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MINISTRY OF HEALTH AND POPULATION THE NATIONAL TB CONTROL PROGRAM
GUIDELINES ONMANAGEMENT OF TUBERCULOSIS
FOR NON-CHEST PHYSICIANS2008
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Mrs. Mubarak at the launch of Eastern
Mediterranean Stop TB Partnership
TB is a global problem * requiring global solutions, and the strong commitment and cooperation of diverse actors and nation states.
We all have very important * parts to play in providing a launching pad for a momentum in addressing this situation.
Efforts are needed to raise * funds and awareness and to bring assistance to countries heavily burdened by TB…
We praise the efforts of WHO, * the Stop TB Partnership and the Ministries of Health in the region for ensuring implementation of the Stop TB Strategy and making treatment and care available.
The Ministry of Health and Population had reduced TB prevalence in * Egypt by 30% between 1990 and 2005.
Egypt had achieved considerable results, especially in creating more * quality services and facilities for victims of TB, in 39 chest hospitals.
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Preface
Ministry of Health and Population is adopting the UN Millennium Development Goals to be achieved, by 2015, to halve TB prevalence and deaths rates, as compared with 1990.
Tuberculosis control is being carried out through 118 chest centers and 39 chest diseases hospitals with 6351 hospital beds. Tuberculosis control activities are integrated with the primary health care system. The health staff working in these units is highly qualified due to the sustained plan of human resources development.
Of especial note is the fact that the national tuberculosis programme (NTP) has taken innovative approaches to tuberculosis control. One is the collaboration with the private health sector, the so-called private–public mix. NTP has set up a functioning national tuberculosis board involving all interested parties, and consequently all partners, public and private have accepted DOTS as the strategy of choice.
This Guide is meant for all physicians involved in the management of TB in Egypt and provides the reader with practical guidelines and instructions on the management of TB. These guidelines are based on the national policies for tuberculosis control program in Egypt and follow the international guidelines from the World Health Organization (WHO), the International Union against Tuberculosis and Lung Disease (IUATLD).
I am confident that by adhering closely to the information in this guideline, it would be possible to achieve the target eliminating the disease from our country.
Dr. Essam El Moghazy NTP Manager
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Table of contents
General Information About Tuberculosis 4
National Tuberculosis Control Programme (NTP) 6
Diagnosis of TB 8
Case Definition And Case Finding Policy 11
Treatment of TB 15
Treatment Regimens in Special Situations 18
Management of Chronic And Multi- Drug Resistant Cases 22
Tuberculosis in Children 24
Management of Tuberculosis Case Contacts 26
Health Education 27
Preventive Measures of Tuberculosis 28
Collaboration With other Healthcare Providers 30
Practical Approach To Lung Health, PAL 33
International Standards For TB Care (ISTC) 35
The Stop TB Strategy 38
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GENERAL INFORMATION ABOUT
TUBERCULOSIS
WHAT IS TUBERCULOSISTuberculosis is an infectious disease caused mainly by Mycobacterium tuberculosis. Tuberculosis can affect most organs in the body, but the lung is the main organ affected. If left untreated, each person with smear-positive pulmonary TB will infect, on average between 10 to 15 persons per year. Those who will be infected with TB will not necessarily get the disease. The immune system “walls off” the TB bacilli, which can lie dormant for years. When someone’s immune system is weakened, chances of developing TB are increased. On average, 10 percent of the infected individuals develop the disease during their lifetime.
SOURCE OF INFECTIONThere are a number of Mycobacteria responsible for causing the disease in human beings: Mycobacterium tuberculosis; M. Africanum; and M.Bovis.
TRANSMISSION OF INFECTIONInhalation: Inhalation of droplet nuclei, from a patient with smear positive * pulmonary Tuberculosis, caused by sneezing or coughing is the most common way of transmission of TB infection.
Ingestion: Infection usually occurs through milk contaminated with M.Bovis*
Cutaneous: Very rare and of no epidemiological importance (e.g. ear * piercing; tattoos)
Congenital: Very rare – the fetus acquires the infection from the diseased * mother.
EVOLUTION OF PRIMARY INFECTIONThis occurs in a person who gets infection for the first time. In 80 to 90 percent of infected individuals immunity will take the upper hand, ending in spontaneous healing, resolution, fibrosis and calcification. In 10 to 20 percent of infected individuals virulence takes the upper hand and may result in active disease, primary tuberculosis.
Primary TB1. is mostly pulmonary and may be extra-pulmonary. Primary pulmonary TB consists of Ghon’s focus, hilar lymph node and intervening lymphangitis. An example of the extra-pulmonary form of primary TB is intestinal primary TB.
In most instances, even where there are clinical signs present, immunity will come into play and the disease will regress spontaneously. Where it does not, progressive primary tuberculosis or disseminated TB may occur.
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Post Primary Tuberculosis2. Even when immunity takes the upper hand, virulence may again appear and the disease may occur once again after it has been quiescent, post primary TB. This is the usual form of TB encountered and most often appears in the lungs. There are 2 possibilities:
Bronchogenic TB.*
Haematogenous TB: Dissemination by the blood stream to most body * organs e.g. meningeal; glandular, genito-urinary; bone and joint; etc.
When to suspect TB? Tuberculosis should be considered if the patient has:
Persistent cough for two weeks or more. Every individual presenting this * symptom at the health facility should be considered a TB suspect.
Production of sputum which may be blood-stained. *
Breathlessness and chest pain.*
General symptoms such as, loss of appetite, loss of weight, night sweats * and fever.
A history of contact with a TB patient.*
The symptoms and signs of extra-pulmonary TB depend on the organ * involved, e.g chest pain in TB pleurisy and angular deformity of the spine in Pott’s disease.
Global burden of TB:In 1993, WHO declared TB a global emergency.*
It is estimated by WHO worldwide that:*
Nine million new cases of TB occur per year all over the world •
Three million TB deaths per year. •
Tuberculosis poses a major problem for developing countries.•
95 % of all TB cases and 98% of TB deaths occur in developing •countries
75% of TB cases in developing countries are in the economically •productive age group (15- 50 years).
Why does the global burden of TB increase?Improper management practices resulting in poor case detection and * treatment.
Impact of the HIV pandemic.*
Poverty, drug addiction and increasing number of homeless people. *
Tuberculosis in Egypt: In terms of incidence of TB, Egypt is ranked among the mid-level incidence countries. TB in Egypt is considered an important public health problem.
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The annual risk of infection (ARI) represents the percentage of population that will be infected by tubercle bacilli every year. It has been estimated that 1% of ARI corresponds to 50 to 60 new smear-positive TB cases per 100,000 population per year. In 2003, ARI was calculated mathematically with the help of WHO and it was found to equal 28/100,000. If we multiply the ARI by 50 this gives us estimate of the incidence of smear positive TB (0.28 x 50 = 14/100,000). In 2007 a total of 4,883 new sputum smear-positive TB cases were notified. This figure represents 67% of the expected cases according to the estimated incidence.
In 2006 a success rate of 87 percent was achieved in the treatment outcome of new sputum smear-positive TB cases (cure and treatment completed rates combined).
