National TB Program (NTP)

Transcription

1 National TB Program (NTP) National Center for Disease Prevention and Control Department of Health San Lazaro Compound, Rizal Avenue, Sta. Cruz, Manila Telephone No: loc.2350/ Website: NATIONAL TB PROGRAM (NTP) Staff Director III Medical Specialist IV Medical Specialist IV Medical Specialist IV Medical Specialist II Supervising Health Program Officers Senior Health Program Officers Jaime Y. Lagahid, M.D., M.P.H. Rosalind G. Vianzon, M.D., M.P.H. Vivian S. Lofranco, M.D. Anna Marie Celina G. Garfin, M.D. Ernesto A. Bontuyan, Jr., M.D. Cirila D. Negad, R.N., MAN Ma. Arlene T. Rivera, MM - DM Agnes Maria Oliva V. Del Rosario, R.N.D., M.P.S- FNP Ferdinand La Puebla, BSSC., M.A.Candidate 325

2 TUBERCULOSIS Algorithm for Flow of NTP Activities CPM 8 th EDITION 1 TB in Community 2 Symptoms: Cough for 2 weeks or more With or without expectoration Fever Significant weight loss Hemoptysis Chest and/or back pains 3 Case Findings Sputum specimens (3 specimens) with request form for sputum examination 4 Microscopy center Results of the sputum smear examination (sputum - smear examination for diagnosis) 8 5 Diagnosis positive? N Y 6 Initiation of treatment 7 Case holding with DOTS Sputum specimens (3 specimens) with request form for sputum examination 9 Refer the patient to MHO (Municipal Health Officer) for further assessment 10 Go to # 4. Treatment complete? 11 Y Report treatment outcome. Figure 1 N Continue monitoring and supervision. 326

3 Algorithm for the Diagnosis of Pulmonary Tuberculosis 1 TB symptomatic (Cough for 2 weeks or more) 2 Collect three (3) sputum specimens. 3 2 or 3 smear positive? 5 N only one (1) smear positive? N See Figure 3. Y Y 4 Classify as smearpositive TB. See Tables 1 and Collect another 3 sputum specimen immediately. 9 at least one (1) smear positive? N Request for chest x-ray (CXR). Y Classify as smear positive TB Is it consistent with active TB? Y Classify as smear positive TB 12 N Observation/ further exam, if necessary Figure 2 327

4 TUBERCULOSIS Algorithm for the Diagnosis of Smear-Negative Pulmonary Tuberculosis 1 All 3 smear CPM 8 th EDITION 2 Refer to MHO (symptomatic treatment for 2-3 weeks) 3 If symptoms persists, collect another three (3) sputum specimens or 3 smear positive? 6 N Y Classify as smearpositive TB. See Tables 1, and 3. only one (1) smear positive? Y See Figure 2, # 5. 7 N All 3 smear negative See Figure 3a. Figure 3 328

5 1 All 3 smear negative 2 CXR 5 3 abnormal findings on CXR? N observation / further exam Y 4 Refer to TB Diagnostics Committee 6 7 consistent with active TB? N Y Classify as smearnegative TB. See Tables 1 and 3. 8 observation/ further exam Figure 3a 329

6 TUBERCULOSIS Algorithm for Guide to Ensure Treatment CPM 8 th EDITION 1 TB Patient 2 3 Laboratory Register (to be accomplished by the Medical Technologist (MT)) Record of laboratory examination results 3 sputum collection Sputum-smear examination results on diagnosis/ follow-up NTP Treatment Card (to be accomplished by the Rural Health Midwives (RHM))/Nurse Record of the individual patients TB Case number Classification, type and regimen Sputum examination results on diagnosis, for follow-up Drug collection Defaulter action Treatment outcome positive mucopurulent, salivary specimen? 6 4 N Refer to RHM Y 5 NTP TB Register (to be accomplished by the Public Health Nurse (PHN)) Record of Treatment Activity in the RHU (Rural Health Unit) TB case number Classification, type and regimen Sputum examination results on diagnosis and for follow-up Defaulter action Treatment outcome PHN should check the following information initially. These are: - Is the diagnosis correct? - Is the treatment regimen appropriate? Check weekly: - Are all smear-positive cases registered and treated properly with DOT? - Are drugs collected on time? - Are follow-up exams done on time? - Are treatments regular and effective? - Are actions taken to retrieve defaulters? Figure 4 330

