National TB Program (NTP)

CPM 7th EDITION TUBERCULOSIS

National Center for Disease Prevention and Control Department of Health San Lazaro Compound, Rizal Avenue, Sta. Cruz, Manila Telephone No: 743-8301 loc.2350/2352

NATIONAL TB PROGRAM (NTP) Staff



Director III Jaime Y. Lagahid, M.D., M.P.H. Medical Specialist IV Rosalind G. Vianzon, M.D., M.P.H. Medical Specialist IV Vivian S. Lofranco, M.D. Medical Specialist IV Anna Marie Celina G. Garfin, M.D. Medical Specialist II Ernesto A. Bontuyan, Jr., M.D. Supervising Health Program Officers Cirila D. Negad, R.N., MAN Ma. Arlene T. Rivera, M.M.D.M. Senior Health Program Officers Agnes Ma. Oliva V. Del Rosario, R.N.D., M.P.S-FNP Ferdinand Lala Puebla, BSSC., M.A.Candidate

383

TUBERCULOSIS

CPM 7th EDITION

Algorithm for Flow of NTP Activities 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)

5



7

6

Diagnosis positive?

Y



Initiation of treatment

N

Refer the patient to MHO (Municipal Health Officer) for further assessment



9



8



Case holding with DOTS Sputum specimens (3 specimens) with request form for sputum examination

Go to # 4. 11



10

Treatment complete?



Figure 1 384

N

Continue monitoring and supervision.

Y

Report

 treatment outcome.

CPM 7th EDITION TUBERCULOSIS

Algorithm for the Diagnosis of Pulmonary Tuberculosis 1 TB symptomatic (Cough for 2 weeks or more)



2

Collect three (3) sputum specimens.

4



3

2 or 3 smear positive? N

only one (1) smear positive?

6 Y



8

7 Collect another 3 sputum specimen immediately.

at least one (1) smear positive?

 9





N

Classify as smearpositive TB. See Tables 1 and 3.





5

Y

Y



Classify as smear positive TB.

N

Request for chest x-ray (CXR).

See Figure 3.

11



10

Is it consistent with active TB?



12

Y



Classify as smear positive TB

N

Observation/ further exam, if necessary

Figure 2 385

TUBERCULOSIS

CPM 7th EDITION

Algorithm for the Diagnosis of Smear-Negative Pulmonary Tuberculosis 1 All 3 smear



2

Refer to MHO (symptomatic treatment for 2-3 weeks)



3

If symptoms persists, collect another three (3) sputum specimens 5



4

2 or 3 smear positive?



6

Y



Classify as smearpositive TB. See Tables 1, and 3.

N

only one (1) smear positive?

Y



See Figure 2, # 5.



See Figure 3a.

N



7

All 3 smear negative

Figure 3

386

CPM 7th EDITION TUBERCULOSIS

1 All 3 smear negative



2

CXR

4



3

abnormal findings on CXR?

Y

Refer to TB

 Diagnostics Committee

N

observation / further exam

7



6



5

consistent with active TB?

Y



Classify as smearnegative TB. See Tables 1 and 3.

N



8

observation/ further exam

Figure 3a

387

TUBERCULOSIS

CPM 7th EDITION

Algorithm for Guide to Ensure Treatment 1

TB Patient



2

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



3

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

positive mucopurulent, salivary specimen? N



6

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



4

5

Refer to RHM

Y



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 4 388

CPM 7th EDITION TUBERCULOSIS

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 ju­ risdiction.

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 389

TUBERCULOSIS

CPM 7th EDITION

Guide to Case Finding 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.

 MICROSCOPY CENTER (To be accomplished by the MT) 1. Register in the NTP Laboratory Register. 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

390

CPM 7th EDITION TUBERCULOSIS

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

1. Physical assessment and prescription of appropriate regimen for the TB patient according to the patient type and the classification

To be done by PHN (initially)

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.

To be done by the health workers

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

4. Intake of first dose • Record the date when treatment started. • Record the due date of the 1st follow-up sputum examination in the NTP Treatment Card

To be done by the health workers and treatment partners

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 by: 1. PHN 2. RHM 3.Treatment partner 4. TB patient

6. Record keeping 1. Maintain and update the TB Register. 2. Maintain and update the NTP Treatment Card at the RHU/BHS. 3. Maintain and update the NTP ID Cards both of the treatment partner and the patient. 4. Keep the NTP ID Card.

391

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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 understand 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 392

CPM 7th EDITION

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. 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

CPM 7th EDITION TUBERCULOSIS





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. 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 Exa­ mination.

