Brazil s Model for SLDs Quality Assurance and Management: A Country Perspective. Joel Keravec MSH/SIAPS Brazil Country Director

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1 Brazil s Model for SLDs Quality Assurance and Management: A Country Perspective Joel Keravec MSH/SIAPS Brazil Country Director IOM Workshop Washington DC - July 2012

2 Brazil TB/DR-TB Context Size : 8,547,403 square km Number of states: 27 (including federal district); 5,565 districts with 40,081 health units Life expectancy: 72 years GDP per capita: 11,273 US$ (source: IMF/2010) 82% population living in urban area 71,000 cases/year incidence: 37/ 100,000 popul. TB/HIV co-infection: 10 14% 700 MDRTB cases notified / year Primary Resistance to R= 1,5% and H=6% 17 and combined (R+H)= 1,4% (DRS 2008) MDRTB Treatment Success Rate 70% (2010) All TB drugs are free of charge to patient, quality assured, not available in private sector, TB/DR-TB treatment available in public sector only National guidelines: 100% adopted

3 How TB drugs are supplied? NTP quantifies needs and MoH-pharmacy department procures quality assured drugs Local procurement for all SLDs drugs manufactured by local manufacturing firms (primarily para-statal, or private sector) Amikacin, Ethionamide, Ofloxacin/Levofloxacin Exception drug terezidon which is currently imported DR-TB Guidelines were officially modified in May 2010 Brazil is now using GDF/GLC mechanism for procuring partial regimens for SLDs not produced in country (Capreomycin, Cycloserine, PAS, Clofazimine) through an agreement with PAHO since GDF has no office in country

4 MoH-pharmacy Dept procures all SLDs for NTP open tendering process for private sector manufacturers, at market prices direct procurement agreements with government producers from the public pharmaceutical manufacturers network, at negotiated concessionary prices exclusively from manufacturers officially Anvisa (Brazil NRA) + a GMP certificate (WHO or Anvisa) is always required, among other QA prerequisites (mix of technical criteria vs price) Requires WHO pre-qualified suppliers when using PAHO agreement for non registered products

5 How Product Quality is Assured? Registration and documentation analysis Pre-Q status / Production consistency (# and batches sizes) Production Sites Inspection / GMPs Drug QualiyTesting (samples) Post-marketing surveillance / Monitoring Federal and State Regulatory Agencies (ANVISA, VISA, and Public Health Lab Network) monitor manufacturers, pharmacies, government warehouses Functional reporting mechanisms within the Health System

6 Brazil Laboratory Network for Drug Quality Testing INCQS / National Institute for Quality and Control NRA National Lab Reference Accredited by INMETRO ISO/IEC Recognized by ILAC (International Laboratory Accreditation Cooperation ) - Head of Proficiency Testing Programs for all Public Laboratory Network - API QA/preQ Program starting with NRA 27 Public Health State Laboratories Reference Labs (1 / State) 2 of them currently accredited / ISO-IEC Brazilian Pharmacopeia with INCQS/Anvisa/Universities/Manufacturers develop Reference Materials / Reference Standards (66 RS for medicines 170 RS for pesticides)

7 Strategy for implementing a National Quality Testing Program for TB drugs Created synergy with MOH Program for QA monitoring on essential drugs (Proveme) Organized a stakeholders meeting with NTP, Anvisa, Pharmacy Department, INCQS (National Ref Lab), Lab Network, State Sanitary Surveillance Regulatory context for a national TB drugs QA program Analytical capacity / Standards Sampling procedures Matrix of responsibilities Established a working group carrying out activities, results monitoring & regulatory measures enforcement

8 TB Drug Quality Testing Program: Phase I Findings Results of Brazil TB Drug Quality Testing Program, Phase I Failed due to labeling Failed due to tests Percentage 13% 19% 32% 71 samples collected (FLDs+SLDs) 70 analyzed 14 different products 11 different manufacturers 10 active ingredients 0% 5% 10% 15% 20% 25% 30% 35% QA program for Phases I and II includes: All FLDs + SLDs Rifabutin Clarithromycin Clofazimin Terezidon Amikacin Ethionamide Ofloxacin/Levofloxacin 5 Non-compliance with Standards, Brazil TB Drug Quality Testing Program (Phase I) Labeling Weight variation Content uniformity Dissolution 3 2 Potency Active principle NB: (4 in 1) and (2 in 1) FDCs introduced in 2010 were analyzed during phase II results to be published yet

9 TB Drug Quality Testing Program: Actions Taken Results and quality defects: manufacturers notified by the National Regulatory Authority Analytical Methods APIs Production process / formulation analyzed by a multi-disciplinary group to determine any influence on product safety & efficacy batches which were not meeting adequate quality standards were recalled Working Group Model created a healthy environment where agencies: interact with manufacturers for improving drug quality and harmonize analytical methods define concerted legal actions limiting risk of creating shortage decentralize M&E / TB drug quality testing capacity to the state level provide access to reports from the public sector on product quality with more transparency for stakeholders (physicians, society in general) 2 public SLDs manufacturers agreed in joining WHO pre-q program

10 Other programmatic aspects of QA: Quantification, Ordering & Distribution, Rational Use and Pharmacovigilance Case notification and management Medicines supply and stock control Epidemiological surveillance / Reports Information DR-TB Patients and SLDs are managed within one single integrated web-based platform (e-tb Manager/SITE TB) 10

11 Batch expiration date traçability

12 Note Simulation Data for Demo Register drug dispensation

13 Adverse effects registration and monitoring (PV)

14 Conclusions Major challenges for SLDs public manufacturers are: access to QA APIs (not produced in country/lack of certification / preq limitations imposed by public procurement rules for APIs bidding) high taxes burden / production costs compared to India/China small internal DR-TB market with reduced local economic incentives (South-South health collaboration or PPPs to supply international mechanisms would be useful to expand this market) Brazil s model for SLDs QA and management can be described as a rationally established environment where the state is a key actor from drugs production & procurement to rational use, with efficient systems in place for QA monitoring and evaluation which can serve as a useful benchmark to reflect on / develop a potential strategic framework able to protect the imminent introduction of new SLDs

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