The Need and Challenges of Decentralization

MDR Program Statistics & KZN position Challenges in managing MDRs in KZN Decentralization and the way forward Miscellaneous Program Updates

Early initiation of ART (within 2 weeks) in all TB & DR-TB co-infected

All MDR-TB on treatment within 5 days after confirmation

All PHC to provide ART and MDR-TB by 2016

Improved MDR-TB success rate to 60%

Decreasing number of TB cases: Increasing MDR-TB cases

10/17/2014 Dr. Norbert Ndjeka 4

353 610388 882 405 982 396 554 389 974

344 748

7 350 8 026 9 070 7 386 10 085 141610

50 000

100 000

150 000

200 000

250 000

300 000

350 000

400 000

450 000

2007 2008 2009 2010 2011 2012

Notified TB Notified MDR-TB

Treatment Success 40.3

Defaulters16.9

Mortality 17.3

Failures 5.9

Treatment Success

Defaulters

Mortality

Failures

Treatment Success 17.5

Defaulters 9.1

Mortality 49

Failures 7.9

Treatment Success

Defaulters

Mortality

Failures

Laboratory diagnosed MDR-TB

Province 2010 2011 2012 Totals (%)

EC 1782 2178 2205 6165 19.5

FS 267 412 390 1069 3.4

GP 934 1643 1198 3775 11.9

KZN 2032 (27.5%) 1825 (18.9%) 6630 (46.8%) 10487 33.2%

LP 126 290 266 682 2.2

MP 312 824 760 1896 6.0

NC 353 427 373 1153 3.6

NW 158 473 267 898 2.8

WC 1422 2013 2072 5507 17.4

Total 7386 10085 14161 31632 100%10/17/2014 Dr. Norbert Ndjeka 7

MDR-TB Started on Treatment

Prov 2007 2008 2009 2010 2011 2012 2013 2013 - %

EC 932 772 847 927 1207 1062 2098 20.8%

FS 158 233 148 167 214 201 479 4.7%

GP 497 414 512 607 572 417 484 4.8%

KZN 788 1039 927 1788 1733 2571 3804 37.7%

LP 71 104 88 119 152 135 292 2.9%

MP 148 272 198 298 313 591 896 8.9%

NC 145 148 253 230 264 243 272 2.7%

NW 156 159 175 143 188 268 212 2.1%

WC 439 890 995 1034 1000 1006 1558 15.4%

Total 3334 4031 4143 5313 5643 6494 10095 20.8%

10/17/2014 Dr. Norbert Ndjeka 8

MDR-TB Started on Treatment

0

500

1000

1500

2000

2500

3000

3500

4000

EC FS GP KZN LP MP NC NW WC

2007

2008

2009

2010

2011

2012

2013

9

The Lion’s Share

XDR-TB cases started on treatmentProv.

2007 2008 2009 2010 2011 2012 2013 Total %EC

171 135 135 224 208 204 211 1288 32.7FS

7 7 6 5 16 9 16 66 1.7GP

45 40 25 30 33 26 19 218 5.5KZN

170 163 177 235 211 267 239 1462 37.2LP

2 0 3 3 11 3 6 28 0.7MP

0 3 5 6 5 8 30 57 1.4NC

11 8 13 37 51 26 3 149 3.8NW

4 1 9 14 6 14 32 80 2.0WC

64 34 58 61 68 144 157 586 14.9Total 474 391 431 615 609 701 713

393410/17/2014 Dr. Norbert Ndjeka

10

EasternCape

Free State GautengKwaZulu-

NatalLimpopo

Mpumalanga

North WestNorthern

CapeWestern

Cape

Success 27.8% 54.6% 28.0% 62.1% 44.1% 26.1% 63.6% 35.9% 21.5%

Failed 13.1% 5.5% 3.7% 1.1% 4.2% 2.0% 5.2% 11.0% 8.6%

0.0%

10.0%

20.0%

30.0%

40.0%

50.0%

60.0%

70.0%

Succ

ess

& F

aile

d

15

Top of the Pile Lowest Failure Rate

EasternCape

FreeState

GautengKwaZulu-

NatalLimpopo

Mpumalanga

NorthWest

NorthernCape

WesternCape

Died 27.7% 17.2% 20.8% 13.2% 11.9% 20.1% 9.2% 13.3% 13.2%

Defaulted 16.2% 16.0% 22.4% 9.2% 31.4% 7.4% 11.6% 33.7% 27.1%

0.0%

5.0%

10.0%

15.0%

20.0%

25.0%

30.0%

35.0%

40.0%

Die

d &

Def

ault

ed

One of lowest death & defaulter rates

16

A. Data is faulty ( Data not validated)B. Many patients died or are lost to follow upC. KZN (esp Ethekwini) has not decentralized.D. All of the Above (1 , 2 & 3)E. Data is correct & KZN program is really doing well

