Pharmaceutical Management and Scaling up MDR-TB Care Delivery: Last mile Challenges and Solutions. Andre Zagorski November 12, 2012 Kuala Lumpur

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1 Pharmaceutical Management and Scaling up MDR-TB Care Delivery: Last mile Challenges and Solutions Andre Zagorski November 12, 2012 Kuala Lumpur

2 USAID-funded Systems for Improved Access to Pharmaceuticals and Services (SIAPS; follow up to RPM, RPM Plus, SPS) Objectives of SIAPS TB portfolio: 1. Pharmaceutical Governance for TB strengthened at Global Level and country level 2. Capacity for TB pharmaceutical supply management and services increased and enhanced 3. Improved utilization of information for TB control decision making 4. Improved financing strategies for expedited access to new TB tools and pharmaceutical services 5. Improved pharmaceutical services and access to TB products to achieve TB Goals

3 Challenges in pharmaceutical management for tuberculosis Gap between the known and proven good pharmaceutical management practices, and their application by the global initiatives and NTPS Weak public health systems, including: pharmaceutical regulation not supporting NTP needs standards and delivery of pharmaceutical services: from supply chains to patient human resources capacity and leadership pharmaceutical management information systems: lack of valid data for forecasting and quantification Weak management of finance: ranging from total lack of funding for SLD to underutilization of available funds for IQA SLD

4 resulting in: No access to IQA SLD in some countries Other countries, access to IQA SLDs limited despite the availability of funds and medicines from global initiatives (GF, GDF) Stock-outs and treatment interruptions (but little analysis available of the underlying reasons): Forecasting and quantification mistakes Late procurement/ordering and delivery Country supply chain bottlenecks Expiry and waste of procured SLD Risky market for potential IQA SLD suppliers

5 Stakeholders mobilization as solution Forecasting Quantification Early Warning Systems roles: Global: timely reactions to demand changes Country: preventing stock-outs and treatment interruptions

6 Forecasting for PMDT and scale-up Provides number and type of DR-TB cases that a health system can effectively diagnose and treat in a projected period Crucial for strategic planning (NTP, donors) and market shaping Requires full TB program evaluation, including: reliability of case finding: diagnosis systems and their effectiveness, epidemiological data capacity of health system (staff, treatment facilities, etc.) capacity of medicines supply system: registration and clearance of medicines; distribution (storage and transportation); inventory management practices and information management: stock levels, consumption and pipeline data reporting, and stock-outs monitoring ( early warning system ) available funding Done for GF projects? WHO and GLC PMDT surveys? Evaluation concerns and implementation of interventions monitored?

7 Quantification Quantities of each specific product to be procured or ordered for a given period of time Crucial for continuous treatment of current cases and guaranteed start of treatment of to be diagnosed cases Requires ongoing data collection and processing, e.g.: Actual number of cases on treatment by regimen (or % of each SLD in regimens) Cases to be enrolled during the next period by regimen Actual consumption data (by product, by month, etc.) Medicines pipeline data (stock, pending deliveries, expiry data) Procurement lead times (order approval, placing, etc.) Finance lead times (disbursement, payment to suppliers) Done by GF, GLC, GDF consultants? Local capacity developed?

8 Early Warning of Stock-outs Systems: Solutions at country level Country early warning systems, which are not necessarily software-based, but rather a set of SOPs for collecting and processing data (data collection part of supervision and regular R&R) = good inventory control practices Electronic solutions, e.g.: full e-tb Manager for quantification and inventory management (Brazil); utilization of only the quantification module (expand to inventory management module) on-line GDF and GF mandatory (as a condition for support) quarterly reporting of case enrollment and medicines stock data currently missing

9 Solutions at the country level: Full Electronic System: e-tb Manager A comprehensive web based application for strenghtening TB control programs by integrating case management, medicines inventory control, surveillance, and reporting into a single platform Case notification and management Medicines supply and stock control Epidemiological surveillance / Reports Information 9

