Transcript Chapter 4 - Definitions - World Health Organization

Drug Management of
Second-line anti-TB drugs through
the Green Light Committee mechanism
for programmes funded by the Global Fund to
Fight Against AIDS, tuberculosis and malaria
Geneva, 13 December, 2005
Fabienne Jouberton
Ernesto Jaramillo
World Health Organization
Green Light Committee mechanism:
Linking independent concepts
ACCESS
RATIONAL
USE
GLC
POLICY
Advantages of applying to the GLC
mechanism
Access to quality-assured drugs following
international accepted standards
(including WHO)
Access to low-cost drugs
Access to a continuous drug supply,
essential for treatment success
Access to technical assistance to ensure
rational drug use
Advantages of applying to
the GLC mechanism
Access to an external monitoring
mechanism
Creation of wide evidence base for
national policy development
Ensures consolidation of DOTS as the
strategy to control TB
Collaboration agreed with the GFATM
“to help contain resistance to secondlineanti-TB drugs and consistent with the
policies of other international funding
sources, all procurement of medications to
treat MDR-TB must be conducted through
the Green Light Committee (GLC)”
Third Board Meeting, 10-11 October, 2002
The Global Fund to Fight AIDS, Tuberculosis and Malaria
Collaboration agreed between
the GLC and GFATM
“Specific funding for DOTS-Plus and support to purchasing
second-line drugs for the management of MDR-TB will be granted
upon submission, review, and approval of an application to the GLC
GFATM will provide a GLC application form to the countries
approved for funding by the Board; and will make this form part of
the GFTAM form for the next rounds.
“GLC will monitor DOTS-Plus and the use of second-line drugs
throughout the entire period of funding by GFATM. If case
monitoring visits reveal the (potential) misuse of second line drugs
the GLC will communicate the findings to the GFATM and the
procurement of preferentially priced drugs may be interrupted”
Drug management cycle of second-line
anti-TB drugs
Drug selection;
Assurance of drug quality;
Quantitative assessment of drug requirements;
Management of procurement and distribution;
Ensuring rational drug use.
Main variables in the drug procurement of
second-line anti-TB drugs
Drug registration status of products selected
Customs regulations for importing drugs
Drug forecast based on treatment regimen,
cohort size and pace of patient enrolment
Shelf-life of the products
Main variables in the drug procurement of
second-line anti-TB drugs
Lead time for delivery of the drugs
Estimated size of buffer stock (two to three
times the delivery delay)
Drug labelling
Procurement for GLC-approved projects
 Approved pilot project signs a contract with WHO
 WHO-GLC Secretariat introduce the approved
project to the procurement agency
 Procurement agency sends a quotation to the
project under request
Procurement for GLC-approved projects
 The project sends a firm order to procurement agency
 Procurement agency starts procuring the project after
pre-payment
 Delivery delay after pre-payment, between 2-4 months
 Any change in the project’s drug request that exceeds
10% of what was originally GLC approved has to be
reviewed and approved by the GLC
Procurement for GLC-approved projects
 Current suppliers were selected and pre-qualified by
the PA and endorsed by WHO (meeting WHO GMP
or approved by a stringent national drug regulatory
authority) in line with the GFATM procurement policy
 Forecasting is made for each pilot project according
to the treatment regimen (buffer stock 10%)
 GLC monitors drug storage procedures and facilities
at the project sites
 Rational use is guaranteed by the stringent review
procedures to applications, period monitoring, site
visits and tracking down of the drugs procured to the
project
Procurement for GLC-approved projects
 Important facts to take into account:
Most countries require drugs to be registered
before importation
The PA does not keep any stock for these drugs
Manufacturers produce on demand (in India, US,
Europe)
Procurement for GLC-approved projects
 Important facts to take into account:
 Market size (small, particularly for Cycloserin,
Capreomycin and PAS)
 Labelling (Russian and English are the ones
widely used in the GLC projects)
 Short shelf lives (Capreomycin and PASER: 24
months, Cycloserin: 18 months) and one product
in cold chain
Experience in drug management with
GLC-approved projects
 Bad practices:
- Waiting for the drugs without placing an order
(Manual of procurement for GLC approved
projects available on the web site)
- Looking at the payment modalities only at the
time to purchase the drugs
- Negociating exemption to registration only at
the time to import the drugs
Experience in drug management with
GLC-approved projects
 Bad practices:
- Forecasting the needs without taking in
consideration all variables presented
- Storing the drugs in a inadequate place
- Neglecting communication between the
project, the NTP, the PR and WHO
procurement officer (Ms Fabienne Jouberton
<joubertonf @ who.int >)
How to improve drug management of
second-line anti-TB drugs
 Good practices:
Please suggest recommendations on how to
use the GF grant to ensure proper drug
management of second-line TB drugs