MANAGEMENT OF DRUG-RESISTANT TUBERCULOSIS — MODULE C by Alexander Pascual

MODULE MANAGEMENT OF DRUG-RESISTANT TUBERCULOSIS

TREAT MDR-TB PATIENTS

TRAINING FOR HEALTH FACILITY STAFF IN THE PHILIPPINES

MODULE

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

Treat MDR-TB Patients

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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Objectives of this module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 1. Initiate treatment of an MDR-TB patient. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 1.1 Propose drug regimens for confirmed DR/MDR cases according to the WHO Guidelines . . . . . . . . . . . . . . . . . . . . . . 11 1.2 TB drugs used to treat drug-resistant TB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 1.3 Determine whether there are other special circumstances affected by the regimen . . . . . . . . . . . . . . . . . . . . . . . . 13 1.4 Design the proposed treatment regimen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 1.4.1 Review the patient’s DST results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 1.4.2 Confirm the patient’s history of drug use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 1.4.3 Select all drugs for the patient that can be considered effective. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 1.4.4 Select all drugs from Group 1 that the patient may receive . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 1.4.5 Select one drug from Group 2 that the patient may receive. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 1.4.6 Select one drug from Group 3 that the patient may receive. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 1.4.7 Select additional drugs from Group 4 that the patient may receive. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 1.4.8 Select additional drugs from Group 5 that the patient may receive. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 1.4.9 Calculate dosage for each patient. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 1.5 Present proposed regimen to the Consilium . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Exercise A: Individual work with discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 1.6 Enroll the MDR-TB patient at the Treatment Center . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 1.6.1 Contact patient for scheduling of enrollment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 1.6.2 Inform the patient on the enrollment procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 1.6.3 Classify patients using the Social Case Study Report Form (SCSRF)

and Socioeconomic Classification Guide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

1.6.4 Request baseline DSSM, culture, DST, chest x-ray and blood chemistries using appropriate forms.. . . . . . . . 37 1.6.5 Ensure that the items in the Enrollment Checklist are accomplished to complete enrollment. . . . . . . . . . . . . 39 1.7 Prepare the patient’s Category IV Treatment Card. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 1.7.1 Record general patient information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 1.7.2 Record previous TB treatment, registration group, HIV information, and Consilium decision . . . . . . . . . . . . 41 1.7.3 Record the DSSM, culture and DST results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 1.7.4 Record TB treatment regimen and dosage for both phases. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 1.8 Complete the Category IV Register with patient information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

Exercise B: Written Exercise. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54 1.9 Obtain a drug packet for the patient. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 1.9.1 Inform the patient about the different drugs in the treatment regimen . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

Treat MDR-TB Patients

MODULE C

2. Supervise the patient during the entire period of treatment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62 2.1 Directly observe each treatment and record on the Category IV Treatment Card. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62 2.1.1 Receive the MDR-TB patient each day. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62 2.1.2 Administer and directly observe the patient take anti-TB drugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62 2.1.3 Mark the Category IV Treatment Card for each supervised treatment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 2.1.4 Record changes to the drug regimen on the Category IV Treatment Card. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66 2.1.5 Weigh the patient monthly, and report any significant change in weight

to the physician for dose adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

2.1.6 Sign the PMDT Patient’s Booklet, write the date of the next appointment,

remind the patient to return for the next appointment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70

2.1.7 Mark the patient’s name on the Daily Attendance Sheet. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71 2.2 Continue providing information about MDR-TB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73 2.3 Review the PMDT Patient’s Booklet weekly or whenever the patient visits

and update the Treatment Center copy of the Category IV Treatment Card . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73

3. Monitor the patient for adverse drug reactions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74 3.1 Continuously assess the patient for adverse drug reactions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74 3.2 Document ADRs on the Patient’s Progress Report Form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74 3.3 Explain the probable cause of ADR and the action to be taken to the patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76 3.4 Perform intervention for mild adverse drug reactions and document all actions taken

on Category IV Treatment Card . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76

3.5 Make referral to Treatment Center physician as necessary for moderate or severe ADRs. . . . . . . . . . . . . . . . . . . . . . 78 3.6 Propose a regimen change and present this to the Consilium using the Consilumex . . . . . . . . . . . . . . . . . . . . . . . . . 80 3.6.1 After Consilium approval, document the change on the Category IV Treatment Card. . . . . . . . . . . . . . . . . . . 81

Exercise C: Written Exercise. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82

4. Monitor progress of treatment by follow-up examinations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86 4.1 Determine when the patient is due for follow-up examinations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86 4.2 Collect sputum for follow-up examinations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86 4.3 Record results of laboratory examinations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88 4.4 Decide on appropriate action needed. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103 4.4.1 Decide whether to decentralize the patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103 4.4.2 Use physical exam, sputum examination results and attendance history

for decisions once the patient is decentralized. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103

4.5 Monitoring progress of treatment by follow-up laboratory examinations: summary of schedule. . . . . . . . . . . . . . . 103 4.6 Implement treatment decisions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104 4.6.1 Decentralize patient to a Treatment Site. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104 4.6.2 Shift the patient to continuation phase of treatment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104 4.6.3 If the patient is at risk of treatment failure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104 4.6.4 Ensure that all measures have been taken to avoid treatment default. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105 4 Treat MDR-TB Patients

4.6.5 If a culture-negative patient becomes culture-positive. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105 4.6.6 If a patient’s DST results have changed from baseline. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106 4.6.7 Initiate counseling for possible treatment failure before terminating treatment . . . . . . . . . . . . . . . . . . . 106

Exercise D: Written Exercise with Individual Feedback . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107 Follow-up laboratory examinations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107

5. Determine treatment outcome . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109 5.1 Identify patients for final treatment outcome. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109 5.1.1 Present cases for determination of outcome (cured, completed and failed)

to the Consilium using the Consiliumex. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111

5.2 Record final outcome on Category IV Treatment Card. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111 5.3 Record the final outcome on the Category IV Register . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112 5.4 Provide patient education for post-treatment follow-up. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113 5.4.1 Fill-out the Post-treatment follow-up form. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113

Exercise E: Written Exercise with Individual Feedback . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115

Summary of important points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120

Self-assessment questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122

Answers to Self-assessment questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128

References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135

Annexes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136 A: Recommended daily dosages of anti-TB drugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137 B: Anti-TB Drugs available for use in the Philippines under a programmatic setting. . . . . . . . . . . . . . . . . . . . . . 140 C: Socioeconomic Classification Guide for MDR-TB patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141

D: Social Case Study Report Form (SCSRF) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144

E: Category IV Treatment Card. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148 F: Category IV Register . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152 G: Monthly follow-up visit to the Treatment Center physician . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155

Treat MDR-TB Patients

MODULE C

6 Treat MDR-TB Patients

MODULE C

Introduction In Module B: Detect Cases of MDR-TB, you learned how to identify MDR-TB suspects and determine whether they have MDR-TB. This module describes how to treat MDR-TB or patients with confirmed resistance to anti-TB drugs. As with drug-susceptible TB, treatment for MDR-TB consists of two different phases of taking special combinations of drugs, particularly the intensive phase and the continuation phase. In the Philippines, patients who receive treatment for MDR-TB have regimens that are both individualized (designed according to the results of their drug susceptibility testing or DST) and empiric (based on history of anti-TB treatment). MDR-TB Treatment duration is much longer. A minimum of 18 months is required for each MDR-TB patient. The Treatment Center physician, along with the Consilium, will decide on the appropriate drugs to be used in the patient’s regimen. During the intensive phase of treatment, an MDR-TB patient takes at least 4 drugs deemed effective, including an injectable, depending on the DST results and/or the patient’s history of use of these drugs. During the continuation phase, the patient takes all of the drugs except the injectable. During both phases the drugs are taken every day except Sundays. Some patients acquire drug-resistant TB which develops while on previous treatments, either because supervised treatment was not done properly, the patient did not take the medications, or both. If the anti-TB drugs are taken incorrectly or irregularly, the patient will not be cured and further drug resistance may develop. Other patients contract a drug-resistant strain as a result of transmission from a person with MDR-TB. Once a patient has confirmed drug resistance it is vital that MDR-TB patients take all their medications correctly to be cured minimizing the risk of relapse. The treatment of MDR-TB in many of these patients represents the last opportunity for them to be cured, and in many cases, the last opportunity to continue living. MDR-TB can have high mortality rates because most patients have been chronically ill. If MDR-TB patients are left to take drugs by themselves, at least 30% will not comply with their treatment (that is, take the treatment as directed). Predicting who will or will not comply is difficult. Health workers must take an active role to ensure that every patient takes the recommended drugs, in the right combinations, on the correct schedule, for the appropriate duration. The best way to ensure this is for a trained health worker or a community TB treatment partner to observe each patient swallow the drugs. This is called directly observed treatment (DOT, also known as fully supervised treatment). Supervised treatment for MDR-TB patients is necessary throughout the entire regimen. This takes place in the Treatment Center for patients who are still sputumpositive. Once a patient has culture converted (become culture-negative) for at least one month, and the current smears are negative, the patient will be decentralized. Once decentralized, the patient will usually receive treatment during the week at his or her local DOTS facility which is called a Treatment Site for the remainder of treatment as long as the treatment continues to progress as planned. On Saturdays and holidays, when the Treatment Sites are closed, the MDR-TB patient will receive the dose at the Treatment Center unless a community treatment partner such as a barangay health worker or a volunteer is able and willing to provide supervised treatment outside the Treatment Site. The patient must be evaluated by the Treatment Center physician at least monthly.

Treat MDR-TB Patients

MODULE C

DOT means the health worker has to: •

ensure that the drugs are swallowed.

•

know immediately if treatment is interrupted and allow the health facility to take action, such as tracing the interrupting patient and encouraging the patient to resume treatment.

•

establish a supportive relationship with the patient. A good relationship enables the patient to discuss questions or fears about the disease and treatment, thereby allowing the health worker to monitor and supervise the patient adequately.

The first-line drugs used to treat drug-susceptible TB are very efficacious and tolerable, whereas, second-line drugs (SLD) used to treat MDR-TB are less efficacious and cause more adverse drug reactions (ADR). The ADRs occur mainly during the first few months of treatment. As some ADRs are self-limiting and resolve after a short time, others can be treated with drugs according to the symptoms experienced by the patient. All ADRs must be managed or treated until the patient develops a tolerance for these effects or until the ADRs resolve by themselves. Reducing the drug dose may be an alternative and the withdrawal of the drug or its replacement should be taken as a last measure. The very serious ADRs are not too common and it is important to be aware that without adequate treatment, MDRTB mortality is very high. In cases in which there is resistance to multiple drugs and only a few drugs can be used, stopping any of these drugs because of severe ADRs, for example may result in treatment failure. The effect of Category IV treatment on a patient with pulmonary TB must be monitored by follow-up sputum smear, culture and if necessary, DST. Negative sputum smears and cultures at specific times indicate good treatment progress, which encourages the patient to continue treatment and motivates the health worker responsible for supervising the treatment. Culture examinations are also required to determine whether the TB patient is cured, or failed. Below is a summary list of the procedures to treat MDR-TB cases. Initially: • Design the patient’s treatment regimen based on DST results and history of treatment. •

Present to the consilium for approval of regimen design.

•

Inform the patient and family about MDR-TB and its treatment.

•

Weigh the patient and prepare the patient’s Category IV Treatment Card.

•

Prepare the patient’s initial dose.

•

Give the patient a brief orientation on the drugs that will be taken and the expected ADRs associated with each drug.

•

Prepare the PMDT Patient’s Booklet.

On an ongoing basis: •

Supervise and record drug intake daily until completion of treatment.

•

Monitor whether the patient has side-effects.

•

Continue to give the patient information and support for continuing treatment.

At specified intervals: •

During the intensive phase, collect one sputum specimen monthly for follow-up smear and culture examination; in the continuation phase, collect one sputum specimen monthly for smear and every 2 months for culture.

•

Conduct a physical examination once a month and as needed.

•

Do blood chemistries (example, liver and renal function tests) every three months for patients 50 years and older and every six months for younger patients; and do chest x-ray every six months, or more often when necessary, record results and take necessary action.

8 Treat MDR-TB Patients

MODULE C

Objectives of this module Participants will be able to: •

Refer to section:

Determine appropriate treatment regimen using the DST

1.1

results and patients’ history of drug use •

Prepare a patient’s Category IV Treatment Card, including

1.7

specifying the treatment regimen and dose •

Administer supervised treatment and record it on the

Category IV Treatment Card •

Recognize side-effects and what to do

•

Determine when an MDR-TB patient is due for follow-up

4.1

examination •

Interpret the results of follow-up exams and decide

4.4 – 4.6

on the appropriate course of action •

Determine treatment outcome

Note: Some procedures are described in their appropriate places in the sequence of steps for treating MDR-TB cases, but more detail is provided in other modules: •

Providing information about MDR-TB to the patient and the family is taught in Module D: Inform Patients about MDR-TB.

•

Dealing with problems, such as when a patient stops coming for treatment, is taught in Module E: Ensure Continuation of MDR-TB Treatment.

•

Preparing patient’s drugs is taught in Module F: Manage Drugs and Supplies for MDR-TB.

If you need to look up an unfamiliar word, refer to the glossary at the end of Module A: Introduction. The flow chart on the next page summarizes the tasks and forms that will be discussed in this module.

Treat MDR-TB Patients

MODULE C

Figure 1 . Flow chart for the treatment of MDR-TB patients

MDR-TB patient or seriously ill MDR-TB suspect

FORMS USED

TC physician proposes drug regimen to Consilium

•

Consiliumex

Consilium approves drug regimen

Enroll the MDR-TB patient at the Treatment Center (TC) • Contact patient for enrollment • Inform the patient on the enrollment procedures • Request baseline laboratory tests

Supervise the patient during the entire period of treatment • Directly observe each treatment • Continue providing information about TB

Monitor the patient for adverse drug reactions (ADRs) • Directly observe each treatment • Continue providing information about TB

10 Treat MDR-TB Patients

• • •

• • • •

Kasunduan or Contract Enrollment Checklist Social Case Study Report Form (SCSRF) and S o cio economic Classification Form Mycobacteriology Request Form Chest X-ray Request Form Blood Chemistry Request Form Category IV Register

•

Category IV Treatment Card

Monitor the progress of treatment by follow-up examinations: • Smears: monthly until treatment is completed • Cultures: monthly during the intensive phase and every two months during the continuation phase or whenever indicated • DST: every 4 months while culture-positive when resistance amplification is suspected • Chest x-ray: every 6 months • Blood chemistries: every 6 months for patients younger than 50 years; every 3 months for patients 50 years and older.

•

Progress Report Form

Implement treatment decisions

•

Consiliumex

Determine treatment outcome

•

Post-treatment Follow-up Form

MODULE C

1. Initiate treatment of an MDR-TB patient 1.1 Propose drug regimens for confirmed DR/MDR cases according to the WHO Guidelines The Treatment Center physician will design a treatment regimen for each MDR-TB patient. This proposed treatment regimen will be presented for approval to the Consilium before the patient begins treatment. There are many factors to consider to design a treatment regimen for MDR-TB patients. This section will provide the basic principles behind the design of MDR-TB treatment regimens. However, it is important to note that using this guide alone will not be sufficient to design a treatment regimen.

1.2 TB drugs used to treat drug-resistant TB All health care personnel in PMDT should be familiar with the different drugs and WHO classifications for TB drugs used to treat patients with drug-resistant strains. The table on the following page provides a summary of the different anti-TB drugs. The drugs are grouped according to hierarchy, starting with the group that is most important to include in a drug regimen for drug-resistant TB (DR-TB).

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TABLE 1 Drug grouping and basic principles for guiding the selection of MDR-TB regimens1

GROUPING

DRUGS (ABBREVIATION)

Principles

Group 1 – First-line oral antiTB agents

Isoniazid** (H); Rifampicin** (R); Ethambutol (E); Pyrazinamide (Z)

These drugs are the most potent and best tolerated anti-TB drugs. They should be used in patients only where there is laboratory evidence or clinical history to suggest their efficacy. The newer rifamycins should be considered ineffective if results of DST show resistance to rifampicin. Patients with strains resistant to low H level but are susceptible to higher concentrations may benefit from high-dose H.

Group 2 – Injectable anti-TB agents

Streptomycin (S); Kanamycin (Km); Amikacin (Am); Capreomycin (Cm); Viomycin* (Vi)

One injectable agent should be given to every patient. There is a hierarchical order for injectables based on efficacy, adverse effects and cost. If the strain is susceptible, streptomycin (S) is the injectable agent of choice. Otherwise, Kanamycin (Km) is the logical second choice given its low cost and good experience of use. Km and Amikacin (Am) are considered to be very similar and have close to 100% cross-resistance. However, because in the Philippines, Am is very expensive and the available preparation causes more pain on the injection site, Am is only seldom used. If an isolate is resistant to S, Km and amikacin, then Capreomycin (Cm) should be used. Viomycin is very similar to Cm and they share a high level of cross-resistance.

Group 3 – Fluoroquinolones

Ofloxacin (Ofx); Levofloxacin (Lfx); Moxifloxacin (Mfx); Gatifloxacin* (Gfx)

One fluoroquinolone should be used if the strain is susceptible. Currently, the most potent available quinolones in descending order based on invitro activity and animal studies are: moxifloxacin (Mfx) = gatifloxacin (Gfx)> levofloxacin (Lfx) > ofloxacin (Ofx). However, the long-term safety of the newer generation fluoroquinolones (Mfx, Gfx and Lfx) has not yet been fully evaluated. The choice of fluoroquinolones is based on efficacy and cost. Based on cost in the Philippines, the order of available quinolones is: ofloxacin < moxifloxacin <levofloxacin

Group 4 – Oral bacteriostatic second-line anti-TB drugs

Ethionamide* (Eto); Prothionamide (Pto); Cycloserine (Cs); Para-aminosalicylic acid (PAS); Terizidone* (Trd) Thioacetazone* (Th)

These are added based on estimated susceptibility, drug history, efficacy, adverse effects, profile and cost. • If only one of these agents is neede d, ethionamide/ prothionamide is often added because of its proven efficacy and low cost. • If two agents are needed, cycloserine is commonly used in addition to ethionamide/ prothionamide. • If necessary to add a third agent, PAS should be used. It is costly, has significant gastrointestinal adverse effects of the micro-granule formulation and requires cold chain for storage which make it less convenient to use. • Since the combination of ethionamide/prothionamide and PAS has a high incidence of potentiated gastrointestinal adverse effects, these two agents are commonly used together only when all three Group 4 agents are needed. • Ethionamide/prothionamide may be started at a low dose (250 mg) for a few days and then gradually increased every 3–5 days until the full dose is reached. • Terizidone (Trd) contains 2 molecules of Cs and has an efficacy believed to be similar to Cs, although there are no direct studies comparing both. • Thioacetazone (Th) should be used only in HIV-negative patients and should not be chosen over other Group 4 drugs due to its toxicity (rashes, Stevens-Johnson Syndrome) and its relatively weak anti-TB action.

These principles are taken from the WHO Guidelines for the Programmatic Management of Drug-Resistant Tuberculosis, Geneva, World Health Organization (WHO/HTM/TB/2006.361).

12 Treat MDR-TB Patients

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GROUPING Group 5 – Agents with unclear efficacy (not recommended by WHO for routine use in MDR-TB patients)

DRUGS (ABBREVIATION) Clofazimine (Cfz)*; Amoxicillin/ Clavulanate (Amx/ Clv); Clarithromycin (Clr); Linezolid* (Lzd)

Principles These are not recommended by WHO for routine use in MDR-TB treatment because their contribution to the efficacy of multidrug regimens is unclear. However, they can be used in cases where adequate regimens are impossible to form with the drugs from Groups 1–4.

* Not being used in the PMDT country program **Used in patients who are susceptible to H and/or R (DR-TB only)

Vitamin B6 (pyridoxine) should be given to all patients receiving cycloserine to prevent adverse neurological side effects at 50 mg for every 250 mg of cycloserine.

1.3 Determine whether there are other special circumstances affected by the regimen There are a number of conditions that should be investigated by the health care worker to ensure that additional measures should be taken before treatment. These conditions or circumstances should have been noted in the MDR-TB Screening Form. Be sure to check the form as you decide how to design each patient’s proposed regimen. Each patient’s situation should be handled differently and must be taken into account before treatment begins to ensure the most effective management. Below is a list of some common conditions of patients and some general guidelines. 1. HIV-infection – HIV prevalence in the Philippines is 0.01 -0.03 per cent in the general population and < 1% in the most at risk populations. Among HIV patients in general, however, TB is the most prevalent co-infection (50%) and occurs as TB disease in 40%. TB/HIV particularly MDR-TB/HIV coinfected patients present a challenge for treatment strategies. The patient with DR-TB disease and HIV will require intensive medical care to decrease the high level of mortality. Coordination between the team treating DR-TB and the HIV control program for training, care and treatment is an essential component. MDR-TB/HIV coinfection rate has the potential to increase rapidly in any country where infection control and TB/HIV management activities are not fully implemented. 2. Substance dependence - Patients with substance dependence disorders should be offered treatment for their addiction. Complete abstinence from alcohol or other substances should be strongly encouraged, although active consumption is not a contraindication for anti-TB treatment. If the treatment is repeatedly interrupted because of the patient’s addiction, therapy should be suspended until successful addiction treatment or measures to ensure adherence have been established. 3. Psychiatric disorder - Adverse effects from cycloserine may be more prevalent in the psychiatric patient, but the benefits of using this drug may outweigh the potential higher risk of adverse effects. Hence, the use of cycloserine is not absolutely contraindicated. However, close monitoring is recommended if this is used in patients with psychiatric disorders. 4. Liver disorder - Patients with a history of liver disease can receive the usual DR-TB chemotherapy regimens provided there is no clinical evidence of chronic active liver disease, hepatitis virus carriage, acute viral hepatitis, or excessive alcohol consumption. Otherwise, pyrazinamide should be avoided and other drugs known to cause hepatotoxicity should be used with caution, such as isoniazid and rifampicin which may be used in DR-TB, ethionamide, prothionamide and PAS. Close monitoring of liver enzymes is necessary. 5. Seizure disorder - Cycloserine should be avoided in patients with active seizure disorders that are not well controlled with medication. However, in cases where cycloserine is a crucial component of the treatment regimen, it can be given with the anti-seizure medication adjusted as needed to control the seizures. Active seizures that present for the first time during anti-TB therapy are likely to be the result of an adverse effect of one of the antiTB drugs which should be suspended either temporarily or permanently depending on the level of control of the seizure. Treat MDR-TB Patients

MODULE C

6. Renal insufficiency - These patients require very close supervision and dose modification of certain drugs. Monitor the creatinine and BUN level at least once every 3 months while on the injectable until noted to be stable. Refer to the table on dosage adjustment for renal insufficiency in Annex A Recommended dosages of anti-TB drugs. 7. Diabetes mellitus – These patients require very close supervision and under co-management with a specialist. Fasting blood sugar, creatinine and potassium levels should be monitored monthly until stable then quarterly thereafter. Oral hypoglycemics may require patients to increase the dosage. The use of ethionamide/prothionamide may make it more difficult to control insulin levels. 8. Children –Refer to the recommended pediatric doses for SLDs in Annex A Recommended dosages of anti-TB drugs. Although children are presumed to have the same DST pattern as the index case, this may not necessarily happen and every effort must be done to confirm drug-resistance and avoid unnecessary exposure to toxic drugs. However, many times a pediatric patient will have a negative culture; and regimens can only be designed based on the DST data of the contact. Although no long-term studies have proven the safety of drugs given for prolonged periods in children, MDR-TB is life-threatening and the risks and benefits of treatment should be discussed with the family. There is no anti-TB drug that is absolutely contraindicated in children including the fluoroquinolones whose benefit outweighs the risk. 9. Breastfeeding mothers – Babies of MDR-TB mothers may be placed on formula due to the secretion of drugs in the breast milk particularly since there is limited experience in prolonged exposure of infants to MDR-TB drugs. The option on whether to breastfeed or not is best discussed with the mother. Should she decide to breastfeed, she should wear an N95 mask while breastfeeding. While she is smear-positive, it is best for other family members to take care of the baby to prevent transmission. 10. Use of oral contraception – Patients generally have no problems unless there is frequent vomiting caused by anti-TB drugs which can lead to poor absorption of the oral contraceptive. Contraceptive drugs can also interact with rifampicin used in rifampicin-susceptible DR-TB cases leading to decreased contraceptive efficiency. In this case, other forms of contraception should be advised. 11. Pregnancy – Treatment for MDR-TB is not contraindicated but injectables are not allowed. Ethionamide should also be avoided because of teratogenic effects noted in animal studies. Since there have been limited studies on the effects of SLDs on the pregnant patient, particularly to the fetus, treatment may be postponed till the second trimester since most teratogenic effects happen on the first trimester. However, if the condition of the mother is severe or life-threatening, treatment using 3 to 4 oral drugs deemed effective should be started sooner but excluding injectable agents and ethionamide. Immediately post-partum, as necessary, therapy should be reinforced with an injectable or other drugs.

14 Treat MDR-TB Patients

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1.4 Design the proposed treatment regimen Treatment regimens for MDR-TB patients should consist of at least four drugs with either certain, or almost certain, effectiveness. If the evidence about the effectiveness of a drug is unclear, the drug can be included in the regimen but should not be depended upon for success. Often, more than four drugs may be started if the DST pattern is unknown, if effectiveness is questionable for one or more agents, or if extensive, bilateral pulmonary disease is present. Drugs are selected based on DST, drug history, efficacy, adverse effects profile and cost. To design a regimen, take the following steps.

1.4.1 Review the patient’s DST results Review the patient’s DST results from the TB Symptomatics Masterlist. If the DST results are resistant to a certain drug, this drug should not be included in the regimen. Only drugs documented with either certain or almost certain effectiveness should be used. If the evidence about the effectiveness of a drug is unclear, the drug can be included in the regimen but it should not be counted as one of the four core drugs.

1.4.2 Confirm the patient’s history of drug use Every effort should be made to supplement the patient’s memory with objective records from previous health care providers to determine the history of drug use. A detailed clinical history can help to indicate which drugs are likely to be ineffective. The probability of acquired resistance to a drug increases with the length of time it has been used. In particular, if a patient had positive smears or cultures during a period of regular drug administration, there may be a high possibility of resistance to that drug. If a patient used a drug for longer than one month with persistent positive smears or cultures, the strain should be considered as “probably resistant” to that drug. This is particularly true for E and Z. For the injectable, even with previous use of more than a month, if the DST shows a susceptible result, this can still be considered as one of the four core drugs. The rationale for this is that DST to the injectables is more reliable than the DST to E and Z.

1.4.3 Select all drugs for the patient that can be considered effective Based on the above criteria and depending on the special circumstances of the patient as described in section 1.3, come up a list of the drugs that may possibly be used in the patient’s treatment regimen.

1.4.4 Select all drugs from Group 1 that the patient may receive Always use Group 1 drugs, the first-line anti-TB drugs whenever there is no proof of resistance. Drugs can be included in the regimen if DST results show susceptibility, however for E and Z, they should not be counted as among the four effective drugs unless these were never used or were used for less than a month. For example, when designing regimens for patients who have received previous treatment HREZ, and with DST results showing susceptibility for Group 1 drugs E, Z, the two drugs can be used, but should not be counted as part of the four core drugs. The rationale for this is that the DST is not reliable for these two drugs.

1.4.5 Select one drug from Group 2 that the patient may receive Always use one Group 2 agent, an injectable, either an aminoglycoside or capreomycin for a minimum of 6 months and must be given until after four consecutive negative cultures have been achieved since that start of treatment. If DST results do not document any resistance, generally use S then Km, Am then Cm in order of priority. Note that clinical data show that S can be still be used instead of Km as a core drug even if prior use of S has been documented as long as DST result for S shows susceptibility. For example, when designing regimens for patients who have received previous treatment HREZS, and with DST results showing susceptibility for Group 1 drugs E, Z, the two drugs can be used, but should not be counted as part of the four core drugs, while S can be used and considered a core drug. The rationale for this is that the DST for the aminoglycosides is more reliable than the DST for E and Z.

1.4.6 Select one drug from Group 3 that the patient may receive Always use one Group 3 agent, a fluoroquinolone (FQ) unless there is documented resistance to all drugs in this group. The preferred drug to use for patients with no previous FQ use is Ofloxacin due to its low cost and data on long-term safety and efficacy.

Treat MDR-TB Patients

MODULE C

1.4.7 Select additional drugs from Group 4 that the patient may receive Use one or more Group 4 drugs, the oral bacteriostatic SLDs, to complete at least four reliable drugs in the regimen. If only one of these agents is needed, prothionamide/ethionamide is added first because of its proven efficacy and low cost. If two agents are needed, cycloserine is commonly used in conjunction with prothionamide/ethionamide. If necessary, PAS may be added. It should be noted however that PAS is costly, and has significant gastrointestinal adverse effects. It also needs cold chain storage making it less convenient to use. Since the combination of prothionamide/ethionamide and PAS has a high incidence of gastrointestinal adverse effects, these two agents are commonly used together only when all three Group 4 agents are needed.

1.4.8 Select additional drugs from Group 5 that the patient may receive Only use the Group 5 agents, drugs with unclear efficacy, if four reliable drugs cannot be formed using Groups 1-4 either because of resistance, previous use or adverse drug reaction.

1.4.9 Calculate dosage for each patient Once the regimen has been designed, calculate the correct dosages for the patient based on his or her weight, age and other circumstances such as renal insufficiency. You can use the table in Annex A for reference. Divide the recommended dosage with the number of milligrams per tablet or capsule (common presentation of the drug) in order to obtain the number of units to be administered. To illustrate how this process works, read through the following example.

