HAEMOVIGILANCE dan LOOK BACK

sebagai Persyaratan GMP

Seminar
“HEMOVIGILANCE DALAM PELAYANAN DARAH”

Siti Asfijah Abdoellah

Kasubdit Surveilan dan Analisis Risiko PT dan PKRT
Direktorat Pengawasan Distribusi PT dan PKRT, Badan POM
 HAEMOVIGILANCE dan LOOK
BACK sebagai Persyaratan GMP

Siti Asfijah Abdoellah

Kasubdit Surveilan dan Analisis Risiko PT dan PKRT
Direktorat Pengawasan Distribusi PT dan PKRT, Badan POM
Outlines
• Pengantar tentang Badan POM
• Pengawasan Keamanan Obat Beredar: Farmakovigilans
• Haemovigilance: WHO Guideline
• WHO Global Database for Adverse Reaction Reports of
Blood Products
• Haemovigilance dalam Peraturan Kepala Badan POM ttg
CPOB di UTD dan Pusat Plasmaferesis
• Rencana Pengembangan Haemovigilance System di
Indonesia
• Kesimpulan dan Penutup
BADAN POM
PERATURAN PRESIDEN
No. 80 Tahun 2017

Badan POM RI mempunyai

Tugas Pemerintahan di Bidang Pengawasan Obat dan Makanan

PENGUATAN KELEMBAGAAN BADAN POM

FUNGSI STRATEGIS DALAM PERLINDUNGAN DAN PENINGKATAN KUALITAS HIDUP

MASYARAKAT INDONESIA DAN UNTUK MENDUKUNG DAYA SAING NASIONAL, DAN
DALAM RANGKA PENINGKATAN EFEKTIVITAS PENGAWASAN OBAT DAN
MAKANAN
VISI
Obat dan Makanan Aman Meningkatkan
Kesehatan Masyarakat dan Daya Saing Bangsa

MISI

1. Meningkatkan sistem pengawasan Obat dan

Makanan berbasis risiko untuk melindungi
masyarakat
2. Mendorong kemandirian pelaku usaha dalam
memberikan jaminan keamanan Obat dan
Makanan serta memperkuat kemitraan dengan
pemangku kepentingan
3. Meningkatkan kapasitas kelembagaan Badan POM

5
 PENGAWASAN PRA-PEMASARAN DAN
PASCA-PEMASARAN

KEGIATAN PRE MARKET KEGIATAN POST MARKET

Pengembangan Konsistensi Mutu
produk :  Pemeriksaan Sarana
Pemenuhan
Formulasi, CPOB Prod. dan Dist.
Stabilitas, BA,  Sampling dan
BE Pengujian
Konsistensi Keamanan:
Efikasi, Pharmacovigilance
Admin Dossier  Monitoring ESO/Surveilan KIPI
Keamanan
/ Farmakovigilans Obat program
dan Mutu ATM
 Pemantauan Implementasi
Farmakovigilans oleh IF
 Risk Management Approaches
Evaluasi
Produk Konsistensi Informasi
 Monitoring
Penandaan
 Was Iklan/Promosi
Izin Edar
 APAKAH FARMAKOVIGILANS ITU?

PHARMACOVIGILANCE
(WHO 2002)
Pharmakon
(Greek) = Medical The science and activities relating to the
Substances detection, assessment, understanding and
prevention of adverse effects or any other
drug-related problem

(suatu keilmuan dan aktivitas tentang deteksi,

pengkajian (assessment), pemahaman dan
pencegahan efek samping atau masalah
Vigilia (Latin) =
lainnya terkait dengan penggunaan obat)
To keep watch
Deteksi Dini (ESO, Interaksi Obat, peningkatan frekuensi ESO,
faktor risiko)

Assessment on long term safety

Study of potential risk group of population (children, elderly,

pregnant women)

