Running Head: TUBERCULOSIS DIRECTLY OBSERVED THERAPY PROGRAM 1

Tuberculosis Directly Overserved Therapy, short-course Program

A Research Report Submitted to:

Professor Amanda V. Lachica
English Department
University of Santo Tomas

In Partial Fulfillment of the Course

Requirements in English 3 (Academic Writing)

by:
Domingo, Nica Victorina A.
Saturno, John Elcid M.
Yu, Lauren Therese C.

Nov. 9, 2015
Abstract
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Due to the high frequency of Tuberculosis cases here in the Philippines, the search for alternative

and effective medication has been needed. Studies revealed that the pathogen is becoming more

resistant to the conventional methods of medication in this country making Tuberculosis

prominent in terms of mortality rate. Thus, this study has been conducted to inform the people

about Tuberculosis including the latest and most effective way of combating it. The World Health

Organization released a procedure to treat the disease and has been made protocol for all cases of

Tuberculosis in the world including our country, referred to as (TB-DOTS) or Tuberculosis

Directly Observed Therapy, short-course. The procedure combines both medication and direct

one-to-one observation of the patient to ensure full recovery rather than false recoveries

manifested from conventional methods preventing the pathogen from acquiring drug resistance.

The protocol is both effective and affordable reducing the tendency for self-medication which

could induce false recovery causing drug resistance of the pathogen.

(Keywords: Tuberculosis Pathogen, Tuberculosis Directly Observed Therapy, short-course)

Chapter 1:
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INTRODUCTION

Historical background:

Tuberculosis is one of the most documented pathogenic disease in the world. Its existence

has proved to be a very strong indication of its prominent effect in humanity as mentioned all

throughout history. Since it would take a longer time for the certain manifestations of the body to

be confirmed as symptoms of Tuberculosis, many of the suspected patients neglect the severe

consequences of the disease if left untreated. Upon watching a documentary we realized that in

the Philippines alone, many Filipinos are not well-educated about the disease especially those

living in the urban areas, and once infected would resolve to self-medication that causes the

pathogen to be drug-resistant and become more difficult to kill. The World Health Organization

introduced a control procedure for the treatment of the disease, the Tuberculosis Directly

Observed Therapy, short-course (TB-DOTS). The treatment is available and affordable in our

country but our fellowmen needs to be educated more about the therapy and eliminate in their

minds that the disease is incurable.

Statement of the Problem:

This study deals with how Tuberculosis Directly Observed Therapy, short course is

performed. More specifically, it tries to answer the following questions.

1. How would Tuberculosis patients undergo TB-BOTS?

2. What are the different procedures done to different kinds of patients (i.e. person

infected with HIV)?

3. What is the indication of the completion of the program?

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Objectives of the Problem:

This library research aims:

1. to describe how Tuberculosis is manifested in the human body and how TB.
2. to describe the procedures of TB-DOTS.
3. to raise awareness that Tuberculosis is treatable.

Scope and Limitations of the study:

The scope of this research will include the background of Tuberculosis where the first

detection, manifested symptoms, and transmission of disease will be discussed. More elaborate

discussion about the pathogen Mycobacterium tuberculosis will also be tackled including its

morphology, growth and reproduction, and mutation leading to drug-resistance. The discussion

about the Tuberculosis Directly Observed Therapy, short-course (TB-DOTS) will also include

how our infected countrymen can enroll to the said program and the procedure and guidelines

given by the World Health Organization.

Importance of the Study:

Being well educated about an infectious disease is important for the infected person to

know the certain treatment one must undergo, medications to be taken, and precautions to be

observed thus lessening the possibility of transmitting the disease. Having an idea about TB-

DOTS will help alleviate the belief that Tuberculosis is incurable and refrain patients from self-

medicating that will make the pathogen drug-resistant.

Definition of Terms:

For better understanding the following terms are defined operationally:

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Chapter 2:
DISCUSSION

Tuberculosis (TB) is the sixth leading cause of morbidity and mortality in the Philippines;

the country is ninth out of the 22 highest TB-burden countries in the world and has one of the

highest burdens of multidrug-resistant TB. (wpro.who.int, 2013)

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This infectious disease is curable through Tuberculosis Directly Observed Therapy, short-

course (TB-DOTS). This therapy is a control strategy recommended by the World health

organization, and uses a patient-centered case management approach when treating persons with

active TB disease. Directly Observed Therapy means that a trained health care worker or other

designated individual (excluding a family member) provides the prescribed TB drugs and

watches the patient swallow every dose. (American Thoracic Society and Infectious Diseases

Society of America, 2003) According to WHO, The most cost-effective way to stop the spread

of TB in communities with a high incidence is by curing it. The best curative method for TB is

known as DOTS. (WHO factsheet (revised), 1996).

