Evaluation of CDOB Implementation as Quality Assurance System at PBF in Surabaya

  • VANNINA AGUSTINI UNIVERSITAS AIRLANGGA
  • WAHYU UTAMI UNIVERSITAS AIRLANGGA
  • WAHONO SUMARYONO UNIVERSITAS PANCASILA
  • UMI ATHIYAH UNIVERSITAS PANCASILA
  • ABDUL RAHEM UNIVERSITAS PANCASILA

Abstract

Good Pharmaceutical Distribution Practice is called as CDOB in Indonesia is a guidelines to ensure pharmaceutical product quality throughout the distribution chain..This guideline consist of nine aspects, and pharmaceutical wholesalers (PBF) are required to implement the principle in the guideline as part of compliance to the pharmaceutical wholesaler regulation. The purpose of this research is to assess the extent of the implementation of Good Pharmaceutical Distribution Practices in the pharmaceutical daily operation.This research is descriptive with random sampling technique to determine which pharmaceutical wholesalers to be selected. The samples were 41 pharmaceutical wholesalers in Surabaya and they were given questionnaire they need to answer.. The data were collected in the period of August until September 2015, where the CDOB certifi cation was not mandatory yet. According to data collected, results show that 40 out of 41 (97.56%) PBF do not possessed CDOB certifi cate. From 41 PBFs, 18 (43.90%) PBF has met ≥80% CDOB, 16 (39.02%) PBF has met ≥65 - <80% CDOB, 6 (14.63%) PBF met ≥ 50 - <65% CDOB and 1 (2.44%) PBF met <50% CDOB. There was 1 (2.44%) PBF never conduct a study of the quality management, 4 (9.76%) offi cial pharmacist of respective PBF had never attended CDOB’s training and 5 (12.20%) PBF all their personnel have not been trained CDOB, 5 (12.20%) PBF never check the registration number, there are 2 (4.88%) PBF rarely keep the appropriate medication storage temperature indicated on the drug packaging.Overall, it may be said that not all the PBF in Surabaya implemented 9 aspects of CDOB. This could aff ect directly or indirectly to the quality of pharmaceutical products they distributed. CDOB certifi cation however, just became mandatory in November 2017.

References

1. Quick DJ, Embrey M, Clack M, Olson C, Baraclogh A. MDS-3: Managing access to medicines and health technologies. Arlington, VA: Management sciences for health. part II: pharmaceutical management. 2012.

2. BBPOM Surabaya. Laporan tahunan Balai Besar Pengawas Obat dan Makanan di Surabaya tahun 2013. Surabaya; 2014.

3. Newton P N, F M Fernández, A Plançon, D C Mildenhall, M D Green, L Ziyong, E M Christophel, et al, A collaborative epidemiological investigation into the criminal fake artesunate trade in South East Asia. PLoS Medicine. 2008.5(2):e32.

4. Badan POM RI. Peraturan Kepala Badan Pengawas Obatdan Makanan Republik Indonesia Nomor HK.03.1.34.11.12.7542 tahun 2012 tentang pedoman teknis cara distribusi obat yang baik. Jakarta; 2012.

5. Badan POM RI. Keputusan Kepala Badan Pengawas Obatdan Makanan Republik Indonesia Nomor HK.00.05.3.2522 tahun 2003 tentang penerapan pedoman cara distribusi obat yang baik, Jakarta; 2003.

6. Kementrian Kesehatan RI. Peraturan Menteri Kesehatan RI No. 1148/MenkeS/Per/VI/2011 tentang pedagang besar farmasi, Jakarta; 2011.

7. Putra Anthonius Ade Purnama, HartiniYustina Sri, Implementasi cara distribusi obat yang baik pada pedagang besar farmasi di Yogyakarta. Jurnal Farmasi Indonesia. 2010. 6(1):48-54.

8. BBPOM Surabaya. Laporan tahunan Balai Besar Pengawas Obat dan Makanan di Surabaya tahun 2014. Surabaya; 2015.

9. Werther Jr., William B and Keith Davis. Human resources and personal management. Fifth Edition. 1996. New York: McGraw-Hill, Inc.

10. Mangkunegara, Anwar Prabu. Perencanaan dan pengembangan sumber daya manusia. 2003. Bandung :Refi ka Aditama.

11. World Health Organization. Technical suplement to WHO technical report series, No. 961. 2011. Temperature Mapping of Storage Area.

12. Suardi, Rudi. Sistem manajemen mutu ISO 9000:2000. Bandung: PT. Remaja Rosdakarya. 2001.

13. Vesper K H & Gartner W B. Measuring progress in enterpreunership education. This paper presented at the National Academy of Management Associating Meeting, Cincinnati, Ohio, 9-14 Agustus. 1996.
Published
2017-04-30
How to Cite
AGUSTINI, VANNINA et al. Evaluation of CDOB Implementation as Quality Assurance System at PBF in Surabaya. JURNAL ILMU KEFARMASIAN INDONESIA, [S.l.], v. 15, n. 1, p. 70-76, apr. 2017. ISSN 2614-6495. Available at: <http://jifi.farmasi.univpancasila.ac.id/index.php/jifi/article/view/458>. Date accessed: 25 feb. 2020.
Section
Articles