Management of Tuberculosis Training for Health Facility Staff. J: Reference Booklet. WORLD HEALTH ORGANIZATION Geneva

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1 Management of Tuberculosis Training for Health Facility Staff J: Reference Booklet WORLD HEALTH ORGANIZATION Geneva

2 WHO/CDS/TB/ j Management of Tuberculosis Training for Health Facility Staff J REFERENCE BOOKLET Job-aids, worksheets, and forms for use by health facility staff World Health Organization Geneva 2003

3 Acknowledgements Management of Tuberculosis Training for Health Facility Staff This set of training modules has been prepared by the Stop TB Department, World Health Organization, Geneva, through a contract with ACT International, Atlanta, Georgia USA. The project was coordinated by Karin Bergstrom. Fabio Luelmo was the main technical adviser. The American Lung Association (ALA), the American Thoracic Society (ATS), the Centers for Disease Control and Prevention (CDC), Atlanta and the Royal Netherlands Tuberculosis Association (KNCV) have all contributed to the development of the modules through the Task Force Training (TFT) of the Tuberculosis Coalition for Technical Assistance (TBCTA). The modules were field-tested in Malawi through the support of the National Tuberculosis Control Programme of Malawi. This publication was partially funded by the Office of Health, Infectious Diseases and Nutrition, Bureau for Global Health, United States Agency for International Development, through the Tuberculosis Coalition for Technical Assistance, a cooperative agreement to accelerate the implementation and expansion of the DOTS strategy in developing countries.

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5 Sputum collection and diagnosis Reference Booklet Table of Contents Identify TB suspects...2 Collect sputum for examination...3 Register of TB Suspects, with instructions...4 Request for Sputum Examination, with instructions...6 Send sputum samples to laboratory...8 Diagnosis based on sputum smear microscopy...9 Diagnosis by clinician...9 Drug regimens Select treatment category...10 Select drug regimen...11 Anti-TB drug treatment in special situations...12 How to read the drug code...13 Standard number of doses for phases of different duration...13 Give preventive therapy to household contacts...14 Give BCG vaccine if needed...14 Treatment Tuberculosis Treatment Card, with instructions...15 Directly observe TB treatment...20 Recognize and manage side-effects...20 Identify and supervise community TB treatment supporters...21 Schedule for follow-up sputum examinations...23 Conduct home visits for patients who miss a dose...24 Summary of actions after interruption of TB treatment...25 Tuberculosis Referral/Transfer Form, with instructions...26 Treatment outcomes...27 Informing patients about TB Guide for initial patient information about TB...28 Guide for continuing patient information about TB...30 Guide for informing patients about HIV and TB...32 Monitoring worksheets Key points about monitoring...33 Worksheet 1: Data on TB case detection...34 Worksheet 2: Data on TB treatment...35 Summary Worksheet: Indicators to monitor TB case detection and treatment...36 Analyse indicators...37 Drug box assembly Assemble drug boxes...38 Worksheet for drug box assembly...39 Blank forms Request for Sputum Examination...41 Register of TB suspects...42 Tuberculosis Referral/Transfer Form...43 Tuberculosis Treatment Card...44

6 Identify TB suspects Ask every adult (aged 15 years or more) who comes to the health facility: Do you have a cough? For how long have you been coughing? Any adult who has coughed for 2 weeks or more is a TB suspect for pulmonary tuberculosis and should have a sputum examination. 2

7 Collect sputum for examination Sputum collection and diagnosis Explain that the TB suspect needs a sputum examination to determine whether there are TB bacilli in the lungs. List the TB suspect s name and address in the Register of TB Suspects. (See next page.) Label sputum containers (not the lids). 3 samples are needed for diagnosis of TB. 2 samples are needed for follow-up examination. Fill out Request for Sputum Examination form. (See page 6.) TB SPECIMEN Name: Health facility: Date: Specimen no. Explain and demonstrate, fully and slowly, the steps to collect sputum. Show the TB suspect how to open and close the container. Breathe deeply and demonstrate a deep cough. The TB suspect must produce sputum, not only saliva. Explain that the TB suspect should cough deeply to produce sputum and spit it carefully into the container. Collect Give the TB suspect the container and lid. Send the TB suspect outside to collect the sample in the open air if possible, or to a wellventilated place, with sufficient privacy. When the TB suspect returns with the sputum sample, look at it. Is there a sufficient quantity of sputum (not just saliva)? If not, ask the TB suspect to add some more. Explain when the TB suspect should collect the next sample, if needed. (See schedule below.) Schedule for collecting three sputum samples Day 1: Collect "on-the-spot" sample as instructed above (Sample 1). Instruct the TB suspect how to collect an early morning sample tomorrow (first sputum after waking). Give the TB suspect a labelled container to take home. Ask the TB suspect to bring the sample to the health facility tomorrow. Day 2: Receive early morning sample from the TB suspect (Sample 2). Collect another "on-the-spot" sample (Sample 3). When you collect the third sample, tell the TB suspect when to return for the results. Store Check that the lid is tight. Isolate each sputum container in its own plastic bag, if possible, or wrap in newspaper. Store in a cool place. Wash your hands. Send Send the samples from health facility to the laboratory. (See page 8.) Total time from collection until reaching laboratory should be no more than 5 days. 3

