1. “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

2. 2 |2 | 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 Shortage of Medicines is happening everywhere ??

3. 3 |3 | 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/42- features/1021-self-medication-expired-drugs-aggravate- spread-of-resistant-tb http://www.independent.co.ug/index.php/features/features/42- features/1021-self-medication-expired-drugs-aggravate- spread-of-resistant-tb Shortage of Medicines is happening everywhere ??

4. 4 |4 | 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.

5. 5 |5 | 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 Product fails in it’s analysis. 8- Programs don’t follow neither Push nor Pull system of distribution

6. 6 |6 | Causes of medicines stock out (3)

7. 7 |7 | Methodology (1): A regional survey has been done during the GDF/ WHO field visits in 15 (100% of the surveyed countries) of GDF supported countries, 12 (80%) of them were supported by GFATM/GDF (DP service). 76 Directors of the pharmacy depts. at MOH, NTP staff were interviewed; the questionnaire endorsed GDF/ WHO questionnaires about;. 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.

8. 8 |8 | Methodology (1): The questionnaire endorsed GDF/ WHO questionnaires about; 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.

9. 9 |9 | 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..

10. 10 | 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

11. 11 | 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.

12. 12 | 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??

13. 13 | 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.

14. 14 | 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.

15. 15 | 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.

16. 16 | 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 2 nd line drugs (1 st line is in process)

17. 17 | Key words: Anti-TB medicines (ATBM), Drug supply system, Global Fund (GFATM), Global Drug Facility (GDF), drug shortage,

18. Any Questions & Suggestions?