Why does KZN Data looking better than other provinces

A. Data is faulty ( Data not validated)B. Many patients died or are lost to follow upC. KZN (esp Ethekwini) has not decentralized.D. All of the Above (1 , 2 & 3)E. Data is correct & KZN program is really doing well

Why does KZN Data looking better than other provinces

Data not adequately validated Manually submitted – not truly validated Some patients diagnosed on Gene Xpert not included Outcomes incomplete – Data not captured Files lost

KZN patients only included in stats after arrival at MDR units With a 6 week waiting period many have died and are not included Patients are mobile , attend multiple clinics and are hard to trace

KZN has essentially not decentralized to clinic level resulting in long waiting lists. Once we decentralize outcomes may worsen

DR-TB treatment still centralized Increased Risk of transmission in hospital Poor outcomes of DR-TB cases Increasing numbers of treatment failures Palliative care – Program required Inadequate Recording and Reporting (R & R)

10/17/2014 Dr. Norbert Ndjeka 16

Advantages Manage MDR-TB patients closer to home Enables MDR-TB treatment as soon as

diagnosis is made Reduce transmission of DR-TB by earlier Rx More beds available Improved adherence to medication Improved cost effectiveness

10/17/2014 Dr. Norbert Ndjeka 17

Solution - Decentralize MDR TB Mx.

1842

44

169 145 147205

275

390

481469

567

689

11311197

1143

13811417

1606

1809

1 4 7 66

37

85

181 164

201191

154

210

234

2 4 9 9 10 17

129

656

586 604

878900

1091

0

200

400

600

800

1000

1200

1400

1600

1800

2000

1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

MDR

OP

XDR

Waiting List 21/08/2014 Pat. Nos. Waiting Period

Males – awaiting beds 70 6 Weeks

Females – awaiting beds 79 6 Weeks

New Outpatients awaiting Rx

74 4 weeks

Paediatrics waiting 7 3 weeks

Total 230

XDR and Ill cases are prioritized (10 XDRs in the list)

MDRs who are ill and at home are prioritized

> 65 % are started as outpatients

Many patients who are eventually offered a bed - have passed on

Inpatients There are not enough Beds

Sick and XDR Patients are dying on waiting list (6 weeks)

Outpatients There is not enough capacity / staffing at KDHC to see

more stable outpatients

No funds to employ more staff.

Outpatients wait > 4 weeks to start MDR treatment

3 districts in KZN do not have MDR units They are still referring all patients to KDHC

Increasing the burden to KDHC

“XDRs drugs” are only available at KDHC Drugs like Clofazimine, Capreomycin & PAS are

not available at decentralized sites making it necessary to refer pre-XDRs , XDRs and treatment failures to KDHC

increasing the burden of Inpatients at KDHC XDRs on Bedaquiline program need extra

monitoring and occupy beds at KDHC There are no MDR units other than KDHC

in Ethekwini Ethekwini is the highest burden area Provincial referral site for problem patients

A. Urgent Situational Analysis will be carried outB. Special Funds and Support will diverted to assistC. KZN needs to Decentralize to sort their problemsD. There is no crises/problemE. National is aware and planning major interventions

What was the National response to KZN crises?

A. Urgent Situational Analysis will be carried outB. Special Funds and Support will diverted to assistC. KZN needs to Decentralize to sort their problemsD. There is no crises/problemE. National is aware and planning major interventions

What was the National response to KZN crises?

KZN and Ethekwini needs to decentralize to sort their problems out. Support will be provided through the

National programs but there is not going to be any special crises intervention in KZN

Interventions Comment

Increase Staff in KDHC MDR Clinic

No Funding for posts in foreseeable future. Provincial finance in crises

Fast Track Beds at KDHC -(96 beds)

New OPD - Progress is slow Ward renovations just started

Access for MDR Units to XDR Rx to cut flow to KDHC

No program started. Province hesitant to move with this as experience and regular staff is lacking in some decentralized units

Increase Ethekwini bed Capacity

Looked into. No hospitals have suitable situation and infrastructure. Charles James Santa Centre and Don Mackenzie may be used as temporary measure. FOSA may close

Expand MDR Sites in the Province

Requires external funding and support

Ethekwini DistrictDecentralization Program for CHC and District hospital

Program needs to be driven by district with support of province. Needs much discussion

Meeting held between KDHC / District /Province Decision made in principal to start a process of

Decentralization in Ethekwini Identify high burden Clinics and District Hospitals in

Ethekwini

Make an assessment of the Sites

Engage managers and staff of the site

Train the sites to manage MDRs

Set up SOPs to manage process

KDHC to facilitate this!

