Introduction

Speakers: Dr. Thalath Hussain Specialist Internal Medicine Chairperson, Infection Control Committee and Ms. Analyn D. Imperial Infection Control Nurse Training Coordinator NATIONAL TUBERCULSIS CONTROL PROGRAM

Introduction Tuberculosis is one of the most ancient diseases affecting human being since many decades, caused by Tuberculosis mycobacterium discovered by Robert Koch in 24 March, 1882 in Berlin City. WHO had assigned that day to be the world tuberculosis day. In April 1993, WHO declared tuberculosis as a global health emergency and invited all members for rapid interference to prevent the spread of the disease. According to WHO statistics in the year 1995, there were 50 millions tuberculosis cases worldwide and about eight millions expected to be infected with tuberculosis yearly, most of them are youth and adults. About 3 millions deaths were reported and is estimated that about 90 millions will be infected with tuberculosis during the coming 10 years. WHO has adopted DOTS strategy to be implemented in all countries including the Kingdom of Saudi Arabia. The strategy depends on observing tuberculosis patients swallowing their medications with regular follow-up. This strategy proved that it could cure more than 90% of patients.

National Tuberculosis Control Program (NTP) Goal Aims to eliminate tuberculosis in the kingdom to a degree that resembles no danger on health, economy or social aspects of the community. Objectives Raising cure rate of pulmonary smear positive tuberculosis to more than 85% by the year 2005. Detecting more than 70% of the estimated tuberculosis cases by the year 2005. Decreasing the incidence rate of pulmonary smear positive tuberculosis among nationals to 1/100,000 by the year 2010.

What is Tuberculosis? Tuberculosis - is an infectious disease caused in most cases by micro-organism called Mycobacterium tuberculosis . Infection usually occurs by inhalation of infected droplet nuclei through the lung which may then spread to other parts of the body via the blood stream, lymphatic system, via the airways or by direct extension to other organs. Infection with Bovine mycobacteria, transmitted by ingestion of raw milk, is less prevalent in humans and mostly occurs in bovine animals. There are other strains of mycobacteria which may cause tuberculosis but their occurrence is rare and most of which are drug-resistant.

Mode of transmission The micro-organism usually enters the body by inhalation through the lungs where infection is presented by a primary lesion. The infectious case (smear positive) of tuberculosis expels micro-organisms into air in tiny droplets when coughing, sneezing or laughing. These small droplets dry rapidly, become droplet nuclei carrying the micro-organism and may remain suspended in air for several hours. These droplet nuclei containing micro-organisms may be inhaled by another person who enters the room. After inhalation, the big particles usually expelled by the secretions and cilia of the upper respiratory system while the smaller particles are settled in the lung, multiplying and causing a primary lesion from which infection may spread to other parts of the body through blood and lymphatic system. Inhalation of mycobacteria does not mean occurrence of tuberculosis, as the amount of bacilli inhaled may be not sufficient to be manifested by illness and this case is called "tuberculosis infection". Only 10% of those infected individuals may progress to a manifest disease.

Pulmonary Tuberculosis is the most common form where the disease affects the lung parenchyma. This form accounts for about 80% of tuberculosis and it is the only form of tuberculosis that may be infectious. Extra Pulmonary Tuberculosis In this form the disease affects organs other than the lung parenchyma. It can affect bones, glands, genitourinary system, nervous system and intestine. Tuberculosis can affect any part of the body. Tuberculosis suspect: Persons who are complaining of continuous cough for more than 3 weeks combined with sputum in addition to one or more of the following: fever chest pain difficult breathing weight loss hemoptysis

Manifestations of Extra Pulmonary Tuberculosis: Differ according to the organ affected, for example: Enlarged lymph nodes. Painful and swollen joint Paraplegia due to affection of the vertebral column Headache and fever, neck stiffness and confusion due to meningitis Infertility due to affection of the genital system.

