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Foreword

For decades now, tuberculosis (TB) has been a major public health hazard contributing to the
considerable loss of productive man-hours. Hence, controlling TB to a level where it is no longer a
public health problem is a priority under the Health Sector Reform Agenda. This, in turn, is envisioned
to contribute significantly to the poverty reduction efforts of the government.

Successful TB control depends largely on the capacity of various health care facilities to
administer TB management based on technically sound, evidence-based, and consistent policies and
procedures. Adopting standardized TB management protocols and guidelines facilitates effective program
implementation in all parts of the country. Hence, Executive Order No. 187, series of 2003, institutionalized
the Comprehensive and Unified Policy for Tuberculosis.

The National Tuberculosis Control Program (NTP) Manual of Procedures (MOP) is decidedly
a milestone in the implementation of standardized management protocols and guidelines for all health
care facilities in the country involved in TB cure and prevention. This revised version (4th edition) of the
MOP embodies new strategies and initiatives designed to contribute to national targets of 70-per-cent
case detection and 85-per-cent cure rate. Among these initiatives are: a) collaboration with key partners
through installation of Public-Private Mix DOTS (PPMD) units; b) expansion of DOTS services to cover
other health –related sectors like teachers and school personnel, the military, and those in prisons; c)
shift from single-dose to fixed-dose combination anti-TB drugs, which aims for improved treatment
compliance and better logistics management; d) adoption of a quality assurance system for more reliable
sputum microscopy; e) strengthening of TB Diagnostic Committees to support the management of less
infectious cases; and f) adoption of policy statements governing monitoring, supervision, and evaluation,
as well as advocacy activities on TB cure and prevention.

The MOP has undergone a series of revisions involving partners/implementers as external


reviewers and sources of critical technical and editorial inputs. The NTP is extremely grateful to all those
who contributed to the development and revision of the MOP, which aims to contribute to more effective
ways of implementing the NTP throughout the Philippines. For their technical expertise and financial
assistance in making this product a success, acknowledgment goes to the following: The Global Fund
to fight AIDS, Tuberculosis and Malaria (GFATM); Japan International Cooperation Agency (JICA);
Local Enhancement and Development for Health Project – Management Sciences for Health (LEAD-
MSH); Medicos Del Mundo (MDM); Philippine Coalition Against Tuberculosis (PhilCAT); Philippine
Tuberculosis Initiatives in the Private Sector (PhilTIPS); Tropical Disease Foundation, Incorporated
(TDFI); United States Agency for International Development (USAID); World Health Organization (WHO);
and World Vision Development Foundation, Incorporated (WVDFI).

We hope that the MOP will be a tool for unifying our efforts towards the attainment of our vision
of a TB-free Philippines.

HON. FRANCISCO T. DUQUE III, MD, MSc.


Secretary of Health

Department of Health December 2005


Republic of the Philippines

i
Credit Page

A publication of the Department of Health (DOH), Government of the Philippines, in cooperation with
the following local and international key stakeholders and partners:
Board of Advisers:

1. Dr. Myrna Cabotaje, NCDPC, DOH

2. Dr. Jaime Lagahid, IDO, DOH

3. Dr. Jennifer Ann Mendoza-WI, PhilCAT

Technical Working Group (TWG) Technical Review Panel (TRP)

Department of Health Department of Health

1. Dr. Anna Marie Celina Garfin, NCDPC 1. Dr. Rosalind Vianzon, NCDPC

2. Dr. Ernesto Bontuyan Jr., NCDPC 2. Ms. Cirila Negad, NCDPC

3. Ms. Agnes del Rosario, NCDPC 3. Ms. Arlene Rivera, NCDPC

4. Mr. Ferdinand La Puebla, NCDPC 4. Dr. Vivian Lofranco, LCP

5. Ms. Ellen Melia Castillo, NTRL 5. Dr. Nora Cruz, NTRL


6. Ms. Edna Nito, NCHP 6. Ms. Paz Rostrata, NTRL

Centers for Health Development Centers for Health Development

1. Dr. Lydia Rogando, CHD–Bicol 1. Dr. Sylvia Somontan, CHD–Caraga


2. Dr. Flor Elona, CHD–Eastern Visayas 2. Dr. Eloisa Segura, CHD–Davao
3. Dr. Willie Cabauatan, CHD–Cagayan Valley 3. Dr. Amelia Medina, CHD–NCR
4. Ms. Joy Tabotabo, CHD–Central Visayas 4. Dr. Edith Caloyloy, CHD–Western Visayas
5. Ms. Gemma Tan, CHD–Ilocos 5. Ms. Marilou Gecosala, CHD–Northern Mindanao
Local Government Units Local Government Units
1. Dr. Niela Jorvina, Laguna Provincial Health Office 1. Dr. Bernard Caspe, Iloilo City Health Office
2. Dr. Christina Giango, Cebu Provincial Health Office 2. Dr. Ma. Lourdes San Juan, Pasay City Health Office
3. Ms. Evangeline Rambuyon , Negros Provincial Health Office 3. Dr. Marian Isiderio, Eastern Samar Provincial Health Office
4. Ms. Letty Rivera, Batangas Provincial Health Office 4. Ms. Teresita Puente, Pasig City Health Office
Partners 5. Ms. Myla Espino, Pasig City Health Office
1. Dr. Michael Voniatis, WHO 6. Ms. May Fernando, Bulacan Provincial Health Office
2. Dr. Tomohiro Shirahama, JICA Partners
3. Dr. Arthur Lagos, JICA 1. Dr. Mariquita Mantala, LEAD for Health Project
4. Dr. Marilyn Gorra, PhilTIPS 2. Dr. Jubert Benedicto, PhilCAT
5. Dr. Charles Yu, PhilTIPS 3. Ms. Amelia Sarmiento, PhilCAT
6. Mr. Jose Ibarra Angeles, PhilTIPS 4. Mr. Albert Angelo Concepcion, PhilCAT
7. Ms. Elaine Umali, WVDFI 5. Dr. Maria Rubio, MDM

6. Dr. Jose Luis Portrero, MDM

7. Dr. Ma. Imelda Quelapio, TDFI/GFATM

8. Dr. Melvin Magno, WVDFI

Publications Staff

1. Dr. Ma. Theresa Velasco, Technical Editor

2. Ms. Laila Garcia, Assistant Technical Editor

3. Ms. Rose Gonzales, Creative Director

ii
Manual Outline

FOREWORD i
CREDIT PAGE ii
MANUAL OUTLINE iii
LIST OF ACRONYMS v
LIST OF TABLES viii
LIST OF FIGURES ix
GLOSSARY x

CHAPTER I INTRODUCTION
Prevalence of TB In the Country 1
History of TB Control in the Philippines 2
Vision, Mission, and Goal of the NTP 9
NTP Objectives and Strategies 9
Roles of Collaborating Agencies 11
Functions of Health Workers 13

CHAPTER II CASE FINDING


I. Objective 18
II. Definition of Terms 18
III. Policies 18
IV. Procedures 19
V. Quality Assurance for DSSM 27

CHAPTER III CASE HOLDING


I. Objective 28
II. Definition of Terms 28
III. Policies 31
IV. Procedures 35
V. Treatment Outcome 50
VI. Summary Guide 50

CHAPTER IV RECORDING AND REPORTING


I. Objective 53
II. Policies 53
III. NTP Recording Forms 54
IV. Persons Responsible for the Recording Forms 73
V. NTP Reporting Forms 74

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CHAPTER V LOGISTICS MANAGEMENT
I. Product Selection 82
II. Procurement 83
III. Distribution and Storage 83
IV. Rationale Use, Monitoring, and Evaluation 85

CHAPTER VI MONITORING, SUPERVISION, AND EVALUATION


I. Objective 90
II. Policies 91
III. Procedures 92
IV. Monitoring Forms 94

CHAPTER VII OVERVIEW OF THE HEALTH PROMOTION


PROGRAM FOR THE NTP 101

ANNEXES
1 Guidelines for Implementing Tuberculosis 105
Control Program in Children (AO No. 178 Series of 2004)
2 Sample Packages of FDCs & SDFs 115
3 The TB Diagnostic Committee (TBDC) 117

iv
List of Acronyms

AFB Acid Fast Bacilli

BCG Bacille Calmette-Guerin

BFAD Bureau of Food and Drug

BHS Barangay Health Station

BHW Barangay Health Worker

CDR Case Detection Rate

CHD Center for Health Development

CHO City Health Officer or City Health Office

CIDA Canadian International Development Agency

CRUSH TB Collaboration in Rural and Urban Sites to Halt Tuberculosis

CUP Comprehensive and Unified Policy for TB Control in the Philippines

CXR Chest X-ray

DILG Department of Interior and Local Government

DOH Department of Health

DOT Directly Observed Treatment

DOTS Directly Observed Treatment, Short Course

DRS Drug Resistance Survey

DSSM Direct Sputum Smear Microscopy

E Ethambutol

EP Extra pulmonary Tuberculosis

EPI Expanded Program for Immunization

EQA External Quality Assessment

FDC Fixed Dose Combination

FEFO First Expiry, First Out

FHSIS Field Health Services Information System

FM Family Member

GDF Global Drug Facility

GFATM Global Fund to Fight AIDS, Tuberculosis, and Malaria

H Isoniazid

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HSRA Health Sector Reform Agenda

IEC Information, Education and Communication

JICA Japan International Cooperation Agency

LCE Local Chief Executive

LCP Lung Center of the Philippines

LGU Local Government Unit

MC Memorandum Circular

MDR-TB Multiple Drug Resistant TB

MHC Main Health Center

MHO Municipal Health Officer

MOP Manual of Procedures

MT Medical Technologist

NCC-PPMD National Coordinating Committee for PPMD

NCDPC National Center for Disease Prevention and Control

NCHP National Center for Health Promotion

NGO Non-Government Organization

NHIP National Health Insurance Program

NIT National Institute of Tuberculosis

NPS National TB Prevalence Survey

NTP National Tuberculosis Control Program

NTRL National Tuberculosis Reference Laboratory

OIF Oil Immersion Field

PAS Para-Amino Salicylate

PCCP Philippine College of Chest Physicians

PD Presidential Decree

PhilCAT Philippine Coalition Against Tuberculosis

PHO Provincial Health Office

PMA Philippine Medical Association

PPMD Public-Private Mix DOTS

PSMID Philippine Society for Microbiology and Infectious Disease

PTB Pulmonary Tuberculosis

PTSI Philippine Tuberculosis Society, Inc.

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QA Quality Assurance

QC Quality Control

QI Quality Improvement

R Rifampicin

RA Republic Act

RAD Return After Default

RCC-PPMD Regional Coordinating Committee for PPMD

RHM Rural Health Midwife

RHU Rural Health Unit

S Streptomycin

SCC Short Course Chemotherapy

SDF Single Drug Formulation

TB Tuberculosis

TBCS TB Control Service

TBDC Tuberculosis Diagnostic Committee

TCL Target Client List

UNICEF United Nations Children’s Fund

USAID United States Agency for International Development

UST University of Santo Tomas

WB World Bank

WHO World Health Organization

WPRO Western Pacific Regional Office

Z Pyrazinamide

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List of Tables

Table 1.1 Comparative Data between 1981-1983 NPS and 1997 NPS

Table 3.1 Classification of TB Cases

Table 3.2 Types of TB Cases

Table 3.3 Recommended Category of Treatment Regimen

Table 3.4 Treatment Regimen for Categories I & III: 2HRZE/4HR (FDC)

Table 3.5 Treatment Regimen for Category II: 2HRZES/HRZE/5HRE (FDC)

Table 3.6 Treatment Regimen for Categories I & III: 2HRZE/4HR (SDF)

Table 3.7 Treatment Regimen for Category II: 2HRZES/HRZE/5HRE (SDF)

Table 3.8 Drug Dosage per KG Body Weight

Table 3.9 Schedule of DSSM Follow-up for Categories I and III

Table 3.9.a Schedule of DSSM Follow-up for Category II

Table 3.10 Treatment Modifications for New PTB Smear-Positive Cases Based on the Results
of DSSM Follow-up for Category I Treatment Regimen Without Extension

Table 3.10.a Treatment Modifications for New PTB Smear-Positive Cases Based on Results of
DSSM Follow-up for Category I Treatment Regimen With Extension

Table 3.10.b Treatment Modifications for PTB Smear-Positive Cases Based on the Results of DSSM
Follow-up for Category II Treatment Regimen Without Extension

Table 3.10.c Treatment Modifications for PTB Smear-Positive Cases Based on DSSM Follow-up
Results for Category II Treatment Regimen With Extension

Table 3.11 Guide in Managing Adverse Reactions to Anti-TB Drugs

Table 3.12 Treatment Modifications for New Smear-Positive Cases Who Interrupted Treatment

Table 3.12.a Treatment Modifications for Relapse and Treatment Failure Cases Who Interrupted
Treatment
Table 4.1 Persons Responsible for the Recording Forms

Table 5.1 Computation for Quarterly Drug Requirement for Stop TB Kits

Table 5.2 Computation for Quarterly FDC BP Drug Requirement

Table 5.3.a Computation for Quarterly SDF BP Drug Requirement

Table 5.3.b Computation for Quarterly SDF Tablets Drug Requirement

Table 5.4 Computation for Annual Estimated Supplies for DSSM

Table 5.5 Computation for Annual Estimated Recording and Reporting Forms

Table 6.1 Program Indicators

Table 7.1 Health Promotion Activities for Addressig Various Tasks

viii
List of Figures

Figure 1.1 Flow of NTP Activities

Figure 2.1 Flow Chart for the Diagnosis of Pulmonary TB

Figure 2.2 Flow Chart for the Diagnosis of Smear-Negative Pulmonary TB

Figure 2.3 Guide to Case Finding

Figure 2.4 Guide to Diagnosis and Initiation of Treatment

Figure 3.1 Category I Treatment Modification Based on DSSM Follow-up Results

Figure 3.2 Category II Treatment Modification Based on DSSM Follow-up Results

Figure 3.3 Category III Treatment Modification Based on DSSM Follow-up Results

Figure 3.4 Guide to Case Holding

Figure 3.5 Guide to Ensuring Treatment

Figure 5.1 Anti-TB Drug Management Cycle

Figure 6.1 Flow of Reporting

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Glossary

Active Case Finding Purposive effort by a health worker to find TB cases from among TB
symptomatics in the community who do not consult in a DOTS facility

Advocacy Communicating with other people to gain their support for an issue
and influence their behavior in a specified way

Case Finding An activity to discover or find TB cases

Case Holding An activity to treat TB cases through proper treatment regimen and
health education

Community Organizing It is a continuous and sustained process of educating the people for
them to understand and develop their critical consciousness of their
existing conditions. It entails organizing the people to work collectively
and efficiently on their immediate and long-term problems and
mobilizing people to develop their capability and readiness to respond
to and take action on their immediate/long-term needs.

Cure Rate Number of new smear-positive pulmonary TB cases registered in a


specified period who were cured divided by the total number of new
smear-positive pulmonary TB cases registered in the same period
multiplied by 100.

DOT Directly Observed Treatment [A trained DOTS facility worker (or


treatment partner) personally observes the smear-positive patient
take anti-TB medicines everyday during the whole course of treatment.]

DOTS Directly Observed Treatment Short-Course (A comprehensive strategy


to control TB). The five components of DOTS are:
1. Government commitment to ensuring sustained, comprehensive
TB control activities;
2. Case detection by DSSM among symptomatic patients self-
reporting to health services (passive case finding);
3. Standard short-course chemotherapy using regimens of six to
eight months, for at least all confirmed smear-positive
cases; complete drug taking through DOT supervised by DOTS
facility workers during the whole course of treatment for all smear-
positive cases;
4. A regular, uninterrupted supply of all essential anti-tuberculosis
drugs and other materials; and
5. A standard recording and reporting system that allows assessment
of case finding and treatment results for each patient and of the
tuberculosis control program’s overall performance.

DOTS Facility Any facility providing DOTS services; includes BHS/BHC, RHU/MHC,
PPMD unit, hospital-based DOTS facility, and DOTS implementing
units, e.g., prisons, schools, HMOs, military facilities, etc.

x
Health Education The part of health care that is concerned with promoting health
behavior (It helps people understand their behavior and how it affects
their health. It also encourages behavior that promotes health,
prevents illness, cures disease, and facilitates rehabilitation. It is
also a process by which individuals and groups of people learn to
behave in a manner conducive to promotion, maintenance, or
restoration of health.)

Health Promotion A process of enabling people to take action to improve health (It is
needed in order to build health public policy, create supportive
environment, develop personal skills, reorient health services, and
strengthen community action.)

Health-seeking Behavior What people do in order to maintain health and/or return to health,
ranging from individual behavior to collective behavior; includes what
is done and why it is done (It concerns specific steps taken; it is
sometimes called hierarchy of resort.)

Information, Education A process of generating information or release of ready-made


and Communication (IEC) information or prototypes, as well as distribution through all selected
channels of communication

MDR-TB A condition which is resistant against at least Isoniazid and Rifampicin

Networking A process of linking up with individuals, groups, and institutions on


the basis of a common objective

Passive Case Finding Finding a case of tuberculosis from among TB symptomatics who
present themselves at the DOTS facility

Physician Over-all in charge of running and operating the DOTS facility for the
private-initiated PPMD; includes rural health physicians, municipal
health officers, and hospital-based physicians

Political Commitment The act of pledging or giving an obligation among Local Chief
Executives, such as Governors, Mayors, and other government
officials

PPMD Coordinator Person responsible for coordinating DOTS activities for the private-
initiated PPMD

Private-Initiated PPMD Private facility, with private referring physicians, providing DOTS
services

Public-Initiated PPMD Public facility, with private referring physicians, providing DOTS
services

Sectoral Support Groups of people who provide support or sustain one another by
discussing common problems, such as tuberculosis, alcoholism, etc.

Smear-Negative When a DSSM has all three negative results

Smear-Positive When a DSSM has at least two positive results

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Social Marketing An adaptation of commercial marketing, sales concepts, and techniques
to the attainment of social goals (It seeks to make health-related
information products easily available and affordable to low-income
populations and those at risk while promoting the adoption of healthy
behavior.)

Social Mobilization A process of engaging people in action, redirecting existing or creating


new resources to achieve a society’s or a community’s social goals (It
implies wide-scale participation. It is also a process of bringing together
all feasible and practical inter-sectoral and social allies to raise people’s
awareness of the demand for a particular development program, to
assist in the delivery of resources and services, and to strengthen
community participation for sustainability and self-reliance.)

Sputum Microscopy for DSSM done for TB symptomatics to establish a diagnosis of TB (Three
Diagnosis sputum specimens should be collected.)

Sputum Microscopy for DSSM done to monitor the sputum status of a patient after treatment
Follow-up is initiated (Only one sputum specimen is collected, preferably the early
morning phlegm.)

Sputum Specimen Material from the respiratory tract brought out by coughing (This material
is used for DSSM.)

TB Network A brand name for DOH’s re-energized fight against TB (It is a systematic
and nationwide movement spearheaded by DOH to control TB. It is
considered the official communication handle of NTP.)

TB Symptomatic Any person exhibiting symptoms or signs suggestive of tuberculosis, in


particular cough of long duration (two or more weeks), and with or
without one or more of the following symptoms: fever; chest and/or back
pains not referable to any musculo-skeletal disprders; hemoptysis or
recurrent blood-streaked sputum; significant weight loss; and other
symptoms, such as sweating, fatigue, body malaise, and shortness of
breath

Tubercle Bacillus Mycobacterium tuberculosis that causes tuberculosis (It is acid-fast


stained with Ziel-Nielsen staining method.)

Note: The definitions in this section apply only to the terms’ usage in this Manual of Procedures.

xii
Introduction
Introduction

PREVALENCE OF TB IN THE COUNTRY

Tuberculosis (TB) has been a major public health problem in the Philippines for the past several
decades. Research has shown that while TB is curable, the disease adversely affects a large segment
of the population, particularly the economically productive sector. The causal agent, Mycobacterium
tuberculosis, is easily transmitted through airborne droplet nuclei when patients with pulmonary TB
cough or sneeze. If left untreated, TB could lead to a disabling condition and even death. Also, partial
treatment of cases may cause drug resistance that could lead to non-cure.

In 2002, TB was the sixth among the 10 leading causes of death and the 10 leading causes of
illness in the country. While the mortality rate from TB has decreased in the past 20 years (from 206
deaths per 100,000 population in 1982 to 36 deaths per 100,000 in 2002), still around 75 Filipinos die
of TB everyday. Globally, the Philippines is one of 22 countries identified by the World Health Organization
(WHO) as having a high burden of TB, ranking at ninth worldwide. It ranks third in terms of new smear-
positive TB notification rate in the WHO-Western Pacific Region (WHO Report 2003).

Comparative data gathered from two National Tuberculosis Prevalence Surveys (1981-1983
and 1997) reflect an encouraging trend in TB control in the country, although the changes have not been
dramatically significant (Table 1.1). The annual risk of TB infection, or the probability of a child getting
infected with TB within a year, declined very slightly in 15 years, from 2.5 per cent in 1982 to 2.3 per
cent in 1997. This measure is generally accepted as a sensitive indicator. The percentage of the
population afflicted with TB decreased from 6.6/1,000 in 1981-1983 to 3.1/1,000 in 1997. The prevalence
of culture-positive cases likewise declined very slightly from 8.6/1,000 to 8.1/1,000. Percentage of
radiographic findings suggestive of TB has remained the same at 4.2% in the 15 years between the two
surveys. The 1997 NPS also revealed that TB cases were about three times more common among
males than females and most of these cases were in the 30- to 59-year-old age bracket representing
the economically productive age group in the country.

Table 1.1. Comparative Data between 1981-1983 NPS and 1997 NPS

1981-1983 1997

1. Annual risk of TB infection 2.5% 2.3%

2. Prevalence of sputum smear-positive cases 6.6/1,000 3.1/1,000

3. Prevalence of culture-positive cases 8.6/1,000 8.1/1,000

4. Radiographic findings suggestive of TB 4.2% 4.2%

1
Introduction

HISTORY OF TB CONTROL IN THE PHILIPPINES

The Beginnings

TB control efforts in the Philippines reflect a continuous struggle to curb the spread of a curable
but highly infectious disease with great implications on the nation’s productivity.

The earliest organized initiative on TB control in the Philippines can be traced to a private
organization, the Philippine Islands Anti-Tuberculosis (precursor of the Philippine Tuberculosis Society,
Inc. or PTSI), way back in 1910. The Society put up a TB hospital in Quezon City; this was later re-named
Quezon Institute after President Manuel L. Quezon, who was afflicted with the disease. The period 1910-
1929 was largely devoted to case finding and in-patient services at a time when the only treatment
regimen available consisted of bed rest, isolation, or hospitalization.

The 1930s and 1940s witnessed a more organized approach to TB control in the wake of the
increasing incidence of TB cases in the country. The TB Commission under the Philippine Health Service
was established in 1932 through Republic Act (RA) 3743. The Bureau of Health took over the powers
and duties of the TB Commission in 1933. More laws were later enacted to bolster the anti-TB initiatives.
RA 4130 (Sweepstakes Law) established the Philippine Charity Sweepstakes Office (PCSO) primarily
to raise funds to support PTSI’s operations. Most notable among PCSO’s initial achievements were the
setting up of Chest Clinics in selected areas of the country and acceleration of in-patient activities.

From the ‘50s onward, dramatic strides in TB cure have been taken worldwide. Streptomycin
injection was first used as part of TB treatment in 1949. With assistance from the United Nations Children’s
Fund (UNICEF), the BCG vaccination program was introduced in the Philippines between 1951 and 1952
as a preventive measure against TB. Triple therapy, consisting of the anti-TB drugs Isoniazid (INH), Para-
amino salicylate (PAS), and streptomycin, was initiated in 1954.

Organizational changes to step up the TB control program were also effected in the ‘50s and
‘60s. In 1950, the TB Commission evolved into the Division of Tuberculosis under the supervision of the
Secretary of Health. The Division in turn established the TB Center at the DOH Compound and collaborated
with the TB Ward of San Lazaro Hospital. The move allowed for expanded services, which included chest
x-ray, sputum and bronchial washing examinations, and case holding. Treatment at that time consisted
of streptomycin injection plus oral PAS tablets.

