Drug Shortages and Patient Safety

McLaughlin, Milena M.; Skoglund, Erik

doi:10.1097/nan.0000000000000101

Cited by 7 publications

(6 citation statements)

References 13 publications

(13 reference statements)

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“…The characteristics of drug shortages, such as the assortment or range of non-available products, are different in each country but there are some common themes. In the USA, the majority of shortages were reported to occur among sterile injectable medications (McLaughlin and Skoglund, 2015 ). In addition, the number of generic medicines experiencing shortages in the USA has risen appreciably in recent years from 154 in 2007 to 456 in 2012 (United States Government Accountability Office Report, 2014 ).…”

Section: Introductionmentioning

confidence: 99%

Systemic Measures and Legislative and Organizational Frameworks Aimed at Preventing or Mitigating Drug Shortages in 28 European and Western Asian Countries

Bochenek

Abilova

Alkan³

et al. 2018

Front. Pharmacol.

110

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Drug shortages have been identified as a public health problem in an increasing number of countries. This can negatively impact on the quality and efficiency of patient care, as well as contribute to increases in the cost of treatment and the workload of health care providers. Shortages also raise ethical and political issues. The scientific evidence on drug shortages is still scarce, but many lessons can be drawn from cross-country analyses. The objective of this study was to characterize, compare, and evaluate the current systemic measures and legislative and organizational frameworks aimed at preventing or mitigating drug shortages within health care systems across a range of European and Western Asian countries. The study design was retrospective, cross-sectional, descriptive, and observational. Information was gathered through a survey distributed among senior personnel from ministries of health, state medicines agencies, local health authorities, other health or pharmaceutical pricing and reimbursement authorities, health insurance companies and academic institutions, with knowledge of the pharmaceutical markets in the 28 countries studied. Our study found that formal definitions of drug shortages currently exist in only a few countries. The characteristics of drug shortages, including their assortment, duration, frequency, and dynamics, were found to be variable and sometimes difficult to assess. Numerous information hubs were identified. Providing public access to information on drug shortages to the maximum possible extent is a prerequisite for performing more advanced studies on the problem and identifying solutions. Imposing public service obligations, providing the formal possibility to prescribe unlicensed medicines, and temporary bans on parallel exports are widespread measures. A positive finding of our study was the identification of numerous bottom-up initiatives and organizational frameworks aimed at preventing or mitigating drug shortages. The experiences and lessons drawn from these initiatives should be carefully evaluated, monitored, and presented to a wider international audience for careful appraisal. To be able to find solutions to the problem of drug shortages, there is an urgent need to develop a set of agreed definitions for drug shortages, as well as methodologies for their evaluation and monitoring. This is being progressed.

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Section: Introductionmentioning

confidence: 99%

Systemic Measures and Legislative and Organizational Frameworks Aimed at Preventing or Mitigating Drug Shortages in 28 European and Western Asian Countries

Bochenek

Abilova

Alkan³

et al. 2018

Front. Pharmacol.

110

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“…The United States (US) is the country with more publications in the field (26 references) than many other countries. Many of these publications describe the professionals’ perspective of the situation at the health care jurisdictional level (Morrison, 2011; Golembiewski, 2012; Griffith et al, 2012; Becker et al, 2013; McKeever et al, 2013; McLaughlin et al, 2013; Bible et al, 2014; Goldsack et al, 2014; Butterfield et al, 2015; Caulder et al, 2015; McLaughlin and Skoglund, 2015; Gabrielli et al, 2016; Parsons et al, 2016; Setayesh and Mackey, 2016; Bocquet et al, 2017; Fox and Tyler, 2017; Mazer-Amirshahi et al, 2017; Rinaldi et al, 2017; Schwartzberg et al, 2017). Another study performed a comparison of medicines shortages between two hospital settings, one from Arabia Saudi and the other from the US (Alsheikh et al, 2016).…”

Section: Resultsmentioning

confidence: 99%

“…Published studies in hospitals allow a better follow up of the health consequences of medicine shortages (Pauwels et al, 2015; de Weerdt et al, 2017); which is more difficult in ambulatory care (Golembiewski, 2012; Becker et al, 2013; Goldsack et al, 2014; Jagsi et al, 2014; Chen et al, 2016). This scoping review identified a number of published articles describing inpatient challenges regarding medicine shortages in the US (Morrison, 2011; Golembiewski, 2012; Griffith et al, 2012; Becker et al, 2013; McKeever et al, 2013; McLaughlin et al, 2013; Bible et al, 2014; Goldsack et al, 2014; Butterfield et al, 2015; Caulder et al, 2015; McLaughlin and Skoglund, 2015; Gabrielli et al, 2016; Parsons et al, 2016; Setayesh and Mackey, 2016; Bocquet et al, 2017; Fox and Tyler, 2017; Mazer-Amirshahi et al, 2017; Rinaldi et al, 2017; Schwartzberg et al, 2017).…”