Example of how to decide on a treatment regimen for MDR-TB Patient AJ is a 33 year old male patient who has been treated by a private practitioner and has never sputum converted. He has received HREZS for over a period of a number of months, and his DST results show HR resistance and susceptibility to Z, E and S. He weighs 45 kgs. 1. Review the patient’s DST results The DST results show HR resistance and susceptibility to Z, E and S. 2. Confirm the patient’s history of drug use The patient has received HREZS for over a period of a number of months. 3. Select all drugs for the patient that can be considered effective In this case HR cannot be used. E and Z can be included in the regimen but should not count towards the 4 core drugs. Drugs belonging to other groups may then be considered. 4. Select all drugs from group 1 which the patient may receive E and Z can be included in the regimen since there is no proof of resistance, but should not count towards the 4 core drugs even if the patient is susceptible because of previous use. 5. Select one drug from group 2 which the patient may receive Select S from group 2 as it is shown to be susceptible and the DST for S is more reliable than the DST results for E and Z. This is the first reliable drug among the four core drugs in the regimen. 6. Select one drug from group 3 which the patient may receive Select Ofx from group 3. This is the second reliable drug among the four core drugs in the regimen. 7. Select additional drugs from group 4 which the patient may receive Select Pto and Cs from group 4 as two additional drugs. These are the 3rd and 4th drugs that complete the four core drugs in the regimen. 8. Select additional drugs from group 5 which the patient may receive Not necessary. Regimen and dose per day

The regimen will be E Z S Ofx Pto Cs with S Ofx Pto and Cs being the four core drugs. To know how many tablets or capsules to give for each drug, divide the recommended dosage with the number of mgs per tablet in the common preparation. Hence, for this patient who weighs 45 kgs., he will be given 3 tablets of E (1,200 mg / 400 mg/tab = 3 tabs), 3 tablets of Z (1500 mg/500 mg/tab = 3 tabs), 750 mg of S, 4 tablets of Ofx (800 mgs /200 mg/tab = 4 tabs), 2 tabs of Pto (500 mg/250 mg/tab) and 2 caps of Cs (500 mgs/250 mg/cap) daily. 16 Treat MDR-TB Patients

MODULE C

The following table summarizes the important points to remember when designing an MDR-TB treatment regimen. Box 1: Basic principles of designing MDR-TB treatment regimens

•

Regimens should consist of at least four reliable drugs with either certain, or almost certain, effectiveness. If the evidence about the effectiveness of a drug is unclear, the drug can be included in the regimen but it should not be counted as one of the four core drugs.

•

More than four drugs may be started if the DST pattern is unknown, if effectiveness is questionable for a drug or drugs, or if extensive, bilateral pulmonary disease is present.

•

Always use Group 1 drugs, the first-line anti-TB drugs whenever there is no proof of resistance or if clinical history suggests efficacy

•

Always use one Group 2 agent, an injectable, either an aminoglycoside or capreomycin for a minimum of 6 months and must be given until after four consecutive negative cultures have been achieved from start of treatment.

•

Always use one Group 3 agent, a fluoroquinolone.

•

Use one or more Group 4 drugs, the oral bacteriostatic SLDs, to complete at least four reliable drugs in the regimen

•

Only use the Group 5 agents, drugs with unclear efficacy, if four reliable drugs cannot be formed by Groups 1-4 either because of resistance, previous use or ADR.

Other points to remember: •

Early MDR-TB detection and prompt initiation of treatment are important ways to achieve successful outcomes.

•

Regimens should be based on the DST pattern and the history of drugs taken by the patient particularly the first-line anti-TB drugs. For S, there is data to show that even with previous use and if the patient is still susceptible, it can still be used as a reliable drug.

•

Treatment is for a minimum duration of 18 months. The resistant bacilli take longer to kill because the SLDs that need to be used are less effective than first-line agents and the clinician must ensure that all bacilli are killed in order to lessen the chances of a relapse or further increases in resistance.

•

Drugs are administered daily for six days a week.

•

Use maximum doses particularly for drugs that have been used in the past.

•

When possible, Z, E and the FQs should be given once per day because this dosing may be more efficacious. However in children, the recommendation is to give Ofx and Cfx twice a day. (See Annex A for the pediatric dosing of second-line anti-TB drugs).

•

Once-a-day dosing is permitted for other second-line drugs, depending on patient tolerance. However, ethionamide/prothionamide, cycloserine and PAS may be given in divided doses as long as each divided dose for the day is supervised.

•

Z can be used for the entire treatment if it is judged to be effective. Many MDR-TB patients have chronically inflamed lungs that theoretically produce the acidic environment in which Z is active.

•

The drug dosage should be determined by weight. A suggested weight-based dosing scheme is shown in Annex A: Recommended dosages of anti-TB drugs.

These principles are taken from the WHO Guidelines for the Programmatic Management of Drug-Resistant Tuberculosis, Geneva, World Health Organization (WHO/HTM/TB/2006.361). Please refer to Annex B: Anti-TB drugs available for use in PMDT in the Philippines. Treat MDR-TB Patients

MODULE C

Figure 1: How to read the drug code for MDR-TB treatment regimens TB treatment regimens are described using a standard code which indicates the intensive phase regimen and its duration in months, and the continuation phase regimen and its duration in months. Drugs are written in abbreviated form.

The code shows the 2 phases of the regimen, the intensive phase and the continuation phase separated by a slash. The letters correspond to the drugs to take during the phase.

Streptomycin (S) Ofloxacin (Ofx) Prothionamide (Pto) Cylcoserine (Cs)

Example:

6 SOfxPtoCs/12 Ofx PtoCs

The number before the letters is the duration of the phase in months. The Intensive Phase is 6 months and the Continuation Phase is 12 months.

This continuation phase is of 12 months’ duration.

In the above regimen, the intensive phase is 6 months of Streptomycin, Ofloxacin, Prothionamide and Cycloserine. The continuation phase is 12 months of Ofloxacin, Prothionamide and Cycloserine.

1.5 Present proposed regimen to the Consilium As described in Module B: Detect Cases of MDR-TB, the PMDT program in the Philippines has defined a group called a Consilium to approve treatment regimens and make technical decisions for MDR-TB patients. A CONSILIUM is a multidisciplinary group composed of program staff, physicians, nurses and other relevant health care workers with expertise on MDR-TB management in the Treatment Center. This group meets regularly to confirm diagnosis, design treatment regimens and evaluate response to treatment by consensus utilizing accepted standards. The Consilium: •

reviews the cases presented for confirmation of diagnosis, enrollment or follow-up.

•

approves the proposed enrollment regimen, regimen change, treatment outcome or any action point relevant to the case presented.

•

arrives at a consensus on decisions when the way to management of an MDR-TB case is unclear and complicated.

The following page illustrates how the Consilium works in the management of MDR-TB patients.

18 Treat MDR-TB Patients

MODULE C

Chart 1: Consilium Process

CASE DISCUSSIONS

For enrollment

CASE DECISIONS

Designing a treatment regimen

For management during treatment prior to outcome eligibility Adverse events

Dose change; drug change; discontinuation of offending agent; drug re-challenge; holding off offending agent temporarily; prescription of ancillary drug

Change in DST pattern

Discontinuation of drug; drug change

Change to a more appropriate drug or dose

Drug change; dose change; discontinuation of drug; continuation of present regimen

Shift to Continuation Phase

Discontinuation of injectable

For determination of treatment outcome

Cured; Treatment completed; Failed treatment; Died; Defaulted; Transferred out

The Treatment Center physician designs the enrollment regimen based on the DST and/or history of drug use. This proposed drug regimen will be presented to the Consilium for approval. He must complete the first page of the Consiliumex as discussed in section 6 of Module B: Detect Cases of MDR-TB. Any future change in regimen due to change in weight, ADR, change in DST pattern, shift to continuation phase, must be presented to the Consilium for approval. He must complete the 2nd or succeeding pages of the Consiliumex as needed. For patients who are due for determination of outcome, the Treatment Center physician must complete the last page of the Consiliumex and present it to the Consilium for approval.

Now do Exercise A – Written Exercise When you have reached this point in the module, do exercise A. Follow the instructions for Exercise A. When you have finished the exercise, review your answers with a facilitator.

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Exercise A: Individual work with discussion Selecting a treatment regimen for MDR-TB This exercise is to work on the design of MDR-TB treatment regimens. Work individually on this exercise. Ask your facilitator for help if you do not understand what to do. 1. Below are the recent DST results of three patients. For each patient, develop a treatment regimen based on their drug resistance pattern. As we know, DST is not the only basis for regimen design. In the next few pages are MDR-TB Screening Forms which you should use to help you design the patient’s regimen. 2. Write down the correct dosages for each patient as well.

Cases

Case 1 • HR-resistant • Sensitive to Z, E, S, Km, Cfx, Ofx, Lfx • Other drugs: DST not done

Case 2 • HRE-resistant • Sensitive to Z, S, Km, Am, Ofx, Cfx, Lfx • Other drugs: DST not done

Case 3 • Contact of HRZES-resistant case (Index case is the mother.) • HRES-resistant • Sensitive to Z, Km, Am, Ofx, Cfx, Lfx • Other drugs: DST not done

20 Treat MDR-TB Patients

Regimen

Dosage

Case 1 REP U

Programmatic Management of Drug - Resistant TB (PMDT)

MODULE C

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:

4 MMC/TDF

KASAKA

LCP

Others, specify

Screening code: (TC-YY-MM-NNNN) (mm/dd/yy)

Date: 11 / 12/ 2007

I. Demographics Name:

Amador Surname

Ambrosio

Given Name

Sex: 3 Male Date of birth: 11/11/1977 (mm/dd/yy) Female

Age: 30

Nationality: Filipino Religion: Roman Catholic

Permanent address: 2062-1 Anak Bayan , Sta. Ana, Manila

zip code

Andres

Middle Name

Place of birth:

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

1009

Tel. no.: 123-1234

1009

Tel. no.: 123-1234

City address: 2062-1 _Anak Bayan , Sta. Ana, Manila

zip code

Manila

area code+ tel #

E-mail address: hindiakosiamador@yagoo.com Family monthly income: 10, 000 Php Carpenter Occupation: Employer: Office address: None Tel. no.: N/A

Spouse: Ambrosia B. Amador Address/ Contact #: 2062-1 _Anak Bayan , Sta. Ana, Manila Amador Amador Amalya Amador Father: Mother: Parent’s address: 2062-1 _Anak Bayan , Sta. Ana, Manila Tel. no.:

Person to notify in case of emergency: Ambrosia B. Amador Address: 2062-1 _Anak Bayan , Sta. Ana, Manila

area code+ tel #

Relationship: spouse Tel. No.: 123-1234

area code+ tel #

Referred by: 3 HC Govt Inst PPMD FBO NGO Pvt MD/Institution Specify name, Anak Bayan Health Center Address of referring facility: Anak Bayan, Sta. Ana, Manila Number of household contacts: 3 Less than or equal 10 yrs old: 0 More than 10 yrs old: 3 Chief Complaint/s: persistently symptomatic, AFS (+) at the end of Category I treatment

II. Review of Symptom/s

3 Cough 3 Fever 3 Back/ chest pain 7 Hemoptysis 3 Weight loss 3 Night sweats

Other symptoms: 3 Dyspnea at rest 3 Dyspnea on exertion 7 Pedal edema

Duration in month/s

7 2 8

1 1 week

7 7

Comments

productive, whitish color, minimal amount worsens in the afternoon more on right upper lung area approx. 10 kg.

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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. 2. 3. 4. 5. 6. 7.

Treatment facility

( mos.)

05/01/07

3 HRZE / 2HR

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

Anak Bayan Health Center

MDR

Duration

2 year (s)

3 Diabetes Mellitus 7 Cancer 7 HIVinfection/AIDS 7 Kidney disease 7 Lung disease 7 Epilepsy 7 Psychiatric condition 7 Others

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

DOTS (Y/N)

Comments: (drugs taken, status, etc.)

Takes insulin injections pre breakfast/supper Status

7 Concomitant drugs / Duration:

Previous surgery: 7 None Pneumonectomy/ Lobectomy Others, specify

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 3 Never Type (shabu, marijuana, etc)

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

Sexual History:

22 Treat MDR-TB Patients

Non MDR

Allergy: Drugs: Type of reaction: No known food or drug allergies 1. 2.

Outcome

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

sexually inactive for approximately 8 months

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V. Physical examination and laboratory procedures: Height: 168 cm Vital Signs: Temp: 37.6 Celsius BP: 130/90 mmHg

System examination:

Weight: 51.8 Kg. PR/ HR: 95 / min O2 sat by Pulse oximeter: %

0 = Not done 1 = Normal 2 = Abnormal

cachectic, distressed

Skin:

cold clammy skin, pale nail beds

Oropharynx:

Cardiovascular:

Thorax & Lungs:

No BCG scar

(+) crackles heard on both upper lung fields, more on the right (+) use of accessory muscles

Use of accessory muscles: Abdomen:

Genito-Urinary:

Extremities:

Neurological:

Lymph Nodes:

Endocrine:

(+) multiple cervical lymphadenopathy

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

/min

Describe abnormalities

General Health:

BCG scar:

RR at rest:

AFS (+) on 5th month monitoring

Date

10 / 31 / 07

Other laboratory results: Liver function tests

Renal function tests

CBC

FBS, etc.

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Chest X-ray: Date: 11 / 6

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/ 07

Right Lung

1,2

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: 3 TB suspect New

3 Retreatment

If retreatment, check any of the following types.

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

3 None

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

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: 3 For smear x

2 3 For TB culture x Category II Treatment while awaiting DST; stop treatment if non3 For Drug susceptibility testing 3 Start TB treatment, specify regimen: converter on 3rd month and refer to Treatment Center. Prescribe ancillary drugs or drugs for co-morbidity, or symptomatic treatment Others

Attending MD:

24 Treat MDR-TB Patients

Dave Verzosa, M.D

Date:

11/27/07

Case 2

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MODULE C

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:

4 MMC/TDF

KASAKA

LCP

Others, specify

Screening code: (TC-YY-MM-NNNN) (mm/dd/yy)

I. Demographics Name:

Malakas

Rolando

Surname

Given Name

Sex: 3 Male Date of birth: 11/05/1944 (mm/dd/yy) Female

Date: 11/05/2007

Makisig

Age: 63

Middle Name

Place of birth: Manila

Nationality: Filipino Religion:Roman Catholic Civil status: Single 3 Married Widowed Living together Divorced/ legally separated

Permanent address: Blk. 54 Lot 12 Jasmine St., Brgy. Comembo, Makati City zip code 1217

Tel. no.: 132-1234

City address: Blk. 54 Lot 12 Jasmine St., Brgy. Comembo, Makati City zip code 1217

area code+ tel #

E-mail address: akonamansimalakas@yagoo.com Family monthly income: 150, 000 Php Occupation: Executive Director Employer: Alana Corp. Office address: Tel. no.:

Spouse: Zenaida B. Malakas Address/ Contact #: Blk. 54 Lot 12 Jasmine St., Brgy. Comembo, Makati City Michael Malakas Father: Mother: Amie Malakas Parent’s address: Blk. 54 Lot 12 Jasmine St., Brgy. Comembo, Makati City Tel. no.:

spouse Person to notify in case of emergency: Zenaida B. Malakas Relationship: Address: Blk. 54 Lot 12 Jasmine St., Brgy. Comembo, Makati City Tel. No.: 132-1234

area code+ tel #

Referred by: HC Govt Inst PPMD FBO NGO 3 Pvt MD/Institution Specify name, Dr. Banaue Address of referring facility: Manila Number of household contacts: 5 Less than or equal 10 yrs old: 2 More than 10 yrs old: 3 Chief Complaint/s: persistently symptomatic

II. Review of Symptom/s

3 Cough 3 Fever 3 Back/ chest pain 7 Hemoptysis 7 Weight loss 7 Night sweats

Other symptoms:

3 Dyspnea at rest

3 Dyspnea on exertion 3 Pedal edema

Duration in month/s

2 2 8

Comments

productive, whitish color, minimal amount

on both upper back

8 6

Pitting edema on both lower extremities MDR - TB SCREENING FORM | page 1 of 4 Treat MDR-TB Patients

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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 )

( mos.)

1. Aug. 2001 2. Aug. 2002 3. 2005-2006 4. 5. 6. 7.

Treatment facility

2 HRZE / 1 HR 2 HRZES/1HRZE/5HRE 8 Quadtab

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

Pio Del Pilar Health Center Pio Del Pilar Health Center Private MD

MDR

(Y/N)

Y Y N

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

Status

(+) renal failure; on hemodialysis 2x a week

3 Concomitant drugs / Duration: Cannot be recalled by patient; taken for 3 years.

Previous surgery: 7 None Pneumonectomy/ Lobectomy Others, specify

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 3 Never Type (shabu, marijuana, etc)

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

Sexual History:

26 Treat MDR-TB Patients

4 2 5

Comments: (drugs taken, status, etc.)

Allergy: Drugs: Type of reaction: No known food or drug allergies 1. 2.

Outcome

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

Non MDR

Duration

7 Diabetes Mellitus 7 Cancer 7 HIVinfection/AIDS 3 Kidney disease 7 Lung disease 7 Epilepsy 7 Psychiatric condition 7 Others

DOTS

sexually inactive for approximately 11 months

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V. Physical examination and laboratory procedures: Height: 165 cm Vital Signs: Temp: 37.6 Celsius BP: 140/90 mmHg

Weight: 51.5 Kg. PR/ HR: 95 / min O2 sat by Pulse oximeter: %

0 = Not done 1 = Normal 2 = Abnormal

System examination:

distressed

Skin:

cold clammy skin and pale nail beds

Oropharynx:

Cardiovascular:

Thorax & Lungs:

Use of accessory muscles:

Abdomen:

Genito-Urinary:

Extremities:

Neurological:

Lymph Nodes:

Endocrine:

/min

No BCG scar

(+) crackles on both upper lung fields (+) use of accessory muscles

with fistula on left arm, (+) edema on both lower extremity

(+) multiple cervical lymphadenopathy

Laboratory procedures: Smear, Culture and DST results from other laboratory not done

Describe abnormalities

General Health:

BCG scar:

RR at rest:

Date

Other laboratory results: Liver function tests

Renal function tests

CBC

FBS, etc.

Creatinine clearance - 25ml/min. (10/31/07)

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Programmatic Management of Drug - Resistant TB (PMDT)

NOT AVAILABLE

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

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 Non-DOTS Other (+) Other (-)

Disease other than TB, specify

VII. Plan: 3 For smear x

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

Attending MD:

28 Treat MDR-TB Patients

Dave Verzosa, M.D

Date:

11/05/07

Case 3

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MODULE C

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:

4 MMC/TDF

KASAKA

LCP

Others, specify

Screening code: (TC-YY-MM-NNNN) (mm/dd/yy)

Date: 03/02/2007

I. Demographics Name:

Sex:

Sansalido Surname

Laura

Given Name

Male Date of birth: 02/14/1999 (mm/dd/yy) 3 Female

Age: 8

Aman

Middle Name

Place of birth: Manila

Nationality: Filipino Religion:Roman Catholic Civil status: 3 Single Married Widowed Living together Divorced/ legally separated

Permanent address: 1234 Jollie Bee St., San Jose, Batangas

zip code

4227

Tel. no.:

1013

Tel. no.: 143-1235

City address: 2425 Buendia St., Brgy. Pinoy, Tondo Manila

zip code

area code+ tel #

Family monthly income: 8, 000 Php Employer: Tel. no.:

E-mail address: Occupation: none Office address:

Spouse: Address/ Contact #: Father: Jose Sansalido Mother: Maria Sansalido 2425 Buendia St., Brgy. Pinoy, Tondo Manila Parent’s address: Tel. no.: 143-1235

Person to notify in case of emergency: Jose Sansalido Relationship: father Address: 2425 Buendia St., Brgy. Pinoy, Tondo Manila Tel. No.: 143-1235

area code+ tel #

Referred by: 3 HC Govt Inst PPMD FBO NGO Pvt MD/Institution Specify name, Anak Bayan Health Center Address of referring facility: Anak Bayan, Sta. Ana, Manila 3 Number of household contacts: Less than or equal 10 yrs old: 0 More than 10 yrs old: Chief Complaint/s: persistently symptomatic

II. Review of Symptom/s

3 Cough 3 Fever 3 Back/ chest pain 7 Hemoptysis 3 Weight loss 7 Night sweats

Other symptoms:

7 Dyspnea at rest

3 Dyspnea on exertion 7 Pedal edema

Duration in month/s 1 2 3

Comments

productive, whitish color, minimal amount worsens in the afternoon on both upper back

approx. 5 kg

after climbing 1 flight of stairs

MDR - TB SCREENING FORM | page 1 of 4 Treat MDR-TB Patients

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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 )

DOTS (Y/N)

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

Anak Bayan Health Center

( mos.)

2006

1. 2. 3. 4. 5. 6. 7.

2 HRZE / 2HR

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

Non MDR Contact of patient with HRZES res

Duration

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

7 Diabetes Mellitus 7 Cancer 7 HIVinfection/AIDS 7 Kidney disease 7 Lung disease 7 Epilepsy 7 Psychiatric condition 7 Others

Status

Allergy: Drugs: Type of reaction: No known food or drug allergies 1. 2.

7 Concomitant drugs / Duration:

Previous surgery: 7 None Pneumonectomy/ Lobectomy Others, specify

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 3 Never Type (shabu, marijuana, etc)

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

Sexual History:

30 Treat MDR-TB Patients

Outcome

Treatment facility

No sexual relationship

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Programmatic Management of Drug - Resistant TB (PMDT)

V. Physical examination and laboratory procedures:

Height: 121 cm Weight: 35 Kg. Vital Signs: Temp: 37.6 Celsius PR/ HR: 95 / min BP: mmHg O2 sat by Pulse oximeter: %

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

0 = Not done 1 = Normal 2 = Abnormal

2 1 0 0

/min

Describe abnormalities

cachectic, distressed

cold clammy skin and pale nail beds

(+) wheezes on both upper lungs (+) use of accessory muscles

0 1 0

2 0

(+) multiple cervical lymphadenopathy

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

RR at rest:

AFS 2+, 1+, 0

Date

02 / 20 / 07

Other laboratory results: Liver function tests

Renal function tests

CBC

FBS, etc.

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Chest X-ray: Date: 02 / 20

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/07

Right Lung

Left Lung

2, 1

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: 3 TB suspect New

3 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

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 Non-DOTS Other (+) Other (-)

Disease other than TB, specify

VII. Plan: 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 Others

Attending MD:

32 Treat MDR-TB Patients

Dave Verzosa, M.D

Date:

03/02/07

MODULE C

When you have finished this exercise, notify a facilitator and review your answer with them.

Then read until the next exercise.

1.6 Enroll the MDR-TB patient at the Treatment Center To begin treatment for MDR-TB, each patient must go through the enrollment process at the Treatment Center where he will begin to receive treatment

1.6.1 Contact patient for scheduling of enrollment Once the Consilium has approved the patient’s treatment regimen, contact the patient by phone, text message, letter, or ask the local DOTS facility to inform the patient of the schedule for start of treatment. Every effort must be done to locate the patient quickly.

1.6.2 Inform the patient on the enrollment procedures When the patient reports to the Treatment Center for enrollment, a detailed discussion must take place to inform the patient on the treatment process using the Kasunduan/Contract as described in Module B: Detect Cases of MDRTB and module D: Inform Patients about MDR-TB. Opportunity for questions from the patient should be allowed. If the patient agrees to all the procedures, he signs the Kasunduan/Contract. An accountable significant other or household family member must sign the contract together with the Treatment Center staff who administers the contract.

1.6.3 Classify patients using the Social Case Study Report Form (SCSRF) and Socioeconomic Classification Guide The Social Worker uses the Social Case Study Report Form (SCSRF) and arranges for a home verification visit. The Socioeconomic Classification Guide will help the health workers assess the needs of the patients. See annex C: Socioeconomic Classification Guide for an example of this guide. A health care worker must interview the MDR-TB patient and his or her relatives about their socioeconomic conditions to determine the appropriate assistance that the patient may need to ensure treatment adherence. The health care worker will use and fill out the SCSRF when the home visit is made. The SCSRF shows the family composition and the average monthly income of each member, the source of financial support that the patient would be receiving while on MDR-TB treatment, and the financial obligations which are the monthly expenses such as house rental, water and electricity. From these data, the health worker makes an assessment on the needed assistance and gives recommendations. See accomplished parts of the SCSRF on the next page for a patient who is being prepared for treatment. The entire form can be found in the Reference Booklet.

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Example of Social Case Study Report Form S NE PI

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MODULE C

Social Case Study Report Form Date: 10-17-05

I. IDENTIFYING INFORMATION Nickname: Jose

Patient’s full name: Age: 50

Civil status: M

Sex: M

Date of birth: Balagtas Jose, Amorsolo

Religion: Roman Catholic Place of birth: Jose

Permanent address: 2425 Buendia St. Balut Tondo, Manila Temporary address: N/A Contact number/s: (02) 244-6847 Occupation: laborer

Monthly income: none

Educational attainment: Vocational Graduate

Family monthly income: Php 6,000.00

II. PROBLEM PRESENTED

Mr. Balagtas was diagnosed of Multi-drug Resistant Tuberculosis. He is seeking for medical assistance for second line anti-tb treatment

III. FAMILY COMPOSITION Current address

Average monthly income (Php)

Relationship to Patient

Age & Civil status*

(city only, “same”=living with patient’s temp. address)

Joy Balagtas

Wife

48/M

Same as above

High School Graduate

Vendor

6,000.00

Marites Balagtas

Daughter

18/S

Same as above

High School Graduate

None

Paul Balagtas

Son

14/S

Same as above

Student- High School

None

Angelo Balagtas

Son

4/S

Same as above

N/A

None

Mylene Balagtas

Daughter

16/S

Same as above

4th year HS

None

Name

Educational attainment

Occupation

* Legend: s=single, m=married, l=living together, sep=separated, w=widowed If deceased, write year of death Social Case Study Report Form | page 1 of 4

34 Treat MDR-TB Patients Social Case Study Report Form | page 1 of 4

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Social Case Study Report Form | page 3 of 4

VI. ASSESSMENT

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Class: B C1 3 C2 A Refer to Socoioeconomic Classification Guide

THIS IS A CASE OF A 50 YEAR OLD, MALE, MARRIED AND PRESENTLY RESIDING AT 2425 BUENDIA STREET, BALUT TONDO, MANILA. HE IS A FATHER OF THREE CHILDREN AGED 4 TO 18 YEARS OLD. Mr. Balagtas used to work as a laborer and stopped working when he got sick. Consequently, he is quite dependent on his relatives. Fortunately one sibling is willing to provide financial support during the course of treatment. His sister is very supportive of his treatment despite the minimum wage she earns. She is eager to provide all the needs of the patient until he finishes the course.

VII. RECOMMENDATION/S

Enabler/s:

3 Food Allowance 3 Transportation allowance 3 Housing allowance

In view of the above information, I recommend assistance through transportation allowance, food allowance and housing allowance. These will help the patient continuously adhere to MDR-TB treatment.

MDR-TB housing facility Not applicable

Prepared by:

Shiela Alvarez, RSW

Date:

10/22/05

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RESIDENCE VERIFICATION

Complete Address:

Buendia Street

Street

Village/Subdivision

245 Unit/House #/Floor

Balut

Baranggay

Landline #: (02) 244-6847

Tondo

Municipality

Relocation due to treatment?

yes

Relationship of owner to patient:

Tenure status of housing:

months

in-law

3 yes

parent

sibling

friend

others:

owned/ being amortized 3 rented

Type of dwelling material:

weeks

3 no

3 none

057

Zip Code

years

Name of owner: Owner informed of patient’s illness?

Manila

City

Mobile #:

Length of stay in community

# of bedrooms:

Bldg./Apt. Name

concrete

no other relative:

rent-free w/ consent from owner rent-free w/o consent from owner

3 semi-concrete

wood

# of windows in patient’s bedroom: 1

# of windows in patient’s house: 1

# of persons sleeping in the same house with the patient for the past 3 months: 4 Distance of residence to the Health Facility: 3 blocks away Treatment Center: MMC Treatment Site: Barangay Pinagkaisahan Interviewee: Joy Balagtas Relationship to patient: Findings:

Action taken:

The house of the patient is small and has one window

––

which shows poor ventilation

––

Sheila Alvarez, RSW

Verified by: 36 Treat MDR-TB Patients

wife

Health education conducted to patient and family members Reiterated Informed Consent to patient and to his wife.

10/23/05

Date:

MODULE C

Page 4 of the SCSRF is the Residence Verification Form, which confirms the patient’s residence in the address stated in his records. This portion of the form describes the house where the patient lives including the tenure status of housing, the type of dwelling material, the ventilation of the house and the infection control measures that the patient must observe to avoid transmission to household members.

1.6.4 Request baseline DSSM, culture, DST, chest x-ray and blood chemistries using appropriate forms. Using the Mycobacteriology Request Form, instruct the patient that another round of sputum will need to be collected to establish the baseline status upon treatment. The process of sputum collection for smear, culture and DST is the same as described in module B: Detect Cases of MDR-TB, section 4. Additionally, chest x-ray and blood chemistries should be requested using corresponding Request Forms which can be found below.

Example of a Chest X-ray Request Form

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Chest X-ray Request Form Treatment Center: ______________ KASAKA QI 02-04-25-0081

Screening Code:

Category IV Registration No.: -Date requested: Name: Age/ Sex:

10/24/2005

Balagtas, Jose A.

