Laporan Mengikuti 7th Meeting of the Subgroup on Public-Privite

Mix for TB Care and Control

Grand Palais, Lille, France 23-24 October 2011

Oleh : 1. Dyah Erti Mustikawati

2. Asik Surya

Ditjen PP&PL Kementerian Kesehatan RI 2011

A. Pendahuluan Latar Belakang Tuberkulosis atau TB masih merupakan masalah kesehatan masyarakat yang menjadi tantangan global. Indonesia merupakan negara pertama diantara negara-negara dengan beban TB yang tinggi di wilayah Asia Tenggara yang berhasil mencapai target Millenium Development Goals untuk TB pada tahun 2006, yaitu 70% deteksi dini dan 85% kesembuhan. Saat ini, Indonesia juga menghadapi berbagai tantangan bar seperti halnya TB/HIV, MDR-TB, TB pada anak dan masyarakat rentan lainnya, dan penemuan kasus TB mengalami stagnansi dalam beberapa tahun belakangan ini.. Fenomena seperti ini dialami bukan saja oleh Indonesia, tetapi juga pada negara-negara yang tergolong TB high burden countries. Pada Global report tahun 2011 dilaporkan bahwa rata-rata penurunan insidens di tingkat global sebesar 1,3% dan jumlah kasus baru diperkirakan 8,8 juta di tahun 2010. Sedangkan angka mortalitas akibat TB menunjukkan penurunan yang cukup tajam dengan penurunan sampai 46 persen sejak tahun 1990, Beban permasalahan TB terbesar ada di regional Asia Tenggara (40%), Africa (26%), Western Pacific (19%) dengan India merupakan Negara yang berkontribusi terbesar (26%). Proporsi angka kematian akibat TB yang terbesar juga terjadi di Asia Tenggara (47%) dimana kontribusi India dan China adalah 35%. Pencapaian paling dramatic dicapai oleh China, yang selama kurun waktu 1990-2010 karena berhasil mendokumentasikan penurunan insidens rata-rata 3,4% pertahun, angka prevalence turun sampai 50% dalam 20 tahun dan angka mortalitas turun sampai 80 persen. Dalam Global report 2011, juga dilaporkan bahwa pencapaian Case Detection Rate ditingkat global adalah 65% (range 63-68%) dan Success Rate 87%. Walaupun data tersebut menunjukkan bahwa strategi DOTS efektif untuk pengendalian TB, tetapi dirasakan bahwa dalam beberapa tahun belakangan ini peningkatan CDR sangat lamban dan mengakibatkan insidens di tingkat global turun terlalu lambat. Untuk itu pelu dilakukan upaya-upaya yang lebih strategis untuk mengendalikan beban penyakit TB di masyarakat masih sangat tinggi dan semakin meningkat permasalahannya dengan ko-infeksi TB/HIV, resistensi obat TB dan tantangan lainnya. Strategi global mendatang akan diarahkan untuk bisa mendeteksi semua kasus TB serta mendeteksi dan mengobati kasus TB lebih awal (universal akses) agar terjadi pemutusan mata rantai penularan TB dan mempercepat penurunan insidens menuju “World TB Free 2050”, mendeteksi dan mengelola kasus TBMDR,

LAPORAN PERJALANAN DINAS 7th Meeting of the Subgroup on Public-Privite Mix for TB Care

and Control Grand Palais, Lille, France

23-24 October 2011 Dilaporkan oleh : Dyah Erti Mustikawati, MPH (NTP Manager) Dr. Asik Surya, MPPM (Deputy NTP Manager)

Tanggal Perjalanan Dinas : 23-24 Oktober 2011 Sumber Pendanaan: GF-ATM Komponen TB

serta meningkatkan pengelolaan Koinfeksi TBHIV. Secara global diamati bahwa keterlibatan sektor swasta dalam pengendalian TB masih sangat terbatas, dibeberapa Negara seperti India dan Rusia malahan dirasakan “uncontrollable”. Situasi ini dikhawatirkan akan menjadi bom waktu untuk mencetuskan terjadinya epidemi TBMDR di masa mendatang. Berbagai pendekatan PPM sudah dilaksanakan oleh beberapa Negara di berbagai region dan terbukti menunjukkan adanya peningkatan notifikasi, tetapi tampaknya upaya yang dilakukan belum secara menyeluruh sehingga hasilnya dirasa masih sangat minimal. Sub Core group PPM dibentuk oleh STB-WHO untuk merekomendasikan isu-isu strategis terkait PPM dan membuat terobosan-terobosan yang bisa meningkatkan keterlibatan sektor swasta dalam pengendalian TB. Kelompok Core group PPM dipimpin oleh Philip Hopewell dan biasanya group ini mengadakan teleconference bersama para anggotanya setiap 2-3 bulan sekali dengan agenda pembahasan yang disepakati bersama. Kasubdit TB diundang secara resmi sebagai anggota grup ini sejak bulan September 2010 lalu dan sudah secara aktif terlibat dalam 4 kali telekonferens. Mengawali pelaksanaan Konferensi IUATLD ke 42, Sub core group PPM menginisiasi pertemuan PPM yang ke 7. dengan mengundang seluruh anggota aktif PPM sub core group dan NTP dari Negara HBC untuk saling belajar, dan saling bertukar pengalaman pelaksanaan kegiatan PPM pada tingkat global dan menemukan strategi dan pendekatan yang berbasis eviden yang sesuai dengan kehususan lokal. Tujuan Umum pertemuan. 1. Melakukan review kemajuan pelaksanaan PPM pada tingkat global danregional 2. Bertukar pengalaman tentan proses dan luaran pelaksanaan PPM 3. Mendiskusikan potensi PPM dalam mengenalkan diagnostik baru dan obat baru

untuk TB. 4. Identifikasi komponen dan kegaiatan kunci untuk rencanan aksi global dalam

melibatkan semua penyedia layanan melalui pendekatan PPM.

Peran Peserta Indonesia Indonesia, diwakili Dyah Erti Mustikawati memeberikan presentasi tentang kemajuan dalam melakukan ekspansi kegiatan PPM TB diberbagai institusi, dan inisiasi pendekatan PPM komprehensif dengan 6 pilar yang dharapkan dapat dijadikan lesson learnt. B. PROSES DAN METODE Proses dan Metode Pertemuan dilakukan dengan metode interaktif, aktif dan partisipatif , berbasis masalah, menggunakan data dan pengalaman yang dialami oleh masing masing negara. Melakukan tukar menukar pengalaman dan pengetahuan diantara peserta. Proses dilakukan melalui presentasi, tanya jawab, diskusi kelompok serta mebuat rekomendasi. Diskusi Kelompok dibagi sesuai dengan Key Components of PPM Subgroup’s Work Plan 2012-2013:

• Group 1: Strengthening country capacity to scale up engagement of all care providers

• Group 2: Engaging pharmacies in TB care and control • Group 3: Using PPM programmes to introduce new diagnostics and drugs to

private sector • Group 4: Strengthening advocacy and surveillance for PPM Output / Luaran masing masing kelompok diskusi adalah : • Daftar kegaiatan pokok (List of key activities) dan stakeholders terkait • Rekomendasi paling penting masing masing untik WHO/Stop TB Partners dan

the NTPs, respectively • 10 minutes untuk melaporkan dalam plenari, 2 slide masing masing kelompok

C. HASIL PERTEMUAN Hasil pertemuan terdiri dari hasil diskusi kelompok dan rekomendasi Hasil Diskusi Kelompok Kelompok 1 : Strengthening country capacity to scale up engagement of all care providers Kegiatan pokok (Key activities):

1. Memiliki seorang focal person pada tingkat negara/regional /gobal; a. harus melihat PPM sebagai cross-cutting strategy; b. pendekatan sistem kesehatan untuk akses universal dan bukan

menjadi strategi yang terpisah c. harus di backed-up oleh sebuah Technical Group; jika negara belum

memiliki menjadi prioritas NTP dimana focal person harus mengkolaborasikannya /link-up with.

2. Memasukan dalam skema pembiayaan / financing scheme untuk kesinambungan semua kegiatan untuk PPM.

a. resource generation harus dibangun dalam pendekatan PPM; b. meningkatkan peluang pembiayaan internal (internal financing

opportunities), contoh seperti sistem asuransi sosialnegara. 3. Berkoordinasi dengan program kesehatan diluar program pengendalian TB

nasional /NTP,seperti KIA, PTM (diabetes mellitus) untuk tambahan sumber daya.

4. Melakukan advokasi untuk meningkatkan sumber daya domiestik untuk program TB, perlu melibatkan ahli ekonomi untuk kegiatan ini.

5. Mengembangkan dan merivisi rencana strategi PPM untuk menjamin pendekatan yang komprehensif dan integratif.

6. Menjalankan mekanisme untuk roll-out toolkit (adopsi dan adaptasi) berdsarkan situasi negara

7. Menjamin ketersediaan komoditas TB seperti obat dan sarana diagnostik dieluruh sektor yang terlibat.

8. Dokumentasi input PPM melalui standarisasi indikator dan piranti elektornik yang sesuai.

9. Menguatkan kerangka hukum yang mendukung ayanan TB, seperti pengenalan PPM ke mitra lain (seperti TB didalam tempat kerja)

Rekomendasi Untuk WHO/Stop TB Partnership:

1. Menjamin dukungan adanya focal person global and regional selain melakukan restrukturisasi orgnisasional.

2. Membangun konsultasi dengan mitra kunci untuk menstandarisir metodologi roll-out toolkit yang mencakup standar indikator kegiatan yang berfokus kepada indikator luaran (outcome indicators).

3. Melakukan assessment yang memungkinkan negara dapat mengadopsi dan membangun kegiatan yang berkesinambungan dalam pendekatan PPM. Misalnya memanfaatkan country’s social security system

4. Membuat dokumen dalam bahasa yang mudah dipahami. Untuk NTP’s:

1. Menunjuk focal person PPM pada tingkat negara 2. Adopsi indikator yang standar dan piranti elektornik yang sesuai untuk

mengukur kegaiatan PPM. 3. Mengembangkan / merivisi rencana strategi PPM dengan mencakup

pendekatan PPM yang komprehensif dan integratif. 4. Menguatkan kerangka hukum terkait layanan TB, seperti TB didalam tempat

kerja. Kelompok 2: Engaging pharmacies in TB care and control Kegiatan pokok

• Mengembangkan strategi keterlibatan apotek (pharmacy) sebagai bagian perencanaan nasional keseluruhan, dengan mencontoh apa yang telah dilakukan oleh mitra lain.

• Menentukan peran apotek yang terdaftar dan tidak terdaftar (registered vs unregistered pharmacies)

• Mengembangkan MOU formal dengan Ikatan Apoteker Nasional (national pharmacy association) dan memanfaatkan asosiasi untuk kerjasama dengan anggotanya.

