Post on 30-May-2015
description
RNTCPDr. Gyanshankar Mishra
MD (Pulmonary Medicine) DNB(Respiratory Diseases)Assistant Professor
Dept. of Pulmonary Medicine, GMC Nagpur
RNTCPTreatmento Objectives of TB treatmento Basis of TB treatmento Case definitionso Treatment regimenso Special situationso Directly Observed Treatment (DOT)o Monitoring of patientso Treatment outcomeo Advanced categories under RNTCP – CAT IV & CAT V
o The objectives of RNTCP are to achieve and maintain a cure rate of at least 85% among new sputum smear-positive cases and to achieve and maintain detection of atleast 70% of such cases in the population.
Basis of TB treatmento Intermittent (thrice weekly) treatment
regimenso Treatment given under direct observationo Standardized treatment regimens in two
categorieso Regimen decided by MO on basis of
o Sputum smear resultso History of previous anti-TB treatmento Disease classification (pulmonary/extra pulmonary)o Severity of illness
1. Political and
administrative
commitment
2. Good quality
diagnosis, primarily
by sputum smear
microscopy
3. Uninterrupted
supply of good
quality drugs
4. Directly observed treatment
(DOT)
5.Systematic
monitoring and
accountability
Components of DOTS
o A pulmonary TB suspect is defined as:An individual having cough of 2 weeks or moreContacts of smear-positive TB patients having cough of any durationSuspected/confirmed extra-pulmonary TB having cough of any durationHIV positive patient having cough of any duration
o Pulmonary Tuberculosis, Smear-Positiveo TB in a patient with atleast one smear-positive
for AFB out of the two initial sputum smear examination by direct microscopy
o Pulmonary Tuberculosis, Smear Negativeo A patient with symptoms suggestive of TB with
two smear examination negative for AFB, with evidence of pulmonary TB by microbiological methods (culture positive or by other approved molecular methods) or Chest Xray is classified as having smear negative pulmonary tuberculosis
o Extra Pulmonary Tuberculosiso Tuberculosis in any organ other than lungs
(eg. pleura, lymph nodes, intestine, genitor-urinary tract, joint and bones, meninges of the brain etc).
o The diagnosis should be based on strong clinical evidence with the following investigationso Smear/Culture from extrapulmonary siteso Histopathological examination oro Radiological examination oro Biochemical and cytological examination
including FNAC
Case definitionso NEW
o A TB patient who has never had treatment for TB or has taken anti-tuberculosis drugs for less than one month
o RELAPSEo A TB patient who was declared cured or
treatment completed by a physician, but who reports back to the health service and is now found to be sputum smear positive.
Case definitions (contd)o TRANSFERRED IN
o A TB patient who has been received for treatment into a Tuberculosis Unit, after starting treatment in another unit where s/he has been registered.
o TREATMENT AFTER DEFAULTo A TB patient who received anti-tuberculosis
treatment for one month or more from any source and returns to treatment after having defaulted, i.e., not taken anti-TB drugs consecutively for two months or more, and is found to be sputum smear positive.
Case definitions (contd)o FAILURE
o Any TB patient who is smear positive at 5 months or more after starting treatment.
o CHRONICo A TB patient who remains smear-positive
after completing a re-treatment regimen but has not been initiated on MDR TB treatment
o OTHERSo TB patients who do not fit into the above
mentioned types. Reasons for putting a patient in this type must be specified
Treatment Regimens
Category ofTreatment Type of Patient Regimen*
Category I All new pulmonary (smear-positive andnegative), extra pulmonary and ‘others’ TB patients.
2H3R3Z3E3+ 4H3R3
Category II TB patients who have had more than one month anti-tuberculosis treatment previously
Relapse , Failure, Treatment After Default ,Others
2H3R3Z3E3S3 + 1H3R3Z3E3 + 5H3R3E3
Basis for RegimensCAT I: New sputum smear Positive patients,
high bacillary population, chances for naturally occurring resistant mutants higher,therefore 4 drugs in intensive phase
CAT II: Because of previous treatment, chances of harboring resistant bacilli are higher; hence 5 drugs in IP and total duration of treatment is 8 months.In continuation phase lower bacterial population;hence less chance of resistant organisms, therefore 3 drugs are enough.
Regimen for Non-DOTS treatment in RNTCP Areas
o Self administered non rifampicin containing regimen
o Needed in few cases of adverse reaction to rifampicin and pyrazinamide
o Upto a maximum of 1% of patients may get Non-DOTS treatment in an RNTCP area.
o Tuberculosis treatment card to be filled for these patients as well
Regimen for Non-DOTS treatment in RNTCP Areas
Treatment RegimenNon-DOTS Regimen 2HSE+10 HE
DOTS in the context of HIVDOTS can:o Prolong and improve the quality of life.o Prevent emergence of MDRTB.o Stop the spread of TB.o Reverse the trend of MDRTB.
o In the context of HIV, failure to use DOTS can result in - rapid spread of disease - tripling of cases - increased drug resistance.
Special situationso Hospitalization
o general policy is treatment on ambulatory basis.
o Indoor treatment adviced if general condition of patient is seriouso Pneumothoraxo Massive haemoptysiso Large pleural effusion
o Treatment with prolongation pouches supplied by DTO of the district in which hospital is situated.
