The Federal Democratic Republic of Ethiopia. Ministry of Health

Transcription

1 The Federal Democratic Republic of Ethiopia Ministry of Health Training material on Programmatic management of Drug resistant Tuberculosis in Ethiopia for GHWs Facilitators Guide July

2 Training material on Programmatic management of Drug resistant Tuberculosis for GHWs In Ethiopia Facilitators guide i

3 Contents Contents... ii ACKNOWLEDGMENT... iii Introduction Epidemiology and basics of Drug resistant Tuberculosis MDR-TB Programmatic Design, coordination and management Case Finding & Contact Tracing of M(X)DR-TB in Ethiopia Laboratory aspects of DR-TB in Ethiopia DRTB Patient classification and definition of terms Treatment of DR-Tuberculosis Patient preparation Treatment of Drug resistant Tuberculosis Management of Adverse Drug Reactions during M(X) DR-TB treatment MDR-TB in special conditions and situation DRUG-RESISTANT TUBERCULOSIS AND HIV Co-Management Programmatic management of MDR-TB in Children Infection prevention and control Recording and Reporting in MDR-TB Case studies on MDR TB... 2 Annex 2: Annex ii

4 ACKNOWLEDGMENT Federal ministry of Health believe this material would be of paramount importance to train general health workers in the management of MDR-TB in Ethiopia as the service expands to involve increasing number of health professionals and hence, would like to thank all experts involved in the development of the material. Development of this national MDR-TB modular training material are the great efforts of Dr Anteneh kassa (FMOH/PHSP), Biruck Kebede (FMOH), Dr Andargachew Kumsa (FMOH/ICAP-E), Dr Ahmed bedru (TB CARE-I), Dr Ezra Shimeles (TB CARE-I), Addisalem Yilma (TB CARE I), Dr Dawit Assefa (TB CARE-I), Dr Getachew Dessalegn ( TB CARE-I), Dr Abera Bekele ( WHO-E), Dr Beniam Feleke ( CDC-E), Dr Ermias Diro( Gondar university), Dr Daniel Meressa (St peter hospital/ghc), Dr Yared Tedla (St Peter hospital) and Dr Mulugeta Tsegaye (ALERT). We also wish to pass appreciation to Rwanda PMDT center of excellence for allowing us to adapt the case studies used in this training material. Special thanks are owed to TBCARE I Ethiopia for covering the cost of the workshop for development of this training material and for field testing of the material. iii

5 Introduction to the course Introduction General Objectives of the course: To build and strengthen the knowledge, attitude and skill of HCWs who are working at different level of health system so that they can be involved in the care, management and follow up of MDR patients according to the National PMDT Guidelines. COURSE OBJECTIVES By the end of this five-day course, participants are expected to: Describe the epidemiology and basics of Drug resistant TB Discuss program design, co-ordination and management of DR-TB in Ethiopia Discuss case finding strategy for MDR-TB Describe the laboratory methods used in the diagnosis of DR-TB Classify and register patients in standardized forms Prepare patients, initiate treatment and monitor treatment in MDR-TB patients Manage MDR-TB in especial condition, children and adverse reactions Identify infection control policies and different measures Recognize the recording and reporting forms in MDR-TB program Training methodologies: This five days training of programmatic management of Drug Resistant TB in Ethiopia targets General Health workers involved in management of MDR- 1

6 TB patients. The package has got four days theoretical instructor-led classroom training followed by one-day practical attachment to MDR-TB hospitals. To effectively deliver the intended training objectives, this training is designed using modular methodology following adult learning principles. The training uses series of case-studies that will foster the knowledge and skill of health professionals in identifying MDR-TB suspects, interpreting the lab results, constructing treatment regimen using standardized regimen with subsequent possible individualizations. These case studies are designed in such a way that one group of trainee will manage one case starting from identifying the case as MDR-TB suspects and interpreting laboratory results followed by designing the appropriate treatment regimen and monitoring treatment response over the course of treatment, and finally assisting to practice defining treatment outcome to individual cases and entering patients data on proper recoding forms. On the one-day practical attachment all trainees are expected to attach to MDR-TB treatment centers where they: Observe the general set up of the program and clinical management of MDR-TB patients Divide themselves into three groups to practice PMDT aspects, Infection control aspects and Patient s perspectives of the program management Discuss the findings from the hospital visit in large group after recoding the key findings using standardized templates for each aspect. Each participant should receive: 1 training module for the participants 1 Case Book contains cases used for discussion throughout the course 1 national MDR-TB guidelines The following eight modules will be covered over the first four days of the training: Module 1: Epidemiology and Basics of DR-TB Module 2: MDR-TB program design, co-ordination and management Module 3: case finding in MDR-TB Module 4: laboratory aspect of MDR-TB Module 5: Treatment of MDR-TB 2

7 Module 6: MDR-TB in Special condition Module 7: Infection Control Module 8: Recording and Reporting in DR-TB Additional materials: Guideline for Clinical and programmatic management of TBL & TB/HIV in Ethiopia th edition. This is reference document for all guidelines for the management of TB, Leprosy and TB/HIV. It is assumed that all trainees have received training on this guideline before proceeding to MDR-TB management. MDR-TB suspect identification, evaluation and referral procedures- Job aid Adverse effect management job aid and desk reference Class size should not exceed 20 participants. Two or more facilitators are recommended to provide enough supervision during the group sessions and case work. Program managers are recommended to be trained using separate three-days training material using power point methodology to allow free discussion on all matters regarding the program design, co-ordination and management in Ethiopia. Getting started: Introduction of each other Setting ground Rules Determining Expectation Introducing Course schedule Giving pre-test Questions A. Introduction of each other All participants, trainers and training organizers of the training team should introduce themselves and briefly tell the participants about their background and training, emphasizing their enthusiasm for the opportunity to work with this group. B. Setting ground Rules 3

