FEDERAL MINISTRY OF HEALTH

Transcription

1 FEDERAL MINISTRY OF HEALTH DEPARTMENT OF PUBLIC HEALTH NATIONAL TUBERCULOSIS, LEPROSY AND BURULI ULCER CONTROL PROGRAME.

2 THE NEW ANTI-TB DRUG FORMULATIONS FOR CHILDREN: STRATEGIES FOR ROLL-OUT IN NIGERIA PAEDIATRIC ASSOCIATION OF NIGERIA/UNAPSA CONFERENCE DR. URHIOKE OCHUKO NTBLCP, FMOH 24TH JANUARY, 2018

3 Programme Background Tuberculosis Situation in Nigeria Challenges with Childhood TB Control OUTLINE OF PRESENTATION Efforts of the National Tuberculosis and Leprosy Control Programme (NTBLCP) to improve childhood TB case detection Update on the new Paediatric Anti-Tuberculous Drug Formulations Modalities for Roll-out of the new Paediatric Anti-Tuberculous Drug Formulations Role of Paediatricians in roll-out of the New Paediatric Anti-Tuberculous Drug Formulations Conclusion 3

4 BACKGROUND The National Tuberculosis, Leprosy and Buruli Ulcer Control Programme (NTBLCP) Established in 1988 to coordinate and ensure the successful control of Tuberculosis (TB), Leprosy and Buruli ulcer in Nigeria Operates along the three tiers of Government (Federal, State and LGA) Currently operating a 6 year National Strategic Plan (NSP) for Tuberculosis ( ) Service provision for the three diseases is integrated into the existing National health system TB services are provided through: 6,753 DOTS centres, 2,551 Microscopy centres, 390 GeneXpert sites, 27 DR-TB treatment centres and 10 Reference laboratories (Calabar, Zaria, Nasarawa, Lagos, Port-Harcourt, Yola, Kano, Jos, Ibadan and Umuahia ) 4

5 TUBERCULOSIS SITUATION IN NIGERIA 2017 Global TB report for Nigeria revealed that: Nigeria is among the 30 high burden countries for TB, TB/HIV and Rifampicin Resistant -TB (RR-TB)/Multi-drug Resistant TB (MDR-TB) Estimated incidence of all forms of TB is 219/100,000 population (407,000 cases); RR-TB/MDR-TB 4.3% and 25% respectively among new and previously treated TB cases (5,200 cases) Notified only 100,433 cases in 2016; TB treatment coverage of 24% Mortality rate (excluding HIV + TB) for all forms of TB is 62/100,000 population Mortality rate (HIV + TB only) for all forms of TB is 21/100,000 population 5

6 TUBERCULOSIS SITUATION IN NIGERIA 2 Nigeria is among countries with very low TB Case finding among children. In 2016, the country notified 5414 childhood TB cases out of the estimated 40,000 cases Annual childhood TB notification rate of 6% compared to estimated 10% of all forms of TB cases Lower notification among children aged 0-4 years 6

7 7 YEAR TREND OF TB CASES < 15 YEARS NOTIFIED Total Case Child TB (3%) (6%) 6% 6% 6% 6% 6% 5.4%

8 AGE STRATIFICATION OF NOTIFIED CHILDHOOD TB CASES Total 0-4 years 5-14 years

9 CHALLENGES WITH CHILDHOOD TB CONTROL Low case detection Low programme coverage/access Incomplete notification Difficulty with diagnosis especially among younger children Inadequate capacity for detecting and managing childhood TB 9

10 EFFORTS OF NTBLCP TO IMPROVE DETECTION OF CHILDHOOD TB CASES Integration of TB care into Reproductive, Maternal, Newborn, Child, and Adolescent Health plus Nutrition (RMNCAH+N) services Expansion of TB treatment and diagnostic facilities Introduction of Xpert/MTB RIF assay Training of doctors and nurses on diagnosis and management of childhood TB Development of Guidelines, SOPs and IEC materials on Childhood TB Provision of fund for Chest x-ray diagnosis of TB in children 10

