MISSION REPORT

SUPPORTING THE TRANSITION OF PAEDIATRIC ANTI-TB MEDICINES

IN THE PHILIPPINES

Mission Team: Xiulei Zhang, WHO/HQ – HIS/EMP/PAU

Fabienne Jouberton, GDF/Stop TB Partnership

Date: 5-18 September 2015

Travel Request: TR897076

Background The Speeding Treatments to End Paediatric TB (STEP-TB) is a three-year project developed

by the TB Alliance and WHO (the Department of Essential Medicines and Health Products

and Global TB Programmes). It aims to accelerate the development and uptake of properly

formulated and affordable high quality paediatric fixed-dose combinations (FDCs).

Developed products are FDC1: Rifampicin 75 mg + Isoniazid 50 mg + Pyrazinamide 150mg;

and FDC2: Rifampicin 75mg + Isoniazid 50 mg. FDCs are dispersible and are available in

mango, strawberry or raspberry flavours. They have been produced by one manufacturer

since mid-2015.

The revised dosing was published by WHO in 2010 Rapid Advice and re-iterated in the

second edition of the Guideline for National Tuberculosis Programmes on the Management of

Tuberculosis in Children published in early 2014. Now WHO and TB Alliance are supporting

countries to accelerate national assessments and incorporation of childhood TB in the

National Tuberculosis Programmes (NTP).

Terms of Reference of the Mission The objective of the mission was to support the Philippines to achieve smooth transition from

old paediatric TB medicines to new formulations. The specific objectives were:

I Briefing

To brief stakeholders including the Department of Health (DOH), the National

TB Programme, Food and Drug Administration (FDA), Management Science

for Health (MSH) in country, and the Philippine Paediatrician Society on the

development of the new paediatric TB FDCs.

II Preparing for the phase-out of old formulations

i. To visit sites to gather information about medicine consumption and the Anti-

TB Drug Information Management System, where the NTP operates, and

public and private facilities where children are treated; and

ii. To discuss the phase-out framework for old medicines with stakeholders.

III Preparing for the phase-in of new formulations

i. To discuss and address the potential obstacles for introducing the new FDCs

into the country, including regulatory policies, procedures and timelines, and

possible registration with NMRA; and,

ii. To draft phase-in plan including quantification of the needs of new paediatric

FDCs, steps and timelines

IV Other issues

i. To identify technical support needed: future national TB training plans,

technical gaps, job aids/dosing guidance.

ii. To identify job aids /checklist needed for supply management and prescribers.

The Mission

1. Introduction

After the mission briefing, the Philippine NTP provided a report of its national TB control

framework and policies regarding to TB drug managements, which are summarized as

follows:

1.1) The National TB Control Programme (NTP) of the Philippines

The NTP is one of the public health programmes being managed and coordinated by the

Infectious Diseases for Prevention and Control Division (IDPCD) of the Disease Prevention

and Control Bureau (DPCB) of the Department of Health (DOH). The NTP works closely

with various offices of the DOH such as the Central Office Bids and Awards Committee

(COBAC) and the Food and Drug Administration (FDA) for drug and supplies management.

The 17 DOH Regional Offices (RO), through their Regional NTP teams, manage TB at the

regional level, while the provincial health and city health offices, through their provincial/city

teams, are responsible for TB control efforts in provinces and cities. TB diagnostic and

treatment services are provided by DOTS facilities which could either be the public health

facilities such as the rural health units, health centers, hospitals, school clinics, military

hospitals, and prison/jail clinics, or NTP-engaged private facilities such as private clinics,

private hospitals, drug stores and others. All DOTS Centers report to the NTP on case finding

and case management data.

