Tuberculosis (2005) Department of Health

Transcription

1 (2005) Department of Health

2 Department of Health National Tuberculosis Control Program San Lazaro Compound, Rizal Avenue, Sta. Cruz, Manila Telephone No: loc. 2350/ Dr. Myrna Cabotaje NCDPC, DOH 2. Dr. Jaime Lagahid IDO, DOH 3. Dr. Jennifer Ann Mendoza-Wi Philippine Coalition Against Tuberculosis (PhilCAT) Board of Advisers Department of Health Technical Working Group (TWG) 1. Dr. Anna Marie Celina Garfin National Center for Disease Prevention and Control (NCDPC) 2. Dr. Ernesto Bontuyan Jr. NCDPC 3. Ms. Agnes del Rosario NCDPC 4. Ms. Ferdinand La Puebla NCDPC 5. Ms. Ellen Melia Castillo National Tuberculosis Reference Laboratory (NTRL) 6. Ms. Edna Nito National Center for Health Promotion (NCHP) Center for Health Development 1. Dr. Lydia Rogando Center for Health Development (CHD)-Bicol 2. Dr. Flor Elona Center for Health Development (CHD)-Eastern Visayas 3. Dr. Willie Cabauatan Center for Health Development (CHD)-Cagayan Valley 4. Ms. Joy Tabotabo Center for Health Development (CHD)-Central Visayas 5. Ms. Gemma Tan Center for Health Development (CHD)-Ilocos Local Government Units 1. Dr. Niela Jorvina Laguna Provincial Health Office 2. Dr. Christina Giango Cebu Provincial Health Office 3. Ms. Evangeline Rambuyon Negros Provincial Health Office 4. Ms. Letty Rivera Batangas Provincial Health Office Partners 1. Dr. Michael Voniatis World Health Organization (WHO) 2. Dr. Tomohiro Shirahama JICA 3. Dr. Arthur Lagos JICA 4. Dr. Marilyn Gorra PhilTIPS 5. Dr. Charles Yu PhilTIPS 6. Mr. Jose Ibarra Angeles PhilTIPS 7. Ms. Elaine Umali WVDFI 207

3 Technical Review Panel (TRP) Department of Health 1. Dr. Rosalind Vianzon National Center for Disease Prevention and Control (NCDPC) 2. Ms. Cirila Negad NCDPC 3. Ms. Arlene Tivera NCDPC 4. Dr. Vivian Lofranco Lung Center of the Philippines (LCP) 5. Dr. Nora Cruz National Tuberculosis Reference Laboratory (NTRL) 6. Ms. Paz Rostrata National Tuberculosis Reference Laboratory (NTRL) Center for Health Development 1. Dr. Sylvia Somontan Center for Health Development (CHD)-Caraga 2. Dr. Eloisa Segura Center for Health Development (CHD)-Davao 3. Dr. Amelia Medina Center for Health Development (CHD)-NCR 4. Dr. Edith Caloyloy Center for Health Development (CHD)-Western Visayas 5. Ms. Marilou Gecosala Center for Health Development (CHD)-Northern Mindanao Local Government Units 1. Dr. Bernard Caspe Iloilo City Health Office 2. Dr. Ma. Lourdes San Juan Pasay City Health Office 3. Dr. Marian Isiderio Eastern Samar Provincial Health Office 4. Ms. Teresita Puente Pasig City Health Office 5. Ms. Myla Espino Pasig City Health Office 6. Ms. May Fernando Bulacan Provincial Health Office Partners 1. Dr. Mariquita Mantala LEAD for Health Project 2. Dr. Jubert Benedicto PhilCAT 3. Ms. Amelia Sarmiento PhilCAT 4. Mr. Albert Angelo Concepcion PhilCAT 5. Dr. Maria Rubio MDM 6. Dr. Jose Luis Portrero MDM 7. Dr. Ma. Imelda Quelapio TDFI/GFATM 8. Dr. Melvin Magno WVDFI Publication Staff 1. Dr. Ma. Theresa Velasco Technical Editor 2. Ms. Laila Garcia Assistant Technical Editor 3. Ms. Rose Gonzales Creative Director 208

4 Algorithm for the Diagnosis of Pulmonary Tuberculosis TB symptomatic (cough for 2 weeks or more) Three (3) sputum collection A. 2 or 3 Smear-Positive? Y Classify as Smear- Positive TB 5 N B. Only One (1) Smear-Positive? Y See Figure 2.1a 6 N C. All 3 Smear-Negative Y See Figure 2.2 Figure B. Only One (1) Smear-Positive Collect another 3 Sputum Specimens Immediately If at least one (1) Smear-Positive? Y Classify as Smear- Positive TB 5 N 6 7 Request for CXR Y Consistent with active TB? Y Classify as Smear-Positive TB N 8 Observation/ further exam, if necessary. Figure 2.1a 209

5 Algorithm for the Diagnosis of Smear-Negative Pulmonary Tuberculosis 1 C. All 3 Smear-Negative 2 Refer to Physician (Symptomatic Tx for 2-3 wks) 3 If symptoms persist, request for CXR Abnormal findings on CXR? TB Diagnostic Committee Y Consistent with active TB? Y Classify as Smear- Negative TB N N 8 9 No Abnormal findings on CXR Not consistent with active TB 10 Observation/ further exam Figure

6 Figure 1.1. Flow of NTP Activities COMMUNITY Symptoms of TB Cough for two or more weeks, with or without Fever Chest and/or back pains not referable to any musculoskeletal disorders Hemoptysis or recurrent blood-streaked sputum Other symptoms, such as sweating, fatigue, body malaise, shortness of breath DOTS FACILITY Case Finding Sputum specimen (3 specimens) with NTP Laboratory Request Form for Direct Sputum Smear Microscopy MICROSCOPY CENTER Diagnosis Initiation of Treatment Case Holding with DOTS Treatment Completion (Result of the DSSm. If results are Smear negative and with chest x-ray suggestive of TB, refer to TBDC for evaluation.) T B D C Sputum specimen (1 specimen) with Laboratory Request Form for DSSM MICROSCOPY CENTER Results (DSSM for follow-up) Report Treatment Outcome/Request Supplies Monitoring and Supervision 211

