2013 NTP

MANUAL OF
PROCEDURES
Case Holding
Case Holding
TO ENSURE EFFECTIVE AND
COMPLETE TREATMENT OF ALL
TB CASES FOR BOTH ADULTS AND
CHILDREN
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 (TB Disease Registration Group)
Registration Group Definition
never had treatment for TB* or less than one (<1) month
New
intake

• Previously cured or treatment completed in their most

recent treatment
Relapse
• presently diagnosed with bacteriologically-confirmed or
clinically-diagnosed TB.
Retreatment

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 (TB Disease Registration Group)
Registration Group Definition
• previously treated
• lost to follow-up for two months or more in their
Treatment After Lost most recent course of treatment
to Follow-up (TALF)
Retreatment

• currently diagnosed with bacteriologically-

confirmed or clinically-diagnosed TB.

Previous Treatment • previously treated

Outcome Unknown • outcome after their most recent course of treatment
is unknown or undocumented.
(PTOU)

Patients who do not fit into any of the categories listed

Other above.
• registered in a DOTS facility
• transferred to another DOTS facility with proper
Transfer-in referral slip to continue the current treatment
regimen.
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 Type of TB Patient Treatment
Treatment Regimen

Pulmonary TB, new

Category I 2HRZE/4HR
Extra-pulmonary TB, new (except CNS/ bones or joints)

Category Ia Extra-pulmonary TB, new (CNS/ bones or joints) 2HRZE/10HR

Previously treated drug susceptible TB (pulmonary or

extra-pulmonary)
 Relapse
2HRZES/1HRZE
Category II  Treatment After Failure
/5HRE
 Treatment After Lost to Follow-up (TALF)
 Previous Treatment Outcome Unknown
 Other

Previously treated drug susceptible EPTB (CNS/ bones 2HRZES/1HRZE

Category IIa
or joints) /9HRE
TB Disease Registration Group
Category of Type of TB Patient Treatment Regimen
Treatment
ZKmLfxPtoCs
Standard
Regimen Drug  Individualized once DST
RR-TB or MDRTB
Resistant result is available
(SRDR)  Treatment duration for at
least 18 months

Individualized based on
Regimen for
XDR-TB DST result and history of
XDR
previous treatment
Policies
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
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 Category B
• NCR • CAR - Baguio City
• CHD 3 - Angeles City • CHD 3 - Olongapo City
• CHD 7 - Cebu City, Mandaue • CHD 4A – Rizal - Cainta,
City, Danao City Antipolo City, Cavite -
• CHD 11 - Davao City Bacoor, lmus, Dasmarinas
City, Batangas - Lipa City,
Batangas City
• CHD 4B - Puerto Princesa City
• CHD 6 - Iloilo City, Bacolod
City
• CHD 7 – Talisay, Lapu-Lapu
City
• CHD 9 - Zamboanga City
• CHD 10 - Cagayan de Oro City
• CHD 12 - General Santos City
• CHD Caraga - Butuan City
Procedures (Treatment and
registration)
Inform the patient that he/she has TB disease and
motivate him/her to undergo treatment.
Provide, as necessary, the following key messages
for TB patients and their families:
◦ The need for at least 6-8 months of supervised, well-
documented TB treatment with good compliance
◦ Free medicines in a DOTS program
◦ Public health facilities offer free bacteriology services
(DSSM, Xpert MTB/Rif and/or MTB culture and DST).
Treatment and registration
Provide, as necessary, the following key
messages (con’t):
◦ Schedule of follow-up DSSM for monitoring
◦ tracing mechanism if lost to follow-up by which the
patient will be contacted
◦ How to address possible adverse drug reactions
◦ Relevance of contact investigation
◦ Cough etiquette and other pertinent infection control
measures
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 partner:
◦ DOTS facility staff, or
◦ a 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 patient’s 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 Continuation Phase
2 HRZE 4 HR
30 – 37 Kgs. 2 2
38 – 54 Kgs. 3 3
55 – 70 Kgs. 4 4
> 70 Kgs. 5 5

Continuation
Intensive Phase (daily)
Phase (daily)
First 2 mos. 3rd mo. 4th to 8th mo.*
Category II
HRE
HRZE HRZE
S
No. of tablets No. of tablets
No. of tablets
30 – 37 Kgs. 2 2 2
38 – 54 Kgs. 3 3 3
1 gm
55 – 70 Kgs. 4 4 4
> 70 Kgs. 5 5 4
Treatment Category and Dosages
Drug Adults Children
5 (4 – 6) mg/kg, 10 (10-15) mg/kg,
Isoniazid (H) not to exceed 400mg daily not to exceed 300mg daily

