Establishment and Application of an Index System for the Risk of Drug Shortages in China: Based on Delphi Method and Analytic Hierarchy Process

Document Type : Original Article

Authors

1 Department of Pharmacy, Xiangya Hospital, Central South University, Changsha, China

2 National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, Central South University, Changsha, China

3 Hunan Drug Shortage Surveillance and Early Warning Center, Changsha, China

4 The Hunan Institute of Pharmacy Practice and Clinical Research, Changsha, China

5 Department of Pharmacy Practice, College of Pharmacy and Health Sciences, Western New England University, Springfeld, MA, USA

6 Department of Epidemiology and Health Statistics, XiangYa School of Public Health, Central South University, Changsha, China

7 Department of General Surgery, Xiangya Hospital, Central South University, Changsha, China

Abstract

Background 
At present, the avoidance of drug shortages mainly relies on expert experience. This study aimed to establish an evaluation index system for the risk of drug shortages in medical institutions in China and to apply the system to guide the graded management of drugs in short supply.

Methods 
A two-round Delphi process was conducted to determine the indicators in the index system. The weight value of each indicator was calculated using analytic hierarchy process (AHP) methods. The data of drugs in short supply from January 1 to December 31, 2020 in Hunan province were collected and evaluated using this index system. The evaluation scores, which ranged from 0 to 100, were calculated.

Results 
A three-level index system with four first-level indicators, 11 second-level indicators, and 36 third-level indicators was constructed by the two rounds of the Delphi process. The expert authority coefficient (Cr) of the first and second rounds of consultation were 0.88 and 0.90, respectively. The Kendall’s coefficients of concordance (Kendall’s W) for the two rounds of consultation were 0.44 and 0.50, respectively (P < .05). For the first-level indicators ‘supply stability,’ ‘causes of shortage,’ ‘medicine availability in medical institution’ and ‘pharmaceutical properties,’ the weight values were 0.3253, 0.2489, 0.2398, and 0.1860, respectively. Based on the risk evaluation score, drugs (dosage strength) at high risk of shortage included sodium thiosulfate (0.64 g), posterior pituitary lobe hormones (1 mL:6 IU), protamine sulfate (5 mL:50 mg), thrombin (500 U), urokinase (10 WU), and rotundine sulfate (2 mL:60 mg).

Conclusion 
An indexed system for the risk assessment of drug shortages in China was established to guide the graded response to drug shortages in medical institutions and the implementation of differential management strategies to address these shortages.

