MDR Training CourseNTP-EgyptCairo,February, 2012

Follow up examination for progress

& Treatment outcomes.

By the end of this lecture the participant should be able to

Develop a regular Follow Up Schedule for monitoring the patient throughout the treatment regimen

Identify ways for early detection of adverse reaction and make recommendation for management.

Become familiar with the various definitions of treatment outcomes

Objective

Guidelines for Patient Treatment Enrollment

• Ambulatory based strategy. The treatment center will enroll the patient under CAT-IV treatment on an ambulatory basis provided that – A strong DOT policy is in place, – An infection control policy is well implemented to prevent household transmission

of DR-TB to another contact, – A proper mechanism for early recognition/management of treatment adverse

reaction is established which might include – Admission to an in-patient DR-TB designated treatment site due to severe adverse

reactions.

• Hospitalization based strategy. The treatment center will admit the patient into a hospital to begin CAT- IV treatment until such a time when the patient shows evidence of treatment tolerance and no signs or symptoms of adverse reactions. The patient can then be discharged for ambulatory treatment provided conditions for DOT are in place.

The Treatment Regimen is divided into two phases

• The Intensive Phase– This phase should take place for at least 6 months after conversion.

• The Continuation Phase– This phase should take place for 20 months past culture conversion

Monitoring the Patient• Patients should be monitored closely for signs of treatment failure and

adverse effects.• Clinically, the most important way to monitor response to treatment is

through regular history-taking and physical examination. • The classic symptoms of TB– cough, sputum production, fever and weight

loss – generally improve within the first few months of treatment and should be monitored frequently by health-care providers.

• The recurrence of TB symptoms after sputum conversion, for example, may be the first sign of treatment failure.

• For children, height and weight should be measured regularly to ensure that they are growing normally.

• A normal growth rate should resume after a few months of successful treatment.

Case management during the intensive phase treatment

the following tests should be done:• Monthly:

– Clinical exam and body weight.– Sputum for direct AFB microscopy on a minimum 2 consecutive days.– Sputum for AFB Culture.– Hgb, ESR, KFT, lytes– Audiometry and visual tests.

• Every 3-6 months:– LFT, Thyroid FT– CXR

Make treatment decisions based on physical examination, laboratory results and attendance history

• The appropriate actions for the patient will depend on– how the patient is responding to treatment, – and whether the result of the culture is negative or positive. – Meet with the patient to explain the results of the follow-up examinations and

the next step of treatment.

• Two expected steps in the treatment process can occur when the patient’s treatment is progressing well (patient is culture negative). The patient:– may be decentralized to a local health facility to continue treatment– may begin the continuation phase of treatment.

If the patient’s treatment is not progressing well, the patient will be re-examined and the regimen may need to be adjusted.

The Review Panel will need to approve any of these steps.

Monthly monitoring visits to the Referral Centre The Referral Centre physician takes the following actions during the monthly monitoring visit:• Evaluates the patient’s clinical condition and response to treatment by

physical examination including weight, history and any other measures needed, e.g. blood test.

• Reviews the MDR-TB Treatment Card to confirm that the patient has adhered to treatment and that the treatment has been directly observed. If the patient is not taking the drugs as needed, every effort must be made to ensure compliance.

• For patients whose treatment has been decentralized, copy from the pt’s treatment card

• If a patient has irregular attendance at the local health facility, the physician and staff should talk with the patient to reinforce the importance of adherence to treatment and the consequences of missing doses.

• Information added to the card by the Referral Centre about observations, physician’s recommendations, laboratory results, etc. will be copied later by the local health facility onto their copy of the card.

• Reviews the bacteriological data.

Monthly monitoring visits to the Referral Centre (cont’d)

• Reviews the treatment progress and regimen in relation to medical history, close contacts and all DST reports. If the regimen is deemed inadequate, a new regimen needs to be designed and presented for approval to the Review Panel.