8 Instructions and example: Use one row for every TB suspect (person coughing more than 2 weeks). Assign a number to each TB suspect; enter the name, age and address; and collect sputum. Enter the date sputum samples are sent to the lab. Complete the rest of the form as shown in the example below. Year 2002 REGISTER OF TB SUSPECTS Facility: Patangeta Health Centre 4 Date TB Suspect Number Name of TB Suspect M Age F Complete Address Date Sputum Sent to Record Neg Lab if negative, or if positive, record the grade. Date Results Received Results of Sputum Examinations / Evaristo Sarda 48 Rambar Village, Bardu 10/10 17/10 Neg Neg Neg 333 Jai Shrestha Center Street, Patakangeta 10/10 17/10 Neg Neg Neg TB Treatment Card opened? (record date) Observations/ Clinician s diagnosis 9/ Ahmed Masud 44 House 4/1E, Street 12, Bel Village 10/10 17/10 Neg + Neg Ref d for Ass ment 335 Sheena Arday 34 1A Hope Road, Patangeta 12/10 17/ / Phyllis Kotei Long Street, Patangeta 10/10 17/10 Neg Neg Neg 10/ Emil Avornyo 38 Bulo House, Market St, Patangeta 12/10 17/10 Neg Neg Neg 338 Mary Abatu Primos Road, Patangeta 12/10 17/ /10 12/ Grace Msiska 27 Parmu Village 17/10 24/10 Neg Neg Neg 15/ Mary Musowe Airport Rd, Patangeta When 17/10 a result 24/10 is Neg Neg Neg scanty, record the 341 Josiah Kasere 24 Isoli Village number. 17/10 24/10 Neg Neg Neg 16/ Kamran Nyathi 49 Half Tree Rd, Isoli Village 19/10 24/ / Sarah Nyathi 39 Half Tree Rd, Isoli Village 19/10 24/10 Neg Neg Neg Ref d fever, cough 344 Mohammed Fazal Dubar St, Patangeta 17/10 24/10 Neg Neg Neg Physician ref d 17/ Mansour Osman 54 10A Market Rd., Patangeta 19/10 24/10 Neg Neg Neg 18/ Nesa Farah 36 Parmu Village 19/10 24/10 Neg Neg Neg 30/10 ExtPul TB/Cat III 347 Bhagban Dutta D Airport Rd, Patangeta 24/10 31/10 Neg Neg Neg 19/ A.K. Prakash 55 Middle Street, # 22, Raman 24/10 31/10 Neg Neg Neg 22/ K. Misra 31 Street 9, Bel Village 24/ Ram Singh 22 Bulrat Street, # 4, Patangeta 24/10 31/10 Neg Neg Neg 351 Reeza Himonga 25 Rickshaw Rd, K House, Patangeta 24/10 31/10 Neg Neg Neg Mary Abatu has smear-positive TB. So does Sheena Arday and Kamran Nyathi. A treatment card was opened for each of them. A clinician diagnosed extrapulmonary TB, and a treatment card was opened. Year This suspect s results were not received. Ask the laboratory about them. REGISTER OF TB SUSPECTS Facility

9 Date TB Suspect Number Name of TB Suspect M Age F Complete Address Date Sputum Sent to Lab Date Results Received Results of Sputum Examinations TB Treatment Card Opened? (record date) Observations/ Clinician s Diagnosis 5

10 Instructions and example: Request for Sputum Examination Fill out the Request for Sputum Examination as shown below in an example for a new TB suspect. Write the patient s complete name and address. Send this form with the patient s sputum samples to the microscopy laboratory. After the sputum examination, the laboratory will complete the results section and then return the form to the health facility. (Note that this same form is used when requesting sputum examination for diagnosis and also when sending sputum for follow-up of treatment.) TB LABORATORY FORM REQUEST FOR SPUTUM EXAMINATION Name of health facility Patangeta Health Centre Date 10/10/02 When this form is Name used of patient Mary Abatu Age _19_ Sex: Record M either F the TB suspect number, or for a follow-up of the patient s District TB Number. When the treatment, the Reason Complete address 33 Primos Road, Patangeta examination is for diagnosis, record the TB for Examination is suspect number. When it is for follow-up of Follow-up. District treatment, Kelbe record the District TB Number (assigned by the district after diagnosis). Reason for examination: Diagnosis TB Suspect No. 338 When the examination is for OR Follow-up Patient s District TB No.* diagnosis, the disease site is not Disease site: Pulmonary Extrapulmonary (specify) yet known; do not tick a site. Number of sputum samples sent with this form 3 For diagnosis of a TB suspect, Date of collection of first sample 10/10/02 Signature of specimen collector three samples should be included. (Only two samples are required for * follow-up Be sure to enter the patient s District TB No. for follow-up of patients on TB treatment. examination.) RESULTS (to be completed by Laboratory) Date that sputum If positive, the technician samples were Lab Serial No also ticks a box under examined by the Grading to indicate the laboratory(a) Visual appearance of sputum: quantity of acid-fast bacilli technician present. Mucopurulent Blood-stained Saliva (b) Microscopy: DATE SPECIMEN RESULTS POSITIVE (GRADING) scanty (1 9) 16/10/02 1 POS Results column tells 16/10/02 2 whether POS each sample was found 16/10/02 3 positive or negative for POS acid-fast bacilli. Date 16/10/02 Examined by (Signature) If less than 10 bacilli are seen in the sample, the The completed form (with results) should be sent to the health facility and to the District technician writes the Tuberculosis Unit. number seen in the scanty box. 6

