Is the private sector prepared to engage in MDR-TB management? Findings from the Philippines Tauhid Islam WHO/WPRO
PPM and PMDT: The Philippines Why PPM-PMDT? Assessments Finding way forward!
The Philippines: The pioneer country in conceptualizing PPM model 1993: PhilCAT 1995: PPM DOTS project 1999: PPM DOTS-Plus 2003: DoH adopted PPM strategy 2004: Operational guidelines 2010: PhilPACT 2010-16 2011: 12% contribution to total notifications of new TB cases 2012: 24% contribution to total notifications of new TB cases 2013: 171 (26%) public hospital, 157 (24%) private hospitals engaged, 8513 private practitioners trained on DOTS
The Philippines: Commendable progress in PMDT scale up Good progress has been achieved in case finding and the scaling up against their targets The enrolment increased four times in 2011 compared to 2010 Programme covers all 17 regions 45 treatment and satellite treatment centers 18 culture, 3 DST and 20 GeneXpert No. of patients 2500 2000 1500 1000 500 0 Yearly enrolled 526 566 2056 1953 01 02 03 04 05 06 07 08 09 10 11 12 Year
Why PPM-PMDT? The same onion model applies! Despite progress, the number of MDR-TB cases notified in 2011 represents 19% of estimated caseload (among notified) of the Philippines.
Estimated MDR-TB among notified are within NTP network 4. Present to health facilities but not diagnosed 3. Public or private but not notified 2. NTP or collaborating providers but not reported 1. Recorded in notification data
Moving towards outside NTP network 4. Present to health facilities but not diagnosed 3. Public or private but not notified 2. NTP or collaborating providers but not reported 1. Recorded in notification data
Opening the PANDORA BOX Major challenge! And opportunity to strengthen the system Specialized Hospital Specialized lab Specialist doctors Long duration of Tx Difficult patients ADR Availability of QA drugs Catastrophic expenditure
A story line Pharmacy Traditional healer Private hospital Private practitioners NGO FBO Public health center/dots Public hospital/dots Public hospital
A story line Private Specialist TB doctor Private Hospital Public PMDT centres
A story line Private laboratory Public laboratory
A story line Private market drugs NTP drugs
PPM-PMDT Is it the same modality as PPM DOTS?? The strategic information is crucial for understanding where the 'missing MDR-TB cases' are being diagnosed and treated, assessing the quality of private sector MDR diagnosis and care, and developing appropriate mechanism. Detailed assessment should include the following sectors Private physicians Hospitals Laboratory Drug market
1 A survey among specialist private practitioners on the practise in dealing with MDR-TB suspects and patients in the Philippines
Methodology A pre-tested short questionnaire survey Pulmonologists and infectious disease (ID) specialists who are active members of two medical societies in the Philippines were approached PTSI: Philippines Tuberculosis Society Inc PSMID: Philippines society for Microbiology and Infectious Disease The questions were either emailed to respondents, or provided in hard copies during a meeting and a national convention. The questions were sent to a total of 220 members of the two societies The survey yielded 152 respondents (69%) response rate
Findings 87% (132) encountered at least one highly suspected or laboratory-confirmed MDR-TB patients in their practice in the last 12 months. The average number of MDR-TB patients seen was 6 in the last 12 months. 86% specialist practitioners referred their MDR-TB patients to other facilities or physicians Among those who referred their cases, 33% specified that they referred them to NTP approved sites (either MDR-TB and/or DOTS facilities) 11% (15) managed themselves.
