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A Study on Drug Traceability in Pharmaceutical Supply Chain

제약 공급망에서 의약품 유통 이력추적에 관한 연구

  • Received : 2014.12.10
  • Accepted : 2015.01.10
  • Published : 2015.02.28

Abstract

Pharmaceutical companies over the world are exposed to risks of lessened sales and negative impact on corporate image due to circulation of counterfeit drugs, which eventually threatens safety of patients. thus, in order to eradicate distribution of counterfeit drugs, many countries are taking initiatives to legalize and set serialization through e-Pedigree, which is based on RFID technology or barcode system to track and trace distribution of drugs from point of manufacturing to usage. therefore, this study contemplates domestic and international management system of medical drugs and suggests application methods of e-Pedigree based on RFID technology that promotes safety of patients and distribution of drugs.

세계적으로 유통되고 있는 가짜의약품으로 인하여 제약사들은 판매수익과 기업브랜드 이미지에 큰 피해를 입고 있는 실정이고, 불법적으로 유통된 의약품이 복용 또는 투약된 환자(소비자)들은 생명에 위협을 받을 가능성이 점점 더 높아지고 있다. 이러한 가짜의약품의 유통을 근절시키기 위하여 세계 각국에서는 의약품의 생산에서부터 소비자에게 판매될 때까지 즉 의약품 유통과정을 추적하여 가시성있는 이력관리를 할 수 있도록 RFID 및 barcode 등 IT기반의 e-Pedigree(electronic pedigree)의 법제화 및 일련번호 관리제도를 도입하고 있다. 따라서, 본 연구에서는 국내 외 의약품 관리체계를 고찰하고 RFID 기반의 e-Pedigree 적용방안을 제시함으로써 국내 제약산업의 유통합리화와 이를 통한 소비자 안전성을 제고시키는데 그 목적이 있다.

Keywords

References

  1. Gunnar Senneset and Eskil Foras, "Challenges regarding implementation of electronic chain traceability," British Food Journal, Vol. 109, No. 10, pp. 805-818, 2007. https://doi.org/10.1108/00070700710821340
  2. Samuel Fosso Wamba, Abhijith Anand, Lemuria Carter, "A literature review of RFID-enabled healthcare applications and issues," International Journal of Information Management, Vol. 33, pp. 875-891, 2013. https://doi.org/10.1016/j.ijinfomgt.2013.07.005
  3. S.K. Kwok, S.L. Ting, Albert H.C. Tsang and C.F. Cheung, "A counterfeit network analyzer based on RFID and EPC," Industrial Management & Data Systems, Vol. 110, No. 7, pp. 1018-1037, 2010. https://doi.org/10.1108/02635571011069086
  4. Yongjung Choi, Daehee Han, Haejune Jeong, Woochul Han and Hyunsoo Kim, "The Evaluation of Effectiveness on RFID system based Logistics process," Journal of The Korea Society of Computer and Information, Vol. 15, No. 6, pp. 111-120, June 2010. https://doi.org/10.9708/jksci.2010.15.6.111
  5. Kwang NamGung, Yongjung Choi, "A Study on Introduction of e-Pedigree for eradicating Counterfeit Drugs in Pharmaceutical Industry," Proceedings of Korea Society of Computer Information, Vol. 20, No. 1, pp. 51-54, January 2012.
  6. Congress.gov (U.S), https://www.congress.gov/
  7. Remko van der Togt, Piet. J.M. Bakker and Monique W.M. Jaspers, "A framework for performance and data quality assessment of Radio Frequency IDentification (RFID) systems in health care settings," Journal of Biomedical Informatics, Vol.44, pp 372-383, 2011. https://doi.org/10.1016/j.jbi.2010.12.004
  8. Ministry of Health and Welfare(MW), http://www.mw.go.kr
  9. H.H. Cheung and S.H. Choi, "Implementation issues in RFID-based anti-counterfeiting systems," Computers in Industry, Vol. 62, pp. 708-718, 2011. https://doi.org/10.1016/j.compind.2011.04.001
  10. Ministry of Health and Welfare/Ministry of Food and Drug Safety, Pharmaceutical Affairs Law, March 2014.
  11. Korea Health Industry Development Institute(KHIDI), 2013 Pharmaceutical Industry Analysis Report, December 2013.
  12. Ministry of Food and Drug Safety(MFDS), Statistical yearbook of the food and drug, No. 12, 2010.
  13. Brain D. Finlay, "Counterfeit drugs and national security", STIMSON report, 2011.
  14. eMedico, http://www.emedico.co.kr
  15. World Health Organization (WHO), http://www.who.int
  16. Yakup.com, http://www.yakup.com
  17. Hankyung.com, http://kizmom.hankyung.com
  18. News1, http://news1.kr
  19. Korea Trade-Investment Promotion Agency (KOTRA), http://www.globalwindow.org
  20. Board of Pharmacy(CA), http://www.pharmacy.ca.gov
  21. Je-yong Son, A Study on the application of e-Pedigree to prevent distribution of counterfeit aircraft parts, Master thesis, Korea Aerospace University, 2013.
  22. Yongjung Choi, Jaegak Hwang, Marie Kim, Hyunsoo Kim, Taewoo Chang, Daehee Han and Haejune Jung, Specification of e-pedigree in Pharmaceutical Industry (TTAK.KO-06.0261), Telecommunication Technology Association (TTA) Standard, June 2011.
  23. Dongjin Kim, Hyunsoo Kim, Jongmin Lee and Junghoon Han, "Study on the amount of data associated with the application of the e-pedigree in pharmaceutical supply chain," Korean Journal of Logistics, Vol. 21, No. 3, pp. 107-120, September 2013. https://doi.org/10.15735/kls.2013.21.3.008
  24. Michael Paik, Jay Chen, Lakshminarayanan Subramanian, "Epothecary: cost-effective drug pedigree tracking and authentication using mobile phones," MobiHeld '09 Proceedings of the 1st ACM workshop on Networking, pp. 13-18, November 2009.
  25. Jack Stradley and Dale Karraker, "The Electric Part Supply Chain and Risks of Counterfeit Parts in Defense Applications," IEEE Transactions on Component and Packaging Technologies, Vol. 29, No. 3, September 2006.
  26. EPCglobal, Pedigree Ratified Standard ver1.0, January 2007.