11 TB LABORATORY FORM REQUEST FOR SPUTUM EXAMINATION Name of health facility Name of patient Date Age Sex: M F Complete address District Reason for examination: Diagnosis TB Suspect No. OR Follow-up Patient s District TB No.* Disease site: Pulmonary Extrapulmonary (specify) Number of sputum samples sent with this form Date of collection of first sample Signature of specimen collector * Be sure to enter the patient s District TB No. for follow-up of patients on TB treatment. RESULTS (to be completed by Laboratory) Lab. Serial No. (a) Visual appearance of sputum: Mucopurulent Blood-stained Saliva (b) Microscopy: DATE SPECIMEN RESULTS POSITIVE (GRADING) scanty (1 9) Date Examined by (Signature) The completed form (with results) should be sent to the health facility and to the District Tuberculosis Unit. 7

12 Send sputum samples to laboratory υ υ υ υ υ Keep the samples in a refrigerator or in as cool a place as possible until transport. When you have all three samples, pack the sputum containers in a transport box. Enclose the Request for Sputum Examination. (See previous page.) If there are samples for more than one patient, enclose a Request for Sputum Examination for each patient s samples. If a patient does not return to the health facility with the second sample within 48 hours, send the first sample to the laboratory anyway. Send the samples to the laboratory as soon as possible. Do not hold for longer than 3 4 days. The total time from collection until reaching the laboratory should be no more than 5 days. Sputum samples should be examined by microscopy no later than 1 week after they have been collected. Prepare a dispatch list to accompany each transport box. (See example below.) The dispatch list should identify the sputum samples in the box. Before sending the box to the laboratory: Check that the dispatch list states: the correct total number of sputum containers in the box, the identification numbers on the containers, the name of each patient. Check that a Request for Sputum Examination is enclosed for each patient. Close the box carefully. Write the date on the dispatch list. Put the dispatch list in an envelope and attach envelope to the outside of the transport box. Example TB sputum samples dispatch list Health facility: Patangeta Health Centre Contents: Total number of sputum containers: 9 In this example, the specimen ID number is the TB suspect number followed by -1, -2, or -3. TB suspect name Specimen ID numbers Sheena Arday 335-1, 335-2, Emil Avornyo 337-1, 337-2, Mary Abatu 338-1, 338-2, Packed by (signature): Date: 12/10/02

13 8 Diagnosis based on sputum smear microscopy (three sputum samples) If: Two (or three) samples are positive Only one sample is positive All samples are negative Then: Patient is sputum smear-positive (has infectious pulmonary TB) Diagnosis is uncertain. Refer patient to clinician for further assessment. Patient is sputum smear-negative for infectious pulmonary TB. - If no longer coughing, no treatment is needed. - If still coughing, refer to a clinician if available, or treat with a non-specific antibiotic such as co-trimoxazole or ampicillin. If cough persists, repeat examination of three sputum smears. Diagnosis by clinician Clinicians may diagnosis a patient by sputum smear microscopy (as above) or by using X-rays, clinical assessment, and complimentary tests (e.g. culture, other methods). The left column below shows possible case classifications. The far right column shows the definition of each. Case classification Diagnosed by Definition used for diagnosis Pulmonary TB, sputum smear-positive (PTB+) Pulmonary TB, sputum smear-negative (PTB ) Extrapulmonary TB Health worker or clinician Clinician Clinician Clinician Two or more initial sputum smear examinations positive for Acid-Fast Bacilli (AFB) One sputum smear examination positive for AFB plus Radiographic abnormalities consistent with active pulmonary TB as determined by a clinician OR One sputum smear-positive for AFB plus sputum culture positive for M. tuberculosis Case of pulmonary TB that does not meet the above definition for smear-positive TB A patient with TB of organs other than the lungs. Any patient in whom both pulmonary and extrapulmonary TB are diagnosed should be classified as having pulmonary TB. 9

14 1. Determine type of patient Select treatment category Type of patient New Relapse Treatment after failure Treatment after default Transfer in Other Definition A patient who has never had treatment for TB or who has taken anti- TB drugs for less than 1 month A patient previously treated for tuberculosis who has been declared cured or treatment completed, and is diagnosed with bacteriologically positive (smear or culture) TB A patient who is started on a re-treatment regimen after having failed previous treatment A patient who returns to treatment, positive bacteriologically, following interruption of treatment for 2 months or more A patient who has been transferred from another TB register to continue treatment All cases that do not fit the above definitions. (This group includes chronic case, a patient who is sputum positive at the end of a retreatment regimen.) 2. Based on disease classification (site), laboratory results, and type of patient, select treatment category. A clinician diagnoses and prescribes treatment for cases in the shaded boxes. The health worker or a clinician can select the treatment category for the other cases (unshaded). Disease site Laboratory results Type of patient Recommended treatment category New CAT I Relapse CAT II Pulmonary Sputum smearpositive a Previously treated Treatment after failure Treatment after default CAT II Usually CAT II Chronic or MDR-TB CAT IV Sputum smear-negative b c CAT I or III Extrapulmonary b CAT I or III c a If only one sputum sample is positive, the patient must be referred to a clinician for diagnosis. b Pulmonary sputum smear-negative cases and extrapulmonary cases may rarely be previously treated (treatment after failure, relapse, treatment after default, chronic). Diagnosis should be based on bacteriological and pathological evidence. c As recommended by WHO, Category III treatment may be the same regimen as for Category I. Each country will decide whether Category I and III are different drug regimens or not. If they are different, the selection of a regimen for a particular patient will depend on the severity of disease. 10