In the Philippines, under the National TB Control Program (NTP), one of the public

health programs being managed and coordinated by the Infectious Disease Office (IDO) of the

National Center for Disease Prevention and Control (NCDPC) of the Department of Health

(DOH), Tutok Gamutan or (DOTS) strategy for TB control has commenced in 1997 and

nationwide coverage was achieved in 2003. Due to the rising number of TB cases noted in the

country, the Philippine Health Insurance Corporation (PhilHealth), a government insurance,

reminds its members that the treatment for pediatric and adult tuberculosis is covered through is

outpatient Directly-Observed Treatment Short-course package. PhilHealth members with

confirmed TB cases may enroll in the TB-DOTS program through any of the more than 800

private and public health facilities nationwide (philhealth.gov.ph, 2012). According to PhilHealth

President and CEO Dr. Eduardo P. Banzon (2012), PhilHealth pays P4,000.00 for the entire six-

month treatment which includes diagnostic work-up, consultation services and drugs provided on

or after enrolment into the DOTS." Despite having free anti-TB medication various reasons have

been cited for the high mortality rate caused by Tuberculosis, this includes lower than expected
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use of the health centers and failures to complete treatment by the patients. 53% of the

population seeks care from private practitioners and end up paying for medications they could

obtain for free (Auer, 2000).

The prevention of Tuberculosis mainly depends on preventing exposure and infection

especially for those health workers who are at high risk for becoming infected during their duty.

For vulnerable populations such as young children (i.e., 0-4 years old) and people living with

HIV (PLHIV) who are already exposed or infected, the aim is preventing progression to TB

disease. Prevention of TB can be achieved through the following: TB infection control (TB IC),

universal use of BCG and isoniazid preventive therapy (IPT). (Manual of Procedures for the

National TB Control Program, 2013). TB infection control as a part of the general infection

control program is a three-level hierarchy of control measures designed to ensure prompt

detection of infectious patients, airborne precautions, and treatment of people who have

suspected or confirmed TB disease. (Centers for Disease Control and Prevention, 2012).

The three-level hierarchy includes the administrative controls, environmental controls, and the

use of respiratory protection control, with the managerial activities ensuring that these

interventions are implemented. The administrative controls are the first line of defense and the

most important level in the hierarchy of TB IC, it is the first priority regardless of the availability

of resources because it impacts the largest number of people. It is primarily intended to reduce

the risk of uninfected people who are exposed to people who have TB disease. The

environmental controls are the second line of defense which includes technologies for the

removal or inactivation of airborne infectious droplet nuclei. Cost-effective environmental

control measures that could be used at the DOTS facilities are natural ventilation and mixed-

mode mechanical ventilation such as use of fans together and opening the windows and door to
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improve natural ventilation. The last line of defense are the respiratory protection control, the use

of respiratory protection equipment can further reduce the risk for exposure of health care

workers.

Persons with suspected TB disease, in the lungs (pulmonary), experience coughing for

longer than 3 weeks, hemoptysis (coughing up blood), and chest pain. If TB disease is in other

parts of the body (extrapulmonary) such as the kidney, spine, and brain, symptoms will depend

on the area affected. Medical evaluation for TB includes medical history, physical examination

which can provide valuable information about the patients overall condition and other factors

that may affect how TB is treated, such as HIV infection or other illnesses, Mantoux tuberculin

skin test (TST) or the TB blood test can be used to test for M. tuberculosis infection. Additional

tests are required to confirm TB disease. The Mantoux tuberculin skin test is performed by

injecting a small amount of fluid called tuberculin into the skin in the lower part of the arm. The

test is read within 48 to 72 hours by a trained health care worker, who looks for a reaction

(induration) on the arm. The TB blood test measures the patients immune system reaction to M.

tuberculosis. A doctor may order for a chest x-ray, this may show white flakes or patches usually

in the upper part of the lungs. This may mean an active TB infection or a past infection. To

further evaluate the patient, a sputum test is requested. The doctor may ask the patient to submit

a sample of his/her sputum the mucus that comes up when you cough. The samples are then

tested for TB bacteria. However, this test isnt foolproof. Even if the person has TB, the sputum

test will only be positive in 50-percent of cases. (Ong, 2012) For all patients examined positive

of the disease, the initial M. tuberculosis isolate should be tested for drug resistance. It is crucial

to identify drug resistance as early as possible to ensure effective treatment. Drug susceptibility

patterns should be repeated for patients who do not respond adequately to treatment or who have
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positive culture results despite 3 months of therapy. Susceptibility results from laboratories

should be promptly reported to the primary health care provider and the state or local TB control

program.

