{"paper_id":"05de4527-dd35-4c26-8dcc-5678124e2803","body_text":"Proactive Risk Assessment Using Failure Mode and Effects Analysis in a Management Model of Anesthetic Drugs and Class I Psychotropic Drugs in Inpatient Pharmacy: A Pilot Project | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Article Proactive Risk Assessment Using Failure Mode and Effects Analysis in a Management Model of Anesthetic Drugs and Class I Psychotropic Drugs in Inpatient Pharmacy: A Pilot Project Lulu Zhang, Xiuling He, Yimeng Wang, Li Huang, Xiaoxia Du, Mingzhou Liu This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6090426/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 13 Aug, 2025 Read the published version in Scientific Reports → Version 1 posted 16 You are reading this latest preprint version Abstract Objctive: In China, anesthetic drugs and class I psychotropic drugs are among the most stringently managed special medications within medical institutions. In this study, we aimed to use Failure Mode and Effects Analysis (FMEA) to conduct a proactive risk assessment of management models for these drugs, addressing their unique management requirements. Methods: We established a multidisciplinary team and identified five main stages of the process. Each stage was divided into micro-activities to identify potential failure modes and their possible consequences. A risk priority number for each failure mode was calculated. Results: The management of anesthetic drugs and class I psychotropic drugs in inpatient pharmacy revealed 15 types of failure mode. The high-priority errors identified included patients' inability to receive medications in a timely manner and discrepancies between the number of empty ampules collected and dispensed, the latter of which could increase the management risks associated with these drugs. Conclusion: The FMEA method can be used to identify failures in the management of anesthetic drugs and class I psychotropic drugs and in the design and implementation of a targeted information management system integrating modern information technology. Health sciences/Health care Health sciences/Health occupations Health sciences/Risk factors Anesthetic drugs and Class I psychotropic drugs Failure mode and effects analysis Information management Medical institutions Introduction Special medications in China are classified and controlled according to their pharmacological characteristics. Anesthetic drugs and psychotropic drugs are legislated and managed separately from stimulants and precursors used for drug production, creating several relatively independent management systems with varying control measures that intersect but differ from each other 1 . In China, the classification of anesthetic and psychotropic drugs is straightforward, and control measures are relatively unified and managed according to whether the drugs are used for medicinal purposes. Regarding drugs listed in the directory, some can be produced, supplied, and used in China as specified, whereas others are subject to uniform and strict management across all stages, regardless of their addictive potential or potential harmfulness. Anesthetic drugs and class I psychotropic drugs are specially managed according to laws and regulations in China. These drugs have a dual nature; On the one hand, they are essential for clinical diagnosis and treatment owing to their strong analgesic and sedative effects. On the other hand, their non-standard and continuous use can lead to dependencies; if these drugs enter illegal channels, they can cause serious social harm and may even involve criminal activity 2 . The management of anesthetic and class I psychotropic drugs in medical institutions not only needs to comply with relevant laws, regulations, and administrative rules but also requires regular oversight by health administrative departments and drug regulatory authorities 3 . The \"Notice on strengthening the management of anesthetic drugs and class I psychotropic drugs in Medical Institutions,\" issued by national Health Commission of the People's Republic of China in September 2020, emphasized improving the level of information management for these drugs and strengthening their full-process management to achieve traceable, accountable management from source to destination. Nevertheless, proactive, referable information management processes are lacking, making information management for these drugs challenging. Additionally, it is necessary to stratify the risk according to management regulations and procedures for anesthetic drugs and class I psychotropic drugs. All the above factors expose these processes to a high risk of adverse events because it is estimated that nearly 50% of such events could be prevented via risk management policies, including proactive and reactive tools 4 . In this study, we explored management models for anesthetic drugs and class I psychotropic drugs in medical institutions. Failure Mode and Effects Analysis (FMEA) is a proactive risk management tool designed to identify possible errors in the drug flow process and their potential consequences, thereby reducing adverse events and enhancing process safety. Initially applied in the military sector during the 1940s, this tool was used to analyze potential errors and their impact on mission outcomes as well as safety for the personnel and equipment involved 5 . Similarly, the management of anesthetic drugs and class I psychotropic drugs within health care systems, which are complex organizations, requires a rigorous management process to achieve a closed-loop system for drug management. The FMEA is a proactive and forward-looking method that can be used to identify potential failures before they occur 6 . The FMEA process involves several continuous steps, including the analysis of clinical processes and their breakdown into macro-activities. Within each macro-activity, relevant micro-activities and all possible failure modes are identified. Next, each failure mode is analyzed to determine all potential consequences. Subsequently, a so-called Risk Priority Number (RPN) is calculated for each failure mode, which is ranked based on the likelihood of occurrence, detectability of the error, and severity of its consequences. Thus, a multidisciplinary team can establish a main priority list and develop specific corrective action plans and timelines according to these priorities. Finally, monitoring is carried out to verify the effectiveness of the implemented measures 7 . In this context, the purpose of the present study was to determine an appropriate and safe management model for the information management of anesthetic drugs and class I psychotropic drugs to ensure the safety and standardization of drug management. To develop this model, we used the FMEA method with the following specific objectives: (a) To identify error modes and related causes in the management of anesthetic drugs and class I psychotropic drugs; (b) Plan specific measures for the information management of anesthetic drugs and class I psychotropic drugs; (c) Provide pharmacists involved in the process with operational procedures and standardized management tools. Methods This study was approved as a quality improvement project by the Institutional Safety and Quality Committee and was exempt from requiring Human Research and Ethics Committee approval. To ensure a comprehensive and accurate, we established a multidisciplinary team comprising multiple professionals, including doctors, pharmacists, nurses, and information engineers. We confirm that the research methodology was conducted in strict accordance with the standardized operating procedures and guidelines of the FAME framework. All processes, including data collection, analysis, and reporting, were carried out in alignment with FAME's established protocols to ensure consistency, accuracy, and compliance with relevant regulations. Additionally, all team members involved in the study received appropriate training to adhere to these standardized procedures, and informed consent was obtained where applicable. This approach guarantees the integrity and reliability of the research outcomes. The focus of this study model was on the design of an information management process for anesthetic drugs and class I psychotropic drugs. The multidisciplinary team studied the process and identified five main stages of information management for anesthetic drugs and class I psychotropic drugs, as follows: 1. Prescription issuance; 2. Prescription verification; 3. Drug dispensing and distribution; 4. Empty ampule/waste patch recovery; 5. Reporting and data management. Subsequently, each stage was divided into micro-activities to identify potential failure modes and their possible consequences. The FMEA tool was used to quantify the risk of each potential failure mode across three dimensions: severity (S), occurrence (O), and detectability (D). These dimensions were rated on a scale of 5 to 1, from highest to lowest, assigning a weighted importance to each 8 . The magnitude of risk is represented by the RPN, which is given by RPN=S×O×D A higher RPN value indicates a greater risk of failure. Based on the RPN value, it is possible to determine the need for and urgency of control measures to reduce post-event losses at a lower cost. Four levels of intervention priority were determined, based on the RPN value: RPN > 30 indicates very high priority; 20 < RPN < 29 indicates high priority; 10 < RPN < 19 indicates medium priority; and RPN < 10 indicates low priority. This pilot project is applicable in the management of all anesthetic drugs and class I psychotropic drugs at the Henan Provincial People’s Hospital in China. In 2024, the hospital issued a total of 133,160 medical orders for anesthetic drugs and class I psychotropic drugs. This included 118,620 orders for injectable drugs, 3307 orders for patches, and 11,233 orders for oral formulations. The usage quantity for each type is shown in Table 1. Table 1. Consumption of anesthetic drugs and class I psychotropic drugs in the inpatient pharmacy of people's hospital of henan province, China in 2024 Drug Name Specification Quantity Proportion Midazolam Injection 10 mg 125,746 30.96% Remifentanil