8 The facilitator and participants first decide upon the ground rules for this training workshop. At the beginning of a training session, the group needs to identify and agree upon ground rules or guidelines for its work, and also to understand why rules are important. The trainer should ensure that certain common rules are included (see box below). Common ground rules Respecting each other, even when you disagree Agreeing to participate actively Having the right not to participate in an activity that makes you feel uncomfortable Listening to what other people say without interrupting them Respecting others ideas, opinion or suggestion, even when it is wrong Not using put-downs (i.e., snubbing or humiliating people on purpose) Respecting confidentiality Being on time Turning off/ silent cell phones An especially important rule in a workshop dealing with sensitive issues is to respect all participants privacy and confidentiality; it should be made clear that no one is allowed to share personal information about other trainees outside the group. Some groups also operate with a rule encouraging people to share their feelings if they are offended or hurt by someone, so that the offender has a chance to apologize. This can be especially relevant in cases where participants feel hurt or insulted by jokes or remarks related to gender, ethnicity, or personal characteristics. Once all participants have agreed on a set of rules, the list is posted in the training room for the entire duration of the workshop. At times, it may be necessary to remind participants of the agreed-upon rules. C. Determining participants Expectation and concerns Give an opportunity for participants to speak about their expectations from the training sessions and to state any concerns regarding the training that they would like to have addressed. Record their responses on a flip chart and post it on the wall. 4

9 Assess which expectations are likely to be met in the course of the training workshop and which ones may go beyond its scope. The facilitator provides a brief explanation of the training team s expectations for successful workshop, being sure to incorporate participants expectations. The facilitator also needs to explain what will happen during the training sessions in the next few days, so that participants are aware of what to expect. At the end of the workshop, a review of these initial expectations should be part of the evaluation. D. Introducing Course schedule Make brief description on how the five days will be used to be delivered the training sessions as this will guide participants to be prepared for sessions where they are interested in or have knowledge gap. The Five-days national PMDT course Agenda for General Health workers Day One Time Session 8:30-9:00am Registration 9:00-9:30am Welcome and Introduction 9:30-10:00am Pretest 10:00-10:30am Epidemiology of MDRTB 10:30-10:45am Tea Break 10:45-11:00 am Basics of MDRTB 11:00-12:30pm Program Design 3:30-3:45pm Lunch 1:30-3:30pm MDRTB program Design cont 3:30-3:45 pm Tea break 3:45-5:00pm Case finding & contact tracing in 5:00-5:10pm Day Evaluation Wrap-up Day Two Session 8:30-8:45am Recap of Day one 8:45-10:00am Laboratory Diagnosis of MDRTB 10:00-10:30 am Patients classification and 10:00-10:30 am Tea Break 10:30-10:45am Case studies: Identify MDR-TB 10:45-11:30am Tea break 10:45-12:30pm MDRTB treatment: Patients 3:30-3:45pm Lunch 1:30-3:30pm MDRTB treatment: treatment of DR 3:30-3:45 pm Tea beark 3:45-4:15pm MDRTB treatment: treatment of DR 4:15 5:00pm Case study: Laboratory Results 5:00-5:10pm Day Evaluation 5

10 Wrap-up Day three Session 8:30-8:45am Recap of Day two 8:45-10:00am Treatment monitoring and follow-up 10:00-10:30 am Adherence support and monitoring 10:30-10:45am Tea Break 10:45-11:00am Management of MDR-TB Treatment 11:00-11:30am Management of Adverse Drug 11:30 12:30pm Case studies: Side effects 12:30-1:30pm Lunch 1:30-3:30pm MDR- TB in special conditions and 3:30-3:45pm Tea break 3:45 4:00pm MDR- TB and HIV Co-Management 4:00-5:00pm Programmatic management of MDR- 5:00-5:10pm Day Evaluation Wrap-up Day Four Session 8:30-8:45am Recap of Day three 8:45 10:30am Infection prevention and control 10:30-10:45am Tea Break 10:45-12:30pm Infection prevention and control 12:30-1:30pm Lunch 1:30-3:30pm Recording and reporting in MDR-TB 3:30-3:45pm Tea break 3:45-4:20pm Recording and reporting in MDR- 4:20-4:50pm Post test 4:50-5:00pm Group formation for practical 5:00-5:10pm Day Evaluation Wrap-up Day Five Session 8:30 am - 12:30pm Practical attachment 12:30 1:30pm Lunch 1:30 3:00pm Discussion on practical cases 3:00 3:30pm wrap-up 3:30-3:45pm Tea break 3:45 4: 50pm Closing ceremony and Certification 5:00 pm End of the training E. Administering pre- and post-test Questions These test questions represent the different objectives expected to be covered in this training packages with aim to assess the knowledge, attitudes and skill of the participants before and after completing the training sessions. Before administering the test, inform participants that the total time allowed is 30minutes and tell them to put their private code number given by 6

