MANAGEMENT OF DRUG-RESISTANT TUBERCULOSIS — MODULE B

MODULE MANAGEMENT OF DRUG-RESISTANT TUBERCULOSIS

B

DETECT CASES OF MDR-TB

TRAINING FOR HEALTH FACILITY STAFF IN THE PHILIPPINES

Detect Cases of MDR-TB

a

MODULE

B Management of Drug-Resistant Tuberculosis Training for Health Facility Staff in the Philippines

Detect Cases of MDR-TB

Acknowledgements National Library of the Philippines Cataloguing in Publication Data Management of Drug-resistant Tuberculosis Training for Health Facility Staff in the Philippines 1) Tuberculosis (Disease) – Multidrug-Resistant Tuberculosis 2) Training Modules ISSN # 2012-2675 Recommended citation: Tropical Disease Foundation and Department of Health, Philippines, 2008. Management of Drug-resistant Tuberculosis Training for Health Facility Staff in the Philippines © Tropical Disease Foundation (TDF) and Department of Health, Philippines (DOH) 2008.

All rights reserved. Copying and/or transmitting portions or all of this work without permission, or selling this material or portions of this material for profit, may be a violation of applicable law. The publishers encourage dissemination of these modules and will normally grant permission to reproduce portions of this work. The published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the Tropical Disease Foundation and the Department of Health, Philippines be liable for damages arising from its use.

Requests for permission to reproduce, in part or in whole, or to translate the training modules should be addressed to either of the agencies below: Tropical Disease Foundation, Philippine International Center for Tuberculosis, Amorsolo corner Urban Avenue, Makati 1229, Philippines, Fax No. (+63 2) 810 2874; email: tetupasi@tdf.org.ph Center for Infectious and Degenerative Diseases, National Center for Disease Prevention and Control, Department of Health, 3rd Floor, Bldg.

13, San Lazaro Compound, Sta. Cruz, Manila, Philippines, Fax: (632) 711-6804, email: rgvianzon10@yahoo.com

Cover and text design: Digix Design Studio / Alexdesigns.ph Printed in the Philippines

These training modules for Drug-resistant Tuberculosis will be used by the National TB Program, Infectious Disease Office, National Centers for Disease Prevention and Control, Philippine Department of Health and its partners in the Local Government Units in the integration of the Programmatic MDR-TB Management into the National TB Program.

The documents were prepared by the core team of the Programmatic Management of Drug-Resistant TB (PMDT) Program of the Tropical Disease Foundation, Philippines with the technical assistance from the WHO: Ma. Imelda D. Quelapio, MD, PMDT Executive Officer & Program Manager Nona Rachel Mira, RN, MPH, Training Officer Virgil Belen, RN, Nurse Clinical Coordinator Ruth Orillaza-Chi, MD, Medical Clinical Coordinator Albert Angelo L. Concepcion, RN, MHSS, Program Coordinator Nerizza Múñez, RPh, Drugs and Supplies Management Coordinator Grace Egos, RMT, MSPH, Laboratory Manager Thelma E. Tupasi, MD, Program Director Jacob H. Creswell, MPH, WHO Consultant

With contributions from: Michael Evangelista, RMT – PMDT Laboratory Coordinator John Stuart Pancho, RN – Training Assistant Roberto Belchez, RN - Field Coordinator Gail de las Alas, RSW, MSSW – Social Worker Coordinator The contributions from the following are also acknowledged: The technical inputs, editorial review and coordination provided by Dr. Michael N. Voniatis, WHO Medical Officer for Stop TB in the Philippines; the guidance provided by Ms. Karin Bergstrom of the Stop TB Department, WHO–HQ, Geneva; the technical support of the Stop TB Unit of the WHO Western Pacific Regional Office (WPRO); the collaboration and support of the technical and managerial staff of the National TB Programme, Department of Health, Philippines, in particular Dr. Rosalind G. Vianzon, National TB Program Manager and Dr. Vivian Lofranco, focal point on MDR-TB at DOH; the Center for Health Development, the National Capital Region, the NTP Coordinators of the local government units in Metro Manila, Philippines, the MDR-TB Treatment Center staff, and other partners.

The production of the module is supported by WHO Regional Office for the Western Pacific and WHO Headquarters, with funding from Eli Lilly and the United States Agency for International Development. The opinions expressed herein are those of the authors and do not necessarily reflect the views of the World Health Organization and the donors.

Contents Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Objectives of this module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 1. Identify MDR-TB suspects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Exercise A: Written exercise . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 1.1 Refer MDR-TB suspects to the appropriate Treatment Center. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Exercise B: Written exercise. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

2. Collect and record patient data for the MDR-TB suspect. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 2.1 Fill out the MDR-TB Screening Form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 2.2 Fill out the PMDT Acknowledgement Form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 2.3 Fill out the TB Symptomatics Masterlist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Exercise C: Written exercise. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 2.4 Make a referral to the Consilium if necessary and enter the patient in the Category IV Register . . . . 58

3. Discuss the “Paunawa” or Terms of Understanding with the patient. . . . . . . . . . . . . . . . . . . . . . . . . 60 3.1 Provide patient education on MDR-TB and the diagnostic process . . . . . . . . . . . . . . . . . . . . . . . . . . 60 3.2 Obtain patient’s signature in Panawa or Terms of Understanding . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

4. Collect sputum for smear, culture and DST. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 4.1 Enlist the MDR-TB suspect’s cooperation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 4.2 Fill out the Mycobacteriology Request Form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 4.3 Collect sputum samples from the MDR-TB suspect . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63 4.3.1 Alternative methods of sputum collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63 4.4 Pack the sputum samples and send to the laboratory. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 4.4.1 Prepare the Laboratory Receiving Form for Specimens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

Exercise D: Written exercise. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

5. Receive and record the smear and culture results

in the TB Symptomatics Masterlist and decide on the appropriate action . . . . . . . . . . . . . . . . . . . . 72 5.1 Record the smear results in the TB Symptomatics Masterlist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74 5.2 Decide on the appropriate action in response to the smear results. . . . . . . . . . . . . . . . . . . . . . . . . . . 76 5.3 Record the culture results in the TB Symptomatics Masterlist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76 5.4 Decide on the appropriate action in response to the culture results. . . . . . . . . . . . . . . . . . . . . . . . . . 78

6. Receive and record the DST results in the TB Symptomatics Masterlist,

Category IV Register and Consiliumex . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79 6.1 Record DST results in the TB Symptomatics Masterlist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

Exercise E

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82

Detect Cases of MDR-TB

3

MODULE B

6.2 Assign a Pre-enrollment number to the patient if confirmed to have MDR-TB . . . . . . . . . . . . . . . . . . 92 6.3 Record the results in the patient’s chart and in Consiliumex . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93 6.4 Schedule a case for presentation at the next Consilium meeting . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93 Example of a Consiliumex showing Consilium decision on treatment regimen.. . . . . . . . . . . . . . . . . 95 6.5 Return an updated Acknowledgement Form to the referring DOTS facility. . . . . . . . . . . . . . . . . . . . . . 99

7. Inform MDR-TB suspects of laboratory test results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101 7.1 Patients with drug resistance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101 7.2 Patient with no drug resistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101

8. Trace household contacts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102 8.1 Obtain a written consent from the patient in Kasunduan/”Contract” for treatment

and interview the patient’s household contacts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102

8.2 Complete the list of the patient’s contacts on the Contact Initial Investigation Form

and conduct interviews . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105

8.3 Instruct patients’ symptomatic household contacts to receive appropriate care and follow-up . . 107 8.4 Evaluate children by physical exam, chest x-ray and TST. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107

Summary of important points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108 Self-assessment questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110 Answers to self-assessment questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113 Annexes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113 Annex A. Proper Collection of Specimen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113 Annex B. Procedures for Obtaining Sputum Specimens in Children. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117 Annex C. Proper Labeling, Sealing and Transportation of Specimen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120

4 Detect Cases of MDR-TB

Introduction The detection of multidrug-resistant TB (MDR-TB) is more complex and time-consuming than the detection of a case of TB that is susceptible to first-line drugs. To stop transmission, early detection of MDR-TB is important. Failure to detect MDR-TB will lead to the spread of the drug-resistant strain to others, intake of incorrect treatment regimens, amplification of drug resistance and poor treatment outcomes.

Patients with pulmonary TB (PTB) excrete tubercle bacilli that can be detected by examining their sputum under a microscope, that is, by direct sputum smear microscopy (DSSM). However, drug resistance cannot be diagnosed with DSSM alone. This is because a positive smear of drug-resistant TB (DR-TB) looks the same as a positive smear of drug-susceptible TB. They are caused by the same organism, Mycobacterium tuberculosis (M. tuberculosis).

To detect if the strain of TB is resistant or not, a culture and drug susceptibility test (DST) must be done. This laboratory procedure determines if the M. tuberculosis strain does not grow in the presence of anti-TB drugs. If the strain grows, it is said to be resistant to that drug. The sputum must therefore be cultured, and a DST of the isolated M. tuberculosis from the culture must be done. MDR-TB demonstrates resistance to at least isoniazid and rifampicin, the two most powerful anti-TB drugs, with or without resistance to other anti-TB drugs. All patients with suspected MDR-TB must therefore have culture and DST in addition to smear, to confidently diagnose MDR-TB or any type of drug resistance.

Ideally, all TB symptomatics should undergo DSSM, culture and DST. However, given the limited resources available in the Philippines at the moment, this is not possible for all of the TB suspects in the country. To more efficiently diagnose those patients who have MDR-TB, a list of risk groups for MDR-TB will be described in detail in the following pages. To detect cases of resistance early, health facilities should check for MDR-TB risk factors in all TB patients or persons who present with symptoms suggestive of PTB, primarily cough. All persons presenting at a DOTS facility who are found to be at high risk should be referred to an MDR-TB Treatment Center for diagnosis.

Confirmed MDR-TB cases by DST, as well as those highly suspected of MDR-TB, still unconfirmed but needing immediate treatment must be presented to the consilium for further discussion and possible initiation of a Category IV regimen. The consilium is a multi-disciplinary case management committee composed of program staff, physicians, nurses and other relevant health care workers with expertise on MDR-TB management. This committee meets regularly to confirm the diagnosis, determine treatment regimens, assess response to treatment, and determine final outcome through a consensus using standards based on the WHO Guidelines for Programmatic Management of Drug-resistant TB. Pulmonary MDR-TB patients are generally infectious cases since they are often chronic cases, and have more extensive lung damage. They discharge tubercle bacilli into the air by coughing, sneezing, etc. Close contacts of MDR-TB cases, e.g., in the home, can become infected with a drug-resistant strain of TB when they breathe in a significant amount of tubercle bacilli. The longer MDR-TB cases are untreated, the greater will be the likelihood that they will infect their close contacts.

Early identification of MDR-TB suspects should be a priority for every DOTS facility, in order to promptly treat the infectious cases before they spread the drug-resistant strain to others. Early treatment of these cases increases the likelihood of a favorable outcome and minimizes destruction of the lungs by the microorganism. It also limits the amplification of resistance and prevents the emergence of extensively drug-resistant TB (XDR-TB).

Detect Cases of MDR-TB

5

MODULE B

Objectives of this module Participants will learn to: • • • • • • • • • •

Identify MDR-TB suspects Refer MDR-TB suspects for screening using the MDR -TB Suspects Referral Form Collect and record patient data from the MDR-TB suspect Fill out and use the MDR-TB Screening Form, the Acknowledgement Form, and the TB Symptomatics Masterlist Make an early referral to the Consilium Provide patient education using the Paunawa or Terms of Understanding Collect sputum samples and request the necessary tests Use laboratory results to identify MDR-TB cases Inform MDR-TB suspects of the results and begin additional care as needed Check household contacts of MDR-TB cases

If you need to look up an unfamiliar word, refer to the glossary in Module A.

6 Detect Cases of MDR-TB

Refer to section: 1 1 2 2 2 2 4 5, 6 7 8

MODULE B

1. Identify MDR-TB suspects MDR-TB suspects are TB symptomatics with an identified risk to develop MDR-TB. To detect these patients, high-risk groups for MDR-TB based on findings from the DOTS-Plus pilot project and the nationwide drug resistance survey (DRS) have been identified as shown in Box 1. In general, previous anti-TB treatment is a risk factor for resistance and therefore, all previously treated patients should be referred to the MDR-TB Treatment Center for screening and diagnosis.

By asking a few basic questions to TB suspects and by correctly monitoring current TB patients, DOTS facilities will be able to detect a large number of patients with high risk for MDR-TB in a timely manner.

The symptoms of pulmonary TB are the same as for MDR-TB, in particular, cough for two weeks or more. Other symptoms of TB include fever, chest and/or back pain, hemoptysis (coughing up of blood), weight loss and others such as night sweats, fatigue, body malaise, and shortness of breath. Being a contact of an MDR-TB case puts both new and retreatment patients at high risk for MDR-TB. Experience at the Tropical Disease Foundation (TDF) showed that among 1,737 MDR-TB contacts, 251 (14%) had radiographic evidence of TB. From these, 181 who submitted sputum and had available results, 42 (23%) turned out culture-positive, with MDR noted in 24 (57.1%), drug resistance other than MDR-TB in 7 (16.7%) and pan-susceptibility in 11 (26.2%).

For retreatment cases, some patient types have higher MDR-TB prevalence than others. In the Philippines, information regarding this is still being gathered, and all retreatment cases are considered at risk of being MDR-TB. Among patients receiving DOTS Category II treatment, MDR-TB is suspected if there is non sputum smear-conversion on the third month of treatment. A limited study from the TDF DOTS-Plus pilot project showed that of 22 Category II non-converters among 226 enrolled patients, MDR-TB was noted in 73% (16). On the other hand, of 36 Category I non-converters on month 2 among 181 enrolled cases, MDR-TB was noted in only 6%.

Additionally, if a patient presents to a DOTS facility with TB and reports that he has already received two or more courses of anti-TB treatment that were self-administered upon prescription of a doctor, that patient should be suspected of having MDR-TB and be referred to an MDR-TB Treatment Center. A treatment course is defined as at least a month of intake of anti-TB drug(s) excluding prophylactic treatment.

While HIV is not by itself a risk factor for MDR-TB, since TB/HIV coinfected patients usually have negative sputum smear results, HIV-positive individuals who have TB symptoms should be investigated for resistance using culture and DST. Furthermore, HIV co-infection with MDR-TB is a severe disease with a very high mortality rate and should be diagnosed promptly for immediate treatment.

Without proper detection and treatment of persons who are at high risk for DR-TB, there is a great danger that DR-TB will continue to spread in the community.

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MODULE B

The following table describes the high-risk groups for MDR-TB. BOX 1: High-risk groups for MDR-TB

A. Retreatment cases 1. Failure –– Category I failure: a patient who remains (or becomes) sputum smear-positive on the 5th month or later of DOTS Category I treatment –– Category II failure (chronic TB case): a patient who remains (or becomes) smear-positive on the 5th month or later of DOTS Category II treatment or who remains sputum-positive at the end of a retreatment regimen 2. Relapse of category I or II: a patient who has been declared cured or treatment completed, and is diagnosed with bacteriologically (smear or culture) positive TB 3. Return after default: a patient who returns to treatment with positive bacteriology (smear or culture) following interruption of treatment for two months or more 4. “Other” type of patient: a patient with one month or more of anti-TB drug intake under the DOTS strategy that cannot be classified into any type of retreatment, or a patient with one month or more of non-DOTS treatment. a) Non-DOTS patient whether sputum-positive or sputum-negative b) “Other-positive”: a sputum-positive patient with one month or more of DOTS treatment who cannot be typed as Treatment failure, Relapse, or Return after default. For example, a patient who is smear-negative initially then turned out to be positive at sputum follow-up during DOTS treatment . c) “Other negative:” a sputum-negative patient with one month or more of DOTS treatment who cannot be typed as Treatment failure, Relapse, or Return after default. For example, a patient who returns to TB treatment with negative bacteriology (smear or culture) following interruption of treatment for two months or more *A treatment course is defined as at least a month of intake of anti-TB drug(s) excluding primary and prophylactic treatment.

5. Non-converter of Category II: a patient who remains smear-positive at the end of the third month of DOTS Category II treatment

B. New or retreatment cases 6. Symptomatic contact of a confirmed or suspected drug-resistant patient: A “contact” refers to a household contact who is a person who normally sleeps in the same dwelling unit as the drug-resistant index case for at least three months and has a common arrangement for preparation and consumption of food. This patient has a higher risk of contracting the drug-resistant strain of the index case.

7. HIV-positive patient who has pulmonary or extra-pulmonary TB symptoms or has chest x-ray findings suggestive of TB: HIV infection by itself is not a risk factor specifically for MDR-TB, but for TB, in general.

Since HIV-infected patients with MDR-TB have high mortality, early diagnosis through culture and DST are recommended.

8 Detect Cases of MDR-TB

MODULE B

Now do Exercise A – Written Exercise When you have reached this point in the module, you are now ready to do Exercise A. Follow the instructions for Exercise A. Do this excercise by yourself.

Then discuss your answers with a facilitator.

Exercise A: Written exercise Identify MDR-TB Suspects In this exercise you will identify those patients that should be considered high-risk for having MDR-TB. Read each of the cases below. For each case, put a check on “Yes” for those who should be considered MDR-TB suspects and determine to which high-risk group they belong. Put a check on “No” for those who are not considered MDR-TB suspects.

Case 1 A 34 year old female patient, who took only 4 months of Category I treatment last year, has returned to the DOTS facility. The patient was sputum smear (-) on the 2nd and 4th months of follow-up but thereafter stopped treatment since she was already feeling better. Now the patient complains of a persistent cough for the last 4 weeks with back pain, hemoptysis and weight loss. Sputum examination result was smear-positive.

MDR-TB suspect? Yes High-risk group

No

Case 2 A female patient who has received 3 different courses of TB medications over a period of many years with a private doctor has come to your facility for consultation. The patient said she took all of the medicines and completed treatment each time but now has a cough and fears it may again be TB. She also has weight loss, hemoptysis, occasional fever, chest pain and night sweats. She has come to the DOTS facility because she no longer has money to pay for treatment.

MDR-TB suspect? Yes High-risk group

No

Case 3 A 55 year old male has been complaining of cough for three weeks, night sweats and fatigue. When interviewed, he says that he has not been sick for a long time but his wife told him he must come in to be checked because their 25 year old son who lived in the same house with them died of MDR-TB last year. The patient has no history of TB and has a normal chest x-ray.

MDR-TB suspect? Yes High-risk group

No

Detect Cases of MDR-TB

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MODULE B

Case 4 A 17 year-old female student has come to your DOTS facility for cough of more than two weeks and fever of five days. She has never been diagnosed or treated for TB in the past. She denies exposure to anybody with TB in the home or in school. You examine her and she has rales on both lower lung fields.

MDR-TB suspect? Yes High-risk group

No

Case 5 A female patient, 18 years old, who is being treated for HIV in one of the treatment hubs in Metro Manila develops fever, and weight loss. The DOTS facility recognized her to be the sister of a non-converting Category II patient who has been going to this health center for TB treatment.

MDR-TB suspect? Yes High-risk group

No

Case 6 A Category II (relapse) male patient just finished the third month of treatment and is still smear-positive. He still has cough and back pain and has been losing weight. The patient has had no adverse events and complies with the treatment schedule.

MDR-TB suspect? Yes High-risk group

No

When you have finished this exercise, please discuss your answers with a facilitator.

Then read until the next exercise.

10 Detect Cases of MDR-TB

MODULE B

1.1 Refer MDR-TB suspects to the appropriate Treatment Center Once a patient has been identified to be an MDR-TB suspect in a DOTS facility, he should be referred to the appropriate MDR-TB Treatment Center using the MDR-TB Suspects Referral Form. This form is available in DOTS facilities.

To complete the MDR-TB Suspects Referral Form, the referring DOTS facility fills in the date, the suspect’s name and the demographic information. Write the name of your DOTS facility and the Treatment Center to which the patient is being referred. Write the reasons for referring, e.g., factors that make the patient at risk for MDR-TB. Write the details being asked for on the TB history and treatment.

If the patient being referred has been on DOTS treatment, a photocopy of the DOTS Treatment Card should be sent along with the MDR-TB Suspects Referral Form. If not, a referral note should be sent along which details the TB history including the history of use of anti-TB drugs. Instruct the patient to present the MDR-TB Suspects Referral Form and the copy of the DOTS Treatment Card or referral note when he or she visits the Treatment Center for assessment.

Depending on the location of the local government unit or city/municipality where the DR-TB suspect resides or is identified, the referring DOTS facility will send the patient to the designated Treatment Center guided by the zoning map (Figure 1). This illustrates the location of the different Treatment Centers currently limited to Metro Manila. Table 1 shows the details of the zoning map and is just a guide which may be modified to suit the patient’s convenience, in case his residence is nearer another Treatment Center than the one suggested in the map. If the patient was identified as an MDR-TB suspect at an MDR-TB Treatment Center itself, the MDR-TB Suspects Referral Form need not be accomplished. An example of the form is shown on page 14. See Reference Booklet for instructions on how to fill it out.

Figure 1. Zoning map for referral of MDR-TB suspects 1

DJNRMH DOTS Center, (formerly TALA Hospital) Caloocan City

2

LCP- PHDU DOTS Center, Quezon City

3

KASAKA-QI MDR-TB Housing Facility , Quezon City

4

PTSI Tayuman DOTS Center, City of Manila

5

TDF-MMC DOTS Clinic, Makati City

6

Treatment Center in MMSouth (to be set-up)

1 2

3 4

5

6

DJNRMH: Dr. Jose N. Rodriquez Memorial Hospital KASAKA-QI: Kabalikat sa Kalusugan – Quezon Institute LCP-PHDU: Lung Center of the Philippine – Public Health Domiciliary Unit PTSI: Philippine Tuberculosis Society, Inc. TDF-MMC: Tropical Disease Foundation – Makati Medical Center

DOTS facilities, whether public or private, from all over Metro Manila may refer their MDR-TB suspects to any of the Treatment Centers shown above. The Treatment Center which is most proximal to the patient’s residence or address would be most convenient to the patient and should be selected.

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MODULE B

A flow chart for the referral of MDR-TB suspects is illustrated in Figure 2, page 14.

Table 1. Zoning of local government units and MDR-TB Treatment Centers

ZONE

LGU Caloocan: North Bayan

1

Malabon Navotas

MDR-TB Treatment Centers Dr. Jose N. Rodriguez Memorial Hospital (DJNRMH) DOTS Center KASAKA-QI MDR-TB Housing Facility PTSI Tayuman DOTS Center KASAKA-QI MDR-TB Housing Facility PTSI Tayuman DOTS Center

Valenzuela

LCP-PHDU DOTS Center PTSI Tayuman DOTS Center

Marikina

LCP-PHDU DOTS Center

Pasig Pateros 2

Taguig

QC

3

TDF-MMC DOTS Clinic

Manila Tondo Sta. Mesa Sampaloc Others Makati Mandaluyong San Juan

LCP –PHDU DOTS Center KASAKA-QI MDR-TB Housing Facility DJNRMH Treatment Center

PTSI Tayuman DOTS Center KASAKA-QI MDR-TB Housing Facility TDF-MMC DOTS Clinic TDF-MMC DOTS Clinic KASAKA-QI MDR TB Housing Facility

Las Pinas 4

Muntinlupa Paranaque

TDF-MMC DOTS Clinic Treatment Center in MM-South

Pasay

Figure 2. Flow chart for the referral of MDR-TB suspects 12 Detect Cases of MDR-TB

Example of an MDR-TB Suspects Referral Form

MODULE B

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MDR-TB Suspects Referral Form 4 / 25/ 05

Be guided by the zoning Jose

Amorsolo map on Name Balagtas Last First Name Middle name Figure 1 and 50 y/o Male Table 1 when Age Sex identifying the Address 2425 Buendia St. Brgy. Balut, Tondo appropriate ( House # and name of street) Treatment Tel. No. (02) 244-6847 City/Province Manila Region NCR Center

Date of Referral (mm/dd/yy)

Referring Health Center or DOTS facility: Sampaguita H.C. Name of HC/PPMD/ DOTS facility: Address of Facility: #3436 Balut Tondo City Manila Region NCR

Tel. No. (02) 244-6999 Fax No. (02) 244-6999

Referring MD Dr. A. Madrid

Referred to (Please check)

4

MMC/TDF Clinic KASAKA QI

Dr. Jose N. Rodriguez Memorial Hospital (TALA) PTSI Tayuman

Lung Center of the Philippines (LCP)

Others, pls. specify _________________________

Reason/s for referring MDR-TB suspect

4

Category I failure Category II failure Relapse Category I Relapse Category II

Non-converter of category II Symptomatic contact of confirmed or

suspected drug-resistant index case HIV-positive with TB symptoms

Return After Default (RAD) Other:

The reason for referral is clearly checked based on TB history Non-DOTS patient that does not fit above and previous treatment.

Other (+) Other (-)

TB History and treatment Date start of tx.

1997 2003

September 14, 2004

Where

Rosal Health Center Sampaguita Health Center Sampaguita Health Center

By whom

Anti-TB drugs taken and duration

Outcome

2 HRZE

4 HR

Unknown

2HRZES

4HRZE

Failed

3 HRZES 3 HRZE

Failed

To the referring facility: Kindly attach a photocopy of the NTP Treatment Card.

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MODULE B

•

•

MDR-TB suspects Retreatment cases o Failure:  Category I  Category II o Relapse  Category I  Category II o Return after default o “Other” o Non-converter of Category II New or retreatment cases o Symptomatic contact of MDR-TB patients o HIV (+) patient

FORMS USED

•

MDR-TB Suspects Referral Form

•

MDR-TB Screening Form Acknowledgement Form “Paunawa” or Terms of Understanding TB Symptomatics Masterlist

Refer to MDR-TB Treatment Center (TC)

Suspect assessed by TC physician Non-MDR-TB suspect: Refer back to referring physician/DOTS facility

Confirmed MDR-TB suspect

Submit 2 sputum specimens for smear, culture and DST

• • •

• •

Suspect is not seriously ill

Suspect is seriously ill

Await laboratory results

Refer to Consilium

Release of results: • DSSM: 4-5 days after the last specimen collection • Culture: 3-3.5 months after specimen collection • DST: 4-5 months after specimen collection

•

Consiliumex

•

Smear and culture result DST result Laboratory Releasing Form (Results)

• •

•

Inform referring facility of results

14 Detect Cases of MDR-TB

Mycobacteriology Request Form Laboratory Receiving Form (Specimens)

Acknowledgement Form

MODULE B

Now do Exercise A – Written Exercise When you have reached this point in the module, you are ready to do Exercise B. Turn to the next page and follow the instructions for Exercise B. Do this exercise by yourself. Then discuss your answers with a facilitator.

