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‘Current situation in control
   strategies and Health
Systems in Asia – Malaysia’



         Hishamshah Ibrahim, MD
       Ministry of Health, MALAYSIA
  Thursday, 9 February 2012,12:25 – 12:35 AM
National Programme in Malaysia
(Designated: THALASSAEMIA PREVENTION & CONTROL PROGRAMME)


   1. Public awareness & health education
        TV advertorials/Radio adverts/Mass media
   2. Population Screening & laboratory diagnosis
        Screening of focus groups
            Adolescents, Pre-marital age group, High risk families, cascade screening
        Improved laboratory diagnosis at all levels
            + Pre-natal diagnosis

   3. Comprehensive management of patients
         Setting a National KPI for quality of care

   4. Thalassaemia registry
   5. Cost Implications
Monday, 10 May 2004
Dr Chua: Registry proposed to track thalassaemia cases
THE HEALTH MINISTRY WANTS TO SET UP
A NATIONAL THALASSAEMIA REGISTRY TO FIND OUT
  THE LEVEL OF INCIDENCE ON THE DISORDER.

Health Minister Datuk Dr Chua Soi Lek said a report on the registry was in its final stage
  of preparation by a task force headed by the ministry’s Family And Health
  Development Division director Datuk Dr Narimah Awin.

“I expect to table it to the Cabinet in two months,” he said after launching the first
    National Thalassaemia seminar in Kuala Lumpur on Sunday. Thalassaemia is a
    genetic disorder, which disrupts red blood cell-formation. The red blood cells are
    easily destroyed and have a short lifespan, resulting in anaemia, causing patients to
    become pale and easily tired.

Dr Chua said: “The problem starts when both parents are carriers. This has a
   multiplying effect as they will produce children with thalassaemia major, who
   generally require blood transfusion and iron therapy treatment.” Between 3% and 5%
   of Malaysians are carriers of this genetic disorder.
National Programme in Malaysia
  (THALASSAEMIA PREVENTION & CONTROL PROGRAMME)


 1. Public awareness & health education
     TV advertorials/Radio adverts/Mass media
 2. Population Screening & laboratory diagnosis
     Screening of focus groups
         Adolescents, Pre-marital age group, High risk families, cascade screening
     Improved laboratory diagnosis at all levels
         + Pre-natal diagnosis

 3. Comprehensive management of patients
      Setting a National KPI for quality of care

 4. Thalassaemia registry updates
 5. Cost Implications
      Cabinet memorandum
The Strategy & Policy of Prevention (Source: WHO)

             Strategy & Policy
                                                                         % of baseline number of
                                                                              new cases of
                                                                              thalassaemia
Policy 1:   No prevention programme (baseline situation)                         100%

Policy 2:   Best possible care (BPC) + Retrospective genetic                      60%
            counseling (RGC) after the 1st affected child is diagnosed

Policy 3:   BPC + RGC + Prenatal diagnosis (PND) & abortion in                    50%
            subsequent affected pregnancies
Policy 4:   BPC + RGC + Prospective pre-marital carrier screening            25-50% - slow
            and counseling (PPMC) and no PND (+abortion)                    (over 20 years)

            In Malaysia: BPC + RGC + some PPMC +
 Policy                                                                     25-50% - slow
            ‘Voluntary’ population based screening + Family
  4.5       screening. Minimal PND + abortion.                                 (?years)

Policy 5:   BPC + RGC + PPMC + Population based screening +              Approximately 25%
            Family screening of index cases and no PND (+abortion)
Policy 6:   BPC + RGC + PPMC + PND (+abortion) + antenatal                       <10%
            screening
ALGORITHM FOR VOLUNTARY AND CASCADE SCREENING
                                                                                                                Index Case – Thalassaemia
                       Walk-in for voluntary                                                                          Major /Carriers
                           screening



                       Pre-test counselling           Offer pre-test counselling and screening for family            Offer pre-test counselling and screening for
                                                      members                                                        immediate family members
                                                      (Uncles, aunts and cousins of the index case)                  (Parents + siblings of the index case)




                               FBC                                                                                        Send FBC result & unstained PPBF slide with
                                                                                                                          remaining blood to Hospital for Hb analysis