NATIONAL TUBERCULOSIS CONTROL PROGRAMME (NTP)The Ministry of Health and Population (MOHP) has established the National Tuberculosis Control Programme NTP in 1979. It is a detailed plan of action for effective TB control. NTP is implemented through the Directorate-General of Chest Diseases and carried out through:
118 Chest Disease Dispensaries;*
39 Chest Disease Hospitals.*
Tuberculosis control activities are currently integrated with the primary health care system which is constituted of more than 4000 primary health care (PHC) units.
Directly Observed Treatment with Short Course Chemotherapy (DOTS)
DOTS means that an observer watches the patient swallowing his tablets, in a way that is sensitive and supportive to the patient’s needs. This ensures that a TB patient takes the right anti-TB drugs, in the right doses, at the right intervals.
WHO has adopted DOTS in an attempt to prove that simple supervision of anti-TB treatment will lead to a high cure rate. World Bank recognizes the DOTS strategy as one of the most cost-effective of all health interventions.
Why DOTS?Some TB patients refuse hospitalization due to social and economic * causes.
Cure rate is low due to: poor patient compliance; poor health education; * long distance to chest clinic; long duration of treatment; etc.
The development of drug resistant strains of TB should be prevented.*
There was a need to integrate TB services with the general health * services.
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What are the principles of DOTS strategy.Sustained government commitment to TB control.*
Case detection through sputum-smear microscopy in the general health * services.
Standardized short-course chemotherapy to all TB cases under proper * case management conditions.
Regular, uninterrupted supply of all essential anti-tuberculosis drugs.*
Monitoring system for programme supervision and evaluation.*
Applying DOTS in Egypt NTP adopted DOTS strategy by establishing the demonstration sites in 1996. One hundred percent of chest facilities adopted DOTS by August 2000, providing TB patients with the possibility to take their treatment at the health facility nearest to their home either the PHC or the chest unit.
By applying DOTS strategy, a successful treatment outcome was ensured. Success rates of 90 to 95 percent are common. The key to this successful treatment outcome is the commitment to treatment adherence by both patients and health staff. It is important to realize that prevention of defaulting is easier and less time consuming than tracing defaulters and convincing them to continue the treatment.
Role of the chest clinic:
Registration in the TB register. *
Issue TB treatment card to each patient: keeping one copy at the chest * clinic; and the other at the PHC.
Supply anti-TB drugs to PHC centers.*
Health education for TB patients. *
Ensure DOT with short course chemotherapy (ambulatory or * hospitalized).
Register & examine contacts of TB patients. *
Monitor treatment at PHC centre to observe if the PHC staff is: *
Collecting the required drugs. •
Reporting new patients to director of district health directorate. •
Updating TB Treatment cards through monthly reports from the PHC •centre.
Monitor the treatment progress by timely sputum-smear examination.*
Evaluation of treatment & recording treatment outcome in the TB * register.
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Role of the PHC centre:Provide TB patients with daily supervised treatment with anti-TB drugs * according to prescribed regimen, dosage and duration;Provide patients, who are unable to attend at the PHC centre on a * daily basis (e.g. handicapped patients) with supervised treatment at the patient’s home;Retrieve patients who did not attend the PHC centre for their daily * treatment;Record daily attendance and anti-TB drug intake in the TB treatment * card;Health education and counseling to TB patients, their contacts and the * community;Timely referral of TB patients to the chest clinic for follow up sputum * examination;Order and collect the required quantity of anti-TB drugs for TB patients;* Refer TB suspects and contacts of TB patients to chest clinic for * examination to chest clinic.
DIAGNOSIS OF TUBERCULOSIS
The diagnosis of adolescents and adults with symptoms suggestive of pulmonary TB should be confirmed by detecting Acid Fast Bacilli (AFB) through the direct smear examination of the sputum. This diagnostic procedure ensures the detection of the majority of symptomatic pulmonary TB patients and helps to limit the number of patients who are unnecessarily put on treatment with anti-TB drugs.
Every pulmonary TB suspect should submit three sputum samples for microscopy. The chances of finding AFB are greater with three sputum samples than with two samples or one sample. Moreover, the chance that a patient is wrongly diagnosed, and wrongly put on anti-TB treatment (a false-positive case) is negligible. Secretions build up in the airways overnight. So an early morning sputum sample is more likely than a sample later in the day to contain tubercle bacilli. It may be difficult for an outpatient to provide three early morning sputum samples. The recommended method for sputum collection is described below.
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Routine sputum collection
Day 1 Sample 1
- Patient provides, under supervision, an “on-the-spot” sample when he presents to the health facility.
- Patient gets a sputum container to take home to get early- morning sputum sample the following morning.
Day 2 Sample 2 Sample 3
- Patient brings an early morning sample.- Patient provides another on the spot “sample under supervision”.
NB. If a patient is unable to produce a sputum sample, a nurse may help him to give a good cough and bring up some sputum. This must be done in a well-ventilated area, preferably in the open air.
Value and Role of Diagnostic Tools for Pulmonary TB
A number of tools to diagnose pulmonary TB are available to the physician. Tools, which are most relevant for the NTP, are:
A) Bacteriology1- Detection of TB bacilli
Direct smear microscopy*
The direct smear microscopy of sputum is a reliable and simple technique for detecting Mycobacteria in order to diagnose pulmonary TB. The method consists of microscopic examination of a specimen of sputum that has been spread on a slide, and stained by the Ziehl-Neelsen method.
Laryngeal swabs; gastric lavage; bronchoalveolar lavage; pleural * fluid
These investigations should be performed in specialized centers.
Culture*
Culture of sputum is more sensitive than smear examination, but it takes 4 to 8 weeks before the result is known. It also requires well-equipped laboratories with skilled staff. Culture allows the study of anti-TB drug resistance.
2- Detection of the immune response to TB bacilli:
Tuberculin skin Test (TST) When a healthy person is infected for the first time with the tubercle bacilli, the body will develop a specific immune response. This immune reaction (cell-mediated immunity) can be assessed by TST. Tuberculin is an antigen produced from dead tubercle bacilli, purified protein derivative (PPD). In the Mantoux test, 0.1 ml of tuberculin is injected
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intradermally. Most people infected by M. tuberculosis or vaccinated by BCG will react to TST and develop an induration at the site of injection. The diameter of this induration is measured after 48 to 72 hours. Results are recorded in millimeters. If it is 10 mm or more, the test is interpreted as “positive”. If not previously vaccinated by BCG, the person will be considered infected by M. tuberculosis. After BCG vaccination the test will usually be positive, so if the child is vaccinated with BCG and in the first 3 years of age, an induration of 15 mm is considered positive. A positive TST is of no diagnostic value for adult TB, but in a non-BCG-vaccinated individual it indicates infection by Mycobacterium, without proof of tuberculosis disease. A negative TST is a fairly good indication that there is no TB infection. There are occasions that TST gives a “false” negative reaction e.g. sarcoidosis, improper storage of PPD , improper dilution, immuno-compromising situations like malnutrition, malignancy, cytotoxic drugs, corticosteroids therapy, severe bacterial infections including severe forms of TB itself like miliary Tuberculosis, diabetes and HIV.
3- Histo-pathological diagnosis of TB
Through a biopsy of the suspected lesion e.g. lymph node biopsy and pleural biopsy.
4- Detection of metabolic end products of TB bacilli: BACTEC
BACTEC is complicated and expensive, and is available only in specialized centers.