• Discusses treatment progress with the patient and answers the patient’s questions. It is important that the patient have an opportunity to share any concerns with the physician and that the physician treat these concerns with respect.

Determine when a patient may be decentralized

• Treatment for MDR-TB begins in the Referral Centre or hospital and continues

there as long as a patient is still culture positive. Once a patient has become culture negative, the patient may continue the treatment at a local health facility which is more convenient for the patient. This is called treatment decentralization.

• Criteria for treatment decentralization: – Patient is culture negative for at least one month and smear-negative for the last two

months – Patient is able to attend a local health facility for daily treatment or has access to a

trained provider of directly-observed treatment.– The patient should also be tolerating the drugs in the regimen. The Referral Centre

physician will review patients who meet these criteria and will present these cases to the Review Panel. Once approved by the Review Panel, the patient can be decentralized.

Determine when a patient may be decentralized (cont’d)

• When a patient is eligible for treatment at a local health facility, carry out the following

procedures:

– Coordinate with the District TB Officer to ensure the local facility staff are trained and able to receive the patient and supervise the patient’s continuing treatment for MDR-TB. If the patient is in the intensive phase of treatment, the regimen includes an injection, so the person providing the directly-observed treatment must be trained to give the injection.

– Inform the patient that the treatment is progressing well, and that the patient is eligible to receive treatment at a local health facility as soon as other criteria for decentralization are met. Remind the patient that there are still many months of treatment needed and emphasize the importance of continuing the treatment.

– Explain the process of decentralization: that is, the care will remain the same except that the patient will be able to go to a local facility closer to home for daily treatment. Every month it will still be necessary to come to the Referral Centre for monthly monitoring and follow-up.

– A treatment supporter is needed to directly observe treatment to provide the treatment on a sixth day each week. The local health facility would be responsible to identify, train and supervise a community treatment supporter for MDR-TB treatment.

Determine when a patient may be decentralized (cont’d)

• Prepare the drugs, supplies, forms and the personal history of the patient to be sent to the

local health facility.• Prepare 2 copies of the patient’s MDR-TB Treatment Card (one for the local facility and one

copy for the patient). The starting date of treatment by the local facility will be the day the patient is referred. Keep the original MDR-TB Treatment Card at the Referral Centre. The patient’s copy of the MDR-TB Treatment Card must be available and carried by the patient at all times while receiving treatment.

• Reiterate the importance of the patient’s copy of the MDR-TB Treatment Card. It will serve as the link between the Referral Centre and the local facility and will be used to update the Referral Centre's original during the monthly monitoring visits to a physician.

• Your national TB control programme may have slightly different criteria.

Take necessary action for patients who are not progressing as planned

• Patients who are not progressing well after month 4-5 of treatment are at high risk of treatment failure and should have another DST.

• A patient’s treatment is not progressing well if, by month 4 or 5 of treatment, the patient:– has not had culture conversion, or– had culture conversion but then reverted to culture positive, or– does not improve clinically (symptoms get worse, or symptoms disappear and then

reappear). • Poor treatment progress may be due to one or more of the following:

– The treatment was poorly supervised and drugs were not taken correctly or on schedule.– There is 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 is a problem with drug absorption.

– The patient’s regimen is not adequate and the bacilli may have resistance to drugs the patient is receiving.

If a patient is at high risk of treatment failure, the Referral Centre physician should:

• Request DST for second-line drugs from the last positive culture. • Present the case again to the Review Panel for possible change of regimen.• Explain to the patient that the positive laboratory or clinical examination results

mean that the drugs do not seem to be working as hoped. • If the patient has been decentralized, explain that treatment will be moved back to

the Referral Centre. • Continue to give directly-observed treatment to the patient with the prescribed

regimen until a decision has been made to change it. • If the Review Panel recommends a regimen change, request the new drugs in the

regimen and discontinue the other drugs. Retrieve the unused drugs from the local facility.

When the DST results are received, if they have changed from baseline showing further or different resistance:

• 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 Referral Centre physician for a physical exam and for possible changes in the treatment regimen.