11 the training organizers. The facilitator should encourage the participants to answer the questions from their own perspectives. A sample pre-test questionnaire is provided below. It is advised to identify and discuss questions missed by most on pre-test among the facilitators (-on facilitators meeting) in order to get are requiring due focus when addressing the topic addressing these question and also to discuss questions after post-test. Below is the test Questions with their answers. Course test for MDR-TB Training for General Health workers in Ethiopia Participants Code. Name: Part I: Circle the correct answer; please provide one response per question (three pts each) 1. The term multidrug-resistant tuberculosis implies resistance to: A. At least rifampicin B. Isoniazid and streptomycin C. At least Isoniazid and rifampicin D. All first line drugs E. Isoniazid, Rifampicin plus one of second-line injectable and one of fluoroquinolones 2. Cause of MDRTB include: A. Monotherapy B. Non-adherence C. Inadequate dose D. Poor drugs quality E. All 3. Follow up sputum smear a new TB patient is positive at the second month of treatment. What action will you take? A. Extend the intensive phase by one month B. Start continuation phase and send sample for DST C. Start continuation phase and repeat sputum smear at third month D. Start continuation phase and repeat sputum smear at fifth month E. Stop first line Anti-TB treatment and refer to MDRTB treatment center. 4. One is False: A. Smear-negative adult MDR-TB cases cannot be infectious. B. Household contacts are particularly important for MDR-TB in young children C. Children with MDR-TB is usually non infectious D. Indoor exposure is a significant risk factor for MDR-TB in children 5. Which patients group does not need Drug Susceptibility test (DST) in Ethiopian context? A. failure of retreatment case B. Known contact of MDRTB cases C. All New cases 7

12 D. Cases from high risk group like HCWs E. None 6. For which anti-tb drugs is drug susceptibility testing most accurate? A. INH and EMB B. RIF and STM C. INH and RIF D. RIF and EMB E. All of the above 7. One is not major criteria for discharge for MDR-TB patients admitted with hospitalization model: A. Smear conversion, B. Culture conversion C. Patient s general condition D. Satisfactory follow-up plan. 8. One is not the principle of MDR-TB treatment: A. To include first line drugs if sensitivity confirmed B. To use at least four effective new drugs C. To use an injectable agent D. To include fluoroquinolones E. None 9. Advantages of Standardized regimen does not include: A. Simpler implementation B. Simplicity in drug ordering C. Chance for individualization of treatment regimen D. Less chance of mismanagement E. Less need for highly technical laboratories 10. Cross resistance between Anti-TB drug is not documented between: A. Capreomycin and viomycin B. Amikacin and kanamycin C. Amikacin and capreomycin D. Ofloxacillin and Levofloxacillin E. Protionamide and Ethionamide 11. False about MDR-TB in children: A. Are treated in the same way as adult MDR-TB, except in certain conditions B. All anti tuberculosis drugs should be dosed according to body weight C. Fluoroquinolones are contraindicated in treatment of MDR-TB in children D. Adverse events of second line drugs seem to be less common among children than among adults E. Objective weight loss or failure to gain weight adequately could be first signs of treatment failure 12. Regarding MDR-TB treatment in pregnancy, one of the following is false: A. Effect of second line drugs on pregnancy is unknown B. Usually start treatment during first trimester C. Avoid aminoglycoside during pregnancy D. Need frequent follow up 8

13 E. No contraindication to start second line anti-tb Medication 13. The most common drug adverse effect of MDR-TB drugs is: A. Central nervous system effects B. Peripheral neuropathy C. Hearing loss D. Gastrointestinal effects E. Hepatitis 14. Pyridoxine should be routinely prescribed for all MDR-TB patients on: A. Kanamycin B. Ethionamide C. Cycloserine D. Levofloxacin E. Pyrazinamide 15. One is Least toxic MDR-TB agent in pregnancy: A. Fluoroquinolones B. Aminoglycosides C. Capreomycin D. Ethionamide 16. How will you manage MDR-TB patient on treatment who presents with loss of hearing? A. Discontinue all the injectable drugs B. Replace kanamycin with Amikacin C. Divide the dose of injectable drug in to twice daily dose D. Reduce the frequency of injectable drug 17. Which of the following conditions is reliable indicator of treatment failure? A. Sputum smear positive and culture negative at 4th month treatment B. Worsening of cough and radiologic findings at 10th month of treatment C. Persistence of symptom with Sputum culture positive at 5th month of treatment D. Massive hemoptysis and dyspnea with worsening CXR findings. E. None 18. One of the following is not administrative component of TB infection control measures? A. Triage B. separation C. cough hygiene D. particulate respirator E. None 19. Triage is defined as: A. Prompt identification of suspects B. Expedited service delivery C. Separated waiting areas D. Alternate clinic days and hours for MDR-TB and Other TB patients Part II: Write T for correct statement or F for wrong statement in the space provided (Three points each) 9

14 ( T ) MDR-TB treatment strategies depend on local epidemiology. (T ) Standardized regimens are most useful when drug resistance is low. (T ) Empiric regimen in Ethiopia is reserved for certain group of patients only. (T) MDR-TB regimens should contain at least four new effective drugs. (F) Treatment for extra-pulmonary MDR-TB should be extended. (F) In patient with known psychiatric illness, use of Cycloserine is absolutely contraindicated. (F ) Pyrazinamide can be re-administered in TB patient who developed drug induced hepatitis. (T ) First-line Anti-TB drug(s) may be used for treatment of MDR-TB. (T ) Rifampicin mono-resistance is usually treated with MDR-TB treatment regimen. Part III: Match each of the adverse effect from column B with its associated Anti-TB drugs from column A. ( Three points each) Answer Column A Column B C 1. Ethambutol A. Hypokalemia E 2. Cycloserine B. Hypothyroidism A 3. Capreomycin C. Vision changes B 4. Ethionamide D. Arthralgia D 5. Pyrazinamide E. Psychosis F. Materials checklist i. For facilitators Material and Supplies for facilitators Mark (3) Facilitators Guide Participant s manual National guideline on clinical and programmatic management of DR-TB Flip charts with markers Pretest Questionnaires Daily evaluation and course evaluation form Material and Supplies for participants Mark (3) Participant s manual Case study book Facilitators Guide Filed visit templates( template for PMDT, Infection control & Patient s 10