Hydrochloride for Injection 1 mg 118,900 29.28% Hydrocodone Bitartrate Extended-Release Tablets 10 mg 81,102 19.97% Hydromorphone Hydrochloride Injection 2 mg 23,721 5.84% Midazolam Injection 2 mg 16,713 4.12% Sufentanil Citrate Injection 50 μg 9185 2.26% Hydrocodone Bitartrate Extended-Release Tablets 40 mg 6634 1.63% Codeine Phosphate Tablets 15 mg 6505 1.60% Morphine Sulfate Extended-Release Tablets 30 mg 5001 1.23% Fentanyl Transdermal Patch 4.125 mg 4517 1.11% Morphine Hydrochloride Injection 10 mg 4245 1.05% Pethidine Hydrochloride Injection 50 mg 1037 0.26% Hydrocodone Bitartrate Injection 10 mg 835 0.21% Sufentanil Citrate Injection 0.1 mg 718 0.18% Fentanyl Transdermal Patch 2.5 mg 571 0.14% Pethidine Hydrochloride Injection 0.1 g 377 0.09% Fentanyl Transdermal Patch 4.2 mg 287 0.07% Results In the management of anesthetic drugs and class I psychotropic drugs, 15 failure modes were identified. Table 2 presents the main priority list derived from applying the FMEA method to the management of these drugs. As shown in Table 2, the high-priority errors identified included patients not receiving their medication on time as well as inconsistencies between the number of empty ampules collected and the number dispensed, the latter of which potentially increases the management risk for these drugs. Table 2. Proposed main list from the application of FMEA to the management of anesthetic drugs and class I psychotropic drugs Collinear Category Potential Failure Mode Cause of Failure Impact of Failure RPN Doctor's order issuance and prescription printing Incomplete prescription information No patient identity or proxy identity information Patients cannot receive medication on time 7.78 Prescription not written using specified red form Doctor unclear about drug classification Patients cannot receive medication on time 5.51 Inappropriate dosage Doctor did not follow regulations, ordered daily doses for inpatients Patients cannot receive medication on time 13.46 Inappropriate frequency Fentanyl patch not administered at 72-hour intervals Patients cannot receive medication on time 13.33 Inappropriate route of administration Drug intended for subcutaneous injection during surgery prescribed as IV drip Patients cannot receive medication on time 6.16 Incomplete diagnosis Prescription diagnosis includes only the first diagnosis Patients cannot receive medication on time 13.46 Nurse's review and order transmission No patient order information Nurse forgot to transmit order Patients cannot receive medication on time 4.21 Nurse retrieves prescription from pharmacy Prescription information does not match HIS order information Doctor did not cancel excess orders; nurse did not verify prescription against order information Patients cannot receive medication on time 11.85 Pharmacist prescription review and billing Dispensing information does not match prescription information Pharmacist did not carefully verify prescription against order information Incorrect medication dispensing, patients cannot receive medication on time 12.22 Medication dispensing Medication dispensing error Similar drugs not differentiated, dispensing details unclear Incorrect medication dispensing, patients cannot receive medication on time 20.58 Registering injectables or patches for recycling Incomplete registration of empty ampule recovery Large volume of dispensing data, cannot manually record in real-time Discrepancy between the number of empty ampules dispensed and collected 38.09 Nurse administers medication Error in executing order Nurse did not perform \"three checks and seven matches\" Incorrect medication use by patient 9.63 Returning empty ampules/waste patches to pharmacy Incomplete recovery of used empty ampules/waste patches Used drug ampules/patches not returned to pharmacy in a timely manner Discrepancy between the number of empty ampules dispensed and collected 30.35 Pharmacist periodically totals and destroys recorded empty ampules/waste patches Records do not match actual recovery numbers Inability to accurately log recovery numbers Discrepancy between the number of empty ampules dispensed and collected 25.28 Usage record registration Manual recording of drug use too complex Incomplete data from information systems Excessive manual input required 17.50 Abbreviation:HIS: hospital information system; IV: intravenous drip Discussion The core objective for information management of anesthetic drugs and class I psychotropic drugs is to prevent these drugs from entering illegal channels and to ensure that drug management complies with regulations governing the management of anesthetic and class I psychotropic drugs in Chinese medical institutions. According to management materials from the National Health Commission and other departments, the management requirements for anesthetic drugs and class I psychotropic drugs include the following. 1. Strict adherence to a dual-person operation system is required throughout the process. 2. Secure storage facilities (cabinets) must be locked. 3. Prescriptions for anesthetic drugs and class I psychotropic drugs must be issued daily, with each prescription covering only the standard daily dosage. 4. The personnel preparing and verifying prescriptions must carefully check, sign for, and register the anesthetic drugs and class I psychotropic drugs. 5. Medical institutions must maintain a special register for prescriptions of anesthetic drugs and class I psychotropic drugs, which includes the patient's (or proxy's) name, gender, age, national identification number, medical record number, disease name, drug name, specification, quantity, prescribing physician, prescription number, prescription date, dispenser, and checker. 6. Anesthetic drugs and class I psychotropic drugs purchased by medical institutions are to be used clinically only within the institution. 7. Relevant surveillance videos must be stored for at least 180 days. 8. Specific individuals must be assigned to oversee each stage of storage, with clear responsibilities, and shift changes must be recorded. 9. When patients use injectables or patches, they must return empty vials or used patches from the previous batch upon re-dispensing, and the number of these returned items should be recorded. In the management practices of medical institutions in China, the management processes for anesthetic drugs and class I psychotropic drugs cover numerous key stages, including storage, issuance, dispensing, use, recording, and recovery, all governed by detailed and strict regulations 9,10,11 . These regulations are designed to ensure the safety and compliant use of these drugs, mitigating their potential risks. Anesthetic and class I psychotropic drugs have unique value as medical tools, but these drugs can be like a \"double-edged sword\"; the line between their use as therapeutic agents and their potential to become societal hazards is very thin 12,13 . Therefore, stringent management of these drugs is particularly crucial. The authors’ medical institution is a three grade-A tertiary general hospitals with heavy medical responsibilities, and the usage of anesthetic and class I psychotropic drugs is quite substantial. Although the current management model ensures the safety use of drugs to some extent, the process is extremely cumbersome and requires substantial human and material resources. More importantly, even with these measures, it is still difficult to completely eliminate potential loopholes in the management process, thereby increasing the risk of drug abuse and illegal circulation. Key challenges to be addressed include avoiding dispensing errors, ensuring that all empty vials/waste patches are collected after dispensing, and saving manpower while adhering to management regulations. The manual review of prescriptions can delay the timely administration of medication to patients. At our hospital, we have moved the order review to earlier in the process, conducting reviews of medication appropriateness, dosage, and frequency when a doctor issues the order. This provides immediate alerts and intercepts to prevent errors and avoids the need for revisions 14,15,16 . According to management requirements, when patients use injectable or patch forms of anesthetic and class I psychotropic drugs, they should return the original batch's empty vials or used patches at the time of the next dispensing, and the numbers retrieved should be recorded. However, the closed-loop process of issuing-dispensing-retrieving these drugs involves many steps and often relies on manual recordkeeping, making the process cumbersome and labor-intensive 17 . Management issues such as delays in vial recovery or ineffective counting by pharmacists can lead to discrepancies between actual and recorded quantities 18,19 . Sole reliance on manual records cannot ensure accurate recovery of all dispensed drugs, nor can it guarantee that the drug dispensing checks are conducted by two individuals. Introducing an intelligent electronic medicine cabinet system could help. Such a system would require dual login for access and set a fixed position for each drug, enabling real-time interaction with the hospital information system for dynamic management of basic drug information and quantities. Weighing scales and digital displays can be used to ensure accuracy in drug dispensing, providing reminders about drug types and ensuring precise drug preparation 20 . After the dispensation of drugs, pharmacists are required to manually encode and sign each prescription. Additionally, prescription information must be registered in a dedicated record book. A dual printing method can be used to systematically print the codes for all dispensed orders on a fingerprint-logged information report, enabling the extraction of report print information. Given this context, leveraging information technology to meet the stringent management requirements for anesthetic and class I psychotropic drugs while effectively saving on human and material resources becomes a considerable challenge. This study was centered around this goal, aiming to identify a more efficient and intelligent management system. By ensuring the safe use of these drugs, we also sought to optimize