• Melibatkan apoteker informal melalui NGO atau badan lainnya. • Memberikan pelatihan dan dukungan supervisi berkelanjutan untuk menjamin

umpan balik dan rekognisi. • Memasukan apoteker dalam Global Fund applications

Rekommendasi untuk WHO/Stop TB

• Disseminasi the WHO/FIP Joint Statement secara luas dan mepromosikan kerjasama asosiasi apoteker, departemen pendidikan farmasi, dan pabrik dalam kemitraan nasional.

• Dukungan monitoring dan evaluation pelaksanaan: memasukkan keterlbatan apoteker dalam global report, dan mengkompilasi best practices and tools untuk dapat digunakan negara sebagai contoh dalam perencanaan.

• Beralih dari disease-specific kepada a health systems/integrated approach yang mencakup TB

Kelompok 3 : Using PPM programmes to introduce new diagnostics and drugs to private sector

Recommendasi - Diagnostics WHO / StopTB

• STB partners bekerja bersama pabrik alat diagnostik (diagnostics manufacturers) untuk mendapatkan laporan yang lebih baik tentang diagnostik yang diadakan oleh sektor swasta pada negara dengan beban TB tinggi.

NTP • NTP mengaudate kebijakan diagnostik, termasuk case notification dan case

management categories, memasukkan new diagnostic tools sehingga sektor swasta dapat melaporkan secara tepat.

• Dinas Kesehatan dan Kementerian kesehatan harus mengantisipasi kebutuhan sektor swasta untuk mengadopsi teknologi diagnostik dan menjamin mekanisme berjalan baik untuk menjamin kualitas, regulasi dan akreditasi. Untuk mencapai ini, NTP harus berkolaborasi dengan departemen/bagian yang bertanggung jawab hal ini didalam kementerian kesehatan.

• Masing masing negara memperkuat sistem untuk monitoring impor alat diagnostik baru.

Recommendasi - Obat (Drugs) WHO / StopTB / international

• Terhadap hasil trial dan persetujuan WHO kepada paduan baru, STB partners dan GDF memprioritaskan pengembangan co-blistered moxifloxacin-yang mengandung paduan lini pertama.

• STB partners to quantify the public health case of open access vs restricting access for new, patent-protected TB drugs.

• UNITAID, GDF dan mitra lain membiayai pengadaan obat baru dengan cara promosi penggunaan obat baru didalam NTP dan PPM, dan membiayai projects rolling out combined diagnostics and drugs.

Cross-cutting (international dan national ) • Dengan adanya pengunaan quinolones didalam sektor swasta sebagai obat

lini pertama, dan adanya kemungkinan peningkatan penguunaaanya, WHO and NTP harus meningkatkan surveillance of quinolone resistance termasuk dalam pengobatan pasien.

• Pabrik (Manufacturers) dand NTP/MoH menjamin, dalam penguatan kolaborasi pihak berwenang terhadap regulasi , agar obat MDR paten, single-source, hanya dijual kepada sektor publik dan program PPM atau channels yang menjamin mutunya.

• PPM working group, STB partners, WHO dan NTPs mengupdate PPM tools untuk menangani management pasien MDR-TB yang memanfaatkan sector swasta.

Recommendations To the DOTS Expansion Working Group and the Stop TB Coordinating Board: 1. Accord the PPM Subgroup full Working Group status (or equivalent in the new

structure)

2. Effectively communicate to Stop TB Partners and NTPs, the proven impact of achieving significant increase in TB case notifications through engagement of large hospitals; FBOs and NGOs; and individual private practitioners through intermediary agencies such as national professional associations and social franchising organisations.

3. Disseminate the WHO/FIP Joint Statement widely and promote engagement of pharmacy associations, academic pharmacy departments, and drug manufacturers as part of national policies to promote rational drug use

4. Track sale and use of new diagnostics in public and private sectors in collaboration with manufacturers

5. Sustain funding of global, regional and national PPM support structures 6. Develop the public health case for restricting access for new, patent-protected TB

drugs. 7. Funding for procurement of new TB drugs should be awarded in a manner that

would promote use of new drugs within NTP and PPM programmes To Ministries of Health / National TB Programmes 1. In view of the limited scale up of PPM despite substantial evidence of

effectiveness, prioritize further scale up of PPM approaches using ISTC and other tools to improve access and quality of TB services, and document and report the results.

2. Intensify engagement of large hospitals by securing commitment of top hospital management, ensuring internal coordination among hospital departments for proper management and reporting of TB patients and networking with peripheral health centres to develop effective referral systems.

3. Considering the proven benefits of effective involvement of individual private practitioners in reaching the poor while achieving early and higher TB case detection, scale up engagement of private practitioners in TB care and control using intermediary agencies such as national professional associations and social franchising organisations encouraging at the same time, documentation of the processes and outcomes of such initiatives to enable rapid scale up.

4. Undertake a national situation assessment on the current and potential role of pharmacists in TB care and control and, where appropriate, adapt and implement the WHO/FIP Joint Statement as part of a national operational plan in collaboration with national pharmacy association

5. Advocate with the drug regulatory agencies to enforce existing (or create new) regulations on import/manufacture/dispensing of TB drugs

6. Improve the quality of the PPM components of Global Fund proposals paying particular attention to measuring PPM contribution to TB care and consider including PPM as a high-impact intervention in reprogramming of existing projects.

7. Seek collaboration with other public health programmes and incorporate PPM component into multi-sectoral proposals to mobilize additional resources

8. Include PPM in ACSM strategy documenting and disseminating successful collaboration

9. Strengthen the system for monitoring of importation of new diagnostics and set up system of quality assurance, regulation and accreditation for the users of new diagnostics

10. Work with regulatory authorities and drug manufacturers to restrict availability of new TB drugs to NTPs and NTP-affiliated care providers

To the PPM Subgroup secretariat 1. Support documentation and dissemination of innovative and effective PPM

approaches being implemented in diverse country settings and facilitate scaling up of successful initiatives.

2. Develop an action plan based on the strategies outlined in the white paper and the above recommendations

3. Continue supporting countries to strengthen and improve PPM surveillance. D. LESSON LEARNT INDONESIA DALAM PERTEMUAN

PPM menjadi salah satu pendekatan dan strategi nasional pengendalian TB dalam stranas TB 2010-2014 dan dijabarkan lebih lanjut dalam Rencana Aksi Nasional untuk PPM-TB 2010-2014

PPM di Indonesia telah melibatkan berbagai penyedia layanan seperti RS, rutan/lapas, workplace/ industry, DPS, asuransi kesehatan, PT kesehatan (FK, Fkep, FKM), sektor kesehatan diluar kementerian kesehatan seperti pada Kemenhan, Polri.

Pengembangan Model PPM Indonesia yang dikembangkan berdasarkan analisis situasi permasalahan secara menyeluruh dan dikembangkan menjadi pendekatan yang sistimatis, komprehensif dan integratif PPM-TB beserta pembagian kewenangan yang jelas antara berbagai unit dilingkungan Kementerian Kesehatan dan unit Profesib, memperoleh sambutan yang sangat positif baik dari para anggota PPM sub working group maupun dari NTP manager di HBC, bahkan pendekatan Indonesia ini diusulkan oleh Philip Hopewel untuk diangkat sebagai konsep dalam White paper PPM yang saat ini sedang disusun oleh working group PPM.

Adapun 6 pilar PPM comprehensive Indonesia adalah sbb:

6.Community System Strengthening

-Function as advocator raise fund and commitment,

- Increase public awareness, function as public watch to ensure deliveries of quality services,

-increasing awareness of right and responsibility of the patients (patient's charter).

-Social Mobilization, suspect identification, increasing demand creation, intensifying the services of TB in

slum areas and prison-Leading: NGO, FBO, CSO-TA: FHI, other partners

4.Qualified TB Diagnostic

-Approach: Strengthening lab network and Quality Assurance

(public and private) DST, Culture and Microscopic

-Leading: Directorate of Medical Support

- TA: KNCV and JATA

2.Public/Private Hospital Services

- Approach: Hospital Accreditation, Implementation TB

DOTS as Minimum Standard requirement for accreditation of

Hospitals- Leading: Directorates of Referral

Health Services-TA: KNCV

3.Quality DOTS services by Private Practitioners and

Specialist

- Approach: Implementation of ISTC for all TB care and treatment from all care

providers, increasing professional responsibility to cure TB

patients, rewarding through cumulative credits mechanism for

licensing/certification-Leading: IMA

-TA: ATS,

5.Quality of anti TB Drug Dispensing and rational

Use of Drug

-Approach: law enforcement, establishment of

networking and monitoring system, WHO prequalification

-Leading: Indonesian Pharmacist Association, DG of Pharmaceutical

Services, Indonesian FDA-TA: USP and MSH

1.Basic DOTS ServicesAt Puskesmas

-Approach: Surveillance System Strengthening and MIFA, Improving

quality of care, increasing coverage of TBHIV, reaching un-reach pop at

remote are (DTPK), increasing referral to Quality DOTS Services

-Leading: NTP-TA: WHO, FHI and other partners

E. TINDAK LANJUT

1. Sosialisasi lebih lanjut secara harmonis stranas TB, RAN-PPM, dan 6 pilar PPM.

2. Penguatan sistem dan pendekatan yang komprehensif dan sinergis sesuai dengan 6 pilar PPM

3. Penguatan dan inisiasi PPM dengan mitra potensial, antara lain keterlibatan sektor farmasi, apoteker, askes, jamkesnas/jamkesda.

4. Implementasi lebih lanjut dukungan regulasi antara lain akreditasi RS dimana DOTS menjadi salah satu unsur standar yang harus dipenuhi.

5. Penguatan surveillance, berkolaborasi dengan pusdatin dan surveilans sel 6. Ekspansi Implemntasi ISTC di kalangan profesi DPS (dokter umum dan

spesialis) untuk dukungan terhadap cakupan layanan TB yang berkualitas dan akuntable

7. Berkolaborasi dengan ditjen bina farmasi, BPOM, manufaktur obat lokal, dll. melakukan penguatan manajemen obat dengan one gate policy, mendapatkan prekualifikasi WHO untuk obat TB yang dibuat di Indonesia, pengaturan obat TB dipasaran, penggunaan obat yang rasonal, SOP custom clearence, pharmacovigilance obat TB.

8. Bekerjasama dengan direktorat laboratorium melakukan penguatan sistem diagnostik TB (mikroskopis, kultur, DST, geneXpert)

9. Promosi dan kesinambungan program melalui kegiatan AKMS. Penguatan peran masyarakat dan pasien TB sebagai advokator untuk meningkatkan komitmen dan pendanaan program.

