surveillance and clinical research of diseases caused by ... · surveillance and clinical research...
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Surveillance and Clinical Research of Diseases Caused by Immunization
at Sulianti Saroso IDH, Jakarta
Vivi Lisdawati, MSi., Apt., PhD.Director of Research
Sulianti Saroso IDH, DG of HS, MoH RoINovember 13 , 2019
Tokyo, Japan
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Sulianti SarosoInfectious Diseases Hospital
Surveillance of Diseases Caused by Immunization at Sulianti Saroso IDH
Clinical Research / Clinical Trial at Sulianti Saroso IDH
Halal Certification for Drugs and Pharmaceutical Supplies in Indonesia
Material Transfer Agreement (MTA) Regulation
Ministry of Health : Strategic Plans for 2020-2024
OUTLINE
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INDONESIA
1. MEGA BIODIVERSITY2. HOT SPOTS of ZOONOSIS
3. VARIOUS TROPICAL INFECTIOUS DISEASE4. HIGH POPULATION
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DISEASES OUTBREAKS 20..
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Sea portAir port
Ground crossingSea port
National
International
Outbreak
Outbreak
Outbreak
IHR (2005)- Reducing the risk of disease
circulation.- Prevent, detect, assess, report
and respond action.
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100 GENERAL HOSPITAL OF INFECTIOUS DISEASES NETWORKS
RSU:14
Nasionansi561
Districs
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ADRESS:JL. BARU SUNTER PERMAI RAYANorth Jakarta. 14340.
8
Surface area ± 4 HA = 0.04 Km2
Building area
± 1.6HA = 0.016 Km2
LOCATION
SULIANTI SAROSO IDH
(Referral Hospital for ERID in Indonesia)
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Hospital Profile Technical Unit of the Ministry of Health, RoI. Specific Hospital for Infection Diseases, Class A Type
with National Accreditation (SNARS ED.1) Teaching Hospital (AHS – UI) 156 beds
Ruang Isolasi
9
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2016 2017 2018No Diseases No Diseases No Diseases1 Animal Bites 1 Animal Bites 1 Animal Bites
2 Foot injury 2 Foot injury 2 Foot injury
3 Fever 3 Hand injury 3 Hand injury
4 Hand injury 4 Fever 4 Dyspepsia
5 DHF 5 Gastroenteritis 5 Fever
6 Gastroenteritis 6 Dyspepsia 6 Abdominal Pain
7 Gastritis 7 Abdomen pain 7 GED
8 Dyspepsia 8 HIV 8 ISPA
9 Tuberculosis 9 ISPA 9 Asthma
10 Abdomen pain 10 Tuberculosis 10 Headache
10 most cases at emergency unityear 2016 - 2018
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2016 2017 2018
No DISEASES No DISEASES No DISEASES1 HIV 1 HIV 1 HIV2 Tuberculosis 2 Tuberculosis 2 Tuberculosis3 ISPA 3 ISPA 3 Other Primary Gonarthosis
4Ear diseases & Prosesus Mastoid 4
Ear diseases & Prosesus Mastoid 4 ISPA
5 Pneumonia 5 GED 5Chronic Obstructive Pulmonary Disease
6 GED 6
Bronkitis, Emfisema & Others Obstructive Pulmonary Diseases 6 GED
7 Gastritis 7 Pneumonia 7 Pneumonia8 Urinary Tract Infection 8 Urinary Tract Infection 8 Otitis Media9 Faringitis 9 Faringitis 9 Urinary Tract Infection10 DHF 10 Dermatitis 10 Pulpitis
10 most infectious Disease cases at outpatient unit year 2016 - 2018
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2016 2017 2018No Disease No Diseases No Disease1 HIV 1 HIV 1 HIV2 DHF 2 Dispepsia 2 GED
3 Tuberculosis 3 Tuberculosis 3Chronic Obstructive Pulmonary Disease
4 GED 4 GED 4 Tuberculosis5 Gastritis 5 Pneumonia 5 ISPA6 Pneumonia 6 ISPA 6 Typhoid Fever7 Sepsis 7 Urinary Tract Infection 7 Difteri8 Typhoid Fever 8 Typhoid Fever 8 DHF9 ISPA 9 DHF 9 Pneumonia10 Urinary Tract Infection 10 Sepsis 10 Urinary Tract Infection
10 most infectious Disease cases at inpatient unit year 2016 – 2018
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Surveillance , Infection Prevention & Control Health Promotion, Collaboration human-animal animal early warning