15 Select drug regimen Refer to your national TB manual for the drug regimens recommended in your country. The regimens below use fixed-dose combination drugs. (See page 13 for How to read the drug code ) Category I regimen Initial phase (2 months) Continuation phase (4 or 6 months) Regimen 2(HRZE) 4(HR) 3 6(HE) Patient s weight Daily 56 total doses (Isoniazid 75 mg + rifampicin 150 mg + pyrazinamide 400 mg + ethambutol 275 mg) 3 times per week 48 total doses (Isoniazid 150 mg + rifampicin 150 mg) for 4 months Daily 168 total doses (Isoniazid 150 mg + ethambutol 400 mg) for 6 months kg kg kg Over 70 kg Drug regimens Category II regimen Initial phase (3 months) Continuation phase ( 5 months) Regimen 2(HRZE)S/1(HRZE) 5(HR) 3 E 3 5(HR)E Patient s weight Daily 84 total doses of HRZE plus 56 doses of S (Isoniazid 75 mg + rifampicin 150 mg + pyrazinamide 400 mg + ethambutol 275 mg) Streptomycin (vials, IM) 2 months 3 times per week 60 total doses (Isoniazid 150 mg + rifampicin 150 mg) + ethambutol 400 mg Daily 140 total doses (Isoniazid 75 mg + rifampicin 150 mg) + ethambutol 400 mg kg kg kg 4 1 g* Over 70 kg 5 1 g* * 750 mg for patients aged over 60 years Category III regimen May be same as Category I (see above) or as below (without ethambutol in initial phase) Initial phase (2 months) Continuation phase (4 or 6 months) Regimen 2(HRZ) 4(HR) 3 6(HE) Daily 56 total doses 3 times per week 48 total doses Daily 168 total doses (Isoniazid 75 mg + (Isoniazid 150 mg + (Isoniazid 150 mg + Patient s rifampicin 150 mg + rifampicin 150 mg) ethambutol 400 mg) weight pyrazinamide 400 mg) for 4 months for 6 months kg kg kg Over 70 kg

16 Anti-TB drug treatment in special situations Pregnancy Ask women patients whether they are or may be pregnant. Most anti-tb drugs are safe for use in pregnancy with the exception of streptomycin. Do not give streptomycin to a pregnant woman as it can cause permanent deafness in the baby. Pregnant women who have TB must be treated, but their drug regimen must not include streptomycin. Use ethambutol instead of streptomycin. Refer pregnant TB patients to a clinician who can prescribe an anti-tb drug regimen. Oral contraception Rifampicin interacts with oral contraceptive medications with a risk of decreased protection against pregnancy. A woman who takes the oral contraceptive pill may choose between the following two options while receiving treatment with rifampicin: following consultation with a clinician, she could take an oral contraceptive pill containing a higher dose of estrogen (50 µg). Alternatively, she could use another form of contraception. Breastfeeding A breastfeeding woman who has TB can be treated with the regimen appropriate for her disease classification and previous treatment. The mother and baby should stay together and the baby should continue to breastfeed in the normal way. Give the infant a course of preventive therapy (isoniazid). When preventive therapy is completed, give the infant BCG if not yet immunized. (See page 14.) HIV patients on antiretrovirals TB patients with HIV infection or HIV/AIDS may experience a temporary worsening of symptoms and signs after beginning TB treatment. In TB patients infected with HIV, treatment with antiretrovirals may interact with treatment of TB, reducing the efficacy of antiretrovirals and of anti-tb drugs and increasing the risk of drug toxicity. In patients with HIVrelated TB, the priority is to treat TB. Options are to defer antiretroviral treatment until TB treatment is completed; defer until completing the initial phase and use HE in the continuation phase; or use antiretrovirals that are less likely to interact with anti-tb drugs. 12

17 How to read the drug code for TB treatment regimens TB treatment regimens are described using a standard code where each anti-tb drug has an abbreviation. Those abbreviations are: Isoniazid (H) Rifampicin (R) Pyrazinamide (Z) Ethambutol (E) Streptomycin (S) The code shows the 2 phases of the regimen, separated by a slash. The letters correspond to the drugs to take during the phase. This continuation phase is of 4 months duration. Example one: A common regimen is written: The number before the letters is the duration of the phase in months. This initial phase is 2 months. 2(HRZE) / 4(HR) 3 A subscript number after a letter is the number of doses of that drug per week. Frequency of treatment with the combination HR tablet should be 3 times per week. When 2 or more drugs (letters) appear in parentheses, this indicates a combination tablet of those drugs. If there is no subscript after a letter, frequency of treatment with that drug is daily. These initialphase drugs should be taken daily. The above regimen uses 2 fixed-dose combinations (also called FDCs). In the initial phase of 2 months, each day the TB patient would take a certain number (depending on the patient s weight) of the combination tablet of isoniazid, rifampicin, pyrazinamide and ethambutol. In the continuation phase, the TB patient would take a certain number of FDCs of isoniazid and rifampicin (HR) 3 times per week for 4 months. Example two: 2(HRZE)S/1(HRZE) /5(HR) 3E 3 The initial phase is 3 months but has two parts. For 2 months drug treatment includes an FDC with isoniazid, rifampicin, pyrazinamide and ethambutol (HRZE) administered daily and also a daily injection of streptomycin (S). In the third month drug treatment is with the combination tablet (HRZE); the streptomycin is not given. The continuation phase is 5 months. Drug treatment is with the FDC tablet, (HR), given 3 times per week (subscript number 3 after the letters) and ethambutol (E), also given 3 times per week. Standard number of doses for phases of different duration Daily regimen (1 month = 28 doses) Multiply the number of months in the phase by 28: 2 months = 56 doses 3 months = 84 doses 5 months = 140 doses 6 months = 168 doses 3 times per week regimen (1 month = 12 doses) Multiply the number of months in the phase by 12: 4 months = 48 doses 5 months = 60 doses 13