management processes and enhance efficiency, providing new ideas and methods for drug management in medical institutions. The addition of informational devices plays a crucial role in optimizing drug management. After the analysis, the working group developed action plans and related monitoring methods for the corrective measures taken, summarized in Table 3. Table 3. Improvement plans for fault modes highly prioritized by the FMEA working group Process/Activity Improvement Action Monitoring Doctor's order issuance and prescription printing Unreasonable prescription Add a preliminary review step in the system when issuing orders, with alerts for inappropriate orders Extract necessary information directly from the patient's file, with alerts for incomplete information Regular verification of prescription accuracy Prescription review phase Generate a quick response code at the top left corner of the printed prescription Pharmacists scan this to display corresponding charges in the HIS system Regular verification of accuracy Compiling forms and multidisciplinary team reporting of order information Medication dispensing Drug dispensing Implement smart electronic medicine cabinets with fixed slots for each drug and digital displays. Use weighing scales to determine the quantity of drugs. Interface the smart cabinets with the HIS system to remind staff of drug pickup locations and quantities based on HIS order information Regular verification of accuracy Determine whether the quantity of drug matches the order information Empty vial/Waste patch recovery The number of items recovered matches the number of items dispensed After dispensing injectables or patches, automatically log the order in the smart electronic cabinet system. Place a block on re-dispensing until recovery is confirmed. Regular verification of accuracy The number of drugs dispensed and number of empty vials recovered Data registration Manual recording of drug usage information is overly cumbersome Automate the generation of usage records from prescription data to simplify the process, eliminating the complexity of manual record-keeping The system generates prescription codes based on the time of drug dispensation and uses a dual printing process to display these codes and the pharmacist's signature on prescriptions Regularly verify the accuracy of prescription information and the completeness of table data Abbreviation:HIS: hospital information system Conclusion This paper discusses the application of FMEA for proactive risk assessment in the management of anesthetic drugs and class I psychotropic drugs in inpatient pharmacy. By thoroughly analyzing potential failure modes and their causes within the management process, we successfully identified 15 key risk points and formulated corresponding improvement measures. In the case of Henan Province People's Hospital, we conducted an FMEA on the entire process of managing anesthetic drugs and class I psychotropic drugs. By calculating the RPN, we identified priority areas for improvement and devised intelligent reform measures. The application of FMEA can make risk investigation more systematic and scientific. FMEA is a proactive analytical method that allows for the prediction and assessment of risks before they occur, enabling the implementation of effective countermeasures. This approach to proactive risk assessment helps health care institutions establish comprehensive risk management mechanisms to ensure the safe and rational use of anesthetic drugs and class I psychotropic drugs. FMEA can also facilitate the digital and intelligent reform of management processes. By building systems for pre-review of medical orders, smart interception of empty vials/waste patches, and automatic generation of reports, management efficiency can be improved and drug supervision and rational medication use can be strengthened. The implementation of these reform measures is valuable for medical institutions and is worth extending to other areas. The use of FMEA for proactive risk assessment in the management of anesthetic drugs and class I psychotropic drugs in inpatient pharmacy can achieve important outcomes. This approach can not only reduce management risks but can also enhance the quality and efficiency of management. In the future, the application of FMEA should be enhanced together with continuous improvement of management processes to provide greater patient safety and ensure rational medication use. Study Limitations Although this study achieved positive results regarding active risk assessment for anesthetic drugs and class I psychotropic drugs in inpatient pharmacy using FMEA, there are some limitations that should be considered and improved in future research. Firstly, this study was conducted using the Henan Provincial People’s Hospital as a sample. Although the sample is somewhat representative, the results may be influenced by the specific hospital environment and cultural background. Therefore, when generalizing to other medical institutions, it is necessary to consider the actual conditions and differences among different hospitals. Secondly, data collection and processing are critical stages in FMEA. The data in this study mainly came from the HIS and surveys, which may include some subjectivity and errors. Future research could consider using more objective and comprehensive data collection methods to improve the accuracy and reliability of the analysis. Thirdly, in this study, we primarily focused on internal management processes of the inpatient pharmacy , without fully considering the impact of external factors on the management of anesthetic drugs and class I psychotropic drugs. For instance, changes in policies and regulations, as well as the stability of suppliers, could greatly affect drug management. Future research could expand the scope of the study to comprehensively consider the impact of both internal and external factors on management risks. In summary, this study achieved certain outcomes in applying FMEA for proactive risk assessment in the management of anesthetic drugs and class I psychotropic drugs in inpatient pharmacy; yet, some limitations remain. Future research should delve deeper into these limitations to help in the development of more comprehensive and accurate risk management strategies and to offer suggestions for medical institutions. Declarations This study focuses on the application of the FAME management tool and primarily involves the analysis of existing administrative and operational data. It does not directly engage with human subjects in a way that requires obtaining informed consent, nor does it involve any experimental interventions on humans or animals. Therefore, according to the relevant national regulations and institutional review board standards, the need for ethics approval for this study is deemed unnecessary. Acknowledgements We extend our gratitude to the Henan Provincial People’s Hospital for their support in the implementation of the project. Author contributions Lulu Zhang and Xiuling He designed and executed the study, listened to lectures from FMEA experts, and wrote the manuscript. Yimeng Wang，Li Huang，Xiaoxia Du and Mingzhou Liu conceived the study, participated in its study, and helped to draft the manuscript.All the authors have read and approved the final manuscript. Funding This research was not supported by any funding. Competing interests The authors declare no competing interests. References Man, C., Zou, W., Yang, S., Guan, X. & Shi, L. Study On the Control of Anesthetic and Psychotropic Drugs V — Comparative Study of Domestic and International Control Systems for Anesthetic and Psychotropic Drugs. China Pharmacy . 28, 23-26 (2017). Liu, D. et al. Consensus On Information Management of Anesthetic Drugs and Class I Psychotropic Drugs in Medical Institutions. Herald of Medicine . 41, 1-7 (2022). Xv, Y., Chen, Q. & Chen, X. Interpretation of New Policies Related to the Management of Anesthetic and Psychotropic Drugs in Medical Institutions. China Prescription Drug . 20, 45-46 (2022). De Vries, E. N., Ramrattan, M. A., Smorenburg, S. M., Gouma, D. J. & Boermeester, M. A. The Incidence and Nature of in-Hospital Adverse Events: A Systematic Review. Quality & safety in health care . 17, 216-223 (2008). Liu, H., Liu, L. & Liu, N. 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Supplementary Files 2024.xlsx file.xlsx Cite Share Download PDF Status: Published Journal Publication published 13 Aug, 2025 Read the published version in Scientific Reports → Version 1 posted Editorial decision: Revision requested 13 Jun, 2025 Reviews received at journal 12 Jun, 2025 Reviews received at journal 04 Jun, 2025 Reviews received at journal 29 May, 2025 Reviewers agreed at journal 26 May, 2025 Reviewers agreed at journal 25 May, 2025 Reviewers agreed at journal 25 May, 2025 Reviews received at journal 16 May, 2025 Reviews received at journal 12 May, 2025 Reviewers agreed at journal 07 May, 2025 Reviewers agreed at journal 07 May, 2025 Reviewers invited by journal 07 May, 2025 Editor assigned by journal 05 May, 2025 Editor invited by journal 25 Mar, 2025 Submission checks completed at journal 21 Mar, 2025 First submitted to journal 23 Feb, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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13:53:08\",\"currentVersionCode\":1,\"declarations\":\"\",\"doi\":\"10.21203/rs.3.rs-6090426/v1\",\"doiUrl\":\"https://doi.org/10.21203/rs.3.rs-6090426/v1\",\"draftVersion\":[],\"editorialEvents\":[{\"content\":\"https://doi.org/10.1038/s41598-025-13377-6\",\"type\":\"published\",\"date\":\"2025-08-13T15:57:36+00:00\"}],\"editorialNote\":\"\",\"failedWorkflow\":false,\"files\":[{\"id\":89310555,\"identity\":\"c98ecd97-a520-4dab-bee7-1ac7c90aaba2\",\"added_by\":\"auto\",\"created_at\":\"2025-08-18 16:07:54\",\"extension\":\"pdf\",\"order_by\":0,\"title\":\"\",\"display\":\"\",\"copyAsset\":false,\"role\":\"manuscript-pdf\",\"size\":668757,\"visible\":true,\"origin\":\"\",\"legend\":\"\",\"description\":\"\",\"filename\":\"manuscript.pdf\",\"url\":\"https://assets-eu.researchsquare.com/files/rs-6090426/v1/d653c9de-e6e9-4df5-ab68-edf4ab2d38ec.pdf\"},{\"id\":82496931,\"identity\":\"df96bcb2-78b7-4353-b9a2-5ecbd66a53c4\",\"added_by\":\"auto\",\"created_at\":\"2025-05-12 08:01:45\",\"extension\":\"xlsx\",\"order_by\":0,\"title\":\"\",\"display\":\"\",\"copyAsset\":false,\"role\":\"supplement\",\"size\":13210,\"visible\":true,\"origin\":\"\",\"legend\":\"\",\"description\":\"\",\"filename\":\"2024.xlsx\",\"url\":\"https://assets-eu.researchsquare.com/files/rs-6090426/v1/7a4e2279434d182ff908edfa.xlsx\"},{\"id\":82498948,\"identity\":\"95dd6880-1a71-451c-8e16-d51934b56735\",\"added_by\":\"auto\",\"created_at\":\"2025-05-12 08:25:45\",\"extension\":\"xlsx\",\"order_by\":1,\"title\":\"\",\"display\":\"\",\"copyAsset\":false,\"role\":\"supplement\",\"size\":18226,\"visible\":true,\"origin\":\"\",\"legend\":\"\",\"description\":\"\",\"filename\":\"file.xlsx\",\"url\":\"https://assets-eu.researchsquare.com/files/rs-6090426/v1/098c12df01dd37dd4f266691.xlsx\"}],\"financialInterests\":\"No competing interests reported.