Epidemiological InvestigationSpecimen Collection/shipmentAssess need and resourcesInterpret laboratory resultTake a decision
Implement control strategiesCoordination, Media Surveillance, laboratorySocial interventionCase management, IPCPhysiological supportEthical IssuesLogisticEnvironment
Evaluation outbreak management & Documentation
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Early Warning and Response Systems (EWRS)
Server EWRSMoH
SMS
Central/Surveillance
Provinces
Districts
alert
alert
alert
Epidemiology Investigation in
the Field
Laboratory
Verification/ Validation
Feedback
Province
District
Feedback
Primary Health Care sends EWRS SMS reports every week to the server
USING TEXT MESSAGES
alert
Source: PHEIC Office
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EWARS form PHC by SMS gateway
EWRS
Source: PHEIC Office
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Surveillance system in HMIS SS-IDH( WAG and application e-SURETRIPSS )
EWARS form PHC / PHO by WAG
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SURVEILLANCEEPIDEMIOLOGY of DCI FLOWCHART at SS-IDH
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DATA UTILIZATION
PLANNING FOR SUPPLIES
PLANNING FOR QUALITY SERVICES
PLANNING FOR R & D
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MEASLES SURVEILLANCE
Jan Feb Mar Apr Mei Juni Juli Agust Sept Okt Nov Des Total2015 2 4 1 1 3 4 2 1 0 2 5 0 252016 4 6 15 13 20 12 2 7 5 3 1 3 912017 1 0 1 1 1 0 1 1 0 0 0 0 62018 0 1 0 0 0 0 0 0 0 0 0 0 1
0
10
20
30
40
50
60
70
80
90
100
Jum
lah
Measles Case Trends by Month at the Inpatient InstallationYear 2015-2018
0
20
40
60
80
100
2015 2016 2017 2018
24
87
5 11 4 1 0
Number of Measles Cases by Age Group at the Inpatient Installation, Year 2015-2018
Anak Dewasa
0
10
20
30
40
50
2015 2016 2017 2018
15
45
4 110
46
2 0
Number of Measles Cases by Gender at the Inpatient Installation,
Year 2015-2018
Laki-Laki Perempuan
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TETANUS SURVEILLANCE
0
5
10
15
20
2015 2016 2017 2018
17
12
64
Tetanus Case Trends by Yearat the Inpatient Installation, Year 2015-2018
0
5
10
15
2015 2016 2017 2018
5 52
0
12
74 4
Number of Tetanus Cases by Age Groupat the Inpatient Installation, Year 2015-2018
Anak (≤18 thn) Dewasa (>18 thn)
0
5
10
15
2015 2016 2017 2018
14
11
0
43
1
6
0
Number of Tetanus Cases by Genderat the Inpatient Installation, Year 2015-2018
Laki-Laki Perempuan
0123456
0
2
1
2 2
1 1 1
0 0
1
6
2 2
0
3
1
0 0
2
1 1
0 00
1
0
2 2
0 0
1
0 0 0 00
1
0 0
3
0 0 0 0 0 0 0
Number of Tetanus Cases by Patients Domicile at the Inpatient Installation, Year 2015-2018
2015
2016
2017
2018
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0 1 2 5 2 0 1 0 0 3 1 1 4 3 2 1 2 2 2 8 1 2 5 5 6 4 3 1 3 3 3 4 9 7 6
211
604639
1715141528
19201114
-50
0
50
100
150
200
250
Jan
Feb
Mar Apr
Mei
Jun
Jul
Agt
Sept
Okt
Nov
Des Jan
Feb
Mar Apr
Mei
Jun
Jul
Agt
Sept
Okt
Nov
Des Jan
Feb
Mar Apr
Mei
Jun
Jul
Agt
Sept
Okt
Nov
Des Jan
Feb
Mar Apr
Mei
Jun
Jul
Agt
Sept
Okt
Nov
Des
2015 2016 2017 2018
Trends of Diphtheria Case in Inpatient Installation, Year 2015-2018
0
50
100
150
200
250
300
2015 2016 2017 2018
16 31
174 187
0 6
86111
1637
260298
Number of Diphtheria Cases by Age Group in Inpatient Installation, Year 2015-2018
Anak (≤ 18 thn) Dewasa ( > 18 thn) Total
2015 2016 2017 2018Laki-laki 9 23 138 150Perempuan 7 14 122 148Total 16 37 260 298
923
138 150
7 14122
148
16
37
260298
0
50
100
150
200
250
300
350
Tota
l
Number of Diphtheria Cases by Genderin Inpatient Installation, Year 2015-2018
0 50 100 150 200 250
Luar Bodetabek
Depok
Kota Tangerang Selatan
Kab. Tangerang
Kota Tangerang
Kab. Bogor
Kota Bogor
Kab. Bekasi