7 National Tuberculosis Control Program Manual of Procedures, 2005 CASE FINDING Case finding, which is the identification and diagnosis of TB cases among individuals with suspected signs and symptoms of TB, is a basic step in TB control. Fundamental to case finding is the diagnostic method adopted by the NTP because: 1. It provides a definitive diagnosis of active TB; 2. The procedure is simple; 3. It is economical; and 4. A microscopy center could be put up even in remote areas. DSSM results serve as bases for categorizing TB symptomatics according to standard case definition. These are also used to: a) monitor progress of patients with sputum smear-positive TB while they are receiving anti TB treatment; and b) confirm cure at the end of treatment. I. OBJECTIVE Early identification and diagnosis of TB cases II. DEFINITION OF TERMS TB symptomatic any person with cough for two or more weeks with or without the following symptoms: fever; chest and/or back pains not referable to any musculo-skeletal disorders; hemoptysis or recurrent blood-streaked sputum; significant weight loss; and other symptoms, such as sweating, fatigue, body malaise, shortness of breath Active case finding a health worker s purposive effort to find TB cases (among TB symptomatics in the community) who do not consult with personnel in a DOTS facility Passive case finding finding TB cases among TB symptomatics who present themselves in a DOTS facility III. POLICIES 1. DSSM shall be the primary diagnostic tool in NTP case finding. 2. All TB symptomatics identified shall be asked to undergo DSSM for diagnosis before start of treatment, regardless of whether or not they have available X- ray results or whether or not they are suspected of having extra-pulmonary TB. The only contraindication for sputum collection is hemoptysis; in which case, DSSM will be requested after control of hemoptysis. 3. Pulmonary TB symptomatics shall be asked to undergo other diagnostic tests (X-ray and/or culture), if necessary, only after they have undergone DSSM for diagnosis with three sputum specimens yielding negative results. The TBDC will evaluate the results of the chest X-ray, together with the clinical history and findings, and will recommend whether or not the case will be started on treatment. 4. Since DSSM is the primary diagnostic tool, no TB diagnosis shall be made based on the results of X-ray 212 examinations alone. Likewise, results of the skin test for TB infection (PPD skin test) should not be used as bases for TB diagnosis in adults. 5. All municipal and city health offices shall be encouraged to establish and maintain at least one sputum microscopy unit in their areas of jurisdiction. 6. Private-initiated Public-Private Mix DOTS (PPMD) units shall each have an in-house microscopy service. 7. Passive case finding shall be implemented in all DOTS facilities. Concomitant active case finding shall be encouraged only in areas where a cure rate of 85 per cent or higher has been achieved, or in areas where no sputum-smear positive case has been reported in the last three months. 8. Only trained medical technologists or microscopists shall perform DSSM (smearing, fixing, and staining of sputum specimens, as well as reading, recording, and reporting of results). However, in far flung areas, BHWs or other community health volunteers may be allowed to do smearing and fixing of specimens, as long as they have been trained and are supervised by their respective NTP medical technologists/microscopists. IV. PROCEDURES A. Identification of TB Symptomatics (To be accomplished by DOTS facility staff) 1. Identify TB symptomatics consulting at the DOTS facility. Look out for those having cough for two or more weeks, with or without one or more of the following signs and symptoms: a. fever; b. chest and/or back pains not referable to any musculo-skeletal disorders; c. hemoptysis or recurrent blood-streaked sputum; d. significant weight loss; and e. other symptoms, such as sweating, fatigue, body malaise, and shortness of breath. 2. Motivate TB symptomatic to undergo DSSM. Explain importance of the procedure and that of submitting three sputum specimens. Obtaining results from three sputum specimens increases the probability of finding acid fast bacilli. 3. Record details of each specimen submission (name of TB symptomatic, date of submission, and result) in the TB Symptomatics Masterlist/TB Symptomatics Target Client List. 4. Encourage household members of identified TB cases, who are also TB symptomatics, to undergo DSSM. B. Collection and Transport of Sputum Specimens to the Microscopy Center (To be accomplished by DOTS facility staff) 1. Explain the importance of submitting three sputum specimens taken within two days. a. First specimen, also referred to as spot specimen, is collected at the time of consultation, or as soon as the TB symptomatic is identified. b. Second specimen is the very first sputum produced early in the morning immediately after waking up. It is collected by the patient according to instructions given by the DOTS facility staff. c. Third specimen, or second spot specimen, is collected when the TB symptomatic comes back to the DOTS facility to submit the second specimen. d. All specimens should be collected according to