7 National Tuberculosis Program - Manual of Policies and Procedures A. CASE FINDING The basic step in TB control is the identification and diagnosis of TB cases among individuals with suspected signs and symptoms of TB. This is referred to as case finding. Fundamental to case finding is the detection of infectious cases through direct sputum-smear examination. This is the principal diagnostic method adapted by the new NTP because of the following reasons: 1. It provides a definitive diagnosis of active TB. 2. The procedure is simple. 3. It is economical. 4. A microscopy center could be organized even in remote areas. I. Objective The general objective of case finding is the early identification and diagnosis of TB cases. II. Policies 1. Direct sputum-smear examination shall be the primary diagnostic tool in NTP case finding. a. All TB symptomatics identified shall be made to undergo smear examination for diagnosis prior to initiation of treatment, regardless of whether they have available x-ray results or whether they are suspected of having extra-pulmonary TB. The only contraindication for sputum collection is massive hemoptysis. b. It is only after a pulmonary TB symptomatics has undergone a sputum examination for diagnosis with three sputum specimens and subsequently yielded negative results that he shall be made to undergo other diagnostic tests such as x-ray, culture and others, if necessary. c. Sputum smear examination is the preferred method for the diagnosis of TB. No diagnosis of TB shall be made based on the result of x-ray examinations alone. Skin tests for TB infection (PPD skin test) should not be used as a basis for the diagnosis of TB in adults. d. All municipal and city health offices shall be encouraged to establish and maintain at least one sputum microscopy unit in their areas of jurisdiction. 2. Passive case finding shall be implemented in all health stations. Concomitant active case finding shall be encouraged only in areas where a cure rate of 85 percent or higher has been achieved, or in areas where no sputum smear positive case has been reported in the last three months. 3. Only adequately trained medical technologist or NTP microscopist shall perform sputum-smear examination (smearing, fixing and staining of sputum specimens, reading the smear). III. Procedures 1. Identification of TB symptomatics is the responsibility of all RHU (Rural Health Unit) and BHS (Barangay Health Station) staff. The responsible person (all health workers) shall identify TB symptomatics among patients consulting at the health center. These are persons having cough for two or more weeks duration, and those with or without one or more of the following signs and symptoms: a) fever b) sputum expectoration c) significant weight loss d) hemoptysis or recurrent blood-streaked sputum e) chest and/or back pains not referable to any musculo-skeletal disorders f) other symptoms such as sweat with chills, fatigue, body malaise, shortness of breath The responsible person, who can be any health workers, shall educate and encourage identified TB symptomatic cases for sputum submission. TB Symptomatics Masterlist / TB Symptomatics Target Client List (or TB Symptomatics Target Client List) may be optionally utilized for confirmation of three sputum collection in addition to Laboratory Request Form for Sputum Examination. The responsible person shall encourage household members of identified TB cases, who also have symptoms suspecting TB, to undergo sputum examination. 2. Collection and transport of sputum specimens to the Microscopy Center are the responsibilities of MHO (Municipal Health Officer)/ PHN (Public Health Nurse) / RHMS (Rural Health Midwives) at the RHU and BHS. It is crucial for TB symptomatics to under- 331

8 TUBERCULOSIS Guide to Case Finding CPM 8 th EDITION Sputum Collection Unit (To be accomplished by the RHM/PHN/MHO) 1. (Optional) Register the patient in TB Symptomatics* Masterlist (or TB Symptomatics Target Client List). 2. Explain the importance of three (3) sputum collection to the TB symptomatics. 3. Label each sputum containers (name and serial no. 1, 2, 3). 4. Collect three (3) sputum specimens (spot, early morning, spot). 5. Fill-up the Laboratory Request Form for Sputum Examination. Confirm three (3) sputum collection. 6. Pack and send the specimen/s to the Microscopy Center with the Laboratory Request Form for Sputum Examination. * TB Symptomatics with symptoms as: Cough for 2 weeks or more, sputum expectoration, fever, significant weight loss, chest and/or back pains, hemoptysis. 1. Register in the NTP Laboratory Register. MICROSCOPY CENTER (To be accomplished by the MT) 2. Record the date received and the Laboratory Serial No. in the Laboratory Request Form for the Sputum Examination. 3. Sputum-Smear Examination: smearing, fixing, staining and reading slides. 4. Record the results in the Laboratory Request Form for Sputum Examination and in the NTP Laboratory Register. 5. Send back accomplished Laboratory Request Form for Sputum Examination to the collection unit. SPUTUM COLLECTION UNIT (To be accomplished by the RHM/PHN/MHO) 1. (Optional) Record the results in the TB Symptomatics Masterlist (or TB Symptomatics Target Client List). 2. Inform and explain the result to the patient (if doubtful, immediately collect another 3 specimens for confirmation). 3. Refer to MHO and PHN. DIAGNOSIS AND INITIATION OF TREATMENT 332

9 Guide to Diagnosis and Initiation of Treatment Clinical Diagnosis To determine patient type and classification and is done by RHM, PHN, MHO 1. Verify information gathered on case finding Symptoms/condition of patient Result of sputum examination Result of further examination (i.e., CXR, culture, etc.) Source of infection 2. Verify sputum smear examination results 3. Review history of previous treatment INITIATION OF TREATMENT To be done by MHO To be done by PHN (initially) To be done by the health workers 1. Physical assessment and prescription of appropriate regimen for the TB patient according to the patient type and the classification 2. Registration Fill-up the NTP Treatment Card. Fill-up two NTP ID Cards, one is for the treatment partner and the other is for the patient. Register in the TB Register. 3. Health education with emphasis on key messages such as: TB is infectious. TB can be cured but requires regular drug intake. Results of irregular drug intake. Side effects of anti-tb drugs. Importance of follow-up sputum smear examinations. Importance of family/treatment partner support. To be done by PHN To be done by the health workers and treatment partners 4. Intake of first dose Record the date when treatment started. Record the due date of the 1 st follow-up sputum examination in the NTP Treatment Card and NTP ID Cards. 5. DOT Assign a treatment partner. Do DOT for both intensive and Maintenance phases of treatment. Conduct weekly consultation meeting at the health facility during the whole course of treatment. To be done 6. Record keeping by: 1. Maintain and update the TB Register. 1. PHN 2. Maintain and update the NTP Treatment Card at the RHU/BHS. 2. RHM 3. Maintain and update the NTP ID Cards both of the treatment partner and the patient. 3. Treatment 4. Keep the NTP ID Card. partner 4. TB patient 333