Congress passed RA 1136 (Tuberculosis Law) in 1954. This became the basis for the creation
of both the Division of Tuberculosis under an appointed Director and the National Tuberculosis Center
of the Philippines (NTCP) established at the DOH Compound. The NTP received a boost from RA 1136
with the provision of funds to support its operations.

The first ever TB prevalence survey, the Minglanilla Prevalence Survey, was conducted in 1964
in Cebu province. Survey results placed the prevalence of smear-positive cases at 4/1,000. During this
period, Quezon Institute was operating at its largest bed capacity at 1,350 beds.

2
Introduction
Expansion of the TB Control Program

The late ‘60s through to the mid-‘70s witnessed a vigorous nationwide expansion of the TB
program through accelerated and expanded control activities at the rural health units (RHUs), which
were established under RA 1086. The strengthened RHUs increasingly took on greater responsibility
for TB control efforts. PTSI launched the domiciliary care program in 1973, a move which eventually
led to the reduction of Quezon Institute’s bed capacity to 700. As the new TB Control Program was
implemented in all RHUs, the admissions at Quezon Institute began to be limited only to the seriously
ill cases.

It was also in 1973 that the Philippine College of Chest Physicians (PCCP) was formed as an
accredited non-government organization (NGO) society of the Philippine Medical Association (PMA)
with TB as one of its initial primary concerns. The partnership between DOH and PTSI was intensified
as the two organizations defined, complemented, and supported each other’s roles in TB control. The
new thrust emphasized the following: 1) importance of BCG vaccination; 2) case finding through sputum
microscopy; and 3) case holding/treatment through domiciliary means.

The partnership likewise paved the way for the establishment of the National Institute of
Tuberculosis (NIT) in 1976, with support from WHO and UNICEF. NIT focused on human resource
development, in the process carrying out operational researches and providing training to local and
foreign health workers on TB control using the primary health care approach. The year was also
highlighted by the issuance of a Presidential Decree (PD) requiring compulsory BCG vaccination, which
became a prime component of the Expanded Program for Immunization (EPI). Two years later, in 1978,
PTSI adopted the NTP policies and guidelines in its catchment areas.

Nearly two decades after the Minglanilla survey, NIT conducted the first National TB Prevalence
Survey (NPS) in 1982-1983, with assistance from WHO and UNICEF. Another significant development
during this period was the establishment of the Lung Center of the Philippines (LCP) as a tertiary hospital.
LCP became a referral center for pulmonary cases, including TB.

Contemporary Milestones

The ‘80s through to the ‘90s and the beginning years of the new millennium witnessed the
implementation of significant organizational and technical strategies that further strengthened TB control
efforts in the Philippines. This was also the time when the NTP Manual of Procedures was developed
and revised.

3
Introduction

Organizational Strategies

The reorganization of the Department of Health after the People Power revolution in 1986,
through Executive Order 119, paved the way for the establishment of the TB Control Service (TBCS)
under the Office for Public Health Services. A year later, the Strengthened National TB Control Program
was launched. Under this program, the TBCS was given a P200-million budget for drugs.

The NTP got a big boost in 1990 with the financial and technical support from the Italian
government and World Bank (WB) under the five-year Philippine Health Development Project.

In the early 1990s, the Local Government Code of 1991 paved the way for the devolution of
health services, including delivery of TB services, from DOH to the LGUs. While DOH remained at the
helm of policy development, regulation, and provision of technical and financial assistance, the LGUs
managed the TB program and delivered their services to their constituents through the RHUs and the
Barangay Health Stations (BHSs).

A showcase of this new health service delivery paradigm was the TB control project in Cebu.
The Cebu project, with technical and financial support from JICA, tested the WHO-recommended policies
and guidelines, improved laboratory facilities with the establishment of the Regional TB Laboratory in
Cebu City and upgrading of microscopy centers, and systematized TB data collection and recording.

A council created in 1993 by PCCP to act as its working arm for TB successfully released in
1994 a set of algorithms on the diagnosis and treatment of TB. An external evaluation of the NTP done
in 1993 noted that while case-finding activities improved tremendously, problems in case holding persisted.
In 1995, the TBCS issued through Administrative Order No. 1-A series of 1995 the revised policies and
guidelines on the diagnosis and management of TB which, in essence, adopted the WHO-recommended
policies. The thrust adopted by NTP was to improve case holding activities.

The forging of partnerships and active interactions among the various sectors engaged in the
fight against TB became more evident in the ‘90s. The Philippine Coalition Against Tuberculosis (PhilCAT)
was organized in 1994 to serve as coordinating body for the various government and non-government
agencies, private groups, academe, and other concerned institutions involved in TB control. The
organizations that banded to form PhilCAT include PCCP, DOH, Philippine Society for Microbiology and
Infectious Disease (PSMID), PTSI, Cure TB, and the American College of Chest Physicians-Philippine
Chapter.

The joint advocacy of these organizations was largely responsible for the issuance of Proclamation
No. 840 issued by the President of the Philippines in 1996. The proclamation declared August 19 of
every year as the National TB Day. March 24, on the other hand, is observed as World TB Day. On both
occasions, DOH, in collaboration with PhilCAT and other partners, conducts activities that would draw
public attention to the organized fight against TB.

4
Introduction
In September 1998, the NTP became one of the DOH flagship programs. Memorandum Circular
(MC) No. 98-155 issued by the President, then concurrent secretary of the Department of Interior and
Local Government (DILG), pronounced the TB Control Program as the highest priority health program
of the LGUs and prescribed the DOTS strategy.

The Health Sector Reform Agenda (HSRA) adopted by DOH in 1999 made the National TB
Control Program one of the top priorities among the public health programs. The organizational reforms
under the HSRA led to the clustering of various public health programs, merging of offices, and significant
reduction in manpower, all designed to improve delivery of health services. The following specific
objectives of the HSRA were likewise seen to impact positively on the TB sector:

• To secure funding for priority public health programs;


• To promote the development of local health systems and to ensure their effective performance;
• To provide fiscal autonomy to government hospitals;
• To strengthen the capacities of health regulatory agencies; and
• To expand the coverage of the National Health Insurance Program (NHIP).

Technical Strategies
In 1986, a new treatment regimen was introduced in the National TB Control Program -- the
Short-Course Chemotherapy (SCC), which highlighted use of Rifampicin, 2HRZ/4HR. During this period,
a fourth drug – streptomycin or ethambutol – was also being used for the intensive phase of treatment
regimen at the Quezon Institute for confined or in-patients. The SCC was adopted nationwide in 1987.
To ensure treatment compliance, the various drugs were packaged in blister-packs, an innovative strategy
that was later adopted by neighboring countries.

Over the years, greater compliance with the NTP through a standard national policy to guide
all stakeholders has been perceived as a pressing need. The Comprehensive and Unified Policy (CUP)
for Tuberculosis Control in the Philippines was developed jointly by DOH and PhilCAT in 2003. As
specified in Executive Order No. 187 series of 2003, the CUP is an instrument to harmonize and unify
TB control efforts in the Philippines in the public and private sectors. The CUP, among other provisions,
emphasizes the adoption of the NTP’s DOTS (Directly Observed Treatment, Short Course) strategy.

Implementation of the DOTS strategy goes back to the mid-1990s when an intensified national
campaign to increase awareness about TB and to mobilize support for its prevention and control was
launched. In 1995, the TB Clinic of the University of Santo Tomas (UST) initiated the use of DOTS in
managing its out-patient TB cases. DOH piloted the DOTS strategy in three areas in 1996 through the
CRUSH TB (Collaboration in Rural and Urban Sites to Halt Tuberculosis) project. DOTS was pilot-tested
in Iloilo City, Antique, and Batangas. Results from this project became the basis for expansion of the
new NTP to other areas and made possible the subsequent nationwide implementation of DOTS.

5
Introduction

The NTP officially adopted DOTS strategy with the issuance of Administrative Order No. 24
series of 1996. DOTS implementation hinges on five components: 1) political commitment; 2) diagnosis
by sputum microscopy; 3) Directly Observed Treatment (DOT), i.e., supervised treatment; 4) uninterrupted
drug supply; and 5) standardized recording and reporting.

DOTS was subsequently replicated in 30 areas in 1997-1998 and in all public-sector health
facilities in the country by 2001. DOTS expansion was facilitated by the active participation of LGUs,
the implementation of DOTS with BHWs as treatment partners, and the support from various international
agencies, such as WHO, WB, JICA, World Vision-Canadian International Development Agency (CIDA),
Australian Aid (AusAID), and Medicos del Mundo. It has also gained access to international resources,
such as the Global Drug Facility (GDF) and Global Fund on AIDS, TB and Malaria (GFATM), to augment
supply of anti-TB drugs in the country.

The second NPS was conducted in 1997. In 1999, a new consensus on TB diagnosis, treatment,
and control was forged through a consultative process coordinated by PSMID, PCCP, and DOH under
the auspices of PhilCAT.

Initiatives to strengthen the NTP included delivery of quality DOTS services through expansion
of DOTS implementation in all government health facilities. The National TB Reference Laboratory
(NTRL) was established in 2002 to improve quality assurance of microscopy through the established
network of microscopy facilities. It is also spearheading the national drug resistance survey (DRS).

The NTRL also spearheads the implementation of the External Quality Assessment (EQA)
nationwide. The EQA refers to a system of periodic independent measurement of performance through
collaboration with another competent laboratory; it aims to maintain high quality results from the microscopy
centers.

To improve the quality of diagnosis among sputum smear-negatives with chest x-ray findings
suggestive of PTB, the NTP initiated the creation of TB Diagnostic Committees. The TBDCs are
established at the provincial and city levels to review the sputum smear-negatives with chest x-ray
findings suggestive of PTB. The TBDC is chaired by the NTP medical coordinator, with members from
both the public and private sectors. TB experts, who represent various disciplines, also sit on the
committee. The TBDC evaluates, by consensus, the appropriate recommendations for quality patient
management. (Refer to Annex 3 for more information on the TBDC.)

By the end of 2002, public sector DOTS coverage has reached almost 100 per cent. Despite
this achievement, case detection rate (CDR) has remained below the 70-per-cent target. It was learned
from the 1997 NPS and other local studies that a significant number of TB cases sought care from the
private sector. In this context and within the DOTS expansion strategy, DOH adopted in 2003 the national
strategy of Public-Private Mix DOTS (PPMD).

6
Introduction
The PPMD is a strategy designed to increase case detection and to synchronize the management
of TB both in the public and private sectors. A PPMD unit can be public- or private-initiated depending
on where DOTS service provision is offered. In a public-initiated PPMD unit, DOTS services are centered
in a public DOTS facility with the private physicians referring patients for services. In a private-initiated
PPMD, the operations and management of DOTS services are centered on a privately owned and
managed DOTS facility. Whether public- or private-initiated, PPMD units implement DOTS in consonance
with the approved operational policies, standards, and technical guidelines of the NTP (Refer to
Operational Guidelines for Public—Private Mix DOTS in the Philippines, DOH and PhilCAT, 2004).

With PhilCATS’ support, the strategy was implemented to further mobilize private sector
physicians, professional societies and academicians, and other NGOs. In addition, additional resources
were secured for PPMD implementation through international donors.

Certification of DOTS facilities is an initiative to ensure that quality DOTS is implemented in


both public and private facilities. Guided by the Sentrong Sigla framework, it provides an assurance to
health seekers from the public and private sectors that a TB DOTS Center is capable of providing safe
and effective DOTS services. Moreover, certification ensures standardization of the provision of DOTS
services through a uniform set of standards. DOTS certification is a prerequisite to PhilHealth accreditation
and a means for the facility to avail itself of the PhilHealth TB outpatient benefit package.

In 2003, the NTP also started the shift from single dose formulation (SDF) to fixed dose
combination (FDC) drugs. This simplifies treatment, prevents development of drug resistance, and
ensures regular and complete drug delivery to DOTS centers. The NTP is also upgrading the various
CHD TB Reference Centers to improve its microscopy component.

Another milestone in the NTP, DOTCh (DOT in Children), was piloted in three areas between
2002 and 2005. The pilot phase paved the way for testing the guidelines developed by the Task Force
for TB in Children composed of experts from the public and private sectors. (Details about the strategy
may be found in Annex 1: Administrative Order 178).

7
Introduction

Development of the NTP Manual of Procedures

The NTP Manual of Procedures (MOP) is the basis for NTP implementation in all DOTS facilities.

Early development of the NTP Manual of Procedures dates back from 1969 however, the first
NTP Manual of Procedures (MOP) was developed in 1980. This MOP highlighted the use of sputum
microscopy as the primary diagnosis tool and the introduction of the Standard Drug Regimen for TB
treatment.

In 1988, the first MOP was revised. This 2nd edition presented the results of the 1981- 1983
First National TB Prevalence Survey (NPS). This also marked the adoption of the Short Course
Chemotherapy (SCC) for the management of TB cases under the NTP.

In 1997, the Technical Guidelines of the New TB Control Program was developed by the
Department of Health (DOH), in collaboration with DOH-JICA (Japan International Cooperation Agency)
Public Health Development Project and the WHO Western Pacific Regional Office (WPRO), in accordance
to the recommendations from the external evaluation conducted by WHO in 1993. This document
emphasized on D.O.T.S. (Directly Observed Treatment-Short Course) or “Tutok Gamutan” as the NTP’s
core framework for a nationwide TB control strategy. Subsequently, the start of rapid expansion of DOTS
in the country in 1997 embodied, as well, the implementation of this material/document.

The NTP Manual of Procedures (MOP) 3rd edition was written in 2001. The change from the
previous Technical Guidelines reflected that the publication was useful, not only for training , but also
in providing instructions or procedures to all health personnels in their delivery of TB services. This MOP
also served as a vital tool in the orientation/training of the private sector and other government agencies
in their implementation of NTP-DOTS.

In 2004, the Department of Health initiated the fourth revision of the MOP in the light of current
initiatives and policy changes in the NTP. These initiatives included the use of fixed dose combination
anti-TB drugs, EQA, adoption of the Public-Private Mix DOTS, strengthening of the TB Diagnostic
Committees, DOTS facility certification and accreditation, and development of the health promotion plan
specific to TB. Thus, with all these developments, it is but rational for the NTP to recast the MOP into
its current presentation.

8
Introduction
VISION, MISSION, AND GOAL OF THE NTP

Vision: A country where TB is no longer a public health problem

Mission: Ensure that TB DOTS services are available, accessible, and affordable to the communities
in collaboration with the LGUs and other partners

Goal: To reduce prevalence and mortality from TB by half by the year 2015 (Millennium
Development Goals)

TARGETS:
1. Cure at least 85 per cent of the new sputum smear-positive TB cases discovered
2. Detect at least 70 per cent of the estimated new sputum smear-positive TB cases

NTP OBJECTIVES AND STRATEGIES

The NTP’s four-pronged set of objectives calls for improvement of access to and quality of
services, enhancement of patients’ health-seeking behavior, sustainability of support for TB control
activities, and strengthening management of TB control services at all levels.

Objective A:
Improve access to and quality of services provided to TB patients, TB
symptomatics, and communities by health care facilities and providers
Strategies:
1. Enhance quality of TB diagnosis.
• Adopt quality assurance system for direct sputum smear examination, including external
quality assurance.
• Establish more TB Diagnostic Committees and expand their functions to include TB in
children
• Strengthen the network of quality laboratory services in accordance with NTRL
roles/functions.
2. Ensure TB patients’ treatment compliance.
• Implement an efficient drug supply management system.
• Adopt directly observed treatment (DOT) through treatment partners.
3. Ensure public and private health care providers’ adherence to the implementation of national
standards of care for TB patients.
• Establish and sustain public-private mix DOTS, including the public-public mix DOTS.
• Expand hospital-based DOTS.
• Advocate for the widespread adoption of a comprehensive and unified policy on TB.

9
Introduction

4. Improve access to services through innovative service delivery mechanisms for patients living in
challenging areas (geographically isolated communities, with peace and order problem, culturally-
different, and those in institutions like prisons).

Objective B:
Enhance the health-seeking behavior on TB by communities, especially the TB symptomatics
Strategies:
1. Develop effective, appropriate, and culturally-responsive IEC/ communication materials.
2. Organize barangay advocacy groups.

Objective C:
Increase and sustain support and financing for TB control activities
Strategies:
1. Facilitate implementation of TB-DOTS facilities certification and accreditation.
2. Build TB coalitions among different sectors.
3. Advocate for counterpart input from local government units.
4. Mobilize/extend other resources to address program limitations.

Objective D:
Strengthen management (technical and operational) of TB control services at all levels.
Strategies:
1. Enhance managerial capability of all NTP program managers at all levels.
2. Establish an efficient data management system for both public and private sectors.
3. Implement a standardized recording and reporting system.
4. Conduct regular monitoring and evaluation at all levels.
5. Advocate for political support through effective local governance.

10
Introduction
ROLES OF COLLABORATING AGENCIES

Department of Health
1. Formulate plans, policies, and standards.
2. Advocate for political commitment and awareness of TB control in the community.
3. Oversee program implementation in coordination with the LGUs.
4. Provide logistics assistance in terms of:
• Anti-TB drugs;
• Laboratory supplies;
• Prototypes of educational materials; and
• NTP recording and reporting forms.
5. Provide technical assistance, including training of LGU staff.
6. Monitor and evaluate regularly NTP activities, including Quality Assurance System and TBDC
implementation/operation.
7. Collate and analyze data from all reports and feedback findings and recommendations to LGU staff
concerned.
8. Collaborate with PhilCAT, NGOs, and the private sector to promote and implement the PPMD
strategy.
9. Initiate, through the CHDs, DOTS certification at the regional level.
10. Implement hospital-based DOTS for DOH-retained hospitals.
11. Together with the National Center for Health Promotion, orchestrate the development of
information/education/communication (IEC) materials.

International Partners
1. Provide technical assistance in the development or revision of policies, guidelines and standards.
2. Provide financial support to augment the fund gap of the NTP.
3. Participate in key activities of the NTP such as monitoring and evaluation.
4. Participate as technical advisors in the existing organizational structures of the NTP as necessary.

Local Government Units (LGUs)


1. Develop local policies and work for passage of resolutions on program implementation.
2. Develop a local plan on TB control, in consultation with DOH/CHD and other stakeholders.
3. Designate a Provincial/City Medical NTP Coordinator and/or other staff, such as nurses and medical
technologists.
4. Assign the NTP Medical and Nurse Coordinators as the Chairperson and Secretariat of the TBDC,
respectively.
5. Ensure the presence of physicians, nurses, midwives, and community volunteers at the municipal-
level facility.
6. Implement the plan and provide resources for the following:
• Monitoring/supervision/evaluation;
• Capability building;
• Drugs for Category 3 patients and SDF for patients who develop adverse drug reactions;
• Augmentation of laboratory supplies
• NTP reporting forms, referral forms, laboratory request forms;

11
Introduction

• TBDC activities;
• Local IEC materials;
• Manpower; and
• Quality assurance activities.
7. Evaluate and monitor implementation of plan.
8. Implement hospital-based DOTS and referral system in LGU hospitals.
9. Prepare, analyze, and submit quarterly reports.
10. Implement External Quality Assurance for laboratory.
11. Plan, initiate, and implement PPMD activities in accordance with the National Strategy on PPMD.

PhilCAT and Other Private Partners


1. Participate in the formulation of plans, policies, guidelines, and standards.
2. Advocate DOTS in the private sector.
3. Participate in the initiation and implementation of PPMD through the following activities:
• Advocacy;
• Training;
• Monitoring and evaluation;
• Development of advocacy materials; and
• Operations research.
4. Assist in mobilization and management of resources, including human resources, in the
establishment of PPMD.
5. Participate in certification of private DOTS facilities.

Multi-sectoral Agencies
1. National Coordinating Committee for PPMD (NCC-PPMD)
The function of the NCC-PPMD is to discuss and resolve administrative and technical issues related
to PPMD implementation, in cooperation with the RCC-PPMD. These involve:
a. Policy development for Implementation of PPMD;
b. Technical advice to the RCC-PPMD;
c. Monitoring and supervision of PPMD units; and
d. Ensuring availability, adequacy, and regularity of drug supply.

2. Regional Coordinating Committee for PPMD (RCC-PPMD)


The function of the RCC-PPMD, in coordination with the National Coordinating Committee (NCC-
PPMD), is to discuss and resolve managerial and technical issues related to launching and
implementing PPMD units at the regional level. These involve:
a. Technical advice to PPMD Units;
b. Trainings and advocacy activities;
c. Monitoring and supervision of PPMD units;
d. Ensuring availability, adequacy, and regularity of drug supply; and
e. Participation in DOTS certification.

12
Introduction
FUNCTIONS OF HEALTH WORKERS

DOH - NTP Staff


1. Develop national policies and plans.
2. Allocate budget for program implementation, including logistics.
3. Promote advocacy activities to foster political commitment and community awareness.
4. Exercise overall coordination among all NTP stakeholders.
5. Coordinate logistics management.
6. Provide NTP drugs and laboratory supplies.
7. Provide regular technical assistance to CHDs and LGUs, specifically in the areas of training,
monitoring, supervision, and evaluation.
8. Collate and analyze Quarterly Reports for planning and policy development.
9. Set standards for DOTS certification.
10. Conduct operational research on TB.

CHD NTP Coordinators (Physician/Nurse/MT)


1. Develop Work and Financial Plan at CHD level.
2. Promote advocacy activities to foster political commitment at the LGU level, as well as community
awareness.
3. Exercise overall coordination among all NTP stakeholders at the regional level.
4. Ensure adequacy of NTP drugs and supplies at the local level.
5. Provide regular technical assistance in the areas of training and planning.
6. Monitor and evaluate the implementation of NTP and recommend remedial measures to each LGU.
7. Collate and analyze NTP reports for planning purposes.
8. Submit regularly all consolidated Quarterly Reports to DOH (Central).

National TB Reference Laboratory (NTRL) Staff


1. Develop a national plan and policies for NTP laboratory management.
2. Develop and oversee implementation of QA system nationwide.
3. Carry out capability building measures in partnership with the CHDs.
4. Conduct monitoring and supervision in coordination with the CHDs.
5. Provide technical assistance to regional laboratories and to private laboratories engaged with the
NTP, e.g. PTSI.
6. Monitor drug resistance level.
7. Perform EQA to the microscopy centers of CHD-NCR 4A and 4B.

Regional TB Reference Laboratory


1. Oversee the implementation of the NTP’s External Quality Assurance System (EQA) on microscopy
at the regional level.
2. Provide technical assistance to the QA centers and microscopy centers.
3. Develop laboratory management plan on NTP to be integrated with the respective CHD NTP plans.
4. Conduct monitoring, supervision and evaluation of QA centers and microscopy centers on a regular
basis.

13
Introduction

Provincial/City NTP Coordinators (Physician/Nurse/MT)


1. Organize provincial planning, budgeting, and evaluation activities.
2. Implement advocacy activities to generate political commitment and community awareness.
3. Coordinate all NTP activities within the province/city.
4. Ensure availability and adequacy of NTP supplies. Manage drug and laboratory supply system.
5. Conduct trainings to ensure success of program implementation.
6. Monitor, supervise, and evaluate the implementation of NTP and QA and execute corrective or
remedial measures.
7. Collate and analyze quarterly reports of all DOTS facilities.
8. Consolidate all quarterly reports and submit these to CHD NTP coordinator.
9. Implement QA for quality laboratory work at all DOTS facilities.
10. Mobilize resources for TBDC and serve as chairperson/s of the TBDC (NTP medical coordinator).
Serve as secretariat (NTP nurse-coordinator).
11. Assess and refer chronic TB cases to higher level of care.

Physicians
1. Organize planning and evaluation of NTP activities in DOTS facilities.
2. Utilize available resources in the area for TB control activities.
3. Supervise health staff to ensure proper implementation of NTP policies, such as:
a. Identification, examination, and classification of TB cases;
b. Implementation of case holding mechanisms, such as DOT;
c. Analysis and submission of quarterly reports to the PHO/CHO;
d. Referral of TB cases to the TB Diagnostic Committee or other health facilities,if needed;
e. Ensuring proper procedure in the collection and transport of sputum specimen to microscopy
center; and
f. Ensuring adequacy of NTP drugs and supplies.
4. Attend to all diagnosed TB cases for clinical assessment, prescription of appropriate treatment
regimen, and management of adverse drug reactions, if any.
5. Provide continuous health education to all TB patients placed under treatment and encourage family
and community participation in TB control.
6. Coordinate with local chief executives (LCEs) to ensure funds and personnel for program
implementation.

