Use of failure mode and effect analysis to reduce patient safety risks in purchasing prescription drugs from online pharmacies in China
BackgroundOnline pharmacies have gradually penetrated the market, but pose risks to patients' health. Failure Mode and Effect Analysis (FMEA) is an effective and reliable method for reducing pharmacy and medication risks. The purpose of this study was to conduct a prospective risk analysis of t...
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Frontiers Media S.A.
2022-07-01
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Series: | Frontiers in Medicine |
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Online Access: | https://www.frontiersin.org/articles/10.3389/fmed.2022.913214/full |
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author | Qinyuan Hu Qinyuan Hu Haiyao Hu Ming Hu Jun Zhang Liangwen Gou Shuping Shi Jingyi Zhou Naitong Zhou Zhen Huang |
author_facet | Qinyuan Hu Qinyuan Hu Haiyao Hu Ming Hu Jun Zhang Liangwen Gou Shuping Shi Jingyi Zhou Naitong Zhou Zhen Huang |
author_sort | Qinyuan Hu |
collection | DOAJ |
description | BackgroundOnline pharmacies have gradually penetrated the market, but pose risks to patients' health. Failure Mode and Effect Analysis (FMEA) is an effective and reliable method for reducing pharmacy and medication risks. The purpose of this study was to conduct a prospective risk analysis of the process of purchasing prescription drugs from online pharmacies in China to guarantee drug quality and patient safety.MethodsThe FMEA was performed at Sichuan University, China. A multidisciplinary team was assembled comprising a leader, four regulators, four pharmacists, two experts, etc. The process was composed of eight subprocesses: searching for prescription drugs, submitting medication requirements, completing patient information forms, dispensing, delivering, etc. Brainstorming was used to identify and prioritize failure modes, propose corrective actions, and reduce risks. Risk priority numbers were the main criterion and were obtained by multiplying three scores: severity, occurrence and detectability, which were scored by the team The team proposed corrective actions for each selected failure mode.ResultsA total of forty-one potential failure modes were identified, and the causes, effects, and corrective actions of the 30 top failure modes were analyzed. The highest risk value was assigned to “photocopies of paper prescriptions uploaded were reused by patients.” Three failure modes for the S value of 5 were: “drugs are eroded and polluted by moisture or insects in the process of transportation,” “the qualification information of the pharmacies were absent or fake,” and “pharmacists fail to check prescriptions in accordance with Prescription Administrative Regulation.” Of the top failure modes, 36.67% were from Step 5, delivering the drug. After taking corrective measures to control risks, the risks reduced by 69.26%.ConclusionThe results of this study proves that the FMEA is a valuable tool for identifying and prioritizing the risks inherent in online pharmacies. This study shows that there are many potential risks in the process of purchasing prescription drugs from online pharmacies, especially in the drug delivery stage. Enhanced training and the introduction of smart devices may minimize risks. Online pharmacies and Chinese regulators should consider these findings for risk mitigation and the improvement of regulations pertaining to online pharmacies. |
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spelling | doaj.art-f66934a7ef3b4a7a97614544e408fb5d2022-12-22T03:42:34ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2022-07-01910.3389/fmed.2022.913214913214Use of failure mode and effect analysis to reduce patient safety risks in purchasing prescription drugs from online pharmacies in ChinaQinyuan Hu0Qinyuan Hu1Haiyao Hu2Ming Hu3Jun Zhang4Liangwen Gou5Shuping Shi6Jingyi Zhou7Naitong Zhou8Zhen Huang9Key Laboratory of Drug-Targeting and Drug Delivery System of the Education Ministry and Sichuan Province, Sichuan Engineering Laboratory for Plant-Sourced Drug and Sichuan Research Center for Drug Precision Industrial Technology, West China School of Pharmacy, Sichuan University, Chengdu, ChinaAdministration for Market Regulation of Qionglai, Chengdu, ChinaWest China School of Medicine, Sichuan University, Chengdu, ChinaKey Laboratory of Drug-Targeting and Drug Delivery System of the Education Ministry and Sichuan Province, Sichuan Engineering Laboratory for Plant-Sourced Drug and Sichuan Research Center for Drug Precision Industrial Technology, West China School of Pharmacy, Sichuan University, Chengdu, ChinaAdministration for Market Regulation of Chengdu, Chengdu, ChinaKey Laboratory of Drug-Targeting and Drug Delivery System of the Education Ministry and Sichuan Province, Sichuan Engineering Laboratory for Plant-Sourced Drug and Sichuan Research Center for Drug Precision Industrial Technology, West China School of Pharmacy, Sichuan