10 (8 – 12) mg/kg, 15 (10-20) mg/kg,

Rifampicin (R) not to exceed 600mg daily not to exceed 600mg daily

Pyrazinamide 25 (20 – 30) mg/kg, 30 (20-40) mg/kg,

(Z) not to exceed 2g daily not to exceed 2g daily

Ethambutol 15 (15 – 20) mg/kg, 20 (15-25) mg/kg,

(E) not to exceed 1.2g daily not to exceed 1.2g daily

Streptomycin 15 (12 – 18) mg/kg, 30 (20-40) mg/kg,

(S) not to exceed 1g daily 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.
Treatment Category and Dosages
Isoniazid Rifampicin Pyrazinamide Ethambutol Streptomycin*
(200mg/5ml) (200mg/5ml) (250mg/5ml) (400mg/tab) (1g/2ml)
Body Weight (kgs.)
10mg/kg 15mg/kg 30mg/kg 20mg/kg 30mg/kg
ml. ml. ml. Tablet ml (IM injection)
3-3.9 0.75 1.00 1.75 1/8* 0.18
4-4.9 1.00 1.50 2.50 0.24
5-5.9 1.25 2.00 3.00 0.3
¼*
6-6.9 1.50 2.25 3.50 0.36
7-7.9 1.75 2.50 4.25 0.42
8-8.9 2.00 3.00 4.75 0.48
9-9.9 2.25 3.50 5.50 0.54
10-10.0 2.50 3.75 6.00 ½ 0.6
11-11.9 2.75 4.00 6.50 0.66
12-12.9 3.00 4.50 7.25 0.72
13-13.9 3.25 5.00 7.75 0.78
14-14.9 3.50 5.25 8.50 0.84
15-15.9 3.75 5.50 9.00 3/4 0.9
16-16.9 4.00 6.00 9.50 0.96
17-17.9 4.25 6.50 10.25 1.00
18-18.9 4.50 6.75 10.75 1.00
19-19.9 4.75 7.00 11.50 1 1.00
20-20.9 5.00 7.50 12.00 1.00
     
30 7.50 11.25 18.00 1+1/2 1.00

*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.
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 result, do confirmatory testing.

◦ If confirmatory test positive, refer the patient to a

treatment hub for anti-retroviral 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).
Drug Management
FEFO and FIFO
Room Temperature of 12 – 24 degrees celcius (with
daily monitoring log)
Should be place in cabinets or above pallets
PPD vials if opened, should be used within 8 hours
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
Drug(s)
Minor Adverse Reactions probably Management
responsible
Gastro-intestinal intolerance RIF/ INH/PZA Give drugs at bedtime or with small meals.

Any kind of
Mild or localized skin reactions Give anti-histamines.
drugs
Orange/red-colored urine RIF Reassure the patient.

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

Burning sensation in the feet due Give Pyridoxine (Vitamin B6):50-100 mg daily for
INH treatment10 mg daily for prevention.
to peripheral neuropathy
Give aspirin or NSAID. If symptoms persist,
Arthralgia due to hyperuricemia PZA consider gout and request for blood chemistry (uric
acid determination) and manage accordingly.

Flu-like symptoms (fever, muscle

pains, inflammation of the respiratory RIF Give antipyretics.
tract)
Manage adverse drug reactions
Drug(s)
Major Adverse Reactions probably Management
responsible
Any kind of
Severe skin rash due to drugs Discontinue anti-TB drugs and refer to appropriate
hypersensitivity (especially specialist.
Strep)
Any kind of
Discontinue anti-TB drugs and refer to appropriate
drugs
Jaundice due to hepatitis specialist . If symptoms subside, resume treatment and
(especially INH, monitor clinically.
RIF, & PZA)
Impairment of visual acuity
Discontinue ethambutol and refer to an
and color vision due to optic ETH ophthalmologist.
neuritis
Hearing impairment, ringing
of the ear, and dizziness due Discontinue streptomycin and refer to appropriate
Strep specialist .
to damage of the eighth
cranial nerve
Manage adverse drug reactions
Drug(s)
Major Adverse Reactions probably Management
responsible
Oliguria or albuminuria due to Streptomycin Discontinue anti-TB drugs and refer to appropriate
renal disorder Rifampicin specialist.
Discontinue isoniazid and refer to appropriate
Psychosis and convulsion Isoniazid specialist.
Thrombocytopenia, anemia, Discontinue anti-TB drugs and refer to appropriate
Rifampicin specialist
shock

◦ 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
Challenge Doses
Likelihood of
Drug Causing a
Reaction Day 1 Day 2 Day 3

Isoniazid 50mg 300mg full dose

least likely
Rifampicin 75mg 300mg full dose
Pyrazinamide 250mg 1000mg full dose
Ethambutol 100mg 500mg full dose
Streptomycin most likely 125mg 500mg full dose
◦ A 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.
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 follow-up 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
How long
Do DSSM
has
Length of if >1 month
patient Disposition
interruption? interruptio
been
n
treated?

Less than 1 month Continue treatment and prolong to compensate

Negative
Continue treatment and prolong to compensate
DSSM

Less than Continue treatment and prolong to

More than 1 month 5 months compensate
(but < 2months)
Positive
DSSM
More than
Classify as “Treatment Failed”
5 months

More than 2 months 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
Recommended dose and frequency for patients with
Change in
Drug creatinine clearance <30mL/min or for patients
frequency?
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 immune-compromised 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
Outcome Definition

• bacteriologically-confirmed TB at the beginning of

treatment
Cured • 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 • 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

Died treatment.
Treatment Outcomes
Outcome Definition

• A patient whose treatment was interrupted for 2

Lost to
consecutive months or more.
follow-up

• A patient for whom no treatment outcome is

assigned. (This includes cases transferred to
Not
another DOTS facility and whose treatment
Evaluated
outcome is unknown.)

Treatment • The sum of cured and treatment completed

Success
Thank you.