“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); • Country A ; stock out of RHZE due to delay in funding transfer. • Country B; stock out of RH due to mismanagement of the treatment regimens (not following the Guidelines). • Country C; stock out of S due to misdistribution (Push and or/of Pull system). • Country D; stock out RHZ 150/60/30 due to port clearance delay
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/42-features/1021-self-medication-expired-drugs-aggravate-spread-of-resistant-tb
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; • The inadequate funding (Political commitment) . • Poor selection and quantification of medicines and lack of prioritization.
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
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;. 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.
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.
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..
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
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.
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??
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.
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.
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.
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)
Key words: • Anti-TB medicines (ATBM), Drug supply system, Global Fund (GFATM), Global Drug Facility (GDF), drug shortage,