10. Mendokumentasikan pelaksanaan PPM komprehensif model Indonesia agar bisa dijadikan best practices. Baseline study sudah dilaksanakan melalui KAP survey pada DPs dan selanjutnya akan dilaksanakan berbagi macam studi bersama dengan TORG untuk mengukur keberhasilan pelaksanaan pendekatan PPM komprehensif ini. Jakarta, November 2011

LAMPIRAN 1

Seventh Meeting of the Subgroup on Public-Private Mix for TB Care and Control 23-24 October 2011, Lille, France

Provisional Agenda

23 October 2011 8:30 - 9:00 Registration

Session I: Introduction Chair: Phil Hopewell 9:00 - 9:10 Welcome, objectives and agenda Phil Hopewell 9:10 - 9:15 Opening remarks M Raviglione / D Weil

9:15 - 9:30 Discussion on the meeting agenda

All

Session II: Panel: Global and regional progress Chair: J M Chakaya

9:30 - 10:00 Global progress and issues Mukund Uplekar

10:00 -10:30 Panel discussion: Regional perspectives Regional Advisors / their representatives: AFR, AMR, EMR, EUR, SEAR, WPR

COFFEE 10:30 – 10:45

Session III: Spotlight: Country progress Chair: D’Arcy Richardson 10:45 -11:15 Scaling up PPM in Nigeria J Obasanya

11:15 -11:45 Scaling up PPM in Indonesia D Mustikawati

11:45 -12:15 Scaling up PPM in Myanmar T Lwin

12:15 - 12:30 Social franchising for TB care: global experience May Sudhinaraset

LUNCH 12:30 – 13:30

Session IV: Innovative approaches Chair: S Egwaga 13:30 – 14:00 Systematic approach to engaging hospitals:

Philippine experience L Vianzon

14:00 - 14:30 Engaging pharmacies: country experiences D’Arcy Richardson

14:30 - 15:00 WHO-FIP joint statement on role of pharmacists in TB care and control

Monica Dias

15:00 -15:15 Rational use of TB drugs: country approaches

Mukund Uplekar

COFFEE 15:15 – 15:30

Session V: New tools and approaches Chair: L Vianzon 15:30 -16:00 New TB drugs and the private market William Wells 16:00 -16:30 Gene Xpert and the private sector Evan Lee

16:30 -17:00 PPM in TB REACH S Sahu

24 October 2011

Session VI: The future of PPM: Resources and Strategies Chair: J Voskens 9:00 - 9:15 Tapping resources and promoting tools for PPM C Vincent

9:15 - 9:30 PPM and the Global Fund SS Lal

9:30 - 10:00 White Paper on the future of PPM P Hopewell COFFEE 10:00 – 10:30

Session VII: Group work: PPM Subgroup Action Plan 10:30 -10:45 Guidance on proposed group work K Lönnroth

10:45 -12:30 Group Work LUNCH 12:30 – 13:30

Plenary Chair: Phil Hopewell 13:30 - 15:00 Reporting back by groups

COFFEE 15:00 – 15:30

Session VIII: Conclusions and recommendations 15:30 - 17:00 Conclusions and recommendations P Hopewell

17:00 Closing remarks M Uplekar

Lampiran 2 Final Recommendations

Engaging all care providers in TB care and control through public–private mix (PPM) approaches and promoting the International Standards for Tuberculosis Care (ISTC) are among the core components of the global Stop TB Strategy. Strengthening health systems through the involvement of all relevant health-care providers outside the national TB programmes (NTPs) is essential to meet the TB-related Millennium Development Goals and reach the targets for tuberculosis (TB) control set out in the Global Plan to Stop TB 2006–2015. The Stop TB Partnership’s Subgroup on Public–Private Mix for TB Care and Control (PPM Subgroup) has been instrumental in assisting countries to enhance collaboration among diverse public, private, voluntary and corporate care providers to improve access to high-quality TB care to all who need it. The seventh meeting of the PPM Subgroup, supported by the TB CARE Program of the United States Agency for International Development (USAID), was organized in Lille, France, on 23 and 24 October 2011. The presentations, discussions and in-depth deliberations in break- out groups over the two days covered a wide range of topics. These included: overall progress in PPM implementation from global, regional and country perspectives; innovative initiatives such as engaging pharmacists in TB care and control and country experiences with ensuring rational use of TB drugs; and implications of introduction of new diagnostics and new drugs for TB for PPM. Ways to harness resources for PPM expansion and a comprehensive “white paper” on “increasing the effectiveness of the Stop TB Partnership in engaging all care providers” were also discussed. Facilitated by area experts, the participants formed small groups to discuss actions required under four specific areas: strengthening country capacity for PPM scale up, engaging pharmacists in TB care and control, using PPM programmes for introducing new diagnostics and drugs and strengthening advocacy and surveillance for PPM. The meeting concluded with full agreement on the following recommendations addressed to the DOTS Expansion Working Group and the Stop TB Coordinating Board; ministries of health and national TB programmes; and the secretariat of the PPM Subgroup: To the DOTS Expansion Working Group and the Stop TB Coordinating Board:

1. Accord the PPM Subgroup full Working Group status (or equivalent in the new structure). Engaging all care providers through context-specific PPM approaches is widely accepted now as integral and essential to achieving universal access to quality TB care. Successive global TB control reports have shown significant and increasing contribution of non-programme care providers to TB care and control. The need and potential of further PPM scale up to help address stagnating case notifications and slow decline in TB incidence are very clear. PPM approaches should also be incorporated into other components of the Stop TB Strategy including programmatic

management of MDR-TB, collaborative TB/HIV activities, operational research on the uptake of new diagnostics and drugs, and ACSM (Advocacy, Communication and Social Mobilization). According the PPM Subgroup full Working Group status would help accelerate expanding access to quality TB care through the engagement of all care providers approached by people with symptoms of TB; and give the subgroup the mandate to drive much needed mainstreaming of PPM into the various components of the Stop TB Strategy.

2. Communicate effectively to Stop TB Partners and NTPs, the PPM

approaches with proven impact on TB care and control. Evidence from PPM scale up in diverse country settings shows that significant increase in case notifications while maintaining high treatment success rates is achievable by prioritizing engagement of large hospitals and large faith-based and non-governmental organizations. Country experiences also indicate that productive involvement of private practitioners is greatly facilitated by entrusting the task of engaging them to intermediary agencies such as professional associations and social franchising organizations. There is also a need to prioritize and scale up workplace TB programmes.

3. Disseminate the WHO/FIP Joint Statement widely and promote

engagement of pharmacy associations and drug regulatory bodies in national partnerships to Stop TB. Pharmacists have been shown to contribute to TB care and control in various ways including early referral of TB symptomatics, treatment support to patients and ensuring rational use of TB drugs. Enhancing the engagement of pharmacists will require documentation of working approaches to engage pharmacists and compiling and disseminating country experiences on best practices. Highlighting the contribution of pharmacists to TB control could further stimulate pharmacy engagement. Collaboration with pharmacists should be undertaken through an integrated and comprehensive health systems approach that extends, where possible, beyond TB care and control.

4. Track sale and use of new diagnostics in public and private sectors in

collaboration with national authorities and manufacturers. Availability of new diagnostic tests for TB such as geneXpert MTB/RIF has opened up new possibilities to strengthen and expand collaboration between the public and private sectors. Tracking sale of new geneXpert machines and cartridges should go hand in hand with ensuring adherence to recommended protocols for diagnosis, treatment and notification of TB and drug-resistant TB. For this purpose, a coordinated approach to set up collaboration among NTPs, the manufacturers, private sector laboratories and care providers is recommended.

5. Develop the public health case for protecting new TB drugs from

irrational use and work with stakeholders to identify channels through which new TB drugs should be made available. Evidence shows that large quantities of TB drugs are misused outside NTPs especially in countries with a large private sector. Irrational use of TB drugs leads to emergence and spread of multidrug resistant TB. In order for them to remain effective, new TB drugs need to be protected from potential irrational use. It is important

therefore to develop the public health case on the extent to which sales, distribution, prescription and dispensing rights for new TB drugs should be restricted. Furthermore, it is also essential to determine effective ways of ensuring rational use and wide availability of new TB drugs. This will require all stakeholders including NTPs, regulatory authorities, drug manufacturers and professional associations working closely together to address the issue.

6. Advise ways to secure and sustain resources for PPM scale up. In view

of the likelihood of fewer resources being available to scale up and sustain PPM programmes, countries need to be advised and assisted to secure funding through available and new TB-specific resources as well as those accessible from multi-sectoral, integrated initiatives.

To National TB Programmes and Ministries of Health

1. Prioritize scaling up PPM and ensure documentation and reporting of contributions of non-programme care providers. The global TB report of 2011 shows that non-programme public and private care providers contributed about 20% to 40% of the notified TB cases in 20 countries including 10 high TB-burden countries. A general observation has been that in areas where PPM is being implemented, the proportion of private care providers actively collaborating with NTPs still remains modest. In order to detect all TB cases and detect them early, NTPs need to prioritize further PPM scale up while providing any additional necessary inputs. In doing so, NTPs should also ensure that contribution of non-programme providers to referral, diagnosis and treatment of TB cases is documented as part of routine recording and is reported to the national as well as global levels.

2. Intensify engagement of large hospitals to improve case notifications

and treatment success of people with TB presenting to hospitals. In many countries a large proportion of TB symptomatics and cases present themselves to and are managed in large hospitals. Evidence from some settings shows that significant proportions of these cases are not managed per TB program guidelines and are not notified. Setting up mechanisms for interdepartmental coordination within hospitals and linkages with peripheral public and private health facilities for referral and follow up has been shown to help increase case notification and improve TB care.

3. Consider using intermediary agencies to scale up engagement of formal

and informal private practitioners. While engaging solo private practitioners has been shown to increase early case detection, working with a large number of formal and informal private practitioners, training and orienting them, supervising them and providing them adequate support poses challenges for NTPs. Experiences in several countries have shown that intermediary agencies such as social franchising organizations, non-governmental organizations and professional associations can be very effective in engaging private practitioners in TB care and control.

4. Adapt and implement the WHO/FIP joint statement on the role of

pharmacists in TB care and control. Pharmacists are the first point of

contact for many people with symptoms of TB and have been shown to contribute to TB care and control in various ways including, for example, early identification and referral of TB symptomatics. The recently launched Joint Statement on the role of pharmacists in TB care control by WHO and the International Pharmaceutical Federation(FIP) describes how pharmacists can collaborate with TB programmes and urges NTPs and national pharmacy associations to work together to tap the potential of pharmacists in enhancing early case detection and improving TB care.

5. Secure resources through TB specific and multi-sectoral channels to

help scale up PPM programmes. In many countries PPM initiatives are being implemented with support from external project-based funding. Scaling up and sustaining PPM programmes will require continued availability of resources. In preparing for a potential shortfall in the availability of external finances, NTPs should secure funding to sustain and expand PPM initiatives not only through traditional channels such as the Global Fund and other funding agencies, but also multi-sectoral and multi-programme initiatives designed to achieve synergy and improve efficiency.

6. Strengthen the system for monitoring of importation of new diagnostics

and set up a system of quality assurance, regulation and accreditation for the users of new diagnostics. Introduction of new tests such as geneXpert MTB/RIF for the diagnosis of TB and drug-resistant TB will increase the monitoring responsibilities of NTPs. NTPs should use the opportunity not only to strengthen their own system of laboratory quality assurance but also to monitor sale of the new machines in the private sector. Instituting methods for certifying and accrediting private providers eligible to use new diagnostics may need to be set up. Further, NTPs should ensure that all patients diagnosed as TB and drug-resistant TB receive appropriate treatment and care and are duly notified.