5- Detection of DNA of TB bacilli: polymerase chain reaction (PCR)PCR is 100% specific, but its sensitivity is about 85 %. Moreover, it is expensive and requires specialized skills and equipment.
B) RadiographyX-rays are not specific. TB can mimic any chest disease on the X-ray. Furthermore, it is difficult to differentiate in an X-ray between clinically active and inactive old lesions of pulmonary TB. It is not justified to start anti-TB treatment on radiographic basis. However, radiography can be of help in certain occasions, such as childhood TB; miliary TB; hilar lymphadenopathy; extra-pulmonary TB and, lack of sputum.
No chest X-ray pattern is absolutely typical of pulmonary TB
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CASE DEFINITION AND CASE FINDING POLICYWhy case definition?
The purposes of case definition are:
Proper patient registration and case notification;*
Prioritized treatment of sputum smear-positive cases, the main source of * infection in the community;
Evaluation of the proportion of cases according to site, bacteriology and * treatment history;
Cohort analysis of treatment outcomes.*
Why match standardized treatment regimen to diagnostic category?
The reasons for matching standardized treatment regimen to diagnostic category are:
To avoid under-treatment of previously treated cases and therefore to * prevent acquired resistance;
To maximize cost-effective use of resources and to minimize side-effects * for patients by avoiding unnecessary over-treatment.
What determines case definition?
The determinants of case definition are:
Site of TB disease.*
Bacteriology (result of sputum smear).*
History of previous treatment of TB.*
Note. Any person given treatment for tuberculosis should be recorded as a case. Incomplete “trial” tuberculosis treatment should not be given as a method for diagnosis.
Diagnostic classification of TB
A case of TB is defined as a patient with symptomatic disease due to lesions caused by Mycobacterium TB. Depending on the site of the disease TB can be classified as either Pulmonary or Extra-Pulmonary TB. The importance of defining the site is for recording and reporting purposes. Pulmonary TB occurs in 80 to 85 percent of all cases and extra-pulmonary TB in 15 to 20 percent.
A) Definitions of pulmonary TBThe definitions described in this chapter are important for purposes of monitoring the disease and for comparison from place to place. They must therefore follow international recommendations.
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1. Smear-positive pulmonary TB
A sputum smear-positive pulmonary TB patient is defined in one of three ways.
A patient with at least TWO sputum specimens positive for acid-fast bacilli * by microscopy; or,
A patient with at least ONE sputum specimen positive for acid-fast * bacilli by microscopy, AND radiographic abnormalities consistent with pulmonary TB, AND a decision by a physician to treat with a full course of anti-TB chemotherapy; or,
A patient with at least ONE sputum specimen positive for acid fast bacilli * by microscopy, which is culture positive for M. tuberculosis.
2. Smear-negative pulmonary TB
A sputum smear-negative pulmonary TB patient is defined in one of the following ways:
TWO sets (taken at least 2 weeks apart) of at least TWO sputum specimens 1. negative for acid-fast bacilli on microscopy AND radiographic abnormalities consistent with pulmonary TB and a lack of clinical response despite one week of a broad-spectrum antibiotic AND a decision by a physician to treat with a full curative course of anti-TB chemotherapy; or,
A patient who fulfills any of the following criteria:2.
Severely ill AND at least TWO sputum specimens negative for acid-* fast bacilli by microscopy AND radiographic abnormalities consistent with extensive pulmonary TB (interstitial or miliary) AND a decision by a physician to treat with a full curative course of anti-TB chemotherapy; or,
A patient whose initial sputum smears were negative, who had sputum * sent for culture initially, and whose subsequent sputum culture result is positive; or,
A patient whose initial sputum smears were negative and is diagnosed * positive for acid-fast bacilli by other diagnostic means.
B) Definition of extra-pulmonary TBAn extra-pulmonary TB patient is defined in one or both of two ways.
A patient with clinical AND/OR radiological AND histological evidence 1. consistent with active extra-pulmonary TB AND a decision by a physician to treat with a full curative course of anti-TB chemotherapy; or
A patient with at least one culture specimen from an extra-pulmonary site 2. positive for Mycobacteria TB.
N.B. Tuberculous intrathoracic lymphadenopathy (mediastinal and/or hilar) and tuberculous pleural effusion, without radiographic abnormalities in the lungs, constitute cases of extra-pulmonary TB.
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History of previous treatment: In order to identify patients who are at increased risk of acquired drug resistance and to prescribe appropriate treatment, a case should be defined according to whether or not the patient has previously received TB treatment. The following definitions are used:
•New: A patient who has never had treatment for TB or who has taken anti-tuberculosis drugs for less than 1 month.
•Relapse: Relapse refers to the circumstance in which a patient becomes and remains culture-negative while receiving antituberculosis drugs but, at some point after completion of therapy, either becomes culture-positive again or experiences clinical or radiographic deterioration consistent with active tuberculosis
•Treatment after failure: A patient who is started on a re-treatment regimen after having failed previous treatment.
• Treatment after default: A patient who returns to treatment, positive bacteriologically, following interruption of treatment for 2 months or more.
•Transfer in: A patient who has been transferred from another TB register to continue treatment.
•Other: All cases that do not fit the above definitions according to history of treatment. This group includes chronic case, a patient who is sputum-positive at the end of a re-treatment regimen.
Case finding policyCase detection is either passive or active. For the NTP the most important method through which TB patients are discovered is passive case finding.
A) Passive Case Detection
TB patients are detected among individuals who have symptoms and who seek health care. It is very important to create awareness in the community and among the medical professions about the symptoms suggestive of TB e.g. persistent cough for two weeks or more, usually productive; low grade fever; night sweats; loss of weight and appetite.
B) Active Case Detection
The health services go to the community to detect TB cases. Mass examination by X-ray of large numbers of persons has been abandoned because of its high costs and the small number of TB cases detected by this method. Currently, active case detection is applied only for certain risk groups:
Contacts of pulmonary TB patients;1. Individuals who are in need of a health certificate;2. Other risk groups:3.
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Health staff, especially laboratory staff dealing with sputum examination.* Closed communities, e.g. army, prison, etc. * Patients with immuno-suppressive diseases, e.g., HIV infection.* Patients under immunosuppressive treatment, e.g. corticosteroids.*
TB will be detected most efficiently where health care providers and community members are highly conscious of the symptoms suggestive of TB.Management of TB suspectsTuberculosis suspect: Any person who presents with symptoms or signs suggestive of TB, in particular cough of long duration (more than 2 weeks).
TB Suspect
X-ray & physician’s judgement
Repeat AFB microscopy
BroadSpetrumantibiotics
AFB+++ ++- AFB+--
AFB---AFB+++ ++- +--
X-ray & physi-cian’s judge-
ment
Consider other diagnoss
Treat as smear negative
PTB
Treat as smear positive
PTB
AFB---
AFB Microscopy
No TB
Improved(not TB)
No improvement
Yes TB
Yes TB
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TREATMENT OF TUBERCULOSIS
Aim of treatment:Treatment of TB patients, specially the pulmonary smear-positive is the best method to cut transmission of infection. The aim of treatment is to cure the patient, to reduce death from active TB or its late effects, to treat TB patients adequately to prevent relapse, to prevent the spread of infection to others and prevent emerging or resistant strains.