18 Give preventive therapy to household contacts A household contact is a person who lives (that is, sleeps and eats at least one meal per day) in the home of a TB patient and who is therefore at greater risk of being infected. TB patients should bring to the health facility the following household contacts to be checked for TB: any children aged less than 5 years in the household any others in the household who have cough If a contact has TB, begin treatment for TB. For household contacts aged less than 5 years who do not have TB, give preventive therapy as described below. Preventive therapy with isoniazid for TB contacts aged less than 5 years Give preventive therapy with isoniazid ONLY to children who do not have TB or possible TB. Children aged less than 5 years are at special risk. If a child aged less than 5 years has cough, fever, or weight loss, refer to clinician for assessment of TB. If child does not have TB, give isoniazid (H) daily for 6 months to prevent TB. Give 5 mg/kg isoniazid daily for 6 months. See child monthly. Give 1 month s supply at each visit. Note: If your country also recommends preventive therapy with isoniazid for older household contacts (school-age children and/or adults), give it to these contacts also. Give 5 mg/kg isoniazid daily for 6 months, up to a maximum dose of 300 mg daily. This preventive therapy must not be given to any child or adult who has TB or possible TB. Give BCG immunization if needed Immunization with BCG can reduce the chance of developing TB by 50 80% if given before infection. After a course of preventive therapy, give one dose of BCG vaccine to children aged less than 2 years who have not already had BCG immunization. Determine whether a child has already had BCG by checking the child s immunization card or checking for a scar on the upper left arm. Follow the recommendations of your country s immunization programme and use sterile procedures to administer any vaccine. A child who is receiving preventive therapy with isoniazid should first complete the course of isoniazid and then receive BCG immunization. 14

19 Instructions and example: Front of TB Treatment Card Record general patient information at the top of the card as shown below. Be sure to get a full address. If patient has a community treatment supporter outside the health facility, also write that name and address. The District TB Number is assigned when the patient is entered in the District TB Register. The District TB Coordinator or your supervisor should inform you or record it on the TB Treatment Card. Record the drug regimen for the initial phase on the front of TB Treatment Card. Tick the category of treatment and the frequency. Under the patient s category (I, II, III or IV) on the card, in the boxes above each drug abbreviation, write a digit to indicate the number of tablets of that drug in each dose. Use the patient s weight and refer to the drug table in your national TB manual to determine the tablets needed. For streptomycin (S), which is given by injection, write the number of grams in one dose. FDCs (fixed-dose combinations) are tablets that contain 2, 3 or 4 different anti-tb drugs in the appropriate dosages. To record the drug regimen when FDCs are used, circle (or put between parentheses) the abbreviations of the drugs in the combination tablet and write the number of tablets per dose in one of the boxes. Use tick marks ( ) to indicate days that a dose is directly observed. Use a dash ( ) to show a Sunday or regular day off. Use a zero (0) to show a missed appointment. Use a longer line to show days that drugs were self-administered. Treatment Tick the box for the category of treatment. Tick the frequency of the treatment regimen. Write the number of tablets for 1 dose. Enter results of sputum examinations here. Circle or use parentheses to show drugs combined in one tablet (FDCs). For Category I, cross out the drug that will not be given, E or S. This patient received her first dose on 6 May. 10 May was a Sunday. She missed an appointment on 20 May. She was given drugs for selfadministration May. 15 At the end of the month, record the doses given in the month and the cumulative total doses. If there is a community TB treatment supporter, enter date, treatment category (I, II, III, or IV), and number of doses given to the supporter to administer.

20 Back of TB Treatment Card Use the back of the TB Treatment Card to record the regimen for the continuation phase and doses given during that phase. At the appropriate time, record the treatment outcome (see page 27). Use the Observations section to record comments at any time. Example 1: This patient comes three times weekly (Monday, Wednesday, and Friday) for directly observed treatment. The blank days are non-scheduled days. The dashes indicate Sundays, when the health facility is closed. The zeroes (0) indicate missed appointments. Use this space to record a transfer or other comments. For a transfer patient, contact the new health facility to find out final treatment outcome. Be sure to record a contact person and address here. Example 2: Below is part of the back of the TB Treatment Card for a patient on self-administered treatment. The patient comes once a month (about every 28 days) to obtain drugs. An X shows the day when the health worker gives the drugs to the patient. A line is drawn to show the number of days for which drugs are given. This patient has received enough drugs to self-administer through 19 December. The patient should get more drugs by 20 December. 16

21 Summary: Marking the TB Treatment Card = directly observed treatment given (a dash) = Sunday (or regular day off) 0 = missed appointment No mark = non-scheduled day in 3 times (blank day) per week regimen days for which drugs were (Line drawn = supplied for self-administered through some treatment days) = day that drugs are collected in a self-administered regimen If a community TB treatment supporter is directly observing treatment, copy the tick marks from the treatment supporter s card each month when you resupply the treatment supporter with drugs. 17