7. Work with drug regulatory authorities and other stakeholders to address

availability of new TB drugs to non-programme care providers and ensure their rational use. Considering global evidence on massive misuse of first-line TB drugs in the private market in many high TB-burden countries, NTPs should be alert as to how the “precious few” new TB drugs, when available, will be made accessible to and used appropriately in the private market. In collaboration with stakeholders including drug manufacturers, drug regulatory authorities, professional associations, civil society and Stop TB partners, NTPs should assess the extent to which the availability of new TB drugs to the private sector should be restricted and ways of effectively enforcing any restriction.

To the PPM Subgroup Secretariat

1. Support documentation and dissemination of innovative and effective PPM approaches and facilitate scaling up of successful initiatives. The PPM Subgroup secretariat, advised by the PPM Core Group, should facilitate and coordinate documentation and dissemination

of innovative approaches such as engaging pharmacists in TB care and control, PPM-related interventions in TB REACH supported projects, and initiatives for introducing new diagnostics and drugs in the private sector.

2. Pursue strategies and activities outlined in the white paper on

engaging all care providers to increase effectiveness of the Stop TB Partnership. The white paper lists clear objectives and strategies to further PPM expansion and the PPM tool-kit provides the tools to help implement many of the strategies outlined. The Subgroup secretariat, advised by the PPM Core Group, should use the white paper and the PPM tool-kit to pursue PPM expansion and mainstreaming.

3. Continue supporting countries to strengthen and improve PPM

implementation including surveillance. Precise data on the contribution of PPM initiatives to TB control have now been reported in two successive reports on global TB control. It is important to ensure that there is continuity in this reporting. The Secretariat should follow up and help produce PPM-specific data for the global TB report from an increasing number of countries.

Lampiran 3

White paper Increasing the effectiveness of the Stop TB Partnership in engaging

all care providers

Introduction The fourth component of the Global Strategy to Stop TB is to “Engage all care providers,” an approach to ensure universal access to high quality tuberculosis (TB) services through the involvement of all public, voluntary, corporate and private providers and the adoption of the “International Standards for Tuberculosis Care (ISTC)”. Such engagement requires a systematic approach to identifying the providers and facilities that have potential to deliver services for TB, ensuring that the services are of high quality, and developing and maintaining linkages between these services and the appropriate public health authorities. In accordance with this strategy, a number of initiatives have been launched, tools developed, consultants trained and utilized, and country level programs developed and implemented. In addition, the ISTC, now in its second edition, has been widely distributed, translated into 12 languages, utilized by many national TB control programs (NTPs), and endorsed by a large number of national and international organizations. All of these activities have created a strong foundation for new approaches to TB care and control with increasing engagement of all providers, as called for in the Global Strategy to Stop TB. Despite the progress made over the past several years, scale-up has been slow and there still remain many challenges to achieving systematic engagement of all providers. The current situation with, on the one hand, the accomplishments and availability of a range of tools (culminating in the publication of “Public-Private Mix for TB care and Control: A Toolkit”) and, on the other hand, the enormous task of scaling-up globally, calls for a re-conceptualization of the role, of the Public-Private Mix Subgroup and a thorough re-examination of its composition, objectives, strategies, and activities Rationale Most persons ultimately shown to have TB first seek and receive care from

non-TB program providers Persons with an illness do not commonly recognize the specific nature of the illness and, thus, may seek care from any of a wide array of health care providers. This has been well-documented to be the case with many persons who are ultimately proven to have TB. The providers from whom care is sought may or may not conduct a proper evaluation leading to a diagnosis of TB, but, even when the correct diagnosis is established, the providers may not be linked to a public health TB program, often utilize incorrect drug regimens, fail to monitor adherence and outcomes, and rarely notify public health authorities of the case. Consequently, effective, systematic engagement of non-NTP providers is essential to ensuring universal access to high quality TB services.

Public sector DOTS continues to be successful, but universal access to effective services for TB can be achieved only by systematic engagement of all providers.

DOTS programs, largely operating through the public sector, have been widely implemented and successful in addressing “usual” TB. However, it is increasingly apparent that broad and effective engagement of health care providers outside the public sector is critical to achieving the goals of universal access to TB services and to early accurate diagnosis and successful treatment. Although DOTS requires continued attention, its success enables TB care and control efforts also to focus on important remaining problem areas, many of which reside within the private health care sector and non-MOH public sector, rather than in public health TB control programs and, thus, are best addressed via private or non-MOH/NTP sector initiatives. Such initiatives should focus particularly on hospitals, prisons, military health care systems, workplace systems, urban slums, etc. It is essential to develop linkages that enable private clinicians to fulfill

their public health responsibilities in providing tuberculosis services. TB control programs provide quality control, reporting, treatment monitoring and contact tracing services that, generally, individual clinicians and hospitals do not have access to but that would enable non-program clinicians to fulfill their public health responsibilities. In order to improve the quality of TB diagnosis and treatment in the private sector, interventions will often be required to change the behavior of clinicians. Moreover, government-operated incentives to promote the changes may be necessary. This may involve the development of insurance schemes or other funding mechanisms and/or other health system interventions to improve quality. Practitioners may need to utilize local public health services and other agencies to assess the adherence of the patient and to address poor adherence when it occurs. Collaborations may also be necessary to ensure that persons who are in close contact with patients who have infectious TB are evaluated and managed in line with international recommendations. Finally, linkages between MOH/NTP public sector programs and private clinicians/non-MOH public services are necessary to ensure reporting of both new and retreatment TB cases and their treatment outcomes in conformance with applicable legal requirements and policies. Public sector programs should dedicate sufficient resources, both human

and financial, to the implementation of PPM activities. It is easy for the size and importance of the private sector in providing TB services to be underestimated. Substandard care from private clinicians may result in prolonged infectiousness, drug resistance, more severe illness, and possibly death. The magnitude of unregulated, unmonitored treatment in the private sector is suggested by data on drug usage that have revealed the true size of the private TB drug market in certain high burden countries. The evident size of the problem is not yet matched by the scale of PPM efforts under DOTS programs. Consequently, increased advocacy is needed so that all parties insist on sufficient, dedicated human and financial resources for a scaled-up PPM response. This should be reflected in terms of prioritization both centrally (e.g., in preparing Global Fund proposals) and in the provinces and districts (e.g., assigning staff who are accountable and have time available for PPM activities and utilizing indicators of impact). TB care is increasingly complicated, often requiring specialized expertise.

Because of drug resistance, HIV infection and other co-morbidities, diagnosis and treatment of TB are often complicated. Treatment of multiple drug-resistant TB (MDR TB), for example, often requires special expertise that is not present in primary care settings, the main point of care for standard control programs. TB occurring in persons with HIV infection is complicated because of more obscure presentations with a broad differential diagnosis, often requiring more extensive, sometimes invasive, diagnostic evaluation. Moreover, treatment of both diseases involves drugs with overlapping toxicity profiles, drug interactions, immune reconstitution reactions, and the potential for other opportunistic infections and neoplasms to occur at any time. TB in children, likewise, may be difficult to diagnose because of its paucibacillary nature and the frequency of extra-pulmonary involvement. All of these situations are likely to require radiographic examinations and more extensive laboratory testing for diagnosis, monitoring and assessment of possible adverse reactions. Common to all these concerns with TB care becoming increasingly complicated is the need to ensure that the costs of services do not impose a barrier to effective care for poor people. This may involve insurance schemes and/or other health system interventions to improve access. The association of TB with co-morbidities, other than HIV infection, also complicates management. There are a number of conditions that are either risk factors for TB or are common in patients with the disease. Many of these can adversely affect treatment outcome. These include immunosuppressive disorders, diabetes mellitus, malnutrition, renal insufficiency, hepatic disease, alcoholism, other substance abuse and tobacco use. Clinicians must take individual risk factors into account and carry out the necessary tests to evaluate co-morbid conditions relevant to tuberculosis treatment response and outcome. The identification of these types of cases requires a more integrated health systems approach to TB control. For all the above reasons, it is essential that there be particularly strong linkages forged between TB control programs and private sector providers/non-MOH/NTP public services, particularly specialist physicians, academic institutions, NGO hospitals, and tertiary referral hospitals, that can provide the services required in the modern care of TB. Tb control programs are often not in a position to implement preventive

measures such as treatment of latent infection and infection control. TB clinics and control programs per se are not positioned to provide TB prevention services because, in general, the patients seen in TB clinics either already have or are suspected of having TB. Primary care services and/or outreach clinics such as those providing care for high risk populations, especially HIV care, are much better able to undertake screening and preventive treatment than are TB clinics. Moreover, infection control measures are more likely to be developed and implemented by facilities managers and facility infection control committees than by TB control programs. Private sector involvement is either implicit or explicit in the activities of all

the Stop TB Partnership working groups.

The engagement of all care providers requires a comprehensive and systematic approach that goes beyond the DOTS Expansion Working Group (DEWG). Currently, the Public-Private Mix Subgroup has been nearly exclusively related to its parent group. Coordination across the other working groups has been largely non-existent or ineffectual. Moreover, the name of the subgroup implies a narrow focus, predominantly on developing formalized DOTS programs either within private sector institutions or between the private sector and TB control programs. However, as described above much of what is needed now is not within the usual definition of DOTS, but, rather, is developing the linkages and referral systems that provide the services required to manage complicated patients effectively, reach more of the vulnerable populations and to implement prevention measures. Thus, the subgroup, to operate effectively, needs much better coordination with other working groups, especially the MDR TB Working Group and the TB-HIV Working Group and with other subgroups within the DEWG, particularly the ACSM Subgroup . In addition to coordinating with the implementation working groups, there needs to be coordination with the research working groups. As a case in point, considerable thought needs to be given to the utilization of the highly-sought-after point-of-care diagnostic test by private providers. Likewise, how would a new drug be introduced to the private sector and how would the drug be best protected against misuse that would lead to resistance? Objectives and Strategies To be effective in providing guidance for the engagement of all providers in delivering high quality TB services, the subgroup must focus on approaches to address the problems described in the rationale. Although tools, policy guidance, model guidelines, and consultation will continue to be necessary, a broader set of strategies and activities should be undertaken by the Stop TB Partnership and by all relevant stakeholders. The proposed objectives and strategies to improve the engagement of all providers are listed below. This list is intended as a starting point for discussions and work-plan development. Obviously, new strategies may be included and suggested strategies deleted as circumstances change and as new ideas and approaches develop. Objective 1. To contribute to the goal of universal access to high quality diagnostic and treatment and prevention services through appropriate engagement of care providers, healthcare facilities and laboratories: Strategies 1 Promote and facilitate systematic identification and mapping of all relevant providers, facilities, and laboratories utilizing the National Situation Assessment (NSA) from the PPM Toolkit 2. Facilitate development of linkages among all relevant providers, facilities and laboratories to form a comprehensive, integrated network for care using the appropriate tools from the Toolkit and other resources. 3. Promote improvements in the quality of TB diagnosis and treatment and prevention by utilizing the International Standards of Tuberculosis Care (ISTC) and other relevant resources;

