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Monitoring Throughout Treatment

Interim. Draft Module 7B - September 2008. Monitoring Throughout Treatment. Project Partners. Collaborative project. Funded by the United States Agency for International Development (USAID). Module Overview. Clinical Response Monitoring Monitoring for Adverse Reactions.

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Monitoring Throughout Treatment

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  1. Interim Draft Module 7B - September 2008 Monitoring Throughout Treatment

  2. Project Partners • Collaborative project Funded by the United States Agency for International Development (USAID)

  3. Module Overview • Clinical Response Monitoring • Monitoring for Adverse Reactions International Standards 10 and 14

  4. Learning Objectives At the end of this presentation, participants will be able to: • Describe the components of clinical response monitoring • Describe the common adverse reactions to each of the first-line drugs anti-tuberculosis drugs

  5. Question Why is monitoring important for patients being treated for TB?

  6. Monitoring Patients on TB Treatment • Patient monitoring and treatment supervision are two separate functions • Patient monitoring is necessary to: • Evaluate the response of the disease to treatment • Identify and intervene early when patient has adverse reactions to TB treatment • Minimize treatment interruptions • Document treatment outcomes

  7. Monitoring Patients on TB Treatment (2) • Requires regular contact between the patient and a care provider

  8. ISTC Standard 10 All patients should be monitored for response to therapy, best judged in patients with pulmonary TB by follow-up sputum microscopy (2 specimens): • At completion of the initial phase of treatment (2 months) • 5 months, and • At the end of treatment Patients who have positive smears during the 5th month of treatment should be considered as treatment failures and have therapy modified appropriately.

  9. ISTC Standard 10 (2) In patients with extrapulmonary tuberculosis and in children, the response to treatment is best assessed clinically. Follow-up radiographic examinations (chest X-rays) are usually unnecessary and may be misleading.

  10. Clinical Response Monitoring PTB • Radiographic assessments are unreliable for evaluating response to treatment • Clinical assessment alone can be unreliable and misleading in assessing PTB patients’ response to treatment  Sputum smear microscopy is the best method to judge response to treatment in patients with pulmonary TB (PTB)

  11. Monitoring Response to TreatmentCategory I Response to treatment for the new sputum smear-positive PTB patient should be monitored by: • Sputum smear examination (two sputum specimens) • Weight at the start of treatment then monthly until patient’s weight is stable • Review of TB symptoms present at time of diagnosis and documentation when symptoms resolve

  12. Timing of Sputum Specimens Initial Phase Continuation Phase Isoniazid Rifampicin Pyrazinamide Ethambutol 0 1 2 3 4 5 6 months Diagnostic Assessment for failure End of intensive phase Completion

  13. Monitoring Response to Treatment (2)Category I If sputum remains smear-positive at the end of month 2: • Extend initial phase for an additional month. After 3rd month, the continuation phase must be initiated • May consider collection of sputum at end of 3rd month to evaluate smear conversion

  14. Monitoring Response to Treatment (3)Category I • Having a positive sputum smear at completion of 5 months of treatment = treatment failure • Obtain drug susceptibility testing • Begin a retreatment regimen

  15. Criteria for Discharging the Sputum Smear-positive Patient from Hospital • Collect the first follow-up sputum specimen after 2 weeks of anti-tuberculosis treatment • Discharge from hospital may be considered if the following can be documented:  Clinical improvement noted by decrease in symptoms  Bacteriological response noted by decrease in number of AFB on smear  Community support in place to ensure successful continuation of treatment as an outpatient

  16. ISTC Standard 14 • An assessment of the likelihood of drug resistance should be obtained for all patients • based on history of prior treatment, • exposure to a possible source case having drug-resistant organisms, • and the community prevalence of drug resistance • Patients who fail treatment and chronic cases should always be assessed for possible drug resistance • For patients in whom drug resistance is likely, culture and drug susceptibility testing should be performed promptly