\",\"formattedTitle\":\"Proactive Risk Assessment Using Failure Mode and Effects Analysis in a Management Model of Anesthetic Drugs and Class I Psychotropic Drugs in Inpatient Pharmacy: A Pilot Project\",\"fulltext\":[{\"header\":\"Introduction\",\"content\":\"\\u003cp\\u003eSpecial medications in China are classified and controlled according to their pharmacological characteristics. Anesthetic drugs and psychotropic drugs are legislated and managed separately from stimulants and precursors used for drug production, creating several relatively independent management systems with varying control measures that intersect but differ from each other\\u003csup\\u003e1\\u003c/sup\\u003e.\\u0026nbsp;\\u003c/p\\u003e\\n\\u003cp\\u003eIn China, the classification of anesthetic and psychotropic drugs is straightforward, and control measures are relatively unified and managed according to whether the drugs are used for medicinal purposes. Regarding drugs listed in the directory, some can be produced, supplied, and used in China as specified, whereas others are subject to uniform and strict management across all stages, regardless of their addictive potential or potential harmfulness.\\u003c/p\\u003e\\n\\u003cp\\u003eAnesthetic drugs and class I psychotropic drugs are specially managed according to laws and regulations in China. These drugs have a dual nature; On the one hand, they are essential for clinical diagnosis and treatment owing to their strong analgesic and sedative effects. On the other hand, their non-standard and continuous use can lead to dependencies; if these drugs enter illegal channels, they can cause serious social harm and may even involve criminal activity\\u003csup\\u003e2\\u003c/sup\\u003e. The management of anesthetic and class I psychotropic drugs in medical institutions not only needs to comply with relevant laws, regulations, and administrative rules but also requires regular oversight by health administrative departments and drug regulatory authorities\\u003csup\\u003e3\\u0026nbsp;\\u003c/sup\\u003e.\\u003c/p\\u003e\\n\\u003cp\\u003eThe \\u0026quot;Notice on strengthening the management of anesthetic drugs and class I psychotropic drugs in Medical Institutions,\\u0026quot; issued by national\\u0026nbsp;Health\\u0026nbsp;Commission\\u0026nbsp;of the\\u0026nbsp;People\\u0026apos;s\\u0026nbsp;Republic\\u0026nbsp;of\\u0026nbsp;China in September 2020, emphasized improving the level of information management for these drugs and strengthening their full-process management to achieve traceable, accountable management from source to destination. Nevertheless, proactive, referable information management processes are lacking, making information management for these drugs challenging. Additionally, it is necessary to stratify the risk according to management regulations and procedures for anesthetic drugs and class I psychotropic drugs. All the above factors expose these processes to a high risk of adverse events because it is estimated that nearly 50% of such events could be prevented via risk management policies, including proactive and reactive tools\\u003csup\\u003e4\\u003c/sup\\u003e. In this study, we explored management models for anesthetic drugs and class I psychotropic drugs in medical institutions.\\u003c/p\\u003e\\n\\u003cp\\u003eFailure Mode and Effects Analysis (FMEA) is a proactive risk management tool designed to identify possible errors in the drug flow process and their potential consequences, thereby reducing adverse events and enhancing process safety. Initially applied in the military sector during the\\u0026nbsp;1940s, this tool was used to analyze potential errors and their impact on mission outcomes as well as safety for the personnel and equipment involved\\u003csup\\u003e5\\u003c/sup\\u003e. Similarly, the management of anesthetic drugs and class I psychotropic drugs within health care systems, which are complex organizations, requires a rigorous management process to achieve a closed-loop system for drug management. The FMEA is a proactive and forward-looking method that can be used to identify potential failures before they occur\\u003csup\\u003e\\u0026nbsp;6\\u003c/sup\\u003e. The FMEA process involves several continuous steps, including the analysis of clinical processes and their breakdown into macro-activities. Within each macro-activity, relevant micro-activities and all possible failure modes are identified. Next, each failure mode is analyzed to determine all potential consequences. Subsequently, a so-called Risk Priority Number (RPN) is calculated for each failure mode, which is ranked based on the likelihood of occurrence, detectability of the error, and severity of its consequences. Thus, a multidisciplinary team can establish a main priority list and develop specific corrective action plans and timelines according to these priorities. Finally, monitoring is carried out to verify the effectiveness of the implemented measures\\u003csup\\u003e7\\u003c/sup\\u003e.\\u003c/p\\u003e\\n\\u003cp\\u003eIn this context, the purpose of the present study was to determine an appropriate and safe management model for the information management of anesthetic drugs and class I psychotropic drugs to ensure the safety and standardization of drug management. To develop this model, we used the FMEA method with the following specific objectives:\\u003c/p\\u003e\\n\\u003cp\\u003e(a) To identify error modes and related causes in the management of anesthetic drugs and class I psychotropic drugs;\\u003c/p\\u003e\\n\\u003cp\\u003e(b) Plan specific measures for the information management of anesthetic drugs and class I psychotropic drugs;\\u003c/p\\u003e\\n\\u003cp\\u003e(c) Provide pharmacists involved in the process with operational procedures and standardized management tools.\\u003c/p\\u003e\"},{\"header\":\"Methods\",\"content\":\"\\u003cp\\u003eThis study was approved as a quality improvement project by the Institutional Safety and Quality Committee and was exempt from requiring Human Research and Ethics Committee approval. To ensure a comprehensive and accurate, we established a multidisciplinary team comprising multiple professionals, including doctors, pharmacists, nurses, and information engineers.\\u0026nbsp;\\u003c/p\\u003e\\n\\u003cp\\u003eWe confirm that the research methodology was conducted in strict accordance with the standardized operating procedures and guidelines of the FAME framework. All processes, including data collection, analysis, and reporting, were carried out in alignment with FAME\\u0026apos;s established protocols to ensure consistency, accuracy, and compliance with relevant regulations. Additionally, all team members involved in the study received appropriate training to adhere to these standardized procedures, and informed consent was obtained where applicable. This approach guarantees the integrity and reliability of the research outcomes.\\u003c/p\\u003e\\n\\u003cp\\u003eThe focus of this study model was on the design of an information management process for anesthetic drugs and class I psychotropic drugs.\\u003c/p\\u003e\\n\\u003cp\\u003eThe multidisciplinary team studied the process and identified five main stages of information management for anesthetic drugs and class I psychotropic drugs, as follows:\\u003c/p\\u003e\\n\\u003cp\\u003e1. Prescription issuance;\\u003c/p\\u003e\\n\\u003cp\\u003e2. Prescription verification;\\u003c/p\\u003e\\n\\u003cp\\u003e3. Drug dispensing and distribution;\\u003c/p\\u003e\\n\\u003cp\\u003e4. Empty ampule/waste patch recovery;\\u003c/p\\u003e\\n\\u003cp\\u003e5. Reporting and data management.\\u003c/p\\u003e\\n\\u003cp\\u003eSubsequently, each stage was divided into micro-activities to identify potential failure modes and their possible consequences.\\u003c/p\\u003e\\n\\u003cp\\u003eThe FMEA tool was used to quantify the risk of each potential failure mode across three dimensions: severity (S), occurrence (O), and detectability (D). These dimensions were rated on a scale of 5 to 1, from highest to lowest, assigning a weighted importance to each\\u003csup\\u003e8\\u003c/sup\\u003e. The magnitude of risk is represented by the RPN, which is given by\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cem\\u003eRPN=S\\u0026times;O\\u0026times;D\\u003c/em\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eA higher RPN value indicates a greater risk of failure. Based on the RPN value, it is possible to determine the need for and urgency of control measures to reduce post-event losses at a lower cost. Four levels of intervention priority were determined, based on the RPN value: RPN \\u0026gt; 30 indicates very high priority; 20 \\u0026lt; RPN \\u0026lt; 29 indicates high priority; 10 \\u0026lt; RPN \\u0026lt; 19 indicates medium priority; and RPN \\u0026lt; 10 indicates low priority.\\u003c/p\\u003e\\n\\u003cp\\u003eThis pilot project is applicable in the management of all anesthetic drugs and class I psychotropic drugs at the Henan Provincial People\\u0026rsquo;s Hospital in China. In 2024, the hospital issued a total of 133,160 medical orders for anesthetic drugs and class I psychotropic drugs. This included 118,620 orders for injectable drugs, 3307 orders for patches, and 11,233 orders for oral formulations. The usage quantity for each type is shown in Table 1.