10 TUBERCULOSIS stand the importance of submitting three sputum specimens during their consultation. MHO/PHN/ RHMS, who are in charge of the initial consultation, shall educate TB symptomatics on the purpose of sputum examination. It is essential to obtain quality sputum specimen for proper diagnosis of TB. The responsible health worker shall demonstrate how to produce good sputum by instructing TB symptomatics as follows: Rinse his / her mouth with water. Breathe deeply two times, holding the breath for a few seconds after each inhalation and then exhaling slowly. After inhaling deeply the third time, at the height of inspiration cough strongly and spit the sputum in the container. The responsible health worker shall supervise the patient from behind during the procedure and observe contamination precautions. It is recommended to collect sputum specimens outside where aerosols containing TB bacilli are diluted and sterilized by direct sunlight in order to prevent health workers from inhalation hazards. The responsible health worker shall collect three sputum specimens within two days according to these procedures: First specimen is also referred to as spot specimen. It is collected at the time of consultation, or as soon as the TB symptomatics is identified. Second specimen or early morning specimen. It is the very first sputum produced early in the morning immediately after waking up, and collected by the patient according to the instructions given by the health workers. Third specimen is also referred to as spot specimen. It is collected at the time the TB symptomatics comes back to health facility to submit the second specimen. The responsible health worker shall label the body of the sputum cup with the patient s complete name and the name of the referring unit, seal each sputum specimen container, pack it securely and transport it to a microscopy unit or laboratory as soon as possible or not later than four days from collection. Otherwise, the specimens should be properly stored in cool, dark, and safe place. No specimen shall remain unexamined over the weekend. The specimen should be sent together with the laboratory request form for sputum smear examination to the microscopy center. CPM 8 th EDITION 3. Smearing, fixing, staining and reading of sputum specimens are the responsibilities of the trained NTP medical technologist or NTP microscopist at the microscopy center. They will do the following: a. Record the information in the NTP Laboratory Register. b. Smear, fix, stain, and read the slides. c. Interpret smear examination result or the individual readings of the three specimens and the final written laboratory diagnosis in the sputum microscopy results portion of the returned Laboratory Request Form for Sputum Examination, to determine diagnostic classification, such as: Smear positive result occurs when at least two sputum smear results are positive. When the sputum collection unit receives this positive result, the nurse/midwife shall inform the patient of the result of the sputum examination and refer him/her to the MHO for assessment and initiation of treatment. Doubtful result shows only one positive out of three sputum specimens examined. The nurse shall inform the midwife of the result of the sputum examination to allow her to collect another three sputum specimens. If at least one specimen from the second set of specimen turns out to be positive, the laboratory diagnosis is positive. Refer the patient to MHO assessment and initiation of treatment. If all three specimens from the second set of specimen turn out to be negative, the laboratory diagnosis is negative. Refer the patient to MHO for assessment with X-ray examination. Smear negative shows that all three sputum smear results are negative. The nurse shall inform the TB symptomatics about the result of the sputum examination and refer the patient to MHO for further assessment. The municipal health officer may treat the patient with symptomatics treatment of antibiotics and/or anti-cough agents for two to three weeks. If symptoms persist, collect another three specimens for smear examination. d. Record the examination results in the NTP Laboratory Register and the lower portion of the Laboratory Request Form for Sputum Examination. 334

11 e. Inform the responsible health worker of the results of the examination as soon as it is available by sending back the accomplished Laboratory Request Form for Sputum Examination. B. CASE HOLDING The procedure that ensures that patients complete treatment is referred to as case holding. Chemotherapy is the only way to stop the transmission of TB. It is senseless 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. While effective anti-tb drugs are available in the country, there are still many TB patients who are not cured. This is due to many patients who stop taking or irregularly take their drugs. The long duration of treatment, six months on the average, makes it most likely for patients to be remiss in drug intake. Treatment compliance is necessary to cure TB and avoid drug resistance. Poor treatment compliance may lead to the following outcomes: Chronic infectious illness, death or drug resistance. 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 in order to achieve sufficient cure rate and, at once, prevent drug resistant TB. DOT works by assigning a responsible person to observe or watch the Table 1. Classification of TB Cases Location of Lesion Sputum-Smear Examination Definition of Terms Smear Positive 1. A patient with at least two sputum specimens positive for AFB (acid-fast bacilli) with or without radiographic abnormalities consistent with active TB, or Pulmonary TB 2. A patient with one sputum specimen positive for AFB and with radiographic abnormalities consistent with active TB as determined by a clinician, or 3. A patient with one sputum specimen positive for AFB with sputum culture positive for M. tuberculosis. Smear Negative 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 Medical officer to treat the patient with anti-tb drugs. Extra-Pulmonary TB 1. A patient with at least one mycobacterial smear/culture positive from an extra-pulmonary 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 TB and there is a decision by a medical officer to treat the patient with anti- TB drugs. 335