• The Referral Centre physician will present the case again to the Review Panel 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 DST reports. • Continue to give directly-observed treatment to the patient with the prescribed

regimen until a decision has been made to change it.• If the Review Panel recommends a regimen change, request the new drugs and

discontinue the other drugs; and retrieve the unused drugs from the local facility. Depending on the progress of the patient and his or her physical state and needs, refer the patient to the psychosocial team at the Referral Centre.

Propose a regimen change and present it to the Review Panel for approval

• For a severe adverse effect:

• When a patient has resistance to multiple drugs, and therefore only a few drugs can be used, withdrawing one of them may result in treatment failure.

• The Referral Centre physician who has evaluated the MDR-TB patient with a severe adverse effect will need to present the case and the proposed regimen change to the Review Panel.

• A drug will be withdrawn because of an adverse effect only when 4 reliable drugs can still be included and there is no other course of action. The Review Panel approves all regimen changes unless there is an emergency. In those cases the change should be reviewed afterwards by the Panel.

• When a patient has resistance to multiple drugs, and therefore only a few drugs can be used, withdrawing one of them may result in treatment failure.

Propose a regimen change and present it to the Review Panel for approval(cont’d)

• For an increase or decrease in the patient’s weight:• Every month, each patient is weighed and the weight recorded on the MDR-TB Treatment Card. for an adjustment that

needs to be made to the daily number of tablets/capsules/sachets/mg. • For discontinuation of the injectable agent at the start of the continuation phase:• The Referral Centre physician will identify patients who meet the criteria to begin the continuation phase (that is, patient

has received the injectable agent for at least six months and for at least four months after becoming and remaining smear or culture-negative) . A patient can begin the continuation phase of treatment, that is, discontinue the injectable agent and continue taking the oral drugs for at least 18 past conversion.

• Record changes to the drug regimen on the MDR-TB Treatment Card • As soon as a regimen change is approved by the Review Panel or as soon as the decision to make a change is made (in an

emergency situation), the Referral Centre physician should record the regimen change on the patient’s MDR-TB Treatment Card as described below. The new drugs must be requested immediately. All drugs that are discontinued must be returned to the pharmacist or designated staff at the Referral Centre.

• Record any regimen change, including discontinuation or change in dosage, on the MDR-TB Treatment Card. This allows

anyone to easily see when there has been a change in the medication.

Change the MDR-TB regimen when required and with Review Panel approval

• During the course of treatment for MDR-TB, a patient’s regimen may need to be

changed when:– The patient has a severe adverse drug effect (only when no other course of action is

possible)– An increase or decrease in the patient’s weight necessitates a corresponding change in

the dose of medication– The injectable agent will be discontinued at the start of the continuation phase

• A decision to modify a drug regimen can only be made by a Referral Centre physician with agreement from the Review Panel.

Case management during the Continuation Phase

the following tests should be done: Monthly:

Clinical exam and body weight. Sputum for direct AFB microscopy on a minimum 2 consecutive days.

Bimonthly: Sputum for AFB Culture. Hgb, ESR.

Every 3-6 months:– TFT– CXR

Definitions for diagnostic Category IV treatment outcomes

• Cured. A Category IV patient who has completed treatment according to programme protocol and has 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 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 Category IV patient who has completed treatment according to programme protocol 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).

Definitions for diagnostic Category IV treatment outcomes (cont’d)

• Died. A Category IV patient who dies for any reason during the course of MDR-TB 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 clinical or radiological response or adverse events. These latter failures can be indicated separately in order to do subanalysis).

• Defaulted. A Category IV patient whose treatment was interrupted for two or more consecutive months for any reason without medical approval.

• • Transferred out. A Category IV patient who has been transferred to another reporting and recording unit and for whom the treatment outcome is unknown.

• Patients who have transferred in should have their outcome reported back to the treatment centre from which they originally were registered. The responsibility of reporting their final outcomes belongs to the original treatment centre.

Thank You