2013 NTP

MANUAL OF
PROCEDURES

Case Holding
Anna Marie Celina G. Garfin, MD
Ramon P. Basilio, MD
Infectious Diseases Office
Disease Prevention and Control Bureau

Case Holding
Set

of procedures which ensures that

patients complete their treatment

assignment of the appropriate treatment

regimen

supervised drug intake

support to patients

monitoring response to treatment through

follow-up DSSM

Definition of Terms
Registration Group
New

Relapse
Retr
eat
men
t

(TB Disease Registration Group)

Definition

never had treatment for TB* or less than one (<1)

month intake
Previously cured or treatment completed in
their most recent treatment
presently diagnosed with bacteriologicallyconfirmed or clinically-diagnosed TB.
A previously treated for TB and whose treatment
failed at the end of their most recent course

Treatment OR
After Failure
A patient for whom sputum examination cannot be
done and who does not show clinical
improvement anytime during treatment.

Definition of Terms
Registration Group

(TB Disease Registration Group)

Definition

previously treated
Re TreatmentAfter
tr Lost to Follow-up
(TALF)
ea

lost to follow-up for two months or more in

their most recent course of treatment
currently diagnosed with bacteriologicallyconfirmed or clinically-diagnosed TB.

tm

Previous
previously treated
en Treatment
outcome after their most recent course of
t Outcome Unknown treatment is unknown or undocumented.
(PTOU)
Other

Transfer-in

Patients who do not fit into any of the categories

listed above.
registered in a DOTS facility
transferred to another DOTS facility with
proper referral slip to continue the current
treatment regimen.

Drug Formulations
Fixeddose

combination (FDCs) - > 2 firstline anti-TB drugs are combined in one

tablet
HR
HRE
HRZE

Single

drug formulation (SDF) each drug

prepared separately
Tablet

or capsule

Syrup
injectable

Policies
All

diagnosed TB cases shall be provided

with adequate and appropriate anti-TB
treatment regimen promptly.

Anti-TB

treatment shall be done through a

patient-centered, directly observed
treatment (DOT) to foster adherence.

TB

treatment under the NTP shall conform

to standardized regimens.

TB Disease Registration Group

Category of
Treatment

Type of TB Patient

Treatment
Regimen

Pulmonary TB, new

Category I

Category Ia

Extra-pulmonary TB, new (except CNS/ bones or

joints)
Extra-pulmonary TB, new (CNS/ bones or joints)

Previously treated drug susceptible TB

(pulmonary or extra-pulmonary)
Relapse
Category II Treatment After Failure
Treatment After Lost to Follow-up (TALF)
Previous Treatment Outcome Unknown
Other
Category IIa

Previously treated drug susceptible EPTB (CNS/

bones or joints)

2HRZE/4HR

2HRZE/10HR

2HRZES/1HRZE
/5HRE

2HRZES/1HRZE
/9HRE

TB Disease Registration Group

Category of
Treatment
Standard
Regimen
Drug
Resistant
(SRDR)

Type of TB Patient

Treatment Regimen
ZKmLfxPtoCs

RR-TB or MDRTB

Regimen for
XDR-TB
XDR

Individualized once
DST result is available
Treatment duration for
at least 18 months
Individualized based on
DST result and history of
previous treatment

Policies
All

retreatment patients should be

screened for MDR-TB before
initiating Category II treatment
regimen.

Fixed-dose

combination (FDC) should

be used except in children unable
to take tablet formulations.

The

national and local government

units (LGUs) shall ensure provision of
drugs to all TB cases.

Policies
Quality

of FDCs must be ensured.

Out-patient

treatment shall be the

preferred mode of care.

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.

Policies
Treatment

response of PTB patients

shall be monitored through follow-up
DSSM and clinical signs and symptoms.

Tracking

mechanism for patients lost

to follow-up shall be put in place.

Appropriate

infection control
measures shall be observed at all
times based on TB Infection Control
guidelines.

Policies
All

registered TB patients in
Category A and B sites, shall be
offered Provider-initiated HIV
Counselling and Testing (PICT).

All

confirmed drug resistant TB

cases shall be offered PICT.