Exercise B: Written exercise Filling out the MDR-TB Suspects Referral Form The purpose of this exercise is to practice completing an MDR-TB Suspects Referral Form. Use the blank MDRTB Suspects Referral Form provided for each of the cases below. This form is important so that identified MDR-TB suspects are correctly referred to Treatment Centers for the proper tests. The cases for this exercise are the cases you encountered in Exercise A. Assume that you are the referring physician and write your name on the space provided in the Form.

Case 1 34 year old female patient, Sonia Santos Sariwa, with present address at # 23 Santol St., Barangay San Antonio, Cavite City. Tel. No. (046) 431-4086.

Date of birth: August 18, 1973 She finished 4 months of Category I treatment in your DOTS facility, Santol Health Center in the patient’s own barangay. She started in June of 2002 and was sputum smear (-) on the 2nd month. After 2 months of HR, she was again smear (-) on the 4th month of follow-up. The patient felt better and decided to abandon treatment despite your strong advice.

Today is November 29, 2007 and the patient has returned complaining of a persistent cough for the last 4 weeks with back pain, hemoptysis and weight loss. Sputum was smear-positive.

The contact telefax number of your health center is (046) 431-25253.

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MDR-TB Suspects Referral Form Date of Referral (mm/dd/yy) Name

Last

Age

First Name

Middle name

Sex

Address

Brgy.

( House # and name of street)

City/Province

Region

Tel. No.

Referring Health Center or DOTS facility: Name of HC/PPMD/ DOTS facility:

Tel. No.

Address of Facility:

Fax No.

City

Region

Referring MD Referred to (Please check)

MMC/TDF Clinic KASAKA QI

Dr. Jose N. Rodriguez Memorial Hospital (TALA) PTSI Tayuman

Lung Center of the Philippines (LCP)

Others, pls. specify _________________________

Reason/s for referring MDR-TB suspect Category I failure Category II failure

Non-converter of category II Symptomatic contact of confirmed or

Relapse Category I Relapse Category II

suspected drug-resistant index case

HIV-positive with TB symptoms

Return After Default (RAD) Other:

Non-DOTS patient that does not fit above Other (+)

Other (-)

TB History and treatment Date start of tx.

Where

By whom

Anti-TB drugs taken and duration

To the referring facility: Kindly attach a photocopy of the NTP Treatment Card.

16 Detect Cases of MDR-TB

Outcome

MODULE B

Case 2 Rolanda Ramirez Reloz, 49 years old, has received 3 different courses of TB medications over a period of many years with Dr. A. Reyes as her private doctor.

The patient’s treatment history started in: • August 2003: Myrin P Forte x 3 months and Myrin x 3 months • 2nd treatment: August 2005: Myrin P Forte x 6 months • 3rd treatment: December 2006: 3 months of Econokit- MDR and 4 months of Econopack She said she took all the medicines and claimed to have finished treatment each time but now has a cough and fears it may again be TB. She also has weight loss, hemoptysis, occasional fever, chest pain and night sweats. She has come to your DOTS facility today, December 3, 2007, because she no longer has money to pay for treatment.

Chest x-ray done a week ago showed a cavitary lesion on the right upper lobe, infiltrates on the left lower lobe and minimal pleural effusion, right.

Mrs. Reloz is presently residing at 44526 Jhonny St., Brgy. Pio del Pilar, Makati City. Tel: 989014301. Date of birth is September 2, 1958. Your facility is Pio del Pilar Health Center, Brgy Pio del Pilar, Makati City. Telephone no. 8889045

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MDR-TB Suspects Referral Form Date of Referral (mm/dd/yy) Name

Last

Age

First Name

Middle name

Sex

Address

Brgy.

( House # and name of street)

City/Province

Region

Tel. No.

Referring Health Center or DOTS facility: Name of HC/PPMD/ DOTS facility:

Tel. No.

Address of Facility:

Fax No.

City

Region

Referring MD Referred to (Please check)

MMC/TDF Clinic KASAKA QI

Dr. Jose N. Rodriguez Memorial Hospital (TALA) PTSI Tayuman

Lung Center of the Philippines (LCP)

Others, pls. specify _________________________

Reason/s for referring MDR-TB suspect Category I failure Category II failure

Non-converter of category II Symptomatic contact of confirmed or

Relapse Category I Relapse Category II

suspected drug-resistant index case

HIV-positive with TB symptoms

Return After Default (RAD) Other:

Non-DOTS patient that does not fit above Other (+)

Other (-)

TB History and treatment Date start of tx.

Where

By whom

Anti-TB drugs taken and duration

To the referring facility: Kindly attach a photocopy of the NTP Treatment Card.

18 Detect Cases of MDR-TB

Outcome

MODULE B

Case 3 Santiago Suma Santos, a 55 year old male with present address at 2062-1 Anak Bayan, Paco, Manila. Tel. 530-55555, has been complaining of cough for three weeks, night sweats and fatigue. When interviewed, he says that he has come upon his wife’s advice considering that their 25 year old son died of MDR-TB last year. He has had no history of TB but now has minimal infiltrates on the left upper lobe on the film done December 1, 2007.

Date of birth: April 2, 1952 Your DOTS facility is J. Fabella Health Center, San Andres, Manila. Telefax. no. 530-444444.

Today is December 5, 2007.

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MDR-TB Suspects Referral Form Date of Referral (mm/dd/yy) Name

Last

Age

First Name

Middle name

Sex

Address

Brgy.

( House # and name of street)

City/Province

Region

Tel. No.

Referring Health Center or DOTS facility: Name of HC/PPMD/ DOTS facility:

Tel. No.

Address of Facility:

Fax No.

City

Region

Referring MD Referred to (Please check)

MMC/TDF Clinic KASAKA QI

Dr. Jose N. Rodriguez Memorial Hospital (TALA) PTSI Tayuman

Lung Center of the Philippines (LCP)

Others, pls. specify _________________________

Reason/s for referring MDR-TB suspect Category I failure Category II failure

Non-converter of category II Symptomatic contact of confirmed or

Relapse Category I Relapse Category II

suspected drug-resistant index case

HIV-positive with TB symptoms

Return After Default (RAD) Other:

Non-DOTS patient that does not fit above Other (+)

Other (-)

TB History and treatment Date start of tx.

Where

By whom

Anti-TB drugs taken and duration

To the referring facility: Kindly attach a photocopy of the NTP Treatment Card.

20 Detect Cases of MDR-TB

Outcome

MODULE B

Case 5 A female patient, Susana Sandok Sarmiento, 18 years old, who is being treated for HIV in one of the treatment hubs in Metro Manila develops fever, and weight loss. Your staff at the Quirino Health Center recognized her to be the sister of a non-converting Category II patient who has been going to this health center for TB treatment. Chest x-ray of Susana done on October 8, 2007 showed a normal result.

Today is December 6, 2007.

Date of birth: June 18, 1989 Present address is at 1598 Interior 86 P. Quirino Avenue, Pandacan, Manila with telephone number 589-63636.

Your Health Center is located in Quirino Ave., Pandacan, Manila with telephone no. 599-0001.

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MDR-TB Suspects Referral Form Date of Referral (mm/dd/yy) Name

Last

Age

First Name

Middle name

Sex

Address

Brgy.

( House # and name of street)

City/Province

Region

Tel. No.

Referring Health Center or DOTS facility: Name of HC/PPMD/ DOTS facility:

Tel. No.

Address of Facility:

Fax No.

City

Region

Referring MD Referred to (Please check)

MMC/TDF Clinic KASAKA QI

Dr. Jose N. Rodriguez Memorial Hospital (TALA) PTSI Tayuman

Lung Center of the Philippines (LCP)

Others, pls. specify _________________________

Reason/s for referring MDR-TB suspect Category I failure Category II failure

Non-converter of category II Symptomatic contact of confirmed or

Relapse Category I Relapse Category II

suspected drug-resistant index case

HIV-positive with TB symptoms

Return After Default (RAD) Other:

Non-DOTS patient that does not fit above Other (+)

Other (-)

TB History and treatment Date start of tx.

Where

By whom

Anti-TB drugs taken and duration

To the referring facility: Kindly attach a photocopy of the NTP Treatment Card.

22 Detect Cases of MDR-TB

Outcome

MODULE B

Case 6 Patient Rodolfo Remo Robles, 30 years old, was declared cured from Category I treatment which started on June 1, 2006 in Poblacion Health Center. However, he went into relapse for which the 2nd treatment was started on September 3, 2007. Treatment with Category II is ongoing at your DOTS facility, Poblacion Health Center in the same street and barangay where the patient resides.

Today, December 7, 2007, the patient is on his 3rd month of treatment and the follow-up smear result came out positive. He still has cough and back pain and has been losing weight. The patient has had no adverse events and complies with the treatment schedule.

Present address is at 276281 Poblacion Sn Vicente St., Bayanan, Muntinlupa City. Tel 5305555.

Date of birth: March 28, 1977 Tel no. of your health center is 8098420.

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MDR-TB Suspects Referral Form Date of Referral (mm/dd/yy) Name

Last

Age

First Name

Middle name

Sex

Address

Brgy.

( House # and name of street)

City/Province

Region

Tel. No.

Referring Health Center or DOTS facility: Name of HC/PPMD/ DOTS facility:

Tel. No.

Address of Facility:

Fax No.

City

Region

Referring MD Referred to (Please check)

MMC/TDF Clinic KASAKA QI

Dr. Jose N. Rodriguez Memorial Hospital (TALA) PTSI Tayuman

Lung Center of the Philippines (LCP)

Others, pls. specify _________________________

Reason/s for referring MDR-TB suspect Category I failure Category II failure

Non-converter of category II Symptomatic contact of confirmed or

Relapse Category I Relapse Category II

suspected drug-resistant index case

HIV-positive with TB symptoms

Return After Default (RAD) Other:

Non-DOTS patient that does not fit above Other (+)

Other (-)

TB History and treatment Date start of tx.

Where

By whom

Anti-TB drugs taken and duration

To the referring facility: Kindly attach a photocopy of the NTP Treatment Card.

24 Detect Cases of MDR-TB

Outcome

MODULE B

When you have finished this exercise, please discuss your answers with a facilitator.

Then read until the next exercise.

Detect Cases of MDR-TB

25

MODULE B

2. Collect and record patient data for the MDR-TB suspect The Treatment Center will receive the MDR-TB suspect referred by the DOTS facility and if you work at the Treatment Center, you will proceed to obtain and record information about the suspect and his condition and medical history.

This background information will be recorded on the MDR-TB Screening Form. Later, this patient will be registered in the TB Symptomatics Masterlist.

2.1 Fill out the MDR-TB Screening Form The MDR-TB Screening Form is an individual form for each MDR-TB suspect that holds a large amount of background information about the patient. It is necessary that the Treatment Center staff fills out the form completely and accurately to provide the most precise information for each patient’s record. The Treatment Center physician is responsible for monitoring the completeness and accuracy of the MDR-TB Screening Form.

The MDR-TB Screening Form is a record of the following: I. II. III. IV. V. VI. VII.

MDR-TB suspects’ demographics and contact information MDR- TB suspects’ present medical complaint and symptoms MDR-TB suspects’ past medical history especially previous TB treatment and exposure; co-morbid conditions such as HIV, diabetes mellitus, kidney or liver disease, etc.

Social history Doctor’s physical examination findings and laboratory procedures Assessment or initial diagnosis and the specific type of suspect and risk factors for drug-resistance Plan for diagnosis and/or treatment

The Screening code is the unique identification number assigned to every TB symptomatic who undergoes the process of screening at the Treatment Center (See table below). This number is given once the patient is entered in the TB Symptomatics Masterlist for PMDT. See Reference Booklet for instructions on how to fill out the TB Symptomatics Masterlist.

Table 2 :Screening code (TC-YY-MM-NNNN)

Code

TC

YY MM NNNN

Description Treatment Center: 01– TDF-MMC DOTS Clinic 02– KASAKA-QI MDR-TB Housing Facility 03– LCP-PHDU DOTS Center 04– Dr. Jose N. Rodriguez Memorial Hospital (DJNRMH)- DOTS Center 05– Philippine Tuberculosis Society Inc. (PTSI) Tayuman DOTS Center Current year the patient was screened, e.g., 08 for 2008 Current month the patient was screened, e.g., 01 for January Accrual number that begins with 0001 at the start of every month

The example on page 28 shows that the patient, Jose Balagtas, with Screening Code 02-05-04-0081 was screened in KASAKA-QI MDR-TB Housing Facility in April 2005 and was the 81st TB or MDR-TB suspect to be screened since the start of the month in that Treatment Center. Permanent address is the address where the patient has stayed on a long-term basis, e.g., in the province, while the current address is the residence where he can be contacted while undergoing diagnosis for TB or MDR-TB, e.g., relocation address in Metro Manila.

• • •

Elaborate on the patient’s symptoms including duration, and other details, e.g., quantification of weight loss, or blood during hemoptysis, etc.

Write the patient’s past TB treatment: what drugs were taken, where treated, whether DOTS or non-DOTS, and the outcome of such treatments; exposure to active TB or MDR-TB; comorbid illnesses, allergy, etc.

Write the smoking, alcohol and drug use, and sexual history.

26 Detect Cases of MDR-TB

MODULE B

•

•

•

Write the physical examination findings, and laboratory procedures that were done prior to the screening, the radiographic findings including an illustration of where the radiographic lesions are found in the lungs.

Finally, write down your assessment of the patient, whether TB or non-TB, and if new or retreatment. If the patient is a retreatment case, specify what category, whether failure of category I or II, return after default, relapse of category I, II or IV, or “other”. Specify also if there are risk factors other than a history of treatment, e.g., being a contact of an MDR-TB case, non-conversion of Category II treatment, TB symptomatic HIVpositive, or whether he has had 2 or more treatment courses.

Write the management plans, e.g., what sputum examinations to make and how many specimens for each.

A filled out MDR-TB Screening Form is shown on the following pages. See Reference Booklet for instructions on how to fill this out.

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Example of an MDR-TB Screening Form REP U

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MDR - TB SCREENING FORM Mark with check ( ) if symptom is present, PE is done and disease is present, otherwise, mark with (X). Please ensure the completeness of all information.

Screening code: TC: 02= KASAKA 4 KASAKA Screened at: MMC/TDF LCP Others, specify YY:/05= 04 /28 052005 Screening code: (TC-YY-MM-NNNN) 02-05-04-0081 Date: MM: 04= April (mm/dd/yy) 0081: 81st patient to be I. Demographics screened in Balagtas Jose Amorsolo Name: KASAKA in April Surname Given Name

Middle Name 2005

Manila Sex: 3 Male Date of birth: 01/20/ 55 Age: 50 y/0 Place of birth: (mm/dd/yy)

Female Permanent Nationality: Filipino Religion: Roman Catholic Civil status: Single 3 Married Widowed address is the Living together

patient’s long2425 Buendia St., Balut, Tondo, Manila term Permanent address address:

zip code

1772

Divorced/ legally separated

Tel. no.:

(02) 244-6847

City address:

Same as above

zip code

Tel. no.:

E-mail address: Occupation: Office Cityaddress:

None Family monthly income: None N/A Employer: None Tel. no.:

area code+ tel #

area code+ tel #

N/A

area code+ tel #

address Joy Balagtas Address/ Contact #: (02) 244-6847 Spouse: is the Father: Mother: Lorna Balagtas (Deceased) address Eduardo Balagtas (Deceased) in Metro Parent’s address: Tel. no.: Manila

area code+ tel # Daughter whereto the Person notify in case of emergency: Marites Balagtas Relationship: patient is 2425 Buendia St., Balut, Tondo, Manila Address: Tel. No.: staying

area code+ tel # to access Referred by: 3 HC Govt Inst PPMD FBO NGO Pvt MD/Institution diagnosis Sapaguita Health Center

Specify name, and #3436 Balut, Tondo, Manila possibleof referring facility: Address treatment.

2 3 Number of household contacts: 5 Less than or equal 10 yrs old: More than 10 yrs old: Persistent coughing with fresh blood Chief Complaint/s:

II. Review of Symptom/s 3 Cough 3 Fever 3 Back/ chest pain 3 Hemoptysis 3 Weight loss 3 Night sweats

Other symptoms: 3 Dyspnea at rest 3 Dyspnea on exertion 7 Pedal edema 28 Detect Cases of MDR-TB

Duration in month/s > 6 months

3 weeks

> 6 months

4 Months

6 months

3 weeks

> 1 month > 6 months

Comments With expectoration of yellowish sputum Remittent, usually in the afternoon Right upper back pain Last episodes 4/23/05 2 TBSP Approximately 10 kg

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III. Past Medical History: Validate Historythe of previous TB treatment: (from first to last) information in the MDRRegimen and duration Treatment facility DOTS Start date TB Suspects ( mm/dd/yyyy ) ( mos.)

(Y/N) Referral Form by 2HRZES 4HRZE Rosal Health Center doing actual 1. 2003 interview of 2003

2HRZES 4HRZE

Sampaguita Health Center 2. the patient’s 2HRZES 3HRZE Sampaguita Health Center 3. 9/14/04 TB treatment 4. history.

5.

6.

7.

Exposure to active TB: No If Yes Co- morbidities

MDR

5 3 3

Comments: (drugs taken, status, etc.)

2 year (s) year (s) year (s) year (s) year (s) year (s) year (s) year (s)

Y Y Y

3 Non MDR

Duration

3 Diabetes Mellitus 5 Cancer 5 HIVinfection/AIDS 5 Kidney disease 5 Lung disease 5 Epilepsy 5 Psychiatric condition 5 Others

Outcome

(1=cured, 2=tx completed, 3=failed, 4=defaulted, 5=unknown)

Glibenclamide 5mg TID Status

Check for other drugs used by the patient to help identify comorbidities.

Allergy: Drugs: Type of reaction: NA 1. None 2.

5

Concomitant drugs / Duration:

None Pneumonectomy/ Lobectomy Others, specify Previous surgery: 3

Date of surgery: Complications:

NA NA

/

/

IV. Social History: Tobacco/ Cigarettes Alcohol Current Current Past 3 Past 3 Never Never Sticks/day x yrs Type /bottles /day x yrs Beer 2/day x 35yrs 20 sticks/day x 31yrs

Women: LMP / / G P (mm/dd/yy)

Drug Abuse Current Past 3 Never Type (shabu, marijuana, etc)

Contraceptive use (for women only): No yes, specify

Sexual History: Had

two partners other than wife / commercial sex workers

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V. Physical examination and laboratory procedures: Height: 167 cm

Vital Signs: Temp: 37.4 Celsius BP: 120/80 mmHg

Weight: 49. 2 Kg. PR/ HR: 90 / min O2 sat by Pulse oximeter: %

0 = Not done 1 = Normal 2 = Abnormal

System examination:

2 2

General Health: Skin:

1 1 2

BCG scar: Oropharynx: Cardiovascular: Thorax & Lungs:

2 1 1 1 1 1 1

Use of accessory muscles: Abdomen: Genito-Urinary: Extremities: Neurological: Lymph Nodes: Endocrine:

AFB 2+

Ambulatory, cachectic Poor skin turgor

Present

(+) wheezing, bilateral lung fields, decreased breath sounds on R lung field

(+) SCM, intercostal retractions

Date

02/ 15 / 05

/

/

Always ask for results of smear, culture & DST done prior to consultation, if available.

/

/

Other laboratory results: Liver function tests

Renal function tests

CBC

FBS, etc.

30 Detect Cases of MDR-TB

None

/min

Describe abnormalities

Laboratory procedures: Smear, Culture and DST results from other laboratory

28

RR at rest:

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Chest X-ray: Date:

04 / 17

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MODULE B Programmatic Management of Drug - Resistant TB (PMDT)

/ 2005

Right Lung

Left Lung

1

8

2

2

0 - Normal

7 - Fibrosis

1 - Cavitary

8 - Fibrothorax

2 - Infiltrate

9 - Bullae

3 - Nodule

10 - Pleural effusion

4 - Miliary TB

11 - Pneumothorax

5 - Intrathoracic lymphadenopathy

12 - Bronchiectasis

6 - Endobronchial spread

14 - Consolidation

13 - Atelectasis 15 - Mass

VI. Assessment: Based on the patient’s TB treatment history, select the appropriate category.

TB suspect 3 New

3

Retreatment

If retreatment, check any of the following types.

3

If new or retreatment, check any of the following risk factors.

None Symptomatic contact of confirmed/ Based on suspected MDRTB patient the patient’s Non-converter of Categorybackground, II Symptomatic HIV-positive symptoms, HIV status, Category 2 or more non-DOTS treatment course

Drug-resistant TB suspect (Categories) Category I Failure 3 Category II Failure Return after Default (RAD) Category I Relapse Category II Relapse Category IV Relapse Other

II conversion, and number of treatment courses, select the appropriate risk factors for drug resistance.

Non-DOTS Other (+) Other (-)

Disease other than TB, specify

VII. Plan: 3 For smear x 2 3 For TB culture x 2 3 For Drug susceptibility testing

Start TB treatment, specify regimen: Prescribe ancillary drugs or drugs for co-morbidity, or symptomatic treatment

The Treatment Center physician ensures the completeness of data on the MDR-TB Screening Form.

Others

The plan for diagnosis and treatment indicates the sputum tests to be performed and how many samples are needed in order to confirm the assessment.

Attending MD:

Dr. Dan Rivera

Date:

4 / 28 / 05

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MODULE B

2.2 Fill out the Acknowledgement Form After the patient has been interviewed and examined by the Treatment Center physician with all data recorded on the MDR-TB Screening Form, he will fill out the Acknowledgement Form in duplicate copies. Tick the box for “initial diagnosis”. This form is used to inform the referring DOTS facility or doctor that the MDR-TB suspect has been received and examined by the Treatment Center. The Treatment Center physician addresses the form to the referring physician or DOTS facility, writes down the pertinent data including relevant history, past treatment, patient type and physical examination findings. He also writes down the initial diagnosis, and management plans such as laboratory procedures to confirm the diagnosis, or any symptomatic treatment being given. See the Reference Booklet for instructions on how to fill out the Acknowledgment Form.

There are some patients for whom the treatment of TB needs to be stopped while waiting for the DST results.

This depends on the suspect’s history of TB treatment or the outcome he had from these treatments. There are also patients who will be referred back to the referring DOTS facility for continuation of DOTS treatment while waiting for DST results. The Treatment Center physician will be the one to advise the patient on what to do with his current treatment and will write this advice down on the Acknowledgement Form. All previously treated patients, symptomatic contacts of drug-resistant cases, whether new or retreatment, are suspects for drug resistance; hence, these patients are candidates for sputum culture and DST in addition to smear. HIV patients with TB symptoms should also have culture and DST because of the high mortality in TB/HIV co-infection.

DOTS facilities are advised to refer all their previously treated symptomatic patients, whether smear-positive or smear-negative, Category II non-converters, symptomatic contacts of confirmed or suspected drug-resistant cases, and HIV cases with TB symptoms to MDR-TB Treatment Centers. The following table will guide the Treatment Center when giving advice to patients. This decision table may undergo some changes as more evidence on this matter is gathered from the experience in the Philippines.

Table 3: Decision table for patients awaiting DST results

Type of suspect

Action to take

–– –– –– ––

Relapse Return after default Category I failure “Other” with only one previous treatment

Start Category II regimen while awaiting DST. If smear non-converter on Category II (on month 3), stop treatment and refer back to the MDR-TB Treatment Center and await DST.

–– ––

Category II failure Previously treated patients with two or more treatment courses in the past

Stop treatment and await DST.

––

Symptomatic contact of a confirmed or suspected drugresistant case

Action will depend on consilium decision guided by smear result, previous history and clinical status

HIV positive with TB symptoms

Start Category I regimen, if new Start Category II or Category IV, if previously treated, depending on joint decision of consilium and HIV doctor.

––

MDR-TB suspects who are noted to be critically ill at the time of screening or are clinically deteriorating are immediately referred to the Consilium for case discussion and possible expedited treatment using the appropriate regimen. This is discussed in more detail in section 2.4 in this module.

After completing the Acknowledgement Form, give one copy to the patient to be given back to his referring physician or facility and attach the other copy to the MDR-TB Screening Form which remains at the Treatment Center. There are occasions when the patient is unable to give this back to the referring physician. Hence, a copy of the accomplished Acknowledgement Form may need to be sent directly by telefax, if the contact number is known. An example of a PMDT Acknowledgement Form is shown on the next page.

Later when DST results have been received by the Treatment Center, another Acknowledgement Form is completed and sent to the referring physician or facility this time with the box for “final diagnosis” ticked and updated information on the patient given.

32 Detect Cases of MDR-TB

Example of the Acknowledgement Form MODULE B

REP U

S NE PI

Programmatic Management of Drug - Resistant TB (PMDT)

F THE PHI LIP IC O BL

Acknowledgement Form Date: 4/28/05

3 Initial Diagnosis

To: Dr. A. Madrid

Sampaguita Health Center

Final Diagnosis

Duplicate copy of PMDT Acknowledgement Form must always be made.

Tondo, Manila

Thank you for referring your patient diagnosis/management.

Jose A. Balagtas

Pertinent findings/ Laboratory examinations:

, for further TB

The patient must give the duplicate copy to the referring MD.

Received anti –TB treatment since 1997

Failure of category II treatment on two occasions.

