+ All Categories
Home > Documents > The real magnitude of MDR-TB in Iraq Introduction 1 …phd.iq/LionImages/PDFStore/(revised...

The real magnitude of MDR-TB in Iraq Introduction 1 …phd.iq/LionImages/PDFStore/(revised...

Date post: 26-Apr-2020
Category:
Upload: others
View: 1 times
Download: 0 times
Share this document with a friend
25
1 Tuberculosis in the world and in Iraq Nearly one third of the global population i.e. two billion people is infected with Mycobacterium tuberculosis and at risk of developing the disease. More than eight million people develop active Tuberculosis (TB) every year, and about two million die. (Figure 1) More than 90% of global TB cases and deaths occur in the developing world, where 75% of cases are in the most economically productive age group (15-54 years).An adult with TB loses on average three to four months of work time, which results in the loss of 20-30% of annual household income. Co-infection with human immunodeficiency virus (HIV) significantly increases the risk of developing TB. 250,000 deaths due to TB/HIV over the world occur each year. The main reasons for the increasing burden of TB globally are: poverty, collapse of health infrastructure, weak national TB control programs and the impact of HIV. Iraq is considered to be a middle burden country with TB, and occupies rank 108 globally and 7 in eastern Mediterranean region among countries with TB burden size. According to WHO report, the estimated incidence of TB in Iraq is 45/100000 population (I.e. estimated total new TB cases is around 15000 per year), while the prevalence is 74/100000 and the mortality is 3/100000. The real magnitude of MDR-TB in Iraq is unknown as no drug resistance survey (DRS) was conducted yet .With reference to the Global TB Control WHO Report 2009, the percentage of Multi- Drug Resistance TB (MDR-TB) among new cases in Iraq is 3%, and among retreatment cases it is 38%. The estimated number of MDR among all cases is 988, and among smears positive SS+ve cases is 719. Introduction 1 Figure 1 Estimated TB incident rate 2011 Global tuberculosis report 2012. Objectives of the curriculum 1. To incorporate national TB-DOTS control Program continuously into medical teaching curriculum as an initiative for comprehensiveness of public health programs in different health sectors. 2. To keep updating medical students in diagnosis, treatment and prevention of TB according to international standards.
Transcript
Page 1: The real magnitude of MDR-TB in Iraq Introduction 1 …phd.iq/LionImages/PDFStore/(revised curriculum...1 survey (DRS) was conducted yet .With Tuberculosis in the world and in Iraq

1

Tuberculosis in the world and in

Iraq

Nearly one third of the global population

i.e. two billion people is infected with

Mycobacterium tuberculosis and at risk of

developing the disease. More than eight

million people develop active Tuberculosis

(TB) every year, and about two million

die. (Figure 1)

More than 90% of global TB cases and

deaths occur in the developing world,

where 75% of cases are in the most

economically productive age group (15-54

years).An adult with TB loses on average

three to four months of work time, which

results in the loss of 20-30% of annual

household income.

Co-infection with human

immunodeficiency virus (HIV) significantly

increases the risk of developing TB.

250,000 deaths due to TB/HIV over the

world occur each year.

The main reasons for the increasing

burden of TB globally are: poverty,

collapse of health infrastructure, weak

national TB control programs and the

impact of HIV.

Iraq is considered to be a middle burden

country with TB, and occupies rank 108

globally and 7 in eastern Mediterranean

region among countries with TB burden

size. According to WHO report, the

estimated incidence of TB in Iraq is

45/100000 population (I.e. estimated

total new TB cases is around 15000 per

year), while the prevalence is

74/100000 and the mortality is

3/100000.

The real magnitude of MDR-TB in Iraq

is unknown as no drug resistance

survey (DRS) was conducted yet .With

reference to the Global TB Control WHO

Report 2009, the percentage of Multi-

Drug Resistance TB (MDR-TB) among new

cases in Iraq is 3%, and among

retreatment cases it is 38%. The

estimated number of MDR among all

cases is 988, and among smears positive

SS+ve cases is 719.

Introduction 1

Figure 1

Estimated TB incident rate 2011

Global tuberculosis report 2012.

Objectives of the curriculum

1. To incorporate national TB-DOTS control Program continuously into medical teaching curriculum as an initiative for comprehensiveness of public health programs in different health sectors.

2. To keep updating medical students in diagnosis, treatment and prevention of TB according to international standards.

Page 2: The real magnitude of MDR-TB in Iraq Introduction 1 …phd.iq/LionImages/PDFStore/(revised curriculum...1 survey (DRS) was conducted yet .With Tuberculosis in the world and in Iraq

2

Tuberculosis 2

What is Tuberculosis (TB)?

TB is a bacterial, infectious disease caused

by Mycobacterium Tuberculosis complex

(Human, Bovis and Africana), these

organisms are also known as tubercle

bacilli (because they cause lesion called

tubercle) or acid fast bacilli (AFB) because

it resist the acid decolorization during the

staining process (Figure 2).

TB affects all races all ages & all organs.

Infection occurs almost exclusively

through the respiratory system by

inhalation of tubercle bacilli. The lung is

the main organ affected. Each smear-

positive PTB (pulmonary TB) will transmit

infection to (10 – 15 persons) in year.

Those who will be infected with TB will

not necessarily get the disease; the

immune system "walls off" the TB bacilli,

which can remain dormant for years.

About 5 -10 % of the infected individuals,

have chance of developing TB disease

during their lifetime.

Transmission of Infection?

