Manual of Procedures NTP 5th Edition
Manual of Procedures NTP 5th Edition
Manual of Procedures NTP 5th Edition
Procedures of
the National
Tuberculosis
Control Program
5th Edition
contents
ii
FOREWORD
iv
PREFACE
vii
List of Accronyms
Chapter 1.
INTRODUCTION
15
Chapter 2.
CASE FINDING
33
Chapter 3.
CASE HOLDING
53
Chapter 4.
PREVENTION OF TB
59
Chapter 5.
RECORDING AND REPORTING
107
Chapter 6.
MANAGEMENT OF TB DRUGS AND DIAGNOSTIC
SUPPLIES
115
121
127
135
149
REFERENCES
ANNEXES
152
Foreword
his Manual of Procedures (MOP) for the National TB Control Program (NTP) is the
basis for the implementation of the tuberculosis control program in all DOTS facilities
in the Philippines.
The MOP seeks to accomplish the following: (a) provide technical policies and
guidelines on the diagnosis, treatment and counselling of TB patients, (b) specify procedures
on how to put in place important NTP support health systems such as logistics, recording
and reporting, and monitoring and evaluation systems, (c) guide the different organizational
levels on how to conduct monitoring, evaluation, and supervision, and (d) prescribe the
roles and tasks of those involved in the management of the TB control program including TB
service provision.
Earlier versions of the NTP Manual of Procedures were conceived in the 1960s. However, the
first MOP was developed in 1980. It highlighted the use of sputum microscopy as the primary
diagnostic tool and introduced the Standard Drug Regimen for TB treatment. In 1988, the first
MOP was revised. This 2nd edition presented the results of the 1981 83 First National TB
Prevalence Survey (NTPS) and provided for the adoption of the Short Course Chemotherapy
(SCC) for the management of TB cases.
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 Cooperative
Agency) Public Health Development Project and the World Health Organization (WHO)
Western Pacific Regional Office (WPRO), in accordance with recommendations lifted from
the external evaluation conducted in 1993. This document emphasized the DOTS Strategy
(Directly Observed Treatment-Short Course) as the NTPs core framework for a nationwide TB
control strategy.
The third edition of the NTP MOP was written in 2001. This publication transformed the
previous Technical Guidelines into a Manual of Procedures that would be useful not only
in training, but also in providing instructions or procedures for the guidance of all health
personnel in their delivery of TB services.
In 2004, DOH initiated the revision of the MOP 4th edition that included the use of fixed dose
combination anti-TB drugs and the adoption of external quality assurance, public-private
mix DOTS, strengthening of the TB Diagnostic Committees, DOTS facility certification and
accreditation, and the development of the health promotion plan specific to TB.
This 2013 MOP, 5th edition adds the following vital components: (a) integration of guidelines
for the diagnosis and treatment of adult and pediatric TB cases, susceptible, and drug-resistant
TB cases, (b) introduction of intensified case finding for vulnerable groups, (c) inclusion of
the new diagnostic tools in the algorithm, (d) inclusion of new chapters on TB prevention, TBDOTS referral system, and DOTS certification and accreditation and (e) adoption of records
and reports based on new international standards.
ii
The primary users of this MOP are health service providers (physicians, nurses, medical
technologists, midwives, community volunteers) implementing DOTS in the different service
delivery points: public health facilities such as health centers and rural health units, public
hospitals, clinics of other government agencies; or private health facilities such as private
clinics, private hospitals, laboratories and pharmacies. The secondary users of this MOP are
the TB control program managers at the national, regional, provincial and city levels who will
be guided when they plan, implement, monitor and evaluate the TB control activities in their
areas. Thirdly, this MOP could also be used by policy makers at the national and local levels,
national and international donors, and program advocates.
Many institutions, groups, and individuals participated in the development of this 2013 MOP.
The MOP Technical Writing Group initially reviewed and introduced the changes based on
the technical guidelines issued by the WHO, advocated through the International Standard
on TB Care, collected experiences from the field, as well as feedback from other local and
international partners. The Technical Review Panel provided expert advice. The draft MOP
underwent a series of consultations with different stakeholders to ensure its technical validity,
soundness, feasibility and acceptability.
To keep it abreast with developments in the health care industry, the MOP will be regularly
reviewed and updated to ensure that they are responsive to the needs of Philippine health
care providers, supportive of the DOH strategic direction, and consistent with international
standards in TB care.
iii
Preface
his Manual of Procedures of the National TB Control Program, 5th edition, provides
the updated standardized policies and guidelines on the provision of quality TB care
and the necessary systems to put in place to enable us to address the problem of
TB. All health care providers, therefore, whether public or private, must provide TB
diagnostic, treatment and counselling services to patients in accordance with this
MOP. This will ensure that TB patients get cured, duration of TB transmission is reduced, and
poor outcomes are prevented.
The economic burden of TB in the country due to premature mortality and morbidity totalled
Ph8 billion pesos with 500,000 disability adjusted life years lost annually. The Department
of Health, in coordination with its partners, leads and coordinates efforts to control TB. The
main approach is to detect all TB cases promptly, treat them properly, and notify them fully.
This is part of the Universal Health Care or Kalusugang Pangkalahatan that will enable the
Philippines to achieve its Millennium Development Goals and the objectives of the 2010
2016 Philippine Plan of Action to Control Tuberculosis. The MOP is a major tool of this activity.
Involvement of many stakeholders, both local and international, in the development of this
MOP ensured that the policies and guidelines are consistent with the international standards,
and are feasible and acceptable. They include the members of the Technical Writing Group
and the Technical Review Panel and representatives from the DOTS facilities, provincial
and city health offices, regional health offices, non-governmental organizations, private
organizations and other government offices. I wish to thank them all, including our partners
from the World Health Organization, U.S. Agency for International Development, the Global
Fund Against AIDS, TB and Malaria, the Japan International Cooperation Agency, and the
Korean International Cooperation Agency. I also commend the Disease Prevention and
Control Bureau for orchestrating the processes of updating this MOP.
I call on all health organizations and facilities to ensure that all their health care providers
possess the capability to provide quality TB care through training and supervision. Only
through well trained cadres could our fight against TB bring us closer to our vision of a TBfree Philippines.
ENRIQUE T. ONA, MD, FPCS, FACS
Secretary of Health
iv
Table No. 2
Table No. 3
Table No. 4
10
Table No. 5
13
Table No. 6
TB Disease Classification Based on Anatomical Site and
Bacteriological Status
19
Table No. 7
25
Table No. 8
25
Table No. 9
34
Table No. 10
35
Table No. 11
Category I 2HRZE/4HR
38
Table No. 12
Category II 2HRZE/HRZE/5HRE
39
Table No. 13
39
Table No. 14
41
Table No. 15
44
Table No. 16
45
Table No. 17
48
Table No. 18
49
50
Table No. 21
51
Table No. 22
52
Table No. 23
110
Table No. 24
111
Table No. 25
112
Table No. 27
112
116
132
Table No. 30
139
Table No. 31
144
Table No. 32
145
List of Reports
Report 1.
90
Report 2
92
Report 3a
Report 3b
96
Report 4
98
Report 5a
100
Report 5b
102
Report 5c
103
Report 6
106
94
List of Figures
Figure No. 1 Organizational Structure of the Countrys Health
Delivery System Including the Different Units Supporting the NTP
Figure No. 5
Diagnostic Algorithm 31
Figure No. 6 Screening of Pediatric Drug-Susceptible Household Contacts of TB
vi
32
42
42
109
vii
NOSIRS
NPS/NTPS
NTP
NTRL
PhilHealth/PHIC
PhilPACT
PHO
PICT
PLHIV
PMDT
PPD
PPMD
PZA
QAS
RCC
RHU
RIF
RO
RRTB
RSS
SDF
TAP
TBDC
TBIC
TML
TSR
TST
UHC
WHO
viii
1
CHAPTER
Introduction
Tuberculosis is a major public health problem in the Philippines. In 2010, TB was the 6th
leading cause of mortality with a rate of 26.3 deaths for every 100,000 population and
accounts for 5.1% of total deaths.1 This is slightly lower than the five-year average of 28.6
deaths per 100,000 population. More males died (17,103) compared to females (7,611).
The country had conducted three National TB Prevalence Survey (NTPS) that describe the
magnitude and the trend of the TB problem. The results were as follows:
Table No.1/National TB Prevalence Surveys 1983-2007
Indicator
Prevalence of culture positive TB
Prevalence of sputum
smear-positive TB
Prevalence of those with CXR
findings suggestive of TB
Annual Rate of Infection
Rate of TB symptomatic
NTPS 19832
8.6/1,000
6.6/1,000
NTPS 19973
8.1/1,000
8.1/1,000
NTPS 20074
4.7/1,000
2.0/1,000
4.2%
4.2%
6.3%
2.5%
17.0%
2.3%
18.4%
2.1%
13.5%
TB is more prevalent among males compared to females and among the 25 55 year old age
group. It is also higher among the malnourished and diabetics. The 1997 survey showed
that prevalence of TB among the urban poor in Metro Manila is twice that of the general
population.
The first national Drug Resistance Survey was done in 2003 2004 and revealed the following
prevalence of drug resistance: 4% among the new cases, 21% among the re-treatment cases,
and 5.7% combined.5 The second national Drug Resistance Survey was done in 2011 2012
and showed a decrease in the prevalence of drug resistance among new cases from 4% to
2%. However, there was no change in the prevalence of drug resistance re-treatment cases
which remained at 21%.
The Philippines and its health care delivery system
The Philippines, an archipelago with 7,100 islands, has a population of around 97 million in
2012 with a population growth rate of 1.9%. Geographically, it is divided into three main islands
namely Luzon, Visayas and Mindanao. There are 17 regions, including the Autonomous
Region of Muslim Mindanao, 82 provinces, 135 cities and 1,493 municipalities. Functional
literacy rate is high at 86%. In 2011, the country was categorized as a low to middle income
country with gross national income per capita of $4,160.6
The decentralized health care system is managed, coordinated and regulated by the
Department of Health (DOH) that is composed of the Central Office, 17 Regional Offices
(ROs) and retained hospitals. Integrated basic health services including TB diagnostic and
treatment services are provided by 2,314 rural health units (RHUs)/health centers (HCs) and
16,219 barangay health stations (BHS) that are under the local municipal/city government
units. Majority of the RHUs/HCs have a TB microscopy laboratory that provides Direct Sputum
Smear Microscopy (DSSM). The locally-managed Provincial Health Office (PHO)/City Health
Office (CHO) provide technical oversight over these peripheral health units. Communities
support these health units through the community health teams (CHTs) that include barangay
health workers (BHWs).
The private sector is also engaged in the production and provision of health goods and
services through private clinics, hospitals and laboratories, drug stores, and other facilities.
The DOH encourages public-private sector collaboration in health.
DOH priorities and strategies are contained in its health agenda called Universal Health
Care (UHC) or Kalusugang Pangkalahatan (KP) that aims to ensure financial risk protection
for the poor, provide access to quality health services, and attain health related Millennium
Development Goals (MDGs). Specific health targets including that for TB control are
contained in the National Objectives for Health.
The National TB Control Program (NTP)
The NTP is one of the public health programs being managed and coordinated by the
Infectious Diseases for Prevention and Control Division (IDPCD) of the Disease Prevention
and Control Bureau (DPCB) of the DOH. The NTP has the mandate to develop TB control
policies, standards and guidelines, formulate the national strategic plan, manage program
logistics, provide leadership and technical assistance to the lower health offices/units, manage
data, and monitor and evaluate the program. The programs TB diagnostic and treatment
protocols and strategies are in accordance with the global strategy of STOP TB Partnership
and the policies of World Health Organization (WHO) and the International Standards for TB
Care (ISTC).
The NTP works closely with various offices of the DOH such as the Health Promotion and
Communications Service (HPCS) for advocacy, communication and social mobilization,
the Epidemiology Bureau (EB) and Knowledge Management and Information Technology
Service (KMITS) for data management, Health Policy Development and Planning Bureau
(HPDPB) for policy and strategic plan formulation, Material Management Division (MMD),
Central Office Bids and Awards Committee (COBAC) and Food and Drug Administration
(FDA) for drug and supplies management, the National TB Reference Laboratory of the
Research Institute for Tropical Medicine (NTRL-RITM) for laboratory network, Lung Center of
the Philippines (LCP) for MDR-TB related research and training activities and the 17 ROs for
technical support to the implementing units. It also coordinates with the Philippine Health
Insurance Corporation (PhilHealth) for TB-DOTS accreditation and utilization of the TB-DOTS
outpatient benefit package.
The DOH Regional Offices through their Regional NTP teams, manage TB at the regional
level while the provincial health and city health offices, through their provincial/city teams
are responsible for TB control efforts in provinces and cities. TB diagnostic and treatment
services that are in accordance with NTP protocol are provided by DOTS facilities which could
either be the public health facilities such as the RHUs, health centers, hospitals; other public
health facilities such as school clinics, military hospitals, prison/jail clinics; NTP-engaged
private facilities such as private clinics, private hospitals, private laboratories, drug stores
and others. Community groups such as the community health teams and barangay health
workers participate in community-level activities.
NTP closely works with the 17 government offices and five private organizations in compliance
with the Comprehensive and Unified Policy (CUP) issued by the Office of the President in
2003.7 Under the framework of public-private collaboration in TB-DOTS, NTP collaborates
with non-governmental organizations such as the Philippine Coalition Against TB (PhilCAT),
a consortium of 60 groups, and the 100-year old Philippine TB Society, Inc. (PTSI) and many
other organizations. Various developmental partners and their projects provide technical
and financial support to NTP such as the WHO, United States Agency for International
Development (USAID), Global Fund Against AIDS, TB and Malaria (Global Fund), Research
Institute of TB/Japan Anti-TB Association (RIT/JATA), Korean Foundation for International
Health (KOFIH) and Korean International Cooperation Agency (KOICA).
Figure No. 1 Organizational Structure of the Countrys Health Delivery
System Including the Different Units Supporting the NTP.
NATIONAL
Department of Health
Other Clusters
DOH Hospitals
Health Operations
DPCB
IDPCD
BGY
MUN / CITY
PROVINCIAL
REGIONAL
NTRL
Regional Offices
Infectious Disease Cluster
Regional Hospitals
Municipal
Hospitals
Provincial/City/District
Hospitals
Municipal/City
Health Centers
DOH Hospital
(Hospital TB Team)
Infectious Disease Cluster
TB Unit
(MD, Nurse, MT Coordinator)
Regional Hospital
(Hospital TB Team)
Technical Office
TB Team
(MD, Nurse, MT Coordinator)
Provincial / CityHealth
HealthOffice
Office
Provincial/City
Technical Office
Private
Hospitals/Clinics
Private
Hospitals/Clinics
Provincial/City/District Hos.
Private Hospital/Clinic
(Hospital TB Team)
Municipal/City Health Ctr
(MD, Nurse)
Municipal/
Private Hospital/Clinic
(Hospital/ClinicTB Team)
Bgy Health Station (BHS)
(Midwife)
established at the DOH compound. The close collaboration between the Ministry of Health
and the PTSI led to the establishment of the National Institute of Tuberculosis in 1976 that
conducted operational studies including the first National TB Prevalence Survey (NTPS) that
helped NTP strengthen its strategies. The TB Control Service (TBCS), with around 30 staff,
was created under the Office of Public Health Services of the Department of Heath after the
EDSA People Power in 1986. In 2000, with the re-organization of the DOH, the TBCS was
disbanded and some of its staff were absorbed by the newly created Infectious Disease
Office (IDO) of the National Center for Disease Prevention and Control (NCDPC). In 2013,
rationalization of the DOH central and regional offices was implemented and the number of
staff was decreased. Integration of programs and activities was advocated to cope with the
changes.
Technical approaches to TB management have substantially changed over the years. Before
the 1970s, BCG immunization as a preventive tool was implemented nationwide with the
help of UNICEF. Chest X-ray (CXR) examination was then utilized as the main diagnostic tool.
The 12-month standardized treatment composed of INH and Streptomycin was used to treat
TB and patients were hospitalized.
In 1978, sputum microscopy as a primary TB diagnostic tool and ambulatory treatment were
adopted as policies of the organized National TB Control Program (NTP). The short course
chemotherapy composed of Isoniazid, Rifampicin, and Pyrazinamide was prescribed as the
indicative mode of treatment over a period of six (6) months since 1987. Public-private mix
DOTS (PPMD) was implemented in 2003 together with DOTS certification and accreditation of
health facilities. Guidelines for the diagnosis and treatment of children was issued by DOH in
2004.8 Management of multi-drug resistant TB cases started in 1999 and was mainstreamed
into the NTP in 2008 through the integration of Programmatic Management of Drug-resistant
-TB (PMDT) into NTP.9 In 2011, the NTP introduced rapid TB diagnostic tools such as Line
Probe Assay (LPA), Mycobacterium Growth Indicator Tube (MGIT) and Xpert MTB/RIF.
Current key initiatives to respond to the TB problem
The overarching strategy of the NTP is the DOTS or directly observed treatment short course
that was started in the country in 1996. It has five basic elements, (a) availability of quality
assured sputum microscopy, (b) uninterrupted supply of anti-TB drugs, (c) supervised
treatment, (d) patient and program monitoring, and (e) political will. This was expanded
under the WHO-endorsed STOP TB strategy that the country adopted from 2006 2010. In
2010, DOH issued the 2010 2016 Philippine Plan of Action to Control TB (PhilPACT) as the
roadmap for controlling TB.
Key Initiatives of the NTP
1. Public-private mix DOTS (PPMD) engagement of the private sector such as private
practitioners, pharmacies, and hospitals to adopt the NTP policies and guidelines and,
hence, support the TB control efforts. PPMD staff were trained on TB-DOTS including
the referral system. They either manage TB cases or refer them to other DOTS facilities.
Around 6% of total TB cases nationwide were contributed by this initiative in 2008.
2. Enhanced hospital TB-DOTS strengthening of the internal and external referral
systems and quality of TB diagnosis and treatment in hospitals.10 Hospitals could either
act as a referring hospital or DOTS-providing hospital. All or most of the TB cases are
referred to the DOTS facilities and the outcomes are tracked. A pilot study from 2010-2012
showed that 73% of around 13,000 TB cases were successfully referred to health centers
and RHUs.
Baseline in 1990
(Rate Per 100,000)
393
1,000
55
2012
(Rate Per 100,000)
265
461
ith24
2012
(Estimated number)
260,000
450,000
23,000
According to the WHO, the Philippines is one of the seven countries that have already
achieved the MDGs in 2012.
Two major indicators are used to measure the progress of TB control the case detection
rate (CDR) and the treatment success rate (TSR). In 2010, the WHO strongly suggested that
CDR of all forms of TB be used instead of the CDR of new smear-positive TB cases since
the incidence of the latter group is quite uncertain. Internationally, TSR is used instead of the
cure rate.