B. CASE HOLDING The procedure that ensures that patients complete treat-

ment 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

Table 1. Classification of TB Cases Location of Lesion Sputum-Smear Examination Smear Positive

Pulmonary TB

Extra-Pulmonary TB

Smear Negative

Definition of Terms 1. A patient with at least two spu­tum specimens positive for AFB (acid-fast bacilli) with or without radio­graphic abnor­ malities consistent with active TB, or 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. 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.

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. 393

TUBERCULOSIS

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 patient take the correct medications daily during the whole course of treatment.

CPM 7th EDITION

Table 2. Types of TB Cases Types of TB Cases

Definition of Terms

New

A patient who has never had treatment for TB or who has taken anti-tuber­culosis drugs for less than one month.

Relapse

A patient previously trea­ted for tuberculosis, who has been declared cured or treatment completed, and is diagnosed with bacterio­logically positive (smear or culture) tuberculosis.

Failure

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 on page 10.)

A patient who, while on treat­ment, is sputum smear positive at five months or later during the course of treatment.

Return after Default

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.)

A patient who returns to treatment with positive bac­ teriology (smear or cult­ure), following inter­rup­tion of treatment for two months or more.

Transfer-in

A patient who has been transferred from another facility with proper referral slip to continue treatment.

Other

All cases who do not fit into any of the above defi­ni­tions.

I. Objective The general objective of chemotherapy is to treat TB cases effectively and completely especially pulmonary sputum smear positive cases. II. Definition of Terms

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 reli­ 394

This group includes: 1. A patient who is starting treatment again after inter­ rupting treatment for more than two months and has re­mained or be­came smear negative. 2. A patient, who was initially registered as new smearnegative case, turned out to be smear-positive during the treatment. (The treat­ ment 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.

CPM 7th EDITION TUBERCULOSIS

Table 3. Treatment Regimens Regimen

Regimen I: 2HRZE / 4HR

Regimen II: 2HRZES / 1HREZ / 5HRE

TB Patient to be Given Treatment • New pulmonary smear positive cases • New seriously ill pul­mo­ nary smear negative cases with extensive parenchy­ mal involve­ment • New severely ill extra-pul­ monary TB cases • • • •

Failure Cases Relapse Cases RAD (smear +) Other (smear +)

Drugs and Duration of Treatment

Dose Adjustment by Body Weight

HRZE for two months during the intensive phase.

Add one tablet of 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.

HR for 4 months during the maintenance phase.

HRZES for the first two months, then HRZE for the third month during the intensive phase. HRE for the next five months during the main­ tenance phase.

Regimen III: 2 HRZ/4HR

• New smear-negative but with minimal pulmo­nary TB on radiography as confirmed by a medical officer • New extra-pulmonary TB (not serious)

able 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 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.

HRZ for 2 months during Add one tablet of INH (100 the intensive phase. mg), PZA (500 mg) each for the patient with more HR for 4 months during the than 50kg body weight maintenance phase. before the initiation of the treatment.

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 1/2 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. 395

TUBERCULOSIS

CPM 7th EDITION

Table 4. Drug Dosage Adjustment Drug Isoniazid Rifampicin Pyrazina- mide

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



Strepto- mycin

15 (12-18) mg/kg, and not to exceed 1 g daily

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 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). 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 396

Towards the YES end of the 2nd month Towards the end of the 3rd month Towards the end of the 4th month



Ethambutol 15 (15-20) mg/kg, and not to exceed 1.2 g daily

Schedule of Category 1 (2 HRZE/4 HR) Sputum Smear Follow-up Regular With One Examination Treatment Month of Extension (HRZE)

(If negative)

YES

YES

Towards the end of the 5th month In the beginning of the 6th month

(If positive)





Dose per kg body weight and maximum dose

Table 5a. Schedule of Sputum Smear Follow- up Examination (Category I)

YES

YES(*1)

In the beginning of the 7th month

YES(*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 and 7b.)

*1

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 partner shall make sure that the patient takes his/ her drugs daily. After intake of the drugs, the treat-

CPM 7th EDITION TUBERCULOSIS

ment 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.  The patient should undergo follow-up sputum examination on specified dates (See Tables 5a, 5b on pages 13 and 14 respectively). 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, 5b on pages 13 and 14 respectively.) 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 CoInfected Cases 1. Refer seriously ill patients to the nearest hospital

Table 5b. Schedule of Sputum Smear Follow-up Examination (Category II and III)



Towards the end of the 2nd month



Towards the end of the 3rd month

YES

(If positive)

Towards the end of the 4th month

(If negative)

YES



Towards the end of the 5th month



Towards the end of the 6th month



Towards the end of the 7th month



In the beginning of the 8th month



Schedule of Category II (2HRZES/1HRZE/5HRE) Sputum Smear Follow-up Regular Treatment With One Month of Examination Extension (HRZE)





Category III ( 2 H R Z /

YES

YES YES

YES (*2)

In the beginning YES (*2) of the 9th 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, 8b)

397

TUBERCULOSIS

CPM 7th EDITION

Table 6. Guide in Managing SCC Drugs Side Effects

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.

