1_17_372_Mission Report PMDT PNG 2010

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					  TECHNICAL ASSISTANCE FOR THE
 PROGRAMMATIC MANAGEMENT OF
MULTIDRUG-RESISTANT TB (MDR-TB) IN
PAPUA NEW GUINEA: MISSION REPORT



             June 28 – July 7, 2010

         Ma. Imelda D. Quelapio, MD *




       * Tropical Disease Foundation, Philippines



                                                    1
Acknowledgments
Acknowledgment is hereby made to the National Department of Health, Papua New
Guinea (Disease Control Branch, National TB Programme), the Central Public
Health Laboratory, Port Moresby General Hospital, Provincial Health Offices, World
Health Organization – PNG, World Vision Foundation International, Hope World
Wide, NCD Health and other stakeholders and partners.




                                                                                     2
Contents
Acronyms                                                         4


I. Background                                                    5

II. Terms of reference and Activities                            6

III. Findings                                                    8

IV. Recommendations                                              14

V. Annexures
      1A - Key persons met                                       20
      1B - Activities conducted during this mission              21
      2A - Workshop agenda for the preparation of MDR-TB
            Guidelines in PNG                                    22
      2B - Participants in the Workshop for the preparation of
            MDR-TB Guidelines in PNG                             23
      3 – Participants of the Advocacy symposium on
            MDR-/XDR-TB                                          24
      4 - Response to the challenge of drug-resistant TB, NDOH   25
      5 - NDOH staff trained in PMDT                             26
      6 - Proposed framework for PMDT activities 2011-2015       29




                                                                      3
Acronyms

AusAID      Australian Agency for International Development
CPHL        Central Public Health Laboratory
DGH         Daru General Hospital
DOT         Directly Observed Treatment
DOTS        Directly Observed Treatment, Short-course
DRS         Drug resistance surveillance
DR-TB       Drug-resistant TB
DST         Drug Susceptibility Testing
EQA         External Quality Assurance
FDC         Fixed Dose Combination
GDF         Global Drug Facility
GLC         Green Light Committee
IMR         Institute of Medical Research
HIV         Human Immunodeficiency virus
MDR         Multidrug-resistant TB
NCD         National Capital District
NDOH        National Department of Health
NSP         New -smear positive
NTP         National TB Program
PMDT        Programmatic management of drug-resistant TB
PMGH        Port Moresby General Hospital
PNG         Papua New Guinea
QMRL        Queensland Mycobacterium Reference Laboratory
SLD         Second-line drug
The Union   International Union against Tuberculosis and Lung Diseases
WVI         World Vision International
WHO         World Health Organization
XDR-TB      Extensively drug-resistant TB




                                                                         4
Technical Assistance for the programmatic management of MDR-TB
in Papua New Guinea: Mission Report

Date of mission: June 28 – July 7, 2010
Consultant: Ma. Imelda D. Quelapio, MD




I.         BACKGROUND

           DOTS was introduced in Papa New Guinea (PNG) in 1997 starting in the
           National Capital District (NCD) and Lae District. 1 Under the Stop TB Strategy for
           PNG, the NTP plans to cover 80% of the population in the 67/87 districts and
           20/20 provinces in the country in a phased manner within five years (October
           2007 – September 2012).2 At the present time, DOTS has been implemented in
           9 out of 20 provinces covering 61% of population through funding from the Global
           Fund to Fight AIDS, TB and Malaria (GFATM).

           In 2007, the estimated annual incidence of all forms of TB in PNG was 250 per
           100 000 population; among new smear-positives (NSPs), this was 108 per
           100 000 and the prevalence of all cases was 430 per 100 000. The estimated TB
           mortality was 60 per 100 000. With a population of 6.6 million, these rates
           correspond to 15,796 incident cases for all types, 6,815 incident NSP cases,
           27,197 prevalent cases, and 3,817 deaths.3 Based on NTP data, case detection
           in 2009 among NSPs was 31% with a treatment success in 2008 of 73%.

           For a long time, PNG was faced with the challenge of uncertain and meagre
           funding for TB control.1,2 Loose TB drugs obtained from local procurement have
           been used until 2007 when fixed drug combination (FDC) was introduced
           procured through the Global Drug Facility. The long use of drugs with uncertain
           quality and a high pill burden for patients, the lack of an overall DOTS strategy
           until recently, could be factors to consider as contributory to the emergence of
           multidrug-resistant TB (MDR-TB) facing PNG for years.

           Since 1995, MDR-TB has been informally addressed through clinical treatment
           offered in hospitals using locally procured second-line anti-TB agents. During this

1
 Country Status Report of National TB Program, Papua New Guinea (1997-2005) NTP, NDOH
2
 Report of Joint Review Mission for National TB Program in Papua New Guinea (2006-2010) NTP,
NDOH
3
    Global TB Control 2009: Epidemiology, Strategy and Financing, 2009. WHO/HTM/TB/2009.411

                                                                                               5
         time, there was scarce evidence for the proper treatment of MDR-TB. Neither
         was there strong political will to treat these cases and the priority was heavily just
         on DOTS. However, more recently, guidelines and recommendations on the
         comprehensive management of drug-resistant TB (DR-TB) through a framework
         have been made available based on best evidence. 4,5 There has been financial
         and political momentum and a global push to treat this dreaded strain in the
         context of a programmatic approach integrated in national TB programmes. The
         National Department of Health (NDOH) of PNG has decided to collectively
         address this problem and put together its own national Guidelines for the
         Programmatic Management of Drug-resistant TB (PMDT) guided by the available
         WHO guidelines with consideration of its unique setting and own experience in
         DR-TB management. It was mainly for this purpose that this technical assistance
         was arranged.



II.      TERMS OF REFERENCE AND ACTIVITIES
         The terms of reference of this mission are as follows:

         1. To visit sites of MDR-TB management and relevant TB service delivery areas

         2. To review the MDR-TB Guidelines development process in PNG

         3. To expand the existing framework of the National MDR-TB Guidelines and
            prepare a pre-final draft of the Guidelines

         4. To suggest a framework for MDR-TB activities to be incorporated in the next
            NTP strategic plan of 2011 - 2015

         5. In conjunction with a focal person in the NTP, to prepare an initial draft of GLC
            application by PNG, focusing on needs assessment of the NTP



      This mission was accomplished through site visits to areas relevant in the
      management of DR-TB, meetings and discussions with key persons who have been
      involved or who will potentially be involved in the management of DR-TB. (Annex 1A
      and Annex IB). A major activity in this mission was participation in a two-day
      workshop for the preparation of the MDR-TB Guidelines spearheaded by the NTP
      and attended by various stakeholders (Annex 2A and Annex 2B). This workshop

4
 Guidelines for the Programmatic Management of Drug-resistant TB, WHO/HTM/TB/2006.361
5
 Guidelines for the Programmatic Management of Drug-resistant TB, Emergency Update 2008,
WHO/HTM/TB/2008.402

                                                                                              6
       aimed to discuss the contents of the national MDR-TB Guidelines for PNG and to
       inform the participants of the current WHO Guidelines on PMDT 5. Participants
       included representatives from the central and provincial levels of healthcare and
       other NTP partners. Another important activity was an advocacy symposium on
       MDR-TB and XDR-TB (Extensively drug-resistant TB) convened by WHO-PNG
       attended by various stakeholders (Annex 3). During this symposium, the NDOH
       response to the challenge of drug-resistant TB was presented by the Deputy Health
       Secretary (Annex 4).