50 / M Birth date:

3 Baseline Follow-up _______ mos. Requested procedure:

3 Postero-anterior upright (PA)

1/20/1955 Index Contact

CXR is requested at: a. Baseline to all patients prior to initiation of Category IV treatment b. Every six months while on treatment and whenever necessary c. Every six months posttreatment

Apico-lordotic Others, specify: Requesting physician License number:

Dan A. Rivera, MD 01-12345

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MODULE C

Blood Chemistry Request Form

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BLOOD CHEMISTRY Request Form Patient Classification: Screening Code:

02-05-04-0081

Category IV Registration No. Name:

Balagtas, Jose Amorsolo

Address:

3 C Date Requested:

10/24/2005

Requesting Physician: Dan A. Rivera 50 / M Age/Sex: _________

Tondo, Manila

Schedule:

SCR

Enrolled:

Yes

3 BAS 3 No

Follow-up: month of tx: _________

Months post-treatment: _________

Category:

New

3 Retreatment

BLOOD CHEMISTRY TEST Kidney Function

3 FBS

3 BUN

3 Uric Acid

3 Crea

Liver Function tests

Electrolytes

3 AST 3 ALT Total Protein

3 K 3 Ca 3 Mg

Others: Blood chemistry is requested: d. At baseline to all patients prior to initiation of Category IV treatment e. Every six months while on treatment for patients below 50 y/o, every 3 months for 50 y/o and above, and whenever necessary

38 Treat MDR-TB Patients

MODULE C

1.6.5 Ensure that the items in the Enrollment Checklist are accomplished to complete enrollment The following are other requirements for enrollment which are measures to ensure sustainability of the long treatment. These are all listed in the Enrollment Checklist which is shown below: Enrollment Checklist 1. Barangay Certificate from the Barangay Chairman which states that the patient is a legitimate resident of the barangay 2. Photocopy of any valid ID with picture, if available 3. Letter from the person who will support the patient while on treatment 4. Detailed sketch of the patient’s residence in relation to the nearest health center, address and telephone number of the health center 5. If unemployed: Affidavit of Income Status from the Municipal Hall signifying that the patient is currently unemployed 6. If employed: Certificate of Employment and Income Tax Return stating the monthly income of the patient or income of the person who will support the patient while on treatment, e.g., spouse, son/daughter, etc 7. Photocopy of monthly income or pension voucher of retired patients or retired person who will support the patient while on treatment, if available 8. If renting a place: photocopy of the contract of house rental or letter from the house owner that the patient is a tenant

Tick when completed ______________ ______________ ______________ ______________ ______________ ______________

______________ ______________

The requirements will help determine the support needed by the patient and facilitate default follow-up should adherence become a problem in the future. As soon as all the requirements are accomplished, the patient comes to the Treatment Center for start of Category IV treatment.

1.7 Prepare the patient’s Category IV Treatment Card The Category IV Treatment Card is the record of the patient’s diagnosis and MDR-TB treatment. It has 4 pages. In the following page is an example of the first page of the Category IV Treatment Card. A complete Category IV Treatment Card can be found in Annex D of the Reference Booklet. Refer to the Card as you read this section. Whenever a patient is diagnosed to have DR or MDR-TB, and is enrolled for treatment, open a Category IV Treatment Card. See the example card on the next page for the patient who has undergone the necessary steps for enrollment and has recently began treatment. The Category IV Treatment Card will be kept at the Treatment Center. It is essential that the card is filled out completely and accurately and then kept up to date throughout treatment. When the patient is decentralized, the Treatment Site will be provided by the designated Treatment Center staff another copy of the Category IV Treatment Card with the date of supervised treatment starting on the day the patient was endorsed to the Treatment Site. This is discussed in detail in Module E: Ensure continuation of MDR-TB Treatment. It is important that the Category IV Treatment Card provided to the Treatment Site be filled-out completely and accurately. The Treatment Center maintains the original Category IV Treatment Card. Both the Treatment Center and Treatment Site staff should periodically update and refer to the PMDT Patient’s Booklet for the information on the patient’s management. Please refer to the Reference Booklet for the PMDT Patient’s Booklet. The PMDT Patient’s Booklet is also used each time a patient returns to the Treatment Center for monthly evaluation by the Treatment Center physician.

Treat MDR-TB Patients

Balagtas, Jose A.

3HRZES 3HRZE

9/14/2004

Yes

3 No

Failed

unknown

Treatment outcome

H = Isoniazid R = Rifampicin Z = Pyrazinamide E = Ethambutol S = Streptomycin

First-line drugs

Km = Kanamycin Am = Amikacin Cm = Capreomycin Cfx = Ciprofloxacin Ofx = Ofloxacin Lfx = Levofloxacin Mfx = Moxifloxacin

Gfx = Gatifloxacin Pto = Prothionamide Eto = Ethionamide Cs = Cycloserine PAS = P-aminosalicylic acid Clr = Clarithromycin AmxClv = Co-amoxiclav

Second-line drugs

Drug abbreviations

For Enrollment Case Management Case Management Case Management Case Management

12/26/2005 1/9/2006 3/20/2006 5/2/2006

(5) Consilium meetings 10/18/2005

New After Cat I failure After Cat II failure After Cat IV failure After default Cat I relapse Cat II relapse Cat IV relapse Transfer-in Other 10.1 Non-dots tx 10.2 Other (+) 10.3 Other (-)

Purpose

1 2 3 4 5 6 7 8 9 10

10/24/05

Y 3 N

(+)

(-)

start continuation phase 5/10/06

DC Cs/ add PASER

DC Z due to arthralgia

Increase dose due to increase in weight

For initiation of category IV treatment

Decision

ART= antiretroviral therapy CPT= co-trimoxazole preventive therapy

N Started on CPT: Y Date: ____/____/ _____

N Started ART: Y Date: ____/____/ _____

Results:

Date of test: ____/____/ _____

HIV testing done:

(3) HIV information

KASAKA-QI Round 2

Funding source: (14) CLASS: (15) CLASS: A

select one only (√)

Extrapulmonary Both

(2) Registration group

Initial height: (9) 167 cm Site of disease: 3 Pulmonary

Date

If Yes, specify drug and duration of use: _____________________________________________

Used second line drugs previously? (4)

2HRZES 4HRZE

2003

4HR

2HRZE

1997

Regimen (write regimen in drug abbreviation)

Start date (if unknown, put year)

Previous TB treatment episodes (1)

No.

contact no.:

(02) 244-6347

City address: (3) (02) 244-6847 Contact numbers: (4) Person to notify (relationship) and (5) Marites Balagtas ( daughter)

Treatment Center: (13)

Treatment start date: (12)

02- 05 - 0097

( TC - YY - NNNN )

Category IV Registration No. (11 )

( MM / DD / YYYY )

01/20/55

50 / M

Initial weight: (8) 49.2 kg

Date of birth (7)

Age / Sex: (6)

REP U

(Last name, First name, MI)

2425 Balut Street, Tondo, Manila

Permanent address: (2)

Name: (1)

Category IV Treatment Card

Programmatic Management of Drug - Resistant TB (PMDT)

F THE PHI LIP IC O BL

S NE PI

Contact Initial Investigation Form/ Page 1 of 4

Category IV Treatment Card (page 1) MODULE C

MODULE C

1.7.1 Record general patient information Fill in the general patient information at the upper portion of the front of the Category IV Treatment Card, as shown on the previous page. Be sure to write the patient’s complete address. The Permanent address refers to the patient’s residence where he has been staying on a long-term basis prior to start of MDR-TB treatment. The City address is the address where the patient will be staying while on treatment. The City address is the one that you could use to visit the patient, if he does not report during a scheduled visit. Also record the name, relationship to patient, and address of a contact person for emergency purposes. This should be a person such as a family member, a neighbor or a friend, who will know how to find the patient if not at home. Then, tick the correct Site of Disease whether pulmonary or extrapulmonary. The Treatment Center staff will write the Pre-enrollment No. (YY-NNNN) assigned when the patient is either confirmed to be MDR by DST or with a Consilium decision to start treatment even without DST confirmation due to strong suspicion. This number should have been entered on the last column of the TB Symptomatics Masterlist. Once the patient is started on Category IV treatment, a Category IV number is created (TC-YY-NNNN) and the patient is entered unto the Category IV Register. TC refers to the Treatment Center code, YY refers to the year patient is enrolled and NNNN refers to the chronologic number which starts with 0001 at the start of each year. As soon as the patient is started on treatment, a Category IV Treatment Card is opened where the Category IV Registration No. is recorded together with other patient data.

1.7.2 Record previous TB treatment, registration group, HIV information, and Consilium decision Be sure to complete the succeeding sections of the Category IV Treatment Card containing information about previous treatment episodes. Use of first-line as well as second-line drugs should be reflected on this box using drug acronyms as written at the bottom of the Category IV Treatment Card. Refer to the second page of the patient’s MDRTB Screening Form for information on his previous TB treatment episodes.

Category IV Treatment Card (Previous TB treatment episodes)

Previous TB treatment episodes (1) Regimen (write regimen in drug abbreviation)

No.

Start date (if unknown, put year)

1997

2003

2HRZES 4HRZE

Failed

9/14/2004

3HRZES 3HRZE

Failed

2HRZE

4HR

Treatment outcome unknown

Tick the appropriate box for Registration Group, as shown in the example on the following page for two different patients. This information will be found on the MDR-TB Screening Form which is described in Module B: Detect MDRTB Cases, section 2.2.

Treat MDR-TB Patients

MODULE C

Category IV Treatment Card (Registration group)

select one only (√)

(2) Registration group 1

New

After Cat I failure

After Cat II failure

After Cat IV failure

After default

Cat I relapse

Cat II relapse

Cat IV relapse

Transfer-in

Other 10.1 Non-dots tx 10.2 Other (+) 10.3 Other (-)

On the HIV information box, write the date of HIV testing, date and results if available, and if positive, whether started on antiretroviral treatment (ART) and cotrimoxazole preventive therapy (CPT). This information is taken from the patient.

Category IV Treatment Card (HIV information)

(3) HIV Information HIV testing done: Date of test: Results: Started ART: Date:

____/____/ _____ (+)

(-)

Y N ____/____/ _____

Y N Started on CPT: Date: ____/____/ _____ ART= antiretroviral therapy CPT= co-trimoxazole preventive therapy

Write the date of the Consilium meeting when the decision to treat the patient was made. The purpose of the initial presentation to the Consilium is usually for regimen design and enrollment. Once the Consilium Officer signs the Consiliumex, the enrollment of the patient is already approved. Subsequently during the treatment course, as the patient is presented to the Consilium for case management or for treatment outcome determination, write the date, the purpose of presentation and the decision arrived at by the team.

42 Treat MDR-TB Patients

MODULE C

1.7.3 Record the DSSM, culture and DST results Find the results of the DSSM, culture and DST in the “Sputum Results” section of the Consiliumex (first page) validated by checking the official DST Result form sent by the DST Center. On page 4 of the Category IV Treatment Card, under “Sputum Monitoring” the Treatment Center physician records the date of sputum collection at screening (S1 and S2, if there were two screening dates), and at baseline (B), i.e., sputum collected within the last 30 days prior to the start of treatment or within 7 days after the start of treatment. Write also the specimen numbers and the smear and culture results. Since in the Philippines, there are two possible methods for AFB smear by different laboratories, either by Auramine Rhodamine or Ziehl Neelsen stain, there is a guide for the reporting of each method in the Category IV Treatment Card. Culture is reported by the laboratory according to the number of colonies. The guide shows how culture is to be reflected on the “Sputum Monitoring” box of the Category IV Treatment Card. The following page shows page 4 of the Category IV Treatment Card. Record the results of the DST on the Category IV Treatment Card in the section for “Drug Susceptibility Testing (DST) results.” Record the date the DST result was released by the laboratory and the specimen number which are both found in the official DST Result form, Write “ND” (not done) if DST for a drug was not performed. Fill out all the cells.

Treat MDR-TB Patients

Month of Treatment

6th 12th 18th 24th

S1 S2 B 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24

Request Given

Patient name:

4/20/2006

3/24/2006

2/23/2006

1/25/2006

12/22/2005

(2) Post-treatment follow-up

Ensure monthly DSSM and culture exam during the intensive phase.

4+ 2+ 0 0 0 0 0

02-P-50616-1 02-P-50801-1 02-P-51011-1 02-P-51211-1 02-P-51301-1 02-P-51411-1 02-P-51523-1

10/22/2005

11/22/2005

DSSM

02-P-50001-1

Laboratory No.

4/28/2005

Date collected

DSSM

Monitor frequently for progress of treatment and possible decentralization.

MTB 0 0 0 0

MTB

TBC

DSSM/Culture

(1) Sputum monitoring

Balagtas, Jose A

Category IV Treatment Card | page 4 of 4

MTB

TBC

10/10/2005

S ND

R ND

Km Am Cm Cfx Ofx Lfx Mfx

1+ 2+ 3+ 4+

1-9 AFB per 10 fields 1-9 AFB per field 10-90 AFB per field > 90 AFB per field

+n 1+ 2+ 3+

1-9 AFB per 100 OIF 10-99 AFB per 100 OIF 1-10 AFB per OIF >10 AFB per OIF

# of colonies 1+ 2+ 3+ 4+

10-100 100-200 200-500 >500

0 <10 colonies

No growth

Recording cultures (TBC) # of colonies

No AFB seen

Recording AFB smear using Ziehl Neelsen stain

No AFB in at least 60 fields (2 sweeps)

Recording AFB using Auramine Rhodamine CODES

Trans-out

Defaulted

Failed

Died

Completed

Cured

OUTCOME

DATE

Pto Eto

PAS

Other

F THE PHI LIP IC O BL

REP U

DATE

Reason if Died/Defaulted OR Facility transferred to

(5)Treatment outcome

Normal 8 Fibrothorax Cavity 9 Bullae Infiltrates 10 Pleural Nodule effusion Miliary TB 11 Pneumothorax Intrathoracic 12 Bronchiectasis ymphadenopathy 13 Atelectasis 6 Endobronchial 14 Consolidation spread 15 Mass 7 Fibrosis Follow-up 21 Improved 22 Progressed. Specify using codes above 23 Stable

0 1 2 3 4 5

READING Baseline

(4) Chest X-ray readings

NOTATION method: R=Resistant S=Susceptible N=Non-viable C=Contaminated ND=Not done

02-P-50001-1

Programmatic Management of Drug - Resistant TB (PMDT)

(3) Drug Susceptibility Testing (DST) results

02-05-0097

Date released Laboratory No.

Category IV Registration No.

Mtb

Category IV Treatment Card (DST results) S NE PI

MODULE C

1.7.4 Record TB treatment regimen and dosage for both phases The Category IV regimen is recorded in the second page of the Category IV Treatment Card under “Category IV Regimen”. The date when the drugs are started is recorded on the first row as well as the dosage of each of the drugs stated as number of units (tablets, capsules or sachets for the oral drugs and number of grams or G for the injectables). Anytime the regimen is modified, the date when this was changed, and the corresponding changes will be reflected on the succeeding rows of this section. In this section, complete the appropriate boxes according to the regimen of the patient. (See example on the next page). Consult Annex A: Recommended dosages of anti-TB drugs for the specific dosages of each drug. In the box below each drug abbreviation, write a digit to indicate the number of tablets, capsules or sachets of that drug in a dose. For injectable agents, write the number of G in one dose. One dose consists of all the drugs, in the correct amounts that the patient should take in a day. Use the patient’s weight and refer to the recommended drug dosages to determine the number of units needed for one dose. Later in the treatment course, any change in the regimen, whether in the composition of drugs or in the dosage of at least one drug, is reflected on the next row under Category IV Regimen by specifying the new regimen and the date of the change in regimen. Mark an X for the drug that was discontinued. Please see example on the next page. A “Comments” box below the dosages on the same page is supposed to reflect the reason for every change in regimen and/or dosage. Note that the dates on this section correspond to the dates when changes in the regimen were made.

On the following page is an accomplished page 2 (Category IV Regimen section) of the Category IV Treatment Card.

Treat MDR-TB Patients

12/27/05 1/10/06 3/20/06 5/10/06

Date

5/10/06

3/20/06

01/10/06

12/27/05

10/24/05

DATE

DRUG Preparation

300 mg

500 mg

Z 1G

Comments

400 mg

0.75

Km 1G

200 mg

Ofx

Mark with X the drugs that are discontinued

Balagtas, Jose A

Specify reason/s for change in regimen

increase dose of Z, Km, Pto and Cs due to inc. in wt. d/c Z due to joint pains d/c Cs due to suicidal attempt and add PASER d/c Km, start continuation phase

CATEGORY IV REGIMEN (date started and dosage) Patient name: change of dosage and cessation of drugs:

Category IV Treatment Card | page 2 of 4

Lfx 500 mg

Date

500 mg

Cfx 400 mg

Mfx 400 mg

Gfx

250 mg

Pto/ Eto

Pas

Comments

250 mg

Others

REP U

2 3

Others

02-05-0097

500 mg

Clr

Category IV Registration No.

Programmatic Management of Drug - Resistant TB (PMDT)

F THE PHI LIP IC O BL

S NE PI

MODULE C

Administration of drugs using the Consiliumex and the Category IV Treatment Card Because of the toxic effects of SLDs, an incremental dosing is recommended for Pto, Cs, and PAS to reach full dose on or before the 7th day. The counting of complete dose will start on the day the patient received the recommended dose. The following section of the Consiliumex serves as guide in how SLDs are introduced.

CONSILIUM DISCUSSION 001 – RECOMMENDATION ON ENROLMENT REGIMEN RECOMMENDED REGIMEN AND DRUG INTRODUCTION GUIDE: 52

KGS

REGIMEN

SYMBOL

DAY 1

DAY 2

DAY 3

DAY 4

DAY 5

DAY 6

DAY 7

Cycloserine

1 cap

2 caps

3 caps (FD)

Prothionamide

Pto

1 tab

2 tabs

3 tabs (FD)

PASER

PAS

1 sachet

2 sachets (FD)

2 sachets

LATEST WEIGHT SECOND-LINE DRUG

DRUGS IN REGIMEN (USE SYMBOL)

MD IN CHARGE

PREPARATION

For Paser, the FD was reached on the 4th day.

NO. OF UNITS PER DAY

For Cs and Pto the full or recommended dose (FD) was reached on the 7th day.

COMMENTS: CONSILIUM OFFICER

DATE

In the above form, Pto, Cs, and PAS are to be given simultaneously starting with the lowest dose, gradually increasing up to the full or recommended dose on or before the 7th day. Regimen changes are also reflected on page 3 of the Category IV Treatment Card “Administration of drugs”. This will be demonstrated in section 2.1.3 where an example is shown. The change is indicated by encircling the cell corresponding to the date when the change was made. The weight taken monthly will be recorded on the third to the last column. This weight will determine drug dosages and will later be helpful to track the patient’s weight gain or weight loss. The total number of doses taken monthly and cumulatively will be reflected in the last two columns. This will guide the health workers in determining whether a patient is due for shifting to the continuation phase or is eligible for treatment completion. For continuation phase: the patient must have taken a total of 156 doses (26 days per month for 6 months) from the time of culture conversion. For treatment completion: the patient must have taken a total of 468 doses (26 days per month for 18 months) from the time of culture conversion. The form on the next page shows the daily administration of drugs. Treat MDR-TB Patients

TRC

NMB

TRC

Feb-06

Mar-06

Apr-06

May-06

NMB

NMB NMB

TRC

NMB

IBL

NMB

Note: Encircle date of regimen change

X = drugs not taken / Absent I = incomplete regimen H = Sunday/ Holiday

NMB

TRC

IBL

NMB NMB

TRC

12th mo

9th mo

6th mo

3rd mo

Baseline

NMB

TRC

NMB

CXR

10/21/05

10/21/06

4/21/2006

NMB

NMB NMB

TRC

ABG

HW initials

NMB

TRC

NMB

26 TRC

18th mo 24th mo

10/21/06

TRC

1023/07

NMB

NMB NMB

IBL

NMB

54.9

54.6

52.1

51.3

49.1

49.2

31 Wt (Kg)

NMB NMB

(√) if done

CXR HW initials

7/21/2007

4/23/2007

1/21/2007

Schedule

1023/07

REP U

(√) if done

Blood chemistry

HW initials

173

148

123

100

Monthly Cumulative # of doses taken doses taken

Column on “Cumulative number of doses” guides health workers on whether a patient is for shifting to continuation phase or completion of treatment.

Schedule

TRC

NMB NMB NMB

NMB NMB

4/23/2007

NMB

NMB NMB

15th mo

TRC

7/21/2006

CPR

HW initials

21st mo

(√) if done

TRC

NMB NMB NMB NMB

NMB NMB

TRC

NMB

Blood chemistry

TRC

NMB

4/21/2006

1/21/2006

10/21/05

Schedule

NMB NMB

A circle indicates a regimen change on this date. Reason for the regimen change is found on page 2 of this form.

NMB

TRC

(√) if done

Schedule

NMB

NMB NMB NMB NMB NMB

NMB NMB NMB NMB NMB NMB

NMB NMB NMB NMB

NMB NMB

MARK IN THE BOXES: Initials of HW (3 letters)=Supervised TC/TS= Treatment Center/ Site DOT

TRC

NMB NMB NMB

Jan-06

NMB

Dec-05

6 NMB NMB

NMB NMB

NMB NMB NMB NMB

TRC

NMB NMB

Oct-05

Nov-05

Month / Year

02-05-0097 Category IV Registration No.

ADMINISTRATION OF DRUGS (one line per month) Patient name: Balagtas, Jose A

Programmatic Management of Drug - Resistant TB (PMDT)

Category IV Treatment Card | page 3 of 4

F THE PHI LIP IC O BL

S NE PI

MODULE C

Sputum Monitoring During Category IV treatment, DSSM monitoring is done monthly and should be recorded on page 4 of the Category IV Treatment Card under the “Sputum monitoring” box, DSSM column. Only the first day of sputum collection is recorded under the ‘Date collected’ column even if two sputum collections were done on screening and at baseline. Culture is also done monthly during the intensive phase and every 2 months during the continuation phase. The results must be recorded in the “TBC” column accordingly. Instructions on how to fill out this form can be found in the Reference Booklet. The example on the next page shows the monthly sputum monitoring starting at baseline until month 6 of a patient. This example shows positive baseline bacteriology (DSSM and culture). Culture conversion occurred on month 1, while DSSM conversion occurred on month 2.

Treat MDR-TB Patients

Month of Treatment

6th 12th 18th 24th

S1 S2 B 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24

4+ 2+ 0 0 0 0 0

MTB 0 0 0 0

MTB

TBC

(2) Post-treatment follow-up

For baseline (B) as well as for screening (S1), only the date of collection of the first specimen is recorded.

02-P-50616-1 02-P-50801-1 02-P-51011-1 02-P-51211-1 02-P-51301-1 02-P-51411-1 02-P-51523-1

10/22/2005 11/22/2005 12/22/2005 1/25/2006 2/23/2006 3/24/2006 4/20/2006

3 3 3 3 3 3 3

DSSM

Laboratory No.

4/28/2005 02-P-50001-1

Date collected

DSSM

DSSM/Culture

(1) Sputum monitoring

Request Given

Patient name:

Category IV Treatment Card | page 4 of 4

MTB

TBC

10/10/2005

R S

Z R

E ND ND

Pto Cs PAS Eto ND ND ND ND

Km Am Cm Cfx Ofx Lfx Mfx

(3) Drug Susceptibility Testing (DST) results

Programmatic Management of Drug - Resistant TB (PMDT)

+n 1+ 2+ 3+

1-9 AFB per 100 OIF 10-99 AFB per 100 OIF 1-10 AFB per OIF >10 AFB per OIF

# of colonies 1+ 2+ 3+ 4+

10-100 100-200 200-500 >500

0 <10 colonies

No growth

Recording cultures (TBC) # of colonies

No AFB seen

Recording AFB smear using Ziehl Neelsen stain

> 90 AFB per field

1-9 AFB per field

1-9 AFB per 10 fields

10-90 AFB per field

No AFB in at least 60 fields (2 sweeps)

Recording AFB using Auramine Rhodamine

1,2,8 21

10/21/2005 4/21/2006

Trans-out

Defaulted

Failed

Died

Completed

Cured

OUTCOME

CODES

DATE

Other

REP U

Reason if Died/Defaulted OR Facility transferred to

Ensure that the patient has been presented to the consilium for determination of treatment outcome

DATE

(5)Treatment outcome

0 1 2 3 4 5

READING Baseline

(4) Chest X-ray readings

NOTATION method: R=Resistant S=Susceptible N=Non-viable C=Contaminated ND=Not done

02-P-50001-1

Date released Laboratory No.

Category IV Registration No.

Mtb

F THE PHI LIP IC O BL

S NE PI

MODULE C

1.8 Complete the Category IV Register with patient information Upon initiation of the Category IV regimen, enter the patient’s information in the Category IV Register. Information for columns 1 to 15 should be available at this time. Make sure to fill out all the data being asked for. See the example on the following page. All the information are the same ones you used to fill out the Category IV Treatment Card. A copy of the Category IV Register is also available in Annex E and in the Reference Booklet where instructions on how to fill this form out are provided. Enter all patients being started on Category IV regimen on the day the first dose was administered. This ensures that no patients are forgotten or missed. The Category IV Register is a very important source of information. As you go through this course, you will find out that this is your source reference for determining tratment outcome.

Treat MDR-TB Patients

52 Treat MDR-TB Patients

02-05-0097

4/28/05

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

Date screened mm/dd/yy (1)

10/24/05

Treatment start date mm/dd/yy (3)

Balagtas, Jose A.

Last name First name and middle name

Name (4)

Address (7)

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

(9) Chest x-ray result

2425 Balut St., Tondo, Manila

Street no. and name Brgy. City, Region

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

01/20/55

Date of birth mm/dd/yy

1- Male 2- Female

(5) Sex

Sex (5)

Age (yrs) (6)

Category IV Register

Programmatic Management of Drug - Resistant TB (PMDT)

Example of portion of Category IV Register to be filled out at the beginning of treatment

REP U

10/27/05

1, 2, 3

Date done mm/dd/yy

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

Registration group (10)

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

10-Other patient w/

(10) Registration group

Site of disease (8)

Chest xray result (9)

F THE PHI LIP IC O BL

S NE PI

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

(11) Previous TB treatment

Previous TB treatment (11)

Category IV Register/ Page 1 of 3

04/29/05

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

Ofx

Cfx

Lfx

Other

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

10/10/05

(14)

mm/dd/yy

released

Date DST

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)

S - Susceptible R - Resistant ND - Not Done

Drug Susceptibility Testing (DST) (13)

Category IV REGISTER | page 2 of 3

10/12/05

mm/dd/yy (15)

Tx center

Date received by s/c

/ /

mm/dd/yy

s/c

mo 0

/ /

mm/dd/yy

s/c

mo 1

/ /

mm/dd/yy

s/c

mo 2

/ /

mm/dd/yy

s/c

mo 3

/ /

mm/dd/yy

s/c

mo 4

/ /

mm/dd/yy

s/c

mo 5

/ /

mm/dd/yy

s/c

mo 6

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

/ /

mm/dd/yy

s/c

mo 7

Programmatic Management of Drug - Resistant TB (PMDT)

REP U

/ /

mm/dd/yy

s/c

mo 8

F THE PHI LIP IC O BL

/ /

mm/dd/yy

s/c

mo 9

S NE PI

Treat MDR-TB Patients

MODULE C

Now do Exercise B – Written Exercise When you have reached this point in the module, do Exercise B. When you have finished the exercise, review your answers with a facilitator.

Exercise B: Written Exercise Preparing a Category IV Treatment Card

The purpose of this exercise is to practice preparing Category IV Treatment Cards for patients beginning MDR-TB treatment. •

For Treatment Site staff, prepare a Category IV Treatment Card for Case 1 only.

•

For Treatment Center staff, prepare Category IV Treatment Cards for Cases 1, 2, and 3.

If any of the instructions are unclear, ask a facilitator for assistance and clarification. Use the information provided on the MDR-TB Screening Forms in Exercise A and the Consiliumex forms and additional information in the next pages to prepare a Category IV Treatment Card for each patient. To prepare each card, carry out the following steps: 1. Record all the general patient information on the top section of the card based on available data from the Screening Form, Consiliumex and additional data written below the Consiliumex. 2. Record if the patient has had previous TB treatment. 3. Mark the Registration group. 4. Complete the HIV information, if known. 5. On page 4 of the Category IV Treatment Card, record the results of the screening sputum smear and culture examinations in the ‘Sputum monitoring’ section based on the Consiliumex and the additional information given below. 6. Record the DST results of the patient in the “Drug Susceptibility Testing” section. 7. Then using the information provided in the Consiliumex find the approved drug regimen for the patient and the doses for the patient’s weight. Fill in the number of tablets (or grams for the injectable agent) for each dose for the beginning of treatment.

After completing each case, review your work with a facilitator.

