsified Diazepam Container of 1000 tablets Labelled Diazepam Laboratory analysis confirms zero Diazepam but presence of Haloperidol Haloperidol is used for the treatment of Schizophrenia
WHO Member State Mechanism MANDATE GOVERNANCE PURPOSE World Health Assembly 65.19 2012 1 Chair 11 vice Chairs Regional rotation International collaboration from a public health perspective on sub-standard, spurious, falsely labelled, falsified and counterfeit (SSFFC) medical products
CURRENT ACTIVITIES Developing National Strategies and Training Field Detection Technologies Risk Communication and Awareness Definitions Global Focal Point Network Socio Economic study of the public health impact of SSFFC medical products
WHO Global Surveillance System Available in English, French, Spanish and Portuguese 125 Member States trained Over 400 Regulatory personnel trained 18 large procurement agencies sensitized Over 1300 Suspect Products Reported Incidents occurred in 90 countries 17 WHO Global Drug alerts and numerous warnings WHO Technical Assistance in over 100 Cases
Globalization = Increased Vigilance December 2012, Pakistan 50 deaths WHO International Alert Colombia and Peru trace the API September 2013, Paraguay 46 patients hospitalised Global Impact 8 Countries 4 Continents WHO International Alert
Reports by Region African Region 47% European Region Region of the Americas 21% Western Pacific Region 2% 5% 8% 17% Eastern Mediterranean Region South-East Asia Region
What's the harm for public health? Patients and consumers health Confidence in medicines, healthcare providers, health systems Anti microbial resistance Undermining vaccination programmes Economic damage to health systems, loss of productivity, prolonged treatment regimes Increased out of pocket expenses to consumers
Reported Therapeutic Categories Antiparasitic products, insecticides and Antiinfectives for systemic use Nervous system Genito-urinary system and sex hormones Antineoplastic and immunomodulating Alimentary tract and metabolism Musculo-skeletal system Respiratory system Cardiovascular system Various Systemic hormonal preparations Blood and blood forming organs Sensory organs Dermatologicals 0 50 100 150 200 250 300
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
IMPORTANCE OF NETWORKS (WEST AFRICA 2012-16)
Falsified Antibiotics by API (Global) Phenoxymethylpenicillin, 7% Ampicillin, 7% Sulfamethoxazole, 16% 4% Amoxicillin 24% 3% 23% 2% 1% Amoxicillin Sulfamethoxazole Ampicillin Phenoxymethylpenicillin Clarithromycin Gentamicin Cloxacillin ceftriaxone Lincomycin Ciprofloxacin Cefuroxime Fusidic Acid Ceftazidime Benzylpenicillin Chloramphenicol Doxycycline Nitrofurantoin Penicillin Oxacillin Azithromycin Dihydrate Amikacin sulfate Cefpodoxime Ofloxacin Levofloxacin Pefloxacin Benzathine benzylpenicillin Sulfanilamide Linezolid Erythromycin Stearate Nalidixic Acid Erythromycin
Reproductive Health Products Laboratory analysis indicate zero Active Pharmaceutical Ingredient Available in public and private health care facilities Frequently WHO pre qualified products Frequently genuine batch numbers
Falsified Vaccines (Source: National Ministries of Health Alerts and Govt Press releases) 1995 Niger Meningitis 2015 Meningitis Shortage Public Supply 2010 China Rabies 2500 Deaths 1 Death 2013-2016 8 Arrests 2013 Rabies 10,800 Doses 17 Arrests 2009 Philippines Influenza Tetanus Rabies Vaccine Clinics 2016 Indonesia Hepatitis B Tuberculosis Polio Tetanus 23 Arrests 2010 Cameroon Meningitis High prices Stock Shortage 2016 Bangladesh Yellow Fever
VULNERABILITIES Access Affordability Availability Quality Governance Poor Procurement Corruption Unethical practice Supply Chain Integrity Porous Borders Weak Regulatory oversight Medical Products On-line
New Initiatives SMART PHONE APPLICATION WHO PORTAL SEARCH TOOL HCP NMRA WHO
WWW.WHO.INT/MEDICINES/REGULATION/SSFFC/
rapidalert@who.int Michael Deats Group Lead, SSFFC Medical Products deatsm@who.int Pernette Bourdillon-Esteve System Analyst bourdillonestevep@who.int Diana Lee Technical Officer leedi@who.int