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Journal of Systems Science and Complexity

, Volume 31, Issue 6, pp 1571–1590 | Cite as

Which Inspection Approach Is Better to Prevent Drug Fraud: Announced or Unannounced?

  • Manman Zhang
  • Juliang Zhang
  • T.C.E. Cheng
  • Jose Maria Sallan
  • Guowei Hua
Article

Abstract

In recent years, there are many crimes related drug fraud occuring in China and many experts think that the main cause is that China Food and Drug Administration (CFDA) adopts announced inspection (AI). In order to circumvent this difficulty, CFDA has exploited unannounced inspection (UI) since 2014. In this paper, the authors study the problem of which one performs better, AI or UI. Specifically, the authors consider a supervisor, which decides the inspection approach, inspection strength and punishment to force the firm to put self-inspection effort to meet the requirements of Good Manufacturing Practice, and a firm, which produces a drug and decides its self-inspection effort. The authors use game theory to model this problem, characterize the equilibrium policies under AI, and compare the effects of the two approaches on preventing drug fraud under complete and incomplete information. The results show that under the complete information, UI performs better if the firm’s technical level and the inspection cost are low and AI performs better otherwise. When the supervisor doesn’t know the firm’s technical level, if the low technical level is high, AI performs better. Otherwise, UI performs better if the inspection cost is low and AI performs better if the inspection cost is high.