1.2) Current Policies

The NTP shall ensure that drugs selected for use are in accordance with international

guidelines; are indicated in the national standard guidelines; registered with the Philippine

FDA; and included in the national formulary. Quantification and ordering shall be based on

distribution rates, projected case finding targets and provision of buffer stocks. Buffer stocks

should be maintained at:

1 quarter buffer at DOTS facilities

1 quarter buffer at PHO/CHO (District Level)

6 months buffer at CHD (City/Regional Level )

12 months buffer at national level

According to the NTP manager, the supply of anti-TB drugs in the Philippines have been

unreliable and irregular, so a 12 month buffer at a national level is indicated.

Medicines and supplies shall be stored under appropriate conditions and accounted for

through proper recording and reporting. Stock status should be reflected in the National

Online Stock Inventory Reporting System (NOSIRS).

DOTS centers can access the medicines for treatment of TB that meet following criteria: ①

Registration of medicines with FDA; ②Inclusion in the National Formulary; ③Inclusion in

the disease-centered standard treatment guideline.

1.3) Procurement and distribution

The procurement process for first line drugs (FLDs) for adults from the domestic market

includes NCDPC for forecasting & quantification, COBAC for purchase order/contract and

LMD for logistic management. The downloadable desktop management tool, QuanTB,

created by the Improved Access to Pharmaceuticals and Services (SIAPS) project, helps to

improve quantification at the central level. Distribution information management is paper-

based at the moment, and information including receipts, storage, and delivering shall be

complete, accurate, and analyzed in a timely way.

Since 2008, the NTP has been procuring paediatric anti-TB medicines from Concept

Pharmaceuticals, Ltd (based on India). Kit content for a complete treatment course (6

months) includes: 7 bottles Isoniazid (syrup, 200mg/5ml; 120 ml preparation in amber

bottle), 7 bottles Rifampicin (oral suspension, 200mg/5ml; 120 ml preparation in amber

bottle), 4 bottles Pyrazinamide (oral suspension, 250mg/5ml suspension, 120 ml preparation

in amber bottle), and Ethombutol (200 mg per tablet). Kit for prophylaxis treatment for

children includes five bottles Isoniazid (Syrup 200mg/5ml syrup).

2. Case finding of TB in children in the past and projection for the next years

According to the NTP, the TB recording and reporting system to date in the Philippines is

paper based and collected annually, and electronic- and Internet-based reporting systems will

be rolled out nationwide by the end of 2015. Before 2012, all forms of childhood TB were

part of regular reporting information. Unfortunately, since 2012, only smear positive TB has

been required to be reported. Accomplishment from 2010 to 2012 is showed as table 1.

Table 1. Accomplishment (2010-2012)

Year 2010 2011 2012

Reported TB in children 11,857 21,837 21,988

Total TB cases 174,535 206,088 216,929

% children 7 11 10

The WHO mission and the Philippine NTP discussed and agreed that as the Philippines was

increasing its efforts in paediatric TB case finding, 11% could be regarded as the appropriate

proportion of childhood TB among total TB cases, for the purpose of projecting childhood

TB notifications in following several years. Likewise, based on previous years’ trends of case

finding , it is assumed that TB of all forms increases by 6% annually.

Based on the above assumptions and 2014 cases finding data, estimated TB in children from

2015-2018 are as table 2.

Table 2. 2015-2018 Projected case notification (based on 2014 data)

Year Increase over

last year

Total TB cases (adult and children)

Estimated children

A B=A×11%

2014 261,081 28,719

2015 6% 276,746 30,442

2016 6% 293,351 32,269

2017 6% 310,952 34,205

2018 6% 329,609 36,257

Although according to national guidelines all reported cases are required to be enrolled in the

treatment, no data of annual treatment achievements were collected by the NTP.

3. Stock on hand and pending order of paediatric TB medicines

3.1) At Central level

The mission visited central warehouses, including Quirino warehouse, which is the central

storage for DOH pharmaceuticals commodities, and the one that stores paediatric TB

medicines. The facility does not have certification, but when a delivery arrives one

pharmacist from FDA comes to perform post-shipment inspection and sampling for quality

control testing. Apart from space constraints, the drug organization, stock management,

storage condition and security measures are at an acceptable level.