                                                 Hb-normal                                  YES
   Hb – normal             Hb-low                MCH < 27
   MCH >27                 MCH < 27                                                                                           All can be performed on one 2.5cc EDTA sample




    Post-test           Check & treat for iron
   counselling           deficiency anaemia                                                                                              Definitive
                                                                                                                                         diagnosis                       Normal
                                                                                                            UNCERTAIN


                                                                                                                                                  YES
                                                 NO

                           Response to                           Consult Haematologist/Paediatrician/Physician                      Thalassaemia carrier
                            treatment


                         YES

                             Continue
                             treatment                 Consider DNA analysis
                                                                                          NO            Definitive          YES         Counselling
                                                       Further investigation as
                                                             appropriate                                diagnosis




List of clinics that conduct thalassaemia screening is available at
http://fh.moh.gov.my/uploads/pend_kes/kk_talasemia.pdf
Would Malaysian couples accept this option?
          Non-Directed Counselling
            Thalassaemia counsellors




                                      
Would Malaysian thalassaemia carriers accept this?
Assessment of Prevention programme
       – Secondary Indicator


   Birth of new thalassaemia
    patients
      Prevention programme

   Population screening
     Have not reached targets
       1 birth cohort annually
       All target groups
Birth of new Thalassaemia patients
                      - surrogate index for good control programme
                 2002
                            2003
                                       2004
                                                 2005
                                                            2006
                                                                   2007
                                                                          2008
                                                                                 2009
    Year




                                                                                        2010
                                                                                               2011
   New
         226 177 192 184 175 167 137                                             82      14     1
  Births
                                                              ? Policy 4.5




(Malaysian Thalassaemia Registry 2009 – unpublished data)
National Programme in Malaysia
  (THALASSAEMIA PREVENTION & CONTROL PROGRAMME)


 1. Public awareness & health education
     TV advertorials/Radio adverts/Mass media
 2. Population Screening & laboratory diagnosis
     Screening of focus groups
         Adolescents, Pre-marital age group, High risk families, cascade screening
     Improved laboratory diagnosis at all levels
         + Pre-natal diagnosis

 3. Comprehensive management of patients
      Setting a National KPI for quality of care

 4. Thalassaemia registry
 5. Cost Implications
Iron Chelation Therapy




Launched in
2010 by
YBMK during
the WORLD
THALASSAEMIA
DAY




                         12
CLINICAL INDICATORS
        FOR QUALITY MANAGEMENT
           Indicators                           Significance
Percentage of leucoreduced Packed    Good blood transfusion service
Red Blood Cell (PRBC) units issued      Leucoreduction better done at Blood bank
                                        Provision of adequate budget
to transfusion dependent
thalassaemia patients
Percentage of transfusion                       Prompt treatment
dependent patients with serum
ferritin > 1000 µ/L receiving iron
chelation therapy
Percentage of patients with mean         Quality of chelation therapy
annual serum ferritin < 2500 µg/L                National KPI

Mortality rate per annum                          Mortality trend
Other Indicators to measure quality of
        clinical management
•   Percentage of patients with SF >5000 mcg/L
•   Percentage of patients with SF >10000 mcg/L
•   Percentage of leucoreduced pRBC used
•   Percentage of patients with pre-transfusion Hb < 9 gm%
•   Percentage of patients with Hepatitis B/C positivity
•   Percentage of patients with short stature
•   Percentage of patients with delayed puberty
•   Percentage of patients with Diabetes/Impaired GTT
•   Percentage of patients with hypothyroidism or other
    endocrinopathies
•   Percentage of patients with osteopaenia/osteoporosis
•   Percentage of patients with T2* value < 20 ms
•   Percentage of patients with Liver iron > 7 mg/gm DW
Quality of care indicators
   1. Mortality
     Survival curves
     Causes of death
     Role of Compliance

   2. Morbidity
     Multi-organ toxicities
     Serum Ferritin levels
Causes of Death in Thalassaemia,
           Malaysia, 2006 – 2009 (n=124)
                                                            TOTAL
                           Causes
                                                           No     %
             Cardiac                                       47    38
             Infections                                    20    16
             Liver Disease                                 3      2
             Endocrine                                     15    12
             Thrombosis                                    1      1
             Tumours                                       3      3
             *Others                                       5      4
             Unknown/Unspecified                           30    24
                            TOTAL                          124   100
(Malaysian Thalassemia Registry 2010 – unpublished data)
Quality of care indicators
1. Mortality
  Survival curves
  Causes of death
  Role of Compliance