Side Effects

Drug(s) Responsible

What to Do?

Minor Side Effects: Patient should be encouraged to continue taking medicines

4. Pain at the injection site Streptomycin

Apply warm compress. Rotate sites of injection.

5. Burning sensation of the feet Isoniazid due to peripheral neuropathy

Give pyridoxine (vitamin B6): 100-200 mg daily for treatment; 10 mg daily for prevention

6. Arthralgia due to hyperurice- Pyrazinamide mia

Give aspirin or NSAID. If symptoms persist, consider gout and give allopurinol.



Give antipyretics.

7. Flu-like symptoms (fever, muscle pains, inflammation of the respiratory tract)

Rifampicin

Major Side Effects: Discontinue taking medicines and refer to MHO/CHO immediately 1. Severe skin rash due to hyper- Any drugs (espe- sensitivity cially streptomycin) 2. Jaundice due to hepatitis Any drugs (especial- ly isoniazid, rifampicin and pyrazinamide)

Discontinue anti-TB drugs and refer to MHO/CHO.



3. Impairment of visual acuity Ethambutol and color vision due to optic neuritis

Discontinue ethambutol and refer to an ophthalmo- 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 due to renal disorder

Streptomycin Rifampicin

6. Psychosis and convulsion Isoniazid 398

7. Thrombocytopenia, anemia, shock

Rifampicin

Discontinue anti-TB drugs and refer to MHO/CHO. If symptoms subside, resume treatment and monitor clinically.

Discontinue anti-TB drugs and refer to MHO/CHO. Discontinue isoniazid and refer to MHO/CHO. Discontinue anti-TB drugs and refer to MHO/CHO.

CPM 7th EDITION TUBERCULOSIS

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 on page 15). E. Monitoring Patient Response to Treatment Monitor the sputum smear status of all patients under treatment, including initially sputum smear

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 on page 17 and Table 7b2 on page 18. Table 7a. Treatment Modifications Based on the Results of the Sputum Follow-Up Examination Towards the end In the beginning of the 6th month th of the 4 month 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, repeat smear examination immediately for confirmation and consult with Provincial/City/

CHD TB coordinators through MHO/ CHO

If smear negative in the repeated smear examination continue the maintenance phase (HR) and do the smear examination towards the end of the 6th month of treatment

If smear negative, declare as "Cure." If smear positive, declare as "Treatment Failure," then re-register as "Failure" and start Regimen-II.

If smear positive again in the repeated smear examination declare as "Treatment Fai- lure," then re-register as "Failure" and start Regimen II.

If smear positive, If smear negative, continue the maintenance phase continue the (HR) and do the smear examination towards the maintenance phase end of the 6th month of treatment. (HR). If smear positive, declare as "Treatment Failure", then re-register as "Failure" and start Regimen II. *1

Towards the end of the 6th month(*1)

If smear negative, declare as "Cure." If smear positive, declare as "Treatment Failure", then re-register as "Failure" and start Regimen-II.

Check the follow-up sputum smear examination towards the end of the 6th month of the treatment only for the patient who has smear positive in the beginning of the 6th month and shows smear negative in the repeated smear examination; and for the patient who has smear positive towards the end of the 4th month turns out to be negative in the beginning of the 6th month. 399

TUBERCULOSIS

CPM 7th EDITION

negative patients, according to the standard schedule (See Tables 5a on page 13 and 5b on page 14.) and modify treatment based on the sputum follow-up examination results (See Tables 7a on page 16, 7b1 on page 17, 7b2 on page 18, 8a on page 19 and 8b on page 20).

F. Management of Lost and Referred Cases 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 on page 21). 3. Relapse and failure cases who interrupted treatment, shall be managed according to recommended schedule (see Table 9b on page 22). 4. Treatment will be continued for patients who were

Table 7b1. Treatment Modifications Based on the Results of the Sputum Follow-up Examinations for Regimen-I with Extension Towards the end of the 3rd month



Towards Towards the the end of In the beginning of the 7th month end of the th the 5 month 7th month(*2)

If smear negative, If smear nega­

start the mainte­ tive, continue nance phase (HR). 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, repeat smear exa­mi­ na­­tion imme­diately for confir­ma­tion and con­sult with Provincial/City/CHD TB Coor­dina­tors through MHO/CHO.

If smear negative in the repeated exami­ na­tion, continue the maintenance phase (HR) and do the smear examination towards the end of the 7th month of treat­ ment.

If smear negative, dec­ lare as "Cure." If smear positive, dec­ lare as "Treatment Failure," then re-re­ gister as "Failure" and start Reg. - II.

