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Pharmacovigilance program in Indonesia has been started and promoted by NADFC (National Agency for Drug and Food Control) as the national drug control authority. The main goal of pharmacovigilance program is not only to improve patient's safety of using drugs, but also to contribute towards the evaluation of benefit, danger, effectiveness and risks of using certain drugs, and also to encourage the safety, rationality, and effectiveness (including cost savings) of using drugs.

So far, the system that has been adopted in Indonesia concerning this activity is a spontaneous report delivered by health professionals using a yellow form which is a standard report of adverse drug reactions. It needs efforts to improve feedbacks because the reporting rate of spontaneous reporting system is still low compared to the number of population or the number of drugs distributed in Indonesia. To overcome these challenges, Indonesia has to strengthen they system and network of pharmacovigilance in all areas and healthcare facilities.

Based on what have been done, WHO once again offered its supports to NADFC to strengthen the program of pharmacovigilance in Indonesia by holding a workshop for health professionals with the theme of Strengthening Drug Safety Monitoring in Indonesia—National Pharmacovigilance Workshop from October 23 to October 25, 2017 in Bekasi. The workshop was attended by 135 participants consisting of hospitals and Community Health Centers in Sumatra, Java, and Bali, Health Department of DKI Jakarta (either Provincial Health Department or Public Health Service of DKI Jakarta), Health Department of Bekasi City, Health Department of Tanggerang City, and also Provincial Office of NADFC in Jakarta, Bandung, Semarang, Surabaya and Serang.

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In 2017, NADFC starts to conduct the supervision of the implementation of pharmacovigilance for HIV/AIDS, Tuberculosis, Malaria (ATM) drug programs. The supervision is conducted in order to implement Ministerial Decree of Ministry of Health Republic of Indonesia Number HK.02.02/ Menkes/164/2015 Date of April 30, 2015 on the Tryout of Pharmacovigilance for HIV/AIDS, Tuberculosis, Malaria (ATM) drugs at Healthcare service facilities. Those Healthcare service facilities conducting the tryouts according to the Decree are as follow:

AIDS PROGRAM

A.          DKI JAKARTA

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Pada tanggal 21 Agustus 2017, untuk kali ketiga Badan POM menyelenggarakan Workshop/Peningkatan Kompetensi Farmakovigilans bagi Tenaga Kesehatan di Rumah Sakit Pendidikan yaitu RS Universitas Sumatera Utara (USU), Medan.  Kegiatan ini dihadiri oleh high level management RS USU (Direktur Utama dan Direktur Pelayanan Medik & Keperawatan) dan tenaga kesehatan (dokter, apoteker, perawat) dari RS USU serta Kepala Balai Besar POM di Medan dan 4 orang staf.

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The NADFC held a Pharmacovigilance Competence Improvement Workshop for the healthcare professionals of the RSPAD Gatot Subroto on May 26, 2017 at Hotel Best Western Premier The Hive, Jakarta.  The workshop aimed at improving the health professionals’ (doctors, pharmacists, nurses) knowledge of pharmacovigilance and at improving their roles in monitoring and reporting drug side effects for patient safety as the ultimate target.

The workshop, which was attended by healthcare professionals from the RSPAD Gatot Soebroto and the NADFC, was officially opened by the Head of Surveillance and Risk Analysis of Therapeutic Product and Household Medical Supplies, Siti Asfijah Abdoellah, S.Si., Apt., M.Med.Sc. The opening was then followed by a presentation on “Pharmacovigilance and Patient Safety” by Jarir At Thobari, MD, MSc., Ph.D from the Faculty of Medicine, Gadjah Mada University (UGM).  The next presentation was “Pharmacovigilance Program in Indonesia” by Siti Asfijah Abdoellah, S.Si., Apt., M.Med.Sc.. The last presentation was “Monitoring and Reporting of Adverse Drug Reactions (ESO/ Efek Samping Obat) at the RSPAD Gatot Soebroto and Its Obstacles” by the Military Health Officer Lieutenant Colonel  drs. Sutarno, M.Si., Apt. as the Head of the Planning and Control of Medical Supplies Procurement Department (Kabagrendalada Bekkes) of  the RSPAD Gatot Soebroto.

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