Nurses
1. Together with other NTP staff / workers, manage the procedures for case-finding activities.
2. Open the NTP treatment card.
3. Assign and supervise a treatment partner for patient who will undergo DOTS.
4. Supervise rural health midwives (RHMs) to ensure proper implementation of DOTS.
5. Maintain and update the TB Register.
6. Facilitate requisition and distribution of drugs and other NTP supplies.
7. Provide continuous health education to all TB patients placed under treatment and encourage family
and community participation in TB control.

14
Introduction
8. In coordination with the physician, conduct training of health workers.
9. Prepare, analyze, and submit the quarterly reports to PHO/ CHO.

Midwives
1. Together with other health staff, implement the following case-finding activities:
a. Identify TB symptomatics and collect sputum specimens for microscopy.
b. Refer all diagnosed TB cases to physician or nurse for clinical evaluation and initiation of
treatment.
c. Maintain and update NTP Treatment Cards. (Use of TB Symptomatics Masterlist/ TB Symptomatics
Target Client List is optional).
2. Implement DOT with treatment partners.
a. Provide continuous health education to all TB patients placed under treatment and encourage
family and community participation in TB control activities.
b. Conduct regular consultation meetings (preferably weekly) with the assistance of the physician
or nurse during the course of treatment.
c. Collect sputum specimen for follow-up examination on the scheduled date/s during the
course of treatment.
d. Report and retrieve defaulters within two (2) days.
e. Refer patients with adverse drug reactions to physician for further evaluation and management.
f. Supervise and instruct community health volunteers who would be the treatment partners to
ensure proper implementation of DOT.

Medical Technologists or Microscopists*


1. Do DSSM for diagnosis and follow-up.
2. Inform the physician, nurse, or midwife of the DSSM result.
3. Maintain and update the NTP Laboratory Register.
4. Prepare quarterly report on laboratory activities and submit this to the physician or nurse.
5. Prepare and submit the quarterly laboratory supplies requirement to the physician.
6. Store sputum smears to allow sampling by the provincial or city NTP coordinator for blinded
re-checking as part of the External Quality Assessment.

* Microscopists are medical or paramedical regular staff of the DOTS facility that is trained to do basic sputum microscopy.

15
Introduction

Barangay Health Workers (BHWs) and other Community Health Volunteers


Barangay Health Workers (BHWs) and other community health volunteers are key players in the
implementation of DOTS.
1. Refer TB symptomatics to the DOTS facility for sputum collection.
2. Implement DOT, together with the health personnel.
3. Keep and update the NTP ID Cards.
4. Report and retrieve defaulters within two (2) days.
5. Attend regular consultation meetings with the health personnel, together with the patient and
treatment partner.
6. Refer patients with adverse reactions, if any, to the health personnel.
7. Provide health education to the patient, family members, and the community.

Hospital-based NTP Coordinators


1. Coordinate all NTP activities in the hospital with the assistance of the CHD and Provincial NTP
coordinators.
2. Supervise hospital NTP health workers to ensure proper implementation of the following NTP
policies:
a. Identification and examination of TB symptomatics with DSSM;
b. Implementation of DOT for identified cases;
c. Ensuring availability and adequacy of anti-TB drugs and supplies;
d. Referral of patients to RHU/MHC for continuation of treatment
(NTP Referral Form should be properly filled out by physician or nurse.); and
e. Provision of continuous health education to all patients placed under DOT.
3. Encourage patient’s family members to participate in TB control activities.

16
Introduction
Figure 1.1. Flow of NTP Activities

Symptoms of TB
COMMUNITY
Cough for two or more weeks, with or without:
• Fever
• Chest and/or back pains not referable to any
musculo-skeletal disorders
• Hemoptysis or recurrent blood-streaked sputum
• Significant weight loss
• Other symptoms, such as sweating, fatigue, body malaise, shortness of
breath

DOTS FACILITY
Case Finding
Sputum specimens (3 specimens) with NTP Laboratory Request Form
for Direct Sputum Smear Microscopy

MICROSCOPY CENTER

Diagnosis (Results of the DSSM. If results are Smear negative and with chest
x-ray suggestive of TB, refer to TBDC for evaluation. )

Initiation of Treatment TBDC

Case Holding with DOTS Sputum specimen (1 specimen) with Laboratory


Request Form for DSSM

MICROSCOPY CENTER

Treatment Completion Results (DSSM for follow-up)

Report Treatment Outcome / Request Supplies

Monitoring and Supervision

17
Case Finding

Case finding, which is the identification and diagnosis of TB cases among individuals with

Case Finding
suspected signs and symptoms of TB, is a basic step in TB control. Fundamental to case finding is the
detection of infectious cases through direct sputum smear microscopy (DSSM). DSSM is the principal
diagnostic method adopted by the NTP because:

1. It provides a definitive diagnosis of active TB;


2. The procedure is simple;
3. It is economical; and
4. A microscopy center could be put up even in remote areas.

DSSM results serve as bases for categorizing TB symptomatics according to standard case
definition. These are also used to: a) monitor progress of patients with sputum smear-positive TB while
they are receiving anti–TB treatment; and b) confirm cure at the end of treatment.

I. OBJECTIVE
Early identification and diagnosis of TB cases

II. DEFINITION OF TERMS


TB symptomatic – any person with cough for two or more weeks with or without the
following symptoms: fever; chest and/or back pains not referable to any musculo-skeletal disorders;
hemoptysis or recurrent blood-streaked sputum; significant weight loss; and other symptoms, such
as sweating, fatigue, body malaise, shortness of breath

Active case finding – a health worker’s purposive effort to find TB cases (among TB
symptomatics in the community) who do not consult with personnel in a DOTS facility

Passive case finding – finding TB cases among TB symptomatics who present themselves
in a DOTS facility

III. POLICIES
1. DSSM shall be the primary diagnostic tool in NTP case finding.
2. All TB symptomatics identified shall be asked to undergo DSSM for diagnosis before start of
treatment, regardless of whether or not they have available X-ray results or whether or not they
are suspected of having extra-pulmonary TB. The only contraindication for sputum collection
is hemoptysis; in which case, DSSM will be requested after control of hemoptysis.

18
3. Pulmonary TB symptomatics shall be asked to undergo other diagnostic tests (X-ray and/or
culture), if necessary, only after they have undergone DSSM for diagnosis with three sputum
specimens yielding negative results. The TBDC will evaluate the results of the chest X-ray,
together with the clinical history and findings, and will recommend whether or not the case will
Case Finding

be started on treatment.
4. Since DSSM is the primary diagnostic tool, no TB diagnosis shall be made based on the results
of X-ray examinations alone. Likewise, results of the skin test for TB infection (PPD skin test)
should not be used as bases for TB diagnosis in adults.
5. All municipal and city health offices shall be encouraged to establish and maintain at least one
sputum microscopy unit in their areas of jurisdiction.
6. Private-initiated Public-Private Mix DOTS (PPMD) units shall each have an in-house microscopy
service.
7. Passive case finding shall be implemented in all DOTS facilities. Concomitant active case
finding shall be encouraged only in areas where a cure rate of 85 per cent or higher has been
achieved, or in areas where no sputum-smear positive case has been reported in the last three
months.
8. Only trained medical technologists or microscopists shall perform DSSM (smearing, fixing, and
staining of sputum specimens, as well as reading, recording, and reporting of results). However,
in far flung areas, BHWs or other community health volunteers may be allowed to do smearing
and fixing of specimens, as long as they have been trained and are supervised by their respective
NTP medical technologists/microscopists.

IV. PROCEDURES
A. Identification of TB Symptomatics
(To be accomplished by DOTS facility staff)
1. Identify TB symptomatics consulting at the DOTS facility. Look out for those having cough
for two or more weeks, with or without one or more of the following signs and symptoms:
a. fever;
b. chest and/or back pains not referable to any musculo-skeletal disorders;
c. hemoptysis or recurrent blood-streaked sputum;
d. significant weight loss; and
e. other symptoms, such as sweating, fatigue, body malaise, and shortness of breath.
2. Motivate TB symptomatic to undergo DSSM. Explain importance of the procedure and
that of submitting three sputum specimens. Obtaining results from three sputum specimens
increases the probability of finding acid fast bacilli.
3. Record details of each specimen submission (name of TB symptomatic, date of submission,
and result) in the TB Symptomatics Masterlist/TB Symptomatics Target Client List.
4. Encourage household members of identified TB cases, who are also TB symptomatics,
to undergo DSSM.

19
B. Collection and Transport of Sputum Specimens to the Microscopy Center
(To be accomplished by DOTS facility staff)
1. Explain the importance of submitting three sputum specimens taken within two days.
a. First specimen, also referred to as spot specimen, is collected at the time of consultation,

Case Finding
or as soon as the TB symptomatic is identified.
b. Second specimen is the very first sputum produced early in the morning immediately after
waking up. It is collected by the patient according to instructions given by the DOTS facility
staff.
c. Third specimen, or second spot specimen, is collected when the TB symptomatic comes
back to the DOTS facility to submit the second specimen.
d. All specimens should be collected according to instructions given by the DOTS facility
staff. The first and third specimen collections are supervised by the DOTS facility staff to
ensure quality sputum specimen collection. If quality sputum is not collected within two
days, the patient is given one week to complete the three-specimen collection. If the patient
fails to complete the three-specimen collection within one week, another set of three should
be collected.
2. Prepare sputum cup and request form. Label body of sputum cup, indicating patient’s complete
name, and order of specimen (1st, 2nd, or 3rd).
3. Demonstrate how to produce quality sputum. Advise patient to:
a. Rinse his/her mouth with water.
b. Breathe deeply, hold breath, then exhale slowly. Repeat the entire sequence twice.
c. Cough strongly at the height of deep inspiration after inhaling deeply for the third time, and
spit the sputum in the container.

Observe precautions against infection during the demonstration. Stay behind the patient.
Collect specimen outside the DOTS facility where aerosols containing TB bacilli are diluted and
sterilized by direct sunlight.

4. Collect specimen and check quantity and quality of sputum.


5. Seal sputum specimen container, pack it securely, and transport it to a microscopy center or
laboratory, together with the completely filled up NTP Laboratory Request Form for DSSM. Do
this as soon as possible or within four days after collection.
6. If specimen cannot be sent to a microscopy unit early enough, store it in a cool, dark, and safe
place. No specimen shall remain unexamined over the weekend.

20
C. Smearing, Fixing, and Staining of Sputum Specimen and Reading, Recording, and Reporting
of Results
(To be accomplished by medical technologist or microscopist)
Case Finding

1. Record the information in the NTP Laboratory Register, including the type of sputum specimen
submitted, i.e., mucoid, purulent, blood-streaked, or salivary.
2. Smear, fix, and stain each slide.
3. Read each slide and interpret the result as follows:

0- No AFB seen in 300 oil immersion field (OIF)

+n – 1-9 AFB seen in 100 OIF

1+ - 10 – 99 AFB seen in 100 OIF

2+ - 1-10AFB /OIF in at least 50 fields

3 + -more than 10 AFB/OIF in at least 20 fields

4. Interpret the results of the three specimens and write the final laboratory diagnosis in the lower
portion of the NTP Laboratory Request Form for DSSM and on the Remarks column of the
NTP Laboratory Register. Laboratory diagnoses are classified as follows:
a. Smear-positive - at least two positive sputum smear results
b. Doubtful - only one positive out of three sputum specimens examined (Request for another
set of three sputum specimens).
• If at least one specimen from the second set of specimens is positive, laboratory
diagnosis is positive.
• If all three specimens from the second set of specimens are negative, laboratory
diagnosis is negative.
c. Smear-negative - all three sputum smear results negative
5. Send request form back to requesting unit.

D. Decision on Patient’s Diagnosis Based on Laboratory Results


(To be accomplished by DOTS facility staff)
1. Inform patient of result.
• If positive, refer patient to physician for assessment and initiation of treatment; and,
• Encourage household members with signs and symptoms of TB to consult at DOTS facility.
• If doubtful, ask patient to submit another three sputum specimens within one week.
• If negative, refer patient to physician for further assessment.

21
E. Diagnosis of Smear-negative Patients with Persistent Symptoms
(To be accomplished by physician)
1. Re-assess smear-negative patients with persistent symptoms of TB. (Refer to Flow Chart 2.1
& 2.2)

Case Finding
2. Refer patient for X-ray examination, if warranted.
3. If X-ray findings are suggestive of TB, refer patient to the TBDC. In areas where there is no
TBDC, physician may manage the patient.

F. Referral to TBDC
(To be accomplished by physician)
1. Fill up TBDC Referral Form and send it to TBDC, together with all available chest X-ray films.
2. Wait for TBDC evaluation of results, which is sent back to the DOTS facility.
3. Carry out TBDC recommendations.

For detailed information about TBDC, refer to Annex 2.

G. Summary of Procedure
The following four flow charts summarize the procedure for TB case finding:
1. Flow Chart for the Diagnosis of Pulmonary Tuberculosis;
2. Flow Chart for the Diagnosis of Smear-Negative Pulmonary Tuberculosis;
3. Guide to Case Finding; and
4. Guide to Diagnosis and Initiation of Treatment.

22
Figure 2.1. Flow Chart for the Diagnosis of Pulmonary TB
Case Finding

TB Symptomatic
(cough for 2 weeks or more)

Three (3) sputum collection

A. 2 or 3 Smear-Positive B. Only one (1) Smear-Positive C. All 3 Smear-Negative

Classify as Collect another 3 Sputum Refer to Physician


Smear-Positive TB Specimens Inmmediately (Observe him/her with
Symptomatic
Treatment for 2 or 3 weeks)

If at least one (1) Smear-Positive If all Smear-Negative If symptoms persist,


request for CXR
(Refer to the flow chart
on the next page.)
Classify as smear-Positive TB Request for CXR

If consistent with active TB If not consistent with active TB

Classify as smear-positive TB If necessary


Observation/further exam.,

23
Figure 2.2. Flow Chart for the Diagnosis of Smear-Negative Pulmonary TB

This flow chart assists the physicians in making a decision for smear-negatives.

Case Finding
C. All 3 Smear-Negative

Refer to Physician
(Symptomatic Tx for 2-3 wks)

If symptoms persist, request for CXR

Abnormal No Abnormal
findings on findings on
CXR CXR

TB Diagnostic Observation/
Committee further exam.

Consistent Not
with active TB Consistent
with active TB

Classify as
Observation/
Smear-
Negative TB further exam.

24
Figure 2.3. Guide to Case Finding

SPUTUM COLLECTION UNIT


Case Finding

(To be accomplished by DOTS facility staff)


TB Symptomatics are those
1. (Optional) Register patient in TB Symptomatics Masterlist (or TB Symptomatics Target with cough for 2 or more weeks
Client List) (see Chapter IV, p. 54). with or without 1 or more of the
following:
2. Explain the importance of three sputum collections to the TB symptomatics.
• Fever
3. Label each sputum container (name and order no.1,2,3). • Chest and/or Back pains
• Hemoptysis
4. Collect three quality sputum specimens (1st spot, early morning, 2nd spot). • Significant weight loss
• Other symptoms, such as
5. Fill-up NTP Laboratory Request Form for DSSM (see Chapter IV, p. 56). sweating, fatigue, body
Confirm three sputum collections.
malaise, shortness of
breath
6. Pack and send specimen/s to the Microscopy Center, together with the
completely filled up NTP Laboratory Request Form for DSSM.

MICROSCOPY CENTER
(To be accomplished by the medical technologist/microscopist)

1. Register in the NTP Laboratory Register (see chapter IV. p. 59)

2. Record date received and Laboratory Serial No. in the Laboratory Request Form for
DSSM (see chapter IV. p. 56)

3. Perform DSSM: smearing, fixing, staining, and reading slides.

4. Record results in the Laboratory Request Form for DSSM (see chapter IV. p. 56) and
in the NTPLaboratory Register (see chapter IV. p. 59)

5. Send back accomplished Laboratory Request Form for DSSM to the collection unit (see chapter IV. p. 56)

SPUTUM COLLECTION UNIT


(To be accomplished by DOTS facility staff)

1. (Optional) Record results in the TB Symptomatics Masterlist (or TB Symptomatics


Target Client List) (see Chapter IV, p. 54).

2. Explain result to the patient (If doubtful, immediately collect another 3 specimens for
confirmation).

3. Refer to physician/nurse.

DIAGNOSIS AND
INITIATION OF TREATMENT

25
Figure 2.4. Guide to Diagnosis and Initiation of Treatment

CLINICAL DIAGNOSIS
To determine patient type and classification; done by DOTS facility staff

Case Finding
1. Verify information gathered on case finding.
• Symptoms/condition of patient
• Results of sputum examinations
• Results of further examination (i.e., CXR, TBDC’s recommendations, culture, etc.)
• Source of infection

2. Verify DSSM results.

3. Review history of previous treatment.


• When was previous treatment taken? For how long?
• Where was the previous treatment taken?
• What anti-TB drugs were taken?
• What was the DSSM result?
• What was the treatment outcome?

To be done by INITIATION OF TREATMENT


Physician 1. Physical assessment and prescription of appropriate
category of treatment regimen for TB patient according to
patient classification and type

Nurse 2. Registration
• Fill up NTP Treatment Card (see Chapter IV, p. 60).
• Fill up two NTP ID Cards (see Chapter IV, p. 63), one
for treatment partner and one for patient.
• Register in the TB Register (see Chapter IV, p. 65).

Designated DOTS Facility Staff 3. Health education with emphasis on key messages,
such as:
• TB is infectious.
• TB can be cured but cure requires regular drug intake.
• Irregular drug intake impedes cure and results in chronic
cases.
• Anti-TB drugs have side-effects.
• It is important to have follow-up DSSM examinations.
• Family/treatment partner support is important.

Nurse 4. Intake of first dose


• Record date when treatment started.
• Record due date of the first DSSM follow-up in the
NTP Treatment Card (see Chapter IV, p. 60) and
NTP ID Cards (see Chapter IV, p. 63).

Designated DOTS Facility Staff/ 5. DOT


Treatment Partners • Assign a treatment partner.
• Do DOT for both intensive and continuation phases of
treatment.
• Conduct weekly consultation meetings at the
DOTS facility during the whole course of treatment.

Nurse/Midwife 6. Record keeping


• Maintain and update TB Register.
• Maintain and update NTP Treatment Card
at the DOTS facility.
• See to it that both treatment partner and
patient maintain, update, and keep NTP ID Cards.

26
V. QUALITY ASSURANCE FOR DSSM

The quality assurance (QA) program is a series of regular activities carried out to monitor
the laboratory’s overall performance towards maintaining high quality results. DSSM results are
Case Finding

highly significant not only to the patient but also to the entire NTP. As such, it is essential for the
QA program to: 1) ensure that the reported results are accurate; 2) identify practices that are
potential sources of error; and 3) ensure that appropriate corrective actions are initiated.

A. OBJECTIVE
Assurance of high quality DSSM services in NTP

B. COMPONENTS
QA for DSSM includes the following:
1. Quality Control (QC) is the systematic internal monitoring of working practices, technical
procedure, equipment, and materials, including quality of stains. These are performed
regularly by the NTP medical technologist or microscopist.
2. External Quality Assessment (EQA) is a system of periodic independent measurement
of performance through collaboration with another competent laboratory at a higher level
(province or city). The trained NTP provincial or city coordinators and controllers are
responsible for EQA.
3. Quality Improvement (QI) is a process by which the components of smear microscopy
diagnostic services are analyzed by trained NTP provincial or city coordinators. This is
a continuous undertaking designed to identify and address problem areas, which in turn
will help ensure quality of DSSM services.

C. POLICIES
1. In the DOTS facility, the NTP-trained medical technologist/microscopist shall maintain
QC of routine work.
2. A Quality Assurance Center shall be established in every province and highly urbanized
city to ensure that QA activities are maintained in all DOTS facilities. Provincial/city health
offices are responsible for EQA, which includes blinded slide rechecking and on-site
evaluations by persons identified to perform such activities.
3. CHDs and their regional laboratories shall support the provincial/city QA centers.

Procedures and forms are found in the Manual on the Quality Assurance for Sputum Smear
Microscopy, March 2004.

27
Case Holding

Case holding is the procedure which ensures that patients complete their treatment. Chemotherapy
is currently the only way to stop the transmission of TB. While effective anti-TB drugs are available in
the country, there are still many TB patients who are not cured. This is because many patients stop
taking anti-TB drugs or they take their drugs irregularly. Patients are usually remiss in drug intake due
to the long duration of treatment. The shortest duration of treatment is six months.

Treatment compliance is necessary to cure TB and avoid development of drug resistance. It

Case Holding
is useless to search for cases if they could not be treated properly after they have been found. It would
only encourage false hopes on the part of the patient.

Poor treatment compliance may lead to the following outcomes: chronic infectious illness; drug
resistance; or death. Second-line anti-TB drugs for drug resistant cases are very expensive and most
are not available in the country. The best way to prevent the occurrence of drug resistance is through
regular intake of drugs for the prescribed duration. The strategy developed to ensure treatment
compliance is called Directly Observed Treatment (DOT). It is one of the key components of DOTS
towards achieving sufficient cure rate and preventing drug-resistant TB. DOT works by assigning a
responsible person to observe or watch the patient take the correct medications daily during the whole
course of treatment.

I. OBJECTIVE

Effective and complete treatment of TB cases, especially pulmonary sputum smear-positive cases

II. DEFINITION of TERMS

A. Classification of TB cases - TB cases shall be classified based on the location of lesions,


as well as the result of DSSM (Table 3.1).

28
Table 3.1 Classification of TB Cases

Location of Lesion DSSM Result Definition of Terms

1. A patient with at least two sputum


specimens positive for AFB, with or without
radiographic abnormalities consistent with
active TB
Smear-Positive OR
2. A patient with one sputum specimen
positive for AFB and with radiographic
abnormalities consistent with active
Case Holding

pulmonary TB as determined by a
physician
Pulmonary TB
OR
(PTB)
3. A patient with one sputum specimen
positive for AFB and sputum culture
positive for M. tuberculosis

A patient with at least three sputum specimens


negative for AFB with radiographic abnormalities
Smear-Negative consistent with active TB, and there has been
no response to a course of antibiotics and/or
symptomatic medications, and there is a decision
by a physician and /or TBDC to treat the patient
with a full course of anti-TB chemotherapy

1. A patient with at least one mycobacterial smear/culture positive


from an extra-pulmonary site (organs other than the lungs: pleura,
lymph nodes, genito-urinary tract, skin, joints and bones, meninges,
intestines, peritoneum, and pericardium, among others)
Extra-Pulmonary OR
TB (EP) 2. A patient with histological and/or clinical evidence consistent with
active extra pulmonary TB and there is a decision by a physician
to treat the patient with anti-TB drugs

Note: All EP cases shall undergo DSSM prior to treatment.

B. Types of TB cases - TB cases shall be categorized based on the history of anti-TB treatment
(Table 3.2). A thorough understanding of the types of TB cases is necessary in determining the
correct category of treatment regimen.

29
Table 3.2. Types of TB Cases

Types of TB Cases Definition of Terms

New A patient who has never had treatment for TB or who has taken anti-
TB drugs for less than one month

Relapse A patient previously treated for TB, who has been declared cured or
treatment completed, and is diagnosed with bacteriologically positive
(smear or culture) TB

Treatment Failure A patient who, while on treatment, is sputum smear-positive at five

Case Holding
months or later during the course of treatment

Return After A patient who returns to treatment with positive bacteriology (smear or
Default culture), following interruption of treatment for two months or more
(RAD)

Transfer-in A patient who has been transferred from another facility adopting NTP
policies with proper referral slip to continue treatment

Other All cases who do not fit into any of the above definitions.
This may also include the following:
1. Other (positive) – a patient who was initially registered as a new
smear-negative case and turned out to be smear-positive during
treatment;
2. Other (negative) – a patient who interrupted treatment for two or
more months and has remained or become smear-negative upon
return for treatment; and
3. Chronic case – a patient who remains sputum-positive at the end
of a re-treatment regimen.

