Case Holding (TB-DOTS Training)

Case holding a set of procedures which ensures that patients complete their treatment involves assignment of the appropriate regimen based on the diagnosis and previous history of treatment

Case holding supervised drug intake with support to patients monitoring responses to treatment through follow- up sputum smear microscopy

Objective To ensure effective and complete treatment of all TB cases for both adults and children

TB Registration Group cases are assigned a registration group based on history of previous treatment aside from anatomical classification necessary in determining correct treatment regimen

Case 1 A patient is referred to you for treatment of TB. On history – taking, he said that he previously took anti-TB medications for 2 weeks about a year ago. How would you register this patient? a.New b.Relapse c.Treatment failure d. others

Case 1 A patient is referred to you for treatment of TB. On history – taking, he said that he previously took anti-TB medications for 2 weeks about a year ago. How would you register this patient? a.NEW b.Relapse c.Treatment failure d. others

New patient who has never had treatment for TB patient who has taken anti-TB drugs LESS THAN ONE MONTH

Case 2 A patient previously treated for TB and has been declared cured is referred to you with clinically diagnosed TB. What registration group would you classify this patient? a.New b.Relapse c.Treatment after failure d.Treatment after lost to follow-up

Case 2 A patient previously treated for TB and has been declared cured is referred to you with clinically diagnosed TB. What registration group would you classify this patient? a.New b.RELAPSE c.Treatment after failure d.Treatment after lost to follow-up

Relapse patient previously treated for TB who has been DECLARED CURED or COMPLETED TREATMENT presently diagnosed with either bacteriologically- confirmed or clinically diagnosed TB

Case 3 A 6 year old child is clinically diagnosed to have TB. He was previously treated but did not show any clinical improvement. How would you register this patient? a.New b.Relapse c.Treatment after failure d.Treatment after lost to follow-up

Case 3 A 6 year old child is clinically diagnosed to have TB. He was previously treated but did not show any clinical improvement. How would you register this patient? a.New b.Relapse c.TREATMENT AFTER FAILURE d.Treatment after lost to follow-up

Treatment after failure patient previously treated and whose treatment failed at the end of their most recent course

Treatment after failure This includes the following: 1. sputum smear/culture is positive at 5 months or later during treatment 2. Clinically diagnosed patient for whom sputum exam cannot be done and does not show clinical improvement

Treatment after lost to follow-up (TALF) previously treated for TB but was lost to follow-up for two months or more in their recent course of treatment MONTHS OR MORE currently diagnosed with either bacteriologically- confirmed or clinically diagnosed TB

Previous treatment outcome unknown (PTOU) previously treated for TB but whose outcomes after their most recent course are unknown or undocumented

Other patients who do not fit into any of the categories

TB Registration groups new relapse treatment after failure treatment after lost to follow-up (TALF) previous treatment outcome unknown (PTOU) other

Directly Observed Treatment (DOT) method to ensure treatment compliance provide constant and motivational supervision to TB patients

Drug formulations 1.Fixed dose combinations (FDCs) 2.Single drug formulation (SDF)

Category of Treatment Category Ipulmonary TB, new Extra-pulmonary TB, new except CNS/bones/joints Category IaExtrapulmonary TB, new (CNS/bones/joints)

Category of Treatment Category IIpulmonary or extra-pulmonary previously treated drug susceptible TB ◦ relapse ◦ Treatment after failure ◦ TALF ◦ PTOU ◦ other

Category of Treatment Category IIa extra-pulmonary previously treated drug susceptible TB bacteriologically –confirmed or clinically diagnosed – CNS/bones/joints

Category of Treatment Standard Regimen Drug Resistant (SRDR) rifampicin resistant or multidrug resistant XDR TB regimen extensively drug resistant TB

Case A 1 year old child is diagnosed to have TB meningitis. What treatment regimen would you recommend? a.2HRZE/4HR b.2HRZE/10HR c.2HRZES/1HRZE/5HRE d.2HRZES/1HRZE/9HRE

Case A 1 year old child is diagnosed to have TB meningitis. What treatment regimen would you recommend? a.2HRZE/4HR b.2HRZE/10HR c.2HRZES/1HRZE/5HRE d.2HRZES/1HRZE/9HRE

Treatment Regimen Category I: 2HRZE/4HR Category Ia: 2HRZE/10HR Category II: 2HRZES/1HRZE/5HRE Category IIa: 2 HRZES/1HRZE/9HRE

Treatment Regimen If a patient is diagnosed to have Standard regimen drug resistant (SRDR), what is the least duration of treatment? a.Six months b.Nine months c.Twelve months d.Eighteen months

Treatment Regimen If a patient is diagnosed to have Standard regimen drug resistant (SRDR), what is the least duration of treatment? a.Six months b.Nine months c.Twelve months d.EIGHTEEN MONTHS

Standard Regimen Drug Resistant treatment for at least 18 months individualized once DST result is available

XDR TB Regimen individualized based on DST result is available history of previous treatment

All retreatment plans should be screened for MDR –TB before initiating Category II treatment regimen.