If smear positive in the repeated exami­­ nation, declare as "Treatment Fail­ ure," then re-register as "Failure" and start Reg. - II. If smear posi­ tive, continue the maintenance phase (HR) any­ way.

If smear negative, continue the maintenance phase (HR) and do the smear examination towards the end of the 7th month of treat­ ment.

If smear negative, dec­ lare as "Cure." If smear positive, dec­ 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 7th month of treatment only for the patient who has smear positive in the beginning of the 7th month and shows smear negative in the repeated smear examination; and for the patient who has smear positive towards the end of the 5th month and turns out to be negative in the beginning of the 7th month.

400



CPM 7th EDITION TUBERCULOSIS

Table 7b2. Treatment Modifications Based on the Results of the Sputum Follow-up Examinations for Regimen-I with Extension Towards the end of the 3rd month

If smear positive, start the mainte­ nance phase (HR) anyway.



Towards Towards the the end of In the beginning of the 7th month end of the th the 5 month 7th month(*2) If smear nega­tive, If smear negative, complete the maintenance continue the main­­­ phase until the end of the treatment course and te­­­­nance phase declare as "Cure." (HR). If smear positive, repeat smear exa­­­­mi­­na­tion im­ m e­ d i a t e­ l y f o r con­fir­ma­tion and con­sult Provin­cial/ Ci­ty/CHD TB Coor­ dina­tors through MHO/CHO.

If smear negative in the repeated exami­na­tion, continue the mainte­ nance phase (HR) and do the smear exami­ nation towards the end of the 7 th month of treat­ment.

If smear negative, dec­ lare as "Cure." If smear positive, dec­ lare as "Treat­ment Fail­ure," then re-re­ gister as "Fail­ure" and start Reg. - II.

If smear positive in the repeated exami­nation, declare as "Treatment Fail­ure," then re-register as "Failure" and start Reg. - II. If still smear po­ sitive, declare as "Treatment Fail­ ure," then re-register as "Fail­ure" and start Reg. - II. Check the follow-up sputum smear examination towards the end of the 7th month of treatment only for the patient who has smear positive in the beginning of the 7th month and shows smear negative in the repeated smear examination; and for the patient who has smear positive towards the end of the 5th month and turns out to be negative in the beginning of the 7th month.

*2

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 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 oc­ casions 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 completed 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

401

TUBERCULOSIS

CPM 7th EDITION

REGIMEN II  Do sputum smear examinations for follow- up towards the end of the 3rd 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 8th month th of the 5 month



Towards the end of the 8th month(*3)

If smear negative, If smear negative, complete the maintenance continue the phase until the end of the treatment course maintenance phase and declare as "Cure." (HRE). 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 8th 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 dec lare 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 8th 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 8th month of the treatment only for the patient who has smear positive in the beginning of the 8th month and shows smear negative in the repeated smear examination; and for the patient who has smear positive towards the end of the 5th month turns out to be negative in the beginning of the 8th month.

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 smear402

positive during the treatment. (Note: This case will be re-registered as "Other" with a new TB case number.) 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.

CPM 7th EDITION TUBERCULOSIS

Table 8b. Treatment Modifications Based on the Results of the Sputum Follow-up Examinations for Regimen - II With Extension Towards the end of the 4th month



Towards Towards the the end of In the beginning of the 9th month end of the the 6th month 9th month(*4)



If smear posi- If smear nega- tive, or smear tive continue negative start the mainte- the mainte- nance phase nance phase (HRE). (HRE) anyway.

If smear negative, complete the main­­tenance phase until the end of the treatment course and declare as "Cure."

If smear positive, repeat smear exa­­mination im-me­diately for confir­mation and consult with Provincial/City/CHD TB Co­ordinators through MHO/ CHO.

If smear negative in the repeated smear examination continue the main­tenance phase (HRE) and do the smear examination towards the end of the 9th month of treatment.

If smear negative dec­ lare as "Cure."

If smear positive, dec­lare as "Treatment Failure."

If smear positive again in the re-peated smear examination, complete the maintenance phase (HRE) until the end and declare as "Treatment Fail-ure." If smear positive, continue the maintenance phase (HRE) anyway.

If smear negative, continue the main­­tenance phase (HRE) and do the smear examination towards the end of the 9th month of treatment.

If smear negative, declare as "Cure." If smear positive complete the main­tenance phase (HRE) until the end of the treatment course and declare as "Treat­ ment Failure."

If still smear positive, complete the maintenance phase (HRE) until the end of the treatment course and declare as "Treatment Failure." *4

Check the follow-up sputum smear examination towards the end of the 9th month of treatment only for the patient who has smear positive in the beginning of the 9th month and shows smear negative in the repeated smear examination; and for the patient who has smear positive at the end of the 6th month and turns out to be negative in the beginning of the 9th month. 403

TUBERCULOSIS

CPM 7th EDITION

Table 9a. Treatment Modifications for New Smear-Positive Cases Who Interrupted Treatment Length of Treatment

Length of Interruption

Do a Smear?