(+) wheezing, bilateral lung fields, decreased breath sounds on R lung field To consider Multidrug-resistant TB

Plans/Recommendations:

For AFS/TBC and DST

Await DST result prior to initiation of treatment

Clinic Physician:

Dr. Dan Rivera

Contact numbers: 742-1534/ 781-3761 to 65 loc. 146 Treatment Center: KASAKA QI Treatment Center

Detect Cases of MDR-TB

33

MODULE B

2.3 Fill out the TB Symptomatics Masterlist Proceed to register the patient in the TB Symptomatics Masterlist.

The TB Symptomatics Masterlist is a record of ALL TB suspects, including TB and MDR-TB suspects seen at the MDRTB Treatment Center. It is particularly useful for monitoring case detection activities and the results of all sputum examinations requested for screening from the laboratory. See Module G: Monitoring MDR-TB Case Detection and Treatment for a discussion about how to use this register for monitoring MDR-TB case detection.

Whenever you identify a TB or an MDR-TB suspect, list this patient in the TB Symptomatics Masterlist. An example of an accomplished Masterlist is shown on the next pages.

Be sure to complete the screening code, date of screening as well as the complete name and address, date of birth and sex of the patient. The complete address will enable the staff at the Treatment Center to locate the patient once the results of the tests confirm TB or MDR-TB and the patient does not return.

34 Detect Cases of MDR-TB

SALCEDO, Myrna Cortez

TAN, Vincent Lim

SANTOS, Sylvia Gomez

MANYO, Avelina Corazon

LEGAZPI, Agapito Rivera

SALDUVERA, Manny Manuel

02-05-04-0082 04/28/05

02-05-04-0083 04/28/05

02-05-04-0084 04/29/05

02-05-05-0001 05/02/05

02-05-05-0002 05/02/05

02-05-05-0003 05/10/05

(1) TX Centers: 01 - TDF-MMC DOTS Clinic 02 - KASAKA-QI MDR-TB Housing Facility 03 - LCP-PHDU DOTS Center 04 - DJNRMH DOTS Center 05 - PTSI Tayuman DOTS Center 06 - ________ 07 - ________

BALAGTAS, Jose Amorsolo

Last, First and Middle name (3)

02-05-04-0081 04/25/05

Screening Code Date screened TC-YY-MM-NNNN mm/dd/yy (1) (2)

Name

08/03/85

19

12/23/67

39

12/23/67

39

02/02/78

27

03/28/83

23

05/26/58

48

01/20/55

50

Date of birth (mm/dd/yy) (5)

Age (completed yrs)

This refers to the facility or MD/ who / referred the patient to the Treatment / Center not necessarily the one/ who gave the last TB treatment.

Unit 555, Rancher's Appartle, Kakarong St., Brgy. Sta. Cruz, Makati City, NCR

#2 ABC cmpd. Mabuhay St., Payatas, Manila NCR

#2 ABC cmpd. Mabuhay St., Payatas, Manila NCR

47 National Road, Brgy. San Vicente, Bacacay Albay Bicol Region

Arlegui St. Malacanang cmpd, Manila NCR

75 Sta Mesa Heights, Sta Mesa, Manila NCR

2425 Buendia St. Balut Tondo, Manila NCR

No. of street, street, City, Region (4)

Address

(6)

3

0

5

3

4

2

(8) Funding: 0- Gen fund 2- Round 2 5- Round 5 99- Others; specify ____________

(6) Sex: 1- Male 2- Female

1

1

2

2

1

2

3

(7)

Sex

1

No. of previous TB treatment

TB Symptomatics Masterlist

Programmatic Management of Drug - Resistant TB (PMDT)

5

5

5

5

5

5

5

(8)

Sta. Cruz HC

patient Merlie Camias

Vergonville DOTS Center

Dr. Artemis Malunsay

Sta Monica Hospital

Greenview Dots Center

Sampaguita HC

Name of Health facility/ Private MD

NCR

Dr. Reyes

0

0

Dr. Lauro Macandog

Philippine General Hospital

Greenview Dots Center

Sampaguita HC

Health facility/ Private MD

1 - New 2 - After Cat I failure 3 - After Cat II failure 4 - After Cat IV failure 5 - After default 6 - Cat I relapse 7 - Cat II relapse

1

1

7

10.1

10.1

5

3

Registration group (12)

8 - Cat IV relapse 9 - Transfer-in 10 - Other patient w/ 10.1 Non-DOTS 10.2 Other (+) 10.3 Other (-)

NCR

Makati

NCR

Manila

NCR

Las Pinas

5

Albay

NCR

Manila

NCR

Manila

NCR

Manila

City/ Region

Site where last treated for TB (11)

(12) Registration group

Makati

NCR

Manila

NCR

Las Pinas

5

Albay

NCR

Manila

NCR

Manila

NCR

Manila

City/ Region

Referring site or referring doctor (10)

F THE PHI LIP IC O BL

REP U

(9) Source of referral 1- Govt. DOTS facility 2- Govt. Non-DOTS Facility 3- Private DOTS Facility 4- Private Non-DOTS Facility 5- Faith-based unit/NGO DOTS Facility 6- Faith-based unit/NGO Non-DOTS Facility 7- Walk - in

1

7

1

4

2

3

1

(9)

Source of referral

Page 1 of the TB Symptomatics Masterlist

Funding

S NE PI

Detect Detect Cases CasesofofMDR-TB MDR-TB

35

/

2+ / MTB

04/28/05

1+ /MTB 04/28/05

0 /MTB

04/29/05

4+ /MTB 05/02/05 1+ /MTB 05/02/05 0 / MTB 05/10/05

/

1,2,8 04 / 17 / 05

1,2

03/ 21 /05

1,15 01 /22 /05

1,2,3

04/02/05

1,2 04 /27 /05 2 04 /25 /05 1,2 05/05/05

1, 2, 3, 4, 5, 6

1,3,4

1,3,4,5

1

1, 2, 3, 4, 5, 6

1,3

1, 2, 3, 4, 5, 6

2

1

4

4

4

0

1

(13) Risk factors 0 - None 1 - Household contact of MDR 2 - Non-converter cat II 3 - HIV-positive 4- ≥ 2 non-DOTS treatment courses

/

/

/

/

/

/

05 / 02 / 05

0 /MTB

3+ /MTB 05 / 2/05

04 / 29 / 05

0 / MTB

4+ / MTB 04/26/05

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/ /

/ / /

/

(15) CXR results 0 - Normal 1 - Cavitary 2 - Infiltrate 3 - Nodule 4 - Miliary TB 5 - Intrathoracic lymphadenopathy 6 - Endobronchial spread 7 - Fibrosis 8 - Fibrothorax

/

/

for DOTS. /local health center / / /

/

/

/

S

R

R

R

R

H

9 - Bullae 10 - Pleural effusion 11 - Pneumothorax 12 - Bronchiectasis 13 - Atelectasis 14 - Consolidation 15 - Mass 16 - others, specify ______________

/

/

/ / / / A/ pansusceptible case is/ referred to/ the

(14) Symptoms: 0- None 1- Cough 2- Fever 3- Chest/back pain 4- Hemoptysis 5- Weight loss 6- Night sweats

/

/

/

3+ / MTB 05/03/05 1+ / MTB 05/03/05 1+ / MTB 05/11/05

3+ / MTB 04/25/05

(15)

(14)

Date sputum collected (mm/dd/yy)

Screening (DSSM/ culture results) (16)

(13)

Date done

CXR results

Risk factors

36 Detect Cases of MDR-TB

Symptoms

TB Symptomatics Masterlist | page 2 of 2

Page 2 of the TB Symptomatics Masterlist

S

R

R

R

R

R

S

S

R

S

R

S

S

Pending

S

R

S

S

Km

S

S

R

S

S

Ofx

S

S

R

S

S

Cfx

S

S

S

S

S

Lfx

ND

ND

ND

ND

ND

H - Isoniazid R - Rifampicin Z - Pyrazinamide E - Ethambutol S - Streptomycin Km - Kanamycin Ofx - Ofloxacin Cfx - Cifloxacin Lfx - Levofloxacin

/

/

/

/

/

/

8/31/05

9/23/05

10/5/05

9/14/05

10/10/05

Date DST released

/

/

/

/

/

/

9/6/05

9/6/05

9/27/05

10/11/05

9/20/05

10/18/05

Consilium date

Registration date (mm/dd/yy) (18)

4.

5.

6.

7.

8.

Suspects with at least 1 culture positive result Suspects with DST results Suspects with HR resistance Number of suspects with pre-enrollment number Number of patients with treatment start date

REP U

05-0079 8/10/2005 09/07/05 Referred to LHC 05-0080 8/30/2005

10/4/2005

05-0097

05-0098 11/8/2005

Lost before enrollment

05-0096

05-0099 11/24/2007

Enrolled? If YES, indicate treatment start date. If NO, indicate reason.

Pre-enrollment No. (19) (YY-NNNN)

/ / A Pre-enrollment No. is/assigned to/ all TB symptomatics who are either a) proven MDR-TB by DST, or b) decided Summary by the consilium to start treatment even without DST 1. Number of DR-TB suspects confirmation due to high clinical suspicion. Both groups 2. Suspects with 2 sputum specimens tested are3. all forwith start treatment.

Suspects at leastof 1 culture results

ND

ND

ND

ND

ND

Other Other

Make sure MDR –TB confirmed patients are immediately presented to the consilium for regimen design and start of treatment.

S

R

R

S

R

E

(17) DST results S = susceptible R = resistant ND = not done

S

S

R

S

S

Z

DST results (17)

Programmatic Management of Drug - Resistant TB (PMDT)

F THE PHI LIP IC O BL

S NE PI

MODULE B

For Treatment Site Staff When you have reached this point in the module, your facilitator will show you a sample of the TB Symptomatics Masterlist. After a short discussion, continue reading on page 58.

For Treatment Center Staff Exercise C – Written Exercise When you have reached this point in the module, you are ready to do Exercise C. See instructions below for Exercise C. Do this exercise by yourself.

Exercise C: Written exercise Recording in the TB Symptomatics Masterlist In this exercise each of you will be given a TB Symptomatics Masterlist. Use the patient data provided in the MDR-TB Screening Forms in the following pages, enter each TB suspect and complete the TB Symptomatics Masterlist. Work individually on this exercise. Ask your facilitator for help if you do not understand what to do.

• • • •

List each of the 5 MDR-TB suspects presented below in the TB Symptomatics Masterlist and fill out Columns 1-15.

Assign each, in sequence, a Screening code. Assume that the last code in the Masterlist was TC-YYMM-096.

Funding source is Round 5 GFATM. Assume that the patients went to the Treatment Center on the day that you as the referring MD made the MDR-TB Suspects Referral Form.

Detect Cases of MDR-TB

37

Case 1: REP U

Programmatic Management of Drug - Resistant TB (PMDT)

S NE PI

F THE PHI LIP IC O BL

MDR - TB SCREENING FORM Mark with check ( ) if symptom is present, PE is done and disease is present, otherwise, mark with (X). Please ensure the completeness of all information.

Screened at:

3

MMC/TDF

KASAKA

LCP

Others, specify

Screening code: (TC-YY-MM-NNNN)

Date:

(mm/dd/yy)

I. Demographics Sariwa Name:

Sex:

3

Surname

Male Date of birth: Female

Sonia

Given Name

August 18, 1973 (mm/dd/yy)

Age:

Nationality: Filipino Religion: Catholic

34

11/29/2007

Santos

Middle Name

Place of birth:

Cavite

Civil status: 3 Single Married Widowed Living together Divorced/ legally separated

Permanent address: 23 Santol St., Barangay San Antonio, Cavite City

zip code 4100 Tel. no.: (046) 431-40086

area code+ tel #

City address:

zip code

Tel. no.:

area code+ tel #

none

10 000 Php Family monthly income: none Employer: none Tel. no.:

E-mail address: Occupation: Office address:

Spouse: none Address/ Contact #: Eufronio Sariwa (deceased)

Sofriana Sariwa Father: Mother: Parent’s address: 23 Santol St., Barangay San Antonio, Cavite City Tel. no.:

Person to notify in case of emergency: Sofriana Sariwa Address: 23 Santol St., Barangay San Antonio, Cavite City

area code+ tel #

(046) 431-40086

area code+ tel #

Relationship: mother

(046) 431-40086 Tel. No.:

area code+ tel #

HC Govt Inst PPMD FBO NGO Pvt MD/Institution Referred by: 3 Specify name, Santol Health Center Address of referring facility: Barangay San Antonio, Cavite City 3

Number of household contacts: Less than or equal 10 yrs old: 0 More than 10 yrs old: persistent cough with hemoptysis Chief Complaint/s:

II. Review of Symptom/s

Cough Fever Back/ chest pain Hemoptysis Weight loss Night sweats Other symptoms: 5 Dyspnea at rest 3 Dyspnea on exertion 5 Pedal edema

3 5 3 3 3 5

38 Detect Cases of MDR-TB

3

Duration in month/s

1

Comments productive, minimal amt., whitish in color

1

1

on both upper lung area, greater in right dark red in color, 4 episodes for the last 2 wks approximately 5 kg

1

REP U

MDR - TB SCREENING FORM | page 2 of 4

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F THE PHI LIP IC O BL

Programmatic Management of Drug - Resistant TB (PMDT)

III. Past Medical History:

History of previous TB treatment: (from first to last) Regimen and duration

Start date

( mm/dd/yyyy )

1. June 2.

3.

4.

5.

6.

7.

( mos.)

2002

2 HRZE / 2 HR

Co- morbidities

MDR

(Y/N)

Outcome

(1=cured, 2=tx completed, 3=failed, 4=defaulted, 5=unknown)

Y

4

Non MDR

Duration

Comments: (drugs taken, status, etc.) year (s) year (s) year (s) year (s) year (s) year (s) year (s) year (s)

5 Diabetes Mellitus 5 Cancer 5 HIVinfection/AIDS 5 Kidney disease 5 Lung disease 5 Epilepsy 5 Psychiatric condition 5 Others

DOTS

Santol Health Center

No If Yes Exposure to active TB: 3

Allergy: Drugs: 1.

2.

Treatment facility

Status

Type of reaction:

No known food or drug allergies

Concomitant drugs / Duration:

None Pneumonectomy/ Lobectomy Others, specify Previous surgery: 3

Date of surgery: Complications:

/

/

IV. Social History: Tobacco/ Cigarettes Alcohol Current Current Past Past Never 3 Never 3 Sticks/day x yrs Type /bottles /day x yrs

0 Women: LMP 11 / 29 / 2007 G P (mm/dd/yy)

Drug Abuse Current Past Never 3 Type (shabu, marijuana, etc)

0

yes, specify Contraceptive use (for women only): No 3

Sexual History:

sexually active

pills

Detect Cases of MDR-TB

39

REP U

MDR - TB SCREENING FORM | page 3 of 4

Programmatic Management of Drug - Resistant TB (PMDT)

V. Physical examination and laboratory procedures: Height: 155 cm Vital Signs: Temp: 37.5 Celsius BP: 130/90 mmHg

System examination: General Health: Skin: BCG scar: Oropharynx: Cardiovascular: Thorax & Lungs: Use of accessory muscles: Abdomen: Genito-Urinary: Extremities: Neurological: Lymph Nodes: Endocrine:

Weight: 43 Kg. PR/ HR: 98 / min RR at rest: O2 sat by Pulse oximeter: %

0 = Not done 1 = Normal 2 = Abnormal

2 2 0

0 2

1 0

1 0 2 0

distressed, cachectic, generally weak (+) pallor of skin, conjunctiva, palms, & nail beds (-) BCG scar

(+) crackles heard on both upper lung fields, more on the right

(+) use of accessory muscles

(+) papable cervical lymph nodes

DSSM 0 / 2+ / 1+

Date 11

/ 25 / 2007

/

/

/

/

Other laboratory results: Liver function tests

Renal function tests

CBC

FBS, etc.

40 Detect Cases of MDR-TB

/min

Describe abnormalities

Laboratory procedures: Smear, Culture and DST results from other laboratory

25

S NE PI

F THE PHI LIP IC O BL

REP U

MDR - TB SCREENING FORM | page 4 of 4

Chest X-ray: Date:

/

S NE PI

F THE PHI LIP IC O BL

MODULE B Programmatic Management of Drug - Resistant TB (PMDT)

/

Right Lung

Left Lung

0 - Normal

7 - Fibrosis

1 - Cavitary

8 - Fibrothorax

2 - Infiltrate

9 - Bullae

3 - Nodule

10 - Pleural effusion

4 - Miliary TB

11 - Pneumothorax

5 - Intrathoracic lymphadenopathy

12 - Bronchiectasis

6 - Endobronchial spread

14 - Consolidation

13 - Atelectasis 15 - Mass

VI. Assessment: TB suspect 3 New

3 Retreatment

If retreatment, check any of the following types.

If new or retreatment, check any of the following risk factors.

3 Drug-resistant TB suspect (Categories) Category I Failure Category II Failure 3 Return after Default (RAD) Category I Relapse Category II Relapse Category IV Relapse Other

3

None Symptomatic contact of confirmed/ suspected MDRTB patient Non-converter of Category II Symptomatic HIV-positive 2 or more non-DOTS treatment course

Non-DOTS Other (+) Other (-)

Disease other than TB, specify

VII. Plan: 2 For smear x 2 3 For TB culture x Category II Treatment while awaiting DST; 3 For Drug susceptibility testing 3 Start TB treatment, specify regimen: stop treatment if non-converter on 3rd month 3 Prescribe ancillary drugs or drugs for co-morbidity, or symptomatic treatment Others

Attending MD:

Dave Verzosa, MD

Date:

11/29/2007

Detect Cases of MDR-TB

41

Case 2: REP U

Programmatic Management of Drug - Resistant TB (PMDT)

S NE PI

F THE PHI LIP IC O BL

MDR - TB SCREENING FORM Mark with check ( ) if symptom is present, PE is done and disease is present, otherwise, mark with (X). Please ensure the completeness of all information.

Screened at:

3

MMC/TDF

KASAKA

LCP

Others, specify

Screening code: (TC-YY-MM-NNNN)

Date:

(mm/dd/yy)

I. Demographics Reloz Name:

Sex:

3

Surname

Male Date of birth: Female

Rolanda

Given Name

September 02, 1958

Age:

(mm/dd/yy)

Nationality: Filipino Religion: Catholic

49

12/03/2007 (Saturday)

Ramirez

Middle Name

Place of birth:

Makati

Civil status: Single Married 3 Widowed Living together Divorced/ legally separated

Permanent address: 44526 Jhonny St., Pio del Pilar, Makati City

zip code 1230 Tel. no.: 989014301

area code+ tel #

area code+ tel #

City address: 44526 Jhonny St., Pio del Pilar, Makati City

zip code 1230 Tel. no.: 989014301

none 50 000 Php Family monthly income: Manager Mano Mano Manufacturing Company Employer: 44526 Jhonny St., Pio del Pilar, Makati City Tel. no.:

E-mail address: Occupation: Office address:

Spouse: Rolly Reloz (deceased) Address/ Contact #: Christian Ramirez Father: Mother: Sarah Ramirez Parent’s address: Purok 31, Barangay Pampanga, Davao City, Davao del Sur Tel. no.:

Son Person to notify in case of emergency: Rolex Reloz Relationship: Address: 44526 Jhonny St., Pio del Pilar, Makati City Tel. No.: 989014301

area code+ tel #

none

area code+ tel #

area code+ tel #

HC Govt Inst PPMD FBO NGO Pvt MD/Institution Referred by: 3 Specify name, Pio del Pilar Health Center Address of referring facility: Barangay Pio del Pilar, Makati City 5

Number of household contacts: Less than or equal 10 yrs old: 3 More than 10 yrs old: persistent cough Chief Complaint/s:

II. Review of Symptom/s

Cough Fever Back/ chest pain Hemoptysis Weight loss Night sweats Other symptoms: 5 Dyspnea at rest 3 Dyspnea on exertion 5 Pedal edema

3 3 3 3 3 3

42 Detect Cases of MDR-TB

Duration in month/s 2 wks

1 wk

1

1

1

2

Comments productive, minimal amt., whitish in color usually in the afternoon on both lung area, greater in right upper area dark red in color, 1 episode for the last wk approximately 7 kg

REP U

MDR - TB SCREENING FORM | page 2 of 4

S NE PI

F THE PHI LIP IC O BL

Programmatic Management of Drug - Resistant TB (PMDT)

III. Past Medical History:

History of previous TB treatment: (from first to last) Regimen and duration

Start date

( mm/dd/yyyy )

1. Aug. 2003 2. Aug. 2005 3. Dec. 2006 4.

5.

6.

7.

( mos.)

Treatment facility

3 Myrin P Forte / 3 Myrin Dr. A. Reyes (private MD) 6 Myrin P Forte Dr. A. Reyes (private MD) 3 Econokit / 4 Econopack Dr. A. Reyes (private MD)

No If Yes Exposure to active TB: 3 Co- morbidities

MDR

N N N

5 5 5

Comments: (drugs taken, status, etc.) year (s) year (s) year (s) year (s) year (s) year (s) year (s) year (s)

Status

Allergy: Drugs: Type of reaction: No known food or drug 1.

2.

(Y/N)

Outcome

(1=cured, 2=tx completed, 3=failed, 4=defaulted, 5=unknown)

Non MDR

Duration

5 Diabetes Mellitus 5 Cancer 5 HIVinfection/AIDS 5 Kidney disease 5 Lung disease 5 Epilepsy 5 Psychiatric condition 5 Others

DOTS

allergies

Concomitant drugs / Duration:

None Pneumonectomy/ Lobectomy Others, specify Previous surgery: 3

Date of surgery: Complications:

/

/

IV. Social History: Tobacco/ Cigarettes Alcohol Current Current Past Past Never 3 Never 3 Sticks/day x yrs Type /bottles /day x yrs

5 Women: LMP 11 / 25 / 2007 G P (mm/dd/yy)

Drug Abuse Current Past Never 3 Type (shabu, marijuana, etc)

5

No yes, specify Contraceptive use (for women only): 3

Sexual History:

sexually inactive_for more than a year

Detect Cases of MDR-TB

43

REP U

MDR - TB SCREENING FORM | page 3 of 4

Programmatic Management of Drug - Resistant TB (PMDT)

V. Physical examination and laboratory procedures: Height: 157 cm 37.5 Vital Signs: Temp: Celsius BP: 130/90 mmHg

System examination: General Health: Skin: BCG scar: Oropharynx: Cardiovascular: Thorax & Lungs: Use of accessory muscles: Abdomen: Genito-Urinary: Extremities: Neurological: Lymph Nodes: Endocrine:

Weight: 44 Kg. 98 PR/ HR: / min RR at rest: O2 sat by Pulse oximeter: %

0 = Not done 1 = Normal 2 = Abnormal

2 2 0 0 2 1 0 1 0 2 0

24

Describe abnormalities

distressed, cachectic (+) pallor of skin, conjunctiva, palms, & nail beds (-) BCG scar (+) crackles heard on both lung fields (+) use of accessory muscles

(+) palpable cervical lymph nodes

Laboratory procedures: Smear, Culture and DST results from other laboratory

Date

/

/

/

/

/

/

Other laboratory results: Liver function tests

Renal function tests

CBC

FBS, etc.

44 Detect Cases of MDR-TB

/min

S NE PI

F THE PHI LIP IC O BL

REP U

MDR - TB SCREENING FORM | page 4 of 4

Chest X-ray: Date:

11

/

26

S NE PI

F THE PHI LIP IC O BL

MODULE B Programmatic Management of Drug - Resistant TB (PMDT)

/

2007

Right Lung

Left Lung

1

2

10

0 - Normal

7 - Fibrosis

1 - Cavitary

8 - Fibrothorax

2 - Infiltrate

9 - Bullae

3 - Nodule

10 - Pleural effusion

4 - Miliary TB

11 - Pneumothorax

5 - Intrathoracic lymphadenopathy

12 - Bronchiectasis

6 - Endobronchial spread

14 - Consolidation

13 - Atelectasis 15 - Mass

VI. Assessment: TB suspect 3 New 3 Retreatment

If retreatment, check any of the following types.

If new or retreatment, check any of the following risk factors.

3 Drug-resistant TB suspect (Categories) Category I Failure Category II Failure Return after Default (RAD) Category I Relapse Category II Relapse Category IV Relapse 3 Other

3

None Symptomatic contact of confirmed/ suspected MDRTB patient Non-converter of Category II Symptomatic HIV-positive 3 2 or more non-DOTS treatment course

Non-DOTS Other (+) Other (-)

Disease other than TB, specify

VII. Plan: 2 3 For smear x 2 3 For TB culture x 3 For Drug susceptibility testing

Start TB treatment, specify regimen: Prescribe ancillary drugs or drugs for co-morbidity, or symptomatic treatment

3

Others

Await DST results prior to initiation of treatment if DSSM (+). If DSSM (-), refer to TBDC.

Attending MD:

Dave Verzosa, MD

Date:

12/03/2007

Detect Cases of MDR-TB

45

MODULE B

Programmatic Management of Drug - Resistant TB (PMDT)

S NE PI

F THE PHI LIP IC O BL

REP U

Case 3:

MDR - TB SCREENING FORM Mark with check ( ) if symptom is present, PE is done and disease is present, otherwise, mark with (X). Please ensure the completeness of all information.