2. Morbidity
  Multi-organ toxicities
  Serum Ferritin levels
Multi-organ toxicities in Thalassaemia
      patients: HUKM (2003) & IPHKL (2004)

   Complications                                Prevalence
   Growth impairment                            54.5%*
   Pubertal delay                               21.2%*
   Lung dysfunction                             33.3%*
   Hypothyroidism (subclinical)                 5.6%#
   Osteoporosis                                 84.2%*
   Impaired GTT                                 44.4%*, 22.2%#
   Diabetes mellitus                            1.9%#
   Cardiac dysfunction                          70%*
   Hepatitis C seropositive                     22.4%*, 9.3%#
(HUKM- 2003*, IPHKL-2004#   >10 years (n=54))
Percentage (%) of thalassaemia patients by States
                grouped by Serum Ferritin levels
       (<2500, 2501 – 10000, >10000) µg/L, Malaysia 2009




Many states have incomplete data for serum ferritin level levels of their patients
                                               (Malaysian Thalassaemia Registry 2009 – unpublished data)
How high should we set KPI?

                                                   80%
                                                                    70%
PERCENTAGE (%)




                                                                                      60%
                                  50%                                                                  50%

                                                                                                                        40%




                 Serum Ferritin level of transfusion dependent patients by Age groups, Malaysia, 2010 (n=1594) – unpublished data
Serum Ferritin (µg/L), < 10 years old, transfusion
dependent thalassaemia patients, IPHKL, 2009 - 2010

    National targeted KPI is 60% of transfusion dependent Thalassaemia
     patients below 10 years old to have serum ferritin levels < 2500 µg/L


                                2009                          2010
  Serum Ferritin
                       No.        (%)       (%)       No.       (%)          (%)
      (µg/L)
      < 1000             5       11.4                  10       16.9
                                           50.0                              64.4
    1000-2499           17       38.6                  28       47.5
    2500-4999           17       38.6                  15       25.4
    5000-9999            5       11.4      50.0         6       10.2         35.6
     > 10,000            0        0.0                   0        0.0
      TOTAL             44       100        100        59       100          100
Therapeutic goals
Parameter        Normal    Mild     Moderate Severe

Liver Iron       <1–2      3–7       7 – 15   > 15
Concentration
(mg Fe/g dw)
T2* (ms)          > 20    15 - 20   10 – 15   <10

Serum Ferritin   < 300    <1000      1000-    >2500
(µg/ml)                              2500

NTBI/LPI/LCI      To be kept within normal limits
Optimal chelation
 Start Iron Chelation therapy if serum ferritin > 1,000 µg/L


                            MONOTHERAPY
      •DFO 20 – 40 mg/kg/day (children)/50 - 60 mg/kg/day (adults)
     •DFX 20-30 mg/kg/day in young children more than 2 years old
               •DFP 75-100 mg/kg/day in older children


   Adequate chelation:                           Inadequate chelation:
•Serum ferritin <2,500 µg/L                    •Serum ferritin >2,500 µg/L
     •T2*heart >20ms                                •T2*heart <20ms
  •LIC < 7mg Fe/gm DW                            •LIC > 7 mg Fe/gm DW
                                               (If MRI is available, T2* MRI for those >10)

(If MRI is available, T2* MRI for those>10)
                                              •Check compliance
                                              •Optimise monotherapy
Continue current iron chelator & aim for
      serum ferritin < 1,000 µg/L             •Consider combination therapy
Management strategy by stratifying
      patients by risk groups
                                          Assess iron load
Low/Good                                  Stratify patients by
   Risk                                    risk group
                                          Adopt appropriate iron
                                           chelation strategies




  National cohort of thalassaemia patients in Malaysia – Dec 2009
National Programme in Malaysia
  (THALASSAEMIA PREVENTION & CONTROL PROGRAMME)


 1. Public awareness & health education
     TV advertorials/Radio adverts/Mass media
 2. Population Screening & laboratory diagnosis
     Screening of focus groups
         Adolescents, Pre-marital age group, High risk families, cascade screening
     Improved laboratory diagnosis at all levels
         + Pre-natal diagnosis

 3. Comprehensive management of patients
      Setting a National KPI for quality of care

 4. Thalassaemia registry
 5. Cost Implications
04 March 2005

RM40mil to treat 600,000 victims of thalassaemia
PUTRAJAYA
……………………………………………………..