15 perspective) National guideline on clinical and programmatic management of DR-TB Course schedules Jobs aids on MDRTB suspect identification and referral Job aid and Desk reference for ADRs management N-95 and surgical mask-samples Notebook and marker for Participants Participants name tag ii. For participants iii. MDRTB recording and reporting formats recording and reporting formats Mark (3) 1. MDR TB Treatment card( Blank) 2. MDR TB Treatment card (filled) 3. Patient Profile 4. MDR TB register Book(blank) 5. MDR TB register Book(filled) 6. Lab request form 7. Labs register for TB culture 8. Lab worksheet for TB culture & identification 9. Monthly follow up center reporting format 10. Quarterly reporting format (case finding ) 11. Quarterly reporting format MDR TB treatment Enrollment 12. Six months interim report 13. Annual/final report 14. MDR TB Suspect register 15. MDR TB follow up register 11

16 Module One: Epidemiology and Basic of DR-TB 1. Epidemiology and basics of Drug resistant Tuberculosis. Learning Objectives: By the end of this unit, participants will be able to: Describe the epidemiology of Drug resistant TB. Discuss the basics of Drug-Resistant TB Discuss risk factors associated with DR-TB Time allotted: Material needed: Participants manual and facilitators guide, Flip chart and Markers. Process: Facilitator tip: Tell them the epidemiology of MDRTB is not well studied and more evidence on the incidence and prevalence needs to be collected globally. The MDRTB prevalence is largely influenced by the degree of prior exposure to anti-tb drugs. Make note that DRS is the key to understand the epidemiology of MDRTB among the new and previously treated. Tell them that the diagnostic and treatment need gap is still huge in most countries globally. Emphasize strengthening the TB control program has to be the main focus as diagnosis and treatment of DRTB is 1. Introduce the session objectives and time allowed for this module. 2. Make one participants to read loud session 1.1 on Epidemiology of MDR-TB. Elaborate the global and national situations on MDR-TB. Discuss on the need for Drug resistance survey (DRS) and the need for countries to repeat the survey every three to five years to exactly determine the situation and trends of Drug resistant TB in the population. 3. Continue reading section 1.2 on Basics of MDR-TB which dictates the microbiologic basis of Drug Resistance in TB, explain main causes of MDR-TB putting inadequate treatment as the main cause for development of MDR-TB in the world. 4. Make two participants sitting in-line to discuss table 1 on causes of inadequate treatment and identify factors that apply 12

17 complicated. Facilitator tip: Give emphasis to the section: why managing MDR-TB is more difficult than managing drug susceptible and table 1 on cause of inadequate treatment as causes of DR-TB. Facilitator tips: Tell to the participants that the implementation of all the components of STOP TB Strategy is essential in the prevention and control of DR-TB. Tell them also that to give due focus on the control of DR-TB, an expanded framework of the existing DOTS Strategy is required. for the local setting for three minutes before making reflections to the entire large group. Put a remark that classifying DR-TB as primary and secondary is not important for the programmatic management neither of MDR-TB case nor to making treatment choice. Make note that for program using standardized multidrug combination therapy used supervision, the risk for naturally occurring mutation to cause drug resistant TB is very rare. Rather primary resistant (i.e. diagnosing resistance in new patients) indicate the presence of circulating drug resistant form of TB in the community. 5. Before discussing session 1.3 on National MDR-TB implementation framework, Use a flip chart to brainstorm key components DOTS strategy and STOP TB STRATEGY as it is the basis for TB control program. Then try to explain how The MDR-TB implementation framework is linked and differed from the original strategy. Closure: Summarize Module one using session objectives. Table1.1 Causes of DR tuberculosis Health-care provider/program related factors: Inappropriate guidelines Non-compliance with guidelines Absence of guidelines Drug related factors: inadequate supply or quality Poor quality Unavailability of certain drugs due to stock-outs of delivery disruptions Patient- related factors: inadequate drug intake Poor adherence/default Lack of or inadequate patient information If Treatment not given for free 13

18 Poor training Poor supervision No monitoring of treatment provision Poorly organized or funded TB control program Inadequate regimens Lack of DST Poor access to health care Poor storage conditions Wrong doses or combinations (manufacture related) Lack of transportation money or support Drug adverse effects/interaction, Social barriers Mal-absorption Substance/alcohol dependence 14

19 Module Two: MDR-TB Program Design, coordination and management in Ethiopia 2. MDR-TB Programmatic Design, coordination and management Learning Objectives: By the end of the session, Participants' will be able to: Describe the MDRTB program Design Identify treatment delivery strategies Discuss MDRTB program coordination Describe selection and preparation of MDRTB centers Time Allotted: Facilitators tip: In the MDR-TB implementation frame work, MDR- TB program is vertically implemented up to the level of TIC and integrated into the original TB program at the TFC level, meaning ANY TB DOT CLINIC CAN SERVE AS TFC so long as necessary preparation is made by the centers and local program manager(-woreda HO). Facilitator s TIPs: Tell the participants that hospitalized model was the first model in Ethiopia to treat MDR- TB patients in the pilot Material Needed: Participant s manual, facilitator guide, Flip chart, Marker Process: 1. Introduce the Module 3 with its learning objectives and reminding the time allowed to complete the module. 2. Select participants to read session 2.1 part by part with intervening series of discussions. 3. Explain the national program recommends two models of care to enrol MDR-TB patients to treatment considering patient conditions, infrastructural and human resource capacity of the MDR-TB treatment centers. 4. Inform participants that the hospitalized model was the initial one, but now the international experiences and WHO recommendation (WHO Update) for countries is to shift to Ambulatory care model while maintaining optimal 15