        Site visits were made to:
              Port Moresby General Hospital (PMGH) Out-patient TB Clinic and MDR-
                TB Ward: the main areas where MDR-TB cases are currently being
                treated in PNG.
              Central Public Health Laboratory (CPHL): the national TB reference
                laboratory
              Central Drug Warehouse, Badili: the national drug storage of NDOH
              Nine Mile District Health Facility: a public DOTS health center in Port
                Moresby
        Interviews and discussions were made with:
              key persons for the programmatic and clinical management of DR-TB,
                laboratory management, drug management of TB, data management of
                TB
              an MDR-TB patient
              a treatment partner/observer of the MDR-TB patient
        Participation in Workshop for MDR-TB Guidelines preparation (Lae, Morobe)
        Discussion on the GLC application template with the NTP, CPHL, PMGH and
         WHO- PNG.


III.      FINDINGS IN THE MISSION

A. Magnitude of the DR-TB problem in PNG
       The magnitude of the DR-TB problem in PNG has been estimated only through
       modelling by WHO.6 The country’s first Drug Resistance Surveillance (DRS) is set
       to be started this year through funding from the Global Fund to Fight AIDS, TB and
       Malaria (GFATM), albeit for only two provinces (NCD and Morobe) 7 and with
       technical support from the Queensland Mycobacterium Laboratory (QMRL).


6
  Multidrug and Extensively drug-resistant TB (M/XDR-TB): 2010 Global Report on Surveillance and Response.
WHO/HTM/TB/2010.3
7
  Papua New Guinea Proposal to the GFATM Round 6, July 2006

                                                                                                             7
      The 2010 WHO Report 6 estimates the MDR-TB rate in PNG among new cases at
      1.9% (95% CI: 0.0-7.5) and 13.8% (95% CI: 0.0-36.2) among previously treated
      cases. An estimated 530 (95% CI: 9-1,300) MDR-TB cases occur yearly among new
      and incident new and relapse TB cases and 73 (95% CI: 0-210) among incident
      acquired MDR-TB cases with a total of 603 (95% CI: 0-1,200) cases every year.

      Although DRS has not yet been done, there are data available locally that support
      the presence of MDR-TB cases in PNG. The table below shows the three surveys
      done by CPHL, PNG-Institute of Medical Research (IMR) and Daru General Hospital
      (DGH) with varied drug-resistance rates. Specimens at CPHL and DGH were mostly
      from DR-TB suspects collected randomly rather than consecutively; hence, results
      should be interpreted with caution. Specimens at PNG-IMR were from TB cases in
      the community, but at this point in time, it is not clear whether these were
      consecutively enrolled cases from a given microscopy centre.



                         Table 1. Local data on DR-TB available in PNG

        Agency           Period            No. studied              Rate of drug-resistant TB
         that           covered         No. of    No. with             Any           MDR-TB
      conducted                        patients     DST             resistance     (no. and %)
      the survey                                  results          (no. and %)
      CPHL*               2008-          126         63              53 (84%)        26 (41%)
                          2010
      PNG IMR**           2009-          150            49           5 (10%)             3 (6%)
                          2011
      DGH ***             2009            28            24           17 (71%)           11 (46%)
       * Funded by WHO        ** With Swiss Tropical Inst., PGMH, QMRL        *** Funded by AusAID




B. Political commitment

      Clearly, there is government commitment to expand DOTS and an increasing
      recognition of the MDR-TB problem in PNG.

       DOTS continues to expand in a phased manner. The first External Review of the
        NTP was conducted in May 2009 highlighting the progress of DOTS
        implementation and various recommendations.8 While full DOTS is not yet in



8
    The Global Drug Facility Mission Report (PNG), Mar 22-26, 2010 (John Holley, Peter Heibling)

                                                                                                     8
         place in all areas, PNG has shifted to FDCs and are now available nationwide;
         and DOTS recording / reporting tools have been introduced.

      Although MDR-TB patients are receiving treatment, there is no institutional and
       systematic strategy yet within the NTP to confront this problem.

      There has been interest to establish capacity for MDR-TB management in the
       country. Four staff from the NDOH have been trained in PMDT (Annex 5).

      While the government has been allocating funds for the local procurement of
       drugs for MDR-TB patients, resources for a comprehensive programmatic DR-TB
       management, including human resource development and training, ancillary
       drugs and patient enablers, recording and reporting, infection control, etc., have
       not yet been identified.



C. Diagnosis and the laboratory aspect

      The CPHL has staff dedicated to TB work.

      It is managed by a Director assisted by a Laboratory Manager, an Officer-in-
       charge of the TB laboratory and WHO supported laboratory staff.

         o All staff are trained for microscopy; 2 are trained on solid and liquid culture.
           There is GFATM funding for additional laboratory training this year and next
           year.

      EQA implementation has been continuously progressing since 2007 with a
       current coverage of 62% of smear microscopy centers (77 of 124 microscopy
       centres were visited in 2009).

      CPHL has experience in culture.

         o TB culture used to be performed in CPHL in the first quarter of 2010;
           however, due to inadequate biosafety measures noted in a recent mission,9
           this was temporarily stopped.

         o Culture and DST have been done in PNG’s supranational laboratory, QMRL
           at a 137 USD/specimen. This continues to be the arrangement at the moment
           for DR-TB suspects covered by a contract with WHO.

      Current case-finding strategy

9
    TB-Infection Control Consultancy Visit, Papua New Guinea, 10-20 May 2010 (Arch. Thea Zuccotti)


                                                                                                     9
     o DR-TB suspect referrals from city clinics are admitted to the TB ward of
       PGMH where sputum is collected and sent to CPHL.

     o For referrals from other provinces, sputum specimens are transported from
       there to CPHL.

     o CPHL in turn sends the specimens to QMRL for culture and DST.

   For MDR-TB treatment follow-up, smears are done every three months after
    treatment start and are used as the basis for “conversion” and likely success.
    Culture is never done for patients on category IV treatment except at baseline.



D. Treatment for MDR-TB

   Ninety-four MDR-TB cases have been initiated treatment since 1995 using
    second-line drugs (SLDs) mainly in PMGH, although a number have likewise
    been treated in other provinces.