11 UPDATE ON THE NEW PAEDIATRIC ANTI-TUBERCULOUS DRUG FORMULATIONS 11

12 RATIONALE FOR INTRODUCING THE NEW PAEDIATRIC ANTI-TUBERCULOUS DRUG FORMULATIONS Inadequate dosages of the old Paediatric anti-tb FDC tablets for some children New FDC formulation has addressed the problem by revising the dosage New dosing in line with WHO recommendations 12

13 ADVANTAGES OF THE NEW FORMULATIONS Appropriate strength Dispersible in water within 10 seconds Simple and child-friendly Pleasant fruit flavours (mango, strawberry and raspberry) - Better adherence Easy to administer without cutting or splitting of tablets Minimal instructions for service providers and care givers

14 PACKAGING OF THE NEW PAEDIATRIC ANTI- TUBERCULOUS DRUG FORMULATIONS Intensive phase Continuation phase Intensive phase Continuation phase 14

15 DIFFERENCES BETWEEN THE OLD AND NEW PAEDIATRIC ANTI-TUBERCULOUS DRUG FORMULATIONS Old New Old New Drug Strength FDC* Intensive Continu ation Not appropriate for some children RHZ (60/30/150mg) RH (60/60mg) Appropriate RHZ (75/50/150mg) RH (75/50mg) Weight band (Kg) Weight cut-off (adult dosing) <5 5 9 >9 13 >13 18 Children >18Kg <4 4 7 >7 11 >11 15 >15 but <25 Children >25Kg 15

16 REGIMEN AND DOSAGES FOR CHILDREN WITH SUSCEPTIBLE PTB/EPTB CASES Pre-treatment weight (Kg) Daily Regimen <4 4-7 >7-11 >11-15 >15 - <25 25 Intensive phase (2months) Combined tablets: RHZ (75mg+50mg+150mg) Ethambutol tablet (100mg) Continuation phase (4 months) Combined tablets of RH (75 mg + 50 mg) ½ ½ ½ Adult tablets 16

17 REGIMEN AND DOSAGES FOR CHILDREN WITH TB MENINGITIS AND OSTEO-ARTICULAR TB Daily Regimen Pre-treatment weight (Kg) <4 4 7 >7 11 >11 15 >15 - <25 25 Intensive phase (2 months) Combined RHZ tablets (75mg+50 mg+150 mg) Ethambutol tablet (100mg) Continuation phase (10 months) Combined tablets of RH (75mg+50mg) ½ ½ ½ Adult tablets 17

18 ADMINISTERING THE NEW PAEDIATRIC ANTI-TB DRUG FORMULATIONS Step 1: Select appropriate number of tablets Step 2: Dissolve in 20ml of water Step 3: Rock gently to dissolve (Dissolves in 10 seconds) Step 4. Once dissolved, give the child immediately 18

19 KEY INFORMATION ON THE NEW PAEDIATRIC ANTI-TB DRUG FORMULATIONS Close monitoring of children on the new paediatric formulations Look out for adverse drug events (particularly related isoniazid and Rifampicin) Management and reporting of adverse drugs events 19

20 Insert Copy of The Yellow Form

21 MODALITIES FOR ROLL-OUT OF THE NEW PAEDIATRIC FORMULATIONS All DOTS facilities in Nigeria are to commence the new formulation for newly enrolled patients from 15 th February, 2018 Old patients on the older formulations should continue with the older formulations Sensitization of paediatricians, programme officers, doctors and other health care workers on the new formulations Six facilities selected for monitoring of the new formulations Developed Standard operating procedures, rapid advice and orientation manual on the new formulations 21

22 MODALITIES FOR ROLL-OUT OF THE NEW PAEDIATRIC FORMULATIONS 2 Standard operating procedure on new formulation Rapid advice on the new formulations Orientation manual on new formulation 22

23 ROLE OF PAEDIATRICIANS IN ROLL-OUT OF THE NEW FORMULATIONS Disseminate orientation materials and standard operating procedures on the new paediatric formulations Orientation of doctors, nurses and other health workers on the new paediatric formulations Monitor and document important findings 23

24 CONCLUSION The NTBLCP in collaboration with stakeholders has rolled out modalities for smooth introduction of the new formulations in Nigeria Key policy documents and guidelines developed and disseminated The support of paediatricians is however needed to ensure the roll out of the new formulations in Nigeria is hitch-free. 24

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26 THANK YOU FOR YOUR ATTENTION