2 An assessment of The potential role of the private sector in managing MDR-TB in the Philippines
Study preparation: Involving all stakeholders
Methodology Semi-structured questionnaires Trained field interviewers (6 pulmonologists) One-on-one interviews with the study subjects
Study population: response rate
Geographic involvement of study population
Hospitals Aware Not aware 100% 13% 4% 53% 54% % hospitals 80% 60% 40% 87% 96% 20% 47% 46% 0% Free TB dxcs Free TB drugs Free MDR-TB dxcs Free MDR-TB drugs
Anti-TB drugs No. pharmacies Single: H, R, Z, E 33 (46%) FDC: HRZE 62 (89%) HRE, HRZ 30-55 (42%-76%) HR 31 (43%) Injectables Streptomycin 39 (54%) Amikacin 56 (78%) Kanamycin 0 Capreomycin 0 Fluoroquinolones Ofloxacin 35 (49%) Levofloxacin 35 (49%) Ciprofloxacin 33 (46%) Moxifloxacin 31 (43%) Anti-TB drugs in hospital pharmacies (n=72) Oral b-static SLDs Ethionamide, Cycloserine, PAS Group 5 drugs Clofazimine 0 Clarithromycin 69 (96%) CoAmoxiclav 72 (100%) Imipenem/Meropenem 55 (76%) Linezolid 31 (43%) 0
Private Practitioners Treatment rate among MDs who saw TB/MDR-TB patients
Use of standard regimens for TB New cases (n=108) Standard Regimen: 2HRZE/4HR Previously treated cases (n=86) Standard Regimen: 2HRZES/HRZE/5HRE Other regimens 18% 28% 82% 72%
Regimens for chronic TB cases 20 regimens by 21 MDs 11. 2HRZES/HRZE/5HRE (2) 12. 2HRZES/HRZE/6HRE 13. 2HRZES/4-6HRZE/HR 14. HRZE/HRE + S, Lfx 15. HRZE + 1 wk Cfx or Mfx 16. HRZE + any FQ (Ofx, Lfx, Mfx) 17. 3HRZES + 1 mo Lfx (sometimes) 18. 2HRZESFq/HRZEFq/5HRE 19 2HRZESCfx/HRZECfx/3HRECfx+2HRE 20. HRZE initially. If resistant + 2-3 S and/or Cfx until end of treatment Regimens for DR-TB suspects (9 regimens by 21 MDs) HRZE(S) + FQ + Cla
Regimens for MDR-TB patients 6 regimens for 6 MDs 1. HRZES Lfx 18-24 mos 2. HRZES Ofx/Lfx/Mfx 2 mos after (-) 3. HZES Lfx Till CD4 ct normal 4. 2HRZES Cfx/10HRZE Cfx 12 mos (Amikacin sometimes) 5. HRZES Cfx (Amikacin) 24 mos 6. HRZE Cfx/Mfx Cla 12 mos Practices: Ambulatory in all 6 No treatment partner in 4 Family member in 3, volunteer, public HW Injectable: 2-6 mos
Private laboratories Procedure No. (%) laboratories Method Smear microscopy 14 (100%) Kinyoun s (8) Zhiel Neelsen (7) Fluorescence (3) Culture 14 (100%) Solid (13) Liquid (12) DST 12 (86%) MGIT (8) Conventional (5) Molecular techniques 4 Xpert MTB/RIF (3) Line probe assay (HAIN test) - 1
Q to MDs. Are you interested and willing to (further) collaborate with gov t for MDR-TB control?
