The Effect of Unannounced Inspection on Prevention of Drug Fraud

Manman Zhang , Juliang Zhang , T.C.E. Cheng , Guowei Hua , Xiaojie Yan , Yi Liu

Journal of Systems Science and Systems Engineering ›› 2019, Vol. 28 ›› Issue (1) : 63 -90.

PDF
Journal of Systems Science and Systems Engineering ›› 2019, Vol. 28 ›› Issue (1) : 63 -90. DOI: 10.1007/s11518-018-5382-8
Article

The Effect of Unannounced Inspection on Prevention of Drug Fraud

Author information +
History +
PDF

Abstract

Alarge number of incidents related to fake/inferior-quality drugs have occurred in China in recent years. In order to reduce drug crimes, the China Food and Drug Administration (CFDA) has exploited the new supervision approach, i.e., unannounced inspection (UI), since September 2014. However, the effectiveness of UI in driving drug producers to put more effort into meeting the requirements of Good Manufacturing Practice (GMP) is yet to be ascertained. In this paper we apply game theory to study the effects of UI on the prevention of drug fraud, drug producers’ profits, and social welfare under scenarios of complete and incomplete information. We show that UI is not always an effective way of supervision. Specifically, if the upper bound on the punishment is not very large, UI can drive the firmto make the largest self-supervision effort only when the firm’s technical level is high and the supervision cost is low. Otherwise, UI cannot drive the firm to make the largest self-supervision effort. Under incomplete information, firms with a high technical level would adopt more self-supervision and make more profit than those with a low technical level. Moreover, we design a new mechanism under incomplete information that can incentive drug producers to make greater self-supervision effort to meet the requirements of GMP under certain conditions.

Keywords

Drug supervision / healthcare system / game theory / Nash equilibrium / incomplete information / mechanism design

Cite this article

Download citation ▾
Manman Zhang, Juliang Zhang, T.C.E. Cheng, Guowei Hua, Xiaojie Yan, Yi Liu. The Effect of Unannounced Inspection on Prevention of Drug Fraud. Journal of Systems Science and Systems Engineering, 2019, 28(1): 63-90 DOI:10.1007/s11518-018-5382-8

登录浏览全文

4963

注册一个新账户 忘记密码

References

[1]

Anis AH, Wen Q. Price regulation of pharmaceuticals in Canada. Journal of Health Economics, 1998, 17(1): 21-38.

[2]

Avenhaus R, Canty MJ. Inspection games, 2012.

[3]

Babich V, Tang CS. Managing opportunistic supplier product adulteration: Deferred payments, inspection, and combined mechanisms. Manufacturing and Service Operations Management, 2012, 14(2): 301-314.

[4]

Badri MA, Davis D, Davis D. A study of measuring the critical factors of quality management. International Journal of Quality and Reliability Management, 1995, 12(2): 36-53.

[5]

Baiman S, Fischer PE, Rajan MV. Information, contracting, and quality costs. Management Science, 2000, 46(6): 776-789.

[6]

Baiman S, Fischer PE, Rajan MV. Performance measurement and design in supply chains. Management Science, 2001, 47(1): 173-188.

[7]

Balachandran KR, Radhakrishnan S. Quality implications of warranties in a supply chain. Management Science, 2005, 51(8): 1266-1277.

[8]

Becker GS. Crime and punishment: an economic approach. Journal of Political Economy, 1968, 76(2): 169-217.

[9]

Border KC, Sobel J. Samurai accountant:^A theory of auditing and plunder. The Review of Economic Studies, 1987, 54(4): 525-540.

[10]

Brocas I. Optimal regulation of cooperative R&D under incomplete information. The Journal of Industrial Economics, 2004, 52(1): 81-120.

[11]

Carbonari L, Atella V, Bhattacharya J. Pharmaceutical industry, drug quality and regulation–evidence from^US and Italy, 2010, CEIS Working Paper No. 138. Available at SSRN: https://ssrn

[12]

Chander P, Wilde LL. A general characterization of optimal income tax enforcement. The Review of Economic Studies, 1998, 65(1): 165-183.

[13]

Chao GH, Iravani SMR, Savaskan RC. Quality improvement incentives and product recall cost sharing contracts. Management Science, 2009, 55(7): 1122-1138.