Due to zero stock of paediatric TB medicines at the time of the mission, only bin cards,

delivery receipts and relevant documents were reviewed. Documents showed that paediatric

TB medicines have been procured from Concept Pharmaceuticals since 2008. The warehouse

has been out of stock since November 2014, and the 2014 order had not been delivered as of

September 18, 2015, despite its scheduled arrival at the central warehouse in July 2015.

There were stockouts in the central warehouses between annual orders in the past three

consecutive years: July 12-August 15 2013 (33 days), March 12-May 22, 2014 (70 days), and

November 3 2014 to September 5 2015 (the date of WHO mission) (over 10 months).

There is a history of backorders from Concept Pharmaceuticals in 2013 (PO 2012-10-441).

The time from date of notice to proceed to date of receipt of delivery was 6 months, which

exceeded the required the maximum of 120 calendar days.

3.2) At Peripheral level

The NTP did not have the number of the 17 Regional Offices with stockouts at the time of

mission. The NTP stated that there is a contingency plan to response to stockouts: in the event

of stockout at central warehouse, Regional Offices can procure drugs locally and distribute to

the NTP offices of lower levels, and subsequently ask for reimbursement from the Central

NTP Office. At the time of the visit, there were no statistics of stock on hand in the Regional

Offices, Provincial Offices, and DOTS facilities.

3.3) At DOTS facilities visited

Three DOTS facilities were visited, including the National Children’s Hospital and Bo.

Fugoso Health Center, which are public institutions and work under the regulations of the

NTP. They had both run out of drugs for childhood TB distributed from the NTP in May

2015. However, there were no stockouts in the two facilities, because the hospital and the

Regional Office had procured drugs from domestic markets before their supplies were

exhausted. INH, RFP, and PZA in syrups and Ethambutol in tablets are procured locally in

accordance with governmental procedures. Anti-TB drugs for children include 7 bottles

Isoniazid/Pyridoxine HCL (20mg/20mg per 5ml syrup), 7 bottles Rifampicin (200 mg/5 ml

suspension, 120mL), 4 bottles Pyrazinamide (250 mg/5 ml suspension, 120 mL), and

Ethombutol (200mg per tablet). During the visit, the stock on hand of various drugs in

National Children’s Hospital was enough to last for 3-6 months, while there were sufficient

drugs in Bo. Fugoso Health for 5-20 months. Their drug information management systems

are paper based and data is reported to their respective District Office on a monthly basis.

The Fr. Angelo Falardi Health Clinic (supported by Payatas Orione Foundation) is a non-

government organization whose personnel as well as medical supplies and medicines are

funded by a charity based in New York. No stockout had been reported, and drugs are

procured each month from the domestic market by the clinic, instead of being obtained from

the NTP. These drugs are provided to TB patients for free, and are the same as those provided

by the National Children’s Hospital.

TB doctors in the three facilities mentioned children’s complaints over the syrups’ flavours,

and that Ethambutol was difficult to swallow.

4. Progress for introducing the new FDCs

4.1) Registration with FDA

During the discussion with the Philippine FDA, it was noted that according to Philippine

policy (Guidelines for Current Good Manufacturing Practice (cGMP) Clearance and

Inspection for Foreign Drug Manufacturers), prior to registration, all importers of drug

products must obtain GMP clearance from FDA for each of their foreign drugs. So GMP

hereby is a requirement for product registration. The average processing time is 8-10 weeks,

in some extreme circumstances, the process could be done within one month.

Since 6 June 2015, MacLeod has been attempting to file a regulatory submission, but before

the Philippine authorities will be able to accept it, GMP clearances of its three manufacturing

sites need to be obtained. However, there is no clear timeline as to when GMP Clearance will

be scheduled, so dossiers have not yet been submitted to the Philippine FDA.