By 2012, the countrys CDR, all forms, was 82% while the treatment success rate was 90%.12
CDR by region varied from 46% to 114% while Treatment Success Rate varied from 71% to
94%. Figure 2 below show the trend of program performance from 2000 to 2011.
Figure No. 2. Trends in TB Case Detection Rate, Cure Rate and Treatment
Success Rate. Philippines. 2000-2012
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
For PMDT, enrolment of DR-TB cases continuously increased since inception in 1999 (Figure
3). To date, there had been a total of 9,887 DR-TB patients enrolled in treatment protocols
with more than 2,000 patients enrolled annually since 2011. However, case holding is the
major challenge, as the rate of default continued to increase annually (see Figure 4 on page
8).
Figure No. 3 DRTB Cases Initiated on Treatment Annually and Cumulatively
under PMDT, Philippines, 1999-2013.
TB-free Philippines
Goal:
Incidence Rate:
246/100,000
Prevalence Rate:
414/100,000
Mortality Rate: 23/100,000
Targets by 2016:
90%
90%
75%
Strategies
10
Local government
units - provincial/
city level
LGU - municipal/
city level and
other health
facility
11
Hospitals
(under DOH, LGU
or private)
Partners
(CUP agencies,
technical
assistance
providers, donor
agencies, etc.)
12
Nurse
13
Midwife
Medical
Technologists/
Microscopists
14
2
CHAPTER
Case Finding
I. INTRODUCTION
16
B. Turnaround time the time from collection of first sputum sample to initiation of
treatment for TB. The desired turnaround time is five (5) working days.
C. Passive case finding - when symptomatic patients are screened for disease activity
upon consultation at the health facility.
D. Active case finding a health workers purposive effort to find TB cases in the
community or among those who do not consult with personnel in a DOTS facility.
E. Intensified case finding active case finding among individuals belonging to
special or defined populations (e.g., high-risk groups including those who consult or find
themselves at the facility for other purposes):
5.1. Close contact a person who shared an enclosed space, such as the household, a
social gathering place, workplace or facility, for extended periods within the day with
the index case during the 3 months before commencement of the current treatment
episode.14
5.2. High-risk clinical groups individuals with clinical conditions that put them at risk of
contracting TB disease, particularly those with immune-compromised states (e.g.,
HIV/AIDS, diabetes, end-stage renal disease, cancer, connective tissue diseases,
autoimmune diseases, silicosis, patients who underwent gastrectomy or solid organ
transplantation and patients on prolonged systemic steroids).15
5.3. High-risk populations persons with known high incidence of TB, particularly those
in closed environments or living in congregate settings that promote easy disease
transmission (e.g., inmates, elderly, Indigenous People, urban/rural poor).15
F. Children any person who is less than 15 years old.
G. Contact investigation - A systematic process intended to identify previously
undiagnosed cases of TB among the contacts of an index case.14
H. Index case - the initially-identified TB case of any age in a specific household or other
comparable setting in which others may have been exposed. The index case may or
may not be the source case.14
I. Source case- A person with infectious TB who is responsible for transmitting TB to
another person. A source case could be any of the following: a smear positive TB case
(adult or child) undergoing treatment for TB, a person (usually adult) who has undergone
TB treatment in the past, or a person (usually adult) who is not yet on treatment but has
laboratory results suggestive of active TB.14
J. Presumptive TB any person whether adult or child with signs and/or symptoms
suggestive of TB whether pulmonary or extra-pulmonary, or those with CXR findings
suggestive of active TB. 16 (Refer to page 21, Identification of Presumptive TB for operational
definition of signs and symptoms.)
17
b.
Clinically diagnosed A PTB patient who does not fulfil the criteria for
bacteriological confirmation but has been diagnosed with active TB by a
clinician or other medical practitioner who has decided to give the patient a
full course of TB treatment. This definition includes cases diagnosed on the
basis of CXR abnormalities or suggestive histology, and extra-pulmonary cases
without laboratory confirmation.
18
Bacteriological
status
Definition of Terms
Smearpositive
Bacteriologicallyconfirmed
Pulmonary
(PTB)
Clinicallydiagnosed
Extrapulmonary
(EPTB)
Bacteriologicallyconfirmed
Clinicallydiagnosed
19
20
Two sputum specimens of good quality shall be collected, either as frontloading (i.e.,
spot-spot one-hour apart) or spot-early morning specimens, based on the patients
preference.17 The two specimens should be collected at most within 3 days.
F.
Available rapid diagnostic test (e.g., Xpert MTB/RIF) shall be used for TB diagnosis
among presumptive DRTB, PLHIV with signs and symptoms of TB, smear negative adults
with CXR findings suggestive of TB smear negative children and EPTB.18
G. If Xpert MTB/RIF is inaccessible, smear negative patients shall be evaluated by the DOTS
physician who shall decide using clinical criteria and best clinical judgment. If in doubt,
the case may be referred to a clinician/specialist within the area or to a TB Diagnostic
Committee (TBDC) as long as the recommendation could be made within two (2) weeks.
H. Tuberculin skin test (TST) shall not be used as the sole basis for TB diagnosis. It shall be
used as a screening tool for children. A 10mm induration is considered a positive TST
reaction. Only trained health worker shall do the testing and reading.
I.
All DOTS facilities, whether public or private are encouraged to establish their own
in-house microscopy unit. However, in cases where this is not possible, access to an
officially linked NTP-accredited microscopy unit would be acceptable.
J.
All municipalities and cities shall ensure access to quality-assured microscopy services.
One microscopy center shall cater to, at most, 100,000 population. In difficult to
access areas, remote smearing stations (RSS) manned by trained volunteers could be
established.
K. All laboratories providing DSSM services or other TB diagnostic tests, whether public or
private, shall participate in the External Quality Assessment (EQA) system of the NTP.
L.
All presumptive DRTB shall be referred to the nearest DOTS facility with PMDT services
for screening or an Xpert site for testing.
Note the patients general information on the individual treatment record or patients
chart.
2.
Ask or check for clinical signs and symptoms to identify a presumptive TB.
a. For patients 15 years old and above, a presumptive TB has any of the
following:
i. Cough of at least 2 weeks duration with or without the following symptoms:
Significant and unintentional weight loss,
Fever,
Bloody sputum (hemoptysis),
Chest/back pains not referable to any musculoskeletal disorders,
Easy fatigability or malaise,
Night sweats, and
Shortness of breath or difficulty of breathing;
21
high risk populations (elderly, urban poor, inmates and other congregate
settings).
b. For patients below 15 years old, a presumptive PTB has any of the following:
i. At least three (3) of the following clinical criteria:
ii. Any one (1) of the above signs and symptoms (clinical criteria) in a child who
is a close contact of a known active TB case.
c. CXR findings suggestive of PTB, with or without symptoms, regardless of age.
d. Presumptive extra-pulmonary TB may have any of the following:
Pleural effusion;
Pericardial effusion;
22
erythema nodosum).
For PLHIV with signs and symptoms of TB, refer the patient to a DOTS facility with
PMDT services for screening or to an Xpert site for testing.
2. Prepare the sputum cups and the Form 2a. NTP Laboratory Request Form. Label
the body of the sputum cup (i.e., not the lid), indicating patients complete name,
and order of specimen collection (i.e., 1st, and 2nd).
For Xpert MTB/RIF, prepare a sputum cup or 50ml conical tube and Form 2a.
NTP Laboratory Request Form. Label the body of the sputum cup/conical tube,
indicating patients complete name and indicating specimen for Xpert.
3. Demonstrate how to produce quality sputum. Mucus from the nose and throat, and
saliva from the mouth are NOT good specimens. Advise the patient to:
a. Clean mouth by thoroughly rinsing with water. Food particles or other solid
particulates may inhibit the test for Xpert MTB/RIF.
b. Breathe deeply, hold breath for a second or two, and then exhale slowly. Repeat
the entire sequence two (2) more times.
c. Cough strongly after inhaling deeply for the third time and try to bring up sputum
from deep within the lungs.
d. Expectorate the sputum in the sputum cup or conical tube.
e. Collect at least 1 teaspoonful (5-10ml) for DSSM. For Xpert MTB/RIF, sputum
sample should not be less than one (1) ml.
f. Examine the specimen to see that it is not just saliva. Repeat the process if
necessary.
23
4. Observe proper precautions against infection during the demonstration. Stay behind
the patient. Collect specimen in a well-ventilated designated sputum collection
area, or outside the DOTS facility.
5. Collect the first specimen (i.e., spot) at the time of the first consultation. Collect the
second spot specimen after at least an hour, or the following morning. If the second
sputum specimen is not submitted within three days from the first specimen, a new
set of two (2) sputum specimens should be collected unless the first specimen
already tests positive for AFB.
6. Check quantity and quality of sputum. Wipe off the external surface of the sputum
cup or conical tube if needed and wash your hand thoroughly with soap and water.
7. Seal the sputum cup or conical tube, pack it securely, and transport it to a microscopy
center or Xpert site together with the completely filled up Form 2a. NTP Laboratory
Request Form.
8. If the specimen cannot be sent to a microscopy unit early enough, prepare the
smears immediately and then store them appropriately. Smearing can be done by
trained volunteers before transport to the microscopy center.
9. Inform the patient when to return for follow-up consultation regarding the results.
C. Procedure for direct sputum smear microscopy
24
Conventional Light
Microscopy
No AFB seen in 300 oil
immersion field (OIF)
Confirmation required*
Fluorescence Microscopy
200x magnification
1 length = 30 fields
400x magnification;
1 length = 40 fields
No AFB observed/1
length
Confirmation required*
+n
1+
3-24 AFB/1field
2+
25-250/1 field
7-60/1 field
3+
>250 / 1 field
>60 / 1 field
4. Interpret the results of the two specimens and write the final laboratory diagnosis
in the lower portion of Form 2a. NTP Laboratory Request Form for DSSM and on
the Remarks column of Form 3. NTP Laboratory Register (Microscopy and GX).
Laboratory diagnoses are classified as follows:
5. Send the request form with its corresponding results back to requesting unit within
three (3) working days.
D. Procedure for Xpert MTB/RIF
1. Record the patient information in Form 3. NTP Laboratory Register (Microscopy
and GX).
2. Prepare the Xpert MTB/RIF cartridge, process the sputum sample and load it in the
GeneXpert Dx machine. Start the test.
3. When the test is finished, view test result. Xpert MTB/RIF results are reported as
follows:
Table No. 8/Xpert MTB/RIF Results and interpretation
T
RR
TI
Invalid/no result/error
25
4. Interpret the result and write the final laboratory diagnosis in the lower portion of
Form 2a. NTP Laboratory Request Form and in Form 3. NTP Laboratory Register
(Microscopy and GX).
5. Send the request form with its corresponding results back to the requesting unit
within three (3) working days.
E. Tuberculin skin testing (for patients less than 15 years old)
1. Perform the TST according to the standard set of procedures.
2. Read and interpret the test between 48 to 72 hours from the time it was administered.
A positive TST is an area of induration of the skin with diameter of 10mm or more.
F. Diagnosis of extra-pulmonary TB (EPTB)
G. Decision on diagnosis based on laboratory results (see Figure no. 5 on page 31)
1. If sputum smear positive, classify as bacteriologically-confirmed PTB.
2. For patients who are at least 15 years old with negative DSSM results or DSSM not
done, refer the patient for CXR.
a. If CXR findings are suggestive of TB and patient has access to Xpert MTB/RIF,
refer the patient to an Xpert site for testing.
b. If CXR findings are suggestive of TB but patient has no access to Xpert MTB/
RIF or could not expectorate, the DOTS physician will use his best clinical
judgment to decide if active TB. Referral to a specialist or a TB Diagnostic
Committee may be done if reasonably accessible or able to render a decision
within 2 weeks. If the physician or TBDC decides to treat as active TB, classify
as clinically-diagnosed PTB.
c. If CXR is normal or not suggestive of TB, investigate for other causes of cough
or refer to a specialist.
3. For patients below 15 years old who are smear negative but can expectorate, refer
to an Xpert site if accessible. If patient has no access to an Xpert site or cannot
expectorate, perform TST. If TST is negative, request for CXR.
a. Decide to treat as active TB if the child has any three of the following criteria19
26
i.
ii.
iii.
iv.
v.
b. If patient fulfills three (3) out of five (5) criteria, classify as clinically-diagnosed
PTB.
c. If patient does not fulfil at least three (3) out of five (5) criteria, investigate further
or refer to a specialist.
4. If Xpert MTB/RIF is done and tests positive for MTB, classify as bacteriologicallyconfirmed PTB. Cases that are Rifampicin-resistant should be referred to a DOTS
facility with PMDT services for DR-TB treatment. Cases that are Rifampicin-sensitive
may be treated with first line drugs based on registration group (see Chapter 2. Case
Finding on page 15).
If Xpert MTB/RIF result is negative for MTB, investigate further or refer to a specialist.
The physician may still decide to treat based on the clinical criteria.
27
d. Once the contacts are at the DOTS facility, interview each of them (or their
caregiver) for signs and symptoms of TB, and history of TB diagnosis and
treatment.
e. If CXR is available and feasible (e.g. provided for free by the facility, or affordable
to the patient), perform CXR on all household members whether symptomatic
or not.
f. All household contacts identified to be a presumptive TB shall be evaluated
based on the NTP case finding procedures.
g. All asymptomatic household contacts less than 5 years old of a bacteriologicallyconfirmed index case shall undergo TST. If TST is negative, these contacts
should be given IPT. If TST is positive, rule out TB disease with CXR before
giving IPT. (Refer to Figure no. 6 on page 32)
However, if TST and CXR are not available, the child contact of a bacteriologicallyconfirmed index case can be given IPT based on the physicians clinical
assessment.21
h. All asymptomatic household contacts less than 5 years old of a clinicallydiagnosed index case shall undergo TST. If TST is negative, do not give IPT
and advise to seek/consult immediately if signs and symptoms of TB develop.
If TST is positive, give IPT.
i. All asymptomatic household contacts 5 years old and above (with normal
CXR findings, if done) are advised to seek/consult immediately if signs and
symptoms of TB develop.
j. Update Form 4. TB Treatment/IPT Card (of the index case) once household
contacts have been screened and results of diagnostic procedure become
available.
k. All children given IPT are recorded using the separate Form 4. TB Treatment/
IPT Card and registered in Form 9. IPT Register. The procedure for IPT is
discussed in Chapter 4 on the Prevention of TB.
2. Screening household contacts of DR-TB cases
a. Evaluate all household contacts of diagnosed DR-TB cases by screening for
signs and symptoms and CXR.
b. Refer all household contacts identified as presumptive TB to a DOTS facility
with PMDT services for DR-TB screening.
c. All household contacts that have no signs and symptoms nor CXR findings
should be advised to immediately return to the DOTS facility if signs and
symptoms of TB develop.
28
29
c. TB treatment shall start once the patient is found to have active TB based on
the Xpert MTB/RIF testing or if with radiographic findings consistent with TB.
d. PLHIV with RR-TB shall be referred to a DOTS facility with PMDT services.
e. PLHIV with no active TB (no symptoms, negative for TB in Xpert MTB/RIF and
CXR) shall be given IPT for 6 months (see Chapter 4. Prevention of TB on page 53).
f. All PLHIV given IPT are recorded using Form 4. TB Treatment/IPT Card and
registered in the Form 9. IPT Register.
6. TB during disasters
30
Following a disaster situation and after the acute relief operations, the objective
is to re-establish TB services to reduce mortality and morbidity due to interrupted
treatment arising from lack of follow-up, drugs, facilities, and human resource. The
strategies to achieve this objective and the algorithm to ensure that all existing TB
patients resume treatment will be detailed in the DOH tech guidelines for TB in
disaster.
Notes:
*Unable to produce sputum
Category I Treatment
MTB positive,
Rif-resistant
MTB positive,
Rif-sensitive
No
Chest x-ray
findings
suggestive
of TB?
Xpert Result
Diagnosis
Classification
Diagnostic Test
No
History of
previous
treatment?
Question
Yes
Xpert
MTB/Rif
result?
MTB negative
Not TB or investigate
further/refer to specialist
Yes
DSSM
positive?
Yes
No
No or not
done
COLOR LEGEND
Refer to PMDT
services for
evaluation
Bacteriologically
confirmed PTB,
Retreatment
Bacteriologically
confirmed PTB
History of
previous
treatment?
Yes
Category II Treatment
(for Rif-sensitive)
Bacteriologically
confirmed PTB,
New
No
PRESUMPTIVE TB:
Cough of at least 2 weeks in an adult (age >15 y/o)
A child (<15 y/o) w/ any 3 out of 6 criteria for TB Signs/Symptoms
Chest X-ray suggestive of tuberculosis
Cough of any duration in a high risk individual or a close contact of
an active TB case (adult/adolescent)
Treatment
Disposition
Clinically
diagnosed TB
(PTB if CXR+ or
with cough)
Not TB or
investigate
further/refer to
specialist
Yes
With access
to Xpert
MTB/Rif?
Yes
Age
<15 y/o?
No or
UPS*
Decision of MD or TBDC?
31
32
Clinically
diagnosed PTB
Yes
With access
to CXR and
findings are
suggestive
of TB?
Yes
Yes
No
Other lab
findings
suggestive
of TB?
No
Give Isoniazid
Preventive
Therapy
Tuberculin
Skin Test
positive?
No
Classification of
Index Case?
Bacteriologically
confirmed PTB
Age
<5 y/o?
Yes
Question
Classification
Disposition
Diagnostic Test
Treatment
Age >5,
<15 y/o?
COLOR LEGEND
No
Tuberculin
Skin Test
positive?
Clinically
diagnosed PTB
Asymptomatic
household contacts
3
CHAPTER
Case Holding
I.
INTRODUCTION
ase holding is the set of procedures which ensures that patients complete their
treatment. While effective anti-TB drugs are available in the country, there are still
many TB patients who are not cured because they stop taking anti-TB drugs or
take them irregularly. This may lead to chronic infectious illness, drug resistance,
or death. The best way to prevent the occurrence of these events is through the
regular intake of appropriate drugs for the prescribed duration.
Case holding involves assignment of the appropriate treatment regimen based on diagnosis
and previous history of treatment, supervised drug intake with support to patients, and
monitoring responses to treatment through follow-up sputum smear microscopy.
II. OBJECTIVE
To ensure effective and complete treatment of all TB cases for both adults and children.
III. DEFINITION of TERMS
A. TB Disease Registration Group16: Cases are assigned a registration group based
on history of previous treatment in addition to classification based on anatomical site
and bacteriologic confirmation. The registration groups of TB cases is necessary in
determining the correct treatment regimen.
Retreatment
Registration Group
Definition of Terms
New
A patient who has never had treatment for TB* or who has taken
anti-TB drugs for less than one (<1) month.
Relapse
A patient previously treated for TB, who has been declared cured
or treatment completed in their most recent treatment episode,
and is presently diagnosed with bacteriologically-confirmed or
clinically-diagnosed TB.