54 Treat MDR-TB Patients

MODULE C

Consiliumex Case 1:

REP U

S NE PI

F THE PHI LIP IC O BL

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

CONSILIUMEX

Category IV Registration No:

GENERAL INFORMATION: NAME

Amador

Ambrosio (Last)

AGE

SEX

Andres

(First)

(Middle)

WEIGHT ON SCREENING 51.7

KGS

2062-1 Anak Bayan, Sta. Ana, Manila

METRO MANILA ADDRESS

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

Same as above

PERMANENT ADDRESS

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

NCR

REGION

TDF-MMC DOTS Clinic

TREATMENT CENTER

Dave Verzosa MD

MD IN CHARGE

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

5/01/07 3HRZE / 2 HR- (Failed) After Cat I failure

CHEST X-RAY RESULTS 11/06/07 – Cavity on upper right lung, infiltrates BUL NAME OF OTHER LABORATORY DST RESULT

DATE DST RELEASED Resistant to:

Susceptible to:

CULTURE CENTER (Screening)

DATE SPECIMEN COLLECTED

DST CENTER (Screening) DST RESULT (Screening)

11/12/07

DATE DST RELEASED 4/27/08 Resistant to:

Susceptible to:

Z E S Km Cfx Ofx Lfx

DST RESULT (Baseline) Resistant to: Note: to be filled in once available

Susceptible to:

WEIGHT MONITORING: (TO BE CONSTANTLY UPDATED EVERY CONSILIUM MEETING BY THE SECRETARIAT) CONSILIUM DISCUSSION 001 (E) 002 003 004 005

DATE

WEIGHT (KGS)

5/03/08

21.7

CONSILIUM DISCUSSION

DATE

WEIGHT (KGS)

006 007 008 009 010 (TO) CONSILIUMEX | page 1

Treat MDR-TB Patients

MODULE C

CONSILIUM DISCUSSIONS CONSILIUM DISCUSSION 001 – RECOMMENDATION ON ENROLMENT REGIMEN RECOMMENDED REGIMEN AND DRUG INTRODUCTION GUIDE: 51.7

KGS

REGIMEN

SYMBOL

DAY 1

DAY 2

DAY 3

DAY 4

DAY 5

DAY 6

DAY 7

Cycloserine

1 cap

2 caps

Prothionamide

Pto

1 tab

2 tabs

PASER

PAS

1 sachet

2 sachets

LATEST WEIGHT SECOND-LINE DRUG

Z E S Ofx Pto Cs

MD IN CHARGE

DAV

DRUGS IN REGIMEN (USE SYMBOL)

PREPARATION

NO. OF UNITS PER DAY

500mg

4 tabs

400mg

3 tabs

1000mg

1G vial

Ofx

200mg

4 tabs

Pto

250mg

3 tabs

250mg

3 caps

COMMENTS: CONSILIUM OFFICER

Ruth Orillaza- Chi, MD

Case 1: DSSM and culture results: • 1st : 1+/ MTB: collected on Nov 12, 2007 (Laboratory No. 01-T-07-8978) • 2nd : 2+/ MTB: collected on Nov 13, 2007 Treatment start date: May 19, 2008 Category IV Registration number: 01-08-0830

56 Treat MDR-TB Patients

DATE

5/03/08

MODULE C

Case 2:

REP U

S NE PI

F THE PHI LIP IC O BL

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

CONSILIUMEX

Category IV Registration No:

GENERAL INFORMATION: NAME

Malakas

Rolando (Last)

AGE

Makisig (First)

SEX

(Middle)

WEIGHT ON SCREENING 51.75

KGS

Blk 54 Lot 12 Jasmine St.,Barangay Comembo Makati City

METRO MANILA ADDRESS

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

Same as above

PERMANENT ADDRESS

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

NCR

REGION

TDF-MMC DOTS Clinic

TREATMENT CENTER

Dave Verzosa MD

MD IN CHARGE

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

8/2001 – 2HRZE / 1HR (Defaulted) 8/2002 – 2HRZES/ 1HRZE/ 5HRE (Treatment completed) 2005 – 2006 – 8 Quadtab (unknown) Other Non-DOTS

CHEST X-RAY RESULTS Not Available NAME OF OTHER LABORATORY

DATE DST RELEASED

DST RESULT

Resistant to:

Susceptible to:

CULTURE CENTER (Screening)

TDFI

DST CENTER (Screening)

TDFI

DATE DST RELEASED 4/21/08

DST RESULT (Screening)

Resistant to:

Susceptible to: Z S Km Am Cfx Ofx Lfx

DATE SPECIMEN COLLECTED

HRE

DST RESULT (Baseline) Resistant to: Note: to be filled in once available

10/30/07

Susceptible to:

WEIGHT MONITORING: (TO BE CONSTANTLY UPDATED EVERY CONSILIUM MEETING BY THE SECRETARIAT) CONSILIUM DISCUSSION 001 (E) 002 003 004 005

DATE

WEIGHT (KGS)

04/26/08

51.7

CONSILIUM DISCUSSION

DATE

WEIGHT (KGS)

006 007 008 009 010 (TO)

Treat MDR-TB Patients

MODULE C

CONSILIUM DISCUSSIONS CONSILIUM DISCUSSION 001 – RECOMMENDATION ON ENROLMENT REGIMEN RECOMMENDED REGIMEN AND DRUG INTRODUCTION GUIDE: 50

KGS

REGIMEN

SYMBOL

DAY 1

DAY 2

DAY 3

DAY 4

DAY 5

DAY 6

DAY 7

Cycloserine

1 cap

2 caps

Prothionamide

Pto

1 tab

2 tabs

PASER

PAS

1 sachet

2 sachets

LATEST WEIGHT SECOND-LINE DRUG

Z S Ofx Pto Cs

MD IN CHARGE

CML

DRUGS IN REGIMEN (USE SYMBOL)

PREPARATION

NO. OF UNITS PER DAY

500 mg

3 tabs 3x/ wk

1000 mg

750 mg 3x/wk

Ofx

200 mg

4 tabs 3x/wk

Pto

250 mg

2 tabs daily

250 mg

2 caps 3x/wk

COMMENTS: CONSILIUM OFFICER

Ruth Orillaza- Chi, MD

Case 2: AFB smear and culture results: • 1st : 4+/ MTB: collected on Oct 30 , 2007 Laboratory No. 01-T-07-8878 • 2nd : 4+/ MTB: collected on Nov 5, 2007 Treatment start date: May 10, 2008 CategoryIV Registration No. 01-08-0828

58 Treat MDR-TB Patients

DATE

4/26/08

MODULE C

Case 3

REP U

National Tuberculosis Program

S NE PI

F THE PHI LIP IC O BL

Programmatic Management of Drug - Resistant TB (PMDT)

CONSILIUMEX

Category IV Registration No:

GENERAL INFORMATION: NAME

Sansalido

AGE

Laura (Last)

SEX

Aman (First)

(Middle)

WEIGHT ON SCREENING

KGS

2425 Buendia St. Brgy. Pinoy, Tondo, Manila

METRO MANILA ADDRESS

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

1234 Jollie Bee St. San Jose Batangas

PERMANENT ADDRESS

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

Region IV-A

REGION

TDF-MMC DOTS Clinic

TREATMENT CENTER

Dave Verzosa, MD

MD IN CHARGE

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

2006 – 2HRZE/ 2 HR (defaulted) RAD

CHEST X-RAY RESULTS 2/20/07 - PTB Cavitary, RUL, with bilateral lung infiltrdates NAME OF OTHER LABORATORY

DATE DST RELEASED

DST RESULT

Resistant to:

Susceptible to:

CULTURE CENTER (Screening)

TDFI

DST CENTER (Screening)

TDFI

DATE DST RELEASED 8/08/08

DST RESULT (Screening)

Resistant to:

Susceptible to: Z Km Cfx Ofx Lfx

DATE SPECIMEN COLLECTED

HRES

DST RESULT (Baseline) Resistant to: Note: to be filled in once available

3/20/08

Susceptible to:

WEIGHT MONITORING: (TO BE CONSTANTLY UPDATED EVERY CONSILIUM MEETING BY THE SECRETARIAT) CONSILIUM DISCUSSION 001 (E) 002 003 004 005

DATE

WEIGHT (KGS)

8/15/08

CONSILIUM DISCUSSION

DATE

WEIGHT (KGS)

006 007 008 009 010 (TO)

Treat MDR-TB Patients

MODULE C

CONSILIUM DISCUSSIONS CONSILIUM DISCUSSION 001 – RECOMMENDATION ON ENROLMENT REGIMEN RECOMMENDED REGIMEN AND DRUG INTRODUCTION GUIDE: 32

KGS

REGIMEN

SYMBOL

DAY 1

DAY 2

DAY 3

DAY 4

DAY 5

DAY 6

DAY 7

Cycloserine

1 cap

2 caps

Prothionamide

Pto

1 tab

2 tabs

PASER

PAS

1 sachet

2 sachets

LATEST WEIGHT SECOND-LINE DRUG

Z Km Ofx Pto Cs

MD IN CHARGE

DAV

DRUGS IN REGIMEN (USE SYMBOL)

PREPARATION

NO. OF UNITS PER DAY

500mg

2 tabs

750mg

Ofx

200mg

3 tabs

Pto

250mg

2 tabs

250mg

2 caps

COMMENTS: CONSILIUM OFFICER

Dr. Ruth O. Chi

Treatment start date: 11/23/08 Category IV Registration No: 01-08-0032 March 8, 2008 – DSSM (3+) TBC (MTB), Laboratory No. 01-T-08-3128 DSSM (3+) TBC (MTB)

When you have finished this exercise, notify a facilitator and review your answer with them.

Then read until the next exercise.

60 Treat MDR-TB Patients

DATE

8/15/08

MODULE C

After preparing the Category IV Treatment Card, the next step is drug preparation.

1.9 Obtain a drug packet for the patient Obtain the drug packet earlier prepared by the Treatment Center pharmacist from the patient’s plastic folder containing his chart. Each drug packet contains the patient’s daily dose of the treatment ready for administration excluding PASER and the injectable, if part of the regimen. Everyday a drug packet will always be placed inside the plastic folder for each patient. Be sure that you have obtained the correct regimen, with the required drugs and total number of doses specified on the drug dosage chart.

See Module F: Manage Drugs and Supplies for MDR-TB for more information about how and when to prepare the necessary drugs.

1.9.1 Inform the patient about the different drugs in the treatment regimen Inform the patient about the anti-TB drugs he will receive using the Drug Flip Chart. A copy of this patient education tool can be found in the Reference Booklet. You should inform the patient about the different drugs to be used, the dose (number of pills) frequency and possible side effects or drug reactions. This task is described in more detail in module D: Inform Patient about MDR-TB.

Treat MDR-TB Patients

MODULE C

2. Supervise the patient during the entire period of treatment 2.1 Directly observe each treatment and record on the Category IV Treatment Card Supervise the patient’s intake of anti-TB drugs every day. This means that at every appointment a health worker must observe the patient actually swallow the drug. You must ensure that the patient swallows each of the drugs. When health workers just give the drugs to patients but do not watch patients swallow them, the patients may take some but not all of the drugs, sell some of the drugs, save them for later, or forget taking all the drugs, etc.

The primary way to prevent transmission of MDR-TB to health workers and others at the health facility is for MDR-TB patients to take their drugs regularly. They will generally then become non-infectious in one or two months. Good ventilation in the place where treatment is provided is also important.

When supervising treatment, make it quick and easy for the MDR-TB patient. Do not make MDR-TB patients wait in line at the MDR-TB facility. Prioritize MDR-TB patients once they arrive. All health care workers must understand that because of the patient’s condition, making them wait is not acceptable and smear-positive MDR-TB patients should be treated as quickly as possible to reduce the risk of transmission of drug-resistant strains. Any delays discourage MDR-TB patients from continuing treatment.

2.1.1 Receive the MDR-TB patient each day Greet the patient using his name and ask how he feels or if he experienced any adverse reaction since the last dose, personal or social problems, etc. If there is a problem that you cannot resolve, refer the patient to a Treatment Center or Treatment Site physician or the psychosocial team as necessary. Should there be a need for further management by specialists, this will be coordinated by the physician in the Treatment Center. See Section 3 if there are drug reactions being experienced.

2.1.2 Administer and directly observe the patient take anti-TB drugs The steps involved in administering DOT to an MDR-TB patient are described on the next page.

62 Treat MDR-TB Patients

MODULE C

Box 2: How to supervise MDR-TB treatment 1. Greet the patient in a cordial manner, addressing the patient by his or her name. Offer a seat if available. Ask if he experienced any adverse reaction since the last dose, personal or social problems, etc. 2. Receive the PMDT Patient’s Booklet from the patient. 3. Take out the corresponding Category IV Treatment Card for the patient. 4. If the patient becomes nauseated, suggest taking the drugs with food, like a candy. 5. Open the patient’s packet of medications for the day from the patient’s plastic chart. Check the prepacked medications against the Category IV Treatment Card for accuracy before giving it to the patient. 6. Put the tablets or capsules into the patient’s medicine cup and then watch the patient swallow the tablets. If it is difficult to swallow them one after the other, the patient may pause briefly. The drugs must be taken in one sitting. yy

Ensure that PASER is taken properly with an acidic medium following the steps below: ––

Pour acidic juice into clear glass or any wide-mouthed bowl. Acidic juice could be calamansi, pineapple, orange and apple juice. Please take note that water, coconut juice, iced tea and other non-acidic juice are not appropriate for PASER.

––

Pour the PASER granules into the glass of juice. The granules will not dissolve in the juice.

––

Swirl and sip the mixture using a straw with the appropriate diameter ensuring that all PASER granules are ingested by the patient.

PASER mixed with the acidic medium yy

Ensure that fluoroquinolones are not taken within two to three hours of a meal containing milk or any product with calcium, magnesium, aluminum and iron. Examples of this are antacids and nutritional supplements.

7. If the patient’s regimen includes an injectable, use a sterile needle and syringe. Check the Category IV Treatment Card for the correct dose of the injectable agent. See Module F: Manage Drugs and Supplies for MDR-TB for the preparation of specific injectables. 8. Appreciate the patient for continuing treatment and remind him when to come in for the next dose by writing this on the PMDT Patient’s Booklet. 9. Document the supervised dose on page 3 the Category IV Treatment Card. Treat MDR-TB Patients

MODULE C

2.1.3

Mark the Category IV Treatment Card for each supervised treatment

On the first day that you give supervised treatment, begin marking treatment administered on the “Administration of Drugs” section on page 3 of the Category IV Treatment Card. In the table on page 65, the numbers on the top row represent the days of the month. Each row represents one month. Write the month and year when the patient started treatment on the leftmost column and the months following in the succeeding rows. Affix your initials on the days when you supervised a patient take his medicines. For example, if the first day of treatment is October 24, 2005, write Oct ‘05 in the first column and your initials under 24 of this row. When you put your initials on the Category IV Treatment Card you are affirming that the patient took all the drugs under your supervision on that day. If there are no initials on a particular date, it will mean that the drugs were not taken. The health worker must not forget to affix his initials as soon as he administered the drugs otherwise, he will forget which patients he actually supervised. Use the following marks to update the patient’s Category IV Treatment Card. •

Three letter initials after drug administration Each day that you observe the patient swallowing the drugs, affix three-letter initials on the box representing the date.

•

“X“ for missed doses If the patient does not come for a treatment, put an “X” under that date to indicate that a dose was missed.

•

“I” for incomplete doses If a patient only takes some of the drugs, write an “I” in the appropriate box for “incomplete”.

•

“H” for drug holidays Sundays and holidays will have an “H” mark on the box indicating that no dose was required.

•

“TS” if drug administration was done at a Treatment Site For patients who are decentralized to Treatment Sites, “TS” will be written in pencil on the Treatment Center copy of the Category IV Treatment Card on the days that the patient is believed to be taking the drugs at the Treatment Site. Since this needs confirmation during the patient’s next visit at the Treatment Center, the staff will verify using the PMDT Patient’s Booklet (see example on page 71) whether the patient indeed took the drugs at the Treatment Site. This can also be confirmed through monitoring by telephone (described in section 2.1.6). Once verified, the staff overwrites the “TS” written in pencil with ink. If the patient missed a dose, overwrite it with an “X“.

•

“TC” if drug administration was done at a Treatment Center Similarly, on the days the patient is scheduled to report at the Treatment Center, “TC” will be written on the Treatment Site copy of the Category IV Treatment Card. The TS staff can verify if indeed the patient went to the Treatment Center by checking the PMDT Patient’s Booklet. Sometimes a patient will not be able to come for supervised treatment for a day or more because of a conflict such as travel or a funeral. This will be counted as an absence and should be avoided to the extent possible while the patient is under treatment. Under no circumstances will drugs be given to a patient for self-administered treatment. Rather, the missed doses on these absences will be made up at the supposed end of treatment.

Some patients may not understand this policy for MDR-TB treatment. It is vital that you explain why supervised treatment is so important and that they must comply strictly with MDR-TB treatment as it may represent their last opportunity to be cured of the disease. Explain to the patient that it is impossible for a health worker to decide which patients have valid reasons to bring home their medicines for self administration. Some patients may have valid reasons, while others will make up reasons to avoid going to the health center. Experience at MMC/TDF has shown that if one patient is allowed to self administer, other patients will demand that they also be given the chance for the same or different reasons. For a health worker level, it is impossible to determine which reasons are to be considered as valid and which are not. Explain that in many countries all over the world supervised treatment is shown to have much higher chances of curing patients. These are rules for the benefit of the patient and since treatment for MDR-TB is often a last resort, is an expensive and long process, every measure must be taken to ensure that the treatment is a success. This discussion should be conducted with utmost respect for the patient, emphasizing the fact that our ultimate concern is for his cure. 64 Treat MDR-TB Patients

NMB

Dec-05

Jan-06

Feb-06

Apr-06

May-06

NMB

TRC

NMB

TRC

NMB

IBL

Treat MDR-TB Patients

NMB

Note: Encircle date of regimen change

X = drugs not taken / Absent I = incomplete regimen H = Sunday/ Holiday

MARK IN THE BOXES: Initials of HW (3 letters)=Supervised TC/TS= Treatment Center/ Site DOT

TRC

Mar-06

TRC

NMB

TRC

NMB

TRC

NMB

IBL

NMB

TRC

NMB

10/21/05

10/21/06

12th mo 10/21/06

7/21/2006

9th mo

4/21/2006

ABG

NMB

Schedule

NMB

1/21/2006 4/21/2006

TRC

NMB

HW initials

NMB

6th mo

10/21/05

(√) if done

NMB

TRC

3rd mo

Baseline

Schedule

CXR

Missed doses on November 9, 10, 2005

NMB

TRC

NMB

TRC

NMB

TRC

NMB

NMB NMB

NMB

TRC

NMB

(√) if done

Blood chemistry

CPR

HW initials

24th mo

21st mo

18th mo

15th mo

NMB

Presumed to be taking his drugs at the Treatment Site, to be validated during Treatment Center visit using the PMDT Patient’s Booklet.

TRC

NMB

7 NMB

NMB

Oct-05

Nov-05

Month / Year

1023/07

4/23/2007

Schedule

TRC

NMB

TRC

NMB

54.9

54.6

52.1

51.3

49.1

49.2

31 Wt (Kg)

(√) if done

CXR HW initials

7/21/2007

4/23/2007

1/21/2007

Schedule

1023/07

F THE PHI LIP IC O BL

REP U

(√) if done

HW initials

173

Blood chemistry

173 0

148

123

100

Monthly Cumulative # of doses taken doses taken

October 24, 2005 was the start of Treatment.

NMB

IBL

NMB

Category IV Registration No.

ADMINISTRATION OF DRUGS (one line per month) Patient name:

Programmatic Management of Drug - Resistant TB (PMDT)

Category IV Treatment Card | page 3 of 4

Example of page 3 Category IV Treatment Card S NE PI

MODULE C

If a patient misses a scheduled day but comes the next day, give the patient only one day’s drugs to take in front of you. Do not give a double dose. Since the patient must complete a certain number of doses, each missed dose will delay or extend the completion of the phase and the overall treatment by a day.

2.1.4 Record changes to the drug regimen on the Category IV Treatment Card During the course of treatment for MDR-TB, a patient’s regimen may be changed. This can be due to: •

An increase or decrease in weight

•

Discontinuation of the injectable agent during continuation phase

•

A change in the DST pattern

•

An ADR

•

Failure or non-conversion to negative bacteriology

The change in regimen must always be approved by the Consilium although in emergency situations such as a severe ADR, the attending physicians may order the regimen changed immediately and present it in the next consilium meeting. Document every change in regimen. This provides an easy way to track when a change takes place. Any regimen change, including discontinuation of a drug or change in dose, must be reflected on both page 2 of the Category IV Treatment Card under “Category IV Regimen”, and page 3, under “Administration of Drugs”. On page 2 of the Card, write the date when the regimen or change in the regimen was administered and the changed number of tablets or grams of the injectable. The date under “Comments” at the bottom of page 2 must correspond to the date the change in the regimen was actually done as encircled in the upper box portion of the page. On page 3 of the Card, encircle the date when the revision was made. On the following pages, different examples on how to fill out the Category IV Treatment Card are provided. Refer to the completed page 2 or “Category IV Regimen” section of the Treatment Card and page 3 or “Administration of Drugs” section, in the next few pages which are used to illustrate the examples given below.

2.1.5 Weigh the patient monthly, and report any significant change in weight to the physician for dose adjustment Many times, weight gain can be a sign of improvement for TB patients and weight loss may signify that there is a problem. Every month, weigh the patient to track progress. The dose of the medications may need to be altered if there is significant weight gain or loss. On page 3 of the Category IV Treatment Card under “Administration of Drugs”, document the patient’s weight on the column marked “weight (kg)” for each month. If there is a need to change the dose, the physician will order the change in dose, complete the Category IV Treatment Card as described in the example 1 on the following pages. Example 1. Change in dosage of drugs due to increase in weight Example 2. Discontinuation of a drug due to ADR Example 3. Discontinuation of a drug due to severe ADR with replacement of a new drug Example 4. Discontinuation of an injectable to shift to continuation phase Example 1: Change in dosage of drugs The patient’s weight was documented to have increased from 49.2 kg to 51.3 kg during the monthly monitoring on December 27, 2005 as shown on page 3 of the Category IV Treatment Card. As indicated in Annex A: Recommended dosages of anti-TB drugs, this warrants a change in the dose. Hence, on page 2 of the Category IV Treatment Card on page 68, the second row indicates that on December 27, Z was increased from 3 to 4 tablets, Km from 750 mg to 1000 mg, Pto/Eto from 2 to 3 tablets and Cs from 2 to 3 capsules. In the box for “Comments”, the reason for the change is documented. On page 3 of this Category IV Treatment Card, on page 69, further below, the cell corresponding to December 27 is encircled.

66 Treat MDR-TB Patients

MODULE C

Example 2. Discontinue the drug due to ADR On January 2-4, 2006, the patient incurred absences from supervised treatment due to joint pains (see page 69). It was noted that he had hyperuricemia; hence, on January 10, Z was discontinued as noted on page 68. On page 2 of the Card under “Category IV Regimen”, the box under Z contain an “X” indicating the discontinuation of that drug. The rest of the drugs remain the same. In the box for “Comments”, the reason for the change is documented. On page 3 of the Card, the cell corresponding to January 10 is encircled. Example 3. Discontinue the drug due to severe ADR with replacement of a new drug On March 16-18, 2006, the patient again incurred absences. Note the (“X“) on the boxes corresponding to these dates on page 3 of the Category IV Treatment Card. It was learned that he had been depressed and quiet the previous days, with decreased appetite. On March 17, he was shouting in his room and was found to have slashed his wrist using a kitchen knife. This was known by the Treatment Center during the home visit where the patient was immediately referred for psychosocial and medical care. He came on March 20 where Cs was discontinued. On page 2 of the Treatment Card, Cs has an “X” indicating that this drug has been discontinued. To maintain four reliable drugs, PASER 2 sachets were added. In the box for “Comments”, the reason for the change is documented. On page 3 of the Card, the cell corresponding to March 20 is encircled. Regimen change is also done with or without a replacement drug whenever a new DST shows that drugs are ineffective owing to resistance of the TB bacilli. Example 4. Discontinue the injectable during the shift to continuation phase The patient completed 156 doses of the injectable on May 9, 2006 as can be deduced from the last column of the form on page 69. Hence, on May 10, the injectable was discontinued to mark the start of continuation phase. In the box for “Comments” on page 70, the reason for the change is documented. Note that the other requirement for shifting to continuation phase is at least 4 consecutive months of negative culture which the patient has achieved as shown on page 4 of the Category IV Treatment Card . See page 50.

Treat MDR-TB Patients

12/27/05 1/10/06 3/20/06 5/10/06

Date

5/10/06

3/20/06

01/10/06

12/27/05

10/23/05

DATE

DRUG Preparation

300 mg

500 mg

0.75

Comments

400 mg

E 1G

Km 1G

Am 1G

200 mg

Ofx

Balagtas, Jose A

increase dose of Z, Km, Pto and Cs due to inc. in wt. d/c Z due to joint pains and hyperuricemia d/c Cs due to suicidal attempt and add PASER d/c Km, start continuation phase

CATEGORY IV REGIMEN (date started and dosage) Patient name: change of dosage and cessation of drugs:

Category IV Treatment Card | page 2 of 4

Lfx 500 mg

Date

500 mg

Cfx 400 mg

Mfx 400 mg

Gfx

250 mg

Pto/ Eto

2 2

Pas

Comments

250 mg

Others

REP U

Others

02-05-0097

500 mg

Clr

Category IV Registration No.

Programmatic Management of Drug - Resistant TB (PMDT)

F THE PHI LIP IC O BL

S NE PI

NMB

Dec-05

Jan-06

Feb-06

Apr-06

May-06

NMB

TRC

NMB

TRC

NMB

IBL

Treat MDR-TB Patients

NMB

Note: Encircle date of regimen change

X = drugs not taken / Absent I = incomplete regimen H = Sunday/ Holiday

MARK IN THE BOXES: Initials of HW (3 letters)=Supervised TC/TS= Treatment Center/ Site DOT

TRC

Mar-06

TRC

NMB

TRC

NMB

TRC

NMB

IBL

NMB

TRC

NMB

TRC

NMB

10/21/05 1/21/2006 4/21/2006 7/21/2006 10/21/06

Baseline

3rd mo

6th mo

9th mo

12th mo

Schedule

(√) if done

CXR

Note: Encircle date of regimen change

TRC

NMB

ABG

HW initials

TC/TS = Treatment Center/ Site DOT X = Drugs not taken / Absent I = Incomplete regimen H = Sunday/holiday

MARK IN THE BOXES: Initials of HW (3 letters=Supervised)

NMB

10/21/06

7/21/2006

4/21/2006

1/21/2006

10/21/05

Schedule

NMB

TRC

NMB

TRC

(√) if done

NMB

TRC

CPR

HW initials

NMB

Blood chemistry

TRC

NMB

NMB NMB

NMB

24th mo

21st mo

18th mo

15th mo

TRC

NMB

TRC

NMB

7 NMB

NMB

Oct-05

Nov-05

Month / Year

ADMINISTRATION OF DRUGS (one line per month) Patient name: Balagtas, Jose A

Category IV Treatment Card | page 3 of 4

Treatment Card (Page 3)

1023/07

7/27/2007

4/23/2007

1/21/2007

Schedule

TRC

NMB

TRC

NMB

27 NMB

NMB

(√) if done

CXR

NMB

IBL

NMB

7/21/2007

4/23/2007

1/21/2007

1023/07

REP U

(√) if done

HW initials

173

Blood chemistry

173 0

148

123

100

Monthly Cumulative # of doses taken doses taken

Schedule

54.9

54.6

52.1

51.3

49.1

49.2

31 Wt (Kg)

HW initials

NMB

Category IV Registration No. 02-05-0097

Programmatic Management of Drug - Resistant TB (PMDT)

F THE PHI LIP IC O BL

S NE PI

MODULE C

2.1.6 Sign the PMDT Patient’s Booklet, write the date of the next appointment, remind the patient to return for the next appointment. The PMDT Patient’s Booklet is used to remind the patient of the next appointment as well as to show the examinations that are due to be done and the results of these examinations, including any significant event occurring during the visit at either the Treatment Center or Treatment Site. This will allow both facilities to know the status of the patient. Transfer significant information written on this card to your copy of the Category IV Treatment Card whether you are based at the Treatment Center or Treatment Site. You must sign the PMDT Patient’s Booklet every day that the patient comes in for treatment and return the card to him with the date of the next appointment and other instructions. For most patients this will be the following day, or Monday. In the case of patients that have already been decentralized, the patient visits the Treatment Center once a week (on Saturdays) if a community-based DOT has not been arranged, or monthly for follow-up with the Treatment Center MD otherwise. If you work at a Treatment Site, check the PMDT Patient’s Booklet to confirm the compliance at the Treatment Center weekly and to check other updates.

70 Treat MDR-TB Patients

MODULE C

Example of the PMDT Patient’s Booklet

PMDT Patient’s Booklet Patient name:

Balagtas, Jose A

Category IV Registration No. Exam/s due

Results

05-05-0097

Date

Regimen

Signature

Others/ Remarks

10/24/05

ZKm Ofx PtoCs

NMB

10/25/05

ZKm Ofx PtoCs

NMB

Nausea/ vomiting / reassured, ice chips

10/26/05

ZKm Ofx PtoCs

TRC

n/v, epigastric pain/ Rx paracetamol, antacid

10/27/05

ZKm Ofx PtoCs

NMB

10/28/05

ZKm Ofx PtoCs

NMB

n/v, epigastric pain, fever

10/29/05

ZKm Ofx PtoCs

NMB

nausea persistent, relieved epigastric pain

10/31/05

ZKm Ofx PtoCs

NMB

11/01/05

ZKm Ofx PtoCs

NMB

11/01/05

ZKm Ofx PtoCs

NMB

11/02/05

ZKm Ofx PtoCs

NMB

11/03/05

ZKm Ofx PtoCs

TRC

11/05/05

ZKm Ofx PtoCs

NMB

11/07/05

ZKm Ofx PtoCs

NMB

11/08/05

ZKm Ofx PtoCs

TRC

nausea

2.1.7 Mark the patient’s name on the Daily Attendance Sheet The Daily Attendance Sheet is a tool to track patient adherence. It is filled out by the Treatment Center staff at the end of each clinic day marking with a dot ( l ) the patients who did not actually arrive at the Treatment Center. Patients who came are marked with a check ( 3 ). If, at the end of the day, you notice that a patient has not come in for treatment, all efforts must be made to contact him to find out the reason for the absence and ensure that no further doses are missed. Refer to Module E: Ensure Continuation of MDR-TB Treatment for more information.

Treat MDR-TB Patients

72 Treat MDR-TB Patients

Balagtas, Jose

02 - 05 - 0097

Legend:

( l ) = Absent

Andoy, Anita

02 - 05 - 0096

( / ) = Present

Santos, Edna

02 - 05 - 0095

Kabayan, Narciso

Malapit, Brendon

02 - 05 - 0093

02 - 05 - 0094

Lopez, Jun

02 - 05 - 0093

Garcia, Edwin

Patient name

02 - 05 - 0092

Registration No.

Category IV

W TH F

TS TS TS TS TS

W TH F

TS TS TS TS TS

The patient was absent on this day and on all days with dots ( l ).

W TH F

REP U

TS TS TS TS TS

The patient was supervised in PTSI-QI Housing Facility.

TS TS TS TS TS

W TH F

10 11 12 14 15 16 17 18 19 21 22 23 24 25 26 28 29 30 31

W TH F

TS TS TS TS TS

F THE PHI LIP IC O BL

S NE PI

NO.

Month and Year

Category IV Daily Attendance Sheet

(PMDT)

Programmatic Management of Drug - Resistant TB

11/21-26/07 confined in QI

c/o treatment site

REMARKS

MODULE C

An example of the Daily Attendance Sheet is shown below. A check means that the patient took the drugs under supervised treatment at the Treatment Center; an “X” means that he failed to visit the Treatment Center; and “QI” for this case means that he took meds at the KASAKA-QI MDR-TB Housing Facility.