Not everyone who is infected by the bacteria becomes sick. Two TB-related conditions

exists: latent TB infection and TB disease. Both latent TB infection and TB disease can be

treated. Person infected with latent TB have the TB bacteria in their body but does not look nor

feel sick and even their chest x-ray looks normal because the bacteria are not active and may be

kept dormant in their body for a long period time, even decades. They do not manifests the

symptoms, and they cannot spread TB bacteria to others. However, once the bacteria become

active in the body and multiply, the person will go from having latent TB infection to being sick

with TB disease. For this reason, people with diagnosed with latent TB infection are often

prescribed treatment to prevent them from developing TB disease. Treatment of latent TB

infection is essential for controlling and eliminating TB. Because there are less bacteria in a

person with latent TB infection, treatment is much easier. The medications used to treat latent TB

infection include Isoniazid (INH), Rifampin (RIF), Rifapentine (RPT). Certain groups of people

such as those with weakened immune systems are at very high risk of developing TB disease

once infected with the pathogen. The pathogen will become active (multiplying in the body) if

the immune system can't stop them from growing. When TB bacteria are active, this is called Tb

disease. TB disease will make a person sick and may be able to spread the bacteria to people with

whom they spend many hours. TB disease can be treated by taking several drugs for 6 to 9

months. Drugs are chosen with a stepwise selection process through five groups on the basis of

efficacy, safety, and cost. There are 10 drugs currently approved by the U.S. Food and Drug

Administration (FDA) for treating TB. Of the approved drugs, the first-line anti-TB agents that
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form the core of treatment regimens include: Isoniazid (INH), Rifampin (RIF) Ethambutol

(EMB) Pyrazinamide (PZA). Regimens for treating TB disease have an initial phase of 2 months,

followed by a choice of several options for the continuation phase of either 4 or 7 months (total

of 6 to 9 months for treatment).

Although basic TB regimens are broadly applicable, there are modifications that should

be made under special circumstances for the treatment to be efficient such as people with HIV

infection, drug resistance, pregnancy, or treatment of children.

Untreated TB disease represents a greater hazard to a pregnant woman and her fetus than

does its treatment. Because of the risk of TB to the fetus, treatment of TB in pregnant women

should be initiated whenever the probability of maternal disease is moderate to high. The initial

treatment regimen should consist of Isoniazid, Rifampin, and Ethambutol. Although all of these

drugs cross the placenta, they do not appear to have teratogenic effects. Streptomycin is the only

anti-TB drug documented to have harmful effects on the human fetus (congenital deafness) and

should not be used. Although detailed teratogenicity data are not available, Pyrazinamide can

probably be used safely during pregnancy and is recommended by the World Health

Organization (WHO) and the International Union Against Tuberculosis and Lung Disease

(IUATLD). If Pyrazinamide is not included in the initial treatment regimen, the minimum

duration of therapy is 9 months. Women taking anti-tuberculosis treatment can breastfeed

because only low levels of drugs are passed into the milk. However, levels are not high enough

to provide effective treatment for the baby. (American Thoracic Society, 2003)
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People who are the most vulnerable to infection are those who are already infected by

Human Immunodeficiency Virus (HIV) because of their weak immune system. They have a high

risk of progressing a latent TB to active TB. The approach to the treatment of tuberculosis in the

HIV-infected patient is complex and must address the patient's requirement for antiretroviral

therapy (ART), potential drug reactions, and complications related to the immune reconstitution

inflammatory syndrome HIV infection significantly increases the risk of progression from latent

to active TB disease. The CD4 cell count influences both the frequency and severity of active TB

disease. Active TB also negatively affects HIV disease. It may be associated with a higher HIV

viral load and more rapid progression of HIV disease. Active pulmonary or extrapulmonary TB

disease requires prompt initiation of TB treatment. The treatment of active TB disease in HIV-

infected patients should follow the general principles guiding treatment for individuals without

HIV. Treatment of drug-susceptible TB disease should include a standard regimen that consists

of Isoniazid (INH), a Rifamycin (Rifampin or Rifabutin), Pyrazinamide, and ethambutol given

for 2 months, followed by INH and a Rifamycin for 4 to 7 months. Certain areas of uncertainty

remain, including the regimen duration, dosage and frequency of administration of anti-TB

drugs, optimal timing of initiation of ART and optimal anti-TB drug combination for patients on

second line treatment.