Note: *Treatment for primary and latent tuberculosis infection should not be considered as a previous TB treatment.

C. Directly Observed Treatment (DOT) - DOT is a method developed to ensure treatment compliance
by providing constant and motivational supervision to TB patients. DOT works by having a responsible
person, referred to as treatment partner, watch the TB patient take medicines everyday during
the whole course of treatment.

Any of the following could serve as treatment partner: a) DOTS facility staff, such as the
midwife or the nurse; or b) a trained community member, such as the BHW, local government
official, or former TB patient. A member of the patient’s family may not be as reliable as a health
worker in serving as treatment partner, but he/she may be assigned as treatment partner
during weekends and holidays.

30
DOT can be done in any accessible and convenient place for the patient (e.g., DOTS
facility, treatment partner’s house, patient’s place of work, or patient’s house) as long as the
treatment partner can effectively ensure the patient’s intake of the prescribed drugs and monitor
his/her reactions to the drugs. It is important to supervise the smear-positive TB patients’ daily
anti-TB drug intake during the intensive and continuation phases of short-course chemotherapy.

III. POLICIES
Case Holding

a. Aside from clinical findings, treatment of all TB cases shall be based on a reliable
diagnostic technique, namely, DSSM.
b. Domiciliary treatment shall be the preferred mode of care.
c. Patients with the following conditions shall be recommended for hospitalization:
1. massive hemoptysis;
2. pleural effusion obliterating more than one-half of a lung field;
3. miliary TB;
4. TB meningitis;
5. TB pneumonia; and
6. those requiring surgical intervention or with complications.
d. All patients undergoing treatment shall be supervised (DOT). No patient shall initiate
treatment unless the patient and DOTS facility staff have agreed upon a case holding
mechanism for treatment compliance.
e. The national and local government units shall ensure provision of drugs to all smear-
positive TB cases.
There are two formulations of anti-TB drugs:
1. Fixed–dose combination (FDCs) – Two or more first-line anti-TB drugs are combined
in one tablet. There are 2-, 3-, or 4-drug fixed-dose combinations.
2. Single drug formulation (SDF) – Each drug is prepared individually: INH, ethambutol,
and pyrazinamide are in tablet form while rifampicin is in capsule form. These
drugs are usually in blister packs good for one week.

The Department of Health shall ensure the provision of FDC drugs to LGUs and other
DOTS facilities for all TB cases, giving priority to smear-positive cases. However, LGUs shall
procure a portion (at least 5% of the expected cases) of the requirements for SDF for those with
adverse reactions necessitating withdrawal of FDC and for Category III cases.
f. Quality of FDCs must be ensured. FDCs must be ordered from a source with a track record
of producing FDCs according to WHO-prescribed strength and standard of quality.
g. Treatment shall be based on recommended category of treatment regimen (Table 3.3).

31
Table 3.3. Recommended Category of Treatment Regimen

TB Treatment Regimens
Category Type of TB Patient
Intensive Phase Continuation Phase

I New smear-positive PTB, 2HRZE 4HR


New smear-negative PTB with
extensive parenchymal
lesions on CXR as assessed
by the TBDC, EPTB, and
severe concomitant HIV

Case Holding
disease

II Treatment Failure, Relapse, 2HRZES/HRZE 5HRE


RAD, Other

III New smear-negative PTB with 2HRZE 4HR


minimal parenchymal lesions
on CXR as assessed by the
TBDC

IV Chronic (still smear-positive Refer to specialized facility or


after supervised re-treatment) DOTS Plus Center

Refer to Provincial/City NTP


Coordinator

h. Dosage per Category of Treatment Regimen


a. Fixed-Dose Formulation

The number of tablets of FDCs per patient will depend on the body weight. Hence, all patients
must be weighed (using kilogram as a unit) before treatment is started. Tables 3.4 and 3.5 show the
treatment regimens for specific categories while Annex 2 shows sample packages of FDCs and SDFs.

32
Table 3.4. Treatment Regimen for Categories I & III: 2HRZE/4HR (FDC)

Body Weight (kg) No. of Tablets per Day No. of Tablets per Day
Intensive Phase Continuation Phase
(2 months) (4 months)
FDC-A (HRZE) FDC-B (HR)

30-37 2 2
38-54 3 3
55-70 4 4
Case Holding

> 70 5 5

Table 3.5. Treatment Regimen for Categories II: 2HRZES/HRZE/5HRE (FDC)

Body Weight (kg) Intensive Phase Continuation Phase

First Two months Third month


FDC-B E
FDC-A (HR) 400 mg
FDC-A
STREPTOMYCIN (HRZE)
(HRZE)

30-37 2 750 mg
0.75 g 2 2 1
38-54 3 750 mg
0.75 g 3 3 2
55-70 4 750 mg
0.75 g 4 4 3
> 70 5 750 mg
0.75 g 5 5 3

b. Single Drug Formulation


Simply add one tablet of INH (100mg), PZA (500mg), and E (400mg) each for the patient weighing
more than 50kg before treatment initiation. Modify drug dosage within acceptable limits according to
patient’s body weight, particularly those weighing less than 30kg at the time of diagnosis (Table 3.8).

Table 3.6. Treatment Regimen for Categories I & III: 2HRZE/4HR (SDF)

ANTI-TB Drugs No. of Tablets per Day No. of Tablets per Day
Intensive Phase Continuation Phase
(2 months) (4 months)

Isoniazid (H) 300mg 1 1


Rifampicin (R) 450mg 1 1
Pyrazinamide (Z) 500mg 2
Ethambutol (E) 400mg 2

33
Table 3.7. Treatment Regimen for Categories II: 2HRZES/HRZE/5HRE (SDF)

ANTI-TB Drugs No. of tablets per day No. of tablets per day
Intensive Phase Continuation Phase
(3 months) (5 months)

First 2 months 3rd month


Isoniazid (H) 300mg 1 1 1
Rifampicin (R) 450mg 1 1 1

Case Holding
Pyrazinamide (Z) 500mg 2 2
Ethambutol (E) 400mg 2 2 2
Streptomycin (S) 1gm 1 vial/day*

* 56 vials for two months

Table 3.8. Drug Dosage per KG Body Weight

Drug Dose per kg body weight and maximum dose

Isoniazid 5 (4-6) mg/kg, and not to exceed 400mg daily

Rifampicin 10 (8-12) mg/kg, and not exceed 600mg daily

Pyrazinamide 25 (20-30) mg/kg, and not to exceed 2g daily

Ethambutol 15 (15-20) mg/kg, and not to exceed 1.2g daily

Streptomycin 15 (12-18) mg/kg, and not to exceed 1g daily

34
IV. PROCEDURES

A. Initiation of Treatment and Registration


1. Inform the patient that he/she has TB and motivate him/her to undergo treatment.
2. Refer patient living outside the catchment area to the most accessible DOTS
facility where his/her treatment can be supervised.
3. Weigh the patient.
4. Refer patient to a physician for pre-treatment evaluation.
5. Open the NTP Treatment Card and two NTP ID Cards (one for treatment partner
Case Holding

and one for patient) and start the treatment.


6. Watch patient swallow the initial dose.
7. Register patient in the TB Register.

B. Ensuring Treatment Compliance through DOT


1. Together with the patient, identify a treatment partner.
2. Explain the importance of treatment compliance to the patient.
3. Administer patient’s drugs daily. Emphasize the following to both patient and
treatment partner:
a. Patient and treatment partner should meet at their agreed treatment
unit everyday.
b. Drugs should be taken 2-3 hours after a regular meal.
c. Treatment partner should make sure that the patient swallows his/her
drugs daily.
d. After intake of drugs, treatment partner should sign the
treatment partner’s NTP ID Card, as well as the patient’s NTP ID Card.
4. Motivate treatment partner to be vigilant about patient’s treatment regimen.
a. On Saturdays, Sundays, and holidays, when the DOTS facility is closed,
Treatment could be done at home but should be supervised by a trained
family member.
b. Treatment partner should emphasize key messages, such as:
• TB can be cured but cure requires regular drug intake for the
prescribed duration.
• Patient should report any adverse drug reaction.
• Patient should undergo follow-up sputum examination on specified
dates. Schedule of DSSM follow-up for Categories I and III patients
is shown in Table 3.9 while Table 3.9.a shows the schedule for those
in Category II.

35
Table 3.9 Schedule of DSSM Follow-up (Categories I and III)

Schedule of Category I Category III


DSSM (2HRZE/4HR) (2HRZE/4HR)
Follow-up
With One-
Regular Month Regular Treatment
Treatment Extension
(HRZE)

Case Holding
Towards end of YES (If positive) YES
nd
2 month

Towards end of (If negative) YES

3rd month

Towards end of YES

4th month

Towards end of YES

5th month

Beginning of YES1

6th month

Beginning of YES1

7th month

1
Check DSSM follow-up results at the end of treatment (during the last week of treatment) for the patient who was smear-positive in the last DSSM follow-
up and smear-negative in the repeated DSSM (Tables 3.10, and 3.10.a, and Figures 3.1, and 3.3).

36
Table 3.9.a Schedule of DSSM Follow-up (Category II)

Category II (2HRZES/HRZE/5HRE)
Schedule of
DSSM With One-Month
Regular Treatment Extension (HRZE)
Follow-up

Towards end of
2nd month
Case Holding

Towards end of
YES (If positive)
3rd month

Towards end of
(If negative) YES
4th month

Towards end of
YES
5th month

Towards end of
YES
6th month

Towards end of

7th month

Beginning of
YES1
th
8 month

Beginning of
YES1
9th month

1
Check DSSM follow-up results at the end of treatment (during the last week of treatment) for patients who were smear-positive in the last DSSM
follow-up and smear-negative in the repeated DSSM (Tables 3.10.b, and 3.10.c, and Figures 3.2).

37
5. Conduct regular (preferably weekly) consultation meetings with patient and treatment partner
for treatment evaluation at the DOTS facility.
6. Exert effort to contact patient when he/she fails to report on due date.

C. Monitoring Response to Treatment


1. Monitor sputum smear status of all patients under treatment, including initially sputum-smear
negative patients, according to the standard schedule (Tables 3.9 and 3.9.a).
2. Modify treatment based on DSSM follow-up results (Tables 3.10, 3.10.a, 3.10.b, and 3.10.c,
and Figures 3.1, 3.2, and 3.3).

Case Holding
Treatment Modifications Based on Results of DSSM Follow-up

Category I Treatment Regimen

1. Do DSSM follow-up towards the end of the second month of treatment.


2. If the result is negative, start continuation phase (HR) and follow recommendations in Table
3.10.
3. If the result is positive, extend intensive phase (HRZE) for another month.
Refer to Table 3.10.a for treatment modifications of smear-positive patients after follow-up
examination.

38
Table 3.10. Treatment Modification for New PTB Smear-Positive Cases Based on the Results of
DSSM Follow-up for Category I Treatment Regimen Without Extension

Towards end of Beginning of 6th Month Towards end of 6th


4th Month Month1

If smear-negative, If smear-negative, complete continuation


phase until end of treatment course and
continue
declare as cured.
continuation phase
If smear-positive, If smear-negative in the If smear-negative,
Case Holding

(HR).
repeat DSSM repeated DSSM, declare as cured.
immediately for continue continuation
confirmation and phase (HR) and do
consult DOTS DSSM towards end of If smear-positive, declare
Physician as Failed; re-register as
6th month of treatment.
Treatment Failure and start
with Category II treatment
regimen.

If smear-positive again
in the repeated DSSM,
declare as Failed; re-
register as Treatment
Failure and start with
Category II treatment
regimen.

If smear-positive, If smear-negative, continue continuation phase If smear-negative,


continue continuation (HR) and do DSSM towards end of 6th month declare as cured.
phase (HR). of treatment.
If smear-positive, declare
as Failed; re-register as
Treatment Failure and
start with Category II
treatment regimen.

If smear-positive, declare as Failed, re-register


as Treatment Failure and start with Category
II treatment regimen.

1
Check DSSM follow-up results towards the end of the sixth month of treatment only for patients who are: 1) smear-positive in the beginning of the
th
6 month and smear-negative in the repeated DSSM; and 2) smear-positive towards the end of the fourth month but turned out to be negative in
th
the beginning of the 6 month.

39
Table 3.10.a Treatment Modification for New PTB Smear-Positive Cases Based on the Results
of DSSM Follow-up for Category I Treatment Regimen With Extension

Towards Towards End


End of 3rd of 5th Month Beginning of 7th Month Towards End of 7th
Month Month1

If smear- If smear-negative, If smear-negative, complete continuation


negative, start continue phase until end of treatment course and
continuation continuation declare as cured.
phase (HR). phase (HR).
If smear-positive, If smear-negative in If smear-negative, declare as
repeat DSSM the repeated cured
immediately for examination, continue
confirmation and continuation phase

Case Holding
consult DOTS (HR) and do DSSM
physician. towards end of 7th
month of treatment.
If smear-positive, declare as
failed; re-register as Treatment
failure and start Category II
treatment regimen

If smear-positive in the
repeated examination,
declare as failed; re-
register as treatment
failure and start
Category II treatment
regimen.

If smear-positive, If smear-negative, declare as


If smear-negative, continue continuation
continue cured.
phase (HR) and do DSSM towards end of
continuation 7th month of treatment. If smear-positive, declare as failed;
phase (HR). re-register as treatment failure
and start Category II treatment
regimen.

If still smear-positive, declare as failed;


re-register as treatment failure and start
Category II treatment regimen.

If smear- If smear- If smear-negative, complete continuation


positive, start negative, continue phase until end of treatment course and
continuation continuation declare as cured.
phase (HR). phase (HR).
If smear-positive, If smear-negative in If smear-negative, declare as
repeat DSSM the repeated cured.
immediately for examination, continue
confirmation and continuation phase If smear-positive, declare as
consult DOTS (HR) and do DSSM failed; re-register as treatment
physician. towards end of 7th failure and start Category II
month of treatment. treatment regimen
If smear-positive in the
repeated examination,
declare as failed; re-
register as treatment
failure and start Category
II treatment regimen.

If still smear-
positive, declare as
failed; re-register as
treatment failure and
start Category II
treatment regimen.

1
Check DSSM follow-up results towards the end of the seventh month of treatment only for patients who are: 1) smear-positive in the beginning
of the seventh month and smear-negative in the repeated DSSM; and 2) smear-positive towards the end of the fifth month and turned out to
be negative in the beginning of the seventh month.

40
Category II Treatment Regimen

1. Do DSSM follow-up towards the end of the third month of treatment.


2. If DSSM result is negative, start continuation phase (HRE) and refer to Table 3.10.b.
3. If DSSM result is positive, extend intensive phase (HRZE) treatment for another month. Refer
to Table 3.10.c.

Table 3.10.b Treatment Modification for PTB Smear-Positive Cases Based on the Results of
DSSM Follow-up for Category II Treatment Regimen Without Extension
Case Holding

Towards End of Towards End of 8th


Beginning of 8th Month 1
5th Month Month

If smear- negative, If smear-negative, complete continuation phase


continue continuation until the end of the treatment course and declare
phase (HRE). as cured.

If smear-positive, If smear-negative in the If smear-negative,


repeat DSSM repeated DSSM, declare as cured
immediately for continue continuation
confirmation and phase (HRE) and do
consult DOTS DSSM towards end of
physician. 8th month. If smear-positive,
declare as failed

If smear-positive again in
the repeated DSSM,
complete continuation
phase (HRE) until end of
treatment course and
declare as failed.

If smear- positive, If smear-negative, continue continuation phase If smear-negative,


continue continuation (HRE) and do DSSM towards end of 8th month. declare as cured
phase (HRE).
If smear-positive,
declare as failed.

If smear-positive, complete continuation phase


(HRE) until end of treatment course and declare
as failed.

1 th th
Check DSSM follow-up results towards the end of the 8 month of treatment only for patients who are: 1) smear-positive in the beginning of the 8
th
month and smear-negative in the repeated DSSM; 2) smear-positive towards the end of the 5 month and turned out to be negative in the beginning
th
of the 8 month.

41
Table 3.10.c Treatment Modifications for PTB Smear-Positive Cases Based on DSSM Follow-up
for Category II Treatment Regimen With Extension

Towards End Towards End Beginning of 9th Month Towards End of


of 4th Month of 6th Month 9th Month1

If smear-negative, complete
If smear- If smear- continuation phase until end of
positive or negative, treatment course and declare as cured
smear- continue
negative, start continuation
continuation phase (HRE).
phase (HRE). If smear- If smear-negative in If smear- negative,

Case Holding
positive, repeat the repeated DSSM, declare as cured.
DSSM continue
immediately for continuation phase
confirmation (HRE) and do
and consult DSSM towards end If smear- positive,
DOTS of 9th month of declare as failed.
physician. treatment.

If smear positive
again in the
repeated DSSM,
complete
continuation phase
(HRE) until end of
treatment and
declare as failed.

If smear- positive, If smear negative, continue If smear- negative,


continue continuation phase (HRE) and do declare as cured.
continuation DSSM towards end of 9th month of
phase (HRE). treatment.

If smear-positive,
complete
continuation phase
(HRE) until end of
treatment course
and declare as
failed.

If still smear-positive, complete


continuation phase (HRE) until end of
treatment and declare as failed.

1
Check DSSM follow-up results towards the end of the ninth month of treatment only for patients who are: 1) smear-positive in the beginning of
the ninth month and smear-negative in the repeated DSSM; and 2) smear-positive towards the end of the sixth month and turned out to be negative
in the beginning of the ninth month.

42
Category III Treatment Regimen

1. Do DSSM follow-up towards the end of 2nd month of treatment.


2. If the result is negative, start continuation phase (HR).
3. If the result is positive, declare as Failed, re-register as Other, and start Category II treatment
regimen.

Summary of Treatment Modification Based on DSSM Follow-up Results


Case Holding

Figure 3.1. Category I Treatment Modification Based on DSSM Follow-up Results*


CATEGORY - I

1st mo. 2nd mo. 3rd mo. 4th mo. 5th mo. 6th mo. 7th mo.

HRZE HR

If negative, *
If positive,
HRZE
With Extension HR

*
Figure 3.2. Category II Treatment Modification Based on DSSM Follow-up Results*
CATEGORY - II

1st mo. 2nd mo. 3rd mo. 4th mo. 5th mo. 6th mo. 7th mo. 8th mo. 9th mo.

H R Z ES HRZE HRE

If negative, *
If positive,
HRZE HRE
With Extension

Figure 3.3. Category III Treatment Modification Based on DSSM Follow-up Results*

CATEGORY – III

1st mo. 2nd mo. 3rd mo. 4th mo. 5th mo. 6th mo.

HRZE HR

*Check DSSM follow-up results at the end of treatment for patients who were smear-positive in the last DSSM follow-up and smear-negative in the
repeated DSSM.

43
D. Management of Adverse Reactions to Drugs

Closely monitor the occurrence of minor and major reactions to drugs, especially during
the intensive phase. (Table 3.11). There are major side effects that necessitate withdrawal of the
responsible drug. Since FDC drugs are already used, there is a need to switch to SDF whenever
side effects to one or more components of the FDC are suspected.

Table 3.11. Guide in Managing Adverse Reactions to Anti-TB Drugs

Adverse Reactions Drug(s) probably Management


responsible

Case Holding
Minor

1. Gastro-intestinal intolerance Rifampicin/INH Give medication at bedtime or give small meals.

2. Mild skin reactions Any kind of drugs Give anti-histamines.

3. Orange/red colored urine Rifampicin Reassure the patient

4. Pain at the injection site Streptomycin Apply warm compress. Rotate sites of injection.

5. Burning sensation in the feet Isoniazid Give Pyridoxine (Vitamin B6):


due to peripheral neuropathy 100-200mg dailly for treatment
10mg daily for prevention.

6. Arthralgia due to Pyrazinamide Give aspirin or NSAID.


hyperuricemia
If symptoms persist, consider gout and request
for blood chemistry (uric acid determination
and manage accordingly).

7. Flu-like symptoms (fever, Rifampicin Give antipyretics.


muscle pains, inflammation
of the respiratory tract)
Major

1. Severe skin rash due to Any kind of drugs Discontinue anti-TB drugs and refer to DOTS
hypersensitivity (especially Streptomycin) physician.

2. Jaundice due to hepatitis Any kind of drugs Discontinue anti-TB and refer to DOTS
(especially Isoniazid, physician
Rifampicin, and
Pyrazinamide) If symptoms subside, resume treatment and
monitor clinically.
3. Impairment of visual acuity Ethambutol Discontinue Ethmbutol and refer to an
and color vision due to optic ophthalmologist.
neuritis

4. Hearing impairment, ringing Streptomycin Discontinue Streptomycin and refer to DOTS


of the ear, and dizziness due physician.
to damage of the eihth
cranial nerve
5. Oliguria or albuminuria Streptomycin Discontinue anti-TB drugs and refer to DOTS
due to renal disorder Rifampicin physician.

6. Psychosis and convulsion Isoniazid Discontinue Isoniazid refer to DOTS physician.

7. Thrombocytopenia, anemia, Rifampicin Discontinue anti-TB drugs and refer to DOTS


shock physician.

For details on the management of adverse drug reactions, refer to the Interventions for Tuberculosis Control
and Elimination [International Union Against Tuberculosis and Lung Disease (2002), pp. 87-91].

44
E. Management of Cases Who Interrupted Treatment
1. Perform routine DSSM on defaulters who come back for chemotherapy. Refer patients to
DOTS physician for re-evaluation and re-treatment.
2. Manage new smear-positive patients who interrupted treatment according to recommended
treatment modification (Table 3.12).
3. Manage Relapse and Treatment failure cases who interrupted treatment according to recommended
treatment modification (Table 3.12.a).
4. Continue treatment for patients who were referred or transferred with proper referral slip.
However, do DSSM on patients without properly accomplished referral slip.
Case Holding

45
Table 3.12 Treatment Modifications for New Smear-Positive Cases Who Interrupted Treatment

Length of Length of Do a Result of Register again? Treatment


treatment Interruption smear? smear modification

Less than one Less than 2 No No, use same treatment Continue Category I
month weeks card. Treatment Regimen

2 weeks or more Yes Positive No, open a new treatment Restart Category I
card (Use same TB case Treatment Regimen
number). again

Negative No, use same treatment Continue Category I

Case Holding
card. Treatment Regimen

One to two Less than 2 No No, use same treatment Continue Category I
months weeks card. Treatment Regimen

2 to 8 weeks Positive No, use same treatment Complete remaining


card. intensive phase; add
Yes one extra month of
intensive phase.
Negative No, use same treatment Continue Category I
card. Treatment Regimen.

More than 8 Positive Close previous registration Start Category II


weeks but still as Defaulted; re-register as Treatment Regimen
within 6-month Yes RAD and open a new
treatment treatment card (new TB
regimen case number).

Negative Close previous registration Start Category II


as Defaulted; re-register Treatment Regimen
under Other and open a
new treatment card. (New
TB case number).

More than two Less than 2 No No, use same treatment Continue Category I
months weeks card. Treatment Regimen

2 to 8 weeks Positive Close previous registration Start


as Defaulted1; re-register
Yes Category II Treatment
as RAD and open a new
Regimen
treatment card. (New TB
case number).

Negative No, use same treatment Continue Category I


card. Treatment Regimen.

More than 8 Positive Close previous registration Start Category II


weeks but still as Defaulted; re-register as Treatment Regimen
within 6-month RAD and open a new
treatment Yes treatment card. (New TB
regimen case number).

Negative Close previous registration Start Category II


as Defaulted; re-register Treatment Regimen
under Other and open a
new treatment card (New
TB case number).

1
This is the exceptional case categorizing as Defaulted a patient who interrupted treatment at less than 8 weeks.

46
Table 3.12.a Treatment Modifications for Relapse and Treatment Failure Cases Who Interrupted
Treatment

Length of Length of Do a Result of Register again? Treatment


treatment Interruption DSSM? DSSM modification

Less than one Less than 2 No No, use same treatment Continue Category II
month weeks card. Treatment Regimen

2 weeks or more Yes Positive No, open a new treatment Restart Category II
card. Treatment Regimen
Case Holding

Negative No, use same treatment Continue Category II


card. Treatment Regimen

One to two Less than 2 No No, use same treatment Continue Category II
months weeks card. Treatment Regimen

2 to 8 weeks Positive No, use same treatment Complete remaining


card. intensive phase; add
Yes one extra month of
intensive phase.
Negative No, use same treatment Continue Category II
card. Treatment Regimen.