Daily Attendance Sheet

MODULE C

2.2 Continue providing information about MDR-TB As you continue to see a patient daily to supervise treatment, continue to reinforce messages about MDR-TB treatment. Give support for the patient to continue taking the drugs on schedule and to complete all the required doses. The patient should be informed about the dangers of irregular or incomplete treatment. (See Module D: Inform Patients about MDR-TB.) Review the following information with the patient daily or whenever necessary during the intensive phase and once a month during the continuation phase: •

How the patient is coping with the drugs and the adverse reactions he is experiencing

•

If the patient has any questions, concerns or doubts

•

Importance of continuing treatment

•

Type, color, quantity of drugs, and frequency of dosing

•

Frequency and importance of required sputum examinations and the meaning of results

•

Consequence if the patient takes only some of the drugs or stops treatment

2.3 Review the PMDT Patient’s Booklet weekly or whenever the patient visits and update the Treatment Center copy of the Category IV Treatment Card All patients will begin receiving MDR-TB treatment at the Treatment Centers and the duplicate Category IV Treatment Card will be brought to the Treatment Site once a patient is decentralized (see Module E: Ensure Continuation of MDRTB Treatment). He will receive treatment at a local Treatment Site usually 5 days a week. The sixth day (Saturday) and holidays will continue to be at the Treatment Center unless a barangay health worker or volunteer arranges a home visit to the patient on Saturdays. If you work at the Treatment Center you will receive the PMDT Patient’s Booklet when he visits on Saturdays and holidays or monthly during his regular check up with the physician. This card documents the patient’s adherence, and problems encountered during his Treatment Site visits and needs to be reviewed. If the patient is irregular in his attendance, reinforce the importance of adherence to treatment and the consequences of missing doses. Coordinate with the Treatment Site to correct the problem. See Module E: Ensure Continuation of MDR-TB Treatment for a discussion of strategies for problem solving with patients with irregular intake of drugs.

Treat MDR-TB Patients

MODULE C

3. Monitor the patient for adverse drug reactions MDR-TB treatment involves the use of multiple drugs and many patients may experience difficulties or drug intolerance. The health care personnel cannot predict if the patient will experience an adverse drug reaction to an anti-TB drug. The use of a drug should not be restricted because of the reaction it might have. Some elderly patients or patients who are seriously ill may tolerate the medications well. However, others could have serious problems with relatively simple regimens. Timely detection and adequate management of ADRs are vital for a successful treatment outcome. Most ADRs occur during the first few months of treatment. Some ADRs resolve after some time, others can be treated with drugs according to the symptoms experienced by the patient. In general, the ADR should be treated and the patient should be encouraged to tolerate these effects until they resolve by themselves. Experiencing ADRs is one of the main reasons for defaulting, and some patients may need additional support especially at the beginning of treatment when ADRs can be intense.

3.1 Continuously assess the patient for adverse drug reactions Most MDR-TB patients complete their treatment without any serious ADRs. However, most patients will experience some mild ADRs during treatment and the proper management of these side effects is vital to successful outcomes. Monitor side effects by: • asking patients to report problems as they develop. • asking patients daily to determine whether they have developed any side effects. Prior to giving the patient his daily dose, ask the patient how he is feeling. Listen carefully to his answer and note for any complaints that may indicate side effects of the anti-TB drugs. Observe also for any signs of ADRs. An ADR may be minor or may be serious. If the patient has minor side effects, continue giving anti-TB drugs. Review the table on pages 77–79 to help identify when to continue, modify or discontinue drugs. Reassure the patient and give advice on how to relieve the symptoms. Bear in mind that side effects are more common in HIV-infected people, in the elderly and in those with co-morbidities.

3.2 Document ADRs on the Patient’s Progress Report Form All ADRs, default, and other significant events related to the patient’s treatment, actions or interventions taken by the Treatment Center, and the staff responsible must be documented on the Patient’s Progress Report Form. You should write down the type of problem the patient experienced such as an adverse event and the suspected drug, or absence from supervised treatment, and the action taken such as giving an ancillary drug or making a home visit. An example of the Patient’s Progress Report Form is shown on the following page.

74 Treat MDR-TB Patients

11/12/05

11/11/05

10/29/05

10/28/05

10/26/05

10/25/05

Date

Reassured, Rx Paracetamol q 4 hrs., antacid

Continue paracetamol, antacid

n/v, epigastric pain, fever

E p i g a s t r i c p a i n m o re severe, nausea relieved

Rx. Lansoprazole, advised to avoid acidic drinks

Rx NSAID

Absent due to joint pains (11/9-10/07)

Hyperurecimia

For Uric acid test

vomiting relieved, slightly relieved epigastric pain and nausea persistent.

D/C Paracetamol, reassured, Rx metoclopramide

Reassured, ice chips

Intervention

Nausea and vomiting (n/v)

Problem (ADR, Default, Others)

KASAKA QI

Balagtas, Jose A

Treatment facility:

Name:

Pto, Z

Pto

Suspect drug

REP U

Leave this column blank if the reason for default is other than ADR

ff-up if symptoms persist

for ff-up

ff-up if symptoms persist

Remarks

Category IV Registration No.

Patient’s Progress Report Form

Programmatic Management of Drug - Resistant TB (PMDT)

F THE PHI LIP IC O BL

S NE PI

Treat MDR-TB Patients

05-05-0097

TRC

DAV

NMB

DAV

NMB

Staff

MODULE C

3.3 Explain the probable cause of ADR and the action to be taken to the patient When a patient experiences an ADR he may be scared or frightened or may want to discontinue the TB drugs. Discuss with the patient the possible reasons for the ADR and what steps can be taken to try to alleviate the problem. For minor ADR’s Treatment Site physician can give symptomatic relief as indicated in the table on the next page. Explain to the patient that when necessary, even with some persisting ADRs, he still needs to continue taking the drugs to prevent increased drug resistance and possibly death. Ancillary drugs or advice on non-pharmacologic measures to counteract the ADRs and assist the patient to tolerate the ADRs to the extent possible needs to be given. If the patient continues to complain about a minor side-effect even after following the advice, refer the patient to the Treatment Center physician for a follow-up examination.

3.4 Perform intervention for mild adverse drug reactions and document all actions taken on Category IV Treatment Card For mild ADRs, there are steps that you can take to help the MDR-TB patient continue taking the drugs. In table 4 on the following page, a number of common minor ADR are listed along with how to manage them and the suspect drugs causing them. There are some ancillary drugs that can help alleviate mild ADRs but in general, patients must tolerate them in the hope that they will soon disappear.

76 Treat MDR-TB Patients

MODULE C

Table 4 Mild ADR

Adverse Reactions

Suspected Agents

Suggested Management

Anorexia

Z, Eto/Pto, FQ

Appetite stimulant, eg. pizotifen

Arthralgias

Z, FQ

Non steroidal anti- inflammatory drugs(NSAID), paracetamol, exercise therapy

Change in behavior (talkativeness, irritability)

Cs, Ofx

Haloperidol Pyridoxine 50mg per 250 mg of Cs up to 200 mg/day as maximum

Cutaneous reactions

H, R, Z, E, Eto/Pto, Cs, PAS, S and other aminoglycosides

Antihistamines Hydrocortisone creams

Depression

Cs,H, FQ, Eto/Pto

Selective serotonin reuptake inhibitors (fluoxetine, sertraline), tricyclic antidepressants (amitriptyline)

Diarrhea

PAS

Rehydration Loperamide

Excessive salivation

Eto/Pto

Ice chips,metoclopromide

Flu like syndrome

Paracetamol

Gastritis

PAS, Eto/Pto

Antacids (eg. Calcium carbonate, H2 blockers, proton pump inhibitors)

Gynecomastia

Eto/Pto

Reassurance, surveillance

Headaches

Eto/Pto

Non steroidal anti- inflammatory drugs(NSAID), paracetamol, exercise therapy

Insomnia

Antihistamine, zolpidem

Metallic taste

Eto/Pto

assurance

Musculoskeletal pain

No specific drug

Non steroidal anti- inflammatory drugs(NSAID), paracetamol

Nausea and vomiting Olfactory hallucination

Eto/Pto, PAS, R H, Z, E, FQ

Rehydration Metclopromide Divide dose (AM & PM) as long as supervised

Eto/Pto

reassurance

Peripheral Neuropathy

INH, Cs, S, Km, Eto/Pto, FQ

Increase pyridoxine to maximum daily dose (200 mg/day) Tricyclic antidepressants such as amitriptyline

Pain at injection site

S, Km, Am, Cm

Cold compress

Photophobia

Eto/Pto

reassurance

Vertigo/dizziness

S, Km, Cm, Eto/Pto

Betahistine, Cinnarizine

Treat MDR-TB Patients

MODULE C

3.5 Make referral to Treatment Center physician as necessary for moderate or severe ADRs If a patient has one of the moderate to severe ADRs listed in table 4, a physician should examine the patient immediately to take proper action. Refer the patient to a physician at the Treatment Center for care and follow-up. Table 5 Moderate to Severe ADRs

Adverse Reactions Acute renal failure

Suspected Agents S, Km, Am, Cm

Suggested Management • • • •

Discontinue suspect drug. Consider using Cm if an aminoglycoside had been the prior injectable in the regimen. Consider dosing 2 to 3 times a week if drug is essential to the regimen and patient can tolerate (close monitoring of creatinine). Adjust the dose according to creatinine clearance. See Annex A: Recommended Dosages.

Bartter-like syndrome (decrease in serum potassium, magnesium and calcium)

Cm, Km, Am, S

• •

Check electrolytes (K, Mg, Ca). Replace electrolytes as needed.

Generalized hypersensitivity (Stevens-Johnson syndrome)

Any drug

•

Withdrawal of the drugs and refer to specialist.

Hearing loss

S, Km, Am, Cm, Clr

•

Document hearing loss and compare with baseline audiometry if available. change parenteral treatment to Cm if appropriate (no resistance confirmed or suspected). Increase frequency and/or lower dose of suspected agent if this can be done without compromising the regimen. Discontinue suspected agent if this can be done without compromising the regimen.

• • • Hemolysis

•

Discontinue drug and referral to specialist

Hepatitis/jaundice

Z, H, R, Eto/Pto, PAS, E, FQ

•

Discontinue therapy pending resolution of hepatitis. Eliminate other potential causes of hepatitis. Consider suspending most likely agent permanently. Reintroduce remaining drugs, one at a time with the most hepatotoxic agent first, while monitoring liver function.

• •

Hypothyroidism

PAS, Eto/Pto

•

Initiate thyroxine therapy.

Intractable vomiting

Eto/Pto, PAS, H, E, Z

•

Assess for dehydration, initiate rehydration if indicated. Divide the dose (AM and PM) as long as it is supervised. Discontiue suspected agent if this can be done without compromising the regimen.

• • Optic neuritis

78 Treat MDR-TB Patients

•

Discontinue drug and refer to ophthalmologist.

MODULE C

Adverse Reactions Psychosis/psychotic symptoms (violent/suicidal tendencies)

Suspected Agents Cs, H

Suggested Management • • •

Discontinue suspected agent for a short period of time (1-4 weeks) while psychotic symptoms are brought under control. Antipsychotic treatment, referral to psychiatrist. Lower the dose of suspected agent if this can be done without compromising regimen.

Purpura

•

Discontinue drug and refer to specialist

Seizures

Cs, H, FQ

•

Discontinue suspected agents pending resolution of seizures. Anticonvulsant therapy (phenytoin, valproic acid). Discontinue suspected agent if this can be done without compromising regimen.

• •

The main objective is to identify these possible reactions, detect them in an early stage and refer the patient to Treatment Center physician for study and further action. **Note: Dose adjustments or drug withdrawal must always be done at the Treatment Center. The preceding tables summarize the adverse drug reactions during treatment. It can also serve as a guide to the health worker as to whether anti-TB drugs will be discontinued or not. The drugs in bold font are more strongly associated with the adverse effect than the other drugs not in the group. There are a number of measures that can be taken for patients with ADRs in general. •

Since most ADRs occurring most frequently during the early months of treatment diminish with time, informing patients of this fact reassures them.

•

Giving small doses of the oral SLDs then slowly increasing the dose until the full recommended dosages are reached. For example, for a patient requiring 3 tablets of Pto, give 1 tablet each for 3 days, then 2 tablets for the next 3 days then 3 tablets thereafter. The same can be followed for Cycloserine and PAS.

•

Giving of ancillary drugs for symptomatic treatment, e.g., an anti-emetic for nausea, or a pain reliever for arthralgia, is a necessary step in most patients.

•

Splitting the dose into morning and afternoon dosages is an alternative for the Pto, Cs and PAS as long as both doses are supervised either at a Treatment Center or by atrained health worker during home-based supervised therapy. Splitting of doses is not applicable to Z, E and the FQs.

•

Reducing the drug dose to the lower acceptable limit, may be an alternative. Refer to Annex A for the dose range of certain drugs.

•

Withdrawal of the drug may be done as long as it does not compromise the regimen, i.e., still four reliable drugs are included; otherwise, another drug should be given as a replacement. Discontinuing a drug should be done as a last resort measure.

It is important to be aware that without an adequate regimen MDR-TB mortality is very high and in cases in which there is resistance to multiple drugs, and therefore only a few drugs are effective, to stop using one of them may result in treatment failure. Reminder: If at any time you observe that a patient’s condition has significantly worsened, refer the patient to a physician at the Treatment Center for further assessment and treatment.

Treat MDR-TB Patients

MODULE C

3.6 Propose a regimen change and present this to the Consilium using the Consilumex After the Treatment Center physician has evaluated the MDR-TB to require a change in regimen or dose patient, he will present the case and the proposed change to the Consilium using the Consiliumex. Generally, the Consilium approves regimen changes. The following are examples of Consilium decisions made for a dosage change due to an increase in weight, and for drug discontinuation due to a serious ADR, and drug replacement.

CONSILIUM DISCUSSION 002 – RECOMMENDATION FOR CASE MANAGEMENT AND/OR CHANGE IN REGIMEN TREATMENT AND RECOMMENDED CHANGE IN REGIMEN INTENSIVE PHASE

Month of treatment

CONTINUATION PHASE

Month of treatment

2nd

Regimen Regimen

Increase in weight

REASON/S FOR CHANGE IN REGIMEN

ZKmOfxPtoCs

RECOMMENDED REGIMEN DISCONTINUED OR ADDED DRUG/S

Z KmOfxPtoCs

none

WEIGHT

51.3

KGS

DRUGS IN NEW REGIMEN (USE SYMBOL)

PREPARATION

NO. OF UNITS PER DAY

500

Ofx

200

Pto

250

COMMENTS: CONSILIUM OFFICER

80 Treat MDR-TB Patients

Ma. Imelda D. Quelapio, MD

DATE

12/26/05

MODULE C

TREATMENT AND RECOMMENDED CHANGE IN REGIMEN INTENSIVE PHASE

Month of treatment

CONTINUATION PHASE

Month of treatment

5th

Regimen Suicidal tendency

REASON/S FOR CHANGE IN REGIMEN

ZKmOfxPtoPAS

RECOMMENDED REGIMEN DISCONTINUED OR ADDED DRUG/S

Z KmOfxPtoCs

Regimen

Cs discontinued; PAS added

WEIGHT

51.3

KGS

DRUGS IN NEW REGIMEN (USE SYMBOL)

PREPARATION

NO. OF UNITS PER DAY

500mg

Ofx

200mg

Pto

250mg

PAS

COMMENTS: CONSILIUM OFFICER

Ruth Orillaza-Chi, MD

DATE

3/18/06

In an emergency situation, the Treatment Center physician should make the decision to change the regimen before the case is presented to the Consilium.

3.6.1 After Consilium approval, document the change on the Category IV Treatment Card Once the approval is received the Treatment Center physician should record any regimen change on the patient’s Category IV Treatment Card. To mark the change, the physician will record the new regimen on page 2 of the Category IV Regimen section of the Category IV Treatment Card. On page 3 of the Card, the Administration of Drugs section, the date when the regimen was changed must be circled as explained in section 2.1.4. All drugs that are to be discontinued must be returned to the pharmacist or designated staff at the Treatment Center. The new drugs must be requested immediately.

Now do Exercise C – Written Exercise

When you have reached this point in the module, read and follow the instructions for Exercise C. Do this by yourself and discuss your answers with a facilitator.

Treat MDR-TB Patients

MODULE C

Exercise C: Written Exercise Giving supervised treatment Individual work on written exercise The purpose of this exercise is to document supervised treatment in the Category IV Treatment Cards of patients receiving MDR-TB treatment. In this exercise you will practice recording treatment on a Category IV Treatment Card for Mr. Ambrosio Amador. Fold out the Category IV Treatment Card for Mr. Amador provided to you. 1. Write your three letter initials on the days that you supervised treatment. Write your three letter initials: __ __ __ 2. Use the information provided below to update the patient’s Category IV Treatment Card. •

For Treatment Site staff a. Update Mr Amador’s Category IV Treatment Card using the information provided in boxes. b. Update page 3 of his treatment card starting on the date of patient endorsement to your facility. Assume that you are a staff of Jasmine Health Center providing supervised treatment to the patient.

•

For Treatment Center staff Update Mr. Amador’s Category IV Treatment Card, pages 1-4, using all the information below. Ambrosio submitted baseline specimens on May 14 and 15, 2008. The DSSM results were 1+ and 2+. Baseline CXR done on May 14, 2008 showed progression of the bilateral infiltrates and increase in the right upper lung cavity.

Ambrosio began his treatment on Monday, May 19, 2008. He came and received directly observed treatment on the following days: May 19, 20, 21, 22, 23, 24. Ambrosio complained about dizziness for a week which seemed manageable and he continued with his treatment. May 25 was Sunday. He received directly observed treatment on May 26, 27, 28, 29, 30, 31. June 1 was Sunday. He received directly observed treatment on June 2, 2008. He did not come on June 3, 4, and 5. The TC staff found out from his cousin through phone call that he had transferred to the house of another relative, also in Manila because of a family conflict. The TC staff coordinated with the nearest DOTS facility, Jasmine Health Center for default follow-up. Early in the morning on June 6, the Jasmine Health Center worker visited the patient’s home and found that Ambrosio had been sick and complaining of severe nausea and dizziness. The health worker was able to convince Ambrosio to report at the Treatment Center that same day. On June 6, because of his severe symptoms, the TC physician gave ancillary medicines and revised the regimen, replaced prothionamide with PASER 4 grams/sachet, 2 sachets per day, with a plan to present it to the Consilium. Ambrosio received supervised treatment, took PASER instead of prothionamide along with the other drugs. The TC physician emphasized to Ambrosio the importance of not missing treatment and Ambrosio promised to continue taking his drugs. He also expressed willingness to be decentralized to Jasmine Health Center. * For Treatment Site staff, update page 2 of the Category IV Treatment Card.

82 Treat MDR-TB Patients

MODULE C

Ambrosio received directly observed treatment on June 7, 9, 10, 11, 12, 13, and 14. June 8 was Sunday. On June 11, the Consilium approved the change in regimen made by the TC physician. He will no longer be taking prothionamide and instead be given PASER continuously. * For Treatment Site staff, update page 1 of the Category IV Treatment Card.

June 15 was Sunday. Ambrosio received directly observed treatment on June 16, 17, 18, 19, 20, 21. His weight was 51 kg. June 22 was Sunday. He received supervised treatment on June 23, 24, 25, 26, 27. On June 25, 2008 the facility received the first sputum follow-up DSSM results. The specimen was collected on June 18, 2008 and the result was negative. After taking his drugs on June 28, he told the TC nurse that he plans on a trip to visit her mother for 4 days. The TC nurse explained to him the possible consequences of interrupted treatment and that he will not be given any medicines for self-administration. Ambrosio went ahead with his plan to visit his mother in the province. He returned to the TC and received supervised treatment on July 4 and 5. July 6 was Sunday. Ambrosio received treatment on July 7, 8, 9, 10, 11, 12. July 13 was Sunday. He received directly observed treatment on July 14, 15, 16, 17, 18, 19. His weight was 52.8 kg. July 20 was Sunday. He received supervised treatment on July 21, 22, 23, 24, 25, 26. The facility received the smear results for the July sputum follow-up. Sputum specimen was collected on July 19 and the result was negative. July 27 was Sunday. From July 28 to September 27, 2008, the patient was adherent to supervised treatment at the Treatment Center. The baseline culture result, released in August, turned out positive for M. TB. His DSSM results for August 19 and September 19 were all negative. The culture result for the specimen collected in June came out in September and was positive for TB. The culture result for the specimen collected in July came out in September and was negative. His weight, taken on August 19, and September 19 were 54.2 kg and 55 kg, respectively. September 28, 2008 was Sunday. Patient Decentralization. Refer to Module E: Ensure Continuation of MDR-TB Treatment. **By this time, Ambrosio already has one negative culture and 4 negative monthly smears. He was eligible for decentralization to a Treatment Site after having at least one negative culture and 3 negative smears. The staff from Jasmine Health Center underwent training and after proper coordination, Ambrosio was endorsed to the staff of Jasmine Health Center, a Treatment Site, on September 29, 2008, Monday. He received treatment for the first time at the Treatment Site on September 29. The Treatment Site nurse will supervise the barangay health worker in providing supervised treatment to Ambrosio. He agreed to come to the DOTreatment Site facility from Mondays to Fridays and report weekly, every Saturday, for supervised treatment at the Treatment Center. He took drugs on September 30 to October 3 at the Treatment Site. Treat MDR-TB Patients

MODULE C

He received supervised treatment at the Treatment Center on October 4. October 5 was Sunday. He received treatment on October 6 to 10, 2008 at the Treatment Site. He received supervised treatment at the Treatment Center on October 11. October 12 was Sunday. He received directly observed treatment on October 13 to 17 at the Treatment Site. He received treatment at the Treatment Center on October 18 and submitted a sputum specimen. His weight was 55.3 kg. October 19 was Sunday. He received directly observed treatment on October 20 at the Treatment Site. By a phone call, the Treatment Site nurse informed the Treatment Center staff that Ambrosio did not come for treatment at the Treatment Site on October 21 and 22. He came back the following day. He claimed that he originally planned to just stay overnight to attend the funeral of his close friend in a nearby province but floods and mud slides caused by heavy monsoon rains made transportation difficult. He received treatment on October 23 and 24 at the Treatment Site. The DSSM result for the specimen collected on October 18 was negative. His culture result for the specimen collected on August 19 was negative. He received supervised treatment at the Treatment Center on October 25. October 26 was Sunday. He received supervised treatment on October 27, 28, 29, 30, 31, 2008 at the Treatment Site. He received supervised treatment at the Treatment Center on November 1, 2008. November 2 was Sunday. He received treatment on November 3, 4, 5, 6, 7 at the Treatment Site. On November 8, after taking his drugs, he told the Treatment Center staff he wanted to attend his brother’s birthday celebration in Cebu on November 14 and 15. The Treatment Center staff reiterated to Ambrosio the need to adhere to treatment and the possibility of relapse. He received supervised treatment at the Treatment Site on November 10, 11, 12, 13, and 14. On November 15, 2008, the patient came to the Treatment Center and received supervised treatment.

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

84 Treat MDR-TB Patients

MODULE C

Discussion after Exercise C Write your answers to the questions below. When everyone is ready, there will be a group discussion of these questions. 1. A health worker was very busy and a line of people were waiting. The health worker recognized an MDR-TB patient, Mary Galang, and did not want to keep her waiting long. She signaled to Mary to come ahead of the queue and handed her the day’s tablets. She told Mary to take the tablets home and swallow them when she found something to drink. What could happen to the tablets? (List 5 different possibilities) • • • • • 2. What should the health worker have done when handing the tablets to Mary?

3. If an MDR-TB patient does not take the anti-TB drugs correctly or on schedule over a period of time, what might be the consequences?

Then read until the next exercise.

Treat MDR-TB Patients

MODULE C

4. Monitor progress of treatment by follow-up examinations Monitor patients with pulmonary MDR-TB by periodic follow-up DSSM, culture and DST examinations. These laboratory examinations are important to determine the patient’s progress and to make decisions about care. When the regimens have been designed correctly and the anti-TB drugs are taken regularly sputum smear and culture will generally convert to negative. Culture conversion is the best indicator that the treatment was taken regularly and was effective. Monthly visits to the Treatment Center physician are necessary for all MDR-TB patients. Sputum exams as well as a number of blood tests are used to monitor patient health and the need for other interventions. The Treatment Center physician can evaluate clinical improvement, answer any questions the patient may have about the disease or treatment, and provide support for continuing the treatment. See Annex F for a brief description of steps that a Treatment Center physician should perform at a follow-up visit. For patients with extrapulmonary MDR-TB, the progress of treatment is monitored by the Treatment Center physician who assesses clinical status. Increase in the patient’s weight is also a useful indicator.

4.1 Determine when the patient is due for follow-up examinations You will collect sputum for follow-up examinations monthly till end of treatment. Sputum will always be collected at the Treatment Centers. For all MDR-TB patients, the sputum tests and other procedures will be run according to the following schedule: •

DSSM: monthly until treatment is completed.

•

Culture: monthly during the intensive phase and every two months during the continuation phase and anytime when the monthly smears are positive.

•

DST: every 4 months while culture-positive when amplification is suspected.

•

Chest x-ray: every 6 months.

•

Blood chemistries: every 6 months for patients younger than 50 years; every 3 months for patients 50 years and older.

Note that the above list is meant for patients who progress through treatment as planned. A DST, chest x-ray or blood chemistry may be requested at any time at the physician’s discretion.

4.2 Collect sputum for follow-up examinations One sputum specimen is required for a follow-up sputum examination each month. Sputum will always be collected every 28-30 days at the Treatment Centers. For example, if the patient began treatment on October 24, the follow up sputum collection will be done on or before November 24. During the patient’s monthly schedule for sputum examination, give the patient a labeled sputum container and collect the spot sample at the Treatment Center. Review with the patient how to collect the sputum. See Module B: Detect Cases of MDR-TB for guidance for sputum collection. Also weigh the patient and record the weight on the Category IV Treatment Card. Complete a Mycobacteriology Request Form to send with the sputum sample. Complete the form much as you would for a diagnostic examination. However, in the “Schedule” section, tick the box “follow-up: month of treatment _____.“ This refers to the timing of sputum collection being requested, whether it’s the 2nd month, or 5th month from start of treatment to indicate that this examination is a follow-up during treatment. The health worker completes the form and submits sputum sample for follow-up examination.

86 Treat MDR-TB Patients

MODULE C

Follow these guidelines for sputum collection as would happen with any TB patient. One sputum sample is collected for the follow up tests. •

•

• •

Follow up sample is collected “on the spot.” Give instructions. Explain why the sputum is needed and show the patient how to cough up sputum and handle the container. The patient is then directed to a well-ventilated place or to a sputum collection booth to collect the sample. Observe and guide the patient during sample collection. A green sticker with the name of the Treatment Center, patient’s name and date of collection will be attached to the body of the cup (not on the lid) to serve as indicator that the specimen is for DSSM and culture only (no DST) such as for follow-up during the intensive phase and the every other month followup during the continuation phase. A white sticker label means the request is only for DSSM, e.g., for some months of the follow-up during the continuation phase. A blue sticker indicates that the examinations requested are DSSM, culture and DST, e.g. for screening and baseline specimens and occasionally during follow up when amplification is suspected.

Example of sputum cup labels: STICKER LABELS ON SPUTUM CUPS FOR REQUESTED PROCEDURE

PMDT Request for DSSM only (white)

Treatment center: ________________ Laboratory no. ___________________ Name: __________________________ Date collected: ___________________

Request for DSSM and Culture (green)

Treatment center: ________________ Laboratory no. ___________________ Name: __________________________ Date collected: ___________________

PMDT

PMDT Request for DSSM, Culture and DST (blue)

Treatment center: ________________ Laboratory no. ___________________ Name: __________________________ Date collected: ___________________

Remember: • • • • • •

Attach the appropriate colored labels on the body of the containers (not the lids) 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, not just saliva. If not, ask the MDR-TB suspect to add more. After collecting the sputum, be sure that the lid is closed tightly. Store in a refrigerator or in a styrobox with ice if sputum will not be transferred immediately to the Culture Center. Wash your hands thoroughly with soap and water.

Treat MDR-TB Patients

MODULE C

4.3 Record results of laboratory examinations The laboratory technician at the Culture Center will record the examination results of DSSM and culture in the Laboratory Register and official results will be sent to the Treatment Center through a messenger. All results received at the Treatment Center will be recorded in the Category IV Register. Culture Centers will maintain their own Laboratory Register while DST Centers will also maintain their own. The Laboratory Register for Culture Centers will report the DSSM and culture results and will keep the portion for the DST results blank.