20 phase. Ambulatory model, on the other hand is introduced recently to accelerate the expansion of the service to the regions as the infrastructure demand for the later model is relatively affordable and also evidences are coming, internationally, that the ambulatory model can have equivalent treatment outcome. In the implementation of the Ambulatory model, the program provides two options for patient care considering convenience for the patients and the risk of infection in the treatment centers; hence, there is tradeoff between the options. The decision to put patients on either of the options is left for the MDRTB team at TIC. Facilitator tips: referral involves two groups of patients: referral of suspects and referral of cases. Referral of MDRTB suspects is well discussed later in the case finding section. The referral of cases starts from the DOT clinic when the patient is confirmed to have MDRTB. Tell them that these confirmed cases, needs immediate linkage to the nearest designated treatment initiating treatment outcome of the patients. Tell them that Ethiopia has developed national protocol to guide program managers on the implementation of this care model. 5. Facilitator needs to clearly put the advantage of ambulatory model over the hospitalized: a) minimizes time before treatment; b) improve access as it requires less renovation work; c) reduce stigma and inconvenience for patients as they will not be admitted for long period of time to receive treatment and d) reduce hospital admission cost and risk for the health care workers. 6. Countries, in their program design, may choose to implement either clinic-based or home-based Ambulatory model depending on the countries existing situation and health system as integrating to the existing system is very critical as the program expands in the country; hence, Ethiopia has decided to implement the clinic-based model of care where patient are expected to visit Health facilities to receive injections and practice DOT. 7. In Ethiopia, both models may continue to be implemented for some time till the country level experiences developed well. 8. Facilitators then need to explain the difference between two levels of MDR-TB treatment centers as TIC and TFC. Discuss also their roles and responsibilities in the treatment delivery. 9. Read and discuss the three phases in treatment delivery. Make not that both models have got three phases and only differ in phase one where patient are not admitted as rule in order to be initiated with treatment. Phases of hospitalized model Ambulatory model treatment Phase I Intensive phase Intensive phase inpatient outpatient (stabilization phase) 16

21 center to be initiated with MDRTB treatment. After the patient is initiated on treatment, these patients will be later linked to the nearest TFC to continue the DOTS and treatment follow up. These patients will have scheduled visit to the TIC in addition to incidental referral for side effects management. Hence, inform the participants to use standard referral forms for proper communication. Facilitators tips: Explain the information flow using the flow chart provided in the participant manual. Tell them that the report from TFC is not a duplicate of the one produced from TIC as they have same patients. The program uses the report from TIC as the main source. Hence, TFC must give input on the patients status for the TIC on monthly basis to update the database at TIC. Inform the participants this will dealt in detail on day four in Module Eight on recording and reporting section. Phase II Intensive phase Intensive phase outpatient outpatient Phase III Continuation Phase Continuation Phase outpatient outpatient 10. Read section 2.2 about Referral networking and communication mechanism and facilitator needs to explain using the following tips. 11. Select a participant to section 2.3 on lab service Arrangement and facilitator should explain that the national/regional TB program and national/ regional TB reference laboratories designed lab networking and sample transportation system using courier service from EMS in order to transport patient specimens from designated collection sites to diagnostic labs for culture and DST services which will reduce delay in receiving test results and reduce patient s discomfort as they should be transported to submit samples and collect their result. 12. The next participant reads on section 2.4 about the data management system and explain the information flow using the figure 1.1( See below) 13. Tell them this section will be dealt in detail in module eight. 17

22 Module Three: Case Finding & Contact Tracing of M(X)DR-TB in Ethiopia 3. Case Finding & Contact Tracing of M(X)DR-TB in Ethiopia LEARNING OBJECTIVES By the end of this unit, participants will be able to: Identify MDR-TB suspects Facilitator tip: Emphasize that symptoms of TB and its resistant forms is difficult to distinguish. Explain to the students that the list of risk factors for drug resistant TB could be longer but it is advised for individual countries to develop its own strategy based on epidemiology, burden and resource available. The national TB program has developed its own list considering these conditions. Inform MDR- TB suspect list for one country could vary from the list in other. Manage MDR-TB suspect between identification and initiation of MDR-TB treatment. Record and interpret the results of the different exams Conduct contact investigation TIME Allotted: Materials: Participant s manual, Facilitators guide, Job aid on MDR-TB suspect identification, evaluation and referral procedures, Flip chart, and markers. Process: 1. Introduce the Module 3 with its learning objectives and reminding the time allowed to complete the module. 2. Ask participants which type of patients they consider as MDR-TB suspect? record their responses on flip chart before going to the subject proper. 3. Select one volunteer to read loud section 3.1 Identify MDR-TB suspects and make note that the clinical manifestation and the radiologic changes seen patient with Drug resistant TB is similar to Drug susceptible TB. For the definitive diagnosis DST is mandatory. 18