More than 8 Positive Close previous registration Restart Category II


weeks but still as Defaulted; re-register as Treatment Regimen
within 8-month Yes
RAD and open a new
treatment treatment card.
regimen
Negative Close previous registration Restart Category II
as Defaulted; re-register Treatment Regimen
under Other and open a
new treatment card.

More than two Less than 2 No No, use same treatment Continue Category II
months weeks card. Treatment Regimen

2 to 8 weeks Positive Close previous registration Restart Category II


as Defaulted1; re-register Treatment Regimen
Yes as RAD and open a new
treatment card.
Negative No, use same treatment Continue Category II
card. Treatment Regimen.

More than 8 Positive Close previous registration Restart Category II


weeks but still as Defaulted; re-register as Treatment Regimen
within 8-month Yes RAD and open a new
treatment treatment card.
regimen
Negative Close previous registration Restart Category II
as Defaulted; re-register Treatment Regimen
under Other and open a
new treatment card.

1
This is the exceptional case categorizing as Defaulted a patient who interrupted treatment at less than 8 weeks.

47
F. Management of Referred Cases
1. Assess and categorize all TB cases properly referred for continuation of treatment by other
DOTS facilities as Trans-in and manage them in accordance with NTP policies and guidelines.
Return the duplicate referral form to the referring unit.
2. Evaluate all other referred patients in accordance with NTP policies and guidelines.

G. Management of TB in Special Situations*


1. Pregnancy
Ascertain whether or not a woman is pregnant before she starts TB treatment. Most

Case Holding
anti-tuberculosis drugs are safe for pregnant women, except Streptomycin, which is ototoxic
to the fetus. Advise a pregnant woman that successful treatment of TB with the recommended
standardized treatment regimen is important for a successful outcome of pregnancy.
2. Breastfeeding
A breastfeeding woman afflicted with TB should receive a full course of TB treatment.
Timely and properly applied chemotherapy is the best way to prevent transmission of tubercle
bacilli to the baby. All anti-tuberculosis drugs are compatible with breastfeeding. A woman
taking these drugs can safely continue to breastfeed. Mother and baby should stay together
and the baby may be breastfed in the normal way. Give the baby prophylactic isoniazid for at
least three months beyond the time the mother is considered to be non-infectious. Defer BCG
vaccination of the newborn until the end of isoniazid prophylaxis.
3. Oral Contraceptives
Rifampicin interacts with oral contraceptive medications with a risk of decreased
protective efficacy against pregnancy. Advise a woman receiving oral contraceptives while on
rifampicin treatment that she has the following options: 1) take an oral contraceptive pill
containing a higher dose of estrogen (50 ), following consultation with a clinician; or 2) use
another form of contraception.
4. Liver Disorders
Isoniazid, rifampicin, and pyrazinamide are all associated with hepatitis. Of the three
drugs, rifampicin is least likely to cause hepatocellular damage, although it is associated with
cholestatic jaundice. Of the three agents, pyrazinamide is the most hepatotoxic.
Patients with the following conditions can receive the usual short course chemotherapy
regimens provided there is no clinical evidence of chronic liver disease: hepatitis virus carriage;
a past history of acute hepatitis; and excessive alcohol consumption. However, hepatotoxic
reactions to antituberculosis drugs may be more common among these patients and should
therefore be anticipated.

* Source: Treatment of Tuberculosis: Guidelines for National Programs WHO/CDS/TB 2003.313

48
5. Established Chronic Liver Disease
Patients with liver disease should not receive pyrazinamide. Isoniazid plus rifampicin
plus one or two non-hepatotoxic drugs, such as streptomycin and ethambutol, can be used
for a total duration of eight months. Alternative regimens are 9RE or 9SHE in the intensive
phase, followed by HE in the continuation phase, with a total treatment duration of 12 months.
Recommended treatment regimens are therefore 2SHRE/6HR, 9RE, or 2SHE/10HE.
6. Acute Hepatitis (e.g., Acute Viral Hepatitis)
It is not common for a patient to have TB concurrently with acute hepatitis unrelated
to TB or TB treatment. Clinical judgment is necessary. In some cases, it is possible to defer
Case Holding

TB treatment until the acute hepatitis has been resolved. In other cases, when it is necessary
to treat TB during acute hepatitis, the combination of SE for three months is the safest option.
If the hepatitis has been resolved, then put the patient on a continuation phase of six months
isoniazid and rifampicin (6HR). If the hepatitis has not been resolved, SE should be continued
for a total of 12 months.
7. Renal Failure
Isoniazid, rifampicin, and pyrazinamide are either eliminated almost entirely by
biliary excretion or metabolized into non-toxic compounds. These drugs, therefore, can be
given in normal dosages to patients with renal failure. Patients with severe renal failure
should receive isoniazid with pyridoxine to prevent peripheral neuropathy.

Streptomycin and ethambutol are excreted by the kidney. Where facilities are
available to monitor renal function closely, streptomycin and ethambutol may be given in
reduced doses. The safest treatment regimen for patients with renal failure is 2HRZ/4HR.
8. Treating TB and HIV*
In patients with HIV-related TB, the priority is to treat TB, especially smear-positive
PTB to stop transmission. However, patients with HIV-related TB can have Anti-Retroviral
Therapy (ART) and anti-TB treatment at the same time, if managed carefully. Careful
evaluation is necessary in judging when to start ART. In the case, for example, of a patient
with a high risk of death during the period of TB treatment (i.e. disseminated TB and/or CD4
count <200/mm3), it may be necessary to start ART concomitantly with TB treatment. On
the other hand, for a patient with smear-positive PTB as the first manifestation of HIV
infection, who does not appear to be at risk of dying, it may be safer to defer ART until the
initial phase of TB treatment has been completed. This decreases the risk of immune
reconstitution syndrome and avoids the risk of drug interaction between Rifampicin and a
Protease Inhibitor (PI).

Possible options for ART in patients with TB includes the following:


• Defer ART until completion of TB treatment.
• Defer ART until the completion of the initial phase of TB treatment and then use
Ethambutol and Isoniazid in the continuation phase.

• Treat TB with a Rifampicin-containing regimen and use efavirenz + two Nucleoside


Reverse Transcriptase Inhibitors (NsRTIs).

* Source: TB/HIV A Clinical Manual, 2nd Edition WHO/HTM/TB/2004.329

49
V. Treatment Outcome

A. Cured - a sputum smear-positive patient who has completed treatment and is sputum smear-
negative in the last month of treatment and on at least one previous occasion in the continuation
phase

B. Completed Treatment - a patient who has completed treatment but has not met the criteria
for cure or failure
This group includes:

Case Holding
• A sputum smear-positive patient who has completed treatment but without DSSM follow -
up during the treatment, or with only one negative DSSM during the treatment, or without
DSSM in the last month of treatment.
• A sputum smear-negative patient who has completed treatment

C. Died - a patient who died for any reason during the course of treatment

D. Failed
• A patient who is sputum smear-positive at five months or later during the treatment
• An initially sputum smear-negative patient before starting treatment who becomes
smear-positive during the treatment. (Note: This case will be re-registered as Other with
a new TB case number.)

E. Defaulted - a patient who interrupted treatment for two consecutive months or more

F. Transferred out: A patient who transferred to another DOTS facility with proper referral slip
for continuation of treatment and whose treatment outcome is not known

VI. Summary Guides

The case holding procedure is summarized in the following Guide to Case Holding
and the accompanying Guide to Ensuring Treatment.

50
Figure 3.4. Guide to Caseholding

AT THE TREATMENT UNIT (DOTS Facility)


To be done by DOTS 1. Conduct health education for both patient and his/her family. Emphasize the
facility staff following key messages:
• Importance of regular drug intake;
• Results of irregular drug intake;
• Side effects of anti-TB drugs;
• Necessity of DSSM follow-up; and
• Importance of family and treatment partner support.
2. Conduct regular consultation meetings with patient and treatment partner
during the course of treatment.
Case Holding

To be accomplished 3. Monitor and record treatment regularity.


by DOTS facility staff • TB Register (nurse) (see Chapter 4, p. 67)
and treatment partner • NTP Treatment Card (midwife) (see Chapter 4, p. 60)
• NTP ID Card (Treatment Partner and TB patient) (see
Chapter 4, p. 63)

To be accomplished by 4. Do DSSM follow-up on time.


DOTS facility staff • Label container with the name of the patient.
• Collect 1 sputum specimen (preferably early morning specimen).
• Fill up the NTP Laboratory Request Form for DSSM (see Chapter 4, p. 56).Pack
the specimens securely and send to microscopy center, together with duly
accomplished NTP Laboratory Request Form for DSSM

AT THE MICROSCOPY CENTER


(To be accomplished by the Medical Technologist or Microscopist)
Register in the NTP Laboratory Register (see Chapter 4, p. 59).

Smear, fix, stain, and do microscopic examination.

Record the results in the NTP Laboratory Request Form for DSSM.
(see Chapter 4, p. 57) and in the NTP Laboratory Register (see Chapter 4, p. 59)

Send the NTP Laboratory Request Form for DSSM to the treatment unit.

AT THE TREATMENT UNIT (DOTS Facility)


To be accomplished Record DSSM results and due date of DSSM follow-up examination in the NTP
by DOTS facility staff Treatment Card ((see Chapter 4, p. 60). Any follow-up examination with smear-
positive results must be referred to the physician.
To be accomplished Record the results in the TB Register. (see Chapter 4, p. 67).
by DOTS facility staff

To be accomplished Inform treatment partner of DSSM results so that he/she can update the NTP ID
by DOTS facility staff Card (see Chapter 4, p. 63).

To be accomplished Upon Treatment Completion:


by DOTS facility staff 1. Evaluate and record treatment outcome in the TB Register (see Chapter 4,
p. 67) and NTP Treatment Card (see Chapter 4, p. 60).
2. Prepare and submit the Quarterly Report on Treatment Outcome (see Chapter
4, p. 79).

51
Figure 3.5 Guide to Ensuring Treatment

Recorded information should be checked to ensure consistency of records of TB patients

NTP Treatment Card

(To be accomplished by DOTS facility staff)


Record of Individual patients
• TB Case number

Case Holding
• Classification, type, and regimen
• DSSM results on diagnosis, for follow-up
• Drug collection
• Defaulter action
• Treatment outcome

The nurse should check the following NTP Laboratory Register


information weekly:
- is diagnosis correct? (To be accomplished by the MT)
- is treatment regimen approriate? Record of laboratory examination
- are all smear-positive cases registered and results
treated properly with DOT? - 3 sputum collections
- are drugs collected on time? - DSSM results on diagnosis / for
- are follow-up exams done on time? follow-up
- are treatments regular and effective?
- are actions taken to retrieve defaulters?

TB Register

(To be accomplished by the DOTS facility staff)


Record of Treatment Activity in the DOTS Facility
• TB Case number
• Classification, type, and regimen
• DSSM results on diagnosis, and for follow-up
• Defaulter action
• Treatment outcome

52
Recording and Reporting

Recording and reporting are important in the implementation of a successful TB control program.
Availability of records ensures provision of appropriate and effective care for patients. Through efficient
recording, health workers can monitor that each TB symptomatic found is examined and cured. Records,
therefore, should contain accurate, complete, and up-to-date information on patient’s diagnosis,
treatment, follow-up examinations, and treatment outcome.

Aside from information on patient’s coverage and care, records also provide information on
program efficiency and effectiveness, as well as availability of drugs and other NTP supplies at the
DOTS facilities. This section of the Manual of Procedures is designed to generate and provide the
minimum set of information, through various forms, required for program planning at different levels.

Recording and Reporting


I. OBJECTIVES

1. Provision of information that would help program implementers plan on how best to improve
the quality of DOTS services.
2. Provision of information that would help program supervisors plan on how best to assist TB
control program implementers

II. POLICIES

1. Recording and reporting for NTP shall be implemented at all DOTS facilities in the country,
including Public-Private Mix DOTS units, and government and private hospitals.
2. Recording and reporting shall include all cases of TB, classified according to internationally
accepted case definitions.
3. Recording and reporting for NTP shall use the FHSIS network for routine reporting and feedback.
4. Records and reports shall allow for the calculation of the main indicators for program evaluation
(see Chapter VI Monitoring, Supervision and Evaluation).
5. All quarterly reports should be sent to the DOH through channels (DOTS facility to PHO/CHO
to CHD to NCDPC-DOH). Quarterly reports should reflect the additionality of cases reported
from various units in the province/city/municipality (e.g. PPMD, hospitals, NGOs).

53
III. NTP RECORDING FORMS

These are the recording forms used by the NTP:


• TB Symptomatics Masterlist/TB Symptomatics Target Client List (Optional);
• NTP Laboratory Request Form for DSSM;
• NTP Laboratory Register;
• NTP Treatment Card;
• NTP Identification Card;
• TB Register;
• TBDC Masterlist;
• NTP Referral Form; and
• TBDC Referral Form

For recording forms used in the Quality Assurance for sputum microscopy, please refer to the
Recording and Reporting

Manual on Quality Assurance for Sputum Microscopy.

1. TB Symptomatics Masterlist /TB Symptomatics Target Client List


(Optional)

This record confirms the three sputum collections done at the DOTS facilities. Maintained
by the designated DOTS facility staff, the TB Symptomatics Target Client List of FHSIS may
be used in areas where the TB Symptomatics Masterlist is not available.

TB SYMPTOMATICS MASTERLIST

Family Date of Name Address Age Sex Date Sputum X-Ray TB Remarks
Serial Regis- (3) (4) (5) (5) Collected/ Examination Case (12)
No. tration Examiation Number
(1) (2) Results (11)
Date Date &
1st 2nd
(7) (8) referred Result (10)
for X-ray
(9)

54
Following are the information needed for each item on the TB Symptomatics Masterlist (to be filled
out by the midwife or any designated DOTS facility staff):

(1) Family serial number based on the family consultation record or annual serial number for
TB symptomatics in the clinic
(2) Date (mm/dd/yr) the TB symptomatic was discovered.
(3) Patient’s full name (family name written first in bold capital letters, followed by first name)
(4) Patient’s full address, including landmarks/telephone number (if possible) so the patient
can be traced in case he/she does not return to get his/her examination results
(5) Patient’s age in years
(6) Patient’s sex (M for male and F for female)
(7) Date (mm/dd/yy) when each sputum specimen was collected and corresponding results of
the first set of sputum specimen collected.
(8) Date and results of sputum collection in TB symptomatics who had doubtful smear results

Recording and Reporting


on the first examination
(9) Date (mm/dd/yr) patient was referred for an X-ray examination
(10) Date (mm/dd/yy) when X-ray result was received by DOTS facility staff and the results
(11) TB Case Number for patients who have been diagnosed with TB and registered
(12) Any significant information pertaining to symptomology and referral or diagnostic findings,
such as “patient with massive hemoptysis, referred to hospital”

Note: Target Client List (TCL) may be used as TB Symptomatic Masterlist in Public DOTS facilities.

55
2. NTP Laboratory Request Form for DSSM

This form is accomplished by the DOTS facility staff when he/she requests for DSSM (diagnosis
or follow-up). All specimens should be sent, together with this NTP Laboratory Request Form for
DSSM, to the microscopy center. The accomplished form should be returned immediately to the
referring unit with corresponding results from the medical technologist/microscopist.

NTP Laboratory Request Form for Direct Sputum Smear Microscopy


(Upper Portion)

To be filled out by Health Worker

Name of Collection unit: 1 Date of Submission: 2

Name of Patient: 3 Age 4 Sex M F 5

Address (in full) 6

Disease Classification: 7 Pulmonary Extra-pulmonary Site:


Recording and Reporting

Reason for Examination: 8 Diagnosis Follow-up

TB case No.
9
Specimen Date of Collection
1
2
3
10 11
Signature of Speciment Collector: Designation of Specimen Collector:

(Signature over Printed Name)

(Be sure to enter the patient’s TB case No. for follow-up of patient’s Chemotheraphy)

Following are the information needed on each item in the upper portion of the NTP Laboratory Request
Form for DSSM (to be filled out by the DOTS facility staff):
(1) Name of DOTS facility (BHS/RHU/PPMD/hospital) where sputum specimen was collected
(2) Date (mm/dd/yr) when sputum specimens were sent to the laboratory/microscopy unit
(3) Patient’s full name (family name first, followed by first name)
(4) Patient’s age in years
(5) Patient’s sex (Check M for male and F for female)
(6) Patient’s full address, including landmarks/telephone number (if possible) so the patient can be
traced in case he/she does not return to get his/her examination results
(7) Disease Classification: Check Pulmonary box if patient is a pulmonary TB suspect or the Extra-
Pulmonary box for TB of organs other than the lung, i.e., pleura (TB pleurisy), bones, genito-urinary
tract, etc., and the site (Specify the affected site).

56
(8) Reason for examination: Check Diagnosis Box for sputum specimen collected for diagnosis from
tuberculosis symptomatic (three-specimens). Check Follow-up Box to follow up smear status of
patients under treatment (one specimen) and write the TB case number.
(9) Date when each of the sputum specimens was collected [Date of collection of each sputum
specimen should correspond with number on the sputum container label: for diagnosis (three
specimens); for follow-up (one specimen)].
(10) Name and signature of Sputum Collector
(11) Designation of Specimen Collector

NTP Laboratory Request Form for Direct Sputum Smear Microscopy


(Lower Portion)

TO BE FILLED UP BY MEDICAL TECHNOLOGIST or MICROSCOPIST


SPUTUM MICROSCOPY RESULTS

Date Received: 1

Recording and Reporting


2
Laboratory Serial No:

Specimen Number 1 2* 3*

Visual Appearance** 3

Reading 4

Lab. Diagnosis 5

* Specimen Numbers 2 & 3 = not applicable if sputum follow-up


** Muco-purulent, blood stained, saliva, etc.

Date of Examination: 6 Examined by: 7


(Signature over Printed Name)

The completed form (with results) should be sent to the treatment unit to record the results on the
NTP Treatment Card and TB register.

Following are the information needed in the lower portion of the NTP Laboratory Request Form for
DSSM (to be filled out by the NTP medical technologist or microscopist):

(1) Date when sputum specimen was received with this form at the laboratory or microscopy
center

(2) Laboratory serial number assigned for every examination made, whether for
diagnosis or follow-up.

57
(3) Visual appearance of each specimen submitted (Quality of the specimens collected may
affect quality of the examination.) (For visual appearance of the specimens, use the
abbreviation M for muco-purulent, S for salivary, or QNS for inadequate specimen.)

(4) Readings of each specimen examined for DSSM based on this grading scale:

0 - no AFB found in 300 OIF

+n - 1 – 9 AFB in 100 OIF

1+ - 10 – 99 AFB in 100 OIF

2+ - 1 – 10 AFB/OIF in at least 50 visual fields

3+ - >10 AFB/OIF in at least 20 visual fields

(5) Over-all evaluation of specimens submitted for DSSM (A positive result should have at least
two specimens positive. A negative result should have at least three specimens negative.
A doubtful result has only one specimen positive.)
Recording and Reporting

(6) Date when the specimens were examined


(7) Name and signature of medical technologist or microscopist who examined the sputum
specimen

58
3. NTP Laboratory Register

This register, which contains all information on DSSM done by the medical
technologist/microscopist on TB symptomatics and TB patients undergoing treatment, is used in
validating microscopy data recorded on the TB Register. The medical technologist/microscopist
shall maintain this register at the microscopy center.

NTP LABORATORY REGISTER


Lab Date of Name Age Sex Name of Address Reason for Date of Re- Sig. of
Serial Regis- (3) (4) (5) Collection/ (7) Examination (8) Examination/ marks MT/Mi
No. tration Treatment Result (9) (10) crosco
(1) (2) Unit (6) pist
DX F-up (TB 1st 2nd (11)
case no.)

Recording and Reporting


Summary of DSSM (12)

For Diagnosis For Follow-up

No. of No. of symptomatics with No. of symptomatics No. of patients on No.of patients on follow-up
symptomatics 3 sputum specimens diagnosed as sputum follow-up with positive result
examined examined smear-positive

Following are the information that need to be recorded in the NTP Laboratory Register (to be filled
out by the medical technologist or microscopist):

(1) Laboratory serial number assigned for every examination made, whether for diagnosis or for
follow-up
(2) Date when first sputum specimen was received by the microscopy center
(3) Patient’s full name (family name first in bold capital letters, followed by first name)
(4) Patient’s age in years
(5) Patient’s sex (M for male and F for female)
(6) Name of DOTS facility where sputum for diagnosis was collected or name of treatment unit
for patients on follow-up
(7) Patient’s full address, including landmarks or telephone number (if available)
(8) Reason for examination: for diagnosis or follow up (Write TB case number if examination is
for follow-up.)
(9) Date of examination (mm/dd/yy) and results of each sputum specimen examination
(10) Significant information pertaining to the examination, i.e., positive, negative, doubtful, muco-
purulent, salivary, or inadequate specimen
(11) Name and signature of medical technologist or microscopist who examined the sputum
specimens
(12) Summary of DSSM results for diagnosis and follow-up should be done on every page.

59
4. NTP Treatment Card

All TB patients on treatment should have an NTP Treatment Card. This card contains all the
necessary information about the TB patient, the treatment he/she is receiving, drug intake and
collection, and results of DSSM done. The NTP Treatment Card is maintained and updated by the
DOTS facility staff at the DOTS facility where the patient is receiving treatment.

NTP Treatment Card


TB CASE NUMBER 1 DATE THE CARD IS REGION & NAME OF DOTS FACILITY
OPENED 2 PROVINCE
Month day year 3 4

NAME OF PATIENT OCCUPATION AGE SEX Contact Number


5
6 7 8 9
ADDRESS BCG Scar
10 11
[ ] Yes [ ] No [ ] Doubtful
NAME/RELATIONSHIP/ADDRESS OF CONTACT PERSON Contact Number of Responsible Person
12
13
SOURCE OF PATIENT HISTORY OF ANTI-TB DRUG INTAKE: [ ] No [ ] Yes No. of House Hold
[ ] Public [ ] Priviate 14 Contacts:
Duration: [ ] less than 1 mo. [ ] more than 1 mo. 16 17
NAME OF REFERRING PHYSICIAN
Specify drugs: ( ) <10 yrs old
Recording and Reporting

15 When: Where: Smear Status: ( ) > 10 yrs old

CLASSIFICATION OF TB: Category (encircle): 20 II. 2HRZES/1HRZE/5HRE


18 I. 2HRZE/4HR 1. Relapse
[ ] PULMONARY
New Case 2. Treatment Failure
[ ] EXTRA-PULMONARY site: 1. Smear (+) 3. Return After Default (RAD)
2. Seriously III 4. Other (smear+/-)
TYPE OF PATIENT:
19 2.1 Smear (-): with extensive
parenchymal lesion III. 2HRZE/4HR
[ ] New [ ] RETURN AFTER DEFAULT (RAD)
as assessed by the TBDC New Case
[ ] RELAPSE [ ] TREATMENT FAILURE
3. Extra-pulmonary 1. Smear (-): with Minimal extensive
[ ] TRANSFER- IN [ ] OTHER parenchymal lesion
as assessed by the TBDC

SPUTUM EXAMINATION RESULTS/WEIGHT RECORD 21 TREATMENT STARTED: month day year 22


TREATMENT OUTCOME:
Month Due Date Date Examined Result Weight(kg) [ ] CURED [ ] FAILED
23
0 Date: / / Date: / /
2 [ ]TREATMENT COMPLETED [ ] DEFAULTED
3 Date: / / Date: / /
4 [ ]DIED Specify:
5 Date: / / [ ] TRANSFERED OUT
6 Cause: Date: / /
>7 Specify:

Chest X-ray result (if applicable): 24 TBDC Findings and recommendations: 25

26 27
Name of Treatment Partner: Designation of Treatment Partner:

Drug intake (intensive phase) 28


Doses Cumulative
Month 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 18 20 21 22 2324 25 26 27 28 29 30 31 Given for Doses
this Month Given

Drug intake (Continuation phase) 29


Doses Cumulative
Month 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 18 20 21 22 2324 25 26 27 28 29 30 31 Given for Doses
this Month Given

REMARKS: 30

60
Following are the information that needs to be recorded on the form (to be filled out by the nurse or
designated DOTS facility staff):
(1) TB Case Number assigned to a TB case from the TB register
(2) Date when NTP Treatment Card was opened
(3) Name of region and province where the treatment facility is located
(4) Name of DOTS facility where patient is receiving TB treatment
(5) Patient’s full name (family name first in bold capital letters, followed by first name)
(6) Patient’s occupation
(7) Patient’s age in years
(8) Patient’s sex (M for male and F for female)
(9) Patient’s contact number (if available)
(10) Patient’s full address, including landmarks
(11) Presence/absence of BCG scar on patient
(12) Name/relationships/address of a person who can assist the patient for regular treatment during

Recording and Reporting


the entire treatment course
(13) Contact number of responsible person
(14) Source of patient whether from the private or public sector. For private-initiated PPMD units, all
patients registered in their facility for treatment is considered private. For public-initiated PPMD
units and public DOTS facilities, private refers to patients referred by private referring physicians
and public refers to all walk-in patients or those referred by government physicians and hospitals.
(15) Name of referring physician
(16) History of patient’s previous TB treatment (If patient has had previous TB treatment history, mark
Yes and mark whether it is less than a month or more than a month. Specify drug administered
to patient, year, and place where the patient received anti-TB drugs. Include also the result of the
DSSM, if known. )
(17) Number of persons living with the patient, aged below 10 years old or 10 years old and above
(18) Patient’s classification (pulmonary or extra- pulmonary TB)
(19) Type of patient based on previous TB treatment history and results of DSSM before treatment
(New, Relapse, Transferred In, Return After Default, Treatment Failure, Other).
(20) Category of Treatment. Encircle the category of treatment regimen that will be given to the patient.
(21) Sputum examination results/Weight record. Month 0 pertains to the DSSM result before treatment.
Indicate date patient was examined and the DSSM result before treatment in the columns designated.
For the results, write the highest grading among the three specimens examined. The Due Date
for follow-up DSSM, Date Examined when the sputum examination is actually made, and Result
of the follow-up sputum examination should be noted down carefully in the columns of Month 2
to Month 7 according to the schedule of follow-up DSSM. In the last column, write patient’s weight
in kilograms during follow-up DSSM.

