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      Current Situation, Determinants, and Solutions to Drug Shortages in Shaanxi Province, China: A Qualitative Study

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          Abstract

          Objective

          Drug shortages were a complex global problem. The aim of this study was to analyze, characterize, and assess the drug shortages, and identify possible solutions in Shaanxi Province, western China.

          Methods

          A qualitative methodological approach was conducted during May–June 2015 and December 2015–January 2016. Semi-structured interviews were performed to gather information from representatives of hospital pharmacists, wholesalers, pharmaceutical producers, and local health authorities.

          Results

          Thirty participants took part in the study. Eight traditional Chinese medicines and 87 types of biologicals and chemicals were reported to be in short supply. Most were essential medicines. Five main determinants of drug shortages were detected: too low prices, too low market demands, Good Manufacturing Practice (GMP) issues, materials issues, and approval issues for imported drugs. Five different solutions were proposed by the participants: 1) let the market decide the drug price; 2) establish an information platform; 3) establish a reserve system; 4) enhance the communication among the three parties in the supply chain; and 5) improve hospital inventory management.

          Conclusions

          Western China was currently experiencing a serious drug shortage. Numerous reasons for the shortage were identified. Most drug shortages in China were currently because of “too low prices.” To solve this problem, all of the stakeholders, especially the government, needed to participate in managing the drug shortages.

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          Most cited references19

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          Understanding the barriers to setting up a healthcare quality improvement process in resource-limited settings: a situational analysis at the Medical Department of Kamuzu Central Hospital in Lilongwe, Malawi

          Background Knowledge regarding the best approaches to improving the quality of healthcare and their implementation is lacking in many resource-limited settings. The Medical Department of Kamuzu Central Hospital in Malawi set out to improve the quality of care provided to its patients and establish itself as a recognized centre in teaching, operations research and supervision of district hospitals. Efforts in the past to achieve these objectives were short-lived, and largely unsuccessful. Against this background, a situational analysis was performed to aid the Medical Department to define and prioritize its quality improvement activities. Methods A mix of quantitative and qualitative methods was applied using checklists for observed practice, review of registers, key informant interviews and structured patient interviews. The mixed methods comprised triangulation by including the perspectives of the clients, healthcare providers from within and outside the department, and the field researcher’s perspectives by means of document review and participatory observation. Results Human resource shortages, staff attitudes and shortage of equipment were identified as major constraints to patient care, and the running of the Medical Department. Processes, including documentation in registers and files and communication within and across cadres of staff were also found to be insufficient and thus undermining the effort of staff and management in establishing a sustained high quality culture. Depending on their past experience and knowledge, the stakeholder interviewees revealed different perspectives and expectations of quality healthcare and the intended quality improvement process. Conclusions Establishing a quality improvement process in resource-limited settings is an enormous task, considering the host of challenges that these facilities face. The steps towards changing the status quo for improved quality care require critical self-assessment, the willingness to change as well as determined commitment and contributions from clients, staff and management.
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            Impact of drug shortages on U.S. health systems.

            A study was performed to quantify the personnel resources required to manage drug shortages, define the impact of drug shortages on health systems nationwide, and assess the adequacy of information resources available to manage drug shortages. An online survey was sent to the 1322 members of the American Society of Health-System Pharmacists who were identified as directors of pharmacy. Survey recipients were asked to identify which of the 30 most recent drug shortages listed affected their health system, to identify actions taken to manage the shortage, and to rate the impact of each shortage. Employees responsible for completing predefined tasks were identified, and the average time spent by each type of employee completing these tasks was estimated. Labor costs associated with managing shortages were calculated. A total of 353 respondents completed the survey, yielding a response rate of 27%. Pharmacists and pharmacy technicians spent more time managing drug shortages than did physicians and nurses. There was a significant association between the time spent managing shortages and the size of the institution, the number of shortages managed, and the institution's level of automation. Overall, 70% of the respondents felt that the information resources available to manage drug shortages were not good. The labor costs associated with managing shortages in the United States is an estimated $216 million annually. A survey of directors of pharmacy revealed that labor costs and the time required to manage drug shortages are significant and that current information available to manage drug shortages is considered suboptimal.
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              Insights into European Drug Shortages: A Survey of Hospital Pharmacists