88 Treat MDR-TB Patients

02-P-050002-1 02-P-050003-1 02-P-050004-1 02-P-050005-1 02-P-050006-1 02-P-050007-1 02-P-050008-1 02-P-050009-1 02-P-050010-1

Dela Cruz, Juan

Benito, Gerald

Cortez, Juan

Uy, Susan

Tan, Vincent

Santos, Sylvia

Legazpi, Agapito

Garcia, Raymond

Salcedo, Myra

02-P-050010-2

02-P-050009-2

02-P-050008-2

02-P-050007-2

02-P-050006-2

02-P-050002-2

02-P-050001-2

* Laboratory No. : TC - CC - YYNNNN-n TC: Treatment Center: 01- TDF, 02- QI, 03- LCP, 04- TALA, 05- Tayuman C=Culture Center: N- NTRL, T- TDF lab, P- PTSI lab, L- LCP lab

02-P-050001-1

Laboratory No.*

5/3/2005

5/2/2005

4/30/2005

4/29/2005

4/28/2005

5/5/2005

5/3/2005

5/2/2005

4/29/2005

CAT

N - New R - Retreatment

F THE PHI LIP IC O BL

REP U

DATE OF REGISTRATION

LABORATORY REGISTER - Culture Center

Programmatic Management of Drug - Resistant TB (PMDT)

Balagtas, Jose

NAME

Page 1 of the Laboratory Register of a Culture Center: S NE PI

Treat MDR-TB Patients

AGE

SEX

SCR

BAS

SCR

BAS

M07

M08

M02

SCR

DX / FF-UP

LABORATORY REGISTER - Culture Center / Page 1 of 2

Mtb 7/29/05 CVG Mtb 7/28/05 CVG

Mtb 7/29/05 CVG Mtb 8/01/05 CVG Mtb 08/01/05 CVG

Mtb 07/30/05 CVG

Mtb 08/2/05 CVG

Mtb 8/01/05 CVG NG 7/15/05 CVG Mtb 08/15/05 CVG

Mtb 08/01/05 CVG Mtb 8/15/05 CVG Mtb 07/18/05 CVG

Mtb 08/2/05 CVG

Mtb 08/1/05 CVG

4+ 4/30/05 MSE 2+ 5/3/05 MSE

3+ 5/3/05 MSE 0 5/3/05 MSE 1+ 5/3/05 MSE

3+ 5/03/05 MSE

0 5/4/05 MSE

2+ 5/2/05 MSE

0 5/3/05 MSE

Date read: mm/dd/yy

0 5/1/05 MSE 1+ 5/2/05 MSE

1+ 5/1/05 MSE

3+ 4/29/05 MSE 1+ 4/29/05 MSE 1+ 4/29/05 MSE 0 4/30/05 MSE 0 5/1/05 MSE

CULTURE Result Date read / Initials

DSSM Result Date read / Initials

LABORATORY REGISTER - Culture Center | page 2 of 2

Page 2 of the Laboratory Register of a Culture Center:

S=Susceptible

Ofx

R=Resistant ND=Not done

DST Cfx

Lfx

DST Date read

Laboratory Technician

Programmatic Management of Drug - Resistant TB (PMDT)

F THE PHI LIP IC O BL

S NE PI

REP U

02-P-050001-1 02-P-050006-1 02-P-050007-1 02-P-050008-1 02-P-050009-1

Balagtas, Jose

Tan, Vincent

Santos, Sylvia

Legazpi, Agapito

Garcia, Raymond

Laboratory No.*

F THE PHI LIP IC O BL

REP U

8/2/2005

8/1/2005

7/29/2005

7/15/2005

DATE OF REGISTRATION

CAT

N - New R - Retreatment

S NE PI

* Laboratory No. : TC - CC - Year, Accession No - 1st or 2nd specimen TC: Treatment Center: 01- TDF, 02- QI, 03- LCP, 04- TALA, 05- Tayuman CC=Culture Center: N- NTRL, T- TDF lab, P- PTSI lab, L- LCP lab

02-P-050002-1

Dela Cruz, Juan

NAME

LABORATORY REGISTER - DST Center

Programmatic Management of Drug - Resistant TB (PMDT)

AGE

SEX

BAS

SCR

BAS

SCR

Diagnosis/ Follow-up

The Laboratory Register of DST Centers will show the DST results and will keep the portion of the DSSM and Culture results blank as shown in the next page. Results are sent directly to the requesting Treatment Center and not to the Culture Center which sent the isolate.

Below is page 1 of the Laboratory Register of a DST Center

Treat MDR-TB Patients

LABORATORY REGISTER - DST Center / Page 1 of 2

92 Treat MDR-TB Patients

Date read: mm/dd/yy

DSSM Result Date read / Initials

CULTURE Result Date read / Initials

LABORATORY REGISTER - DST Center | page 2 of 2

Page 2 of the Laboratory Register of a DST Center:

R R R S S R

S=Susceptible

Ofx

R-Resistant ND-Not done

DST

Cfx

Lfx

11/9/2005

11/3/2005

10/12/2005

11/15/2005

10/10/2005

9/15/2005

DST Date read

MMB

Laboratory Technician

Programmatic Management of Drug - Resistant TB (PMDT)

F THE PHI LIP IC O BL

S NE PI

REP U

MODULE C

The following steps are followed for the release of DSSM and culture results. •

From the Culture Center, individual results of DSSM and Culture will be printed out. DSSM results will be printed out and released as they are available rather than wait for the culture results.

•

The individual DSSM and Culture results will be segregated according to requesting Treatment Center.

•

Those results belonging to one Treatment Center will be summarized in one sheet of the Releasing Form for Results

•

The summary in the Releasing Form for Results and the individual results for a specific Treatment Center will be delivered by the messenger.

•

The messenger will sign on the Releasing Form for Results which will be filed at the Culture Center. The duplicate will be received by the Treatment Center who will check the completeness of the results by comparing the individual results and the Releasing Form. He calls the Culture Center if there is a discrepancy or question, and documents their agreement on the Form.

Treat MDR-TB Patients

REP U

Programmatic Management of Drug - Resistant TB (PMDT)

F THE PHI LIP IC O BL

S NE PI

94 Treat MDR-TB Patients

Yes

mm/dd/yy

8/01/05

Mtb

TB culture

Date Released:

4/28/2005

02-P-050001-1

1st specimen

DSSM

Date of collection

Lab No.

Category:

PTSI

Sputum

3 Retreatment

Marie Supnet, RMT

Mtb

4/29/2005

02-P-050001-2

2nd specimen

New

Laboratory Supervisor

Francia Gonzales, RMT

3rd specimen

Culture center:

Specimen:

Months post-treatment

Laboratory Technician

Follow-up: month of tx:

3 TB Culture

Baseline

3 DSSM

3 No

3 Screening

EXAMINATION DONE:

Enrolled:

Schedule:

Housing Facility

Treatment center: KASAKA-QI MDR-TB

DSSM AND CULTURE RESULT

Requesting physician: Chi-Orillaza, Ruth M.D.

Age/Sex: 50/M

Patient’s name: Balagtas, Jose

Category IV Registration No.

Below is an example of a DSSM & Culture Result:

MODULE C

The following steps are followed for the release of DST results. •

From the DST Center, individual results of DST will be printed out and released as they are available.

•

DST results belonging to one Treatment Center will be summarized in the Releasing Form for results

•

The individual DST results and the Releasing Form for Results will be delivered by the messenger.

•

The messenger will sign on the Releasing Form for Results which will be filed at the DST Center. The duplicate will be received by the Treatment Center staff who will check the completeness of the results by comparing the individual results and the Releasing Form. He calls the DST Center if there is a discrepancy or question, and documents their agreement on the Form.

Treat MDR-TB Patients

REP U

Programmatic Management of Drug - Resistant TB (PMDT)

F THE PHI LIP IC O BL

S NE PI

96 Treat MDR-TB Patients

3 No

Yes

Enrolled:

New

Levofloxacin (Lfx) 1ug/ml

Pyrazinamide (Z) ______

mm/dd/yy

Laboratory Technician

Michael S. Evangelista

Ciprofloxacin (Cfx )1ug/ml

Ethambutol (E) 5ug/ml

10/10/05

Ofloxacin (Ofx) 2 ug/ml

Rifampicin (R) 5ug/ml

Date Released:

Streptomycin (S) 2ug/ml

3 Retreatment

METHOD USED: Disc Elution / 7H10

Category: R

Drug Susceptibility Testing

Follow-up: month of tx:

Isoniazid (H) 0.1ug/ml

EXAMINATION DONE:

BAS

3 SCR

Schedule:

Months post-treatment

Laboratory Supervisor

Claudette Guray

Other 2nd line drugs:

Kanamycin (Km) 6ug/ml

Date collected 4/28/2005

Age/Sex: 50/M

Chi-Orillaza, Ruth M.D.

DST center: NTRL

Specimen: Sputum

Patient’s name: Balagtas, Jose

Requesting physician:

Culture center: PTSI

KASAKA - QI MDR-TB Housing Facility

Laboratory ID no.

Treatment center:

DRUG SUSCEPTIBILITY TEST (DST) RESULT

Category IV Registration No.

Below is an example of a DST Result:

MODULE C

In the Releasing Form for Results, tick the box for “Culture Center” where the results are coming from and write the name of this Center. Then tick the box for the Treatment Center where the results are to be sent and write the name of this Treatment Center. Tick whether the results being released are DSSM, culture or DST. Fill out the table: column 1 with a laboratory number (TC-C-YY-NNNN-n) the patient’s name (last name first, then the first name), the test requested, the date when sputum was collected, and remarks. At the bottom, the one who prepared the form signs on the space provided for “Endorsed by” and the date, and the one receiving the box signs on the space provided for “Received by” and the date.

During the intensive phase, sputum specimens will be sent for DSSM and culture monthly. During the continuation phase, sputum specimens will be sent monthly for DSSM and every two months for culture. During the continuation phase, if the DSSM is positive and there is no scheduled culture, the Treatment enter staff should collect another specimen for smear and culture even if not on schedule.

Treat MDR-TB Patients

Example of A Laboratory Releasing Form for Results: MODULE C

REP U

S NE PI

F THE PHI LIP IC O BL

Programmatic Management of Drug - Resistant TB (PMDT)

Laboratory Releasing Form For Results From: 3

No.

PTSI

Culture Center (CC)

To:

KASAKA QI

Treatment Center (TC)

Test requested

Date collected mm/dd/yy

DST Center

Laboratory No.*

Name

02-P-050001-2

Balagtas, Jose

TBC

04/29/05

02-P-050010-1

Salcedo, Myra

TBC

04/28/05

02-P-050006-1

Tan, Vincent

TBC

04/28/05

02-P-050007-1

Santos, Sylvia

DSSM

04/29/05

02-P-050014-1

Roces, Maria

TBC

04/28/05

02-P-050017-1

Mendoza, Tina

TBC

04/28/05

02-P-050015-1

Benito, Jamora

TBC

04/28/05

02-P-050004-1

Cortez, Juan

DSSM

04/27/05

02-P-050005-1

Uy, Susan

DSSM

04/27/05

02-P-050007-2

Mendoza, Tina

TBC

04/28/05

11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 DSSM 3

3 Culture (TBC)

DST

* Laboratory No. : TC-C-YY, NNNN-n

98 Treat MDR-TB Patients

Francia Gonzales (PTSI) Endorsed by: ___________________________

08/02/05 Date: _________________________

Mar Rocha (TDF Messenger) Received by: ____________________________

Date: _________________________

08/02/05

Remarks

MODULE C

To complete the Category IV Treatment Card: Record the follow-up DSSM and Culture results on page 4 of the patient’s Category IV Treatment Card corresponding to the “Month of Treatment” row, the actual date of specimen collection and type of examination done. This is shown below. When a patient who was sputum smear-positive changes to sputum smear-negative and maintains this for two consecutive months, there has been “smear conversion.” When a patient who was culture-positive changes to culture-negative and maintains this for two consecutive months, there has been “culture conversion.” Culture conversion is the most important indicator of treatment success for MDR-TB patients.

Page 4 of the Category IV Treatment Card of one patient

Request Given

Month of Treatment

(1) Sputum monitoring DSSM/Culture Date collected

Laboratory No.

DSSM

TBC

DSSM

TBC

4/28/2005

02-P-50001-1

MTB

3 3 3 3 3 3 3

10/22/2005

02-P-50616-1

MTB

11/22/2005

02-P-50801-1

12/22/2005

02-P-51011-1

1/25/2006

02-P-51211-1

2/23/2006

02-P-51301-1

3/24/2006

02-P-51411-1

4/20/2006

02-P-51523-1

S2 B 1 2 3 4 5 6

Example: Recording the follow-up laboratory results in the ‘Sputum Monitoring’ section on the Category IV Treatment Card

7 8 9 10 11

Smear conversion

Culture conversion

12 13 14 15

Sputum monitoring starts at month 1 of treatment

16 17 18 19 20

Correspondingly, enter the reulsts in the Category IV Register as they come. See the above Category IV Treatment Card entries correspond to the entries for the second patient in the following Category IV Register.

Treat MDR-TB Patients

Treatment start date mm/dd/yy (3)

02-05-0098 11/20/05

5/2/05

02-05-0097 10/24/05

4/25/05

05/03/05 02-05-0096 5/15/05

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

Raymond Benito

GARCIA

Jose Amorsolo

BALAGTAS

Myrna Cortez

SALCEDO

Last name First name and middle name

Name (4)

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

(9) Chest x-ray result

Bataan, Region 3

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

5/22/68

34 San Roque St., Kalayaan

Tondo, Manila, NCR

1/20/55 37

2425 Buendia St.,

Sta. Mesa, Manila, NCR

5/6/58 50

75 Sta. Mesa Heights,

Street no. and name Brgy. City, Region

Address (7)

Date of birth mm/dd/yy

1- Male 2- Female

(5) Sex

Sex (5)

Age (yrs) (6)

REP U

05/21/05

4,13

05/19/05

1, 2, 8

05/14/05

1, 2

Date done mm/dd/yy

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

Registration group (10)

10-Other patient w/ 10.1 Non-DOTS 10.2 Other (+) 10.3 Other (-)

(10) Registration group

Site of disease (8)

Chest xray result (9)

S NE PI

Date screened mm/dd/yy (1)

Category IV Register

Programmatic Management of Drug - Resistant TB (PMDT)

F THE PHI LIP IC O BL

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

(11) Previous TB treatment

Previous TB treatment (11)

Category IV Register/ Page 1 of 3

Example: Marking the follow-up laboratory results on the Category IV MDR-TB Register (left hand side of the form)

MODULE C

or 7 days post-treatment start (result not yet available upon treatment) 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 1: Screening DST or DST result available pre-treatment Row 2: Baseline DST or DST done within 30 days prior to treatment start

(13) Drug Susceptability Testing (DST)

Sputum for baseline DST was collected on 10/22/05.

/ was collected on 4/28/05.

/ Sputum for screening DST

DST results of / / screening and baseline / / sputum samples.

04/15/06

11/05/05

3/07/06

10/10/05

10/2/05

Other

Lfx

Cfx

Ofx

Date DST released mm/dd/yy (14)

S - Susceptible R - Resistant ND - Not Done

Drug Susceptibility Testing (DST) (13)

11/20/05

5/2/05

10/22/05

4/28/05

05/15/05

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

Category IV REGISTER | page 2 of 3

04/16/06

11/10/05

3/10/06

10/10/05

10/9/05

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

Mtb

/ /

11/25/05

11/20/05

10/23/05

10/22/05

/ /

05/15/05

mm/dd/yy

s/c

mo 0

MTB

/ /

12/24/05

11/22/05

06/12/05

mm/dd/yy

s/c

mo 1

Example: Marking the follow-up laboratory results on the Category IV MDR-TB Register (middle part of the form)

MTB

/ /

1/22/05

12/22/05

07/10/05

mm/dd/yy

s/c

mo 2

MTB

/ /

2/25/06

1/25/06

08/07/05

mm/dd/yy

s/c

mo 3

MTB

/ /

3/23/06

2/23/06

09/04/05

mm/dd/yy

s/c

mo 4

MTB

5/20/06

4/20/06

10/30/05

mm/dd/yy

s/c

mo 6

11/27/05

mm/dd/yy

s/c

mo 7

/ /

DSSM and Culture results during the monthly sputum follow-up starting on month 1 / / / / / /

4/24/06

3/24/06

10/02/05

mm/dd/yy

s/c

mo 5

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

Programmatic Management of Drug - Resistant TB (PMDT)

REP U

/ /

12/25/05

mm/dd/yy

s/c

mo 8

s/c

mo 9

/ /

01/22/06

mm/dd/yy

F THE PHI LIP IC O BL

S NE PI

Treat MDR-TB Patients

101

1/28/06

mm/dd/yy

s/c

mo 11

mo 10

mm/dd/yy

s/c

mo 12

s/c

mo 13

mm/dd/yy

Category IV REGISTER | page 3 of 3

mm/dd/yy

s/c mm/dd/yy

s/c

mo 19

SUMMARY

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 20

1. Extrapulmonary 2. Trans-in 3. Other

Excluded

mm/dd/yy

s/c

mo 18

Sputum monitoring continues monthly / / / / / / / / until/the/ end of / CAtegory IV treatment.

mm/dd/yy

s/c

mo 17

mm/dd/yy

s/c

mo 16

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

mm/dd/yy

s/c

mo 14

mm/dd/yy

s/c

mo 21

mm/dd/yy

s/c

mo 23

mm/dd/yy

s/c

mo 24

Post-treatment follow-up monitoring (18)

REP U

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

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

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

mm/dd/yy

s/c

mo 22

Programmatic Management of Drug - Resistant TB (PMDT)

F THE PHI LIP IC O BL

HIV status

Continuation of Category IV Register S NE PI

MODULE C

4.4 Decide on appropriate action needed The appropriate action for the patient will depend on when the laboratory examinations are done (that is, in what month of treatment), and whether the result of the culture is negative or positive.

4.4.1 Decide whether to decentralize the patient All MDR-TB patients begin treatment at a Treatment Center. Those patients who have met the criteria for decentralization may be considered for endorsement to the Treatment Site. (See Module E: Ensure Continuation of MDR-TB Treatment). All patients who are culture-negative for at least one month should be considered for decentralization as long as this is followed by two consecutive negative smears. The process of decentralizing a patient is described in more depth in Module E: Ensure Continuation of MDR-TB Treatment.

4.4.2 Use physical exam, sputum examination results and attendance history for decisions once the patient is decentralized A patient will receive supervised treatment at least five days a week at the Treatment Site once decentralized. A trained Treatment Site partner, ideally not a family member may supervise the treatment on a Saturday. Otherwise, the patient will have to go to the Treatment Center on Saturdays and holidays. The patient must go to the Treatment Center monthly for physical examination by the Treatment Center physician and to have other tests done. Use the results of the tests, the patient’s response to treatment and his/her attendance record to make decisions about beginning the continuation phase or if additional actions need to be taken. At the end of the sixth month of treatment, most patients will have negative culture results. To be eligible for the continuation phase the patient must have 4 consecutive negative culture results followed by two consecutive negative smears and must have received an injectable agent for least 6 months (156 doses) from culture conversion. The Treatment Center physician will review patients who meet these criteria and will present these cases to the Consilium. Once approved by the Consilium, they can begin the continuation phase of treatment. If a patient still has a positive sputum smear or culture at the sixth month of treatment, this may indicate one of the following: • • •

The treatment was poorly supervised and drugs were not taken correctly or on schedule. There was a slow rate of sputum conversion, for example, if a patient had widespread destruction of lung tissue and an initial heavy bacillary load, or if there was a problem with drug absorption. The patient’s regimen may not be adequate and the bacilli may have resistance to some drugs the patient is receiving.

The patient should be evaluated by a Treatment Center physician for possible change in regimen. If you find that the patient is not taking the drugs, every effort must be made to ensure adherence. See Module E: Ensure Continuation of MDR-TB Treatment for a description of possible solutions.

4.5 Monitoring progress of treatment by follow-up laboratory examinations: summary of schedule Remember to collect one sputum sample for follow-up sputum examination monthly so that the results will be available at regular intervals and that there are no major delays in receiving culture results.

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All MDR-TB patients should have: • • • • •

DSSM: monthly until treatment is completed. Culture: monthly during the intensive phase and every two months during the continuation phase or when needed. DST: every 4 months while culture-positive when amplification is suspected. Chest x-ray: every 6 months. Blood chemistries: every 6 months for patients younger than 50 years; every 3 months for patients 50 years and older.

Since there is no pre-established duration for MDR-TB regimens because the time for conversion is not predictable the schedules for DST, chest x-rays and blood chemistries must be monitored throughout treatment.

4.6 Implement treatment decisions Meet with the patient to explain the results of the follow-up examinations and the next step of treatment.

4.6.1 Decentralize patient to a Treatment Site •

Explain to the patient who has culture converted followed by at least 2 negative smears that the treatment is progressing well, inform the patient that he is eligible to receive treatment at his/her local DOTS facility as soon as other criteria for decentralization are met. A detailed explanation of the steps to decentralize a patient can be found in Module E: Ensure Continuation of MDR-TB Treatment.

•

Congratulate the patient, however, explain that there are still a number of months to continue and emphasize the importance of continuing the treatment.

•

Explain to the patient about the process of decentralization, and that the care will remain the same, the patient will be able to go to a Treatment Site in his community, and that every month it will still be necessary for him to come to the Treatment Center for treatment and follow-up. The possibility for Treatment Site staff or a barangay health worker to supervise treatment on Saturdays will be discussed during initial endorsement.

•

Reiterate to the patient the importance of the PMDT Patient’s Booklet. This will serve as a link between the Treatment Center and the Treatment Site. This must be available and carried by the patient at all times while he is receiving treatment.

4.6.2 Shift the patient to continuation phase of treatment •

Explain to the patient who has had a negative culture result for 4 consecutive months from the beginning of treatment and has received an injectable agent for at least 6 months that the treatment has worked well. He is no longer infectious and is ready to begin the next phase of treatment. Congratulate the patient, but explain that there are still a number of months to continue and the importance of continuing the treatment.

•

Be sure that the patient finishes all doses of the intensive phase drugs, and then start the patient on continuation phase. The continuation phase will not include the injectable agent, unless there are no other treatment options.

•

Explain to the patient about the continuation phase of treatment, including that the injection will no longer be given, the schedule, and how long this treatment phase will last.

•

Begin giving the patient the continuation phase of treatment, marking the Category IV Treatment Card each time that you administer the drugs as you did during the intensive phase.

4.6.3 If the patient is at risk of treatment failure Patients who do not show signs of improvement after four months of treatment are at risk for treatment failure. All patients who do not culture convert, clinically improve, or have reappearance of disease after month 4 of treatment, should be considered high-risk for treatment failure. •

A review of the Category IV Treatment Card should be done to confirm that the patient has adhered to treatment and that the treatment has been adequately supervised.

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•

• • • • • •

Review the treatment regimen in relation to medical history, household contacts and all DST reports. If the regimen is deemed inadequate, a new regimen needs to be designed and presented for approval to the Consilium. The bacteriological data should be reviewed. Often, the smear and culture data are the strongest evidence of a patient’s response to therapy. One single positive culture in the presence of an otherwise good clinical response can be due to a laboratory contaminant or error. In this case, subsequent cultures that are negative or in which the number of colonies is decreasing may help prove that the apparently positive culture result did not reflect treatment failure. Send the latest positive culture for DST which is at least 4 months after the date of the last DST done. Explain to the patient that the positive laboratory or exam results mean that the drugs do not seem to be working as hoped. The patient is still infectious and may need a different drug regimen. Explain to the patient that a Treatment Center physician will review his medical file and will present the case to the Consilium to decide what action should be taken. Continue to give supervised treatment to the patient with the prescribed regimen until a decision has been made to change it. Refer the patient for possible psychosocial intervention. If a decentralized patient suddenly becomes smear-positive, collect another specimen the following day and do a culture. If still DSSM-positive, refer back to Treatment Center. If negative, and the patient is improving, continue treatment at the Treatment Site and wait for the culture results.

4.6.4 Ensure that all measures have been taken to avoid treatment default Try to find out what has happened to any patient who stops coming for treatment and try to convince the patient to resume treatment. Also, prevent loss of contact with patients by reminding them to inform you if they are going to move to another address, so that if possible, you can coordinate their transfer to another health facility for MDRTB treatment. See module E: Ensure Continuation of MDR-TB Treatment for suggestions on how to better maintain contact with patients and minimize defaults.

4.6.5 If a culture-negative patient becomes culture-positive •

• •

• • •

•

If a patient suddenly reconverts to culture positive, the Treatment Center physician will present the case again to the Consilium for possible change of regimen after reviewing the following: • the Category IV Treatment Card to confirm that the patient has adhered to treatment and that the treatment has been adequately supervised. • the treatment regimen in relation to medical history, household contacts and all DST reports. If the regimen is deemed inadequate, a new regimen needs to be designed by the Consilium. • the bacteriologic data. Often, a persistently positive smear and culture are the strongest evidence that a patient is not responding to therapy. However, one single positive culture in the presence of an otherwise good clinical response can be caused by a laboratory contaminant or error. In this case, subsequent cultures that are negative or in which the number of colonies is decreasing may help prove that the patient is improving. Send the latest positive culture for DST which is at least 4 months after the date of the last DST specimen For decentralized patients, explain to the patient that he will continue treatment at the Treatment Center until he becomes culture-negative for at least one month followed by 2 consecutive monthly smears before returning to the Treatment Site. The Treatment Center staff will inform and discuss the patients’ culture status with the Treatment Site staff and inform him that the patient should continue treatment at the Treatment Center. Explain to the patient that the positive laboratory or exam results mean that the drugs do not seem to be working as hoped. The patient will have to return to the Treatment Center for continued treatment if he has been endorsed to a Treatment Site. Immediate sputum collection for culture should be done at the Treatment Center. Continue to give supervised treatment to the patient with the prescribed regimen until a Consilium decision has been made to change it. If the consilium recommends a regimen change, request the new drugs in the regimen and discontinue the other drugs. Retrieve discontinued drugs from the Treatment Site if necessary. (See Module F: Manage Drugs and Supplies for MDR-TB) Refer the patient to the Treatment Center for possible referral to psychosocial team. Treat MDR-TB Patients

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4.6.6 If a patient’s DST results have changed from baseline •

•

• • •

Explain to the patient that the laboratory results mean that the drugs may not be effective in killing the TB bacilli. The patient will have to see a Treatment Center physician for a physical exam and for a possible change in the treatment regimen. The Treatment Center physician will present the case again to the Consilium for possible regimen change after: • Conducting a physical exam and assessing the progress of the patient. • Reviewing the treatment regimen in relation to medical history, previous treatment, contacts and all previous DST reports. Continue to give supervised treatment to the patient with the prescribed regimen until a decision has been made to change it. If the Consilium recommends a regimen change, request new drugs and discontinue other drugs; and retrieve drugs from the Treatment Site. (See module F: Manage Drugs and Supplies for MDR-TB) Depending on the progress of the patient and his physical state and needs, refer the patient to the psychosocial team at the Treatment Center.

4.6.7 Initiate counseling for possible treatment failure before terminating treatment For patients who are considered to have failed outcome, Treatment Center staff should initiate counseling and provide moral support through a psychologist or psychosocial team before terminating treatment. This can be devastating to a patient and must be handled with utmost caution and good timing.

Now do Exercise D – Written Exercise and Individual Feedback When you have reached this point in the module, read and follow the instructions for Exercise D. When you have finished the exercise, review your answers with a facilitator.

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Exercise D: Written Exercise with Individual Feedback Follow-up laboratory examinations The purpose of this exercise is to practice making decisions about what actions to take based on different follow-up laboratory results. For this exercise you will decide on the action to take for each MDR-TB patient based on followup laboratory results. You may refer to the schedule for follow-up sputum smear and culture examinations in the module on Section 4.1. Decide on the action to take for each patient based on sputum smear examination results. Case 1: AA , a diabetic with poor sugar control, who was decentralized to a Treatment Site on the 3rd month experienced worsening cough and weight loss. Below are the sputum smear and culture examination results from this patient’s Category IV Treatment Card. Results of sputum examination Month

Date

Smear

Culture

Weight (kg)

5/10/08

M. tb

6/12/08

7/11/08

8/8/08

9/6/08

10/10/08

What is the appropriate action for this patient now? Explain what the health worker should do and why. Case 2: LS Results of sputum examination Month

Date

Smear

Culture

Weight (kg)

11/28/08

M. tb

12/2/08

51.2

1/2/09

51.5

2/3/09

52.5

3/2/09

5 Above are the results of LS’s sputum smear and culture examinations. What is the appropriate action for this patient now? Explain what the health worker should do now.

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Case 3: JT The following are the results of JT’s sputum smear and culture examinations:

Results of sputum examination Month

Date

Smear

Culture

Weight (kg)

9/28/07

M. Tb

10/10/07

M.Tb

11/11/07

12/12/07

1/1/08

2/2/08

What is the appropriate action for this patient? Case 4: RM Below are the sputum smear and culture examination results from this patient’s Category IV Treatment Card. The patient is almost asymptomatic and the chest x-ray is improving significantly. His weight is increasing. Results of sputum examination Month

Date

Smear

Culture

Weight (kg)

5/5/08

M.tb

6/10/08

7/11/08

60.5

8/12/08

9/9/08

10/11/08

11/11/08

59.5

12/15/08

n/d

1/13/09

2/9/09

n/d

62.5

3/8/09

pending

What is the appropriate action for this patient now? Explain what the health worker should do and why.

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

Then read until the next exercise.

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5. Determine treatment outcome The criteria used to determine treatment outcomes for MDR-TB patients are different than those used for TB patients receiving DOTS category I, II or III treatment. The results of the bacteriological tests, specifically cultures, are used to determine treatment outcomes for each patient. At least 18 months of treatment after culture conversion should have been completed before a treatment outcome could be considered cured. Generally, when a patient has fulfilled the criteria for a treatment outcome, especially cured, treatment completed, or failed, the case will be presented to the Consilium for approval. Once the Consilium gives the approval and the last dose of treatment is given, the patient will have a final treatment outcome. For patients who are ‘cured’ or ‘treatment completed’, follow-up tests are required over the next two years.

5.1 Identify patients for final treatment outcome The treatment outcomes for MDR-TB are the same as for drug-susceptible TB, except that in MDR-TB, these have different definitions. Table 7 provides the definitions of the six possible treatment outcomes. All patients’ progress should be monitored to determine if they fit the criteria for any of the outcome definitions. Table 7: Definitions of treatment outcomes

Treatment outcome

Definition

Cured

A culture-positive patient who has completed treatment with at least five consecutive negative cultures from samples collected at least 30 days apart in the final 12 months of treatment. If only one positive culture a is reported during that time, and there is no concomitant clinical evidence of deterioration, a patient may still be considered cured, provided that this positive culture is followed by a minimum of three consecutive negative cultures taken at least 30 days apart

Treatment completed

A patient who has completed treatment approved by the Consilium, but does not meet the definition for cure because of lack of bacteriological results (i.e. fewer than five cultures were performed in the final 12 months of treatment). These include patients who are extrapulmonary or have negative cultures at the start of treatment.

Failed

Treatment will be considered to have failed if two or more of the five cultures recorded in the final 12 months of therapy are positive, or if any one of the final three cultures is positive. (Treatment will also be considered to have failed if a clinical decision has been made to terminate treatment early because of poor response or adverse events. These latter failures can be indicated separately to do sub-analysis.)

Died

A patient who died for any reason during the course of treatment

Defaulted

A patient whose treatment was interrupted for 2 consecutive months or more for any reason

Transferred out

A patient who has been transferred to another recording and reporting unit with proper referral form and for whom the treatment outcome is not known.

a A positive culture requires greater than 10 colonies on solid media. If less than 10 colonies are detected in one culture, a second culture should be done and should also contain less than 10 colonies. With these two isolates having less than 10 colonies, the culture should be interpreted as

positive.