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24 1. Take out the patient s TB Treatment Card. Directly observe TB treatment 2. Pour a glass of water for the patient. (If the patient gets nausea, suggest taking the drugs with food or gruel.) 3. Open the patient s box of drugs. Take out all the drugs that the patient should take today. 4. Put the tablets into the patient s hand and then watch the patient swallow the tablets one at a time. If the patient finds it difficult to swallow them one after the other, the patient may pause briefly. The drugs must be taken together to make sure that they work together. 5. If the patient s regimen includes streptomycin, give the injection after the patient has swallowed all the tablets. Use a sterile needle and syringe. Check the TB Treatment Card for the correct dose of streptomycin. 6. Record the treatment on the TB Treatment Card. Recognize and manage side-effects Ask how the patient is feeling and listen carefully to identify any complaints that may indicate side-effects. Minor side-effects Anorexia, nausea, abdominal pain Joint pains Burning sensation in feet Orange/red urine Major side-effects Itching of skin, skin rash a Deafness (confirm that this is not due to ear wax) Dizziness, lack of balance Jaundice (yellow skin or eyes) Vomiting repeatedly b Difficulty with vision Management Take drugs with food or gruel Aspirin Pyridoxine 100 mg daily Reassure patient that this is expected (with rifampicin) Management Stop anti-tb drugs. Refer the patient urgently to a clinician. a Itching of skin is extremely serious if the patient is taking thioacetazone (not recommended by WHO). b Vomiting repeatedly is a problem because the drugs are not being absorbed. Vomiting with confusion is very serious because it is a sign of liver failure. Refer a vomiting patient to a clinician. Reminder: If at any time you observe that a patient s condition has significantly worsened, refer the patient to a clinician or hospital for further assessment and treatment. 20

25 Identify and supervise community TB treatment supporters Some TB patients live far away or do not find it convenient to come to a health facility for treatment. For these patients, a treatment supporter in the community is needed to directly observe treatment at a place and time more convenient for the TB patient. Community TB treatment supporters must be persons who can be supplied with drugs and supervised by the health facility. Some individuals already have an established relationship with the health services because they are already paid for or have responsibility for healthrelated activities. These individuals are most likely to carry out all the responsibilities of a community TB treatment supporter effectively. The order of preference in terms of supervision by the health services is as follows: 1. trained community health worker 2. health facility staff in the community (such as in his or her own village after work) 1 3. community or workplace volunteer. The health facility will need to prepare the community TB treatment supporter to do the following essential tasks. Essential tasks of a community TB treatment supporter Agree on a time and place to meet the TB patient. Do not make the patient wait. Give the patient the anti-tb drugs at each appointment according to the schedule. Check the drugs to be sure that they are correct. Watch the patient swallow all the drugs. Record on the TB Treatment Card each time the patient takes the drugs. Be aware of possible side-effects. Have the patient eat food with the tablets if needed to reduce nausea. Refer the patient to the health facility if the sideeffects continue. Encourage the patient to continue coming for TB treatment. Respond quickly if the patient misses a scheduled treatment. When a patient misses a dose for more than 24 hours, visit the patient s home. Find out what caused the interruption. Give the treatment. If you are unable to find the patient or convince the patient to continue the treatment, contact the health facility for help without delay. Go to the health facility to collect a resupply of drugs each month. Ask the patient to accompany you if possible. Show the patient s TB Treatment Card. Review how the patient is doing and discuss any problems. Make arrangements if you or the patient will be away for a few days. Give the patient enough drugs to self-administer for a maximum of 1 week or refer the patient to the health facility to decide what is to be done. Someone else may be asked to help during this time. Be sure that the patient goes to the health facility when the next follow-up sputum examination is due. 1 If the patient s treatment regimen will include streptomycin, only a health worker who is trained to give sterile injections can be the community TB treatment supporter. 21

26 About TB: Important information for a community TB treatment supporter TB is a disease caused by germs. It spreads most easily when it is in a person s lungs. TB spreads to others when someone with TB coughs or sneezes. TB can be stopped from spreading by treating and curing persons who have it. People with TB have many different symptoms. The major symptom of TB in the lungs is coughing for more than 2 weeks. TB can be cured if the patient takes anti-tb drugs regularly, on schedule, for the full duration of treatment, that is until the patient has taken all doses needed. It is important for the TB patient to take all the anti-tb drugs for the entire treatment, or the disease may become incurable. A patient can prevent the spread by: Taking regular treatment to become cured of TB Covering the mouth and nose when coughing or sneezing Opening windows and doors to allow fresh air to flow through the home. About giving treatment Give the patient the drugs in a well-ventilated place. If the patient takes the drugs regularly, he or she will become non-infectious in about 2 weeks. Possible minor side-effects are: No desire to eat, nausea, abdominal pain give drugs with food or gruel. Joint pains refer patient to health facility. Burning sensation in the feet refer patient to health facility. Orange/red urine reassure the patient that this is normal for the drug. Possible major side-effects: Itching of skin, skin rash, deafness, dizziness, jaundice, vomiting repeatedly, difficulty with vision. If any major side-effect occurs, stop anti-tb drugs immediately and inform the health facility worker. Refer the patient urgently to the health facility. For a daily regimen, it is customary to give 6 doses per week. If the patient misses a dose, give the missed dose on return. Do not give a double dose on any day. Then continue according to the schedule. The duration of treatment will be extended to complete all doses in the regimen. Periodically, the patient will need to go the health facility for sputum collection for follow-up sputum smear examinations. Most patients must go for follow-up sputum examinations at the end of the initial phase, after 5 months of treatment, and in the last month of treatment. Reminder: Sputum should be collected several days before results of the sputum examination are needed. Collect sputum in the last week of the specified month of treatment so that the results of the examination will be available at the end of the month. 21

