Second Africa TB Regional Conference on Management of TB Medicines. Africa TB Conference 2012, Zanzibar December 5-7, 2012

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1 Second Africa TB Regional Conference on Management of TB Medicines Africa TB Conference 2012, Zanzibar December 5-7, 2012

2 Minimal TB Medicine wastage: Nigeria Experience switching TB regimens Presentation by Dr Joshua Obasanya NTP Manager Pharm Linus Odoemene Head of Logistics unit

3 Background Regimen Switch New TB treatment guidelines released by WHO/Global Drug Facility (GDF), in 2010 strongly recommended the phasing out of the ethambutol (E)/isoniazid (H) containing category one regimen. The New Regimen Contains rifampicin (R) and isoniazid (H) in continuation phase. Resistance to RH technically defines multidrug-resistantn (MDR) TB Nigeria must switch in 2011 or face widespread stock-outs because the GDF, sole supplier for Nigeria, had de-listed EH from product list NTP Challenges About 30 out of 37 state TB programs are considered too weak to commence RH regimen. This raises grave concerns about stock-outs, high wastages, and RH resistance. CAUTION: Resistance to RH is MDR-TB

4 Objective of the Presentation To describe how the NTP has successfully switched from EH to RH category one regimen with minimal stock-outs and wastages

5 PSM Flow Chart FMOH coordinating bodies Partners Donors GDF/GLC Principal recipients CCM PSM TWG FCMS NTP PSM Carrier Zonal stores State medical stores Service delivery points (SDPs) National level Zonal (region) level State level Local govt. area level SDP level

6 Anticipated Risks for National Level Regimen Switch STOCK OUTS: Unreliable procurement and shipment system Shipments delayed for 6-13 months Shipments over fragmented (4-6 batches instead of 2) EH had been phased out of the GDF list of drugs Weak logistics management information system (LMIS) in country HIGH DRUG WASTAGE Excess loose drug components: e.g., excess EH of 290,000 blisters ($380,000) Low capacity to manage patients kits (NTP was also transiting from use of loose drugs to patient kits) Low capacity to manage drugs at SDP level LOW CAPACITY AT THE SDP LEVEL Weak drug/programmatic management of TB in many states High defaulter rates in many states

7 The Transition Process Objectives To strengthen the capacity of the central unit of NTP to plan and coordinate the transition process. To improve the standards of DOTS implementation in line with the criteria for switching to RH regimen.

8 Criteria for Selecting States for Switching STATE LEVEL Programmatic capacity of states to implement RH regimen 10 patient index values: 9 12 SDP Reporting > 90% CAT 1 availability at SDP > 90% at quarter end Capacity to use LMIS for performance improvement Defaulter rate: not more than 5-7% Treatment success rate: greater than 80% NATIONAL LEVEL Favorable RH/EH regimen coverage (months of stock) Availability of category 2 regimen (in view of low stock level of category 2 ) Considerations for final mop-up in each zone (region)

9 Approach National committees for transition planning and monitoring GAP analysis Sensitizing and training of mangers, supervisors, and DOTS providers Development and use of EH/RH status monitoring tool (switch surveyor designed and developed by NTP) Loose drug bundling (conversion to patient kits) Procurement of loose drugs Any state program, once transitioned to RH regimen, cannot be returned to the EH regimen.

10 Approach and Activities National committees for transition planning and monitoring Transition plan developed (World Health Organization (WHO) support) Setting of standards of program performance for states (WHO support). Development and printing of two SOPs (TBCARE support): SOP on the use of 6 months regimen SOP for the engagement of treatment supporter GAP analysis (TBCARE support) General sensitization using quarterly review meetings (GF sctivity) SWITCH SURVEYOR tool developed (NTP )

11 Approach and Activities (2) Nationwide stock assessment(ntp) Order placed for RHZE to mop up excess EH (GF support) Mentoring and supportive supervision to selected states (TBCARE support) Post implementation evaluation/on-site data validation Any state programme, once transited to RH regimen cannot be returned to the old EH regimen.