Lack of Knowledge and Expertise on MDR Lack of Staffing to take on an additional

program (doctors and nurses) Lack of space to run an additional program Inability to store and dispense MDR

treatment Lack of X-ray and Audiology facilities Lack of transport to access medication and

do patient tracing Lack of Reporting mechanism for the

program No extra staff/ funds will be made available

Phased in program Training for identified sites – to be done

by KDHC Certain Clinics,(CHCs at first) & certain

District Hospitals to receive stable MDR patients who have completed injectables

KDHC to write a 6 month repeat script Clinic to assess these patients monthly

and do sputum monthly. Review 6 monthly at KDHC

Clinic to submit monthly sputum to KDHC for the EDR

If any Mx problems – discuss with KDHC Once expertise built up ,and depending

on Audio and X Ray capacity, clinic could be upgraded to initiate treatment.

Will initially reduce the size of the follow up clinic at KDHC.

Other interventions are needed to impact on waiting list.

KDHC to facilitate this!

Problem : Patients waiting 5 weeks for treatment Proposal Allow certain sites to access MDR /XDR Rx from KDHC /

PPSD Problem

▪ Open to abuse of medication▪ Mismanaged patients▪ Loss of continuity in treatment

Formalize a system of presentation of patient to KDHC with Key information

▪ History , Blood results , Audio , X-ray , sputum results ▪ Appointment made simultaneously

KDHC will approve a months supply of Meds Site needs to take responsibility for patient until

taken over KDHC to facilitate this!

A.Wonderful Strategy – Its going to work in Ethekwini

B. We are wasting time and resources - its not feasible

C. We have severe constraints but there are no other options – we will have to try it

D.I have an great alternate plan that will work – I will contact you (iqbal.master@kznhealth.gov.za)

E. Just give up now – we are fighting a losing battle with MDR

Your Opinion on Decentralization ?

A.Wonderful Strategy – Its going to work in Ethekwini

B. We are wasting time and resources - its not feasible

C.We have severe constraints but there are no other options – we will have to try it

D.I have an great alternate plan that will work – I will contact you (iqbal.master@kznhealth.gov.za)

E. Just give up now – we are fighting a losing battle with MDR

Discordance with Gene Xpert Current Research at KDHC /KZNBedaquiline Clincal Access program Linezolid access

In some patients we cannot confirm Gene Xpert

In others Gene Xpert differs from LPA and DST In some all 3 are different e.g.▪ Gen Xpert – Rif Resistant

▪ LPA - Rif sensitive and INH Resistant

▪ DST – Fully sensitive

How should we manage these patients ?

A.Believe the Gene Xpert – it is very sensitive and now has 4 probes

B.Believe the LPA - it is a confirmatory test for the Gene Xpert

C. Believe the DST as it is the Gold Standard

D.Repeat the Gen Xpert or do an additional DST and take the best of the 2

E. You can repeat a test but you need to use your Clinical Judgement eventually

National Advice:If you have discordance with Gen Xpert you should?

A.Believe the Gene Xpert – it is very sensitive and now has 4 probes

B.Believe the LPA - it is a confirmatory test for the Gene Xpert

C. Believe the DST as it is the Gold Standard

D.Repeat the Gen Xpert or do an additional DST and take the best of the 2

E.You can repeat a test but you need to use your Clinical Judgement eventually

National Advice:If you have discordance with Gen Xpert you should?

E. Can repeat the tests (DST / Gene Xpert) but will need to use your clinical judgement eventually

National is not prepared to put out a written policy on discordance.

Traditionally DST was the gold standard. Some experts now believe that Gen xpert is

picking up subclinical resistance Best to stratify your patients Consider extent of disease past TB treatment Failure to respond to treatment MDR contacts HIV status and CD4 count & Use your clinical judgement

Stream Study – shortened MDR Rx – (9 mths) Continuing with 1st stage > 78 patients Planning to start 2nd phase (Stream 2) once Ethics and logistics

are resolved ▪ Planned injection free arm + BDQ

New site planned in PMB (Doris Goodwin) MSC Study – Mesenchymal stromal cell transfusion

in MDR treatment failures – safety study Ethics approved Awaiting MCC approval

Next Study – injection free regimen 6-9 mths 5 provinces Funding from Medunsa university Run from Western Cape BDQ/LZD/PZA/Laevo/Ethio or INH+

National TB program for XDRs and Pre-XDRs Run under research conditions Very Labour intensive Much paper work Informed consent 3 committees Regular bloods and ECGS (main worry is QT prolong.) Need support to run program

Added to Background XDR regimen for 6 months Often added with Linezolid Cannot use with Moxifloxacin , Efavirenz, clarithromycin

Program at KDHC 35 patients enrolled

▪ 4 completed 6 months

20 patients currently on BDQ 11 patients awaiting drugs 39

Cost in region of R7500 per patient /month Is currently a motivational item Used mainly with Bedaquiline in XDR

patients Have been able access it In region of 40 patients approved

Budgets will be blown High side effect profile Anaemia Thrombocytopenia Peripheral Neuropathy Optic Neuritis

We face many challenges in the MDR program in KZN

Despite limited resources and severe financial constraints we do not have many options

We have to support the process of decentralization in response to the crises ! No matter where it takes us!

My Colleagues All Health workers AWACC Committee for inviting me?