   Existing Treatment strategy: In PMGH, smear-positive DR-TB suspects with
    known HIV status referred from city clinics are admitted in the MDR-TB ward
    even before DST confirmation.

     o   Patients who had previously received unsupervised category II are restarted
         on Category II regimen.

     o   Patients who had previously received supervised category II are started on
         category IV regimen.

     o   Patients are confined while smear-positive usually till the 4th month. Once
         smear-negative, the injectable is discontinued and patients are discharged
         through the TB Clinic of the hospital. Instructions are given regarding the
         next follow-up, and drugs are supplied to the patient and/or his treatment
         partner, usually a family member.

     o   Category IV regimen: A standardized regimen is used consisting of an
          injectable (amikacin from 1995 till early 2009 and capreomycin since 2009-
          2010), a fluoroquinolone (ofloxacin) and two oral bacteriostatic second-line
          drugs (SLDS), ethionamide and cycloserine. Seventy patients have been
          given the earlier regimen with amikacin while 24 have been started on the
          new regimen with capreomycin.




                                                                                       10
      Table 2. Standardized Category IV regimen for MDR-TB used in PNG

   Period                   1995-2009           2009-present
   No. treated (N=94)       70                  24
   Regimen
      Injectable            Amikacin 1 gr       Capreomycin 500-750 mg
                                                OD
      Fluoroquinolone       Ofloxacin           Ofloxacin 200 mg BID
      Other oral            Ethionamide         Ethionamide 250 mg BID
      bacteriostatic SLDS   Cycloserine         Cycloserine 250 mg BID


  o   Although the above regimen is consistent with the general principles for
      regimen design recommended by the WHO Guidelines, 5 more information is
      needed to validate the rationale for the use of capreomycin as the injectable
      of choice and ofloxacin as the fluoroquinolone of choice.

  o   The drug dosages applied need to be in line with those recommended in the
      guidelines. Recommendations are weight-based 5

             Capreomycin – 1 gram daily for patients >51 kg, given OD rather
              than in split doses
             Ofloxacin – at least 800 mg daily for patients >33 kg daily
             Ethionamide and Cycloserine – at least 750 mg daily for >51kg

  o   The injectable is given only for 4 months as soon as the smear turns
      negative. The recommendation is at least 6 months of the injectable and at
      least 4 months from the time of sputum conversion for better chances of a
      sustained negative bacteriologic status.

 Treatment areas:

  o   PMGH MDR-TB ward: This is a 55-bed ward only for non-acutely ill sputum-
      positive retreatment cases and confirmed MDR-TB cases with known HIV
      status. The cases are managed by a senior clinician and TB specialist who
      has been treating MDR-TB since 1995. He is assisted by a team of registrars
      (MDs), nurses and other paramedical workers.

          The area of the ward is spacious with jalousies on both sides of the
           room.

          The ward is divided by a semi-complete wall separating males and
           females. Patients are mixed regardless of bacteriologic and HIV status.



                                                                                   11
            (No segregation of immunocompromised in-patients from open TB
            cases is being done).

           Infection control measures such as administrative controls, engineering
            controls and personal protective equipment are not observed.

   o   PMGH TB clinic: This is an outpatient clinic where TB and MDR-TB patients
       follow-up after discharge from the Ward and during the continuation phase.
       Three registrars, a resident medical doctor and a paramedical health
       extension officer assist the senior TB specialist.

   o   Other provinces: Treatment areas in other provinces have not been
       assessed.

 Supervised therapy or directly observed treatment of MDR-TB patients is done
  strictly by the ward nurses twice daily at 9AM and 9PM which is commendable.
  However, supervised therapy is not strictly enforced after discharge. The
  medicines are provided to patients through their family members, and taken on a
  self-administered basis.

 There are many patients who have not followed up since discharge. There is no
  mechanism in place for actual default tracing other than through phone calls.

 Current patients:

   o   Of the 94 total patients put on treatment since 1995, 24 patients are on the
       current regimen, of whom 7 are confirmed MDR-TB by QMRL. Ten patients
       are currently admitted in the ward, while 14 have been discharged.

   o   Twenty- one other MDR-TB patients are receiving category IV treatment in
       other provinces: 13 in Western Province (11 in Daru), 2 in Lae (Morobe), 2 in
       Madang, 2 in Milne Bay Province.

   o   Physicians in other provinces consult the TB specialist in PMGH through
       phone. No training on MDR-TB management is in place at the moment.
       Drugs are either picked up or transported to the requesting physicians and
       replenished as necessary based on phone call requests (No invoice or drug
       order form raised and submitted).


 Adverse drug effects from locally procured SLDs are surprisingly uncommon, and
  in fact, not considered a problem at all among patients receiving treatment.




                                                                                  12
    HIV testing is done in all TB/MDR-TB patients; however, there is no policy to
     separate the HIV-infected TB cases from the infectious TB cases.

    Western Province: a special area in PNG (source: Presentation during Workshop
     by Asst. TB/HIV Officer, Daru General Hospital –Annex 2A)


      The Western Province is a low density province with 2 people/km 2 and a
      population of around 186,000. It has three districts: North, Middle and South Fly.
      Daru Island is in the South Fly District which shares its border with Australia and
      Indonesia. There is free movement of people between these treaty villages in
      PNG and Australia. As DOTS expansion under the GFATM,7 has set the Western
      Province for the last year (2011), the TB services are not in place. Hence, people
      have the tendency to access TB treatment across the border with Australia. It
      was however, noted that DOTS is not being implemented in these cases and
      patients return to PNG as treatment defaulters harboring the risk for drug-
      resistance.

      Since 2001-2008, there have been 35 patients from the treaty villages diagnosed
      with MDR-TB cases. Most cases come from Mabuduan (33%), Dary (19%) Dimiri
      (17%) and others.

      Eleven patients have been put on the PNG category IV regimen since Oct 17,
      2009 in the Daru General Hospital (DGH), 10 of whom are confirmed and one
      suspected. Two cases were started on regimens from Australia.

      The challenges encountered in DGH are as follows: a) lack of coordination of
      patient referrals between PNG and Australia; b) confusion of different drugs and
      treatment regimens, c) lack of supervision and monitoring of TB treatments, d)
      delay and ineffective clinical management of TB patients (results received late,
      lack of guidelines to follow), e.g., mono- and poly-resistant cases e) lack of
      trained work force to manage MDR cases, f) lack of beds, isolation ward, g) lack
      of systematic drug procurement, drug supply management and h) lack of culture
      capacity for monitoring of treatment.



D. Uninterrupted supply of drugs

    SLDS used in PNG are locally procured. However, none are WHO pre-qualified
     (http://apps.who.int/prequal/ - tuberculosis) as of the date of the visit.




                                                                                      13
              Table 3. List of SLDs used for MDR-TB and their manufacturers

                            Drug                             Manufacturer
                    1. Amikacin 500 mg vial       Biochem Pharma, India
                    2. Capreomycin 1 g vial       North China Pharmaceutical
                                                  Corporation, China
                    3. Ofloxacin 200 mg tab       Intas, India
                    4. Ethionamide 250 mg tab     Lupin, India
                    5. Cycloserine 250 mg tab     Lupin, India
               Source of information: NDOH Pharmaceuticals Medical Supplies Branch, NDOH

       While cost of the standard regimen is apparently lower using locally procured
        drugs compared to drugs procured through the GLC mechanism, the quality of
        drugs remains uncertain.