The Philippine FDA acknowledged that thus far, all drugs purchased through UN agencies

benefit from a waiver and can be imported without registration.

4.2) Inclusion into National Formulary

After a discussion with the NTP, the Formulary Executive Committee (FEC) stated that it is

only amenable to including the new FDCs on the formulary if it is in the WHO Model List of

Essential Medicines. However, the next generation of the WHO Model List is only expected

to be released in April 2017.

4.3) Inclusion in the standard treatment guideline

The TB-centered treatment guideline, the NTP Manual of Procedure 2013, is already in place,

and dosages per body weight are nearly same as that of the latest WHO guideline. Experts

from the Philippine Paediatricians Associations had expressed concerns over the difference of

minimal dosage of INH between the WHO guideline and the current Philippines, but finally

agreed on the dose and range of Isoniazid in WHO guideline 10 (7-15) (mg/kg body weight)

after obtaining relevant supporting documents.

The Philippine NTP has agreed that in due time it will issue a memo to include the new FDCs

into the selected list of drugs for treating TB in children.

4.4) Training and job aids

Training pertaining to the new FDCs is regarded as necessary, especially on the proper

administration of the drugs. However, technical assistance from WHO/GDF/TB Alliance on

the training is not deemed necessary by the NTP.

Job aids are necessary to help prescribers and pharmaceutical managers to remember the

proper dosage and administrative requirements. TB Alliance has been in contact with the

Philippine NTP with regards to this.

5. Phasing out of syrups and phasing in of FDCs

5.1) Phasing out: pending 2014 order and the forthcoming 2015 order

The medicines order in 2014 that was supposed to be delivered in July 2015, is rescheduled

for delivery in October 2015. The manufacturer Concept Pharmaceuticals claimed the

backorder was due to lack of raw materials. The ordered quantity was 35,000 kits that will

provide for 35,000 treatments. It is estimated that 32,269 children will be diagnosed with TB

in 2016, and accordingly about 32,269 kits will be consumed in 2016. When considering

package roundup, losses and damages, the 2014 order will be good for use in 2016.

The NTP intends to place the same order for syrups later this year as it did in 2014, of 35,000

kits. It plans to use its 2015 budget and order from Concept Pharmaceuticals . The 2015 order

is expected to be able to cover 2017 consumption. See annex 1 for details.

5.2) Phasing in: order with 2016 budget for FDCs

After discussion between the DOH and WHO mission, the Philippine NTP expressed an

interest in procuring FDCs through GDF with its 2016 budget, and the anticipated FDCs

procured will cover the 2018 treatment needs. As the 2015 order will be able to cover 2017

consumption, and six months of overlapping period for the two formulations is indispensable

for smooth transition, the ideal time for starting using FDCs at facility level is October 2017.

When considering the timeline of phasing in FDCs, time for producing, packing, shipping

and waiver application need to be factored in. The first batch of FDCs should arrive at the

central warehouse in the second quarter of 2017. After inspection by FDA facilities, FDCs

must be in stock no later than the last quarter of 2017. The proposed timeline from WHO on

the above-mentioned action items is illustrated in annex 2.

However, there is the possibility that MacLeod will complete the registration with FDA early

in 2016. In this case, the waiver will be uncalled for, and the DOH will procure FDCs directly

from the domestic market, rather than through GDF.

5.3) Quantification of needs of FDCs

The quantification is based on the following assumptions:

Treatment regimen is 2HRZE/4HR

Weight bands are used as illustrated in annex 3

75% of the children younger than 15 years old have body weight under 25 kg, and

their average body weight is 12-15 kg

For a child whose body weight is 12-15 kg, the treatment is of 3 tablets of HRZ in

intensive phase and 3 tablets of HR in continuous phase

Childhood TB (all forms) constitutes 11% of TB of all ages

Case finding increases annually by 6%

A 25% (3 month) buffer is taken into account

The FDCs to be procured with the 2016 budget will be used at facilities from Octo

2017 to the end of 2018, with 6 months of over lapping period (October 2017-

March 2018)

Based on the above assumptions, the recommended initial order for HRZ is 5,670,120 tablets,

and the order for HR is 11,340,240 tablets. Of course, appropriate round up will apply for the

final order according to packing sizes. For details, see annex 4.