61
(22) Date (mm/dd/yy) when first dose was actually taken by patient
(23) Treatment Outcome: Cured, Treatment Completed, Died, Failed, Defaulted, Transferred Out. Date
is when the patient stopped taking medicines.
(24) Result of patient’ chest x-ray
(25) TBDC findings and recommendations
(26) Name of treatment partner assigned to patient
(27) Designation of treatment partner: PHN, RHM, BHW or FM
(28) Drug intake during the intensive phase. Write the month when the patient started treatment in the
first column and initial the corresponding day of drug intake. The treatment partner will place his
initials in the corresponding column for the day the treatment was directly observed. X will be
drawn in the box if the patient missed taking the drugs. If the drugs will be self administered by
the patient draw a horizontal line. At the end of the month count the total number of doses given
to the patient and write in the corresponding column. The last column is the cumulative count of
the total number of doses given to the patient. This will facilitate the counting of the doses that the
Recording and Reporting

patient still needs to take to complete the intensive phase of treatment.


(29) Drug intake during the continuation phase. Fill up this table in the same manner as in filling up the
intensive phase of treatment.
(30) Record pertinent information that occurred during the treatment course, i.e., adverse reactions and
reasons for failure to follow-up or defaults tracing action done.

62
5. NTP Identification Card
All TB patients should be issued an NTP Identification card. This is a source of information
on the patient‘s diagnosis, treatment regimen, schedule of drug-taking, and DSSM results.
Both the TB patient and the treatment partner should have a copy of the NTP ID card.
The treatment partner initials the NTP ID Card each time he/she sees the patient take
his/her drugs. The treatment partner keeps and maintains the NTP ID card to monitor the
patient’s drug compliance.

Certification NTP
Identification Card
This certifies that the patient, TB Case No. 1
6
bearer of this NTP ID card, has been
CURED (completed the required treatment,
Mga Paalala
daily supervised by the health 1. Ang TB ay nakakahawa pero nagagamot.

Recording and Reporting


personnel/BHW of 2. Ang mga gamot ay kailangan araw-araw
7 RHU/Health na inumin upang tuluyang gumaling.
3. Kailangang magpasuri ng plema sa
Center and, with negative smear follow-up
itinakdang araw ng health worker upang
result at the end of the treatment).
malaman kung gumaling na.
8 4. Kapag magaling ka na higit kang
Issued this day of , 20 makakatulong sa iyong pamilya at
kabarangay.
2
Name of DOTS facility:
9
Name of Patient: 3
Physician
(Signature over Printed Name) Address: 4

Treatment Partner/s: 5

10 11 12
Disease Classification Category [ ] I [ ]II [ ] III Type of Patient
[ ] Pulmonary Date Treatment started [ ] New [ ] Treatment Failure
[ ] Extra-pulmonary [ ] Relapse [ ] Return after Default
Site Mo. Day Year [ ] Trans-in [ ] Other

13
Sputum Examination Results/Weight
Schedule Before 1 2 3 4 5 6 >7
Tx mo mos mos mos mos mos mos
Date of exam
Result
Weight

Drug intake (Intensive phase) 14

Doses Cumulative
Month 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 18 20 21 22 2324 25 26 27 28 29 30 31 Given for Doses
this Month Given

Drug intake (Continuation phase) 15


Doses Cumulative
Month 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 18 20 21 22 2324 25 26 27 28 29 30 31 Given for Doses
this Month Given

63
(1) TB Case Number assigned to a TB case from the TB register
(2) Name of health facility/treatment unit where patient is receiving TB treatment
(3) Patient’s full name (family name first in bold capital letters, followed by first name)
(4) Patient’s full address, including landmarks/telephone number (if available) to easily trace him/her
(5) Treatment partner’s full name (family name first in bold capital letters, followed by first name)
(6) Name of the patient
(7) Name of DOTS facility where the patient is taking his/her treatment
(8) Date when the patient was declared cured
(9) Name of the DOTS facility physician
(10) Disease classification (Check if pulmonary or extra-pulmonary. Specify site.)
(11) Prescribed treatment regimen and exact date when treatment started (mm/dd/yr)
(12) Type of patient (Check if New, Relapse, Transfer-in, Treatment Failure, Return After Default, or
Other.)
(13) Data on all DSSM done. (Indicate date when the DSSM was done. For the results, write the highest
Recording and Reporting

grading among the three smears examined. Specify patient’s weight in kilograms during follow-
up DSSMs.)
(14) Drug intake during the intensive phase. Write the month when the patient started treatment in the
first column and initial the corresponding day of drug intake. The treatment partner will place his
initials in the corresponding column for the day the treatment was directly observed. X will be drawn
in the box if the patient missed taking the drugs. If the drugs will be self administered by the patient
draw a horizontal line. At the end of the month count the total number of doses given to the patient
and write in the corresponding column. The last column is the cumulative count of the total number
of doses given to the patient. This will facilitate the counting of the doses that the patient still needs
to take to complete the intensive phase of treatment.
(15) Drug intake during the continuation phase. Fill out this table in the same manner as in filling up
the intensive phase of treatment.

64
6. TB Register
This register gives information on the type and classification of TB cases, treatment regimen,
DSSM results, and treatment outcome of all patients registered in the DOTS facility. The nurse at
the DOTS facility maintains this register. This is one of the main sources of data in the calculation
of case detection rate, cure rate, and other program indicators.

TB REGISTER
Year:

DATE OF TB NAME AGE SEX ADDRESS HEALTH Source of Name of CLASS OF CATE-
TYPE OF PATIENT (11)
REGISTRA CASE NO. FACILITY Patient (8) Referring TB DIAG. GORY
TION Physician (P/EP) (12)
(1) (2) (3) (4) (5) (6) (7) Pub Pri (9) (10)
New Re- Trans. Re- Treat Other
lapse In turn ment
after Fai-
default lure

Recording and Reporting


(13)
New Smear Relapse Trans-in Return After Treatment Other Smear EP
Positive Default Failure Positive Negative Negative

M F M F M F M F M F M F M F M F M F

(13)

Total Number of Patients under the following Categories

Category I Category II Category III

65
Following are the information that needs to be recorded on the form (to be filled out by nurse):

(1) Exact date when the patient was registered in the TB Register
(2) Case Number assigned to a TB case after registration
(3) Patient’s full name (family name first in bold capital letters, followed by given or first name)
(4) Patient’s age in years
(5) Patient’s sex (M for male and F for female)
(6) Patient’s complete address, including phone number and nearest landmark, if available, to easily
locate patient
(7) Name of DOTS facility or treatment unit where the patient is receiving treatment
(8) Source of Patient wheather from the private or public sector. For private-initiated PPMD units,
all patients registered in their facility for treatment is considered private. For public-initiated PPMD
units and public DOTS facilities, private refers to patients referred by private referring physicians
and public refers to all walk-in patients or those referred by government physicians and hospitals.
(9) Name of referring physician
Recording and Reporting

(10) Disease classification: “P” for Pulmonary TB, “EP” for Extra-Pulmonary TB
(11) Type of patient under the appropriate column provided
(12) Prescribed treatment regimen by Category: I, II, III
(13) Summary of the different types of TB patients and category of treatment regimens should be done
on every page.

66
TB REGISTER

DATE SPUTUM EXAMINATION RESULTS/ TREATMENT OUTCOME Type TBDC Remarks


STARTED WEIGHT RECORD (14) (15) of Tx Review (CXR result
TX (13) (upper space: date of exam / middle Partner (Y/N) etc)
row: results / lower space: weight) (16) (17) (18)
nd rd th th th th
Before 2 mo. 3 mo. 4 mo. 5 mo. 6 mo. >7 mo. Cured Tx Died Failed Defaulted Trans Out
TX. Compl.

Recording and Reporting


(19)
Type of Patient Cured Tx completed Died Failed Defaulted Trans-out
New Smear-Positive

New Smear-Negative

Relapse
Treatment Failure

Return After Default

Following are the information needed for each item on the TB Register (to be filled out by the nurse):

(13) Date when patient first started treatment


(14) DSSM done (Indicate date of examination in the upper row, examination results in the middle row,
and weight in kilogram in the lower row.)
(15) Appropriate treatment outcome and exact date (mm/dd/yr) when patient stopped or completed
treatment or his/her last day of drug intake
(16) Treatment Partner: PHN / RHM / BHW / FM / Others
(17) TBDC review for smear-negative cases only. Write Y if case was evaluated and N if not done
(18) Remarks (Result of CXR and any information about the patient’s status or any action taken on
his/her behalf). For patients that will be re-registered write the new TB case number in the old
registration and the previous TB case number in the new registration.
(19) Summary of treatment outcome per type of patient should be done on every page.

67
7. TBDC Masterlist
This register, maintained by the TBDC secretariat, gives information on all smear-negative TB
suspects referred to and evaluated by the TBDC.

TBDC MASTERLIST
No. Referring Patient’s Patient Age Sex Occu- Date Date of TBDC Diagnosis (11) Tx.
(1) Unit (2) Name (3) Type (5) (6) pation Address (8) of Refe- TBDC Category
(N/R) (7) rral (9) Meeting Act. TB Inactive Other LD (I, II or III)
(4) (10) (N/R) TB (12)
Recording and Reporting

Note: Patient type (from referring unit) – write N if new and R if re-treatment; TBDC Diagnosis (1) Active TB – write N if new and R if re-treatment; (2)
Inactive TB – check this column if inactive case; (3) Other Lung Disease – check this column if other lung disease; Treatment category - refers
to the category of anti-TB treatment recommended by the TBDC (I, II, III).

Following are the information needed for each item on the TBDC Masterlist (to be filled out by the
TBDC Secretariat – NTP Nurse Coordinator):

(1) Serial number of patient referred to the TBDC


(2) Name of referring DOTS facility
(3) Patient’s name, family name first followed by first name and the middle initial
(4) Patient type (Write N for new case and R for re-treatment)
(5) Patient’s age in years
(6) Patient’s sex (M for male and the F for female)
(7) Patient’s occupation
(8) Patient’s exact address, including phone number and landmark, if available, to easily locate
the patient
(9) Date (mm/dd/yy) when the patient was referred to TBDC
(10) Date (mm/dd/yy) when the TBDC meeting was conducted to evaluate the patient
(11) Result of the TBDC evaluation
• If patient is with active TB, write N for new or R for re-treatment case under the
column Active TB
• If patient is diagnosed with inactive TB, put a check mark under this column
• If patient is diagnosed to have other lung disease, put a check mark under this column.
(12) Treatment Category given to the patient, if applicable.

68
NTP Referral Form
(Fill out in duplicate)
TB CASE NUMBER 1

2
To:

Please facilitate completion of treatment of patient bearing this referral form.


(To be accomplished by Referring Treatment Unit)

Name of Referring Unit: 3 Contact/Fax number/ email address 4


Full address of Referring Unit: 5
7 8 9 10
Name of Patient: 6 Age: Sex: [ ] M [ ] F Weight: Date Treatment Started
11
Present Address of Patient Patient’s Contact No. 12
New Address of Patient 13 Patient’s New Contact No.14
17
16
Classification of the Patient 15 Type of the Patient Category of Treatment
[ ] Pulmonary [ ] New [ ] Relapse [ ] Category I
[ ] Extra-pulmonary, [ ] Treatment Failure [ ] RAD [ ] Category II
site: [ ] Transfer-In [ ] Other (+) / (-) [ ] Category III

Recording and Reporting


Treatment Course and Smear Examination results 18

Month/Drugs Before
Treatment
1 2 3 4 5 6 7 8 9 10

FDC A
FDC B
H
R
Z
E
S
Smear exam. result
*Check the appropriate column of the number of months the drugs were taken. If drugs were taken for less
than a month, write the number of days the patient took the drugs in the appropriate column.

Remarks: 19
Printed Name & Signature of Referring DOTS staff
20 Designation 21 Date Referred 22

(To be accomplished by the Receiving Treatment Unit)


Date Received: 23

Name of Receiving Unit 24 Telephone/Fax Number 25


Full address of Receiving Unit 26 29
Name of Patient 27 Age: 28 Sex: [ ] M [ ] F TB Case No. 30
Name of Receiving DOTS Facility Staff & Signature 31 Designation 32
(Please send back a copy of this form to the Referring Unit as soon as patient has resumed treatment and registered.)

69
Following are the information needed on each item of the NTP Referral Form (to be filled out by the
DOTS facility staff):

(1) TB case number of the patient


(2) Name of DOTS facility where the patient will be referred
(3) Name of DOTS facility where the patient is registered and receiving treatment for TB
(4) Contact/fax number or e-mail address(if available) of the DOTS facility where the patient is registered
(5) Full address of the DOTS facility where the patient is registered
(6) Patient’s full name (family name first, followed by first name)
(7) Patient’s age in years
(8) Patient’s sex (M for male and the F for female)
(9) Patient’s weight in kilograms
(10) Date (mm/dd/yy) patient started on treatment as indicated in the NTP Treatment card
(11) Patient’s present complete address
(12) Patient’s contact number
Recording and Reporting

(13) New address of the patient


(14) Patient’s new contact number
(15) Patient’s classification (Check if Pulmonary or Extra-pulmonary. Indicate site.)
(16) Patient’s type (Check if New, Relapse, Treatment Failure, Return After Default, Transfer-in, Other.)
(17) Appropriate treatment regimen prescribed to the patient (Check if Category I, II. or III.)
(18) Drugs prescribed for the patient and DSSM results on diagnosis and for follow-up.
(19) Any pertinent action on the patient’s referral or transfer (e.g., “transferred for continuation of
treatment” or “with massive hemoptysis, advised for hospitalization”)
(20) Person who accomplished the NTP Referral Form (printed name and signature)
(21) Designation of person referring the patient
(22) Date (mm/dd/yy) when this NTP Referral Form was accomplished
(23) Date (mm/dd/yy) the NTP Referral Form was received
(24) Name of Receiving Treatment Unit
(25) Telephone/fax number of the receiving treatment unit
(26) Full address of the receiving unit.
(27) Name of the patient
(28) Patient’s age in years
(29) Patient’s sex (M for male and the F for female)
(30) New TB case number of the patient
(31) Person who accomplished the NTP Referral Form (printed name and signature)
(32) Designation of person who has received the patient

70
9. TBDC Referral Form
This form gives information on the results of DSSM, chest X-ray and PE findings, history
of present illness, and history of anti-TB drug treatment. It also contains the findings and
recommendations of the TBDC. This form should be filed out by the nurse in the DOTS facility
once returned by the TBDC.

TB Diagnostic Committee (TBDC) Referral Form

(To be filled out by the referring unit)


TBDC name: CHD: Province/City:
Referring unit: Date of Referral:
I. Patient’s Data
Name: Age: Sex: M [ ] F[ ]
Address: Occupation:
Contact Person: Relation to Patient:
Address:

2. DSSM Result 1st set 2nd set


Date of examination
Result

3. History of present illness (signs/symptoms), other information, and relevant physical findings
Signs/symptoms and duration Other signs/symptoms, duration, any important history (e.g. TB

Recording and Reporting


[ ] cough exposure, smoking history, co-existing disease, etc.)
[ ] sputum production
[ ] hemoptysis
[ ] fever
[ ] weight loss Important PE findings:
[ ] tiredness
[ ] chest/back pain
[ ] dyspnea

4. List any treatment taken for the present illness.


State the duration of treatment.

5. History of relevant past illness


(PTB and/or other diseases)

6. History of past anti-TB treatment yes [ ] no [ ]

6a. If yes, check the anti-TB drugs taken. Indicate the dates, duration of drug intake & treatment outcomes
Drug Date Duration of Intake 6b. Outcome of past anti-TB treatment:
[ ] INH [ ] < 1 mo. [ ] 1mo or > [ ] Cured Remarks re: past treatment
[ ] RMP [ ] < 1 mo. [ ] 1mo or > [ ] Completed
[ ] PZA [ ] < 1 mo. [ ] 1mo or > [ ] Not completed
[ ] EMB [ ] < 1 mo. [ ] 1mo or > [ ] Failed
[ ] Strep [ ] < 1 mo. [ ] 1mo or > [ ] Not known

7. Referring unit’s clinical impression: 7a. Any treatment prescribed by referring unit:
[ ] Active TB [ ] New [ ] Re-treatment
[ ] Inactive TB [ ] Other (non-TB lung disease)

8. TBDC diagnosis (to be filled up by the TBDC secretariat)

8a. [ ] Active TB 8b. [ ] Inactive TB 8c. [ ] Other lung disease 8d. [ ] Others
[ ] new
[ ] re-treatment

9. TBDC recommendations (Please print; use additional pages if necessary)


[ ] Anti-TB treatment Category [ ] I [ ] II [ ] III [ ] start [ ] re-start [ ] continue
[ ] No anti-TB treatment
[ ] Stop anti-TB treatment

Others:

10. TBDC Chairperson (for referring unit)


(print and sign) 13. Received by:

11. TBDC secretariat


(print and sign)

12. Date of TBDC meeting: 14. Date received:

71
Following are the information needed for the upper portion of the TBDC Referral Form (to be filled out
by DOTS facility staff)

TBDC Data – Name of the TBDC, the CHD and Province/City where it belongs

Data on Referring unit – Name of the Referring unit and the date (mm/dd/yy) when the referral was
made

(1) Data on patient

• Full name (family name first, followed by first name)


• Complete address
• Age in years
• Occupation
• Sex (M for male, F for female)
Data on contact person
Recording and Reporting

• Full name (family name first, followed by first name)


• Complete Address
• Relation to patient
(2) Results of DSSM (Indicate results of the first and second set collection.)
(3) History of present illness (Indicate all relevant signs/symptoms and duration, as well as important
physical examination findings.)
(4) Treatment previously taken for present illness (Specify treatment and duration.)
(5) History of relevant past illness (Indicate whether or not patient has had PTB
and/or other diseases.)
(6) Past anti-TB treatment (List all treatment regimens undergone.)
(6.a) Checklist of anti-TB drugs taken (For each drug, specify date taken and duration of intake.)
(6.b) Outcome of past anti-TB treatment (Specify if: patient has been cured; treatment completed
or not completed; treatment failed; or outcome of treatment is not known. Indicate additional
remarks about previous treatment.)
(7) Referring unit’s clinical impression (Indicate whether it is active TB, inactive TB, new, re-
treatment, or other non-TB lung disease.

(7.a) Treatment prescribed by referring unit

Following are the information needed for the lower portion of the TBDC Referral Form (to be
filled out by the TBDC secretariat – NTP Nurse Coordinator):

(8) TBDC diagnosis


(8.a) Active TB (Check if new or re-treatment.)
(8.b) Inactive TB
(8.c) Other lung disease
(8.d) Others

72
(9) TBDC recommendation
Specify:
• Anti-TB treatment, No anti-TB treatment, or Stop anti-TB treatment
• Treatment regimen Category I, II, or III
• Start, re-start, or continue treatment
• Write down additional impressions or instructions. Use additional page/s, if
necessary.
(10) Printed name and signature of the TBDC chairperson
(11) Printed name and signature of person responsible in the TBDC secretariat
(12) Date of TBDC meeting when referral was evaluated
(13) Printed name and signature of person in referring unit who received the accomplished
TBDC Referral Form
(14) Date (mm/dd/yy) when referring unit received back TBDC Referral Form

Recording and Reporting


IV. Persons Responsible for the Recording Forms

Table 4.1. Persons Responsible for the Recording Forms

Responsible for
Responsible for Initial
Records Maintenance and
Recording
Updating

TB Symptomatics Masterlist/TB Designated DOTS Facility Staff Designated DOTS


Symptomatics Target client List Facility Staff
(optional)

NTP Laboratory Request Form for Designated DOTS Facility Staff


Sputum Examination

NTP Laboratory Register Medical Technologist and Medical Technologist


Microscopist and Microscopist

NTP Treatment Card Nurse Designated DOTS


Facility Staff

NTP Identification Card Nurse Treatment Partner

TB Register Nurse Nurse

NTP Referral Form Nurse/Physician Nurse/Physician

TBDC Masterlist NTP Nurse Coordinator NTP Nurse Coordinator

TBDC Referral Form Physician/Nurse Physician/Nurse

73
V. NTP REPORTING FORMS

The NTP Reporting Forms consist of the following:


• NTP Quarterly Report on Laboratory Activities;
• NTP Quarterly Report on All TB Cases;
• NTP Quarterly Report on Drug Inventory and Requirement;
• NTP Quarterly Report on Treatment Outcome;
• Quarterly TBDC Accomplishment Report; and,
• EQA reports – (refer to the Manual on Quality Assurance for Sputum Smear Microscopy)

1. NTP Quarterly Report on Laboratory Activities

This report provides information on the total number of TB symptomatics’ collected


sputum specimens and the total number of smear-positive cases identified quarterly. This is
accomplished by the medical technologist or microscopist at the microscopy center of the
Recording and Reporting

DOTS facility. The source of data for this report is the NTP Laboratory Register. An optional
Counting Sheet for Laboratory Activities Report is also available.

The NTP Quarterly Report on Laboratory Activities is submitted to the provincial or city
NTP Coordinators who consolidate and analyze the data. The CHD NTP coordinators collate
and analyze the data from provinces, cities and PPMD units. Collated data are then submitted
to the National Center for Disease Prevention and Control (NCDPC) of the Department of
Health.

74
Quarterly Report on NTP Laboratory Activities
(Source of Data- NTP Laboratory Register)

Name of Province/City: TB symptomatics/patients

Name of DOTS Facility: Examined during Quarter of

Total population of catchment area: Date Reported:

Prepared by:

Designation:

Casefinding:

Laboratory activities TOTAL

Recording and Reporting


1. No. of TB Symptomatics examined:

2. No. of TB Symptomatics with 3 sputum specimens:

3. No. of TB Symptomatics diagnosed as smear-positive


with 2 or more positive results:
(including the number of doubtful cases in the
1st collection with at least one positive result
in the 2nd collection set)

4. Positivity Rate*

5. No. of TB Symptomatics with Doubtful result:

Treatment Follow-up

6. No. of follow-up examinations done

7. Number of smear-positive cases among


the follow-up examinations
∗ Positivity rate is an important indicator of microscopy performance.
Positivity Rate = Total no. of sputum smear positive cases x 100
Total no. of TB symptomatics examined

75
COUNTING SHEET FOR LABORATORY ACTIVITIES REPORT (Optional)
_______ Quarter of _______

Page START TOTAL No. of TB No. of TB No. No. No.


