Gambaran Pedoman

Pharmacovigilance Obat
Program ATM

Jarir At Thobari

Fac. Medicine
Universitas Gadjah Mada
 Pharmacovigilance
“The science and activities
relating to the detection,
assessment, understanding,
and prevention of adverse
effects or any other possible
drug related problem”

World Health Organization, The importance of pharmacovigilance: safety

monitoring of medicinal products. Geneva 2002
Pharmacovigilance
Major Aims

 early detection of unknown safety problems

 detection of increases in frequency
 identification of risk factors
 quantifying risks
 preventing patients from being affected
unnecessarily
Aims of PV in public health
programs
 Similar with major aim of PV
 Strengthening reporting system for serious
ADE for public health programs
 Identification prevalence of non-serious ADE
on for public health programs
 Building surveillance system (detection and
reporting adverse drug events)
Scope of Pharmacovigilance
Adverse (drug) event (AE/ADE)
 Any untoward medical occurrence in a
patient…administered a pharmaceutical
product and which does not necessarily have
a causal relationship with this treatment.
 Can be any sign, symptom, or abnormal lab
result temporally associated with a treatment.
What is most important?
Temporal association
Condition detected/ diagnosed after
study drug
Study drug start

4 days after drug given, stomach

ulcer is diagnosed
Serious Adverse Event

Any untoward medical occurrence that at any dose

 Results in death

 Is Life-threatening

 Requires inpatient hospitalisation or prolongation

of existing hospitalisation
 Results in persistent or significant disability/
incapacity
 Is a congenital anomaly/birth defect
Adverse Drug Reaction (ADR)
 All noxious and unintended responses to
a medicinal product related to any dose
should be considered adverse drug
reactions.
A causal relationship between a medicinal
product and the event is at least a
reasonable possibility, i.e. the relationship
cannot be ruled out.
PV Framework
Pharmacovigilance Methods
 Spontaneous reporting (passive
surveillance)
 Passive AE reporting by health professional
 Useful in identifying unexpected and rare AE
 No denominator of exposure
Pharmacovigilance Methods
 Active surveillance
 systematic approach to collect comprehensive ADE
data
 searching for exposures or events at sentinel site
facilities
 following up patients who have been exposed to
medicines of interest.
 More expensive than spontaneous reporting
 obtain a denominator of persons exposed to
medications of interest
 Active surveillance
 Cohort Event Monitoring
 Follow patients treated with a particular medicine and
collecting information on outcomes
 Registry
 Follow patients with the same characteristic(s): disease
registry, specific exposure (drug registry) or a type of
exposure on specific life event (pregnancy exposure
registry)
 also advocated for using registries to assess the safety
of anti malarial medicines
 Formal observational studies (case control and
cohort studies
Duration of Cohort
 For most medicines the duration of monitoring is
limited.
 It is determined by the length of treatment to be
monitored in individual patients, and the time it
takes to reach the desired cohort size.
 For TB therapy, treatment of individual patients
is monitored for a period that is considered to be
appropriate for the identification of both short-
and long-term effects
Pharmacovigilance public
health programs

 HIV/AIDS, tuberculosis, malaria, vaccinations

 the structure and organization of the existing
national systems will help determine how the
public health program pharmacovigilance efforts
should be designed and integrated.
 public health program’s system may provide a
model for the eventual establishment of a
national system.
Patients selection
 Patients might be recruited from selected
health facilities that are representative of the
whole country, designated as
monitoring/sentinel sites.
 From a practical point of view, monitoring
sites may be selected where there is high
incidence, good infrastructure, facilities, and
record-keeping.
Subgroup interests
 Children
 Patients with HIV/AIDS or another specific
co-morbidity
 Pregnancy
Acquiring data
 Patient information
 Medical record number
 Date of birth, Sex. BW, Height (BMI)
 History of significant illness (e.g. Liver/kidney disease)
 Other conditions present at the time of treatment
 Treatment details
 Compliance and effectiveness
 Reason for stopping
 Concomitants medicines
PHP ORGANIZATION
Others
Trachomatis
H.I.V
LEVEL
Tuberculosis
Malaria, filariasis
Vaccines
M
A
L
PUBLIC A
N HEALTH R
A
PROGRAMMES
I
T
I A
PROGRAMME MANAGERS
O
N
A
L

