ACTIVE DRUG SAFETY

MONITORING AND
MANAGEMENT
 Learning Outcomes
At the end of this session, participants should
be able
Sessionto:
objectives
o Explain aDSM system and essential components
in aDSM
o Define aDSM, adverse event, adverse drug
reaction, rechallenge and dechallenge
o Identify the different packages in aDSM
reporting and the package of choice by the
Philippines

Department of Health – National TB Control Program

 Learning Outcomes
At the end of this session, participants should
be able to:objectives
Session
o Recognize SAE and AESI
o Report SAE and AESI by using FDA
Suspected Adverse Reactions Form (aDSM
Reporting Form)

Department of Health – National TB Control Program

 Active Drug Safety Monitoring and
Management (aDSM)

- The active and systematic clinical and

laboratory assessment of DR-TB patients
while on DR-TB treatment with:
a. new TB drugs
b. novel MDR-TB regimens
c. XDR-TB regimens
- To detect, manage adverse events and
report suspected or confirmed drug toxicities

Department of Health – National TB Control Program

 Active Drug Safety Monitoring and
Management (aDSM)

• Essential component in treating DR-TB.

• One of the key activities in aDSM is the

reporting of all serious adverse events (SAE)
and adverse events of special interests (AESI).

• But it should be noted that active clinical and

laboratory monitoring of patients for
surveillance of any adverse events (AEs) and
prompt and appropriate management of AEs
regardless of severity are equally important.

Department of Health – National TB Control Program

 Procedures
1. Report all SAE or AESI through the prescribed
reporting form or system.

2. Complete the report through PViMS.

3. In case PViMS is not accessible, complete the

FDA Suspected Adverse Reactions Form
(aDSM reporting form). The paper report shall
be submitted to CHD Regional NTP
Coordinator and National Drug Policy
Compliance Officer (NDPCO). This shall be
later entered into PViMS by NDPCO.

Department of Health – National TB Control Program

 Procedures
4. Through PViMS or paper format, submit the
report within 2 working days from
occurrence of event or
immediately upon receipt of information.

5. Manage all adverse events accordingly.

Department of Health – National TB Control Program

 Definition of Terms
ADVERSE EVENT vs. ADVERSE DRUG REACTION

Adverse Event

• A negative or harmful health experience that

occurs during treatment, which may or may
not be associated with the medicine

Adverse Drug Reaction (ADR)

• A harmful effect suspected to be caused by a

medicine when used at normal therapeutic
doses

Department of Health – National TB Control Program

 Definition of Terms
Serious Adverse Events (SAE) - any untoward
medical occurrence that at any dose:

 Results in death
 ls life threatening
 Requires in-patient hospitalization or results in
prolongation of existing hospitalization
 Results in persistent disability/incapacity
 ls a congenital anomaly/birth defect
 AEs that do not immediately result in one of
the above outcomes, but which require an
intervention to prevent a serious outcome are
included.

Department of Health – National TB Control Program

 Definition of Terms
Adverse Event of Special Interests (AESI) - adverse
event documented to have occurred during clinical
trials and for which the monitoring program is
specifically sensitized to report regardless of its
seriousness, severity or causal relationship to the TB
treatment. These are the following:

1. Acute kidney injury (acute renal failure)

2. Hepatitis (defined as increases ALT or AST ≥5x
the upper limit of normal (ULN), or increases in
ALT or AST ≥3x ULN with clinical
manifestations, or increases in ALT or AST ≥3x
ULN with concomitant increase in bilirubin
≥1.5x ULN)
Department of Health – National TB Control Program
 Definition of Terms
3. Hypokalemia
4. Myelosuppression (manifested as anemia,
thrombocytopenia, neutropenia or leucopenia)
5. Optic nerve disorder (optic neuritis) or retinopathy
6. Ototoxicity (hearing impairment, hearing loss of
any degree)
7. Pancreatitis
8. Peripheral neuropathy (paresthesia)
9. Prolonged QT interval (Fridericia correction) of
>500 ms or >60 ms increased from baseline
10. Psychiatric disorders and central nervous system
toxicity (e.g. depression, psychosis, suicidal
intention, seizures)

Department of Health – National TB Control Program

 DEFINITION OF TERMS
Causality Assessment
- The evaluation of the likelihood that a TB medicine
was the causative agent of an observed adverse
reaction.

Dechallenge
- Withdrawal of a medicine from a patient following
an AE.
AE resolves following
Positive dechallenge: withdrawal of the medicine

Negative dechallenge: AE continues despite

withdrawal of the medicine
Department of Health – National TB Control Program
 DEFINITION OF TERMS

Rechallenge
- Reintroduction of the medicine
following withdrawal and recovery
from the AE.

Positive rechallenge: the AE recurs

Negative rechallenge: the AE does
not recur

Department of Health – National TB Control Program

Department Memorandum No. 2020 – 0177
Department Memorandum No. 2020 – 0177
aDSM Checklist (English Version)
Department Memorandum No. 2020 – 0177
aDSM Checklist (Filipino Version)
 DOH Administrative Order 2020 - 0025

Objective

The Administrative order aims to:

A. General:
Provide policies and guidelines on the
implementation of aDSM for all
patients with TB using new anti-TB
drug, a repurposed drug, or a new
regimen.
DOH Administrative Order 2020 - 0025
of the Philippines
Republic
Department of Health
OFFICE OF THE SECRETARY

JUN 02 2020

ADMINISTRATIVE ORDER
oped
No. 2020 -

SUBJECT: Policv and Guidelines on the Implementation of Active Drug Safety

Monitoring and Management (aDSM) of
the National Tuberculosis
Control Program (NTP)

I. RATIONALE

The Disease Prevention and Control Bureau - National Tuberculosis Control Program
(DPCB-NTP) has been implementing the use of Standard Shorter Treatment Regimen (SSTR)
which reduces the treatment duration for patients with multi-drug resistant tuberculosis
(MDR-TB) from eighteen (18) months to nine (9) months. Moreover, the DPCB-NTP has
already introduced the use of new anti-TB drugs such as Bedaquiline (BDQ) and Delamanid
(DLM), and repurposed drugs such as Linezolid (LZD), Clofazimine (CFZ), and
Imipenem/Cilastatin (IPM/CLS), for patients with drug-resistant TB (DR-TB) the country. in
These two (2) new interventions in TB management require active surveillance as part of
pharmacovigilance for patients under MDR-TB and extensively Drug-Resistant TB (XDR-
TB) treatment. In 2015, the Active Tuberculosis Drug-Safety Monitoring and Management
(aDSM) Framework for Implementation of the World Health Organization (WHO)
recommended immediate action for countries to adopt aDSM to complement the
aforementioned interventions of the TB program.