Analisis benefit/risk (rasio manfaat-risiko), sehingga dapat

dilakukan risk control yang tepat

8
BADAN POM
BAGAIMANA CARA MELAPORKAN?

Electronic base / Online reporting: e-MESO

Yellow Form

pv-center@pom.go.id Link: http://e-meso.pom.go.id/

 FORM PELAPORAN MESO
(Form Kuning)
1. Informasi
Pasien

2.Informasi
Efek Samping

4.Informasi
Pelapor
3.Informasi
Obat

10 10
 JENIS KEJADIAN TIDAK DIINGINKAN DAN ATAU EFEK
SAMPING OBAT

SERIUS
 Kematian
 Mengancam jiwa
 Perawatan di RS
 Perpanjangan Perawatan di RS
 Menimbulkan kecacatan
 Kelainan bawaan sejak lahir
 Tambahan: Clinically medical important
11
 Pharmacovigilance Processes on Risk – Benefit
Assessment :
Risk Management approaches

Risk Detection/ Risk Risk Control/ Risk

Identification Assessment Minimization Communication

Signaling dari: Review/assessment Expert Panel Review: Communications

ICSRs; process of all data - Advisory Committee measures:
PSURs/PBRERs; and supporting of PV DDL/HCPL, Safety
Jurnals; Studies; evidences/scientific - National Committee Alerts, publish in
Global Issues documents to of Drug Evaluation website or ADRs
evaluate risk-benefit - Relevant Bulletin, Letters
balance clinicians/experts to Company
For recommendation of
appropriate regulatory
action
 HOW ABOUT
HAEMOVIGILANCE?
What is haemovigilance?
Haemovigilance is a set of surveillance procedures covering the
entire transfusion chain, from the donation and processing of
blood and its components, to their provision and transfusion to
patients and their follow-up. It includes the monitoring,
reporting, investigation and analysis of adverse events related
to the donation, processing and transfusion of blood, and taking
actions to prevent their occurrence or recurrence. (WHO)

Haemovigilance was established in the mid-1990s in response

to concerns regarding transfusion-transmitted viral infections.
Why haemovigilance is needed?
The transfusion of blood and blood products is a life-saving intervention.
Blood is a medical product of human origin.
There are risks of adverse events associated with the donation of blood
and its components, and with the transfusion of blood and blood products
to patients.
Adverse events include all reactions, incidents, near misses, errors,
deviations from standard operating procedures and accidents associated
with blood donation and transfusion.
Learning from adverse events and identifying system problems can drive
the introduction of measures to enhance the quality, safety, efficacy and
cost-effectiveness of blood and blood products as well as of the donation
and transfusion processes.
Quality System
Haemovigilance should be fully integrated into the quality systems of
all institutions involved with the blood and blood products supply
chain, including donation, testing, processing, inventory management,
storage and distribution, and clinical transfusion, to ensure donor and
patient safety at all levels.
Quality System
Within each organization that is responsible for elements of the transfusion
chain an effective quality (management) system should be in place. This
system should ensure consistent practice through the use of written
procedures and regular audit. A quality improvement cycle should be in place
producing demonstrable results through quality indicators.

In blood transfusion services there should be a comprehensive quality system

in place and haemovigilance should be embedded within this system.

In hospitals, transfusion committees should be in place to ensure appropriate

clinical use of blood, effective training of staff, and monitoring and evaluation
of clinical practice. The transfusion committee should oversee the
implementation of haemovigilance in the hospital, regularly review the results
and monitor the effectiveness of improvement measures.
Goals of Haemovigilance
The goal of haemovigilance is continuous quality improvement of the
transfusion chain through corrective and preventive actions to improve
donor and patient safety, improve transfusion appropriateness, and
reduce wastage.
At its core, a haemovigilance system resembles any continuous quality
improvement cycle and shows the same elements and activities.
As such, haemovigilance should be embedded into every step of the
transfusion chain, and into every organization that has responsibility for
a part of that chain.
Improve Donor and Patient Safety
Haemovigilance systems can improve donor and patient safety by:
• identifying trends in adverse events and reactions;
• determining root causes and raising awareness;
• providing evidence for the development and amendment of policies
to improve practices;
• guiding research;
• functioning as a rapid alert and early warning of emerging risks;
• achieving and demonstrating improvement.
Characteristic of Successful Haemovigilance System