Lab. Persons Sympto- Sympto- of TB of TB of
No. matics matics Sympto- Sympto- Follow-up
Examined with 3 matics matics Examina-
Sputum with 2 or with tion
Specimens more Doubtful Done
Positive Results

5
Recording and Reporting

10

2. NTP Quarterly Report on All TB Cases


This report summarizes the NTP case finding on all TB cases (new smear-positive cases,
relapses, treatment failure, Return After Default, Other, smear-negative cases, and extra-pulmonary)
for monitoring and evaluation of program implementation. This is accomplished by the nurse at the
DOTS facility. Source of data for this report is the TB Register.

The NTP Quarterly Report on All TB Cases is submitted to the provincial or city NTP coordinators
who consolidate and analyze the data. The CHD NTP coordinators collate and analyze the data
from provinces, cities and PPMD units. Collated data are then submitted to the NCDPC of the DOH.

76
Quarterly Report on All TB Cases
(Source of Data – TB Register)

Name of CHD: Patients Registered during the Quarter of year

Name of PHO/CHO: Date Submitted:

Name of DOTS facility: Prepared by:


Name and Designation

A. All TB cases registered during the quarter:


New Relapse Trans-in RAD Treatment Other (6) New Smear- Extra-
Type of Smear- (2) (3) (3) Failure Negative pulmonary
Patient/Sex/ Positive (1) (5) (7) (8)
DOTS facility Positive Negative
M F M F M F M F M F M F M F M F M F

Public

Private

Subtotal

Recording and Reporting


Total

B. Breakdown of New Pulmonary smear-positive cases by age and sex:


Age-group (years)
65 and
0-9 10 - 14 15 - 24 25 - 34 35 - 44 45 - 54 55 - 64 above Total
M F M F M F M F M F M F M F M F M F Total*

* Should be the same as the total in Column 1 of A

C. Treatment Regimen given:

Type of Treatment Regimen Category I Category II Category III

Cases initiated treatment

3. NTP Quarterly Report on Drug Inventory and Requirement

This report contains the summary of the number of cases according to category of treatment
regimen to calculate the drug requirement at the DOTS facility and provinces. Source of data
for this report is the TB register. The nurse accomplishes this report, which he/she submits to the
provincial or city NTP coordinators. The provincial and city NTP coordinators consolidate data and
submit these to the CHD NTP coordinators. The CHD NTP coordinators then consolidate and
submit report to the NCDPC of the DOH.

77
Drug Inventory and Requirement Report
(Source of Data – Quarterly Reports and Physical inventory)

Category No. of STOP TB Kit STOP TB H syr R syr Z syr


Cases Categories Kit (200mg/ (200mg/ (250mg/
I & III Category II 5 ml 5 ml 5 ml
120ml) 120ml) 120ml)
I & III
II
Total for Cat. I, II & III
Total + Buffer
(Total multiplied by 2)
Available on hand
Re-order for
Cat. I, II & III

Childhood TB (x 7) (x 7) (x 4)
Total + Buffer
(Total multiplied by 2)
Recording and Reporting

Available on hand
Total re-order

Category No. of F D C A FDC B E S H syr R syr Z syr


Cases ( H R Z E ) (HR) (BP) (vial) (200mg/ (200mg/ (250mg/
(BP) (BP) 5 ml 5 ml 5 ml
120ml) 120ml 120ml
I & III (x 6) (x 12)

II (x 9) (x 15) (x 10) (x 56)

Childhood TB (x 7) (x 7) (x 4)

Total for Cat. I, II & III


Total + Buffer
(Total multiplied by 2)

Available on hand

Total

78
4. NTP Quarterly Report on Treatment Outcome

This report contains information on the outcome of treatment for a group of patients who were
treated 13-15 months earlier. Such information serves as basis for evaluating the effectiveness of
treatment regimen. Source of data for this report is the TB register. This report is accomplished by
the nurse.

The NTP Quarterly Report on Treatment Outcome is submitted to the provincial or city NTP
coordinators who will consolidate and analyze the data. The CHD NTP coordinators will collate and
analyze the data from the provinces, cities and PPMD units. Collated data shall be submitted to the
NCDPC of the DOH.

NTP Quarterly Report on the Treatment Outcome of Pulmonary TB Cases


(Source of Data – TB Register)

Recording and Reporting


Name of Region: Patients registered during the Date Reported :
Name of PHO/CHO: Quarter of Prepared by :
Name of DOTS facility : Designation:

Total Number of (1) (2) (3) (4) (5) (6) (7)


Pulmonary TB Cases
( Copy the total Cured Com- Died Failed Defaul- Trans- Total
Type pleted ted ferred No.
number reported in Treat- out Evalua-
the Case Finding ment ted
Report during the
same quarter)

1. New Cases

1.1 Smear ( + )
1.2 Smear ( - )
2. Re-treatment

2.1 Relapse
2.2 Treatment Failure
2.3 Return After
Default
Grand Total

* Of these, ___________(number) were excluded from evaluation of chemotherapy for the following reasons:
_____ Trans-in
_____ Extra-pulmonary
_____ Other

79
5. Quarterly TBDC Accomplishment Report

This report contains information on the total number of cases referred from different health
facilities and evaluated by the TBDC, with the corresponding findings and recommendations. This
serves as the basis for monitoring and evaluation of the quality of diagnosis among referred smear-
negative, X-ray positive cases. The sources of data for this report are the TBDC Referral Forms
and TBDC Masterlist. The NTP nurse coordinator accomplishes this report and submits it to the
CHD NTP coordinator. Collated reports are submitted to the NCDPC of the DOH.

QUARTERLY TBDC ACCOMPLISHMENT REPORT FORM

Name of Region: Name of Province/City:


Recording and Reporting

Name of the TBDC: Date Submitted:


Data for the Quarter Prepared by:
year

1. Total no. of (smear-neg./X-ray pos.) TB symptomatics referred to TBDC

TBDC Diagnosis
2. Total number of active TB cases diagnosed by TBDC
2.1. Classification of active TB cases diagnosed by TBDC TB, New:
TB Retreatment:
Total:
3. Total number of inactive TB patients
4. Total number of patients diagnosed as “other lung disease”
5. Total number of patients evaluated by TBDC for this quarter
6. Total number of patients recommended by the TBDC for
anti-TB treatment this quarter

80
Following are the information needed in the Quarterly TBDC Accomplishment Report Form:

General Information: Name of Region and province/city and CHD, Name of the TBDC, Date (mm/dd/yy)
when the report was submitted, Quarter of the year that the data are reported and Name and Signature
of the person who prepared the report.

(1) Total number of TB symptomatics referred to TBDC.


(2) Total number of active TB cases diagnosed by the TBDC
Classification of referred TB cases diagnosed by TBDC
• Number of new TB cases
• Number of re-treatment TB cases
• Total TB cases (new + Re-treatment)
(3) Total number of inactive TB patients
(4) Total number of patients diagnosed as “Other Lung Diseases”

Recording and Reporting


(5) Total number of patients evaluated by the TBDC for the present quarter
(6) Total number of patients recommended by the TBDC for anti-TB treatment in this quarter

81
Logistics Management

One of the five components of the DOTS strategy is uninterrupted supply of quality-assured
anti-TB drugs ( isoniazid, rifampicin, pyrazinamide, ethambutol, and streptomycin). Therefore all DOTS
facilities should have adequate supply of these anti-TB drugs to ensure that drugs are available when
patients need them. An adequate supply of anti-TB drugs would also result to prevention of TB transmission
and development of multi-drug resistant cases. NTP supplies should also be adequate to ensure
continuous detection of TB cases. NTP supplies include sputum cups, glass slides and slide boxes,
reagents, syringes, and recording and reporting forms.

To ensure the regular supply of anti-TB drugs and their appropriate use, each step of the anti-
TB drug management cycle must be followed (Figure 5.1). The NTP coordinators should closely monitor
the entire process even if they are not directly responsible for each step.

Figure 5.1. Anti-TB Drug Management Cycle

Product
Selection

Logistics Management
Management Support
- information system
Rational Use,
- organization/staffing
Monitoring & Procurement
- budgeting
Evaluation
- training

Distribution
and Storage

I. Product Selection. Product selection is the process of establishing a limited list of essential anti-
TB drugs to be procured based on the treatment guidelines. Specifications of each drug should be
defined and should include the following: drug description; generic name; local trade name; dosage
form; strength; and package presentations.

82
II. Procurement. Procurement is the process of acquiring anti-TB drugs through purchase or donation.
The process includes quantifying drug needs, selecting methods for purchasing, selecting reliable
suppliers, managing tenders, assuring quality, and ensuring compliance with contract terms.

The NTP coordinator’s contribution to procurement usually involves estimation and calculation
of the quantities of each drug needed. The NTP coordinator must also ensure that drugs and other
supplies are correctly quantified so that every TB patient can begin treatment without delay and
complete treatment without interruption. If the budget does not cover the cost of all drugs to be
procured, the quantity of drugs must be decreased according to the number of cases, since all
drugs must be available when needed by the patient.

III. Distribution and Storage. Distribution is the process by which procured anti-TB drugs are received
at the port of entry, cleared through customs, and transported from the central warehouse to the
regional, provincial health offices, up to the DOTS facilities where they are dispensed to the patients.
Distribution of drugs from the time these were received at the port until these are distributed to the
different health facilities should be monitored carefully. TB drugs should be cleared rapidly through
customs to avoid deterioration in the port of entry.

Quality and quantity of TB drugs should be inspected before distribution from the receiving
warehouse. Random samples of each shipment need to be inspected to check out labeling
(language, dosage strengths, dosage form, and expiry date), quantities received, and condition
Logistics Management

of the drugs against specifications of the contract. Random samples should be sent also to
the Bureau of Food and Drug (BFAD) for identification test to determine the content of the
active ingredient and dissolution test.

Once the drug shipment has passed quality inspection and testing, the drugs may be
distributed to and stored at local warehouses and DOTS facilities.

The following are storage procedures that will ensure that drugs and other supplies
are: a) protected from theft and unauthorized access; b) protected from heat, light, moisture/rain,
dust, pest, poison, and fire; and c) easy to find.

A. Protected from Theft and Unauthorized Access


1. Store drugs and other supplies in a secured stock room.
2. Maintain accurate and up-to-date records to ensure that if supplies are stolen,
DOTS facility workers know the missing amount from the stock. DOTS facilities
should maintain a stock card for every kind of drug or supply to monitor the amount
received and dispensed. See Form 5.1.
3. Ensure access to supplies. However, limit access to one or two persons and ensure
that one person is always available to distribute the supplies.

83
Form 5.1. Sample Stock Card
Name of Item: Stop TB Kit Category I & III
Unit: Kit

Quantity Remarks
Description Total (Expiration
Date value date, lot no.,
(Received from/Issued to)
In Out Balance etc.)

08/28/05 10

09/05/05 Received from CHD 2000 2010

09/06/05 Issued to PHO 500 1510 08/2007, SL417

B. Protected from heat, light, moisture/rain, dust, pest , poison, and fire
1. Store drugs and NTP supplies separately from office supplies, insecticides, and chemicals to
avoid contamination.
2. Store drugs in a cool place, away from direct sunlight.
3. Keep the roof in good condition to prevent leakages.
4. Store drugs and other supplies off the ground by using pallets and away from walls to reduce
moisture and to promote air circulation.

Logistics Management
5. Keep stock room clean and well-ventilated.
6. Ensure that fire safety equipment is available and accessible.

C. Easy to Find
1. Store drugs according to their expiration date. Make sure each drug’s expiration date is marked
clearly.
2. Use FEFO ( First Expiry, First Out): First drugs to expire should be used or distributed first.

84
IV. Rational use, monitoring, and evaluation. Rational drug use entails correct diagnosis, followed
by correct prescribing, labeling, dispensing, and ensuring that patient adheres to recommended
treatment regimens. Fixed Dose Combinations promote good practices; these can contribute to
fewer prescribing and dispensing errors because there are fewer tablets to handle at any one time.
Use of TB kits assures the availability of drugs for the entire duration of treatment. However, the
use of TB kits does not replace DOT.

Drug logistics cycle should be monitored regularly to ensure that the right quantities of anti-
TB drugs are available when needed.

Procurement of anti-TB drugs shall be done annually through public bidding.


Under the National Tuberculosis Control Program, the DOH Central Office shall procure the drugs
and NTP supplies because these cost less with bulk purchase.

Once the drugs have been delivered, inspected, and analyzed for quality by the Bureau of
Food and Drug, these will be sent to the Centers for Health Development for distribution to the
different provinces and cities. The provincial LGUs then will distribute the drugs to the different
DOTS facilities. Drug requirements of the DOTS facilities will be based on their usage for the past
quarter. The DOTS facilities must submit the NTP Quarterly Report on Drug Inventory and
Requirement regularly to the provincial/city NTP Coordinator. The consolidated data will then be
submitted to the CHD NTP Coordinator.
Logistics Management

The quantity of drugs to be requested is determined through the following computations,


depending on the drug preparation to be procured -- either TB kits, blister packs of FDC or SDF:

A. Stop TB Kits (Table 5.1)


1. Count the number of patients registered in the previous quarter per category.
2. Compute the quantity of TB drugs required per category. For Stop TB kits, the total
number of Stop TB kits required is equal to the total number of patients per category. For
FDC and SDF blister packs and SDF tablets, the total quantity of drugs required depends
on the factor to be multiplied with the number of patients per category (See Tables 5.1,
5.2, 5.3, & 5.4).

85
Table 5.1. Computation for Quarterly Drug Requirement for Stop TB Kits

Stop TB Kit for Cat I


Category Stop TB Kit for Cat II
and III

Category I No. of cases


Category II No. of cases
Category III No. of cases
Total
Total kits required x 2
Stock with Buffer Total kits required x 2
Stock on Hand
Total Kits to be requested

B. Blister Packs of Fixed Dose Combination Drugs (FDCs)

Table 5.2. Computation for Quarterly FDC BP Drug Requirement

FDC- A FDC- B ETHAMBUTOL STREP-


Category
(BP) (BP) (BP) TOMYCIN

Category I No. of cases X 6 No. of cases X12

Logistics Management
Category II No. of cases X 9 No. of cases X 15 No. of cases X 10 No. of cases X 56

Category III No. of cases X 6 No. of cases X 12

Total Total BP x 2 Total BP x 2 Total BP x 2 Total BP x 2

Stock with Buffer

Total BP to be
requested

86
C. Single Drug Formulation (SDF)

Table 5.3.a Computation for Quarterly SDF BP Drug Requirement

Category SCC I SCC II Ethambutol 400 SM


(HRZ) BP (HR) BP mg/tab (1 gm/vial)

Category I No. of cases x 8 No. of cases x 16 No. of cases x 112

Category II No. of cases x 12 No. of cases x 20 No. of cases x 448 No. of cases x 56

Category III No. of cases x 8 No. of cases x 16 No. of cases x 112

TOTAL

Stock with Buffer Total BP x 2 Total BP x 2 Total tablets x 2 Total vials x 2

Stock on Hand

Total BP to be
requested

Table 5.3.b Computation for Quarterly SDF Tablets Drug Requirement


Logistics Management

Category Isoniazid Rifampicin Pyrazinamide Ethambutol 400 SM


(400 mg/tab) (400mg/cap) (500mg/tab) mg/tab (1 gm/vial)

Category I No. of No. of No. of No. of cases x 112


cases x 168 cases x 168 cases x 112
Category II No. of No. of No. of No. of cases x 448 No. of
cases x 224 cases x 224 cases x 168 cases x 56

Category III No. of No. of No. of No. of cases x 112


cases x 168 cases x 168 cases x 112

TOTAL

Stock with Total x2 Total x2 Total x2 Total x2 Total x2


Buffer
Stock on
Hand

Total drugs
to be
requested

87
3. Multiply by 2 the quantity of drugs required to get the total stocks needed. This already includes the
buffer stock.
4. Count the stocks on hand and subtract total from the total stocks required. The difference will be
the quantity of drugs to be requested.
5. Submit the NTP Quarterly Report on Drug Inventory and Requirement, together with other NTP
quarterly reports every first week of the succeeding quarter, to the provincial/city NTP coordinators
who will then submit the report to the CHD NTP coordinator.
6. Buffer stocks must be maintained at all levels to avoid stock-outs. The adequate reserve level must
be as follows:

Level Buffer Stock

DOH / CHD Six months

Province/City Three months

DOTS Facility Three months

The LGUs are tasked to procure drugs for Category III patients and for patients who will develop
adverse reactions to FDC drugs. The LGUs are also encouraged to procure other supplies to support
local TB activities

Logistics Management
The following tables will guide the NTP coordinator in estimating the NTP supplies
required by the DOTS facilities.

Table 5.4. Computation for Annual Estimated Supplies for DSSM

Expected No. of Examination


Total
Sm (+) identified*
For Diagnosis For Treatment

A B (A x 10X3) C (A x 3) D (B+C)

*(Total population x 133/100,000) x 75%

88
Table 5.4 (Cont.)

Microscopy Supplies Unit of measurement Number of boxes/


required per item bottles required

Sputum cups, 1,000/box D x 1 pc D/1,000


Glass slides, 72 pcs/box D x 1 pc D/72

Immersion oil, 100cc/btl D x 0.15 cc D/770

Pre-mixed, Hot stain


Carbol Fuschin D x 4 cc D/500
Acid Water D x 8 cc
Acid alcohol D x 4 cc
Methylene blue D x 2 cc

Table 5.5 Computation for Annual Estimated Recording and Reporting Forms

Name of Form and Record Quantity Needed for each


DOTS Facility

NTP Laboratory Request form for DSSM 1 per patient

NTP Laboratory register 1/500 patients


Logistics Management

Treatment Card 1 per patient

ID Card 2 per patient

TB Register 1/200 patient

Quarterly Report on Laboratory Activities 12 per year

Quarterly Report on New Cases and Relapses 12 per year

Quarterly Report on Treatment Outcome 12 per year

NTP Referral Form 3% of the new smear positive cases

TBDC Referral Form 37% of smear positive cases

*Basis for this computation will be the previous year’s annual accomplishment.

89
Monitoring, Supervision, and Evaluation

Monitoring is an on-going process of collecting and analyzing information about program


implementation. It involves: a) regular assessment of whether or not activities are being carried out as
planned and how these activities are being done; and b) identifying problems and implementation
bottlenecks. Data and information gathered through monitoring should be immediately processed,
analyzed, and disseminated to stakeholders who can make the best use of such.

Supervision is an essential management tool to ensure that implementers carry out the program’s
policies, standards, and procedures correctly, effectively, and efficiently. It is also an opportunity for
supervisors to do the following:

1. Discuss with DOTS facility staff important issues related to the program;
2. Check records and reports;
3. Acknowledge and reinforce good performance;
4. Help DOTS facility staff identify and correct inadequacies or weaknesses in
performance;
5. Give feedback and solicit ideas on how to improve program implementation;
6. Provide exit feedback with corresponding recommendations about problems identified to improve
program implementation; and
7. Provide on-the-job training.

Evaluation is the regular assessment of the process or development of any given


program or project with particular focus on its effectiveness and impact. This process is carried out
by each of the NTP coordinators by analyzing indicators, data, and relevant information from records,
reports, and feedback from field health implementers, surveys, and studies done by other agencies.

Monitoring Supervision
Monitoring and evaluation ideally go hand-in-hand. While monitoring entails observation and
description of how the project/program is being conducted, evaluation involves interpretation of results and Evaluation

or change over time. The question in monitoring is: Are things going all right? The question in evaluation
is: So, did it work?

90
Monitoring and evaluation together can enable program implementers to:
• Better understand how the program is working;
• Make informal decisions regarding operations;
• Ensure most effective and efficient use of resources;
• Look at the extent to which the program/project is having or has had the desired impact; and
• Fine-tune future program impact.

I. OBJECTIVES

A. Ensure that program implementers adhere to NTP policies and guidelines.


B. Monitor progress of program implementation and identify areas of improvement to maintain
quality DOTS implementation.
C. Evaluate NTP activities to determine if program targets of 70 percent case detection rate and
85 percent cure rate are reached and maintained. Identify problems and recommend and
institute possible solutions.

II. POLICIES

A. The provincial or city NTP coordinators shall serve as NTP supervisors at the RHU or MHC
level. They shall be responsible for: 1) regular monitoring (at least quarterly) of DOTS facilities,
hospitals, PPMDs, and all other certified DOTS centers; and 2) evaluating progress and
performance of NTP. In coordination with the DOH/CHD NTP coordinators, they shall see to
it that DOTS facilities operate in accordance with NTP directions, standards, and technical
policies.
B. The following shall serve as NTP supervisors at specific levels: municipal health officer at the
RHU; PHN at the BHS; PPMD physician at the PPMD unit; and chief of hospital at the hospital.
MHOs shall also visit the BHS to maintain good working relationships between the coordinators
and the health workers. Frequency of visit will depend on the BHS’ level of performance, as
Monitoring Supervision

well as that of the health workers.


and Evaluation

C. With the Quality Assurance System as guide, the CHD/PHO/CHO shall monitor regularly (at
least quarterly) the performance of laboratory services and functionality of the TB Diagnostic
Committee.
D. The health staff concerned with NTP at each level shall regularly analyze data from quarterly
reports using standard program indicators and provide feedback of findings with corresponding
recommendations to the staff or authorities concerned.
E. Continuous advocacy efforts to secure commitment of LGUs to counter-share in the purchase
of anti-TB drugs and other supplies shall be undertaken.

91
Figure 6.1 Flow of Reporting

Data Collection and Analysis DOTS Facilities First week of the quarter

Data collection, consolidation,


PHO/CHO Second week of the quarter
analysis and feedback

Data collection, consolidation Third week of the quarter


analysis and feedback CHD

Data collection, consolidation


NCDPC - DOH analysis and feedback RCC-PPMD

Partner Agencies

Reports include: a) Quarterly Report on all TB cases; b) Quarterly Report on the Treatment Outcome;
c) Quarterly Report on NTP Laboratory Activities; d) Drug Inventory and Requirement Report; and, e)
Quarterly Report on External Quality Assessment (Refer to Manual on Quality Assurance for Sputum
Smear Microscopy).

III. PROCEDURES

Monitoring Supervision
and Evaluation
A. Monitoring and Supervision Activities

Identify areas to be visited and determine frequency of visits. Those with problems should be
visited more frequently. Use the following guidelines for supervisory visits:
1. Compare and verify that all information in the following records are accurate and consistent:
• TB Register with NTP Laboratory Register (Verify that all smear positives in the NTP
laboratory register are registered and started on treatment in the TB register. Verify
also that smears of patients for DSSM follow-up are examined and are on time.)
• TB Register with NTP Treatment Cards
• NTP TB Laboratory Register with NTP Treatment Cards

92
2. Review NTP treatment cards. Check for the following:
• There is a TB case number
• Type and classification of patient is correct
• DSSM was done for diagnosis and follow-ups are on time
• Category of treatment regimen is correct
• Intensive phase is extended for patients that are still smear positive at the end of the
intensive phase
• Drug intake is complete
• Treatment outcome is correct

3. Review TB Register. Check for the following:


• TB case number
• Type and classification of patient is correct
• DSSM results on diagnosis is done and follow-up is done on time
• Conversion rate at the end of the second or third months of treatment
• Treatment outcome is correct

4. Review NTP Laboratory Register. Check for the following:


• TB case number of patients for the follow-up examination are written
• Rate of three sputum specimen collections is more than 90%
• Positivity rate is between 10 to 20 percent

5. Observe DOTS facility staff are giving correct and relevant health education to the patients
and DOT is done correctly

6. Interview DOTS facility staff and patients

7. Conduct physical inventory of NTP drugs and other supplies.

Coordinators/supervisors must share all relevant information and recommendations


Monitoring Supervision

arising from the visits, preferably in writing, with DOTS facility staff concerned. Courses of
and Evaluation

action to address deficiencies, mistakes, and acts of carelessness must be discussed and
solutions agreed upon by both supervisor and the concerned DOTS facility staff. For further
details on Monitoring and Supervision, please refer to Handbook for Quality DOTS: Pointers
to Improve Monitoring and Supervision.