[14]

Chater A. FDA warns^RFID needed now to protect drug safety. Drug Store News, 2006, 28(17): 55

[15]

Chen J, 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.

[16]

Chen KH, Metcalf RW. The relationship between pollution control record and financial indicators revisited. Accounting Review, 1980, 55(1): 168-177.

[17]

China Food and Drug Administration. The Food and Drug Regulatory Statistical Yearbook 2013. Retrieved December 23, 2014, http: //samr.cfda.gov.cn/WS01/CL0108/111300.html.

[18]

China Food and Drug Administration. The Food and Drug Regulatory Statistical Yearbook 2014. Retrieved July 24, 2015, http: //samr.cfda.gov.cn/WS01/CL0108/125301.html.

[19]

China Food and Drug Administration. The track inspection result ofNorth China Pharmaceutical Group Xiantai Pharmaceutical. Retrieved March 29, 2016, http: //samr.cfda.gov.cn/WS01/CL1760/148787.html.

[20]

China Food and Drug Administration. Unannounced inspection status of Xiuzheng pharmaceutical group co., LTD. (Liuhe factory). Retrieved November 15, 2014, http: //samr.cfda.gov.cn/WS01/CL1760/109230.html.

[21]

Cockburn R, Newton PN, Agyarko EK, Akunyili D, White NJ. The global threat of counterfeit drugs: Why industry and governments must communicate the dangers. PLoS Medicine, 2005, 2(4): 302.

[22]

Damania R. Environmental controls with corrupt bureaucrats. Environment and Development Economics, 2002, 7(3): 407-427.

[23]

Danzon PM, Chao LW. Cross–national price differences for pharmaceuticals: How large, and why. Journal of Health Economics, 2000, 19(2): 159-195.

[24]

Danzon PM, Chao LW. Does regulation drive out competition in pharmaceutical markets. The Journal of Law and Economics, 2000, 43(2): 311-358.

[25]

Dechenaux E, Samue A. Announced vs. surprise inspections with tipping–off. European Journal of Political Economy, 2014, 34: 167-183.

[26]

Dechenaux E, Samuel A. Optimal fines under announced and surprise inspections. Journal of Public Economic Theory, 2016, 18(5): 786-801.

[27]

Dechenaux E, Samuel A. Regulatory inspection regimes and oligopoly competition, 2015, Available at SSRN: https: //ssrn.

[28]

Fisher FM, Temin P. Returns to scale in research and development: What does the schumpeterian hypothesis imply. Journal of Political Economy, 1973, 81(1): 56-70.

[29]

Goodman C, Kachur SP, Abdulla S, Bloland P, Mills A. 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.

[30]

Handley SM, Gray JV. Inter–organizational quality management: The use of contractual incentives and monitoring mechanisms with outsourced manufacturing. Production and Operations Management, 2013, 22(6): 1540-1556.

[31]

Harsanyi JC. Games with incomplete information played by "Bayesian" players, I–III: Part I. The basic model. Management Science, 1982, 14(3): 159-182.

[32]

Hengster P, Hermann M, Pirkebner D, Draxl A, Margreiter R. Islet isolation and^GMP, ISO 9001: 2000: What do we need–a 3–year experience. Transplantation Proceedings, 2005, 37(8): 3407-3408.

[33]

Henningfield JE, Schuster CR. Risk management and post–marketing surveillance of^CNS drugs, 2009, Drug and Alcohol Dependence 105(3): S56–S64.

[34]

Hsieh CC, Liu YT. Quality investment and inspection policy in a supplier–manufacturer supply chain. European Journal of Operational Research, 2010, 202(3): 717-729.

[35]

Hurwicz L, Reiter S. Designing Economic Mechanisms, 2006.

[36]

Innes R. Violator avoidance activities and selfreporting in optimal law enforcement. Journal of Law, Economics, and Organization, 2001, 17(1): 239-256.

[37]

Klimberg R, Revelle C, Cohon J. Improving the effectiveness of^FDA drug inspection. Operations Research, 1992, 40(5): 845-855.