From an organizational perspective:

 an efficient, adequately resourced and sustainable national system, involving all

relevant stakeholders;
 non-punitive environment and based on a learning culture;
 confidentiality (the source of submitted data being protected);
 an integral part of the quality system of health care establishments,
encompassing the entire transfusion chain;
 traceability from the blood donor and blood unit to recipient and vice versa,
allowing adverse events to be tracked and investigated, and corrective action to
be implemented;
 standards and definitions in line with international recommendations;
 education and training;
 feedback reporting to the stakeholder community.
Characteristic of Successful Haemovigilance System
From an operational perspective:
• simple to use;
• clear and standardized reporting forms;
• written standard procedures to initiate, investigate and coordinate
reports;
• timely reporting of trends with expert analysis and recommendations
for improvement to minimize rates of occurrence or recurrence;
• mechanisms to monitor the implementation of corrective and
preventive actions in a timely manner and to demonstrate improved
safety and clinical outcomes.
TRACEABILITY
Traceability describes the ability to reliably follow the information trail from donor to recipient and vice
versa in a timely manner. Traceability is essential to ensure the ability to recall at-risk products, to
identify recipients of non-conforming products that may require additional follow-up, and to fully
investigate adverse events.

The key elements of traceability are:

 a system to uniquely identify each donor, donation (together with its associated samples
and blood components) and recipient;
 a system for record keeping throughout the transfusion pathway that captures the
identifiers at each stage and maintains necessary linkages;
 documentation of the actual administration of blood components to the intended recipient
or of their final disposal;
 secure methods for transcription of critical data to ensure accuracy;
 system for information storage capable of retaining traceability records for long periods
(e.g. European Union directives require traceability for 30 years from time of donation and
transfusion);
 procedures that assist staff in following the traceability path (e.g. standard operating
procedures to support look-back activity).
HAEMOVIGILANCE IN THE DONATION AND
PROVISION OF BLOOD AND BLOOD PRODUCTS
The haemovigilance system should address the detection,
identification, documentation and reporting of adverse events,
including the following:
events occurring before, during and after the donation of blood or
blood components;
release of non-conforming products;
significant deviations from protocols;
errors and near misses;
adverse reactions with blood products delivered by the blood
transfusion service.
HAEMOVIGILANCE IN THE DONATION AND
PROVISION OF BLOOD AND BLOOD PRODUCTS
The system should ensure the thorough investigation and
documentation of adverse events and should include root cause
analysis and corrective and preventive actions as part of a continuing
improvement cycle.

The blood transfusion service should maintain close links with the
hospitals (hospital blood bank, transfusion safety officers, transfusion
committee, treating clinicians) they serve, and the blood transfusion
service should provide assistance to hospitals in the investigation of
adverse events.
HAEMOVIGILANCE IN CLINICAL TRANSFUSION
(Hospital)
The haemovigilance system should address the detection, identification,
documentation and reporting of adverse events occurring in the hospital,
including the following:
errors in the collection and testing of blood samples;
errors in the identification of patients;
inappropriate use of blood products (e.g. accidental overtransfusion);
incorrect blood product transfused;
significant deviations from protocols;
near misses;
adverse reactions associated with the transfusion of blood products.
HAEMOVIGILANCE IN CLINICAL TRANSFUSION
(Hospital)
The system should include root cause analysis and corrective and
preventive actions as part of a continuing improvement cycle.

The transfusion committee (every hospital should have the transfusion

committee) should maintain close links with the blood transfusion
service that provides the blood products, so that investigation of
adverse events can be efficient and timely measures can be initiated to
prevent transfusion of related blood products.
NATIONAL HAEMOVIGILANCE ACTIVITY

Within a national framework, the responsibilities of a national haemovigilance office include:

 putting in place mechanisms for data collection, validation and analysis, publication and
dissemination of reports, development of recommendations and monitoring implementation;
 receiving adverse event reports from blood transfusion services and hospitals;
 reviewing reports to ensure the quality of reporting;
 identifying trends and investigating underlying causes;
 providing expert guidance to address root causes and improve safety;
 identifying improvements in the processes of the transfusion chain;
 improving education in haemovigilance;
 producing an annual national haemovigilance report;
 possible development of a rapid alert and early warning platform to communicate and share
information;
 linkage interfacing with other relevant national systems, regional schemes and international
activities;
 periodic review, monitoring and evaluation of the haemovigilance system.
Standard Reporting Form
Reporting should be performed using a standard form, either by a
paper or electronic system. A two-stage method of adverse event
reporting may be used, in which an initial short report is submitted,
followed by a more detailed report when investigations are completed.