8 instructions given by the DOTS facility staff. The first and third specimen collections are supervised by the DOTS facility staff to ensure quality sputum specimen collection. If quality sputum is not collected within two days, the patient is given one week to complete the three-specimen collection. If the patient fails to complete the three-specimen collection within one week, another set of three should be collected. 2. Prepare sputum cup, indicating patient s complete name, and order of specimen (1 st, 2 nd, or 3 rd ). 3. Demonstrate how to produce quality sputum. Advise patient to: a. Rinse his/her mouth with water. b. Breathe deeply, hold breath, then exhale slowly. Repeat the entire sequence twice. c. Cough strongly at the height of deep inspiration after inhaling deeply for the third time, and spit the sputum in the container. Observe precautions against infection during the demonstration. Stay behind the patient. Collect specimen outside the DOTS facility where aerosols containing TB bacilli are diluted and sterilized by direct sunlight. 4. Collect specimen and check quantity and quality of sputum. 5. Seal sputum specimen container, pack it securely, and transport it to a microscopy center or laboratory, together with the completely filled up NTP Laboratory Request Form for DSSM. Do this as soon as possible or within four days after collection. 6. If specimen cannot be sent to a microscopy unit early enough, store it in a cool, dark, and safe place. No specimen shall remain unexamined over the weekend. C. Smearing, Fixing, and Staining of Sputum Specimen and Reading, Recording, and Reporting of Results (To be accomplished by medical technologist or microscopist) 1. Record the information in the NTP Laboratory Register, including the type of sputum specimen submitted, i.e., mucoid, purulent, blood-streaked, or salivary. 2. Smear, fix, and stain each slide. 3. Read each slide and interpret the result as follows: 0- No AFB seen in 300 oil immersion field (OIF) +n 1-9 AFB seen in 100 OIF AFB seen in 100 OIF AFB /OIF in at least 50 fields 3 + -more than 10 AFB/OIF in at least 20 fields 4. Interpret the results of the three specimens and write the final laboratory diagnosis in the lower portion of the NTP Laboratory Request Form for DSSM and on the Remarks column of the NTP Laboratory Register. Laboratory diagnoses are classified as follows: a. Smear-positive - at least two positive sputum smear results b. Doubtful -only one positive out of three sputum specimens examined (Request for another set of three sputum specimens). If at least one specimen from the second set of specimens is positive, laboratory diagnosis is positive. If all three specimens from the second set of specimens are negative, laboratory diagnosis is negative. c. Smear-negative - all three sputum smear results negative 5. Send request form back to requesting unit. D. Decision on Patient s Diagnosis Based on Laboratory Results (To be accomplished by DOTS facility staff) 1. Inform patient of result. If positive, refer patient to physician for assessment and initiation of treatment; and, Encourage household members with signs and symptoms of TB to consult at DOTS facility. If doubtful, ask patient to submit another three sputum specimens within one week. If negative, refer patient to physician for further assessment. E. Diagnosis of Smear-negative Patients with Persistent Symptoms (To be accomplished by physician) 1. Re-assess smear-negative patients with persistent symptoms of TB. (Refer to Flow Chart 2.1 & 2.2) 2. Refer patient for X-ray examination, if warranted. 3. If X-ray findings are suggestive of TB, refer patient to the TBDC. In areas where there is no TBDC, physician may manage the patient. F. Referral to TBDC (To be accomplished by physician) 1. Fill up TBDC Referral Form and send it to TBDC, together with all available chest X-ray films. 2. Wait for TBDC evaluation of results, which is sent back to the DOTS facility. 3. Carry out TBDC recommendations. G. Summary of Procedure The following four flow charts summarize the procedure for TB case finding: 1. Flow Chart for the Diagnosis of Pulmonary Tuberculosis; 2. Flow Chart for the Diagnosis of Smear-Negative Pulmonary Tuberculosis; 3. Guide to Case Finding; and 4. Guide to Diagnosis and Initiation of Treatment. V. QUALITY ASSURANCE FOR DSSM The quality assurance (QA) program is a series of regular activities carried out to monitor the laboratory s overall performance towards maintaining high quality results. DSSM results are highly significant not only to the patient but also to the entire NTP. As such, it is essential for the QA program to: 1) ensure that the reported results are accurate; 2) identify practices that are potential sources of error; and 3) ensure that appropriate corrective actions are initiated. A. OBJECTIVE Assurance of high quality DSSM services in NTP B. COMPONENTS QA for DSSM includes the following: 1. Quality Control (QC) is the systematic internal monitoring of working practices, technical procedure, equipment, and materials, including quality of stains. These are performed regularly by the NTP medical technologist or microscopist. 2. External Quality Assessment (EQA) is a system of periodic independent measurement of performance 213

9 through collaboration with another competent laboratory at a higher level (province or city). The trained NTP provincial or city coordinators and controllers are responsible for EQA. 3. Quality Improvement (QI) is a process by which the components of smear microscopy diagnostic services are analyzed by trained NTP provincial or city coordinators. This is a continuous undertaking designed to identify and address problem areas, which in turn will help ensure quality of DSSM services. C. POLICIES 1. In the DOTS facility, the NTP-trained medical technologist/microscopist shall maintain QC of routine work. 2. A Quality Assurance Center shall be established in every province and highly urbanized city to ensure that QA activities are maintained in all DOTS facilities. Provincial/city health offices are responsible for EQA, which includes blinded slide rechecking and on-site evaluations by persons identified to perform such activities. 3. CHDs and their regional laboratories shall support the provincial/city QA centers. Procedures and forms are found in the Manual on the Quality Assurance for Sputum Smear Microscopy, March CASE HOLDING Case holding is the procedure which ensures that patients complete their treatment. Chemotherapy is currently the only way to stop the transmission of TB. While effective anti-tb drugs are available in the country, there are still many TB patients who are not cured. This is because many patients stop taking anti-tb drugs or they take their drugs irregularly. Patients are usually remiss in drug intake due to the long duration of treatment. The shortest duration of treatment is six months. Treatment compliance is necessary to cure TB and avoid development of drug resistance. It is useless to search for cases if they could not be treated properly after they have been found. It would only encourage false hopes on the part of the patient. Poor treatment compliance may lead to the following outcomes: chronic infectious illness; drug resistance; or death. Second-line anti-tb drugs for drug resistant cases are very expensive and most are not available in the country. The best way to prevent the occurrence of drug resistance is through regular intake of drugs for the prescribed duration. The strategy developed to ensure treatment compliance is called Directly Observed Treatment (DOT). It is one of the key components of DOTS towards achieving sufficient cure rate and preventing drug-resistant TB. DOT works by assigning a responsible person to observe or watch the patient take the correct medications daily during the whole course of treatment. I. OBJECTIVE Effective and complete treatment of TB cases, especially pulmonary sputum smear-positive cases II. DEFINITION of TERMS A. Classification of TB cases - TB cases shall be 214 classified based on the location of lesions, as well as the result of DSSM (Table 3.1). B. Types of TB cases - TB cases shall be categorized based on the history of anti-tb treatment (Table 3.2). A thorough understanding of the types of TB cases is necessary in determining the correct category of treatment regimen. C. Directly Observed Treatment (DOT) - DOT is a method developed to ensure treatment compliance by providing constant and motivational supervision to TB patients. DOT works by having a responsible person, referred to as treatment partner, watch the TB patient take medicines everyday during the whole course of treatment. Any of the following could serve as treatment partner: a) DOTS facility staff, such as the midwife or the nurse; or b) a trained community member, such as the BHW, local government official, or former TB patient. A member of the patient s family may not be as reliable as a health worker in serving as treatment partner, but he/she may be assigned as treatment partner during weekends and holidays. DOT can be done in any accessible and convenient place for the patient (e.g., DOTS facility, treatment partner s house, patient s place of work, or patient s house) as long as the treatment partner can effectively ensure the patient s intake of the prescribed drugs and monitor his/her reactions to the drugs. It is important to supervise the smear-positive TB patients daily anti-tb drug intake during the intensive and continuation phases of shortcourse chemotherapy. III. POLICIES a. Aside from clinical findings, treatment of all TB cases shall be based on a reliable diagnostic technique, namely, DSSM. b. Domiciliary treatment shall be the preferred mode of care. c. Patients with the following conditions shall be recommended for hospitalization: 1. massive hemoptysis; 2. pleural effusion obliterating more than one-half of a lung field; 3. miliary TB; 4. TB meningitis; 5. TB pneumonia; and 6. those requiring surgical intervention or with complications. d. All patients undergoing treatment shall be supervised (DOT). No patient shall initiate treatment unless the patient and DOTS facility staff have agreed upon a case holding mechanism for treatment compliance. e. The national and local government units shall ensure provision of drugs to all smear positive TB cases. There are two formulations of anti-tb drugs: 1. Fixed dose combination (FDCs) Two or more first-line anti-tb drugs are combined in one tablet. There are 2-, 3-, or 4-drug fixed-dose combinations. 2. Single drug formulation (SDF) Each drug is prepared individually: INH, ethambutol, and pyrazina-