Section: Resultsmentioning

confidence: 99%

Medicine Shortages: Gaps Between Countries and Global Perspectives

et al. 2019

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Introduction: Over the last decade, global health policies and different research areas have focused on the relevance and impact of medicine shortages. Published studies suggest there have been difficulties with access to medicines since the beginning of the 20th century, and there have been advances in our understanding and management of the problem since then. However, in view of global and regional health care concerns with shortages, we believe this phenomenon needs to be characterized and described more fully regarding the types of medicines affected, possible causes, and potential strategies to address these. The aim of this scoping review was to identify, compare if possible, and characterize the recent literature regarding the situation of medicines shortages between countries, and provide different perspectives, including a global context and national approaches. Methodology: A scoping study presented as a narrative review of the situation and findings principally based on published articles. Results: Based on the reported cases in the literature, a typology of medicines shortage and supply interruption episodes and their causes were proposed; national approaches to notify and manage the medicines shortages cases were described and classified by update frequency; principal differences between market and supply chain management perspectives of the situation were identified and global and countries’ perspectives were described. Conclusion: Policy makers require solutions that prevent those cases in which the population’s health is affected by episodes of medicine shortages and/or interruption in the supply chain. There is also a need to generate a glossary related to logistics management and the availability of medicines which will be useful to understand and overcome shortages. In addition, recognize that potential solutions are not only related with actions linked to research, development and innovation, but much wider. Overall, we believe this article can act as a basis for future discussions in this important area.

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“…Other studies have also identified information flow as an essential focus area in managing DCs owing to drug shortage. 3,4,14,17 However, timely communication and ensuring that messages about DCs reach everyone is difficult and can be extremely time consuming. 4,17 The pharmacy personnel in the focus group interviews acknowledged this.…”

Section: Discussionmentioning

confidence: 99%

Drug change: ‘a hassle like no other’. An in-depth investigation using the Danish patient safety database and focus group interviews with Danish hospital personnel

Poulsen

Rishøj²,

Fischer³

et al. 2019

Therapeutic Advances in Drug Safety

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Background: Drug change (DC) is a common challenge in Danish hospitals. It affects the work of hospital personnel and has potentially serious patient safety consequences. Focus on medication safety is becoming increasingly important in the prevention of adverse events. The aim of this study is to identify and describe patient safety challenges related to DCs, and to explore potential facilitators to improve patient safety in the medication process in Danish hospital setting. Method: Two qualitative methods were combined. Data were obtained from the Danish Patient Safety Database (DPSD) containing incidents reports of adverse events related to DCs. Additionally, five semi-structured focus group interviews with hospital personnel (doctors, nurses, pharmacists and pharmacy technicians) from the five regions of Denmark were held. Results: The DPSD search identified 88 incidents related to DCs due to tender or drug shortage. The incidents were linked to prescribing errors, incorrect dose being dispensed/administered, and delayed/omitted treatment. Four themes from the interviews emerged: (1) challenges related to the drug itself; (2) situational challenges; (3) challenges related to the organization/IT systems/personnel; (4) facilitators/measures to ensure patient safety. Conclusion: DC is as a complex challenge, especially related to drug shortage. The results allow for a deeper understanding of the challenges and possible facilitators of DCs on the individual and organizational level. Pharmacy personnel were identified to play a key role in ensuring patient safety of DCs in hospitals. Indeed, this emphasizes that pharmacy personnel should be engaged in developing patient safety strategies and support hospital personnel around drug changes.

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Drug Shortages and Patient Safety

Cited by 7 publications

References 13 publications

Systemic Measures and Legislative and Organizational Frameworks Aimed at Preventing or Mitigating Drug Shortages in 28 European and Western Asian Countries

Systemic Measures and Legislative and Organizational Frameworks Aimed at Preventing or Mitigating Drug Shortages in 28 European and Western Asian Countries

Medicine Shortages: Gaps Between Countries and Global Perspectives

Drug change: ‘a hassle like no other’. An in-depth investigation using the Danish patient safety database and focus group interviews with Danish hospital personnel

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