4 .6 Implement treatment decisions

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.

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.

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.