Screened at:

3

MMC/TDF

KASAKA

LCP

Others, specify

Screening code: (TC-YY-MM-NNNN)

Date:

(mm/dd/yy)

I. Demographics Santos Name:

Surname

Santiago

Given Name

12/05/2007

Suma

Middle Name

Makati Sex: 3 Male Date of birth: April 02, 1952 Age: 55 Place of birth: (mm/dd/yy)

Female Married Nationality: Filipino Religion: Catholic Civil status: Single 3 Widowed

Living together

Permanent address: 2062-1 Anak Bayan, Paco, Manila

zip code 1007

Divorced/ legally separated

Tel. no.:

53055555

Tel. no.:

53055555

City address:

2062-1 Anak Bayan, Paco, Manila

zip code

1007

area code+ tel #

area code+ tel #

none 30 000 Php Family monthly income: Accounting Clerk Employer: Manila City Hall Padre Burgos St., Manila 5247141 Tel. no.:

E-mail address: Occupation: Office address:

Spouse: Luzviminda Santos Address/ Contact #: John Santos Father: Mother: Diana Santos

Parent’s address: 2062-1 Anak Bayan, Paco, Manila Tel. no.:

Person to notify in case of emergency: Luzviminda Address: 2062-1 Anak Bayan, Paco, Manila

53055555

Santos

Relationship:

Tel. No.:

area code+ tel #

area code+ tel #

53055555

area code+ tel #

HC Govt Inst PPMD FBO NGO Pvt MD/Institution Referred by: 3 Specify name, J. Fabella Health Center Address of referring facility: San Andres, Manila 3

0 Number of household contacts: Less than or equal 10 yrs old: More than 10 yrs old: persistent cough Chief Complaint/s:

II. Review of Symptom/s

Cough Fever Back/ chest pain Hemoptysis Weight loss Night sweats Other symptoms: 5 Dyspnea at rest 3 Dyspnea on exertion 5 Pedal edema

3 5 3 5 5 3

46 Detect Cases of MDR-TB

Duration in month/s 3 wks

1

1

3

Comments productive, minimal amt., whitish in color

on left upper lung area; aggravated by cough

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III. Past Medical History:

History of previous TB treatment: (from first to last) Regimen and duration

Start date

( mm/dd/yyyy )

Exposure to active TB: No If Yes Co- morbidities

3 MDR

(Y/N)

Outcome

(1=cured, 2=tx completed, 3=failed, 4=defaulted, 5=unknown)

Non MDR

Duration

Comments: (drugs taken, status, etc.) year (s) year (s) year (s) year (s) year (s) year (s) year (s) year (s)

5 Diabetes Mellitus 5 Cancer 5 HIVinfection/AIDS 5 Kidney disease 5 Lung disease 5 Epilepsy 5 Psychiatric condition 5 Others

Status

Allergy: Drugs: Type of reaction:

No known food or drug

1.

2.

DOTS

No previous TB treatment

1.

2.

3.

4.

5.

6.

7.

( mos.)

Treatment facility

allergies

Concomitant drugs / Duration:

None Pneumonectomy/ Lobectomy Others, specify Previous surgery: 3

Date of surgery: Complications:

/

/

IV. Social History: Tobacco/ Cigarettes Alcohol Current Current Past Past Never 3 Never 3 Sticks/day x yrs Type /bottles /day x yrs

Women: LMP / / G P (mm/dd/yy)

Drug Abuse Current Past Never 3 Type (shabu, marijuana, etc)

Contraceptive use (for women only): No yes, specify

Sexual History:

sexually inactive for a year

Detect Cases of MDR-TB

47

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Programmatic Management of Drug - Resistant TB (PMDT)

V. Physical examination and laboratory procedures: Height: 169 cm 37.3 Vital Signs: Temp: Celsius BP: 130/80 mmHg

System examination: General Health: Skin: BCG scar: Oropharynx: Cardiovascular: Thorax & Lungs: Use of accessory muscles: Abdomen: Genito-Urinary: Extremities: Neurological: Lymph Nodes: Endocrine:

Weight: 60 Kg. PR/ HR: 84 / min RR at rest: O2 sat by Pulse oximeter: %

0 = Not done 1 = Normal 2 = Abnormal

1 1 0 0 2 1 0 1 0 2 0

22

Describe abnormalities

(+) BCG scar (+) crackles heard on left upper lung field

(+) palpable cervical lymph nodes

Laboratory procedures: Smear, Culture and DST results from other laboratory

Date

/

/

/

/

/

/

Other laboratory results: Liver function tests

Renal function tests

CBC

FBS, etc.

48 Detect Cases of MDR-TB

/min

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Chest X-ray: Date:

12

/

01

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MODULE B Programmatic Management of Drug - Resistant TB (PMDT)

/

Right Lung

2007 Left Lung

2

0 - Normal

7 - Fibrosis

1 - Cavitary

8 - Fibrothorax

2 - Infiltrate

9 - Bullae

3 - Nodule

10 - Pleural effusion

4 - Miliary TB

11 - Pneumothorax

5 - Intrathoracic lymphadenopathy

12 - Bronchiectasis

6 - Endobronchial spread

14 - Consolidation

13 - Atelectasis 15 - Mass

VI. Assessment: TB suspect 3 3 New

Retreatment

If retreatment, check any of the following types.

If new or retreatment, check any of the following risk factors.

None

3 Symptomatic contact of confirmed/ suspected MDRTB patient Non-converter of Category II Symptomatic HIV-positive 2 or more non-DOTS treatment course

Drug-resistant TB suspect (Categories) Category I Failure Category II Failure Return after Default (RAD) Category I Relapse Category II Relapse Category IV Relapse Other Non-DOTS Other (+) Other (-)

Disease other than TB, specify

VII. Plan: 2 3 For smear x 2 3 For TB culture x 3 For Drug susceptibility testing 3 Start TB treatment, specify regimen: 5 Prescribe ancillary drugs or drugs for co-morbidity, or symptomatic treatment

3

Others

Present to consilium

Attending MD:

Dave Verzosa, MD

Date:

12/05/2007

Detect Cases of MDR-TB

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Case 5: MODULE B

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MDR - TB SCREENING FORM Mark with check ( ) if symptom is present, PE is done and disease is present, otherwise, mark with (X). Please ensure the completeness of all information.

Screened at:

3

MMC/TDF

KASAKA

LCP

Others, specify

Screening code: (TC-YY-MM-NNNN)

Date:

(mm/dd/yy)

I. Demographics Sarmiento Name:

Sex:

3

Surname

Male Date of birth: Female

12/06/2007

Susana

Given Name

June 18, 1989 (mm/dd/yy)

Sandok

Age:

Nationality: Filipino Religion: Catholic

18

Middle Name

Manila

Place of birth:

Civil status: 3 Single Married Widowed Living together Divorced/ legally separated

Permanent address: 1598 Interior 86 P. Quirino Avenue, Pandacan, Manila

zip code 1011 Tel. no.: 599-00001

City address:

1598 Interior 86 P. Quirino Avenue, Pandacan, Manila zip code 1011

Tel. no.:

599-00001

none Family monthly income: none Employer:

E-mail address: Occupation: Office address:

Spouse: none Father: Sergio Parent’s address:

Person to notify in case of emergency: Marie Sarmiento Address: 1598 Interior 86 P. Quirino Avenue, Pandacan, Manila

area code+ tel #

area code+ tel #

20 000 Php

Tel. no.:

Address/ Contact #: Sarmiento Marie Sarmiento Mother: 1598 Interior 86 P. Quirino Avenue, Pandacan, Manila Tel. no.:

Relationship: Tel. No.:

area code+ tel #

599-00001

area code+ tel #

mother 599-00001

area code+ tel #

HC Govt Inst PPMD FBO NGO Pvt MD/Institution Referred by: 3 Specify name, Quirino Health Center Address of referring facility: Quirino Avenue, Pandacan, Manila 7

4 Number of household contacts: Less than or equal 10 yrs old: More than 10 yrs old: fever and weight loss Chief Complaint/s:

II. Review of Symptom/s

Cough Fever Back/ chest pain Hemoptysis Weight loss Night sweats Other symptoms: 5 Dyspnea at rest 5 Dyspnea on exertion 5 Pedal edema

5 3 5 5 3 5

50 Detect Cases of MDR-TB

Duration in month/s

2 wks

1

Comments

worsens in the afternoon approx. 10 kg

3

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III. Past Medical History:

History of previous TB treatment: (from first to last) Regimen and duration

Start date

( mm/dd/yyyy )

Exposure to active TB: No If Yes Co- morbidities

MDR

(Y/N)

year (s) year (s) 1 year (s) year (s) year (s) year (s) year (s) year (s)

Outcome

(1=cured, 2=tx completed, 3=failed, 4=defaulted, 5=unknown)

3 Non MDR

Duration

5 Diabetes Mellitus 5 Cancer 3 HIVinfection/AIDS 5 Kidney disease 5 Lung disease 5 Epilepsy 5 Psychiatric condition 5 Others

Comments: (drugs taken, status, etc.)

Status currently being treated for HIV at a treatment hub

Allergy: Drugs: Type of reaction:

No known food or drug

1.

2.

DOTS

No previous TB treatment

1.

2.

3.

4.

5.

6.

7.

( mos.)

Treatment facility

allergies

Concomitant drugs / Duration:

None Pneumonectomy/ Lobectomy Others, specify Previous surgery: 3

Date of surgery: Complications:

/

/

IV. Social History: Tobacco/ Cigarettes Alcohol Current Current Past Past Never 3 Never 3 Sticks/day x yrs Type /bottles /day x yrs

30 / 2007 0 Women: LMP 11 / G P (mm/dd/yy)

Drug Abuse Current Past 3 Never Type (shabu, marijuana, etc)

shabu 0

No yes, specify Contraceptive use (for women only): 3

Sexual History:

sexually inactive for a year

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51

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Programmatic Management of Drug - Resistant TB (PMDT)

V. Physical examination and laboratory procedures: Height: 157 cm 37.8 Vital Signs: Temp: Celsius BP: 130/80 mmHg

System examination: General Health: Skin: BCG scar: Oropharynx: Cardiovascular: Thorax & Lungs: Use of accessory muscles: Abdomen: Genito-Urinary: Extremities: Neurological: Lymph Nodes: Endocrine:

Weight: 42 Kg. PR/ HR: 100 / min RR at rest: O2 sat by Pulse oximeter: %

0 = Not done 1 = Normal 2 = Abnormal

2 2

0 0 1

26

Describe abnormalities

cachectic, in distress, generally weak (+) skin pallor (+) BCG scar

1 0 1 0 2 0

(+) palpable cervical lymph nodes

Laboratory procedures: Smear, Culture and DST results from other laboratory

Date

/

/

/

/

/

/

Other laboratory results: Liver function tests

Renal function tests

CBC

FBS, etc.

52 Detect Cases of MDR-TB

/min

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Chest X-ray: Date:

10

/

08

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MODULE B Programmatic Management of Drug - Resistant TB (PMDT)

/

Right Lung

0

2007 Left Lung

0

0 0

0

0 - Normal

7 - Fibrosis

1 - Cavitary

8 - Fibrothorax

2 - Infiltrate

9 - Bullae

3 - Nodule

10 - Pleural effusion

4 - Miliary TB

11 - Pneumothorax

5 - Intrathoracic lymphadenopathy

12 - Bronchiectasis

6 - Endobronchial spread

14 - Consolidation

13 - Atelectasis 15 - Mass

VI. Assessment: TB suspect 3 3 New

Retreatment

If retreatment, check any of the following types.

If new or retreatment, check any of the following risk factors.

None Symptomatic contact of confirmed/ suspected MDRTB patient Non-converter of Category II 3 Symptomatic HIV-positive 2 or more non-DOTS treatment course

Drug-resistant TB suspect (Categories) Category I Failure Category II Failure Return after Default (RAD) Category I Relapse Category II Relapse Category IV Relapse Other

3

Non-DOTS Other (+) Other (-)

Disease other than TB, specify

VII. Plan: 2 3 For smear x 2 3 For TB culture x 3 For Drug susceptibility testing 3 Start TB treatment, specify regimen: Start Catergory I while awaiting culture and DST results

Prescribe ancillary drugs or drugs for co-morbidity, or symptomatic treatment

3

Others

Continue HIV treatment.

Attending MD:

Dave Verzosa, MD

Date:

12/06/2007

Detect Cases of MDR-TB

53

Case 6: MODULE B

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S NE PI

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MDR - TB SCREENING FORM Mark with check ( ) if symptom is present, PE is done and disease is present, otherwise, mark with (X). Please ensure the completeness of all information.

Screened at:

3

MMC/TDF

KASAKA

LCP

Others, specify

Screening code: (TC-YY-MM-NNNN)

Date:

(mm/dd/yy)

I. Demographics Robles Name:

Surname

12/07/2007

Rodolfo

Given Name

Remo

Middle Name

Sex: 3 Male Date of birth: March 28, 1977 Age: 30 Place of birth: Manila (mm/dd/yy)

Female Nationality: Filipino Religion: Catholic Civil status: 3 Single Married Widowed

Living together

Divorced/ legally separated

Permanent address: 1919 Mekeni St., Barangay Mahayahay, Apalit, Pampanga

zip code 2016 Tel. no.: none

City address:

area code+ tel #

276281 Poblacion, San Vicente St., Bayanan, Muntinlupa City zip code 1772 Tel. no.: 123-4567

none Family monthly income: laborer Employer:

E-mail address: Occupation: Office address:

Spouse: none Father: Pablo Robles Parent’s address:

Person to notify in case of emergency: Romeo Robles Relationship: Address: 1598 Exterior 86 P. Quirino Avenue, Pandacan, Manila Tel. No.:

Tel. no.:

(deceased)

area code+ tel #

20 000 Php

area code+ tel #

Address/ Contact #: Rita Robles (deceased) Mother: Tel. no.:

area code+ tel #

brother 599-10001

area code+ tel #

HC Govt Inst PPMD FBO NGO Pvt MD/Institution Referred by: 3 Specify name, Poblacion Health Center Address of referring facility: Sn. Vicente St., Putatan, Muntinlupa City 0

0 Number of household contacts: Less than or equal 10 yrs old: More than 10 yrs old: persistently symptomatic Chief Complaint/s:

II. Review of Symptom/s 3 Cough 5 Fever 3 Back/ chest pain 5 Hemoptysis 3 Weight loss 5 Night sweats

Other symptoms: 5 Dyspnea at rest 5 Dyspnea on exertion 5 Pedal edema 54 Detect Cases of MDR-TB

0

Duration in month/s

3

Comments productive, minimal in amt., whitish color

3

both in the upper lung area

1

approx. 10 kg

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III. Past Medical History:

History of previous TB treatment: (from first to last) Regimen and duration

Start date

( mm/dd/yyyy )

1.

2.

3.

4.

5.

6.

7.

( mos.)

06/01/06 09/03/07

Treatment facility

2 HRZE / 4 HR Poblacion Health Center 2 HRZES / 1 HRZE Poblacion Health Center

No If Yes Exposure to active TB: 3 Co- morbidities

MDR

Y Y

1 ongoing

Comments: (drugs taken, status, etc.) year (s) year (s) year (s) year (s) year (s) year (s) year (s) year (s)

Status

Allergy: Drugs: Type of reaction:

No known food or drug

1.

2.

(Y/N)

Outcome

(1=cured, 2=tx completed, 3=failed, 4=defaulted, 5=unknown)

Non MDR

Duration

5 Diabetes Mellitus 5 Cancer 5 HIVinfection/AIDS 5 Kidney disease 5 Lung disease 5 Epilepsy 5 Psychiatric condition 5 Others

DOTS

allergies

Concomitant drugs / Duration:

None Pneumonectomy/ Lobectomy Others, specify Previous surgery: 3

Date of surgery: Complications:

/

/

IV. Social History: Tobacco/ Cigarettes Alcohol Current Current Past Past Never 3 Never 3 Sticks/day x yrs Type /bottles /day x yrs

Women: LMP / / G P (mm/dd/yy)

Drug Abuse Current Past Never 3 Type (shabu, marijuana, etc)

Contraceptive use (for women only): No yes, specify

Sexual History:

sexually inactive

Detect Cases of MDR-TB

55

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V. Physical examination and laboratory procedures: Height: 160 cm 37.4 Vital Signs: Temp: Celsius BP: 130/80 mmHg

System examination: General Health: Skin: BCG scar: Oropharynx: Cardiovascular: Thorax & Lungs: Use of accessory muscles: Abdomen: Genito-Urinary: Extremities: Neurological: Lymph Nodes: Endocrine:

Weight: 45 Kg. PR/ HR: 93 / min RR at rest: O2 sat by Pulse oximeter: %

0 = Not done 1 = Normal 2 = Abnormal

23

Describe abnormalities

2

cachectic, in distress

2

(+) crackles heard over both upper lung fields

2

0 0

(+) skin pallor (–) BCG scar

1 0 1 0 2 0

(+) palpable cervical lymph nodes

Laboratory procedures: Smear, Culture and DST results from other laboratory Date DSSM 2+

12 /

03 / 2007

/

/

/

/

Other laboratory results: Liver function tests

Renal function tests

CBC

FBS, etc.

56 Detect Cases of MDR-TB

/min

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MODULE B MDR - TB SCREENING FORM | page 3 of 4

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Chest X-ray: Date:

/

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MODULE B Programmatic Management of Drug - Resistant TB (PMDT)

/

Right Lung

Left Lung

0 - Normal

7 - Fibrosis

1 - Cavitary

8 - Fibrothorax

2 - Infiltrate

9 - Bullae

3 - Nodule

10 - Pleural effusion

4 - Miliary TB

11 - Pneumothorax

5 - Intrathoracic lymphadenopathy

12 - Bronchiectasis

6 - Endobronchial spread

14 - Consolidation

13 - Atelectasis 15 - Mass

VI. Assessment: TB suspect 3 New

3

Retreatment

If retreatment, check any of the following types.

If new or retreatment, check any of the following risk factors.

None Symptomatic contact of confirmed/ suspected MDRTB patient

3 Non-converter of Category II Symptomatic HIV-positive 2 or more non-DOTS treatment course

Drug-resistant TB suspect (Categories) Category I Failure Category II Failure Return after Default (RAD) 3 Category I Relapse Category II Relapse Category IV Relapse Other Non-DOTS Other (+) Other (-)

Disease other than TB, specify

VII. Plan: 2 3 For smear x 2 3 For TB culture x 3 For Drug susceptibility testing

Start TB treatment, specify regimen: Prescribe ancillary drugs or drugs for co-morbidity, or symptomatic treatment

3

Others

Stop current treatment and await DST.

Attending MD:

Dave Verzosa, MD

Date:

12/07/2007

Detect Cases of MDR-TB

57

MODULE B

When you have finished this exercise, please discuss your answers with a facilitator.

Then read until the next exercise.

2.4 Make a referral to the Consilium if necessary and enter the patient in the Category IV Register The diagnosis of MDR-TB through laboratory tests takes a number of months. In general, patients wait for confirmation of the diagnosis of MDR before they are prepared for the start of treatment. However, there are occasions that the MDR-TB suspect may be critically ill at the time of first consultation. The physician having interviewed the patient and made a physical examination must be able to assess the patient’s general condition. Some patients may need to be started on treatment urgently before the DST results are available or they will be at risk of dying. These patients should be recognized by the physician, and these cases should be presented immediately to the Consilium.

The Consilium must approve for start of treatment all patients who require MDR-TB treatment. These are patients who have either been confirmed MDR-TB by DST, or are clinically suspected MDR-TB needing urgent treatment even prior to DST results.

DST results together with other factors in the patient’s history allow the design of treatment regimens that are tailored to the specific resistance pattern of the patient to increase the likelihood of treatment success. To present cases to the consilium, the Treatment Center physician must fill out the Consiliumex for every patient. He will then present these cases in a Consilium meeting. An example of the Consiliumex and a discussion of the necessary steps to present a case to the Consilium can be found in section 6 of this module. See the Reference Booklet for instructions on how to fill out the Consiliumex.

The following criteria must be met among MDR-TB suspects screened to qualify for urgent treatment without the benefit of DST results: 1. The patient must first be sputum smear-positive (at least two) and/or culture-positive (at least once) if pulmonary, but not necessarily for children and for extra-pulmonary TB (EPTB).

2. The patient must be suspected to be MDR-TB based on history and risk factors.

3. The patient must have any ONE of the criteria for Category IV treatment listed in Table 4 below.

Table 4: Criteria for initiation of Category IV treatment without DST results

Criteria

Condition

1. Acute respiratory failure and on mechanical ventilation 2. Clinical signs and symptoms without any other condition as likely cause, with the following vital signs (any one).

a. Hypotension b. RR > 28/min or 02 < 90% at room air c. PR > 100/min with RR > 28/min or 02 sat <90% at room air With or without significant weight loss

58 Detect Cases of MDR-TB

MODULE B

4. Massive hemoptysis due to TB

a. > 600 cc/24 hours b. > 300 cc/episode c. Any amount w/ signs and symptoms of hemodynamic compromise: hypotension, and/or anemia

4. Progression of chest x-ray findings (new lesions)

a. b. c. d.

Infiltrates Cavities Pneumothorax Pleural effusion, etc.

PLUS any one of the above clinical signs and symptoms (no. 2 above) 5. Significant co-morbidity such as any immunosuppressed state

a. b. c. d.

HIV-positive Cancer Post-organ transplant On any immunosuppressive agent

5. EPTB that is life-threatening with or without bacteriologic evidence

Intracranial lesions including abscess, meningitis, POTT’s disease, etc.

6. Children with any one of the ff three: a) positive tuberculin skin test (equal or more than 10 mm) OR b) positive family contact OR c) a chest x-ray finding consistent with TB PLUS three of the five of the following symptoms of TB in children: a) chronic cough or wheeze for > 2 weeks b) unexplained fever > 2 weeks c) weight loss/ failure to gain weight/loss of appetite d) failure to respond to 2 weeks appropriate antibiotic for lower respiratory infection e) failure to regain previous state of health 2 weeks after a viral infection or exanthem, e.g., measles.

For pulmonary TB, the decision for empiric Category IV treatment must require at least sputum smear-and/or culturepositive results. However, this is not required for children and for patients with EPTB who are MDR-TB suspects.

All patients with a Consilium decision for expedited treatment must be started at once on Category IV regimen.

Once started on treatment, he must be entered into the Category IV Register.

Detect Cases of MDR-TB

59

MODULE B

3. Discuss the Paunawa or Terms of Understanding with the patient The MDR-TB suspect will most likely not understand what MDR-TB is and what the process is for diagnosis and treatment. Because of the complex nature of the diagnosis of MDR-TB, we need to explain to the patient the lengthy diagnostic steps which he will undergo and the prospect of treatment. After the patient is informed about MDR-TB and the next steps in the diagnostic workup, he will be asked to sign the Paunawa or Terms of Understanding to indicate that he has been informed of the steps in the diagnosis and possible treatment, and is agreeable to receive treatment

3.1 Provide patient education on MDR-TB and the diagnostic process Inform the MDR-TB suspect clearly and in a sensitive way about the possibility of having MDR-TB. This may be the first time you will discuss MDR-TB with the patient and the MDR-TB suspect may be quite scared or nervous about what he has. All communication must be kind, supportive and medically correct. You should provide information on: • • •

• •

Steps in the diagnosis of MDR-TB; diagnostic tests to be done (DSSM, culture, DST) Possibility of stopping present TB treatment to prevent amplification of resistance Timelines for receiving test results: Patient must call for results after the expected timeline for the release of results: • DSSM: 4-5 days after specimen collection • Culture: 3-3.5 months after specimen collection • DST: 4-5 months after specimen collection Contact numbers of the MDR-TB Treatment Center where screening was done; other contact numbers which patients can call Ways to prevent transmission of TB to household contacts

The Paunawa or Terms of Understanding should be read to the patient and explained in a way that the patient can understand. The Paunawa or Terms of Understanding form can be found in the Reference Booklet. For more information about how to speak with a patient at this stage, see Module D: Inform Patients about MDR-TB.

3.2 Obtain patient’s signature in Paunawa or Terms of Understanding Once the MDR-TB suspect has been informed about MDR-TB and the diagnostic process, the patient’s signature must be obtained to signify that he understands and is in agreement with the diagnostic procedures and the possible long and complicated treatment for MDR-TB. Patients may not want to sign or may be wary about doing so. You should explain to him the significance of his signature. If he signs, this means that: • he is in agreement to undergo the sputum test and that he pledges to adhere to the requirements of diagnosis.

• he understands that since the treatment for MDR-TB is complex, accurate diagnosis is crucial.

• he is aware of the prospect of MDR-TB treatment and that cure requires strict adherence to treatment.

Reassure the MDR-TB suspect that the signature is required to ensure that both the health worker and the patient are together committed to the best possible outcome and this information is meant to make him aware of the rather complicated process and prevent any misunderstanding.

60 Detect Cases of MDR-TB

MODULE B

4. Collect sputum for smear, culture and DST Upon screening, every MDR-TB suspect should submit two sputum specimens at the Treatment Center for DSSM and culture to be done at the assigned Culture Center and for DST to be done at the DST Center. Just like the zoning for Treatment Centers in Table 1, there is also Culture Center assignment per Treatment Center and DST Center assignment per Culture Center (see Table 5). While sputum collection will be done at the Treatment Center and culture at a Culture Center, DST will be done at a DST Center.

Table 5: Designated Culture and DST centers for each Treatment Center

Treatment Center

Culture Center

DST Center

TDF-MMC DOTS Clinic

TDF TB Laboratory

TDF TB Laboratory

NTRL if patient is coming from Muntinlupa, Las Pinas, Paranaque and Pasay

NTRL if coming from Muntinlupa, Las Pinas, Paranaque and Pasay

KASAKA-QI MDR-TB Housing Facility

PTSI Laboratory

NTRL

LCP-PHDU DOTS Center

LCP Laboratory

DJNRMH DOTS Center

LCP Laboratory

PTSI Tayuman DOTS Center

PTSI Laboratory

Treatment Center – MM South (to be identified)

NTRL

NTRL: National TB Reference Laboratory TDF: Tropical Disease Foundation

TDF TB Laboratory NTRL NTRL

LCP: Lung Center of the Philippines PTSI: Philippine Tuberculosis Society, Inc.

The diagnosis of MDR-TB is crucial and must be accurate since treatment required is very long with expensive drugs that have many side effects. Hence, even if an MDR-TB suspect has culture and DST results from other referral sites, he must submit 2 more sputum samples at the MDR-TB Treatment Center for DST confirmation by a laboratory with quality assurance from a supranational laboratory. At present, these laboratories include the Tropical Disease Foundation (TDF) TB Laboratory, and the National TB Reference Laboratory (NTRL). The Cebu Regional Reference Laboratory (CRRL) will also be undergoing DST proficiency testing as well as other laboratories in the Philippines and will become future DST Centers for PMDT.

4.1 Enlist the MDR-TB suspect’s cooperation Explain the reason for sputum examination and enlist the MDR-TB suspect’s cooperation. Explain that sputum smear and culture are essential for detecting MDR-TB and are the first two steps needed in order to run a DST.