              Drug shortages are a complex and global phenomenon. When a drug cannot be delivered at the moment of patient demand, every stakeholder in the health care system is affected. The aim of this study was to investigate the characteristics, clinical impact, financial impact and management of drug shortages in European hospital pharmacies and identify opportunities for prevention and mitigation of drug shortages in Europe. An online survey was designed based on a review of the literature and interviews and was sent to subscribers of Hospital Pharmacy Europe between June and September 2013. Forty-five percent of respondents (n = 161) indicated that life sustaining or life preserving drugs such as oncology drugs were affected by drug shortages. More than 30% of respondents indicated that drug shortages in Europe were always or often associated with increased costs for hospitals, increased personnel costs and more expensive alternative drugs (n = 161). On the question when information about a drug shortage was obtained, 42% of respondents answered that information from the pharmaceutical company was obtained at the time of no delivery, 50% indicated that information from the wholesaler was obtained at the time of no delivery, while 40% of respondents indicated that information was never or rarely received from the government (n = 161). Fifty seven percent of respondents strongly agreed that an obligation to the producer to notify further shortages could help to solve the problem (n = 161). These results showed that pharmaceutical companies and wholesalers are already involved in the management of drug shortages, while a role is still reserved for the government. Mandatory notification in advance and centralized information can help to reduce workload for hospital pharmacists, will allow early anticipation of drug shortages and will facilitate mitigation of the clinical impact on patients.
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                Author and article information

                Contributors
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                25 October 2016
                2016
                : 11
                : 10
                : e0165183
                Affiliations
                [1 ]Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmacy, Xi'an Jiaotong University, Xi’an, China
                [2 ]Center for Drug Safety and Policy Research, Xi'an Jiaotong University, Xi’an, China
                Jagiellonian University, POLAND
                Author notes

                Competing Interests: The authors have declared that no competing interests exist.

                • Conceptualization: CJY LNW.

                • Data curation: WFC QS.

                • Formal analysis: CJY WWZ.

                • Funding acquisition: CJY YF.

                • Investigation: CJY LNW.

                • Methodology: CJY YF.

                • Project administration: CJY.

                • Resources: YF.

                • Software: LNW WFC.

                • Supervision: YF.

                • Validation: CJY YF.

                • Visualization: ZJL.

                • Writing – original draft: CJY YF.

                • Writing – review & editing: CJY YF.

                Article
                PONE-D-16-14953
                10.1371/journal.pone.0165183
                5079602
                27780218
                cc9d89f8-76eb-4200-a140-bf7a499c8f5a
                © 2016 Yang et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 13 April 2016
                : 8 October 2016
                Page count
                Figures: 0, Tables: 4, Pages: 16
                Funding
                Funded by: funder-id http://dx.doi.org/10.13039/501100001809, National Natural Science Foundation of China;
                Award ID: 71503197
                Award Recipient :
                Funded by: funder-id http://dx.doi.org/10.13039/501100001809, National Natural Science Foundation of China;
                Award ID: 71473192
                Award Recipient :
                Funded by: China Medical Board Open Competition Research Program
                Award ID: 14-196
                Award Recipient :
                Funded by: Young Talent Support Plan
                Award Recipient :
                This work is supported by National Natural Science Foundation of China (71503197 and 71473192) the China Medical Board Open Competition Research Program (14-196), and the “Young Talent Support Plan” of Xian Jiaotong University. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
                Categories
                Research Article
                Medicine and Health Sciences
                Pharmacology
                Drugs
                Social Sciences
                Economics
                Resource Management (Economics)
                Shortages
                Medicine and Health Sciences
                Pharmacology
                Drug Information
                People and Places
                Population Groupings
                Professions
                Pharmacists
                People and Places
                Geographical Locations
                Asia
                China
                Medicine and Health Sciences
                Pharmacology
                Drug Research and Development
                Medicine and Health Sciences
                Pharmacology
                Pharmacokinetics
                Drug Distribution
                Physical Sciences
                Materials Science
                Raw Materials
                Custom metadata
                All relevant data are within the paper and its Supporting Information files.

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