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eTable 1. Consumption of anesthetic drugs and class I psychotropic drugs in the\\u0026nbsp;\\u003c/strong\\u003e\\u003cstrong\\u003einpatient\\u0026nbsp;\\u003c/strong\\u003e\\u003cstrong\\u003epharmacy of people\\u0026apos;s hospital of henan province, China in 2024\\u0026nbsp;\\u003c/strong\\u003e\\u003c/p\\u003e\\n \\u003ctable border=\\\"1\\\" cellspacing=\\\"0\\\" cellpadding=\\\"0\\\" width=\\\"667\\\"\\u003e\\n \\u003ctbody\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd style=\\\"width: 295px;\\\"\\u003e\\n \\u003cp\\u003e\\u003cstrong\\u003eDrug Name\\u003c/strong\\u003e\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 148px;\\\"\\u003e\\n \\u003cp\\u003e\\u003cstrong\\u003eSpecification\\u003c/strong\\u003e\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 112px;\\\"\\u003e\\n \\u003cp\\u003e\\u003cstrong\\u003eQuantity\\u003c/strong\\u003e\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 111px;\\\"\\u003e\\n 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\\u003ctd style=\\\"width: 112px;\\\"\\u003e\\n \\u003cp\\u003e1037\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 111px;\\\"\\u003e\\n \\u003cp\\u003e0.26%\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd style=\\\"width: 295px;\\\"\\u003e\\n \\u003cp\\u003eHydrocodone Bitartrate Injection\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 148px;\\\"\\u003e\\n \\u003cp\\u003e10 mg\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 112px;\\\"\\u003e\\n \\u003cp\\u003e835\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 111px;\\\"\\u003e\\n \\u003cp\\u003e0.21%\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd style=\\\"width: 295px;\\\"\\u003e\\n \\u003cp\\u003eSufentanil Citrate Injection\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 148px;\\\"\\u003e\\n \\u003cp\\u003e0.1 mg\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 112px;\\\"\\u003e\\n \\u003cp\\u003e718\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 111px;\\\"\\u003e\\n \\u003cp\\u003e0.18%\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd style=\\\"width: 295px;\\\"\\u003e\\n \\u003cp\\u003eFentanyl Transdermal Patch\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 148px;\\\"\\u003e\\n \\u003cp\\u003e2.5 mg\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 112px;\\\"\\u003e\\n \\u003cp\\u003e571\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 111px;\\\"\\u003e\\n \\u003cp\\u003e0.14%\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd style=\\\"width: 295px;\\\"\\u003e\\n \\u003cp\\u003ePethidine Hydrochloride Injection\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 148px;\\\"\\u003e\\n \\u003cp\\u003e0.1 g\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 112px;\\\"\\u003e\\n \\u003cp\\u003e377\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 111px;\\\"\\u003e\\n \\u003cp\\u003e0.09%\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd style=\\\"width: 295px;\\\"\\u003e\\n \\u003cp\\u003eFentanyl Transdermal Patch\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 148px;\\\"\\u003e\\n \\u003cp\\u003e4.2 mg\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 112px;\\\"\\u003e\\n \\u003cp\\u003e287\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 111px;\\\"\\u003e\\n \\u003cp\\u003e0.07%\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003c/tbody\\u003e\\n \\u003c/table\\u003e\\n\\u003c/div\\u003e\"},{\"header\":\"Results\",\"content\":\"\\u003cp\\u003eIn the management of anesthetic drugs and class I psychotropic drugs, 15 failure modes were identified. Table 2 presents the main priority list derived from applying the FMEA method to the management of these drugs.\\u003c/p\\u003e\\n\\u003cp\\u003eAs shown in Table 2, the high-priority errors identified included patients not receiving their medication on time as well as inconsistencies between the number of empty ampules collected and the number dispensed, the latter of which potentially increases the management risk for these drugs.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eTable 2. Proposed main list from the application of FMEA to the management of anesthetic drugs and class I psychotropic drugs\\u0026nbsp;\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003ctable border=\\\"1\\\" cellspacing=\\\"0\\\" cellpadding=\\\"0\\\" width=\\\"680\\\"\\u003e\\n \\u003ctbody\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd style=\\\"width: 127px;\\\"\\u003e\\n \\u003cp\\u003eCollinear Category\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 174px;\\\"\\u003e\\n \\u003cp\\u003ePotential Failure Mode\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 185px;\\\"\\u003e\\n \\u003cp\\u003eCause of Failure\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 129px;\\\"\\u003e\\n \\u003cp\\u003eImpact of Failure\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 66px;\\\"\\u003e\\n \\u003cp\\u003eRPN\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd rowspan=\\\"6\\\" style=\\\"width: 127px;\\\"\\u003e\\n \\u003cp\\u003eDoctor\\u0026apos;s order issuance and prescription printing\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 174px;\\\"\\u003e\\n \\u003cp\\u003eIncomplete prescription information\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 185px;\\\"\\u003e\\n \\u003cp\\u003eNo patient identity or proxy identity information\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 129px;\\\"\\u003e\\n \\u003cp\\u003ePatients cannot receive medication on time\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 66px;\\\"\\u003e\\n \\u003cp\\u003e7.78\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd style=\\\"width: 174px;\\\"\\u003e\\n \\u003cp\\u003ePrescription not written using specified red form\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 185px;\\\"\\u003e\\n \\u003cp\\u003eDoctor unclear about drug classification\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 129px;\\\"\\u003e\\n \\u003cp\\u003ePatients cannot receive medication on time\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 66px;\\\"\\u003e\\n \\u003cp\\u003e5.51\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd style=\\\"width: 174px;\\\"\\u003e\\n \\u003cp\\u003eInappropriate dosage\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 185px;\\\"\\u003e\\n \\u003cp\\u003eDoctor did not follow regulations, ordered daily doses for inpatients\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 129px;\\\"\\u003e\\n \\u003cp\\u003ePatients cannot receive medication on time\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 66px;\\\"\\u003e\\n \\u003cp\\u003e13.46\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd style=\\\"width: 174px;\\\"\\u003e\\n \\u003cp\\u003eInappropriate frequency\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 185px;\\\"\\u003e\\n \\u003cp\\u003eFentanyl patch not administered at 72-hour intervals\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 129px;\\\"\\u003e\\n \\u003cp\\u003ePatients cannot receive medication on time\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 66px;\\\"\\u003e\\n \\u003cp\\u003e13.33\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd style=\\\"width: 174px;\\\"\\u003e\\n \\u003cp\\u003eInappropriate route of administration\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 185px;\\\"\\u003e\\n \\u003cp\\u003eDrug intended for subcutaneous injection during surgery prescribed as\\u0026nbsp;IV drip\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 129px;\\\"\\u003e\\n \\u003cp\\u003ePatients cannot receive medication on time\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 66px;\\\"\\u003e\\n \\u003cp\\u003e6.16\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd style=\\\"width: 174px;\\\"\\u003e\\n \\u003cp\\u003eIncomplete diagnosis\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 185px;\\\"\\u003e\\n \\u003cp\\u003ePrescription diagnosis includes only the first diagnosis\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 129px;\\\"\\u003e\\n \\u003cp\\u003ePatients cannot receive medication on time\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 66px;\\\"\\u003e\\n \\u003cp\\u003e13.46\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd style=\\\"width: 127px;\\\"\\u003e\\n \\u003cp\\u003eNurse\\u0026apos;s review and order transmission\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 174px;\\\"\\u003e\\n \\u003cp\\u003eNo patient order information\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 185px;\\\"\\u003e\\n \\u003cp\\u003eNurse forgot to transmit order\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 129px;\\\"\\u003e\\n \\u003cp\\u003ePatients cannot receive medication on time\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 66px;\\\"\\u003e\\n \\u003cp\\u003e4.21\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd style=\\\"width: 127px;\\\"\\u003e\\n \\u003cp\\u003eNurse retrieves prescription from pharmacy\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 174px;\\\"\\u003e\\n \\u003cp\\u003ePrescription information does not match\\u0026nbsp;HIS order information\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 185px;\\\"\\u003e\\n \\u003cp\\u003eDoctor did not cancel excess orders; nurse did not verify prescription against order information\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 129px;\\\"\\u003e\\n \\u003cp\\u003ePatients cannot receive medication on time\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 66px;\\\"\\u003e\\n \\u003cp\\u003e11.85\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd style=\\\"width: 127px;\\\"\\u003e\\n \\u003cp\\u003ePharmacist prescription review and billing\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 174px;\\\"\\u003e\\n \\u003cp\\u003eDispensing information does not match prescription information\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 185px;\\\"\\u003e\\n \\u003cp\\u003ePharmacist did not carefully verify prescription against order information\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 129px;\\\"\\u003e\\n \\u003cp\\u003eIncorrect medication dispensing, patients cannot receive medication on time\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 