Complications of Tuberculosis: Miliary tuberculosis: The most prevalent manifestations of this form of tuberculosis are fever, loss of body weight accompanied by cough, enlarged lymph glands and enlarged spleen. Tuberculosis meningitis: The manifestations of tuberculosis meningitis are similar to those of other forms of meningitis but their appearance is usually more slowly. It may be accompanied by fever, cough, vomiting and behavioral changes which usually appear early in the course of the disease followed by other usual manifestations of meningitis in addition to other symptoms as: Hemoptysis Pneumothorax Pleural Effusion Cardio-Pulmonary insufficiency

Definitions of tuberculosis cases: Tuberculosis is classified according to the site affected into pulmonary or extra pulmonary and pulmonary tuberculosis may be smear positive or smear negative. Pulmonary smear positive case- a patient has at least two sputum samples positive for acid-fast bacilli by direct microscopy or a patient who has only one sputum sample positive for acid-fast bacilli by direct microscopy with radiological manifestations consistent and a decision by the physician to treat as tuberculosis or a patient who has one sputum smear positive for acid fast bacilli by direct microscopy positive sputum culture. Pulmonary smear negative case- a patient who has at least two sets (two weeks apart) of sputum samples negative for acid fast bacilli by direct microscopy with radiological chest manifestations consistent with tuberculosis and decision by the physician to treat as tuberculosis accompanied with no response to non-specific broad spectrum chemotherapy or a patient who was initially smear negative for acid fast bacilli by direct microscopy but has a positive sputum culture. Extra-Pulmonary tuberculosis- a patient who has a fluid culture positive for acid fast bacilli from organs other than the lung parenchyma (pleural fluid, lymph node aspirate, genitourinary fluids, bone aspirate or pericardial aspirate ) or has a positive tissue culture for acid fast bacilli by direct microscopy but has a positive sputum culture.

Classification of tuberculosis patients according to history of anti- tuberculosis medication: New Tuberculosis case A tuberculosis patient who never had anti-tuberculosis medications before or had anti-tuberculosis medications for less than four weeks. Relapse case A tuberculosis patient declared cured from any form of tuberculosis and come back with pulmonary smear positive tuberculosis. Treatment failure A patient who was initially smear negative and converted by the end of the second month of regular treatment into smear positive or a tuberculosis patient who was initially smear positive and remains positive by the end of the fourth month of regular treatment.

Treatment after default (TAD) A tuberculosis patient who interrupted his treatment for more than two months, after taking anti-tuberculosis drugs for more than a month, and come back with pulmonary smear positive tuberculosis. Transferred- out patient A tuberculosis patient who has been transferred from one district to another. Transferred- in patient A tuberculosis patient who has been transferred to one district from another. Chronic case A tuberculosis patient who has completed two fully supervised anti-tuberculosis treatment courses and remains smear positive. Those patients are mostly having multi-drug resistant tuberculosis.

Diagnosis of Tuberculosis Method of Diagnosis Sputum examination The main method for diagnosis of tuberculosis is smear examination. Direct sputum examination of suspects should be performed and three sputum samples should be collected during a period of two days. The first sample has to be collected in the first interview with the patient (on spot) the second sample should be a morning sample collected by the patient at home and the third sample should be collected on the second interview (on spot). The patient should collect the sample in a good ventilated room away from other patients under supervision of trained personnel. The patient mouth should be cleaned from food remnants. If the first sample was found to be positive and the patient did not come for the second sample, he should be traced again to complete the samples. During waiting for smear results nonspecific broad spectrum antibiotics and symptomatic medications could be administered, if required. If there is no improvement by this medication and smear results were found to be negative, the patients must be examined clinically and by X-ray with collection of another set of sputum samples.

X-ray Diagnosis by means of radiological examination in patients suspected of tuberculosis is unreliable. Abnormalities identified on a chest radiograph may be due to tuberculosis or to a variety of other conditions, and the appearance on the radiograph is not specific for tuberculosis. So it is recommended to diagnose tuberculosis by direct smear examination for acid fast bacilli. Chest radiograph may be helpful in those patients who are not sputum smear positive, for assessment of contacts and in diagnosis of miliary tuberculosis with smear negative results, but it should be ready by a competent physician.