Kota Bekasi
Jakarta Selatan
Jakarta Barat
Jakarta Timur
Jakarta Pusat
Jakarta Utara
1458
2327
2367
1273
5184
60116
89210
Number of Diphtheria Cases by Patients Domicile in Inpatient Installation, Year 2015-2018
DIPHTHERIA SURVEILLANCE
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Outcome of Diphtheria
DeceaseSurvive
January – October 2018
5,8 %
94,2 %
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Percentage of Measles Immunization in IndonesiaYear 2007-2016
Source: Indonesian Health Profile 2017
= Data Program
= Data Health National Survey
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COVERAGE OF TT5 IMMUNIZATION ON ELIGIBLE WOMAN IN INDONESIA YEAR 2016
Source: Indonesian Health Profile 2017
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DROP OUT NUMBERS of DPT / HB1-Measles IMMUNIZATION IN BABYYEAR 2007-2016
Source: Indonesian Health Profile 2017
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Coverage of Basic Immunization In Baby By Province Year 2016
Source: Indonesian Health Profile 2017
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Vaccination Issues in Indonesia
1. Anti-Immunization Movement: Back to nature Limited access Religion
2. Incomplete immunization.
3. Pros and cons of “HALAL” vaccine.
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LAWS OF THE REPUBLIC INDONESIANUMBER 33 YEAR 2014 REGARDING
HALAL PRODUCT GUARANTEE
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2019
Government Regulation Number 31 Year 2019: Regulation of Implementation of Law Number 33 / 2014
regarding Halal Product Guarantee; As of October 17, 2019, Law 33 of 2014 concerning Halal
Product Guarantee was officially enacted; One of the mandates of this Act is the establishment of the
Halal Product Guarantee Agency (BPJPH) as a halal certificate issuing body and all food and cosmetics products circulating in Indonesia for Muslims must be halal-certified.
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http://www.halalmui.org/mui14/index.php/main/go_to_section/58/1366/page/1
HAS 23000:
Priority Covered:
food beverage products,
cosmetics, medicines, and other products
on stage
HALAL ISSUE
The UlamaCouncil of Indonesia
(MUI)
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http://www.halalmui.org/mui14/index.php/main/go_to_section/58/1366/page/1
HALAL ISSUE
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CLINICAL RESEARCH / CLINICAL TRIALat SS IDH
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Institutional Ethics
Committee
Critical point of the assessment elements
in the SNARS ed.1 accreditation
standards
the Flowchart of Ethical Clearance
Submission at Ethics
Committee in SS-IDH
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National Health Insurance Partnership Policy
National Health
Insurance Agency (BPJS)
Health Facilities
with National
Accreditation (KARS) Hospital:
SNARS Ed.1
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CLINICAL RESEARCH / CLINICAL TRIAL
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38
Monitoring Clinic for Clinical Research / Clinical Trial
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Method's Development for Early Detection of TB in HIV Patient
AHS – UI MoU / IA
Collab with
Clinic Mon Unit
DataAnalysis activities
60% process
volunteers Enrolled
Research Network with
5 PHCOperational Research
Retrosp.Research
Basic data
Prospective Research
(OR)
Collab with
MR Unit
CRUactivities
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Diagnostic Kit Development for Early Detection of Hep-B
AHS – UI MoU / IA
Collab with
Clinic Mon Unit
Collab Data
Analysis
80% process
volunteers Enrolled
Research Network with
5 PHCClinical Trial non
Intervension
Lab Test
Basic data
from ITB Univ.