4. Foster collaborations between public health TB programs and professional societies; 5. Promote collaborations between public health TB programs and academic institutions; 6. Foster collaborations with local civil society organizations, and communities to increase awareness of and demand for high quality TB services; 7. Strengthen global, regional and local technical capacity to develop, conduct and evaluate programs to engage all providers through utilization of the PPM toolkit and other relevant resources. 8. Conduct activities to highlight the current extent of private sector involvement in providing TB services and encourage countries to dedicate resources that are commensurate with the size of the problem. Objective 2. To strengthen health systems through promotion of effective engagement of all providers: Strategies 1. Promote scale-up of linkages between hospitals and public health TB programs utilizing/adapting the Engaging Hospitals tool in the Toolkit as well as other resources. 2. Promote improvements the quality of services to vulnerable populations; 3. Promote the use of the ISTC as a framework for identification of gaps in tuberculosis care and utilize the analysis to determine appropriate private sector roles; 4. Identify and document models of specialized referral services for patients with complex diagnostic and treatment problems; 5. Examine and document models of bidirectional referrals between specialized providers and tuberculosis control programs; and 6. Promote documentation of approaches (qualitative) and outcomes (quantitative) and implementation of operations research to increase the evidence base for engaging all providers. Objective 3. To promote best practices for implementation and scale-up for engagement of all providers by providing guidance and tools for global, regional, country-specific policies, strategies and plans: Strategies 1. Adjust generic tools and develop training materials for utilization by regional, country, and local levels for planning and implementation of engagement activities; 2. Promote regionalization of engagement strategies to suit local care provider-mixes and regional priorities; 3. Review the use of incentives and enablers – which work, which are necessary, in which situations, and why? 4. Review the choices that have been made with regard to task mixes – which mixes work, in which situations, and why? How do these choices compare to the indicative task-mix in the PPM toolkit, and what explains any differences? 5. Review the resources necessary to implement meaningful PPM programs in different situations (small providers; large providers, etc).

6. Strengthen measurement and evaluation of engagement contributions toward country-specific targets; 7. Monitor needs for technical assistance in the field of engagement planning and implementation in coordination with TB-Team and other partners. Objective 4. To ensure that the current and/or potential role of non-program providers is taken into account in the activities of all components of the Stop TB partnership: Strategies 1. Seek full working group status as the “Working Group to Engage all Providers” including representation on the Partnership Coordinating Board; 2. Ensure representation of PPM core group members in other Partnership working groups on a regular basis; 3. Develop joint work plans addressing engagement of non-program providers in the various strategic components including:

o DOTS Expansion Working Group and its subgroups o TB-HIV Working Group o MDR TB Working Group o Laboratory Strengthening Working group o Working Group on New TB Diagnostics o Working Group on New TB Drugs o Working Group on New TB Vaccines

4. Collaborate with the Working Group on New TB Diagnostics and the Introducing New Approaches and Tools (INAT) subgroup to develop a “white paper” on utilization of a point of care test within the private sector; 5. Collaborate with the Working Group on New Drugs and the Introducing New Approaches and Tools (INAT) subgroup to develop a “white paper” on utilization of any new drugs by the private sector. 6. Collaborate with the Private Sector Constituency to develop ways to engage the corporate sector. 7. Develop a model framework / methodology for civil society and patient participation in mapping, monitoring and evaluation of public and/or private services, and a mechanism for reporting results directly to the PPM Working Group. Next Steps To accomplish the objectives and to implement the strategies the following steps are proposed:

Seek full working group status as the “Working Group to Engage all Providers” with representation on the Partnership Coordinating Board.

Revise the Core Group terms of reference as follows: o To provide oversight and coordination of the activities of the working

group; o To ensure coordination of the activities of the working group with those of

other Partnership working groups; o To oversee the preparation of a strategic plan and annual work plans to

implement the strategic plan;

o To participate in and coordinate any revisions of the Global Plan to Stop TB as they relate to the engagement of private sector providers:

o To work with the secretariat in developing the theme and agenda for annual meetings of the working group;

o To serve as the liaison between the Partnership and the Stop TB Department‘s activities in engaging all providers.

o To accomplish these responsibilities the core group members will be assigned specific responsibilities for representing and/or serving as liaison with other Partnership working groups and other relevant groups as follows:

o DOTS Expansion Working Group o TB-HIV Working Group o MDR TB Working Group o Laboratory Strengthening Working group o Working Group on New Diagnostics o Working Group on New TB Drugs o Working Group on New TB Vaccines o Introducing New Approaches and Tools (INAT) subgroup o Patient organizations o NGOs providing or advocating for TB services o Professional societies o Hospitals o Business/corporate sector o Informal providers, pharmacists, and other groups

o The core group will have at least one face-to-face meeting annually and will have bi-monthly telephone conference calls. The conference call agenda will be determined by the secretariat in consultation with the working group chair. These calls may be broken into smaller group 'pre-calls' that then feed into the larger call.

o Core group members who do not participate in 3 consecutive calls will be replaced.

Lampiran 4 Maximizing Access and Efficacy: Defining the Role of the Private Market in New TB Drug Delivery

Contents Abstract ................................................................................................................................................ 24 Objectives ............................................................................................................................................. 25 Background ........................................................................................................................................... 25 Assessing the size, scope and quality of the private sector for TB drugs ................................................. 26

Actions .......................................................................................................................................... 28 Improving the environment for roll-out ................................................................................................. 28

Expansion of public-private mix (PPM) programs ............................................................................... 28 Actions .......................................................................................................................................... 28

Expanding the reach of public programs ............................................................................................ 29 Actions .......................................................................................................................................... 30

Improving regulatory oversight for marketing approvals .................................................................... 30 Actions .......................................................................................................................................... 30

Improving regulatory oversight of quality assurance of TB drugs ....................................................... 30 Actions .......................................................................................................................................... 30

Expanding public sector diagnosis and treatment of multidrug-resistant TB (MDR-TB) ....................... 31 Actions .......................................................................................................................................... 31

Improving the quality of care in the private sector ............................................................................. 31 Action ............................................................................................................................................ 32

Options for roll-out of new TB drugs ...................................................................................................... 32 Development of fixed dose combinations .......................................................................................... 32

Actions .......................................................................................................................................... 32 Commercialization considerations ..................................................................................................... 33 Commercialization option #1: Sales only to the public sector and PPM programs .............................. 33 Commercialization option #2: Sales to both public and private sectors .............................................. 33

Actions .......................................................................................................................................... 34 Conclusion ............................................................................................................................................. 34 References ............................................................................................................................................ 35

Abstract After a long drought with no new TB drugs, there are currently a number of new compounds and regimens undergoing the latest stages of TB drug development. There is an urgent need to prepare for the introduction of these new drugs. This means maximizing uptake, but also promoting responsible use. The private sector will be key to both of these goals. TB is widely considered a public health, public-sector disease. But across ten high burden countries representing 60% of the world’s TB burden, there is as much TB drug volume in the private sector as in the public sector. This private sector presents many challenges due to its lack of centralized guidelines and uniform practices. For example, a total of 111 different first line TB drug dosages and combinations are used across just these 10 countries. Therefore mapping a responsible pathway for the introduction of new TB drugs into the private market will require innovation, deliberate effort, and the participation of many sectors. There is no single solution to this issue, but the size of the response should be commensurate with the size of the problem. There are multiple initiatives that can prepare the ground for new TB drug introduction. Greater government and international support is needed for collaborations called

public-private mix (PPM), and for expanding the reach of public programs, improving regulatory oversight for both marketing approvals and quality assurance of TB drugs, and expanding public sector diagnosis and treatment of multidrug-resistant TB (MDR-TB) so that this is not left to an unregulated private sector. Finally, new ideas and actions are needed to improve the quality of not just the drugs and diagnostics but also the care in the private sector, so that the private sector becomes a responsible and reliable alternative to the public sector for care. Drug developers must consider carefully the options for roll-out in terms of developing fixed dose combinations, choosing countries for early introduction that have the capacity to manage the new drugs, and considering whether to introduce the new TB drugs into both public and private sectors. Not only can the private sector not be ignored in understanding the access equation for TB drugs, but more people and more resources should be directed towards it – with the end goal of rational prescribing that will protect both current and future drugs.

Objectives This document has three objectives:

To raise awareness of the private sector market for TB drugs; To encourage TB stakeholders to engage with the private sector, and to identify mechanisms

for them to engage, with the end goal of maximizing the impact of new TB drugs and protecting them against misuse; and

To provide initial guidance on action points that these stakeholders should undertake.

Background Tuberculosis (TB) remains a global threat that is associated with 1.7 million deaths every year.1 Treatment for TB has been considered primarily as a public health priority, because lengthy, supervised treatment is needed to maximize cure rates, reduce incidence, and minimize the development of resistance. For general healthcare in low income settings, quality of care by physicians in the private sector may equal or exceed the quality in the public sector, especially around provider attitudes. But with TB, the public sector benefits from the presence of a comparatively strong, vertical program structuring the care – i.e., tracking outcomes via standardized treatment registers, mandating follow-up for defaulters, and providing links to the community. This provides a strong push towards treatment completion that is often absent in the private sector. The contrast is even more evident when, as is often the case, the private sector provider is a shopkeeper or minimally trained pharmacist. In the public sector, TB treatment policies are typically based on World Health Organization (WHO) recommendations,2, 3 and for first line treatment most countries4 adhere to a standardized 6 month regimen.1 For a given country, these treatment policies are usually decided centrally and are uniformly applied. National programs have been successful in scaling up this model of treatment to reach 63% of estimated incident cases.1 However, the private sector remains a major player in TB treatment and control.5 Indeed, private providers are responsible for more than half of all healthcare in the world,6 and private expenditure accounts for 45-90% of total expenditure on health in many low and middle income countries.7 Poorer populations within a country typically use private providers just as much, if not more, than

1 This is depicted, in shorthand, as 2HRZE/4RH (2 months of isoniazid (H), rifampicin (R), pyrazinamide (Z) and ethambutol (E), followed by four months of isoniazid and rifampicin).

richer populations, and they are also far more susceptible to TB. To avoid undue impoverishment, not to mention death, it is critical to ensure the quality of TB treatment in the private sector. In the private sector, decision making is made at the healthcare provider or patient level. The World Health Organization (WHO) has tried to increase the reliability of this response in TB treatment by introducing the concept of public-private mix (PPM), which links the private sector to public sector treatment norms.8, 9 PPM has also benefited from use of the International Standards for Tuberculosis Care (ISTC).10 Unfortunately, however, the expansion of PPM in most settings has been relatively limited. This is consistent with the incomplete state of collaboration between public and private healthcare systems generally, both in Africa11 and elsewhere. Today’s TB treatment landscape will be faced with exciting possibilities but also significant challenges as new TB drugs become available. The current TB drug development pipeline includes existing drugs repurposed for TB as well as new chemical entities, and the new regimens are aimed at treating both drug-sensitive and multidrug-resistant TB (MDR-TB).12, 13 Recent studies have reinforced suspicions about the substantial size and poor quality of the private TB drug market in certain high burden countries, particularly in Asia. This is a particular concern for the introduction of new TB drugs. Here, we outline the scope of the issue and suggest next steps on the policy front, with an emphasis on new TB drug introduction.