Category A
NCR
CHD 3 - Angeles City
CHD 7 - Cebu City,
Mandaue City, Danao
City
CHD 11 - Davao City

Category B
CAR - Baguio City
CHD 3 - Olongapo City
CHD 4A Rizal - Cainta,
Antipolo City, Cavite Bacoor, lmus,
Dasmarinas City,
Batangas - Lipa City,
Batangas City
CHD 4B - Puerto
Princesa City
CHD 6 - Iloilo City,
Bacolod City
CHD 7 Talisay, LapuLapu City
CHD 9 - Zamboanga
City
CHD 10 - Cagayan de

Treatment and registration

Do

pre-treatment evaluation. Address all

pertinent health issues appropriately

assign

the corresponding treatment

regimen based on the patients disease
site and registration group.

Open

and accomplish the 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.

Form 4. TB Treatment-IPT Card

Form 4. TB Treatment-IPT Card

Form 5. NTP ID Card

Form 5. NTP ID Card

Revised contents of the treatment

card
SOURCE

OF PATIENT

Public

health centers
Other government facilities/hospitals
Private hospitals/clinics/physician/NGO
clinics
Community
Philhealth

number

Household

contacts

Treatment

card for adult and child

integrated

Treatment and registration

Discuss

with the patient and decide

who will be the most appropriate
treatment partner and where the
treatment will be administered

treatment
DOTS
a

partner:

facility staff, or

trained community member, such

as the barangay health worker
(BHW), local government official, or
a former TB patient.

Treatment and registration

Trained

family members as the sole

treatment partner in special/exceptional
cases:
Poor

access to a DOTS facility due to

geographical barriers (including temporarily
displaced populations)

Debilitated

and/or bed-ridden patients

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 people)

Treatment

of children

Treatment and registration

Trained

family members as the sole

treatment partner
drug

supply on a weekly basis or as

agreed between health worker and family
member.

Streptomycin

IM injections by trained and

authorized health personnel.
If

no access during weekends/holidays,

may forego streptomycin doses during
weekends/holidays provided they still
complete the recommended number of
doses (i.e., 56 doses).

Treatment and registration

Ask

if the patient is a PhilHealth member

or a qualified dependent

Open

the appropriate Standard Regimen

and watch the patient take the initial dose
of medications.

Record

intake in treatment and ID card

Register

the patient in the Form 6a. Drug

Susceptible TB register. Assign a TB case
number.

Form 6a. Drug Susceptible TB Register

Form 6a. Drug Susceptible TB Register

Treatment Category and Dosages

No. of tablets per day
Category I

Intensive Phase
2 HRZE
2
3
4
5

30 37 Kgs.
38 54 Kgs.
55 70 Kgs.
> 70 Kgs.

Continuation Phase
4 HR
2
3
4
5

Intensive Phase (daily)

First 2 mos.

3rd mo.

Category II
HRZE
No. of tablets
30 37 Kgs.
38 54 Kgs.
55 70 Kgs.

2
3
4

1 gm

HRZE
No. of tablets
2
3
4

Continuation
Phase (daily)
4th to 8th mo.*
HRE
No. of
tablets
2
3
4

Treatment Category and Dosages

Drug

Rifampicin
(R)

Adults
5 (4 6) mg/kg,
not to exceed 400mg
daily
10 (8 12) mg/kg,
not to exceed 600mg
daily

Pyrazinamide
(Z)

25 (20 30) mg/kg,

not to exceed 2g daily

30 (20-40) mg/kg,
not to exceed 2g daily

Ethambutol
(E)

15 (15 20) mg/kg,

not to exceed 1.2g
daily

20 (15-25) mg/kg,
not to exceed 1.2g daily

Streptomycin
(S)

15 (12 18) mg/kg,

not to exceed 1g daily

30 (20-40) mg/kg,
not to exceed 1g daily

Isoniazid (H)

Children
10 (10-15) mg/kg,
not to exceed 300mg daily
15 (10-20) mg/kg,
not to exceed 600mg daily

Note: Dosage for children are higher since there are more metabolizing enzymes
among children than adults leading to faster metabolism.

Treatment Category and Dosages

Isoniazid
(200mg/5ml)

Rifampicin
(200mg/5ml)

Pyrazinamide
(250mg/5ml)

Ethambutol
(400mg/tab)

Streptomycin*
(1g/2ml)

10mg/kg

15mg/kg

30mg/kg

20mg/kg

30mg/kg

ml.

ml.

ml.