In the WHO aDSM Framework for Implementation Manual (2015), WHO defines aDSM
as the active and systematic, clinical, and laboratory assessment of
patients while on treatment
using new anti-TB drugs, novel MDR-TB regimens or XDR-TB regimens detect, manage, to
and report suspected or confirmed drug toxicities. aDSM aims to reduce risks from drug-
related harms in patients on new anti-TB drugs, novel treatment regimens, or XDR-TB
regimens, to generate standardized aDSM data to enhance the detection of new signals, and
to formulate policy and guideline updates on TB treatment. This is distinct from existing
mechanism of spontaneous reporting system implemented by the National Pharmacovigilance

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 This allows decision makers to identify potential adverse events related to medicine use,
and consequently implement decisions for improving patient safety. The Department of
Health - Pharmaceutical Division (DOH-PD), which is in charge of monitoring medicine
distribution under public health programs (PHPs) in different health facilities, has included
pharmacovigilance of PHPs in
its operations, as authorized by the FDA. In 2017, the DOH-
PD has adopted the PViMS for adverse events observed mainly in patients with DR-TB
receiving new anti-TB drugs with shorter regimen.

The aDSM implementation is

an integral component of
the comprehensive package of TB
services that will be provided to all patients with TB using a new anti-TB drug, a repurposed
drug, or a new regimen. This is aligned with the goal of the “Universal Health Care Act” to
provide comprehensive quality and cost-effective health care services for
all. This is also one
of the key strategies to support the realization of the goal of the FOURmula One Plus, to
achieve better health outcomes, particularly for patients with TB.

IT. OBJECTIVES

This Administrative Order (AO) aims to:

A. General:

Provide policies and guidelines on the implementation of aDSM for

all patients with

a
TB using a new anti-TB drug, repurposed drug, or a new regimen.

B. Specific:

ll. Define the roles and responsibilities of DOH offices, stakeholders, and partners
VIVA
involved in the implementation of the aDSM system in the country;
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2. Provide guidelines for the establishment of partnerships with Local Government
Units (LGUs) and Hospitals in implementing the aDSM in the country; and,
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3. Standardize data collection and processing of Adverse Events (AE) reports from
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the implementing health facilities to further assess the safety of a new drug, a
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repurposed drug or a new regimen for DR-TB.

IH. SCOPE AND COVERAGE

This Order shall apply to all health facilities, both public and private, and health
professionals providing treatment to all patients with TB using a new anti-TB drug, a
repurposed drug or a new regimen, the DOH concerned offices, Centers for Health
Development (CHDs), Ministry of Health -
Bangsamoro Autonomous Region in Muslim
Mindanao (MOH-BARMM), LGUs, and other stakeholders involved in

ne
Iv. DEFINITION OF TERMS

. Adverse Drug Reaction (ADR) refers to a response to a medicine that is noxious

—

and unintended, and which occurs at doses normally used in humans.

. Adverse Event (AE) refers to any untoward medical occurrence that may present
—

during treatment with a pharmaceutical product, but which does not necessarily have a
causal relationship with this treatment.

. Adverse Event of Special Interest (AESI)- refers to an AE documented to have

occurred during clinical trials and for which the monitoring program is specifically
sensitized to report regardless of its seriousness, severity or causal relationship to the
TB
treatment. (Refer to Annex A)

. Causality Assessment (CA) refers to the evaluation of the likelihood that a TB

—

medicine was the causative agent of an observed adverse event.

. Expected Serious Adverse Event (Expected SAE)

(SAEs) or reaction which occurred in a
~ refers to serious adverse events
human study participant from previous
researches or investigations. This can also be considered as any SAEs listed in the drug
literature.

. Extensively Drug-Resistant Tuberculosis (XDR-TB) — refers to a form of TB caused

by Mycobacterium tuberculosis that is resistant in vitro to the effects of any
fluoroquinolone (e.g., levofloxacin, moxifloxacin) and second line injectable agent
(e.g., amikacin), in addition to at least both isoniazid and rifampicin.

. Individual Case Safety Report (ICSR) refers to a document that contains

—

information describing the adverse event/s related to the administration of one or more
medicinal products to an individual patient.

. Intermediate Package refers to the level of monitoring in aDSM that includes serious
—

adverse events as well as adverse events of special interest.

Multi Drug-Resistant Tuberculosis (MDR-TB) — refers to a form of TB caused by

Mycobacterium tuberculosis that is resistant in vitro to the effects of at least both
isoniazid and rifampicin.

. Pharmacovigilance — refers to the science and activities relating to the detection,

assessment, understanding, and pr ny other drug-related
problem. CERTIFIED TRUE COPY

JUN 09 2020

_
MARIA CRISHNA
Seana,
KMITS - RECORDS SECTI;
Department of Health
4, 4
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K. Public Health Programs (PHPs) — refers to programs initiated by the DOH involving,
among others, the promotion of access to essential medicines in the public sector to
address priority diseases.

L. Repurposed Drug — refers to a drug that is recommended by WHO for

use in the
treatment of TB but was approved by a regulatory authority for the treatment of other
infectious diseases.

M. Serious Adverse Event (SAE) — refers to an AE

that is life
threatening or results in
death, requires hospitalization or prolongation of hospitalization, results in persistent or
significant disability or incapacity, or a congenital anomaly. AEs that do not
immediately result in one of these outcomes, but which require an intervention to
preventa serious outcome, are included.

N. Signal — refers to reported information on a possible causal relationship between an

adverse event and a drug in which the relationship was unknown or incompletely
documented previously. Usually more than a single report is required to generate signal,
depending upon the seriousness of the event and the quality of the information.