-Air Borne: When patients with PTB

speak ,and particularly when they cough

or sneeze, they produce an aerosol of

droplets from the bronchial tree, each of

which contains a number of bacilli ,The

number of infectious droplets projected

into atmosphere by a patient is very high

when coughing (3500) or sneezing (1

million).When they come in to contact

with air they rapidly dry and become very

light particles, however, they still

containing live bacilli, that remain

suspended in the air .In enclosed space,

the droplets can remain suspended for

long time, and the bacilli remain alive for

long time in the dark. The closer and more

prolonged the contact with an infectious

patient, the greater the risk of infection,

as this linked to the density of the bacilli

in the air the individual breaths and the

amount of the air inhaled.

-Ingestion: by contaminated un -

pasteurized milk (M. bovis).

-Rare routes of transmission:

cutaneous, trans placental, & transsexual

transmissions.

Incubation period:

Incubation period is 3-8 weeks in primary

TB, and up to years in post primary TB

(Table 1).

Table 1

Timetable of TB

Time from infection Manifestation

3-8 weeks Primary complex, positive tuberculin skin test

3-6 months Meningeal , miliary ,plural disease

Up to 3 years GI,bone and joint, lymph node

Around 8 years Renal tract inf.

From 3 years onwards

Post - primary disease due to reactivation of inf.

Figure 2 Mycobacterium Tuberculosis

Visualization using Ziehl-Neelsen stain.

Page 3: The real magnitude of MDR-TB in Iraq Introduction 1 …phd.iq/LionImages/PDFStore/(revised curriculum...1 survey (DRS) was conducted yet .With Tuberculosis in the world and in Iraq

3

Evolution of infection

1. Primary Tuberculosis:

When a few virulent tubercle bacilli

penetrate the pulmonary alveoli of a

healthy person, they are phagocytosed by

the alveolar macrophages, in which they

multiply. Other macrophages and

monocytes are attracted and Participate

in the process of defense against

infection. The resulting (infectious focus)

made up of inflammatory cells, is referred

to as primary focus. The bacilli and the

antigens that they liberate are drained by

the macrophages through the lymphatic

system to the nearest lymph nodes. Inside

the lymph node, the T lymphocytes

identify the M. tuberculosis antigens and

are transformed in to specific T

lymphocytes, leading to liberation of

lymphokines and activation of

macrophages that inhibit the growth of

the phagocytosed bacilli. The

inflammatory tissue formed in the

primary focus is replaced by fibrous scar

tissue in which the macrophages

containing bacilli are isolated and die. This

primary focus is the site of tuberculosis-

specific caseating necrosis. This focus

contains (1000-10000) bacilli which

gradually lose their viability and multiply

more and more slowly. Some bacilli can

survive for months or years, these are

known as (Latent bacilli) this is indicated

by the development of a delayed-type

hypersensitivity which can be

demonstrated by tuberculin skin test and

this process takes period about 6-8weeks

from the beginning of the infection.

2. Secondary focus: Post primary

Before immunity is established, bacilli

from the primary infectious focus or from

the nearest lymph node are transported

and disseminated throughout the body by

lymph system and then via the blood

stream. Secondary foci containing a

limited number of bacilli are thus

constituted, particularly in the lymph

nodes, serous membranes, meninges,

bones, liver, kidneys and lungs. As soon as

an immune response is mounted most of

these foci spontaneously resolve.

However, a number of bacilli may remain

latent in the secondary foci for months or

even years.

Primary TB is mostly pulmonary and may

be extra- pulmonary e.g. intestinal

primary TB.

80 – 90 % of infected individual's

immunity will take the upper hand,

ending in spontaneous healing, resolution

fibrosis and calcification.

In 10 – 20 % of infected individual

virulence takes the upper hand and may

result in active disease. This results in

primary TB when initial infection causes

the individual to develop clinical disease.

In most instances, even where there are

clinical signs present, immunity will get

the role to play and the disease will

regress spontaneously. Where it does not,

progressive primary TB or disseminated

TB may occur.

When should tuberculosis be

suspected?

The onset of the disease is often

insidious; symptoms often develop slowly,

on several weeks. Chest symptoms are

often nonspecific, cough is almost always

present with sputum production. Possibly

chest pain & or dyspnoea. Less commonly

haemoptysis may occur.

Systemic symptoms: fever in the evening

(on average 38°C) heavy night sweat, loss

of appetite, loss of weight & a general

sense of malaise.

Page 4: The real magnitude of MDR-TB in Iraq Introduction 1 …phd.iq/LionImages/PDFStore/(revised curriculum...1 survey (DRS) was conducted yet .With Tuberculosis in the world and in Iraq

4

Suspected TB patient is any patient have

cough more than 3 weeks not responding

to ordinary treatment (figure 5).

Page 5: The real magnitude of MDR-TB in Iraq Introduction 1 …phd.iq/LionImages/PDFStore/(revised curriculum...1 survey (DRS) was conducted yet .With Tuberculosis in the world and in Iraq

5

Case definition 3

A case of TB is defined as a patient on

whom tuberculosis has been confirmed by

bacteriology or diagnosed by a clinician.

Purpose of case definition

1. Proper patient registration and case

notification. 2. To evaluate the trend in the

proportion of the new smear positive cases & smear positive relapse & other retreatment cases.

3. Commencement of appropriate treatment categories for TB cases & cohort analysis of treatment outcome.

What determines case

definition?

1. Site of TB disease:

TB affects the lungs in more than 80% of

cases & called pulmonary TB. TB can

affects a various organs & called extra

pulmonary TB.

2. Severity of TB disease:

Bacillary load, extent of the disease &

anatomical site is considered in

determining TB disease severity.