Tuberculin testing (Mantoux test) Tuberculin is a purified protein derivative from tubercle bacilli and is called purified protein derivative (PPD). Following infection with M. tuberculosis, a person develops hypersensitivity to tuberculin. Tuberculin injected into the skin of an infected person produce a delayed local reaction after 24-72 hours. The reaction is quantified by measuring the diameter of skin induration at the site of injection. Negative - less than 10 mm, regardless whether or not the person has had BCG. Positive - 15mm. or more is considered positive in individuals who have had BCG. Patient with HIV infection an induration of 5mm is considered positive.

Diagnosis of extra-pulmonary tuberculosis Investigations differ according to the site of the disease. Miliary tuberculosis; tuberculin test may be negative and the diagnosis should be based on X-ray findings. Tuberculous meningitis; CSF should be examined chemically and by microscope in addition to culture. Tuberculin test is usually positive and radiological chest abnormalities usually found. Contacts of a tuberculosis case Family members of pulmonary smear positive cases (Index case) and other direct contacts must be examined to exclude or confirm their affection with tuberculosis. Any contact with cough should have his sputum examined at the time of contact listing and after three months in addition to tuberculin testing.

What Transmission Based Precaution Used for TB Patients

Treatment of Tuberculosis General roles of tuberculosis treatment Tuberculosis treatment must not be started before confirmation of diagnosis. It has to be started after receiving laboratory reports for at least two smear positive sputum samples. In case of the presence of only one positive sputum sample, the decision of treatment should be taken by the physician. In absence of positive laboratory smear results, the decision of treatment should be taken by the physician guided by clinical and X-ray findings and at least two sputum samples negative by microscopy for acid fast bacilli. In treatment of tuberculosis the following should be put in mind. Anti-tuberculosis drugs should be used according to the recommended categories for the recommended period and under direct supervision.

Directly Observed Treatment, Short course (DOTS) Is considered to be the optimal way for treating tuberculosis patients because of the following Short duration of treatment helps patients to adhere to treatment. Rapid conversion of sputum from positive to negative decreases the chance of infection transmission. The high cure rate compared with low cost. Decreased complications of tuberculosis. Decreasing the chance of emergence of drug resistant tuberculosis. Decreasing mortality rate.

Phases of treatment Divided into two phases Initial Intensive Phase – for a period not less than two months where 3-4 drugs are used. 2. Continuation Phase – for a period not less than four months where at least two drugs are used. The use of this combination of drugs in the intensive phase, including rifampicin, helps to eliminate tuberculosis bacilli from the body and decrease the chance of emergence of resistant strains. It is recommended to extend the intensive phase by one month if sputum remains positive by the end of the second month of treatment in new cases and end of the third month in re-treatment cases. Duration of Treatment The duration of treatment should be not less than six months and there is no need for expansion of this period if the patient adheres to treatment, except in some exceptional cases.

General procedures that should be followed during treatment The patient should be followed-up regularly during the period of treatment to ensure his adherence to treatment and to perform follow-up sputum smear examination. The priority of follow-up should be for pulmonary smear positive patients where sputum must be examined at the end of the second month of treatment (third month in case of relapse or failure), fifth month and at the end of treatment. If smear remains positive by the end of the second month (third month in relapse and failure case) the intensive phase should be extended for another month (third month in new cases and fourth month in relapse and failure cases) till the sputum converted to negative then the continuation phase has to be started. If smear remains positive by the end of the third month (fourth month in relapse and failure cases), the treatment must be stopped for three days and a sputum sample should be examined by culture and sensitivity then the continuation phase has to be continued to the fifth month. If sputum remains positive by the fifth month the patient has be registered as a failure case. If the patient was initially pulmonary smear negative and by the end of the second month of treatment converted to positive, he should also be registered as a failure case.