23 Facilitators tip: emphasize the need for contact investigation, recognizing and properly monitoring for evidence of treatment failure among TB patients on treatment and need for linking the diagnosed patient for prompt treatment. Tell them also not to decide on further action before the DST result. Need for continuing treatment with FLD for those with DST showing susceptible TB. Discuss with the students why list of conditions are considered as risk factor for the development of DR-TB. 4. Circulate the job aid showing MDR-TB suspects in Ethiopia and give them chance to compare with the list on the flip chart. 5. Read section 3.2 on case finding strategies in Ethiopia and ask participants how effective these each strategies to identify suspects in cost effective and efficient manner. 6. Describe the Procedures for MDR-TB suspect identification, evaluation and referral designed for Ethiopia, and then ask participants to read and discuss on what action to take for each suspect case as provided in participants manual section Decide on what action to take based on the patients' risk group. And ask their opinion. 7. In Ethiopia, SLD DST is not routinely recommended and not available till now as country level SLDs exposure is not significant; however, XDR-TB suspected patients need to undergo second line DST. At the moment SLDs DST service is under process to be started at the National TB reference laboratory to provide the service for selected patients. 8. Ask a volunteer to read load section 3.3 contact tracing and investigation and Emphasize on the need to actively trace all close contact of MDR-TB suspected or confirmed cases as they contact have high risk of acquiring MDR-TB. HEWs need to be actively involved in tracing contacts of MDR-TB patients. All symptomatic contacts and any contact from known High risk groups(- under-fives, diabetic and HIV infected) must undergo evaluation by experienced team. 9. On section 3.4 evaluation of children for MDR-TB, put remark that the chance of children to acquire TB and progress to active form of TB is higher if they come inclose contact with TB and/or MDRTB patients; in addition, confirmation of diagnosis is barely possible due to difficulty of collecting proper sample. However, all attempt must be made to confirm the diagnosis though children may be but on MDR- TB treatment empirically. 10. Remind the students that No Chemoprophylaxis is 19

24 recommended to treat latent TB and prevent development of MDR-TB. Hence, Children under five years needs regular screening for development of Active symptoms every three months for at least two years as they have high likelihood of disease progression due to their immature immune system. Closure: The facilitator should close this session by putting remark that: Designing the appropriate case finding strategy and expedited identification of suspects and accessing them diagnostic test is key for controlling and prevention of the transmission of drug resistant form of TB. Active contact training od close contact is one of the key step on case finding of MDR-TB cases In contact tracing, Focus must be given for high-risk groups. Now it is time to facilitate Case studies Part one: identifying MDR- TB suspects and classification: See instruction on Facilitator guide for case studies at the end this booklet. 20

25 Module four: Laboratory Diagnosis of DR-TB in Ethiopia 4. Laboratory aspects of DR-TB in Ethiopia LEARNING OBJECTIVES By the end the session participants will be able to explain: The role of culture, LPA and DST in the diagnosis of MDR-TB Advantages and limitations of the different diagnostic techniques The algorithm of MDR-TB Diagnosis Time allotted: Materials: Process: 1. Facilitator introduces the learning objectives for module four on laboratory Aspects of DR-TB in Ethiopia. 2. Ask participants to name the different lab methods they know to diagnose TB and record their response on Flip chart 3. Ask them which methods could be helpful for diagnosis of drug resistant form of TB. 4. Ask volunteers to read loud section 4.1 Diagnosis of DRTB part by part. 5. Discuss the advantages and disadvantages of each lab techniques mentioned on the manual. 6. Ask participants to read and discuss section 4.2 MDR-TB 21

26 diagnostic algorism in Ethiopia with the participant net to them for five minutes, and then summarize for them by explaining how the algorism,- see figure 4.1 below-,should be used in day to day practice to diagnose suspects identified from the TB clinic. National Algorism for DST service The national program has developed an algorism to confirm the diagnosis of MDRTB from samples of MDRTB suspects. See Figure 4.1 below. 22

27 Module Five: MDR-TB Patient classification and definition of terms 5. DRTB Patient classification and definition of terms LEARNING OBJECTIVES By the end the session participants will be able to: Classify, categorize & register DRTB patients in a standardized fashion Assign patients to appropriate treatment regimens Assign the MDR-TB patient into standardized treatment outcome Time allotted: Facilitator tips WHO has designed the terms and names used in MDR-TB program to be in similar fashion with the standard terms and name used for Drug susceptible TB to avoid confusion by introducing to many terminologies; however, the definitions used to explain these terms and names could vary when we use Materials: participant s manual, Flip chart, markers and case study book for participants and case study Master book for the facilitator. Process: 1. Introduce the module five on Patient classification and definition of terms using the learning objectives. 2. Ask participants to recall how TB patients are classified and put into different registration groups from their previous trainings/ practice in the TB program. 3. List down the different groups on flip chart 23

28 them from TB and MDR-TB as the diagnostic technics, follow-up modalities and criteria to define the outcomes are different. 4. Now ask volunteer to read section 5.1 Definition of Drug- Resistance TB and ask the participant whether they understood the difference among each group. 5. Give time for them to read the different classification and definitions of treatment outcomes in MDRTB program and how their definition differs one from the other on section 5.2 and Now you have finished module five, and it is time for participants to start working on case studies using case study book for participants. 24