10 Figure 2.3 Guide to Case Finding SPUTUM COLLECTION UNIT (To be accomplished by DOTS facility staff) 1. (Optional) Register patient in TB Symptomatics Masterlist (or TB Symptomatics Target Client List) 2. Explain the importance of three sputum collections to the TB symptomatics. 3. Label each sputum container (name and order no. 1, 2, 3). 4. Collect three quality sputum specimens (1st spot, early morning, 2nd spot). 5. Fill-up NTP Laboratory Request Form for DSSM 6. Pack and send specimen/s to the Microscopy Center, together with the completely filled up NTP Laboratory Request Form for DSSM. TB Symptomatics are those with cough for 2 or more weeks with or without 1 or more of the following: Fever Chest and/or Back pains Hemoptysis Significant weight loss Other symptoms, such as sweating, fatigue, body malaise, shortness of breath MICROSCOPY CENTER (To be accomplished by the medical technologist/microscopist) 1. Register in the NTP Laboratory Register 2. Record date received and Laboratory Serial No. in the Laboratory Request Form for DSSM 3. Perform DSSM: smearing, fixing, staining, and reading slides. 4. Record results in the Laboratory Request Form for DSSM and in the NTP Laboratory Register 5. Send back accomplished Laboratory Request Form for DSSM to the collection unit SPUTUM COLLECTION UNIT (To be accomplished by DOTS facility staff) 1. (Optional) Record results in the TB Symptomatics Masterlist (or TB Symptomatics Target Client List) 2. Explain result to the patient (If doubtful, immediately collect another 3 specimens for confirmation). 3. Refer to physician/nurse. DIAGNOSIS AND INITIATION OF TREATMENT 215

11 Figure 2.4. Guide to Diagnosis and Initiation of Treatment CLINICAL DIAGNOSIS To determine patient type and classification; done by DOTS facility staff 1. Verify information gathered on case finding. Symptoms/condition of patient Results of sputum examinations Results of further examination (i.e., CXR, TBDC s recommendations, culture, etc.) Source of infection 2. Verify DSSM results. 3. Review history of previous treatment. When was previous treatment taken? For how long? Where was the previous treatment taken? What anti-tb drugs were taken? What was the DSSM result? What was the treatment outcome? To be done by Physician Nurse Designated DOTS Facility Staff Nurse Designated DOTS Facility Staff/ Treatment Partners Nurse/Midwife initiation OF TREATMENT 1. Physical assessment and prescription of appropriate category of treatment regimen for TB patient according to patient classification and type 2. Registration Fill up NTP Treatment Card Fill up two NTP ID Cards, one for treatment partner and one for patient. Register in the TB Register 3. Health education with emphasis on key messages, such as: TB is infectious. TB can be cured but cure requires regular drug intake. Irregular drug intake impedes cure and results in chronic cases. Anti-TB drugs have side-effects. It is important to have follow-up DSSM examinations. Family/treatment partner support is important. 4. Intake of first dose Record date when treatment started. Record due date of the first DSSM follow-up in the NTP Treatment Card and NTP ID Cards 5. DOT Assign a treatment partner. Do DOT for both intensive and continuation phases of treatment. Conduct weekly consultation meetings at the DOTS facility during the whole course of treatment. 6. Record keeping Maintain and update TB Register. Maintain and update NTP Treatment Card at the DOTS facility. See to it that both treatment partner and patient maintain, update, and keep NTP ID Cards. 216