University, Chengdu, ChinaKey Laboratory of Drug-Targeting and Drug Delivery System of the Education Ministry and Sichuan Province, Sichuan Engineering Laboratory for Plant-Sourced Drug and Sichuan Research Center for Drug Precision Industrial Technology, West China School of Pharmacy, Sichuan University, Chengdu, ChinaKey Laboratory of Drug-Targeting and Drug Delivery System of the Education Ministry and Sichuan Province, Sichuan Engineering Laboratory for Plant-Sourced Drug and Sichuan Research Center for Drug Precision Industrial Technology, West China School of Pharmacy, Sichuan University, Chengdu, ChinaKey Laboratory of Drug-Targeting and Drug Delivery System of the Education Ministry and Sichuan Province, Sichuan Engineering Laboratory for Plant-Sourced Drug and Sichuan Research Center for Drug Precision Industrial Technology, West China School of Pharmacy, Sichuan University, Chengdu, ChinaAdministration for Market Regulation of Chengdu, Chengdu, ChinaBackgroundOnline pharmacies have gradually penetrated the market, but pose risks to patients' health. Failure Mode and Effect Analysis (FMEA) is an effective and reliable method for reducing pharmacy and medication risks. The purpose of this study was to conduct a prospective risk analysis of the process of purchasing prescription drugs from online pharmacies in China to guarantee drug quality and patient safety.MethodsThe FMEA was performed at Sichuan University, China. A multidisciplinary team was assembled comprising a leader, four regulators, four pharmacists, two experts, etc. The process was composed of eight subprocesses: searching for prescription drugs, submitting medication requirements, completing patient information forms, dispensing, delivering, etc. Brainstorming was used to identify and prioritize failure modes, propose corrective actions, and reduce risks. Risk priority numbers were the main criterion and were obtained by multiplying three scores: severity, occurrence and detectability, which were scored by the team The team proposed corrective actions for each selected failure mode.ResultsA total of forty-one potential failure modes were identified, and the causes, effects, and corrective actions of the 30 top failure modes were analyzed. The highest risk value was assigned to “photocopies of paper prescriptions uploaded were reused by patients.” Three failure modes for the S value of 5 were: “drugs are eroded and polluted by moisture or insects in the process of transportation,” “the qualification information of the pharmacies were absent or fake,” and “pharmacists fail to check prescriptions in accordance with Prescription Administrative Regulation.” Of the top failure modes, 36.67% were from Step 5, delivering the drug. After taking corrective measures to control risks, the risks reduced by 69.26%.ConclusionThe results of this study proves that the FMEA is a valuable tool for identifying and prioritizing the risks inherent in online pharmacies. This study shows that there are many potential risks in the process of purchasing prescription drugs from online pharmacies, especially in the drug delivery stage. Enhanced training and the introduction of smart devices may minimize risks. Online pharmacies and Chinese regulators should consider these findings for risk mitigation and the improvement of regulations pertaining to online pharmacies.https://www.frontiersin.org/articles/10.3389/fmed.2022.913214/fullFMEA analysisprescription drugsonline pharmacypatient safetyrisk reduction |
spellingShingle | Qinyuan Hu Qinyuan Hu Haiyao Hu Ming Hu Jun Zhang Liangwen Gou Shuping Shi Jingyi Zhou Naitong Zhou Zhen Huang Use of failure mode and effect analysis to reduce patient safety risks in purchasing prescription drugs from online pharmacies in China Frontiers in Medicine FMEA analysis prescription drugs online pharmacy patient safety risk reduction |
title | Use of failure mode and effect analysis to reduce patient safety risks in purchasing prescription drugs from online pharmacies in China |
title_full | Use of failure mode and effect analysis to reduce patient safety risks in purchasing prescription drugs from online pharmacies in China |
title_fullStr | Use of failure mode and effect analysis to reduce patient safety risks in purchasing prescription drugs from online pharmacies in China |
title_full_unstemmed | Use of failure mode and effect analysis to reduce patient safety risks in purchasing prescription drugs from online pharmacies in China |
title_short | Use of failure mode and effect analysis to reduce patient safety risks in purchasing prescription drugs from online pharmacies in China |
title_sort | use of failure mode and effect analysis to reduce patient safety risks in purchasing prescription drugs from online pharmacies in china |
topic | FMEA analysis prescription drugs online pharmacy patient safety risk reduction |
url | https://www.frontiersin.org/articles/10.3389/fmed.2022.913214/full |
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