  17. Monitoring Response to TreatmentCategory II Response to treatment for the previously treated sputum smear-positive PTB patient should be monitored by: • Two sputum specimens for smear and culture examination at the following intervals: • At the end of initial phase (month 3) • During continuation phase (month 5) • At the end of treatment • Weight – baseline and monthly until stable • Review of TB symptoms

  18. Monitoring Response to Treatment (2)Category II If patient has a positive sputum smear at the end of month 3: • Extend initial phase of treatment with 4 drugs for an additional month, and • Collect and send sputum specimens for smear exam again at end of 4th month

  19. Monitoring Response to Treatment (3)Category II If patient has a positive sputum smear at the end of month 4: • Send sputum to the national or regional laboratory for TB culture and drug susceptibility testing (DST) • Initiate continuation phase • If DST results show resistance to 2 of the 3 drugs employed in the continuation phase: • Refer patient to a specialized centre for evaluation of treatment with second-line anti-TB drugs

  20. New Sputum Smear-negative PTB Patient (usually Category III) • Consider sputum exam at the end of the 2nd month to assess for: • An error at the time of the initial diagnosis • Non-adherence to treatment • A patient initially diagnosed as: • Sputum smear-negative and • Treated as Category III and • Is sputum smear-positive at the end of 2nd month •  Must be re-registered as sputum smear-positive and starta full course of treatment as a Category II patient

  21. Monitoring for Extra-pulmonary TB • Observe for signs of clinical improvement • Weight gain • Symptom resolution

  22. Treatment Interruption and Default If interruption in treatment is less than 1 month: • Try to find the patient • Identify and address the cause of interruption • Continue treatment and prolong it to make up for missed doses If treatment is interrupted for 1-2 months: • Try to find the patient • Identify and address the cause of treatment interruption

  23. Treatment Interruption and Default (2) If interruption in treatment for 1-2 months: • Collect 3 sputum smears for AFB; continue treatment while waiting for results • If smear-negative or EPTB, continue treatment and prolong it to compensate for missed doses • If one or more smears are positive: • and treatment received <5 months, continue to compensate for missed doses • and Category I treatment received > 5 month: start Category II regimen • and Category II treatment received > 5 month: refer and obtain drug susceptibility testing (DST)

  24. Treatment Interruption and Default (3) Interruption for > 2 months (defaulter): • Do 3 sputum smears • Solve the cause of interruption, if possible • No treatment while waiting for results • If smears are negative or EPTB, clinical decision on individual basis whether to restart or continue treatment, or no further treatment • One or more positive smear: • Category I, start Category II • Category II – refer (may evolve to chronic; get DST)

  25. Monitoring for Adverse Reactions • Should be conducted regularly and include a monthly nurse or MD assessment • Toxicity and hypersensitivity reactions may require a change to the drug regimen • Complaints of drug side effects must be promptly referred for evaluation  Prompt recognition and appropriate management of adverse drug reactions is essential to the successful treatment of TB

  26. Monitoring: Adverse Reactions (2) • Drugs are listed in order of relative likelihood of causing adverse reaction. • INH/RIF and RIF/PZA appear to have synergistic effects in causing hepatitis

  27. Drug-induced Hepatotoxicity Hepatotoxic reactions: • Transaminase elevation age-dependent with INH • Transaminase elevation dose-dependent with PZA • Cholestasis (increase in bilirubin and alkaline phosphatase) with RIF

  28. Adverse Reactions: Rash Classic drug-related rash Severe skin rash from Thiaocetazone

  29. Adverse Reactions: Rash (2) • Any of the first-line anti-TB drugs can cause a rash • If causing only minor itching: • Antihistamines may be prescribed • TB medications continued • Petechial rash suggests thrombocytopenia: • Check platelets; if low, assume rifampicin hypersensitivity and discontinue RIF

  30. Adverse Reactions: Rash (3) • Generalized erythematous rash: • Stop all drugs immediately (if acutely ill with TB, may consider 3 alternative drugs) • When rash has improved significantly, begin rechallenge • One drug at a time at 2–3 day intervals • Start with RIF (most important and least likely to have caused the rash) then INH, EMB, and PZA • If rash recurs, the last drug added is the likely cause and should be discontinued