3. Bacteriological result of sputum smear examination:

a. Smear positive pulmonary

tuberculosis (PTB)

- Either a patient with at least two

sputum specimens positive for AFB by

microscopy.

- Or patient with one sputum specimen

positive for AFB & radiographic

abnormalities consistent with active

pulmonary TB . Decision by a physician

to treat with a full curative course of anti

TB chemotherapy.

- Or with at least one sputum specimen

positive for AFB with culture positive for

AFB.

- Under programmed conditions when

microscopy lab services are available and

diagnostic criteria are properly applied,

Pulmonary T.B smear positive case

represent at least 65% of the

total(PTB)cases in adults and 50% or more

of all TB cases.

b. Smear negative (PTB):

Either a patient fulfills all the following

criteria.

- Two sets (taken at least 2 weeks apart)

of at least two sputum specimen negative

for AFB.

- Radiographic abnormalities consistent

with active pulmonary TB & a lack of

clinical response despite one week of

broad spectrum antibiotics (except

quinolones).

- A decision by a physician to treat with

full curative course of anti TB

chemotherapy.

Or a patient who fulfills the following

criteria with three specimen of sputum

smear negative for AFB radiographic

abnormalities consistent with active

pulmonary TB and a decision by physician

to treat with full curative course of anti-

TB chemotherapy.

c. Extra – pulmonary TB: Are patients with tuberculosis in organs

other than the lungs (e.g. pleura, lymph

nodes, abdomen, genitourinary tract,

skin, joints and bones, meninges).

Diagnosis should be based on one culture

positive specimen or histological or strong

clinical evidence consistent with active

extra-pulmonary disease, followed by a

Page 6: The real magnitude of MDR-TB in Iraq Introduction 1 …phd.iq/LionImages/PDFStore/(revised curriculum...1 survey (DRS) was conducted yet .With Tuberculosis in the world and in Iraq

6

decision by a clinician to treat with a full

course of anti-TB chemotherapy.

A patient in whom both pulmonary and

extra-pulmonary tuberculosis has been

diagnosed should classify as pulmonary

case.

4. Case classification according to

previous treatment.

On diagnosis, patients are classified for

registration according to previous TB

treatment:

New case: Patient who has never had

treatment for tuberculosis or who has

taken anti TB chemotherapy for less than

4 weeks.

Relapse: patient who has been declared

cured from T.B in the past by a physician

after one full course of chemotherapy &

now has become bacteriologically positive

(at least one smear or culture)

tuberculosis.

Treatment failure: Patient who while on

treatment remained or become again

smear positive 5 months after

commencing treatment. It is also a patient

who was initially smear negative before

starting treatment and become smear

positive after second month of treatment.

Treatment defaulter: patient who does

not take drugs or interrupts treatment for

two months or more & return to the

health services with smear positive

sputum consider as treatment failure or

return with smear negative in this case

continues his treatment but from the

start.

Chronic cases: Patient who remained or

became again smear positive after

completing a fully supervised retreatment

regimen.

Page 7: The real magnitude of MDR-TB in Iraq Introduction 1 …phd.iq/LionImages/PDFStore/(revised curriculum...1 survey (DRS) was conducted yet .With Tuberculosis in the world and in Iraq

7

Diagnosis of TB 4

Diagnosis of pulmonary TB in

adult:

a. If after interview and clinical

examination there is no evidence of

another cardio pulmonary condition in a

patient who presents with cough lasting

for more than 3 weeks pulmonary

tuberculosis should be suspected.

Bacteriological examination of the sputum

must be performed on 3 consecutive

sputum for direct smear examination of

AFB.

b.Certain radiological abnormalities are

consistent with TB:

Nodules: round shadow with clearly

defined borders. (Figure 3).

Patchy shadow: irregular border

infiltration.

Cavities are the most characteristic

sign of TB. (Figure 4 ).

Some radiographic shadow show TB

sequel:

Nodules that are fully or partially

calcified.

Satellite abnormalities.

Fibrosis.

Fine walled bullae /Cavities.

Specific aspects of childhood TB: a. Primary pulmonary TB: Primary

infection is asymptomatic. In (10%) of cases primary infection has clinical manifestation. b. Generalized symptoms. c. Mucocutaneous manifestation (Erythèma Nodosum, Phlyctenular conjonctivites). d. Radiological sign: typical primary complex.

Isolated mediastinal lymphadenopathy

Segmental consolidation associated

with mediastinal lymphadenopathy.

e. History contact to index case.

f. Positive tuberculin skin test.

Figure 4

Upper lobe cavitary lesion

Figure 3 A rounded opacity in the left lung apex. Partially overlapping with the left anterior first rib. This abnormality is consistent with a pulmonary nodule.

Figure 3 A rounded opacity in the left lung apex. Partially overlapping with the left anterior first rib. This abnormality is consistent with a pulmonary nodule.

Figure 3 A rounded opacity in the left lung apex. Partially overlapping with the left anterior first rib. This abnormality is consistent with a pulmonary nodule.

Page 8: The real magnitude of MDR-TB in Iraq Introduction 1 …phd.iq/LionImages/PDFStore/(revised curriculum...1 survey (DRS) was conducted yet .With Tuberculosis in the world and in Iraq

8

Diagnosis of pulmonary TB

Points to be remembered in the diagnosis of pulmonary TB: 1. Over 80% of patients with smear

positive pulmonary T.B have at least one or more respiratory symptoms for more than three weeks.

2. The most frequent respiratory symptom is the cough followed by expectoration. Over 90% of patients with smear positive pulmonary TB develop cough while only 20% of them have haemoptysis.