O. Unexpected Serious Adverse Event (Unexpected SAE) — refers to serious adverse

events or reaction, the nature and severity of which is not consistent with domestic
labeling or market authorization, or unexpected from the characteristics of the drug.

GENERAL GUIDELINES

A. The DOH, through the PD, shall create a National aDSM Coordination Committee
(NaCC) to oversee and support the implementation of aDSM in health facilities
providing treatment for TB.

B. The DOH-PD and the DPCB-NTP shall adopt and implement aDSM following the
intermediate package level of monitoring for all
patients with TB using a new anti-TB
drug, a repurposed drug, or a new regimen.

C. All health facilities providing treatment for TB shall adopt the prescribed mechanism
for reporting SAEs and AESIs experienced by patients with utmost confidentiality by
using the assigned TB-registration number instead of the patient’s name.

D. All healthcare professionals (e.g., physicians, nurses, and midwives) providing TB

services shall be trained on TB disease and AE management to
ensure safety of the
patients as stated in the Administrative Order 2016-0040 also known as the “Revised
Policies and Guidelines on the Implementation of the Programmatic Management of

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 E. The healthcare professional shall promptly identify and properly manage AEs in
order
to deliver the best possible patient care based on the approved or acceptable clinical
pathways of the DPCB-NTP.

F. The DOH-PD in coordination with DPCB-NTP and Health Promotion and

Communication Service (HPCS) shall initiate strategic communications and awareness
campaigns on aDSM to ensure momentous support which will create a sustainable
change.

G. The CHDs, MOH-BARMM, LGUs, health facilities providing treatment for TB, and
other stakeholders shall implement the prescribed communications and awareness
campaigns on aDSM.

VI. SPECIFIC GUIDELINES

A. Composition of the National aDSM Coordination Committee (NaCC) and

Operational Procedures for Meetings

1. The NaCC shall be composed of relevant stakeholders from the DOH-PD, DOH-
NTP, and FDA.

2. The NaCC shall besupported by ad hoc members from other DOH offices such
as but not limited to the following offices: Epidemiology Bureau (EB), HPCS,
and the Knowledge Management and Information Technology Service (KMITS).

3. The NaCC shall convene at least twice a year for the program implementation
review (PIR).

4. The NaCC members shall fill out a form declaring their conflict of interest before
each meeting and submit this to the secretariat. Members with potential conflict of
interest can exercise partial participation in the deliberation on a specific topic but
will not be allowed to vote on the matter.

5. The decision and/or recommendation of the NaCC shall be based on unanimous

agreement by the group.

6. The NaCC shall be supported by staff from DOH-PD who shail serve as the
secretariat.

CERTIFIED TRUE COPY

*
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4typ 6
MARIA NAP. RIVERA
KMITS - RECORDS SECTIO
Department of Heaith
—_——
.
Page 5
- -
 B. Management of Adverse Events (AEs)

1. Detection of AEs

All healthcare professionals (e.g., physicians, nurses, midwives) providing

treatment for TB shall detect and manage adverse events through active and
systematic baseline and follow-up clinical, laboratory, and diagnostic
monitoring.

2. Clinical Management of AEs

a. Upon detection of AEs, the physician-in-charge shall conduct a thorough

assessment of the patient for proper clinical management.
b. Appropriate laboratory or diagnostic test/s when indicated shall be requested to
obtain objective evidence of the AEs.
c. The reported AEs as identified shall be managed with reference to the
Programmatic Management of Drug-Resistant TB (PMDT) implementation
guidelines.
d. The patient shall be referred to a specialist, when necessary, for further
evaluation and management.

3. Recording and Reporting of SAEs and AESIs

a. All SAEs and AESIs shall be recorded using the prescribed NTP forms (refer to
Annex B) and reported to DOH-PD through PViMS or any prescribed web-
based reporting system within two (2) working days (refer to Annex C).
b. In health facilities where PViMS or any prescribed web-based reporting system
is not available, the appropriate form (refer to Annex D) shall be filled out. The
form shall be submitted to the CHD or MOH - BARMM NTP Coordinator, copy
furnished the National Drug Policy Compliance Officer (NDPCO) designate at
the CHD or MOH-BARMM. The NDPCO designate shall encode the data
through PViMS or any prescribed web-based reporting system within two (2)
working days.
c. Adverse events (AEs) that are suspectedto be due to a quality defect of an anti-
TB drug shall be reported immediately to the FDA. Appropriate number of
samples shall be submitted to confirm the quality of medicine as mandated
under FDA Circular No. 2018-013 (Risk Management Plan for Drug
ViewA
Establishments) and its amendments. The healthcare professionals may consult
the DOH-hired pharmacists for any other quality issues with the medicine.
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a. The DOH-PD shall determine the relationship between the anti-TB drug/s and

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event/s by conducting causality assessment of reported SAEs and AESIs using
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 the WHO — Uppsala Monitoring Center (UMC) system for standardized case
causality assessment. Other causality assessment methods may also be used, when
necessary.
b. DOH-hired Pharmacists shall collect additional data that are essential in conducting
causality assessment. The health facilities providing TB services shall allow the
DOH-hired Pharmacists to validate AE reports and collect supplemental data as
required by the DOH-PD, inaccordance with Republic Act No. 10173 also known
as the “Data Privacy Act of 2012” Section 13.e.
c. SAEs and AESIs needing expert opinion as determined by DOH-PD shall be
compiled and reported to an aDSM Causality Assessment Committee (aCAC).
Such cases shall then be reviewed and assessed by the Committee to come up with
a recommended causality assessment (Refer to Annex E and F for the
composition/qualifications and operational procedures for meetings).
d. The DOH-PD shall submit individual case report of SAEs and AESIs to FDA not
later than fifteen (15) days after the completion of causality assessment through
an electronic system. The FDA shall then transmit the data to WHO- UMC.
e. The DOH-PD shalltransmit the data to WHO Global aDSM Database developed
by the WHO/Global TB Programme (GTB) and WHO/Special Programme for
Research and Training in Tropical Diseases through PViMS or
any other prescribed
web-based reporting system.

