Dataset Information

Prospective Risk Assessment of Medicine Shortages in Europe and Israel: Findings and Implications.

ABSTRACT: Introduction:While medicine shortages are complex, their mitigation is more of a challenge. Prospective risk assessment as a means to mitigate possible shortages, has yet to be applied equally across healthcare settings. The aims of this study have been to: 1) gain insight into risk-prevention against possible medicine shortages among healthcare experts; 2) review existing strategies for minimizing patient-health risks through applied risk assessment; and 3) learn from experiences related to application in practice. Methodology:A semi-structured questionnaire focusing on medicine shortages was distributed electronically to members of the European Cooperation in Science and Technology (COST) Action 15105 (28 member countries) and to hospital pharmacists of the European Association of Hospital Pharmacists (EAHP) (including associated healthcare professionals). Their answers were subjected to both qualitative and quantitative analysis (Microsoft Office Excel 2010 and IBM SPSS Statistics®) with descriptive statistics based on the distribution of responses. Their proportional difference was tested by the chi-square test and Fisher's exact test for independence. Differences in the observed ordinal variables were tested by the Mann-Whitney or Kruskal-Wallis test. The qualitative data were tabulated and recombined with the quantitative data to observe, uncover and interpret meanings and patterns. Results:The participants (61.7%) are aware of the use of risk assessment procedures as a coping strategy for medicine shortages, and named the particular risk assessment procedure they are familiar with failure mode and effect analysis (FMEA) (26.4%), root cause analysis (RCA) (23.5%), the healthcare FMEA (HFMEA) (14.7%), and the hazard analysis and critical control point (HACCP) (14.7%). Only 29.4% report risk assessment as integrated into mitigation strategy protocols. Risk assessment is typically conducted within multidisciplinary teams (35.3%). Whereas 14.7% participants were aware of legislation stipulating risk assessment implementation in shortages, 88.2% claimed not to have reported their findings to their respective official institutions. 85.3% consider risk assessment a useful mitigation strategy. Conclusion:The study indicates a lack of systematically organized tools used to prospectively analyze clinical as well as operationalized risk stemming from medicine shortages in healthcare. There is also a lack of legal instruments and sufficient data confirming the necessity and usefulness of risk assessment in mitigating medicine shortages in Europe.

SUBMITTER: Miljkovic N

PROVIDER: S-EPMC7114887 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Prospective Risk Assessment of Medicine Shortages in Europe and Israel: Findings and Implications.

Miljković Nenad N Godman Brian B Kovačević Milena M Polidori Piera P Tzimis Leonidas L Hoppe-Tichy Torsten T Saar Marika M Antofie Ioan I Horvath Laszlo L De Rijdt Thomas T Vida Róbert György RG Kkolou Elena E Preece David D Tubić Biljana B Peppard Joan J Martinez Alicia A Yubero Cristina Garcia CG Haddad Ratiba R Rajinac Dragana D Zelić Pavle P Jenzer Helena H Tartar Franci F Gitler Gunda G Jeske Martina M Davidescu Michal M Beraud Guillaume G Kuruc-Poje Darija D Haag Kristine Sakstrup KS Fischer Hanne H Sviestina Inese I Ljubojević Gordana G Markestad Anne A Vujić-Aleksić Vesna V Nežić Lana L Crkvenčić Anica A Linnolahti Johanna J Ašanin Bogdan B Duborija-Kovačević Nataša N Bochenek Tomasz T Huys Isabelle I Miljković Branislava B

Frontiers in pharmacology 20200326

<h4>Introduction</h4>While medicine shortages are complex, their mitigation is more of a challenge. Prospective risk assessment as a means to mitigate possible shortages, has yet to be applied equally across healthcare settings. The aims of this study have been to: 1) gain insight into risk-prevention against possible medicine shortages among healthcare experts; 2) review existing strategies for minimizing patient-health risks through applied risk assessment; and 3) learn from experiences relate ...[more]