Adverse event reports to the national system should not include

information that could identify the patient, donor, reporter or any
other individual involved, but should include a unique identifier
enabling the national haemovigilance coordinator to request further
details if necessary.
Standard Reporting Form
The adverse event report should include:
a description of the adverse event or near miss;
a graded assessment of the clinical outcome (from no reaction or
minor signs to death, i.e. the severity);
an assessment of the probability that the adverse event was caused
by the transfusion (i.e. the imputability);
information on action taken by the blood centre or hospital.
RAPID ALERT SYSTEMS
The haemovigilance system may include a rapid alert or early warning
mechanism for the rapid dissemination of information on important
events, emerging hazards or trends. Such a system should not replace
urgent notification to the blood centre of adverse events requiring
immediate action, e.g. post-transfusion sepsis or blood bag defects.
 Preferred term Count
Pyrexia 208
1 190 ICSRs Chills 187
(Blood (synonym for Blood, whole)) Pruritus 91
Rash 91
Urticaria 91
Dyspnoea 60
Hepatitis C 53
Hypotension 48
Hypersensitivity 47
Anaphylactic reaction 38
Transfusion reaction 35
Injection site reaction 33
Death 30
Vomiting 23
Product quality issue 22
TOP 20 Chest pain 20
Headache 18
Sepsis 17
Phlebitis 16
Rash erythematous 15
 Bagaimana dengan
Haemovigilance di Indonesia?
 PERATURAN KEPALA BADAN POM RI NO. 10 TAHUN 2017 TENTANG
PENERAPAN PEDOMAN CARA PEMBUATAN OBAT YANG BAIK DI UNIT
TRANSFUSI DARAH DAN PUSAT PLASMAFERESIS

Bab 2 Personalia

Butir 2.3.e :
Kepala UTD dan Pusat Plasmaferesis bertanggungjawab untuk menjamin
ketersediaan sistem manajemen mutu dan sistem hemovigilans di UTD dan
Pusat Plasmaferesis

Glosarium :
Sistem Hemovigilans adalah sistem yang menjamin ketertelusuran dan
pemberitahuan tentang kejadian dan reaksi serius yang tidak diinginkan
 PERATURAN KEPALA BADAN POM RI NO. 10 TAHUN 2017 TENTANG
PENERAPAN PEDOMAN CARA PEMBUATAN OBAT YANG BAIK DI UNIT
TRANSFUSI DARAH DAN PUSAT PLASMAFERESIS

LOOK - BACK

1.39 Sistem tertulis tersedia untuk melaksanakan prosedur look-back. Proses ini
hendaklah dapat menelusur kembali produk yang diambil dari donor ke resipien
akhir dan dari resipien kembali ke donor, dan sebaiknya menggunakan
database komputer.

1.40 SPO tersebut hendaklah diikuti apabila ditentukan secara retrospektif bahwa
donasi darah atau plasma semestinya disisihkan dari pengolahan, misal, kantong
diambil dari donor yang ditolak karena hasil pemeriksaan virusnya reaktif,
berperilaku risiko tinggi atau risiko lain terkait dengan penyakit menular (look-back
donor).
 PERATURAN KEPALA BADAN POM RI NO. 10 TAHUN 2017 TENTANG
PENERAPAN PEDOMAN CARA PEMBUATAN OBAT YANG BAIK DI UNIT
TRANSFUSI DARAH DAN PUSAT PLASMAFERESIS