Keywords

Drug inspection game theory healthcare incomplete information public policy 

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References

  1. [1]
    Zhang M M, Zhang J L, Cheng T C E, et al., The effect of unannounced inspection on prevention of drug fraud, Journal of Systems Science and Systems Engineering, https://doi.org/ 10.1007/s11518-018-5382-8, 2018.Google Scholar
  2. [2]
    Rosen S, Authority, control, and the distribution of earnings, Bell Journal of Economics, 1982, 13(2): 311–323.Google Scholar
  3. [3]
    Fisher F M and Temin P, Returns to scale in research and development: What does the schumpeterian hypothesis imply? Journal of Political Economy, 1973, 81(1): 56–70.Google Scholar
  4. [4]
    Chen K H and Metcalf R W, The relationship between pollution control record and financial indicators revisited, Accounting Review, 1980, 55(1): 168–177.Google Scholar
  5. [5]
    Badri M A, Davis D, and Davis D, A study of measuring the critical factors of quality management, International Journal of Quality and Reliability Management, 1995, 12(2): 36–53.Google Scholar
  6. [6]
    Srinidhi B and Balachandran K R, Strategic positioning and cost management along various quality dimensions, International Journal of Quality Science, 1996, 1(2): 8–25.Google Scholar
  7. [7]
    Chen J and Hu Q, Optimal payment scheme when the supplier’s quality level and cost are unknown, European Journal of Operational Research, 2015, 245(3): 731–742.MathSciNetzbMATHGoogle Scholar
  8. [8]
    What can we see from the violations of Sichuan Shuzhong Pharmaceutical? http://www.china daily.com.cn/hqcj/2011-05/23/content 12560926.htm, 2011.Google Scholar
  9. [9]
    Tongrentang’s drug was recalled in Hong Kong due to mercury exceeded five times, but falsely claimed that the drug was not produced by them to avoid responsibility, http://finance. sina.com.cn/consume/puguangtai/20130516/090315483719.shtml, 2013.Google Scholar
  10. [10]
    Hengster P, Hermann M, Pirkebner D, et al., Islet isolation and GMP, ISO 9001: 2000: What do we need a 3-year experience, Transplantation Proceedings, 2005, 37(8): 3407–3408.Google Scholar
  11. [11]
    Atella V, Bhattacharya J, and Carbonari L, Pharmaceutical industry, drug quality and regulation — Evidence from US and Italy, CEIS Working Paper No. 138, Available at SSRN: https://ssrn.com/abstract=1316805, 2008.Google Scholar
  12. [12]
    Rodriguez J, How to prepare for a systems-based inspection-understanding FDA’s risk-based inspections approach, Journal of GXP Compliance, 2005, 9(4): 14.Google Scholar
  13. [13]
    Cockburn R, Newton P N, Agyarko E K, et al., The global threat of counterfeit drugs: Why industry and governments must communicate the dangers, PLoS Medicine, 2005, 2(4): e100.Google Scholar
  14. [14]
    Goodman C, Kachur S P, Abdulla S, et al., Drug shop regulation and malaria treatment in Tanzania — Why do shops break the rules, and does it matter? Health Policy and Planning, 2007, 22(6): 393–403.Google Scholar
  15. [15]
    Handley S M and Gray J V, Inter-organizational quality management: The use of contractual incentives and monitoring mechanisms with outsourced manufacturing, Production and Operations Management, 2013, 22(6): 1540–1556.Google Scholar
  16. [16]
    Jia J and Zhao H, Mitigating the U.S. Drug shortages through pareto-improving contracts, Production and Operations Management, 2017, 26(8): 1463–1480.Google Scholar
  17. [17]
    Becker G S, Crime and punishment: An economic approach, Journal of Political Economy, 1968, 76(2): 169–217.Google Scholar
  18. [18]
    Polinsky A M and Shavell S, The theory of public enforcement of law, Nanjing Business Review, 2005, 1(1): 45–76.Google Scholar
  19. [19]
    Lazear E P, Speeding, terrorism and teaching to the test, The Quarterly Journal of Economics, 2006, 121(3): 1029–1061.Google Scholar
  20. [20]
    Kim S H, Time to come clean? Disclosure and inspection policies for green production, Operations Research, 2015, 63(1): 1–20.MathSciNetzbMATHGoogle Scholar
  21. [21]
    Gray J V, Anand G, and Roth A V, The influence of ISO 9000 certification on process compliance, Production and Operations Management, 2015, 24(3): 369–382.Google Scholar
  22. [22]
    Rui H and Lai G, Sourcing with deferred payment and inspection under supplier product adulteration risk, Production and Operations Management, 2015, 24(6): 934–946.Google Scholar
  23. [23]
    Yan X, Zhao H, and Tang K, Requirement or promise? An analysis of the first-mover advantage in quality contracting, Production and Operations Management, 2015, 24(6): 917–933.Google Scholar
  24. [24]
    Lee H and Li C, Supplier quality management: Investment, inspection, and incentives, Production and Operations Management, 2018, 27(2): 304–322.Google Scholar
  25. [25]
    Chen L and Lee H L, Sourcing under supplier responsibility risk: The effects of certification, audit, and contingency payment, Management Science, 2017, 63(9): 2795–2812.Google Scholar
  26. [26]
    Fiene R, Unannounced vs. announced licensing inspections in monitoring child care programs, Certification, 1996, 6: 1–6.Google Scholar
  27. [27]
    Zorn A, Lippert C, and Dabbert S, Supervising a system of approved private control bodies for certification: The case of organic farming in Germany, Food Control, 2012, 25(2): 525–532.Google Scholar
  28. [28]
    Bravo C P, Ramírez I V, Neuendorff J, et al., Assessing the impact of unannounced audits on the effectiveness and reliability of organic certification, Organic Agriculture, 2013, 3(2): 95–109.Google Scholar