Special Situations (contd)o Pregnancy and post natal period
o Streptomycin not to be given. Other drugs in RNTCP are safe
o Breast feeding should continueo Chemoprophylaxis for baby if mother is smear
positive
o Renal failureo Rifampicin, isoniazid and pyrazinamide can be
giveno Streptomycin and ethambutol require close
monitoring
Directly observed treatment (DOT) is one element of the
DOTS strategy
An observer watches and helps
the patient swallow the tablets
Direct observation ensures treatment for the entire course• with the right
drugs• in the right
doses• at the right
intervals
Directly Observed Treatment
DOTS StrategyA strategy to ensure treatment completion in
whicho Treatment observer (DOT provider) must be
accessible and acceptable to the patient and accountable to the health system
o DOT provider administers the drugs in intensive phase.
o Ensures that the patient takes medicines correctly in continuation phase.
o Provides the necessary information and encouragement for completion of treatment.
A suitable DOT provider and DOT center is selected in consultation with patient
Tuberculosis Treatment Card is accurately and completely filled after initial home visit
Initial counseling at the health facility and at patients home is important to achieve treatment compliance
Ensure that treatment is being directly observed for all doses of the intensive phase and the first of the thrice weekly dose in the continuation phase
Drug administration
Why are correct doses important?
Ref: Mishra G, Mulani J. Tuberculosis Prescription Practices In Private And Public Sector In India. NJIRM. 2013; 4(2): 71-78.
Why are correct doses important?
Ref: Mishra G, Mulani J. Tuberculosis Prescription Practices In Private And Public Sector In India. NJIRM. 2013; 4(2): 71-78.
Streptomycin injections should be given•After oral drugs are administered•With disposable syringes and needles
Chemoprophylaxis
to be given to children (under 6 years of age) of smear-positive patients
Patients missing doses should be traced and put back on treatment•Within one day in intensive phase•Within one week in continuation phase
Drug administration(contd)
Monitoring of Treatmento Follow up sputum
microscopy determineso Conversion rateo Cure rate
o Sputum smear microscopy scheduleo Initial sputum examinationo End of Intensive phase of
treatmento 2 months into Continuation
phase of treatmento End of treatment
Cat. of Rx
Pre–RxSputum
Test at month
If: result
Then
Cat–1+ 2 - C.P. – Sputum at 4 & 6 m
+ I.P. for 1month, Sp. At 3, 5 & 7
- 2- C.P. Sputum at 6 months
+ I.P. for 1 month, SP. at 3, 5 & 7
Cat–II + 3 - C.P. Sputum at 5 & months
+ I.P. for 1 month, Sp. at 4, 6 & 9
Schedule of follow-up sputum smear examination
CURED
• Initially sputum smear-positive patient who has completed treatment and had negative sputum smears, on two occasions, one of which was at the end of treatment
TREATMENT COMPLETED
• Sputum smear-positive patient who has completed treatment, with negative smears at the end of the intensive phase but none at the end of treatment.• Sputum smear-negative TB patient who has received a full course of treatment and has not become smear-positive during or at the end of treatment.• Extra-pulmonary TB patient who has received a full course of treatment and has not become smear-positive during or at the end of treatment
Treatment Outcomes
Treatment Outcomeso DIED
o Patient who died during the course of treatment regardless of cause
o FAILUREo Any TB patient who is
smear positive at 5 months or more after starting treatment.
DEFAULTED•A patient who has not taken anti-TB drugs for 2 months or more consecutively after starting treatment.
TRANSFERRED OUT
•A patient who has been transferred to another Tuberculosis Unit/ District and his/ her treatment result (outcome) is not known.
Treatment outcomes
Advanced RNTCP RegimesDrug Resistant TB (PMDT)
o MDR TB – Resistant to INH & Rifampicin
CAT IV – MDR TBINITIAL INTENSIVE PHASE : 6- 9 monthso Inj. Kanamycino Tab Ethionamideo Tab Ofloxacino Tab. Pyrazinamideo Tab. Ethambutolo Cap CycloserineCONTINUATION PHASE : 18 monthso Tab Ethionamideo Tab Ofloxacino Tab Ethambutolo Cap Cycloserine
CAT V- XDR TB
o XDR TB- MDR TB+ Resistant to Second line injectable Anti TB drug & Fluroquinolone
CAT V- XDR TBThe Intensive Phase (6-12 months) will
consist of 7 drugs Capreomycin (Cm), PAS, Moxifloxacin (Mfx), High dose-INH, Clofazimine, Linezolid, and Amoxyclav
The Continuation Phase (18 months) will consist of 6 drugs –
PAS, Moxifloxacin (Mfx), High dose-INH, Clofazimine, Linezolid, and Amoxyclav
Some practical pointso 1. TB is a notifiable disease.o 2. If you not sure of individualized treatment regime, please do
not start it. Instead you may register the patient under RNTCP.o 3. Do not start a fluroquinolone to a TB suspect.o 4.Please do simple sputum microscopy for afb smear for all TB
suspects, rather than directly starting from higher investigations like CT scan.
o 5. Serological TB tests are banned in India eg. TB IgG and TB IgM.o 5. Do not even attempt to treat drug resistant TB, in absence of
requisite training. Refer to specialist/ RNTCP /PMDT.