“WE WILL ALSO START
A CENSUS TO REGISTER
ALL THALASSAEMIA PATIENTS
AND CARRIERS IN THE COUNTRY
BEGINNING WITH SECONDARY SCHOOL
  STUDENTS”
  ……………………….Datuk Chua Soi Lek
Epidemiology – Malaysia
 Number of Patients
 Distribution Pattern
   Changing trend - patients surviving & living longer
   Geographical distribution
       Borneo
       Bordering Thailand
   Age groups
 Clinical Diagnoses
   Ethnicity
Number of Thalassaemia patients
          (by States, Malaysia, 2006 – 2010)




Increasing Trend  Old cases + New cases
           Better reporting + New births + Less mortality
+ Increasing number of survivors because of better treatment
Prevalance rate of thalassaemia patients per
         100,000 population by states, Malaysia 2009




(Malaysian Thalassemia Registry 2009 – unpublished data)
Changing Thalassaemia Demographic Pattern
         Comparing Italy with Malaysia

          Malaysia is @20 years behind.
                                   Developed countries
                                   • Less young patients
                                   • More older patients
                                   Developing countries
                                   • More young patients
                                   • Less older patients




                                           University of Turin, Italy
We have more patients surviving
         Patient population cohort, Malaysia 2002  2006  2010

 • More children are surviving  adolescents  young adults
 • Presence of more older patients
 • Patient population cohort shifting to the right


             2002                               2006                           2010
   Median Age group: 5 – 9 yrs                 Median Age group: 5 – 10 yrs   Median Age group: 10 – 15 yrs

          35.6 %

                    27.6 %
                               18.2 %
12.6 %

                                        6%


 0-4       5-9      10-14      15-19    > 20

                 Age (years)


  (n = 1683(@30 hospitals)
Thalassaemia by Clinical diagnoses, Malaysia, 2009


               Clinical Diagnosis                           N     (%)
           Beta thalassaemia major                         2109   44.7

           Hb E-Beta thalassaemia                          1489   31.6
           Beta thalassaemia
                                                           465    9.8
           intermedia
           HbH Disease                                     476    10

           *Others                                         176    3.7

                            TOTAL                          4715   100

(Malaysian Thalassemia Registry 2009 – unpublished data)
Thalassemia by Ethnicity, Malaysia 2009
                                                                                          Malaysian
 Ethnic                                                        (%)
                                                                                          population
 Malay                                                        62 %                         50.4 %
 Kadazan-Dusun                                                14 %                          3.6%*
 Chinese                                                      13 %                          23.7%
 Other Indigenous
 ethnic groups (minus                                                                       7.4%
                                                              10 %
 Kadazan Dusun)
 Others                                                                                     7.8%
 Indian                                                        1%                           7.1%
 TOTAL                                                         100                          100 %
(Malaysian Thalassemia Registry 2009 – unpublished data). * estimates for Kadazan-Dusun
Diagnoses by ethnic groups, 2010




              Various ethnic groups exhibit different thalassaemia phenotypes

(Malaysian Thalassemia Registry 2010 – unpublished data)
Distribution of Patients by Iron
            Chelation, Malaysia, 2009

                                                                    Patients
                                     Chelators
                                                             No.                %

                                   Desferrioxamine (DFO)     1479              65.7
       Currently on regular Iron




                                   Deferiprone (DFP)         222               9.9
              Chelation




                                   Deferasirox (DFX)         217               9.6
                                   Desferrioxamine (DFO) +
                                                             332               14.8
                                   Deferiprone (DFP)

                                   Total                     2250          100 %



(Malaysian Thalassemia Registry 2009 – unpublished data)
National Programme in Malaysia
  (THALASSAEMIA PREVENTION & CONTROL PROGRAMME)