Treatment After
A patient who has been previously treated for TB and whose
Failure
treatment failed at the end of their most recent course. (See
definition of Failed treatment outcome in Section H);
This includes:
A patient whose sputum smear or culture is positive at 5
months or later during treatment.
A clinically diagnosed patient (e.g., child or EPTB) for whom
sputum examination cannot be done and who does not show
clinical improvement anytime during treatment.
Treatment After
A patient who was previously treated for TB but was lost to
Lost to Follow-up
follow-up for two months or more in their most recent course of
(TALF)
treatment and is currently diagnosed with either bacteriologicallyconfirmed or clinically-diagnosed TB.
Previous
Patients who have been previously treated for TB but whose
Treatment
outcomes after their most recent course of treatment are
Outcome Unknown
unknown or undocumented.
(PTOU)
Other
Patients who do not fit into any of the c ategories listed above.
*Prophylaxis and treatment for latent TB infection (LTBI) are not counted as anti-TB treatment
34
Patients who had been registered in a DOTS facility and are transferred to another DOTS
facility with proper referral slip to continue the current treatment regimen, or Transfer-in
patients, will be designated a registration group based on the registration group of the
referring facility aside from Transfer-in. These cases should NOT be reported in the casefinding and case-holding quarterly reports since they will be reported by the referring
facility.
B. 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 anti-TB drugs every day during the whole course of treatment.
C. Drug formulations
1.
Fixeddose 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, namely: HR,
HRE and HRZE. These are usually provided in kits with boxes of blister packs
corresponding to treatment phases of an average-weight patient.
2.
Single drug formulation (SDF) Each drug is prepared individually, either as tablet,
capsule, syrup or injectable (Streptomycin) form.
IV. POLICIES
A. All diagnosed TB cases shall be provided with adequate and appropriate anti-TB
treatment regimen promptly.
B. Anti-TB treatment shall be done through a patient-centered, directly observed treatment
(DOT) to foster adherence. DOT should be carried out in settings that are most accessible
and acceptable to the patient. Exert all efforts to decentralize DR-TB patients as soon as
possible to a treatment facility most accessible to the patient.
C. Anti-TB treatment regimen shall be based on anatomical site, and bacteriologic status
including drug resistance and history of prior treatment. Except in cases of adverse drug
reactions and special circumstances requiring treatment modifications, TB treatment
under the NTP shall conform to standardized regimens specified in the table below.
Table No. 10/Recommended Treatment Regimen for Adults and Children24, 25
Category of
Treatment
Category I
Category Ia
Classification and
Registration Group
Pulmonary TB, new (whether bacteriologicallyconfirmed or clinically-diagnosed)
Extra-pulmonary TB, new (whether bacteriologically-confirmed or clinically-diagnosed)
except CNS/ bones or joints
Extra-pulmonary TB, new (CNS/bones or joints)
Treatment
Regimen
2HRZE/4HR
2HRZE/10HR
35
Category IIa
Relapse
Treatment After Failure
Treatment After Lost to Follow-up (TALF)
Previous Treatment Outcome Unknown
Other
Extra-pulmonary, Previously treated drug susceptible TB (whether bacteriologically-confirmed
or clinically-diagnosed - CNS/bones or joints)
Standard Regimen
Rifampicin Resistant -TB or
Drug Resistant
Multidrug ResistantTB
(SRDR)
XDR TB Regimen
2HRZES/1HRZE
/5HRE
2HRZES/1HRZE
/9HRE
ZKmLfxPtoCs
Individualized
once DST result
is available
Treatment
duration for at
least 18 months
Individualized
based on DST
result and history
of previous
treatment
D. All retreatment patients should be screened for MDR-TB before initiating Category II
treatment regimen. Initiating Category II treatment regimen without MDR-TB screening
can only be done in areas where access to PMDT services is not possible.
E. A patients anti-TB regimen shall be comprised of at least four (4) first-line drugs. Fixeddose combination (FDC) should be used except in children unable to take tablet
formulations.
F. The national and local government units (LGUs) shall ensure provision of drugs to all TB
cases. LGUs should allocate funds for drugs and supplies in the event of unforeseen
supply interruptions to ensure the continuity of treatment within their areas of jurisdiction.
G. 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.
H. Out-patient treatment shall be the preferred mode of care. However, patients with lifethreatening conditions shall be recommended for hospitalization.
I. A TB patient diagnosed during confinement in a hospital may start treatment using
NTP drug supply upon the approval of the hospital TB team. Once discharged, the
patient shall be referred by the hospital TB team to a DOTS facility for registration and
continuation of the assigned standard treatment regimen.
J. Treatment response of PTB patients shall be monitored through follow-up DSSM and
clinical signs and symptoms. All adverse drug reactions (ADRs), whether minor or major,
shall be reported using the official reporting form of the FDA. (See Annex B on page 153).
36
K. Tracking mechanism for patients lost to follow-up shall be put in place to ensure that
patients who fail to follow-up as scheduled are immediately traced.
L.
Inform the patient that he/she has TB disease and motivate him/her to undergo
treatment. For patients less than 18 years old, talk to the parent/guardian regarding
the need for the child to undergo treatment. Provide, as necessary, the following key
messages for TB patients and their families:
The need for at least six to eight (6-8) months of supervised, well-documented
TB treatment with good compliance
Public health facilities offer free bacteriology services (DSSM, Xpert MTB/RIF
and/or MTB culture and DST).
2.
3.
Open and accomplish Form 4. TB Treatment/IPT Card and two (2) Form 5. NTP ID
Cards - one for the patient and the other for the treatment partner.
4.
Discuss with the patient and decide who will be the most appropriate treatment
partner and where the treatment will be administered if it is not possible to receive
treatment at the DOTS facility.
37
DOT can be done in any accessible and convenient place for the patient (e.g.,
DOTS facility, treatment partners house, patients place of work, or patients house)
as long as the treatment partner can effectively ensure the patients intake of the
prescribed drugs and monitor his/her reactions to the drugs. 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 a former TB patient.
DOT schedule is in conflict with the patients work/school schedule and unable
to access other DOTS facilities
Cultural beliefs that limit the choice of a treatment partner (e.g., indigenous
peoples)
Treatment of children
In such cases where a family member is the treatment partner, drug supply is to
be distributed on a weekly basis or as agreed by the health worker and the family
member.
6. Start the appropriate Standard Regimen and watch the patient take the initial dose
of medications. Refer to tables below for the dosage.
Table No. 11/Category I 2HRZE/4HR
38
Intensive Phase
Continuation Phase
2 months of
4 months* of (HR) daily
(HRZE) daily
No. of tablets per day
2
2
3
3
4
4
5
5
First 2 months
HRE
No. of tablets
2
3
4
5
S
(1g/2ml)
1 g ***
Third month
HRE
No. of tablets
2
3
4
5
HRE
No. of tablets
2
3
4
4
Table No. 13/Drug Dosage per Kg Body Weight (if using SDFs)
Drug
Isoniazid (H)
Rifampicin (R)
Pyrazinamide (Z)
Ethambutol (E)
Streptomycin (S)
Adults25
5 (4-6) mg/kg,
not to exceed 400mg daily
10 (8-12) mg/kg,
not to exceed 600mg daily
25 (20-30) mg/kg,
not to exceed 2g daily
15 (15-20) mg/kg,
not to exceed 1.2g daily
15 (12-18) mg/kg,
not to exceed 1g daily
Children26
10 (10-15) mg/kg,
not to exceed 300mg daily
15 (10-20) mg/kg,
not to exceed 600mg daily
30 (20-40) mg/kg,
not to exceed 2g daily
20 (15-25) mg/kg,
not to exceed 1.2g daily
30 (20-40) mg/kg,
not to exceed 1g daily
Note: Dosage for children are higher since there are more metabolizing enzymes among children than
adults leading to faster metabolism.27
39
Ethambutol
(400mg/tab)
20mg/kg
Tablet
1/8*
1/4*
1/2
3/4
1+1/4
1+1/2
Streptomycin*
(1g/2ml)
30mg/kg
ml
0.18
0.24
0.3
0.36
0.42
0.48
0.54
0.6
0.66
0.72
0.78
0.84
0.9
0.96
1.02
1.08
1.14
1.20
1.26
1.32
1.38
1.44
1.5
1.56
1.62
1.68
1.74
1.8
*If child is a newborn (less than 4 weeks), consider referral to pediatrician so that Streptomycin can be
used instead of Ethambutol.
40
9. In Category A or B sites and among all DRTB cases, offer PICT to all patients aged
15 years old and above. If the patient consents to testing, refer the patient to a
trained medical technologist for testing. If patient does not consent, offer testing
again during subsequent visits. Results of HIV screening will be written in Form 2b.
NTP Laboratory Result Form for HIV testing and sent to the physician.
B. Follow-up clinic visits
1. During follow-up, ask for the patients Form 5. NTP ID Card and inquire how he/she
has been since the last clinic visit. Ask the patient about the following:
a. General well-being
b. Progression or resolution of symptoms
c. Adverse drug reactions or side effects
d. Compliance to treatment and DOT
e. Any problem or concerns regarding the treatment so far
2. If the patient underwent HIV testing, the physician should provide post-test
counselling. A reactive result on the HIV screening test necessitates confirmatory
testing. Refer again the patient to the medical technologist for blood extraction and
send specimens to STI-AIDS Central Cooperative Laboratory. Refer the patient to a
treatment hub for anti-retroviral treatment (ART) if confirmatory test is positive.
3. Weigh the patient monthly and record this in Form 4. TB Treatment/IPT Card. Note
if additional tablets or dose adjustments are required, patients should gain enough
weight to be re-classified into the next dosing category.
4. Always check if the patient is scheduled to shift treatment phases and/or if he/she is
due for follow-up DSSM (see next section). If so, advise the patient accordingly and
provide the necessary sputum cups.
5. For patients qualified for PhilHealths TB/DOTS Outpatient Benefit Package in
the accredited DOTS facility, file the appropriate Claim Form at the end of each
treatment phase. (See Chapter 9 Procedure on Philhealth Claims Processing on page 127)
6. Acknowledge the patient once he/she has completed the entire treatment duration
for his/her treatment category.
C. Monitoring Response to Treatment
Treatment response of PTB patients shall be monitored by follow-up DSSM (i.e., one
specimen for each instance) according to the standard schedule below25.
41
INTENSIVE PHASE
3
[
CONTINUATION PHASE
If sm+, label
as failed
If sm+, label
as failed
INTENSIVE PHASE
CONTINUATION PHASE
if sm +, refer to
PMDT
sm+
if sm+, label
as failed
if sm+, label
as failed
INTENSIVE PHASE
4
[ [
if sm+, refer
to PMDT
CONTINUATION PHASE
if sm+,
label
as failed
if sm+,
label
as failed
1. For new cases on Category I, follow-up DSSM shall be done at the end of the
intensive phase, at the end of the 5th month, and at the end of treatment.
a. If sputum positive at the end of the intensive phase, proceed to the continuation
phase but repeat DSSM at the end of the 3rd month.
i)
If still smear-positive at the end of the 3rd month, refer to a DOTS Facility
with PMDT services for screening or to an Xpert Site for testing. Continue
treatment while waiting for PMDT recommendations or Xpert MTB/RIF
result.
ii) If smear-negative at the end of the 3rd month, repeat DSSM at the end of
the 5th month.
42
2. For retreatment cases on Category II, follow-up DSSM shall be done at the end of
the intensive phase, at the end of the 5th month, and at the end of treatment.
a. If smear-positive at the end of the intensive phase, refer to a DOTS facility with
PMDT services for screening. Start continuation phase while waiting for PMDT
recommendations.
If sputum-negative at the end of the intensive phase, repeat DSSM at the end of
the 5th month.
For EPTB patients and patients where DSSM was not done, treatment response will
be assessed clinically (e.g., weight gain, resolution of symptoms).
43
7. Flu-like symptoms
(fever, muscle pains,
inflammation of the
respiratory tract)
Major
1. Severe skin rash due to
hypersensitivity
2. Jaundice due to hepatitis
Drug(s) probably
responsible
Rifampicin/Isoniazid/
Pyrazinamide
Any kind of drugs
Rifampicin
Streptomycin
Isoniazid
Pyrazinamide
Rifampicin
Any kind of
drugs (especially
Streptomycin)
Any kind of drugs
(especially Isoniazid,
Rifampicin, and
Pyrazinamide)
Ethambutol
3. Impairment of visual
acuity and color vision due
to optic neuritis
4. Hearing impairment,
Streptomycin
ringing of the ear, and
dizziness due to damage
of the eighth cranial nerve
5. Oliguria or albuminuria
Streptomycin/
due to renal disorder
Rifampicin
44
Management
Isoniazid
7. Thrombocytopenia,
anemia, shock
Rifampicin
2. There might be a need to switch to SDF whenever side effects to one or more
components of the FDC are suspected. SDFs are to be provided according to the
SDF dosage guide.
3. Once the ADR has resolved, reintroduce anti-TB drugs one by one following the
schedule below.28
Table No. 16/Reintroduction of Anti-TB Drugs Following Drug Reaction
Drug
Isoniazid
Rifampicin
Pyrazinamide
Ethambutol
Streptomycin
Likelihood of Causing a
Reaction
Least likely
Most likely
Challenge Doses
Day 1
50mg
75mg
250mg
100mg
125mg
Day 2
300mg
300mg
1000mg
500mg
500mg
Day 3
full dose
full dose
full dose
full dose
full dose
Start with the drug least likely to be responsible for the reaction at a small challenge
dose, (i.e., 50 mg Isoniazid). The dose is gradually increased over three (3) days. If
there is no reaction after the 3rd day, add the second drug at a small challenge dose,
(i.e., 75 mg Rifampicin). The procedure is repeated, adding in one drug at a time and
gradually increasing the dose. A reaction after adding in a particular drug identifies
that drug as the one responsible for the reaction.
4. Once the adverse reaction to a drug is confirmed, the offending drug must be replaced
with another drug. For patients with major drug reactions to all first line drugs, refer to
DOTS facilities with PMDT services or specialist for proper treatment regimen.
E. Deciding when a PTB patient is no longer infectious during treatment
1. In situations where the patient needs a certificate to return to work, assess the
patients infectiousness based on DSSM results and clinical improvement during
treatment.
2. For bacteriologically-confirmed patients, sputum microscopy examination can be
done one (1) month after start of treatment for purposes of certifying that the patient
can return to work. Issue a certificate that the patient is no longer infectious and can
safety return to work only after demonstrating sputum conversion to smear negative.
No bacteriologically-confirmed case should be allowed to return to work without a
negative follow-up smear examination.
3. For clinically-diagnosed patients (smear-negative or smear not done), it is possible to
issue a certificate that the patient is no longer infectious and can safely return to work
after two (2) weeks of appropriate and adequate therapy for as long as treatment
compliance is assured and there is clinical improvement or no clinical deterioration.
45
If treatment received is less than five (5) months, continue treatment and
prolong to compensate for missed doses.
ii. If treatment received is five (5) months or more, close the treatment card,
classify the patient as having a treatment outcome of Treatment Failed
(see Section H. Treatment Outcomes on page 49) and refer the patient to a
PMDT Treatment Facility for MDR screening.
4. If patient interrupted treatment for two (2) months or more, classify as having
a treatment outcome of Lost to Follow-up (see Section H. Treatment Outcomes on
page 49). Close the previous registration, repeat DSSM and follow the case-finding
policies and procedures.
G. Treatment Modifications for Special Situations24
1. Pregnancy
Ascertain whether or not a woman is pregnant before she starts TB treatment. Most
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 (i.e., 2HRZE/4HR) is important
for a successful outcome of pregnancy. Pregnant women taking Isoniazid should be
given Pyridoxine (Vitamin B6) at 25 mg/day.
2. Breastfeeding
46
Supplemental Pyridoxine (i.e., vitamin B6) should be given to the infant who is taking
INH or whose breastfeeding mother is taking INH.21
3. Oral Contraceptives
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.
It is necessary to wait for the liver function tests to revert to normal and clinical
symptoms (e.g., nausea, abdominal pain) to resolve before reintroducing the antiTB drugs. If it is not possible to perform liver function tests, it is advisable to wait an
extra two (2) weeks after resolution of jaundice and upper abdominal tenderness
before restarting TB treatment. Once drug-induced hepatitis has resolved, the drugs
are reintroduced one at a time, beginning with Rifampicin. After three to seven (3-7)
days, Isoniazid may be reintroduced. In patients who have experienced jaundice
but tolerate the reintroduction of Rifampicin and Isoniazid, it is advisable to avoid
Pyrazinamide. If symptoms recur or liver function tests become abnormal as the
drugs are reintro-duced, the last drug added should be stopped.
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 anti-tuberculosis drugs
may be more common among these patients and should therefore be anticipated.
Patients with chronic liver disease should not receive Pyrazinamide. Alternative
regimens are 2SHRE/6HR, 9RE, or 2SHE/10HE.
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 TB treatment until the acute hepatitis has been resolved. When it is necessary
to treat TB during acute hepatitis, the safest option is the combination of SE for three
months and, once the hepatitis has resolved, a continuation phase of six months
Isoniazid and Rifampicin (i.e., 3SE/6HR). If the hepatitis has not been resolved, SE
should be continued for a total of twelve (12) months (i.e., 12SE).
47
7. Renal Failure
Isoniazid and Rifampicin are eliminated by biliary excretion. 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.
Drug
Isoniazid
No change
Rifampicin
No change
Pyrazinamide
Yes
Ethambutol
Yes
Streptomycin
Yes
8. TB/HIV co-infection
48
In patients with HIV-related TB, the priority is to treat TB, especially bacteriologicallyconfirmed 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. For example, in a patient with a high risk of death during the period of TB
treatment (i.e. disseminated TB and/or CD4count <200/mm3), it may be necessary
to start ART concomitantly with TB treatment. On the other hand, for a patient with
bacteriologically-confirmed PTB as the first manifestation of HIV infection and 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 include the following:
Drug interactions can occur during TB treatment and potentially change the pharmacologic
effects of another drug that is given concomitantly. Clinically significant drug interactions
are seen mostly with Rifamficin, Isoniazid, and Fluoroquinolones. Elderly individuals with
significant co-morbidities, as well as the immune-compromised patients (e.g., HIV/AIDS
patients) are at higher risk of developing drug interactions during TB treatment.
Important drug-drug interactions of Rifampicin, Isoniazid and other TB drugs are shown
in Tables 18-20. To minimize drug interactions, it is advisable that drugs be administered
12 hours apart.