  29. [29]
    Waters A B, Vanderslice J, Porucznik C A, et al., Examination of the association between announced inspection and inspection scores, Journal of Environmental Healthe, 2013, 76(2): 8–12.Google Scholar
  30. [30]
    Dechenaux E and Samuel A, Announced vs. surprise inspections with tipping-off, European Journal of Political Economy, 2014, 34(6): 167–183.Google Scholar
  31. [31]
    Dechenaux E and Samuel A, Regulatory inspection regimes and oligopoly competition, Social Science Electronic Publishing, 2016.Google Scholar
  32. [32]
    Dechenaux E, and Samuel A, Optimal fines under announced and surprise inspections, Journal of Public Economic Theory, 2016, 18(5): 786–801.Google Scholar
  33. [33]
    Plambeck E L, Taylor T A, and Zhang Q, Supplier evasion of a buyer’s audit: Implications for auditing and compliance with labor and environmental standards, Working Paper, Stanford University, 2012.Google Scholar
  34. [34]
    Plambeck E L and Taylor T A, Supplier evasion of a buyer’s audit: Implications for motivating supplier social and environmental responsibility, Manufacturing and Service Operations Management, 2016, 18(2): 184–197.Google Scholar
  35. [35]
    Wang S, Sun P, and Véricourt F D, Inducing environmental disclosures: A dynamic mechanism design approach, Operations Research, 2016, 64(2): 371–389.MathSciNetzbMATHGoogle Scholar
  36. [36]
    Hsieh C C and Liu Y T, Quality investment and inspection policy in a supplier-manufacturer supply chain, European Journal of Operational Research, 2010, 202(3): 717–729.zbMATHGoogle Scholar
  37. [37]
    Krysiak F C and Oberauner I M, Environmental policy `a la carte: Letting firms choose their regulation, Journal of Environmental Economics and Management, 2010, 60(3): 221–232.zbMATHGoogle Scholar
  38. [38]
    Balachandran K R and Radhakrishnan S, Quality implications of warranties in a supply chain, Management Science, 2005, 51(8): 1266–1277.zbMATHGoogle Scholar
  39. [39]
    Drug quality announcement (No.4, 2013), http://www.sda.gov.cn/WS01/CL1872/95069.html, 2013.Google Scholar
  40. [40]
    Koh R, Schuster E W, Chackrabarti I, et al., Securing the pharmaceutical supply chain, White Paper, Auto-ID Labs, Massachusetts Institute of Technology, 2003, 1–19.Google Scholar
  41. [41]
    Chater A, FDA warns RFID needed now to protect drug safety, Drug Store News, 2006, 28(17): 55.Google Scholar
  42. [42]
    McClellan M, Fundamental improvements in drug safety for the 21st Century: Time for systematic, electronic infrastructure, AEI-Brookings Joint Center for Regulatory Studies, Statement of testimony to the US Senate HELP Committee on March 14, 2007. http: //aei − brookings.org/admin/authorpdfs/redirectsafely.php?fname =../pdffiles/Testimony07 − 9topost.pdf, 2007.Google Scholar
  43. [43]
    Reske K A, Jenkins T, Fernandez C, et al., Beneficial effects of implementing an announced restaurant inspection program, Journal of Environmental Health, 2007, 69(9): 27–34.Google Scholar
  44. [44]
    Diamond H, Minimax policies for unobservable inspections, Mathematics of Operations Research, 1982, 7(1): 139–153.MathSciNetzbMATHGoogle Scholar
  45. [45]
    Eeckhout J, Persico N, and Todd P E, A theory of optimal random crackdown, American Economic Review, 2010, 100(3): 1104–1135.Google Scholar
  46. [46]
    The unannounced inspection result of Xiuzheng Pharmaceutical (Liuhe Plant), http://www.sda. gov.cn/WS01/CL1760/109230.html, 2014.Google Scholar
  47. [47]
    The track inspection result of North China Pharmaceutical Group Xiantai Pharmaceutical, http://www.sda.gov.cn/WS01/CL1760/148787.html, 2016.Google Scholar
  48. [48]
    Beilu Pharmaceutical, Hansen Pharmaceutical and other pharmaceutical companies involved in the “chromium exceeded” event, http://finance.sina.com.cn/stock/s/2016-01-05/docifxneept3710146. shtml, 2016.Google Scholar
  49. [49]
    Lim W S, Producer-supplier contracts with incomplete information, Management Science, 2001, 47(5): 709–715.zbMATHGoogle Scholar
  50. [50]
    Baiman S, Fischer P E, and Rajan M V, Information, contracting, and quality costs, Management Science, 2000, 46(6): 776–789.Google Scholar
  51. [51]
    Baiman S, Fischer P E, and Rajan M V, Performance measurement and design in supply chains, Management Science, 2001, 47(1): 173–188.zbMATHGoogle Scholar
  52. [52]
    Chao G H, Iravani S M R, and Savaskan R C, Quality improvement incentives and product recall cost sharing contracts, Management Science, 2009, 55(7): 1122–1138.zbMATHGoogle Scholar
  53. [53]
    Harsanyi J C, Games with incomplete information played by “Bayesian” players, I−III: Part I. The basic model, Management Science, 2004, 50(12): 1804–1817.Google Scholar

Copyright information

© Institute of Systems Science, Academy of Mathematics and Systems Science, Chinese Academy of Sciences and Springer-Verlag GmbH Germany, part of Springer Nature 2018

Authors and Affiliations

  • Manman Zhang
    • 1
  • Juliang Zhang
    • 1
  • T.C.E. Cheng
    • 2
  • Jose Maria Sallan
    • 3
  • Guowei Hua
    • 1
  1. 1.Department of Logistics Management, School of Economics and ManagementBeijing Jiaotong UniversityBeijingChina
  2. 2.Department of Logistics and Maritime StudiesThe Hong Kong Polytechnic University, Hung Hom, KowloonHong KongChina
  3. 3.Department d’Organizacio d’EmpresesUniversitat Politècnica de CatalunyaTerrassaSpain

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