 1. Public awareness & health education
     TV advertorials/Radio adverts/Mass media
 2. Population Screening & laboratory diagnosis
     Screening of focus groups
         Adolescents, Pre-marital age group, High risk families, cascade screening
     Improved laboratory diagnosis at all levels
         + Pre-natal diagnosis

 3. Comprehensive management of patients
      Setting a National KPI for quality of care

 4. Thalassaemia registry
 5. Cost Implications
      Commitment of additional funding from the Government 2012
Summary – Thalassaemia update
1. The Malaysian National Thalassaemia Prevention &
   Control Programme started in 2005
2. United stakeholders & strong political will
3. Changing epidemiology in Malaysia
     Total number of registered patients are increasing
     Total number of birth is declining
     Unique Geographical & Ethnic distribution
4. Patient management & outcomes are improving
     Monitoring of clinical outcome parameters
5. More resources required to improve the programme
TEriKMa
                kAsiH.....

Thalassaemia
  patients


               Tawan Kinabalu
                   2007

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  • 1. ‘Current situation in control strategies and Health Systems in Asia – Malaysia’ Hishamshah Ibrahim, MD Ministry of Health, MALAYSIA Thursday, 9 February 2012,12:25 – 12:35 AM
  • 2. National Programme in Malaysia (Designated: THALASSAEMIA PREVENTION & CONTROL PROGRAMME) 1. Public awareness & health education  TV advertorials/Radio adverts/Mass media 2. Population Screening & laboratory diagnosis  Screening of focus groups  Adolescents, Pre-marital age group, High risk families, cascade screening  Improved laboratory diagnosis at all levels  + Pre-natal diagnosis 3. Comprehensive management of patients  Setting a National KPI for quality of care 4. Thalassaemia registry 5. Cost Implications
  • 3. Monday, 10 May 2004 Dr Chua: Registry proposed to track thalassaemia cases THE HEALTH MINISTRY WANTS TO SET UP A NATIONAL THALASSAEMIA REGISTRY TO FIND OUT THE LEVEL OF INCIDENCE ON THE DISORDER. Health Minister Datuk Dr Chua Soi Lek said a report on the registry was in its final stage of preparation by a task force headed by the ministry’s Family And Health Development Division director Datuk Dr Narimah Awin. “I expect to table it to the Cabinet in two months,” he said after launching the first National Thalassaemia seminar in Kuala Lumpur on Sunday. Thalassaemia is a genetic disorder, which disrupts red blood cell-formation. The red blood cells are easily destroyed and have a short lifespan, resulting in anaemia, causing patients to become pale and easily tired. Dr Chua said: “The problem starts when both parents are carriers. This has a multiplying effect as they will produce children with thalassaemia major, who generally require blood transfusion and iron therapy treatment.” Between 3% and 5% of Malaysians are carriers of this genetic disorder.
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  • 5. National Programme in Malaysia (THALASSAEMIA PREVENTION & CONTROL PROGRAMME) 1. Public awareness & health education  TV advertorials/Radio adverts/Mass media 2. Population Screening & laboratory diagnosis  Screening of focus groups  Adolescents, Pre-marital age group, High risk families, cascade screening  Improved laboratory diagnosis at all levels  + Pre-natal diagnosis 3. Comprehensive management of patients  Setting a National KPI for quality of care 4. Thalassaemia registry updates 5. Cost Implications  Cabinet memorandum