29 Module Six : Treatment of DR-TB 6.Treatment of DR-Tuberculosis INTRODUCTION: In Module Six, participants will be taught the preparation of MDR-TB patients bepfre initiation of treatment. Then they will learn how to design and initiate Second line treatment using different treatment regimens, monitor patients according to the national protocol. The material also teaches management of adverse events and MDR-TB in especial conditions-like pregnant, comorbid conditions, HIV and children. The training will have cases studies on how to construct regimen and management of adverse events. The treatment module is covered in six sections as follow: 6.1 Patient preparation 6.2 Treatment of Drug resistant Tuberculosis 6.3 Treatment monitoring and follow-up 6.4 Management of Adverse Drug Reactions during M(X)DR-TB treatment 6.5 MDR- TB in special conditions and situation 6.6 Management of MDRTB in HIV co-infection 6.7 Programmatic management of MDR-TB in Children LEARNING OBJECTIVES of the treatment module: Assess and prepare patient for treatment Apply the principles of good chronic care in DR TB management Describe principles of DR-TB treatment Identify the national standard MDR-TB Treatment regimen 25

30 Manage MDR-TB in especial conditions Manage MDRTB in children 26

31 6.1 Patient preparation Learning Objectives: By the end of the session participants will be able to know how to; Evaluate MDR-TB patient Prepare patient for treatment Describe and interpret the work up of patient with MDR- TB Time allowed: Materials: Process: Facilitators tip: every patient s relevant information need to be captured on the standardized treatment card. Facilitator tip: Emphasize that MDRTB requires 18-24month of treatment which 1. The facilitator should introduce the section on patient preparation using the learning objective 2. The facilitator should brief the components of patient preparation (i.e. complete patient assessment, Classification and registration, Patient Counselling and adherence initiation and Education to patients and their treatment supporters on MDR-TB). 3. Ask volunteers to read loud section I complete patient assessment and discuss 4. Use MDRTB treatment card to demonstrate how to fill out/register patient s relevant data. 5. Brainstorm on the important issues to be addressed while providing Patient Counselling and adherence initiation for MDR-TB patient using flip chart, and then. 6. Ask a volunteer to read section on Patient Counselling and adherence initiation for MDR-TB patient. 7. Invite the participants to read key elements of health education for MDR-TB patients on the participant manual and explain why each point is worth discussing. 27

32 makes the principles of good chronic care important for successful patient management. Inform the participants to use the 5A s strategy to best counsel the patient. 8. The facilitator needs to discuss the Principles of Good chronic care as it applies to MDRTB management. 9. Explain what 5A mean and emphasize how it would be used in the adherence counselling 10. Ask volunteer to read on section Adherence counselling using 5A s and discuss on the importance of each step to systematically advice the patient. 11. Inform the participants that every patient has to be prepared on for treatment together with the treatment supporter; hence, the health care worker should request the patient to bring the supporter from the outset. 12. Closure: finalize the chapter by asking the participants to ask question which might remain unclear. 28

33 6.2 Treatment of Drug resistant Tuberculosis Learning Objectives By the end of this session, participants will be able to: Identify groups of anti-tb medications Describe principles of designing MDR-TB treatment regimen Familiar with MDR-TB treatment standard regimens in Ethiopia Identify the recommendations of treatment in different conditions Monitor Treatment and follow MDR-TB patient Materials: Process: 1. Facilitator need to explain the session objective 2. Break out the class to read and discuss table Groups of Anti-TB drugs 3. Facilitator should elaborate about each group of drugs and need to further explain which groups are backbones to construct second line TB treatment. Table : Grouping of anti-tuberculosis agents Grouping Group 1: First-line oral agents Drugs Isoniazid (H); Rifampicin (R); Ethambutol (E); Pyrazinamide (Z) Group 2: Injectable agents Streptomycine (S), Kanamycin (Km); Amikacin (Am); Capreomycin (Cm); Group 3: Fluoroquinolones Ofloxacillin (Ofx), Levofloxacin (Lfx), Moxifloxacin (Mfx) 29

34 Group 4: Oralbacteriostatic sec Ethionamide (Eto); Prothionamide (Pto), Cycloserine (Cs); paraaminosalicylic acid (PAS) Group 5: Agents with unclear role in DR-TB treatment (not recommended by the WHO Amoxicillin/clavulanate (Amx/Clv); Clarithromycin (Clr); High-dose isoniazid (High-dose H); a Clofazimine (Cfz);Linezolid (Lzd); Thioacetazone (Thz); Imipenem/cilastatin (Ipm/Cln); for routine use in DR-TB patients) a High-dose H is defined as mg/kg/day. Facilitator tip: Inform the participant that MDRTB treatment regimens could vary also from country to country and also from one person to another as the appropriate regimen ideally has to be individualized based on individual DST. Facilitators tip: Emphasize on cross-resistance and prior exposure to the agent if required to construct individualized treatment regimens Facilitators tip: Empiric regimens are commonly used in specific groups of patients while DST is pending. Empiric regimens can be standardized (ie. all patients from a certain group get the same regimen until DST results return) or individualized for each patient based on the patient s treatment history and contact history. Empiric regimens are strongly recommended since most DST methods have a turnaround time of several weeks. Empiric regimens are useful to avoid clinical deterioration of patients and prevent transmission to secondary cases; however, in settings where rapid DST methods are available it may be 4. Ask volunteers to read loud section principles of designing MDRTB treatment regimen and explain each bullet independently 5. Ask volunteers to read loud Section Standardized regimen in Ethiopia and explain why standardized regimen is preferred in Ethiopian context. 6. Explain also why Standardized regimen followed by individualization is the most preferred regimen but it requires full DST and expert to adjust the regimen individually. 7. Break out the classroom and ask participants to discuss in small group on standard coding of Tb drugs and regimen writing. 8. Explain how to determine Duration of injection and treatment using the example provided on the participant s manual The current recommendation is that the injectable agent should be continued for minimum of 8 months and at least 4 months after culture conversion. The duration of treatment is guided by culture conversion. And treatment should be continued for a minimum of 18 months beyond culture conversion. 9. Ask participants to continue with small groups and make them to read and discuss on section MDRTB regimens in different conditions using table