Analgesics
Antifungals
Anti-retroviral agents
(ARV)
Anti-epileptics
Rifampicin interaction
Markedly reduces levels of Calcium channel blockers
(Nifedipine, Amlodipine, Verapamil)
Reduces levels of B-blockers (Propranolol, Carvedilol)
Isolated reports of interaction with ACE inhibitors (Captopril,
Enalapril, Lisinopril) but minor clinical significance
No interactions found with diuretics (Thiazides,
Spironolactone, Furosemide)
Increases clearance of Paracetamol (but clinical importance
not yet established)
Decreases levels of Diclofenac;
No interaction with Aspirin and Ibuprofen.
Reduces opioid levels (Morphine, Codeine)
Markedly reduces serum concentration of antifungals
(Ketoconazole, Itraconazole)
Serum Rifampicin levels can also be reduced with concurrent
use of Ketoconazole.
Reduces levels of Efavirenz (EFV), Ritonavir and Nevirapine
Increases clearance of Zidovudine
No interactions found with Didanozine, Lamivudine
One report of increased level and toxicity of Carbamazepine
when H and R is given together
Reduces levels of Phenytoin and Valproic acid
49
Isoniazid Interaction
INH absorption is reduced with concurrent use of Aluminum
hydroxide (give INH at least one hour before the antacid)
Increases levels of Carbamazepine markedly and rapidly
Few cases of failures reported; risk of contraceptive failure is
low with concurrent use of INH.
Potential toxicity of Paracetamol even at normal dose when
used with INH; more studies are needed
Increases levels of Phenytoin with concurrent use of INH
Plasma level of Theophylline may be increased
Streptomycin
Fluoroquinolones
(second-line treatment)
Drug Interaction
May interact with thiazide diuretics to cause elevated serum
uric acid levels
May interact with Allopurinol and Probenicid and cause
elevated uric acid levels
Increases risk of ototoxicity or nephrotoxicity when used with
ototoxic or nephrotoxic drugs
Exercise caution when used with anesthetics and
neuromuscular blocking agents as Streptomycin can
prolong the neuromuscular blockade and potentially lead to
respiratory depression
Increases serum theophylline level
Increases anti-coagulant effect of Warfarin
Concurrent use with sucralfate and antacids containing
aluminum, calcium, or magnesium may reduce absorption
of quinolones Serum level of Ciprofloxacin is reduced with
concurrent use of Didanosine.
I. Treatment Outcomes
1. Determine the treatment outcome of patients based on completion of treatment
regimen, DSSM follow-up results and clinical improvement (See Tables 21 and 22 for
outcomes of susceptible and drug-resistant TB cases, respectively on page 51).
2. Record the treatment outcome in Form 4. TB treatment/IPT Card and Form 6a. TB
Register.
3. Using the completely filled-out Form 5. NTP ID Card, issue a Certificate of Treatment
Completion/Cure as a form of recognition for the patients achievement.
50
Treatment completed
Treatment failed
Died
Lost to follow-up
Not Evaluated
Definition
A patient with bacteriologically-confirmed TB at the beginning of
treatment and who was smear- or culture-negative in the last
month of treatment and on at least one previous occasion in the
continuation phase.
A patient who completes treatment without evidence of failure but
with no record to show that sputum smear or culture results in the
last month of treatment and on at least one previous occasion
were negative, either because tests were not done or because
results are unavailable.
This group includes:
A bacteriologically-confirmed patient who has completed
treatment but without DSSM follow-up in the last month of
treatment and on at least one previous occasion
A clinically diagnosed patient who has completed treatment
A patient whose sputum smear or culture is positive at five (5)
months or later during treatment.
OR
A clinically diagnosed patient (child or EPTB) for whom sputum
examination cannot be done and who does not show clinical
improvement anytime during treatment.
A patient who dies for any reason during the course of treatment.
A patient whose treatment was interrupted for two (2) consecutive
months or more.
A patient for whom no treatment outcome is assigned. This
includes cases transferred to another DOTS facility and whose
treatment outcome is unknown.
Note: A patient who is diagnosed to have DR-TB anytime during treatment (i.e., before being declared
treatment failed in the 5th month) shall be excluded from the cohort and is not assigned an outcome if
they are started on second line drug regimen. However, if treatment with a second-line drug regimen
is not possible, the patient is kept in the main TB cohort and assigned an outcome from among those
listed above.
51
Treatment Completed
Treatment Failed
Definition
A patient with bacteriologically-confirmed RR-TB/MDR-TB/XDRTB who has completed at least eighteen (18) months of treatment without evidence of failure AND three or more consecutive
cultures taken at least thirty (30) days apart are negative after the
intensive phase
A patient who completes at least eighteen (18) months of treatment without evidence of failure BUT no record that three or
more consecutive cultures taken at least thirty (30) days apart are
negative after the intensive phase.
Treatment terminated or need for permanent regimen change of
at least two anti-TB drugs because of:
Lack of conversion** by the end of the intensive phase*, or
Bacteriological reversion** in the continuation phase after
conversion** to negative, or
Evidence of additional acquired resistance to fluoroquinolones or second-line injectable drugs, or
Adverse drug reactions (ADRs).
Died
Lost to follow-up
Not evaluated
Treatment Success
A patient who dies for any reason during the course of treatment.
A patient whose treatment was interrupted for two (2) consecutive
months or more.
A patient for whom no treatment outcome is assigned. (This
includes cases transferred out to another treatment unit and
whose treatment outcome is unknown)
The sum of cured and treatment completed
*For Treatment failed, lack of conversion by the end of the intensive phase implies that the patient does
not convert within the intensive phase applied by the program. The intensive phase is a minimum of
six (6) months of second line anti-TB treatment. If the patient does not convert, a cut-off of eight (8)
months of treatment is applied to determine the criteria for treatment failed.
** The terms conversion and reversion of culture as used here are defined as follows:
Conversion (to negative): culture is considered to have converted to negative when two consecutive
cultures, taken at least thirty (30) days apart, are found to be negative. In such a case, the specimen
collection date of the first negative culture is used as the date of conversion.
Reversion (to positive): culture is considered to have reverted to positive when, after an initial conversion,
two consecutive cultures, taken at least thirty (30) days apart, are found to be positive. For the purpose
of defining Treatment failed, reversion is considered only when it occurs in the continuation phase.
52
4
CHAPTER
Prevention of TB
I. INTRODUCTION
Prevention of TB can be achieved through the following: TB infection control (TB IC), universal
use of BCG and Isoniazid Preventive Therapy (IPT).
II. OBJECTIVE
To effectively implement TB preventive measures in DOTS facilities, congregate settings
(jails/prisons, residential institutions), workplace and households.
III. DEFINITION OF TERMS
A. TB Infection Control (TB IC) are specific measures and work practices that reduce the
likelihood of spreading the TB bacteria to others.
B. Administrative control - are measures that will reduce risk of TB transmission by
preventing the generation of droplet nuclei or reducing exposure to droplet nuclei. This
type of control has the greatest impact on preventing the spread of TB.
C. Environmental control are measures that will reduce the concentration of infectious
droplets in the air especially in areas where contamination of air is likely.
D. Respiratory protection controls are measures that involve selection and proper use of
respirators to protect one from inhaling droplet nuclei.
E.
Respirator is a special type of closely-fitted mask with the capacity to filter particles to
protect users from inhaling infectious droplet nuclei.
F.
Managerial activities are essential separate set of measures to facilitate the smooth
implementation of the three (3) components of TB IC: administrative, environmental and
respiratory protection controls.
IV. POLICIES
A. All DOTS facilities and TB laboratories should implement TB IC interventions, following
in order of hierarchy: administrative, environmental and respiratory controls.
B. Managerial activities shall ensure that the above interventions are implemented.
C. Use of respirators shall be limited to identified high-risk areas. Only respirators that meet
international standards (e.g., NIOSH-certified N95 or CE-certified FFP2) shall be used.
Proper training and fit test shall be undertaken for identified health care workers who
will use respirators. Fit testing shall be done every year if the same respirator type will be
used or every time before a new respirator type will be distributed.
D.
54
DOTS facility staff shall ensure that TB patients are informed about TB IC measures for
their households, workplace and community.
E.
All infants should be given a single dose of BCG except those who are known to be HIV
positive, those whose HIV status is unknown but who are born to HIV-positive mothers
and those whose symptoms are suggestive of HIV.
F.
Isoniazid Preventive Therapy for six (6) months shall be given to all eligible child
household contacts and PLHIV once TB disease has been ruled out.
G. In the absence of PPD, symptomatic screening could be used alone to screen household
contacts and identify children who will benefit from Isoniazid Preventive Therapy. The
unavailability of PPD shall not deter the provision of IPT to 0-4 year old children who are
household contacts of bacteriologically-confirmed index cases.
H. IPT should not be given to child contacts of drug resistant TB.
V. PROCEDURES
A. TB Infection Control at the DOTS facilities
Specific measures are provided in the Guidelines on Infection Control for TB and Other
Airborne Infectious Diseases issued by the DOH.31
1.
Managerial activities will ensure the smooth and effective implementation of the
administrative, environmental and respiratory protection control measures. This
includes:
a.
b.
Organizing the infection control committee or team who will be responsible for
the implementation of the TB IC plan;
c.
2.
d.
e.
f.
Administrative Controls are the first line of defense, and the most important
level in the hierarchy of TB IC. It is the first priority regardless of available resources.
Administrative control measures include:
a.
b.
Placing notices that one must immediately inform staff about cough lasting
for two (2) weeks or more; and
ii.
55
For DOTS facilities, the following are practical and simple measures that could be
adopted:
a. Open windows and doors to improve natural ventilation
b. Evaluate and document direction of airflow daily in high-risk areas within the
DOTS facility. Use smoke test (incense sticks or mosquito coil) to visualize air
movement
c. Place or re-arrange furniture and seating such that staff-patient interaction
occur with airflow passing from health worker to patient or between health
worker and patient, rather than from patient to health worker (i.e., airflow from
clean to dirty)
d. Ensure that fans are clean and working properly
56
B. TB IC measures within the household that health care workers should advise TB patients.
1. The importance of early detection and treatment of TB; and prompt screening of
household contacts
2. Methods to reduce exposure:
a. Cough etiquette (i.e., covering mouth and nose when sneezing or coughing)
b. Minimizing time spent by infectious TB patients in crowded public places
c. Opening windows and removing any obstruction to ventilation in rooms where
TB patient sleeps or spends much time
C. TB IC measures mentioned above could be used and implemented in congregate
settings like jails and prisons.
D. Procedure for the administration of BCG vaccine is discussed under the Expanded
Program on Immunization.
E. Isoniazid Preventive Therapy
1. IPT for six (6) months shall be given to the following:
a. Children less than five (5) years old without signs and symptoms of TB and
without radiographic findings suggestive of TB, and who are household
contacts21 of:
i. A bacteriologically-confirmed TB case regardless of TST results
ii. A clinically-diagnos ed TB case (if the child has a positive TST result)
b. PLHIV with no signs and symptoms of TB regardless of age23
2. Children qualified for IPT could be identified through household contact investigation14
(as described in Chapter 2).
3. After ruling-out any signs and symptoms suggestive of TB, start INH at 10mg/kg.
(Refer to Table 14. Drug Administration per Kg body weight in children page 40).
4. Open Form 4. TB Treatment/IPT Card and register the child in Form 9. IPT
Register.
5. Administer IPT for six (6) months. Assess the child at least every two (2) months and
check for presence of signs or symptoms of TB. Weigh monthly and adjust dosage
of INH accordingly if the child gains weight.
6. If the child develops any sign or symptom, evaluate for TB according to case finding
procedures. If the child is assessed to have TB disease, stop IPT, start treatment for
TB disease and declare IPT outcome as failed.
7. After six (6) months of IPT, determine the outcome of IPT and record in Form 4 and
Form 9:
a. Completed IPT a child who has completed six (6) months of IPT and
remains well or asymptomatic during the entire period.
57
b. Lost to follow-up a child who interrupted IPT for two (2) consecutive
months or more.
c. Died - a child who dies for any reason during the course of therapy.
d. Failed a child who developed TB disease (pulmonary or EPTB) anytime
while on IPT
e. Not Evaluated - a child who has been transferred to another health facility
with proper referral slip of continuation of IPT and whose treatment outcome is
not known.
F. Baby born to mother with TB disease21
The risk of the baby being infected with TB is highest if a mother was diagnosed of TB at
the time of delivery or shortly thereafter. In this case, it is very important that health workers
should assess the newborn at once.
1. Assess the newborn. If the newborn is not well, refer them to a specialist/pediatrician.
2. If the newborn is well (absence of any signs or symptoms presumptive of TB), do
not give BCG first. Instead give IPT for three (3) months.
3. After three (3) months, perform TST.
4. If TST is negative, stop IPT and give BCG.
5. If TST is positive and baby remains well, continue IPT for another three (3) months.
6. After six (6) months of IPT and if the baby remains well, give BCG.
7. If TST is not available and the newborn is well, the newborn should receive six (6)
months of IPT followed by BCG immunization.
8. If the mother is taking anti-TB drugs, she can safely continue to breastfeed. However
it would be better to advice the mother to feed the baby before taking the anti-TB
drugs. Mother and baby should stay together and the baby may be breastfed while
on IPT.
58
5
CHAPTER
I. INTRODUCTION
60
All quarterly reports should be sent to the DOH through channels (DOTS facility to PHO/
CHO to RO to DPCB-DOH) based on agreed timeline.
G. Records and reports shall allow for the calculation of the main indicators for program
evaluation. (See Chapter 10. Monitoring, Supervision and Evaluation for the indicators on page 135).
H. The NTP shall release official data annually based on the key program indicators. Request
for other data shall be coursed through a formal letter to the NTP stating the intended use
of the data.
IV. PROCEDURES FOR RECORDING
Below is a summary of the various recording and reporting forms to be used under the NTP.
The records and reports are for both susceptible TB and DR-TB cases, adult and children,
registered in DOTS facilities. This section will describe how each record/forms will be
accomplished.
Records
1. Form 1. Presumptive TB Masterlist
2. Form 2a. NTP Laboratory
Request Form
3. Form 2b. NTP Laboratory Result
Form for HIV testing of TB Patients
4. Form 3. NTP Laboratory Register
(Microscopy and GX)
5. Form 4. TB treatment/IPT card
6. Form 5. NTP ID card
7. Form 6a. Drug Susceptible TB
Register
8. Form 6b. DR-TB Register
9. Form 7. NTP referral form
10. Form 8. Hospital TB referral
logbook
11. Form 9. IPT Register
1.
2.
3.
4.
5.
6.
7.
8.
9.
Reports
Report 1. Quarterly Report on TB Microscopy
and GX Laboratory Examinations
Report 2. Quarterly Report on EQA for TB
Microscopy
Report 3a. Quarterly Report on Case Finding of
Drug Susceptible TB Cases and IPT
Report 3b. Quarterly Report on DR-TB Cases
Report 4. Quarterly Report on Drug and Supply
Inventory and Requirement
Report 5a. Quarterly Report on Treatment
Outcome of Drug Susceptible TB Cases
Report 5b. Quarterly Report on Interim
Treatment Outcome of DR-TB Cases
Report 5c. Annual Report on Treatment
Outcome of DR-TB Cases
Report 6. Quarterly Report of Hospital TB
referrals
If a child fulfills the criteria of a TB case [three (3) out of five (5) criteria]
2.
3.
4.
When and where to trace patients who do not return for follow-up
This record will be maintained at the DOTS facility (e.g., RHU or health center) including those
with PMDT services. Maintaining a presumptive TB Masterlist in the BHS is optional.
61
Accomplish the Presumptive TB Masterlist as follows (See Form 1 on the next page):
62
Column 1: Write the date of consultation (mm/dd/yy) when patient was identified as a
presumptive TB.
Column 2: Write the name of presumptive TB. Family name first, all in capital letters,
then the first name and the middle name.
Column 3: Write the age of the patient in years (as of the last birthday). If less than one
(1) year old, write the age in months (as of last completed month).
Column 5: Write the complete address of the patient. Include where he/she can be
contacted (telephone or mobile) once the diagnostic test result is available.
Column 6: If patient is referred from another facility or practitioner (e.g. hospital, PPMD
unit or private physician), write the name of the referring unit or practitioner. Write also the
name of the BHS if referred from there. Write walk- in if not referred by anyone.
Column 7: Write Y if the patient is a household contact of a known TB case and N if not
a household contact.
Column 8: Write the date/s (mm/dd/yy) when the sputum specimen/s was/were collected
and the result of the examination. (See Table No. 7 on page 25). If DSSM was not done,
write ND. Use red ink if the result is positive.
Column 9: Write the date (mm/dd/yy) when the TST was read and the result. If TST was
not done, write ND (e.g., for adult patients).
Column 10: Write the date (mm/dd/yy) when the CXR was done and the result. If CXR
was not done, write ND.
Column 11: Write date (mm/dd/yy) and results of other diagnostic tests done (e.g.,
Xpert MTB/RIF).
Column 12: Write Y if the patient has been identified as a presumptive DR-TB. If not
considered a presumptive DR-TB, write N.
Column 13: If the patient is eventually registered for treatment, write the TB case
number. If the patient is assessed as not a TB case, indicate not TB. If the patient is
referred to another facility, write the reason for referral and the outcome of referral (i.e.,
accepted or lost). Write other pertinent information in the remarks column.
Date of
Consult
(1)
Name
(SURNAME/First name/Middle name)
(2)
Age
(3)
Form
Presumptive
TB Masterlist
Form 1.1.
Presumptive
TB Masterlist
Sex
(4)
Address and
Address
Contact
No.
(5)
Referring
Unit
(6)
Household
Contact of
a TB Case?
(Y/N)
(7)
1st
2nd
Date Sputum
Collected/
Result
(8)
Date TST
done/
Reading
(9)
Chest Xray
examination
(Date/
result)
(10)
Other
diagnostic
tests
(11)
Presu
mptive
DR-TB?
(Y/N)
(12)
If this is a repeat examination for diagnosis, state reason for repeating (e.g., invalid/
indeterminate result for Xpert).
If DSSM is being done outside the routine follow-up schedule (e.g., certification for
work or after treatment interruption), do not check diagnosis or follow-up but write
the reason in this section.
9. Indicate with a check mark () the type of specimen, whether sputum or other
specimens. If other, specify what specimen is being tested.
10. Indicate the test being requested by checking DSSM, Xpert MTB/RIF, TB Culture,
DST or LPA.
64
11. Indicate the date (mm/dd/yy) of collection of the specimen/s / date if both specimens
where collected on the same day and 2 dates if collected on 2 separate days.
12. Write the name and designation of the specimen collector or DOTS facility staff who
accomplished the form. Affix the signature over the printed name.
The bottom half of the Laboratory Request Form will be for the results of DSSM and/or Xpert
MTB/RIF. This will be accomplished by the TB laboratory as follows:
1. Write the Laboratory Serial number. This will be obtained from Form 3a. NTP
Laboratory Register (Microscopy and GX).