Keywords

References

  1. Iyengar S, Hedman L, Forte G, Hill S. Medicine shortages: a commentary on causes and mitigation strategies. BMC Med. 2016;14(1):124. doi:1186/s12916-016-0674-7
  2. Schwartzberg E, Ainbinder D, Vishkauzan A, Gamzu R. Drug shortages in Israel: regulatory perspectives, challenges and solutions. Isr J Health Policy Res. 2017;6:17. doi:1186/s13584-017-0140-9
  3. Gray A, Manasse HR Jr. Shortages of medicines: a complex global challenge. Bull World Health Organ. 2012;90(3):158-158a. doi:2471/blt.11.101303
  4. Fox ER, McLaughlin MM. ASHP guidelines on managing drug product shortages. Am J Health Syst Pharm. 2018;75(21):1742-1750. doi:2146/ajhp180441
  5. Musazzi UM, Di Giorgio D, Minghetti P. New regulatory strategies to manage medicines shortages in Europe. Int J Pharm. 2020;579:119171. doi:1016/j.ijpharm.2020.119171
  6. Fox ER, Birt A, James KB, Kokko H, Salverson S, Soflin DL. ASHP guidelines on managing drug product shortages in hospitals and health systems. Am J Health Syst Pharm. 2009;66(15):1399-1406. doi:2146/ajhp090026
  7. Acosta A, Vanegas EP, Rovira J, Godman B, Bochenek T. Medicine shortages: gaps between countries and global perspectives. Front Pharmacol. 2019;10:763. doi:3389/fphar.2019.00763
  8. The American Society of Health-System Pharmacists. Drug Shortages Statistics. https://www.ashp.org/Drug-Shortages/Shortage-Resources/Drug-Shortages-Statistics. Accessed July 17, 2020.
  9. Food and Drug Administration. FDA Drug Shortages. https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm. Accessed July 17, 2020.
  10. Hunan Public Resources Trading Service Platform. Drug shortages Reports. http://jyjy.hnsggzy.com/. Accessed July 17, 2020.
  11. Shi Y, Yang P, Li X, et al. Combating drug shortages in China: surveillance warning and practice standardization. Int J Clin Pharm. 2020;42(2):309-314. doi:1007/s11096-020-00987-5
  12. National Health Commission of the People's Republic of China. Notice of the National Health Commission on the monitoring of drug use and comprehensive clinical evaluation. http://www.nhc.gov.cn/yaozs/pqt/201904/31149bb1845e4c019a04f30c0d69c2c9.shtml. Accessed August 16, 2020.
  13. National Health Commision of the People's Republic of China. National Health Commission technical guide for classifcation and grading of drug shortages in medical institutions. http://www.nhc.gov.cn/yaozs/s7653/201907/495842935554402baf6470a7c6244343/files/cebbe102b9b54f2283cedc62aae04749.pdf. Accessed July 20, 2020.
  14. National Health Commission of the People's Republic of China. Regulations for national list of drugs in shortage (trial version). http://www.nhc.gov.cn/yaozs/s7655g/202004/f1cbe67ec7ef4c228ed2290946745d04/files/1ab369dd5c7544f792ae9e08f27056a4.pdf. Accessed July 16, 2020.
  15. Health Commission of Yunnan province. Drug shortage list of Yunan province of 2020 (the first issue). http://ynswsjkw.yn.gov.cn/wjwWebsite/web/doc/UU152341528561864802. Accessed September 3, 2020.
  16. Health Commission of Ningxia Hui Autonomous Region. Drug shortage list of Ningxia Hui autonomous region of 2020. http://wsjkw.nx.gov.cn/info/1040/18687.htm. Accessed September 3, 2020.
  17. Health Commission of Shanxi province. The list of drugs in shortage and the key monitoring list of drugs that are clinically necessary and vulnerable to shortage of Shanxi province (issue 2). http://wjw.shanxi.gov.cn/gsggl08/26506.hrh. Accessed September 3, 2020.
  18. Health Commission of Guizhou province. The list of drugs in shortage (issue 3) and the key monitoring list of drugs that are clinically necessary and vulnerable to shortage (issue 1) of Guizhou province. http://www.gzhfpc.gov.cn/xwzx_500663/tzgg/202006/t20200617_61146538.html. Accessed September 3, 2020.
  19. Health Commission of Guangxi Zhuang Autonomous Region. Drug shortage list of Guangxi Zhuang Autonomous Region (issue 2). http://wsjkw.gxzf.gov.cn/zfxxgk_49572/wsjszh/yzgl_49605/t5237736.shtml. Accessed September 3, 2020.
