WHAT IS TUBERCULOSIS?
"Tuberculosis (TB) is a highly infectious bacterial disease caused by Mycobacterium tuberculi".
TB can affect any part of the body. When it affects the lungs it is called pulmonary TB. The commonest form of TB is pulmonary TB.TB in any other part of the body (i.e. other than lungs) is called extra pulmonary TB.
HOW TUBERCULOSIS SPREADS?
TB germs usually spread through air. When a patient with pulmonary tuberculosis
coughs or sneezes, TB germs are spread in the air in the form of tiny droplets. When these droplets are inhaled by a healthy person s/he gets infected with tuberculosis. This infected person will have a 10% lifetime risk of developing tuberculosis.
MAGNITUDE OF TUBERCULOSIS IN INDIA
In India everyday
• more than 40,000 persons get infected with the TB bacillus
• more than 5000 people develop TB disease
• more than 1000 people die due to TB ( i.e. 2 persons die every 3 minutes)
• annually, about 18 lakh new cases of TB occur of which about 8 lakh are sputum
positive infectious cases
Also, every year
• about 3 lakh children drop out from the school because of their parents had
tuberculosis
• more than 1 lakh women are rejected by their families because of stigma due to
TB
It is estimated that in a year, about 200 TB cases may occur in a population of 1 lakh
CLASSIFICATION OF TUBERCULOSIS
1. Pulmonary 2. Extra-pulmonary
Lymph nodes
Sputum-positive sputum-negative
Bones and joints
Urogenital tract
Nervous system (meninges)
Intestines
"One sputum positive case, if not treated, can infect 10 -15 individuals in one year "
A patient with at least two samples of sputum found positive for Acid-Fast Bacilli (AFB)
by microscopy is known as a sputum-positive case.
OR
A patient with one sample of sputum found positive for AFB by microscopy and having
X-ray abnormalities consistent with active pulmonary tuberculosis is also labeled as a
sputum-positive case. However, this is to be done only by a Medical Officer.
Smear-Positive Pulmonary TB is the most infectious form of Pulmonary TB in Adults
A patient with all three samples of sputum found negative for AFB by microscopy, should after a course of broad spectrum antibiotics repeat the sputum examination. If found negative and X-ray abnormalities are consistent with active pulmonary tuberculosis, it is known as a sputum-negative case. The decision of diagnosing and treating such a case will be taken by the Medical Officer only.
Extra-Pulmonary Tuberculosis
A patient with active tuberculosis of any part of the body other than the lungs is a case
of extra-pulmonary tuberculosis. The decision of diagnosing and treating such a case will be taken by the Medical Officer only.
WHEN SHOULD TUBERCULOSIS BE SUSPECTED?
The symptoms of Pulmonary Tuberculosis are
• cough with expectoration for 3 weeks or more
• chest pain
• sometimes, blood stained sputum (haemoptysis) with systemic symptoms like
ƒ evening rise of temperature
ƒ night sweats
ƒ loss of weight
ƒ loss of appetite
A person with cough for 3 weeks or more is a suspect for TB and is called a chest symptomatic
Extra-pulmonary Tuberculosis
In case of extra-pulmonary TB, symptoms in addition to the above mentioned, depends
on the organ involved, for eg.
• Lymph Node Tuberculosis – Swelling in the neck with or without discharging sinus.
• Tuberculous Meningitis - Headache, fever, drowsiness, mental confusion, neck
rigidity.
• Spinal Tuberculosis – Back pain, fever and at times swelling of the backbone.
HOW TO DIAGNOSE TUBERCULOSIS?
Sputum examination is the main tool for diagnosing pulmonary TB.
Cases of pulmonary tuberculosis are further subdivided into sputum-positive and
sputum-negative cases. When pulmonary tuberculosis is suspected, it is mandatory to conduct sputum examinations to confirm the diagnosis. At least 3 sputum samples (spot – morning - spot) should be collected, preferably within two days, and examined by microscopy only at an RNTCP designated microscopy centre (DMC). A DMC is an identified sputum microscopy laboratory in a PHC, CHC or hospital for 1 lakh population (in tribal areas – 50,000 population). It is equipped with a binocular
microscope, trained lab technician and is supervised by the Senior Tuberculosis Laboratory Supervisor (STLS) at regular intervals. A person with at least two positive sputum samples out of three is a confirmed case of sputum positive pulmonary tuberculosis. This is the most infectious form of tuberculosis. Patients who are smear-negative or have only one smear-positive sample must be referred to the Medical Officer (MO) for further evaluation as per diagnostic algorithm of RNTCP.