66px;\\\"\\u003e\\n \\u003cp\\u003e12.22\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd style=\\\"width: 127px;\\\"\\u003e\\n \\u003cp\\u003eMedication dispensing\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 174px;\\\"\\u003e\\n \\u003cp\\u003eMedication dispensing error\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 185px;\\\"\\u003e\\n \\u003cp\\u003eSimilar drugs not differentiated, dispensing details unclear\\u0026nbsp;\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 129px;\\\"\\u003e\\n \\u003cp\\u003eIncorrect medication dispensing, patients cannot receive medication on time\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 66px;\\\"\\u003e\\n \\u003cp\\u003e20.58\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd style=\\\"width: 127px;\\\"\\u003e\\n \\u003cp\\u003eRegistering injectables or patches for recycling\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 174px;\\\"\\u003e\\n \\u003cp\\u003eIncomplete registration of empty ampule recovery\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 185px;\\\"\\u003e\\n \\u003cp\\u003eLarge volume of dispensing data, cannot manually record in real-time\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 129px;\\\"\\u003e\\n \\u003cp\\u003eDiscrepancy between the number of empty ampules dispensed and collected\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 66px;\\\"\\u003e\\n \\u003cp\\u003e38.09\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd style=\\\"width: 127px;\\\"\\u003e\\n \\u003cp\\u003eNurse administers medication\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 174px;\\\"\\u003e\\n \\u003cp\\u003eError in executing order\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 185px;\\\"\\u003e\\n \\u003cp\\u003eNurse did not perform \\u0026quot;three checks and seven matches\\u0026quot;\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 129px;\\\"\\u003e\\n \\u003cp\\u003eIncorrect medication use by patient\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 66px;\\\"\\u003e\\n \\u003cp\\u003e9.63\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd style=\\\"width: 127px;\\\"\\u003e\\n \\u003cp\\u003eReturning empty ampules/waste patches to pharmacy\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 174px;\\\"\\u003e\\n \\u003cp\\u003eIncomplete recovery of used empty ampules/waste patches\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 185px;\\\"\\u003e\\n \\u003cp\\u003eUsed drug ampules/patches not returned to pharmacy in a timely manner\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 129px;\\\"\\u003e\\n \\u003cp\\u003eDiscrepancy between the number of empty ampules dispensed and collected\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 66px;\\\"\\u003e\\n \\u003cp\\u003e30.35\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd style=\\\"width: 127px;\\\"\\u003e\\n \\u003cp\\u003ePharmacist periodically totals and destroys recorded empty ampules/waste patches\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 174px;\\\"\\u003e\\n \\u003cp\\u003eRecords do not match actual recovery numbers\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 185px;\\\"\\u003e\\n \\u003cp\\u003eInability to accurately log recovery numbers\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 129px;\\\"\\u003e\\n \\u003cp\\u003eDiscrepancy between the number of empty ampules dispensed and collected\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 66px;\\\"\\u003e\\n \\u003cp\\u003e25.28\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd style=\\\"width: 127px;\\\"\\u003e\\n \\u003cp\\u003eUsage record registration\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 174px;\\\"\\u003e\\n \\u003cp\\u003eManual recording of drug use too complex\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 185px;\\\"\\u003e\\n \\u003cp\\u003eIncomplete data from information systems\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 129px;\\\"\\u003e\\n \\u003cp\\u003eExcessive manual input required\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd style=\\\"width: 66px;\\\"\\u003e\\n \\u003cp\\u003e17.50\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003c/tbody\\u003e\\n\\u003c/table\\u003e\\n\\u003cp\\u003eAbbreviation:HIS: hospital information system; IV: intravenous drip\\u003c/p\\u003e\"},{\"header\":\"Discussion\",\"content\":\"\\u003cp\\u003eThe core objective for information management of anesthetic drugs and class I psychotropic drugs is to prevent these drugs from entering illegal channels and to ensure that drug management complies with regulations governing the management of anesthetic and class I psychotropic drugs in Chinese medical institutions.\\u003c/p\\u003e\\n\\u003cp\\u003eAccording to management materials from the National Health Commission and other departments, the management requirements for anesthetic drugs and class I psychotropic drugs include the following.\\u003c/p\\u003e\\n\\u003cp\\u003e1. Strict adherence to a dual-person operation system is required throughout the process.\\u003c/p\\u003e\\n\\u003cp\\u003e2. Secure storage facilities (cabinets) must be locked.\\u003c/p\\u003e\\n\\u003cp\\u003e3. Prescriptions for anesthetic drugs and class I psychotropic drugs must be issued daily, with each prescription covering only the standard daily dosage.\\u003c/p\\u003e\\n\\u003cp\\u003e4. The personnel preparing and verifying prescriptions must carefully check, sign for, and register the anesthetic drugs and class I psychotropic drugs.\\u003c/p\\u003e\\n\\u003cp\\u003e5. Medical institutions must maintain a special register for prescriptions of anesthetic drugs and class I psychotropic drugs, which includes the patient's (or proxy's) name, gender, age, national identification number, medical record number, disease name, drug name, specification, quantity, prescribing physician, prescription number, prescription date, dispenser, and checker.\\u003c/p\\u003e\\n\\u003cp\\u003e6. Anesthetic drugs and class I psychotropic drugs purchased by medical institutions are to be used clinically only within the institution.\\u003c/p\\u003e\\n\\u003cp\\u003e7. Relevant surveillance videos must be stored for at least 180 days.\\u003c/p\\u003e\\n\\u003cp\\u003e8. Specific individuals must be assigned to oversee each stage of storage, with clear responsibilities, and shift changes must be recorded.\\u003c/p\\u003e\\n\\u003cp\\u003e9. When patients use injectables or patches, they must return empty vials or used patches from the previous batch upon re-dispensing, and the number of these returned items should be recorded.\\u003c/p\\u003e\\n\\u003cp\\u003eIn the management practices of medical institutions in China, the management processes for anesthetic drugs and class I psychotropic drugs cover numerous key stages, including storage, issuance, dispensing, use, recording, and recovery, all governed by detailed and strict regulations\\u003csup\\u003e9,10,11\\u003c/sup\\u003e. These regulations are designed to ensure the safety and compliant use of these drugs, mitigating their potential risks. Anesthetic and class I psychotropic drugs have unique value as medical tools, but these drugs can be like a \\\"double-edged sword\\\"; the line between their use as therapeutic agents and their potential to become societal hazards is very thin\\u003csup\\u003e12,13\\u003c/sup\\u003e. Therefore, stringent management of these drugs is particularly crucial.\\u003c/p\\u003e\\n\\u003cp\\u003eThe authors’ medical institution is a three grade-A tertiary general hospitals with heavy medical responsibilities, and the usage of anesthetic and class I psychotropic drugs is quite substantial. Although the current management model ensures the safety use of drugs to some extent, the process is extremely cumbersome and requires substantial human and material resources. More importantly, even with these measures, it is still difficult to completely eliminate potential loopholes in the management process, thereby increasing the risk of drug abuse and illegal circulation. Key challenges to be addressed include avoiding dispensing errors, ensuring that all empty vials/waste patches are collected after dispensing, and saving manpower while adhering to management regulations.\\u003c/p\\u003e\\n\\u003cp\\u003eThe manual review of prescriptions can delay the timely administration of medication to patients. At our hospital, we have moved the order review to earlier in the process, conducting reviews of medication appropriateness, dosage, and frequency when a doctor issues the order. This provides immediate alerts and intercepts to prevent errors and avoids the need for revisions\\u003csup\\u003e14,15,16\\u003c/sup\\u003e.\\u003c/p\\u003e\\n\\u003cp\\u003eAccording to management requirements, when patients use injectable or patch forms of anesthetic and class I psychotropic drugs, they should return the original batch's empty vials or used patches at the time of the next dispensing, and the numbers retrieved should be recorded. However, the closed-loop process of issuing-dispensing-retrieving these drugs involves many steps and often relies on manual recordkeeping, making the process cumbersome and labor-intensive\\u003csup\\u003e17\\u003c/sup\\u003e. Management issues such as delays in vial recovery or ineffective counting by pharmacists can lead to discrepancies between actual and recorded quantities\\u003csup\\u003e18,19\\u003c/sup\\u003e. Sole reliance on manual records cannot ensure accurate recovery of all dispensed drugs, nor can it guarantee that the drug dispensing checks are conducted by two individuals. Introducing an intelligent electronic medicine cabinet system could help. Such a system would require dual login for access and set a fixed position for each drug, enabling real-time interaction with the hospital information system for dynamic management of basic drug information and quantities. Weighing scales and digital displays can be used to ensure accuracy in drug dispensing, providing reminders about drug types and ensuring precise drug preparation\\u003csup\\u003e20\\u003c/sup\\u003e.