2. Write the date (mm/dd/yy) the specimen was received at the laboratory.
3. Under the corresponding column (i.e., specimen 1 or 2 for DSSM or under Xpert
MTB/RIF column) describe the visual appearance of the specimen, whether salivary,
muco-purulent, blood-stained, etc.
4. Indicate the reading. (Refer to Table no. 7 DSSM results and interpretation and
Table 8 Xpert in MTB/RIF results and intrpretation)
5. For DSSM, write the final laboratory diagnosis whether positive or negative. Use red
ink for a positive result.
6. Write the date of examination (i.e., when the reading was done) (mm/dd/yy).
7. Write the name of the medical technologist or microscopist/Xpert technician operator.
Affix the signature over the printed name.
65
Date of Collection
Date Received:______________
Smear Microscopy
SPECIMEN
2*
Xpert MTB/RIF
C. Form 2b. NTP Laboratory Result Form for HIV testing of TB Patients
This form will be used in DOTS facilities offering provider-initiated counseling and testing
(PICT). If the patient consents to HIV testing, standard recording forms of the NEC will be
accomplished by the health worker who offered PICT. The NTP Laboratory Result Form for
HIV testing is accomplished by the medical technologist who conducts the testing. It is accomplished as follows (See Form 2b below):
1. Write the name of the DOTS facility.
2. Write the initials of the patient. (Note: The complete patient name and data are to be
supplied in the NEC forms).
3. Write the date the test was requested (mm/dd/yy).
4. Write the age in completed years and sex (M or F) of the patient.
5. Write the laboratory serial number. This will be from the HIV testing logbook to be
maintained by the medical technologist.
6. Fill-in the following data in the HIV result portion:
a. Testing method used
b. Kit/Reagent used
c. Lot no. of testing kit
d. Result, whether reactive or non-reactive
7. Write the date the test was performed (month/ day/ year).
8. Write the date the test was released (month/ day/ year).
9. Write the printed name of the medical technologist who did the testing.
Affix the signature above the name.
Form 2b. NTP Laboratory Result Form for HIV testing of TB Patients
__________________________________________________________________________________
_____________________________
(Name of the DOTS facility)
Name/Initials: ________________
Age/Sex: _______________
Method Used
Kit/Reagent used
Lot no.
Results
__________________________________
(Signature over printed name)
Medical Technologist
--------------------------------------------------------------------------------------------------------------------------- 67
68
(2)
No.
No. with
with positive
positive
examination result
examination result
DSSM
DSSM
(3)
(MM/DD/YY)
Name
Date
Specimen
Received
(1)
Lab.
Serial
No.
(5)
Sex
No.
No. of
of Follow-up
follow-up
cases examined
cases examined
(4)
Age
(7)
Summary of Examinations
Address
Address and
Contact
(6) No.
(6)
Name of
Collection
Unit
Relapse
New
Diagnosis
1st
No. of MTB
Detected
Xpert MTB/RIF
2nd
Smear Microscopy
Xpert MTB/RIF
No. of Patients
examined
Follow-up
(TB Case
No.)
(8)
(Indicate
registration
group for Xpert)
History of
Treatment
(N/R)
(12)
No. of Indeterminate/
Invalid/Error/
(11)
Remarks
Year __________________
70
Note: The verification of source would be through a duly accomplished referral form/letter
from the referring facility, practitioner or community worker.
For DSSM, if positive, write the higher rating among the 2 specimens in red ink.
Write 0 if negative.
If HIV testing was done, indicate by putting a check mark () before YES under
PICT (no need to write date/result). If HIV testing was not done and for areas not
doing PICT, put a check mark () before NO.
16. Encircle the appropriate treatment regimen and corresponding registration group.
Leave this section blank if the patient is for IPT.
17. Indicate the date treatment or IPT was started.
71
18. Indicate the last day of drug intake as the date (mm/dd/yy) of treatment outcome.
Indicate with a check mark () the treatment outcome. For patients transferred to
another facility for continuation of treatment, get the final outcome from the receiving
facility and indicate that as the treatment outcome. If this is not obtained (ie, no
feedback from receiving facility), assign not evaluated as the outcome.
19. During each monthly visit, write the date (mm/dd/yy) and indicate the weight of the
patient.
For children, indicate the corresponding clinical signs and symptoms present. Write
a check mark () if present and 0 if absent. If unimproved general well-being and
side effects are present, specify the findings using the legend below the card.
20. For children using syrup preparations, indicate the dosage (in ml) of TB drugs during
each visit.
For the back page,
1. Write the full name and designation of the treatment partner.
2. Record the daily intake as follows:
Write the corresponding months for the intensive and continuation phase.
Place the initials of the treatment partner on each box corresponding to the day of
intake.
If the drugs were given for self-administered treatment, write a bracket and
horizontal line on dates drugs were given.
If intake was missed for that day, indicate with a circle (0).
3. Indicate the total number of doses given for each month.
4. Indicate the cumulative doses given (i.e., total number of doses for the month added
to all previous doses in the treatment phase) each month.
5. In the remarks, write other pertinent information during treatment (e.g., reasons for
interruption and interventions done).
72
_____ml
_____ml
_____tab
_____ml
[
[
[
] TREATMENT FAILED
] LOST TO FOLLOW-UP
] NOT EVALUATED
_____ml
_____tab
_____ml
_____ml
_____ml
_____tab
_____ml
_____ml
_____ml
_____ml
_____tab
_____ml
_____ml
_____ml
_____ml
_____tab
_____ml
_____ml
_____ml
_____ml
_____tab
_____ml
_____ml
_____ml
_____ml
_____ml
_____ml
_____ml
_____ml
_____ml
_____ml
_____ml
_____ml
_____ml
_____ml
_____ml
_____ml
_____ml
_____ml
_____ml
_____ml
_____tab
_____ml
_____ml
_____ml
2
3
4
5
6
7
8
9
10
__/__/___ __/__/___ __/__/___ __/__/___ __/__/___ __/__/___ __/__/___ __/__/___ _/__/__
[/] if present, [O] if absent, draw horizontal line if not applicable or write specific sign or symptoms
_____ml
Age Screened
[ ]Doubtful
_____ml
_____tab
_____ml
_____ml
_____ml
IIa. 2HRZES/1HRZE/9HRE
1. EPTB, retx-CNS/bones or joint
_____ml
Weight in Kg.
Date Examined/Results
Initial
___/___/___
[ ]No
HOUSEHOLD MEMBERS:
First Name
BCG Scar:
[ ]Yes
Ia. 2HRZE/10HR
1. EPTB, New-CNS/bones or joint
__/__/___
Height:
____ cm.
]Yes
When:
] 1 mo. or more
[ ]E
[ ]S
TB DISEASE TREATMENT REGIMEN (encircle)
I. 2HRZE/4HR
II. 2HRZES/1HRZE/5HRE
1. PTB, New-bacteriologically confirmed 1. Relapse
2. PTB, New - clinically diagnosed
2. Treatment After Failure
3. EPTB, New
3. TALF
4. PTOU
5. Other
[
] Relapse
[
] Other
[
] TALF
[
] Transfer-in
[
] Treatment After Failure
TREATMENT STARTED:
[ ]Yes
[ ]No
] TB DISEASE
Sex:
3
4
5
6
>7
5. PICT done?
DIAGNOSIS: [
]Community
Age:
____years ____mos.
Date of Birth:
___/___/_____
REGION/PROVINCE
month/day/year
DIAGNOSTIC TESTS:
1. Tuberculin Skin Testing (TST):
2. CXR Findings:
Result: _____mm
____________________
Date read: ___/___/______
Date of exam: ___/___/_____
3. Other exam: __________________
TBDC : __________________
Date of exam: ___/___/______
____________________
4. XPERT MTB/RIF (Date/Results):
5. DSSM Results
Month
Due Date
Date Examined
Result
0
2
SOURCE OF PATIENT:
[ ]Public Health Center
[ ] Other public facilities
[ ]Private
NAME OF PATIENT:
Form
Treatment/IPT
Form 4.4.
TBTB
TREATMENT/
IPT CARDCard
74
10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Doses
given for
this month
Doses
given for
this month
Total doses
given
Total doses
given
Remarks:
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
Month
Month
75
4. Upon completion of treatment, accomplish the certification at the back of the ID card.
Affix the signature of the DOTS physician.
G. Form 6a. Drug Susceptible TB Register
All patients given Category Ia and IIa regimens will be recorded in the Drug Susceptible TB
Register. Drug-resistant TB (DRTB) cases will be recorded in a separate register, Form 6b.
DR-TB Register.
Information for the Drug Susceptible TB Register will come from Form 4. TB Treatment/ IPT
Card. This register will be maintained by health workers at the DOTS Facility.
Accomplish the Drug Susceptible TB Register as follows (See Form 6a on page 79):
At the upper right hand corner, indicate the month and year per page of the register.
Column 1: Write the date (mm/dd/yy) when the patient is registered in the DOTS Facility.
Column 2: Write the TB Case number using the following format _ _-_ _ _-_ _ _. (Year
assign facility number - patient number).
Column 3: Write the full name of the patient. Family name first, all in capital letters, then
the first name and the middle name.
Column 4: Write the date (mm/dd/yy) of birth.
Column 5: Write the age of the patient in years (as of the last birthday). If less than 1
year old, write the age in months (as of last completed month).
76
Column 6: Write F for female and M for male.
Column 7: Write the complete address of the patient. Include where he/she can be
contacted (telephone or cellphone).
Column 8: Indicate with a check the source of the patient following guidelines above in
Form 4. TB Treatment/ IPT Card.
Column 9: Indicate the site of the disease by writing P for pulmonary and EP for
extrapulmonary. If EP, write the specific site below EP.
Column 10: Indicate the classification by bacteriological status by writing BC for
bacteriologically-confirmed and CD for clinically diagnosed.
Column 11: Indicate the registration group by putting a check mark () under the
appropriate column. Patients that are transferred from another DOTS facility will be
indicated as Transfer-in and their assigned registration group from the referring
facility. Please note that these cases should NOT be reported anymore in the case
finding and case holding quarterly reports (see Form 6a on the next page) since they will
be reported by the referring facility.
Column 12: Indicate the treatment regimen by writing I, Ia, II or IIa.
Column 13: Write the date (mm/dd/yy) treatment was started. For transferred-in patients
and patients registered late, this should still reflect the date when TB drugs were first
taken in the facility.
Column 14: Write the date (mm/dd/yy) and results of DSSM and Xpert, including followup DSSM results. The date is written in the upper space and the result is written in the
lower space. (See Table no. 7 page 24 and Table no. 8 on page 25).
Column 15: Indicate the treatment outcome by putting the date (month/ day/ year) of
last drug intake in the appropriate column.
For patients transferred to another facility for continuation of treatment, get the final
outcome from the receiving facility and indicate that as the treatment outcome. If this is
not obtained (ie, no feedback from receiving facility), indicate not evaluated.
For patients that are shifted to a DRTB regimen during treatment, write across the
outcome columns: DRTB- excluded from cohort.
Column 16: For TB patients eligible for PICT (i.e., aged 15 year old and above), indicate
if PICT was done by writing Y for yes and N for No. If done, indicate date (mm/dd/yy)
of testing and the result (whether reactive or nonreactive).
For patients not eligible for PICT (i.e., less than 15 years old), write NA or a dash (-)
under this column.
Column 17: Write other pertinent information about the patient (e.g., CXR result,
Philhealth number, TBDC result).
H. Form 6b. DR-TB Register
For DOTS facilities providing treatment for DRTB cases, all patients given DRTB
treatment will be recorded in the Form 6b. DR-TB Register. (See Form 6b below)
77
78
Date of
Registratio
n
TB
Case
No.
Name
Date
of
Birth
A
G
E
S
E
X
Address
Publi
c
Heal
th
Cent
er
Othe
Priva
r
te
publi
Com
Facil
c
muni
ity/M
Facil
ty
D
ity
Source of Patient
Bact
eriol
Anato
ogica
mical
l
site
statu
(P/EP)
s
(BC/
CD)
New
Rela
pse
TAL
F
Trea
Tran
tme
nt
PTO Othe sferin
After
U
r
Failu
re
REGISTRATION GROUP
Month/Year: ______________________
Treat
ment
Regi
men
Date
Started
TX.
Before
TX.*
DSS
Xpert
M
2nd
mon.
3rd
mon.
4th
mon.
5th
mon.
6th
mon.
7th
mon.
Form
TBREGISTER
Registered
Adult
Children
Form 6a.
6a. TB
FOR for
ADULT
andand
CHILDREN
8th
mon.
Cured
Tx
Compl
Died
Treat
mentF
ailed
Lost
to
Follow
-up
Not
Yes/
evalua
No
ted
TREATMENT OUTCOME
(Write exact date of last intake of drugs)
Date/
Result
PICT Done?
Write result &
date when
PICT was
done
Remarks
(CXR result,
PhilHealth
member TBDC
result, CPT/ART,
etc)
79
80
(MM/DD/YY)
(3) Treatment
Start Date
(MM/DD/YY)
(2) Screening
Date
(4) Name
(M/F)
(6)
Sex
(5)
Age
(MM/DD/YY)
(3) Treatment
Start Date
(MM/DD/YY)
(2) Screening
Date
(4) Name
(M/F)
(6)
Sex
(5)
Age
(7) Permanent Address
(9) History
of TB
Treatment
(11) Risk
Factor/s
(10)
(8) Site of
Disease Registration
(P/EP)
Group
(MM/DD/YY)
(MM/DD/YY)
Date
Date
H R E S Z Ofx Lfx Km Am Cm
Collected
Released
(13)
(14)
Bacteriolo Regimen
gic Status at Start of
at Start of Treatment
Treatment (Initials)
(13)
(14)
Bacteriolo Regimen
gic Status at Start of
at Start of Treatment
Treatment (Initials)
v.021814
Summary: Total No. of Patients Registered ____ No. of Bacteriologically Confirmed MDR/ RR-TB ____ No. of Bacteriologically Confirmed XDRTB ____ No. of Clinically Diagnosed MDR/ RR-TB ____ No. of Other DR-TB ____
Form 6b
Summary: Total No. of Patients Registered ____ No. of Bacteriologically Confirmed MDR/ RR-TB ____ No. of Bacteriologically Confirmed XDRTB ____ No. of Clinically Diagnosed MDR/ RR-TB ____ No. of Other DR-TB ____
(TC-YY-NNNN)
( 1) DR-TB
Registration
Number
National TB Control
Program (NTP)
(9) History
Date
Date
H R E S Z Ofx Lfx Km Am Cm
(11) Risk
Programmatic Management of Drug-resistant
Tuberculosis
(PMDT)
of TB
Collected
Released
Factor/s
R- Resistant, S- Susceptible, ND- Not Done
(MM/DD/YY)
(MM/DD/YY)
Treatment TB Register
Form 6b. Drug-resistant
(TC-YY-NNNN)
( 1) DR-TB
Registration
Number
(10)
(8) Site of
Disease Registration
(P/EP)
Group
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
2 3 4
S/
C
(20)
(21)
HIV
Remarks
Status
S/
C
S/
C
S/
C
S/
C
S/
C
S/
C
(MM/DD/YY)
S/
C
S/
C
S/
C
S/
C
2 3 4
(Results/ Date)
(19) PostTreatment
Follow-up
(18) Date
1
Decentralized
(17)
Treatment
(16)
Site/
Treatment
Partner
Outcome
No. of Cured ___ No. of Compelted Treatment ___ No. of Failed ___ No. of Died ___ No. of Lost to Follow-up ___
v.021814
(20)
(21)
HIV
Remarks
Status
No. of Cured ___ No. of Compelted Treatment ___ No. of Failed ___ No. of Died ___ No. of Lost to Follow-up ___
S/
C
(MM/DD/YY)
S/
C
(18) Date
1
Decentralized
(Results/ Date)
(19) PostTreatment
Follow-up
Region: _______________
Quarter & Year: _________________________________
9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36
Form 6b
S/
C
(17)
Treatment
(16)
Site/
Treatment
Partner
Outcome
Region: _______________
Quarter & Year: _________________________________
(15) Direct Sputum Smear Microscopy (S) , TB Culture (C) and Xpert MTB/RIF (X)
S/
C
S/
X
S/
X
(15) Direct Sputum Smear Microscopy (S) , TB Culture (C) and Xpert MTB/RIF (X)
81
82
TB CASE NUMBER
To:
Date Referred:
Please accommodate the patient bearing this referral form. Kindly inform the Referring DOTS Staff as soon as patient has been
evaluated by calling, sending SMS/email or sending back the Return Slip below.
(To be accomplished by Referring Unit)
Name of Referring Unit
Telephone No.
Fax No.
E-mail Address
Full Address of Referring Unit
Name of Patient
Age
Sex
Patients Address
Weight (kg)
Contact Nos.
o
o
o
o
HH Contact of DR TB case
Non-converter of Category I or II
PLHIV with TB symptoms
Other
History of TB Treatment
Treatment Unit
Anti-TB drugs taken and duration
Signature
Outcome
Designation
Please attach copy of: 1. NTP Treatment Card/s of Previous Treatment/s, 2. Latest DSSM results, 3. Other laboratory results (CXR, TBDC, blood chem.)
RETURN SLIP
Name of Referring Unit: _______________________________________
Address of Referring Unit: _____________________________________
(To be accomplished by Receiving Unit)
Name of Receiving Unit
Date Received
Telephone/Fax No.
Signature
Cellphone number
Designation
84
85
86
(2)
(2)
(1)
Date
Received Referral
No.
by TB
Clinic
(1)
(5)
(9)
BC or CD)
(10)
Group
T - for Trans-out
O
- Others,
(18)
Reasonspecify
for referring (codes)
T - for Trans-out
O - Others, specify
WI - walk-in patients
I - for IPT
TH - referred to a treatment hub
W - Ward
D - for DSSM
PMDT - referred to PMDT facilities
O - OPD
I - for IPT
D - for DSSM
(8)
presumptive
Registration
(10)
Group
WI - walk-in patients
(7)
(9)
(8)
BC or CD)
(6)
Contact
No.
(7)
presumptive
Registration
(5)
Complete Address
(6)
Patient Information
Contact
No.
W - Ward
(4)
Age Sex
(4)
Complete Address
Patient Information
O - OPD
(3)
Name
(3)
Date
Received Referral
No.
by TB8. Hospital
Age Sex
Form
TB Referral Logbook
Name
Clinic
Name
of Hospital _______________________________________________________
Form8.
8.Hospital
Hospital
Referral
Logbook
Form
TBTB
Referral
Logbook
(12)
(11)
(12)
Registered in
another
Treatment
DOTS
Regimen
Facility
(Y/N)*
(11)
Registered in
another
Treatment
DOTS
Regimen
Facility
(Y/N)*
(13)
(write
codes)
Source of
Referral
(13)
(write
codes)
Source of
Referral
87
Date
Consulted/
Evaluated
(1)
IPT No.