4.2 Fill out the Mycobacteriology Request Form All MDR-TB suspects should have a culture and DST done in addition to smear. The Mycobacteriology Request Form is used to request for sputum laboratory tests for detecting MDR-TB. One Mycobacteriology Request Form can be used to request for all three tests of one patient. Specimens other than sputum obtained from other parts of the body with suspected TB may also be sent for smear, culture and DST using this form.

Write the Screening code in the Mycobacteriology Request Form. The Category IV Registration No. is not yet applicable at the time of screening since this number is assigned only once treatment is started. Complete the demographics.

No need to write the complete address, just indicate the city/province. Tick the Culture Center to do the DSSM and culture, and the DST Center to do the DST; tick what kind of specimen is being sent, the examination being requested for and the number of specimens being sent for each procedure. For screening, it is recommended that Detect Cases of MDR-TB

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specimens are sent to the Culture Center on the day of collection; hence, write DSSM X 1 and culture X 1 for this first collection and fill out another request form for the second collection.

For the example below who was referred as a Category II failure, DSSM, TB culture and DST are ticked with the number of specimens needed for DSSM and culture. Under “Schedule”, Screening refers to the first time the patient is being seen as a TB suspect. Baseline refers to the time when a patient is about to be started on Category IV treatment or has just been started on treatment (30 days before treatment and 7 days after start of treatment).

Follow-up refers to the sputum examination requested after Category IV treatment has started beyond 7 days.

Post-treatment refers to the period after a final outcome of cured or completed has been declared. Fill out the date the sputum was collected not the date when the sputum was sent. Indicate whether the specimen was collected as a spot specimen collected at the Treatment Center or at the patient’s home or elsewhere.

The receiving laboratory will fill out the portion on Laboratory No., Volume and Consistency.

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MYCOBACTERIOLOGY REQUEST FORM

Screening Code: 02-05-04-0081 Date requested:

Category IV Registration No.: Name: Balagtas, Jose A. Address: Tondo, Manila

Culture center:

3

TDFI LCP PTSI CTRL (Cebu) NTRL

4/28/05

(if enrolled)

Age/Sex: 50/M Requesting physician: Chi-Orillaza, Ruth M.D.

(City/ Province)

DST center: TDFI

3 NTRL CTRL

Specimen:

3 Sputum

Extrapulmonary specimen, specify:

Requested procedure:

2 3 DSSM x 3 TB culture x 2 3 DST

Contact tracing patient?

Yes

No 3

Others

Schedule:

3 Screening

Enrolled:

Yes

Baseline

Follow-up: month of tx:

3 No

Months post-treatment:

3 New

Category:

Retreatment

1st specimen

2nd specimen

3rd specimen

Type of collection (Please encircle)

Spot

Spot

Spot

Laboratory No.

02-P-058283-1

02-P-058283-2

Salivary

Muco-purulent

Date of collection Home

Home

To be filled in by the laboratory Volume Consistency

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4.3 Collect sputum samples from the MDR-TB suspect Follow the guidelines for sputum collection as would happen with any TB patient. Refer to Annex A: Proper collection of specimen for the diagnosis of TB. Two sputum samples should be collected during a two-day period.

•

Sample one is collected “on the spot.” Give instructions to the patient. Explain why the sputum is needed and show the MDR-TB suspect how to cough up sputum and handle the labeled container. The MDR-TB suspect goes outdoors or to a well-ventilated place or to a sputum collection booth, if available, to collect the sample. Observe and guide the MDR-TB suspect during sample collection. Instruct the patient to collect 5-10 ml of sputum. After the MDR-TB suspect gives the sample to you, give him another labeled container to take home and use the next morning, while you tightly close the lid of the first container.

•

For labeling, use color-coded stickers: þþ A blue label indicating that the sample is for smear, culture and DST should show the name of the Treatment Center, the patient’s name, and date of collection. This is attached to the body of the cup, and not on the lid. þþ A green label means the request is for smear and culture only. þþ A white label means the request is only for smear, e.g., in some months of the follow-up period.

PMDT Tx center: __________________ MMC Lab No.: ___________________ Name: ____________________ Jose Balagtas Date collected: _____________ May 5, 2008

•

Sample two is collected at home by the MDR-TB suspect upon waking up the next morning. The patient brings this second sample to you at the Treatment Center right after collection.

Remember: • • • • •

Attach the label on the container (not the lid) before collecting the sputum samples.

Collect sputum in a well-ventilated area, preferably outdoors or in a sputum collection booth.

Check whether the sample contains sufficient sputum (5-10ml), not saliva. If not, ask the MDR-TB suspect to add more.

After collecting the sputum, be sure that the lid is closed tightly.

Wash your hands thoroughly with soap and water.

Remind the MDR-TB suspect when to return for the results and inform him that the specimen regardless of the DSSM results, will be cultured.

4.3.1 Alternative methods of sputum collection There may be MDR-TB suspects who are unable to produce sputum for examination. Examples of these are children, patients with minimal cough, the HIV-positive patients, etc. In these cases alternative measures to collect sputum should be used. Although it is beyond the scope of this document to describe in detail each process, a general description of some alternate sputum collection methods are described on the next page. See also Annex B: Procedures for Obtaining Sputum Specimens in Children.

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Sputum induction: is a simple procedure for obtaining a sputum sample through deep 15-minute inhalation of a salt solution or hypertonic saline (3% NaCl) with the help of a nebulizer to induce a deep cough, which allows the coughing up of lung secretions. These samples are usually diluted or watery and should be labeled as “induced” so they will not be mistaken for saliva at the laboratory.

Induction can be used for patients who cannot expectorate effectively or provide a quality sample, particularly those who are asymptomatic but have evidence of TB disease such as an abnormal chest x-ray, e.g., in children, or persons with HIV/AIDS. Patients should have fasted for 3-4 hours prior to the procedure to prevent vomiting and aspiration. Induction should be carried out in a well-ventilated place and all personnel in the room should use an N95 mask to avoid infection.

Gastric aspiration is performed by inserting a tube through the patient’s nose and introducing it into the stomach.

The idea is to obtain a sputum sample that has been coughed up and then swallowed. The procedure is usually performed first thing in the morning as the patient tends to swallow sputum during the night. Generally, it is performed only when a sample cannot be obtained through expectoration or induction. Most often, it is used to obtain samples from children. It is recommended that children should not have had food intake in the past 2-3 hours. For logistic reasons gastric aspiration is usually carried out in a hospital setting or in a procedure room that has the necessary materials.

Bronchial aspiration with fiberoptic bronchoscopy is done for the collection of bronchial secretions by aspiration, through the fiberoptic bronchoscope (which is an instrument used for this procedure) performed by a bronchoscopist. These samples are usually diluted or watery and should be labeled as “bronchoscopy specimens” so they will not be rejected at the laboratory. Bronchoscopy should be carried out in a procedure room with infection control measures. This is usually the last resort when sputum is very difficult to collect.

4.4 Pack the sputum samples and send to the laboratory Once the sample is collected, it must be packed and sent to the laboratory immediately. Refer to Annex C: Proper labeling, sealing and transportation of specimens. A smooth packaging and delivery process is vital to ensure that the specimens are processed correctly and in a timely manner. Keep the samples in a refrigerator or in an icebox with refrigerants. If the specimens become too warm, the sputum can degrade and the TB bacteria may not survive, become overgrown by other bacteria in the sputum, thereby diminishing the chances of recovering the bacilli.

From the refrigerator, transfer the sputum containers into a transport box. The Treatment Center will list all the samples for dispatch to a Culture Center on a Laboratory Receiving Form for Specimens. The sputum samples will go together with the individual Mycobacteriology Request Forms for each patient and the Laboratory Receiving Form for Specimens. The latter form should be signed by the messenger or person picking up the transport box. Send the samples to the Culture Center as soon as possible. The delivery process must ensure that the specimens reach the Culture Center within 24 hours of collection. If the samples will not be picked up by the messenger on the same day, keep the samples refrigerated or in the transport box with refrigerants. Make sure the refrigerants are replaced periodically to keep the specimens cool at all times. A sample of a Laboratory Receiving Form is shown in the following pages.

4.4.1 Prepare the Laboratory Receiving Form for Specimens The Treatment Center prepares the Laboratory Receiving Form for Specimens. Tick the box for “Treatment Center” where the specimens are coming from and write the name of your center. Then tick the box for the Culture Center where the specimens are being sent to and write the name of the Culture Center. Table 5 on page 61 of this Module shows the designated Culture Center for each Treatment Center. Fill out column 1 of the table with a consecutive number from 1-25. Should you require more sheets, use another Laboratory Receiving Form and adjust the numbers from 26 onwards. For screening patients, leave blank the columns on “Category IV Registration No.” and the “Laboratory No.” The “Category IV Registration No.” is applicable only to patients who are started on Category IV treatment, while the “Laboratory No.” is applicable only for culture isolates that are being sent from the Culture laboratory to a DST Center. Write the patient’s name, the sputum specimen # over total # required specimens and/ or isolates being transported for each patient, the date of collection of the first specimen (if 2/2) and the requested 64 Detect Cases of MDR-TB

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procedures (for screening patients: DSSM, culture and DST). At the bottom, the one preparing the form signs on the space for “Endorsed by” with the date and the one picking up the box signs on the space provided for “Received by” with the date. See the Reference Booklet for more instructions on how to fill out this form.

Later when the culture turns out positive for TB at the Culture Center, the isolate is sent to the DST Center. The Culture Center fills out the Laboratory Receiving Form, also keeps blank the Category IV Registration No. but writes the Laboratory No. assigned which is TC-C-YY-NNNN-nth specimen.

Table 6. Laboratory No. (TC-C-YY-NNNN-Nth specimen)

Code

Description

TC

Treatment Center (see Table 2)

C

Culture Center T for TDF TB Laboratory N for NTRL L for LCP Laboratory P for PTSI Laboratory

YY

The year the patient was screened

NNNN

The consecutive specimen accrual that begins with 0001 at the start of every year

Nth specimen

Whether the specimen is the 1st or the 2nd specimen

For example, the Laboratory No. 02-P-050021-2 means that the Treatment Center origin of the specimen is the KASAKA-QI MDR-TB Housing Facility, and was sent for smear and culture to PTSI Laboratory in 2005; was the 21st specimen received by the laboratory for the year, and was the second isolate for the patient.

Before sending the transport box to the laboratory, the Treatment Center must check the following: –– –– ––

The number of sputum specimens listed in the Laboratory Receiving Form for Specimens are consistent with the actual number of specimen cups in the transport box.

The names of patients listed on the Laboratory Receiving Form are consistent with the ones written on the labels on the sputum cups in the transport box.

Individual Mycobacteriology Request Forms are enclosed for each of the specimens being sent.

Once the above are done, close and seal the transport box carefully. Then, put the Laboratory Receiving Form for Specimens in an envelope together with the individual Mycobacteriology Request Forms and attach the envelope to the top cover of the transport box or hand it directly to the receiving person.

At the Culture Center, the laboratory staff receiving the transport box will check the contents of the box against the Laboratory Receiving Form for Specimens and sign the form and keep a file copy at the Culture Center. If all specimens and requests in the list are accounted for, he will affix his initials on the form and date and keep a file copy at the Culture Center. If there is a discrepancy, he will call the Treatment Center for verification, document on the Form whatever discussion or agreement was made before filing this form at the Culture Center. The same is done at the DST Center when receiving culture isolates from the Culture Center.

A delivery schedule will be arranged with the laboratory receiving the sample to make sure that the samples can be quickly transported and processed once they are received. On the following page is an example of the Laboratory Receiving Form for Specimens.

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Laboratory Receiving Form For Specimens

From:

3 KASAKA-QI

Sputum

To: 3

Culture Center (CC)

NTRL

Culture Center (CC) DST Center

Isolates

Name

No. of specimens / isolates

Date collected (mm/dd/yy)

Remarks/ Request

1

Balagtas, Jose

2/2

4/28/05

DSSM, TBC, DST

2

Salcedo, Myrna

½

4/28/05

DSSM, TBC

3

Tan, Vincent

½

4

Santos, Sylvia

1/1

5

Roces, Maria

2/2

6

Benito, Gerald

½

7

Cortez, Juan

1/1

4/28/05

DSSM

8

Uy, Susan

1/1

4/28/05

DSSM

9

Mendoza, Tina

2/2

4/28/05

DSSM, TBC, DST

No.

Category IV Registration No.

Treatment Center (TC)

Laboratory no.* (Applicable to ISOLATES only c/o Culture Center

If two4/28/05 specimens are 4/28/05 being submitted together, write 4/28/05 the date of collection of the 4/28/05 FIRST specimen.

DSSM, TBC, DST DSSM, TBC DSSM, TBC, DST TBC

10 11 12 13 14 15 16 17 18 19 20 21 22

Not applicable for screening cases.

Applicable only for enrolled cases with followup specimens being sent.

Not applicable to Treatment Centers.

Applicable only to Culture Centers submitting isolates to DST Centers.

Make sure this list is consistent with the names on the sputum cup labels submitted to the Culture Center.

Verify this information against the Mycobacteriology Request Form.

23 24 25 * Laboratory no. : TC-C-YY, NNNN - Nth specimen

Mar Rocha (TDF messenger) Endorsed by: ___________________________

4/29/05 Date: _________________________

Francia GOnzales (PTSI) Received by: ____________________________

4/29/05 Date: _________________________

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For Treatment Site Staff Group Discussion When you have reached this point in the module, your group will briefly discuss the designated Culture and DST Center for each Treatment Center where you will refer MDR-TB suspects. Use the table on page 61. After the discussion, continue reading on page 72.

For Treatment Center Staff – Written Exercise When you have reached this point in the module, you are ready to do Exercise D. Turn to the next page and follow the instructions for Exercise D. Do this exercise by yourself. Then discuss your answers with a facilitator.

Exercise D: Written exercise Filling out a Mycobacteriology Request Form The purpose of this exercise is to practice completing the Mycobacteriology Request Form for patients that have been identified as MDR-TB suspects.

The following four cases (Cases 1, 2, 3, 5) were the cases you identified as suspects in the previous exercise. Use the data provided in the MDR-TB Screening Forms which have been previously given to you. Completing the Mycobacteriology Request Form is important to ensure that the proper examinations are requested and DR-TB is appropriately detected.

Work on this exercise individually.

1. For each of the following patients, fill out the Mycobacteriology Request Form.

2. Please refer to page 61 for the designated Culture and DST center for the different Treatment Centers.

Assumptions: • All first specimens were collected spot at the Treatment Center while the second specimen was collected at the patient’s home.

• All first samples of the patients were collected on the day of screening and the second samples on the following day except for Case #2 who first came on a Saturday and came back for his second sample on the following Monday.

• The date the MDR-TB Suspect’s Referral Form from the DOTS facility was filled out is the date of screening at the Treatment Center.

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Case 1 Patient Information: Patient is Sonia Santos Sariwa.

Today is November 29, 2007.

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MYCOBACTERIOLOGY REQUEST FORM Screening Code:

Date requested:

Category IV Registration No.:

(if enrolled) Age/Sex:

Name: Address:

Culture center:

(City/ Province)

DST center:

TDFI LCP PTSI CTRL (Cebu) NTRL

Requesting physician:

TDFI NTRL CTRL

Specimen: Sputum Extrapulmonary specimen, specify:

Requested procedure:

Contact tracing patient?

Yes No

DSSM x TB culture x DST

Others

Schedule: Enrolled:

Screening Yes

Baseline

Follow-up: month of tx:

No

Months post-treatment: New

Category:

Retreatment

1st specimen

2nd specimen

3rd specimen

Spot

Spot

Spot

Date of collection Type of collection (Please encircle)

Home

Home

To be filled in by the laboratory Laboratory No. Volume Consistency

68 Detect Cases of MDR-TB

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Case 2 Patient is Rolanda Ramirez Reloz.

Today is December 3, 2007(Monday)

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MYCOBACTERIOLOGY REQUEST FORM Screening Code:

Date requested:

Category IV Registration No.:

(if enrolled) Age/Sex:

Name: Address:

Culture center:

(City/ Province)

DST center:

TDFI LCP PTSI CTRL (Cebu) NTRL

Requesting physician:

TDFI NTRL CTRL

Specimen: Sputum Extrapulmonary specimen, specify:

Requested procedure:

Contact tracing patient?

Yes No

DSSM x TB culture x DST

Others

Schedule: Enrolled:

Screening Yes

Baseline

Follow-up: month of tx:

No

Months post-treatment: New

Category:

Retreatment

1st specimen

2nd specimen

3rd specimen

Spot

Spot

Spot

Date of collection Type of collection (Please encircle)

Home

Home

Home

To be filled in by the laboratory Laboratory No. Volume Consistency

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Case 3 Patient is Santiago Suma Santos.

Today is December 5, 2007.

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MYCOBACTERIOLOGY REQUEST FORM Screening Code:

Date requested:

Category IV Registration No.:

(if enrolled) Age/Sex:

Name: Address:

Culture center:

(City/ Province)

DST center:

TDFI LCP PTSI CTRL (Cebu) NTRL

Requesting physician:

TDFI NTRL CTRL

Specimen: Sputum Extrapulmonary specimen, specify:

Requested procedure:

Contact tracing patient?

Yes No

DSSM x TB culture x DST

Others

Schedule: Enrolled:

Screening Yes

Baseline

Follow-up: month of tx:

No

Months post-treatment: New

Category:

Retreatment

1st specimen

2nd specimen

3rd specimen

Spot

Spot

Spot

Date of collection Type of collection (Please encircle)

Home

Home

To be filled in by the laboratory Laboratory No. Volume Consistency

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Case 5 Patient is Susana Sandok Sarmiento Today is December 6, 2007.

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MYCOBACTERIOLOGY REQUEST FORM Screening Code:

Date requested:

Category IV Registration No.:

(if enrolled) Age/Sex:

Name: Address:

Culture center:

(City/ Province)

DST center:

TDFI LCP PTSI CTRL (Cebu) NTRL

Requesting physician:

TDFI NTRL CTRL

Specimen: Sputum Extrapulmonary specimen, specify:

Requested procedure:

Contact tracing patient?

Yes No

DSSM x TB culture x DST

Others

Schedule: Enrolled:

Screening Yes

Baseline

Follow-up: month of tx:

No

Months post-treatment: New

Category:

Retreatment

1st specimen

2nd specimen

3rd specimen

Spot

Spot

Spot

Date of collection Type of collection (Please encircle)

Home

Home

Home

To be filled in by the laboratory Laboratory No. Volume Consistency

When you have finished this exercise, please discuss your answers with a facilitator.

Then read until the next stop sign.

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5. Receive and record the smear and culture results in the TB Symptomatics Masterlist and decide on the appropriate action The staff at the Culture Center will record the results of the DSSM and the culture in the PMDT Laboratory Register.

The Culture Center will then individually print out the results of the smear on the appropriate Result Form for DSSM and Culture as soon as available for each patient and send these back to the Treatment Center together with a Laboratory Releasing Form for Results. The latter provides a summary list of all the sputum results, whether smear or culture, being sent back to the Treatment Center. This is done similarly by the DST Center as soon as DST results are available.

DSSM results are released as they are available and should not wait for culture results. The Culture Center staff will tick “From” and write the Culture Center’s name. He then ticks “To” and writes the Treatment Center to which the results are being released. On each row he writes the Laboratory No. (TC-C-YYNNNN-nth) and the name of the patient, the test that is being released and the date the sputum was collected. The Culture Center staff who prepared the list signs on the space for “Endorsed by” with the date and the person picking this up will sign on the space provided for “Received by:” and the date. Upon receipt of the results at the Treatment Center, the staff will check the individual results against the Laboratory Releasing Form. If there is no discrepancy, the Treatment Center staff will affix his initials and date on the form and file it. If there is a discrepancy, he will call the Culture Center or the DST Center and document their agreement on the Laboratory Releasing Form and file it. No DST results are released to Culture Centers, only to Treatment Centers. Below is a sample of the Laboratory Releasing Form being sent to the KASAKA-QI MDR-TB Housing Facility.

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Laboratory Releasing Form For Results From:

No. 1 2 3 4 5 6 7 8 9 10

3

PTSI

Culture Center (CC) To:

3

KASAKA-QI Treatment Center (TC)

DST Center

Laboratory no.*

Name

Test requested

Date collected mm/dd/yy

02-P-050001-2

Balagtas, Jose

TBC

04/28/05

02-P-050002-1

Tan, Vincent

TBC

04/28/05

02-P-050002-1 02-P-050003-1 02-P-050004-1 02-P-050007-1 02-P-050005-1 02-P-050006-1 02-P-050007-1 02-P-050007-2

Salcedo, Myra Santos, Sylvia Roces, Maria

Mendoza, Tina

Benito, Jamora Cortez, Juan Uy, Susan

Mendoza, Tina

TBC DSSM TBC TBC TBC

DSSM DSSM TBC

Remarks

04/28/05 04/26/05 04/28/05 04/28/05 04/28/05 04/27/05 04/27/05 04/28/05

11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 DST 3 DSSM 3 Culture (TBC) * Laboratory No. : TC-CC-Year, Accession No-1st or 2nd specimen

Francia Gonzales(PTSI) Endorsed by: ___________________________

07/30/05 Date: _________________________

Mar Rocha (TDF Messenger) Received by: ____________________________

07/30/05 Date: _________________________

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5.1 Record the smear results in the TB Symptomatics Masterlist Upon receipt of results at the Treatment Center, find the suspect’s name in the TB Symptomatics Masterlist (see example on page 81). Record the results of DSSM for each of the samples in column 16 “Screening (DSSM/culture results)” and write the date (mm-dd-yy) of sputum collection on the row below this. Note that the Laboratory Releasing Form will indicate that a combination of DSSM and culture results are being released at the same time and all results whether DSSM or culture must be recorded on the TB Symptomatics Masterlist promptly as they are received.

The messenger assigned to transport specimens is also assigned to pick up the results.

To record DSSM results, write “0” if negative and write the grading “1+”, “2+”, or “3+”, if positive.

On the next page is an actual DSSM result of a patient, Maria Morelos, that has been released to the LCP-PHDU DOTS Center on February 12, 2007 by the LCP Laboratory. Sputum was collected at the Treatment Center on February 7 and 8, 2007. Results show that the first specimen was 2+ and the second was 3+.

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mm/dd/yy

2/12/07

DSSM

No

3

Follow-up: month of tx:

3+ On-going

2+ On-going

Laboratory Technician

Claire Macugay, RMT

2/8/2007

2/7/2007

Retreatment

01-L-070080-2

3

03-L-070080-1

New 2nd specimen

Category:

Months post-treatment

1st specimen

TB Culture

Baseline

Date collected

Sputum

Specimen:

3rd specimen

DST center:

LCP laboratory

Culture center:

Laboratory Supervisor

Lawrence Laqiundanum, RMT

LCP-PHDU DOTS Center

Treatment center:

On page 81, column 16 of the TB Symptomatics Masterlist is filled out. It shows 2+ on February 7, 2007 and 3+ for February 8, 2007.

Date Released:

TB culture

DSSM

Date of collection

Lab No.

3 3

Screening

Yes

3

EXAMINATION DONE:

Enrolled:

Schedule:

Requesting physician: Raymund, Lawrence M.D.

Age/Sex: 45/F

Patient’s name: Morelos, Maria

Category IV Registration No.

DSSM AND CULTURE RESULT

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5.2 Decide on the appropriate action in response to the smear results Even if an MDR-TB suspect’s DSSM results are negative, the Culture Center will automatically process the specimens to isolate and identify M. tuberculosis. There are many cases of smear-negative but culture-positive cases of TB and when MDR-TB is suspected, it is critical to confirm the suspicion with a DST. As culture results are available, the Culture Center will fill out individual results using the DSSM and Culture Result Form.

•

If any of the sputum specimens is smear-positive, this result means that the MDR-TB suspect has infectious pulmonary TB. This result does not signify anything about the possibility of drug resistance for the MDR-TB suspect. The MDR-TB suspect should be informed of the results and reminded to follow up for the culture results in 3-3.5 months from sputum collection. The MDR-TB suspect should also be educated on the infection control precautions to take while at home to avoid spreading TB to those around him.

Important messages to give to the patient are described in Module D: Inform Patients about MDR-TB.

•

If all specimens are smear-negative, the Culture Center also automatically processes them for culture. The MDR-TB suspect can call the Treatment Center for the culture results on or after 3-3.5 months from sputum collection.

5.3 Record the culture results in the TB Symptomatics Masterlist Upon receipt of culture results at the Treatment Center, find the suspect’s name in the TB Symptomatics Masterlist (see example on page 81). Record the results of culture for each of the samples in column 16 “Screening (DSSM/ culture results)”. These entries on culture should already have DSSM results and dates of sputum collection entered previously when the DSSM results were received.

To record culture results, write “0” if negative and write ‘Mtb’ if positive. If the result is less than 10 colonies, write the number of colonies as reported in the result form.

The culture result of the patient Maria Morelos, the example used in Section 5.1 is shown below. This was received by the LCP-PHDU DOTS Center on June 5, 2007 showing both specimens to be positive for M. tuberculosis.

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Date Released:

mm/dd/yy

Laboratory Technician

Claire Macugay, RMT

MTB

MTB

TB culture

06/04/07

3+

2+

Date of collection

Lab No.

DSSM

Retreatment

2/8/2007

3

2/7/2007

New

03-L-070080-2

TB Culture

Category:

Months post-treatment

03-L-070080-1

3

Follow-up: month of tx:

2nd specimen

DSSM

No

Baseline

Date collected

Sputum

Specimen:

3rd specimen

DST center:

LCP laboratory

Culture center:

Laboratory Supervisor

Lawrence Laqiundanum, RMT

LCP-PHDU DOTS Center

Treatment center:

1st specimen

3 3

Screening

Yes

3

EXAMINATION DONE:

Enrolled:

Schedule:

Requesting physician: Raymond, Lawrence M.D.

Age/Sex: 45/F

Patient’s name: Morelos, Maria

Category IV Registration No.