\\u003c/p\\u003e\\n\\u003cp\\u003eAfter the dispensation of drugs, pharmacists are required to manually encode and sign each prescription. Additionally, prescription information must be registered in a dedicated record book. A dual printing method can be used to systematically print the codes for all dispensed orders on a fingerprint-logged information report, enabling the extraction of report print information.\\u003c/p\\u003e\\n\\u003cp\\u003eGiven this context, leveraging information technology to meet the stringent management requirements for anesthetic and class I psychotropic drugs while effectively saving on human and material resources becomes a considerable challenge. This study was centered around this goal, aiming to identify a more efficient and intelligent management system. By ensuring the safe use of these drugs, we also sought to optimize management processes and enhance efficiency, providing new ideas and methods for drug management in medical institutions. The addition of informational devices plays a crucial role in optimizing drug management.\\u003c/p\\u003e\\n\\u003cp\\u003eAfter the analysis, the working group developed action plans and related monitoring methods for the corrective measures taken, summarized in Table 3.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eTable 3. Improvement plans for fault modes highly prioritized by the FMEA working group\\u0026nbsp;\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003ctable border=\\\"1\\\" cellspacing=\\\"0\\\" cellpadding=\\\"0\\\"\\u003e\\u003ctbody\\u003e\\u003ctr\\u003e\\u003ctd style=\\\"width: 206px;\\\"\\u003e\\n \\u003cp\\u003eProcess/Activity\\u003c/p\\u003e\\n \\u003c/td\\u003e\\u003ctd style=\\\"width: 279px;\\\"\\u003e\\n \\u003cp\\u003eImprovement Action\\u003c/p\\u003e\\n \\u003c/td\\u003e\\u003ctd style=\\\"width: 179px;\\\"\\u003e\\n \\u003cp\\u003eMonitoring\\u003c/p\\u003e\\n \\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd style=\\\"width: 206px;\\\"\\u003e\\n \\u003cp\\u003eDoctor's order issuance and prescription printing\\u003c/p\\u003e\\n \\u003cp\\u003eUnreasonable prescription\\u003c/p\\u003e\\n \\u003c/td\\u003e\\u003ctd style=\\\"width: 279px;\\\"\\u003e\\n \\u003cp\\u003eAdd a preliminary review step in the system when issuing orders, with alerts for inappropriate orders\\u003c/p\\u003e\\n \\u003cp\\u003eExtract necessary information directly from the patient's file, with alerts for incomplete information\\u003c/p\\u003e\\n \\u003c/td\\u003e\\u003ctd style=\\\"width: 179px;\\\"\\u003e\\n \\u003cp\\u003eRegular verification of prescription accuracy\\u003c/p\\u003e\\n \\u003cp\\u003e\\u0026nbsp;\\u003c/p\\u003e\\n \\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd style=\\\"width: 206px;\\\"\\u003e\\n \\u003cp\\u003ePrescription review phase\\u003c/p\\u003e\\n \\u003cp\\u003eGenerate a quick response code at the top left corner of the printed prescription\\u003c/p\\u003e\\n \\u003c/td\\u003e\\u003ctd style=\\\"width: 279px;\\\"\\u003e\\n \\u003cp\\u003ePharmacists scan this to display corresponding charges in the HIS system\\u003c/p\\u003e\\n \\u003c/td\\u003e\\u003ctd style=\\\"width: 179px;\\\"\\u003e\\n \\u003cp\\u003eRegular verification of accuracy\\u003c/p\\u003e\\n \\u003cp\\u003eCompiling forms and multidisciplinary team reporting of order information\\u003c/p\\u003e\\n \\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd style=\\\"width: 206px;\\\"\\u003e\\n \\u003cp\\u003eMedication dispensing\\u003c/p\\u003e\\n \\u003cp\\u003eDrug dispensing\\u003c/p\\u003e\\n \\u003c/td\\u003e\\u003ctd style=\\\"width: 279px;\\\"\\u003e\\n \\u003cp\\u003eImplement smart electronic medicine cabinets with fixed slots for each drug and digital displays. Use weighing scales to determine the quantity of drugs.\\u003c/p\\u003e\\n \\u003cp\\u003eInterface the smart cabinets with the HIS system to remind staff of drug pickup locations and quantities based on HIS order information\\u003c/p\\u003e\\n \\u003c/td\\u003e\\u003ctd style=\\\"width: 179px;\\\"\\u003e\\n \\u003cp\\u003eRegular verification of accuracy\\u003c/p\\u003e\\n \\u003cp\\u003eDetermine whether the quantity of drug matches the order information\\u003c/p\\u003e\\n \\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd style=\\\"width: 206px;\\\"\\u003e\\n \\u003cp\\u003eEmpty vial/Waste patch recovery\\u003c/p\\u003e\\n \\u003cp\\u003e\\u0026nbsp;\\u003c/p\\u003e\\n \\u003cp\\u003eThe number of items recovered matches the number of items dispensed\\u003c/p\\u003e\\n \\u003c/td\\u003e\\u003ctd style=\\\"width: 279px;\\\"\\u003e\\n \\u003cp\\u003eAfter dispensing injectables or patches, automatically log the order in the smart electronic cabinet system. Place a block on re-dispensing until recovery is confirmed.\\u003c/p\\u003e\\n \\u003c/td\\u003e\\u003ctd style=\\\"width: 179px;\\\"\\u003e\\n \\u003cp\\u003eRegular verification of accuracy\\u003c/p\\u003e\\n \\u003cp\\u003eThe number of drugs dispensed and number of empty vials recovered\\u003c/p\\u003e\\n \\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd style=\\\"width: 206px;\\\"\\u003e\\n \\u003cp\\u003eData registration\\u003c/p\\u003e\\n \\u003cp\\u003eManual recording of drug usage information is overly cumbersome\\u003c/p\\u003e\\n \\u003c/td\\u003e\\u003ctd style=\\\"width: 279px;\\\"\\u003e\\n \\u003cp\\u003eAutomate the generation of usage records from prescription data to simplify the process, eliminating the complexity of manual record-keeping\\u003c/p\\u003e\\n \\u003cp\\u003eThe system generates prescription codes based on the time of drug dispensation and uses a dual printing process to display these codes and the pharmacist's signature on prescriptions\\u003c/p\\u003e\\n \\u003c/td\\u003e\\u003ctd style=\\\"width: 179px;\\\"\\u003e\\n \\u003cp\\u003eRegularly verify the accuracy of prescription information and the completeness of table data\\u003c/p\\u003e\\n \\u003c/td\\u003e\\u003c/tr\\u003e\\u003c/tbody\\u003e\\u003c/table\\u003e\\n\\u003cp\\u003eAbbreviation:HIS: hospital information system\\u003c/p\\u003e\\n\\n\\n\\n\\n\\n\\n\\n\"},{\"header\":\"Conclusion\",\"content\":\"\\u003cp\\u003eThis paper discusses the application of FMEA for proactive risk assessment in the management of anesthetic drugs and class I psychotropic drugs in inpatient pharmacy. By thoroughly analyzing potential failure modes and their causes within the management process, we successfully identified 15 key risk points and formulated corresponding improvement measures.\\u003c/p\\u003e\\u003cp\\u003eIn the case of Henan Province People's Hospital, we conducted an FMEA on the entire process of managing anesthetic drugs and class I psychotropic drugs. By calculating the RPN, we identified priority areas for improvement and devised intelligent reform measures. The application of FMEA can make risk investigation more systematic and scientific. FMEA is a proactive analytical method that allows for the prediction and assessment of risks before they occur, enabling the implementation of effective countermeasures. This approach to proactive risk assessment helps health care institutions establish comprehensive risk management mechanisms to ensure the safe and rational use of anesthetic drugs and class I psychotropic drugs.\\u003c/p\\u003e\\u003cp\\u003eFMEA can also facilitate the digital and intelligent reform of management processes. By building systems for pre-review of medical orders, smart interception of empty vials/waste patches, and automatic generation of reports, management efficiency can be improved and drug supervision and rational medication use can be strengthened. The implementation of these reform measures is valuable for medical institutions and is worth extending to other areas.\\u003c/p\\u003e\\u003cp\\u003eThe use of FMEA for proactive risk assessment in the management of anesthetic drugs and class I psychotropic drugs in inpatient pharmacy can achieve important outcomes. This approach can not only reduce management risks but can also enhance the quality and efficiency of management. In the future, the application of FMEA should be enhanced together with continuous improvement of management processes to provide greater patient safety and ensure rational medication use.\\u003c/p\\u003e\\u003cp\\u003e\\u003cstrong\\u003eStudy Limitations\\u003c/strong\\u003e\\u003c/p\\u003e\\u003cp\\u003eAlthough this study achieved positive results regarding active risk assessment for anesthetic drugs and class I psychotropic drugs in inpatient pharmacy using FMEA, there are some limitations that should be considered and improved in future research. Firstly, this study was conducted using the Henan Provincial People’s Hospital as a sample. Although the sample is somewhat representative, the results may be influenced by the specific hospital environment and cultural background. Therefore, when generalizing to other medical institutions, it is necessary to consider the actual conditions and differences among different hospitals. Secondly, data collection and processing are critical stages in FMEA. The data in this study mainly came from the HIS and surveys, which may include some subjectivity and errors. Future research could consider using more objective and comprehensive data collection methods to improve the accuracy and reliability of the analysis. Thirdly, in this study, we primarily focused on internal management processes of the inpatient pharmacy , without fully considering the impact of external factors on the management of anesthetic drugs and class I psychotropic drugs. For instance, changes in policies and regulations, as well as the stability of suppliers, could greatly affect drug management. Future research could expand the scope of the study to comprehensively consider the impact of both internal and external factors on management risks.\\u003c/p\\u003e\\u003cp\\u003eIn summary, this study achieved certain outcomes in applying FMEA for proactive risk assessment in the management of anesthetic drugs and class I psychotropic drugs in inpatient pharmacy; yet, some limitations remain. Future research should delve deeper into these limitations to help in the development of more comprehensive and accurate risk management strategies and to offer suggestions for medical institutions.