PMID: 32273845

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Project description:Objective: This study aimed to obtain a comprehensive overview on the perception, attitudes, and experience of European pharmacists with prospective risk assessment procedures in everyday practice, as well as to identify challenges and solutions. This is a follow-up study to the surveys on prospective risk assessment previously carried out within the COST Action 15105 among pharmacists across Europe. Methodology: In-depth interviews were performed using an interview guide comprising 25 questions. Interviews were transcribed ad verbatim and imported into NVivo 10 for framework analysis. In NVivo, the interviews were coded through assigning text segments to a responding code from a coding tree, covering the full content of the interviews. Coded text segments were then charted into a matrix, and analyzed by interpreting all text segments per code. Results: In total, 18 interviews were conducted. From the framework analysis, 6 codes and 12 sub-codes emerged. Overall, despite citing specific issues pertaining to its implementation, the interviewees considered multi-stakeholder and multi-disciplinary prospective risk assessment to be essential. While healthcare professionals reported being aware of the importance of risk assessment, they cited insufficient knowledge and skills to be a major obstacle in everyday practice. They also reported inadequate IT support since a paper-based system is still widely in use, thereby complicating data extraction to carry out prospective risk assessment. Conclusion: While prospective risk assessment was found to be valuable, interviewees also found it to be a resource-intensive and time-consuming process. Due to resource constraints, it may not be possible or desirable to conduct prospective risk assessment for every shortage. However, for critical-essential drugs, it is crucial to have a ready-to-use substitute based on risk assessment. Moreover, potential risks of substitutes on patient health should be identified before a shortage occurs and the substitute is dispensed as an alternative.

Project description:The European Commission requested the EFSA Panel on Plant Health to prepare and deliver risk assessments for commodities listed in Commission Implementing Regulation EU/2018/2019 as 'High risk plants, plant products and other objects'. This Scientific Opinion covers all plant health risks posed by unrooted cuttings of Jasminum polyanthum produced in a protected environment (greenhouse) that are imported from Israel, taking into account the available scientific information, including the technical information provided by the NPPO of Israel by 15 March 2020. The relevance of an EU quarantine pest for this opinion was based on evidence that: (i) the pest is present in Israel; (ii) Jasminum is a host of the pest; and (iii) the pest can be associated with the commodity. The relevance of any other pest, not regulated in the EU, was based on evidence that: (i) the pest is present in Israel; (ii) the pest is absent in the EU; (iii) Jasminum is a host of the pest; (iv) the pest can be associated with the commodity and (v) the pest may have an impact and can pose a potential risk for the EU territory. Six species, the EU-quarantine pest Scirtothrips dorsalis, and the EU non-regulated pests Aonidiella orientalis, Milviscutulus mangiferae, Paracoccus marginatus, Pulvinaria psidii and Colletotrichum siamense fulfilled all relevant criteria and were selected for further evaluation. For these pests, the risk mitigation measures proposed in the technical dossier from Israel were evaluated taking into account the possible limiting factors. For these pests, an expert judgement is given on the likelihood of pest freedom taking into consideration the risk mitigation measures acting on the pest, including uncertainties associated with the assessment. The estimated degree of pest freedom varies among the pests evaluated, with S. dorsalis being the pest most frequently expected on the imported plants. The Expert Knowledge Elicitation indicated, with 95% certainty, that between 9,958 and 10,000 bags per 10,000 would be free of S. dorsalis.

Project description: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.

Project description:The EFSA Panel on Plant health was requested to prepare and deliver risk assessments for commodities listed in the relevant Implementing Acts as 'High risk plants, plant products and other objects' (Commission Implementing Regulation (EU) 2018/2019 establishing a provisional list of high risk plants, plant products or other objects, within the meaning of Article 42 of Regulation (EU) 2016/2031). This scientific opinion covers the plant health risks posed by the following commodities: (i) scions and (ii) grafted plants of Persea americana imported from Israel, taking into account the available scientific information, including the technical information provided by the Plant Protection and Inspection Services from Israel. The relevance of an EU quarantine pest for this opinion was based on evidence that: (i) the pest is present in Israel; (ii) P. americana is a host of the pest and (iii) the pest can be associated with the commodity. The relevance of any other pest, not regulated in the EU, was based on evidence that: (i) the pest is present in Israel; (ii) the pest is absent in the EU; (iii) P. americana is a host of the pest; (iv) the pest can be associated with the commodity and (v) the pest may have an impact and can pose a potential risk for the EU territory. Twenty-six pests (15 insects, one mite, 9 fungi and one viroid) that fulfilled all criteria were selected for further evaluation. For the 26 selected pests, the risk mitigation measures proposed in the technical dossier were evaluated. Limiting factors on the effectiveness of the measures were documented. For each of the 26 pests, an expert judgement is given on the likelihood of pest freedom taking into consideration the risk mitigation measures acting on the pest, including any uncertainties. The fungi Lasiodiplodia pseudotheobromae and Neoscytalidium dimidiatum were the pests most frequently expected on the imported commodities. The Expert Knowledge Elicitation indicated, with 95% certainty, that between 9,573 and 10,000 bundles of scions per 10,000; and 9,747 and 10,000 grafted plants per 10,000 would be free of these two fungi.

Dataset Information

Prospective Risk Assessment of Medicine Shortages in Europe and Israel: Findings and Implications.

Publications

Prospective Risk Assessment of Medicine Shortages in Europe and Israel: Findings and Implications.

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