Essential anti-TB drugs:There are three main properties of anti-tuberculosis drugs: bactericidal activity, sterilizing activity and the ability to prevent resistance.
The essential anti-tuberculosis drugs possess these properties to different extents. Isoniazid and Rifampicin are the most powerful bactericidal drugs, active against all populations of TB bacilli. Rifampicin is the most potent sterilizing drug available. Pyrazinamide and streptomycin are also bactericidal against certain populations of TB bacilli. Pyrazinamide is active only in an acid environment. Streptomycin is bactericidal against rapidly multiplying TB bacilli.
Ethambutol used in association with more powerful drugs to prevent the emergence of resistant bacilli.
ESSENTIAL DRUGRECOMMENDED DAILY DOSAGE
(DOSE RANGE), mg/kg
Isoniazid (H) 5 (4–6)
Rifampicin (R) 10 (8–12)
Pyrazinamide (Z) 25 (20–30)
streptomycin (S) 15 (12–18)
Ethambutol (E) 15 (15–20)
Fixed-dose combination (FDCs) tablets:FDCs contain two or more drugs in one tablet. WHO and NTP strongly recommend the use of FDC tablets for the treatment of TB. FDCs have several advantages over individual loose formulations. First, prescription errors are likely to be less frequent because dosage recommendations are more straight forward and adjustment of dosage according to patient weight is easier.
Second, the number of tablets to ingest is smaller and thus may encourage patient adherence. Third, if treatment is not observed, patients cannot be selective in the choice of drugs to ingest.
Fixed-dose combinations of drugs also have disadvantages. First, if prescription errors do occur, excess dosage (risk of toxicity) or sub-inhibitory
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concentrations of all drugs (favoring development of drug resistance) may result.
Second, health care workers may be tempted to evade directly observed therapy, erroneously believing that adherence is automatically guaranteed.
Third, poor Rifampicin bioavailability has been found for some FDCs, particularly in 3- and 4- drug combinations. Quality assurance is therefore essential.
Finally, using FDCs does not obviate the need for separate drugs for a minority of patients who develop drug toxicity.
The recommended formulations currently available are shown in the following table.
WHO-recommended formulations of essential anti-tuberculosis drugs
Separate drugs
DRUGDOSE FORM (available in
Egypt)STRENGTH (available in
Egypt)
Isoniazid Tablet 100 mg, 300 mg
Rifampicin Capsule 150 mg, 300 mg
Pyrazinamide Tablet 500 mg
Ethambutol Tablet 500 mg
Streptomycin powder for injection in vial 1 g
Fixed-dose combinations of drugs
DRUG DOSE FORM STRENGTH FOR DAILY USE
Isoniazid + RifampicinTablet
75 mg +150 mg150 mg +300 mg
tablet or packof granules (For pediatric use)
30 mg + 60 mg
Isoniazid + Rifampicin + Pyrazinamide
Tablet 75 mg +150 mg+400 mgtablet or pack of granules
(For pediatric use)30 mg+60 mg+150 mg
Isoniazid + Rifampicin + Pyrazinamide + Ethambutol
Tablet75 mg + 150 mg +400 mg + 275
mg
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Number of tablets of 4-FDC drugs according to weight bands:
30-39 kg 2 tab.
40 – 54 kg 3 tab.
55 – 70 kg 4 tab.
>70 kg 5 tab.
Standardized regimensStandardized regimens have the following advantages over individualized prescription of drugs:
Reduce errors in prescription thereby reducing the risk of development * of drug resistance;
Facilitate estimates of drug needs, purchasing, distribution and * monitoring;
Facilitate staff training;*
Reduce costs;*
Facilitate regular drug supply when patients move from one area to * another.
Recommended standardized treatment regimensNew cases:
Treatment regimens have an initial (or intensive) phase lasting 2 months and a continuation phase lasting 4 months. During the initial phase, normally consisting of Isoniazid, Rifampicin, Pyrazinamide and Ethambutol or Streptomycin, the tubercle bacilli are killed rapidly. Infectious patients quickly become non-infectious (within approximately two weeks).symptoms abate. Most patients with smear-positive sputum become smear-negative within two months. During the continuation phase, fewer drugs are necessary but they must be given for a longer time. The sterilizing effect of the drugs eliminates the remaining bacilli and prevents subsequent relapse.
Re-treatment cases:
Previously treated TB patients include those patients who are treated as new cases for more than one month, and who are now smear- or culture-positive (failure, relapse, return after default).
The re-treatment regimen consists of 5 drugs in the initial phase and 3 drugs in the continuation phase. Three of the drugs –RHE – are given throughout the treatment.
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TB DIAGNOSTICCATEGORY
TB PATIENTS
TB TREATMENT REGIMENS
INITIAL PHASE CONTINUATION PHASE
I
New smear-positive patients; New smear-negative PTB with extensive
parenchymal involvement;or severe forms of EPTB
2 HRZE(S) 4 HR
II
Previously treated sputum smear-positive PTB:
- relapse; treatment after interruption; or treatment failure
2 HRZES/1 HRZE
5 HRE
IIINew smear-negative PTB (other than in
Category I); or Less severe forms of EPTB2 HRZE(S)
4 HR
IVChronic and MDR-TB cases
(still sputum-positive after supervised re-treatment)
Specially designed standardized or
individualized regimens are suggested for this category
Direct observation of drug intake is required during the initial phase of * treatment in smear-positive cases, and always in treatment that includes Rifampicin.
Streptomycin may be used instead of Ethambutol. In meningeal TB, * Ethambutol should be replaced by streptomycin.
Whenever possible, drug sensitivity testing is recommended before * prescribing treatment in retreatment cases.
Contacts of patients with culture-proven MDR-TB should be considered * for early culture and sensitivity testing.
Treatment regimens in special situationsThere are a number of special conditions in which different treatment options should be advised. The most important of these conditions are mentioned below.
Pregnancy
A pregnant TB patient should not stop her treatment since the growing fetus is more endangered by untreated TB of the mother than by a correctly prescribed treatment. However, streptomycin should not be administered during the first trimester of pregnancy, because of the possible damage of the 8th cranial nerve. The recommended regimen for pregnant TB patients is: 2HRZ / 7HR
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Breast - feeding
A breast-feeding woman with TB should receive a full course of anti-TB drugs. All anti-TB drugs are compatible with breast-feeding and the woman can safely continue to breast-feed her baby.
Oral contraception
Rifampicin interacts with oral contraceptive medications with a risk of decreased protective efficacy against pregnancy. A woman receiving oral contraception may choose between two options while receiving treatment with Rifampicin: following consultation with a clinician, an oral contraceptive pill containing a higher dose of estrogen (50 µg) may be taken, or another form of contraception may be used.
Hepatic insufficiency
Patients with liver enzymes that do not exceed double the normal value should receive the treatment regimen recommended for their case definition.
Rifampicin may need to be stopped if the liver enzymes are raised after starting the treatment. Patients whose liver enzymes reach more than double their normal value after the start of treatment or, whose liver enzymes are constantly elevated after the start of treatment, should receive a treatment regimen with 2SHE/10HE.
Under no circumstances should Pyrazinamide be given to patients with active liver disease.