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Use the outcome definitions described above to identify each patient who may be eligible for treatment completion and final outcome determination. Final outcome is declared at the Treatment Center except for death and default. For patients who have fulfilled the criteria described in any of the definitions above, take the following actions: •

Cured, Completed treatment and Failed – Present the case along with the supporting documentation for the outcome determination to the Consilium using the Consiliumex. The Consilium will give the final approval of the outcome decision.

•

Defaulted - Inform the Treatment Center that the patient could not be located. The Treatment Center must be informed of the date when the patient reached two consecutive months of missing treatment. The Treatment Center should have known about this non-adherence long before the second month is reached.

•

Died - Inform the Treatment Center that the patient has died, the cause of death and date. Put reason and date of death on the space in the Category IV Treatment Card.

•

Transferred out – this is an interim outcome that should be declared by the transferring treatment center. The patient is registered as a Transfer-in by the receiving treatment center. The final treatment outcome will be relayed by the receiving unit to the original transferring unit. The interim outcome of “transferred out” is replaced with the final outcome.

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5.1.1 Present cases for determination of outcome (cured, completed and failed) to the Consilium using the Consiliumex. The clinical history of each patient who has fulfilled the ‘cured’, ‘treatment completed’ or ‘failed’ definition must be reviewed by the Consilium for approval of the final treatment outcome. The treating physician will fill out the discussion section of the Consiliumex and present the case to the Consilium as shown in the example below.

CONSILIUM DISCUSSION 010 – RECOMMENDATION ON TREATMENT OUTCOME TREATMENT OUTCOME AND SCHEDULE OF FOLLOW-UP EXAMINATIONS INTENSIVE PHASE

Inclusive dates

CONTINUATION PHASE

Inclusive dates

TREATMENT OUTCOME

Cured

FOLLOW-UP EXAMINATIONS

Oct 24, 2005 May 09, 2006

May 10, 2006 May 10, 2007

DATE OF LAST DOSE

DATE

Latest regimen

Z Km Ofx Pto Cs

Latest regimen

Ofx Pto PAS

May 10, 2007

REASON

EXAMINATIONS

1ST FOLLOW-UP

Nov 10, 2007

DSSM, CULTURE, CHEST X-RAY

2ND FOLLOW-UP

May 10, 2008

DSSM, CULTURE, CHEST X-RAY

3RD FOLLOW-UP

Nov 10, 2008

DSSM, CULTURE, CHEST X-RAY

4TH FOLLOW-UP

May 10, 2009

DSSM, CULTURE, CHEST X-RAY

Satisfied Criteria for cure

OTHERS

COMMENTS:

CONSILIUM OFFICER

Ruth Orillaza - Chi, MD

DATE

May 3, 2007

5.2 Record final outcome on Category IV Treatment Card On the last page of the Category IV Treatment Card is a section to record the outcome. Note down the date of the designated outcome. For most patients, the date will be the day the last dose was taken. For patients with the interim outcome of transferred out, the final outcome will be noted on the last day of treatment at the Treatment Center that received the patient. Note that a patient cannot be classified as “Cured”, “Treatment Completed” or “Failed” unless the Consilium has approved the designation. A patient with MDR-TB who completed treatment but did not have the necessary number of negative culture exams examinations can be classified only as “Treatment completed.” Likewise a patient who had a negative culture at baseline (within 30 days before and within 7 days after start of Category IV treatment) and has remained culture-negative all throughout treatment can be classified only as Treatment completed”. A patient who has stopped coming for treatment for 2 consecutive months and cannot be located or cannot be convinced to resume treatment is classified as “Defaulted”. Therefore, do not mark this treatment outcome on a patient’s card until a patient has missed treatment for 2 consecutive months. The date when the last dose was given should be recorded as the date of the outcome. When you transfer a patient from one treatment center to another treatment center to continue treatment, record the date and mark the outcome “Transferred out” on page 4 of the Category IV Treatment Card. You will inquire later about the treatment outcome of that patient from the Treatment Center that received the patient. When you learn the patient’s outcome from the receiving Treatment Center, record the final treatment outcome and the date of that outcome on the Category IV Treatment Card. Only if you cannot determine another outcome will you leave the outcome “Transferred out” with the date of the transfer. Treat MDR-TB Patients

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If a patient was a transfer from another Treatment Center (registration group was “Transfer in”). The receiving Treatment Center registers the patient as Trans-in in the Category IV Register using the original Category IV Registration No. and will not be included in that Treatment Center’s cohort analysis because this patient’s treatment outcome must be reported to the referring Treatment Center. Since cultures are used in order to define cures and failures, it is very important to collect sputum from each patient monthly. Without sputum culture results, a patient cannot be classified as cured. The treatment outcome of every MDR-TB patient managed at the Treatment Site is an important information for monitoring the facility’s performance. For an MDR-TB patient who will be eligible for final treatment outcome, the case will be presented to the Consilium by the Treatment Center. After the outcome has been declared, the original Category IV treatment Card at the Treatment Site will be brought back to the Treatment Center. Later, this information on patient outcomes from all Treatment Sites will be analyzed as a measure of how well the Treatment Center is managing MDR-TB cases. A photocopy of the Category IV Treatment Card will remain at the Treatment Site.

5.3 Record the final outcome on the Category IV Register Fill out the Category IV Register with the final outcome and the date of the last day the patient took the medicines.

Treatment outcome (17) Date of last intake of meds

Post-treatment follow-up monitoring (18) Ff up 1 /

Ff up 2 /

Ff up 3 /

Ff up 4 /

HIV status

(19)

2 /

Cured

5 / 10 / 07 /

2 /

/ /

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

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5.4 Provide patient education for post-treatment follow-up Provide patient education for post-treatment follow-up on the following topics: •

Instruct the patient to adhere to the recommended follow up visits after treatment.

•

Schedule of post-treatment follow-up is every 6 months for 2 yrs.

•

Remind patients of TB symptoms and to seek attention immediately if symptoms develop or household contacts to follow up if they develop symptoms

•

Possibility of relapse/re-infection

•

Healthy lifestyle: exercise, nutrition, no smoking, enough rest, no alcohol

See Module D: Inform Patients about MDR-TB for a detailed description of the information that should be provided during this meeting.

5.4.1 Fill-out the Post-treatment follow-up form The Post-treatment Follow-up Form shown in the next page facilitates communication for follow-up visits after treatment. The Treatment Center completes the top part of the form with the patients’ information including Category IV Registration No., the treatment outcome and the date of the last dose. Fill out the section on “Post-Treatment Follow-up 01” for the patient’s first follow-up visit after the treatment outcome was declared, and the succeeding sections for the succeeding visits. Write the new address, if applicable, in order to locate the patient if he does not follow-up subsequently. If the visit is not scheduled, i.e., not on the 6th, 12th, 18th, or 24th month, write the chief complaint that brought the patient to follow-up. See Post-Treatment Follow-up 02 for an example of this in the next page. In the example shown on the next page. “Post-treatment Follow-up Form 02” was accomplished about 4 months and not six months, from the first follow-up. This was because the patient developed productive cough for 3 weeks and fever and could not wait for the next scheduled follow-up. It should be emphasized to patients that they are welcome to follow-up at the Treatment Center anytime even out of their scheduled visits.

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Example of Post-treatment Follow-up Form MODULE C

REP U

Programmatic Management of Drug - Resistant TB (PMDT)

S NE PI

F THE PHI LIP IC O BL

POST-TREATMENT FOLLOW-UP FORM PATIENT INFORMATION: Name of patient: BALAGTAS, JOSE

(Last name, First name, M.I.)

Category IV Registration No.: 02 – 05 - 0097

Treatment outcome: Cured 05 / 10 / 07 Date of last dose:

2425 Balut Street, Tondo Manila (No., Street name, Purok, Barangay, City, Province, ZIP code) (02) 244-68-47 Contact nos.: E-mail address: Treatment site: Sampaguita Health Center # 3436 Balut, Tondo Manila TS address: (No., Street name, Purok, Barangay, City, Province, ZIP code)

Address:

POST-TREATMENT FOLLOW-UP 01 Any change in address:

If yes, write new address: month post treatment Is this a scheduled visit: Any chief complaint: Symptoms and duration Date

Yes

3 No

Yes

Use permanent address above

11 / 13 / 07

3 Yes

6th month No

Systems:

Cough 3 On &Off x 2 months Fever

Plans: Laboratory procedures:

Prescriptions:

10th month

3 No

cough and fever

Cough 3 productive x 3 weeks Fever 3 x 3 days

Hemoptysis Weight loss

Night sweats

Others

Ht.: 167 PR: 85 BP: 120/80

Wt.: 56kg RR: 22 T : 37.2

Skin: good skin turgor HEENT: anicteric sclerae Chest/Lungs: decreased breath sounds RL

no murmur no palpable masses no clubbing not done

3 DSSM 2x 2x 3 TBC 3 DST With resolution of cavities compared with cxr done in 11/13/07 none

Other plans: Name and Signature of MD:

03/21/08

Back/Chest pain

CXR Comparative reading of CXR:

Use permanent address above

Weight loss

CVS: GI: Extremities: Neuro:

Assessment:

3 No

Yes

Back/Chest pain 3 Hemoptysis

Physical exam: Vital signs:

POST-TREATMENT FOLLOW-UP 02

Dave Vergara, M.D.

Ht.: 167 Wt.: 49.5kg PR: 85 RR: 25 BP: 120/80 T : 37.7 Skin: good skin turgor HEENT: anicteric sclerae Chest/Lungs: decreased breath sounds RL + CVS: GI: Extremities: Neuro:

occasional wheezing in all LF no murmur no palpable masses no clubbing not done

3 DSSM2x 3 TBC 2x 3 DST CXR

no significant difference Paracetamol 500mg/tab every 4 hrs for fever, Amoxicillin 500mg/cap TID x 1 wk. Increase oral fluid intake Dave Vergara, M.D. POST-TREATMENT FOLLOW-UP FORM | page 1 of 2

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Now do Exercise E – Written Exercise with individual feedback When you have reached this point in the module, do Exercise E. Follow the instructions for this exercise. When you have finished the exercise, review your answers with a facilitator.

Exercise E: Written Exercise with Individual Feedback Decide treatment outcomes The purpose of this exercise is to practice determining the treatment outcomes of different patients. Decide and record the treatment outcomes of the following patients.

Case 1: AA In the previous exercise, you found that AA, a diabetic with poor sugar control and weight loss had positive sputum smears on the 4th month for two consecutive months after negative conversion for three months (smear reconversion) with M.tb culture. He was sent back for supervised treatment at the Treatment Center. His last dose was given on May 20, 2009. DB has continued treatment for 12 months now with the following DSSM and culture results: Results of sputum examination Month

Date

Smear

Culture

Weight (kg)

5/10/08

M.tb

6/12/08

7/11/08

8/8/08

9/6/08

M. tb

10/10/08

M. tb

11/9/08

M. tb

12/6/08

1/7/09

M. tb

2/8/09

M. tb

3/9/09

M. tb

4/10/09

M. tb

5/11/09

M. tb

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Record the date and treatment outcome on the excerpt of his Category IV Treatment Card below: (5)Treatment outcome OUTCOME

Reason if Died/Defaulted OR

DATE

Facility transferred to

Cured Completed Died Failed Defaulted Trans-out

Case 2: LS LS completed 21 months of treatment on 10 August 2010. He is adherent to his treatment and is now asymptomatic but he had poor compliance to sputum monitoring. Below are his DSSM and culture results. Results of sputum examination Month

Date

Smear

Culture

Weight (kg)

11/28/08

M.Tb

12/2/08

51.2

1/2/09

51.5

2/3/09

52.5

3/2/09

4/3/09

5/4/09

56.5

56.8

57.1

57.5

57.4

56.5

59.4

8/4/09

10 11

10/2/09

3/8/10

8/6/10

0 ND = not done

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Record the date and treatment outcome on the excerpt of his Category IV Treatment Card below: (5)Treatment outcome OUTCOME

Reason if Died/Defaulted OR

DATE

Facility transferred to

Cured Completed Died Failed Defaulted Trans-out

Case 3: JT JT completed 19 months of MDR-TB treatment on April 7, 2009. Below are her culture examination results. Results of sputum examination Month

Date

Smear

Culture

Weight (kg)

9/28/07

M. tb

10/10/07

M.tb

11/11/07

12/12/07

1/1/08

2/2/08

3/3/08

4/4/08

5/5/08

6/6/08

7/7/08

8/8/08

9/9/08

10/10/08

11/11/08

12/12/08

1/1/09

2/2/09

3/3/09

4/4/09

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Record the date and treatment outcome on the excerpt of her Category IV Treatment Card below: (5)Treatment outcome OUTCOME

Reason if Died/Defaulted OR

DATE

Facility transferred to

Cured Completed Died Failed Defaulted Trans-out

Case 4: RM Below are RM’s sputum smear and culture examination results. It’s been two months since he last came for treatment on June 2, 2009. When the health worker went to his home 2 weeks earlier, the apartment was vacant. The contact person, the vendor, told the health worker that the family had moved away. The vendor said that RM told her that he had finished the MDR-TB treatment. She did not know where they moved. Results of sputum examination

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Month

Date

Smear

Culture

Weight (kg)

5/5/08

M.tb

6/10/08

7/11/08

60.5

8/12/08

9/9/08

10/11/08

11/11/08

59.5

12/15/08

1/13/09

2/9/09

62.5

3/8/09

4/8/09

Pending

5/8/09

pending

MODULE C

Record the date and treatment outcome on the excerpt of RM’s Category IV Treatment Card below: (5)Treatment outcome OUTCOME

DATE

Reason if Died/Defaulted OR Facility transferred to

Cured Completed Died Failed Defaulted Trans-out

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Summary of important points yy

MDR-TB treatment is a long process in which both the health care worker and the patient must dedicate themselves to completing the treatment. If anti-TB drugs are taken incorrectly or irregularly, the patient will not be cured. Many times this treatment represents a patient’s last opportunity to receive treatment.

Health workers must take an active role in ensuring that every MDR-TB patient takes the recommended drugs, in the right combinations, on the correct schedule, for the appropriate duration. A health worker does this by giving supervised treatment, that is, watching each patient swallow the tablets at least 6 days a week. The health worker can immediately detect any interruption in treatment and take action, such as tracing the patient and encouraging the patient to resume treatment. Supervised treatment can also build a supportive relationship that improves adherence to the treatment regimen.

The correct treatment regimen is selected on the basis of the patient’s history of taking medications and most importantly, the results of the DST tests. The Consilium will make the final decision concerning what treatment regimen to give. The Treatment Center physician must make a note of any special circumstances that the patient may have such as HIV/AIDS, diabetes or substance dependence, among others that may necessitate special handling.

The Category IV Treatment Card is the record of the patient’s MDR-TB treatment. Fill it out completely. Be sure to record a complete address, one that you could use to locate a patient who stops coming for treatment. Also record the name and address of a contact person who will know how to locate the patient if needed.

All MDR-TB patients must be listed in the Category IV Register with all required information provided.

Prior to enrollment, baseline sputum for smear, culture and DST using the Mycobacteriology Request Form must be accomplished once the patient returns to the Treatment Center. Chest x-ray and blood chemistries must also be requested in order to begin treatment.

Look up the drug regimen approved by the Consilium for the patient. Record on the Category IV Treatment Card the drugs for both phases of treatment. Record the number of tablets and frequency for each dose.

All patients will begin MDR-TB treatment at a Treatment Center.

Obtain or prepare a drug pouch that will hold the patient’s daily doses of treatment for one week. On this pouch you should mark the name of the patient and the Category IV Registration No. Weekly, prepare enough doses for the patient until the next week and put them in individual plastic packets.

Provide continuing health education to the patient and the family about MDR-TB so that they understand the disease, its public health impact, and the need to complete the treatment regimen correctly. As you continue to see the patient, reinforce messages about MDR-TB treatment and give support for continuing to take the drugs. Ask the patient to inform you of any plans to move or go away for a few days, so that you can arrange uninterrupted treatment.

To supervise TB treatment, remember: ––

Do not make MDR-TB patients coming for supervised treatment wait in a line at the health facility.

––

Watch the patient swallow the tablets.

––

Record the treatment on the Category IV Treatment Card by signing the card below the date with 3 initials. (Record “X” for a missed dose.)

If a patient has a serious and uncontrolled ADR, immediately refer the patient to the Treatment Center MD or hospital. If the patient has minor ADR, reassure the patient, give advice on how to relieve the symptoms without stopping anti-TB treatment, or give an ancillary drug to counteract the side effect. ADRs are more common in people infected with HIV, the elderly and those with comorbidities.

Most MDR-TB patients will experience some side effects during treatment; however, only a very small proportion will require discontinuation of MDR-TB treatment.

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Monitor a patient’s progress by follow-up sputum and culture examinations. Culture conversion from positive to negative is the best indicator that the treatment was taken regularly and was effective. Collect sputum for follow-up examination every month. One sputum sample monthly is required for each follow-up examination.

A patient must be culture negative for at least 1 month followed by 2 consecutive smears in order to be considered eligible for decentralization to a Treatment Site. If the succeeding culture results are positive, continue treating the patient at the Treatment Center. If culture-negative and the other criteria are met, begin the decentralization process.

Once the patient has had 4 consecutive months of culture-negative results, has received an injectable agent for at least 6 months, he may begin the continuation phase, dropping the injectable agent. The Consilium will approve the shift to continuation phase.

When the patient completes treatment, meets the criteria for treatment failure or stops coming for treatment, record the treatment outcome on the Category IV Treatment Card. The possible outcomes are: Cured, Treatment completed, Failed, Died, Defaulted, Transferred out. For patients with prospective outcomes of Cured, Treatment completed, or Failed, the Consilium must review and approve the treatment outcome. The definition of “Cured” is a patient who has completed treatment with at least five consecutive negative cultures from samples collected at least 30 days apart in the final 12 months of treatment.

The Consilium determines the patient’s treatment outcome.

When a treatment outcome is reached, record this on the Category IV Treatment Card and in the Category IV Register.

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Self-assessment questions Answer the self-assessment questions below to check what you have learned. Then compare your answers to those pages 138-143. 1. Initially, a MDR-TB patient’s regimen should include: (check all that apply) At least four drugs with either certain, or almost certain, effectiveness The first-line anti-TB drugs whenever there is no proof of resistance Drugs to which the strain showed susceptibility by DST. An injectable, either an aminoglycoside or capreomycin Isoniazid and Rifampicin, the two most powerful anti-TB drugs b) At a minimum, how long must treatment for MDR-TB last? c) Why is a longer treatment regimen, with more drugs, needed for MDR-TB patients?

2. Fill in the Category IV Treatment Card on the next page for this patient, seen at the MMC Treatment Center , using the information below: Jon Carillon de Guzman, aged 35, male, lives at 477 Mango St., Brgy. San Diego, Pasig City. He will go to the MMC for MDR-TB treatment. His laboratory results are shown below: Lab results and dates – DSSM – Culture – DST released on December 1, 2007 June 13, 2007: DSSM 2+/M. tb (specimen # 01-T-76783-1) June 16, 2007: DSSM 3+/M. tb (specimen # 01-T-76783-2) DST: resistant to H R E S susceptible to Z, Cfx, Lfx, Km Jon had an initial weight of 56 kg . He was treated for TB with Category I regimen about 2 years ago (December 2005) in a health center in Pasig. He had good compliance, completed treatment but now he is sick again. Jon has no comorbidity and is a non-smoker and non-alcoholic beverage drinker. The Consilium approved him for treatment on December 3, 2007 with the following drug regimen: Z Km Ofx Pto Cs. He was started on the regimen on December 5. You observed him take his first dose on this day. 3. Under which circumstances may an MDR-TB patient receive drugs for self-administration? When the patient has to travel When the patient has a family emergency When the patient cannot come to the DOTS center because s/he feels sick When the patient has a family member who will provide supervised treatment When the patient has completed the intensive phase When a patient has never missed a dose 4. a) What is the most critical aspect of directly observed treatment? (select one answer) i. talking to the patient and giving support ii. providing the drugs to the patient iii. watching the patient swallow the drugs iv. recording the treatment on the Treatment Card b) If a patient who takes treatment daily missed an appointment yesterday, what should be given for treatment today? 122 Treat MDR-TB Patients

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5. The following patients have been decentralized to your Treatment Site: a) An MDR-TB patient complains of tolerable headache in the evenings after work and dizziness relieved by lying down. What should you do? b) An MDR-TB patient taking PAS complains of gastritis and diarrhea. What can you do? c) An MDR-TB patient taking Ethambutol complains of blurred vision. What should you do? 6. When should an MDR-TB patient have a first follow-up sputum examination? What tests should be done? 7. Explain to the patient who has had a negative culture result for ___consecutive months from the beginning of treatment and has received an injectable agent for at least ____ months that the treatment has worked well. The patient is no longer _________________________and is ready to begin the next phase of treatment. Congratulate the patient, but explain that there are still a number of months to continue and the importance of continuing the treatment 8. State the treatment decision for the following cases. a) An MDR-TB patient at a Treatment Site has been on treatment for 7 months and has been culture negative for the last 4 months. The patient has been taking all of the medicines with minimal absences and no significant side effects. What is the treatment decision at this time? b) An MDR-TB patient at a Treatment Center has been on treatment for 3 months.His sputum smears have been positive since the 1st month of treatment, however, the culture result of the first month specimen is negative. The patient has been taking all of the medicines with minimal absences and no significant side effects. What is the treatment decision at this time? c) An MDR-TB patient at a Treatment Site has taken treatment for 5 months intensive phase regimen and has been culture negative for the last 3 months. The patient has been taking all of the medicines with minimal absences and no significant side effects. What is the treatment decision at this time? d) An MDR-TB patient at a Treatment Center has taken treatment for 3 months and has been smear negative on months 2 and 3. The last culture (for month 1) came back negative. The patient has been taking all of the medicines with minimal absences and no significant side effects. What is the treatment decision at this time?

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Start date (if unknown, put year)

H = Isoniazid R = Rifampicin Z = Pyrazinamide E = Ethambutol S = Streptomycin

First-line drugs

Km = Kanamycin Am = Amikacin Cm = Capreomycin Cfx = Ciprofloxacin Ofx = Ofloxacin Lfx = Levofloxacin Mfx = Moxifloxacin

Gfx = Gatifloxacin Pto = Prothionamide Eto = Ethionamide Cs = Cycloserine PAS = P-aminosalicylic acid Clr = Clarithromycin AmxClv = Co-amoxiclav

Second-line drugs

Drug abbreviations Date

If Yes, specify drug and duration of use: _____________________________________________

Yes

Regimen (write regimen in drug abbreviation)

Used second line drugs previously? (4)

No.

1 2 3 4 5 6 7 8 9 10

Purpose

New After Cat I failure After Cat II failure After Cat IV failure After default Cat I relapse Cat II relapse Cat IV relapse Transfer-in Other 10.1 Non-dots tx 10.2 Other (+) 10.3 Other (-)

(2) Registration group

CLASS: (15)

(5) Consilium meetings

( TC - YY - NNNN )

(+)

Decision

ART= antiretroviral therapy CPT= co-trimoxazole preventive therapy

Y Started on CPT: Date: ____/____/ _____

(-) Y N Started ART: Date: ____/____/ _____

Results:

Date of test: ____/____/ _____

(3) HIV information HIV testing done:

CLASS:

Funding source: (14)

Treatment Center: (13)

Treatment start date: (12)

select one only (√)

Both

contact no.:

Previous TB treatment episodes (1)

Extrapulmonary

Site of disease:

Treatment outcome

( MM / DD / YYYY )

Pulmonary

REP U

Category IV Registration No. (11 )

Initial height: (9)

Initial weight: (8)

Date of birth (7)

Age / Sex: (6)

Contact numbers: (4) Person to notify (relationship) and (5)

(Last name, First name, MI)

City address: (3)

Permanent address: (2)

Name: (1)

Category IV Treatment Card

Programmatic Management of Drug - Resistant TB (PMDT)

F THE PHI LIP IC O BL

S NE PI

Contact Initial Investigation Form/ Page 1 of 4

Date

DATE

DRUG Preparation

300 mg

500 mg

Z 1G

S 1G

Patient name:

Comments

400 mg

CATEGORY IV REGIMEN (date started and dosage) change of dosage and cessation of drugs:

CATEGORY IV TREATMENT CARD | page 2 of 4

Am 1G

Cm 200 mg

Ofx

Lfx 500 mg

Date

500 mg

Cfx 400 mg

Mfx 400 mg

Gfx 250 mg

Pto/ Eto 4G

Pas

Comments

250 mg

Cs 500 mg

Clr

Category IV Registration No.

Others

Programmatic Management of Drug - Resistant TB (PMDT)

F THE PHI LIP IC O BL

REP U

Others

S NE PI

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125

Note: Encircle date of regimen change

X = drugs not taken / Absent I = incomplete regimen H = Sunday/ Holiday

MARK IN THE BOXES: Initials of HW (3 letters)=Supervised TC/TS= Treatment Center/ Site DOT

Month / Year

(√) if done

Blood chemistry

HW initials

15th mo

12th mo

24th mo

Schedule

21st mo

HW initials

9th mo

(√) if done

CXR

18th mo

Schedule

6th mo

3rd mo

Baseline

ADMINISTRATION OF DRUGS (one line per month) Patient name:

CATEGORY IV TREATMENT CARD | page 3 of 4

Schedule

(√) if done

CXR

REP U

(√) if done

Blood chemistry HW initials

Monthly Cumulative # of doses taken doses taken

Schedule

31 Wt (Kg)

HW initials

Category IV Registration No.

Programmatic Management of Drug - Resistant TB (PMDT)

F THE PHI LIP IC O BL

S NE PI

Month of Treatment

6th 12th 18th 24th

S1 S2 B 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24

Request Given

Patient name:

Date collected

DSSM

(2) Post-treatment follow-up

Laboratory No. TBC

DSSM

DSSM/Culture

(1) Sputum monitoring

CATEGORY IV TREATMENT CARD | page 4 of 4

2 TBC

Km Am Cm Cfx Ofx Lfx Mfx

(3) Drug Susceptibility Testing (DST) results

1+ 2+ 3+ 4+

1-9 AFB per 10 fields 1-9 AFB per field 10-90 AFB per field > 90 AFB per field

+n 1+ 2+ 3+

1-9 AFB per 100 OIF 10-99 AFB per 100 OIF 1-10 AFB per OIF >10 AFB per OIF

# of colonies 1+ 2+ 3+ 4+

10-100 100-200 200-500 >500

0 <10 colonies

No growth

Recording cultures (TBC) # of colonies

No AFB seen

Recording AFB smear using Ziehl Neelsen stain

No AFB in at least 60 fields (2 sweeps)

Recording AFB using Auramine Rhodamine CODES

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Trans-out

Defaulted

Failed

Died

Completed

Cured

OUTCOME

DATE

PAS

Other

REP U

DATE

Reason if Died/Defaulted OR Facility transferred to

(5)Treatment outcome

0 1 2 3 4 5

READING Baseline

(4) Chest X-ray readings

Pto Eto

Programmatic Management of Drug - Resistant TB (PMDT)

NOTATION method: R=Resistant S=Susceptible N=Non-viable C=Contaminated ND=Not done

Date released Laboratory No.

Category IV Registration No.

Mtb

F THE PHI LIP IC O BL

S NE PI

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Now compare your answers with those below and on the following pages.

Answers to self-assessment questions 1. þþ þþ þþ þþ

At least four drugs with either certain, or almost certain effectiveness The first-line anti-TB drugs whenever there is no proof of resistance An injectable, either an aminoglycoside or capreomycin Drugs to which the strain showed susceptibility by DST.

b) 18 months c) Resistant bacilli take longer to kill because the second- line drugs that need to be used are less effective than first- line agents and the clinician must ensure that all bacilli are killed in order to lessen the chances of a relapse or further increases in resistance

The accomplished Category IV Treatment Card for Jon C. de Guzman is shown on pages 129–132. See if you have all the entries in your own Category IV Treatment Card.

128 Treat MDR-TB Patients

December 05

Treatment Completed

H = Isoniazid R = Rifampicin Z = Pyrazinamide E = Ethambutol S = Streptomycin

First-line drugs

Km = Kanamycin Am = Amikacin Cm = Capreomycin Cfx = Ciprofloxacin Ofx = Ofloxacin Lfx = Levofloxacin Mfx = Moxifloxacin

Gfx = Gatifloxacin Pto = Prothionamide Eto = Ethionamide Cs = Cycloserine PAS = P-aminosalicylic acid Clr = Clarithromycin AmxClv = Co-amoxiclav

Second-line drugs

Drug abbreviations 12/3/07

Date

If Yes, specify drug and duration of use: _____________________________________________

Yes

2 HRZE

Regimen (write regimen in drug abbreviation)

Used second line drugs previously? (4)

Start date (if unknown, put year)

No.

Purpose

New After Cat I failure After Cat II failure After Cat IV failure After default Cat I relapse Cat II relapse Cat IV relapse Transfer-in Other 10.1 Non-dots tx 10.2 Other (+) 10.3 Other (-)

Regimen Design

1 2 3 4 5 6 7 8 9 10

(2) Registration group

(+)

Decision

ART= antiretroviral therapy CPT= co-trimoxazole preventive therapy

Y Started on CPT: Date: ____/____/ _____

(-) Y N Started ART: Date: ____/____/ _____

Results:

Date of test: ____/____/ _____

(3) HIV information

Approved for Category IV Treatment

(5) Consilium meetings

HIV testing done:

CLASS:

Funding source: (14) CLASS: (15)

( TC - YY - NNNN ) 12/05/07

Treatment Center: (13) TDF-MMC

Treatment start date: (12)

select one only (√)

Both

contact no.:

Previous TB treatment episodes (1)

Site of disease: 3 Pulmonary Extrapulmonary

Initial height: (9)

Contact numbers: (4) Person to notify (relationship) and (5)

Treatment outcome

( MM / DD / YYYY )

Initial weight: (8) 56 kg

Date of birth (7)

REP U

Category IV Registration No. (11 )

City address: (3)

(Last name, First name, MI) Permanent address: (2) 477 Mango St., Brgy. San Diego, Pasig City

Age / Sex: (6) 35 / M

S NE PI

Name: (1) De Guzman, Jon Carillon

Category IV Treatment Card

Programmatic Management of Drug - Resistant TB (PMDT)

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129

Contact Initial Investigation Form/ Page 1 of 4

Date

12/5/07

DATE

DRUG Preparation

300 mg

500 mg

Z 1G

Comments

400 mg

CATEGORY IV REGIMEN (date started and dosage) Patient name: change of dosage and cessation of drugs:

Category IV Treatment Card | page 2 of 4

Am 1G

200 mg

Ofx

De Guzman, Jon Carillon

Lfx 500 mg

Date

500 mg

Cfx 400 mg

Mfx 400 mg

Gfx

250 mg

Pto/ Eto 4G

Pas

Comments

250 mg

Cs 500 mg

Clr

Category IV Registration No.