Budget for FDCs: the budget of 2015 for TB in children is US$ 582,965 (for 35,000

treatments). The 2016 budget is US $845,873. It is too early to tell if the budget will be

sufficient or not, as the prices of FDCs are not available yet.

6. Recommendations to the Philippine DOH/NTP/FDA

6.1) Buffer stock

According to the NTP’s current policy, buffer stocks at facility level, district level, regional

level and national level altogether will last 24 months. This will lead to medicine expiries,

given most medicines’ 24-month shelf-life and several months of lead time. WHO

recommends that the NTP should maintain about a three month buffer stock at national level

and have a well-timed delivery schedule. In addition, the NTP should contract suppliers to

deliver on a quarterly schedule to ease the pressure on the physical space of central

warehouses.

6.2) Recording and reporting of childhood tuberculosis

The NTP does not collect the number of notified cases that receive treatment, so the

quantification of demands is based on the assumption that all notified cases are treated.This is

unrealistic in most cases. WHO recommends that treatment enrollment and treatment

outcomes are added to quarterly reports, which is crucial to collating demands, consumption

and forecasting.

6.3) Inclusion of FDCs into the national formulary

In order to encourage the swift inclusion of FDCs on the national formulary, the NTP should

consider providing alternative supporting documents to the Formulary Executive Committee,

such as WHO’s new Guidance for National Tuberculosis Programmes on the Management of

Tuberculosis in Children.

6.4) Ensure storage capacity

The NTP needs to have capacity beyond already overwhelmed warehouses for the

forthcoming 2014 order. In the long run, it is recommended suppliers be contracted to deliver

on quarterly basis. As the new FDCs are dispersible tablets,it is recommended that the NTP

has a close monitoring of the products’ storage conditions (temperature and humidity) along

the supply chain at the central and peripheral levels.

6.5) Facilitate of UNOPS registration and waiver application

The NTP and FDA should provide necessary assistance to UNOPS’ registration with FDA,

the signing of the memorandum of understanding with the DOH, and the waiver application

to FDA.

6.6) Transition timeline

The DOH is recommended to tentatively follow the timelines and activities in annex 2 to

ensure a smooth transition.

6.7) Post-marketing/pharmacovigilance

As introduction of FDCs may influence the form and frequency of adverse drug reactions,

WHO advocates active TB drug safety monitoring and management and that

pharmacovigilance remains very relevant.

7. Follow up for GDF/WHO/TB Alliance

7.1) Accelerate the FDCs pricing process

In order for the DOH to develop a practical procurement plan, GDF/WHO/TB Alliance’s

primary concern is to facilitate the pricing of FDCs at the earliest time.

7.2) Preparing for a waiver application

UNOPS, as a UN agency, is entitled to have a registration waiver, but in order to proceed, it

needs to be registered with the FDA which is presently not the case. After registration, GDF –

which is now part of UNOPS – shall be able to apply for a waiver and procure FDCs. Of

course, a memorandum of understanding needs to be signed between UNOPS and the DOH

in advance.

7.3) Facilitating the registration of Macleods

WHO has inspected the sites of Macleods where these paediatrics formulations are produced

and they have been declared GMP compliant. To expedite the waiver application, WHO shall

share the prequalification documents with FDA to support it to provide GMP clearance to

Macleods.

7.4) Updating the Philippines

WHO shall update the Philippines on the progress of pricing, drug availability, and other

information such as package size of the FDCs, to facilitate the order placing.

