Laporan Mengikuti 7th Meeting of the Subgroup on Public-Privite Mix for TB Care and Control Grand Palais, Lille, France October 2011

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1 Laporan Mengikuti 7th Meeting of the Subgroup on Public-Privite Mix for TB Care and Control Grand Palais, Lille, France October 2011 Oleh : 1. Dyah Erti Mustikawati 2. Asik Surya Ditjen PP&PL Kementerian Kesehatan RI 2011

2 LAPORAN PERJALANAN DINAS 7th Meeting of the Subgroup on Public-Privite Mix for TB Care and Control Grand Palais, Lille, France October 2011 Dilaporkan oleh : Dyah Erti Mustikawati, MPH (NTP Manager) Dr. Asik Surya, MPPM (Deputy NTP Manager) A. Pendahuluan Latar Belakang Tanggal Perjalanan Dinas : Oktober 2011 Sumber Pendanaan: GF-ATM Komponen TB Tuberkulosis atau TB masih merupakan masalah kesehatan masyarakat yang menjadi tantangan global. Indonesia merupakan negara pertama diantara negaranegara 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 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 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,

3 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 :

4 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)

5 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

6 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)

7 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

8 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 dan dijabarkan lebih lanjut dalam Rencana Aksi Nasional untuk PPM-TB 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: 1.Basic DOTS Services At Puskesmas 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 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 -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 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 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

9 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

10 LAMPIRAN 1 Seventh Meeting of the Subgroup on Public-Private Mix for TB Care and Control October 2011, Lille, France Provisional Agenda 23 October :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: L Vianzon Philippine experience 14:00-14:30 Engaging pharmacies: country experiences D Arcy Richardson 14:30-15:00 WHO-FIP joint statement on role of pharmacists in Monica Dias TB care and control 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

11 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

12 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 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 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

13 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

14 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, nongovernmental 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

15 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

16 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.

17 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.

18 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.

19 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.

20 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 nonexistent 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;

21 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, countryspecific 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).