10 Tools for countries: Forecasting and Quantification with e-tb Manager

11 Early Warning: How well-managed systems work (Brazil example) Brazil FDA (Anvisa) inspected Terezidone manufacturing site (Fatol / Germany) Manufacturer was in process of moving production to a new plant Issues were raised by inspectors, and pending order was blocked by Anvisa creating a nationwide risk of shortage Immediately : central level investigated all stock positions at all TCs with e-tbm buffer stocks levels for new distributions were decreased for better control of terezidone strategic stock at central level Stock-on-hand levels were calculated to inform MoH NTP sent a statement of real time risk of shortage with detailed data to Anvisa for releasing current pending order as a priority Impact on patients was averted

12 Solutions at Global Level GDF GDF as global clearinghouse (the GDF value added ) Global forecast and market shaping, based on: Information from donors (e.g. the Global Fund) Pharmaceutical and treatment data collected during its own country TB surveys and monitoring missions, and by partners Interface for data reporting (developed, since 2005 based on orders data) Dedicated GDF and partners field officers monitoring countries and collecting data (in process) Quarterly data reporting by NTPs as a conditionality of the GDF support, for grants and direct procurement (in process) Open information sharing with partners (in process)

13 GDF Forecasting & Early Warning Systems Current situation Dashboards (slides provided by GDF) Estimated stockouts risk 6 to 12 months Dashboards SLDs Live Web report PLANNED DELIVERIES - Order not yet confirmed pending Action Quantiti Last Days in Order Serial es Status current Number Planned Change status Pending Action KEN/GR/10/1575 1, Nov Order placed with supplier(s) BWA/DP/11/1889 1, Jun Pending reception by procurement agent of client signed agreement BWA/DP/11/1889 1, Jun Pending reception by procurement agent of client signed agreement BWA/DP/11/1889 2, Jun Pending reception by procurement agent of client signed agreement BWA/DP/11/1889 1, Jun Pending reception by procurement agent of client signed agreement BWA/DP/11/1889 1, Jun Pending reception by procurement agent of client signed agreement BWA/DP/11/1889 1, Jun Pending reception by procurement agent of client signed agreement BFA/GR/11/ Sep Order placed with supplier(s) ARM/DP/11/ Oct Pending reception by procurement agent of client signed agreement GIN/DP/11/ Oct Pending reception by procurement agent of client signed agreement GIN/DP/11/ Oct Pending reception by procurement agent of client signed agreement GIN/DP/11/ Oct Pending reception by procurement agent of client signed agreement GIN/DP/11/ Oct Pending reception by procurement agent of client signed agreement GDF Global SLD PT supply

14 GDF Forecasting & Early Warning Systems Current situation Dashboards (cont. slides provided by GDF) GDF Global SLD Stock out estimated risk at 6 to 12 months Country Stock Out Risk Index by Line Country Name Line Estimated Risk Index in % Afghanistan MDR 100 Belize MDR 100 Botswana MDR 100 Burundi MDR 100 Costa Rica MDR 100 Liberia MDR 100 Lebanon MDR 100 Samoa MDR 100 Zimbabwe MDR 71 Bosnia and Herzegovina MDR 57 Thailand MDR 57 Uruguay MDR 57 Cuba MDR 57 Russian Federation MDR 36 Peru MDR 36 Lao People's Democratic Republic MDR 36 Latvia MDR 29

15 Global Forecasting & Early Warning Systems: Gaps to be addressed by stakeholders/partners: Target health system, not NTP alone Harmonized data collection and sharing by partners Global partners performing country surveys: e.g. GLC, technical agencies include inventory control component Donor-supported field programs (use GDF interface) Data reporting as a condition for any country support (as the GF, GDF, other donors conditions of support) GDF/SIAPS pilot data collection to start in 11 countries (Africa)

16 Conclusions Tools for collecting and processing data exist at the global and country levels Most NTPs have inventory control mechanisms (recording stock, transactions, etc.) but seldom linked with case management/treatment Technical agencies and/or bi-lateral donor programs are present in most high-burden countries (and most other countries with TB problems) Should be involved in strengthening the capacity for data collection and information management GDF is the best existing platform for coordination of stakeholders and harmonization of approaches to pharmaceutical services for MDR-TB scale-up