B. Evaluation
1. The nurse or the designated DOTS facility staff prepares, during the first week of each quarter,
the Quarterly Report on All TB Cases registered during the previous quarter and the Quarterly
Report on the Treatment Outcome of Pulmonary TB Cases registered in the same quarter
last year. While the medical technologist/microscopist prepares the Quarterly Report on NTP
Laboratory Activities of the cases registered during the previous quarter. The physician analyzes
all quarterly reports to evaluate the performance of the DOTS facility. The DOTS facility staff
submits the reports to the provincial/city NTP coordinator.

93
All DOTS facility staff concerned evaluate their performance by analyzing indicators, such
as the following: a) three-sputum collection rate; b) positivity rate; c) proportion of pulmonary
smear-positive cases out of all pulmonary cases; d) case detection rate of new smear- positive
cases; e) case notification rate of new smear-positive cases per 100,000 population; f) sputum
conversion rate at the end of two or three months of treatment for new smear-positive cases; and
g) cure rate of new smear-positive cases.

The provincial/city coordinator should disaggregate the reports of PPMD units to reflect the
additionality of cases in the city/municipality where PPMD is implemented.

2. The source of data for the laboratory activities is the NTP Laboratory register while source
of data for the Quarterly report on All TB cases and Treatment Outcome is the TB register.
Therefore, the information in the report is only as accurate as the information recorded in the
TB Register and the NTP Laboratory Register. The quarterly reports are based on the following
coverage period:

1st
January 1 – March 31
Quarter

2nd
Quarter April 1 – June 30

3rd
Quarter July 1 – September 30

4th
Quarter October 1 – December 31

Monitoring Supervision
The provincial/city NTP coordinators collect, consolidate and analyze all quarterly reports
from the implementing DOTS facilities. The CHD NTP coordinators send the data, consolidated and Evaluation

by province, city, PPMD units, Hospitals, NGOs, etc. from all Quarterly Reports, to the NTP
manager for consolidation and analysis. Recommended courses of action anchored on relevant
findings, based on program indicators (see Table 6.1) gathered from the quarterly reports, should
be used and applied to ensure effective implementation of the TB control program.

IV. MONITORING FORMS

Standardized monitoring tools/checklists based on the program indicators established


shall be used in monitoring, supervision, and evaluation activities.

94
NTP MONITORING TOOL

Date:
CHD: Province:
Monitoring Team:

Monitoring Indicators Facility Facility Facility Facility

POPULATION (Current year)


Period (Quarter) Monitored
I. CASEFINDING (Lab. Register)
A. No. of TB Symptomatics examined
B. No. with 3-sputum specimen
Per cent with 3-Sputum Specimen
C. No. who are Smear (+)
Positivity Rate
II. CASEHOLDING (TB Register/
Treatment Card)
A. Total no. of Patients Initiated Tx
1. Pulmonary:
a. New smear (+)
b. New smear (-) Cat I
Cat III
c. Relapse
d. Treatment Failure
e. Other retreatment
2. Extrapulmonary
% of smear (+) to Total PTB
Case Notification Rate
Case Detection Rate
B. Sputum Conversion
1. No. New Sm(+) due to undergo sputum
examination at 2 mos.
2. No. who underwent sputum exam at 2 mos.
Monitoring Supervision

3. No. who converted


and Evaluation

Efficiency rate = 3/1 (Converted/due)


Efficacy rate = 3/2 (Converted/examined)
C. DOTS Implementation
1. Total No. of Patients under DOTS
2. No. Health Worker as partners
3. No. BHW/BNS as partners
4. No. Other community volunteers
5. No. Family Member as partners
DOTS Implementation Rate

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Monitoring Indicators Facility Facility Facility Facility

D. TREATMENT OUTCOME No. % No. % No. % No. %


1. New Smear (+)
Total No. initiated treatment
Cured
Completed Treatment
Died
Failed
Defaulted
Transferred Out
2. Relapse No. % No. % No. % No. %
Total No. initiated treatment
Cured
Completed Treatment
Died
Failed
Defaulted
Transferred Out
3. New Smear (-) No. % No. % No. % No. %
Total No. initiated treatment
Completed Treatment
Died
Failed
Defaulted
Transferred Out
Quality Assurance - Laboratory No. % No. % No. % No. %
Total No. of errors
Major error
Minor error
Quantification error
(See other monitoring forms in the Manual
of Quality Assurance of Sputum Smear
Microscopy - Forms 3, 6, & 7)
TBDC
A. Total No of Smear(-) C-Xray positive TB
evaluated by TBDC
B. No. of Sm(-), CX-ray (+) confirmed as
active and recommended by TBDC for
treatment
Proportion of Sm(-), CX-ray (+) TB cases
confirmed as active TB & recommended
for Treatment

Monitoring Supervision
and Evaluation

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Monitoring Indicators Facility Facility Facility Facility

E. Drugs and NTP Supplies No. DOE No. DOE No. DOE No. DOE
FDC A (HRZE)
FDC B (HR)
PZA
Ethambutol
Streptomycin (750mg)
Slides
Sputum Cups
AFB Stain
Lab request form
Lab Register
TB Register
TB Symptomatic Masterlist
Treatment card
ID cards
NTP Referral forms
TBDC referral forms
* DOE-Date of Expiration
F. LGU Commitment
A. Municipal NTP budget (amount)
B. Total Health budget (amount)
Proportion of Mun NTP budget to
total health budget (annualy)

C. LGU is providing TEVs/per diem for Yes [ ] Yes [ ] Yes [ ] Yes [ ]


supervision/monitoring No [ ] No [ ] No [ ] No [ ]

Yes [ ] Yes [ ] Yes [ ] Yes [ ]


D. Availability of : No [ ] No [ ] No [ ] No [ ]
1. Medical Technologist Yes [ ] Yes [ ] Yes [ ] Yes [ ]
2. NTP Microscopist No [ ] No [ ] No [ ] No [ ]

G. PPMD
No. of trained referring physicians in
a PPMD Unit
No. of DOTS referring physicians
referring TB suspects for sputum
Monitoring Supervision

microscopy
and Evaluation

No. of DOTS referring physicians


referring TB cases for treatment
Number of New Smear (+) from PPMD

H. Health Promotion
No. of advocacy activities conducted
No. of BCC materials
produced/reproduced/distributed

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FINDINGS: RECOMMENDATIONS:

1. 1.

2.. 2..

3. 3.

4. 4.

5. 5.

6. 6.

7. 7.

8. 8.

9. 9.

10. 10.

Date: MONITORING TEAM MEMBERS:

Monitoring Supervision
and Evaluation

98
Table 6.1. Program Indicators

INDICATORS CALCULATION DATA SOURCE

CASE FINDING

1. Three- sputum Number of TB symptomatics who submitted Laboratory Register


Collection Rate (%)
3 sputum specimens
------------------------------------------------------------- x 100 Quarterly report on laboratory
Total number of TB symptomatics examined Activities

2. Positivity Rate (%) Total number of sputum smear-positive cases discovered Laboratory Register
--------------------------------------------------------------- x 100
Quarterly Report on Laboratory
Total number of TB symptomatics examined Activities

3. Case Detection Number of New smear-positive cases detected TB Register


Rate of new
smear-positive ---------------------------------------------------------------- x 100
cases Number of estimated new smear-positive TB cases Quarterly Report on All TB Cases

(The denominator is a WHO estimation for each country


based on available data including case notifications, mortality
and studies on disease prevalence and risk of infection,
and adjusted for countries with high incidence. These
estimations are reported every year by WHO in the annual
“Global Tuberculosis Control” report.)

4. Case Notification Number of New smear-positive cases notified TB Register


Rate of new ------------------------------------------------------------------- x 100,000
smear-positive Quarterly Report on All TB Cases
cases per 100,000 Total number of population in the specified area
population
Population Statistics
Monitoring Supervision
and Evaluation

99
INDICATORS CALCULATION DATA SOURCE

CASE HOLDING

5. Proportion of Number of Pulmonary smear-positive cases TB Register


pulmonary smear- (New and Relapse) registered
positive cases out of --------------------------------------------------------------- x 100
Total number of pulmonary (New smear-positive, Quarterly Report on All
all pulmonary cases
(%) New smear-negative and Relapse) cases registered TB Cases

6. Sputum conversion Number of New sputum smear-positive cases which TB Register


rate at the end of 2 are smear-negative at the end of 2 months of
months of treatment treatment
for new smear- --------------------------------------------------------------- x 100
positive cases (%) Total number of New sputum smear-positive cases
registered during some period of time

7. Treatment outcomes
* Cure rate: TB Register
for new smear-
positive cases, New Number of cases who were cured
smear-negative --------------------------------------------------------------- x 100 Quarterly Report on the
cases, Relapse Total number of cases registered
Treatment Outcome of
cases, Return After Pulmonary TB Cases
* Completion rate:
Default and Number of cases who completed treatment
Treatment Failure --------------------------------------------------------------- x 100
cases (%). (Each Total number of cases registered
case type is a
different cohort).
* Death rate:
Number of cases who died during the treatment
--------------------------------------------------------------- x 100
(Reminder: There is no cure rate
applied to smear-negative Total number of cases registered
cases.)

*Failure rate:
Number of smear positive cases who still smear positive at five
months or more of treatment
-------------------------------------------------------------- x 100
Total number of cases registered

* Defaulter rate:
Number of cases who defaulted
-------------------------------------------------------------- x 100
Total number of cases registered

* Transfer-out rate:
Number of cases who transferred to another

Monitoring Supervision
DOTS facility with a proper referral / transfer slip

and Evaluation
---------------------------------------------------------------- x 100
Total number of cases registered

PPMD Units
8. Additionality Number of new smear-positive TB cases detected by PPMD* TB Register
--------------------------------------------------------- x 100
Total number of new smear-positive TB cases detected by
city/municipality /province/PPMD

*Note: PPMD refers to cases either detected by a private-initiated


PPMD Unit or referred by a private physician to a public-initiated
PPMD Unit

100
Overview of the Health Promotion Program for the NTP

Health Promotion (HP) is the process of enabling people to take action to improve their health.
Guiding principles for the health promotion component of the National Tuberculosis Control Program
are anchored on the provisions of Administrative Order No. 58 issued by the National Center for Health
Promotion (NCHP) of the Department of Health. Under this set up, there are five general action areas
for health promotion: 1) building health public policy; 2) creating supportive environment; 3) developing
personal skills of the general public; 4) reorienting health services; and 5 strengthening community
participation.

1. Building Health Public Policy


HP goes beyond health care. It puts health on the agenda of policy makers in all sectors and
at all levels, directing them to be aware of the health consequences of their decisions and to accept
their responsibilities for health.

2. Creating Supportive Environment


The links between people and their environment constitute the basis for a socio-ecological
approach to health. Changing patterns of life, work, and leisure have a significant impact on health.
Work and leisure should be a source of health for people. HP generates living and working conditions
that are safe, stimulating, satisfying, and enjoyable.

3. Developing Personal Skills


HP supports personal and social development through information, education for health, and
enhancing life skills. By so doing, it increases the options available to people to exercise more
control over their own health and over their environments, and to make choices conducive to health.

4. Reorienting Health Services


The responsibility for HP in health services is shared among individuals, community groups,
health professionals, health service institutions, and government. They must work together towards
a health care system which contributes to the pursuit of health.

5. Strengthening Community Action


HP works through concrete and effective community action in setting priorities, making
Overview of the HPP

decisions, planning strategies, and implementing them to achieve better health. At the heart of this
for the NTP

process is the empowerment of communities – their ownership and control of their own endeavors
and destinies.

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There are also different communication strategies for HP. These are advocacy, social
mobilization, health education, social marketing, community organizing, and counseling. These
and other strategies may be adopted to increase the intended stakeholders’ level of awareness
and to promote health-seeking behavior for early case detection and assurance of cure.

TB Network (“Kakampi Laban sa TB!” and “Sama-samang sugpuin ang TB!”) is the
official communication handle of the NTP. It also serves as the overarching brand for DOH’s re-
energized fight against TB as it forges partnerships between the public and the private sectors.
The key players in this partnership are DOH, Philippine Coalition Against Tuberculosis (PhilCAT),
Philippine Health Insurance Corporation (PHIC), Local Government Units (LGUs), and the various
DOTS facilities nationwide. During the commemoration of World TB Day (March 24) and National
TB Day (August 19) every year, partnerships and collaborations between and among the public
and private partners are strengthened and highlighted.

Documentation of testimonials and best practices for better HP outcomes are also
important for developing better strategies for HP and eventually better NTP accomplishments.
Any HP activity useful for expediting certification and accreditation of DOTS facilities and promoting
PPMD may also be considered.
Overview of the HPP
for the NTP

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Table 7.1 presents the five areas of health promotion and the corresponding main tasks, intended
audiences, and strategies/major activities. The suggested key messages for each area are also given.

Table 7.1. Health Promotion Activities for Addressing Various Tasks

Areas of Health Main Tasks Intended Strategies/Major Suggested Key


Promotion Audiences/ Activities Messages
Stakeholders

1. Building General political Legislators Advocacy “TB control is a


health public support Donor agencies Social marketing national priority.”
policies (financial, Local Chief Lobbying “TB is a major public
issuance of Executives Sensitization health problem.”
ordinances/ “ TB is the 6th leading
resolutions) cause of illness and
deaths in the
Philippines.”
“TB affects the most
economically
productive age-group
resulting in enormous
economic losses.”
“DOTS is the most
cost- effective strategy
to control TB.”

2. Creating Generate multi- GOs Social mobilization “TB is everyone’’s


supportive sectorial support NGOs Networking concern.”
environment Professional Advocacy Alliance “TB is a major public
societies building/local health problem”
Business sector coalition building “Forging partnerships
Academe TB Network and collaborations in
Media commemoration of all sectors is the key
international and to TB control.”
national TB events
Ensuring availability
of services, drugs,
supplies, etc. CUP
dissemination IEC
(Airing of DOTS
jingle)

3. Developing Improve health TB Social marketing “TB is everyone’s


personal skills seeking Symptomatics Health education concern”
behavior (for TB patients Patient education “TB kills.”
early case General public Counseling “TB is infectious but
detection and IEC (Media campaign: curable.”
assurance of radio, TV, print, “DOTS services are
cure) cinemas, internet) available for free
Enter-educate nationwide.”
activities KAP Surveys
(Pre-Post

Household health
teachings
Parent’s classes/
Overview of the HPP

Testimonials
for the NTP

103
4. Reorienting Encourage & All health workers Capability-building “TB Control is a
health sustain health (public and trainings, refresher national priority.”
services providers’ private) courses, “DOTS is the strategy
participation in orientation/sales to control TB.”
quality DOTS conferences) “DOTS ensures cure.”
implementation Recognitions (MLQ “DOT with a treatment
Awards) partner ensures cure.”
Formative research/
Monitoring and
Evaluation
Documentation

5. Strengthening Encourage Local Community “If you have cough for


community action community officials/Leaders organizing, Primary two weeks or longer,
participation People’s health care, you may have TB.”
Empower Organizations Organization of “Consult at the nearest
community Civic groups support groups (TB DOTS facility if you
Informal sectors Task Forces/ TB have symptoms of
Community patients Advocates), TB.”
groups Community “DOTS services are
assemblies, available for free
Household health nationwide”
teachings, “TB is curable”
Parents’ clases, “TB affects everyone.”
Testimonials, “Daily intake of anti-
Recognition/Awards TB drugs ensures
cure.”
“DOT with a treatment
partner ensures cure.”

TEN COMMANDMENTS FOR TB ADVOCATES

1. Advocates have a duty to respect the dignity, privacy, and self-determination of the clientele.
2. Advocates have a duty to treat everyone they encounter in their work fairly, honestly, and with
respect.
3. Advocates shall endeavor to develop partnerships with present and past recipients of DOTS
services to involve them directly in advocacy activities and to enrich advocacy efforts.
4. Advocates have a duty to be responsive to clients’ complaints and recommendations concerning
the provision of advocacy services.
5. Advocates have a duty to identify, avoid actual and potential conflicts of interest which may
compromise their ability to represent and safeguard the rights of the target beneficiaries.
6. Advocates must seek to assist their clients to participate in making decisions about advocacy
activities and in advocating on their behalf.
7. Advocates must assure that their clients are fully informed about advocacy activities undertaken,
Overview of the HPP

about information which is gathered in the course of advocacy, and about reasonable courses of
for the NTP

actions, implications of actions, and potential outcomes.


8. Advocates have a duty to present facts accurately and honestly.
9. Advocates have a duty to understand applicable laws and procedures for enforcing it.
10. Advocates have a duty to know and improve their own skills and knowledge

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Annex 1

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Annex 3

The TB Diagnostic Committee (TBDC)

BACKGROUND AND RATIONALE

The DOTS Strategy was pilot-tested in the Philippines’ NTP in 1996, and was subsequently
expanded throughout the country. However, the smear (+) cases represented only about 35 percent of
the pulmonary TB cases;1 among the smear-negative but X-ray positive TB cases, about 30-50 percent
were thought to be inactive TB cases. Most of these cases were referrals from the private sector.

A 1997 study conducted in the NTP DOTS pilot sites showed that among cases diagnosed by
chest X-ray, only 25 percent had radiographic findings suggestive of active PTB, 36 percent had “suspicious
shadows” only (or doubtful TB activity), and 39 percent had either normal X-rays or radiographic lesions
secondary to other diseases (Chaulet, P; WHO). There was a high level of over-reading and over-
diagnosis that led to the unnecessary anti-TB treatment of many patients. These patients were subjected
to the psychological burden of being labeled as TB patients, and were exposed to the potential adverse
effects of the anti-TB drugs. Moreover, the situation resulted in the waste of limited resources, particularly
anti-TB drugs.

These observations demonstrate the inherent problems, and the relatively low accuracy, of the
X-ray based diagnosis of TB. To improve the quality of diagnosis among the smear- negative/X-ray
positive TB suspects in DOTS areas, the NTP created TB Diagnostic Committees (TBDC) at the provincial
or city level. These committees were tasked to evaluate the clinical data and X-ray films of the smear-
negative/X-ray positive TB suspects, and to come up with the diagnosis and corresponding therapeutic
recommendations (by consensus) for these patients. The TBDC was subsequently integrated into the
NTP framework for TB case finding.

1
Ahn, DI. Mission Report; TB Prevention and Control. World Health Organization. 1998.
Annexes

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OBJECTIVES

General Objective

TBDC was created to improve the quality of diagnosis among smear-negative PTB cases.

Specific objectives

1. Reduce the level of over-diagnosis and over-treatment among smear-negative PTB cases.
2. Ensure that active cases of smear-negative PTB are detected, and are provided with the appropriate
anti-TB treatment.

TBDC COMPOSITION AND ROLES OF COMMITTEE MEMBERS

The TBDC is chaired by the public sector (NTP Medical Coordinator) whose members come
from the public and the private sectors representing various disciplines. The TBDC is established at the
province or city level, or as an added option, at the district level. The composition of the TBDC is as
follows:

Provincial/City TB Diagnostic Committee:


1. Provincial/City NTP Medical Coordinator
1.1 Acts as the Chairperson of the TBDC (Note: Another TBDC member may be designated as
co-chairperson.)
1.2 Organizes the Committee
1.3 Convenes the Committee regularly
1.4 Moderates the discussions of the committee
1.5 Prepares the quarterly reports of the TBDC
1.6 Monitors and supervises the outputs of the TBDC activities
2. Radiologist
2.1 Reviews, together with the other Committee members, the referred X-ray films

2.2 Provides a description and interpretation of the X-ray findings that will serve as one of the
bases for diagnosis and treatment

3. Clinician/Internist/Pulmonologist
3.1 Provides an analysis of the clinical data of each case for correlation with the radiographic
findings

3.2 Recommends the appropriate intervention(s) for the referred patients

4. Provincial/City NTP Nurse Coordinator


4.1 Consolidates the necessary documents of referred cases prior to each meeting

4.2 Acts as the Committee Secretariat

4.3 Monitors and supervises the outputs of the TBDC activities under the direction of the Chairperson
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ORGANIZING THE TB DIAGNOSTIC COMMITTEE

1. The NTP Coordinators (Provincial or City level) will initiate a preliminary meeting/discussion with
the PHO/CHO regarding the prospective members of the Committee.

2. An initial meeting with the potential members will be convened by the Province/City NTP Coordinators,
in consultation with the PHO/CHO, to discuss the creation of the Committee. The CHD NTP
Coordinators may be invited to provide technical inputs. The participants will be given an orientation
on the NTP, and on the TBDC.

3. The solicitation of membership will be formalized by the PHO/CHO. The operating details, such as
the venue and schedule of the TBDC sessions, will also be finalized.

4. A copy of the final list of members will be provided to the Provincial/City health office and CHD.

Note: A district level TB Diagnostic Committee may also be established as an option, to make the TBDC services more accessible to the peripheral
health units and to reduce the volume of referrals to the Provincial TBDC. The district level TBDC reports to the Provincial/City Medical coordinator.
Monitoring of the district TBDC is the responsibility of the Provincial/City NTP coordinators.

RECORDING AND REPORTING

The TBDC shall make use of the prescribed TBDC referral, recording, and reporting forms (see Chapter

IV – Recording and Reporting). The quarterly TBDC report shall be prepared by the NTP coordinators and submitted

to the CHD together with the other NTP quarterly reports.

FORM GENERAL DESCRIPTION RESPONSIBLE


PERSON

TBDC Referral Form Used for referring smear- negative TB suspects to the Upper portion to be filled-
TBDC. The form has two parts: up by the Physician or
Nurse of the referring
Upper portion contains general information about the DOTS facilities
patient.
Lower portion to be filled-
up by the TBDC
Lower portion contains the TBDC findings/decisions Secretariat, duly signed by
and recommendations. the TBDC Chairperson
and Secretariat

TBDC Masterlist This is the listing of all smear- negative TB suspects TBDC Secretariat
referred to the TBDC.
Quarterly TBDC This is the accomplishment report of the TBDC Provincial /City Medical
Report Form submitted to the CHD on a quarterly basis. or Nurse NTP
Coordinators
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MONITORING AND EVALUATION

Monitoring and evaluation of the TBDC shall be done in conjunction with the regular NTP
monitoring and program review. The NTP Staff of the NCDPC and other TB partners can join the CHD
in the monitoring and evaluation of the TBDC. The TBDC Chairperson shall also ensure that these
recommendations are implemented by the DOTS facilities accordingly.

REFERRAL PROCEDURES (Referring Unit Level)

1. The DOTS facilities shall refer to the TBDC all smear-negative/X-ray positive TB suspects using
the TBDC Referral Form. The referring unit’s physician or nurse shall fill up completely the upper
portion of the TBDC Referral Form.
2. The referring unit should follow the “Flowchart for the Diagnosis of Smear- Negative PTB” (see
Figure 2.2. Flow chart for the diagnosis of smear-negative pulmonary TB).
3. The referring unit sale ensure that all the available chest X-ray films (including old films) and properly
filled up TBDC Referral Form of each referred patient are submitted to TBDC.

TB DIAGNOSTIC COMMITTEE OPERATING PROCEDURES

1. The Secretariat consolidates all documents (including X-ray films) pertaining to each referred case
on the TBDC Masterlist.

2. The Committee reviews/correlates all the documents and deliberates on each referred case during
its regular sessions.
3. The Committee arrives at a consensus regarding the diagnosis and recommendations on patient
management based on the recommended Diagnostic Flowchart (Flow chart for the diagnosis of
smear-negative pulmonary TB). If the Committee feels the need to see the patient, then the patient
will be invited on the next Committee session.
4. The Secretariat writes the TBDC diagnosis and recommendations on the lower portion of the TBDC
Referral Form in accordance with the discussions during the TBDC session. Both the Chairperson
and the Secretariat should affix their signatures on the completed form.
5. The completed TBDC Referral Form is sent back to the referring DOTS facilities for implementation
of the TBDC recommendations. For patients who are recommended for anti-TB treatment, their
respective TBDC Referral Forms should be attached to their respective NTP Treatment Cards. All
other completed TBDC referral forms should be filed for future reference.
6. TBDC sessions shall be held at least twice a month.
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