[38]

Koh R, Schuster EW, Chackrabarti I, Bellman A. Securing the pharmaceutical supply chain. White Paper, Auto–ID Labs, 2003

[39]

Krysiak FC, Oberauner IM. Environmental policy à la carte: Letting firms choose their regulation. Journal of Environmental Economics and Management, 2010, 60(3): 221-232.

[40]

Laffont JJ, Tirole J. A Theory of incentives in procurement and regulation, 1993

[41]

Lapré MA, Mukherjee AS, Wassenhove LNV. Behind the learning curve: Linking learning activities to waste reduction. Management Science, 2000, 46(5): 597-611.

[42]

Leiderman DB. Risk management of drug products and the^US Food and Drug Administration: Evolution and context, 2009, Drug and Alcohol Dependence 105(3): S9–S13

[43]

Lim WS. Producer–supplier contracts with incomplete information. Management Science, 2001, 47(5): 709-715.

[44]

Malik AS. Self–reporting and the design of policies for regulating stochastic pollution. Journal of Environmental Economics and Management, 1993, 24(3): 241-257.

[45]

McClellan M. Fundamental improvements in drug safety for the 21st Century: Time for systematic, electronic infrastructure. AEI–Brookings Joint Center for Regulatory Studies, 2007

[46]

Miller FH. Adverse drug reactions, medical accidents, and patient safety. Boston Univ, 2007

[47]

Mookherjee D, Png I. Optimal auditing, insurance, and redistribution. The Quarterly Journal of Economics, 1989, 104(2): 399-415.

[48]

Myerson RB. Incentive compatibility and the bargaining problem. Econometrica, 1979, 47(1): 61-73.

[49]

Plambeck EL, Taylor T. 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.

[50]

Reyniers DJ, Tapiero CS. Contract design and the control of quality in a conflictual environment. European Journal of Operational Research, 1995, 82(2): 373-382.

[51]

Reyniers DJ, Tapiero CS. The delivery and control of quality in supplier–producer contracts. Management Science, 1995, 41(10): 1581-1589.

[52]

Rice JA. Preparing for an unannounced inspection: What to do when an inspector shows up. Environmental Progress, 1995, 14(3): 209-212.

[53]

Riley JG. Silver signals: Twenty–five years of screening and signaling. Journal of Economic Literature, 2001, 39(2): 432-478.

[54]

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

[55]

Rosen S. Authority, control, and the distribution of earnings. Bell Journal of Economics, 1982, 13(2): 311-323.

[56]

Sina. Beilu Pharmaceutical, Hansen Pharmaceutical and other pharmaceutical companies involved in the "chromium exceeded" event. Retrieved Jannuary 5, 2016, http: //finance.sina.com.cn/stock/s/2016–01–05/doc–ifxneept3710146.shtml.

[57]

Skreta V. Sequentially optimal mechanisms. Review of Economic Studies, 2006, 73(4): 1085-1111.

[58]

Sower VE, Savole MJ. Are acceptance sampling and^SPC complementary or incompatible. Quality Progress, 1993, 26(9): 85-89.

[59]

Spulber DF. Optimal environmental regulation under asymmetric information. Journal of Public Economics, 1988, 35(2): 163-181.

[60]

Srinidhi B, Balachandran KR. Strategic positioning and cost management along various quality dimensions. International Journal of Quality Science, 1996, 1(2): 8-25.

[61]

Starbird SA. Penalties, rewards, and inspection: Provisions for quality in supply chain contracts. Journal of the Operational Research Society, 2001, 52(1): 109-115.

[62]

Stratton SD. The application of lean thinking to pharmaceutical quality systems, defining the^FDA as the customer. Dissertation, California State University. Suzhou City Food and Drug Administration, 2004

[63]

Tzavara D, Héritier A. Quality and environmental regulation: Verifying compliance along the supply chain. Business and Politics, 2012, 14(2): 1-22.

[64]

International Society for Pharmaceutical Engineering. What is GMP. https: //www.ispe.org/initiatives/regulatoryresources/gmp/what–is–gmp.

[65]

Zhang MM, Zhang JL, Cheng TCE, Sallan JM, Hua GW. Which inspection approach is better to prevent drug fraud: announced or unannounced?, 2018.

AI Summary AI Mindmap
PDF

150

Accesses

0

Citation

Detail

Sections
Recommended

AI思维导图

/