Acute hepatitis (e.g. acute viral hepatitis)
The combination of streptomycin and Ethambutol is the safest option until the hepatitis has resolved and can be given up to a maximum duration of three months. The patient can then receive a continuation phase with 6HR, as long as liver enzymes and serum bilirubin are within normal values and sputum smears are negative. If not, a continuation phase with 10 HE is recommended.
Diabetes mellitus
In the presence of TB diabetes becomes more difficult to manage, as is the case with other chronic infectious diseases. Once TB treatment is started the management of diabetes becomes easier. Therefore, patients with diabetes and TB should be given treatment regimens according to their case definition.
Renal failure
Patients with renal insufficiency should be followed by renal function tests. Take into consideration that Isoniazid and Pyrazinamide have cumulative effects. Patients with renal insufficiency should not be given Ethambutol and streptomycin. For patients with impaired renal function the recommended regimen is 2HRZ / 7HR.
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HIV infection
HIV positive patients with TB should not be given thiacetazone. Also streptomycin should, preferably, not be included to guard against transmission of HIV infection. The recommended regimen is 2EHRZ / 10HE. Infection with atypical Mycobacteria is common in HIV positive patients, e.g. Mycobacterium Avium Complex, which will not respond to the anti-TB drugs used. Culture and sensitivity testing is recommended for all patients with HIV.
Monitoring of treatmentEvery TB patient has a very good chance of being cured. Think of the patients you registered and watch their progress as they move toward cure i.e. monitor their treatment as they progress toward completion of chemotherapy and being cured:
Monitor sputum smear examination results at regular intervals, usually at * the end of the second month (end of third month for retreatment cases), end of the fifth month, and at the end of treatment after six or eight months depending on the type of treatment.
In areas implementing DOTS, monitor the drug intake for patients who * are on daily supervised treatment during the intensive phase, and on weekly supervised treatment during the continuation phase.
Practical issues when monitoring TB treatment:
In pulmonary smear-positive cases, the conversion from smear-positive * to smear-negative is the best early indicator that chemotherapy is taken regularly.
After two months of chemotherapy more than 80 % of NEW pulmonary * smear-positive cases should have converted to smear-negative, and after three months this rate should increase to more than 90 %.
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Definitions of Treatment Outcome
CureA patient who is smear-negative in the end of last month of
treatment and on at least one previous occasion.
Treatment completed
A patient who has completed treatment but who does not meet the criteria to be classified as a cure or a failure.
Treatment failure
A patient who remains or becomes again smear-positive at five months or later during treatment.
Also a patient who was initially smear-negative before starting treatment and became smear-positive after
completing the initial phase of treatment.
DiedA patient who dies for any reason during the course of
treatment.
DefaultA patient whose treatment was interrupted for two months or
more.
Transfer outA patient who has been transferred to another reporting
unit outside the Governorate and for whom the treatment outcome is not known.
ADVERSE REACTIONS AND THEIR MANAGEMENT:
Side EffectResponsible Drug(s)
Management
1. Minor Side Effects Always Continue Treatment!
- Anorexia; nausea; Rifampicin Take drugs at night
- Joint pains Pyrazinamide Acetyl salicylic acid
- Burning sensation in feet Isoniazid Pyridoxine 100 mg daily
- Orange colour of urine Rifampicin Reassurance
2. Major Side Effects Stop Responsible Drug!
- Itching of skin / skin rash Streptomycin Stop streptomycin
- Hearing impairment Streptomycin Replace Streptomycin with Ethambutol
- Dizziness (vertigo/nystagmus) Streptomycin Replace Streptomycin with
Ethambutol
- Jaundice Most anti-TB drugsStop all drugs; urgent liver function tests and
prothrombin time
- Visual impairment Ethambutol Stop Ethambutol
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Management of chronic and drug resistant
cases (DR-TB)
Definitions:Chronic: A patient with TB who is sputum-positive at the end of a standard completely supervised re-treatment regimen with essential anti-TB drugs.
MDR-TB: A patient who has active TB with bacilli resistant at least to both rifampicin and INH.
Chronic cases and MDR-TB cases are not synonymous. Chronic patients probably have MDR-TB because they have previously received at least two full courses of treatment with essential antituberculosis drugs. Management of chronic cases becomes an objective for an NTP when DOTS strategy is fully implemented. Full implementation of DOTS is the best prevention against chronic disease and extension of MDR-TB.
Classes of anti-tuberculosis drugs
classes DRUGS (ABBREVIATION)
Class 1 – First-line oralantituberculosis agents
Isoniazid (H); Rifampicin (R); Ethambutol (E);
Pyrazinamide (Z)
Class 2 – Injectableantituberculosis agents
Streptomycin (S); Kanamycin (Km); Amikacin
(Am); Capreomycin (Cm); Viomycin (Vi)
Class 3Fluoroquinolones
Ofloxacin (Ofx); Levofloxacin (Lfx); Moxifloxacin (Mfx); Gatifloxacin (Gfx)
Class 4 – Oral bacteriostaticsecond-line antituberculosis
agents
Ethionamide (Eto); Protionamide (Pto);Cycloserine (Cs); Terizidone (Trd);
P-minosalicylic acid (PAS); Thioacetazone (Th).
Class 5 – Antituberculosis agents with unclear efficacy (not
recommended by WHO for routine use in DR-TB patients)
Clofazimine (Cfz); Amoxicillin/Clavulanate (Amx/Clv); Clarithromycin (Clr); Linezolid
(Lzd)
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Recommended treatment regimens:
Patient resistant to
Treatment regimen
RHSE
Regimen I3 months: Kanamycin or Capreomycin daily + Ofloxacin +
Cycloserine + Ethionamide + PAS then:6 months Kanamycin or Capreomycin 5 times a week + previous
drugs then:12 months Ofloxacin + Cycloserine + Ethionamide + PAS
RHS
Regimen II3 months: Kanamycin or Capreomycin daily + Ofloxacin +
Ethambutol + Ethionamide + Cycloserine then:6 months: Kanamycin or Capreomycin 5 times a week + previous
drugs then:12 months: Ofloxacin + Ethambutol + Ethionamide + Cycloserine
RH
Regimen III3 months streptomycin daily + Ethambutol + Pyrazinamide +
Ofloxacin + PAS then:6 months streptomycin 5 times a week + previous drugs then:
12 months: Ethambutol + Pyrazinamide + Ofloxacin + PAS
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TUBERCULOSIS IN CHILDREN
Diagnosis of TB in children:Suggestive symptoms: Include persistent cough for more than 14 days, not improving with ordinary treatment or even getting worse, fever and night sweat for longer than one week not responding to ordinary antibiotics and failure to thrive or actual documented weight loss even if on a feeding scheme for one month.
History: History of contact with a relative diagnosed as having pulmonary tuberculosis.
Clinical findings: Clinical findings are frequently non specific. The presence of phlyctinular conjunctivitis, erythema nodosum, adenopathy or hepatosplenomegaly must lead to consideration of possible TB.
Investigations:Tuberculin skin test
It is one of the cornerstones of the diagnosis. In absence of BCG vaccinationor after 3 yearsof vaccination, an indurationof ≥10mm isindicative of infection with M. tuberculosis. In a child within the first 3 years ofvaccinationwithBCG,anindurationof≥15mmindicatesinfectionwithM. tuberculosis.