       Some SLDs were stored in the Badili warehouse together with all the other drugs
        of NDOH.

       The PMGH TB Clinic also stores SLDs with an inventory maintained by the
        nurse. Distribution to provinces for the MDR-TB cases is coursed through the TB
        specialist managing this clinic through informal verbal requisitions.



E. Recording and Reporting

       A category IV Register is available in PMGH but needs to be conformed to the
        necessary register format for MDR-TB patients.5

       Other essential forms for PMDT5 such as Category IV Treatment Card, Request
        Forms, etc. still need to be drafted, printed and disseminated.

       No cohort analysis has been done yet on patients started on Category IV
        regimen to determine treatment outcomes.




IV.    RECOMMENDATIONS

      The programmatic management of DR-TB is complex. The requirements for its
      proper implementation are multi-faceted based on a wholistic framework for its
      control.5 It should be underscored though that quality DOTS must remain a priority in
      PNG hand-in-hand with the implementation of PMDT. This mission strongly supports
      that recommendations made in the External Review of the NTP in 2009 2 that have
                                                                                           14
  not yet been acted upon be addressed to ensure a good foundation of DOTS as
  PMDT is initiated.

  Section A below lists four key recommendations for PMDT in PNG. Section B lists
  the specific recommendations based on the different components of the framework.


A. Key recommendations

  1. Fast track the quality implementation of DOTS particularly in areas where there
     are practices that likely promote drug resistance and where MDR-TB treatment
     services are most needed.

  2. Ensure proper treatment of currently enrolled and future MDR-TB cases to
     prevent XDR-TB by putting in place the minimum recommended framework while
     taking into consideration the PNG setting.

  3. Support CPHL in strengthening laboratory capacity including addressing biosafety
     concerns.

  4. Create a core team based within the NTP that will have an oversight of PMDT
     implementation in the country.

  5. Ensure continuous and non-interrupted supply of quality assured Category IV anti-
     TB drugs.

  6. Ensure cohort-based monitoring of PMDT cases and reporting of culture-
     conversion and outcomes.



B. Specific recommendations based on the MDR-TB Control framework

1. Political commitment:

   Secure a more comprehensive funding for a sustainable programmatic approach
    to MDR-TB management thereby ensuring the proper infrastructure in the
    country, e.g., next round of the Global Fund.

   Carefully plan the DRS to produce representative results. Request funding from
    WHO-HQ which is available to complement the current GFATM fund for only two
    provinces. Seek available technical assistance from WHO-WPRO and HQ and




                                                                                       15
           utilize the revised DRS Guidelines.10
           http://whqlibdoc.who.int/publications/2009/9789241598675_eng.pdf

        Revisit the Treaty Agreements with Australia and fast track setting up of DOTS in
         the Western Province to ensure availability of quality services in the PNG side of
         the border.

        Consider application to the Green Light Committee11 to access quality assured
         drugs, technical assistance in various aspects, capacity building, etc.
         http://www.ghdonline.org/drtb/resource/green-light-committee-application-
         instructions/



2.      Laboratory aspects

        Request technical assistance for laboratory aspects through the Global
         Laboratory Initiative http://www.who.int/tb/dots/laboratory/gli/en/ particularly on
         new diagnostics with consideration of PNG’s background, capacity and
         resources.

        Fast track CPHL upgrade to a status that ensures acceptable biosafety
         measures for the performance of culture and DST.

        Strengthen CPHL to lead the laboratory network and expand based on the
         country’s needs.

        Send more CPHL staff for training in QMRL.

        CPHL to do culture and DST in-country for the diagnosis and follow-up of
         treatment. More culture facilities to be established in two or more provinces in
         near future so as to give coverage to cases from all over the country.

        Consider uptake of new diagnostic methods such as Line Probe Assay and fully
         automated NAAT so that turn-around times for MDR-TB diagnosis are
         considerably reduced.

3. Infection control (IC)

          Implement recommendations in the last IC mission particularly for CPHL and the
           treatment areas for TB.9 Ensure segregation & containment of open cases of TB


10                                                     th
     Guidelines for surveillance of drug resistance in TB, 4 ed. WHO/HTM/TB/2009.422
11
     Green Light Committee Application Instructions. WHO/HTM/TB/2010.1

                                                                                               16
      in the medical wards, preferably have a contained area for isolation of smear
      positive in-patients.
     Appoint a focal point for TB-IC.
     Create a pool of IC trainers in PNG and train other health providers as the
      program expands.

4. Treatment delivery

   Complete DOTS expansion (Stop TB Strategy) to entire country as soon as
    possible. Ideally, PMDT should be made available only in those settings where
    Stop TB Strategy has been implemented and community settings for treatment
    observation and patient support during treatment are in place. NTP is
    encouraged to identify this important principle of “add-on” nature of PMDT
    services and therefore implement basic TB services and DOTS first in all the
    provinces on a priority basis. This issue may be taken up by NTP in writing with
    donors such as Global Fund so as to expedite Stop TB strategy expansion to the
    entire country as soon as possible.

   Develop a treatment infrastructure for MDR-TB

      o   Upgrade PMGH ward and TB clinic to become a model site

      o   Replicate in other areas such as Daru General Hospital, etc.

   Ensure quality delivery of treatment:

      o   Implement strict DOT all throughout treatment by trained health/community
          workers preferably, non-family members. Coordinate hospitals with
          peripheral treatment services, and engage partners such as World Vision
          International (WVI), Hope Worldwide, Church Medical Council, etc., in close
          collaboration with the NTP. Utilize ACSM strategies. Preferably, prepare a
          document on Strategy for Community-based PMDT care in Papua New
          Guinea, in collaboration with NTP partners such as WVI and Hope
          Worldwide, so as to cover the communication and adherence issues.

      o   Review regimen used and the corresponding drug dosages and align with
          recommended guidelines. Consider quality, effectiveness, and cost.

      o   Monitor response to treatment through culture and microscopy.

      o   Put in a place a mechanism for tracing treatment interrupters and defaulters.



                                                                                      17
     o    Manage adverse drug reactions adequately: monitor through physical and
          laboratory examinations and provide ancillary drugs for adverse drug
          reactions

     o    Provide psychosocial support such as patient enablers to minimize default.

     o    Do contact tracing to household members of MDR-TB cases and other close
          contacts.

     o    Conduct patient empowerment activities such skills training while on
          treatment, livelihood initiatives, advocacy activities, etc.

   Assess other sites of treatment for completeness of MDR-TB implementation
    framework and quality of service delivery.

   Formalize TB/HIV collaborative activities and offer HIV testing to all TB and
    MDR-TB cases.



4. Human resource development (HRD) and training

   Create a core team led by the NTP Manager assisted by a Focal Person for
    PMDT committed to oversee and provide direction to PMDT implementation in
    the country. This team is composed of point persons for the different components
    of the framework such as treatment delivery, laboratory, infection control, human
    resource development and training, drug management, and recording and
    reporting.