Tablet

ml (IM injection)

1.00
1.50
2.00
2.25
2.50
3.00
3.50
3.75
4.00
4.50
5.00
5.25
5.50
6.00
6.50
6.75
7.00
7.50

1.75
2.50
3.00
3.50
4.25
4.75
5.50
6.00
6.50
7.25
7.75
8.50
9.00
9.50
10.25
10.75
11.50
12.00

1/8*

20-20.9

0.75
1.00
1.25
1.50
1.75
2.00
2.25
2.50
2.75
3.00
3.25
3.50
3.75
4.00
4.25
4.50
4.75
5.00

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
1.00
1.00
1.00
1.00

30

7.50

11.25

18.00

1+1/2

1.00

Body Weight
(kgs.)
3-3.9
4-4.9
5-5.9
6-6.9
7-7.9
8-8.9
9-9.9
10-10.0
11-11.9
12-12.9
13-13.9
14-14.9
15-15.9
16-16.9
17-17.9
18-18.9
19-19.9

3/4

*Note: If child is a newborn (less than 4 weeks), consider referral to Pediatrician so that
Streptomycin can be used instead of Ethambutol.

Treatment and registration

In

Category A or B site and among all

DRTB cases, offer Provider-initiated
Counselling and Testing (PICT) to all
patients aged 15 years old and above.
Results

of HIV screening will be written in

the Form 2b. NTP Laboratory Request
Form for HIV testing and sent to the
physician.

Category A
NCR
CHD 3 - Angeles City
CHD 7 - Cebu City,
Mandaue City, Danao
City
CHD 11 - Davao City

Category B
CAR - Baguio City
CHD 3 - Olongapo City
CHD 4A Rizal - Cainta,
Antipolo City, Cavite Bacoor, lmus,
Dasmarinas City,
Batangas - Lipa City,
Batangas City
CHD 4B - Puerto
Princesa City
CHD 6 - Iloilo City,
Bacolod City
CHD 7 Talisay, LapuLapu City
CHD 9 - Zamboanga
City
CHD 10 - Cagayan de

Form 2b. NTP Laboratory Result Form

for HIV Screening of TB Patients

Follow-up clinic visits

If

the patient underwent HIV testing,

the physician should provide post-test
counselling.
reactive
If

result, do confirmatory testing.

confirmatory test positive, refer the

patient to a treatment hub for antiretroviral treatment (ART)

Monitor 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.

Monitor Response to Treatment

Category I - end of intensive phase, end of the 5th month, end

of treatment.

Note: For clinically diagnosed new patients, no need to repeat 5th

month and end of treatment follow-up DSSM if already smear negative
at end of intensive phase

Monitor Response to Treatment

Category II- end of intensive phase, end of the 5th month,

end of treatment
If

Sm- at the end of treatment, classify outcome as cured or

treatment completed.

If

sputum positive at the end of treatment, classify outcome as

treatment failed and refer to a PMDT treatment facility for
screening.

For EPTB patients and patients where DSSM was not done,
treatment response will be assessed clinically (e.g. weight gain,
resolution of symptoms).

2013 NTP
MANUAL OF
PROCEDURES

Case Holding II

Manage adverse drug reactions

Closely

monitor the occurrence of minor

and major reactions to drugs, especially
during the intensive phase.
Manage

minor reactions appropriately.

Major

side effects necessitate withdrawal of

the responsible drug and the need to switch
to single-dose formulation (SDF).

Report

all cases of ADRs by filing the

Adverse Drug Reaction(s) Form (FDA form)

Manage adverse drug reactions

Minor Adverse Reactions
Gastro-intestinal intolerance
Mild or localized skin
reactions

Drug(s)
probably
responsible

Management

RIF/ INH/PZA Give drugs at bedtime or with small meals.

Any kind of
drugs

Give anti-histamines.

Orange/red-colored urine

RIF

Reassure the patient.

Pain at the injection site

Strep

Burning sensation in the feet

due to peripheral neuropathy
Arthralgia due to
hyperuricemia

Apply warm compress. Rotate sites of

injection.

INH

Give Pyridoxine (Vitamin B6):50-100 mg daily

for treatment10 mg daily for prevention.

PZA

Give aspirin or NSAID. If symptoms persist,

consider gout and request for blood
chemistry (uric acid determination) and
manage accordingly.

RIF

Give antipyretics.