DSSM AND CULTURE RESULT

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As soon as this is received at the Treatment Center, write “Mtb” for the February 7 and 8, 2007 specimens after putting a slash to separate this from the DSSM result. See how this is done on page 81, column 16 of the TB Symptomatics Masterlist.

5.4 Decide on the appropriate action in response to the culture results If a patient has at least one positive sputum culture for M. tuberculosis, this means that the MDR-TB suspect has confirmed pulmonary TB. •

If the culture is positive (10 or more colonies), the Culture Center will send the culture isolate to the DST center.

•

If one sputum culture yields a count of < 10 colonies, the second sputum culture must also have a growth of at least < 10 colonies for the culture to be interpreted as positive. Between these two isolates with both < 10 colonies each, send the isolate with more colonies or more luxuriant growth to the DST Center while keeping the other one at the Culture Center.

•

If one sputum culture has <10 colonies and the second culture has negative growth, DST will still be performed on the isolate with < 10 colonies as this is a diagnostic specimen. This is not done for follow-up specimens.

•

If both culture results are negative or have no growth, no further test will be done.

•

If culture result is negative and smear result is positive, refer to the consilium for further discussion and decision on management.

For screening and baseline specimens, the isolates are sent to the DST Center for DST. However, for follow-up specimens, the isolates are simply kept at the Culture Center unless otherwise requested for DST by the Treatment Center.

When the patient with a positive culture calls the Treatment Center for the results, he should be informed that the culture was positive and that the result of the final stage of diagnostic testing will be available in the following weeks. The patient is advised to make a follow-up call 1-2 months after to find out the results of the DST and asked to come in for further examination.

The Culture Center will send the isolates to the DST Center along with the other isolates for DST. All isolates are listed one by one on the Laboratory Receiving Form for Specimens. Tick the “Isolates” box; write down the names of the patients with positive culture results, indicate the laboratory numbers of the isolates. All isolates will be packed in a biobottle and prepared according to guidelines on proper packing and transportation of infectious materials.

The person receiving the box signs the form and brings the box to the DST Center. The DST Center staff will carefully unpack the package in a safety hood and check the isolates against the Laboratory Receiving Form for Specimens. If there is no discrepancy, he affixes his initials and date on the form and files it. However, if there is a discrepancy, the DST Center will call the Culture Center and document their agreement on the form. He then files the form at the DST Center.

78 Detect Cases of MDR-TB

MODULE B

6. Receive and record the DST results in the TB Symptomatics Masterlist, Category IV Register and Consiliumex DST results received at the Treatment Center must be immediately relayed to the referring Treatment Center physician. Should there be any delay in the pick up of results, the DST Center must relay the results of confirmed MDR-TB cases by facsimile or SMS (text message) with the official DST Result Form to follow. Just like the release of culture results, all DST results are also summarized in the Laboratory Releasing Form for Results by the staff at the DST Center. This will be signed by the messenger and brought to the Treatment Center. The staff at the receiving Treatment Center will check the individual results against the Laboratory Releasing Form and contact the DST Center in case of any discrepancy.

6.1 Record DST results in the TB Symptomatics Masterlist If the DST result shows that the M. tuberculosis is “resistant” to a certain drug, this means that the TB bacilli grew despite the presence of the drug in the culture medium. Drug resistance in the DST test signifies that the patient should not receive that drug as part of the anti-TB regimen because the drug will not have any effect on the strain of bacilli that the patient has. If the result was “susceptible”, this means that the DST test found that the specific drug in the culture medium inhibited the growth of the bacilli and that generally, that specific drug can be expected to help cure the patient of TB when given as part of the TB regimen. The Consilium will make the final decision on the TB regimens that patients must receive for MDR-TB treatment. (See Module C: Treat MDR-TB Patients) To record the DST results, find the MDR-TB suspect’s name in the TB Symptomatics Masterlist. If susceptible to a drug, write “S” and if resistant, write “R”. Record the results for each drug tested under Column 17 “DST Results”.

Since DST is the final step in confirming that a patient is MDR-TB, the date when the Treatment Center received this information is very important. Hence, upon receipt of DST results, the Treatment Center should mark this date on the individual DST result form and record this on the TB Symptomatics Masterlist column 18 “Registration date” sub-column “Date DST released”. This should also be recorded in the Category IV Register column 16 which will be discussed later.

Detect Cases of MDR-TB

79

REP U

Programmatic Management of Drug - Resistant TB (PMDT)

45/F

3 Screening 3 Yes

Date Released:

Michael S. Evangelista Laboratory Technician

mm/dd/yy

Levofloxacin (Lfx)

S

S

ND

R

3 Retreatment Disc Elution / 7H10

New

07/10/07

S

Ciprofloxacin (Cfx )

S

Ethambutol (E) 5ug/ml

Pyrazinamide (Z) ______

Ofloxacin (Ofx)

R

Rifampicin (R) 5ug/ml

2/7/2008

Date collected

Sputum

Specimen:

Months post-treatment METHOD USED:

Category: Streptomycin (S)

Drug Susceptibility Testing

Follow-up: month of tx:

R

No

Baseline

Isoniazid (H) 0.1ug/ml

EXAMINATION DONE:

Enrolled:

Schedule:

Raymund, Lawrence M.D.

Morelos, Maria

Requesting physician:

Age/Sex:

Patient’s name:

TDF Laboratory

DST center:

LCP Laboratory

Culture center:

Laboratory Supervisor

Claudette Guray

Amikacin (Ak)

Other 2nd line drugs: S

S

03-L-070080-1

Laboratory ID no.

Kanamycin (Km) 6ug/ml

LCP-PHDU DOTS Center

Treatment center:

As soon as the DST result is received, staff at the LCP-PHDU DOTS Center should fill out Column no. 17 “DST Results“ of the TB Symptomatics Masterlist with “S” to mean “susceptible” and “R” to mean “resistant”.

F THE PHI LIP IC O BL

S NE PI

80 Detect Cases of MDR-TB

Category IV Registration No.

DRUG SUSCEPTIBILITY TEST (DST) RESULT

The DST result of the same patient, Maria Morelos, in Section 5.3 is shown below. This was received by the LCP-PHDU DOTS Center on July 10, 2007 showing that the patient was resistant to H, R and S and susceptible to Z, E, Km, Am, Cfx and Lfx.

MODULE B

(14)

1,2,3,4,5,6

Risk factors

(13)

4

Detect Cases of MDR-TB

81

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(15) CXR results

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02/08/07

02/07/07

3+ / MTB

2+ / MTB

1,2,7

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Date sputum collected (mm/dd/yy)

Screening (DSSM/ culture results) (16)

2/2/07

(15)

Date done

CXR results

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H

R

R

S

E

(17) DST results

S

Z

R

S

S

Km

ND

Ofx

DST results (17)

S

Cfx

TB Symptomatics Masterlist

S

Lfx

Programmatic Management of Drug - Resistant TB (PMDT)

F THE PHI LIP IC O BL

REP U

S

Other Other Am

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Summary

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7/12/07

Consilium date

Registration date (mm/dd/yy) (18) Date DST released

S NE PI

(13) Risk factors

Symptoms

7/21/07

07-0419

Enrolled? If YES, indicate treatment start date. If NO, indicate reason.

Pre-enrollment # (19) YY-NNNN

Column 18 “Registration date” refers to the date that confirmed the need for Category IV treatment either by a) the DST result or, b) consilium decision even without the DST result by virtue of a high clinical suspicion for MDR-TB. For the latter group of patients, write the date when the Consilium decided to start Category IV treatment under “Consilium date” of the same column, and keep blank the boxes for “DST results” and “Date DST released”. Both groups, when presented to the Consilium, are generally approved for treatment and all patients belonging to either group will be assigned a Pre-enrollment No. which will be explained in the next few pages.

Below, you will find the completed Columns 16, 17 and 18 of the TB Symptomatics Masterlist for patient, Maria Morelos.

MODULE B

MODULE B

For Treatment Site staff, skip Exercie E and continue reading from section 6.2, page 92 until the Summary of important points and tell your facilitator when you have reached that point.

For Treatment Center Staff Exercise E – Written Exercise When you have reached this point in the module, you are ready to do Exercise E. Follow the instructions for Exercise E. Do this exercise by yourself.

Exercise E Recording Results on the TB Symptomatics Masterlist In this exercise you will practice recording the results of the laboratory tests in the TB Symptomatics Masterlist for three patients. Use the information written on actual result forms provided to you. Work individually on this exercise.

If any of the instructions are unclear, ask a facilitator for clarification.

The DSSM, culture and DST results for Cases 1, 2 & 3 who were MDR-TB suspects listed on the TB Symptomatics Masterlist in Exercise C page 37 are shown in the next pages. The results for the other MDR-TB suspects, Cases 5 & 6 have not yet been released.

Record the results of the sputum examination of the patients on columns 16, 17 and 18 of the TB Symptomatics Masterlist provided to you in the previous exercise.

82 Detect Cases of MDR-TB

Programmatic Management of Drug - Resistant TB (PMDT)

REP U

34/F

Date Released:

TB culture

DSSM

Date of collection

Lab No.

mm/dd/yy

DSSM

No

Follow-up: month of tx: Retreatment

Ongoing

1+

Laboratory Technician

John Umali, RMT

Ongoing

2+

11/30/2007

2nd specimen

3

01-T-079781-2

New

1st specimen 11/29/2007

Sputum

Months post-treatment

Specimen:

01-T-079781-1

Category:

Laboratory Supervisor

3rd specimen

TDF Laboratory

Culture center:

Claudette Guray, RMT

TDF-MMC DOTS Clinic

Treatment center:

DSSM AND CULTURE RESULT

TB Culture

Baseline

12/07/07

3 3

Screening

Yes

3

EXAMINATION DONE:

Enrolled:

Schedule:

Requesting physician: Verzosa, Dave, MD

Age/Sex:

Patient’s name: Sariwa, Sonia S.

Category IV Registration No.

DSSM result:

MODULE B

S NE PI

F THE PHI LIP IC O BL

Detect Cases of MDR-TB

83

REP U

Programmatic Management of Drug - Resistant TB (PMDT)

F THE PHI LIP IC O BL

S NE PI

84 Detect Cases of MDR-TB

49/F

Date Released:

TB culture

DSSM

Date of collection

Lab No.

DSSM

No

mm/dd/yy

Follow-up: month of tx:

Ongoing

0

Laboratory Technician

John Umali, RMT

Ongoing

0

12/5/2007

01-T-079782-2

12/3/2007

Sputum

Retreatment

01-T-079782-1

3

2nd specimen

New

1st specimen

Category:

3rd specimen

TDF Laboratory

Culture center:

Laboratory Supervisor

Claudette Guray, RMT

TDF-MMC DOTS Clinic

Months post-treatment

Specimen:

Treatment center:

DSSM AND CULTURE RESULT

TB Culture

Baseline

12/08/07

3 3

Screening

Yes

3

EXAMINATION DONE:

Enrolled:

Schedule:

Requesting physician: Verzosa, Dave, MD

Age/Sex:

Patient’s name: Reloz, Rolando R.

Category IV Registration No.

DSSM result:

MODULE B

Programmatic Management of Drug - Resistant TB (PMDT)

REP U

45/M

Date Released:

TB culture

DSSM

Date of collection

Lab No.

DSSM

No

mm/dd/yy

Follow-up: month of tx:

Retreatment

Ongoing

3+

Laboratory Technician

John Umali, RMT

Ongoing

1+

12/6/2007

01-T-079783-2

3

01-T-079783-1

New 2nd specimen

12/5/2007

Sputum

Months post-treatment

Specimen:

1st specimen

Category:

3rd specimen

TDF Laboratory

Culture center:

Laboratory Supervisor

Claudette Guray, RMT

TDF-MMC DOTS Clinic

Treatment center:

DSSM AND CULTURE RESULT

TB Culture

Baseline

12/10/07

3 3

Screening

Yes

3

EXAMINATION DONE:

Enrolled:

Schedule:

Requesting physician: Verzosa, Dave, MD

Age/Sex:

Patient’s name: Santos, Santiago S.

Category IV Registration No.

DSSM result:

MODULE B

S NE PI

F THE PHI LIP IC O BL

Detect Cases of MDR-TB

85

REP U

Programmatic Management of Drug - Resistant TB (PMDT)

F THE PHI LIP IC O BL

S NE PI

86 Detect Cases of MDR-TB

34/F

Date Released:

TB culture

DSSM

Date of collection

Lab No.

mm/dd/yy

DSSM

No

Follow-up: month of tx:

Retreatment

Mtb

1+

John Umali, RMT

Laboratory Technician

Mtb

2+

11/30/2007

01-T-079781-2

3

01-T-079781-1

New 2nd specimen

11/29/2007

Sputum

Months post-treatment

Specimen:

1st specimen

Category:

Laboratory Supervisor

3rd specimen

TDF Laboratory

Culture center:

Claudette Guray, RMT

TDF-MMC DOTS Clinic

Treatment center:

DSSM AND CULTURE RESULT

TB Culture

Baseline

03/15/08

3 3

Screening

Yes

3

EXAMINATION DONE:

Enrolled:

Schedule:

Requesting physician: Verzosa, Dave, MD

Age/Sex:

Patient’s name: Sariwa, Sonia S.

Category IV Registration No.

Culture result:

MODULE B

Programmatic Management of Drug - Resistant TB (PMDT)

REP U

49/F

Date Released:

TB culture

DSSM

Date of collection

Lab No.

DSSM

No

mm/dd/yy

3

Follow-up: month of tx:

Retreatment

0

Mtb

John Umali, RMT Laboratory Technician

Negative

0

12/5/2007

01-T-079782-2

3

01-T-079782-1

New 2nd specimen

12/3/2007

Sputum

Months post-treatment

Specimen:

1st specimen

Category:

3rd specimen

TDF Laboratory

Culture center:

Laboratory Supervisor

Claudette Guray, RMT

TDF-MMC DOTS Clinic

Treatment center:

DSSM AND CULTURE RESULT

TB Culture

Baseline

03/25/08

3 3

Screening

Yes

3

EXAMINATION DONE:

Enrolled:

Schedule:

Requesting physician: Verzosa, Dave, MD

Age/Sex:

Patient’s name: Reloz, Rolando R.

Category IV Registration No.

Culture result:

MODULE B

S NE PI

F THE PHI LIP IC O BL

Detect Cases of MDR-TB

87

REP U

Programmatic Management of Drug - Resistant TB (PMDT)

F THE PHI LIP IC O BL

S NE PI

88 Detect Cases of MDR-TB

45/M

Santos, Santiago S.

Date Released:

TB culture

DSSM

Date of collection

Lab No.

DSSM

No

mm/dd/yy

3

Retreatment

Mtb

3+

12/5/2007

Laboratory Technician

John Umali, RMT

Mtb

1+

12/6/2007

01-T-079783-2

New

01-T-079783-1

Category:

Months post-treatment

Sputum

Specimen:

2nd specimen

TB Culture

Follow-up: month of tx:

3rd specimen

TDF Laboratory

Culture center:

Laboratory Supervisor

Claudette Guray, RMT

TDF-MMC DOTS Clinic

Treatment center:

DSSM AND CULTURE RESULT

1st specimen

3

Baseline

03/17/08

3 3

Screening

Yes

3

EXAMINATION DONE:

Enrolled:

Schedule:

Requesting physician: Verzosa, Dave, MD

Age/Sex:

Patient’s name:

Category IV Registration No.

Culture result:

MODULE B

Programmatic Management of Drug - Resistant TB (PMDT)

REP U

Date Released:

mm/dd/yy

04/20/08

S

Laboratory Technician

Michael S. Evangelista

Levofloxacin (Lfx)

Ciprofloxacin (Cfx )

R

Ethambutol (E)

Pyrazinamide (Z)

Ofloxacin (Ofx)

R

Rifampicin (R)

New

3

S

S

ND

R

Retreatment

Months post-treatment METHOD USED: Disc Elution / 7H10

Streptomycin (S)

Drug Susceptibility Testing

Follow-up: month of tx:

R

No

Baseline

Isoniazid (H)

3

Screening

Yes

3

EXAMINATION DONE:

Enrolled:

Schedule:

Requesting physician: Verzosa, Dave, MD

Category:

Laboratory Supervisor

Claudette Guray

Amikacin (Am)

Other 2nd line drugs:

Kanamycin (Km)

DST center:

Date collected

TDF Laboratory

TDF Laboratory

Sputum

11/29/2007

Culture center:

Specimen:

Patient’s name: Sariwa, Sonia

Age/Sex: 34/F

01-T-079781-1

TDF-MMC DOTS Clinic

Laboratory ID no.

Treatment center:

DRUG SUSCEPTIBILITY TEST (DST) RESULT

Category IV Registration No.

DST result:

S

S

MODULE B

S NE PI

F THE PHI LIP IC O BL

Detect Cases of MDR-TB

89

REP U

Programmatic Management of Drug - Resistant TB (PMDT)

F THE PHI LIP IC O BL

S NE PI

90 Detect Cases of MDR-TB

mm/dd/yy

Date Released: 04/25/08

S

Laboratory Technician

Michael S. Evangelista

Levofloxacin (Lfx)

Ciprofloxacin (Cfx )

S

Ethambutol (E)

Pyrazinamide (Z)

Ofloxacin (Ofx)

R

Rifampicin (R)

New

3

S

S

ND

S

Retreatment

Laboratory Supervisor

Claudette Guray

Amikacin (Am)

Other 2nd line drugs:

Kanamycin (Km)

TDF Laboratory

12/3/2007 Months post-treatment

DST center:

Date collected

METHOD USED: Disc Elution / 7H10

Category: Streptomycin (S)

Drug Susceptibility Testing

Follow-up: month of tx:

R

No

Baseline

Isoniazid (H)

3

Screening

Yes

3

EXAMINATION DONE:

Enrolled:

Schedule:

Requesting physician: Verzosa, Dave, MD

Age/Sex: 49/F

TDF Laboratory

Sputum

Specimen:

Patient’s name: Reloz, Rolanda

01-T-079781-1 Culture center:

Laboratory ID no.

TDF-MMC DOTS Clinic

Treatment center:

DRUG SUSCEPTIBILITY TEST (DST) RESULT

Category IV Registration No.

DST result:

S

S

MODULE B

DST result:

Programmatic Management of Drug - Resistant TB (PMDT)

REP U

Date Released:

mm/dd/yy

04/28/08

S

Laboratory Technician

Michael S. Evangelista

Levofloxacin (Lfx)

Ciprofloxacin (Cfx )

R

Ethambutol (E)

Pyrazinamide (Z)

Ofloxacin (Ofx)

R

Rifampicin (R)

New

3

S

S

ND

S

Retreatment

Months post-treatment

12/5/2007

Date collected

METHOD USED: Disc Elution / 7H10

Category: Streptomycin (S)

Drug Susceptibility Testing

Follow-up: month of tx:

R

No

Baseline

Isoniazid (H)

3

Screening

Yes

3

EXAMINATION DONE:

Enrolled:

Schedule:

Requesting physician: Verzosa, Dave M.D.

Age/Sex: 45/M

Sputum

Laboratory Supervisor

Claudette Guray

Amikacin (Am)

Other 2nd line drugs:

Kanamycin (Km)

TDF Laboratory

DST center:

TDF Laboratory

Culture center:

Specimen:

Patient’s name: Santos, Santiago

S

S

01-T-079783-1

Laboratory ID no.

Treatment center: TDF-MMC DOTS Clinic

Category IV Registration No.

DRUG SUSCEPTIBILITY TEST (DST) RESULT

MODULE B

S NE PI

F THE PHI LIP IC O BL

Detect Cases of MDR-TB

91

MODULE B

When you have finished this exercise, please discuss your answers with a facilitator.

For Treatment Center Staff Read through until the Summary of important points in the module and tell your facilitator when you have reached that point.

6.2 Assign a Pre-enrollment No. to the patient if confirmed to have MDR-TB A patient confirmed to be MDR-TB either by DST or by consilium decision should be put on treatment as soon as possible. However, this does not always happen for various reasons, e.g., the patient may have a) gone back to the province and cannot be located (“early default”), b) died, or c) refused treatment.

It is important to track the waiting time of patients from consultation or screening to diagnosis to the time they are treated as MDR-TB. If this is too long, the Treatment Center will have to review its process of diagnosis and enrolment.

The last column, Column 19, of the TB Symptomatics Masterlist is entitled “Pre-enrollment No.”. Not all patients will be assigned this number. As discussed in section 6.1 above, the Pre-enrollment No. is given only to two groups of patients entered in the TB Symptomatics Masterlist, namely a) those who have been confirmed to be MDR-TB by DST and b) those with consilium decision to treat even if not confirmed to be MDR-TB by DST but highly suspected to be MDR-TB from the clinical standpoint. The latter includes critically ill patients who have either pending culture or DST results and cannot wait for these results to be released and immediate treatment needs to be started. This also includes patients who have negative cultures due to intake of drugs with anti-TB action prior to sputum collection, and those with non-viable or contaminated culture in the laboratory.

If the patient with the Pre-enrollment No. is enrolled, write the treatment start date under the Pre-enrollment No. If the patient is not enrolled, indicate the reason why under the Pre-enrollment No. These reasons can be that the patient is lost or has gone back to the province, the patient has died while waiting for treatment, or has decided not to start the treatment at all for whatever reason, etc.

The Pre-enrollment No. is coded as YY (current year)-NNNN (accrual number which starts with 0001 at the start of every year). For example, a patient bearing the Pre-enrollment No. 08-0329 means that the patient qualified for start of treatment in year 2008 and was the 329th patient to be given a Pre-enrollment number in 2008.

Once a patient with a Pre-enrollment No. is started on treatment, he is entered into the Category IV Register. All patients put on treatment will be entered into the Category IV Register and each one is assigned a unique Category IV Registration No. See Module C: Treat MDR-TB Patients and the Reference Booklet for instructions on how to fill out the Category IV Register.

92 Detect Cases of MDR-TB

MODULE B

6.3 Record the results in the patient’s chart and in the Consiliumex Patients who are confirmed to be MDR-TB by DST and those who are critically ill and highly suspected for MDRTB need to be presented to the Consilium. The consilium determines treatment regimens, assesses response to treatment and treatment outcome through a consensus utilizing WHO Guidelines for drug-resistant TB. The Treatment Center physician will fill out the Consiliumex for one case in preparation for presentation to the Consilium. An example of the Consiliumex can be found on the following pages. There are many sections of the Consiliumex. At this point, the physician will be completing first the patient’s general information, TB treatment history, DST pattern and chest x-ray results, then Consilium Discussion 001 – Recommendation on Enrollment Regimen.

6.4 Schedule a case for presentation at the next Consilium meeting The Consilium normally meets every week to discuss cases. The Treatment Center physician must prepare the necessary documents such as the Consiliumex, laboratory results and x-ray films and schedule the case to be presented in the next meeting. The Consilium will make the final decision on what the course of action for the MDRTB patient will be, particularly the MDR-TB regimen design following the principles in the WHO guidelines.

An example of how to fill out the Consiliumex can be found on the following two pages.

Detect Cases of MDR-TB

93

MODULE B REP U

S NE PI

National Tuberculosis Program Programmatic Management of Drug - Resistant TB (PMDT)

F THE PHI LIP IC O BL

CONSILIUMEX

Category IV Registration No:

Must be completely filled out by the Treatment Center physician prior to consilium presentation GENERAL INFORMATION: NAME

Balagtas

Jose (Last)

50

(First)

SEX

METRO MANILA ADDRESS

Amorsolo

M

F

(Middle)

WEIGHT ON SCREENING

49.2

KGS

2425 Buendia Street, Balut Tondo, Manila (No., street, barangay, district, city, ZIP code)

Same as above

PERMANENT ADDRESS

(No., street, barangay, district, city, ZIP code)

REGION

NCR

TREATMENT CENTER

KASAKA

MD IN CHARGE

DAR (initials of Dr. Dan A. Rivera)

TB treatment history is important in making decisions regarding the patient’s regimen design.

TB TREATMENT HISTORY, CHEST X-RAY RESULTS AND DST PATTERN: TB TREATMENT HISTORY AND REGISTRATION GROUP

1997 – 2HRZE, 4HR Government hospital, non-DOTS, unknown 2003 – 2HRZES, 4HRZE, health center DOTS, failed 2004 – 3HRZES, 3HRZES, health center DOTS, failed After cat II failure

CHEST X-RAY RESULTS

Cavity on upper right lung, infiltrates BLL and fibrothorax on LUL

NAME OF OTHER LABORATORY

LCP

DST RESULT

DATE DST RELEASED

Resistant to: HRES

10 / 10 / 05

Susceptible to: Z Km Lfx Clr

CULTURE CENTER (Screening)

TDF

DATE SPECIMEN COLLECTED

10/18/06

DST CENTER (Screening)

TDF

DATE DST RELEASED

02/26/07

DST RESULT (Screening)

Resistant to: HRES

Susceptible to: Z Km Cfx Ofx Lfx

DST RESULT (Baseline) Resistant to: Note: to be filled in Not available once available

Susceptible to: Not available

WEIGHT MONITORING: (TO BE CONSTANTLY UPDATED EVERY CONSILIUM MEETING BY THE SECRETARIAT) CONSILIUM DISCUSSION

DATE

WEIGHT (KGS)

CONSILIUM DISCUSSION

001 (E)

03 / 01 / 07

49.2

006

002

007

003

008

004

009

005

010 (TO)

94 Detect Cases of MDR-TB

DATE

WEIGHT (KGS)

MODULE B

Example of a Consiliumex showing Consilium decision on treatment regimen.

CONSILIUM DISCUSSIONS CONSILIUM DISCUSSION 001 – RECOMMENDATION ON ENROLMENT REGIMEN RECOMMENDED REGIMEN AND DRUG INTRODUCTION GUIDE: LATEST WEIGHT

49.2

SECOND-LINE DRUG

ZKmOfxPtoCs

MD IN CHARGE

DAR

KGS

REGIMEN

SYMBOL

DAY 1

DAY 2

DAY 3

DAY 4

DAY 5

DAY 6

DAY 7

Cycloserine

Cs

1 cap

1 cap

1 cap

2 caps

2 caps

2 caps

FD

Prothionamide

Pto

1 tab

1 tab

1 tab

2 tabs

2 tabs

2 tabs

FD

PASER

PAS

1 sachet

1 sachet

1 sachet

2 sachets

2 sachets

2 sachets

2 sachets

DRUGS IN REGIMEN (USE SYMBOL)

PREPARATION

NO. OF UNITS PER DAY

Z

500 mg

5

Ofx

200 mg

Km

1 G

Pto

250 mg

Cs

250 mg

Make sure all consilium decisions are signed by the Consilium Officer who ensures that all entries are correct.