         Figure 1. Organizational chart of PMDT Core Team under the NTP

                               Program Manager, NTP


                               Focal Point for MDR-TB



     Treatment delivery                                       Human Resource
                                                           Development and Training

         Laboratory and Infection
                                                     Drug management
                 Control


                              Recording and reporting
                                                                                       18
      Create a case management committee (or consilium) to ensure the review of
       individual cases upon enrolment, during treatment and upon treatment
       completion. This also serves as a venue to train more health providers in the
       management of DR-TB.

      Support capacity building to PMDT core team through national trainings,
       exposure and technical assistance. Utilize existing training modules for MDR-
       TB.12,13

      Conduct a Training of Trainers at the central level with support from WHO-
       WPRO and technical assistance from international facilitators. Central trainers
       will then conduct trainings for provincial, district and community levels.

      Draft training materials for key audiences, e.g., central level, provincial, district,
       community partners, etc. based on a task analysis.

      Request technical for different aspects of PDMT, namely, clinical management,
       drug management, recording and reporting, etc.



5. Drug management

      Train the point person for PMDT drug management who will in turn train those in
       charge at different levels.

      Ensure quality assurance of SLDs used in the country to prevent XDR-TB.

      Encourage local manufacturers to participate in the WHO pre-qualification
       program. http://apps.who.int/prequal/. Medical Supplies Branch, NDOH to issue a
       notification/ order that WHO pre-qualified suppliers for TB drugs will be given
       preference over non-prequalified suppliers/ manufacturers during short-listing for
       procurement contract award.

      Set up a drug management system for PNG managed by the core PMDT team.

        o    Procurement: ensure rationale quantification and timely ordering of quality
             drugs to avoid stockout and wastage.



12
  Management of Drug-Resistant Tuberculosis Training for Health Facility Staff. WHO 2010 [Draft]
13
  Management of Drug-resistant TB Training for Health Facility Staff in the Philippines.Tropical Disease
Foundation and Department of Health, Philippines 2008

                                                                                                       19
      o    Storage: ensure a safe and secure space for SLDs at the central level and
           the peripheral areas where MDR-TB is being treated. Maintain an efficient
           inventory system.

      o    Distribution: ensure an efficient issuance of drugs from central to peripheral
           areas.

      o    Use: keep drugs restricted only to authorized health providers.



6. Recording and reporting; program monitoring and evaluation

    Train the point person for recording and reporting who will, in turn, train those in
     charge at different levels.

    Set up an information system for PNG managed by the core team.

      o Draft essential recording and reporting forms for PMDT and incorporate it in
        the existing BMU reporting format.

      o Establish the flow of reporting from peripheral to central levels.

      o Integrate PMDT reporting into a web-based information system integrated
        with DOTS.

    Do a cohort analysis of past, present and future patients.

    M and E:

      o Conduct yearly program implementation reviews to discuss lessons learned
        and bottlenecks.

      o    Conduct a national workshop at least yearly for monitoring of PMDT
          implementation.

      o Request an external monitoring mission for PMDT, preferably via GLC and
        WHO Stop TB before end of 2011.



Annex 6 is a proposed framework of MDR-TB activities to be incorporated in the next
NTP strategic plan for 2011 – 2015 assuming that a comprehensive funding for PMDT
is available. The activities and timelines are to be revisited and tailored as soon as DRS
results are available and targets for diagnosis and treatment are set by the NTP.


                                                                                        20
Annex 1A.
KEY PERSONS MET
 Key agencies and persons                       Designation
National Department of Health (NDOH)
        Dr. Clement Malau                       Health Secretary
        Dr. P. Dakulala                         Deputy Health Secretary
        Mr. Enoch Posanai                       Executive Manager, Public Health
National TB Program (NTP), NDOH
        Dr. Paul Aia                            Manager, National TB Programme (NTP)
        Dr. Robin Yasi                          Regional NTP Officer (Momase)
        Dr. Margaret Kal                        Regional NTP Officer (Islands)
Central Public Health Laboratory (CPHL), NDOH
        Dr. Evelyn Lavu                         Laboratory Director
        Ms. Oscillah Kaminiel                   Laboratory Manager
        Mr. Apeo Manoni                         OIC, TB Laboratory
Pharmaceuticals Medical Supplies Branch, NDOH
        Mr. Vali Karo                           Principal Advisor, Pharmaceuticals
Port Moresby General Hospital
        Dr. Joseph Bana-koiri                   TB Consultant
Partners and Stakeholders
        Dr. Wuatai                              NCD Health
        Marlon Villanueva                       Technical Advisor ACSM World Vision
                                                International (WVFI)
       Mr Simon Kosap                           Hope World Wide
World Health Organization, PNG
       Dr. Eigil Sorensen                       Country Representative
       Dr. Yamuna Mundade                       Medical Officer, TB




                                                                                       21
Annex 1B
ACTIVITIES CONDUCTED DURING THIS MISSION
Date     Activity                                           Persons met
(2010)
Mon      Briefing on Mission TORs                           Dr. Eigil Sorensen, WHO
Jun 28                                                      Dr. Yamuna Mundade, WHO
         Briefing on Mission Activities                     Dr. Paul Aia, NTP Manager
         Visit to Port Moresby General Hospital TB Clinic   Dr. Joseph Bana-Koiri, TB Consultant,
                                                            Registrars, nurse, social worker(s), Dr.
                                                            Aia, Dr. Mundade
Tue      Visit to PMGH TB Ward and participation in         Dr. Joseph Bana-Koiri, Dr Randy Moke
Jun 29   weekly rounds                                      and Team, Dr. Aia
         Visit to Central Public Health Laboratory          Dr. Evelyn Lavu, Lab Director
                                                            Ms. Oscillah Kaminiel, Lab Manager
                                                            Mr. Apeo Manoni, TB Lab OIC
                                                            With Dr. Aia, Dr. Mundade
         Meeting on NTP Drug management                     Mr Graham Wavimbukie, Nat’l Logistics
                                                            Coordinator
         Meeting on Drug Procurement                        Mr. Vali Karo, Principal Advisor
                                                            Pharmaceutical Medical Supplies, NDOH
                                                            Mr. Elani Kou, Senior Purchasing Officer
         Visit to Badili, National Warehouse                Mr Graham Wavimbukie, National
         Port Moresby to Lae, Morobe                        Logistics Coordinator, Ms Kilala Owen:
                                                            Nat’l Logistics Assistant,
                                                            Ms Sepora, Logistics Assistant
Wed      Visit to Nine Mile Clinic (public DOTS Facility,   Sr. Nimai Deravi, Nursing Officer in
Jun 30   Hope Worldwide)                                    charge of DOT Centre and Team
         Meeting on NTP Data Management                     Andrew Kamarepa, National M & E
                                                            Coordinator, NDOH
         Travel from Port Moresby to Lae, Morobe
Thu
Jul 1    Workshop on the preparation of the MDR-TB          See Annex 2A for Workshop agenda and
Fri      Guidelines                                         Annex 2B for participants
Jul 2
Sat      Travel from Lae to Port Moresby
Jul 3    Report writing
Sun      Report writing
Jul 4
Mon      Meeting with NTP to review Draft Guidelines        Dr. Robin Yasi, NTP
Jul 5    Review of MDR-TB Records in PMGH                   Dr. Joseph Bana-koiri
Tue      Meeting to discuss GLC Application template        Dr. Robin Yasi, NTP
Jul 6                                                       Dr. Joseph Bana-koiri, PMGH
                                                            Dr. Evelyn Lavu, CPHL
                                                            Dr. Yamuna Mundade, WHO
         Meeting with NDOH                                  Dr. Dakulala, Deputy Health Secretary
                                                            Dr. E. Sorensen, WHO
Wed      Symposium on MDR/XDR-TB                            See Annex 3 for participants.
Jul 7    Debriefing                                         Mr. Enoch Posanai, Executive Manager,
                                                            Public Health chaired the meeting.
                                                            NTP and other stake-holders
                                                            participated: PMGH, CPHL, NCD Health,
                                                            WHO, World Vision, JTAI and Hope
                                                            World Wide