Less than one month

Less than 2 weeks

No

2 weeks or more

One to two months

Less than 2 weeks

Register Again?

Treatment Modification

No, use the same treatment card.

Continue Regimen-I

Positive

No, open a new treatment card.

Start again on Regimen-I

Negative

No, use the same treatment card.

Continue Regimen-I

No, use the same treatment card.

Continue Regimen-I

No, use the same treatment card.

Complete the remaining Intensive Phase, add one extra month of Intensive Phase.

Negative

No, use the same treatment card.

Continue Regimen-I

Positive

Close the previous registration as "Defaulter," then re-register as "RAD," open a new treatment card.

Start on Regimen-II

Negative

Close the previous regis­tration as "Defaulter," then re-register as "Other," but use the same treatment card.

Continue Regimen-I

No, use the same treatment card.

Continue Regimen-I

Positive

Close the previous registration as "Defaulter,"(*1) then re-register as "RAD," open a new treatment card.

Start on Regimen-II

Negative

No, use the same treatment card.

Continue Regimen-I

Positive

Close the previous registration as "Defaulter," then re-register as "RAD," open a new treatment card.

Start on Regimen-II

Negative

Close the previous regis­tration as "Defaulter," then re-register as "Other," open a new treatment card.

Continue Regimen-I

Result of Smear

Yes

No

2 to 8 weeks Yes

More than 8 weeks

Positive

Yes

More than two months

Less than 2 weeks

No

2 to 8 weeks Yes

More than 8 weeks Yes

This is the exceptional case to define as "Defaulter" for a patient who interrupted treatment of less than eight weeks. *1

404



CPM 7th EDITION TUBERCULOSIS

Table 9b. Treatment Modifications for Relapse and Failure Cases Who Interrupted Treatment Length of Treatment

Length of Interruption

Do a Smear?

Less than one month

Less than 2 weeks

No

2 weeks or more

One to two months

Less than 2 weeks

Register Again?

Treatment modification

No, use the same treat­ment card.

Continue Regimen-II

Positive

No, open a new treatment card.

Start again on Regimen-II

Negative

No, use the same treat­ment card.

Continue Regimen-II

No, use the same treat­ment card.

Continue Regimen-II

Result of Smear

Yes

No

2 to 8 weeks Yes

More than 8 weeks

Positive

Less than 2 weeks

No, use the same treat­ment card.

Continue Regimen-II

Positive

Close the previous regis­ tration as "Defaulter," then re-register as "RAD," open a new treatment card.

Start again on Regimen-II

Negative

Close the previous registration as "Defaulter," the re-register as "Other," but use the same treatment card.

Continue Regimen-II

No, use the same treat­ment card.

Continue Regimen-II

Positive

Close the previous regis­ tration as "Defaulter,"(*2) then re-register as "RAD," open a new treatment card.

Start again on Regimen-II

Negative

No, use the same treat­ment card.

Continue Regimen-II

Positive

Close the previous regis­ tration as "Defaulter," then re-register as "RAD," open a new treatment card.

Start again on Regimen-II

Negative

Close the previous registration as "Defaulter," the re-register as "Other," but use the same treatment card.

Continue Regimen-II

No

2 to 8 weeks Yes

More than 8 weeks

Yes

*2

Complete the re­ mai­ning Intensive Phase, add one extra month of In­ tensive Phase

Negative

Yes

More than two months

No, use the same treat­ment card.

This is the exceptional case to define as "Defaulter" for a patient who interrupted treatment of less than 8 weeks.

405

TUBERCULOSIS

CPM 7th 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 Rifam­ picin, 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 antiTB 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 1996. 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, 2003. 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. 407

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 1994. The 4-drug and 2-drug combinations are included in the WHO Model List of Essential drugs since 1999. 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

CPM 7th EDITION TUBERCULOSIS

Aside from FDCs, single preparation drug such as ethambutol, pyrazinamide, and streptomycin will be used. How much is the cost of treatment using FDC per TB patient? The cost of treating one TB patient belonging to 38 - 54 kg group under Regimen 1 (See Table 2) is almost equal to the cost of the SDF currently being used by NTP (about $11). With simplified procurement and distribution process, FDC will be more cost-effective than the SDF.

Steps in Introducing FDCs in the Advanced Imple­ mentation Sites How will the FDCs be introduced at AIS? There will be three phases of implementation: Phase 1: Preparation of areas

Table 2. 2 RHZE/4RH Body weight (kg)

vehicle has changed. The dosage will follow the guidelines of WHO and IUATLD for individual antiTB drugs as contained in page 26 of the Manual of Procedures (MOP). The number of tablets of FDC per patient will depend on the body weight. Hence, all patients must be weighed (using kilogram as a unit) before treatment is started.

