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Overview of Procurement and
Supply Management Processes
for HIV/AIDS and TB Medicines
Francis Aboagye-Nyame Director, SPS Program
Workshop on Procurement and Supply Management for HIV and TB Products September 5-7, 2011
Intercontinental Hotel Nairobi, Kenya
Outline
Stock-outs of HIV/AIDS and TB commodities
Pharmaceutical Management Framework
Procurement Mechanisms for HIV/AIDS and TB Commodities
Supply Chain Management Systems for HIV/AIDS and TB Commodities
Issues in Procurement and Supply Chain Management for HIV/AIDS and TB Commodities
Summary
2
Stock-Out of HIV/AIDS Commodities:
What is Known Countries reporting a stock-out
of at least one ARV medicine 1 38% in 2009 (94 countries)
34% in 2008 (90 countries)
38% in 2007 (66 countries)
Islamic Republic of Iran, Tunisia, Yemen, and several Central and South American countries cited medicine supply interruption as a notable barrier to access antiretroviral therapy (ART) 2
Source:
1. Towards universal access: scaling up priority HIV/AIDS interventions in the health sector.
Progress report 2010. World Health Organization, United Nations Children’s Fund and UNAIDS.
2. Global Report: UNAIDS Report on the Global AIDS Epidemic 2010.
18% (32/174) 16% (26/167) 20% (35/176) 22% (34/155)
45% (9/20)
9% (2/22)
41% (9/22)
27% (6/22)
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Central Level(2007)
Central Level(2006)
Peripheral Level(2007)
Peripheral Level(2006)
Global HBC (High Burden Countries)
Source:
• Global Tuberculosis Control: Epidemiology, Strategy, Financing. WHO 2009
• Global Tuberculosis Control: Surveillance, Planning, Financing. WHO 2008
Stock-Out of TB Commodities:
What is Known
First-Line Anti-TB Medicines:
Percentage of Countries Reporting Stock Outs
5
Procurement Mechanisms for
HIV/AIDS and TB Commodities
National procurement systems International competitive bidding, national competitive
bidding/others National laws
Global Fund Guidelines
World Bank Guidelines
Global mechanisms Voluntary Pooled Procurement and Capacity Building Services
Supply Chain Management System Project
Global TB Drug Facility
Other UN mechanisms
Nonprofit international suppliers working with governments IDA, Mission Pharma, others
Donations and grants from private parties and manufacturers
6
Issues in Procurement of HIV/AIDS and TB
Commodities (1)
Absence or inadequate procurement policies, rules, regulations, structures, and formal systems for the procurement of quality-assured pharmaceuticals Compliance with international standards and donor requirements
Transparent and competitive processes
Product specifications
Staff skills and experience in procurement management
Funding Insufficient budgetary allocations
Procurement, clearing, storage, distribution, etc.
Funds released at irregular intervals
TRIPS flexibilities not properly utilized by countries
7
Issues in Procurement of HIV/AIDS and TB
Commodities (2)
Global and national markets Limited volumes of pediatric ARVs
Limited sources of quality-assured API
TRIPS limitations
WHO and other prequalification mechanisms limitations
Quantification and supply planning issues Lack of pipeline, enrollment, and consumption data
Complex and fast changing treatment regimens
Push for scale-up
Impact of new diagnostic tools and regimens
8
Procurement and Supply Chain
Management System
Efficient Distribution Systems
Maintains a constant supply of drugs
Keep drugs in good condition throughout the chain
Minimizes losses due to spoilage and expiry
Rationalizes storage points
Uses available transport as efficiently as possible
Reduces theft and fraud
Provides information for forecasting drug needs
10
ARV Supply Chain – Uganda
11
Funders
Procurement Agents
Storage
Distribution
ARV Supply Chain—Ethiopia
12
International/Local
Source
PFSA Central
PFSA Hub
Hospitals Health Centers
Health Posts
CLIENTS
National Health
Program
Units
Regional Health
Bureau/Zonal
Health Department
Woreda
Health Office
Key
Flow of pharmaceuticals
Flow of Information
Flujo de Medicamentos de Segunda Linea para el Tratamiento de TB-MDR
Adq
uisi
cion
Dis
trib
ucio
nU
soS
elec
cion
(6) Transporte
Informacion
necesidades
Informacion
necesidades
Transporte
(8.4) Autoriza
entrega almacen
DISA
Expediente
y tratamiento
(6 / 8.5)
Almacen Socios en
Salud
Recibe y almacena.
