Pentingnya Pharmacovigilance Obat Program PDF
Pentingnya Pharmacovigilance Obat Program PDF
Farmakovigilans Obat
Program ATM
Jarir At Thobari, MD, DPharm, PhD
Dept. Pharmacology & Therapy
Fac. Medicine, Universitas Gadjah Mada/
RSUP Dr. Sardjito
Reference: http://www.merck.com/mmhe/sec02/ch015/ch015e.html
Risk
No medicinal product is entirely or
absolutely safe for all people, in all places,
at all times. We must always live with
some measure of uncertainty.
30000 29037
25000
21591 21031 21511
20000
15534
15000
10362 9793
10000 8747
7195 6048 6907 7312
6073 6266
5184 4655 5114
5000 3665
1700
859
0
s.d. 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014*
700
300
200
100
0
2010 2011 2012 2013 2014*
HIV 0-4 tahun
* sd Juni 2014
Italian Main reasons of discontinuation
Cohort
of first HAART regimen within
I C O
N A 1st year: ICONA
Naive
Antiretroviral
Toxicity
Failure
Non-adherence
Other
Continued
1% Neuropathy
5% 0%
6% Lipodystrophy
30%
7%
Hepatitis
9% Nephrotoxicity
Lactic Acidosis
Lv X, Tang S, Xia Y, Wang X, et al. (2013) Adverse Reactions Due to Directly Observed Treatment Strategy Therapy in Chinese
Tuberculosis Patients: A Prospective Study. PLoS ONE 8(6): e65037. doi:10.1371/journal.pone.0065037
http://www.plosone.org/article/info:doi/10.1371/journal.pone.0065037
Causality assessment of adverse drug reactions due to directly observed treatment
strategy therapy*.
Lv X, Tang S, Xia Y, Wang X, et al. (2013) Adverse Reactions Due to Directly Observed Treatment Strategy Therapy in Chinese
Tuberculosis Patients: A Prospective Study. PLoS ONE 8(6): e65037. doi:10.1371/journal.pone.0065037
http://www.plosone.org/article/info:doi/10.1371/journal.pone.0065037
Influence of adverse drug reactions due to directly observed treatment strategy
therapy on anti-TB treatment pattern.
Lv X, Tang S, Xia Y, Wang X, et al. (2013) Adverse Reactions Due to Directly Observed Treatment Strategy Therapy in Chinese
Tuberculosis Patients: A Prospective Study. PLoS ONE 8(6): e65037. doi:10.1371/journal.pone.0065037
http://www.plosone.org/article/info:doi/10.1371/journal.pone.0065037
METHODS TO STUDY DRUG SAFETY
PROBLEMS
kecacatan permanen
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
Puskesmas
Memberikan laporan
Mengirimkan laporan
Pelacakan
Masyarakat
Koordinasi Komnas PP-KIPI
dan Komda PP-KIPI
Coordinating Centre
RESPONSIBILITIES
Health Authority
Promote National PV activity
Develop a risk management plan
Integrate PHP and PV
Promote policies for best practice
RESPONSIBILITIES
PV Coordinator at National PV centre
SEMUA KTD/ESO
Identifikasi
Management
SEMUA KTD/ESO
Mengumpulkan data laporan KTD/ESO dari fasyankes
SERIUS KTD/ESO
Monitor perkembangan pasien yang mengalami KTD/ESO serius
SEMUA KTD/ESO
Mengumpulkan data laporan KTD/ESO dari Dinkes Kab/Kota