Assessing the size, scope and quality of the private sector for TB drugs A coughing patient will often turn first to a private sector provider,14 for reasons such as proximity, convenience, and better staff attitudes.15 The resulting private sector TB treatment is often delayed,16 expensive14 and inappropriate: in one study in India, 100 private doctors prescribed 80 different regimens,17 and a recent update showed no significant improvement.18 Similarly, private providers in the Philippines were reported to use inappropriate regimens 89% of the time,19 and it is known that patients often run out of money and so cannot complete treatment in the private sector.20 The result of such inconsistent treatment is clear in India, where almost half of all retreatment cases presenting to the public sector had their last TB treatment in the private sector.21 Furthermore, these private TB drug sales represent a significant percentage of total TB treatment. A recent study22 of private sector markets in 10 high burden countries covering 60% of the global burden of TB found evidence of both the substantial size and variability in private TB drug markets. Key findings included that: Near equal amounts of TB drugs are dispensed in the public and private sectors (enough to treat 67% vs. 66% of estimated incidence, respectively). The dosages of 35% of TB drugs sold in the private sector fall outside official recommendations

There were 111 different first‐line TB dosages and combinations being sold in the private sector, compared to the 14 deemed necessary by WHO for rational treatment of children and adults. The private sector is treating significantly fewer than 10% of MDR‐TB patients, and the predominant pattern is the addition of a single drug (a fluoroquinolone) in the absence of other second line drugs.

Figure 1: Number of cases that could be treated with first line TB drugs sold in the private sector

For the purposes of visualization, Figures 1 and 2 adopt the simplifying assumption that all private sector patients are receiving a correct and complete 6-8 month regimen for drug-sensitive TB. This assumption makes it clear that four of the largest high-burden countries – India, Indonesia, Pakistan, and the Philippines – have particularly large private sectors. Enough TB drugs are sold in their private sectors to treat all, or nearly all, incident TB patients with a full TB drug regimen (Figure 2). This is without even considering the 60 to 80 percent coverage by the public sector. The private market in India alone is estimated to include enough TB drugs to treat more than 2 million cases. Thus, some of the highest burden areas for TB are also the highest burden areas for private TB treatment. A global strategy for TB treatment will not be complete without a private sector solution. Figure 2: Percentage of a country's incident TB cases that could be treated with a full regimen of private sector TB drugs

A small number of countries successfully restrict TB treatment to the public sector, but for many countries the dominant presence of private sector health providers make this impractical. Indeed, given the private TB drug volumes noted above, it is unlikely that TB treatment in the private sector will disappear any time soon. Meanwhile, there is potential for a disciplined and well regulated private sector to make an important contribution to TB control by bringing activities closer to patients and expanding the reach of national TB programs. This document explores how best to bring this about while maximizing the effectiveness and lifetime of new TB drugs.

Actions National TB programs, with support from donors, should assess and monitor the state of

their country’s private sector TB treatment.23 Factors to track include the types and numbers of TB providers in the private sector, provider practices, numbers of private sector TB patients, availability and quality of TB drugs in the private sector, and TB treatment delays in private and public sectors.

WHO, technical assistance organizations, donors, and civil society should increase awareness of the scope of the private sector issue for TB and advocate for and fund work on the topics described in this report. There is a particular role for civil society in highlighting the human toll resulting from inadequate implementation of appropriate use policies; human stories are more likely to result in political movement.

Improving the environment for roll-out Multiple policy steps can be taken now to improve the environment into which new TB drugs will be introduced. These steps should prevent or limit irrational TB drug dispensing in the private sector, and thus minimize the generation of new drug resistance.24 Some of these initiatives include:

Expansion of public-private mix (PPM) programs Public-private mix (PPM) programs were established to bring the concepts behind DOTS – including standardized regimens, direct observation of treatment, and standardized reporting and recording of cases and treatment outcomes – to the private sector.8, 9 In some PPM programs, the private sector refers patients to the public sector for treatment,25 and other interventions concentrate primarily on advocacy around treatment norms.26 In most cases, however, patients stay with the private provider and there are “drugs for performance” contracts.27 In these contracts, the public sector provides free drugs to the private sector and, in return, the private sector reports treatment outcomes and ensures adherence to standard regimens.27-31 WHO has issued guidance on implementing PPM approaches,9 a tool for national situation assessments,23 and a toolkit addressing all the major types of providers and distinct PPM issues.32 Approaches vary by country, and depend in particular on which types of private or non-government outlets are seeing the most TB patients. The factors promoting success include a commitment to dialog by both the national TB program (NTP) and private providers, the NTP’s provision of substantial inputs including orientations, improved referral and information systems, and ongoing supervision and monitoring, and the use of a local nongovernmental organization or a medical association as an intermediary.28 Many of the efforts to strengthen the quality of care in the private sector (see below) will also synergize with PPM expansion efforts. Some excellent PPM programs exist and can contribute a significant percentage of case notifications in a particular area.1, 33 At least 15 countries have PPM programs1 but, in general, geographic coverage within each country remains limited.4, 34 The median budget allocated from Global Fund grants to PPM programs is only 5%.34 This and other PPM funding is insufficient to achieve complete coverage, and is not consistent with the size of the private sector for TB treatment.22 Actions

Building on their assessment of the private sector landscape (see above), national TB programs should assess and revise their PPM response as follows: o Conduct or update their comprehensive situation assessment;23 o Evaluate whether existing PPM efforts are targeting outlets that have low costs from a

patient perspective; this is necessary to effectively reach poorer populations;35

o Evaluate whether existing PPM efforts are providing sufficient incentives for private providers, or whether additional financial incentives (for reporting or treatment completion) are required;

o Determine whether there are any existing public-private partnerships (e.g., franchises) that do not currently include TB activities; if so, negotiate the addition of TB activities;

o Determine the current reach of PPM programs relative to the total need (% of country covered geographically; % of estimated total private sector TB patients reached);

o Determine the human resources and funding available and needed, taking into account the potential achievements in case detection;

o Undertake efforts to find and assign as many resources as the size of the issue demands. WHO, technical assistance organizations, and donors should support these efforts

financially and technically. National tuberculosis programmes and national pharmacy associations should work

together to develop policy guidance and mobilize resources to engage pharmacists in TB care and control.36

Expanding the reach of public programs Private market size for TB drugs has generally remained stable22 despite the efforts by NTPs in many countries to increase the public sector’s share of the TB treatment burden, and despite some indications that patient perceptions of public sector TB treatment are changing.20 This suggests that private providers in several HBCs are fulfilling a continued need in the eyes of consumers, who choose to use the private market even though free products are available through their respective public sector TB clinics. It should be possible to make public sector programs more extensive, appealing and flexible, thus potentially reducing consumers’ private sector preference.37 This requires a focus on the needs of users; services must be viewed from the patients’ perspective. The first step is to determine why people choose the private sector and therefore what response is needed (Table 1). In some countries, such as Bangladesh, awareness campaigns have been effective in directing more TB patients to the public sector. It should be noted, however, that many of the other responses listed in Table 1 fall beyond the remit of the national TB program, and require action across the entire health sector. Table 1: Assessing and improving attractiveness of the public sector

Possible reasons for choosing private sector for TB

Response to increase appeal of public sector

Due to habit / same treatment-seeking pattern as for other diseases

Awareness campaign about TB signs and symptoms and free treatment in public sector; vouchers for free diagnosis and treatment for TB patient contacts

Private facilities are easier to access Improve accessibility of public services (number of locations; opening hours); increase linkages between different public services (e.g., TB and HIV services)

Staff attitudes are better in private facilities Motivation and assessment of public sector staff in terms of patient-centered service

Staff knowledge is better in private facilities Training of public sector staff Patients face prohibitive costs when first encountering public sector due to high diagnostic costs38

Examine public sector diagnostic algorithms and costs

For example, tools now exist to assess patients’ perspective on quality of care39 and to improve the existing quality of care.40 Patient activism is needed to increase awareness of these tools and ensure that they are used and that the results impact implementation practices. Actions

Civil society should highlight the patient perspective and advocate for an approach that meets patient needs.

National TB programs should determine the reasons for private sector choice and address the underlying causes either through their own activities or via advocacy to other areas of the government.

National TB programs should ensure their ACSM activities are sufficient to ensure prompt health seeking behavior; the general population should be well informed about TB signs and symptoms and the existence of free public sector TB treatment. In countries where active case finding is prioritized, vouchers for free diagnosis and treatment of patient contacts could be considered. Drug distributors could also be considered as possible partners for distributing TB-related ACSM materials to drug shops and pharmacies, and thus to consumers.

Improving regulatory oversight for marketing approvals Variation in dosing practices has been documented at the provider17-19 and national22 level. Even with standardized regimens, dosage errors can be common,41 and dosage profusion only raises the likelihood that private providers may make mistakes or that their patients will be confused. WHO and the GDF helped to rationalize dosing in the public sector.42 Now, the private sector is keeping alive the confusion that existed previously in the public sector. Actions

National drug regulatory authorities should grant market authorizations only for dosages and regimens recommended by WHO and country guidelines.

WHO should provide guidance to national regulatory authorities on how to implement this recommendation.

National TB programs should promote the use of standardized regimens in the private sector. As a result, manufacturers may be persuaded via provider demand to make available only the strengths recommended by WHO or the NTPs.

Manufacturers could promote more uniformity of treatment via standardization of information in package inserts and roll-out of better provider educational materials.

Improving regulatory oversight of quality assurance of TB drugs The task of ensuring an uninterrupted supply of quality assured TB drugs is challenging for both the public and private sectors.43 But quality assurance is a particular challenge when the TB drug market is so fragmented44 and when there are large numbers of decentralized purchasers in the private sector. More detailed recommendations on quality assurance, which refer to regulation occurring across both public and private sectors, have been summarized recently.43 Actions

National drug regulatory authorities should institute and enforce WHO Good Manufacturing Practices (GMP) and quality control testing for both local and imported products, and consider innovations such as product tracking technologies.

National TB programs could study the flow of TB drugs in the private sector – specifically, what types of buyers and sellers are present at various levels of the distribution chain, and what volumes they handle. This could help the national drug regulatory authority to determine a feasible quality monitoring scheme.