12 TUBERCULOSIS patient take the correct medications daily during the whole course of treatment. I. Objective CPM 8 th EDITION Table 1. Types of TB Cases Types of TB Definition of Terms Cases The general objective of chemotherapy is to treat TB cases effectively and completely especially pulmonary sputum smear positive cases. II. Definition of Terms A. Classification of TB cases - TB cases shall also be classified based on the location of lesions as well as the result of sputum smear examination. (See Table 1) B. Types of TB cases - TB cases shall be categorized based on the history of anti-tb treatment. A thorough understanding on the types of TB cases is necessary in determining the correct treatment regimen. (See Table 2.) C. Directly Observed Treatment (DOT) - DOT is a strategy 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, watching the TB patient take medicines everyday during the whole course of treatment. 1. Who will undergo DOT? All smear positive TB cases should undergo DOT. 2. Who could serve as a treatment partner of a TB patient during DOT? Any of the following could serve as treatment partner of a TB patient: Staff of the health center or clinic such as the midwife or the nurse. Member of the community such as the BHW (Barangay Health Worker), local government official or TB patient. Member of the patient family (last priority). Note: Member of the patient family is generally not reliable as a treatment partner compared with the health workers. It is, therefore, not recommended to assign a family member of the patient as a treatment partner except on weekends and holidays. 3. Where to do DOT? DOT can be done in any accessible and convenient place (e.g., health facility, treatment partner s house, patient s place of work, patient's house) as long as the treatment partner can effectively ensure the patient s 336 New Relapse Failure Return after Default Transfer-in Other A patient who has never had treatment for TB or who has taken anti-tuberculosis drugs for less than one month. A patient previously treated for tuberculosis, who has been declared cured or treatment completed, and is diagnosed with bacteriologically positive (smear or culture) tuberculosis. 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 with proper referral slip to continue treatment. All cases who do not fit into any of the above definitions. This group includes: 1. A patient who is starting treatment again after interrupting treatment for more than two months and has remained or became smear negative. 2. A patient, who was initially registered as new smear-negative case, turned out to be smear-positive during the treatment. (The treatment outcome of this case is "Treatment Failure." Re-register as "Other" for the next treatment.) 3. Chronic case: A patient who is sputum positive at the end of a re-treatment regimen.

13 Table 3. Treatment of Regimens Regimen tb Patient to be Drugs and Duration Dose Adjustment Given Treatment of Treatment by Body Weight Regimen I: New pulmonary smear HRZE for two months Add one tablet of INH 2HRZE / 4HR positive cases during the intensive (100 mg), PZA(500 New seriously ill pulmo- phase. mg), and EB (400 mg) nary smear negative cases each for the patient with extensive parenchy- HR for 4 months during with more than 50kg mal involvement the maintenance phase. body weight before the New severely ill extrapul- initiation of the monary TB cases treatment. Regimen II: Failure Cases HRZES for the first two 2HRZES / Relapse Cases months, then HRZE for 1HREZ / 5HRE RAD (smear +) the third month during the Other (smear +) intensive phase. HRE for the next five months during the maintenance phase. Regimen III: New smear-negative but HRZ for 2 months during Add one tablet of INH 2 HRZ/4HR with minimal pulmonary the intensive phase. (100 mg), PZA (500 TB on radiography as mg) each for the patient confirmed by a medical HR for 4 months during with more than 50kg officer the maintenance phase. body weight before the New extra-pulmonary TB initiation of the (not serious) treatment. intake of the prescribed drugs, and monitor his/her reactions to the drugs. 4. How long is treatment supervised? The patient's daily anti-tb drug intake should be supervised during the intensive and maintenance phases of short-course chemotherapy for all smear-positive TB patients. III. Policies A. Treatment of all TB cases shall be based on reliable diagnostic technique, namely sputum smear examination aside from clinical findings. B. Domiciliary treatment shall be the preferred mode of care. C. Patients recommended for hospitalization are those with the following conditions: 1. massive hemoptysis 2. pleural effusion obliterating more than ½ of a lung field 3. miliary TB 4. TB meningitis 5. TB pneumonia 6. those requiring surgical intervention or with complications D. No patient shall initiate treatment unless the patient and health workers have agreed upon a case holding mechanism for treatment compliance. E. The national (regional) and local government units shall ensure the provision of drugs to all sputum positive TB cases. F. Treatment Regimens by Category - The following abbreviations mean: H - Isoniazid (300 mg) R - Rifampicin (450 mg) Z - Pyrazinamide (1 g) E - Ethambutol (800 mg) S - Streptomycin (1 g) G. Drug dosage adjustment according to the initial body weight of patient. Simply add one tablet of 337

14 TUBERCULOSIS Table 4. Drug Dosage Adjustment Drug Isoniazid Rifampicin Pyrazinamide Ethambutol Dose per kg body weight and maximum dose 5 (4-6) mg/kg, and not to exceed 400 mg daily 10 (8-12) mg/kg, and not to 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 CPM 8 th EDITION Table 5a. Schedule of Sputum Smear Followup Examination (Category I) Schedule of Category 1 (2 HRZE/4 HR) Sputum Smear Follow-up Regular With One Examination Treatment Month of Extension (HRZE) Towards the YES (If positive) end of the 2 nd month Towards the (If negative) YES end of the 3 rd month Streptomycin 15 (12-18) mg/kg, and not to exceed 1 g daily Towards the end of the 4 th month YES INH (100 mg), PZA (500 mg) and EB (400 mg) each for the patient with more than 50kg body weight before the initiation of the treatment (See Table 3 on page 395). Modify drug dosage within acceptable limits according to the body weight of the patient weighing less than 30 kg at the time of diagnosis (See Table 4). IV. Procedures A. Registration and Initiation of Treatment 1. Inform the patient that he/she has TB and motivate the patient to undergo treatment. 2. Refer the patient to a medical officer for pre-treatment evaluation and initiation of treatment. 3. Open the NTP Treatment Card and two NTP ID Cards (one is for the treatment partner and the other is for the patient) and start the treatment using any of the three treatment regimens best suited to the patient s disease classification, type and previous history of treatment. 4. Register the patient in the NTP TB Register. Refer the patient to the most accessible BHS where he/she can have his/her treatment supervised. B. Ensuring Treatment Compliance through DOT 1. Explain the importance of treatment compliance to the patient. 2. Administer the patient s drugs daily. The patient and his/her treatment partner shall meet at their agreed treatment unit everyday. The treatment Towards the end of the 5 th month In the beginning YES (*1) of the 6 th month YES In the beginning YES (*1) of the 7 th month *1 Check the follow-up sputum smear examination at the end of the treatment (during the last week of treatment) for the patient who has smear positive in the last follow-up smear examination and shows smear negative in the repeated smear examination. (See Tables 7a, 7b1 and 7b2) partner shall make sure that the patient takes his/ her drugs daily. After intake of the drugs, the treatment partner shall check and sign the treatment partner s NTP ID Card as well as the patient s NTP ID Card. 3. On Saturdays, Sundays and holidays, when the health center or clinic is closed, treatment could be done at home but should be supervised by a family member. 4. The treatment partner shall regularly motivate the TB patient to continue treatment. The treatment partner shall emphasize key messages, such as: TB could be cured but requires regular drug intake for the prescribed duration. The patient should report any adverse reaction to the drugs. 338