12 mide are in tablet form while rifampicin is in capsule form. These drugs are usually in blister packs good for one week. The Department of Health shall ensure the provision of FDC drugs to LGUs and other DOTS facilities for all TB cases, giving priority to smear-positive cases. However, LGUs shall procure a portion (at least 5% of the expected cases) of the requirements for SDF for those with adverse reactions necessitating withdrawal of FDC and for Category III cases. f. Quality of FDCs must be ensured. FDCs must be ordered from a source with a track record of producing FDCs according to WHO-prescribed strength and standard of quality. g. Treatment shall be based on recommended category of treatment regimen (Table 3.3). h. Dosage per Category of Treatment Regimen a. Fixed-Dose Formulation The number of tablets of FDCs per patient will depend on the body weight. Hence, all patients must be weighed (using kilogram as a unit) before treatment is started. Tables 3.4 and 3.5 show the treatment regimens for specific categories. b. Single Drug Formulation Simply add one tablet of INH (100 mg), PZA (500 mg), and E (400 mg) each for the patient weighing more than 50 kg before treatment initiation. Modify drug dosage within acceptable limits according to patient s body weight, particularly those weighing less than 30 kg at the time of diagnosis (Table 3.8). IV. PROCEDURES A. Initiation of Treatment and Registration 1. Inform the patient that he/she has TB and motivate him/her to undergo treatment. 2. Refer patient living outside the catchment area to the most accessible DOTS facility where his/her treatment can be supervised. 3. Weigh the patient. 4. Refer patient to a physician for pre-treatment evaluation. 5. Open the NTP Treatment Card and two NTP ID Cards (one for treatment partner and one for patient) and start the treatment. 6. Watch patient swallow the initial dose. 7. Register patient in the TB Register. B. Ensuring Treatment Compliance through DOT 1. Together with the patient, identify a treatment partner. 2. Explain the importance of treatment compliance to the patient. 3. Administer patient s drugs daily. Emphasize the following to both patient and treatment partner: a. Patient and treatment partner should meet at their agreed treatment unit everyday. b. Drugs should be taken 2-3 hours after a regular meal. c. Treatment partner should make sure that the patient swallows his/her drugs daily. d. After intake of drugs, treatment partner should sign the treatment partner s NTP ID Card, as well as the patient s NTP ID Card. 4. Motivate treatment partner to be vigilant about patient s treatment regimen. a. On Saturdays, Sundays, and holidays, when the DOTS facility is closed, Treatment could be done at home but should be supervised by a trained family member. b. Treatment partner should emphasize key messages, such as: TB can be cured but cure requires regular drug intake for the prescribed duration. Patient should report any adverse drug reaction. Patient should undergo follow-up sputum examination on specified dates. Schedule of DSSM follow-up for Categories I and III patients is shown in Table 3.9 while Table 3.9.a shows the schedule for those in Category II. 5. Conduct regular (preferably weekly) consultation meetings with patient and treatment partner for treatment evaluation at the DOTS facility. 6. Exert effort to contact patient when he/she fails to report on due date. C. Monitoring Response to Treatment 1. Monitor sputum smear status of all patients under treatment, including initially sputum-smear negative patients, according to the standard schedule (Tables 3.9 and 3.9.a). 2. Modify treatment based on DSSM follow-up results (Tables 3.10, 3.10.a, 3.10.b, and 3.10.c, and Figures 3.1, 3.2, and 3.3). Treatment Modifications Based on Results of DSSM Follow-up Category I Treatment Regimen 1. Do DSSM follow-up towards the end of the second month of treatment. 2. If the result is negative, start continuation phase (HR) and follow recommendations in Table If the result is positive, extend intensive phase (HRZE) for another month. Refer to Table 3.10.a for treatment modifications of smear-positive patients after follow-up examination. Category II Treatment Regimen 1. Do DSSM follow-up towards the end of the third month of treatment. 2. If DSSM result is negative, start continuation phase (HRE) and refer to Table 3.10.b. 3. If DSSM result is positive, extend intensive phase (HRZE) treatment for another month. Refer to Table 3.10.c. Category II Treatment Regimen 1. Do DSSM follow-up towards the end of 2 nd month of treatment. 2. If the result is negative, start continuation phase (HR). 3. If the result is positive, declare as Failed, re-register as Other, and start Category II treatment regimen. D. Management of Adverse Reactions to Drugs Closely monitor the occurrence of minor and major 217

13 Table 3.1 Classification of TB Cases Location of Lesion DSSM Results Definition of Terms Pulmonary TB or (PTB) Smear-Positive Smear-Negative 1. A patient with at least two sputum specimens positive for AFB, with or without radiographic abnormalities consistent with active TB OR 2. A patient with one sputum specimen positive for AFB and with radiographic abnormalities consistent with active pulmonary TB as determined by a physician OR 3. A patient with one sputum specimen positive for AFB and sputum culture positive for M. tuberculosis A patient with at least three sputum specimens negative for AFB with radiographic abnormalities consistent with active TB, and there has been no response to a course of antibiotics and/or symptomatic medications, and there is a decision by a physician and/or TBDC to treat the patient with a full course of anti- TB chemotherapy Extra-Pulmonary TB (EP) 1. A patient with at least one mycobacterial smear/culture positive from an extrapulmonary site (organs other than the lungs: pleura, lymph nodes, genito-urinary tract, skin, joints and bones, meninges, intestines, peritoneum, and pericardium, among others) OR 2. A patient with histological and/or clinical evidence consistent with active extra pulmonary TB and there is a decision by a physician to treat the patient with anti-tb drugs Table 3.2. Types of TB Cases Note: All EP cases shall undergo DSSM prior to treatment. Types of TB Cases New Relapse Treatment Failure Return After Default (RAD) Transfer-in Definition of Terms A patient who has never had treatment for TB or who has taken anti-tb drugs for less than one month A patient previously treated for TB, who has been declared cured or treatment completed, and is diagnosed with bacteriologically positive (smear or culture) TB A patient who, while on treatment, is sputum smear-positive at five months or later during the course of treatment A patient who returns to treatment with positive bacteriology (smear or culture), following interruption of treatment for two months or more A patient who has been transferred from another facility adopting NTP policies with proper referral slip to continue treatment Other 218 All cases who do not fit into any of the above definitions. This may also include the following: 1. Other (positive) a patient who was initially registered as a new smear-negative case and turned out to be smear-positive during treatment; 2. Other (negative) a patient who interrupted treatment for two or more months and has remained or become smear-negative upon return for treatment; and 3. Chronic case a patient who remains sputum-positive at the end of a re-treatment regimen. Note: *Treatment for primary and latent tuberculosis infection should not be considered as a previous TB treatment.