  • 6. The Strategy & Policy of Prevention (Source: WHO) Strategy & Policy % of baseline number of new cases of thalassaemia Policy 1: No prevention programme (baseline situation) 100% Policy 2: Best possible care (BPC) + Retrospective genetic 60% counseling (RGC) after the 1st affected child is diagnosed Policy 3: BPC + RGC + Prenatal diagnosis (PND) & abortion in 50% subsequent affected pregnancies Policy 4: BPC + RGC + Prospective pre-marital carrier screening 25-50% - slow and counseling (PPMC) and no PND (+abortion) (over 20 years) In Malaysia: BPC + RGC + some PPMC + Policy 25-50% - slow ‘Voluntary’ population based screening + Family 4.5 screening. Minimal PND + abortion. (?years) Policy 5: BPC + RGC + PPMC + Population based screening + Approximately 25% Family screening of index cases and no PND (+abortion) Policy 6: BPC + RGC + PPMC + PND (+abortion) + antenatal <10% screening
  • 7. ALGORITHM FOR VOLUNTARY AND CASCADE SCREENING Index Case – Thalassaemia Walk-in for voluntary Major /Carriers screening Pre-test counselling Offer pre-test counselling and screening for family Offer pre-test counselling and screening for members immediate family members (Uncles, aunts and cousins of the index case) (Parents + siblings of the index case) FBC Send FBC result & unstained PPBF slide with remaining blood to Hospital for Hb analysis Hb-normal YES Hb – normal Hb-low MCH < 27 MCH >27 MCH < 27 All can be performed on one 2.5cc EDTA sample Post-test Check & treat for iron counselling deficiency anaemia Definitive diagnosis Normal UNCERTAIN YES NO Response to Consult Haematologist/Paediatrician/Physician Thalassaemia carrier treatment YES Continue treatment Consider DNA analysis NO Definitive YES Counselling Further investigation as appropriate diagnosis List of clinics that conduct thalassaemia screening is available at http://fh.moh.gov.my/uploads/pend_kes/kk_talasemia.pdf
  • 8. Would Malaysian couples accept this option? Non-Directed Counselling Thalassaemia counsellors   Would Malaysian thalassaemia carriers accept this?
  • 9. Assessment of Prevention programme – Secondary Indicator Birth of new thalassaemia patients  Prevention programme Population screening Have not reached targets 1 birth cohort annually All target groups
  • 10. Birth of new Thalassaemia patients - surrogate index for good control programme 2002 2003 2004 2005 2006 2007 2008 2009 Year 2010 2011 New 226 177 192 184 175 167 137 82 14 1 Births ? Policy 4.5 (Malaysian Thalassaemia Registry 2009 – unpublished data)
  • 11. National Programme in Malaysia (THALASSAEMIA PREVENTION & CONTROL PROGRAMME) 1. Public awareness & health education  TV advertorials/Radio adverts/Mass media 2. Population Screening & laboratory diagnosis  Screening of focus groups  Adolescents, Pre-marital age group, High risk families, cascade screening  Improved laboratory diagnosis at all levels  + Pre-natal diagnosis 3. Comprehensive management of patients  Setting a National KPI for quality of care 4. Thalassaemia registry 5. Cost Implications
  • 12. Iron Chelation Therapy Launched in 2010 by YBMK during the WORLD THALASSAEMIA DAY 12
  • 13. CLINICAL INDICATORS FOR QUALITY MANAGEMENT Indicators Significance Percentage of leucoreduced Packed Good blood transfusion service Red Blood Cell (PRBC) units issued  Leucoreduction better done at Blood bank  Provision of adequate budget to transfusion dependent thalassaemia patients Percentage of transfusion Prompt treatment dependent patients with serum ferritin > 1000 µ/L receiving iron chelation therapy Percentage of patients with mean Quality of chelation therapy annual serum ferritin < 2500 µg/L National KPI Mortality rate per annum Mortality trend
  • 14. Other Indicators to measure quality of clinical management • Percentage of patients with SF >5000 mcg/L • Percentage of patients with SF >10000 mcg/L • Percentage of leucoreduced pRBC used • Percentage of patients with pre-transfusion Hb < 9 gm% • Percentage of patients with Hepatitis B/C positivity • Percentage of patients with short stature • Percentage of patients with delayed puberty • Percentage of patients with Diabetes/Impaired GTT • Percentage of patients with hypothyroidism or other endocrinopathies • Percentage of patients with osteopaenia/osteoporosis • Percentage of patients with T2* value < 20 ms • Percentage of patients with Liver iron > 7 mg/gm DW
