“The causes of Anti-TB medicines
shortages in EMR countries and how to
avoid them in the future”
Khaled Sultan
Drug Management Technical Officer,
STOP TB EMRO/WHO
Shortage of Medicines is happening
everywhere ??
 A- Eastern Mediterranean Region (Scenario);
1. Country A ; stock out of RHZE due to delay in funding
transfer.
2. Country B; stock out of RH due to mismanagement of
the treatment regimens (not following the Guidelines).
3. Country C; stock out of S due to misdistribution (Push
and or/of Pull system).
4. Country D; stock out RHZ 150/60/30 due to port clearance
delay
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Shortage of Medicines is happening
everywhere ??
 B- Global (Scenario);
 Uganda Faces TB Drug Shortage on World TB Day
 http://www.tribuneindia.com/2005/20050225/delhi.htm
 http://allafrica.com/stories/201005110919.html
 The Observer - Chronic drug shortage cripples health system
 http://www.independent.co.ug/index.php/features/features/42features/1021-self-medication-expired-drugs-aggravatespread-of-resistant-tb
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Causes of medicines stock out ? (1)
 The stock-out means; that patients who are already on
treatment will have to interrupt the course of treatment.
Patients who interrupt their treatment are at increased
risk of developing multi-drug resistance (MDR) TB. This
exacerbates the crisis as MDR TB is more expensive
and more difficult to treat.
 The stock out may be due to;
1. The inadequate funding (Political commitment) .
2. Poor selection and quantification of medicines and
lack of prioritization.
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Causes of medicines stock out ? (2)
3- Delay in procurement (Lead time)
4- Extensive expiration of medicines ( not following FEFO,
GSP Standards )
Stock out
5- 6- Port clearance delay (in some cases reached to 6
Months ???)
7- Countries don’t follow; GMP & GLP
fails in it’s analysis.
Product
8- Programs don’t follow neither Push nor Pull system of
distribution
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Causes of medicines stock out (3)
Selection
Use
Management
Support
Procurement
Distribution
Policy and Le gal Frame work
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Methodology (1):
 Regional survey for 15 (100%) of the surveyed countries.
 12 (80%) of them receive
GFATM support .
( GDF Direct Procurement ).
 3 (20%) of them receive
GDF support only (grant ).
 Questionnaire used during field visit.
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Methodology (1):
 The questionnaire endorsed GDF/
WHO questionnaires about;
Under
GDF
Support
(GR)
20%
 The availability of the ATBM at the
central /district level.
 Causes of shortage of ATBM at all
levels in these countries.
 How countries were managing their
ATBM supply system.
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Under
GFATM/
Support
(DP/GD
F)
80%
Methodology (2): (Questionnaires)
 How the shortage took place despite the era of these
high quality initiatives.
 what are possible causes behind.
 How (WHO & Countries) have (tried to) manage the
shortage.
 And what is the possibility for having no future shortage
of Anti-TB medicines..
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Results (1)
 However; How many of them have faced real “Shortages”
??
 And if so, what kind of “Shortages” ??
 National ? Provincial? , ….?
Level
 All medicines ? Some? ……?
Size
 How long ?
Duration
Reported
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Results (2)
Usable responses were received as follow;
 20% (3) of the 15 surveyed countries, the shortage was due to
noticeable mismanagement support (Drug Management Cycle) &
political commitment towards Anti-TB medicines funding..
 13.3 % (2) due to unplanned switching to 6 months regimens in 8
months treatment regimens countries.
 26.6 % (4) due to a delay of funding of ATBM, in the 33.3% of the 12
GFATM supported countries.
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Results (3)
 Significant increase in the GDF lead time of anti-TB
medicines orders was reported as a result of the above
reasons in 20% of the surveyed countries.
 The last 20.1% countries the shortage was due to different
reasons ;
 Delay in port clearance.
 Lab analysis delay, etc
 What else??
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Results (4) ;
 Real Status of “Shortages”.
 Have countries faced a real stock out?
 Non of them have faced a typical real stock out.
 The shortages of TB medicines were only representing the
buffer stock (safety stock ) at different levels
 All of them have faced mismanagement of the Drug
management components.
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Conclusion (1):
For the no future shortage of ATBM, it was suggested to;
 Maintaining and increasing the transparency in the drug
procurement and supply mechanism at National level
 Increase funding for the health sector to meet the
funding gap by extensive work on partnership for having
a revolving fund at the regional level;
 Sensitization of communities on the dangers of hoarding
medicines.
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Conclusion (2):
 It was suggested as well to continue working on the
rational use of ATBM and WHO Pre-qualification for
more GDF/WHO pre-qualified suppliers from the
region,
 Establish a new channel of working between GDF/
and GFATM supported countries in terms of
strengthening and improving the Drug Chain
mechanism by increasing the capacity building at all
levels in EMR countries.
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Conclusion (2):
 EMRO has established (Q 3 2010) a Drug
Management online system (DQ online surveillance
system) ; countries are asked to submit their Data
(stock management) on the quarterly basis.
 GDF has established the system of stockpile for 2nd
line drugs (1st line is in process)
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Key words:
 Anti-TB medicines (ATBM), Drug supply system,
Global Fund (GFATM), Global Drug Facility (GDF),
drug shortage,
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Any Questions & Suggestions?