Entrega Tx para 33
dosis/ paciente (Amx+Cl;
Amk; Cap; Moxi)
(9)
Farmacia Centros de
Atencion a las
Personas
Recibe medicamentos
para 2-3 meses (en
equema completo )
(4)
CARE
(Con recursos de
Fondo Mudial)
Compra directa a
GLC/ IDA
(1.2)
DIGEMID
Elabora fichas tecnicas
de productos
farmaceuticos
(7 / 8.4)
Almacen especializado DISA
Recibe (del MINSA en base a
casos programados; del SeS en
base a aprobados por CER) y
distribuye medicamentos
(3)
OGA/ ORE
Compra por
subasta a la baja
(2)
Estrategia TB
Establecen
requerimientos de
compra
(8.1 / 8.3)
CERI
Recibe expediente
y aprueba
tratamiento
(regulares /
estandarizados
(5)
Almacen Central
Recibe y
almacena
medicamentos
(3.1)
DISA / DIRESA
Consolida casos
atendidos de
establecimientos y
estima necesidad
(3.2)
OGA/ ORE
Establece
requerimientos solicita
presupuesto y compra
(1)
Estrategia TB / DGSP
Elabora protocolos de
tramiento para
pacientes con TB MDR
(1.1)
DIGEMID
Elabora Petitorio
Nacional de
Medicamentos
(4.1)
CARE
Desaduana los
medicamentos
adquiridos por GLC /
IDA
(8)
Centros de Atencion a las
Personas
Identifica caso sospechoso y
consulta al CERI.
Completa expediente para
aprobacion de tratamiento
(8.2)
CER (Nacional) /
Unidad Tecnica
Evalúa expediente y
autoriza medicamentos
(casos especiales /
individualizados)
(10)
Centros de Atencion
a las personas
Enfermera entrega
medicamentos a los
pacientes
Consumo
(10.1)
Paciente completa
TX y cura
(10.2)
Paciente fallece o
abandona
Flujo reverso
de medicamentos
(8.3)
(8.3) Comunica
aprobacion Tx
Informa
existencias y
consumo
(8.3) Comunica
(x Correo-E) la
aprobacion Tx
(8.1)
(8.3)
Informacion
pacientes que
finalizan o
abandonan
Transporte
2nd Line TB Supply Chain – Peru
Issues in Supply Chain Management of
HIV/AIDS and TB Commodities (1) Management information systems
Information to make decisions
Policy and legal framework Product registration
Selection
Treatment protocols
Targets vs. service capacity
Procurement Forecasting and quantification
Procedures and processes
Customs and importation clearance
14
Issues in Supply Chain Management of
HIV/AIDS and TB Commodities (2) Storage
Warehousing and storage infrastructure
Scale up
New technologies
Waste management
Security
Inventory management
Inventory parameters
Order processing
Transportation and distribution
15
Issues in Supply Chain Management of
HIV/AIDS and TB Commodities (3)
Prescribing, Dispensing, and Use
Patient Safety
Quality Assurance
Post-Marketing Surveillance
Adverse Drug Events Monitoring
16
Considerations
Scale up of HIV/AIDS programs
Absorptive capacity
Infrastructure
Funding
New Technologies
Treatment regimens
Cut-off points
Diagnostics
17
Summary Pharmaceutical systems are complex
Multiple interrelated components
Decision-making process is complex
Many stakeholders are involved
Systems operate in a dynamic environment
TB and HIV pharmaceutical supply is part of a larger health system
International resources for procurement and technical assistance/capacity building are available
The pharmaceutical management cycle framework guides the systematic analysis and improvement of pharmaceutical systems
18
Thank You
19