  • 15. Quality of care indicators 1. Mortality Survival curves Causes of death Role of Compliance 2. Morbidity Multi-organ toxicities Serum Ferritin levels
  • 16. Causes of Death in Thalassaemia, Malaysia, 2006 – 2009 (n=124) TOTAL Causes No % Cardiac 47 38 Infections 20 16 Liver Disease 3 2 Endocrine 15 12 Thrombosis 1 1 Tumours 3 3 *Others 5 4 Unknown/Unspecified 30 24 TOTAL 124 100 (Malaysian Thalassemia Registry 2010 – unpublished data)
  • 17. Quality of care indicators 1. Mortality Survival curves Causes of death Role of Compliance 2. Morbidity Multi-organ toxicities Serum Ferritin levels
  • 18. Multi-organ toxicities in Thalassaemia patients: HUKM (2003) & IPHKL (2004) Complications Prevalence Growth impairment 54.5%* Pubertal delay 21.2%* Lung dysfunction 33.3%* Hypothyroidism (subclinical) 5.6%# Osteoporosis 84.2%* Impaired GTT 44.4%*, 22.2%# Diabetes mellitus 1.9%# Cardiac dysfunction 70%* Hepatitis C seropositive 22.4%*, 9.3%# (HUKM- 2003*, IPHKL-2004# >10 years (n=54))
  • 19. Percentage (%) of thalassaemia patients by States grouped by Serum Ferritin levels (<2500, 2501 – 10000, >10000) µg/L, Malaysia 2009 Many states have incomplete data for serum ferritin level levels of their patients (Malaysian Thalassaemia Registry 2009 – unpublished data)
  • 20. How high should we set KPI? 80% 70% PERCENTAGE (%) 60% 50% 50% 40% Serum Ferritin level of transfusion dependent patients by Age groups, Malaysia, 2010 (n=1594) – unpublished data
  • 21. Serum Ferritin (µg/L), < 10 years old, transfusion dependent thalassaemia patients, IPHKL, 2009 - 2010  National targeted KPI is 60% of transfusion dependent Thalassaemia patients below 10 years old to have serum ferritin levels < 2500 µg/L 2009 2010 Serum Ferritin No. (%) (%) No. (%) (%) (µg/L) < 1000 5 11.4 10 16.9 50.0 64.4 1000-2499 17 38.6 28 47.5 2500-4999 17 38.6 15 25.4 5000-9999 5 11.4 50.0 6 10.2 35.6 > 10,000 0 0.0 0 0.0 TOTAL 44 100 100 59 100 100
  • 22. Therapeutic goals Parameter Normal Mild Moderate Severe Liver Iron <1–2 3–7 7 – 15 > 15 Concentration (mg Fe/g dw) T2* (ms) > 20 15 - 20 10 – 15 <10 Serum Ferritin < 300 <1000 1000- >2500 (µg/ml) 2500 NTBI/LPI/LCI To be kept within normal limits
  • 23. Optimal chelation Start Iron Chelation therapy if serum ferritin > 1,000 µg/L MONOTHERAPY •DFO 20 – 40 mg/kg/day (children)/50 - 60 mg/kg/day (adults) •DFX 20-30 mg/kg/day in young children more than 2 years old •DFP 75-100 mg/kg/day in older children Adequate chelation: Inadequate chelation: •Serum ferritin <2,500 µg/L •Serum ferritin >2,500 µg/L •T2*heart >20ms •T2*heart <20ms •LIC < 7mg Fe/gm DW •LIC > 7 mg Fe/gm DW (If MRI is available, T2* MRI for those >10) (If MRI is available, T2* MRI for those>10) •Check compliance •Optimise monotherapy Continue current iron chelator & aim for serum ferritin < 1,000 µg/L •Consider combination therapy
  • 24. Management strategy by stratifying patients by risk groups  Assess iron load Low/Good  Stratify patients by Risk risk group  Adopt appropriate iron chelation strategies National cohort of thalassaemia patients in Malaysia – Dec 2009
  • 25. National Programme in Malaysia (THALASSAEMIA PREVENTION & CONTROL PROGRAMME) 1. Public awareness & health education  TV advertorials/Radio adverts/Mass media 2. Population Screening & laboratory diagnosis  Screening of focus groups  Adolescents, Pre-marital age group, High risk families, cascade screening  Improved laboratory diagnosis at all levels  + Pre-natal diagnosis 3. Comprehensive management of patients  Setting a National KPI for quality of care 4. Thalassaemia registry 5. Cost Implications