3. The bacteriological examination of the sputum is the only way in which the diagnosis of pulmonary TB can be confirmed.

4. X- Ray diagnosis of TB is unreliable because other chest disease can look like TB on x- ray.

5. The tuberculin test has a limited value in clinical work in adult but it helps in diagnosis TB in children.

Over 90% with a cavitory pulmonary T.B

or with extensive abnormal infiltration are

smear positive, therefore a patient with

cavitations on chest x ray & repeated

specimen smear for AFB were negative,

probably has a disease other than TB.

Page 9: The real magnitude of MDR-TB in Iraq Introduction 1 …phd.iq/LionImages/PDFStore/(revised curriculum...1 survey (DRS) was conducted yet .With Tuberculosis in the world and in Iraq

9

Management of TB 5

Disciplines in the management of T.B

1. Physician should manage TB cases

without any deviation in combination

of drugs, dosage, duration of

treatment & type of regimen used.

2. Physician demands not only a

detailed knowledge of the drugs

available but also of the most

appropriate regimen for the

individual patient.

3. The available drugs must not be

abused by inadequately trained

doctors.

4. Anti TB chemotherapy is by far the

most important measures in the

treatment of all form of TB and

should be given to every patient with

active disease while surgery plays a

minor role.

5. It is wasteful to treat patients who do

not need it and expose them to the

risk of drug toxicity and to the

domestic penalties as being labeled

tuberculosis.

6. Hospitalization in itself has little or

no effect on the outcome of

treatment. A patient who takes the

drugs regularly will do equally well

whether treatment in or out of the

hospital. However, regular & direct

supervision of patients is of Para

most important.

7. Inpatients treatment is indicated for

severely ill, and for those with

complications of TB (e.g.

haemoptysis, spontaneous

pneumothorax) as for those with

other serious co-existent disease

requiring hospitalization.

8. Pregnant women with TB should

start or continue their treatment for

TB in the same way as other patients;

however, Streptomycin should not be

used because of the risk of toxicity to

the inborn child.

9. The use of Rifampicin or

Streptomycin for diseases other

than mycobacterium diseases

should be avoided or limited to very

carefully considered indication.

10. Anti TB drugs are relatively toxic &

mild side effects are not

uncommon, but in most case no

need for drug withdrawal. Minor

side effects are relatively few

cause, discomfort, they often

respond to symptomatic or simple

treatment. Major side effects are

those giving rise to serious health

hazard & required discontinuation

of the drug & referral to chest

physician.

11. Major (essential) anti TB drugs are:

There are three main properties of

anti TB drugs; bactericidal ability,

sterilizing ability and ability to prevent

resistance.

The essential anti TB drugs possess

these properties to different extent.

Isoniazide (H), Rifampicin (R),

streptomycin (S), Ethambutol (E),

Pyrazinamid (Z), all are able to cure

100% of new T.B cases with sensitive

bacilli. Treatment of T.B is the main

weapon against the fight of the

disease. The bases of TB treatment is

chemotherapy.

Aims of the treatment:

To cure TB patients.

To prevent death.

To prevent relapse.

To decrease transmission to others.

To prevent drug resistance.

Page 10: The real magnitude of MDR-TB in Iraq Introduction 1 …phd.iq/LionImages/PDFStore/(revised curriculum...1 survey (DRS) was conducted yet .With Tuberculosis in the world and in Iraq

10

Figure 5

How to manage a suspected TB patient.

Suspected TB patient

Microscopical

examination of Sputum

for AFB

AFB +ve AFB -ve

Broad spectrum antibiotics

except Quinolones

Improvement No improvement

Repeated AFB

microscopy

AFB -ve AFB +ve

Clinical and radiological

assessment

Not TB TB

Consider other diagnosis Treat as smear –ve

pulmonary TB Treat as smear +ve

pulmonary TB

Page 11: The real magnitude of MDR-TB in Iraq Introduction 1 …phd.iq/LionImages/PDFStore/(revised curriculum...1 survey (DRS) was conducted yet .With Tuberculosis in the world and in Iraq

11

Requirements for adequate

chemotherapy:

1. Good chemotherapy, which is designed to kill mycobacterium & sterilize the body tissues.

2. Prescribed in a correct dosage. 3. Taken regularly by the patients. 4. For a sufficient period of time.

Effects of anti TB chemotherapy:

A good chemotherapy is designed to kill

TB bacilli rapidly, prevent the

development of drug resistance, and

sterilize the host's tissues. The

achievement of these effects requires a

combination of drugs.

Failure of chemotherapy is due to the

irregularity of drugs taking & the high

dropout rate during treatment.

This would be prevented by good health

education, involve whole family in

observing the patients, using special pack

for anti TB drugs & using the latest DOTS

strategy (see p21).

Drug Action:

How do anti tuberculosis drugs work?

(Table 2)

1. Bactericidal action which is defined as

their ability to kill large numbers of

actively metabolizing bacilli rapidly.

2. Sterilizing action- defined as their

capacity to kill special populations of

slowly or intermittently metabolizing semi

dormant bacilli the so called per sisters.

3. Their ability to prevent the emergence

of acquired resistance by suppressing

drug resistant mutants present in all large

bacteria population.

4. Their suitability for intermittent use.

Bactericidal action:

Most of the anti TB drugs with the

exception of Ethambutol have some

bactericidal action but INH is the most

potent bactericidal drug. Rifampcin is also

an important bactericidal drug;

streptomycin and Pyrazinamid are less

potently bactericidal.

Sterilizing action:

Rifampcin and Pyrazinamid are the most

important sterilizing drugs because of

their ability to kill semi dormant bacilli.