15 The patient should undergo follow-up sputum examination on specified dates (See Tables 5a, 5b). 5. The responsible health worker (MHO or PHN or RHM) shall conduct regular (preferably weekly) consultation meeting with the treatment partner together with the patient for treatment evaluation at BHS or RHU. 6. The treatment partner and all the health workers shall immediately exert effort to retrieve a patient upon failure to report on the day the patient is expected. 7. To monitor the response to treatment, follow-up sputum examination should be done on the specified date (See Tables 5a and 5b) Sputum-smear examination for follow-up requires only one specimen collection, preferably collected in the early morning. C. Management of Seriously-ill Cases and HIV Co- Infected Cases 1. Refer seriously ill patients to the nearest hospital facility for evaluation and appropriate treatment. 2. Refer TB cases with known concomitant HIV infection to a medical officer for appropriate action. D. Management of Adverse Reactions to Drugs Closely monitor the occurrence of minor and major reactions to drugs, especially during the intensive phase. (See Table 6). E. Monitoring Patient Response to Treatment Monitor the sputum smear status of all patients under treatment, including initially sputum smear negative patients, according to the standard schedule (See Tables 5a and 5b) and modify treatment based on the sputum follow-up examination results (See Tables 7a, 7b1, 7b2, 8a 8b). F. Management of Lost and Referred Cases Table 5b. Schedule of Sputum Smear Follow-up Examination (Category II and III) Schedule of Category II (2HRZES/1HRZE/5HRE) Sputum Smear Follow-up Regular Treatment With One Month of Examination Extension (HRZE) Towards the end of the 2 nd month YES Category III (2HRZ/4HR) Towards the end YES (If positive) of the 3 rd month Towards the end (If negative) YES of the 4 th month Towards the end of the 5 th month YES Towards the end of the 6 th month YES Towards the end of the 7 th month In the beginning of the 8 th month YES (*2) In the beginning YES (*2) of the 9 th month *2 Check the follow-up sputum smear examination at the end of the treatment (during the last week of the treatment) for the patient who has smear positive in the last follow-up smear examination and shows smear negative in the repeated smear examination (See Tables 8a and 8b) 339

16 TUBERCULOSIS CPM 8 th EDITION Table 6. Guide in Managing SCC Drugs Side Effects Side Effects Drug(s) Responsible What to Do? Minor Side Effects: Patient should be encouraged to continue taking medicines 1. Gastrointestinal intolerance Rifampicin Give medication at bedtime 2. Mild skin reactions Any drugs Give antihistamines. 3. Orange/red colored urine Rifampicin Reassure the patient. 4. Pain at the injection site Streptomycin Apply warm compress. Rotate sites of injection. 5. Burning sensation of the feet Isoniazid Give pyridoxine (vitamin due to peripheral neuropathy B6): mg daily for treatment; 10 mg daily for prevention 6. Arthralgia due to hyperurice- Pyrazinamide Give aspirin or NSAID. mia If symptoms persist, consider gout and give allopurinol. 7. Flu-like symptoms (fever, Rifampicin Give antipyretics. muscle pains, inflammation of the respiratory tract) Major Side Effects: Discontinue taking medicines and refer to MHO/CHO immediately 1. Severe skin rash due to hyper- Any drugs (espe- Discontinue anti-tb drugs sensitivity cially streptomycin) and refer to MHO/CHO. 2. Jaundice due to hepatitis Any drugs (especial- Discontinue anti-tb drugs ly isoniazid, rifampicin and refer to MHO/CHO. and pyrazinamide) If symptoms subside, resume treatment and monitor clinically. 3. Impairment of visual acuity Ethambutol Discontinue ethambutol and color vision due to optic and refer to an ophthalmoneuritis logist. 4. Hearing impairment, ringing Streptomycin Discontinue streptomycin of the ear and dizziness due to and refer to MHO/CHO. the damage of the eighth cranial nerve 5. Oliguria or albuminuria due Streptomycin Discontinue anti-tb drugs due to renal disorder Rifampicin and refer to MHO/CHO. 6. Psychosis and convulsion Isoniazid Discontinue isoniazid and refer to MHO/CHO. 7. Thrombocytopenia, anemia, Rifampicin Discontinue anti-tb drugs shock and refer to MHO/CHO. 340