750 4 2

Clearly indicate the 2 regimen and recommended dosage for the patient

COMMENTS:

For enrollment

CONSILIUM OFFICER

Ma. Imelda D. Quelapio MD

DATE

03 / 01 / 07

An example of a completed Category IV Register is shown in the next few pages.

Detect Cases of MDR-TB

95

96 Detect Cases of MDR-TB

/

/

/

/

11 / 24/ 05

11 / 08/05

10/4/2005

Treatment start date mm/dd/yy (3)

Patient’s unique Category IV Registration No. is given once treatment is started.

/

02-05-0097

4/25/2005

/

02-05-0096

4/28/2005

/

02-05-0095

4/29/2005

/

Category IV Registration No. TC-YY-NNNN (2)

Date screened mm/dd/yy (1)

JOSE AMORSOLO

(5) Sex 1- Male 2- Female

/

/

8– Fibrothorax 9– Bullae 10– Pleural effusion 11– Pneumothorax 12– Bronchiectasis 13– Atelectasis 14– Consolidation 15– Mass 16– Others, specify _______________

P

P

P

Site of disease (8)

REP U

1-New 2-After Cat I failure 3-After Cat II failure 4-After Cat IV failure 5-After default 6-Cat I relapse 7-Cat II relapse 8-Cat IV relapse 9-Transfer-in

/

/

10.1 Non-DOTS 10.2 Other (+) 10.3 Other (-)

3

10.3

10.1

/ /

/ /

/ /

/ /

/ / /

/ / /

04/28/05

/

/

04/27/05

/

/

04/29/05

Date DST specimen collected mm/dd/yy (12) t

1- New 2- First line drugs only 3- First and second-line drugs

(11) Previous TB treatment

2

3

2

Registration Previous TB group treatment (10) (11)

10-Other patient w/

/

/

10/21/05

1,2,8

11/08/05

1, 15

10/03/05

1,2,3

Date done mm/dd/yy

Chest x-ray result (9)

(10) Registration group

Tondo, Manila, NCR

(9) Chest x-ray result

/

/

01 / 20 / 55

0– Normal 1– Cavitary 2– Infiltrate 3– Nodule 4– Miliary TB 5– Intrathoracic lymphadenopathy 6– Endobronchial spread 7– Fibrosis

1

2425 Buendia St., Balut

50

BALAGTAS,

Arlegui St., Malacanang cmpd

23 Manila, NCR

Bacacay, Albay, Bicol Region

47 National Road, Brgy San Vicente

27 02 / 02 / 78

Street no. and name Brgy. City, Region

Date of birth mm/dd/yy

Address (7)

03/28/83

1

2

Sex (5)

Age (yrs) (6)

VINCENT LIM

TAN,

SYLVIA GOMEZ

SANTOS,

Last name First name and middle name

Name (4)

Category IV Register

Programmatic Management of Drug - Resistant TB (PMDT)

F THE PHI LIP IC O BL

S NE PI

Category IV Register/ Page 1 of 3

/

/

/

/

/

/

/

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/

/

/

/

/

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04/28/05

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04/27/05

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R

R

R

R

S

R

S

Z

S

R

R

S

S

R

S

Km

S

R

S

Ofx

S

R

S

Cfx

S

S

S

Lfx

ND

ND

ND

Other

ND

ND

ND

Other

10/10/05

10/5/05

9/23/05

Date DST released mm/dd/yy (14)

Row 1: DST available at start of treatment, usually the DST result at screening. The next rows are for the DST result at baseline and DSTs done while on treatment, if applicable.

R

R

R

E

S - Susceptible R - Resistant ND - Not Done

Drug Susceptibility Testing (DST) (13)

Rows 3 and 4: Other DSTs during treatment H-Isoniazid Km-Kanamycin R-Rifampicin Ofx-Ofloxacin Z-Pyrazinamide Cfx-Ciprofloxacin E-Ethambutol Lfx-Levofloxacin S-Streptomycin

Row 2: Baseline DST or DST done within 30 days prior to treatment start or 7 days post-treatment start (result not yet available upon treatment)

Row 1: Screening DST or DST result available pre-treatment

(13) Drug Susceptability Testing (DST)

R

R

04/29/05

/

H

R

Date DST specimen collected mm/dd/yy (12)

10/11/05

10/10/05

9/26/05

Date received by Tx center mm/dd/yy (15) s/c

mm/dd/yy

s/c

mo 0

09/29/05

09/28/05

2+/MTB

11/07/05

11/04/05

3+/MTB

/ /

/ /

/ /

/ /

10/22/05

10/21/05

4+/MTB

Category IV REGISTER | page 2 of 3

2+/MTB 3+/MTB 3+/MTB

/ /

/ /

/ /

/ /

12/22/2005

/ /

/ /

1/25/2006

0/0

/ /

/ /

mm/dd/yy

s/c

mo 3

The two baseline DSSM and culture results are recorded.

/ /

/ /

11/24/2005

0/0

/ /

/ /

02+/0

mm/dd/yy

s/c

mo 2

mm/dd/yy

s/c

mo 1

/ /

/ /

2/23/2006

0/0

/ /

/ /

mm/dd/yy

s/c

mo 4

/ /

/ /

3/24/2006

0

/ /

/ /

mm/dd/yy

s/c

mo 5

/ /

/ /

/ /

/ /

/ /

mm/dd/yy

s/c

mo 7

s/c

mo 8

REP U

/ /

/ /

/ /

/ /

/ /

mm/dd/yy

Monthly DSSM and culture results are recorded.

/ /

/ /

4/20/2006

0

/ /

/ /

mm/dd/yy

s/c

mo 6

Follow-up DSSM and culture monitoring during treatment (16)

Programmatic Management of Drug - Resistant TB (PMDT)

F THE PHI LIP IC O BL

/ /

/ /

/ /

/ /

/ /

mm/dd/yy

s/c

mo 9

S NE PI

Detect Cases of MDR-TB

97

98 Detect Cases of MDR-TB

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

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/

mm/dd/yy

mm/dd/yy

/

s/c

s/c

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mo 11

mo 10

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mm/dd/yy

s/c

mo 12

s/c

mo 13

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mm/dd/yy

Category IV REGISTER | page 3 of 3

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mm/dd/yy

s/c

SUMMARY

/

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mm/dd/yy

s/c

mo 16

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mm/dd/yy

s/c

mo 17

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/

mm/dd/yy

s/c

mo 19

mm/dd/yy

s/c

mo 20

mm/dd/yy

s/c

mo 21

mm/dd/yy

s/c

mo 22

mm/dd/yy

s/c

mo 23

/

/

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/

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/

1. Extrapulmonary 2. Trans-in 3. Other

Excluded

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mm/dd/yy

s/c

mo 24

Post-treatment follow-up monitoring (18)

HIV status

REP U

/

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(19)HIV status 0-Negative 1-Positive 2-Unknown

/

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/

/

/

/

/

/

2

2

2

Date of last intake of Ff up 1 Ff up 2 Ff up 3 Ff up 4 (19) meds

Treatment outcome (17)

(18) Post-treatment follow-up Row 1: Date : mm/dd/yy Row 2: Symptoms: S- Symptomatic As- Asymptomatic Row 3: Smear/ culture result Row 4: CXR compared with last film done 1 - Improved 2- Progressed, specify using codes in (9) 3 - Stable

/

/

/

/

For a transfer out patient, contact the receiving / Treatment / / Center / /to find/ out / final treatment / / / / outcome.

mm/dd/yy

s/c

mo 18

Follow-up DSSM and culture monitoring during treatment (16) mo 15

Interim Outcome 1. Culture-positive at month 0 2. Culture-negative at month 6 Final Outcome 1. Cured 2. Treatment completed 3. Died 4. Failed 5. Defaulted Still receiving treatment

/

/

/

/

/

mm/dd/yy

s/c

mo 14

Programmatic Management of Drug - Resistant TB (PMDT)

F THE PHI LIP IC O BL

S NE PI

MODULE B

MODULE B

6.5 Return an updated Acknowledgement Form to the referring DOTS facility As soon as a definitive diagnosis has been made at the Treatment Center, you need to inform the referring DOTS facility of the diagnosis and plan for the patient. This is done using the same Acknowledgement Form that is used during screening. This is accomplished in duplicate copies, one for the referring facility through the patient and the other attached to the patient’s records in the Treatment Center. Tick the box for “Final diagnosis”. On this form the physician writes the name of the referred patient, the pertinent laboratory findings particularly DST, the final diagnosis, and the recommendations. If however, the patient has not called or returned to the Treatment Center to pick up his results, the Acknowledgement Form will be sent by facsimile to the referring facility with request for assistance to locate the patient. All efforts should be done to contact the patient, e.g., by land or cell phone, or by a visit. An example of the Acknowledgement Form for final diagnosis is shown in the next page.

Detect Cases of MDR-TB

99

S NE PI

Programmatic Management of Drug - Resistant TB (PMDT)

F THE PHI LIP IC O BL

REP U

MODULE B

Acknowledgement Form Date:

October 11, 2005

To:

Dr. A. Madrid

Sampaguita Health Center

3 Final Diagnosis

Tick final diagnosis for patients with results of sputum test

Tondo, Manila

Thank you for referring your patient diagnosis/management.

Initial Diagnosis

Jose A. Balagtas

, for further TB

Pertinent findings/ Laboratory examinations: AFS 4/25/05

4/26/05

3+

4+

Culture M. tuberculosis

M. tuberculosis

}

DST (released Oct.10, 2005) Resistant to H,R,E,S

susceptible to Z Km, Cfx, Ofx, Lfx

Notify referring MD/ treatment facility regarding the patient’s diagnosis and plan of treatment.

Plans/Recommendations: Final diagnosis is MDR-TB For category IV treatment Please inform patient that he is ready for enrollment.

Please contact the number below for any queries and further instructions.

Clinic Physician:

Dr. Dan. A. Rivera

Contact numbers: 742-1534/ 781-3761 to 65 loc. 146 Treatment Center: KASAKA-QI MDR-TB Housing Facility To be accomplished In duplicate copies: One copy for the Referring physician or facility and one copy attached to the Screening Form at the Treatment Center

100 Detect Cases of MDR-TB

MODULE B

7. Inform MDR-TB suspects of laboratory test results 7.1 Patients with drug resistance If the TB suspect has confirmed drug resistance to one or more TB drugs, inform him clearly and in a sensitive way.

It is important to inform the DR-TB suspect as soon as possible about drug resistance and the next steps that will be taken to start treatment. If a DR-TB suspect does not call or return to the Treatment Center to find out the results on the scheduled time, and the DST result shows drug resistance, a highly proactive search to find the patient needs to be done. All efforts should be made to contact or locate him as soon as possible. Call the patient or his contacts using the numbers recorded in the TB Symptomatics Masterlist within that week. Or you can call the referring DOTS facility to help locate the patient. This may also require you to visit the patient’s address. Patients with MDR-TB who are left untreated can infect many others; moreover, delays in treatment can lead to worse treatment outcomes.

Hence, it is imperative not to lose confirmed MDR-TB cases.

7.1.1 Inform the patient of the results and explain the Consilium process When you inform the patient that the DST showed resistance to TB drugs, explain in simple terms what drug resistance is, and what that means for treatment. Reassure the patient that MDR-TB can be cured, but that it will take dedication and many months of treatment. Drug-resistant TB is a very serious disease but it can be cured and, treatment is given free of charge. It is also important to ensure that the patient will be ready to start treatment once his case has been discussed and is approved for enrollment. Explain that this process may take some time but that they should be ready to begin treatment in the near future.

This is a very important meeting with the MDR-TB patient. At this initial discussion, you will begin to provide important information and support and tell the patient about the future treatment. This is the beginning of a long relationship with the patient, one that is essential for the successful treatment of the disease. All communication must be kind, supportive and medically correct.

Inform the patient about MDR-TB, supervised treatment, the treatment regimen, possible adverse drug reactions, TB transmission, etc. Discuss the patient’s main worries or doubts and answer any questions clearly and positively to encourage him as he prepares to start a long and difficult treatment course. See Module D: Inform Patients about MDR-TB.

7.2 Patient with no drug resistance A patient who has positive culture but does not show resistance to TB drugs can begin treatment for TB according to the standard guidelines of the National TB Program. The Treatment Center physician should refer the patient to the appropriate DOTS facility to begin treatment immediately, explaining well to the patient why treatment need not be done at the MDR-TB Treatment Center.

Detect Cases of MDR-TB

101

MODULE B

8. Trace household contacts 8.1 Obtain a written consent from the patient in Kasunduan/”Contract” for treatment and

to interview the patient’s household contacts The MDR-TB patient will now be asked to sign a contract for treatment. Read the Kasunduan/Contract to the patient and his family member or relative in a way that they can understand. This Contract with the patient is very important because it is another opportunity to explain to the patient what MDR-TB treatment entails, that MDR-TB, although difficult to treat, is curable, and that his adherence to treatment is crucial to treatment success. Answer any questions that the patient might have. Also explain to the patient his rights and responsibilities as a TB patient.

The patient should also be informed of the possibility that his or her household contacts have been infected with a drug-resistant strain of TB and the need to interview and examine all these contacts particularly: 1. all children aged less than five years even without symptoms Studies have shown the increased vulnerability to TB of children less than five years of age among family contacts and the increased estimated risk of progression to disease after infection. Hence, even without the manifestation of symptoms, children of this age group should be screened 2. five years and above who have cough of greater than two weeks Cough of more than two weeks is a cardinal symptom of TB and any person regardless of age manifesting with such should be investigated.

If you are sure that the patient has no more questions, ask him to affix his signature on the second page with the date. The family member or relative should also sign together with the Treatment Center staff. For more information about how to speak with a patient see Module D:Inform Patients about MDR-TB. Before any contact tracing can be performed, a Kasunduan/Contract must be signed by the patient. Patients may not want to sign or may be wary about doing so. You should explain to the patient the reasons for asking for his signature.

• In order to talk to contacts of the patient, consent is required to respect the patient’s privacy.

• If the patient signs in agreement to undergo treatment, it means that he understands the potential side effects of the drugs, pledges to adhere to the requirements of treatment and follow-up.

• Each patient has certain rights and responsibilities when receiving treatment for MDR-TB and these need to be explained and agreed upon.

The Kasunduan/Contract is shown on the next page and can also be found in the Reference Booklet.

102 Detect Cases of MDR-TB

REP U

MODULE B

S NE PI

Programmatic Management of Drug - Resistant TB (PMDT)

F THE PHI LIP IC O BL

KASUNDUAN/ “CONTRACT” PARA SA PASYENTENG MAY MDRTB 1. Ako si _____________________ay napaliwanagan na may sakit na Multidrug-resistant tuberkulosis. ¾¾ Ito ay nakakahawa sa iba. ¾¾ Ito ay di madaling gamutin at nangangailangan ng mahabang panahong gamutan (18-24 buwan o higit pa).

2. Upang gumaling: ¾¾ Kinakailangan kong magpagamot sa pamamagitan ng pag-inom ng gamot araw-araw sa itinakdang TREATMENT CENTER para sa akin. Kung ako ay di nakatira sa Lungsod kung saan nandoon ang Treatment Center, kinakailangang lumipat ako ng tahanan na malapit dito sa loob ng dalawang taon o higit pa upang mas maging madali para sa akin ang pagpunta sa klinika. ¾¾ Kung hindi posible para sa akin ang paglipat ng tahanan ay mananatili ako pansamantala sa half way house sa loob ng 6 na buwan o hanggang sa itinakdang araw sa akin ng klinika. ¾¾ Iinom ako ng 4 o higit pang klaseng gamot (> 10 tableta o kapsula) sa loob ng 18 buwan o higit pa, at bibigyan din ako ng ineksyon araw-araw sa loob ng anim na buwan o higit pa depende sa aking timbang at kondisyon. ¾¾ Ang mga gamot ay maaaring makapagdulot ng mga kakaibang pakiramdam o side effects kung kaya’t kailangan kong makipagtulungan at ipagbibigay alam agad sa mga staff ng klinika upang malunasan ang mga ito.

3. Kung di ko itutuloy o kukumpletuhin ang paggagamot: ¾¾ Maaari kong mahawa ang aking pamilya at ang mga taong nakapaligid sa akin. Ako ay makakahawa sa pamamagitan ng aking pag-ubo, pagbahin, pagsasalita at pagkanta. ¾¾ Ang patigil-tigil na pag-inom ay mas lalong makakapagpalala ng aking kalagayan.

4. Ang mga gamot na tinatawag na second-line drugs para sa tuberkulosis na gagamitin para sa akin ay mahal at di madaling bilihin at nagkakahalaga ng P200,000 o higit pa. ¾¾ Ito ay galing pa sa ibang bansa at kinakailangan pa ng tulong ng Green Light Committee (GLC) at ng World Health Organization (WHO) upang makamit.

5. Upang masubaybayan ang aking paggaling ako ay: ¾¾ Kukunan ng plema buwan-buwan. ¾¾ Ipinaliwanag sa akin na ang eksaminasyong ito ay nagkakahalaga ng higit pa sa 900 Piso bawat isa. ¾¾ Kukunan ng dugo sa braso kada 3 o 6 na buwan o kung kinakailangan. Ipinaliwanag sa akin na ito’y nagkakahalaga ng mahigit-kumulang 2000 piso, ngunit ako’y hindi na pagbabayarin ukol dito upang tulong ng DOTS clinic sa akin. ¾¾ Kukunan ng x-ray sa baga kada anim na buwan o kung kinakailangan habang ako ay nagpapagamot at kada anim na buwan sa loob ng dalawang taon matapos ang panahon ng aking paggagamot. ¾¾ Babalik sa klinika kada anim na buwan sa loob ng dalawang taon matapos ang panahon ng aking paggagamot (ibig sabihin apat na beses pagkatapos ng aking gamutan).

6. Ang mga sakit katulad ng diabetes, high blood at iba pang sakit na walang kinalaman sa TB ay di na sakop ng klinikang ito. Ito’y maaaring ipakonsulta at ipagamot sa ibang doktor.

7. Ang aking kalagayang pinansyal ay aalamin ng mga social worker upang maging basehan ng kakayahan ko sa pagpapatuloy sa aking gamutan at kakayahang tustusan ang iba ko pang pangangailangan habang ako ay nagpapagamot.

8. Kabutihang dulot ng paggagamot: ¾¾ Malaki ang pag-asa ko na ako ay gumaling at hindi na makakahawa pa sa iba. ¾¾ Ako ay makakabalik sa aking trabaho at magiging kapakipakinabang sa aking pamilya at komunidad. ¾¾ Ngunit kung malaki na ang sira ng aking baga dahil sa TB, maaaring hindi na ito bumalik sa normal kagaya ng dati kahit ang aking TB ay nagamot na.

KASUNDUAN/ “CONTRACT” PARA SA PASYENTENG MAY MDRTB | page 1 of 2

Detect Cases of MDR-TB

103

REP U

KASUNDUAN/ “CONTRACT” PARA SA PASYENTENG MAY MDRTB | page 2 of 2

S NE PI

F THE PHI LIP IC O BL

MODULE B Programmatic Management of Drug - Resistant TB (PMDT)

9. Upang mas lalong masiguro ang aking kalusugan at kalusugan ng aking mga kasambahay, dadalhin ko ang aking mga kasambahay sa itinakdang Treatment Center upang suriin sa sakit na tuberkulosis. Kukunan ng x-ray at eksaminasyon sa plema ang aking mga kasambahay kung kinakailangan.

10. Kung ako ay titigil sa gamutan: ¾¾ ipapaalam sa aking mga kasambahay, katrabaho, barangay official for health o sa pinakamalapit na health center sa aming komunidad ang aking kalagayan upang matulungan akong makabalik sa klinika. ¾¾ at nagdesisyon na muling bumalik para magpagamot, maaaring ang tsansang ibinigay sa akin upang makakuha ng libreng gamutan ay mawala na.

11. Hihingin sa akin ang lokasyon at adres ng health center na pinakamalapit sa aking tinitirahan: ¾¾ upang matulungan ang klinika na pabalikin ako sa paggagamot kung sakaling lumiban ako sa pag-inom. ¾¾ Para sa posibilidad na ako ay maendorso upang ipagpatuloy ang aking gamutan sa health center.

12. Kapag ang smear at culture ng aking plema ay negatibo na, ipagpapatuloy ko ang aking gamutan sa pinakamalapit na health center sa aming lugar.

Jose A. Balagtas

Oct. 23, 2005

Normando C. Cuervo

Oct. 23, 2005

Pangalan at lagda ng Pasyente

Pangalan at lagda ng Clinic Staff

Marites S. Sisaldo Pangalan at lagda ng kamag-anak o kasambahay ng pasyente

Petsa

Petsa

Oct. 2005 Make sure that both the 23, patient and family members understand the importance of daily DOT Petsa and completion of treatment.

Treatment Center Staff to please check accordingly and write the telephone and address.

TDF - MMC DOTS Clinic Tel: 893-6066 Address:

3

KASAKA - QI MDR-TB Housing Facility Tel: 742-1534 / 781-3761 to 65 Address: PTSI Compound, E. Rodriguez Ave, Quezon City LCP - PHDU DOTS Center Tel: 929-8324 Address:

104 Detect Cases of MDR-TB

DJNRMH DOTS Center (TALA Hospital) Tel: 962-9877 loc. 217 Address: PTSI - Tayuman DOTS Center Tel: Address Others, please specify,____________________ Tel: Address:

MODULE B

8.2 Complete the list of the patient’s contacts on the Contact Initial Investigation Form and conduct interviews A Contact Initial Investigation Form (CIIF) records all of the patient’s household contacts eligible for contact tracing which include a) all children less than five years even without symptoms, and b) five years and above who have cough for more than 2 weeks. Information on each of the patient’s eligible household contacts should be recorded on the CIIF as shown in the example on the next page.

On the right upper corner of the CIIF, note the total number of contacts regardless of criteria for contact tracing.

From this number, note the number eligible for contact tracing and list their names down. Then, note how many among the eligible were actually traced since not all contacts will be able to come.

Detect Cases of MDR-TB

105

4

Angelo Balagtas

4.

8.

7.

6.

M

M

F

F

Sex (M/F)

Normando Cuervo _____________________________________

Interviewer

son

son

HRES

Negative

16

31

39

49

Weight ( kgs )

1, 3

1

1,4

10/21/05

10/21/05

10/21/05

10/21/05

Symptoms Date of interview

1

3 Mtb

ND

ND

ND

Date

TST

17

mm

4– Non-response to antibiotic for lower resp. tract infection 5– Failure to regain previous state of health 2 wks after viral infection

0 Normal/Negative 1 Cavitary 2 Infiltrate 3 Nodule 4 Miliary Tb 5 Intrathoracic lymphadenopathy

CHEST X-RAY READING 6 Endobronchial spread 7 Fibrosis 8 Fibrothorax 9 Bullae 10 Pleural effusion

10/21/05

10/21/05

10/21/05

10/21/05

Date

3

7

0

2

3

7

0

2

Initial Official

/

0/P

0/P

/

For TBDC/ Pedia

For TBDC

For TBDC

Other comments

ND Not done R Refused P Pending

For ALL Procedures

0/P

0/P

0/P

Result 0/P

BACTERIOLOGY Smear Culture 0 0 1+ MTB 2+ 3+ 4+

10/21/05

10/21/05

ND

10/21/05

Date

Smear/ Culture

1 ≥5 yrs old: ____ 3 <5 yrs old: ____

# of eligible contacts evaluated

11 Pneumothorax 12 Bronchiectasis 13 Atelectasis 14 Consolidation 15 Mass 16 Others, specify _____

CXR

(11)

5 4 4

mendations. _______________________________________________________________________________________________________________

Retrieve old CXR film of Joy Balagtas for comparative reading & presentation to TBDC/ Follow up TBDC recomREMARKS: _______________________________________________________________________________________________________

0– None 1– Cough / wheezing >2wks 2– Unexplained fever >2 wks 3– Loss of weight or appetite/ Failure to gain weight

3 Positive

Susceptible: ZCfxOfxLfxKm

DST: Resistant:

Culture

Negative

First, note the total number of contacts regardless of eligibility, then note the number who are eligible; and lastly, those who were actually traced.

96

157

150

153

Height (cm)

(8)

Smear

SUMMARY: (9) # of contacts identified (10) # of eligible contacts for tracing

REP U

11/24/2007

Baseline mycobacteriology

Date enrolled:

(7)

(6)

Information on this form is confidential.

SYMPTOMS for children <5 yrs old**

daughter

wife

Relationship

List only the household contacts that are eligible for contract tracing.

11/4/01

5/3/91

4/13/87

9/14/53

Date of Birth

DEFINITIONS MDRTB household contact: Someone who sleeps in the same dwelling unit with common arrangement for food preparation & consumption with an MDR-TB patient for at least 3 months.

*Eligibility Criteria for contact tracing: (a) <5 yrs old with or without symptoms** (b) ≥5 yrs with cough of > 2 wks

14

Paul Balagtas

5.

18

Marites Balagtas

48

3.

Joy Balagtas

Age

(02) 244-6847

2.

1.