All confirmed drug resistant TB cases shall be offered provider-initiated counselling and testing (PICT). This includes patients aged 15 years old and above.

Treatment partner DOT can be done in any accessible and convenient place as long as treatment partner can ensure intake of meds. includes any of the following: DOTS facility staff (midwife/nurse) trained community member(BHW, local government official, former Tb patient) trained family members

Treatment partner for family members, drug supply is given on a weekly basis or as agreed by health worker for streptomycin injections; may forego doses during weekends/holidays as long as recommended number of doses is completed

DRUGDOSE Isoniazid10(10-15 mg)/kg Not to exceed 300 mg Rifampicin15(10-20) mg/kg Not to exceed 600 mg daily Pyrazinamide30 (20-40)mg/kg Not to exceed 2 g Ethambutol20(15-25) mg/kg Not to exceed 1.2 g daily Streptomycin30(20-40) mg/kg Not to exceed 1 g daily

Monitoring patients general well-being progression or resolution of symptoms adverse drug reactions or side effects compliance to treatment and DOT any problem or concerns regarding the treatment so far

When do you repeat DSSM?

DSSM Direct sputum smear microscopy ideally done in all patients

When do you repeat DSSM for Category I? a.After 2 weeks of treatment, end of the intensive phase and end of treatment b.After intensive phase, end of 5 th month and end of treatment c.After intensive phase and end of treatment d.End of treatment

When do you repeat DSSM for Category I? a.After 2 weeks of treatment, end of the intensive phase and end of treatment b.AFTER INTENSIVE PHASE, END OF 5 TH MONTH AND END OF TREATMENT c.After intensive phase and end of treatment d.End of treatment

Smear + end of intensive phase Repeat DSSM end of 3 rd month Smear + Refer to DOTS facility With PMDT or an Xpert site Continue treatment Smear - Repeat DSSM at end of the 5 th month CATEGORY I Proceed with continuation phase

Smear - end of intensive phase Repeat DSSM end of 5 th month CATEGORY I Proceed with continuation phase ** For clinically diagnosed new patients, no need to repeat DSSM at the 5 th month and end of treatment if already smear negative at the end of the intensive phase

Smear at end of 5th month Smear + Treatment failure Refer to DOTS facility With PMDT or an Xpert site Continue treatment Smear - Repeat DSSM at end of treatment CATEGORY I

Smear at end of treatment Smear + Treatment failure Refer to DOTS facility With PMDT or an Xpert site Continue treatment Smear - Cured or treatment completed CATEGORY I

Category II DSSM shall be done end of intensive phase end of the 5 th month end of treatment

Smear at end of intensive phase Smear + Refer to DOTS facility With PMDT or an Xpert site Continue treatment Smear - Repeat DSSM at end of the 5 month CATEGORY II Proceed with continuation phase

Smear at end of 5th month Smear + Treatment failure Refer to DOTS facility With PMDT or an Xpert site Continue treatment Smear - Repeat DSSM at end of treatment CATEGORY II

Smear at the end of treatment Smear + Treatment failure Refer to DOTS facility With PMDT or an Xpert site Continue treatment Smear - Cured / treatment completed CATEGORY II

EPTB patients treatment response will be assessed clinically where DSSM was not done

Adverse Drug Reactions Major 1.Severe skin rash – any drug especially streptomycin 2.Jaundice – HRZ 3. impairment of visual acuity/color vision – ethambutol 4.Hearing impairment – streptomycin

Adverse Drug Reactions Major 5. Oliguria/albuminuria – streptomycin/rifampicin 6. Psychosis/convulsion – INH 7. Thrombocytopenia/anemia/shock – rifampicin

Adverse Drug Reactions Minor 1.GI intolerance 2.Mild or localized skin reaction 3.Pain at the injection site 4.Burning sensation in the feet 5.Arthralgia 6.Flu-like symptoms

Adverse Drug Reactions Management: Major: stop the drugs and refer to specialist Minor: supportive