Expanding public sector diagnosis and treatment of multidrug-resistant TB (MDR-TB) In key high burden countries, the volumes of most second line TB drugs in the private sector are currently too small to treat significant numbers of cases with anything approaching a full regimen.22 This may be slowing the emergence of additional second line drug resistance, although the finding of significant fluoroquinolone usage for both TB and non-TB indications22 is consistent with the increasing incidence of fluoroquinolone-resistant TB in certain countries.45 In addition, many of the other drugs are available (albeit in small volumes). With the increasing roll-out of rapid testing for MDR-TB, there is a significant possibility that private sector MDR-TB treatment will expand rapidly in the coming years. Thus, now is the time to act to ensure that all MDR-TB treatment is to the highest possible standard such that cure is maximized and generation of additional drug resistance is minimized. This will include both regulatory and oversight approaches (see above), but also an urgent emphasis on expanding programs for the diagnosis and treatment of MDR-TB that are either conducted or monitored by the public sector. In this effort, private sector laboratory capacity can be an opportunity rather than a threat. Whichever strategy is used, treatment of MDR-TB must not be left to an unregulated private sector. Actions

National TB programs, technical assistance organizations, and donors should support the expansion of MDR-TB diagnosis and treatment programs that are conducted with public sector oversight.

Improving the quality of care in the private sector The necessary expansion of PPM programs (see above) should also be connected with broader efforts to improve public stewardship of private providers based on existing frameworks.11 This requires better regulatory, financing and purchasing policies, and efforts to gather information about health markets, and to support innovative models that can act as stepping stones to broader reforms.46 Two categories of health market innovations47 are of particular interest to PPM expansion efforts. Initiatives that reduce fragmentation of private health systems, via institution or expansion of franchises,48 chains, networks, cooperatives, or professional associations, will create natural partners for PPM expansion efforts. Branding of these groups will often lead more users to access their care. In addition, financing innovations such as social, private or community health insurance, vouchers and contracting, can strengthen incentives for private sector participation in PPM. For example, reimbursement for any health services could be made contingent on the provider’s participation in TB PPM programs (e.g., a minimum number of TB patients referred or reported). Both types of innovations can reduce transaction costs for public and private sectors drastically. Whereas physicians or pharmacists may be unwilling to take on the administrative burden of a TB-only PPM scheme – especially if they see only a handful of TB patients each month – they are likely to be enthusiastic about a broader franchise or insurance scheme that includes TB and other diagnostic and treatment activities. The organization of providers into larger structures also enables the

introduction of other quality assurance measures and schemes, such as vouchers that target subsidies only to high quality providers.49 The private sector cannot be ignored in understanding the access equation. More people and more resources should be directed towards it – with the end goal of rational prescribing that will protect both current and future drugs. The ultimate goal should be a private sector that is a responsible and reliable alternative to the public sector for care. Action

The global health community should stimulate additional, scalable solutions beyond standard PPM, and contribute ideas and actions toward improving quality of care (not just the drugs) in the private sector so that it is a responsible alternative to the public sector for care.

Governments should consider the roles required in healthcare – including regulator, financer and service provider – and make a broad, strategic decision about which of these roles should be filled more by the government and which by the private sector. If the government prioritizes provision of services by the private sector, it can support innovation by purchasing high quality services indirectly through insurance or vouchers, or directly through contracts.

As new, scalable initiatives are introduced for financing and delivery of health services in the private sector, Ministries of Health should maximize the opportunities for incorporating high quality TB treatment into these schemes, with an assurance that the diagnostic and treatment outcomes flow through national TB reporting structures.

Options for roll-out of new TB drugs TB treatment requires consistent administration of a multidrug regimen. Introduction of a single new TB drug raises a valid concern: if the new drug is introduced as the only effective drug in a failing regimen, there will soon be widespread resistance to the new drug.

Development of fixed dose combinations To combat this possibility, there is increasing emphasis on the development of new TB regimens,50 rather than the development of a single TB drug. Ultimately, it would be desirable for these new regimens to be available in the form of a fixed-dose combination, which enforces multidrug administration. In some circumstances this might not be possible – for example, if a regimen is a mixture of old, weight-banded drugs and new, non-weight-banded drugs. Such a regimen would require a different FDC for each weight band, the development of which would be financially prohibitive. However, regimens consisting entirely of new drugs are excellent candidates for FDCs. If the final regimen is clear, and early efficacy studies are particularly promising, drug developers may commit to spend money on FDC development ‘at risk’ (i.e., before Phase III efficacy results are available). In other cases, FDC development, stability testing, registration and availability may occur later, with some period in which only the single drugs are available on the market. Actions

Drug developers should invest in the development and testing of fixed dose combinations that include new TB drugs; donors should support these efforts.

Commercialization considerations Any company with a new TB drug will be faced with a basic commercialization decision: where to register and market the new drug. The first level of this question is about choice of countries for public sector sales. Should marketing occur only in those countries where programmatic management of MDR-TB is judged to be of high quality? How should such “quality” be assessed, and by whom? By the time of launch of new MDR-TB drugs, a lot of countries will have MDR-TB treatment success data, so perhaps that is a place to start. Second, there is a decision about whether to market to both public and private sectors. Some countries, such as Brazil, allow current TB drugs to be procured only by the public sector. In most countries, however, TB drugs are found in both public and private sectors, and thus this second-level decision is needed when introducing new TB drugs. The parameters of this decision are presented below. The ultimate goal is to sell only to providers who are qualified and capable of dispensing TB regimens consistently and reliably.

Commercialization option #1: Sales only to the public sector and PPM programs Under one option for roll-out, new TB drugs could be made available only via public sector procurement agents, which may then distribute them to the public sector facilities plus private providers who are participating in PPM programs. This pathway has the following attributes: Advantages:

- Reduced likelihood of improper drug management, and thus reduced likelihood of emerging drug resistance.

- Easier to monitor early implementation experiences and outcomes, including post-marketing surveillance

- Provides strong incentive for private providers to join PPM programs Disadvantages:

- Reduced access for patients (depending on the country’s barriers to public sector access, and on how long it takes the average TB patient to make his or her way from the private to the public sector)

- Reduced market size for drug companies. Possible consequences include: o higher prices (due to low volumes) o need to find philanthropic support even to cover production and distribution costs o in extreme cases, market exit, resulting in few or no quality-assured suppliers for the

product. - Not possible for drugs that are already used by the private sector for other indications (e.g.,

fluoroquinolones)

Commercialization option #2: Sales to both public and private sectors A strictly regulatory approach may not be realistic for new TB drugs that have other major indications. For example, fluoroquinolones are already widely used for multiple indications, including off-label use for MDR-TB. Outside of PPM programs, it will be difficult to limit their use as a possible first line treatment for TB. In contrast, for new drugs that are registered initially for TB (e.g., TMC207), a higher degree of control is possible. If new drugs are used only for MDR-TB, it may be particularly appealing to limit sales to the public sector. The public health consequences of MDR-TB drug misuse are severe, and the low volumes of MDR-TB drugs and patients mean that pharmaceutical and medical quality assurance may fail if drug distribution and drug provision are not consolidated in the public sector.

However, the pressure to allow private sector access to these drugs is likely to accumulate. Allowing private sector access to a new MDR-TB drug would be more easily justified in a particular country if:

- Public sector MDR-TB treatment in that country is inadequate in terms of patient capacity or geographical access;

- The private sector in the country has taken on a substantial part of the burden of administering MDR-TB treatment; and

- This MDR-TB treatment is documented to be of high quality and/or there is a quality assurance mechanism in place (e.g., monitored based on output-based vouchers, or overseen by a physicians’ association or franchising institution51)

National TB programs should assess these and other factors on a country by country basis in order to derive a locally appropriate policy. This policy should, however, recognize the operating constraints for a pharmaceutical company with a new TB drug. Such a company may have little or no national presence that would allow them to oversee rational use programs and, given the small size of the TB drug market,52 no commercial justification for establishing such a presence. Such a company can, however, exert some control over private sector sales, particularly if the company uses only a single national distributor. Ranging from least to most restrictive, this distributor could:

Document the recipient identity and volume for each sale (minimum requirement) Require proof of MDR-TB diagnosis for each regimen’s worth of drugs sold Require proof of MDR-TB diagnosis at one of a certain limited list of accredited sites Require proof of MDR-TB diagnosis and of use of a standardized regimen (maximum

requirement; controls could be similar to those used during a compassionate use program) It will be important to estimate, for each country, the likely impact of such policies in terms of reducing access for patients and drug volumes for manufacturers. Actions

National TB programs, with assistance from WHO and other technical assistance organizations, should develop policies for responsible introduction of new TB drugs into the private sector. If this leads to a broader objective to restrict all TB treatment and drugs to the public sector, the government will need a multisectoral approach including laws, enforcement, financing, education, and referral mechanisms.

Drug developers should pilot policies and mechanisms for limiting private market sales of new TB drugs to those outlets where rational, multidrug TB treatment can be assured.

Conclusion The global goal for the introduction of new TB drugs should be to maximize health outcomes. This seemingly simple goal requires a balancing act between two objectives: maximizing access to new treatments; and ensuring that access is granted only to treatment outlets that can ensure rational, quality assured treatment. To achieve these two objectives, and thus the overaraching goal, action is needed on multiple fronts by multiple actors. Only through such action can we maximize the lifespan of new TB drugs and realize their full potential. The text of this discussion paper was drafted by William Wells with substantial inputs from Elizabeth Gardiner, David Griffiths, Philip Hopewell, Gina Lagomarsino, Mel Spigelman, Ross Underwood, and

Mukund Uplekar. The content was presented at the 2011 meeting of Stop TB Partnership's Subgroup on Public Private Mix (PPM) for TB Care and Control and was refined based on the subgroup’s feedback.