Diagnosis of TB must be done by a Medical Officer (MO)
NATIONAL TUBERCULOSIS PROGRAMME
The National Tuberculosis Programme (NTP) in India was being implemented since 1962 by establishing District Tuberculosis Centres (DTCs), TB Clinics and TB Hospitals. From its inception, the programme was integrated with the general health services and the service delivery was through the primary health care infrastructure. The results of NTP were not encouraging. The strategy of the NTP was reviewed in 1992. This led to the launching of the Revised National Tuberculosis Control Programme (RNTCP) in 1997, planning to cover the entire country by 2005.
Revised National Tuberculosis Control Programme
Objectives of RNTCP
1. To achieve and maintain a cure rate of at least 85% among newly detected
infectious (new sputum smear-positive) cases, and
2. To achieve and maintain detection of atleast 70% of such cases in the population.
RNTCP is based on the internationally recommended strategy to control TB
known as ‘DOTS’ (Directly Observed Treatment Short course)
WHAT IS DOTS?
DOTS is a systematic strategy which has five components
• Political and administrative commitment.
TB is the leading infectious cause of death among adults. It kills more women than all causes associated with childbirth combined and leaves more orphans than any other infectious disease. Since TB can be cured and the problem can be controlled, it warrants the topmost priority, which it has been accorded by the Government of India. This priority must be continued and expanded at the state, district and local levels.
• Good quality diagnosis.
Top quality microscopy allows health workers to see the tubercle bacilli and is essential to identify the patients who need treatment the most.
• Good quality drugs.
An uninterrupted supply of good quality anti-TB drugs must be available. In RNTCP, a box of drugs for the entire treatment is earmarked for every patient registered, ensuring the availability of the full course of treatment to the patient the moment s/he is registered for treatment. Hence in DOTS, the treatment
will never fail for lack of medicine.
• The right treatment, given in the right way.
The RNTCP uses the best anti-TB medications available. But unless treatment is made convenient for patients, it will fail. This is why the heart of the DOTS programme is "Directly Observed Treatment" in which a health worker, or another trained person who is not a family member, watches as the patient swallows the anti-TB medicines in their presence.
• Systematic monitoring and accountability. The programme is accountable for the outcome of every patient treated. The cure rate and other key indicators are monitored at every level of the health system, and if any area is not meeting expectations, supervision is intensified. The RNTCP shifts the responsibility for cure from the patient to the health system.
ƒ Makes the patient the VIP of the programme
ƒ Places responsibility for patient’s cure on the health system, not on the patient
ƒ Reduces risk to the community by preventing spread of TB
ƒ The best method to ensure cure
WHAT IS ‘CURE’?
A patient who is initially sputum smear-positive and who has completed treatment and had negative sputum smears on two occasions, one of which was at the end of treatment, is declared a ‘cured’ patient.
IMPORTANT POINTS TO REMEMBER ABOUT TUBERCULOSIS SUSPECTS
• The most common symptom of pulmonary tuberculosis is persistent cough for 3 weeks or more
• Health workers should identify tuberculosis suspects as early as possible to stop spread of infection.
• Refer all TB suspects to DMCs/ sputum collection centres for 3 sputum examinations
• DOT is the best method to ensure cure for TB
"DOTS – sure cure for TB"
TREATMENT OF TUBERCULOSIS
The duration of treatment is usually 6 to 8 months. There are two phases in the treatment of tuberculosis: the intensive phase (IP) of 2-4 months and the continuation phase (CP) of 4-5 months, depending upon the category of treatment. During IP, all doses are given under direct observation, three times a week on alternate days for 2-4 months. Thereafter, sputum is examined and if found negative, the CP is started. During CP, the first dose of every week must be administered under direct observation. The patient collects the rest of the drugs for that week from the DOT Provider and consumes them at home.The following week, the patient comes with the empty blister pack, hands it over to the DOT Provider, takes the first dose under direct observation and collects drugs for the rest of the week to be consumed at home.
What are Categories I, II and III?
There are three categories of treatment regimens for patients suffering from tuberculosis (pulmonary or extra-pulmonary).
Drugs are supplied in a Patient Wise Boxes (PWB) containing the full course of treatment for one patient and are packaged in blister packs. The PWBs have a colour code indicating the category of treatment (red for Cat I, blue for Cat II and green for Cat
III). In each PWB, there are 2 pouches, one for IP (marked A) and one for CP (marked B)
For IP, each blister pack contains drugs for one day. For the CP each blister pack contains one week’s supply of medication. The drugs for one month’s extension of the IP (prolongation pouch) are supplied separately.
ƒ There are 52 weeks in a year
ƒ For purpose of the programme and drug administration
ƒ 2 months have been taken as 8 weeks
ƒ 3 months have been taken as 12 weeks
ƒ 4 months have been taken as 18 weeks
ƒ 5 months have been taken as 22 weeks
ƒ
The weeks and months specified above should be strictly adhered
Category I (CAT-I) Treatment Regimen
The anti-TB drugs in CAT-I are supplied in patient wise boxes with red colour labels containing 24 doses for the two months of the intensive phase and 18 weekly blister packs for the four months of the continuation phase.