Adverse Drug Reactions Reintroduction of drugs: ◦ start with drug least likely to cause the reaction at a small dose ◦ gradually increase the dose over 3 days ◦ if no reaction, add second drug at a small dose ◦ repeat procedure until drug responsible for reaction is identified

When can a PTB patient go back to work/school? a.Two weeks if bacteriologically-confirmed b.After one month if bacteriologically confirmed c.After one month if clinically diagnosed d.After two weeks if clinically diagnosed

When can a PTB patient go back to work/school? a.Two weeks if bacteriologically-confirmed b.After one month if bacteriologically confirmed c.After one month if clinically diagnosed d.AFTER TWO WEEKS IF CLINICALLY DIAGNOSED

When can a PTB patient go back to work/school? Bacteriolgically confirmed DSSM after one month is smear negative Clinically diagnosed after two weeks of appropriate therapy

Interrupted Treatment Less than one month: continue tx and prolong to compensate for missed doses Two months or more classify as treatment outcome of “Treatment failed” refer to PMDT Facility for MDR screening

Interrupted Treatment More than one month but less then two months Repeat DSSM If negative, continue tx but prolong If positive, check how long patient has been treated: < 5 months: continue tx and prolong > 5 months: treatment failed

Special situations Pregnancy TB drugs are safe EXCEPT STREPTOMYCIN Breastfeeding should receive full course of TB treatment feed their infants before taking medications supplemental pyridoxine should be given to the infant

Special situations Oral contraceptives interacts with rifampicin Liver disease PZA is the most hepatotoxic INH and Rif are associated with hepatitis

Special situations Liver disease interrupt treatment modified regimen if ALT elevation >3 times the ULN with hepatitis symptoms and/or jaundice if ALT >5 times the ULN, even without symptoms

Special situations Liver disease When do we resume the medications? normal liver function tests and no symptoms if no tests, extra 2 weeks after resolution of s/sxs

Special situations Liver disease How do we resume the medications? one at a time beginning with rifampicin after 3-7 days, INH may be given avoid PZA If s/sxs recur or LFTs become abnormal, last drug should be stopped

Special situations Chronic Liver disease SHOULD NOT RECEIVE PZA 2SHRE/6HR, 9RE or 2SHE/10HE Acute Hepatitis 3SE –once hepatitis resolves continuation phase of 6HR if hepatitis has not resolved 12 SE

Special situations Renal Failure if possible AVOID STREPTOMYCIN adjust doses of ethambutol and PZA HRZE 3 x a week and HR the rest of the week for the intensive phase 4HR for continuation phase

Special situations TB/HIV Coinfection priority is to treat TB anti-retroviral therapy can be given at the same time as the TB meds

Drug Interactions Rifampicin anti-hypertensives (except diuretics) analgesics (increases clearance of paracetamol but clinical importance not yet established) antifungals Anti-epileptics

Drug Interactions Isoniazid antacids carbamazepine paracetamol theophylline phenytoin

Drug Interactions Ethambutol/PZA interact with thiazide diuretics PZA: allopurinol/probenicid Streptomycin: other ototoxic/nephrotoxic drugs Fluoroquinolones: theophylline, warfarin

Treatment Outcomes Cured treatment completed treatment failed died lost to follow-up not evaluated

Cured Drug susceptible TB Cases bacteriologically-confirmed TB at the beginning of treatment smear/culture negative in last month of treatment and at least one previous occasion in the continuation phase

Cured RR-TB/MDR-TB/XDR-TB Patients bacteriologically confirmed and completed at least 18 months of treatment no evidence of failure AND 3 or more consecutive cultures taken at least 30 days apart are negative after the intensive phase

Treatment completed Drug Susceptible completes treatment without evidence of failure no record of sputum smear/culture results either not done or results are unavailable includes clinically diagnosed patients who completed treatment

Treatment completed RR-TB/MDR-TB/XDR-TB Patients completed at least 18 months of treatment without evidence of failure BUT NO record that 3 or more consecutive cultures taken at least 30 days apart are negative after the intensive phase

Treatment failed Drug Susceptible sputum smear/culture positive at 5 months or later during treatment clinically diagnosed patient (child or EPTB) with no sputum exam and no clinical improvement

Treatment failed RR-TB/MDR-TB/XDR-TB Patients Treatment terminated or need for permanent regimen change of at least 2 new anti -Tb drugs because of:  lack of conversion at the end of intensive phase (6-8 months)  bacteriological reversion in the continuation phase acquired resistance to fluoroquinolones/2 nd line drugs adverse drug reactions