Prospective Research
(CR)
MoUIA
CRUactivities
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the Flowchart of Clinical Trial Submission
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Legal Basis for the Protection of Biological Materials
Law NO 18/2002 regarding the National System of Research and Development;
Law Number 36 Year 2009 regarding Health; Government Regulation Number 39 Year 1995 article 6 regarding
Health Research and Development. Government Regulation 41/2006 regarding Licensing Conducts Research
and Development Activities for Foreign Universities (PTA), Foreign Research and Development Institutions (LPPA), Foreign Business Entities (BUAs) and Foreigners (OA) and the Application of Science and Technology;
Minister of Health Regulation No. 657 / 2009 regarding the delivery and use of clinical specimens, biological material and information content (to overseas).
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LAWS OF THE REPUBLIC INDONESIANUMBER 11 /2O19 regarding NATIONAL SYSTEM OF KNOWLEDGE & TECHNOLOGY
FOREIGN RESEARCHERS IN THE LAW OF THE REPUBLIC
OF INDONESIA NUMBER 11 / 2O19 regarding NATIONAL SYSTEM OF KNOWLEDGE &
TECHNOLOGY
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ANNOTATIONS
1. Network and Partnership: Article 72 of Law 11/20192. Licensing: Article 75 of Law 11/20193. Ethical Feasibility: Article 39 of Law 11/20194. Foreign Research Obligations: Article 76 of Law 11/20195. Mandatory Submission and Obligatory to Save Primary Data: Article 40 of
Law 11/20196. Material Transfer (MTA): Article 40 of Law 11/2019 for Health Research
related with Regulation of the Minister of Health of the Republic of Indonesia No.657/Menkes/Per/VIII/2009 regarding Delivery and use of clinical specimens, biological material and information content.
7. Supervision: Article 91 paragraph (2) of Law 11/2019 8. Administrative Sanctions: Article 92 of Law 11/20199. Criminal Sanctions: Article 93 of Law 11/2019
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Criminal Sanctions: Article 93 of Law 11/2019
1. In the event that a foreigner as referred to in Article 92 again violates conducting Research, Development, Study, and Application of Science and Technology in Indonesia without permission, shall be liable to a maximum fine of Rp.4,000,000,000.00 (four billion rupiah).
2. In addition to the principal crime as referred to in paragraph (1), an additional criminal offense may be subjected to in the form of a prohibition to obtain a research permit in the territory of the Republic of Indonesia for a maximum period of 5 (five) years.
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CHALLENGE 0r OPPORTUNITY
1. Research Contracta. Pharmaceutical Company – CRO - Siteb. Benefit – Sharing
2. Central Lab at Overseas Central lab. In Indonesia
3. IPR Part of international concerne : Nagoya Protocol / Standard
Material Transfer Agreement (SMTA) as Resolution at WHA 62/2009.
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EX.
MTA FORM
TYPE 3 - RESEARCH PURPOSE
www.mta.litbang.depkes.go.id
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STRATEGIC PLANNING HEALTH DEVELOPMENTFOR 2020-2024
(HEAD OF PLANNING AND BUDGET BUREAUGENERAL SECRETARIAT, MINISTRY OF HEALTH)
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arigatōgozaimashita