17 1. Perform routine smear examination to lost and defaulted cases, who came back for chemotherapy. Refer patient to a medical officer for re-evaluation and re-treatment. 2. New smear-positive patients who interrupted treatment, shall be managed according to recommended schedule (See Table 9a). 3. Relapse and failure cases who interrupted treatment, shall be managed according to recommended schedule (see Table 9b). 4. Treatment will be continued for patients who were Treatment Modifications Based on the Results of the Sputum Follow-up Examination Regimen I Do sputum smear examinations for follow- up towards the end of the 2nd month of treatment. If the sputum examination result is negative, start maintenance phase (HR) and follow Table 7a. If the sputum examination result is positive, extend intesive Phase (HRZE) for another one (1) month and refer to Tables 7b1 and Table 7b2. Table 7a. Treatment Modifications Based on the Results of the Sputum Follow-Up Examination Towards the end In the beginning of the 6 th month Towards the end of the of the 4 th month 6 th month (*1) If smear negative, continue the maintenance phase (HR). If smear negative, complete the maintenance phase until the end of the treatment course and declare as "Cure" If smear positive, If smear negative in the If smear negative, declare as repeat smear repeated smear examination "Cure." examination continue the maintenance immediately for phase (HR) and do the If smear positive, declare as confirmation and smear examination towards "Treatment Failure," then consult with the end of the 6 th month of re-register as "Failure" and Provincial/City/ treatment start Regimen-II. CHD TB coordinators through MHO/ CHO If smear positive again in the repeated smear examination declare as "Treatment Failure," then re-register as "Failure" and start Regimen II. If smear positive, If smear negative, continue the maintenance phase If smear negative, declare as continue the (HR) and do the smear examination towards the "Cure." maintenance phase end of the 6 th month of treatment. (HR). If smear positive, declare as "Treatment Failure", then re-register as "Failure" and start Regimen-II. If smear positive, declare as "Treatment Failure", then re-register as "Failure" and start Regimen II. *1 Check the follow-up sputum smear examination towards the end of the 6 th month of the treatment only for the patient who has smear positive in the beginning of the 6 th month and shows smear negative in the repeated smear examination; and for the patient who has smear positive towards the end of the 4 th month turns out to be negative in the beginning of the 6 th month. 341

18 TUBERCULOSIS properly referred or transferred with referral slip. However, sputum smear examination for diagnosis should be performed for patients without an accompanying properly filled referral/transfer slip. C. OUTCOME OF TREATMENT A TB patient who undergoes treatment may achieve any of the following treatment outcomes: 1. Cure: A sputum smear-positive patient who has CPM 8 th EDITION been completed treatment and is sputum smear negative in the last month of treatment and on at least one previous occasion. (Note: We have changed the definition of "cure" as above, however, we have not changed the policy to collect follow-up sputum specimen with three occasions for smear positive case - at the end of the intensive phase, in the middle of the maintenance phase, and at the end of the maintenance phase.) 2. Treatment Completed: A patient who has com- Table 7b1. Treatment Modifications Based on the Results of the Sputum Follow-up Examinations for Towards Towards Towards the the end of the end of In the beginning of the 7 th month end of the the 3 rd month the 5 th month 7 th month (*2) If smear negative, If smear nega- If smear negative, complete the maintenance start the mainte- tive, continue phase until the end of the treatment course nance phase (HR). the maintenance and declare as "Cure." phase (HR). 342 If smear positive, If smear negative in If smear negative, decrepeat smear ex- the repeated exami- lare as "Cure." amination imme- nation, continue the diately for confir- maintenance phase If smear positive, decmation and consult (HR) and do the lare as "Treatment with Provincial/City smear examination Failure," then re-re /CHD TB Coordina- towards the end of gister as "Failure" and tors through MHO/ the 7 th month of start Reg. - II. CHO. treatment. If smear positive in the repeated examination, declare as "Treatment Fail lure," then re-register as "Failure" and start Reg. - II. If smear posi- If smear negative, continue the maintenance If smear negative, dective, continue phase (HR) and do the smear examination to- lare as "Cure." the maintenance wards the end of the 7 th month of treatment. phase (HR) If smear positive, decanyway. lare as "Treatment Failure," then re-re gister as "Failure" and start Reg. - II. If still smear positive, declare as "Treatment Failure," the re-register as "Failure" and start Reg. II. *2 Check the follow-up sputum smear examination towards the end of the 7 th month of treatment only for the patient who has smear positive in the beginning of the 7 th month and shows smear negative in the repeated smear examination; and for the patient who has smear positive towards the end of the 5 th month and turns out to be negative in the beginning of the 7 th month.

19 Table 7b2. Treatment Modifications Based on the Results of the Sputum Follow-up Examinations for Regimen-I with Extension Towards Towards Towards the the end of the end of In the beginning of the 7 th month end of the the 3 rd month the 5 th month 7 th month (*2) If smear positive, If smear negative, If smear negative, complete the maintenance start the mainte- continue the phase until the end of the treatment course nance phase (HR) maintenance and declare as "Cure." anyway. phase (HR). If smear positive, If smear negative in the If smear negative, repeat smear exam- repeated examination, declare as "Cure." i ination immediate- continue the maintely for confirmation nance phase (HR) and If smear positive, and consult Provin- do the smear examina- declare as "Treatcial/City/CHD TB tion towards the end ment Failure," then Coordinators of the 7th month re-register as "Failthrough MHO/ of treatment ure" and start Reg - II. CHO. If smear positive in the repeated examination, declare as "Treatment Failure," then re-register as "Failure" and start Reg. - II. If still smear positive, declare as "Treatment Failure," then reregister as "Failure" and start Reg. - II. *2 Check the follow-up sputum smear examination towards the end of the 7 th month of treatment only for the patient who has smear positive in the beginning of the 7 th month and shows smear negative in the repeated smear examination; and for the patient who has smear positive towards the end of the 5 th month and turns out to be negative in the beginning of the 7 th month. pleted treatment but does not meet the criteria to be classified as cure or failure. This group includes: A sputum smear-positive patient initially who has completed treatment without follow-up sputum examinations during the treatment, or with only one negative sputum examination during the treatment, or without sputum examination in the last month of treatment. A sputum smear-negative patient who has completed treatment. 3. Died: A patient who dies for any reason during the course of treatment. 4. Treatment Failure: A patient who is sputum smear-positive at five months or later during the treatment. A sputum smear-negative patient initially before starting treatment and becomes smear-positive during the treatment. (Note: This case will be re-registered as "Other" with a new TB case number.) 343