Annex 1. Phasing out of syrups and suspensions

1. Total ordered kits in 2014 that are expected to arrive in October 2015: 35 000

1) FDA tests and inspection will take about one month.

2) Medicines are expected to arrive at facilities in December to be used for treatment

from the beginning of 2016.

3) It is estimated that 32 269 children will be diagnosed with with TB in 2016, and

accordingly 32 269 kits will be consumed in 2016. When considering package

roundup, loss and damage, the 2014 order is good for use in 2016.

2. 2015 order will be placed by the year-end,products will be delivered by July 2016, and

the quantity is 35 000 kits

1) The ordered products for treatment childhood TB will still be syrups and

suspensions from the same manufacturer.

2) FDA tests and inspection will take about one month.

3) Medicines are expected to arrive at facilities in July 2016, which will ensure the

facilities have three months of buffer (October-December 2016).

4) It is estimated that there will be 34 205 TB in children in 2017, and, accordingly

34 205 kits will be consumed.

5) However, as FDCs are supposed to be introduced in the Philippines by the 2017,

with six month of overlapping period of two preparations, the old preparation can

hold up to first quarter of 2018.

6) In short, the 2015 order of 35 000 kits are good for treatment from the beginning of 2017 up to March 2018

3. The FDCs will be introduced to into the Philippines in 2017, starting to treat patients

from October 2017

10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12

Deliveries to

central level

FDA inspection

and delivery to

facil ities

Treatment with

syrups

Order placing and

releasing budget

Deliveries to

central level

FDA inspection

and delivery to

facil ities

Treatment with

syrups

Order placing and

releasing budget

producing and

pack

Waiver

application

Deliveries to

central level

FDA inspection

and delivery to

facilities

Treatment with

FDCs

2016

order:

FDC

activities

Months of 2016 Months of 2017

Annex 2. Timeline of action points for introducing new FDCs to the Philippines

2014

order:

syrups

2015

2015

order:

syrups

Medicine

s

Months of 2018

Annex 3. Weight band table when using the “new” FDC

Weight bands

Numbers of tablets

Intensive Phase Continuation Phase

RHZ E RH

75/50/150 100 75/50

4-7 kg 1 1 1

8-11 kg 2 2 2

12-15 kg 3 3 3

16-24 kg 4 4 4

25 kg+ Go to adult dosages and preparations

Average

body weight

Annex 4. Quantified needs of new FDCs (June 2016-May 2017)

Time

Expected case finding (all form)

Treatment regimen

# Months

# Doses/ Month

Average Units/Dose

Total No. Tablets

Plus 25% buffer

roundup by

package children

(less than 15 Y)

No. under 25 kg

2015 30442

2017

Jan-Dec

34205 using suspensions and syrups

over lapping period

Oct-Dec

4276 3207 2HRZ 2 28 3 538729 673411

4HR 4 28 3 1077458 1346822

2018

Jan-Mar

4532 3399 2HRZ 2 28 3 571052 713816

4HR 4 28 3 1142105 1427631

Apr-Dec

27193 20395 2HRZ 2 28 3 3426315 4282894

4HR 4 28 3 6852630 8565787

Jan-Dec

36257 2015 order can be used up to March 2018

The initial order for HRZ is 5,670,120 tablets

The initial order for HR is 11,340,240 tablets

Annex 5 Mission Itinerary

SCHEDULE PARTICIPANTS

Day 1 Sept. 7

Venue: Manila Grand Opera Hotel

830am- 930am

10am- 12nn

12nn-1pm

1pm-5pm

1. Meeting with Dr. Henning (WHO)

2. Meeting with Stakeholders to discuss on a. Philippine DOH Procurement Process and Plan for

Procurement of anti-TB drugs and supplies b. PPMP c. Use of FDCs for Children using 2015 budget d. Warehousing e. Delivery Mechanism