No. of tablets per No. of tablets per day Continuday Intensive Phase (2 Months) ation Phase (4 months) RH RHZE

• Orientation of all staff providing anti-TB treatment such as those from Rural Health Units (RHU), hos­ pital, PPMD clinics. • Ordering and distribution of FDC's

30-37

2

2

Phase 2: Implementation of new treatment guidelines on FDCs:

38-54

3

3

55-70

4

4

• Introduction of FDCs

>71

5

5

Phase 3: Monitoring, supervision, and evaluation It is estimated that initial introduction of FDC in AIS and its evaluation will last for one year. However, this might vary from area to area.

How is the quality of FDC s assured? One of the issues of FDCs is the bioavailability of rifampicin. To ensure that the FDCs meet the quality requirements, FDCs will be provided through the Global Drug Facility,which supplies FDCs of WHO-recommended strengths and of proven quality. What will be the dosage schedule of FDCs? The treatment regimens remain the same-- only the

Phase 1: Preparation of areas Activity 1. Orientation of staff Who will be oriented? The approach will be like what was done with the DOTS strategy - a cascading approach. The regional and provincial TB coordinators/trainers will orient the doctors

Table 3. 2RHZES/RHZE/5RHE Body weight (kg)

Intensive Phase RHZE

30-37 38-54 55-70 >71

2 3 4 5

Maintenance Phase Third month

First two months Streptomycin

RHZE

.75 g .75 g .75 g .75 g

2 3 4 5

RH

E 400 mg

2 3 4 5

1 2 2 3

Table 4. 2RHZ/4RH Body weight (kg)

30-37 38-54 55-70 >71

No. of tablets per day Intesive Phase (2 Months) RH 2 3 4 5

Z (400 mg) 2 3 4 5

No. of tablets per day Maintenance Phase (4 months) RH 2 3 4 5

408

TUBERCULOSIS

and nurses of the RHUs, hospitals and clinics. They will in turn orient the midwives. The midwife will orient the BHWs and other treatment partners. These guidelines will be used in the orien­tation.

CPM 7th EDITION

as follows: RHZE RH Z

No. of blister packs

Who will fund the orientation? The Department of Health, both the IDO- NCDPC and CHD, will be responsible for ensuring that funds are available for the orientation of the regional and provincial/city coordinators and physicians and nurses of RHUs, hospitals and clinics. The LGUs will be requested to fund the orientation of midwives and treatment partners. To reduce the cost, orientation may be done during the regular meeting of midwives and BHWs. Activity 2: Initial ordering and distribution of drugs How will the FDCs be distributed?

E Strepto­mycin

Regimen 1 Regimen 2 Regimen 3

6 9

12 15 18

6

No. of vials

10

56

Priorities for Regimen 3 are the new cases. For the initial order, the implementing health facilities will compute for one-quarter requirement plus a one month buffer stock. Subsequent order will be for only one quarter. See order form on page 21. What will be the counterpart of the LGUs re: drug supply?

The IDO will directly distribute the six-month requirement plus a buffer stock of six months (total of 12 months) to the CHD. This will include the FDCs and SDF. The CHD will transfer all these drugs to the PHOs and CHOs of the participating provinces and cities. The provincial/city TB Coordinator will then distribute to the health facilities their three-month requirement plus three-month buffer stock for the initial order. Filling-up of the Order Form will be part of the orientation.

The LGUs are expected to share in the procurement of single formulation drug such as INH, PZA, ethambutol and rifampicin.

Will FDCs be included in the Contract Distribution Scheme (CDS)? For the AIS, the FDC will not be included in the CDS. The CDS is not yet fully implemented and the system does not yet allow inclusion of FDCs.

1. All the RHU/ hospital /clinic staff and treatment partners who are involved in the treatment of TB patients had been oriented. 2. Adequate quantity of FDCs are already in the RHUs. 3. Records and reports are in place.

What will happen to the current supply of SDF?

What will happen to the patients under SDF?

This will depend on the available stocks and expiration dates of the SDF. Hence, all implementing units must conduct an inventory of their anti-TB drugs. They must retain adequate quantity of SDF for TB patients undergoing treatment. The excess must be returned to the PHO/CHO with proper documentation. The provincial TB coordinator will record all these returned drugs. A reserve stock of SDF must be maintained at the PHO/CHO for patients who may need them due to adverse reactions to any of the drug component of FDCs. Allocate SDF for at least 5% of the expected total TB cases in a year. The excess SDF drugs must be returned to the CHD. The latter will distribute this to non-AIS areas.

TB patients w ho had been initiated with the SDF must continue using these preparation until they have completed the required duration.