                                                                                                 22
Annex 2A
WORKSHOP AGENDA FOR THE PREPARATION OF MDR-TB GUIDELINES IN PNG
Day 1 - July 1, 2010
Welcome and Opening                                             P. Aia, NTP Manager
Introductions
Objectives of the workshop /Proposed elements of the            P.Aia
Guidelines
Background on TB Control and DOTS                               M. Kal, NTP Regional Officer
Epidemiology and magnitude of MDR-TB                            P. Aia
Causes of MDR-TB                                                R. Yasi, NTP Regional Officer
MDR-TB/XDR-TB Global Response/GLC                               Y. Mundade, WHO TB Medical Officer
Tea break
EXPERIENCES – Case-finding and Laboratory
National EQA Assessment in TB Microscopy                        J. Kumbu, National Laboratory
                                                                Coordinator
CPHL Surveillance update on MDR-TB in PNG                       E. Lavu, CPHL Director
IMR surveillance on drug-resistant TB                           P. Harino, PNG-IMR Consultant
EXPERIENCES – Clinical /Programmatic management
Clinical experience in current management, PMGH                 J. Bana-koiri, PMGH TB Consultant
DR-TB drug experience, lab diagnosis and management in          A. Marome, Asst. TB&HIV Officer, Daru
Daru General Hospital                                           General Hospital
Experience in the Philippines in Programmatic management of     M. Quelapio, MDR-TB Consultant WHO
DR-TB
Lunch
WHO Framework for PMDT                                          M. Kal
MDR-TB Definitions                                              R. Yasi
DRS                                                             Y. Mundade
Case-finding (detection, diagnosis, classification)             M. Quelapio
Group discussions
Group 1 – Case-finding, lab and diagnostic algorithms Group 2   J. Bana-koiri, M. Quelapio
– DRS                                                           P. Aia, Y. Mundade
Day 2 - July 2
Organization of Lab network including QA for culture and DST    A. Manoni, OIC TB Lab, CPHL
Treatment strategies, second-line drugs                         J. Bana-koiri
MDR-TB PMDT options in implementation                           M. Quelapio
Tea Break
M and E Recording and Reporting                                 Dr. P. Aia
Training and Human resource development                         Dr. P. Aia
Drug management                                                 G. Wavimbukie, National Logistics
                                                                Coordinator
Lunch
Group Discussion
Group 1 – Treatment strategy                                    J. Bana-koiri
Group 2 – Monitoring and community support                      M. Quelapio
Group 3 – Recording and reporting                               M. Kal
Group 4 - Training                                              R. Yasi
Finalization                                                    Dr. P. Aia




                                                                                                    23
Annex 2B.
WORKSHOP PARTICIPANTS FOR THE PREPARATION OF MDR-TB GUIDELINES
IN PNG
AGENCY AND PARTICIPANTS                   DESGINATION
National TB Program
        Dr. Paul Aia                      NTP Manager
        Dr. Robin Yasi                    Regional Medical Officer (Momase)
        Dr. Margaret Kal                  Regional Medical Officer (Islands)
        Mr Graham Wavimbukie              National Logistics Coordinator (JTAI)
National HIV/STI Programme
        Dr John Milan                     Advisor, HIV Treatment and care
Central Public Health Laboratory
        Dr. Evelyn K Lavu                 Senior Specialist MO & Director CPHL
        Mr. Apeo Manoni                   Officer-in-charge, TB Lab
        Janlyn Kumbu                      National Laboratory Coordinator
Port Moresby General Hospital
        Dr. Joseph Bana-koiri             TB Consultant, PMGH
PNG Institute of Medical Research (IMR)
         Paul Harino                      Consultant, PNG-IMR
Provincial Physicians
        Dr Bernard Belari                 Physician, AMGH, Lae
        Dr Cathy Timothy                  Physician, AMGH, Lae
        Dr Kilagi Vanuga                  Physician, Goroka General Hospital
        Dr Sidney James                   Surgeon and Actg CEO, Daru General Hospital
        Dr. Kendaura                      Physician, Goroka
        Sr Lucy Moris                     Provincial Disease Control Officer
        Dr. Naomi Pomat                   WP Communication Officer, Daru
        Sr Lillian Motup                  TB Programme officer, Daru General Hospital
        Abel Marome                       Assistant TB/HIV Officer, Daru Hospital
World Vision International
        Akissa Kawe                       District Coordinator for Lae
World Health Organization
        Dr. Yamuna Mundade                Medical Officer, TB
        Ms. Sabina Waffi                  TB Technical Coordinator WHO (SSA)




                                                                                        24
Annex 3.
PARTICIPANTS OF THE ADVOCACY SYMPOSIUM ON MDR-/XDR-TB
AGENCY AND PARTICIPANTS                        DESGINATION
Dr Paison Dakulala, Deputy Secretary, NDoH – Co-Chairman
Dr Eigil Sorensen, WHO Representative, PNG – Convenor & Co-chair
Other participants:
National Department of Health
        Mr. Enoch Posanai                      Executive Manager, Public Health
        Dr. Goa Tau                            Executive Manager, Medical Standards Division
        Dr. David Mokela                       Chief Pediatrician and Assistant CEO, PMGH
        Dr. Pyakalia                           National Capital District (NCD) Health
        Dr. Wuatai                             NCD Health
        Dr. Joseph Bana-koiri                  TB Consultant, PMGH
        Dr. Evelyn K Lavu                      Senior Specialist Medical Officer, Central Public
                                               Health Laboratory
        Ms. Oscillah Kaminiel                  Laboratory Manager
World Health Organisation
        Mr Anthony Gomes                       Laboratory Specialist
        Dr Mamel Quelapio                      Short-term Consultant
        Dr Agatha Lloyd                        MO HIV Care and treatment
        Dr Fabian Ndenzako                     MO HIV Prevention
        Dr Yamuna Mundade                      MO (TB/Lep)
        Mr Saipo Henry Sikipris                GFATM Grant Co-ordinator
New Zealand AID                                __
World Vision International
        Mr. Marlon Villanueva                  ACSM Technical Adviser/National TB Manager
        Dr. Ernesto Bontuyan                   National TB Coordinator
University of PNG, Medical School
        Professor John Vince                   Professor of Paediatrics




                                                                                                   25
Annex 4.
Response to the challenge of drug-resistant TB, NDOH

                      Response to the Challenge of MDR-TB in PNG



       Papua New Guinea is a high-burden TB country in the Western Pacific Region, as per
WHO estimates. The current estimated prevalence of all forms of TB as per latest estimates is
430 per 100,000 population (for 2007, Tuberculosis Control in the Western Pacific Region, 2009
Report, World Health Organisation). The estimated incidence of positive TB cases in PNG is
108 per 100,000 population (2007).