27 (for pulmonary TB cases only) Months of treatment Treatment category Category I new smear-positive pulmonary [===== =====] [ ] [ ] Category II previously treated smearpositive pulmonary Schedule for follow-up sputum examinations [=========== =====] [ Category III smear-negative pulmonary [===== =====] [ ] ] [========] Initial phase of treatment [ ] Continuation phase of treatment (directly observed) [ ] Alternative continuation phase of treatment (HE self-administered) Follow-up sputum examination due during the last week of the month of treatment Follow-up sputum examination for regimens with 6 months HE self-administered in the continuation phase fi If sputum examination result is negative: Begin or complete continuation phase of treatment. fi If the sputum examination result is positive: At end of initial phase of treatment (Category I or II): Extend the initial phase of treatment by 1 extra month. Review whether treatment has been irregular. If so, discuss with patient the importance of regular treatment. Adjust the schedule for follow-up sputum examination as shown in Figure 12 below. At 5 months or later: Consider the case a treatment failure. Close the TB Treatment Card (Outcome = Treatment failure) and open a new TB Treatment Card (Type of patient = Treatment after failure). Begin Category II treatment (or Category IV if proven multidrug-resistant). At end of initial phase of treatment for a smear-negative pulmonary case (Category III): Open a new TB Treatment Card (Type of patient = Other) and begin Category II treatment. Adjusted schedule for subsequent follow-up sputum examinations (after extra month of initial-phase drugs given) Months of treatment Treatment category Category I with extra month of initialphase drugs [===== ====== =====] [ ] Category II with extra month of initialphase drugs [=========== ===== [ =====] [ ] ] 23

28 Conduct home visits for patients who miss a dose ASK: Why did you miss your appointment? What problems caused you to miss? LISTEN carefully to find out whether there have been difficulties related to: attitudes of the health facility staff who observe treatment waiting time at the health facility transportation work or family commitments side-effects of treatment other health problems HELP the patient to solve problems. Examples of possible causes of missed doses: Coming to the health facility is inconvenient. Patient dislikes coming to the health facility because of the long queue. Supervisor at work kept the patient late. Patient had troublesome side-effects. Patient had difficulty swallowing because of pain (due to oral candidiasis, common in AIDS patients). Patient cannot leave small children at home and is tired of bringing them to the health facility. Possible solutions: Identify a convenient community TB treatment supporter. Make arrangements so that TB patients do not have to wait in a queue. For example, let them enter through a back or side door. Offer to talk with the supervisor and explain the importance of the treatment, or Identify a community TB treatment supporter at work. Give appropriate advice or remedies for sideeffects, or refer the patient if necessary. (See side-effects table on page 20.) Give appropriate advice or remedies or refer patient as necessary. Suggest that a family member or neighbour watch the children. Remind family members/neighbours that the patient must continue treatment to protect their health, particularly the health of the children. If possible, identify a community TB treatment supporter closer to the patient s home. MOTIVATE the patient with statements such as the following: - TB can be cured if you keep coming for the medicine, and then you will not have to worry about it any more. - You only have more doses to take every day. After that, you will come less often. - These are the safest, most effective drugs available to treat TB anywhere in the world. - Almost all patients who take their medicines as recommended are cured. - If you keep taking your medicine, you will not spread TB to your family. - Taking only some of the drugs, or taking them irregularly, is dangerous and can make the disease difficult or impossible to cure. GIVE the missed dose(s) one day at a time. Do not give an extra dose on any day. RECORD a zero (0) on the TB Treatment Card for each day missed. Add a comment on the action taken, for example, home visit, resumed treatment. 24

29 Summary of actions after interruption of TB treatment Interruption for less than 1 month Trace patient Solve the cause of interruption Continue treatment and prolong it to compensate for missed doses Interruption for 1 up to 2 months First: Trace patient Solve the cause of interruption Collect 3 sputum samples While waiting for results, continue treatment Then, take action based on results of sputum examination: If all smears are negative, or patient has extrapulmonary TB If one or more smears positive, and Continue treatment and prolong it to compensate for missed doses Patient has been treated for less than 5 months Patient has been treated for 5 months or more Continue treatment and prolong it to compensate for missed doses If patient was on: Cat I Start Cat II Cat II Refer (may evolve to chronic) Interruption for 2 months or more (default) First: Collect 3 sputum samples Solve the cause of interruption, if possible Do not give treatment while waiting for results Then, take action based on results of sputum examination: If all smears are negative, or patient has extrapulmonary TB If one or more smears positive, and Clinician decides on individual basis whether to restart or continue treatment, or no further treatment Patient was previously on Cat I Patient was previously on Cat II Start Cat II Refer (may evolve to chronic) 25

30 Instructions for Tuberculosis Referral/Transfer Form: Use this form to refer a patient to a clinician or hospital for diagnosis or for special care, or to transfer a patient who is moving to another area. Make three copies of the form: one to send with the patient, one to keep at the health facility, and one for the District TB Coordinator. This form may also be used by clinicians to refer patients to your health facility to register and begin treatment. A blank from is provided on page

31 Treatment outcomes Treatment outcome Cure Treatment completed Treatment failure Died Default Transfer out Definition Sputum smear-positive patient who is sputum smearnegative in the last month of treatment and on at least one previous occasion Patient who has completed treatment but who does not meet the criteria to be classified as a cure or a failure Patient who is sputum smear-positive at 5 months or later during treatment a Patient who dies for any reason during the course of treatment Patient whose treatment was interrupted for 2 consecutive months or more Patient who has been transferred to another recording and reporting unit and for whom the treatment outcome is not known a Also sputum smear-negative patients who become sputum smear-positive at 2 months. 27

