Pharmaceutical Management and Scaling up MDR-TB Care Delivery€¦ · •Electronic solutions,...

Pharmaceutical Management and Scaling up MDR-TB Care Delivery: “Last mile” Challenges and Solutions

Andre Zagorski November 12, 2012

Kuala Lumpur

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

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

…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

• Forecasting

• Quantification

• Early Warning Systems roles: • Global: timely reactions to demand changes

• Country: preventing stock-outs and treatment interruptions

Stakeholders mobilization as solution

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?

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?

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

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

Solutions at the country level: Full Electronic System: e-TB Manager

Tools for countries: Forecasting and Quantification with e-TB Manager

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

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)

GDF Forecasting & Early Warning Systems Current situation Dashboards (slides provided by GDF)

Estimated stockouts risk 6 to 12 months – Dashboards SLDs Live Web report http://gva1swamphion/sree/Reports?op=vs&path=/WHO_HQ_Reports/G1/PROD/INT/Shared/t_GDF_Project2&userid=GDF_ro&password=gdfread1

Order Serial

Number

Quantiti es

Planned

Last Status

Change

Days in current status

Pending Action

KEN/GR/10/1575 1,588 24-Nov-10 716 Order placed with supplier(s)

BWA/DP/11/1889 1,600 15-Jun-11 513 Pending reception by procurement agent of client signed agreement






BFA/GR/11/2085 331 8-Sep-11 428 Order placed with supplier(s)

ARM/DP/11/2178 50 19-Oct-11 387 Pending reception by procurement agent of client signed agreement

GIN/DP/11/2198 274 28-Oct-11 378 Pending reception by procurement agent of client signed agreement




PLANNED DELIVERIES - Order not yet confirmed pending Action

GDF Global SLD PT supply

GDF Forecasting & Early Warning Systems Current situation Dashboards (cont. slides provided by GDF)

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

GDF Global SLD Stock out estimated risk at 6 to 12 months

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)

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

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