       The following are the estimates for PNG for Multi-Drug Resistant-TB (MDR-TB) as per
the 2010 Global MDR-XDR Surveillance Report of WHO:

           –   Percentage MDR amongst new cases: 1.9% (0 to 7.5%, 95% CI)
           –   Percentage MDR amongst re-treatment cases 13.4% (0-36.2%, 95% CI)
           –   Number of MDR-TB among incident new and relapse TB cases 530 (9-1300,
               95% CI)
           –   Number of MDR-TB among incident total TB cases 600 (0-1200, 95% CI)


       By June 2010, more than 30 cases of MDR-TB have been confirmed in PNG. Port
Moresby and Daru have reported most cases, however there are isolated reports from Lae,
Tabubil, Alotau, Madang etc. Keeping in view existing TB situation and lack of representative
survey based information on actual prevalence of MDR-TB in Papua New Guinea it is proposed
to adopt the following strategy to address MDR-TB in Papua New Guinea:



1. Prevent additional emergence of MDRTB and XDR-TB by strengthening all
   DOTS and Stop TB activities and conforming to evidence based best
   practices:

       •   Increase coverage of DOTS implementation so as to reach 100%
           coverage of provinces (currently 9 of 20 provinces)
       •   Prompt initiation on treatment (Time to register) of identified TB cases
       •   Ensuring cure of sputum smear positive TB cases
               – Use Quality assured drugs;
               – Use of drug combinations with appropriate strength (dosage)
               – Appropriate duration of treatment (loose drugs)
               – Supervision of treatment doses intake (DOT)
       •   Evidence based and best-practice based TB treatment:
               – Reducing over-diagnosis of extra-pulmonary and smear negative
                  cases
               – Reducing incorrect categorization

                                                                                           26
                 –  Lab testing at change from Intensive Phase to Continuation Phase
                    of treatment (use of sputum microscopy based follow-up testing)
                    and at end of treatment
         • Drug regulation
                – Stopping indiscriminate prescription of TB drugs
                – Availability in the market
         • Including all TB drugs in Essential Drug List (EDL) and rebate/exemption
            from tax and excise
2.   Strengthen laboratory services for quality assured and timely diagnosis of MDRTB and
     XDR-TB:

         •  Assess and improve quantum of TB suspect referral (> 1%) from the population
         •  Wide-spread access to good quality of smear microscopy
                – Provide widespread access to sputum smear microscopy
                – Strengthen External Quality Assessment
                – Establish efficient sputum transportation mechanism in all parts of the
                    country
        • Good access to sputum / specimen culture for patients failing TB treatment
        • Establishing BSL-3 TB reference lab or in the first stage a BSL-2 plus lab with BSL-3
            practices at Central Public Health Laboratory, Port Moresby
        • Provide TB culture services in select provincial labs, based on need and workload
3.   Expand the programmatic management of MDR-TB and XDR-TB:

         •  Identify a focal point at NTP level to co-ordinate this activity. Additional HR would
            be required at PMGH/ NTP and at CPHL
        • Have phased expansion of services, with initial focus on identified hot-spots in
            the country
        • Develop standard MDR-TB guidelines to ensure standardized treatment in line
            with internationally accepted practices
        • Develop training methodology and plan for capacity building to foster
            incorporation of best practices into NTP services and acceptance of same by
            physicians, clinicians and health care workers in the country
        • Procure and supply good quality second-line drugs in an uninterrupted manner
        • Implementing a rigorous M&E system with robust recording & reporting of PMDT
            activities, ongoing cohort based analysis, feedback to implementing centres and
            publishing of reports quarterly
        • Provide patient support as would be required, including social security
4.   Assessment of Drug Resistance situation in the country:

         • Undertake Drug Resistance Surveillance periodically, with community based
           sampling methodology
        • Gradually develop laboratory capacity to have on-going Routine Drug
           Susceptibility testing for re-treatment cases
5.   Implement infection control measures to avoid MDR-TB and XDR-TB

     transmission to protect patients, health workers, others working in congregate



                                                                                                    27
     settings:

         •  Foster use of natural ventilation in congregate settings of Health facilities –
            adequate window surface areas (> 10% of floor space), use of fans, circulators
            and ventilators
         • Practice triage for TB suspects and patients in congregate settings and OPDs
         • Practice segregation of smear positive cases in in-patient settings. Allow
            ambulatory treatment as soon as smear conversion is achieved
         • Promote use of N-95 masks in laboratories where high risk procedures are done
            or by health workers interacting with potentially sputum smear positive MDR-TB
            patients
6.   Strengthen ACSM to improve care seeking behaviour and cultivate patient-centred
     approach to treatment: Improve patient knowledge, attitudes to TB and build confidence
     and promote General Health services utilization

7.   Promote research and uptake of new TB diagnostics which help in reducing turn-
     around-time and time-to-diagnosis of TB and MDR-TB



The above is a transcription of the plan presented by Dr. Paison Dakulala, Deputy Secretary NHSS,
National Department of Health, Papua New Guinea, at an MDR-TB consensus building workshop of
NDoH, WHO PNG and partners on 05 Jul 2010.




                                                                                              28
Annex 5.
NDOH STAFF TRAINED IN PMDT

  Person trained              Training                         Date       Training agency

  Dr. Joseph Bana-koiri       Advanced Clinical                Feb 2009   The UNION and
  TB Consultant, PMGH, NDOH   Management, MDR-TB                          Tropical Disease
                                                                          Foundation (TDF)
                              Needs Assessment for PMDT        Nov 2009   TDF and Center
                                                                          for Disease
                                                                          Control (CDC)
  Dr. Robin Yasi
  Regional TB Officer, NTP    Needs Assessment for PMDT        Nov 2009   TDF and CDC

  Dr. Kendaura
  Physician, Goroka
                              Infection Control in TB/MDR-TB   Nov 2009   TDF and KNCV
  Dr. Wesong Boko
  Physician, Mt. Hagen




                                                                                             29
Annex 6.
PROPOSED FRAMEWORK OF PMDT ACTIVITIES 2011-2015
Activity                                                         Base    2011    2012   2013     2014   2015
                                                                 line
                                                                 2010
 A.    Political commitment