14 reactions to drugs, especially during the intensive phase. (Table 3.11). There are major side effects that necessitate withdrawal of the responsible drug. Since FDC drugs are already used, there is a need to switch to SDF whenever side effects to one or more components of the FDC are suspected. E. Management of Cases Who Interrupted Treatment 1. Perform routine DSSM on defaulters who come back for chemotherapy. Refer patients to DOTS physician for re-evaluation and re-treatment. 2. Manage new smear-positive patients who interrupted treatment according to recommended treatment modification (Table 3.12). 3. Manage Relapse and Treatment failure cases who interrupted treatment according to recommended treatment modification (Table 3.12.a). 4. Continue treatment for patients who were referred or transferred with proper referral slip. However, do DSSM on patients without properly accomplished referral slip. F. Management of Referred Cases 1. Assess and categorize all TB cases properly referred for continuation of treatment by other DOTS facilities as Trans-in and manage them in accordance with NTP policies and guidelines. Return the duplicate referral form to the referring unit. 2. Evaluate all other referred patients in accordance with NTP policies and guidelines. G. Management of TB in Special Situations* 1. Pregnancy Ascertain whether or not a woman is pregnant before she starts TB treatment. Most anti-tuberculosis drugs are safe for pregnant women, except Streptomycin, which is ototoxic to the fetus. Advise a pregnant woman that successful treatment of TB with the recommended standardized treatment regimen is important for a successful outcome of pregnancy. 2. Breastfeeding A breastfeeding woman afflicted with TB should receive a full course of TB treatment. Timely and properly applied chemotherapy is the best way to prevent transmission of tubercle bacilli to the baby. All antituberculosis drugs are compatible with breastfeeding. A woman taking these drugs can safely continue to breastfeed. Mother and baby should stay together and the baby may be breastfed in the normal way. Give the baby prophylactic isoniazid for at least three months beyond the time the mother is considered to be non-infectious. Defer BCG vaccination of the newborn until the end of isoniazid prophylaxis. 3. Oral Contraceptives Rifampicin interacts with oral contraceptive medications with a risk of decreased protective efficacy against pregnancy. Advise a woman receiving oral contraceptives while on rifampicin treatment that she has the following options: 1) take an oral contraceptive pill containing a higher dose of estrogen * Source: Treatment of Tuberculosis: Guidelines for National Programs WHO/CDS/TB (50), following consultation with a clinician; or 2) use another form of contraception. 4. Liver Disorders Isoniazid, rifampicin, and pyrazinamide are all associated with hepatitis. Of the three drugs, rifampicin is least likely to cause hepatocellular damage, although it is associated with cholestatic jaundice. Of the three agents, pyrazinamide is the most hepatotoxic. Patients with the following conditions can receive the usual short course chemotherapy regimens provided there is no clinical evidence of chronic liver disease: hepatitis virus carriage; a past history of acute hepatitis; and excessive alcohol consumption. However, hepatotoxic reactions to antituberculosis drugs may be more common among these patients and should therefore be anticipated. 5. Established Chronic Liver Disease Patients with liver disease should not receive pyrazinamide. Isoniazid plus rifampicin plus one or two non-hepatotoxic drugs, such as streptomycin and ethambutol, can be used for a total duration of eight months. Alternative regimens are 9RE or 9SHE in the intensive phase, followed by HE in the continuation phase, with a total treatment duration of 12 months. Recommended treatment regimens are therefore 2SHRE/6HR, 9RE, or 2SHE/10HE. 6. Acute Hepatitis (e.g., Acute Viral Hepatitis) It is not common for a patient to have TB concurrently with acute hepatitis unrelated to TB or TB treatment. Clinical judgment is necessary. In some cases, it is possible to defer TB treatment until the acute hepatitis has been resolved. In other cases, when it is necessary to treat TB during acute hepatitis, the combination of SE for three months is the safest option. If the hepatitis has been resolved, then put the patient on a continuation phase of six months isoniazid and rifampicin (6HR). If the hepatitis has not been resolved, SE should be continued for a total of 12 months. 7. Renal Failure Isoniazid, rifampicin, and pyrazinamide are either eliminated almost entirely by biliary excretion or metabolized into non-toxic compounds. These drugs, therefore, can be given in normal dosages to patients with renal failure. Patients with severe renal failure should receive isoniazid with pyridoxine to prevent peripheral neuropathy. Streptomycin and ethambutol are excreted by the kidney. Where facilities are available to monitor renal function closely, streptomycin and ethambutol may be given in reduced doses. The safest treatment regimen for patients with renal failure is 2HRZ/4HR. 8. Treating TB and HIV* In patients with HIV-related TB, the priority is to treat TB, especially smear-positive PTB to stop transmission. However, patients with HIV-related TB can have Anti-Retroviral Therapy (ART) and anti-tb treatment at the same time, if managed carefully. Careful evaluation is necessary in judging when to start ART. In the case, for example, of a patient with a high risk of death during the period of TB treatment 219