Another vulnerable victim of the infectious pathogen are the children. TB disease in

children under 15 years of age (also called pediatric tuberculosis) is a public health problem of

special significance because it is a marker for recent transmission of TB. Also because infants

and young children are more likely than older children and adults to develop life-threatening

forms of TB disease (e.g., disseminated TB, TB meningitis). Among children, the greatest

numbers of TB cases are seen in children less than 5 years of age, and in adolescents older than
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10 years of age. However, unlike in most infected adults, children are less likely to spread TB

bacteria to others because the forms of TB disease most commonly seen in children are usually

less infectious than the forms seen in adults. A doctor may recommend hospitalization for the

initial evaluation and treatment of TB, especially if the child is a young infant, there are severe

drug reactions, and there are other diseases along with TB. However, most kids with tuberculosis

can be treated as outpatients and cared for at home. The treatment is usually in the form of oral

medications. Children are not little adults. Although management strategies are largely the same

with that of the adults, but dosing guidance and options leave a lot to be desired. The standard

regimen of drugs are also to be taken by the child but in a child-friendly formulation for young

children who are unable to swallow tablets. Ideally these should be in solid fixed-dose

combination (FDC) forms that are dispersible in liquids and can facilitate dosages across

different weight groups. The intermittent therapy will remain the backbone of treating pediatric

patients. However, among seriously ill admitted children or those with severe disseminated

disease/ neurotuberculosis, the likelihood of vomiting or non-tolerance of oral drugs is high in

the initial phase. Such patients should be given daily supervised therapy during their stay in the

hospital using daily drug dosages. After discharge they will be taken on thrice weekly DOT

regimen, with suitable modification to thrice weekly dosages. Because children are susceptible to

the disease a vaccine called BCG or bacille Calmette-Guerin, formulated to prevent TB disease.

BCG is used in many countries to prevent childhood TB disease. The BCG vaccine should only

be considered for very select persons who meet specific criteria and in consultation with a TB

doctor.

On the other hand, multidrug-resistant (MDR) and extensively drug-resistant (XDR)

tuberculosis are generally thought to have high mortality rates. Patients infected with that strain
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of Tuberculosis have the most difficult to treat case of Tb disease because the standard regimen

of drugs taken by the patients are not efficient enough in combating the bacteria due to

mutation. Along the first line of defense of high-dose isoniazid, pyrazinamide, and ethambutol

which are thought to as an adjunct for the treatment of MDR and XDR tuberculosis, the second

group is the fluoroquinolones, of which the first choice is high-dose levofloxacin. The third

group are the injectable drugs, which should be used in the following order: capreomycin,

kanamycin, and then amikacin. The fourth group are called the second-line drugs and should be

used in the following order: thioamides, cycloserine, and then aminosalicylic acid. The fifth

group includes drugs that are not very effective or for which there are sparse clinical data. Drugs

in group five should be used in the following order: clofazimine, amoxicillin with clavulanate,

linezolid, carbapenems, thioacetazone, and then clarithromycin. Since this kind of strain is

difficult to treat and there are lack of information about it, The World Health developed the Stop

TB Strategy and guidelines on how to prevent, control and treat MDR-TB by using available

data worldwide.

It is very important that people who have TB disease finish the medicine, treatment completion is

determined by the number of doses ingested over a given period of time, taking the drugs exactly

as prescribed. If they stop taking the drugs too soon, they can become sick again; if they do not

take the drugs correctly, the TB bacteria that are still alive may become resistant to those drugs.

TB that is resistant to drugs is harder and more expensive to treat.

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REFERENCES:
Vianzon R et al. The tuberculosis profile of the Philippines, 20032011: advancing
DOTS and beyond. Western Pacific Surveillance and Response Journal, 2013, 4(2).
doi:10.5365/wpsar.2012.3.4.022

CDC. Treatment of tuberculosis. American Thoracic Society, CDC, and Infectious

Diseases Society of America. MMWR 2003; 52 (No. RR-11).

Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents

MMWR 2009; 58: 1-166

Caminero JA1, Sotgiu G, Zumla A, Migliori GB. Best drug treatment for

multidrug-resistant and extensively drug-resistant tuberculosis. Lancet Infect

Dis. 2010 Sep;10(9):621-9. doi: 10.1016/S1473-3099(10)70139-0.