  31. Adverse Reactions: G.I. • Gastrointestinal intolerance (GI): • GI includes nausea, vomiting, poor appetite, abdominal pain • GI symptoms are common, may be transient, and are caused by many anti-TB drugs, particularly in first few weeks • First, you must rule out hepatitis (ALT/AST) • If there is no hepatitis, consider: • Changing the hour of drug administration • Administering drugs with food

  32. Monitoring Adverse Reactions Case Study

  33. Case 1 • 64-year-old alcoholic male is admitted to the hospital for profound weight loss, abdominal swelling and chronic cough x 4 weeks • Question: Is this a TB suspect? • Question: What diagnostic tests would you order and why?

  34. Case 1 (2) • Sputum for AFB smear and culture is collected • Smears x 3 are negative • Chest X-ray obtained, result as follows…

  35. Case 1 (3) • Patient is started on rifampicin, isoniazid, pyrazinamide, and ethambutol (RHZE) given by DOT • Within 5 days, he feels nauseated and sick • Question: What would you do now?

  36. Case 1 (4) • Medication put on hold • LFTs: T.bili normal, AST= 430, ALT= 380 • No, he is not drinking (confirmed by wife) • Question: What now?

  37. Case 1 (5) • LFTs returned rapidly to normal and MD rechallenged with RIF and EMB • Patient developed itching, weakness, dizziness and “shaking” • Same symptoms with INH rechallenge • Patient off meds for 10 days now and feels very poorly with anorexia, fatigue and general weakness • His wife says he won’t eat her food and they are fighting constantly • Question: What would you do now?

  38. Case 1 (6) • Examine side effects carefully • Spend time with patient and address patient’s concerns • Assess patient’s understanding of the disease His biggest concern: Side effects to his liver. He did not understand the seriousness of his disseminated disease and did not realize it could be cured. Now what?

  39. Case 1 (7) • Careful in-hospital rechallenge. Patient had visible shaking reaction with chattering teeth observed but exam, temperature, pulse and BP were normal. Skin was warm to touch • Rechallenged with rifampicin again and xanax (anti-anxiety medication) added Diagnosis:Anxiety No side effects, LFTs remained normal after INH and EMB added. Xanax discontinued after 2 weeks

  40. Case 1 (8) • Culture confirms M. tuberculosis complex, susceptible to INH, RIF and EMB • Completed 2 months of INH, RIF and EMB. Repeat smears/cultures at end of month 2 are negative • Abdominal girth decreased significantly, and weight up by 10 lbs • Question: What will you do now and how long do you treat this patient?

  41. Case Summary • Patient switched to continuation phase as sputum smears are negative at 2 months • Treated with INH and RIF for another 7 months • Sputum collected at end of treatment was smear and culture negative • Treatment outcome = “cured”

  42. Summary • Patient monitoring is necessary to: • Evaluate the response of the disease to treatment • Identify adverse drug reactions early to avoid treatment interruptions • Sputum smear microscopy is the best method to judge response to treatment in patients with PTB • For patients with EPTB, response to treatment is best assessed clinically • Resolution of symptoms • Weight gain

  43. Summary: ISTC Standards Covered* (2) Standard 10: All patients should be monitored for response to therapy, best judged in patients with PTB by follow-up sputum smear microscopy (at 2 and 5 months and end of treatment). • Positive smears during the 5th month of treatment are considered treatment failures and treatment should be modified appropriately • Response to treatment in EPTB is best assessed clinically • Follow-up radiographs are usually unnecessary and may be misleading * Abbreviated versions

  44. Summary: ISTC Standards Covered* (3) Standard 14: Assessment for drug resistance should be obtained based on a history of: • Prior treatment • Exposure to a possible drug-resistant source • High community prevalence • Treatment failure or chronic disease  If suspicion for drug-resistance, obtain culture and drug-susceptibility testing promptly. *[Abbreviated version]

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