The WHO recommended certain

regimens for each patient category:

Category I: Smear positive case or smear

negative severely ill patient or seriously ill

extra pulmonary T.B, e.g. T.B meningitis,

Miliary T.B, T.B pericarditis& T.B peritonitis.

New cases that are not treated previously as

pulmonary TB or serious extra pulmonary T.B

(meningitis). First line standard regimen (2HRZ

E or (S) +4RH).

Category II: Failure, after failure of a

default, defaulter, Relapses First line

treatment regimen (2HRZES + 1HRZE + 5HRE).

Category III:Less severe sputum smear

negative pulmonary TB and less severe type of

extra pulmonary TB. First line standard

regimen (2HRZ + 4RH).

Category IV: Chronic or drug resistant TB

cases. Second line regimens.

Page 12: The real magnitude of MDR-TB in Iraq Introduction 1 …phd.iq/LionImages/PDFStore/(revised curriculum...1 survey (DRS) was conducted yet .With Tuberculosis in the world and in Iraq

12

Page 13: The real magnitude of MDR-TB in Iraq Introduction 1 …phd.iq/LionImages/PDFStore/(revised curriculum...1 survey (DRS) was conducted yet .With Tuberculosis in the world and in Iraq

13

Optimal management of new

cases of TB

The Iraqi National TB Program (NTP)

(see page 19) committee adapted a new

WHO strategy since October 2000 and

this consists of:

1. Initial daily intensive phase:is

supervised by medical staff or

(patient's family or others). Containing

Rifampcin 450 mg if the patient weight

less than 50 Kg & 600mg if his weight is

more than 50 Kg. Plus INH 300 mg .

Plus 1.5 gm of Pyrazinamid if patient's

weight is less than 50 Kg and 2gm for

patient weighing more than 50 Kg Plus

either Ethambutol 25 gm/Kg or

streptomycin 0.75 gm daily.

2. Continuation phase: Preferable to be

supervised .On the day of receiving

the drug, contain daily Rifampcin and

INH for next 4 months.(Table 3)

Table 3 Possible alternative regimens for treatment category

Alternative TB Treatment regimens

T.B. Patient TB Treatment

category

Continuation phase

Initial Phase

4HR or 6HE

2HRZ E or (S)

New smear + ve patient (Figure 6)

PTB

New smear – ve patient

PTB with extensive parenchyma involvement

New cases of severe forms of extra PTB

I

5HRE

2HRZES +

1HRZE

Sputum smear + ve

Relapse

Treatment failure

Treatment after interruption

II

4HR or 6HE 2HRZ

New s – ve PTB (other than in category I)

New less severe forms of extra PTB

III

NOT APPLICABLE

(refer to WHO guidelines for use of second line drugs in specialized

centers)

Chronic cases (still sputum positive after supervised retreatment)

IV

Page 14: The real magnitude of MDR-TB in Iraq Introduction 1 …phd.iq/LionImages/PDFStore/(revised curriculum...1 survey (DRS) was conducted yet .With Tuberculosis in the world and in Iraq

14

Figure 6

Treatment for the New Pulmonary and extra pulmonary cases

New Pulmonary and extra pulmonary cases

The initial phase 2 HRZE

pulmonary cases

Sputum smear examination (for pulmonary TB cases) at the end of 2nd, 5th, 6th months

For extra pulmonary cases: clinical assessment and other measures e.g. radiology, biopsy, etc.

If smear negative

cases

If smear positive at

5th months

Continuation phase

4HR Retreatment

Page 15: The real magnitude of MDR-TB in Iraq Introduction 1 …phd.iq/LionImages/PDFStore/(revised curriculum...1 survey (DRS) was conducted yet .With Tuberculosis in the world and in Iraq

15

DR TB is a man-made disease (due to non-

compliance, improper drug regimen,

etc.).Primary resistance is prevented by

giving the patient combination of drugs.

Secondary (acquired) TB resistance is

expected to be developed in:

1. A large bacillary population such as

patient with cavitations.

2. Inadequate drug regimens

(inappropriate drugs, insufficient

dosage), drug side effects and

complications.

3. Treatment of DR TB should be done

by or in close consultation with an

expert in the management of these

cases & on hospitalization bases.

4. A single new drug should never be

added to a failing regimen.

5. Treatment duration for DR TB patient

may last 18-24 months by using 4-6

drugs (capriomycin, cyclocerin,

ethionamide, levofloxacine, and PAS).

6. Second line regimens often represent

the patient's last hope for being cured

inappropriate management can thus

have life threatening sequences.

Drug resistance TB patients (DR)

6

Page 16: The real magnitude of MDR-TB in Iraq Introduction 1 …phd.iq/LionImages/PDFStore/(revised curriculum...1 survey (DRS) was conducted yet .With Tuberculosis in the world and in Iraq

16

Figure 7

Retreatment Cases

Relapse, Failure, after Defaulters

Check sputum smear at the end of 3rd, 5th, 8th months

If smear - ve continue on HRE for 5 months

If smear + ve continue on HRZE

Check sputum after 5 months

If smear + ve at the 5th month

If smear + ve at the end of treatment

Culture and sensitivity C/S

If C/S show resistant to 2 or more of the drugs

Drug resistant (DR) case .start

2nd line drugs

Page 17: The real magnitude of MDR-TB in Iraq Introduction 1 …phd.iq/LionImages/PDFStore/(revised curriculum...1 survey (DRS) was conducted yet .With Tuberculosis in the world and in Iraq

17

Management of contacts of

smear positive cases

Children age & adults: any person who

coughs & who was in contact with smear

positive index case (smear positive

pulmonary TB patient) should have three

sputum examinations (Fig.8)

Children aged less than 5 years: any

contact aged less than 5 years who has a

positive tuberculin that not previously

vaccinated with BCG with signs or

symptoms of TB should be treated as

suffering from active TB.