Follow-up of treated patients The occurrence of relapse among patients regularly completed their treatment is rare, so follow-up of those patient after completing their treatment is not required, except if the patients seek advise or on reappearance of symptoms. Categories of treatment The following drugs used in treatment of tuberculosis and their codes Isoniazide (H) Rifampicin (R) Pyrazinamide (Z) Ethambutol (E) Stretomycin (S)

Treatment Categories CAT 1 Administered to new smear positive cases Severe pulmonary smear negative patients (as extensive parenchymal involvement) Severe extra-pulmonary forms (meningitis, pericarditis, miliary and peritoneal tuberculosis). [Intensive phase – 2HRZS(E)] Four anti-tuberculosis drugs are administered daily for two months. If sputum converted to negative the continuation phase should be started, otherwise the intensive phase must be extended for another month. Continuation phase (4HR) Started after conversion of sputum from positive to negative or if the sputum remains positive after expansion of extensive phase to a third month (in this case treatment must be stopped for three days and sputum samples for culture and sensitivity must be collected) and two drugs [Isoniazide and Rifampicin (Ethambutol)] are used daily for four months.

2. CAT2 [2HRZSE/1HRZE/5HRE ] Cases classified as relapse and failure of treatment. Drug resistant tuberculosis should be suspected in these cases Previously treated from tuberculosis for more than one month, treatment must be stopped for three days and a sputum sample for culture and sensitivity must be collected before starting the new category of treatment then drugs must be used in accordance with the results of C/S. A competent follow-up for those patients is recommended to ensure their adherence to treatment because the chance of having drug resistant tuberculosis is being high. Intensive phase [2 HRZSE/1HRZE] Five drugs [Isoniazide, Rifampicin, Pyrazinamide, Streptomycin and Ethambutol] are used daily for two months and then four drugs daily [all drugs mentioned above except for Streptomycin] for one month. If sputum remains positive by the end of the third month, the intensive phase must be fourth month, treatment must be stopped for three days and sputum samples for culture and sensitivity must be collected. Continuation phase [5HRE] Three drugs (Isoniazide, Rifampicin and Ethambutol) are used for five months and if the intensive phase was extended for a fourth month the continuation phase must be extended for a sixth month).

3. CAT3 [2HRZ/4HRor 6 HE] Patients with new smear negative pulmonary tuberculosis (not severe), extra-pulmonary tuberculosis (not critical) and for children complaining of tuberculosis. Initial intensive phase [2HRZ] Three drugs (Isoniazide, Rifampicin and Pyrazinamide) are used daily for 2 months. Continuation phase [4HR or 6HE] Isoniazide and Rifampicin are used daily for four months or Isoniazide and Ethambutol are used daily for six months.

4. CAT4 A special category of treatment used for chronic and resistant tuberculosis case. Treatment must be based on C/S and usually the second line drugs are used for treatment of those patients. Procedures for defaulted cases If patient under treatment in the intensive phase defaulted for two times from the assigned date for him to swallow his medications or defaulted from drug collection for more than one month from the assigned date to collect his drugs in the continuation phase, the procedures mentioned should be applied. In case of re-registering a tuberculosis patient in the district register, a note that he has defaulted from treatment must be recorded in front of his previous TB code in the column of "remarks". Relapse and failure patients must be treated and if they also failed to respond to treatment they must be shifted to the fourth category.

Hospitalization It is important to hospitalize pulmonary smear positive tuberculosis patients during the intensive phase of treatment (two months or more). Also, critical cases, complicated cases and some other cases should be hospitalized if the physician recommends that. Recording and Reporting The National Tuberculosis Control Program requires adequate recording, with periodic reporting of the data about case findings and treatment outcome. This is an essential element for planning, evaluation and follow-up of the program performance.