Name(s) of contacts eligible for tracing*

Telephone Number/s:

(5)

#

Address:

Age:

02-05-0097

50 Sex: 3 M F 2425 Buendia Street, Balut Tondo, Manila

Date of birth: 1/20/1955

(4)

(3)

Index name:

(2)

Jose A. Balagtas

Category IV Registration Number:

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(1)

Contact Initial Investigation Form

Programmatic Management of Drug - Resistant TB (PMDT)

S NE PI

Contact Initial Investigation Form/ Page 1 of 2

F THE PHI LIP IC O BL

MODULE B

MODULE B

8.3 Instruct patients’ symptomatic household contacts to receive appropriate care and follow-up A household contact of an MDR-TB patient with symptoms possesses a risk factor for MDR-TB. He is therefore regarded as an MDR-TB suspect and because he has symptoms, he will need to be entered into the TB Symptomatics Masterlist during screening. This household contact must begin the process of TB detection as other patients in the high-risk groups for MDR-TB. If the contact is confirmed MDR-TB or will be empirically treated with second-line drugs after Consilium approval, then the contact will be entered in the Category IV Register.

All household contacts of a confirmed MDR-TB patient should be interviewed at the Treatment Center for symptoms of TB. Those who are eligible for contat tracing should be evaluated by a physician by history and physical examination.

For all ages with cough of more than two weeks, sputum smear and culture will be done.

For children less than five years old with or without symptoms, the following procedures will be done: • • •

An evaluation by a physician, including history and physical examination.

Tuberculin skin testing (TST) Chest x-ray examination (antero-posterior and lateral position)

TB and to a greater extent, MDR-TB are very difficult to diagnose in children. Many times children are unable to produce or expectorate sputum on their own for examination. Other methods of collection such as sputum induction and gastric aspiration are necessary. See Annex B: Procedures for obtaining sputum specimens in children.

8.4 Evaluate children by physical exam, chest x-ray and TST Evaluation of children who are contacts of MDR-TB patients aims to detect those who are infected and those who have active disease. A TST is first done to determine infection, not disease. If TST induration is 10 mm or greater, TST is positive. This child may need preventive therapy (when the appropriate regimen becomes available) if he has no symptoms and if the chest x-ray is normal. Otherwise, if he has three of five symptoms listed below, or he has an x-ray consistent with TB disease, he may need to be treated.

The five symptoms of TB in young children can be nonspecific, manifesting as any of the following: 1.

2.

3.

4.

5.

Chronic cough or wheeze for >2 weeks Unexplained fever for >2 weeks Weight loss/failure to gain weight/loss of appetite Failure to respond to 2 weeks appropriate antibiotic for lower respiratory infection Failure to regain previous state of health 2 weeks after a viral infection or exanthem, e.g., measles

A child may also have extrapulmonary (EPTB) disease and may manifest with enlarged perihilar lymph nodes by chest x-ray examination.

Patients with three of the five clinical symptoms should be entered into the TB Symptomatics Masterlist. Once all of the diagnostic information has been obtained (physical exam, TST and chest x-ray results) the attending physician in concurrence with the Consilium will come up with a consensus decision as to diagnosis for young children.

All children approved by the Consilium for MDR-TB treatment will be assigned a Pre-enrollment No. recorded on Column 19 of the TB Symptomatics Masterlist. Once enrolled, the treatment start date will be written under the Preenrollment No. and as in adults, the patient will be entered in the Category IV Register and a Category IV Registration No. will be assigned. All patients entered in the Category IV Register should have been entered first into the TB Symptomatics Masterlist.

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MODULE B

Summary of important points •

Health workers should keep in mind that all previously treated patients, as well as non-converters of Category II, symptomatic contacts of MDR-TB, and HIV-positive patients with symptoms of TB, are considered MDR-TB suspects.

•

Any person in these high-risk groups for MDR-TB should be immediately referred to the appropriate Treatment Center using the MDR-TB Suspects Referral Form for screening and diagnosis.

•

At the Treatment Center, screen every MDR-TB suspect and fill out an MDR-TB Screening Form. This includes a physical examination by a physician and his preliminary diagnosis and plans for further diagnosis and/or treatment.

•

Be sure to write down the complete name and complete address of every MDR-TB suspect in the TB Symptomatics Masterlist, so that the TB suspect can be located once the results of the various tests show that the patient has TB and in case the TB suspect does not return.

•

Inform the MDR-TB suspect about the process and discuss the Paunawa or Terms of Understanding with him to continue the diagnosis.

•

Collect two sputum samples from every MDR-TB suspect for diagnosis. Use the Mycobacteriology Request Form and the Laboratory Receiving Form for Specimens to request for sputum examinations and to send the samples to the corresponding Culture Center. When the results of the smear, culture and DST are received from the laboratory, record the results in the TB Symptomatics Masterlist.

–– –– ––

–– ––

All specimens will be cultured at the Culture Center automatically regardless of the smear result.

If culture results are positive, the culture isolate will be sent for DST to a DST Center If the culture results are negative, the treatment center Physician may refer the patient to the Consilium for clinical assessment on whether or not sputum should be recollected or empiric treatment should be given.

If the DST shows that the DR-TB suspect has confirmed MDR, the patient will be assigned a Pre-enrollment No. by the Treatment Center.

Likewise, a patient not confirmed to be MDR-TB by DST but highly suspected to be MDR and decided by the Consilium to start treatment will be assigned a Pre-enrollment No. by the Treatment Center.

•

A patient who has confirmed drug resistance or MDR-TB or those decided by the Consilium to be started on treatment must be informed immediately. If he does not call or visit the Center, locate this patient as soon as possible. Assign a Pre-enrollment No.

•

Present MDR-TB cases confirmed by DST to the Consilium to be able to start treatment immediately to prevent the spread of the disease to others in the household and community and to improve the condition of the patient. Assign a Pre-enrollment No.

108 Detect Cases of MDR-TB

MODULE B

•

Present also to the Consilium cases highly suspected to be MDR-TB even without DST confirmation as not all patients can wait for DST results and there are some culture-negative patients who deserve Category IV treatment.

•

A patient who is started on treatment is entered into the Category IV Register and is assigned a Category IV Registration No.

•

Ask patients with confirmed drug resistance to bring to the DOTS facility all his contacts for interview of symptoms.

•

The following household contacts will be checked for TB and MDR-TB –– Children less than five years regardless of symptoms –– Those five years and above who have cough for more than 2 weeks

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Self-assessment questions 1. List 7 different high-risk groups for MDR-TB who should be referred for testing.

2. How many sputum samples are needed for examination for diagnosis? ___________ When and where are these samples collected? ____________ 3. The __________________________________ is an individual form for each MDR-TB suspect that holds a large amount of background information about the patient. The __________________________________ is a record of all TB suspects, including TB and MDR-TB suspects seen at the MDR-TB Treatment Center.

4. List the data recorded in the TB Symptomatics Masterlist before sputum examination.

(For TC staff only)

5. What are the three tests that are generally to be performed to diagnose MDR-TB?

Under what circumstances can a patient be enrolled in treatment without these tests?

6. If an MDR-TB suspect’s DST results show resistance to H, R and E, the __________________ should be completed to present the case to the _____________ in order to make a decision about treatment. (for TC staff only)

7. What should the health worker tell the patient, if an MDR-TB suspect’s DST results show resistance to H, R and E ?

8. If an MDR-TB suspect’s culture result is negative but the patient is clinically deteriorating, what should you do?

9. If culture results show that an MDR-TB suspect is positive for TB and the DST results show resistance to H and R, but the suspect does not return to the health facility, what should the health worker do?

Why is it important for the health worker to take this action?

10. An MDR-TB suspect who is found to have confirmed MDR-TB may have infected other people with MDR-TB. Who should the confirmed MDR-TB patient ask to come to the health facility to be screened for MDR-TB?

Now compare your answers with those on the next page.

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Answers to self-assessment questions 1. The following groups are considered high risk for MDR-TB and should be referred for testing at a Treatment Center Retreatment cases 1. Failure - Category I failure - Category II failure (chronic TB case) 2. Relapse of category I or II 3. Return after default 4. “Other” type of patients: a) Non-DOTS patients b) “Other –positive” c) “Other-negative” 5. Non-converters of category II New or retreatment cases 6. Symptomatic contacts of a drug-resistant case 7. HIV-positive patients who have pulmonary or extra-pulmonary TB symptoms or have chest x-ray findings suggestive of TB 2. Two samples are needed. They are collected as follows: • First sample (spot sputum specimen): on Day 1 at the Treatment Center.

• Second sample (early morning sputum specimen): on Day 2 at the MDR-TB suspect’s home, first thing after waking.

3. The MDR-TB Screening Form is an individual form for each MDR-TB suspect that holds a large amount of background information about the patient. The TB Symptomatics Masterlist is a record of all TB suspects, including TB and MDR-TB suspects seen at the MDR-TB Treatment Center.

4. Screening Code, date of screening, complete name and address, age, date of birth, and sex, no. of previous TB treatment, source of referral (site or doctor), site where last treated for TB, registration group, risk factors, symptoms, chest x-ray results (if available) 5. Smear, Culture and DST – Clinically deteriorating patients may need to be started on treatment urgently before the DST results are available or they will be at risk of dying. These patients should be identified by the physician, and their cases presented to the Consilium immediately.

6. If an MDR-TB suspect’s DST results show resistance to H, R and E, the Consiliumex should be completed to present the case to the Consilium in order to make a decision about treatment.

7. Inform the patient clearly and in a sensitive way. It is important to inform the MDR-TB suspect as soon as possible about drug resistance and the next steps that will be taken to start treatment.

8. The physician must present the case to the Consilium immediately. Either the culture needs to be repeated or empiric treatment needs to be started.

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9. All efforts should be made to contact or locate the person. Call the patient or his contacts within the week. You may ask the referring DOTS facility to help locate the patient. This may require you to visit the patient’s address recorded in the TB Symptomatics Masterlist.

Patients with MDR-TB who are left untreated can infect many others with MDR-TB and delays in treatment can lead to worse treatment outcomes.

10. If possible, all household contacts of a confirmed MDR-TB patient should be interviewed at the Treatment center for symptoms of TB. All those with symptoms regardless of age, and all children less than five years even without symptoms should be evaluated by a physician by history and physical examination. For all ages with cough of more than two weeks, sputum smear and culture will be done.

End of Module B Congratulations on finishing this module!

112 Detect Cases of MDR-TB

MODULE B

References 1. Guidelines for the Programmatic Management of Drug-resistant Tuberculosis, World Health Organization, Geneva, Switzerland, 2006. (WHO/HTM/TB/2006.361) 2. National Tuberculosis Control Program Revised Manual of Procedures. Manila, Department of Health, 2005.

3. Balane, G. I., Pancho, J. S. R., Tupasi, T. E., et al. Tuberculosis among household contacts of infectious multi-drug resistant TB patients. The International Journal of Tuberculosis and Lung Disease. Vol. 11, No. 11, (November) 2007, Supplement 1: S252 4. Quelapio, M. I. D., Auer, C., Tupasi, T. E., et al. Mainstreaming DOTS-Plus to DOTS: when is culture indicated in DOTS? The International Journal of Tuberculosis and Lung Disease. Vol. 9, No. 11, (November) 2005, Supplement 1: S291 5. Auer, C., Lagahid, J. Y., Tupasi, T. E., et al. Smear positivity at two/three months of treatment: does it indicate MDR-TB? The International Journal of Tuberculosis and Lung Disease. Vol. 9, No. 11, (November) 2005, Supplement 1: S245 6. Concepcion, A. A. L., Maramba, E. K., Tupasi, T. E., et. al. Internal consilium: a standardized approach for MDRTB management. The International Journal of Tuberculosis and Lung Disease, Vol. 10, No. 11, (November) 2006, Supplement 1: S126 7. Concepcion, A. A. L., Quelapio, M. I. D., Tupasi, T. E., et. al. Case management discussions in an internal consilium. The International Journal of Tuberculosis and Lung Disease, Vol. 10, No. 11, (November) 2006, Supplement 1: S125 8. Concepcion, A. A. L., Quelapio, M. I. D., Tupasi, T. E., et. al. Impact of Union Management Courses: Internal Consilium – opportunity for learning, coordination and peer support. The International Journal of Tuberculosis and Lung Disease, Vol. 11, No. 11, (November) 2007, Supplement 1: S203 9. Orillaza – Chi, R. B., Concepcion, A. A. L., Tupasi, T. E., et. al. Internal consilium for programmatic MDR-TB management: Makati, Philippines. The International Journal of Tuberculosis and Lung Disease. Vol. 11, No. 11, (November) 2007, Supplement 1: S263 10. Guidelines for National TB Programmes on the Management of TB in Children, World Health Organization, Geneva, Switzerland, 2006. (WHO/HTM/TB/2006.371; WHO/FCH/CAH/2006.7) 11. Rieder, H. L. Contacts of TB patients in high-incidence countries. The International Journal of Tuberculosis and Lung Disease. 2003, S333 – S336 12. van Rie, A., Beyers, N., Gie, R. P., et. al. Childhood TB in an urban population in South Africa: burden and risk factors. Arch Dis Child. 1999, 80: 433 – 437 13. Miller, F. J. W., Seal, R. M. E., & Taylor, M. D. (1963). Tuberculosis in children. Boston: Little, Brown and Co. 14. Guidelines for the Implementation of the Programmatic Management of Drug-resistant Tuberculosis (PMDT).

Administrative Order No. 2008-0018. Department of Health, Manila, Philippines, May 26, 2008.

Annexes A: Proper collection of specimen for the diagnosis of TB B: Procedures for obtaining sputum specimens in children C: Proper labeling, sealing and transportation of sputum

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Annex A.

PROPER COLLECTION of SPECIMEN for the DIAGNOSIS of

TB

What is TB ?

“TB” (tuberculosis) is a disease that is caused by a bacterium known as Mycobacterium tuberculosis.

It can affect any organ of the body, with the lungs being the most common causing “pulmonary TB” or TB of the lungs.

It is an infectious disease that can be acquired / transmitted by airborne spread of infectious droplets.

A person with TB of the lungs who is coughing is a source of infection.

What is AFB smear/DSSM? Acid-fast bacilli (AFB) smear is a microscopic examination of the patient’s sputum for the presence of bacteria. It is a preliminary test and results are obtained within 24 hours after collection. If positive for AFB, it is a presumptive indication of an infection.

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MODULE B

What is TB culture?

TB culture is a procedure that detects the presence of the bacteria causing TB by allowing it to grow in a system designed for its isolation. Since it grows very slowly compared to other disease-causing bacteria, it may take eight (8) weeks or two (2) months for its growth to be detected. If it is positive for growth, an additional four (4) weeks is required for its final identification.

To be able to do the test, clinical samples from the patient suspected to have TB are collected. Sputum (“phlegm”) is the most common and the specimen of choice.

Collection of sputum samples

Two (2) consecutive early morning sputum samples are preferred but “spot-collection” is acceptable since the finding of the organism is greater with two (2) sputum samples (Diagnostic specimens) than a single collection only.

Proper collection: 1. Rinse your mouth with sterile distilled water before entering the collection booth.

2. Once inside the collection booth, take about three (3) deep breaths and cough forcefully simultaneously upon exhale with the third deep breath.

3. Hold the sputum cup close to the lips and expectorate into it gently after a productive cough.

4. Collect about 5-10ml. (At least up to the first line of the container).

5. Collect only sputum not saliva. Sputum is usually thick and mucoid and produced from deep in the lungs.

Saliva is thin, clear and is of little diagnostic value for tuberculosis.

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6. When the required volume has been collected, close the container tightly to avoid spilling of contents.

7. Allow one minute to stand.

8. Leave the collection booth immediately and submit the specimen to the medical technologist in-charge.

When the physician requests for sputum induction: When the patient is totally unable to expectorate sputum, induction with saline solution can be done. The attending physician will indicate in the request if there is a need for such procedure: 1.

2.

3.

4.

5.

Rinse your mouth with sterile distilled water before entering the collection booth.

Collect sputum inside the collection booth.

Inhale the vapor coming out of the induction machine for about 10 minutes.

Forcefully cough and collect about 5-10ml sample.

The sample will appear like saliva but it is acceptable since it is an “induced sputum.

(For the health-care worker)

Proper labeling of specimen: 1. Use the PMDT sticker to label the sputum cup.

2. Indicate the following on the label: Patient’s name Name of the Treatment center Date of collection Lab ID number 3. Paste the label on the body of the cup, not on the cover.

4. Transport the sputum cup with the collected specimen in an ice box to maintain the viability of the organisms – a styropore box with ice or refrigerants will do.

Keep the sputum cups in upright position during transport.

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MODULE B

Annex B. Procedures for Obtaining Sputum Specimens in Children (Ref: Guidance for National TB Programmes on the Management of TB in Children, WHO/HTM/TB/2006.371; WHO/FCH/ CAH/2006.7)

Procedures for obtaining clinical samples for smear microscopy This annex reviews the basic procedures for the more common methods of obtaining clinical samples from children for smear microscopy: expectoration, gastric aspiration and sputum induction.

A. Expectoration Background All sputum specimens produced by children should be sent for smear microscopy and, where available, mycobacterial culture. Children who can produce a sputum specimen may be infectious, so, as with adults, they should be asked to do this outside and not in enclosed spaces (such as toilets) unless there is a room especially equipped for this purpose.

Procedure (adapted from Laboratory services in tuberculosis control. Part II. Microscopy (1)) 1. Give the child confidence by explaining to him or her (and any family members) the reason for sputum collection.

2. Instruct the child to rinse his or her mouth with water before producing the specimen. This will help to remove food and any contaminating bacteria in the mouth.

3. Instruct the child to take two deep breaths, holding the breath for a few seconds after each inhalation and then exhaling slowly. Ask him or her to breathe in a third time and then forcefully blow the air out. Ask him or her to breathe in again and then cough. This should produce sputum from deep in the lungs. Ask the child to hold the sputum container close to the lips and to spit into it gently after a productive cough.

4. If the amount of sputum is insufficient, encourage the patient to cough again until a satisfactory specimen is obtained. Remember that many patients cannot produce sputum from deep in the respiratory tract in only a few minutes. Give the child sufficient time to produce an expectoration which he or she feels is produced by a deep cough.

5. If there is no expectoration, consider the container used and dispose of it in the appropriate manner.

B. Gastric aspiration Background Children with TB may swallow mucus which contains M. tuberculosis. Gastric aspiration is a technique used to collect gastric contents to try to confirm the diagnosis of TB by microscopy and mycobacterial culture. Because of the distress caused to the child, and the generally low yield of smear-positivity on microscopy, this procedure should only be used where culture is available as well as microscopy. Microscopy can sometimes give false-positive results (especially in HIV-infected children who are at risk of having nontuberculous mycobacteria). Culture enables the determination of the susceptibility of the organism to anti-TB drugs.

Gastric aspirates are used for collection of samples for microscopy and mycobacterial cultures in young children when sputa cannot be spontaneously expectorated nor induced using hypertonic saline. It is most useful for young hospitalized children. However, the diagnostic yield (positive culture) of a set of three gastric aspirates is only about 25–50% of children with active TB, so a negative smear or culture never excludes TB in a child. Gastric aspirates are collected from young children suspected of having pulmonary TB. During sleep, the lung’s mucociliary system beats mucus up into the throat. The mucus is swallowed and remains in the stomach until the stomach empties. Therefore, the highest-yield specimens are obtained first thing in the morning.

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Gastric aspiration on each of three consecutive mornings should be performed for each patient. This is the number that seems to maximize yield of smear-positivity. Of note, the first gastric aspirate has the highest yield. Performing the test properly usually requires two people (one doing the test and an assistant). Children not fasting for at least 4 hours (3 hours for infants) prior to the procedure and children with a low platelet count or bleeding tendency should not undergo the procedure.

The following equipment is needed: • gloves • nasogastric tube (usually 10 French or larger) • 5, 10, 20 or 30 cm3 syringe, with appropriate connector for the nasogastric tube • litmus paper • specimen container • pen (to label specimens) • laboratory requisition forms • sterile water or normal saline (0.9% NaCl) • sodium bicarbonate solution (8%) • alcohol/chlorhexidine.

Procedure The procedure can be carried out as an inpatient first thing in the morning when the child wakes up, at the child’s bedside or in a procedure room on the ward (if one is available), or as an outpatient (provided that the facility is properly equipped). The child should have fasted for at least 4 hours (infants for 3 hours) before the procedure.

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

Find an assistant to help.

Prepare all equipment before starting the procedure.

Position the child on his or her back or side. The assistant should help to hold the child.

Measure the distance between the nose and stomach, to estimate distance that will be required to insert the tube into the stomach.

Attach a syringe to the nasogastric tube.

Gently insert the nasogastric tube through the nose and advance it into the stomach.

Withdraw (aspirate) gastric contents (2–5 ml) using the syringe attached to the nasogastric tube.

To check that the position of the tube is correct, test the gastric contents with litmus paper: blue litmus turns red (in response to the acidic stomach contents). (This can also be checked by pushing some air (e.g. 3–5 ml) from the syringe into the stomach and listening with a stethoscope over the stomach.)

If no fluid is aspirated, insert 5–10 ml sterile water or normal saline and attempt to aspirate again.

• If still unsuccessful, attempt this again (even if the nasogastric tube is in an incorrect position and water or normal saline is inserted into the airways, the risk of adverse events is still very small).

• Do not repeat more than three times.

Withdraw the gastric contents (ideally at least 5–10 ml).

Transfer gastric fluid from the syringe into a sterile container (sputum collection cup).

Add an equal volume of sodium bicarbonate solution to the specimen (in order to neutralize the acidic gastric contents and so prevent destruction of tubercle bacilli).

After the procedure 1.

2.

3.

4.

Wipe the specimen container with alcohol/chlorhexidine to prevent cross-infection and label the container.

Fill out the laboratory requisition forms.

Transport the specimen (in a cool box) to the laboratory for processing as soon as possible (within 4 hours).

If it is likely to take more than 4 hours for the specimens to be transported, place them in the refrigerator (4–8 °C) and store until transported.

5. Give the child his or her usual food.

Safety Gastric aspiration is generally not an aerosol-generating procedure. As young children are also at low risk of transmitting infection, gastric aspiration can be considered a low risk procedure for TB transmission and can safely be performed at the child’s bedside or in a routine procedure room.

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C. Sputum induction Note that, unlike gastric aspiration, sputum induction is an aerosol-generating procedure. Where possible, therefore, this procedure should be performed in an isolation room that has adequate infection control precautions (negative pressure, ultraviolet light (turned on when room is not in use) and extractor fan).

Sputum induction is regarded as a low-risk procedure. Very few adverse events have been reported, and they include coughing spells, mild wheezing and nosebleeds. Recent studies have shown that this procedure can safely be performed even in young infants (2), though staff will need to have specialized training and equipment to perform this procedure in such patients.

General approach Examine children before the procedure to ensure they are well enough to undergo the procedure. Children with the following characteristics should not undergo sputum induction.

• • • • • •

Inadequate fasting: if a child has not been fasting for at least 3 hours, postpone the procedure until the appropriate time.

Severe respiratory distress (including rapid breathing, wheezing, hypoxia).

Intubated.

Bleeding: low platelet count, bleeding tendency, severe nosebleeds (symptomatic or platelet count <50/ml blood).

Reduced level of consciousness.

History of significant asthma (diagnosed and treated by a clinician).

Procedure 1. Administer a bronchodilator (e.g. salbutamol) to reduce the risk of wheezing.

2. Administer nebulized hypertonic saline (3% NaCl) for 15 minutes or until 5 cm3 of solution have been fully administered.

3. Give chest physiotherapy as necessary; this is useful to mobilize secretions.

4. For older children now able to expectorate, follow procedures as described in section A above to collect expectorated sputum.

5. For children unable to expectorate (e.g. young children), carry out either: (i) suction of the nasal passages to remove nasal secretions; or (ii) nasopharyngeal aspiration to collect a suitable specimen.

Any equipment that will be reused will need to be disinfected and sterilized before use for a subsequent patient.

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Annex C. Proper Labeling, Sealing and Transportation of Specimen

8. Ready for transport to Culture center.

1. Use wide-mouthed sterile screw-capped container

PMDT Tx center: __________________ Lab No.: ___________________ Name: ____________________ Date collected: _____________

2. Prepare label with Treatment center, Lab ID no, Patient Name, Date

7. Place the sputum container in an upright position.

6. Prepare an ice box or ice pack.

3. Attach label on the container, do not put the label on the cover.

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4. Tighten cap

5. Secure in a plastic so that specimen does not leak in case of spillage.

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MANAGEMENT OF DRUG-RESISTANT TUBERCULOSIS TRAINING FOR HEALTH FACILITY STAFF IN THE PHILIPPINES

This course is designed to equip health workers with the knowledge, skills and attitudes (KSA) to detect and treat MDR-TB cases, manage first- and second-line drugs, inform patients about MDR-TB, and monitor the success of MDR-TB treatment at both Treatment Centers and Treatment Sites using competency-based training modules. These health workers may include physicians, nurses, midwives, and other health care professionals from the public and private sectors.

This course uses a variety of methods and instructions, including reading, written exercises, discussions, role plays, demonstrations, and observations in a real health facility. Practice, whether in written exercises or role plays, is considered a critical element of instruction.

The complete training course includes the following modules (booklets containing units of instruction). Depending on the structure of your course, you may have been given some or all of these modules: A

Introduction (includes a glossary with definitions of terms that may be unfamiliar)

B

Detect Cases of MDR-TB

C

Treat MDR-TB Patients

D

Inform Patients about MDR-TB

E

Ensure Continuation of MDR-TBTreatment

F

Manage Drugs and Supplies for MDR-TB

G

Monitor MDR-TB Case Detection andTreatment

H

Field Exercise – Observe MDR-TB Management

REF

Reference Booklet on the Management of MDR-TB

The Reference Booklet contains important forms, worksheets, and summaries of procedures taught in the course. It also contains instructions for filling out forms. You can use this booklet as an on-the-job resource.

The course is designed for small groups of participants who are led and assisted by "facilitators" as they work through the course modules. The facilitators are not lecturers as in a traditional classroom. Their role is to answer questions, provide individual feedback on exercises, lead discussions, structure role plays, etc. For the most part, participants work at their own pace through the modules, although in some activities, such as role plays and discussions, the small group works together.

ISSN 2012-2675

Department of Health Government of Philippines

Tropical Disease Foundation, Inc. Makati, Metro Manila, Philippines

World Health Organization

Office of the Representative in the Philippines

9 772012 267009 PRINTED IN THE PHILIPPINES