3. Orientation on GDF/EMP Mission

LUNCH BREAK

4. Discussion on a. Adoption of new WHO childhood TB guideline b. Policy and practical issues regarding the

1. Ms. Fabienne Jouberton - GDF 2. Ms. Cornelia Henning - WHO

1. Ms. Fabienne Jouberton - GDF 2. Dr. Xiulei Zhang - EMP 3. Dr. Celina Garfin - NTP 4. Ms. Monica Coronado - NTP 5. Ms. Donna Gaviola - NTP 6. Ms. Zaza Munez - MSH 7. Dr. Mariquita Mantala - TASC 8. Dr. Benjie Sablan - PAPA 9. Dr. Mary Rosary Santiago - NTP 10. Mr. Jover Francisco - NTP 11. Ms. Princess Mangao - MSH 12. Mr. Arnyl Araneta - PBSP 13. Mr. Armando Castillo - PBSP 14. Ms. Jacqueline Hui - LMD 15. Mr. Erikson Balingit - NCRO 16. Ms. Paola Gonzaga - NTP 17. Mr. Mehmood Anwar - PBSP

introduction of new FDCs c. Job aids/checklists needed for supply management

or prescribes d. Possible re-purchase of syrups to cover transition

period e. Sites to be visited

5. To prepare for phasing out of old medicines a. Collecting statistics of childhood TB b. Stock taking of old paediatric medicines at central

level c. Discussing milestone for phasing out of old

formulation

Day 2 Sept. 8

8am-1pm

1pm-5pm

1. Site Visit a. PhilPost b. Royal Cargo

2. Meeting with UNOPS, COBAC

1. Ms. Fabienne Jouberton - GDF 2. Dr. Xiulei Zhang - EMP 3. Mr. Jover Francisco - NTP 4. Ms. Princess Mangao - MSH 5. Mr. Kurt Baltero - PBSP 6. Ms. Kristine Padilla - NTP 7. Mr. Erikson Balingit - NCRO 8. PHILPOST PERSONEL 9. ROYAL CARGO PERSONEL 1. Ms. Fabienne Jouberton - GDF 2. Dr. Xiulei Zhang - EMP 3. Ms. Ghenimelle Pasumbal - NTP 4. Ms. Zaza Munez - MSH 5. Ms. Kristine Mangao - MSH 6. Dr. Celine Garfin - NTP 7. UNOPS 8. COBAC 9. BIHC 10. WHO Country Office

Day 3 Sept. 9

8am-5pm

TEAM A 1. Site Visit a. National Children’s

Hospital b. Payatas Orione

Foundation, Inc. c. Bo. Fugoso Health

Center

TEAM B 1. Site Visit a. GracePark PMDT STC

w/ DOTS facility b. Bahay Toro Health

Center (IDOTS-facility providing TB sevices to drug susceptible and drug resistant TB cases w/in their catchment)

2. Meeting with PBSP GF

and MSH (TA and quantification of SLD)

TEAM A 1. Ms. Ghenimelle Pasumbal - NTP 2. Ms. Kristine Padilla - NTP 3. Ms. Monic Coronado - NTP 4. Ms. Princess Mangao - MSH 5. Dr. Xuilei Zhang - EMP

TEAM B 1. Ms. Fabien Jouberton - GDF 2. Mr. Jover Francisco - NTP 3. Dr. Mary Rose Santiago - NTP 4. Ms. Michelle Tarubal - NTP 5. Mr. Kurt Baltero - PBSP 6. Mr. Erikson Balingit - NCRO 7. Dr. Marl Mantala - TASC 8. Mr. Arnyl Araneta - PBSP

Day 4 Sept. 10

8am- 12nn

1pm-5pm

1. Site Visit a. QMMC Warehouse

1. Meeting with FDA concerns (registration process, quality assurance and pharmacovigilance)

1. Ms. Fabienne Jouberton - GDF 2. Dr. Xiulei Zhang - EMP 3. Ms. Monic Coronado - NTP 4. Ms. Zaza Munez - MSH 5. Ms. Princess Mangao - MSH 6. Mr. Jover Francisco - NTP 7. QMMC Warehouse Staff