Each weekly blister pack of the CP contains anti-TB drugs for 3 days and vitamin tablets for the remaining 4 days, taken on alternate days This is prescribed for the following types of patients:
• New sputum-positive pulmonary TB cases
• New sputum-negative, pulmonary TB cases, who are seriously ill
• New cases of extra-pulmonary tuberculosis, who are seriously ill
• All new TB cases with known HIV +ve status
Drug Regimen in CAT-I
Intensive Phase for two months
During the intensive phase (IP) of treatment, each and every dose of medicine is to be taken under direct observation of the DOT Provider. DOT is administered at a DOT centre, which is a place convenient to both the patient and the DOT Provider Anti-TB drugs are taken three times a week on alternate days, either on Mondays, Wednesdays and Fridays OR Tuesdays, Thursdays and Saturdays for two months. All empty blister packs should be preserved in the patient wise box (PWB). The anti-TB drugs to be swallowed for each scheduled dose of the intensive phase are:
Isoniazid (H) Rifampicin (R) Pyrazinamide (Z) Ethambutol (E)
300 mg 450 mg 750 mg 600 mg
2 tablets 1 capsule 2 tablets 2 tablets
If a patient in IP does not take medication as scheduled s/he should be traced and given medication within 24 hours. The medication for the following day is given as scheduled. For example, if a patient is receiving DOT on Mondays, Wednesdays and Fridays, but does not take medication on Wednesday, the patient should be found on Thursday and given medication and should take the next dose of medication on Friday, returning to the previous schedule.
Continuation Phase for four months
If the sputum at the end of the I.P. (i.e. at the end of two months) is found to be negative, the patient is started on continuation phase for a period of four months. During the CP, the first dose of the week must be administered under direct observation. The patient collects rest of the drugs for the week from the DOT Provider and consumes them at home. The following week, the patient comes with the empty blister pack, hands it over to the DOT Provider, takes the first dose under direct observation and collects drugs for the rest of the week to be consumed at home. The DOT Provider must collect the empty blister pack and keep it in the PWB.
The anti-TB drugs to be swallowed on each day of the continuation phase are:
Isoniazid (H) Rifampicin (R)
300 mg 450 mg
2 tablets 1 capsule
For patients weighing over 60 kgs, the Medical Officer initiating treatment may prescribe an additional tablet of Rifampicin 150 mg which also needs to be administered. Similarly for pediatric cases, the Medical Officer may adjust the dose according to weight. If the sputum test, at the end of two months of intensive phase treatment remains positive, the four anti-TB drugs of the intensive phase will be continued for one more month. If even at the end of the extended period of intensive phase the sputum test remains positive, the patient will be started on drugs of the continuation phase. Irrespective of the duration of the intensive phase, the duration of the continuation phase remains the same (4 months). If the sputum still remains positive at the end of five months after the start of treatment the patient is taken off CAT-I treatment and the DOT Provider must ensure that the patient is referred to the MO of the PHI for further management.
Category II (CAT-II) Treatment Regimen
This is prescribed for the following types of patients:
• Sputum-positive relapse cases
• Sputum-positive failure cases
• Sputum-positive treatment after default cases
• Others; Extrapulmonary relapse or failure
The anti-TB drugs in CAT-II are supplied in patient wise boxes with blue coloured labels which contains 36 doses for the three months of the intensive phase and 22- weekly blister packs for the five months of the continuation phase. For the continuation phase each weekly pack contains anti-TB drugs for 3 days and vitamin tablets for the remaining 4 days to be taken on alternate days.
Drug regimen in CAT-II
Intensive Phase (I.P.) for three months
During the IP of treatment, each and every dose of medicine is to be taken under the direct observation of the DOT Provider. DOT is administered at a DOT centre, which is a place convenient to both the patient and the DOT Provider Anti-TB drugs are taken three times a week on alternate days, either on Mondays, Wednesdays, Fridays OR Tuesdays, Thursdays and Saturdays for three months. All empty blister packs should be preserved in the patient wise box (PWB). In addition to the following four anti-TB drugs, an injection of streptomycin (0.75 g) is also given intramuscularly for first two months on the same days on which the patient comes to swallow his scheduled dose of anti-TB drugs. The injection is to be given after the patient has swallowed the other drugs.