Flu-like symptoms (fever,

muscle pains, inflammation of the
respiratory tract)

Manage adverse drug reactions

Major Adverse Reactions

Severe skin rash due to

hypersensitivity

Jaundice due to hepatitis

Impairment of visual
acuity and color vision
due to optic neuritis
Hearing impairment,
ringing of the ear, and
dizziness due to damage
of the eighth cranial
nerve

Drug(s)
probably
responsible
Any kind of
drugs
(especially
Strep)
Any kind of
drugs
(especially
INH, RIF, &
PZA)
ETH

Strep

Management

Discontinue anti-TB drugs and refer to

appropriate specialist.

Discontinue anti-TB drugs and refer to

appropriate specialist . If symptoms subside,
resume treatment and monitor clinically.

Discontinue ethambutol and refer to an

ophthalmologist.

Discontinue streptomycin and refer to

appropriate specialist .

Manage adverse drug reactions

Major Adverse Reactions

Drug(s)
probably
responsible

Oliguria or albuminuria due

to renal disorder

Streptomycin
Rifampicin

Psychosis and convulsion

Thrombocytopenia,
anemia, shock

Isoniazid
Rifampicin

Management
Discontinue anti-TB drugs and refer to
appropriate specialist.
Discontinue isoniazid and refer to appropriate
specialist.
Discontinue anti-TB drugs and refer to
appropriate specialist

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.

Manage adverse drug reactions

Once

the ADR has resolved, reintroduce anti-TB

drugs one by one
Likelihood of
Causing a
Reaction

Drug

least likely

Isoniazid
Rifampicin
Pyrazinamide
Ethambutol

most likely

Streptomycin

Challenge Doses
Day 1

Day 2

50mg
75mg
250mg
100mg

300mg
300mg
1000mg
500mg

full
full
full
full

125mg

500mg

full dose

Day 3

reaction after adding in a particular drug

identifies that drug as the one responsible for the
reaction.

Once confirmed, the offending drug must be replaced.

For patients with major ADRs to all first line drugs, refer to
PMDT or specialist for proper treatment regimen.

dose
dose
dose
dose

Deciding when a PTB patient is no longer infectious during

treatment

For bacteriologically confirmed patients, DSSM

can be done one month after start of treatment
for purposes of certifying that the patient can
return to work.

No bacteriologically confirmed case should be

allowed to return to work without a negative followup smear examination.

Deciding when a PTB patient is no longer infectious during treatment

For clinically diagnosed patients (smear

negative or smear not done), it is possible to
clear him after 2 weeks

as long as treatment compliance is assured

there is clinical improvement or no clinical

deterioration.

Once appropriate, issue a certificate that the

patient is no longer infectious and can safely
return to work.

Management of Cases Who Interrupted Treatment

Patients who fail to follow-up as scheduled

should be immediately traced through:
telephone call, text message or
home/workplace visit.

Assess the cause of interruption and agree on

solutions.

Management of Cases Who Interrupted Treatment

Length of
interruption?

Do DSSM if
>1 month
interrupti
on

Less than 1 month

More than 2
months

Disposition

Continue treatment and prolong to compensate

Negative
DSSM

More than 1 month

(but < 2months)

How long
has
patient
been
treated?

Positive
DSSM

Continue treatment and prolong to compensate

Less than
5 months

Continue treatment and prolong to

compensate

More than
5 months

Classify as Treatment Failed

Classify as Lost to Follow-up

Treatment Modifications for Special Situations

Pregnancy

Ascertain whether or not a woman is pregnant

before she starts TB treatment.

anti-TB drugs (HREZ) are safe for pregnant

women, except streptomycin

Supplemental pyridoxine (Vitamin B6) at

25mg/day

Breastfeeding

Mothers with TB can still breastfeed (feed infants

before taking medications).

Supplemental pyridoxine (Vitamin B6) for infants

taking INH or whose breastfeeding mother is
taking INH.

Treatment Modifications for Special Situations

Oral

Contraceptives

Rifampicin

interacts with oral

contraceptive medications with a risk of
decreased protective efficacy against
pregnancy.
take

an oral contraceptive pill

containing a higher dose of estrogen
(50), following consultation with a
clinician; or

use

another form of contraception.

Treatment Modifications for Special Situations

Liver disease or history of liver disease

HRZ are all associated with hepatitis.

In the presence of hepatitis and elevation of liver

enzymes, treatment should be interrupted and,
generally, a modified or alternative regimen used

Wait for liver function tests (LFTs) to revert to

normal and clinical symptoms to resolve before
reintroducing the anti-TB drugs.