20 TUBERCULOSIS CPM 8 th EDITION REGIMEN II Do sputum smear examinations for follow- up towards the end of the 3 rd month of treatment. If the sputum examination result is NEGATIVE, start Maintenance Phase (HRE) and refer to Table 8a. If the sputum examination result is POSITIVE, extend Intesive Phase (HRZE) for another one (1) month and refer to Table 8b. Table 8a. Treatment Modifications Based on the Results of the Sputum Follow-up Examinations for Regimen - II Without Extension Towards the end In the beginning of the 8 th month Towards the end of the of the 5 th month 8 th month (*3) If smear negative, continue the maintenance phase (HRE). If smear negative, complete the maintenance phase until the end of the treatment course and declare as "Cure." If smear positive, If smear negative in the If smear negative, declare as repeat smear repeated smear examination, "Cure." examination continue the maintenance immediately for phase (HRE) and do the If smear positive, declare as confirmation and smear examination towards "Treatment Failure," consult with the end of the 8 th month. Provincial/City/ CHD TB If smear positive again in the coordinators repeated smear examination through MHO/ complete the maintenance CHO phase (HRE) until the end of the treatment course and declare as "Treatment Failure." If smear positive, If smear negative, continue the maintenance phase If smear negative, declare as continue the (HRE) and do the sputum smear examination "Cure." maintenance phase towards the end of the 8 th month. (HRE) anyway. If smear positive, declare as "Treatment Failure" If smear positive, complete the maintenance phase (HRE) until the end of the treatment course and declare as "Treatment Failure." *3 Check the follow-up sputum smear examination towards the end of the 8 th month of the treatment only for the patient who has smear positive in the beginning of the 8 th month and shows smear negative in the repeated smear examination; and for the patient who has smear positive towards the end of the 5 th month turns out to be negative in the beginning 5. Defaulter: A patient whose treatment was interrupted for two consecutive months or more. 6. Transfer out: A patient who has been transferred to another facility with proper referral/transfer slip for continuation of treatment. 344

21 Table 8b. Treatment Modifications Based on the Results of the Sputum Follow-up Examinations for Regimen - II With Extension Towards Towards Towards the the end of the end of In the beginning of the 9 th month end of the the 4 th month the 6 th month 9 th month (*4) If smear posi- If smear nega- If smear negative, complete the tive, or smear tive continue maintenance phase until the end of negative start the mainte- the treatment course and declare the mainte- nance phase as "Cure." nance phase (HRE). (HRE) anyway. If smear positive, If smear negative in repeat smear exa- the repeated smear mination imme- examination diately for confir- continue the mation and consult maintenance phase with Pro-vincial/ (HRE) and do the City/CHD TB Co- smear examination ordinators through towards the end of MHO/CHO. the 9 th month of treatment. If smear negative declare as "Cure." If smear positive, declare as "Treatment Failure." If smear positive again in the repeated smear examination, complete the maintenance phase (HRE) until the end and declare as "Treatment Failure." If smear negative, If smear positive, If smear negative, continue the mainte- declare as "Cure." continue the nance phase (HRE) and do the smear maintenance phase examination towards the end of the 9 th If smear positive (HRE) anyway. month of treatment. complete the maintenance phase (HRE) until the end of the treatment course and declare as "Treatment Failure." If still smear positive, complete the maintenance phase (HRE) until the end of the treatment course and declare as "Treat- * 4 Check the follow-up sputum smear examination towards the end of the 9 th month of treatment only for the patient who has smear positive in the beginning of the 9 th month and shows smear negative in the repeated smear examination; and for the patient who has smear positive at the end of the 6 th month and turns out to be negative in the beginning of the 9 th month. 345

22 TUBERCULOSIS CPM 8 th EDITION Table 9a. Treatment Modifications for New Smear-Positive Cases Who Interrupted Treatment Length of Length of Do a Result of Register Again? treatment Treatment Interruption Smear? Smear Modification Less than Less than 2 No No, use the same treatment Continue one month weeks card. Regimen-I weeks or Positive No, open a new treatment Start again on more Yes card. Regimen-I Negative No, use the same treatment Continue card. Regimen-I One to two Less than 2 No No, use the same treatment Continue months weeks card. Regimen-I 2 to 8 weeks Yes Positive No, use the same treatment Complete the card. remaining Intensive Phase, add one extra month of Intensive Phase. Negative No, use the same treatment Continue card. Regimen-I More than Close the previous registration Start on 8 weeks Positive as "Defaulter," then re- Regimen-II register as "RAD," open a Yes new treatment card. Close the previous registra- Continue Negative tion as "Defaulter," then re- Regimen-I register as "Other," but use the same treatment card. More than Less than 2 No No, use the same treatment Continue two months weeks card. Regimen-I 2 to 8 weeks Yes Positive Close the previous registra- Start on tion as "Defaulter," (*1) then Regimen-II re-register as "RAD," open a new treatment card. Negative No, use the same treatment Continue card. Regimen-I More than Close the previous registra- Start on 8 weeks Positive tion as "Defaulter," then re- Regimen-II register as "RAD," open a Yes new treatment card. Negative Close the previous registra- Continue tion as "Defaulter," then re- Regimen-I register as "Other," open a new treatment card. *1 This is the exceptional case to define as "Defaulter" for a patient who interrupted treatment of less than e i g h t weeks.