5. Feedback

a. The DOH-PD shall send an acknowledgement response to the reporter for every
report received.
b. After the report of adverse event has been assessed, the DOH-PD shall provide
feedback only on the unexpected SAEs. Expected SAEs and AESIs shall not
require feedback unless significant issues have not been addressed to minimize the
occurrence of such events.
c. An active line of communication (e.g., telephone, mobile phone, facsimile, social
media private messages or electronic mail) shall be maintained at all times for
the purpose of feedback reporting within and between all
levels of health delivery
system (national, regional, provincial/city, and municipal).

C. Risk Minimization

—
The FDA shall review all reports of adverse events related to aDSM.

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a5 constitute a signal.
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 4. The FDA shall provide the necessary information to the NaCC, DOH-PD, and NTP.

D. Risk Communication

1. The DOH-PD, in coordination with NTP, HPCS, and FDA, shall develop a
comprehensive aDSM risk communication plan, which shall be disseminated to
relevant stakeholders.

2. The DOH-Media Relations Unit (MRU), in coordination with DOH-PD, Office of the
Chief of Staff (OCS), and FDA, shall prepare and disseminate press releases and
facilitate press conferences, as deemed necessary.

VU. PROGRAM MONITORING AND EVALUATION

A. The DOH-PD shall be the lead, in coordination with the DPCB-NTP and its CHDs and
MOH-BARMM counterparts, in monitoring the implementation of aDSM every (6)
months and shall have the authority to check the documents relevant to aDSM.

B. The DOH-PD, through the CHDs and MOH-BARMM, shall validate the integrity and
transparency of the records of the health facilities.

C. The program shall be evaluated at least once every three (3) years or as often as deemed
necessary by the DOH-PD.

D. Monitoring and Evaluation shall be performed by utilizing a monitoring tool approved

by the NaCC and aligned with the DOH Monitoring and Evaluation guidelines.

VIII. ROLES AND RESPONSIBILITIES

A. DOH Central Offices

1. The DOH-Pharmaceutical Division (DOH-PD) shall:

Lead the implementation of this order and serve as the focal unit for aDSM;
Lead in monitoring the implementation of aDSM every six (6) months;
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Allot funds in support to the implementation of aDSM;

Conduct causality assessment and submit case reports/assessments of SAEs
and AESIs to the FDA, which shall then transmit these data to the WHO-
UMC;
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Transmit the data on SAEs and AESIs to the Global aDSM database;
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f. Create an aCAC which shall be composed of external experts;
a Coordinate with aCAC for causality assessment of complicated cases and

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 providing treatment for TB;
i. Coordinate with the NDPCO designates in the CHDs and MOH-BARMM
for any supplemental data needed for the assessment of reported AEs;
j. Develop and cascade the Manual of Procedures (MOP) for aDSM, duly
consulted with stakeholders and approved by the head of the Health
Regulation Team (HRT);
k. Serve as the secretariat of the NaCC and aCAC;
l. Provide feedback in a timely manner to
stakeholders, as necessary;
m. Maintain and cascade the use of PViMS or any prescribed web-based
reporting system; and,
n. Develop and oversee the implementation of the Risk Communication Plan
(RCP) for aDSM, in
coordination with HPCS and DPCB-NTP.

The National aDSM Coordination Committee (NaCC) shall:

a. Oversee aDSM implementation and its alignment to the DOH National

Objectives Plan;
b. Develop policies, guidelines, and MOPs on aDSM as well as the DPCB-
NTP implementing guidelines; and,
c. Provide recommendation and technical assistance for the implementation
of aDSM.

The aDSM Causality Assessment Committee (@CAC) shall:

a. Review and assess causality assessment reports needing expert opinion;

b. Assess any signal detected and develop necessary risk minimization
measures; and,
c. Assist in the finalization of AE reports, especially those that require expert
opinion.

The DPCB through NTP shall:

a. Formulate and/or modify TB treatment policies based on the

recommendations from national/local authorities and/or intemational
organizations;
. Participate in case investigations of suspected AEs, when necessary;
c. Coordinate aDSM activities with the NTP program managers both at the
national and regional (i.e., CHD and MOH-BARMM) levels;
Train healthcare professionals on the clinical management of AEs; and,
e. Participate in the monitoring and evaluation of the aDSM implementation,
in coordination with DOH-PD and FDA.

CERTIFIED TRUE COPY

&JUN-09 2970
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UN
2970

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MARIA
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KMITS XR

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 5. The Health Promotion and Communication Service (APCS) shall:

a. Develop a national risk communication plan (RCP) for aDSM and cascade
this to the regions to develop their regional risk communication plans;
b. Monitor and evaluate the implementation of the RCP by the Health
Education and Promotion Officers (HEPOs) in their respective regions; and,
c. Provide feedback to the national office and recommend actions, as necessary.

B. The Food and Drug Administration (FDA) shall:

1. Investigate signal/s detected;

2. Respond on events referred by the DOH-PD, through the Center for Drug
Regulation and Research (CDRR)-Pharmacovigilance Unit, for further
investigation and regulatory action;
3. Provide feedback on referred cases of DOH-PD on AEs;
4, Provide technical assistance to DOH-PD and aCAC regarding
pharmacovigilance issues;
5. Coordinate with HPCS, MRU, and DOH-PD in
key messages for advisories and press statement;
preparing and developing

6. Submit reported adverse drug events to the WHO-UMC; and,

7. Participate in the monitoring and evaluation of the aDSM implementation,
in coordination with the DOH-PD and DPCB-NTP.

C. The CHDs and MOH-BARMM through the NDPCO and the NTP Coordinator
shall:

Oversee the aDSM implementation in the regions;

Ensure dissemination of and compliance to aDSM policies and standards;
PYwnNr

Collect supplemental data needed for causality assessment, when necessary;

Coordinate with the LGUs and health facilities requiring additional data
and management of cases;
5. Ensure proper encoding of health facility data into PViMS or
any prescribed
web- based reporting system;
6. Participate in case investigations of suspected AEs;
~ Monitor and evaluate the aDSM implementation in the regions; and,
8. Cascade the Risk and Communication Plan for aDSM to the LGUs.