References 1. WHO. Global tuberculosis control: WHO report 2010. Geneva, Switzerland: World Health Organization; 2010. 2. WHO. Treatment of tuberculosis: Guidelines, 4th edition. Geneva: World Health Organization; 2009. 3. Wells WA, Konduri N, Chen C, Lee D, Ignatius HR, Gardiner E, et al. TB regimen change in the high burden countries. Int J Tuberc Lung Dis. 2010; 14: 1538-47. 4. Wells WA, Konduri N, Chen C, Lee D, Ignatius HR, Gardiner E, et al. Implications of the current tuberculosis treatment landscape for future regimen change. Int J Tuberc Lung Dis. 2011; 15(6): 746-53. 5. Uplekar M, Pathania V, Raviglione M. Private practitioners and public health: weak links in tuberculosis control. Lancet. 2001; 358(9285): 912-6. 6. Private Healthcare in Developing Countries. Analysis of DHS data. 2011 [cited 2011 September 13]; Available from: http://ps4h.org/globalhealthdata.html 7. World Health Organization. National health accounts: Private expenditure on health as a percentage of total expenditure on health, 2009. 2009 [cited 2011 September 13]; Available from: http://gamapserver.who.int/mapLibrary/Files/Maps/PrivateExpPercentTotal_2009.png 8. Uplekar M. Involving private health care providers in delivery of TB care: global strategy. Tuberculosis (Edinb). 2003; 83(1-3): 156-64. 9. WHO. Engaging all health care providers in TB control: guidance on implementing public-private mix approaches. Geneva: World Health Organization; 2006. 10. Hopewell PC, Pai M, Maher D, Uplekar M, Raviglione MC. International standards for tuberculosis care. Lancet Infect Dis. 2006; 6(11): 710-25. 11. World Bank/International Finance Corporation. Healthy partnerships: how governments can engage the private sector to improve health in Africa; 2011. 12. Ma Z, Lienhardt C, McIlleron H, Nunn AJ, Wang X. Global tuberculosis drug development pipeline: the need and the reality. Lancet. 2010; 375(9731): 2100-9. 13. Working Group on New TB Drugs. [cited; Available from: http://www.newtbdrugs.org/ 14. Pantoja A, Floyd K, Unnikrishnan KP, Jitendra R, Padma MR, Lal SS, et al. Economic evaluation of public-private mix for tuberculosis care and control, India. Part I. Socio-economic profile and costs among tuberculosis patients. Int J Tuberc Lung Dis. 2009; 13(6): 698-704. 15. Quality Assurance Project (QAP). Treating tuberculosis in the private sector: Cambodia. Operations research results. Bethesda, MD; 2004. 16. Lonnroth K, Thuong LM, Linh PD, Diwan VK. Delay and discontinuity--a survey of TB patients' search of a diagnosis in a diversified health care system. Int J Tuberc Lung Dis. 1999; 3(11): 992-1000. 17. Uplekar MW, Shepard DS. Treatment of tuberculosis by private general practitioners in India. Tubercle. 1991; 72(4): 284-90. 18. Udwadia ZF, Pinto LM, Uplekar MW. Tuberculosis management by private practitioners in Mumbai, India: has anything changed in two decades? PLoS One. 2010; 5(8): e12023. 19. Portero JL, Rubio M. Private practitioners and tuberculosis control in the Philippines: strangers when they meet? Trop Med Int Health. 2003; 8(4): 329-35. 20. Jaggarajamma K, Balambal R, Muniyandi M, Vasantha M, Thomas B, Nirupa C, et al. Perceptions of tuberculosis patients about private providers before and after implementation of Revised National Tuberculosis Control Programme. Indian J Tuberc. 2009; 56(4): 185-90.

21. Sachdeva KS, Satyanarayana S, Dewan PK, Nair SA, Reddy R, Kundu D, et al. Source of Previous Treatment for Re-Treatment TB Cases Registered under the National TB Control Programme, India, 2010. PLoS One. 2011; 6(7): e22061. 22. Wells WA, Ge CF, Patel N, Oh T, Gardiner E, Kimerling ME. Size and Usage Patterns of Private TB Drug Markets in the High Burden Countries. PLoS One. 2011; 6(5): e18964. 23. WHO and Stop TB Partnership. Public-private mix for TB care and control: A tool for national situation assessment. Geneva; 2007. 24. Nathanson E, Nunn P, Uplekar M, Floyd K, Jaramillo E, Lonnroth K, et al. MDR tuberculosis--critical steps for prevention and control. The New England journal of medicine. 2010; 363(11): 1050-8. 25. Dewan PK, Lal SS, Lonnroth K, Wares F, Uplekar M, Sahu S, et al. Improving tuberculosis control through public-private collaboration in India: literature review. Bmj. 2006; 332(7541): 574-8. 26. Krishnan N, Ananthakrishnan R, Augustine S, Vijayalakshmi NK, Gopi PG, Kumaraswami V, et al. Impact of advocacy on the tuberculosis management practices of private practitioners in Chennai City, India. Int J Tuberc Lung Dis. 2009; 13(1): 112-8. 27. Lonnroth K, Uplekar M, Blanc L. Hard gains through soft contracts: productive engagement of private providers in tuberculosis control. Bulletin of the World Health Organization. 2006; 84(11): 876-83. 28. Lonnroth K, Uplekar M, Arora VK, Juvekar S, Lan NT, Mwaniki D, et al. Public-private mix for DOTS implementation: what makes it work? Bulletin of the World Health Organization. 2004; 82(8): 580-6. 29. Mantala MJ. Public-private mix DOTS in the Philippines. Tuberculosis (Edinb). 2003; 83(1-3): 173-6. 30. Ahmed J, Ahmed M, Laghari A, Lohana W, Ali S, Fatmi Z. Public private mix model in enhancing tuberculosis case detection in District Thatta, Sindh, Pakistan. J Pak Med Assoc. 2009; 59(2): 82-6. 31. Quy HT, Lonnroth K, Lan NT, Buu TN. Treatment results among tuberculosis patients treated by private lung specialists involved in a public-private mix project in Vietnam. Int J Tuberc Lung Dis. 2003; 7(12): 1139-46. 32. WHO and Stop TB Partnership. Public-private mix for TB care and control: A toolkit. Geneva; 2010. 33. Lal SS, Sahu S, Wares F, Lonnroth K, Chauhan LS, Uplekar M. Intensified scale-up of public-private mix: a systems approach to tuberculosis care and control in India. Int J Tuberc Lung Dis. 2011; 15(1): 97-104. 34. Lal SS, Uplekar M, Katz I, Lonnroth K, Komatsu R, Yesudian Dias HM, et al. Global Fund financing of public–private mix approaches for delivery of tuberculosis care. Tropical Medicine & International Health. 2011: no-no. 35. Malmborg R, Mann G, Thomson R, Squire SB. Can public-private collaboration promote tuberculosis case detection among the poor and vulnerable? Bulletin of the World Health Organization. 2006; 84(9): 752-8. 36. WHO, FIP. The role of pharmacists in Tuberculosis care and control: a joint statement by the World Health Organization (WHO) and the International Pharmaceutical Federation (FIP); 2011. 37. Pinto LM, Udwadia ZF. Private patient perceptions about a public programme; what do private Indian tuberculosis patients really feel about directly observed treatment? BMC public health. 2010; 10: 357. 38. Kemp JR, Mann G, Simwaka BN, Salaniponi FM, Squire SB. Can Malawi's poor afford free tuberculosis services? Patient and household costs associated with a tuberculosis diagnosis in Lilongwe. Bulletin of the World Health Organization. 2007; 85(8): 580-5. 39. Massaut S, Van den Broek J, van der Kwaak A. QUOTE TB Light. The Hague; 2009. 40. WHO. Practical guide to improve quality of TB patient care: A participatory approach. Geneva; 2008.

41. Ipuge YA, Rieder HL, Becx-Bleumink M, Kimerling ME. Evaluation and planning in national tuberculosis control programmes: the usefulness of the standardised patient treatment card. East Afr Med J. 1997; 74(12): 816-8. 42. WHO. Fixed-dose combination tablets for the treatment of tuberculosis. Report of an informal meeting held in Geneva, Tuesday 27 April 1999. Geneva: World Health Organization; 1999. 43. Clinton Health Access Initiative, Bill & Melinda Gates Foundation, Global Alliance for TB Drug Development, Global Drug Facility, International Union Against Tuberculosis and Lung Disease, Management Sciences for Health, et al. Falling short: Ensuring access to simple, safe and effective first-line medications for Tuberculosis. New York; 2010. 44. TB Alliance. Pathway to Patients: Charting the Dynamics of the Global TB Drug Market. New York: Global Alliance for TB Drug Development; 2007. 45. Agrawal D, Udwadia ZF, Rodriguez C, Mehta A. Increasing incidence of fluoroquinolone-resistant Mycobacterium tuberculosis in Mumbai, India. Int J Tuberc Lung Dis. 2009; 13(1): 79-83. 46. Lagomarsino G, Nachuk S, Kundra SS. Public stewardship of private providers in mixed health systems: Synthesis report from the Rockefeller Foundation-supported initiative on the role of the private sector in health systems in developing countries. Washington, D.C.; 2009. 47. Center for Health Market Innovations. Program type definitions. 2011 [cited 2011 September 13]; Available from: http://healthmarketinnovations.org/program-type-definitions 48. Prata N, Montagu D, Jefferys E. Private sector, human resources and health franchising in Africa. Bulletin of the World Health Organization. 2005; 83(4): 274-9. 49. Bellows NM, Bellows BW, Warren C. Systematic Review: the use of vouchers for reproductive health services in developing countries: systematic review. Trop Med Int Health. 2011; 16(1): 84-96. 50. Critical Path to TB Drug Regimens. [cited; Available from: http://cptrinitiative.org/ 51. Lonnroth K, Aung T, Maung W, Kluge H, Uplekar M. Social franchising of TB care through private GPs in Myanmar: an assessment of treatment results, access, equity and financial protection. Health policy and planning. 2007; 22(3): 156-66. 52. Schwalbe NR, Wells WA, Geaneotes AP, Forcellina A, Lee MG, Dicola L, et al. Estimating the market for tuberculosis drugs in industrialized and developing nations. Int J Tuberc Lung Dis. 2008; 12(10): 1173-81.

Lampiran 5 THE ROLE OF PHARMACISTS IN

TUBERCULOSIS CARE AND CONTROL Background Every year, more than 9 million new cases of tuberculosis (TB) occur and nearly 2 million people die of the disease. Nearly half a million cases have the multidrug-resistant form of the disease. While Asia bears the largest burden of the disease, sub-Saharan Africa has the highest incidence of drug-susceptible TB and Eastern Europe has the highest incidence of multidrug-resistant TB (MDR-TB). Considerable progress has been made over the past decade: between 1995 and 2009, proper TB care and control averted up to 6 million deaths and cured 41 million people. A great deal of concerted effort is still required if the TB-related Millennium Development Goals are to be met by 2015 and the Stop TB Partnership's vision of a world free of TB is to be realized by 2050. In several countries, national TB programmes have made significant progress in involving diverse public, private, voluntary and corporate health-care providers in TB care and control. Pharmacists constitute an important and essential part of the health work-force. In many countries, pharmacists are the frontline health-care providers and often a first point of contact for people with symptoms of TB. Systematic efforts to involve pharmacists in TB care and control therefore need to be undertaken as a part of strengthening health systems in general and health work-force in particular. Working together: WHO and FIP The World Health Organization (WHO) and the International Pharmaceutical Federation (FIP) intend to intensify their collaboration towards care and control of TB and MDR-TB globally. While recognizing the broader role of pharmacists in the development and use of anti-TB medicines, this joint statement focuses on the role of pharmacists directly involved in delivering care for people with TB. This statement builds on WHO’s mandate in public health and FIP’s previous collaboration with WHO on important public health issues including the role of pharmacists in the fight against the HIV-AIDS pandemic, good pharmacy practice, prevention of anti-microbial resistance and encouraging adherence to long-term treatments. Joint action 1. WHO and FIP have jointly drawn up the basis for action-oriented collaboration between national TB programmes and national pharmacy associations in the fight against TB and MDR-TB. 2. WHO undertakes to promote the need for these collaborative actions to WHO Member States, their national TB programmes and drug regulatory authorities as well as to Stop TB partners worldwide. 3. FIP undertakes to promote these actions to national pharmacy associations worldwide and, through them, to individual pharmacists and to the health authorities of respective countries. 4. Both WHO and FIP will use this joint statement to harness the contribution of pharmacists in delivering health services as part of strengthening health systems.

Dr Hiroki Nakatani Dr Michel Buchmann Assistant Director-General, President World Health Organization International Pharmaceutical

Federation

Lampiran 6