  • 26. 04 March 2005 RM40mil to treat 600,000 victims of thalassaemia PUTRAJAYA …………………………………………………….. “WE WILL ALSO START A CENSUS TO REGISTER ALL THALASSAEMIA PATIENTS AND CARRIERS IN THE COUNTRY BEGINNING WITH SECONDARY SCHOOL STUDENTS” ……………………….Datuk Chua Soi Lek
  • 27. Epidemiology – Malaysia Number of Patients Distribution Pattern Changing trend - patients surviving & living longer Geographical distribution  Borneo  Bordering Thailand Age groups Clinical Diagnoses Ethnicity
  • 28. Number of Thalassaemia patients (by States, Malaysia, 2006 – 2010) Increasing Trend  Old cases + New cases Better reporting + New births + Less mortality + Increasing number of survivors because of better treatment
  • 29. Prevalance rate of thalassaemia patients per 100,000 population by states, Malaysia 2009 (Malaysian Thalassemia Registry 2009 – unpublished data)
  • 30. Changing Thalassaemia Demographic Pattern Comparing Italy with Malaysia Malaysia is @20 years behind. Developed countries • Less young patients • More older patients Developing countries • More young patients • Less older patients University of Turin, Italy
  • 31. We have more patients surviving Patient population cohort, Malaysia 2002  2006  2010 • More children are surviving  adolescents  young adults • Presence of more older patients • Patient population cohort shifting to the right 2002 2006 2010 Median Age group: 5 – 9 yrs Median Age group: 5 – 10 yrs Median Age group: 10 – 15 yrs 35.6 % 27.6 % 18.2 % 12.6 % 6% 0-4 5-9 10-14 15-19 > 20 Age (years) (n = 1683(@30 hospitals)
  • 32. Thalassaemia by Clinical diagnoses, Malaysia, 2009 Clinical Diagnosis N (%) Beta thalassaemia major 2109 44.7 Hb E-Beta thalassaemia 1489 31.6 Beta thalassaemia 465 9.8 intermedia HbH Disease 476 10 *Others 176 3.7 TOTAL 4715 100 (Malaysian Thalassemia Registry 2009 – unpublished data)
  • 33. Thalassemia by Ethnicity, Malaysia 2009 Malaysian Ethnic (%) population Malay 62 % 50.4 % Kadazan-Dusun 14 % 3.6%* Chinese 13 % 23.7% Other Indigenous ethnic groups (minus 7.4% 10 % Kadazan Dusun) Others 7.8% Indian 1% 7.1% TOTAL 100 100 % (Malaysian Thalassemia Registry 2009 – unpublished data). * estimates for Kadazan-Dusun
  • 34. Diagnoses by ethnic groups, 2010 Various ethnic groups exhibit different thalassaemia phenotypes (Malaysian Thalassemia Registry 2010 – unpublished data)
  • 35. Distribution of Patients by Iron Chelation, Malaysia, 2009 Patients Chelators No. % Desferrioxamine (DFO) 1479 65.7 Currently on regular Iron Deferiprone (DFP) 222 9.9 Chelation Deferasirox (DFX) 217 9.6 Desferrioxamine (DFO) + 332 14.8 Deferiprone (DFP) Total 2250 100 % (Malaysian Thalassemia Registry 2009 – unpublished data)
  • 36. National Programme in Malaysia (THALASSAEMIA PREVENTION & CONTROL PROGRAMME) 1. Public awareness & health education  TV advertorials/Radio adverts/Mass media 2. Population Screening & laboratory diagnosis  Screening of focus groups  Adolescents, Pre-marital age group, High risk families, cascade screening  Improved laboratory diagnosis at all levels  + Pre-natal diagnosis 3. Comprehensive management of patients  Setting a National KPI for quality of care 4. Thalassaemia registry 5. Cost Implications  Commitment of additional funding from the Government 2012
  • 37. Summary – Thalassaemia update 1. The Malaysian National Thalassaemia Prevention & Control Programme started in 2005 2. United stakeholders & strong political will 3. Changing epidemiology in Malaysia  Total number of registered patients are increasing  Total number of birth is declining  Unique Geographical & Ethnic distribution 4. Patient management & outcomes are improving  Monitoring of clinical outcome parameters 5. More resources required to improve the programme
  • 38. TEriKMa kAsiH..... Thalassaemia patients Tawan Kinabalu 2007