D. The LGUs (Provincial/City Health Offices), through the designated TB

cSoprdinator shall:
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Implement the aDSM guidelines within the province/municipality/city;
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providing treatment for TB;
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 5. Support administrative and logistical requirements needed for aDSM
implementation, including capacity building for healthcare professionals;
6. Provide logistical support (medical assistance, etc.) for patients requiring
clinical management of SAEs;
7. Authorize CHD and MOH-BARMM staff to validate AE reports and
collect supplemental data as required by the DOH-PD; and,
8. Monitor and evaluate the aDSM implementation.

E. The Health Facilities Providing Treatment for TB shall:

1. Identify promptly the occurrence of any AE and manage properly all

identified
AEs;
2. Collect and encode the reports of SAEs and AESIs into the PViMS or any
prescribed web-based reporting system;
3. Report all SAEs and AESIs to the FDA Pharmacovigilance Unit and National
Pharmacovigilance Center, using the approved prescribed reporting forms and
systems;
4. Coordinate with the CHD or MOH-BARMM, through the NDCPO designates
or assigned DOH-hired Pharmacists, for the encoding of reports to PViMS or
any prescribed web-based reporting system;
5.
6.
Analyze all data generated from implementation of aDSM atthe facility level;
Educate patients to monitor their clinical condition following administration of new
drugs, repurposed drugs or new regimen and to promptly report any AEs to
healthcare professionals;
7, Maintain integrity and transparency of records and make data available to both
the DOH and FDA; and,
8. Participate in the case investigation of suspected AEs.

Ix. FUNDING

Each agency identified in this Order shall endeavor to include in their budget the funds
necessary for its implementation.

X. REPEALING CLAUSE

All rules, issuances, orders, or parts thereof, contrary to or inconsistent with this
Administrative Order are hereby repealed or amended accordingly. All other issuances not
otherwise affected shall remain valid and in
effect.

CERTIFIED TRUE COPY]

(
JUN 09,2020

eneaat eenve
MARIA RA,
,
C
Oepartnient of Health Oh .

ibe
cat Page
11 f12
-
XJ. EFFECTIVITY

This Administrative Order shall take effect after fifteen (15) days following its
of
publication in a newspaper general circulation and upon filing with the University of the
Philippines Law Centerof three (3) certified copies of this Order.

I,
}

FRANCISCO T/DUQUE MD, MSc.

Secretary of Health
‘

CERTIFIED
TRE, Copy
* JUN 092mg =

Page 12 of 12
 ANNEX A
Adverse Events of Special Interest (AESI)

a. Acute kidney injury (acute renal failure)

b. Hepatitis (defined as increases in alanine aminotransferase (ALT) or aspartate
aminotransferase (AST) =5x the upper limit of normal (ULN), or increases in ALT or
AST 23x ULN with clinical manifestations, or increases in ALT or AST >3x ULN with
concomitant increase in bilirubin >1.5x ULN)
c. Hypokalemia
d. Myelosuppression (manifested as anemia, thrombocytopenia, neutropenia, or
leucopenia)
9 Optic nerve disorder (optic neuritis), or retinopathy
rh Ototoxicity (hearing impairment, hearing loss of any degree)
Pancreatitis
Egg

Peripheral neuropathy (paresthesia)

re Prolonged QT interval (Fridericia correction) of >500 ms or >60 ms increased from
baseline
J. Psychiatric disorders and central nervous system toxicity (e.g. depression, psychosis,
suicidal intention, seizures)

Reference:

World Health Organization. (2015). Active tuberculosis drug-safety monitoring and

management (aDSM): Framework for implementation (No. WHO/HTM/TB/2015.28).
World Health Organization.

CERTIFIED TRUE COPY

a
JUN 09 2020
MARIA C P_RIVERA |—
KMITS -
eatin
DS SECTION
~a
RI}

Department of

Page1 of LO
=
ANNEX B

—
Form 4 TB Treatment Card

National TB Control Program (NTF]

Form 4. TBHPT Treatment Card

Featment Facility Nate & Resins Treatment Site Pariner (Ham, Typed Cer Ponas). {
}FB[ }CB{Date Transterred wmacorrrs:

Diagnosis: {
|{Acte) Bl Latent TBtnfecion [Treatment Regimen: TPT [ [CakgayT T
[Categoy Ta [ [Shot [ [Conventional
speniy,
ull Name SURMALE Fest Matte)? Date of Registration wucoryy: [Treatment Start Date anccovrnyy:
TB Case Humber:

Sex
ur) [Date of Birth anvooryry: [Height cont initial Weight gi: Status: Clase:
he
[Civil PhitHleatth Number: {Social

|| indigent

Permanent Address (rst No, Ss Rearpy. Coy

ect, Poin Regn 8 Zp Cot Contact Numbers! E-mail Address:

Current Address fous ho, Seat Sanogay, Cay aeealy Pore Ze Cat Person to notify in ease of emergency, relationship
Repen & contact information:

if (Active)
16, History of TB Treatment: { JNone []FLDOny ( ]FUD and SLD

Anatomical Site; { ] Pulmonary {

]Extrapulmonary fits Treeent are Theatre une AS TR Orgs Latin Catena

ITB Bacteriological Status:{ | Baciertologicaly-confinmed { | Clinicaly-diagnosed atlas!

OR-TB Bacteriological Stah( ]8C RR-TB [ JECMORTB | JBC XOR.7B

L}COWOR-TB [_} Other OR-TB

[Registration Group: { JNew =

Relapse
|| Treatnent After Fature

{| Treatment After Loss to Fi‘Up Hates!