35 more appropriate to wait for the results to ensure appropriate treatment. Facilitator tip: Remind the participants that the coding system is standard and they have to use it on the day to day patient care. Note that at the completion of eight month of therapy, the MDR-TB panel team has to evaluate every patient to decide whether to discontinue or extend the injectable agent. Note: Sputum culture conversion is defined as two consecutive negative cultures, from samples collected at least 30 days apart. Thus one has to await the consecutive month s results; however the date of first sputum collection will be used as a reference point for deciding on the duration of treatment. 10. Ask them what did they learn from the regimen constructed for mono- and poly- DR-TB cases? and tell them R-mono has to be treated with MDR-TB regimen as it is the cornerstone drug for TB treatment. 11. Ask volunteer to read load section 6.3 on treatment monitoring and follow up and summarize the section using table and explain them how to interpret the keys. Key: X: indicates number of tests repetition per interval(month in intensive phase/quarter in continuation phase) Y: only for patients taking Capreomycin and patients at increased risk of electrolyte abnormalities 12. Continue discussing on: 1. Follow-up of the non-adherent patient or the patient who missed treatment Adherence support and monitoring using 5A s Psychosocial and emotional support Nutritional support Now it is time to facilitate Case studies on Part two and three: Interpreting lab results and initiate treatment: See instruction on Facilitator guide for case studies at the end. 6.4 Management of Adverse Drug Reactions during M(X) DR-TB treatment 1. Ask a participant to read loud section 6.4 on Management of Adverse Drug Reactions during M(X) DR-TB treatment. Explain how the adverse reaction is graded according to the degree of severity and how they should be managed using the following information: Mild ADRs. The adverse condition identified is mild one so that it can be managed only with supportive measures using 31

36 ancillary drugs and by explain the condition to the patient and reassuring. Patients with this grade of ADRs should be managed according by the managing HCWs. Moderate ADR: Patients with moderate ADRs are those who require temporary modification in dose/frequency of the offending agents. Hence, the patient needs to referred to treatment initiating center where decision can be made. The health care provider should closely follow the patient and reintroduce the medication as soon as the adverse event is reversed. Prolonged drug discontinuation and use of very low doses of a drug can predispose for TB treatment failure. Severe or life threatening ADR: Severe toxicities like hepatitis, severe psychosis, suicidal ideation or severe hypersensitivity reactions to the drugs may require discontinuation of the offending drug or temporary discontinuation of the whole regimen. Hence, patients with severe ADR need to be urgently referred to Treatment initiating center after discontinuation of the treatment. 2. Break out the class into small groups and instruct participants to find out Annex 2 on specific management of ADRs. Give them sufficient time to study the table and 3. Summarize by emphasizing the common side effects of SLDs and their recommended management. Now it is time to facilitate Case studies on Part four: side effect and complication: See instruction on Facilitator guide for case studies at the end. Guide participants to exercise on part four from case one to nine. 32

37 6.5 MDR-TB in special conditions and situation Learning Objectives: Identify special conditions that may affect or be affected by MDR TB management Assess and formulate appropriate regimen to treat MDR TB in special conditions and situations Monitor patients with special conditions receiving MDR-TB treatment Materials: Manual, Job Aids on ADR Process: 1. Facilitators should introduce section 6.5 MDR-TB in special conditions and situation MDR-TB in special conditions and situation 2. Facilitator should ask participants which especial conditions, with their reason, need attention in patients to be treated for MDR-TB. Record their response on flip chart before continue to section details. 3. Ask volunteer to read loud the especial conditions and situation requiring attention and the general associated reasons and Explain to the participants 4. Then ask the classroom to read and discuss on each condition with the participant sitting next to them. Give adequate time cover all. 5. The summarize with the following considerations to be made when managing a specific condition and situation: 33

38 Special conditions General considerations Pregnancy Pregnancy testing should be routinely done for all women of child-bearing age at the initial assessment for SLD treatment. In non-pregnant, advice use of contraceptives. For Pregnant, assess the patient carefully taking into consideration gestational age and severity of the DR-TB. Consider the risk-benefit of treating pregnant woman with MDR-TB. One of the goals of treatment is achieving early smear conversion to protect the new born. It is better to avoid treatment with second line drugs during first-trimester. In cases of life-threatening conditions, consider treatment regardless of the stage of pregnancy. Generally, it is recommended to initiate MDR-TB therapy during second or third trimester to achieve smear conversion prior to delivery of the baby. Consideration in constructing treatment regimen for pregnant: Cs, FQ, PAS have been used without evidence of fetal damage Start with three or four oral drugs with demonstrated efficacy against the infecting strain, and then reinforce with an injectable agent and possibly other drugs immediately postpartum. Give Pyridoxine for all MDR cases with Pregnancy If pregnancy occurs while on treatment, defer treatment during the first trimester, unless life threatening Use of drugs in pregnancy: Aminoglycosides should not be used in the regimens of pregnant patients, particularly toxic to the developing fetal ear. Capreomycin may carry the same risk of ototoxicity, but is the drug of choice, if an injectable agent cannot be avoided Ethionamide and Prothionamide Ethionamide can increase the risk of nausea and vomiting associated with pregnancy, and Teratogenic effects have been observed in animal studies. 34