Chest radiography
Chest radiography is perhaps the means by which diagnosis of TB in childhood is most frequently supported. The radiological features are either:
Ghon’s focus (alveolar consolidation);*
Mediastinal lymph glands enlargement;*
Complications of either or both: Cavities , Air way obstruction (collapse) * and Infiltration;
Miliary shadows.*
Sputum examination
Young children usually either do not produce or tend to swallow any expectorated sputum. Gastric aspirate of the early morning after 8-20 hours fasting or laryngeal swabs could be used to obtain samples for culture. Sputum induction using hypertonic saline via nebulizer in a child with no history of asthma or chest wheezes or bleeding tendency may increase the yield of gastric aspirate.
Score system
A score system is one way of trying to improve the diagnosis of childhood TB. The basis of a score system is the systematic collection of diagnostic information. A score system helps guiding your clinical judgment. A score
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above a certain threshold indicates a high likelihood of TB. The following table shows a score chart for helping to diagnose childhood TB. A score of 7 or more indicates a high likelihood of TB.
feature 0 1 2 3 4 score
General
Duration of illness
<2w 2-4w >4w
Weight for age
>80% 60-80% <60%
Family history -VE Reported Proved +VE
Tuberculin test
positive
MalnutritionNot
improvingAfter 4 w
Unexplained fever and
night sweats
No response to nonspecific
treatment
Local
Lymph nodes
Joint or bone
swelling
Angle deformity
of the spine
Total score
Treatment of childhood tuberculosisThe main treatment regimen for treating TB in children is 2 RHZ / 4HR. Streptomycin can be added to the previous regimen or replace Rifampicin or Pyrazinamide if any of them is contra-indicated.
Because it is difficult to monitor for ocular toxicity from Ethambutol, this agent is less useful in young children less than 12 years, because it is not possible to detect reliably the loss of acuity and poor color discrimination indicative of retro-bulbar neuritis. Bacteriologic examinations are less useful in evaluating the response to treatment. Thus, clinical and radiographic examinations are of greater importance in children.
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MANAGEMENT OF TUBERCULOSIS PATIENTS
CONTACTS
Prompt contact investigation is essential for TB control. Contact investigations should start with the persons who are most likely to be infected (those who most frequently come in contact with the person who has infectious TB). These close contacts are usually family members or other persons who live in the same household. Active case detection is indicated in this group of individuals.
Management of child contacts of infectious adults:High priority should be given to examining children contact to an infectious TB case. Screening include, a thorough history, clinical examination, TST and Chest x-ray.
Detection of TB cases among adult household contacts:When adult household contacts come to the health facility, ask whether the individual has a cough and if the cough has persisted for 2 weeks or more, the individual is a suspect for pulmonary TB. Collect three sputum samples for sputum examination.
Contact tracing:It is important following notification of a case of TB that appropriate contact procedures be initiated with a view to identifying other cases of TB. Contacts should be screened by TST and chest films. Negative skin reactors should be retested at 6 weeks to exclude the possibility of recent primary infection. Skin test conversion merits chemoprophylaxis.
Preventive chemotherapy:The aim of preventive treatment is to prevent progression of M. tuberculosis infection to disease.
Target groups for preventive treatment:Infants of mothers with PTB: * The infant should receive 6 months INH treatment, followed by BCG immunization. An alternative policy is to give 3 months INH, then perform a TST. If negative, stop the INH and give BCG. If positive, continue another 3 months INH, then stop INH and give BCG.Children under 5 years of age: * If without symptoms should be given 6 months INH preventive treatment. If with symptoms need investigation for TB. If investigations show TB, the child receives anti-TB treatment. If investigations do
not show TB, the child should receive INH preventive treatment.
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HEALTH EDUCATION
Health education is a learning process through which an individual adopts a behavior that is beneficial to health. Lack of community awareness leads to delay in diagnosis and spread of infection in healthy contacts. In addition poor compliance to treatment has adverse effect on success rate as well as leading to development of resistant TB strains.
Target groups for health education:TB patients;*
Contacts of TB patients;*
All community members;*
High risk groups (prisoners, camps, police, army, orphanages, elderly * homes, immune-compromised as HIV/AIDS, diabetics, renal failure and cancer).
Planning a health education programme for TBWhen a health education programme is planned, a number of aspects should be taken into consideration. The most important aspects are mentioned below:
Health education should be nation-wide in both urban and rural areas;*
Health education should be continuous;*
A health education programme should be simple and applicable;*
Health services must be accessible and acceptable for community * members. They will have confidence in the services only if they feel the services are effective;
The health education programme must be integrated in the community * health structure;
All categories of health staff must be well trained in health education;*
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The national policy for TB control should be incorporated into the * curriculum of medical and nursing schools;
Periodic seminars at both central and governorate levels are important * for advocacy and help maintain the active interest of decision-makers and NGOs;
It is essential to have support from the mass media i.e. television, radio * and newspapers, to spread information about the problem of TB in Egypt;
Appropriate materials and aids should be developed, pre-tested, * distributed and then used for the relevant target groups. Examples are TV and radio spots,posters, brochures, booklets, cassettes, flip-overs,etc.
PREVENTIVE MEASURES FOR TUBERCULOSIS
General measures:
The best way to prevent TB is to ensure that all sputum smear-positive TB cases will be cured. More over there are number of general preventive measures that help to reduce transmission of the infection. The most important measures are: environmental sanitation, legislation (e.g. free contact examination), health education, good ventilation, good nutrition and pasteurization of milk.
BCG vaccination:
The national policy in Egypt is to vaccinate all children at birth with BCG. However, BCG vaccination does not influence the transmission of infection. Its main value is to give protection against the serious forms of TB such as TB meningitis and miliary TB which is commonest in the under 5 year’s age group. Babies born to mothers who develop TB shortly before or shortly after delivery are not protected sufficiently quickly by BCG given at birth to avoid the possibility of becoming infected. Neonates should be given daily Isoniazid (5 mg/kg) for six months as prophylactic chemotherapy. BCG, which is inactivated by chemotherapy, can be given after it ends. The maximum effect of BCG is in the first 3-5 years after vaccination. BCG causes a specific lesion that starts as a papule two or more weeks after vaccination. This then becomes ulcerated and heals after several months leaving a scar. Mild reactions are mostly local with or without regional lymph nodes manifestations. Axillary or cervical lymphadenitis usually heals spontaneously and it is best not to treat the lesion if it remains non-adherent to the skin. An adherent or fistulated lymph gland, however, may be drained and an anti-TB drug may be instilled locally. Some authors recommend systemic treatment of severe persistent lesions with erythromycin.
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The prevention of TB in health care facilities:
Patient education: About TB transmission and how to minimize the generation of infectious droplet nuclei.Coughing patients should be instructed to turn their heads and cover their mouth with their hands and preferably with a cloth or tissue when coughing.
Sputum collection: Should be done outside (open environment) and away from other people, not in small rooms such as toilets or other enclosed areas.
Outpatient settings: Patient waiting areas should be open and well-ventilated.
Inpatient management: Establish separate wards or rooms for confirmed infectious TB patients and the wards should be well-ventilated.
Reducing exposure in the laboratory: Sputum collection should not take place in the laboratory; a pass-through window should be used to deliver sputum samples
Radiology: Radiology departments should provide priority service to potentially infectious TB patients to minimize the length of time spent in the department.