{Previous Treatment Outcome Unknown

{| Others

Risk Factors for TB: [|

JNone {| Contact of a Confirmed TRY OR-TB Case

( PLHIV with SYS Suggestive of TB

[Ober
J

[Treatment Outcome: ( }Gued {

]Completed | [Failed [ }Oied | |LosttoFolowup { jExchded Reason: Outcome Date anioowrry,

JUN 09 2626
MARIA
KMITS -

Pagel
 ANNEX C
Process Flow for Reporting and Feedback SAEs and AESIs

DOH Food and Drug

Pharmaceutical Administration
National TB Division ©
Investigation
Control Causality Analysis upon signal ome WHT oO
i
Collate all regional detection
Program ¢ Global UMC
reports, analyzes,
produce summary reporting
report quarterly, and
provide feedback to
subnational level

NACC
\ aCAC
Global
aDSM

CHD and MOH-BARMM NDPCO Designate and

NTP Coordinator
e Notify SAE and AESI cases to DOH-PD immediately.
NDPCO together with the NTP Coordinator shall validate,
analyze, produce quarterly summary report, and provide
feedback to health facilities

PHO and CHO

“")

Health Facilities Providing TB Services

e Collect/encode in PViMS or any prescribed web-based
reporting system or fill up paper form
e Notify SAE and AE of special interest within 2 working days

| Ke A
7

wodae
eg
Department of Hegtth
nine
T
U
ANNEX D
Reporting Form for Adverse Drug Reactions (Food and Drug Administration)

SUSPECTED ADVERSE REACTIONS FORM v & (4/2012) For FDA use only All reports are confidentixi.
“Saving Lives Through Vigilant Reporting” AER
Wo, 2012-0001
Date
recess

*Pavont’s Mame
or Initials, "Sex: OiMate Ofamalc Weight Kg Haight (cm)
Address or Contact “age, Date of Birth (menicktfye}

isle
Modicat History/Admitting Diagnosix: Ethnic group: O Filipina 0 Chinese O Caucasian

Any Known Allergy: Wo Olves, Specity: Prognancy Status:

No
city Is

— Yes (1%,
2%, 3" timaster}

eet inet
Date
taisida
ocho
afenset;______:__am.__pm 9, you corssicter the suactionto ba serious? (1 Yos.if yes indicale why. B No

Describe the resctiom. locluding perivest luboratery dst: (0 Patent died due to reaction
© kerahred of profonged in-patient hospitakization
OO Lie
theesiening
1
CO
twoted persistent or significant disability
Congenital anomaly in the rewbarn
Other cudcome. pe qive detil=
Can thes be dun to Medication Error? [} No
D Yes. 2 yes, which type:
__Presorbing
_Trrecripton
Aden nestration
Gan the adverse reaction be due to:
1. Product quality dofect __No __Yes, Specify, encircle: cofe change; caking: powcdoting: counterfeit; odor change: defective
di

ee
: ;
nen oO

_ imicrotakel
dng expired;
i

Therapeutic failure: No ___ Yes, Socity,

Ht,

2. poor
ress

3 ip

ea]
f

improper
i
roube Of
is fate

Onader-dersing,
+

CTE
pee neh’
“Suspected drun productis)
;
Perrier :
5
7 Pe

: Tal
ore) Sere)

FeO
Petre enue t] en eeeec eerg
reeen oC : Ary
ee
ieee meer
Fe eet eC
Renzows for using 'e the -:Msnufacturer and
Hepeienpae tas

Be

aah dane
Was testment given? O No
ia aha ata daa ted

G Yes (F yes please specify

Quicome:
O Recovered (Date of recovery}: Gi Unrecovered Other cisaatex: fiver renal HPN

O Fatal (Date of death): 1 Urknown Diabetes: CVS Endocine Cancer

Sequelafe: (any pormanont complications or injuries as a result of the ADR) Sechallenge? (Yes Resutt
No
Tianna acs
C1 Yes Pisese specif, ONo GUnknoen P

accross:
*Contact mex,
“Printed Name of Reporter: :

Bevnll

{meidefyr):
Signature o€ reporkar:

Cini Tele
“Profession M0 __RPh__RN__Patent Dentist —_ __other
Dato reported Other

=
Faciley:

National Pharmacovigilance Center

“Saving Lives Through Vigiiant Reporting”
:

Wa ‘Sead compicted farm tax ADR tag, FDA, Civic Drive, Filievess Exaute, Alabunw, Muninhips .1 7X1,
Fad and Qeug Adminsiretesn Or fax bor (00) 07-85-11 fc’
The ADR Una. Send sample, if ao. of umqpect drag for amalysic
Pituineins eke, wom Sona sl

- . RIVE!
MARIA
KMITS S$
SECT
Departitent of Healt
Page of
 ANNEX E
aDSM Causality Assessment Committee Meeting Operational Procedures

The Committee shall convene regularly (once every quarter) during the first year of its
creation and as needed thereafter when there is a call to review and oversee the causality
assessment of reported SAEs and AESIs.

tv The Committee members shall fill out a form declaring their conflict of interest before
each meeting and submit this to the secretariat. Members with potentially conflicting
interest can exercise partial participation in the deliberation on a specific topic but will not
be allowed to vote on the matter.

The decision and/or recommendation of the NaCC shall be based on the unanimous
agreement by the group.

UE

——_———---
CERTIFIED TRUE COPY

JUN
09"“2020
 ANNEX F
aDSM Causality Assessment Committee Qualification and Membership

The Pharmaceutical Division, Program Implementation Monitoring Unit (PIMU), shall serve
as its secretariat.

A. The Committee shall have a representation of the following:

1.Professional affiliation which includes but not limited to the field of academia,
medical professional, clinical practice, research institutes, and government bodies
including public health departments, and regulatory authorities.
2. Major areas of expertise, which include but not limited to respiratory disease,
cardiovascular disease, immunological disease, research, biologics, and drug safety.

B. Conditions for committee membership are the following:

1. The committee members shall be appointed on an ad hoc basis to serve with

of
compensation as indicated in the terms reference.
2. All nominations for new committee member, as well as renewal and discontinuation
of appointments, must be approved by the Secretary of Health.
3. The Committee may request upon department, bureaus, office, agency, or other
instrumentality of the government and local government units for assistance as the
circumstance and exigencies may require.
4. In addition, prior to the confirmation by the DOH of their appointment as
committee member, nominees shall be required to sign a confidentiality
undertaking. The signed confidentiality undertaking shail be maintained by the
DOH-Pharmaceutical Division. All deliberations of the committee are considered
confidential and shall not be disclosed to the public by any member.
5. (stipulate the declaration of COD

C. The members of the committee may be terminated for any of the following reasons:

1. Lack of professionalism involving but not limited to, breach of the confidentiality,
misuse of position for personal gain, bribery and misinterpretation.
2. Undeclared Conflict of Interest (COJ) to the roles and objective of the aDSM that
may arise after the appointment.
3. Failure to attend three (3) consecutive Committee meeting without prior
notification.
CERTIFIED TRUE COPY

UN 09-2070 =

KMITS - SE
Department- of Healt

Page 1 of
 Essential Activities for ADSM
1. Active and systematic clinical and laboratory
assessment during treatment to detect drug toxicity
and Aes –
Are we following the schedule of treatment monitoring?