The anti-TB drugs to be swallowed for each scheduled dose of the intensive phase are:
Isoniazid (H) Rifampicin (R) Pyrazinamide (Z) Ethambutol (E)
300 mg 450 mg 750 mg 600 mg
2 tablets 1 capsule 2 tablets 2 tablets
Continuation Phase (C.P.) for five months
If the sputum test at the end of I.P. (i.e. at the end of three months) is found to be negative, the patient is put on continuation phase for a period of five months. Each weekly blister pack contains anti-TB drugs for three days of the week and vitamins for the remaining days of the week. During the CP, the first dose of the week must be administered under direct observation. The patient collects the rest of the drugs for the week from the DOT Provider and consumes it at home. When the patient returns the next week for the blister pack, s/he must present the empty blister pack of the drugs consumed at home. The DOT Provider must collect the empty blister packs and keep it in the patients PWB The anti-TB drugs to be swallowed for each scheduled dose of the continuation phase are:
Isoniazid (H) Rifampicin (R) Ethambutol (E)
300 mg 450 mg 600 mg
2 tablets 1 capsule 2 tablets
If the sputum test at end of three months of intensive phase remains positive, the four drugs of the intensive phase will continue for one more month. If even at the end of the extended period of intensive phase, the sputum remains positive, the patient will start on drugs of the continuation phase. Irrespective of the duration of the intensive phase, the duration of the continuation phase remains the same (5 months). If sputum still remains positive at the end of five months of continuation phase, the DOT Provider must ensure that the patient is referred to the MO of the PHI for further management.
Category III (CAT-III) Treatment Regimen
This is prescribed for the following types of patients:
• New sputum-negative pulmonary TB cases, who are not seriously ill
• New extra-pulmonary tuberculosis cases, who are not seriously ill.
The anti-TB drugs in CAT-III are supplied in patient wise boxes with green coloured labels which contains 24 doses for two months of the intensive phase and 18 weekly blister packs for the four months of the continuation phase. For the continuation phase each weekly pack contains anti-TB drugs for 3 days and vitamin tablets for the remaining 4 days to be taken on alternate days.
Drug Regimen in CAT-III
Intensive Phase (I.P.) for two months
During the IP of treatment, each and every dose of medicine is to be taken under direct observation of the DOT Provider. DOT is administered at a DOT centre, which is a place convenient to both the patient and the DOT Provider. Anti-TB drugs are taken three times a week on alternate days, either on Mondays, Wednesdays, Fridays OR Tuesdays, Thursdays and Saturdays for two months. All empty blister packs should be preserved in the patient wise box (PWB).
The anti-TB drugs to be swallowed for each scheduled dose of the intensive phase are:
Isoniazid (H) Rifampicin (R) Ethambutol (E)
300 mg 450 mg 750 mg
2 tablets 1 capsule 2 tablets
Continuation phase (C.P.) for four months If the sputum test at the end of the I.P. (i.e. at the end of two months) is found to be negative, the patient is put on the continuation phase for a period of four months. During the CP, the first dose of the week must be administered under direct observation. The patient collects rest of the drugs for the week from the DOT Provider and consumes them at home. When the patient returns the next week for his/her blister pack, he/she must present the empty blister pack of the drugs that were consumed at home. The DOT Provider must collect the empty blister pack and keep it in his/her PWB.
The anti-TB drugs to be swallowed on each day of the continuation phase are:
Isoniazid (H) Rifampicin (R)
300 mg 450 mg
2 tablets 1 capsule
If sputum is found positive at the end of two months of the intensive phase, the patient is withdrawn from Category III and referred to the MO of the PHI for further management. If sputum is found negative at the end of two months of the intensive phase, patient starts anti-TB drugs of the continuation phase.
Management of Contacts of Sputum-Positive Cases
Any person who has a productive cough of any duration and is in contact with a smearpositive case, three sputum samples should be examined as soon as possible for diagnosis, and if negative, s/he should be evaluated by the Medical Officer and also followed up three months later. Children who cannot produce sputum should be examined with other recommended investigations like chest X-ray and tuberculin testing. For all such cases contact the Medical Officer.
INTERACTING WITH PATIENTS
RNTCP recognizes the patient as the VIP (Very Important Person) of the programme. RNTCP also entrusts the responsibility of curing of patients on the programme and not on patients. Therefore it is important for DOT Providers to treat the patients in friendly manner. At the DOT centre, patients should be welcomed, made to take a seat and provided with drinking water. It is also important to ensure that the DOT centre selected for individual patients are near to their residence and are open during the time that is convenient to the patient. The DOT Provider should ensure that the patients who do not come for their scheduled doses are met with, motivated and brought back to treatment. During IP, the patients interrupting treatment should be brought back to treatment within 24 hours and during CP within a week. It is important to identify the cause of interrupting treatment and address the problem in consultation with the patient and if required with the health worker, supervisor or the medical officer of the area. If the DOT Provider is not able to retrieve the patients back on treatment, then the health worker/ supervisor/ MO should be informed immediately.
For more details visit http://www.tbcindia.org for more information regarding tuberculosis and RNTCP
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