(2)
Name
(3)
Month/Year: ________________________________________
FORM 9.9.IPTIPT
REGISTER
Form
Register
Age
(4)
Sex
(5)
Address (6)
(7)
Exposure/
Infection
(E/I)
Date IPT
Started
Completed
(8)
Died
Failed
Lost
to
followup
OUTCOME (9)
Not
Evaluated
REMARKS
(10)
Count the number of patients examined for diagnosis with DSSM. For patients
examined with Xpert, segregate according to registration group- i.e., new, relapse or
other retreatment cases. (TAF, TALF and PTOU).
2.
Among those patients in #1, indicate how many had a positive DSSM or Xpert result.
For Xpert, positive means MTB detected regardless of rifampicin resistance. (i.e.,
RR, T and TI)
3.
For DSSM only, indicate the positivity rate which is number with positive exam (#2)
divided by number examined for diagnosis (#1) or in percentage.
4.
For Xpert only, among those with positive exam or MTB detected, indicate how
many were resistant to Rifampicin or (Rifampicin resistance detected).
5.
Indicate the number of cases where Rifampicin resistance where not detected.
6.
7.
8.
9.
Indicate the number of follow-up DSSM examinations done for the quarter.
89
Name of CHD:______________________________
_ _ _ _ _ _ __ _ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __ _ _ _
Casefinding:
Xpert
Laboratory Activities
1. No. Examined
2. No. with positive examination result: *
3. Positivity Rate**
4. No. with rifampicin resistance
5. No. with rifampicin resistance not detected
6. No. with rifampicin resistance indeterminate
7. No. with error/invalid result
8. No with MTB not detected
For Xpert, all MTB positive result
Positivity Rate = #2 / #1
90
DSSM
New
Relapse
Other
Retreatment
Cases
B.
The quarterly report on EQA for TB Microscopy will be accomplished by the validator (medical
technologist) at the provincial or city Quality Assurance center. Data source for this report will
be the EQA reports being accomplished also by the Provincial or City validators. The RO will
submit this report to the NTRL.
Accomplish Report 2 as follows: (See Report 2 on the next page)
1. Indicate the total number of TMLs (A) in the catchment area that are part of the TB
Laboratory network (i.e., using a TB Laboratory Register). Segregate by private or
public ownership and get the total.
2. Among those in (A), indicate how many participated in EQA (B) for the quarter being
reported. Segregate by private or public ownership and get the totalpercentage,
divide (B) by the total no. of TMLs (A).
3. Indicate the number of TMLs that have less than 5% major errors on EQA (C)
including those that have no major errors. Segregate by private or public ownership
and get the total. For the percentage, divide (C) by the total number of TMLs (A).
4. Indicate the number of TMLs with major errors, regardless of percentage of major
errors (D).
5. Among those with major errors (D), indicate how many were given feedback and
discussed corrective actions (E). Compute the percentage given feedback (i.e., (E)
divided by (D)).
91
Quarter of _______
_______________________________________________________
TB Microscopy Laboratory
Public
Private
TOTAL
(B/A) x 100
(C/A) x 100
Number
(D)
(E)
Percentage,% (E/D)
Noted:
______________________________
NTP Medical/Nurse Coordinator
(signature above printed name)
Note:
This form shall be submitted to the CHD NTP Coordinators together with the copy of EQA Forms 4, 5 and 3 (if
on-site visit was done).
92
C.
The Quarterly report on case finding will be accomplished by the nurse at the DOTS facility.
Data source for this report will be Form 6a. Drug Susceptible TB Register and Form 9. IPT
Register.
Accomplish Report 3a as follows: (see Report 3a on the next page)
1. For Tables A and B: Count the number of TB cases by anatomic site (column
9 in DS TB Register), by bacteriologic status (column 10), and by registration
group (column 11). Segregate by sex (column 6).
For the registration group, all other retreatment cases aside from Relapse (i.e.,
TALF, Treatment after Failure, PTOU and Other) are included under Previously
Treated.
2. For Table C: Count all New and Relapse cases, regardless of anatomic site and
bacteriologic status, and segregate by age group (column 5) and sex (column
6). The total number of new relapse cases from Tables A and B should equal
Table C.
3. For Table D: Count the source of patient (column 8) ONLY for new and relapse
cases. The total number of new relapse cases from Tables A and B should
equal Table D.
4. For Table E: Count the number of pulmonary and extra-pulmonary TB cases
(column 9) that are less than 15 years old (column 5). This will include all
registration groups and bacteriologic status.
5. For Table F: Count the total number of TB patients aged 15 years old and
above who are eligible for HIV testing (i.e., with either a Y or N in column 16).
Among these patients, count how many were actually tested (Y in column 16)
and how many were subsequently confirmed to be positive for HIV.
If there are TB-HIV co-infected patients being given ART or CPT at the DOTS
facility, indicate the number also.
6. For Table G: Count the number of children less than 5 years old and PLHIV that
were initiated on IPT for the quarter.
D.
The Quarterly report on DR-TB cases will be accomplished by the nurse in DOTS facilities
providing PMDT services. Data source for this report will be Form 6b. DR-TB Register. (See
Report 3b below).
This report will be submitted by DOTS facilities with PMDT services to the PHOs/CHOs.
93
Report 3a. Quarterly report on Case Finding of Drug Susceptible TB Cases and IPT
(Source of Data Form 6a. Drug Susceptible TB Register and Form 9. IPT Register)
CHD: ___________________________________
Province/City: ____________________________
Municipality: _____________________________
DOTS Facility: _____________________________
Population of catchment area: _______________
NEW
M
Previously Treated
(except Relapse)
M
F
RELAPSE
F
TOTAL
M
B. Clinically Diagnosed TB Cases Registered During the Quarter by Registration Group and Sex
CLASSIFICATION
Pulmonary
Extrapulmonary
Subtotal
TOTAL
NEW
M
Previously Treated
(except Relapse)
M
F
RELAPSE
F
TOTAL
M
C. All New and Relapse TB Cases (All Forms) by Age and Sex
New
Relapse
Subtotal
TOTAL
94
0-4
5-14
M
F
15-24
M
F
25-34
M
F
35-44
M
F
45-54
M
F
55-64
M
F
>=65
M
F
TOTAL
M
F
Source of Patient
Public Health
Center
Other Public
Facilities
Private
Community
E. TB in Children
Total TB cases less than 15 years old
Number
Pulmonary
Extrapulmonary
F. HIV Status Among 15 Years Old and Above
Number of TB
Cases
registered for
the quarter
No. of cases
tested or with
known HIV
status during
the quarter
No. of TB cases
confirmed
positive for
HIV
CPT
95
CHD: ___________________________________
Province/City: ____________________________
DOTS Facility: _____________________________
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
New
Relapse
Previously Treated
(except Relapse)
Total
New
Relapse
Previously Treated
(except Relapse)
Total
Breakdown of New and Relapse Bacteriologically-confirmed RR / MDRTB and XDRTB Cases Registered During the Quarter by Age, Group and Sex
New
Relapse
Subtotal
Total
0-4
5-14
M F
15-24
M
F
25-34
M
F
96
35-44
M
F
45-54
M
F
No. of DR TB Cases
confirmed positive
for HIV
55-64
M
F
>=65
M
F
Total
CPT
E.
The Quarterly Report on Drug and Supply Inventory and Requirement will be accomplished
by the designated health worker (nurse or midwife) in the DOTS facility. At the provincial, City
and RO level, it will be accomplished by the NTP nurse in coordination with the supply officer.
This report will be the basis for the quarterly allocation of TB drugs to the DOTS facilities. (See
Report 4 on the next page)
Data source for this report will be Report 3a. Quarterly Report on Case Finding of Drug
Susceptible TB and IPT for data on the number of TB cases treated and given IPT, Report 1.
Quarterly Report on TB Microscopy and GX Laboratory Examinations for data on the number
patients undergoing laboratory examinations and the stock cards and inventory reports for the
current stocks of drugs and supplies.
Computations related to this table are to be discussed in Chapter 6 - Management of TB Drugs
and Laboratory Supplies. In addition to data on drug inventory and requisition, DOTS facilities
will indicate in the form if they experienced stock-outs in Category I drugs for adults anytime
during the quarter.
F.
The Quarterly Report on Treatment Outcome of Drug Susceptible TB cases will be accomplished
by the nurse in the DOTS facility. Data source for this report will be Form 6a. Drug Susceptible
TB Register and Form 9. IPT Registered The Treatment outcomes of registered TB patients
will be reported after one year, as follows:
Reporting Period
1 quarter of current year
(eg, April 2013)
nd
2 quarter of current year
(eg, July 2013)
rd
3 quarter of current year
(eg, October 2013)
th
4 quarter of current year
(eg, Jan 2014)
st
For each cohort, count the number of cases corresponding to each treatment
outcome (column 11). Get the total number of patients that have been assigned an
outcome and reflect this in the last column of each table.
Number of patients that have been excluded from the cohort because they were
shifted to a DRTB regimen should be indicated under each table. Transferred
97
CHD: ___________________________________
(Data Source- Stock Inventory Records and Program Reports)
Province/City: ____________________________
Report for ______ Quarter of _______
Municipality:
_____________________________
Date reported: _____________________
CHD: ___________________________________
DOTS
Facility: _____________________________
Prepared
by: _______________________
Province/City:
____________________________
Report
for ______
Quarter of _______
Municipality:
Date
reported: _______________________
_____________________
Total
population_____________________________
of catchment area: ___________
Designation:
DOTS Facility: _____________________________
Prepared by: _______________________
Total
population
of
catchment
area:
___________
Designation:
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _______________________
________________
___________________________________________________________
Treatment Regimen
Treatment Regimen
New cases
Category 1 TB
Kits (Adult)
Category
1 TB
Kits (Adult)
Kits (Children)
Kits (Children)
New cases
Retreatment cases
Retreatment cases
Total
kits to request (=B-C)
Total kits to request (=B-C)
ForFor
DOTS
Facilities:
DOTS
Facilities:
DidDid
your
facility
of Cat
Cat11anytime
anytimeduring
during
this
quarter?
your
facilityexperience
experiencestock-outs
stock-outs of
this
quarter?
YES
YES
NO
NO
province,
city
andregional
regionallevel:
level:
ForFor
province,
city
and
DOTSFacilities
Facilitieswith
withstock-outs
stock-outs of
No.No.
of of
DOTS
of Cat
Cat11ininthis
thisquarter
quarter
Total no. of DOTS facilities
Total
no. of DOTS facilities
(A)
(A)
(B)=Ax2
Total
Stock laboratory
on Hand supplies required in a quarter,
with buffer
(C)
(B)=Ax2
Stock on Hand
Total quantity of supplies to request
(C)
(=B-C)
(=B-C)
Xpert cartridge
Immersion
oil
(in bottles)
Immersion
oil
(in bottles)
Staining Kit
(in bottles)
Staining Kit
(in bottles)
Number
of follow-up
DSSM done
done in
in past
past year
year (A)
(B)
Presumptive
TB with DSSM
Number of follow-up DSSM done in past year (B)
Total laboratory supplies required in a year (C)
= (A X 2) + B
= (A X 2) + B
= (A X 2)+ B
600
= (A X 2)+ B
125
= (A X 2) + B
= (A X 2) + B
= (A X 2)+ B
600
= (A X 2)+ B
125
(=Cx2)
(=D-E)
(=D-E)
CHD: _____________________________
Province/City: ______________________
Cohort for cases registered in ___Quarter of Year ____
Municipality: _______________________
Date reported: __________________________
DOTS Facility: _______________________
Prepared by: ___________________________
Total population of catchment area: ___________
Designation: ___________________________
For Province, City and Regional level:
Total no. of DOTS facilities that submitted reports
Total no. of DOTS Facility
___________________________________________________________
A. Bacteriologically Confirmed New and Relapse TB Cases
Total
number
of TB
cases
Cured
Completed
Died
Failed
Lost to
follow-up
Not
TOTAL
Not
TOTAL
Not
TOTAL
Not
TOTAL
Evaluated
New
Relapse
Note: Exclude from the cohort the cases found to be drug resistant at anytime during treatment.
Number of cases excluded from the cohort= _____________
Completed
Died
Failed
Lost to
follow-up
Evaluated
New
Relapse
Note: Exclude from the cohort the cases found to be drug resistant at anytime during treatment.
Number of cases excluded from the cohort= _____________
Cured
Completed
Died
Failed
Lost to
follow-up
Evaluated
Retreatment
(excluding relapse)
Note: Exclude from the cohort the cases found to be drug resistant at anytime during treatment.
Number of cases excluded from the cohort= _____________
D. Other Cohorts
Total
number
of TB
cases
Cured
Completed
Died
Failed
Lost to
follow-up
Evaluated
PLHIV cases
(all registration groups)
Children Given IPT
100
Note for PLHIV: Exclude from the cohort the cases found to be drug resistant at anytime during treatment.
Number of cases excluded from the cohort= _____________
For the outcome of children given IPT, count the number of children given IPT
during the same reporting period 1 year ago from Form 9. IPT Register. Count
the number of cases corresponding to each treatment outcome.
101
CHD: _____________________________
Province/City: ______________________
DOTS Facility: _______________________
All
Bacteriologicallyconfirmed RR/
MDRTB
All
Bacteriologicallyconfirmed
XDRTB
All Clinicallydiagnosed
MDRTB
Other Drugresistant TB
cases
Total
No. of Transferredin cases excluded from evaluation of interim outcome: _____
102
CHD: _____________________________
Province/City: ______________________
DOTS Facility: _______________________
_______________________________________________________ ____________
Classification of DR
TB
Treatment Outcomes
Cured
Completed
Died
Failed
Lost to
follow
Not
Evaluated
Still
Ongoing*
Total
All
Bacteriologicallyconfirmed RR/
MDRTB
All
Bacteriologicallyconfirmed XDRTB
All Clinicallydiagnosed
MDRTB
Other Drugresistant TB
cases
Total
* Patients that are still on treatment at the time of this reporting.
No. of Transferred in cases excluded from evaluation of outcome = _____
103
104
Data for numbers 13-15 will be obtained from referrals made in the previous quarter,
not the current reporting period (eg, for the 2nd quarter report, refer to cases referred
during the 1st quarter).
13. Indicate the number of confirmed TB cases (column 8) that were referred to other
DOTS facilities (column 16).
14. Indicate the number of referred TB cases that were accepted and registered at the
other DOTS facility (column 21 and 12).
15. Compute the external referral acceptance rate by dividing the number accepted and
registered in other DOTS facilities (#14) with the number of referrals to other DOTS
facilities (#13).
105
Category
Date submitted
Designation
Indicators
TDPH
TDRH
No.
5
6
10
11
12
[=10/8]
[=11/8]
Referral outcome of patients referred during the quarter prior to this reporting period:
106
13
Total no. of TB cases referred to peripheral DOTS facilities during the quarter
prior to this reporting period
14
No. accepted and registered (with TB case number) at the peripheral DOTS
facility
15
6
CHAPTER
I. INTRODUCTION
nti-TB drugs, laboratory and other medical supplies are key elements of the
National TB Control Program (NTP). An uninterrupted supply of diagnostic supplies
and drugs is necessary for the sustained provision of quality TB diagnostic and
treatment services in all service delivery facilities. It promotes better patient care,
improves the public health services credibility, and increases the patients trust
and participation in the program. This can translate to better treatment success and reduced
TB deaths, and contributes to better overall health in the family and community. TB drugs
represent a major out-of-pocket expense for a patient and the family. The high cost of anti-TB
drugs for the poor is a major barrier that limits access to treatment and cure.
This chapter provides general information on the proper management of TB drugs and
diagnostic supplies particularly at the peripheral level. It aims to guide program managers,
particularly the focal persons at the primary level (DOTS facility) on how best to ensure an
uninterrupted supply of drugs and diagnostic supplies through better supply management
practices.
II. OBJECTIVE
To ensure continuous supply of quality TB drugs and diagnostic supplies at all DOTS facilities
nationwide
III. DEFINITION of TERMS
A. Supply chain management cycle a systems-based process consisting of product
selection, quantification and procurement, inventory management (distribution and
storage), and rational use. The cycle is guided by the national policy and legal framework
that defines the goals for the management of drugs and diagnostic supplies and supports
the continuous availability of these commodities and their appropriate use. It is supported
by management systems that include planning, financial management, logistics
information management system, organization and infrastructure, human resources,
training, monitoring and evaluation, and quality monitoring of the commodities and the
logistics process (See Figure No. 6 on page 109).31
B. Product Selection the process of establishing a limited list of essential anti-TB drugs
to be procured based on the treatment guidelines and national formulary. Selection is
guided by inputs from clinicians and laboratory staff as well as by information on the types
of TB to be tested for and treated at different levels of health facilities.
C. Quantification the process of estimating the quantity and cost of the products required
to ensure an uninterrupted supply. It is an ongoing process of monitoring, reviewing, and
updating forecast data and assumptions, and recalculating the total supply requirements
and costs.
D. Procurement - the process of acquiring commodities either through purchase or donation
via international, regional, or local sources of supply.
E. Inventory Management (Distribution and Storage) the process by which the products
procured are received, assessed, and stored until they are distributed to the next level
from the central warehouse to the regional and provincial warehouses, down to the DOTS
108
Rational use of medicines and diagnostic supplies refers to the appropriate, safe,
and effective use of TB drugs and diagnostic supplies based on program guidelines.
G. Quality monitoring refers to the continuous monitoring of the quality of the commodities
and the logistics process for suitability, effectiveness, and efficiency.
Figure No. 9 Policy, Legal and Regulatory Framework of the Supply Chain
Management Cycle
Product selection
Quality
montoring
Quality
montoring
Quality
montoring
Information system
Organization and infrastructure
Human resources
Planning and budgeting
Training and supervision
Monitoring evaluation
Inventory management,
storage, and distribution
to the next level
Quantification
and
Procurement
Quality
montoring
IV. POLICIES
A. The overall management of all TB drug supplies and diagnostic supplies, and the
development and dissemination of corresponding policies and guidelines shall be the
responsibility of the NTP with the support of the MMD, the NTRL/RITM, ROs and the
LGUs. (See Table 18 on page 49)
B. The local government units shall ensure that NTP policies and guidelines for NTP supplies
management are implemented properly at their level. They shall also actively participate
in the monitoring and evaluation of the implementation of these policies and guidelines
C. NTP shall ensure that drugs selected for the use of the program is in accordance to
international guidelines (e.g., WHO), are indicated in the national standard guidelines (i.e.,
NTP-MOP), registered with the Philippines FDA and included in the national formulary.
Standardized fixed dose combination (FDC) of anti-TB drugs shall be used under the
NTP whenever appropriate. The NTP, with the support of NTRL and FDA, shall ensure
the quality of anti-TB drugs and laboratory supplies used in the program.
109
D. Quantification and ordering shall be based on utilization rate, projected increase of cases
due to strengthened case finding and provision of buffer stocks. Buffer stocks equivalent
to 100% annual requirement should be maintained.