How much drugs will be ordered? To simplify the process of ordering, the number of tablets to be ordered will be based on the weight category where most of the patientswould fall (i.e., 38-54 kg group). The number of tablets per patient will be 409

Phase 2: Implementation of new treatment guide­ lines on FDCs When will the shift from SDF to FDCs start? Start giving the FDCs to newly-registered TB patients once the following conditions are met:

Will the intake of FDCs he supervised? Yes. The patient and the treatment partner will agree upon the time of drug intake. It must be two hours after a regular meal. What if there are side effects to FDCs? If there are major side effects, the responsible drug must be discontinued. In this situation, shift from FDC to SDF. Studies showed that this might happen to about 5% of total cases. Hence, RHUs must have at least supplied of SDF for two patients. The PHO will also have a reserve of SDF for this situation. Would there be new records and reports? There will be no change in the format or content of treatment records and reports. However, to facilitate

CPM 7th EDITION TUBERCULOSIS

monitoring and evaluation, records of TB patients under FDCs must be marked. For the Treatment Cards, put a red bar (-) using a red ink pen at the right upper corner. For the NTP Registry, put a red asterisk (*) opposite the first entry of the first patient under FDC and also write under comments the “start of FDC”.The patient number must be continuous. Phase 3: Monitoring, supervision and evaluation of implementation What will be the process of monitoring and evaluation? It is important that the entire process be regularly monitored and assessed. Supervision is also critical in ensuring that the guidelines are properly implemented. Lessons gathered during this advanced implementation will be useful during the expansion to other areas. Regional and provincial/city coordinators must monitor the implementing health facilities monthly during the first three months of implementation and quarterly thereafter. Provincial or city quarterly assessment must also be organized by the regional and provincial/city coordinators. The results must be sent to IDO-NCDPC. The latter will convene semi-annual evaluation workshop of the FDC implementation at AIS. The physician and nurse of the RHUs, clinics and hospitals will then supervise their subordinates. What will be supervised? The supervisors must observe how the staff does the following activities:

fective approach? • Were funds available and adequate? • Were the guidelines useful? Are there things to be changed? Added? Deleted? • What were the common issues raised during the orientation? What issues need clarification? FDC ordering and distribution • What was the ordering and distribution process used? What were the constraints? • Is the ordering form appropriate? Properly filledup? • Did the FDCs come on time? • Were they adequate? • Were there problems in storage? • Were there buffer stocks? • Were there SDF reserve stocks at the province? At the RHU? FDC distribution to patients • Was there any difficulty in explaining the treatment protocol? By doctors? Nurse? Midwife? Treatment partner? • Did the patient understand and follow the instructions? Any specific difficulty’? • Were there instances that SDF need to be given for adverse reactions? What percentages of cases need the SDF? Are these available? At what level? • What are the feedbacks from TB patients? From treatment partners? • Is there a problem in recording? Monitoring, supervision and evaluation

• • • • • •

orientation of midwives and treatment partners giving instructions by health staff to TB patients dosage given to patients drug intake of TB patients management of side effects filling-up of treatment records such as Treatment Card and NTP Registry • preparing reports • storage and distribution of drugs • filling-up of Order Form

• How frequent was the monitoring done by the provincial/regional coordinator? • How frequent was the supervision done by doctors/nurses? • What are the common issues/ problems en­ countered? • Was feedback given to higher level and supervisor? • Is there a problem in reporting? • Were there quarterly assessment conducted? What were the results?

Feedback must be immediately provided to the supervisor and the next higher level.

Treatment outcome

What will be monitored and evaluated?

• How is the treatment outcome compared to the outcome before FDC implementation?

The following guide questions will help in the monitoring and evaluation of various program activities:

NOTE:

Orientation of staff • Were all the staff oriented? If not, why? • What is the duration of orientation per category of health workers? • What approaches were used in the orientation (e.g., modular, lecture type)? Which is the most cost-ef-

Policies and guidelines of other program components such as case finding, case holding, sputum follow-up, health education, recording and reporting and others shall still be based on the 2001 Manual of Procedures. Management of side effects of FDCs There are major side effects that necessitate withdrawal 410