  20. Health Commission of Hainan province. Drug shortage list of Hainan province. http://wst.hainan.gov.cn/swjw/xxgk/0200/0202/202007/t20200703_2813602.html. Accessed September 3, 2020.
  21. National Health Commission of the People's Republic of China. Notice on the issurance of the national list of drugs in shortage. http://www.nhc.gov.cn/yaozs/s7653/202012/f30aad8ec4ba48a9afa2e559f4d20e7c.shtml. Accessed December 31, 2020.
  22. Shang CC. Establishment of Index System for the Risk of Essential Drug Shortages. Beijing: Beijing University of Chinese Medicine; 2017.
  23. The State Council. Suggestions on further stabilizing the supply and price of drugs in shortage. http://www.nhc.gov.cn/bgt/gwywj2/201910/7d2b39c6f68d46bd82f184731de80dcc.shtml. Accessed July 20, 2020.
  24. Jünger S, Payne SA, Brine J, Radbruch L, Brearley SG. Guidance on Conducting and REporting DElphi Studies (CREDES) in palliative care: recommendations based on a methodological systematic review. Palliat Med. 2017;31(8):684-706. doi:1177/0269216317690685
  25. Clough S, Shehabi Z, Morgan C. Medical risk assessment in dentistry: use of the American Society of Anesthesiologists Physical Status Classification. Br Dent J. 2016;220(3):103-108. doi:1038/sj.bdj.2016.87
  26. Lei L, Richards JS, Li ZH, Gong YF, Zhang SZ, Xiao N. A framework for assessing local transmission risk of imported malaria cases. Infect Dis Poverty. 2019;8(1):43. doi:1186/s40249-019-0552-6
  27. Saaty TL. The Analytic Hierarchy Process: Planning, Priority Setting, Resource Allocation. Pittsburgh: RWS Publications; 1996.
  28. Miller GA. The magical number seven plus or minus two: some limits on our capacity for processing information. Psychol Rev. 1956;63(2):81-97.
  29. Drug Classification and Procurement System of Hunan Province. Report of drug shortage, 2020. https://jyjy.hnsggzy.com/. Accessed August 16, 2020.
  30. Chen S, Wang M, Chen L, et al. Development of an indicator system to evaluate nursing safety and quality in ICU. Chin J Nurs. 2014;49(3):270-274.
  31. Whitfield D, Bosson N, Habrat D, et al. Critical medication shortages: effective strategies to maintain continuous medication availability for emergency medical services. Prehosp Emerg Care. 2020;24(2):290-296. doi:1080/10903127.2019.1619001
  32. Serena T, Bates-Jensen B, Carter MJ, et al. Consensus principles for wound care research obtained using a Delphi process. Wound Repair Regen. 2012;20(3):284-293. doi:1111/j.1524-475X.2012.00790.x
  33. Riggs WE. The Delphi technique: an experimental evaluation. Technol Forecast Soc Change. 1983;23(1):89-94. doi:1016/0040-1625(83)90073-2
  34. Schmidt K, Aumann I, Hollander I, Damm K, von der Schulenburg JM. Applying the analytic hierarchy process in healthcare research: a systematic literature review and evaluation of reporting. BMC Med Inform Decis Mak. 2015;15:112. doi:1186/s12911-015-0234-7
  35. Scala NM, Rajgopal J, Vargas LG, Needy KL. Group decision making with dispersion in the analytic hierarchy process. Group Decis Negot. 2016;25(2):355-372. doi:1007/s10726-015-9445-7
  36. Pi HY, Peng PP, Su QQ, Wang YL, Tang JP, Zhang J. A study on long-term care of quality evaluation index system for disabled elderly. Chin J Nurs. 2018;53(9):1110-1114.
  37. National Health Commission of the People's Republic of China. China Health Statistics Yearbook 2019. Beijing: Peking Union Medical College Press; 2019:6-8.
  38. Du C, Zhu H, Fang Y. Institutional complementarities and differences in pharmaceutical circulation systems between foreign countries and China. Finance & Trade Economic. 2015;(4):109-120.
  39. Huang RQ, Li F. Research on the construction of selection index system of drug shortage list based on analytic hierarchy process. Chinese Journal of Health Policy. 2020;13(6):8-13.
International Journal of Health Policy and Management
Volume 11, Issue 12
December 2022
Pages 2860-2868

Files

History

  • Receive Date: 14 May 2021
  • Revise Date: 18 February 2022
  • Accept Date: 23 February 2022
  • First Publish Date: 26 February 2022

Share

How to cite

Statistics