Usual regimens if no clinical evidence of chronic

liver disease (e.g., hepatitis virus carriage, a past
history of acute hepatitis, and excessive alcohol
consumption)

Treatment Modifications for Special Situations

Established Chronic Liver Disease

Avoid PZA
2SHRE/6HR
9RE
2SHE/10HE

Acute Hepatitis

Defer TB treatment until resolved

Safest option is 3SE while waiting for hepatitis to

resolve then 6HR continuation phase.

12SE if hepatitis is unresolved

Treatment Modifications for Special Situations

Renal Failure
Drug

Change in
frequency?

Recommended dose and frequency for patients

with creatinine clearance <30mL/min or for
patients receiving hemodialysis

INH

No change

300mg once daily; or 900mg three times per week

RIF

No change

600mg once daily; or 600mg three times per week

PZA

Yes

25-35mg/kg per dose 3 times per week (not daily)

ETH

Yes

15-25mg/kg per dose 3 times per week (not daily)

Strep

Yes

12-15mg/kg per dose 2 or 3 times per week

FDC-A (HRZE) 3x/wk + FDC-B (HR) for the rest of the week
during the intensive phase.
Continuation

phase may proceed with 4HR.

Treatment Modifications for Special Situations

Renal Failure

2HRZ/4HR is another option

Take meds after hemodialysis

TB/HIV Co-infection

Isoniazid preventive therapy (IPT) with 6H for

HIV+ individuals who, after careful evaluation, do
not have active TB.

Treatment Modifications for Special Situations

TB/HIV Co-infection

Priority is to treat TB, especially bacteriologically

confirmed PTB to stop transmission.

start ART concomitantly with TB treatment (if with

high risk of death)

Defer

ART (if not high risk of dying)

Co-TMX as prophylaxis for other infections

Drug Interactions during TB Treatment

Elderly individuals with significant

comorbidities, as well as the immunecompromised patients (e.g., HIV/AIDS patients)
at higher risk.

To minimize drug interactions, it is advisable

that drugs be administered 12 hours apart.

Listing of drug-drug interactions is available in

the MOP

Treatment Outcomes

Based on completion of treatment regimen,

DSSM follow-up results and clinical improvement
or lack of clinical deterioration.

Record the treatment outcome in the Form 4.

TB treatment/IPT Card and the Form 6a. TB
Register.

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.

Treatment Outcomes
Outcome

Cured

Definition

bacteriologically-confirmed TB at the beginning of

treatment
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

Treatment
completed

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)

Treatment Outcomes
Outcome

Definition

A patient whose sputum smear or culture is

positive at 5 months or later during treatment.
Treatment
failed

Died

A clinically diagnosed patient 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.

Treatment Outcomes
Outcome

Lost to
follow-up

Not
Evaluated

Treatment
Success

Definition

A patient whose treatment was interrupted for

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.)
The sum of cured and treatment completed

Treatment Outcomes
A

patient who is diagnosed to have DR-TB

anytime during the course of treatment
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.

Treatment Outcomes for RR-TB/

MDR-TB/ XDR-TB
OUTCOME

DEFINITION

A patient with bacteriologically confirmed RRTB/MDR-TB/XDR-TB who has completed at least 18

months of treatment without evidence of failure
Cured
AND three or more consecutive cultures taken at
least 30 days apart are negative after the intensive
phase
A patient who completes at least 18 months worth
Treatment of treatment without evidence of failure BUT no
record that three or more consecutive cultures
Completed taken at least 30 days apart are negative after the
intensive phase

Treatment Outcomes for RR-TB/

MDR-TB/ XDR-TB
OUTCOME

DEFINITION
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
Treatment
bacteriological reversion** in the continuation
Failed
phase after conversion** to negative, or
evidence of additional acquired resistance to
fluoroquinolones or second-line injectable
drugs, or
major adverse drug reactions (ADRs)

Treatment Outcomes for RR-TB/

MDR-TB/ XDR-TB
OUTCOME

DEFINITION

Lost to
follow-up

A patient who dies for any reason

during the course of treatment.
A patient whose treatment was
interrupted for 2 consecutive months
or more.

Not
evaluated

A patient for whom no treatment

outcome is assigned.

Died

Treatment The sum of cured and treatment

completed
Success

Thank you.