12 Phase In Approach (1)

13 Phase In Approach(2) Time to focus on a few States: Assess performance of States Sensitize identified States (to be switched) Raise capacity of weak States enough to implement 6 months regimen Determine EH/RH coverage before next shipment Save EH Boost overall supply of CAT 1 kits

14 Timelines Drug order (6 months regimen) placed - Jan 2011 Determination of status of excess loose drug components Jan 2011 Development of switch surveyor (RH/EH monitoring tool ) Mar 2011 Selection of the first 13 states to switch March 2011 SOP on 6 months regimen disseminated April 2011 Sensitisation of state control managers and supervisors April Sept 2011 Mentoring, monitoring, and supportive supervision May Sept 2011 First batch implementation: 15 states (58% case burden) Oct.2011 Delivery of new RHZE orders Feb 2012 Second batch implementation: 3 states (08% case burden) - April 2012 Third batch implementation: 3 states (06% case burden) - July 2012 Fourth batch implementation: 5 states (09% case burden) - July 2012 So far: 21 states (81%) of national case burden 9 states expected to transition in Jan 2013 Balance of 2 states in April 2013

15 Screenshot of SWITCH SURVEYOR tool Next switches Select state to switch CASE BURDEN Ranking Benue 6 STATE POSITION FCT 6 Lagos 1 Kogi 6 Kano 2 Kwara 6 Benue 3 Nasarawa 6 Oyo 4 Niger 8 Kaduna 5 Plateau 6 Plateau 6 Borno 7 Adamawa 6 Delta 8 Bauchi 6 AKWAIBOM 9 Borno 8 Adamawa 10 Gombe 6 Nasarawa 11 Taraba 6 Bauchi 12 To activate SWITCH, replace 8 with 6

16 SWITCH SURVEYOR Tool View RH/EH Projection 00-Jan Jan Jan-00 0 PIPELINE ANALYSIS 00-Jan Jan Jan-00 0 REGIMEN 6-MONTHS Regular COMBINED 00-Jan Jan Jan-00 0 AMC 9, , , Jun Jan Jan-00 0 MOS Jun Jan May-13 0 Stock out date 04-Jun Mar May May-13 10, Jan May-13 6, Apr-13 20, Mar Apr-13 18, Mar-13 29, Mar Mar-13 29, Jan-13 39, Jan-13 2, Jan-13 41,719 State/case data 31-Dec-12 48, Dec-12 4, Dec-12 53,524 6-MONTHS Regular ALL 01-Dec-12 58, Dec-12 6, Dec-12 65,328 States in Oct-12 68, Oct-12 8, Oct-12 77,132 category % in category 70.3% 29.7% 100% Oct-12 77,792 Oct-12 11,144 Oct-12 88,936 Case finding 115,339 26, ,650 Coverage Balance Coverage Balance Coverage Balance % in category 81.4% 18.6% 100% 6-MONTHS 8-MONTHS COMBINED CAT 1 KITS

17 Implementation So Far 120 % cases RH regimen % cases EH regimen July 2011 Oct 2011 April 2012 Jul 2012 Oct 2012 Jan 2013 April 2013 Jul

18 Outcomes Successful transition of 81% of the nations Adult CAT 1 caseload to RH regimen while enhancing CAT 1 stock NTP saved more than 401,827 blisters of EH valued at $425,631.49, Over all savings from improved management of drugs and supplies exceeded a year s budget for drug procurement

19 Strengths Support from partners, notably WHO and TBCARE Strong teams in 17 states (about 47%) achieved through recommendation of NTP to states to delegate duties to Logistics, M&E Lab officers Capacity in NTP to develop LMIS Tools, examples: (a) Switch surveyor - employed in this project to monitor how long stocks of RH and EH would last. (b) PICKnPACK - LMIS tool that provides the third eye managers need to see where issues come from; measure current performance of the supply system; provide feedback to influence behaviour change; and provide support for some difficult to do tasks.

20 Challenges BEFORE TRANSITION: Unreliable procurement and shipment system (from slide 6) Delayed shipment (6-13 months) Fragmented shipments (4-6 batches instead of 2) EH phased out by GDF product list Drug management capacity Large quantities of loose drugs at risk of expiring (EH 290,000 blistered valued at $380,000) Program had little experience for managing patient kits DURING IMPLEMENTATION: Weak teams in 20 states mostly States failing to implement NTP recommendation on delegation of duties Unreliable procurement & shipment procedure Return of un-usable commodities

21 Lessons Early preparation is key to success Decide which approach, nationwide or phased in? Stock management of EH at all levels Carefully set your targets and stick to it Accurate stock projection, forecasting and pipeline monitoring