Q to Hospitals and Labs. Are you interested and willing to (further) collaborate with the gov t for TB/ MDR-TB control? Hospitals for MDR-TB (n=58) Willing Unwilling 45% 55% Laboratories (n=14): 100% willing to collaborate for both TB and MDR-TB control
Possible areas of collaboration with Hospitals (n=64), MDs (n=102) and Laboratories (n=14) Area for collaboration Hospitals No. (%) MDs No. (%) Labs No. (%) 1. Training 59 (95%) 75 (74%) 11 (79%) 2. Becoming a DOTS/MDR-TB referring hospital 54 (92%) 77 (76%) - 3. Becoming a facility for TB laboratory tests 49 (78%) N/A - 4. Establishment of a DOTS facility 42 (76%)* 4 (4%) - 5. Becoming a facility for DR-TB laboratory tests 63 (43%) N/A 12 (86%) 6. Establishment of an MDR-TB facility (or as MD) 24 (38%) 3 (3%) - 7. Advocacy 23 (36%) 81 (79%) 13 (93%) 8. Research 12 (19%) 53 (52%) 14 (100%)
3 Market size and utilization of TB Drugs in the Philippines
NTP driven procurement Procurement year and equivalent cohort year* 2007 2008 2009 2010 2011 GDF 130,784 64,408 Cat I & III Kits Local Procurement 114,544 256,810 378,000 228,157 Total 130,784 178,952 256,810 378,000 228,157 Corresponding notified new and relapse cases* 139,603 146,565 166,323 195,560 203,826 Difference -8,819 32,387 90,487 182,440 24,331 GDF 3,205 Cat II Kits Local Procurement 16,372 Total - 3,205-16,372 - Corresponding notified retreatment cases* 6,289 6,602 8,066 10,528 13,103 Difference -6,289-3,397-8,066 5,844-13,103 Total cost (USD in millions) 2.3 5.5 12 13 5.5
Private sector Anti TB drug sales 120,000,000 100,000,000 80,000,000 60,000,000 40,000,000 20,000,000 0 2007 2008 2009 2010 2011 26 25 24 23 22 21 Millions Dosage unit Sales in USD
Private sector Anti TB drug sales 2007 2008 2009 2010 2011 4FDC (J04A5) 39,021,040 41,895,860 46,120,220 42,456,960 43,103,500 Number of new TB patients can be treated 77,423 249,380 274,525 252,720 256,568 Standard treatment regimen: 4 FDC : 2 FDC = 1 : 2 Private sale: 4 FDC: 2 FDC = 5: 1 Indicates drugs may not be used as per standard treatment regimen
Second line drugs (Source: FDA database) Gr Description Drugs availability Products registered 2 Injectable Kanamycin Yes 2 Amikacin Yes 36 Capreomycin Yes 3 3 Fluroquinolone Moxifloxacin Yes 9 Levofloxacin Yes 120 4 Oral bacteriostatic Cycloserine Yes 1 Ethionamide No NA Protionamide No NA PAS No NA Terizidone No NA 5 Unclear Linezolid Yes 4
TB drug sales in the Philippines (2007-2011) An enormous amount of TB drugs are channelled through the private drug market: Enough to treat 250,000 TB Patients annually assuming compliance with international regimens Combining public and private sales in 2011, TB cases could be treated which is 2.5 times higher Indicating severe under reporting and/or misuse of drugs Not all second line drugs are available in the private market and it is impossible to describe an adequate private sector MDR-TB regimen
Finding Way forward Stakeholders meeting
Is the private sector prepared to engage in MDR-TB management? Focus group discussion Hospital Private Practitioners Private laboratories Reality Quality
Framework Regulate Mandatory notification Accreditation Minimum set of quality criteria Regulation of drug sales Engage Information directory Insurance packages Training curricula Involve academia and medical associations in advocacy plan
To PPM Subgroup In this era of new drugs and diagnostics Revitalize PPM-PMDT task force
Acknowledgments Technical Working Group Proponent: WHO-Western Pacific Region (WPR) in collaboration with the National TB Program (NTP), DOH, Phil., National TB Reference Lab (NTRL), WHO-Phil. Study Team: Dr. Camilo Roa Dr. Maridel Borja Dr. Ma. Imelda Quelapio Dr. Tauhid Islam Dr.Kitty van Weezenbeek Advisory Group: Dr. Jubert Benedicto Dr. Lalaine Mortera Dr. Roentgene Solante Consultant-Interviewers Dr. Shane C. Boiser Dr. Chariza Halun Dr. Lerma Malabag Dr. Jennifer S. San Luis Dr. Andre Tanque Dr. Ma. Philina P. Villamor Ms. Alma Palparan
Acknowledgments Partners Phil Coalition against Tuberculosis (PhilCAT) Phil College of Chest Physicians (PCCP) Phil. Society for Microbiology & Infectious Diseases (PSMID) Phil Tuberculosis Society, Inc. (PTSI) Research Team Jundelle Romulo Gilbert Madriaga Kevin Borja Ruby Lamac Chris Mercado Admin staff: Reissie Francisco Study participants 76 hospitals, 118 Medical Doctors, and 14 laboratories
Thank YOU Salamat Po