32 Guide for initial patient information about TB Use this guide to remind you of what to ask and say during an initial information session with a TB patient. The left column includes examples of questions to ask TB patients. The right column lists messages related to the questions on the left. Emphasize different messages with different patients, depending on their current knowledge about tuberculosis. Throughout the visit: Demonstrate a caring, respectful attitude. Praise and encourage the patient. Speak clearly and simply. Encourage the patient to ask questions. Ask the patient questions such as: Then give relevant messages: What do you understand tuberculosis to be? What do you think may have caused your illness? What is TB? Tuberculosis, or TB, is an illness caused by a germ that is breathed into the lungs. TB germs can settle anywhere in the body, but we most often hear about TB of the lungs. When the lungs are damaged by TB, a person coughs up sputum (mucus from the lungs) and cannot breathe easily. Without correct treatment, a person can die from TB. Have you ever known anyone with TB? What happened to that person? Do you know that TB can be completely cured? TB can be cured TB can be cured with the correct drug treatment. The patient must take all of the recommended drugs for the entire treatment time in order to be cured. Drugs for treatment of TB are provided free of charge. Treatment can be done without interrupting normal life and work. How TB spreads How do you think that TB spreads? TB spreads when an infected person coughs or sneezes, spraying TB germs into the air. Others may breathe in these germs and become infected. It is easy to pass germs to family members when many people live closely together. Anyone can get TB. However, not everyone who is infected with TB will become sick. How to prevent TB from spreading How can you avoid spreading TB? Take regular treatment to become cured. Cover the mouth and nose when coughing or sneezing. Open windows and doors to allow fresh air through the home. There is no need to eat a special diet or to sterilize dishes or household items. 28

33 Who else should be examined or tested for TB? How many people live with you? What ages? Does anyone else in your household have cough? Who has cough? All children aged under 5 years living in the household should be examined for TB symptoms. This is especially important because children aged under 5 years are at risk of severe forms of the disease. Young children may need preventive measures or referral to a clinician. Other household members should be tested for TB if they have cough. Explain the necessity of directly observed treatment Describe details of patient s treatment regimen Explain what to expect and what to do next A health worker must watch you swallow all the drugs according to schedule. This will ensure that you take the correct drugs regularly for the required time. If injections are needed, they will be given properly. By seeing you regularly, the health worker will notice if you have side-effects or other problems. If you do not take all of the drugs, you will continue to spread TB to others in the family or community, and the TB will not be cured. It is dangerous to stop or interrupt treatment, because then the disease may become incurable. With directly observed treatment, the health worker will know if you miss a dose and will quickly investigate the problem. If you must travel, or if you plan to move, tell the health worker so that arrangements can be made to continue treatment without interruption. Explain for the specific patient: duration of treatment frequency of visits for taking treatment where to go for treatment (If preassembled drug boxes are used) All the drugs for treatment are kept in a box with your name on it, so the health facility will not run out of drugs. (If the patient is taking rifampicin) Urine may turn orange/red as a result of the drug. This is expected and not harmful. If you feel nauseous from the drugs, bring a bit of food to eat when taking the next dose. Treatment should not interfere with normal life and work. Make sure that the patient knows exactly where and when to go for the next treatment. Ask questions to ensure that this will be possible and that the patient is committed to return. Remind the patient to bring family and other close contacts for TB testing as needed. Informing patients about TB Review: Ask checking questions (to ensure that the patient remembers important messages and knows what to do next). Reinforce earlier messages, or give more information as needed. 29

34 Guide for continuing patient information about TB Use good communication skills at every visit. At different points in treatment, discuss the messages that are most relevant at the time. At every visit: Demonstrate a caring, respectful attitude. Praise and encourage the patient. Speak clearly and simply. Encourage the patient to ask questions. Be alert for side-effects: Ask general questions to identify side-effects: How are you feeling? Have you had any problems? Listen and look for major sideeffects: Itching of skin, skin rash Deafness Dizziness, lack of balance Jaundice (yellow skin or eyes) Vomiting repeatedly Difficulty with vision Respond as directed: If minor side-effects, give reassurance and advice: If anorexia, nausea, abdominal pain, take drugs with food or gruel. If joint pains, take aspirin. If burning sensation in feet, take 100 mg pyridoxine daily. If orange/red urine, this is normal and expected. If major side-effects, stop anti-tb drugs and refer urgently to a clinician. a As needed, remind patient of one or more relevant messages on right: If the patient has not yet brought household contacts for examination or testing All children aged under 5 years living in the household should be examined for symptoms of TB. Other household members with cough should be tested. If the patient is unfamiliar with the drugs, or a change occurs in the regimen Describe the type, colour, and amount of drugs to be taken. Describe how often drugs should be taken and for how long. (If preassembled drug boxes are used) All the drugs for treatment are kept in a box with your name on it, so the health facility will not run out of drugs. If the patient feels better If the patient may be planning to travel or move If the patient has missed a dose If the patient complains about continuing treatment Even after you feel better, you must continue taking drugs for the entire time. If you plan to travel or move from the area, please inform me. We can make arrangements so that you will not miss any treatments. To be cured, you must take all of the recommended drugs together, for the entire time. If you do not take all of the drugs, you will continue to spread TB to others. Taking only some of the drugs, or taking them irregularly, is dangerous and can make the disease impossible to cure. a If the patient must be referred or hospitalized, explain that it is necessary to continue TB treatment after receiving referral care. The patient should return to the health facility to continue treatment. 30

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