Those without signs or symptoms of

disease should be given preventive

chemotherapy (INH for 6 months)

Children under one year of age with

mothers who are being treated for smear

positive pulmonary TB should be given

Isoniazid if the tuberculin test is negative

at the end of three months, INH may be

stopped & BCG may be given .

Treatment regimens in special

situation:

Treatment for pregnant women: most

anti-TB drugs are safe for use in pregnant

women the exception is streptomycin

which is auto toxic to the fetus should not

be used in pregnancy.

Treatment for breast feeding women: all

the anti-TB drugs are compatible with the

breast feeding.

Patient with liver disease: should not

receive Pyrazinamid. The recommended

regimen are 2 S.H.R.E./6 H.R. OR 2

S.H.E./10 H.E.

Acute viral hepatitis: combination of

Streptomycin and Ethambutol up to a

maximum duration of 3 months until the

acute hepatitis has resolved then

continuation phase of 6 months of INH

and Rifampcin.

Treatment of patients with renal failure:

the safest regimen is 2 H.R.Z. /6 H.R.

Assessment of the Patient:

The three approaches to monitoring progress of patient during treatment are: 1. Clinical Assessment:

Clinical assessment of progress is largely subjective. Disappearance of clinical symptoms, general wellbeing and ability to resume normal activities and weight gain are all pointers to clinical progress. ESR and other tests are unreliable and unnecessary in monitoring progress.

2. Assessment by bacteriology:

The management of patients is generally based on smear microscopy. It is not necessary to examine the sputum every month. The WHO and I.U.A.T.L.D recommended monitoring progress during treatment in smear positive patients through sputum. Smears on three occasions, at second month, fifth month and at the end of treatment. This allows decisions on treatment management to be made with a minimum of tests.

3. Assessment by Radiography:

Assessment by radiographic changes alone can be very misleading.

Management of contacts of smear positive cases and in special situations

7

Page 18: The real magnitude of MDR-TB in Iraq Introduction 1 …phd.iq/LionImages/PDFStore/(revised curriculum...1 survey (DRS) was conducted yet .With Tuberculosis in the world and in Iraq

18

Figure 8

How to manage a child contact of a newly diagnosed patient with tuberculosis

Tuberculin Test is possible

Tuberculin +ve Tuberculin - ve

Child is well Child is well Child is unwell

Full clinical

assessment

Preventive isoniazid for 2

months

Preventive isoniazid for 2

months

Possibility of tuberculosis

possible Possibilityof tuberculosis

possible

Tuberculin - ve Tuberculin +ve

Full treatment for

tuberculosis

Isoniazid for 6 months

Stop isoniazid and

Give BCG

Page 19: The real magnitude of MDR-TB in Iraq Introduction 1 …phd.iq/LionImages/PDFStore/(revised curriculum...1 survey (DRS) was conducted yet .With Tuberculosis in the world and in Iraq

19

National TB program (NTP)

9

Iraq has an estimated 32,249,932

inhabitants. The country is

administratively divided into 18

governorates with varying population

sizes ranging from around 800 thousand

to 7 million. The Ministry of Health has

established the National Tuberculosis

Control Programme (NTP) in 1989 with

WHO support, and introduced the DOTS

strategy in 1998. By 2000, the DOTS

strategy was implemented at all the

Governorate Respiratory and Chest

Disease Clinics – except for the three

northern governorates of Kurdistan Iraq –

assuming 100% population DOTS

coverage regardless of the actual number

of people who have real access to that

clinic. By 2008, the three northern

governorates had started DOTS

implementation.

The Government of Iraq considers TB as a

major public health problem, and keeps

TB control high in the national health

agenda. Currently, many health reforms

are ongoing including the expansion of

the DOTS services into the Basic Package

of Health Services to be delivered

through the nationwide network of

Primary Health Care Centers (PHCCs). The

Government of Iraq invests strongly in

the rebuilding of the health infrastructure

that was damaged during the war and

encourages recruitment of qualified

health personnel. The NTP enjoys the full

support of the Government of Iraq. In

addition to the strong political

commitment to the National TB Control

Program, the government also supports

the procurement of first and second-line

anti TB drugs and the strengthening of

the storage and distribution

infrastructure.

The overall responsibility for TB control

rests with the NTP within the MoH. NTP is

responsible for policy and strategy

formulation, coordination with partners,

as well as planning, implementation and

monitoring of control activities. The

organizational structure of NTP is based on

4 levels:

1. Chest & Respiratory Diseases

Specialized Center at the national

(central) level in Baghdad: It is

responsible for training of staff,

implementation of the national TB

control plan and supervision of

activities in governorates.

2. Nineteen Governorate Respiratory and

Chest Disease Consultation Clinics at

the governorate (intermediate) level:

the governorate clinics are responsible

for diagnosis and registration of TB

cases detected in their geographic

areas. These clinics provide treatment

to their patients or refer them to the

district TB Management Unit for

treatment follow up.

3. There are 126 health districts in Iraq

(peripheral level). The health district’s

core organizational entity is the TB

Management Unit (TBMU)/ District TB

Coordinator (DTC). In each one of

these districts, the main Primary

Health Care Center has a TBMU which

ensures TB diagnosis and treatment.

The TBMUs also have TB register and

reporting facilities. TBMUs are also

responsible for the referral of TB

patients to a PHCC that is the nearest

to the patient’s residence – if available

– and for treatment follow-up of

patients. The TBMU is the basic

management unit in NTP.