2. Management of AEs in a timely manner –

Are we providing care to our patients?

3. Systematic collection and reporting of

standardised data for SAEs and AESI
Are we following the guideline on reporting and recording?

Department of Health – National TB Control Program

 TO WHOM DOES ADSM APPLY
TB PATIENTS RECEIVING:
1. New anti-TB drugs
▪ Bedaquiline (Bdq)
▪ Delamanid (Dlm)

2. Novel MDR-TB regimens

▪ Standard short all Oral Regimen (9-11 month treatment
duration)
Lfx-Bdq-Cfz-Pto-E-Z-HdH
▪ Standard long oral regimens (18-20 months treatment
duration)
Bdq/Dlm containing regimens

3. Extensively drug-resistant TB (XDR-TB) regimens

Philippines: All MDR-TB and XDR-TB patients including
those receiving individualized treatment regimens.
Department of Health – National TB Control Program
 WHAT TO REPORT?
Serious AE – Any untoward
medical occurrence that at any
dose:
• Results in death
• Is life threatening
• Requires inpatient
hospitalization or results in
prolongation of existing AEs of Special Interest
hospitalization • Acute kidney injury
• Results in persistent • Hepatitis
disability/incapacity • Hypokalemia
• Is a congenital • Myelosuppression
anomaly/birth defect • Optic Nerve Disorder
• AEs that do not • Ototoxicity
immediately result in one • Pancreatitis
of these outcomes, but • Peripheral Neuropathy
which require an • Prolonged QT interval
intervention to prevent a (using Fridericia Formula)
serious outcome are • Psychiatric Disorders and
included. . CNS toxicity

Department of Health – National TB Control Program

 WHERE TO REPORT
Submit accomplished ADR reports to:

pharmacovigilance@fda.gov.ph
ntp.pharmacovigilance@gmail.com
dohpdpimu@gmail.com

Subject : SAE and AESI Reporting

NOTE:
For updating of cases: Please submit on the
same email thread or indicate Document
Tracking Number provided by FDA.

Department of Health – National TB Control Program

 WHEN TO REPORT
▪Serious Adverse Event
Within 2 days from notification of the SAE
Death must be reported within 24 hours

▪Adverse Event of Special Interest

Within 2 weeks

Department of Health – National TB Control Program

Practical Hints for aDSM Reporting
FDA form: Reporting Tool
Start your report with filling a brief and
minimal essential information:
1. The specific Adverse Event
2. Lab result:
▪ Relevant baseline
▪ At the time Adverse Event
3. Any other cause/comorbidity that would
contribute to AE
4.Any concomitant medicine taking at the
time of AE occurrence

Department of Health – National TB Control Program

Practical Hints for aDSM Reporting
Examples: FDA form: Reporting Tool
1. Hypokalaemia, on Oct 20 2019 (AESI), no anti-TB drug was
stopped, replace oral K+ tablet, no hospitalization, no other cause
of hypokalemia, not taking any other concomitant medicine
▪ Baseline K+ : 3.9 mmol/L
▪ 10/20/19 K+ : 2.8 mmol/L

2. Patient was referred to the hospital for blood transfusion and

hospitalized 2 days on Oct 17-18, 2019 (SAE)
▪ In lab section: Hb – 7.2 g/dL; baseline Hgb at start of treatment: 12 g/dL
▪ No other cause of anemia, not taking any other concomitant medicine
▪ Stop Lzd, plan to re-introduce 300 mg after recheck CBC is received

3. Patient died at home while in toilet- SAE

▪ Causality assessment committee may ask last ECG done, last electrolyte
test results, last blood sugar level, last TSH level, any h/o of hypertension,
heart disease (e.g. myocardial infarction), Diabetes, any other non-TB
medication patient was taking, etc.

Department of Health – National TB Control Program

Important Points To Keep In Mind
▪ It is not reporting medical error or to use as medico-
legal tool
▪ Reporting does not need to be the event likely
related to anti-TB drugs
▪ We will know only after causality assessment if it is
likely (cannot say definite in majority of cases)
related to anti- TB drug/s in regimen
▪ AEs may be due to other drugs taking for SE
management or comorbidity, or progression of TB
disease itself
▪ If the finding from causality assessment is likely
related to anti-TB drugs, usually it is due to ≥ 1 drug
since many drugs have similar SE (e.g Mfx, Cfz, Bdq,
all have potential QTc prolongation side effect)

Department of Health – National TB Control Program

 REMINDER !!!!
All adverse events (AE) should be managed
clinically

BUT
Only serious adverse events (SAE) and AE of
special interest will be reported to national
authority

Department of Health – National TB Control Program

 How to fill-out the
FDA Suspected Adverse
Reactions Form
(aDSM Reporting Form)
 HOW TO REPORT
FDA 1. Patient
Suspected
Adverse 2. ADR
Reactions
form
(aDSM 3. Suspected and
concomitant
Reporting drugs
Form) 4. Other
information
5. Reporter

https://ww2.fda.gov.ph/attachments/arti
cle/150840/ADR%20Form.pdf
Department of Health – National TB Control Program
Suspected Adverse Reactions Form
 How to fill out the FDA SAR Form

Write the age in years as of the

6 Age
PATIENT’S PARTICULARS last birthday
Write the date of birth
7 Date of Birth
Patient’s Write the initials of the patient (First (mm/dd/yr)
1 Name or letter of First Name, Middle Name, Medical History/
8 Write the complete diagnosis
Initials Surname) Diagnosis
Check the appropriate box if
Check the appropriate box if the patient 9 Ethnic Group the patient is a Filipino, Chinese
2 Sex
is female or male or Caucasian
3 Weight Write the actual weight in kilograms Check the appropriate box if No
10 Any Known Allergy
4 Height Write the actual height in centimeters or Yes; If yes, specify
Check if No or Yes; If yes,
11 Pregnancy Status
Address or encircle if 1st, 2nd or 3rd trimester
5 Contact Write n/a Write the complete name of
Number Hospital/Facility, if the PMDT Treatment Facility
12
admitted and Hospital if the patient is
admitted

