1. DOTS-PLUS IN TANZANIA: PREPARATION PHASE Global DOTS Expansion Working Group Meeting, Paris: 28 October 2004 NTLP - MOH Prepared by: Dr. S. M. Egwaga NTLP - Tanzania

2. Situation of MDR-TB in Tanzania Drug Resistance data available (1999 – 2003) MDR TB among new pulmonary cases 1% or about 60 new cases each year MDR TB in previously treated cases – 6% or 30 cases per year Some of the cases are clinicians dealing with TB patients There is no provision in the DOTS strategy for the management of MDR-TB NTLP - MOH

3. Rationale to deliver MDR-TB in Tanzania Government of Tanzanian has resolved do deliver standard TB care to all patients including the small pool of MDR-TB as part of equity to services and to minimise transmission and spread of MDR-TB The Ministry of Health has decided to establish and integrate a DOTS-plus component within the regular DOTS-programme. Priority remains DOTS-programme and DOTS-plus component will be complementary and not compete for funds. NTLP - MOH

4. External assessment to deliver MDR-TB in Tanzania In May 2003 and March 2004, a DOTS-plus consultant visited the country to assess preparedness to implement DOTS-plus and eligibility to apply to the International Green Light Committee (GLC) for preferentially priced second line drugs. The consultant concluded that DOTS-plus could be introduced in the Tanzanian situation, but a number of essential conditions should first be met. NTLP - MOH

5. Conditions to deliver MDR-TB in Tanzania To update notification system for re-treatment cases to clearly distinguish failures, relapses, treatment after default, chronics and others Strengthen systematic collection of specimen for culture and drug-susceptibility testing in the country for new and re-treatment cases To build quality assured laboratory capacity in order to: –conduct Drug Resistance Surveillance(DRS) –Minimise contamination rate from present 15% to lower levels –diagnose MDR – microscopy, culture and DST –monitor, guide and evaluate category 4 treatment NTLP - MOH

6. Conditions to deliver MDR-TB in Tanzania To establish a reference hospital (future centre of excellence) for the hospitalisation of MDR cases identified country wide To adopt a centralized approach for the intensive phase of treatment of MDR-TB in Tanzanian situation (to concentrate expertise and and build experience) To decentralize the continuation phase, integrating treatment delivery within the regular DOTS programme To appoint personnel (medical doctors and nurses) to work in the MDR-TB hospital NTLP - MOH

7. Conditions to deliver MDR-TB in Tanzania Strengthen laboratory network with lower levels and improve feedback mechanism and with supranational laboratories (MRC) To agree on a relatively cheap category 4 regimen since most of second-line drugs have never been used in the country To consider applying for Category 4 drugs through the GLC To apply to WHO to train personnel from the CRTL and MDR hospital through the GLC mechanism NTLP - MOH

8. Progress made to introduce MDR-TB in Tanzania A new MDR-TB ward for 24 patients under construction within National TB hospital Two medical doctors and 6 nurses deployed specifically to work in the MDR-TB ward Formed a technical committee to oversee implementation of MDR-TB from NTLP, MUCHS and NIMR and TB hospital Updated and computerised TB notification system countrywide with BOTUSA/CDC support to identify failures among re-treatment cases WHO has agreed to train medical personnel together with other 2 countries in SS Africa NTLP - MOH

9. Progress made to introduce MDR-TB in Tanzania Agreed on category 4 treatment regimen: 6 months Pyrazinamide, Ethionamide, Kanamycin, Ofloxacine, Cycloserin / 12 months Ethionamide, Ofloxacine, Pyrazinamide. Estimated cost for cat. 4 regimen about $600-700 per patient – relatively cheaper than in settings with a history of uncontrolled second line drug-use where PAS, Cycloserin and Capreomycin may need to be used, costing up to $3000-3800. Requests to be submitted to GLC for considerations NTLP - MOH

10. Progress made to introduce MDR-TB in Tanzania Quality of laboratory services significantly improved: –Central laboratory under major rehabilitation –New equipment procured –Internal quality control adhered in all procedures –Contamination rate reduced from 15% to 10% in less than one year –Established centralised feedback mechanism to lower laboratories –Improved registration system of MDR-TB cases throughout the country and all data captured centrally NTLP - MOH