E. Procurement of TB drugs and diagnostic supplies at the national and local government
level shall follow the Government Procurement Reform Act or RA 9184 and the DOH
policies, guidelines, and standards for the procurement of TB drugs and laboratory
supplies.
F. Medicines and supplies shall be stored under appropriate conditions and accounted for
through proper recording and reporting. Stock status should be reflected in the National
Online Stock Inventory Reporting System (NOSIRS).
G. The ROs, PHOs and CHOs shall ensure that drugs and diagnostic supplies are promptly
distributed to the next level. The DOH central office shall deliver the NTP commodities to
the ROs. ROs shall deliver the NTP commodities to the PHOs/CHOs. PHOs and CHOs
shall ensure the prompt delivery of the NTP commodities to RHUs/HCs and all other
DOTS facilities. Drugs for DOH retained hospitals within NCR will come from MMD, while
for those outside of NCR, drugs will come from the ROs.
H. The use of medicines shall be guided by the presence of appropriate indications
for treatment based on the NTP standards for diagnosis of TB, and the absence of
contraindications to their use.
I.
Disposal of expired and damaged drugs and diagnostic supplies shall follow the
government rules and regulations.
J. LGUs shall be responsible for the reproduction of all official NTP forms to ensure availability
and adequacy in all RHUs/DOTS facilities including jails and prisons.
K. LGUs shall set aside funds for the emergency procurement of sufficient quantities of
TB drugs and diagnostic supplies in times of impending shortage to ensure continuous
availability of NTP commodities at their service delivery points.
Table No. 23/Management Component and Responsible Units for Managing
NTP Commodities
Component
Selection
Procurement
Distribution
Storage
Use
110
Responsible Unit
IDPCD - NTP
National level for national procurement LGU for local procurement
Allocation:
IDPCD - NTP, RO, PHO and CHO
Distribution:
MMD, RO warehouse, and PHO/CHO warehouse
MMD, RO, PHO warehouses
RHU/HC
DOTS facilities
(RHU/HC, hospitals, etc.)
VI. PROCEDURES
Management of TB commodities in DOTS facilities will be based on the following procedures33,
34, 35
:
A. Calculation of anti-TB drugs and diagnostic supplies
1.
2.
3.
Estimate the number of patients you expect to test and treat for the order period.
The number of patients treated in the previous quarter can be used to guide your
estimate. Alternatively, you can use the number of patients treated in the same
quarter last year to guide your estimate. Consider special activities (intensified case
finding, health promotion activities, etc.) that may result into more patients diagnosed
and requiring treatment.
Calculate buffer stock quantity equivalent to one quarter. For DSSM laboratory
supplies, calculation of annual needs may be done. (See Tables 24-26 on pages 111112 )
Fill-up Order Request Form and submit to PHO/CHO
TB Kits for
Category 1
TB Kits for
Category 2
Expected number of
cases this quarter*
=AX2
=B-C
*The expected number of cases for the coming quarter can be based on the number of cases in
the previous quarter. Another way is to base this on the number of cases in the same quarter of the
previous year. Both methods can be used to come up with a good estimation. Also consider planned
intensified case finding and other activities that may increase the number of cases.
111
Staining Kit
(in bottles)
= (A X 2) + B
= (A X 2) + B
600
= (A X 2) + B
125
=CX2
=CX2
=CX2
=D-E
=D-E
=D - E
Assumptions: 1 staining kit (500 ml. bottle) is good for 125 tests/slides based on 4 ml per test
1 immersion oil (30ml bottle) is good for 600 tests/slides based on 0.05ml per test
**Note: May divide the total quantity to request by the number of pieces per unit of packaging (e.g., Sputum
=AX2
=AX2
=B-C
=B-C
*** Note: May divide the total quantity to request by the number of pieces per unit of packaging (e.g.,
Conical tubes= 25 pieces/pack; sputum cups = 1,000 pcs/pack)
112
113
9. Access to the storage area must be restricted and those authorized to handle supplies
shall be accountable for their actions. Fit doors with security locks, and install bars on
storeroom windows. Maintain inventory records for accountability.
D. Maintaining records for TB drugs and diagnostic supplies
The facility shall maintain proper records for drugs and supplies to facilitate monitoring of
available stocks and consumption.
1. Maintain and update drugs and diagnostic supplies stock records to track
supplies ordered, delivered, consumed, or loaned to another treatment facility;
expiry dates; and as a reference for next order of anti-TB drugs.
2. Perform physical inventory or counting of stock items regularly to monitor stock
levels. Compare the physical counts to quantities written on the stock records or
stock cards.
3. Encode and update data regularly into NOSIRS.
114
Preparing and administering treatment to patients is the focus of all health care activities
in the facility. Treatment must be based on the NTPs guidelines for treatment regimens
and administration and should be recorded on patients treatment cards and on the
TB register. Refer to case finding and case holding chapters on the rational use of
laboratory supplies and drugs.
7
CHAPTER
TB-DOTS
Referral System
I. INTRODUCTION
Public health facilities such as the health centers, rural health units, MDR-TB treatment
centers, satellite treatment centers, treatment hubs,
Other public facilities such as public hospitals and laboratories, jails and prisons,
school clinics and military hospitals
Private health facilities such as private clinics, private hospitals, diagnostic centers,
pharmacies and NGOs, and
Community groups such as the barangay workers, community health teams, TB Task
Forces and many others.
Presumptive TB and TB patients consult this wide array of health care providers as shown by
the 2007 National TB Prevalence Survey and the 2008 National Demographic Health Survey.
In the past years, many of them had been engaged by NTP to participate in TB control under
different initiatives.
Due to different health needs of the presumptive TB and TB patients and the varying capacities
of the health care providers, patients are being referred to other health facilities for transfer
of service or co-management. Specifically, these could be due to any of the following major
reasons:
Table No. 27/Major Reasons for Referrals
Major reasons for
referral
For TB diagnosis
116
Examples
A drug store/CXR facility refers presumptive TB to RHU for
evaluation.
An RHU refers a presumptive extrapulmonary/complicated TB
cases to a hospital.
A private clinic or hospital refers a confirmed TB case for
registration to health center.
PMDT facility refers Rifampicin-susceptible TB to DOTS facilities.
A DOTS facility refers patient to another DOTS facility.
A PMDT treatment facility refers to a DOTS facility for
decentralization
A jail/prison refers a discharged inmate to RHU.
A health center refers a TB patient with liver disease to hospital
PMDT treatment facility refers MDR-TB case under treatment for
serious drug adverse reaction to a hospital.
A health center refers presumptive DR-TB to PMDT treatment
facility
A treatment hub refers a presumptive TB for rapid diagnostic test.
Different NTP initiatives had shown the feasibility and effectiveness of the referral process
such as the public-private mix DOTS, enhanced hospital TB-DOTS and the community referral
system. Controlling TB requires early diagnosis and prompt treatment of TB patients; hence,
there must be systematic process of referral between and among these health facilities and
providers.
II. OBJECTIVE
To ensure that various diagnostic, treatment and information needs of presumptive / confirmed
TB cases are promptly and appropriately addressed through an effective two-way referral
system between health facilities that will:
a. Reduce the delay in the diagnosis and treatment of a TB case
b. Ensure continuity and compliance to treatment
c. Reduce out-of-pocket costs to patients
d. Ensure that TB patient is registered and notified to NTP
External Referral system process of referral from one health facility to another facility or
institution (eg. hospital to health center, jail to prison, jail/prison to health center)
IV. POLICIES
A. Patients shall have the right to know the reason/s for referral and to participate in the
choice of facilities where s/he will be referred.
B. Health care providers have the responsibility of ensuring prompt and appropriate response
to patients health needs by immediate referral for services that can be provided by other
health providers/facilities.
C. A two-way functional referral must be observed by ensuring that a receiving facility
117
G. Patients who were not referred in accordance to NTP policies and procedures shall be
accommodated and evaluated accordingly.
V. PROCEDURES
A. Hospital internal referral system
In some health facilities, like hospitals and big clinics where there are many service
units, there is a need to establish an internal TB referral system. All TB cases identified
by the OPD, wards and other units of the hospitals or sections of the clinics must be
referred to the hospital/ clinic TB team or point person.
1.
2.
Hospital TB team evaluates the patient , fills-up the reply form and records the patient
in the hospital TB referral logbook.
3.
Patient may be provided with NTP drugs while at the hospital. Drugs may come from
the health center where the patient resides or from the hospital TB team.
2.
Identify the DOTS/health facility where he will be referred using the national or local
DOTS facility directory or the list of hospitals/diagnostic centers and mutually agree
with the patient where s/he will be referred.
3.
Fill-out Form 7. NTP referral form, and attach the following, depending on the
purpose of the referral:
a. For diagnosis: request for laboratory examination or CXR examination
4.
118
b.
c.
For MDR-TB screening: results of DSSM, CXR, ID card and copy of previous
Form 4. TB treatment/IPT card if available
Discuss the referral process with the patient and emphasize the importance of giving
a feedback to the referring unit.
5. For hospitals, list the patient to be referred in Form 8. Hospital TB Referral logbook
or write under remarks in Form 6a. Drug Susceptible TB Register or Form 1.
Presumptive TB Masterlist. If patient was given treatment at the ward, fill-up Form
5. NTP ID Card. Upon discharge, refer patient to a DOTS facility and give at least
one or two-week supply of anti-TB drugs.
6. If possible, inform the receiving facility.
7. Receiving facility gives feedback to referring facility through the reply slip of the
referral form, telephone call, SMS, email or other modalities. If the patient was
registered, provide the TB case number in the reply.
8. Once the feedback is received, referring facility staff update the records (i.e., Form
8. Hospital TB Referral Logbook, Form 1. Presumptive TB Masterlist or Form 6a.
Drug Susceptible TB Register, as applicable).
9. If the patient had not gone to the facility within five days, exert efforts to retrieve the
patient through the help of barangay health workers, local officials or community
groups. Ensuring successful referral is a shared responsibility of the referring and
receiving health facility.
C. Referring presumptive DR-TB
1. The following are considered presumptive DR-TB:
a. All re-treatment cases including non-converter of Category II
2. Fill-out Form 7. NTP Referral Form and attach copies of pertinent supporting
documents: old treatment card/s, DSSM result, Chest Xray (plates and results).
3. Record the details of the referral in Form 1. Presumptive TB Masterlist and/or Form
8. Hospital TB Referral Logbook (See procedures for recording hospital referrals
on page 84).
4. Contact the DOTS facility with PMDT services where the patient is to be referred
for proper coordination (i.e., confirm the availability of the service requested and its
requirements) and thereby minimize inconvenience for the patient.
5. The receiving facility shall acknowledge the referral through a return slip, SMS, phone
call, facsimile or mail. Record the outcome of the referral in Form 1. Presumptive
TB Masterlist and/or Form 8. Hospital TB Referral Logbook.
D. Handling TB patients previously managed outside DOTS facility and not referred
according to NTP policies and procedures
There are many patients who go to DOTS facilities with history of taking anti-TB drugs
for few weeks or months either with a private clinic, hospital or other health facility not
implementing NTP procedures. Either they are walk-ins or with a referral letter or note
that is not the NTP referral form. Handle them as follows:
119
1. Get a detailed clinical history following the same procedures as with any presumptive
TB.
2. Secure copies of supporting documents of TB diagnosis, evidence of disease activity
or history of treatment. Verify each, if necessary and, with the patients consent,
contact the attending physician and/or health care facility. Note them accordingly on
the remarks section of the presumptive TB masterlist.
3. Assess the patients willingness and commitment to continue treatment under a
DOTS program.
4. Do DSSM, if not done or done by a non-NTP recognized TB microscopy unit. Record
in Form 3. NTP Laboratory Register as a new presumptive TB. If with DSSM
results from an NTP-recognized diagnostic facility, follow the schedule for follow-up
smears according to appropriate treatment category.
5. The DOTS physician shall exercise best clinical judgement on deciding whether
to continue, modify, restart or discontinue treatment. Register if patient will restart
or continue treatment. (Note: Even if the physician decides to continue treatment,
patient should not be registered as transfer in. Assign a registration group to the
patient based on NTP policies.)
6. Provide the necessary treatment based on the evaluation of the patient and NTP
policies.
7. Provide a feedback to the previous attending physician or facility of the patient.
E. Modes of knowing the outcome of referral
1. Receiving the NTP referral reply slip that has been brought back to the referring
facility by patient/relative or TB coordinator/health center staff, or Faxed, mailed or
e-mailed by the receiving health facility
2. Talking with the receiving health facility through telephone call
3. Following up through SMS or by texting the patient or health facility
4. Reviewing the electronic TB register or TB case register
F. Strengthening and sustaining the TB DOTS referral system
1. Ensure that patient understands the reason for the referral and the importance of
going to the receiving facility.
2. Provide an enabler to TB patients who had been diagnosed, had gone to the health
center and had given feedback. This could be in kind such as rice, grocery item,
callcards, etc. that can be sourced out from partners or LGUs.
3. Avail of the PhilHealth outpatient benefit package and share an amount to the
referring TB care providers.
120
4. Provide motivations and incentives to referring health workers and facilities. This
may be a yearly recognition through giving of plaques or certificates, recommending
them to join an interlocal area visit or participating in scientific conferences, providing
load or other in-kind incentives.
8
CHAPTER
Advocacy, Communication
and Social Mobilization
I. INTRODUCTION
mobilize political and multi-sectoral commitment and sustain adequate resources for TB;
increase awareness and knowledge about the disease as well as the DOTS services
available;
122
J.
K. Barangay Health Worker (BHW) an individual who voluntarily renders primary health
care services in a community after having been accredited to function as such by the local
health board in accordance with the guidelines promulgated by DOH.
IV. POLICIES
A. The Local Health Board of all LGUs shall include ACSM activities in their provincial, city
or municipal health plan.
B. The DOTS facility staff and stakeholders shall advocate with local political leaders to
increase funding for TB programs and institute policy changes to support the implementation
environment.
C. The DOTS facility health staff shall ensure the provision of accurate, reliable and upto-date information to all clients and patients that will motivate them to seek care and
complete treatment.
123
All BHWs, CHTs and CBOs must refer presumptive TB identified in the community and
ensure that these patients go to the DOTS facility.
V. PROCEDURES
A. Advocating for increased funding and policy support from local chief executives.
1.
Ensure that the TB subplan in the annual provincial, city or municipal health plan is
properly prepared and included in the LGU budget.
2.
Advocate, together with support groups and public-private sector collaborating groups
such as the Multisectoral Alliance for TB Control or the TB Provincial Coordinating
Council, for adequate and sustained support for the TB program.
3.
124
1.
Hold regular meetings with media and civic groups for increased coverage of TB
campaigns and activities.
2.
b.
c.
TB is everyones concern.
d.
e.
g. Kung may kakilala kang may TB, dapat silang kumbinsihin na mag-DOTS ang
nag-iisang paraan para gumaling siya nang husto. Naprotektahan mo pa ang
sarili mo.
125
D. Social Mobilization
1. Communicate the need for CBOs and other volunteers, such as the CHTs and
BHWs, to become TB educators, advocates, and treatment partners.
2. Identify CBOs in the locality. Coordinate with the Provincial/City/Municipal
Development Council and local NGOs and/or FBOs in identifying CBOs.
3. Seek assistance of NGOs as Technical Assistance Providers (TAPs) in the
formation, strengthening and sustaining of CBOs/CHTs. Prepare a Memorandum
of Agreement or Understanding to formalize the partnership and define the TA
providers role.
4. Conduct regular monitoring and supervisory dialogues with the CBOs and
TAPs.
126
9
CHAPTER
I. INTRODUCTION
ertification and accreditation are processes which ensure that a DOTS facility is
capable of providing quality DOTS services to presumptive TB and TB patients.
Certification aims to standardize the provision of DOTS by institutionalizing a set
of standards and criteria for a quality-assured DOTS facility. Compliance with
these standards and criteria provides the platform for PhilHealth Accreditation.
DOH Administative Order 2006-0026 Implementing Guidelines in the Conduct of the National
TB Control Program Directly Observed Treatment Short-Course (NTP-DOTS) Certification
established the guidelines and procedures in the conduct of NTP-DOTS Certification
among public and private DOTS facilities, specifically for assessing the quality of TB-DOTS
implementation. In 2013, the DOTS Certification process was revised to decentralize the
issuance of DOTS certificate to the regions, in consonance with the reconstitution of the
National and Regional Coordinating Committees for NTP (NCC-NTP/RCC-NTP) through AO
2006-0026-A.
The Philippine Health Insurance Corporation or PhilHealth is the government agency that is
primarily responsible in providing Filipinos the mechanism to gain financial access to health
services. Facilities like TB DOTS Centers must be accredited before they can participate
as providers of benefit packages. This is to ensure that delivery of health care services to
its members and their dependents are of quality necessary to achieve the desired health
outcomes and member satisfaction.
PhilHealth Circular 17 s. 2003, Accreditation of TB
DOTS facilities, and Circular 8 s. 2006, Amendment to Accreditation of TB DOTS facilities,
laid down the guidelines and standards for accreditation of TB DOTS facilities. In 2012,
PhilHealth issued Circular 54, s 2012 Provider Engagement through Accreditation and
Contracting for Health Services which revised the accreditation guidelines for all health
facilities including TB DOTS Centers.
II. OBJECTIVE
To ensure that DOTS facilities are providing sustainable quality services
III. DEFINITION of TERMS
A.
B. Automatic accreditation - accreditation given to any institutional health care provider that
is licensed or certified by DOH or other certifying body duly recognized by PhilHealth and
has the opportunity to be accredited through basic participation.
C. Certification - refers to the process wherein the Regional Coordinating Committee (RCCNTP) assesses and evaluates a DOTS facility, either public or private, if it has met the
standards for quality DOTS implementation.
D. Certified - a certification decision that results when a health facility demonstrates acceptable
compliance with the core standards for initial certification and / or re-certification
128
E. Not certified - a certification decision that results when an applicant TB-DOTS facility
consistently fails to demonstrate compliance with the core standards for initial and / or
recertification, when certification is withdrawn for other reasons or when the health facility
voluntarily withdraws from the certification process.
F.
Re-certification - pertains to the process wherein the DOTS facility is re-issued a DOH
certificate upon expiration of the certification or 3 years after it was issued.
IV. POLICIES
A. Policies on DOTS Certification
1.
The Department of Health, through the RCC-NTP, shall be the lead agency in the
TB-DOTS certification process. The RCC-NTP shall be responsible for certifying
TB-DOTS centers/facilities in both public and private sectors.
2.
A health facility that provides TB-DOTS services and assumes ownership and
transparency for its operations is eligible for certification.
3.
A DOTS facility shall be awarded certification if it meets the following set of core
standards prescribed by NTP:
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
The TB DOTS center is easily located and patients have convenient and safe
access to the center.
The TB DOTS center provides for the privacy and comfort of its patients and
staff.