23 Table 9b. Treatment Modifications for Relapse and Failure Cases Who Interrupted Treatment Length of Length of Do a Result of Register Again? treatment Treatment Interruption Smear? Smear Modification Less than Less than 2 No No, use the same treatment Continue one month weeks card. Regimen-II 2 weeks or Positive No, open a new treatment Start again on more Yes card. Regimen-II Negative No, use the same treatment Continue card. Regimen-II One to two Less than 2 No No, use the same treatment Continue months weeks card. Regimen-II 2 to 8 Yes Positive No, use the same treatment Complete the weeks card. remaining Intensive Phase, add one extra month of Intensive Phase. Negative No, use the same treatment Continue card. Regimen-II More than Close the previous registra- Start on 8 weeks Positive tion as "Defaulter," then re- Regimen-II register as "RAD," open a Yes new treatment card. Close the previous registra- Continue Negative tion as "Defaulter," then re- Regimen-II register as "Other," but use the same treatment card. More than Less than 2 No No, use the same treatment Continue two months weeks card. Regimen-II 2 to 8 Positive Close the previous registra- Start again on weeks tion as "Defaulter," (*2) then Regimen-II re-register as "RAD," open a Yes new treatment card. Negative No, use the same treatment Continue card. Regimen-II More than Close the previous registra- Start again on 8 weeks Positive tion as "Defaulter," then re- Regimen-II register as "RAD," open a Yes new treatment card. Negative Close the previous registra- Continue tion as "Defaulter," then re- Regimen-II register as "Other," but use the same treatment card. *2 This is the exceptional case to define as "Defaulter" for a patient who interrupted treatment of less than 8 weeks. 347

24 TUBERCULOSIS CPM 8 th EDITION Guidelines on the use of Fixed-Dose Combination Anti-TB Drugs for the National TB Program Introduction Why will the National TB Control Program (NTP) shift from Single-Drug Formulation (SDF) Short Course Chemotherapy (SCC) to Fixed-Dose Combinations (FDCs)? 1. It simplifies treatment of TB patients. FDCs will enhance treatment compliance since the number of tablets that a TB patient will take will be reduced. For example, a patient under Regimen I with an average weight will only take three tablets of FDCs instead of six of single-drug formulation (1 Rifampicin, 2 PZA, 1 INH and 2 Ethambutol) currently being used in the Program. Also, it is easier to calculate the required dosage, hence, the risk of giving wrong dosage will be minimized. 2. It simplifies management of drug supply. This will facilitate the procurement and distribution process. Instead of ordering anti-tb drug preparation such as BP type I, BP type II and the loose preparation of INH, Ethambutol and PZA from various suppliers, the FDCs and others will be supplied by only one source. This also solves the chronic problem of mismatching of delivery of BP type I and II. 3. It prevents monotherapy or selective intake of anti- TB drugs. This will help reduce the emergence of drug resistant TB. 4. It reduces the risk of using Rifampicin for conditions other than TB. What is the situation that led to the shift to FDCs? The Philippines is one of the twenty-two countries with high TB burden. In response to this problem, the Directly Observed Treatment Short Course (DOTS) strategy was initiated in Within six years more than 90% of the population have access to this strategy. One of the major concerns ot NTP in the past years is the availability of effective anti-drugs in the health centers. Hence, there is always a constant search for approaches to improve management of drug supply. In 2002, the Philippines requested and were granted free anti-tb drugs from the Global Drug Facility (GDF). The preparations are in FDCs and these are expected to arrive in March, These will be initially distributed and used in selected areas and its use expanded later. This development will require a major change from the single drug formulation of SCC that NTP had used since 1987 to FDCs. This change will require careful planning and systematic implementation to be successful. Hence. these guidelines are prepared to guide the implementors in the advance implementation sites (AIS) in adopting this change. How will the change from SDF to FDC be implemented nationwide? The change will be implemented in phases. On the first year, one province or big city per region will use the FDCs. These areas will be selected by the Centers for Health Development (CHD) in consultation with the Infectious Disease Office-National Center for Disease Prevention and Control (IDO-NCDPC) and with the agreement of the concerned Provincial Health Office (PHO) or City Health Office (CHO).These areas will he known as advanced implementation sites (AIS). After a year, the use of FDC will be expanded to other provinces and cities. This staggered implementation will give adequate time to assess the initial experiences and address whatever constraints will arise. Facts About FDCs What are FDCs? The Fixed-Dose Combinations (FDCs) are anti-tb drug preparations whereby two or more first line anti-tb drugs are combined in one tablet. There are 2-, 3-, or 4-drug fixed-dose combinations. Are FDCs being used in other countries? Yes. Many countries are already using it. The World Health Organization (WHO) and the International Union Against Tuberculosis (IUATLD) had endorsed the use of FDCs by the NTP since The 4-drug and 2-drug combinations are included in the WHO Model List of Essential drugs since What is the composition of FDCs that will be used in AIS? There will be two types of FDCs - the 4-drug and the 2-drug combinations. The composition is as follows: See Table 1. Table 1 Drug FDC-A FDC-B 4-Drug (RHZE) 2-Drug (RH) Rifampicin (R) 150 mg 150 mg INH (H) 75 mg 75 mg PZA (Z) 400 mg Ethambutol (E) 275 mg 348