LOOK - BACK

Bila donor telah dikonfirmasi memiliki penyakit yang menular melalui produk darah atau memiliki
1.41
perilaku risiko tinggi, donor hendaklah dikeluarkan secara permanen dari donasi darah selanjutnya.
Semua kantong darah dari donor tersebut hendaklah ditelusuri dan tidak digunakan atau dibuat lebih
lanjut, kecuali telah kedaluwarsa dan telah dimusnahkan. Bila kantong darah donor telah digunakan
atau diproses lebih lanjut, hendaklah tersedia prosedur untuk menetapkan tindakan yang tepat.
Notifikasi dan konseling terhadap donor direkomendasikan untuk tujuan kesehatan donor dan
keamanan suplai darah.

1.42 Hendaklah tersedia proses untuk menyelidiki laporan dugaan reaksi transfusi pada resipien, untuk
mengidentifikasi potensi keterlibatan donor (look-back resipien). Donor yang terlibat dalam
penularan penyakit atau membahayakan resipien hendaklah tidak diperbolehkan untuk melakukan
donasi darah lagi. Semua kantong darah lain dari donor yang terlibat hendaklah ditelusuri dan
komponen darahnya dikeluarkan dan ditarik dari penyimpanan, walaupun belum melewati tanggal
daluwarsa.
 PERATURAN KEPALA BADAN POM RI NO. 10 TAHUN 2017 TENTANG
PENERAPAN PEDOMAN CARA PEMBUATAN OBAT YANG BAIK DI UNIT
TRANSFUSI DARAH DAN PUSAT PLASMAFERESIS

LOOK - BACK

1.43 Semua informasi pascadonasi darah hendaklah dicatat dan dijaga. Hendaklah
tersedia sistem untuk melakukan tindakan yang tepat dan cepat untuk
mengeluarkan produk yang belum kedaluwarsa dari distribusi untuk menjamin
keamanan resipien

1.44 Para resipien produk yang teridentifikasi dalam proses look-back hendaklah
diberi nasihat tentang risiko ketertularan penyakit dari produk yang berpotensi
terkontaminasi dan hendaklah ditawarkan untuk dilakukan pengujian terhadap
penanda penyakit, konsultasi dan perawatan medis, jika ada indikasi.
Mengenai plasma yang digunakan untuk fraksionasi, pabrik fraksionasi plasma
hendaklah diberitahukan bila ada kasus look-back.
INITIATION OF HAEMOVIGILANCE SYSTEM IN
INDONESIA

IMPLEMENTATION

DISSEMINATION

FINALIZATION

PUBLIC
CONSULTATION
DRAFTING
HAEMOVIGILANCE
GMP REGULATION GUIDELINE

2017 2018 - .......

KESIMPULAN DAN SARAN
 Pasca diterbitkannya Peraturan tentang GMP atau CPOB untuk Produk
Darah, perlu dilanjutkan dengan pengembangan peraturan atau pedoman
untuk Haemovigilance

 Dalam mengembangkan Haemovigilance System di Indonesia, semua

stakeholder terkait (UTD, Pusat Plasmaferesis, BPOM, KEMKES,
ASOSIASI PROFESI KESEHATAN, RUMAH SAKIT, dan lainnya) perlu
terlibat aktif untuk menjamin bahwa pelayanan produk darah dilaksanakan
dengan standard yang tinggi untuk menjamin donor and patient safety

 Selama masa pengembangan, perlu dipikirkan dan dibuat suatu mekanisme

sementara untuk melaksanakan Haemovigilance dengan mengacu ke
Pedoman WHO dan benchmark ke Negara lain yang sudah bagus
Haemovigilance Systemnya

 Haemovigilance merupakan tanggung jawab bersama dan membutuhkan

dukungan komitmen semua pihak
 Pusat Farmakovigilans Nasional
Direktorat Pengawasan Distribusi Produk
Terapetik dan PKRT
Badan Pengawas Obat dan Makanan
Jl. Percetakan Negara NO. 23
Jakarta Pusat, 10560

Email: pv-center@pom.go.id
Subsite: http://e-meso.pom.go.id