4. There are Primary Health Care Centers

(PHCCs) throughout Iraq (some are

directed by Doctors and others are

directed by paramedical staff) in

addition to a number of main PHCCs

with training functions (peripheral

Page 20: The real magnitude of MDR-TB in Iraq Introduction 1 …phd.iq/LionImages/PDFStore/(revised curriculum...1 survey (DRS) was conducted yet .With Tuberculosis in the world and in Iraq

20

level). The role of PHCCs, other than

main centers, is limited to the

monitoring of patients’ treatment

intake under DOT.

National TB program in Iraq

Vision:A TB-free country, with

elimination of the disease as a public

health problem by 2050.

Goal: To reduce dramatically the country

burden of TB by 2015, in line with the

MDGs and Stop TB partnership targets.

Objectives:

Achieve universal access to high

quality care for all TB patients

including vulnerable populations.

Ensure universal access to diagnosis,

treatment and care for Drug-Resistant

TB (DR-TB).

Protect and promote human rights in

TB prevention, care and control.

Targets:

Halt and begin to reverse the

incidence of TB by 2015;

Reduce the prevalence of and deaths

due to TB by 50% by 2015

STRATEGIC DIRECTIONS

These strategic directions are designed

according to the key component of

International Stop TB Strategy:

1. The political will of the government

Political commitment with increased

and sustained financing

Improving quality and efficiency of

general services in respiratory

illnesses in Primary Health Care

facilities through strengthening DOTS

integration into the Basic Package of

Health Services (BPHS)

Case detection through quality-

assured bacteriology

An effective drug supply and

management system

Strengthening the Monitoring and

Evaluation (M&E) System and impact

measurement

2. Scale-up the prevention and management of Drug-Resistant TB (DR-TB)

3. Addressing TB/HIV, and the needs of

poor and vulnerable populations

Scale-up collaborative TB/HIV activities

Address the needs of TB contacts, and poor and vulnerable populations

4. Engaging all care providers, public, non-governmental and private, by scaling up public-private mix (PPM) approaches to ensure adherence to the International Standards of TB Care.

5. Empowering patients and

communities by scaling up community TB care and creating demand through context-specific advocacy, communication and social mobilization, for the patient empowerment, community involvement and Community Health Worker (CHW) training for community-based DOTS.

6. Enabling and promoting research to improve programme performance.

Developing a national framework for operational research and building local capacity in operational research.

Page 21: The real magnitude of MDR-TB in Iraq Introduction 1 …phd.iq/LionImages/PDFStore/(revised curriculum...1 survey (DRS) was conducted yet .With Tuberculosis in the world and in Iraq

21

DOTS 8

What is DOTS?

Direct Observation Treatment Short

Course (DOTS). DOTS is the new WHO

strategy, it is based on one priority, to

ensure that all sputum smear positive

pulmonary TB complete a full course of

short course chemotherapy with direct

observation of swallowing the drug during

the period of treatment or at least during

the initial phase of treatment. The main

advantage of DOTS is that treatment is

carried out entirely under programed

supervision, only when a second person

directly observes a patient swallowing the

given medication then can be certain that

the patient is actually receiving the

prescribed treatment regimen. No

concealed irregularity can occur as it can

in self-administration regimen, the

treatment observer ensures that

medicines are taken at the correct interval

& in the correct dosage & with that

certainly come benefits both for the

patient & the community. Perhaps the

most immediately apparent is the high

cure rate associated with assured

completion of treatment. Equally

important is the dramatic reduction in the

development of drug resistance.

Adverse effects and treatment

complications can be quickly identified &

addressed.

The basic rules for efficient TB treatment

an initial intensive phase associating at

least four major anti T.B drugs

administrated daily during two months

followed by continuation phase during the

next four months with two major anti T.B

drugs.

The DOTS strategy required five

conditions:

1. The political will of the government.

2. Existence of laboratories network to

identify smear positive pulmonary TB

patients.

3. A network of peripheral health

centers.

4. Regular supply of drugs and reagents.

5. Organization of permanent

surveillance system in order to

supervise the tasks of program and to

evaluate its epidemiological impact.

10 Reasons to use DOTS

1. Cure the patient.

2. Prevents new infection.

3. Stop MDR tuberculosis.

4. Cost effective.

5. Community based.

6. Extends lives of AIDS patients.

7. Protects the workforce.

8. Protects the international travelers.

9. Stimulates economies.

10. Proven effectiveness.

Page 22: The real magnitude of MDR-TB in Iraq Introduction 1 …phd.iq/LionImages/PDFStore/(revised curriculum...1 survey (DRS) was conducted yet .With Tuberculosis in the world and in Iraq

22

Figure 9

DOTS program implementation profile

Diagnosis

Supplies

Training

Supervision

Monitoring and Evaluation

Patient

Chest and Respiratory

Diseases institute Chest and Respiratory

Diseases clinic

Baghdad Governorate

District TB coordinator District TB coordinator

PHCC

Daily treatment

supervisor

Page 23: The real magnitude of MDR-TB in Iraq Introduction 1 …phd.iq/LionImages/PDFStore/(revised curriculum...1 survey (DRS) was conducted yet .With Tuberculosis in the world and in Iraq

23

The bacille Calmette-Guérin BCG was

first used to immunize humans in

1921, and following its introduction

into the WHO Expanded Program on

Immunization in 1974, BCG soon

reach global coverage rates exceeding

80% in countries endemic for TB.