1. Secure financial support for comprehensive PMDT                X
   funding for at least 5 years, e.g from GFATM,
   government, etc.
2. Establish the country burden for drug resistance and do target-setting
   a. Conduct the DRS at 5-year intervals.                        X                                      X
   b. Set targets for case-finding and treatment based on      Base        Incremental increase to reach
       DRS results.                                             line      universal access (80% detection
                                                                           among smear-positives) by 2015
      c. Conduct strategic planning to address DR-TB burden      X
3.    Set a policy for PMDT and ensure the mandate to support implementation in PNG
      a. Draft and finalize national MDR-TB Guidelines           X
      b. Secure official endorsement of PMDT Guidelines,
                                                                 X
           e.g., through a Department Order from the NDOH
      c. Ensure implementation and monitor compliance            X     X        X        X        X      X
4.    Endorse comprehensive financial resource support plan
      via NDoH and Department of Planning and Finance
                                                                 X
      (through NEC submission if considered necessary by
      NDoH)
5.    Apply to the Green Light Committee for PMDT
      implementation to secure quality assured drugs, technical  X
      assistance, capacity building, etc.
6.    Meet and discuss Treaty Agreements with Australia and
                                                                 X
      issue relevant policies for TB and MDR-TB.
7.    Conduct advocacy activities to various levels, partners
                                                                 X     X        X        X
      and stakeholders for sustainability
 B.      Laboratory (subject to Laboratory TA recommendations)

1. Strengthen laboratory infrastructure in PNG
   a. Upgrade CPHL and ensure biosafety measures                   X
   b. Expand laboratory network by setting up other culture               X        X
       laboratories
2. Establish technical capacity for laboratory in-country
   a. Seek technical assistance from experts, e.g., through        X      X
       Global laboratory Initiative (GLI), QMRL, etc.
   b. Send CPHL staff for training in QMRL or other labs           X      X        X
   c. CPHL to draft and finalize Laboratory Manual of              X
       Procedures with internal quality assurance
   d. CPHL to perform culture and DST                              X      X        X     X        X      X
   e. CPHL to participate in yearly proficiency testing for               X        X     X        X      X
       DST conducted by supranational laboratory, QMRL
   f. CPHL to conduct trainings to expansion laboratories                 X        X     X        X
   g. Monitor laboratory procedures through internal quality       X      X        X     X        X      X
       assurance methods.
   h. Request for external evaluation of laboratory                       X        X     X        X      X
       performance.
C.   Infection control

1. Implement recommendations in last mission particularly                       As recommended

                                                                                                         30
   for CPHL, and the treatment areas for TB
2. Appoint a focal person for infection control (IC)            X
3. Create a pool of trainers in IC within PNG                        X
4. Conduct in-country IC trainings                                       As needed in the expansion

D. Treatment delivery

1. Enhance MDR-TB treatment infrastructure in PNG.
   a. Develop PMGH TB ward and TB Clinic as the model            X
       pilot site for other areas to replicate.
   b. Develop expansion MDR-TB centers in other areas,                  X     X
       e.g., in Angaon Memorial General Hospital, etc.
   c. Core team to mentor and monitor sites regularly            X      X     X      X      X     X
2. Establish technical capacity for DR-TB treatment in-country through human resource development
   (see section on HRD below).
3. Ensure quality delivery of treatment
   a. Implement strict DOT from treatment start till
       completion by trained health or community workers,
       preferably non-family members. Ensure coordination
       between hospital and peripheral treatment sites.
       Engage other partners, e.g., WVI, Hope Worldwide,
       Church Medical Council, etc.
   b. Put in place a tracing mechanism for treatment
       interrupters and defaulters
   c. Monitor response to treatment through culture and          X      X     X      X      X     X
       microscopy.
   d. Manage adverse drug reactions: provide ancillary
       drugs and monitor through clinical and laboratory
       tests
   e. Provide psychosocial support such as enablers to
       patients and health workers
   f. Do contact tracing to MDR-TB household members
       and other close contacts.
   g. Conduct other patient-centered and patient
       empowerment activities, e.g., skills training while on
                                                                        X     X      X      X     X
       treatment, livelihood initiatives, etc.

4. Assess treatment areas for MDR-TB in other provinces         X    X       X
4. Implement TB/HIV collaborative activities.                   X    X       X       X      X         X
E. Human resource development (HRD)

1. Create a PMDT core team in the NTP consisting of the
   focal point, and point persons for the different framework   X
   components, to direct the country implementation
2. Create a case management committee or consilium for
                                                                X
   individual case management
3. Provide capacity building on overall PMDT implementation
   a. Seek technical assistance for PMDT from experts
                                                                     X
        through the GLC, WHO, etc.
   b. Train the point person for HRD and training               X
   c. Conduct a Training of Trainers at the central level
                                                                     X
        (NTP) with WHO-WPRO support)
   d. Conduct provincial, district and community level
                                                                     X       X       X
        trainings
4. Use available training materials for key audiences and            X       X


                                                                                                      31
     modify accordingly based on a task analysis in line with
     the MDR-TB Guidelines

F.   Drug management

1. Provide capacity building on drug management
   a. Train the point person on drug management               X
   b. Conduct trainings for persons in charge of DM in
                                                                  X
       PMDT at the central, provincial and district levels.
2. Ensure quality assurance of second-line drugs used in PNG
       a. Ascertain quality of drugs                          X
       b. Encourage manufacturers of locally procured
            SLDs to participate in WHO pre-qualification.
       c. Medical Supplies Branch, NDOH to issue a
                                                              X   X     X   X
            preference notice for WHO pre-qualified suppliers
            over non-qualified suppliers during short-listing
            for procurement contract award.
3. Set up a drug management system for PMDT managed by the core team
   a. Establish a safe, secure and appropriate storage
                                                              X
      space or warehouse at the central level.
   b. Establish storage sites in areas expansion areas.           X     X
   c. Procure quality assured drugs in a timely manner.       X   X     X   X   X   X
   d. Distribute drugs in a timely manner.                    X   X     X   X   X   X
   e. Monitor drug stocks monthly to avoid stockout and
                                                              X   X     X   X   X   X
      wastage
G. Recording and Reporting, Monitoring and Evaluation

1. Provide capacity building on recording and reporting (R & R)
   a. Train the point person on R & R                           X
   b. Conduct trainings for persons in charge of R & R in
                                                                    X   X
      PMDT at the central, provincial and district levels.
2. Set up an information system for PMDT managed by the core team
   a. Draft forms for PMDT records and reports                  X
   b. Incorporate PMDT reporting formats into BMU cohort        X
      reporting mechanism of NTP
   c. Establish the flow of reports from peripheral to central
                                                                X
      levels
   d. Set up a web-based information system incorporated
                                                                    X
      with DOTS.
   e. Core team to monitor R & R implementation
                                                                X   X   X   X   X   X

3. Do a cohort analysis of patients put on treatment            X   X   X   X   X   X
4. Conduct a yearly program implementation review on
                                                                X   X   X   X   X   X
   PMDT
5. Yearly external monitoring of PMDT implementation
                                                                    X   X   X   X   X




                                                                                    32

				
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