Statistics and National Tuberculosis Control Program Case detection Treatment Outcome Cure B. Treatment Completed C. Treatment Interrupted (default) D. Treatment Failure E. Transferred Out F. Died G. Smear Conversion Rate

Tuberculosis codes used by NTP in Saudi Arabia 8 Others 7 Genitourinary 6 Miliary 5 Meningitis and neurological 4 Gastrointestinal 3 Oseomyelitis 2 Lymphadenopathy 1 Pulmonary TB Code Tuberculosis Classification

Laboratory Services Objectives of Bacteriological examinations Detection of tuberculosis and drug resistant cases. Monitoring smear conversion during the course of treatment. Reporting smear examination results Staining method used should be mentioned in addition to the number of AFB seen in the slide. The number of bacilli is very important, as it is related to the degree of infectivity and severity of the disease, the results of smear examination should be recorded qualitatively and quantitatively.

The results should be registered as follows: Negative + ++ +++ +++ One immersion fields 10 < ++ One immersion fields 1-10 + 100 immersion fields 10-99 Record the exact number 100 immersion fields 1-9 NEG 100 immersion fields No AFB Examination results Number of fields Number of bacilli

General Rules A trained person should supervise collection of the sample, as the sample collected under supervision is better than that collected without. The sample must be collected either outside in the open air or in good ventilated room. The sample should be collected away from other patients. Preparation for sputum sample collection The patient's mouth should be cleaned from food remnants by washing with water. Fill-in the sputum examination request form. Explain to the patient reason for the examination, benefits of the examination and how to cough so that the expectoration will come from as deep down in the chest as possible.

Technique for collection a. Ask the patient to cough deeply. b. Be sure that no one standing in front the patient as he coughs. c. Keep the container away enough from the patient mouth to prevent contamination of the outer sides of it. If this occurred recollect another sample using a clean container and dispose the contaminated one. Procedures after collection a. Closely secure the sputum container. b. Wash your hand with a disinfectant. c. Keep the sample in as cool as possible place, refrigerator or a cooler box. d. Preferably, appointments for sputum collection should be given before the date of transportation by 24 hours. e. Give the patient a new sputum container and make quite sure that he has understood that he must spit into the container as soon as he coughs up sputum in the morning.

Transport of sputum specimens Sputum specimens should be transported to the laboratory as soon as possible (within seven days from collection) and it should be stored in a cool place as possible. Samples for each patient should be accompanied with a sputum examination request form. Advanced laboratory investigation for detection of tuberculosis bacilli PCR - Polymerase Chain Reaction- This technique depends on magnifying special parts from the bacteria DNA. It is rapid (few hours), needs low number of bacilli compared with direct microscopy or culturing. Sensitivity for anti- tuberculosis drugs could not be performed by this technique. MGIT- Mycobacterial Growth Indicator Tube- Rapid and sensitivity for anti-tuberculosis drugs could be performed. DNA probe- rapid but needs highly qualified and trained personnel. It is only available in reference laboratories.

Health Education It is considered as one of the main pillars of the National Tuberculosis Control Program. Health education for the patients and their relatives about tuberculosis resembles an important element for cure. Objectives Encouraging patients to seek and adhere to treatment till cure. Encouraging individuals at high risk to follow proper protective measures. Educating community about the disease. Encouraging vaccination of non-vaccinated children with BCG. Encouraging individuals to follow healthy behaviors that protect from infection.

Target Groups General Public Tuberculosis patients and their contacts. Immunocompromised patients. Health care workers. Special categories, as school children and industrial workers. Health education messages Information about the disease a. Symptoms b. Mode of transmission c. Complications d. Preventive measures e. Treatment 2. Importance of children vaccination with BCG. 3. Importance of pasteurization or at least boiling of milk. Importance of medical examination on feeling any symptoms of tuberculosis and adherence to treatment till cure. 5. Consulting a physician for the best protective measures for contacts. For health team, information about program procedures and the role of each individual, training on methods of diagnosis, treatment and prevention.

Introduction

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Introduction