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COLLABORATION WITH OTHER HEALTH CARE
PROVIDERS (PUBLIC-PUBLIC-PRIVATE MIX)
The main challenge for NTP today is how to achieve an increase in the case detection rate. The difference between the estimated level of tuberculosis cases and the number of cases notified can be explained by a number of factors.
•First,thenumberofestimatedcasesmaybelargerthanthetruenumberof TB cases. This gap can be addressed by improving case estimates.
• Second, those facilities included in DOTS (in Egypt 100% of MOHPfacilities) may not correctly diagnose and notify cases. Improving the level of case notification within the MOHP facilities can be addressed by improving laboratory and diagnostic capacities.
•Finally thosewithTBmayself-administer treatmentormaybe treatedoutside the MOHP and hence are never reported. A few cases will never be treated. Improving case notification for these cases can be addressed by collaborating with those outside the MOHP, such as non-profit nongovernmental organizations, private for-profit providers and health providers governed by other ministries.
Collaboration with Health Insurance Organization (HIO):
The collaboration between the HIO and NTP started since 1997 in the form of:
Appointment of a GCT for HIO in each Governorate;
Training of HIO staff on the NTP guidelines;
Registration according to NTP guidelines and the data are reported quarterly to the NTP central unit;
Establishment of specific TB centers in the different governorates for proper diagnosis of TB cases, good recording and reporting of TB patients;
Each specialized tuberculosis centre has a trained chest specialist, a bacteriological laboratory with a trained laboratory technician and a pharmacy containing anti-TB drugs. The results of these centers are encouraging and 476 new smear positive cases were notified from HIO in 2007 (total 1124 all TB forms). NTP came to an agreement with the HIO to restrict the use of antituberculosis drugs especially streptomycin and Rifampicin to these specialist centers. HIO funds all anti-tuberculosis drugs.
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Collaboration with prisons:
Collaboration with the prison sector is one of the most successful models of cooperation. GCTs now supervise treatment of TB patients in prisons TB cases detected in the prisons are reported to the NTP. The prisons now regularly receive adequate anti-tuberculosis drug supplies from the MOHP through the program.
In principle, when the prison doctor suspects TB the patient is examined by an assigned chest specialist who usually visits the prison twice per week.
The NTP provides refreshing training for physicians, nurses and prison officers in tuberculosis about NTP diagnosis and treatment guidelines, and the monitoring, registration and reporting of tuberculosis cases. Training for laboratory technicians is carried out with the help of the central laboratory. In addition health education training was provided for prison social workers.
Collaboration with nongovernmental organizations (NGOs):
There are several different types of NGOs involved in TB control in Egypt. They have a strong community focus which can be used to encourage those with TB to access services. The communities that they serve are most likely to be the poor, the homeless and the uneducated. Their activities cover nearly all of the Egyptian governorates. These NGOs are identified by the GCTs and trained by the NTP on TB control.
Much of the collaboration with NGOs has focused on health education and case detection. Some NGOs run medical caravans.
Collaboration with universities:
The involvement of the universities in the NTP scientific and technical committees was the beginning of collaboration. Many researches have been conducted with the universities. University staff is participating in training on tuberculosis for chest physicians. NTP developed collaboration with a number of universities to notify detected cases to the NTP, 134 new smear positive cases were notified in 2004 (total 378 all TB forms).
Collaboration with private sector:
The importance of private physicians in the identification and treatment of tuberculosis was recognized early by NTP. NTP conducted several studies to assess tuberculosis treatment in the private for-profit sector. NTP has not attempted to exclude private practitioners from tuberculosis diagnosis or treatment by using measures such as banning the sale of tuberculosis drugs
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in the private sector or implementing the mandatory referral of tuberculosis patients. Instead, the interventions focused on encouraging the provision of quality tuberculosis services within the private sector. An intervention study was done in Sharkia governorate in 2004 revealed that collaboration with the private sector increased the case detection rate in the governorate from 44% to 54% within 6 months. This study showed that training and orientation of private practitioners can increase the tuberculosis case notification by private doctors. It also showed that 15 hour training does not have a better result than 5 hour orientation session.
The public—public mix:There are several other departments within the MOHP and other government ministries which do not fall under the control of the NTP. NTP is collaborating with these sectors to unify TB diagnosis, treatment and monitoring e.g. infectious disease (fever) hospitals and teaching hospitals.
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PRACTICL APPROACH TO LUNG HEALTH (PAL)
Respiratory diseases contribute a considerable burden of suffering and death in any part of the world. The most frequent respiratory diseases causing morbidity and mortality in adults are pneumonia and other acute respiratory infections (ARI), tuberculosis, asthma, chronic obstructive pulmonary disease (COPD) and cancer. The Practical Approach to Lung health (PAL) is a syndromic approach to the management of patients who attend primary health care services for respiratory symptoms.
WHY IS PAL USEFUL?
Up to one-third of patients over the age of 5 years attending primary * health care (PHC) settings seek health care for respiratory symptoms.
Ideally, TB cases should be detected among patients with respiratory * symptoms within PHC settings.
Standardized procedures have been clearly defined for the management * of TB and acute respiratory infections (ARI) in children, but no such formulations exist for patients over 5 years of age with respiratory symptoms.
WHAT ARE THE OBJECTIVES OF PAL?
To improve the quality of respiratory case management for the individual * patient.
To improve the efficiency and cost-effectiveness of respiratory care within * health systems.
WHAT ARE THE COMPONENTS OF PAL?
Standardization of health service delivery through the development and * implementation of clinical practice guidelines.
Coordination among different levels of health care as well as between TB * control programmes and the organization of general health services.
WHAT IS THE FOCUS OF PAL?
Tuberculosis (TB) *
Acute respiratory infections (ARI), with a focus on pneumonia *
Asthma *
Chronic obstructive pulmonary disease (COPD) *
WHAT IS THE IMPACT OF PAL ON TB CONTROL?
Secures and empowers TB control in epidemiological transition and/or * when health system changes.
Improves TB case detection and the quality of TB diagnosis. Assists * national health authorities with ongoing health sector reform, and keeps
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TB high on the agenda.
Provides information on TB detection within general health care * services.
WHAT IS THE IMPACT OF PAL ON GENERAL HEALTH SERVICES?
Improves planning and health resource management. *
Addresses the challenge of the burden of respiratory diseases in PHC * through the provision of an essential health care delivery package.
Improves the health management information system. *
Improves the referral system for respiratory conditions in general and TB * in particular.
Strengthens PHC services to increase attendance by patients with * respiratory symptoms.
Reduces the prescription of drugs in general and antibiotics in particular. *
Strengthens the competence of PHC workers. *
Strengthens the confidence of the population in PHC services. *
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INTERNATIONAL STANDARDS FOR TB CARE
The purpose of the International Standards for Tuberculosis Care (ISTC) is to describe a widely accepted level of care that all practitioners, public and private, should seek to achieve in managing patients who have or are suspected of having TB. The Standards are intended to facilitate the effective engagement of all care providers in delivering high-quality care for patients of all ages, including those with sputum smear-positive, sputum smear-negative, and extra pulmonary TB.