\\u003c/p\\u003e\"},{\"header\":\"Declarations\",\"content\":\"\\u003cp\\u003eThis study focuses on the application of the FAME management tool and primarily involves the analysis of existing administrative and operational data. It does not directly engage with human subjects in a way that requires obtaining informed consent, nor does it involve any experimental interventions on humans or animals. Therefore, according to the relevant national regulations and institutional review board standards, the need for ethics approval for this study is deemed unnecessary.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eAcknowledgements\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eWe extend our gratitude to the Henan Provincial People\\u0026rsquo;s Hospital for their support in the implementation of the project.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eAuthor contributions\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eLulu Zhang and Xiuling He designed and executed the study, listened to lectures from FMEA experts, and wrote the manuscript. \\u0026nbsp; \\u0026nbsp;Yimeng Wang，Li Huang，Xiaoxia Du and Mingzhou Liu conceived the study, participated in its study, and helped to draft the manuscript.All the authors have read and approved the final manuscript.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eFunding\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eThis research was not supported by any funding.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eCompeting interests\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eThe authors declare no competing interests.\\u003c/p\\u003e\"},{\"header\":\"References\",\"content\":\"\\u003col\\u003e\\n\\u003cli\\u003eMan, C., Zou, W., Yang, S., Guan, X. \\u0026amp; Shi, L. Study On the Control of Anesthetic and Psychotropic Drugs V \\u0026mdash; Comparative Study of Domestic and International Control Systems for Anesthetic and Psychotropic Drugs. \\u003cem\\u003eChina Pharmacy\\u003c/em\\u003e. 28, 23-26 (2017).\\u003c/li\\u003e\\n\\u003cli\\u003eLiu, D. et al. Consensus On Information Management of Anesthetic Drugs and Class I Psychotropic Drugs in Medical Institutions. \\u003cem\\u003eHerald of Medicine\\u003c/em\\u003e. 41, 1-7 (2022).\\u003c/li\\u003e\\n\\u003cli\\u003eXv, Y., Chen, Q. \\u0026amp; Chen, X. Interpretation of New Policies Related to the Management of Anesthetic and Psychotropic Drugs in Medical Institutions. \\u003cem\\u003eChina Prescription Drug\\u003c/em\\u003e. 20, 45-46 (2022).\\u003c/li\\u003e\\n\\u003cli\\u003eDe Vries, E. N., Ramrattan, M. A., Smorenburg, S. M., Gouma, D. J. \\u0026amp; Boermeester, M. A. The Incidence and Nature of in-Hospital Adverse Events: A Systematic Review. \\u003cem\\u003eQuality \\u0026amp; safety in health care\\u003c/em\\u003e. 17, 216-223 (2008).\\u003c/li\\u003e\\n\\u003cli\\u003eLiu, H., Liu, L. \\u0026amp; Liu, N. Risk Evaluation Approaches in Failure Mode and Effects Analysis: A Literature Review. \\u003cem\\u003eEXPERT SYST APPL\\u003c/em\\u003e. 40, 828-838 (2013).\\u003c/li\\u003e\\n\\u003cli\\u003eLa Russa, R. et al. Proactive Risk Assessment through Failure Mode and Effect Analysis (Fmea) for Haemodialysis Facilities: A Pilot Project. \\u003cem\\u003eFRONT PUBLIC HEALTH\\u003c/em\\u003e. 10, 823680 (2022).\\u003c/li\\u003e\\n\\u003cli\\u003eMicheletta, F. et al. Proactive Risk Assessment through Failure Mode and Effect Analysis (Fmea) for Perioperative Management Model of Oral Anticoagulant Therapy: A Pilot Project. \\u003cem\\u003eINT J ENV RES PUB HE\\u003c/em\\u003e. 19, 16430 (2022).\\u003c/li\\u003e\\n\\u003cli\\u003eWu, C., Tian, Q., Wang, H. et al. Failure mode and effects analysis-based strategies for controlling multidrug-resistant organism infections in cancer patients. Sci Rep 14, 28564 (2024).\\u003c/li\\u003e\\n\\u003cli\\u003eGOV, Notice of the National Health Commission Office On Strengthening the Management of Anesthetic Drugs and Class I Psychotropic Drugs in Medical Institutions,Available at: Http://Www.Nhc.Gov.Cn/Yzygj/S7659/202009/Ee4a21C2756F440E98F78D2533D7539a.Shtml(Accessed September 15, 2020). \\u003c/li\\u003e\\n\\u003cli\\u003eGOV, Ministry of Health. Notice On Issuing \\u0026quot;Regulations On the Management of Anesthetics and Category I Psychotropic Drugs in Medical Institutions\\u0026quot;,Available at: Http://Www.Nhc.Gov.Cn/Wjw/Gfxwj/201304/a2D16F97Ec064065B2185Ebc60Dc3B47.Shtml(Accessed November 14, 2005). \\u003c/li\\u003e\\n\\u003cli\\u003eGOV, Anesthetic and Psychotropic Drug Management Regulations (2016 Revision),Available at: Http://Www.Nhc.Gov.Cn/Fzs/S3576/201808/8F19C4Bd124F4Eae9506Aefb9Cfd9C74.Shtml(Accessed August 30, 2018). \\u003c/li\\u003e\\n\\u003cli\\u003eLiu, X., Li, Z. \\u0026amp; Li, Y. Study On the Control Issues of Psychotropic Drugs in China From a Sino-Us Comparative Perspective. \\u003cem\\u003eMED LAW\\u003c/em\\u003e. 13, 48-52 (2021).\\u003c/li\\u003e\\n\\u003cli\\u003eLi, F. Precise Supervision and Collective Efforts to Cut Off the Channels Where Drugs Transform Into Narcotics. \\u003cem\\u003eChina Anti-Drug Journal\\u003c/em\\u003e, 2023:1.\\u003c/li\\u003e\\n\\u003cli\\u003eXing, X. et al. Fine-Tuning and Effect Evaluation of Anesthesiology Prescription Pre-Verification Rules Based On Evidence. \\u003cem\\u003eChina Pharmacy\\u003c/em\\u003e. 35, 1690-1695 (2024).\\u003c/li\\u003e\\n\\u003cli\\u003eSuo, W. et al. Survey and Analysis of the Current Status of Inpatient Medical Order Review and Verification Work in Beijing\\u0026apos;s Municipal Hospitals. \\u003cem\\u003eChina Pharmacy\\u003c/em\\u003e. 35, 1266-1270 (2024).\\u003c/li\\u003e\\n\\u003cli\\u003ePeng, H. et al. Practice of Promoting Rational Use of Antibacterial Drugs in Outpatient Services through Special Pre-Prescription Verification. \\u003cem\\u003eChina Pharmacy\\u003c/em\\u003e. 32, 2662-2667 (2021).\\u003c/li\\u003e\\n\\u003cli\\u003eLi, Y., Wen, H., Lai, S. \\u0026amp; Li, D. Use of Information Technology to Supervise Special Drugs. \\u003cem\\u003ePharmaceutical Care and Research\\u003c/em\\u003e. 18, 235-237 (2018).\\u003c/li\\u003e\\n\\u003cli\\u003eYuan, L. \\u0026amp; Yang, Y. Problems and Strategies in the Use and Management of Anesthetic Drugs and Class I Psychotropic Drugs. \\u003cem\\u003eClinical Research\\u003c/em\\u003e. 28, 197-198 (2020).\\u003c/li\\u003e\\n\\u003cli\\u003eWang, X. The Application of Pdca Cycle Management in Reducing the Error Rate in the Management of Anesthetic and Psychotropic Drugs in Inpatient Pharmacy. \\u003cem\\u003eContemporary Medicine Symposium\\u003c/em\\u003e. 15, 159-160 (2017).\\u003c/li\\u003e\\n\\u003cli\\u003eYu, Q., Li, T., Li, C. \\u0026amp; Tang, Y. Analysis of the Practical Effects of Intelligent Information Management of Anesthetic Drugs and Class I Psychotropic Drugs in Inpatient Pharmacy. \\u003cem\\u003eEvaluation and Analysis of Drug-Use in Hospitals of China\\u003c/em\\u003e. 24, 502-505 (2024).\\u003c/li\\u003e\\n\\u003c/ol\\u003e\"}],\"fulltextSource\":\"\",\"fullText\":\"\",\"funders\":[],\"hasAdminPriorityOnWorkflow\":false,\"hasManuscriptDocX\":true,\"hasOptedInToPreprint\":true,\"hasPassedJournalQc\":\"\",\"hasAnyPriority\":false,\"hideJournal\":false,\"highlight\":\"\",\"institution\":\"\",\"isAcceptedByJournal\":true,\"isAuthorSuppliedPdf\":false,\"isDeskRejected\":\"\",\"isHiddenFromSearch\":false,\"isInQc\":false,\"isInWorkflow\":false,\"isPdf\":false,\"isPdfUpToDate\":true,\"isWithdrawnOrRetracted\":false,\"journal\":{\"display\":true,\"email\":\"info@researchsquare.com\",\"identity\":\"scientific-reports\",\"isNatureJournal\":false,\"hasQc\":true,\"allowDirectSubmit\":false,\"externalIdentity\":\"scirep\",\"sideBox\":\"Learn more about [Scientific Reports](http://www.nature.com/srep/)\",\"snPcode\":\"\",\"submissionUrl\":\"\",\"title\":\"Scientific Reports\",\"twitterHandle\":\"\",\"acdcEnabled\":true,\"dfaEnabled\":true,\"editorialSystem\":\"stoa\",\"reportingPortfolio\":\"Scientific Reports\",\"inReviewEnabled\":true,\"inReviewRevisionsEnabled\":true},\"keywords\":\"Anesthetic drugs and Class I psychotropic drugs, Failure mode and effects analysis, Information management, Medical institutions \",\"lastPublishedDoi\":\"10.21203/rs.3.rs-6090426/v1\",\"lastPublishedDoiUrl\":\"https://doi.org/10.21203/rs.3.rs-6090426/v1\",\"license\":{\"name\":\"CC BY 4.0\",\"url\":\"https://creativecommons.org/licenses/by/4.0/\"},\"manuscriptAbstract\":\"\\u003cp\\u003e\\u003cstrong\\u003eObjctive: \\u003c/strong\\u003eIn China, anesthetic drugs and class I psychotropic drugs are among the most stringently managed special medications within medical institutions. In this study, we aimed to use Failure Mode and Effects Analysis (FMEA) to conduct a proactive risk assessment of management models for these drugs, addressing their unique management requirements.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eMethods:\\u003c/strong\\u003e We established a multidisciplinary team and identified five main stages of the process. Each stage was divided into micro-activities to identify potential failure modes and their possible consequences. A risk priority number for each failure mode was calculated.\\u0026nbsp;\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eResults: \\u003c/strong\\u003eThe management of anesthetic drugs and class I psychotropic drugs in inpatient pharmacy revealed 15 types of failure mode. The high-priority errors identified included patients' inability to receive medications in a timely manner and discrepancies between the number of empty ampules collected and dispensed, the latter of which could increase the management risks associated with these drugs.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eConclusion: \\u003c/strong\\u003eThe FMEA method can be used to identify failures in the management of anesthetic drugs and class I psychotropic drugs and in the design and implementation of a targeted information management system integrating modern information technology.\\u003c/p\\u003e\",\"manuscriptTitle\":\"Proactive Risk Assessment Using Failure Mode and Effects Analysis in a Management Model of Anesthetic Drugs and Class I Psychotropic Drugs in Inpatient Pharmacy: A Pilot Project\",\"msid\":\"\",\"msnumber\":\"\",\"nonDraftVersions\":[{\"code\":1,\"date\":\"2025-05-12 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