50 mg

Programmatic Management of Drug - Resistant TB (PMDT)

F THE PHI LIP IC O BL

REP U

Others

S NE PI

MODULE C

VAB

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Note: Encircle date of regimen change

X = drugs not taken / Absent I = incomplete regimen H = Sunday/ Holiday

MARK IN THE BOXES: Initials of HW (3 letters)=Supervised TC/TS= Treatment Center/ Site DOT

Dec-07

Month / Year

HW initials

Schedule

(√) if done

Blood chemistry

HW initials

15th mo

12th mo

9th mo

24th mo

21st mo

(√) if done

CXR

18th mo

Schedule

6th mo

De Guzman, Jon Carillon

3rd mo

Baseline

ADMINISTRATION OF DRUGS (one line per month) Patient name:

CATEGORY IV TREATMENT CARD | page 3 of 4

Schedule

(√) if done

CXR

REP U

(√) if done

Blood chemistry HW initials

Monthly Cumulative # of doses taken doses taken

Schedule

31 Wt (Kg)

HW initials

Category IV Registration No.

Programmatic Management of Drug - Resistant TB (PMDT)

F THE PHI LIP IC O BL

S NE PI

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131

Month of Treatment

6th 12th 18th 24th

S1 S2 B 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24

Request Given

01-T76783-1

6/13/07

DSSM

(2) Post-treatment follow-up

Laboratory No.

Date collected

Mtb

TBC

DSSM

DSSM/Culture

(1) Sputum monitoring

Patient name: De Guzman, Jon Carillon

CATEGORY IV TREATMENT CARD | page 4 of 4

Mtb

TBC

01-T76783-1 R

S ND ND S

1+ 2+ 3+ 4+

1-9 AFB per 10 fields 1-9 AFB per field 10-90 AFB per field > 90 AFB per field

+n 1+ 2+ 3+

1-9 AFB per 100 OIF 10-99 AFB per 100 OIF 1-10 AFB per OIF >10 AFB per OIF

# of colonies 1+ 2+ 3+ 4+

10-100 100-200 200-500 >500

0 <10 colonies

No growth

Recording cultures (TBC) # of colonies

No AFB seen

Recording AFB smear using Ziehl Neelsen stain

No AFB in at least 60 fields (2 sweeps)

Recording AFB using Auramine Rhodamine CODES

Trans-out

Defaulted

Failed

Died

Completed

Cured

OUTCOME

DATE

Pto Eto

PAS

ND S ND ND ND ND

Km Am Cm Cfx Ofx Lfx Mfx

(3) Drug Susceptibility Testing (DST) results

Programmatic Management of Drug - Resistant TB (PMDT)

Other

REP U

DATE

Reason if Died/Defaulted OR Facility transferred to

(5)Treatment outcome

0 1 2 3 4 5

READING Baseline

(4) Chest X-ray readings

NOTATION method: R=Resistant S=Susceptible N=Non-viable C=Contaminated ND=Not done

12/1/07

Date released Laboratory No.

Category IV Registration No.

Mtb

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MODULE C

3. There are no circumstances under which MDR-TB patients can receive drugs for self-administered treatment or treatment from a family member. 4. a) iii. watching the patient swallow the drugs. b) Give the patient today’s dose. Do not give a double dose. (See 3.1) 5. a) You should reassure the patient that these side effects are minor inconveniences and will very likely pass. You should tell the patient to continue to take the drugs, give symptomatic treatment, e.g., paracetamol for the headache and an anti-dizziness pill. You instruct him to let you know if they get worse. b) You may split the dose into two times a day with both doses supervised. Assess the state of hydration; give oral fluids if mild, or refer to the Treatment Center or hospital for IV fluids, if severe. Refer to the Treatment Center for ancillary drugs for the gastritis, or for possible referral to a specialist, e.g., if the gastritis is causing bleeding. c) Stop the medicine immediately and refer to the Treatment Center MD. 6. At the end of the first month of treatment the patient should have a DSSM and culture. 7. Explain to the patient who has had a negative culture result for 4 consecutive months from the beginning of treatment and has received an injectable agent for at least 6 months that the treatment has worked well. The patient is no longer infectious and is ready to begin the next phase of treatment. Congratulate the patient, but explain that there are still a number of months to continue and the importance of continuing the treatment 8. a) Patient can begin continuation phase pending a review by the Consilium. Present the case to the Consilium using the Consiliumex. b) Nothing at the moment; just continue treatment. Patient must have at least one negative culture followed by two consecutive negative smears for decentralization. c) Nothing at the moment. A patient must have been receiving an injectable agent for at least 6 months and must have had 4 consecutive months of negative culture to be eligible for the continuation phase. d) Prepare the patient for decentralization.

End of Module C Congratulations on finishing this module!

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134 Treat MDR-TB Patients

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References 1. Guidelines for the Programmatic Management of Drug-resistant Tuberculosis, World Health Organization, Geneva, Switzerland, 2006. (WHO/HTM/TB/2006.361). 2. The National Statistics Coordination Board, 2006. 3. National Tuberculosis Control Program, Revised Manual of Operations, Department of Health, Manila, 2005. 4. 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.

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Annexes A: Recommended daily dosages of anti-TB drugs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137 B: Anti-TB Drugs available for use in the Philippines under a programmatic setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140 C: Socioeconomic Classification Guide for MDR-TB patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141 D: Social Case Study Report Form (SCSRF). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144 E: Category IV Treatment Card . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148 F: Category IV Register . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152 G: Monthly follow-up visit to the Treatment Center physician . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155

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Annex A Recommended daily dosages of anti-TB drugs Medication (Drug Abbreviation), (Common Presentation)

Weight Class < 33 KG

33-50 KG

51-70 KG

> 70 KG (ALSO MAX. DOSE)

GROUP 1: FIRST-LINE ORAL ANTITUBERCULOSIS DRUGS Ethambutol (E) (100, 400 mg) Pyrazinamide (Z) (500 mg)

25 mg /kg 30-40mg/kg

800-1200 mg

1200-1600 mg

1600-2000 mg

1000-1750 mg

1750-2000 mg

2000-2500 mg

GROUP 2: INJECTABLE ANTITUBERCULOSIS DRUGS Streptomycin (S) (1 g vial) Kanamycin (Km) (1 g vial) Amikacin (Am) (1 g vial) Capreomycin (Cm) (1 g vial)

15-20 mg/kg

500-750 mg

1000 mg

800 mg

800-1000 mg

750 mg

750-1000 mg

400 mg

GROUP 3: FLUOROQUINOLONES Ofloxacin (Ofx) (200, 300, 400 mg) Levofloxacin (Lfx) (250, 500 mg) Moxifloxacin (Mfx) (400 mg)

Usual adult dose for MDR-TB is 800 mg Usual adult dose for MDR-TB is 750 mg Usual adult dose for MDR-TB is 400 mg Usual adult dose for MDR-TB is 400 mg

Gatifloxacin (Gfx) (400 mg)

GROUP 4: ORAL BACTERIOSTATIC SECOND-LINE ANTITUBERCULOSIS DRUGS Ethionamide (Eto) (250 mg) Protionamide (Pto) 250 mg Cycloserine (Cs) (250 mg) Terizidone (Trd) (300 mg) P-amino salicylic acid (PAS) (4 g sachet)

500 mg

750 mg

750-1000 mg

15-20 mg/kg 600 mg

600 mg

900 mg

Dosing can vary with manufacture and preparation: check dose recommended by the manufacturer. Thioacetazone (Th) Usual dose is 150 mg for adults GROUP 5: AGENTS WITH UNCLEAR EFFICACY (NOT RECOMMENDED BY WHO FOR ROUTINE USE IN MDR-TB PATIENTS) Clofazimine (Cfz), Amoxicillin/Clavulanate (Amx/Clv), Clarithromycin (Clr, Linezolid (Lzd). Efficacy and dosing in the treatment of drug-resistant TB not fully determined. Isoniazid (H) 900 mg twice weekly Sodium PAS

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Pediatric dosing of second-line antituberculosis drugs DAILY DOSE (MG/KG/DAY)

FREQUENCY DAILY DOSE

MAXIMUM

Streptomycin

20–40

Once daily

Kanamycin

15–30

Once daily

15–22.5

Once daily

Capreomycin

15–30

Once daily

Ofloxacin

15–20

Twice daily

800 mg

Levofloxacin

7.5–10

Once daily

750 mg

Moxifloxacin

7.5–10

Once daily

400 mg

Gatifloxacin

7.5–10

Once daily

400 mg

Ethionamide

15–20

Twice daily

Prothionamide

15–20

Twice daily

Cycloserine

10–20

Once or twice daily

150

Twice or thrice daily

12 g

DRUG

Amikacin

p-aminosalicylic acid * Ethambutol should be dosed at 15 mg/kg

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Dosage adjustment for renal insufficiency Drug

Change in Frequency

Recommended Doseb and Frequency for Patients with Creatinine Clearance <30ml/min or for Patients receiving Haemodialysis

Isoniazid

No change

300mg once daily, or 900 mg three times per week

Rifampicin

No change

600 mg once daily, or 600 mg three times per week

Pyrazinamide

Yes

25-35 mg/kg per dose three times per week (not daily)

Ethambutol

Yes

15-25 mg/kg per dose three times per week (not daily)

Ofloxacin

Yes

600-800 mg per dose three times per week (not daily)

Levofloxacin

Yes

750-1000 mg per dose three times per week (not daily)

Moxifloxacin

No change

400 mg once daily

Gatifloxacin

Yes

400 mg per dose three times per week (not daily)

Cycloserine

Yes

250 mg once daily, or 500 mg/dose three times per week

Terizidone

----

Recommendations not available

Protionamide

No change

250-500 mg per dose daily

Thionamide

No change

250-500 mg per dose daily

P-aminosalycylic acidd

No change

4 g / dose, twice daily

Streptomycin

Yes

12-15 mg/kg per dose two or three times per week (not daily)

Capreomycin

Yes

12-15 mg/kg per dose two or three times per week (not daily)

Kanamycin

Yes

12-15 mg/kg per dose two or three times per week (not daily)

Amikacin

Yes

12-15 mg/kg per dose two or three times per week (not daily)

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MODULE C

ANNEX B Anti-TB Drugs available for use in the Philippines under a programmatic setting Grouping

Drugs (abbreviation)

Group 1 – First-line oral anti-TB agents

Isoniazid (H), Rifampicin (R), Ethambutol (E); Pyrazinamide (Z)

Group 2 – Injectable anti-TB agents

Streptomycin (S); Kanamycin (Km); Amikacin (Am); Capreomycin (Cm)

Group 3 – Fluoroquinolones

Ciprofloxacin (Cfx); Ofloxacin (Ofx); Levofloxacin (Lfx); Moxifloxacin (Mfx); Gatifloxacin (Gfx)

Group 4 – Oral bacteriostatic second-line anti-TB agents

Ethionamide (Eto); Prothionamide (Pto); Cycloserine (Cs); p-aminosalicylic acid (PAS)

Group 5 – Anti-TB agents with unclear efficacy (not recommended by WHO for routine use in MDR-TB patients)

Clofazimine (Cfz); Amoxicillin/Clavulanate (Amx/Clv); Clarithromycin (Clr); Linezolid (Lzd)

140 Treat MDR-TB Patients

MODULE C

ANNEX C Socioeconomic Classification Guide for MDR-TB patients Objective: To determine the socioeconomic classification of MDR-TB patients To identify patients who need enablers To determine the kind of enablers that patients need

Category Class A -Patients whose aggregate monthly family income is equal to or above the NSCB subsistence threshold Class B -Patients whose aggregate monthly family income is more than 50% of the NCSB subsistence threshold

Clinic Share ––

––

–– Class C - Patients whose aggregate monthly income is less than 20% of the NSCB subsistence threshold

––

–– ––

free professional service fee and free second-line anti TB drugs

free professional service and free second-line anti TB drugs free professional service and free second-line anti TB drugs free examinations like sputum examination, chest x-ray, blood chemistry examination. Provision of food basket, transportation allowance Possible admission to KASAKA for 6 months

Patient’s Share

Enablers (project based)

- Donations

Not eligible for enablers

- Donations

Not eligible for enablers

Travel or housing support - Donations

Hospitalization support Ancillary drugs

National Statistics Coordination Board (NSCB) As of 2006 Food threshold for a family of six members……….Php 18,000.00 1. Modifiers related to personal circumstances Eg. Patients in crisis situations Patients with personal limitations Patients with no family, relatives or guardians 2. Modifiers Related to Community Circumstances Eg.

Patients from squatter or slum areas Patients who are affected by natural disasters Patients who are dislocated from their home or community Patients belonging to cultural and ethnic groups.

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MODULE C

Class A- Patients with family of five and have P18,000 food threshold Example: Pt. IPA ( 2 sisters, parents) Monthly income :– P40,000.00 Monthly expenses:

House: 5,000.00 Electricity: 2,000.00 Water: 1,000.00 Tuition fee: 12,000.00

Total expenses = P 20,000.00 P 40,000.00 – P 20,000.00 __________

(monthly income) (monthly expenses)

= P 20,000.00 /31 __________

allowance for food days

= 645.00 645.00/3 meals /5 pax __________

= P43.00

( budget/day/person/meal)

Class B- Patients with family of five and have P9,000.00 food threshold Example: Pt. MMS Monthly income: P13,000.00 Monthly expenses: Water: P 300.00 Electricity: P 800.00 Transpo: P1200.00 Total expenses: P2300.00

13,000.00 – 2,300.00 __________

10,700.00 /31 days __________

345.00 /3 _________

meals/day pax

115.00 /3 _________

meals

P 38.00

142 Treat MDR-TB Patients

(monthly income) (monthly expenses)

meal/pax/day

MODULE C

Class C-1, C-2 –Patients with family of five earn below P 9,000.00 Example: Pt.WMM Monthly income: P6,000.00 Monthly expenses: Water: P 200.00 Electricity: P800.00 House Rent: P3,000.00

Total expenses: P4,000.00

P 6,000.00 – P 4,000.00 __________

P 2,000.00

P 2,000.00 / 31 __________ P 64.00 / 4 __________

P 16.00 /3 __________ P 5.33

(monthly income) (monthly expenses)

days meals/day pax

meals (meal/pax/day)

Note: Regardless of patient classification, patients are entitled to receive free services from the Programmatic Management of MDR-TB. It includes second-line drugs, ancillary drugs, doctors’ professional fees, laboratory examination-DSSM, culture, drug susceptibility testing, blood examination, chest x-ray examination and other examinations related to MDR-TB treatment. This procedure is extracted from the DOH Manual used by the Medical Social Service at the Hospital. Family income is subject to change every year depending on NSCB recommendations.

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MODULE C

Annex D SOCIAL CASE STUDY REPORT FORM

REP U

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F THE PHI LIP IC O BL

SOCIAL CASE STUDY REPORT FORM Date: I. IDENTIFYING INFORMATION Patient’s full name: Age:

Nickname:

Civil status:

Sex:

Date of birth:

Religion: Place of birth:

Permanent address: Temporary address: Contact number/s: Occupation:

Monthly income:

Educational attainment:

Family monthly income:

II. PROBLEM PRESENTED

III. FAMILY COMPOSITION

Name

Relationship to Patient

Age & Civil status*

Current address

(city only, “same”=living with patient’s temp. address)

Educational attainment

Occupation

Average monthly income (Php)

* Legend: s=single, m=married, l=living together, sep=separated, w=widowed If deceased, write year of death SOCIAL CASE STUDY REPORT FORM | page 1 of 4

144 Treat MDR-TB Patients

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SOCIAL CASE STUDY REPORT FORM | page 2 of 4

Programmatic Management of Drug - Resistant TB (PMDT)

IV. FINANCIAL SUPPORT 1. No. of persons providing financial support: _________ 2. Major source of financial support Name:

Relationship to patient:

Address: Contact number/s: Occupation/Source of income: 3. Other source of support Name:

Relationship to patient:

Address: Contact number/s: Occupation/Source of income: 4. Amount received per month: yes

5. Will the financial support be sustained for 2 years?

If no, state alternative plans for sustainability of MDRTB treatment

V. FINANCIAL OBLIGATIONS Monthly expenses as applicable (use highest amount) House rental Water Electricity Others (specify) : __________fare Food Clothing Total

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SOCIAL CASE STUDY REPORT FORM | page 3 of 4

VI. ASSESSMENT

Programmatic Management of Drug - Resistant TB (PMDT)

Class: A B C1 C2 Refer to Socoioeconomic Classification Guide

VII. RECOMMENDATION/S Enabler/s: Food allowance Transportation allowance Housing allowance MDR-TB housing facility Not applicable

Prepared by: 146 Treat MDR-TB Patients

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Date:

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SOCIAL CASE STUDY REPORT FORM | page 4 of 4

S NE PI

F THE PHI LIP IC O BL

Programmatic Management of Drug - Resistant TB (PMDT)

RESIDENCE VERIFICATION Complete Address:

Street

Unit/House #/Floor

Village/Subdivision

Baranggay

Municipality

Landline #: years

Relocation due to treatment?

yes

Zip Code

months

Tenure status of housing: Type of dwelling material:

weeks

Owner informed of patient’s illness?

Relationship of owner to patient:

# of bedrooms:

City

Mobile #:

Length of stay in community

Name of owner:

Bldg./Apt. Name

yes

none

parent

sibling

in-law

friend

others:

no other relative:

owned/ being amortized

rent-free w/ consent from owner

rented

rent-free w/o consent from owner

concrete

semi-concrete

wood

# of windows in patient’s bedroom: # of windows in patient’s house:

# of persons sleeping in the same house with the patient for the past 3 months: Distance of residence to the Health Facility: Treatment Center: Treatment Site: Interviewee:

Relationship to patient:

Findings:

Action taken:

Verified by:

Date: Treat MDR-TB Patients

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148 Treat MDR-TB Patients

Start date (if unknown, put year)

H = Isoniazid R = Rifampicin Z = Pyrazinamide E = Ethambutol S = Streptomycin

First-line drugs

Km = Kanamycin Am = Amikacin Cm = Capreomycin Cfx = Ciprofloxacin Ofx = Ofloxacin Lfx = Levofloxacin Mfx = Moxifloxacin

Gfx = Gatifloxacin Pto = Prothionamide Eto = Ethionamide Cs = Cycloserine PAS = P-aminosalicylic acid Clr = Clarithromycin AmxClv = Co-amoxiclav

Second-line drugs

Drug abbreviations Date

If Yes, specify drug and duration of use: _____________________________________________

Yes

Regimen (write regimen in drug abbreviation)

Used second line drugs previously? (4)

No.

Previous TB treatment episodes (1) 1 2 3 4 5 6 7 8 9 10

Purpose

New After Cat I failure After Cat II failure After Cat IV failure After default Cat I relapse Cat II relapse Cat IV relapse Transfer-in Other 10.1 Non-dots tx 10.2 Other (+) 10.3 Other (-)

(2) Registration group

(5) Consilium meetings

( TC - YY - NNNN )

(+)

Decision

ART= antiretroviral therapy CPT= co-trimoxazole preventive therapy

Y Started on CPT: Date: ____/____/ _____

(-) Y N Started ART: Date: ____/____/ _____

Results:

Date of test: ____/____/ _____

(3) HIV information HIV testing done:

Funding source: (14) CLASS: (15) CLASS: A

Treatment Center: (13)

Treatment start date: (12)

select one only (√)

Both

contact no.:

Treatment outcome

( MM / DD / YYYY )

Pulmonary

REP U

Category IV Registration No. (11 )

Extrapulmonary

Initial height: (9) Site of disease:

Initial weight: (8)

Date of birth (7)

Age / Sex: (6)

City address: (3) Contact numbers: (4) Person to notify (relationship) and (5)

(Last name, First name, MI)

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Permanent address: (2)

Name: (1)

Category IV Treatment Card

Programmatic Management of Drug - Resistant TB (PMDT)

MODULE C

Annex E Contact Initial Investigation Form/ Page 1 of 4

Date

DATE

DRUG Preparation

300 mg

500 mg

Z 1G

S 1G

Patient name:

Comments

400 mg

CATEGORY IV REGIMEN (date started and dosage) change of dosage and cessation of drugs:

CATEGORY IV TREATMENT CARD | page 2 of 4

Am 1G

Cm 200 mg

Ofx

Lfx 500 mg

Date

500 mg

Cfx 400 mg

Mfx 400 mg

Gfx 250 mg

Pto/ Eto 4G

Pas

Comments

250 mg

Cs 500 mg

Clr

Category IV Registration No.

Others

Programmatic Management of Drug - Resistant TB (PMDT)

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Others

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Note: Encircle date of regimen change

X = drugs not taken / Absent I = incomplete regimen H = Sunday/ Holiday

MARK IN THE BOXES: Initials of HW (3 letters)=Supervised TC/TS= Treatment Center/ Site DOT

Month / Year

(√) if done

Blood chemistry

HW initials

15th mo

12th mo

24th mo

Schedule

21st mo

HW initials

9th mo

(√) if done

CXR

18th mo

Schedule

6th mo

3rd mo

Baseline

ADMINISTRATION OF DRUGS (one line per month) Patient name:

CATEGORY IV TREATMENT CARD | page 3 of 4

Schedule

(√) if done

CXR

REP U

(√) if done

Blood chemistry HW initials

Monthly Cumulative # of doses taken doses taken

Schedule

31 Wt (Kg)

HW initials

Category IV Registration No.

Programmatic Management of Drug - Resistant TB (PMDT)

F THE PHI LIP IC O BL

S NE PI

Month of Treatment

6th 12th 18th 24th

S1 S2 B 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24

Request Given

Patient name:

Date collected

DSSM

(2) Post-treatment follow-up

Laboratory No. TBC

DSSM

DSSM/Culture

(1) Sputum monitoring

CATEGORY IV TREATMENT CARD | page 4 of 4

2 TBC

Km Am Cm Cfx Ofx Lfx Mfx

(3) Drug Susceptibility Testing (DST) results

1+ 2+ 3+ 4+

1-9 AFB per 10 fields 1-9 AFB per field 10-90 AFB per field > 90 AFB per field

+n 1+ 2+ 3+

1-9 AFB per 100 OIF 10-99 AFB per 100 OIF 1-10 AFB per OIF >10 AFB per OIF

# of colonies 1+ 2+ 3+ 4+

10-100 100-200 200-500 >500

0 <10 colonies

No growth

Recording cultures (TBC) # of colonies

No AFB seen

Recording AFB smear using Ziehl Neelsen stain

No AFB in at least 60 fields (2 sweeps)

Recording AFB using Auramine Rhodamine CODES

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Trans-out

Defaulted

Failed

Died

Completed

Cured

OUTCOME

DATE

PAS

Other

REP U

DATE

Reason if Died/Defaulted OR Facility transferred to

(5)Treatment outcome

0 1 2 3 4 5

READING Baseline

(4) Chest X-ray readings

Pto Eto

Programmatic Management of Drug - Resistant TB (PMDT)

NOTATION method: R=Resistant S=Susceptible N=Non-viable C=Contaminated ND=Not done

Date released Laboratory No.

Category IV Registration No.

Mtb

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

Treatment start date mm/dd/yy (3)

Last name First name and middle name

Name (4)

Address (7)

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

(9) Chest x-ray result

Street no. and name Brgy. City, Region

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

Date of birth mm/dd/yy

1- Male 2- Female

(5) Sex

Sex (5)

Age (yrs) (6)

REP U

Date done mm/dd/yy

Chest xray result (9)

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

Registration group (10)

10-Other patient w/ 10.1 Non-DOTS 10.2 Other (+) 10.3 Other (-)

(10) Registration group

Site of disease (8)

F THE PHI LIP IC O BL

S NE PI

Date screened mm/dd/yy (1)

Category IV Register

Programmatic Management of Drug - Resistant TB (PMDT)

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

(11) Previous TB treatment

Previous TB treatment (11)

MODULE C

Annex F

Category IV Register Category IV Register/ Page 1 of 3

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

Ofx

R - Resistant

Cfx

Other

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

Date DST released mm/dd/yy (14)

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

Lfx

ND - Not Done

(13) Drug Susceptability Testing (DST)

S - Susceptible

Drug Susceptibility Testing (DST) (13)

CATEGORY IV REGISTER | page 2 of 3

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

/ /

mm/dd/yy

s/c

mo 0

/ /

mm/dd/yy

s/c

mo 1

/ /

mm/dd/yy

s/c

mo 2

/ /

mm/dd/yy

s/c

mo 3

/ /

mm/dd/yy

s/c

mo 4

/ /

mm/dd/yy

s/c

mo 5

/ /

mm/dd/yy

s/c

mo 6

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

/ /

mm/dd/yy

s/c

mo 7

Programmatic Management of Drug - Resistant TB (PMDT)

REP U

/ /

mm/dd/yy

s/c

mo 8

F THE PHI LIP IC O BL

/ /

mm/dd/yy

s/c

mo 9

S NE PI

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mm/dd/yy

s/c

mo 11

mo 10

mm/dd/yy

s/c

mo 12

s/c

mo 13

mm/dd/yy

CATEGORY IV REGISTER | page 3 of 3

mm/dd/yy

s/c

SUMMARY

mm/dd/yy

s/c

mo 16

mm/dd/yy

s/c

mo 17

mm/dd/yy

s/c

mo 18

mm/dd/yy

s/c

mo 20

1. Extrapulmonary 2. Trans-in 3. Other

Excluded

mm/dd/yy

s/c

mo 19

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

mm/dd/yy

s/c

mo 21

mm/dd/yy

s/c

mo 23

mm/dd/yy

s/c

mo 24

Post-treatment follow-up monitoring (18)

REP U

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

Date of last intake of Ff up 1 Ff up 2 Ff up 3 Ff up 4 meds

Treatment outcome (17)

mm/dd/yy

s/c

mo 22

Programmatic Management of Drug - Resistant TB (PMDT)

F THE PHI LIP IC O BL

S NE PI

(19)

HIV status

MODULE C

Annex G Monthly follow-up visit to the Treatment Center physician (Summary for clinicians) The Treatment Center physician conducts monthly clinical evaluation of MDR-TB patients to monitor progress. This visit of the MDR-TB patient to the clinician is routinely done monthly but should also be done even out of schedule on occasions when there are uncontrolled adverse drug reactions, reconversion to positive smear for patients who have been decentralized, and if there are co-morbid illnesses that need attention. Depending on the condition, either the patient is treated at the Treatment Center or referred to a specialist or hospital. This visit should include the steps below. yy

Assess the patient’s general condition. If the patient has difficulty breathing or is acutely ill, first assess and classify the illness. Refer if necessary for serious conditions. Treat the acute illness, if mild.

Weigh the patient.

Review the drugs that the patient is taking. Examine the patient’s Category IV Treatment Card and ask the patient about the drugs actually taken. Ask about symptoms and side effects. If the patient is experiencing side effects, manage them appropriately. This may include reassuring a patient who has minor side effects.

Reinforce important information on MDR-TB and its treatment. Encourage the patient to ask questions. Answer any questions the patient may have about the disease or treatment and discuss any fears or concerns.

Review the results of any recent sputum examinations or other tests. Explain it to the patient in simple terms. If any change in treatment is needed either due to an uncontrolled adverse reaction or a change in the DST pattern, change the regimen at once and schedule the case to be presented in the next consilium. If however, there is uncertainty about what regimen to give, and the change is not urgently needed, present it first in the consilium prior to making any modification. Explain the change to the patient.

Assess whether the patient is improving. If the patient has weight loss, other signs of disease, or poor clinical progress, consider other causes (such as HIV) and give appropriate treatment or refer if needed.

Be familiar with the most frequently associated diseases and other problems of patients with TB and MDR-TB in the area and how to manage them. In an area of high HIV prevalence, the initial medical history should obtain information to assess HIV risk factors. If a patient is known to be HIV-positive, give the necessary support including referral to an HIV clinic and other additional support. Follow-up to identify and treat opportunistic infections. The possible impact of HIV on MDR-TB treatment includes delayed sputum smear and culture conversion, increased mortality, and drug side-effects.

Motivate the patient to take the treatment regularly. Praise the patient for successfully taking the treatment so far, and give the patient support for continuing the treatment. Do not blame the patient when there are problems with adherence. This can discourage patients and cause default. One of the biggest problems in MDRTB control is the negative attitude of health workers toward patients. If there are any problems with continuing the treatment, work with the patient to overcome the problems.

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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)

Detect Cases of MDR-TB

Treat MDR-TB Patients

Inform Patients about MDR-TB

Ensure Continuation of MDR-TBTreatment

Manage Drugs and Supplies for MDR-TB

Monitor MDR-TB Case Detection andTreatment

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

Tropical Disease Foundation, Inc.

World Health Organization

Government of Philippines

Makati, Metro Manila, Philippines

Office of the Representative in the Philippines

9 772012 267009 PRINTED IN THE PHILIPPINES

MANAGEMENT OF DRUG-RESISTANT TUBERCULOSIS — MODULE C

Articles inside

G: Monthly follow-up visit to the Treatment Center physician

B: Anti-TB Drugs available for use in the Philippines under a programmatic setting

Summary of important points

to the Consilium using the Consiliumex

4 .6 Implement treatment decisions

4 .6 .6 If a patient’s DST results have changed from baseline . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106 4 .6 .7 Initiate counseling for possible treatment failure before terminating treatment

Exercise C: Written Exercise

Introduction

3 .5 Make referral to Treatment Center physician as necessary for moderate or severe ADRs

1 .3 Determine whether there are other special circumstances affected by the regimen

Objectives of this module