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


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Articles in Press, Corrected Proof
Available Online from 26 February 2022
  • Receive Date: 14 May 2021
  • Revise Date: 18 February 2022
  • Accept Date: 23 February 2022
  • First Publish Date: 26 February 2022