Extensive clinical trials have been

conducted to assess the protective

efficacy of BCG against pulmonary

TB, but a wide range of vaccine

efficacy values have been observed

probably due in part to differences in

study design and geographical

location. BCG vaccination does not

prevent reactivation of latent TB, the

main source of bacillary dissemination

in the community. Despite these

limitations, and particularly in light of

the growing HIV/AIDS pandemic and

the appearance of multidrug-resistant

M. tuberculosis strains, BCG vaccines

will continue to represent an important

tool in the global fight against TB until

new vaccines are available.

BCG vaccine is part of the national

childhood immunization program.

BCG vaccine has a documented

protective effect against meningitis and

disseminated TB in children. It does

not prevent primary infection. The

impact of BCG vaccination on

transmission of TB is therefore limited.

WHO recommendations on the

use of BCG vaccine

• In countries with a high burden of

TB, a single dose of BCG vaccine

should be given to all infants as soon

as possible after birth. Since severe

adverse effects of BCG vaccination are

extremely rare, all healthy neonates

should be BCG -vaccinated, even in

areas endemic for HIV.

• BCG vaccination should not be given

to (i) infants and children with AIDS,

(ii) infants and children known to be

HIV-infected or (iii) children known to

have other immunodeficiencies.

• In situations where infants have been

exposed to smear-positive pulmonary

TB shortly after birth, BCG

vaccination should be delayed until

completion of six months of INH

preventive therapy (IPT).

• Vaccination of health staff, and

particularly laboratory, is an option

in high-risk environments (in particular

if staff are in close contact with cases

of drug-resistant TB).

• There is no evidence that

revaccination increases protection, and

revaccinationis not recommended.

• Countries with a low burden of TB

may choose to limit BCG vaccination

to neonates and infants of recognized

high-risk groups for the disease or of

tuberculin skin test (TST)-negative

older children. In some low-burden

populations, BCG vaccination has been

replaced by intensified case detection

and supervised early treatment

Until an improved anti-TB vaccine

becomes available, efforts to control

the spread of the disease will continue

to rely on currently available tools,

namely early diagnosis and treatment,

appropriate preventive treatment, and

other public health and infection

control measures

BCG Vaccines 9

Page 24: The real magnitude of MDR-TB in Iraq Introduction 1 …phd.iq/LionImages/PDFStore/(revised curriculum...1 survey (DRS) was conducted yet .With Tuberculosis in the world and in Iraq

24

1- The new rapid TB test – known as

Xpert MTB/RIF- is a fully-automated

diagnostic molecular test. It has the

potential to revolutionize and

transform TB care and control. The

test:

• simultaneously detects TB and

rifampicin drug resistance

• provides accurate results in less than

two hours so that patients can be

offered proper treatment on the same

day

• has minimal bio-safety requirements,

training, and can be housed in non-

conventional laboratories

WHO recommendations on the

use of Xpert MTB/RIF test

• Strong recommendation: Xpert

MTB/RIF rapid test should be used as

the initial diagnostic test in individuals

suspected of MDR-TB or HIV/TB

• Conditional recommendation:

Xpert MTB/RIF rapid test may be used

as a follow-on test to microscopy in

settings where MDR-TB and or HIV is

of lesser concern, especially in smear-

negative specimens (recognizing major

resource implications)

EXPECTED IMPACT

• A three-fold increase in the diagnosis

of patients with drug-resistant TB

• A doubling in the number of TB/HIV

cases diagnosed in areas with high

rates of TB and HIV (compared to

microscopy diagnosis)

2-The use of molecular line probe

assay for detection of resistance anti-

tuberculosis drugs

Genotypic (molecular) methods have

considerable advantages for scaling up

programmatic management and

surveillance of drug-resistant TB,

offering speed of diagnosis,

standardized testing, potential for high

through-put, and fewer requirements

for laboratory biosafety. Molecular line

probe assay (LPA) technology for

rapid detection of multi-drug resistant

tuberculosis (MDR-TB) was endorsed

by WHO in 2008.

New modality in TB diagnosis

10

Page 25: The real magnitude of MDR-TB in Iraq Introduction 1 …phd.iq/LionImages/PDFStore/(revised curriculum...1 survey (DRS) was conducted yet .With Tuberculosis in the world and in Iraq

25

References 1- Global TB control/WHO report

2000.

2- Global tuberculosis report 2012

/WHO 2012.

3- Global tuberculosis report 2009

/WHO 2009.

4- Implementing the WHO stop TB

strategy –A handbook for national

tuberculosis control programs-

WHO/HTM/TB/2008.401.

5- What is DOTS ? WHO / CDSCPC

/ TB / 99 ; 270.

6- You can stop TB ,EMRO , world

TB day 24 march 2000.

7- Stop TB at the source .WHO

report on TB epidemic , 1995.

8- Treatment of TB guideline for

national program ,WHO,97.

9- Fighting TB,WHO/TB/1995.

10- Fiona GTB is global emergency

BMJ ,1993.

11- Horne-N modern drug treatment

of TB oxford university

press,1992

12- Kochi.A.TB control is not what is

used to be ,the TB treatment

observed TB WHO,1996

13- Nadia AIT .Khalid and Donald ,

Enarson .TB a manual for medical

students , WHO,1999.

14- Croften , Horne , Miller. Clinical

TB, IUAT.1992

15- fact sheet- tuberculosis diagnostics

, Xpert MTB/RIF Test-WHO

February 2013

16- The use of molecular line probe

assay for the detection of

resistance to second – line anti –

tuberculosis drug ,expert group

meeting report :Geneva ;February

2013. WHO/HTM/TB/2013.01.


Recommended