The basic principles of care for persons with, or suspected of having, TB are the same worldwide. Diagnosis should be established promptly and accurately, standardized treatment regimens of proven efficacy should be used with appropriate treatment support and supervision, the response to treatment should be monitored, and the essential public health responsibilities must be carried out. Prompt accurate diagnosis and effective treatment are not only essential for good patient care but they are the key elements in the public health response to TB and the cornerstone of TB control. Thus all providers who undertake evaluation and treatment of patients with TB must recognize that not only are they delivering care to an individual, they are assuming an important public health function that entails a high level of responsibility to the community, as well as to the individual patient
Standards for DiagnosisStandard 1. All persons with otherwise unexplained productive cough lasting two–three weeks or more should be evaluated for tuberculosis.
Standard 2. All patients (adults, adolescents, and children who are capable of producing sputum) suspected of having pulmonary TB should have at least two, and preferably three, sputum specimens obtained for microscopic examination. When possible, at least one early morning specimen should be obtained.
Standard 3. For all patients (adults, adolescents, and children) suspected of having extrapulmonary TB, appropriate specimens from the suspected sites of involvement should be obtained for microscopy and where facilities and resources are available for culture and histopathological examination.
Standard 4. All persons with chest radiographic findings suggestive of TB should have sputum specimens submitted for microbiological examination.
Standard 5. The diagnosis of sputum smear-negative pulmonary TB should be based on the following criteria: at least three negative sputum smears; chest radiography findings consistent with TB; and lack of response to a trial of broad-spectrum antimicrobial agents. For such patients, if facilities for culture are available, sputum cultures should be obtained
Standard 6. The diagnosis of intrathoracic (i.e., pulmonary, pleural, and
36
mediastinal or hilar lymph node) TB in symptomatic children with negative sputum smears should be based on the finding of chest radiographic abnormalities consistent with TB and either a history of exposure to an infectious case or evidence of TB infection (positive tuberculin test). For such patients, if facilities for culture are available, sputum specimens should be obtained (by expectoration, gastric washings, or induced sputum) for culture.
Standards for TreatmentStandard 7. Any practitioner treating a patient for TB is assuming an important public health responsibility. To fulfill this responsibility the practitioner must not only prescribe an appropriate regimen but, also, be capable of assessing the adherence of the patient to the regimen and addressing poor adherence when it occurs. By so doing, the provider will be able to ensure adherence to the regimen until treatment is completed.
Standard 8. All patients (including those with HIV infection) who have not been treated previously should receive an internationally accepted first-line treatment regimen using drugs of known bioavailability. The initial phase should consist of two months of Isoniazid, Rifampicin, Pyrazinamide, and Ethambutol. The preferred continuation phase consists of Isoniazid and Rifampicin given for four months. The doses of antituberculosis drugs used should conform to international recommendations. Fixed-dose combinations of two (Isoniazid and Rifampicin, three (Isoniazid, Rifampicin, and Pyrazinamide), and four (Isoniazid, Rifampicin, Pyrazinamide, and Ethambutol) drugs are highly recommended.
Standard 9. To assure adherence, a patient-centered approach to administration of drug treatment, based on the patient’s needs and mutual respect between the patient and the provider, should be developed for all patients. Supervision and support should be gender-sensitive and age-specific, including patient counseling and education.
Standard 10. All patients should be monitored for response to therapy, best judged in patients with pulmonary TB by follow-up sputum microscopy (two specimens) at least at the time of completion of the initial phase of treatment (two months), at five months, and at the end of treatment. Patients who have positive smears during the fifth month of treatment should be considered as treatment failures and have therapy modified appropriately. In patients with extrapulmonary TB and in children, the response to treatment is best assessed clinically. Follow-up radiographic examinations are usually unnecessary.
Standard 11. A written record of all medications given, bacteriologic response, and adverse reactions should be maintained for all patients.
Standard 12. In areas with a high prevalence of HIV infection in the general
37
population and where tuberculosis and HIV infection are likely to co-exist, HIV counseling and testing is indicated for all tuberculosis patients as part of their routine management. In areas with lower prevalence rates of HIV, HIV counseling and testing is indicated for tuberculosis patients with symptoms and/or signs of HIV-related conditions and in tuberculosis patients having a history suggestive of high risk of HIV exposure.
Standard 13. All patients with tuberculosis and HIV infection should be evaluated to determine if antiretroviral therapy is indicated during the course of treatment for tuberculosis. Given the complexity of co-administration of anti-tuberculosis treatment and antiretroviral therapy.
Standard 14. An assessment of the likelihood of drug resistance, based on history of prior treatment, exposure to a possible source case having drug-resistant organisms, and the community prevalence of drug resistance, should be obtained for all patients. Patients who fail treatment and chronic cases
should always be assessed for possible drug resistance. For patients in whom drug resistance is considered to be likely, culture and drug susceptibility testing for isoniazid, rifampicin, and ethambutol should be performed promptly.
Standard 15. Patients with TB caused by drug-resistant (especially MDR) organisms should be treated with specialized regimens containing second-line antituberculosis drugs. At least four drugs to which the organisms are known or presumed to be susceptible should be used, and treatment should be given for at least 18 months.
Standards for Public Health ResponsibilitiesStandard 16. All providers of care for patients with TB should ensure that persons (especially children under 5 years of age and persons with HIV infection) who are in close contact with patients who have infectious TB are evaluated and managed in line with international recommendations.
Standard 17. All providers must report both new and retreatment tuberculosis cases and their treatment outcomes to local public health authorities, in conformance with applicable legal requirements and policies.
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The Stop TB Strategy
Vision A world free of TB.
GoalTo dramatically reduce the global burden of TB by 2015 in line with the Millennium Development Goals (MDGs) and the Stop TB Partnership targets.
Objectives
Achieve universal access to high-quality diagnosis and patient-centred treatment. Reduce the human suffering and socioeconomic burden associated with TB.Protect poor and vulnerable populations from TB, TB/human immunodeficiency virus (HIV) and multidrug-resistant TB (MDR-TB).Support development of new tools and enable their timely and effective use.
Targets
MDG 6, Target 8: «halted by 2015 and begun to reverse the incidence» [of TB] Targets linked to the MDGs and endorsed by Stop TB Partnership – By 2005: detect at least 70% of new sputum smear-positive TB cases and cure at least 85% of these cases – By 2015: reduce prevalence of and deaths due to TB by 50% relative to 1990. – By 2050: eliminate TB as a public health problem (<1 case per million population).
Components of the strategy and implementation approaches1. Pursue high-quality DOTS expansion and enhancement
Political commitment with increased and sustained financing.•Case detection through quality-assured bacteriology.•Standardized treatment with supervision and patient support.•An effective drug supply and management system.•Monitoring and evaluation system, and impact measurement.•
2. Address TB/HIV, MDR-TB and other challengesImplement collaborative TB/HIV activities.•Prevent and control MDR-TB.•Address prisoners, refugees and other high-risk groups and special situations.•
3. Contribute to health system strengtheningActively participate in efforts to improve system-wide policy, human resources, •financing, management, service delivery and information systems. Share innovations that strengthen systems, including the Practical approach to lung •health.Adapt innovations from other fields. •
4. Engage all care providers Public–public and public–private mix approaches.•International standards for tuberculosis care.•
5. Empower people with TB, and communitiesAdvocacy, communication and social mobilization.•Community participation in TB care. •Patients› charter for tuberculosis care.•
6. Enable and promote research Programme-based operational research. •Research to develop new diagnostics, drugs and vaccines.•