1. Ms. Fabienne Jouberton - GDF 2. Dr. Xiulei Zhang - EMP 3. Ms. Monic Coronado - NTP

4. Ms. Zaza Munez - MSH 5. Ms. Princess Mangao – MSH 6. Mr. Jover Francisco - NTP 7. Dr. Celine Garfin - NTP 8. Dr. Marl Mantala - TASC 9. FDA Personnel

Day 5 Sept. 11

9am-12nn

1pm-5pm

1. Meeting for Quantification of new FDCs and Syrups 2. Drafting procurement plan for new FDCs and syrups

3. Debriefing

1. Ms. Fabienne Jouberton - GDF 2. Dr. Xiulei Zhang - EMP 3. Dr. Celina Garfin - NTP 4. Dr. Jun Ogsimer - NTP 5. Ms. Princess Manago - MSH 6. Ms. Zaza Munez - MSH 7. Ms. Kristine Padilla - NTP 8. Dr. Marl Mantala - TASC 9. Ms. Ghenimelle Pasumbal - NTP

1. Ms. Fabienne Jouberton - GDF 2. Dr. Xiulei Zhang - EMP 3. Dr. Celina Garfin - NTP 4. Dr. Jun Ogsimer - NTP 5. Ms. Princess Mangao - MSH 6. Ms. Zaza Munez - MSH 7. Ms. Kristine Padilla - NTP 8. Dr. Marl Mantala - TASC 9. Dr. Mary Rose Santiago - NTP 10. Ms. Donna Gaviola - NTP 11. Mr. Julius Jocson - PD 12. Ms. Jacquiline Hui - LMD 13. Mr. Jonathan Monis - BIHC 14. Ms. Ghenimelle Pasumbal - NTP 15. Ms. Anna Aquino - NCRO

16. Dr. Cornelia Henning - WHO 17. Mr. Arnyl Araneta - PBSP 18. Ms. Lanette Querobin - FDA

Day 6&7 Sept. 12 & 13

WEEKEND

Day 8 Sept. 14

9am-5pm 1. Drafting of procurement plan for new FDCs and syrups 1. Dr. Xiulei Zhang - EMP

Day 9 Sept. 15

9am-5pm 1. Presentation of procurement plan for new FDCs and syrups

2. Meeting with Phil. Paediatric Society

1. Dr. Xiulei Zhang - EMP 3. Dr. Celina Garfin - NTP 4. Ms. Princess Mangao - MSH 5. Ms. Kristine Padilla - NTP 6. Dr. Marl Mantala - TASC 7. Ms. Ghenimelle Pasumbal - NTP 8. Mr. Jover Francisco - NTP

1. Dr. Xiulei Zhang - EMP 2. Dr. Celina Garfin - NTP 3. Dr. Marl Mantala - TASC 4. Ms. Ghenimelle Pasumbal - NTP 5. Mr. Jover Francisco - NTP

Day 8 Sept. 16

9am-5pm 1. Debriefing 1. Dr. Xuilei Zhang - EMP 2. Mr. Erikson Balingit - NCRO 3. Ms. Zaza Munez - MSH 4. Princess Mangao - MSH 5. Jacqueline Hui - LMD 6. Shalala Almadora - WHO 7. Dr. Celine Garfin - NTP 8. Mr. Jover Francisco - NTP

9. Dr. Marl Mantala - TASC 10. Ms. Monic Coronado - NTP 11. Dr. Francisco Ogsimer - NTP 12. Mr. Jonathan Monis - BIHC 13. Ms. Maika Bagunu - BIHC 14. Ms. Kristine Padilla - NTP 15. Ms. Kris Lacanienta - COBAC 16. Ms. Minda Gugol - COBAC 17. Ms. Joyce Ceria - PD