Department of Health – National TB Control Program

 How to fill out the FDA SAR Form

Additional Information Needed:

Please write “NO OTHER POSSIBLE

CAUSES” if none or other causes were
DETAILS OF THE ADVERSE REACTION already eliminated.
13 Date and Time of Onset Write the date (mm/dd/yyyy) and approximate time of onset of the adverse reaction
Check the appropriate box if No or Yes; If yes, check the appropriate box why the reaction is
considered as serious (patients died due to reaction, involved or prolonged in-patient
Do you consider the hospitalization, life threatening, involved persistent or significant disability, congenital anomaly
14
reaction to be serious? in the newborn.
Check the box for other outcome if the adverse event is of special interest and does not fulfill the
definition of serious adverse event.
Briefly write covering; specify adverse event with date of onset, evolution
Describe the reaction (worsening/recovering) of AE, presence of other underlying cause that would contribute to AE or
15 including pertinent not, any comorbidity, any concomitant drug patient is taking at the time of AE, relevant lab
laboratory data test result at the time of AE and the baseline/the normal result in the previous follow
up visit with date. If the space provided is insufficient, use another sheet of the same form.

Department of Health – National TB Control Program

How to fill out the FDA SAR Form

DETAILS OF THE ADVERSE REACTION

16 Can this be due to Check the box if No or Yes; If yes, check if the medication error is due to prescribing,
Medication Error? transcription, dispensing or administration
17 Can the adverse For product quality defect: Check if No or Yes; If yes, encircle if the defect is in the color
reaction be due to change, caking, powdering, counterfeit, odor change, defective container, separation of
product quality components, or undissolved suspension/powder
defect or therapeutic For therapeutic failure:
failure? Check if No or Yes; If yes, encircle if the therapeutic failure is due to antimicrobial
resistance, drug interaction, poor compliance, counterfeit, expired, improper storage,
under-dosing, inappropriate medication, inappropriate route of administration,
excipients/preservatives

Department of Health – National TB Control Program

How to fill out the FDA SAR Form

SUSPECTED DRUG PRODUCTS

Write the brand name of the anti-TB drug(s) and other drugs (i.e. taking
for management of side effects and/or comorbidity) suspected of causing
18 Generic Name and Brand Name
the reaction. One drug per line. If the space provided is insufficient, use
another sheet of the same form.
Write the daily dose in milligrams of each anti-TB drug suspected of
19 Daily Dose
causing the reaction
20 Route Write if oral, subcutaneous, intramuscular or intravenous
21 Date Started Write the date (mm/dd/yr) of the first dose
22 Date Stopped Write the date (mm/dd/yr) of the last dose
Reason(s) for Using the Product Write the reason or indication for using the drug
23
(Indication)
Write the manufacturer and batch/lot # of the anti-TB drug suspected of
24 Manufacturer and Batch/Lot #
causing the reaction

Additional information needed: Please also indicate the name

of the regimen (e.g. SSOR, SLOR FQ-R, SLOR FQ-S, ITR).

Department of Health – National TB Control Program

How to fill out the FDA SAR Form

FDA SAR Report Form

List all other drug/s taken at the same time and/or 3 months before.
25 Concomitant Medication If none, tick the box for No Other drug/s Taken
If the patient is taking other drug/s, write the brand name of the drug. One
26 Brand Name drug per line. If the space provided is insufficient, use another sheet of the
same form.
Write the daily dose in milligrams of each anti-TB drug suspected of causing
27 Daily Dose
the reaction
28 Route Write if oral, subcutaneous, intramuscular or intravenous
29 Date Started Write the date (mm/dd/yr) of the first dose
30 Date Stopped Write the date (mm/dd/yr) of the last dose
Reason(s) for Using the Write the reason or indication for using the drug
31
Product (Indication)
Manufacturer and Write the manufacturer and batch/lot # of the anti-TB drug suspected of
32
Batch/Lot # causing the reaction

Department of Health – National TB Control Program

 How to fill out the FDA SAR Form

MANAGEMENT OF ADVERSE REACTION

Check the appropriate box if No or Yes; If yes, specify the treatment given to
33 Was treatment given?
address the adverse reaction
Check the appropriate box if recovered, fatal, unrecovered or unknown. If
34 Outcome recovered, write the date of recovery (mm/dd/yr); If fatal, write the date of death
(mm/dd/yr)
Check the co-morbidities present in the patient (liver, renal, hypertension,
diabetes, CVS, endocrine, cancer)
35 Other Diseases
Please write NONE if there are no other comorbidities.
Sequela/e (Any permanent Check the appropriate box if No, Yes or Unknown; If yes, specify the sequela (e.g.
complications or injuries as hearing loss)
36
a result of the adverse
reaction)
Check the appropriate box if No or Yes; If yes (i.e. a suspected drug/drugs are
37 Re-challenge reintroduced) write the result of the re-challenge (e.g. re-appearance of adverse
event identified by laboratory or clinical monitoring)
Follow-up laboratory and physical examination results after
Additional Information
managements/interventions were done.
needed:
Please update report with NTP until the final outcome.

Department of Health – National TB Control Program

How to fill out the FDA SAR Form

REPORTER’S PARTICULARS
Printed Name of Write the complete name of the reporter. First name first, then
38
Reporter the middle initial and the surname.
39 Signature of Reporter Sign the report
40 Date Reported Write the date (mm/dd/yr) when the form was accomplished
Write the contact number where the reporter can be contacted
41 Contact Nos.
(telephone or mobile) including area code
42 Email Address Write the email address where the reporter can be contacted
Check the reporter’s profession (MD, RPh, RN, Patient, Dentist,
43 Profession
Other)
Check the reporter’s facility (clinic, trial site, other)
44 Facility
Please indicate the PMDT Facility of assignment.

Department of Health – National TB Control Program

 REFERENCES
1. National Tuberculosis Control Program,
Programmatic Management of Drug –
Resistant Tuberculosis (PMDT
Implementing Guidelines, 2016

2. Active tuberculosis drug-safety monitoring

and management (aDSM), Framework for
implementation, WHO Publication, 2015

Department of Health – National TB Control Program