15 Table 3.3. Recommended Category of Treatment Regimen TB Treatment Regimens Category Type of TB Patient intensive Phase Continuation Phase I New smear-positive PTB, New smear-negative 2HRZE 4HR PTB with extensive parenchymal lesions on CXR as assessed by the TBDC, EPTB, and severe concomitant HIV disease II Treatment Failure, Relapse, RAD, Other 2HRZES/HRZE 5HRE III New smear-negative PTB with minimal parenchymal lesions on CXR as assessed 2HRZE 4HR 4HR by the TBDC IV Chronic (still smear-positive after supervised Refer to specialized facility or re-treatment) DOTS Plus Center Refer to Provincial/City NTP Coordinator Table 3.4. Treatment Regimen for Categories I & III: 2HRZE/4HR (FDC) Body Weight No. of Tabs/Day No. of Tabs/Day (kg) Intensive Continuation Phase Phase (2 months) (4 months) FDC-A (HRZE) FDC-B (HR) > Table 3.5. Treatment Regimen for Categories II: 2HRZES/HRZE/5HRE (FDC) intensive Continuation Body Phase Phase Wt. 1st Two Month 3rd month FDC-B E (kg) FDC-A STREPTO- FDC-A (HR) 400 mg (HRZE) MYCIN (HRZE) > Table 3.7. Treatment Regimen for Categories II: 2HRZES/HRZE/5HRE (SDF) No. of Tabs No. of Tabs /Day /Day intensive Continuation ANTI-TB Drugs Phase Phase (3 months) (5 months) 1st Two 3rd Months Months Isoniazid (H) 300 mg Rifampicin (R) 450 mg Pyrazinamide(Z) 500 mg 2 2 Ethambutol (E) 400 mg Streptomycin (S) 1 gm * 56 vials for two months 1 vial/ day* Table 3.8. Drug Dosage per Kg Body Weight Drug Dose per kg body weight and maximum dose Table 3.6. Treatment Regimen for Categories I & III: 2HRZE/4HR (SDF) 220 No.of Tabs No.of Tabs /Day /Day ANTI-TB Intensive Continuation Drugs Phase Phase (2 months) (4 months) Isoniazid (H) 300 mg 1 1 Rifampicin (R) 450 mg 1 1 Pyrazinamide (Z) 500 mg 2 Ethambutol (E) 400 mg 2 Isoniazid Rifampicin Pyrazinamide Ethambutol Streptomycin 5 (4-6) mg/kg, and not to exceed 400 mg daily 10 (8-12) mg/kg, and not exceed 600 mg daily 25 (20-30) mg/kg, and not to exceed 2 g daily 15 (15-20) mg/kg, and not to exceed 1.2 g daily 15 (12-18) mg/kg, and not to exceed 1 g daily

16 Table 3.9 Schedule of DSSM Follow-up (Categories I and III) Schedule of Category I Category III DSSM (2HRZE/4HR) (2HRZE/4HR) Follow-up R regular With One- Treatment Month regular E extension Treatment (HRZE) Towards end of YES (If positive) YES 2nd month Towards end of (If negative) YES 3rd month Towards end of 4th month Towards end of 5th month YES Beginning of YES 1 6th month YES Beginning of YES 1 7th month 1 Check DSSM follow-up results at the end of treatment (during the last week of treatment) for patients who were smear-positive in the last DSSM follow-up and smear-negative in the repeated DSSM (Tables 3.10, and 3.10.a, and Figures 3.1, and 3.3). Table 3.9.a Schedule of DSSM Follow-up (Category II) Category II (2HRZES/HRZE/5HRE) Schedule of DSSM regular Treatment With One-Month Follow-up extension (HRZE) Towards end of 2nd month Towards end of YES (If positive) 3rd month Towards end of (If negative) YES 4th month Towards end of 5th month YES Towards end of 6th month YES Towards end of 7th month Beginning of YES 1 8th month Beginning of 9th month YES 1 1 Check DSSM follow-up results at the end of treatment (during the last week of treatment) for patients who were smear-positive in the last DSSM follow-up and smear-negative in the repeated DSSM (Tables 3.10.b, and 3.10.c, and Figures 3.2). 221

17 (i.e. disseminated TB and/or CD4 count <200/mm 3 ), it may be necessary to start ART concomitantly with TB treatment. On the other hand, for a patient with smear-positive PTB as the first manifestation of HIV infection, who does not appear to be at risk of dying, it may be safer to defer ART until the initial phase of TB treatment has been completed. This decreases the risk of immune reconstitution syndrome and avoids the risk of drug interaction between Rifampicin and a Protease Inhibitor (PI). Possible options for ART in patients with TB includes the following: Defer ART until completion of TB treatment. Treat TB with a rifampicin-containing regimen and use efavirenz + two Nucleoside Reverse Transcriptase Inhibitors (NsRTIs). Defer ART until the completion of the initial phase of TB treatment and then use ethambutol and isoniazid in the continuation phase. * Source: TB/HIV A Clinical Manual, 2nd Edition WHO/ HTM/TB/ V. Treatment Outcome A. Cured - a sputum smear-positive patient who has completed treatment and is sputum smear negative in the last month of treatment and on at least one previous occasion in the continuation phase B. Completed Treatment - a patient who has completed treatment but has not met the criteria for cure or failure This group includes: A sputum smear-positive patient who has completed treatment but without DSSM follow -up during the treatment, or with only one negative DSSM during the treatment, or without DSSM in the last month of treatment. A sputum smear-negative patient who has completed treatment C. Died - a patient who died for any reason during the course of treatment D. Failed A patient who is sputum smear-positive at five months or later during the treatment An initially sputum smear-negative patient before starting treatment who becomes smear-positive during the treatment. (Note: This case will be reregistered as Other with a new TB case number). E. Defaulted - a patient who interrupted treatment for two consecutive months or more F. Transferred out: A patient who transferred to another DOTS facility with proper referral slip for continuation of treatment and whose treatment outcome is not known 222