The TB DOTS center provides for the safety of its patients and staff.
All patients undergo a comprehensive assessment to facilitate the planning and
delivery of treatment.
All patients have continuous access to accurate and reliable TB diagnostic tests.
A care plan is developed and followed for all patients
Patients have continuous access to safe and effective anti-TB medications
throughout the duration of their treatment.
Policies and procedures for providing care to patients are developed,
disseminated, implemented and monitored for effectiveness
Policies and procedures for managing patient information are developed,
disseminated, implemented and monitored for effectiveness and
The TB DOTS center has an adequate number of qualified personnel skilled in
providing DOTS services.
DOTS facilities which are eligible for accreditation include, but are not limited to,
the following: LGU health units, hospital-based clinics, HMO, factory clinics, churchbased clinics and school-based clinics.
2.
TB DOTS package providers duly certified by DOH are qualified for automatic
accreditation (PhilHealth Circular 54 s. 2012). TB DOTS clinics that are not
certified shall undergo pre-accreditation survey to ensure that they comply with the
standards
.
129
3.
PhilHealth shall provide the benefit package for qualified adult and child TB patients
from any accredited DOTS facility. The package shall include the following:follow-up
sputum smear examination/s, consultation services and anti-TB drugs for the entire
treatment cycle.
4.
The health care provider shall determine the PhilHealths member eligibility and
compliance with the requirements for availment as prescribed by PhilHealth.
5.
The Department of Health recommends the following allocation scheme for the TB
DOTS benefit package: 25% for consultation services of the referring physician
during the treatment course, 35% for the health facility staff including the treatment
partner who had a role in the delivery of services to the patient, 40% for operational
costs involved in providing quality care for TB patients.
When applicable, payment for TB Diagnostic Committee and quality assurance
for sputum microscopy, expenses for training of staff, cost of additional laboratory
supplies and drugs will be included in the operational costs. In cases when there is
no referring physician, the 25% shall be allocated for operational cost.
6.
7.
Failure to submit the above requirements by the end of February shall cause denial
of claims starting March 1 (based on treatment start date). If the requirements are
submitted after February, the health care institution shall apply for re-accreditation.
8.
If the certificate of the TB DOTS provider expires within the year, the facility is given
60 days within which to submit the updated certificate. Failure to submit within 60
days shall cause denial of claims beginning on the 61st day and onwards (based on
treatment start date) until it submits the certificate.
V. PROCEDURES
A. Procedures on Certification
The following steps are based on the Implementing Guidelines on the Flow of DOTS
Certification Process.
130
Application
Certification
Procedure
1) Filling-up of Self-assessment Form (SAF)
2) Request for technical support from the
Technical Assistance (TA) team from the
province/city composed of the Provincial/City
NTP Coordinators, DOH representatives and
private/NGO representatives
3) SAF is accomplished and ready for use by
the certifying team upon their visit
1) Submission of a written Letter of Intention
on Certification (LOIC) to the RO
1) On-site validation of the health facility by the
certifying team
2) Reporting of the certifying teams findings,
rating and over-all decision to the DOTS
facility utilizing the Summary Report on
DOTS Certification and reporting of the
same to RCC-NTP
3) Approval/Disapproval for certification
4) Application for PhilHealth accreditation in
case of approval
5) Notification of TA team in case of
disapproval
6) Re-application for certification in case of
disapproval
Concerned
Agency
Head of DOTS
center/facility
Head of DOTS
center/facility
Certifying team
Certifying team
Certifying team
Head of DOTS
center/facility
RO/Prov/City
Coordinator
RO Coordinator
Head of DOTS
center/facility
Follow-up
RCC-NTP
RO/Prov./City NTP
Coordinators, TA
team
Head of DOTS
center/facility
A summary of the roles of different agencies in the certification process is found in Table No.
29 on the next page.
131
132
Provincial / City
Coordinators
Representative
of the Private
Sector or Local
Coalition
DOTS facility
g. Location Map
h. Updated business permit (for private HCIs only)
3. Submit to the PhilHealth regional office or Local Health Insurance Office the complete
documents and pay the accreditation fee.
4. Upon approval of application, PhilHealth shall issue a certificate of accreditation and
letter of approval which will be sent to the facility.
5. For any concerns regarding accreditation, the facility may inquire at the nearest
PhilHealth Regional Office or Local Health Insurance Office in their area.
133
Claim Form 1
Claim Form 2
3. TB DOTS claims should have the correct ICD 10 Codes and Package Codes
4. Claims shall be processed based on the existing guidelines of PhilHealth.
134
10
CHAPTER
Monitoring,
Supervision and Evaluation
I. INTRODUCTION
It is the role of the DOTS facility staff, especially the physician and nurse to monitor program
performance and supervise the other health workers including Barangay Health Workers and
treatment partners. Periodic evaluation must also be done.
The ROs and PHOs/CHOs NTP coordinators will also provide technical supervision over the
DOTS facilities in their areas.
II. OBJECTIVES
The objectives of MSE are to:
Monitor progress of program implementation, identify gaps and provide basis for
decision making to improve implementation.
Ensure that the program targets of 90% case detection rate for all forms and 90%
treatment success rate for all forms are reached and maintained.
136
V. PROCEDURES
A.
Inform the facilities and health workers beforehand of the planned monitoring to
ensure that the data and the key personnel will be available at that time.
2.
Monitoring and supervision may be done through any of the following methods:
a.
Record and report review can be done at the office or during monitoring visits.
The usual NTP records for review are Form 1. Presumptive TB Masterlist,
Form 3. NTP Laboratory Register and Form 6a. Drug Susceptible TB
Register, Form 4. TB treatment/IPT Card, Quarterly Reports and Stock
Inventory Cards.
i.
Compare and verify that the information in the records and reports are
complete, accurate and consistent. Specifically, compare the information
in Form 3. Laboratory Register, Form 4. TB Treatment/IPT Card and
Form 6a. Drug Susceptible TB Register
ii.
c.
3.
Observe if the DOTS facility staff are giving correct and relevant information
to patients and doing DOT correctly.
ii.
The standard monitoring form and supervisory checklist (See Table no. 23 on page
137
110) can be used for all DOTS facilities. This could be expanded for specific facilities
(e.g., hospitals, jails and prisons).
138
6. Prepare a formal report of the monitoring and supervisions conducted. Give a copy
of the report to the DOTS facility or personnel visited and to the next higher level.
Table No. 30/Standard Monitoring and Supervision Table
Date:__________
Region:_________________ Province/City:______________
DOTS Facility: ___________________
Address: ______________________________
Monitoring Team: ___________________________________________________________
Part 1. Program Indicators
Indicator
Previous
Period
_______
Current Reporting
Period
________
Remarks
OUTCOME INDICATORS
1. Case Notification Rate (all forms)
2. TB Case Detection Rate (all
forms)
3. Notification of MDR-TB
4. Treatment Success Rate (all
forms)
5. Cure Rate (NSP)
6. Treatment Success Rate of
MDR-TB
7. Percent of bacteriologically
confirmed MDR-TB cases with
negative culture after 6 months of
treatment (interim outcome)
SERVICE INDICATORS
8. Total number of presumptive TB
examined
9. Percent contribution from non-NTP
care providers
10. Number of children with TB
detected and given treatment
and those given IPT
TB-HIV COLLABORATION
11. Percentage of TB cases in
category A and B areas with HIV
counselling and testing among
aged 15 years old and above
12. Percentage of DR-TB cases
provided with HIV counseling and
testing among 15 years old and
above
LABORATORY AND LOGISTICS
13. TMLs within EQA standards
(Y/ N)
139
Available
Complete
Remarks
Reports
Report 1. Quarterly Report on
TB Microscopy and GX
Laboratory Examinations
Report 2. Quarterly report on EQA for
TB Microscopy
Report 3a. Quarterly report on Case
Finding of Drug Susceptible
TB Cases and IPT
Report 3b. Quarterly Report on
DR-TB Cases
Report 4. Quarterly report on drug
and supply inventory and
requirement
Report 5a. Quarterly report on
Treatment Outcome of
Drug Susceptible TB Cases
Report 5b. Quarterly Report on
Treatment Interim Outcome
of DR-TB Cases
Report 5c. Annual Report on the
Treatment Outcome of
DR-TB Cases
Report 6. Quarterly report of
hospital TB referrals
Available
Complete
Remarks
140
3. Treatment Outcome
Part 3. Laboratory
Observe/ask for the following:
Indicator
Findings
Previous Period Reporting period
(_____)
(______)
Remarks
Observation
Remarks
141
Availability
Remarks
Determine if the health staff can give key messages about tuberculosis
Question
1. What is tuberculosis/
MDR-TB?
2. How is TB/ MDR-TB
transmitted/spread?
3. How is TB treated?
4. Why is there a need to
refer for DR-TB
screening?
142
Response
Remarks
Response
Remarks
Observation/
Response
Remarks
143
All NTP Quarterly reports will be reviewed and analyzed by the DOTS facility
physician prior to submission to the PHO/CHO. Together with the DOTS facility
staff, the physician will analyze the program indicators to track the progress of
program implementation towards the set goals and objectives (See Section VI,
Program Indicators below).
2.
3.
4.
a.
Plan for the PIR by deciding what program elements to evaluate, what data
collection tools and methods to use and by preparing the necessary logistics.
b.
c.
Analyze and interpret the TB data collected. Report and explain the results of
the analysis.
d.
Discuss strategic directions that will address the program implementation gaps.
e.
Analyze the core program indicators (CDR, CR, TSR) from the LGU scorecard.
RO
144
Functions
Data collection, analysis and
submission to next higher level
Data collection, analysis,
consolidation, feedback and
submission
Data collection, analysis,
consolidation, feedback and
submission
Timeline for
Submission
st
1 week of the month
following end of quarter
2nd week of the month
following end of quarter
3rd week of the month
following end of quarter
DOH-NTP
Definition/Calculation
Number of notified TB, all forms, for
every 100,000 population
Numerator = No. of notified TB, all
forms
Data Source
Report 3a. Quarterly
report on Case
Finding of Drug
Susceptible TB
Cases and IPT
145
3. Notification rate of
MDR-TB
146
9. Percent contribution
from non-NTP care
providers
Percentage of bacteriologically
confirmed MDR-TB cases with
negative culture after 6 months
Numerator: No. of bacteriologically
confirmed MDR-TB cases with
negative culture after 6 months of
MDR-TBtreatment
147
12.Percentage of DR-TB
cases provided with HIV
counseling and testing
among aged 15 years
old and above
Report 2. Quarterly
Report on EQA for
TB Microscopy
148
Report 4. Quarterly
Report on drug and
supply inventory and
requirement
References
1. Department of Health. 2010 Philippine Health Statistics (Draft), Manila, Philippines: DOH, 2010.
2. Department of Health. 1982-83 National Prevalence Survey. Manila, Philippines: DOH, 1983.
3. Department of Health and Tropical Disease Foundation. 1997 National TB Prevalence
Survey. Manila, Philippines: DOH, 1997.
4. Department of Health and Tropical Disease Foundation. 2007 Nationwide TB Prevalence Survey.
Manila, Philippines: DOH, 2007.
5. Philippine Nationwide Drug Surveillance Team. Nationwide Drug Resistance Survey
in the Philippines. Journal of IUATLD. April 2009, pp 500-507.
6. World Bank. Gross National Income per Capita. http://data.worldbank.org/org. July 10, 2013.
7. Department of Health and Philippine Coalition Against Tuberculosis. Comprehensive and Unified
Policy for TB Control in the Philippines. Manila, Philippines: 2003.
8. Department of Health. Administrative Order 2008-2011. Revised guidelines for Implementing
Tuberculosis control Program in Children. Manila, Philippines: DOH,
9. Department of Health. Administrative Order 2008-0018. Guidelines for the Implementation of the
Programmatic Management of Drug Resistant Tuberculosis, Manila, Philippines: DOH, 2008.
10. Department of Health. Administrative Order 140 s. 2004. Revised Guidelines for Hospital Based
TB Control Program Under the Hospitals for Wellness Program. Manila, Philippines: DOH, 2004.
11. World Health Organization. Global Tuberculosis Control 2012. Geneva, Switzerland: WHO, 2012.
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2012.
13. Department of Health. 2010 16 Philippine Plan of Action to Control TB. Manila, Philippines: DOH,
2010.
14. World Health Organization. Recommendations for Investigating Contacts of Persons with Infectious
Tuberculosis in Low- and Middle-Income Countries. Geneva, Switzerland: WHO, 2012.
15. World Health Organization. Systematic Screening for Active Tuberculosis: Principles and
Recommendations. Geneva, Switzerland: WHO, 2013.
16. World Health Organization. Definitions and Reporting Framework for Tuberculosis- 2013 Update.
Geneva, Switzerland: WHO, 2013.
17. Department of Health. Department Memorandum 2013-0021: Revision of NTP Policy on Specimen
Collection and Diagnosis by DSSM. Manila: DOH, 2013.
18. World Health Organization. Automated real-time nucleic acid amplification technology for rapid and
simultaneous detection of tuberculosis and Rifampicin resistance: Xpert MTB/RIF system for the
diagnosis of pulmonary and extra-pulmonary TB in adults and children. Geneva, Switzerland: WHO,
2013.
19. Harrisons Principles of Internal Medicine, 18th ed. McGraw-Hill Medical Publishing Division. New
York, USA. 2011
20. Philippine Pediatric Society (PPS). Tuberculosis in Infancy and Childhood. Manila, Philippines:
PPS, 2010.
149
21. World Health Organization. Guidance for National Tuberculosis Programmes on the Management
of Tuberculosis in Children. Geneva, Switzerland: WHO, 2006.
22.Department of Health. Administrative Order 2009-0003: Technical Guidelines for Implementing
DOTS Strategy in Jails and Prisons. Manila: DOH, 2009.
23. Department of Health. Administrative Order 2008-0022: Policies and Guidelines in the Collaborative
Approach of TB and HIV Prevention and Control. Manila: DOH, 2008.
24. World Health Organization. Rapid Advice: Treatment of Tuberculosis in Children. Geneva,
Switzerland: WHO, 2010.
25. World Health Organization. Treatment of Tuberculosis Guidelines, 4th edition. Geneva, Switzerland:
WHO, 2010.
26. Department of Health and Philippine Pediatric Society, Inc. Joint Statement on Treatment of
Tuberculosis in Children. Quezon City: DOH-PPS, 2011.
27. Bailoy, B., Koren G. The Pediatric Clinics of North America: New Frontiers in Pediatric Drug Therapy,
February, 1997: 44 (1):67
28.Task Force on Tuberculosis, Philippine Practice Guidelines 4Group in Infectious Diseases.
Pulmonary Tuberculosis: Clinical Practice Guidelines. PPGG-ID Philippine Society for Microbiology
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29. World Health Organization. Tuberculosis Care and Control in Refugee and Displaced Population.
Geneva, Switzerland: WHO, 2007.
30. Swart A, Harris V. Drug interactions with Tuberculosis therapy. Continuing Medical Education
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Manila: DOH, 2011.
32. Borade AB, Bansod SV. Domain of Supply Chain Management A state of Art. Journal of Technology
Management and Innovation: Volume 2, Issue 4, 2007.
33. Rational Pharmaceutical Management Plus Program. Managing TB Medicines at the Primary Level.
Submitted to the U.S. Agency for International Development by the Rational Pharmaceutical Plus
Program, Management Sciences for Health, Arlington, VA; 2007.
34. Management Sciences for Health. MDS-3: Managing Access to Medicines and Health Technologies.
www.mds-online.org. MSH: Arlington, VA, 2012.
35. Global Laboratory Initiative, World Health Organization. Guidance for Countries on the Specifications
for Managing TB Laboratories and Supplies. WHO, Geneva; 2011.
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150
Annexes
Refer to
STC/TC for
DR TB
screening
DST for
FLD & SLD
152
Xpert MTB/RIF
Clin/CXR
(TB/EPTB)
No TB
Clinical/CXR
(TB/EPTB)
Xpert MTB/RIF
IPT
Tx for TB
TB/
EPTB
IPT
No
TB/EPTB
ANNEX B. Reporting Form for Adverse Drug Reactions (Food and Drug Administration)
SUSPECTED ADVERSE REACTIONS FORM v 5 (4/2012)
Saving Lives Through Vigilant Reporting
*FIELDS MUST BE COMPLETED.
PATIENTS PARTICULARS
Male
Female
*Age________
No
Yes, Specify:______________________________
Weight ______Kg
Hospital/facility , if admitted:_______________________________________________
Date
of onset:____________; ____am, ____pm
*
No
No
___Prescribing
___Transcription
___Dispensing
___Administration
Can the adverse reaction be due to :
1. Product quality defect ___No
___Yes, Specify, encircle: color change ; caking; powdering ; counterfeit; odor change; defective
Daily Dose
Route
Date
started
Date
stopped
List all other drug/s taken at the same time and/ or 3 months before. If none, check box.
Brand name of the drug
Daily Dose
Route
Date
started
Date
stopped
Manufacturer and
Batch/Lot #
Manufacturer and
Batch & Lot No.
Unknown
No
Signature of reporter:
_______________________________________
____Cancer
Unknown
______HPN
*Contact no:_________________________________________
Email address: ______________________________________
*Profession: __MD ___ RPh ___RN___Patient ___Dentist ___other
*Facility: ___Clinic ____Trial site _____Other
Send completed form to: ADR Unit, FDA, Civic Drive, Filinvest Estate, Alabang, Muntinlupa ,1781.
Or fax to: (02) 807-85-11, c/o The ADR Unit. Send sample, if any, of suspect drug for analysis.
Website: www.fda.gov.ph
153
154
Point
Person
Microscopist
Chairpers
on (Chief
Supt)
Treatment
Partner
CoChairperson
(TB
Coordinator)
Specimen
Collector
DOTS Service
Providing Prison
14
Penal
Superintendent
BuCor Director
Point
Person
Microscopy
Center
Specimen
Transporter
CoChairperson
(Medical
Officer)
Treatment
Partner
DOTS
Referring
Prison
Specimen
Collector
Chairpers
on (Supt)
Medical Coordinator
155
Source Department
of Health.
Memorandum
from Nationalfrom
Epidemiology
Center:
Philippines Priority
Area
for HIV
SOURCE:
Department
of Health.
Memorandum
National
Epidemiology
Center:
Philippine
Priority Areas for HIV
Intervention (PAHI). March 5, 2012
Intervention (PAHI). March 5, 2012.
SOURCE: Department of Health. Memorandum from National Epidemiology Center: Philippine Priority Areas for HIV
Intervention (PAHI). March 5, 2012.
156
157
158
159
160
Remove mask/return to
assigned cell
21
Positive
separate and/or
wear mask
Start treatment
w/in 24 hrs
DSSM
To assigned cell
Negative
TB Symptomatic
Cough
Surveillance
No cough
Inmate
162