TUBERCULOSIS

of the responsible drug. In this case, FDC must be changed to SDF. Policies on the use of the Fixed-Dose Combination (FDC) anti-TB drugs to be incorporated in the manual of procedures of the National Tuberculosis Control Program 1. The Fixed-Dose of Combination (FDCs) Anti-TB drugs will gradually replace the Single Drug Formulation (SDF) for treatment of TB patients under the National Tuberculosis Control Program (NTP). The FDCs shall be initially introduced in one province or city per region, which will be known as the Advanced Implementation Sites (AIS). After a year of experience on FDCs at AIS, this will be expanded to other provinces and cities until all the regions are using the FDCs. 2. The dosage schedule will be in accordance to the internationally prescribed dosage. Intake must be supervised. 3. The Department of Health will provide the FDCs to the local government units and the other health facilities for free. However, LGUs will be encouraged to procure a portion of the requirements for SDF for those with adverse reactions necessitating withdrawal of FDC. 4. Staff of health facilities such as Rural Health Units, hospitals, government and private clinics and treatment partners who will be involved in treatment of TB cases shall be properly trained on the use of FDCs and other new treatment guidelines. 5. Quality of FDCs must be ensured by ordering them from a source with track record of producing FDCs according to World Health Organization (WHO) prescribed strength and standards of quality. 6. The shift from SDF to FDC will be regularly monitored and assessed by the Infectious Disease Office-National Center for Disease Prevention and Control, Centers for Health Development. Provin­ cial Health Offices and the City Health Offices.

.

411

CPM 7th EDITION

FACTS ABOUT FDC The fixed-dose combination (FDCs) are anti-TB drug preparations whereby two or more first line anti-TB drugs are combined in one tablet. The WHO and the International Union Against Tuberculosis recommend the use of FDCs since 1994. They are also included in the WHO Model List of Essential Drugs. There will be two types of FDCs. These are the 4-drug and the 2-drug types that will be used by NTP. The composition will be as follows: Drug

FDC-A 4-Drug (RHZE)

FDC-B 2-Drug (RH)

R i f a mp ic i n (R) INH (H) PZA (Z) Ethambutol (E)

150 mg

150 mg 75 mg

75 mg 400 mg 275 mg

Initial supply will be provided through the Global Drug Facility--a project of the STOP TB Partnership. The FDC and single drug formulation of ethambutol and pyrazinamide are film-coated tablets and packaged in blister packs. There are 28 tablets per blister pack.

TUBERCULOSIS

CPM 7th EDITION

Drugs Mentioned in the Treatment Guideline This index lists drugs/drug classifications mentioned in the treatment guideline. Prescribing information of these drugs can be found in PPD reference systems. Antituberculosis Ethambutol Am-Europharma Ethambutol HCl Biogenerics Ethambutol Odetol Pharex Ethambutol Ethambutol/Isoniazid/Vit B6 Alveodril/ Alveodril Forte Ebutol EMB Forte Etham 500 Ethambin-INH Ethamizid Ethi 400 Fevram Forbutol Norvit Plus Pacibutol Ethambutol/Isoniazid/ Rifampicin Myrin Ethambutol/Rifampicin/ Isoniazid/Pyrazinamide 4D Econokit Econokit-MDR Myrin-P Forte Quadtab Rimstar 4 Ethambutol/Rifampicin/Pyrazinamide/Vitamins Continukit Plus Ethambutol/Rifampicin/ Pyrazinamide/Isoniazid/ Vitamins SCC Kit Viper Isobutol/Rifampicin/Pyrazinamide Molecure 1 & 2 Isoniazid Am-Europharma Isoniazid Bacciter Biogenerics Isoniazid Curazid Forte

412

Norvit Pharex Isoniazid UL Isoniazid 400 Isoniazid/Rifampicin Continupack Isoniazid/Vit B6 Comprilex Pediatric Syrup Isoxin Koccid Nicetal Norvit Plus Odinah Therabacule Trisofort Trisovit UL Isoniazid 400 Isoniazid/Vitamins Trisofort Trisovit Pyrazinamide Am-Europharma Pyrazinamide Biogenerics Pyrazinamide Drugmaker's Biotech Pyrazinamide Mycobak Pharex Pyrazinamide Pyramin Pyrasol PZA-Ciba RiteMED Pyrazinamide Zapedia Zcure Zinaplex Rifampicin Am-Europharma Rifampicin Biogenerics Rifampicin Carfamin Crisarfarm Dipicin Drugmaker's Biotech Rifampicin Fampisec Fevram Koccifam Lypro-cap Medifam

Natricin Forte Odifam Pharex Rifampicin PMI Rifampicin Ramicin Refam Rexilan Ricyn Rifadin Rifamax Rimactane Rimaped RiteMED Rifampicin Tubercox Rifampicin/Isoniazid Bifix Continupack Kidz Kit 2 Rifinah Rifzin Rimactazid 225/Rimactazid 300/Rimactazid 450/ Rimactazid 600



Rifampicin/Isoniazid/Ethambutol Combikids Combi Pack Continukit TRES Tri-Pack Tritab Rifampicin/Isoniazid/Pyrazinamide Bio Combi Pack 1/Bio Combi Pack 2 Econopack Econopack-TDR Kidz Kit 3 M-O-P/M-O Compliance Pack Rifater Streptomycin YSS Streptomycin Sulfate