18 Table Treatment Modification for New PTB Smear-Positive Cases Based on the Results of DSSM Follow-up for Category I Treatment Regimen Without Extension Towards Beginning Towards end of of end of 4th Month 6th Month 6th Month 1 If smear-negative, continue continuation phase (HR). If smear-negative, complete continuation phase until end of treatment course and declare as cured. If smear-positive, If smear-negative in the If smear-negative, repeated DSSM, continue continuation declare as cured. immediately for phase (HR) and do confirmation and DSSM towards end of If smear-positive, declare consult DOTS 6th month of treatment. as Failed; re-register as Physician Treatment Failure and start with Category II treatment regimen. If smear-positive again in the repeated DSSM, declare as Failed; reregister as Treatment Failure and start with Category II treatment regimen. If smear-positive, If smear-negative, continue continuation If smear-negative, continue continuation phase (HR) and do DSSM towards end declare as cured. phase (HR). of 6th month of treatment. If smear-positive, declare as Failed; re-register as Treatment Failure and start with Category II treatment regimen. If smear-positive, declare as Failed, re-register as Treatment Failure and start with Category II treatment regimen. 1 Check DSSM follow-up results towards the end of the sixth month of treatment only for patients who are: 1) smearpositive in the beginning of the 6th month and smear-negative in the repeated DSSM; and 2) smear-positive towards the end of the fourth month but turned out to be negative in the beginning of the 6th month. 223

19 Table 3.10.a Treatment Modification for New PTB Smear-Positive Cases Based on the Results of DSSM Follow-up for Category I Treatment Regimen With Extension Towards End Towards End Beginning of Towards End of 7th of 3rd Month of 5th 7th Month Month If smear-negative, If smear-negative, If smear-negative, complete continuation start continuation continue continua- phase until end of treatment course and phase (HR). tion phase (HR). declare as cured. 224 If smear-positive, If smear-negative in If smear-negative, repeat DSSM the repeated declare as cured immediately for examination, continue confirmation and continuation phase consult DOTS (HR) and do DSSM If smear-positive, declare as physician. towards end of 7th failed; re-register as month of treatment treatment failure and start Category II treatment regimen. If smear-positive in the repeated examination, declare as failed; reregister as treatment failure and start Category II treatment regimen. If smear-positive, If smear-negative, continue continuation If smear-negative, continue phase (HR) and do DSSM towards end of declare as cured. continuation 7th month of treatment. If smear-positive, declare as phase (HR). failed; re-register as treatment failure and start Category II treatment regimen. If still smear-positive, declare as failed; re-register as treatment failure and start Category II treatment regimen. If smear-positive, If smear negative, If smear-negative, complete continuation start continue phase until end of treatment course and continuation continuation declare as cured. phase (HR). phase (HR). If smear-positive, declare as failed; reregister as treatment failure and start Category II treatment regimen. If smear-positive, If smear-negative in If smear-negative, declare repeat DSSM the repeated as cured. immediately for examination, continue If still smear positive, declare confirmation and continuation phase as failed; re-register as consult DOTS (HR) and do DSSM treatment failure and physician. towards end of 7th and start Category II month of treatment. treatment regimen. If smear-positive in the repeated examination, declare as failed; reregister as treatment failure and start Category II treatment regimen. 1 Check DSSM follow-up results towards the end of the seventh month of treatment only for patients who are: 1) smear-positive in the beginning of the seventh month and smear-negative in the repeated DSSM; and 2) smear-positive towards the end of the fifth month and turned out to be negative in the beginning of the seventh month.

20 Table 3.10.b Treatment Modification for PTB Smear-Positive Cases Based on the Results of DSSM Follow-up for Category II Treatment Regimen Without Extension Towards Beginning Towards End of End of 5th Month 8th Month 8th Month 1 If smear- negative, continue If smear-negative, complete continuation continuation phase (HRE). phase until the end of the treatment course and declare as cured. If smear-positive, If smear-negative If smear-negative, declare repeat DSSM in the repeated as cured immediately for DSSM, continue confirmation and continuation phase If smear-positive, declare consult DOTS (HRE) and do DSSM as failed physician. towards end of 8th month. If smear-positive again in the repeated DSSM, complete continuation phase (HRE) until end of treatment course and declare as failed. If smear- positive, continue If smear-negative, continue continuation If smear-negative, declare continuation phase (HRE). phase (HRE) and do DSSM towards end. as cured of 8th month If smear-positive, complete continuation phase (HRE) until end of treatment course and declare as failed. If smear positive, declare as failed. 1 Check DSSM follow-up results towards the end of the 8 th month of treatment only for patients who are: 1) smearpositive in the beginning of the 8 th month and smear-negative in the repeated DSSM; 2) smear-positive towards the end of the 5 th month and turned out to be negative in the beginning of the 8 th month. Table 3.10.c Treatment Modifications for PTB Smear-Positive Cases Based on DSSM Follow-up for Category II Treatment Regimen With Extension Towards End Towards End Beginning of Towards End of 4th Month of 6th Month 9th Month of 9th Month 1 If smear-positive If smear-negative, If smear-negative, complete or smear-negative, continue continua- continuation phase until end of start continuation tion phase (HRE). treatment course and declare as cured phase (HRE). If smear-positive, If smear-negative If smear-negative, repeat DSSM in the repeated declare as cured. immediately for DSSM,continue confirmation and continuation phase If smear- positive, consult DOTS (HRE) and do DSSM declare as failed. physician. towards end of 9th month of treatment. If smear positive again in the repeated DSSM, complete continuation phase (HRE) until end of treatment and declare as failed. If smear- positive, If smear negative, continue continuation If smear- negative, continue continua- phase (HRE) and do DSSM towards end declare as cured. tion phase (HRE). of 9th month of treatment. If still smear-positive, complete continuation phase (HRE) until end of treatment and declare as failed. If smear-positive, complete continuation phase (HRE) until end of treatment course and declare as failed. 1 Check DSSM follow-up results towards the end of the ninth month of treatment only for patients who are: 1) smearpositive in the beginning of the ninth month and smear-negative in the repeated DSSM; and 2) smear-positive towards the end of the sixth month and turned out to be negative in the beginning of the ninth month. 225