L LOCAL COORDINATOR FOR

HEALTH PROGRAMMES HEALTH WORKERS
O
C
A
L PATIENTS
 INTEGRATING PHP AND PV
FUNCTIONAL AND STRUCTURAL RELATIONSHIP

DRUG
REGULATORY
AUTHORITY
HIV / AIDS
Filariasis
Tuberculosis
Malaria
Vaccines Expert Safety Review PV Coordinator
NATIONAL PUBLIC Panel National PV centre
HEALTH
PROGRAMMES

SENTINEL/DISTRICT
INVESTIGATION
TEAM
PATIENTS PATIENTS
Health workers
Reporting Flow (Vaccine)
Menteri Kesehatan

Komnas PP-KIPI Ditjen PP & PL BPOM

Cq. Subdit Imunisasi
Produsen
Vaksin
Komda PP-KIPI Dinas Kesehatan Balai POM
Provinsi

Dinas Kesehatan Rumah Sakit

Kabupaten/Kota

Puskesmas
Memberikan laporan
Mengirimkan laporan
Pelacakan
Masyarakat
Koordinasi Komnas PP-KIPI
dan Komda PP-KIPI
Capacity Building
Capacity Building
1. Developing a functional and sustainable
 regulatory and organizational structure, operational
plan, and guidelines for pharmacovigilance and
medicine safety monitoring
2. Clearly defining the roles and responsibilities of
 expert advisory committees, DTCs, public health
programs, hospitals and clinics, health care providers
and professional associations, academic institutions,
pharmaceutical manufacturers, importers,
wholesalers and retailers, consumers, and media
Capacity Building
 Assuring that infrastructure and staffing needs are
fulfilled (starting with the sentinel pharmacovigilance
center)
 Helping personnel build new skills and
competencies (e.g., clinical pharmacy, active
surveillance methods)
 Institutionalizing appropriate tools (e.g., standard
operating procedures, reporting and communication
forms, job aids) to support improved data collection,
analysis, and reporting
Tanya Jawab
 Prop DKI, dr. Dicky
 Kegiatan ini disayangkan sudah dipenghujung MDG’s
 Pharmacovigiance bs diteruskan
 Dilakukan di beberapa layanan RS dan PKM
 19 satelit ARV PKM dan 20 ARV RS
 Cohort yang ada adalah cohort di RS
 Kasus: diketahui ada MDR, adanya RTL BPOM,
bentuk teknis nya seperti apa
 PV, TB01-TB013, SI AIDs/HIV
 Prov DKI
 Format register sendiri tidak menggunakan format
nasional (RSCM)
 HIV AIDS seumur hidup
 Bu Emil: Penyusunan pedoman (indikator):
 Adverse events
 AE yang meningkat frekuensi nya setelah pemberian
obat
 Interaksi obat 
 Compliance dan resistensi vs. gagal pengobatan
  Spontaneous reporting system vs. CEM
 System sub-sample registration (di pusdatin vital
statistics)  Realtime data
 ESO  pelaporan (tantangan dokumentasi)  praktis
dan sampel
 Sistem alur  sistem rujukan tidak jalan  tidak balik
ke PKM (langsung ke RS)
 Pak Uji
 SRS (sample registration system)  Pak Alok (untuk
kematian untuk ATM)
 Health System Strengthening (PR ya ada di Pusdatin 
Sekjen) subresipeint lintar dirjen/departemen  BPOM
terlibat langsung karena fungsi nya sebagai center PV
dan logistiknya
 Apa yg bisa kita manfaatkan dari SRS?
 Basis nya dari PKM bekerjasama dengan PEMDA
kependudukan, petugas PKM yg secara proaktif melihat
penyebab kematiannya.
 SIGDA dan SIGNAS (koordinasi dengan pusdatin, dengan
mengundang dengan pak Alok)
 Strengthening dokter anak  sosialisasi dan mobilisasi
dokter anak
  Sentinel di dua propinsi (KIPI)
 ATM (kita perlu identifikasi pasien-pasien ATM dirujuk
ke RS mana (rise awareness)
 Bu Ardiani (BinFar)
 Sejalan dengan teman2 di RS, salah satu tupoksi
(adanya akreditasi 2012), mewajibkan pelaporan
MESO
 Sentinel nya nyambung dengan site yg sudah
akreditasi