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PREVENTIVE THERAPY PROBLEMS IN CLINICAL PRACTICE. Uz. Dr. Asiye İNAN SÜER Altındağ , Ankara TB Control Dispensary No. 3 05.04.2013. I have no conflicts of interest to declare. Preventive therapy (PT). *An essential component of national tuberculosis (TB) control programme
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PREVENTIVE THERAPYPROBLEMS IN CLINICAL PRACTICE Uz. Dr. Asiye İNAN SÜER Altındağ, Ankara TB Control Dispensary No.3 05.04.2013
Preventive therapy (PT) *An essential component of national tuberculosis (TB) control programme *One of the most important duty of tuberculosis control dispensary (TCD): Preventive therapy at persons with increased risk of TB
Decision to PT • Hospital or TCD • Exclusion of active TB disease’ • Not examined for active TB : propability of isoniazid (H) resistance
To fill “Preventive Chemotherapy Form” Chest X-ray TST Symptoms and medical history Hepatic enzyme measurement (>35 years or having risk factors) Application at TCD
Application at TCD-Training İnformation about preventive therapy • Treatment duration • Close follow up • Regular use of drug • Side effects • Discontinue treatment at symptom onset, then contact TCD
Application at TCD-Medication • Planning treatment regimen and dosage • Monitoring plan in medical record • Free of charge • Periodically (usually monthly) given drug (at first meeting 15 days, then 30 days) • Pyridoxine (B6 vit)10 mg/day (at risk of peripheral neuropathy) • Give appointment and TCD’s telephone number
Conditions that is necessary alternative regimens -Serious side effect with H/or history -Not suitable 6-9 months treatment -Contacts of H resistance TB case -Contacts of MDR TB case
Alternative regimens 4 months Rifampin (4R) (better completion, less toxicity than 9H) 3/4 months Isoniazid+Rifampin (3/4HR) (equivalent effectiveness, completion of therapy and toxicity has been the same as with H) 3 months İsoniazid+ Rifapentin (3H+RPT) (>12 years, alternative for 9 H)
Efficacy of 3 months of Rifampin for the Prevention of TBPatients with Silicosis Hong Kong Chest Service. Am Rev Respir Dis 1992;145:36-41
Treatment of MDR-TB contacts *Q/QE may be safer, better tolerated . *Recommendations are based on expert opinion. Lobue P, Menzies D. Respirology 2010,15:603-622
Follow up treatment • Periodic control (monthly) • Ask: Symptoms- side effects and compliance • Train and support • Chest X-ray control (three months) • Compliance problems: DOT • Other hepatotoxic medications
Decision of treatment completion According to pause period: 6 months PT--- 9 months 9 months PT--- 12 months 4 months R-PT---6 months completion is acceptable *Am J Respir Crit Care Med 2000;161:S221-S247
Problems of application A-In the beginning of PT B-At follow up period
PT in Turkey-2013(Questionnaire ) • Aim: PT application and problems faced with/recognized during PT • Method: Send to 81 province TB coordinators also all TCDs in İstanbul and Ankara by mail • Answer : 69 Questionnaire forms collected (41 TB coordinators, İst-23 TCDs, Ank-5 TCDs)
A Provinces those answered the Questionnaire (yellow)
A-Problems faced with in the beginning of PT 1-Over indication 2-Wrong medication 3-PT neglicance 4-Age related problems 5-PT without TCD follow up 6-Convincement of person/family
Over indication 1-Active TB case 2-History of TB 3-Acut liver disease PT contrindicated
Wrong medication PT for H resistance/MDR TB case contacts Questionnaire :Treatment of MDR LTBI No------45 , No answer---1 Yes-----23 3 drug? 12 H, 5 H/R/HR 3 different regimen (ZQ/PAS-Q/ PROT-Q/PROT-Z)
PT negligence -Physicians knowledge about PT -Physicians belief about PT -Lack of HCWs at TCDs - Lack of experience
Physician’s opinions about Preventive Therapy* • A questionnaire was applied to 130 physicians from different specifications Soysal F. Solunum 3;27-30, 2001
Age related problems • National TB diagnosis and treatment guideline: Preventive therapy for contacts of TB <35 age • The decision to treat LTBI at over 35 years should be made after careful consideration of risks and benefits. • Preventive therapy at immunesupressed patients: most of over 35 years, no common side effects
Age-related risk of hepatotoxicity • A systematic review, 18.610 participants, 7 relevant studies • The median rate of hepatotoxicity; aged<35 %0,2 aged ≥35 %1,7 “The use of H for the treatment of LTBI is safe in older patients with clinical or biochemical monitoring.” Kunst H. Int J Tuberc Lung Dis 2010
Preventive therapy without TCD follow up -Decision of preventive therapy at hospital -Not registered TCD -H at drugstore - (Adherence to treatment? Clinical monitoring? Treatment completion?
Convincement of person/family Parent/family training Communication
Questionnaire Problems
B- Follow up- problems 1- Side effects 2- Compliance to PT 3- Default
Side effects - Peripheral neuropathy -Hypersensitivity (within days to weeks) -Hepatic adaptation: asymptomatic, transient elevations of transaminase, %10-20 -Hepatotoxicity (within weeks to months) nausea, vomiting, abdominal pain, jaundice or unexplained fatigue
Hepatotoxicity Treatment should be interrupted: • Transaminase elevation more than three times the upper limit of normal (ULN) in the presence of hepatitis symptoms and/or jaundice • Five times the ULN in the absence of symptoms • Bilirubin > 1.5 mg/dl
Isoniazid Hepatotoxicity • H hepatotoxicity is age related 3377 patients, 19 hepatotoxicity (5.6 per 1000) 25-34 years 4.40 35-49 years 8.54 ≥50 years 20.83 • H hepatotoxicity frequently occurs within the first 3 months After 1 month 2.75 per 1000 After 3 month 7.20 After 6 month 4.10 Fountain FF. Chest 2005;128:116-23
Conditions that high risk of side effects • Chronic ethanol consumption • Pregnant/ 3 months post-partum • Viral hepatitis/ pre-existing liver disease • Other hepatotoxic medications • ALT/AST or bilirubin abnormal • Over 35 years Baseline and follow-up serum ALT and bilirubin are recommended for patients with risk factors. ATS . Am J Respir Crit Care Med 2006;174:935-52
Suboptimal compliance 1-Duration of therapy (6-9 months) 2-Logistical issues 3-Adequate communication between health department staff and the patient 4-Negative attidutes towards PT 5- Change of the first indication 6-Difficulties in drug intake
PT Default * E.Kibaroğlu, 4nolu VSD/Ankara, 2012 Toraks kongre sunumu
Questionnaire Problems
Adherence to treatment in contactsReal conditions: Alberta 1990-91 2007 Toraks kongresi, D.Emarson’ın sunumundan