scholarly journals Risk management in an anticancer drug preparation unit: use of Preliminary Risk Analysis method and application to the preparation process

2021 ◽  
Vol 6 (1) ◽  
Author(s):  
Marie-Pauline Gagaille ◽  
Rémi Pieragostini ◽  
Elise Girault ◽  
Yacine Touil ◽  
Marie Chalopin ◽  
...  

Abstract Objectives Preparation of injectable anticancer drugs in hospital pharmacies, in particular of cytotoxics, is a high-risk activity. We used Preliminary Risk Analysis (PRA) to analyse the risks in the different steps of our anticancer drug circuit, including the preparation step (PRA1). Then, to prepare an important change in management of the circuit with the software Chimio® (pooling of three databases for subcontracting), we repeated the analysis of preparation step (PRA2). PRA is known to be time and resource consuming. To overcome this, we developed a strict organisational framework to perform the analysis within a reasonable amount of time. We present the PRA method including its practical implementation, and its application to the anticancer drug preparation process, before and after pooling of Chimio® databases. Methods PRA has two main stages, PRA “system” and PRA “scenario”. A multidisciplinary working group is created for the entire PRA process. PRA “system” is an exploratory and qualitative stage. PRA “scenario” requires the creation of risk assessment tools and decision tools before actually developing, analysing and treating scenarios, with risk reduction actions structured in an action plan. For PRA2 we used the same working group, assessment and decision tools as for PRA1 and we only analysed dangerous situations (DS) that appeared or changed towards more risk, requiring a new action plan. The different PRA only required four 2 h meetings thanks to the investment of a coordinator who is expert in the method. Results In PRA1, the riskiest phase was production while it was the verification and delivery of the finished product in PRA2. The risks were mainly related to management, human and technical dangers in PRA1. Human danger was found to be the main danger in PRA2, followed by organisational danger. Among the 264 scenarios described in PRA1, six of criticality 3 and 69 of criticality 2 have been associated with risk reduction actions. These actions mainly involved managing the risk of human error, with the control system Drugcam® and the standardisation of the pharmaceutical assistants’ training program. In PRA2, 11 scenarios were analysed, including three of criticality 3 and 4 of criticality 2 for which risk reduction measures were taken. Conclusions PRA allowed us to perform an in depth analysis of the highly specific and technical process of anticancer drug preparation. Human danger was one of the most important dangers identified, and it should always be taken into consideration, whatever the measures taken to prevent it. PRA2 was extremely useful to plan the organisation that would result from the new Chimio® database, while involving the team and winning its commitment. It allowed an exhaustive and structured anticipation of this major change. Practical aspects of PRA method implementation we have adopted facilitate its application and can help to deploy it on many areas in our hospitals. Indeed, besides an exhaustive analysis of the risks, this approach promotes collaboration, develops a quality culture and is an excellent tool for team and project management, as well as communication.

2022 ◽  
Vol 12 ◽  
Author(s):  
Neerja Chowdhary ◽  
Corrado Barbui ◽  
Kaarin J. Anstey ◽  
Miia Kivipelto ◽  
Mariagnese Barbera ◽  
...  

With population ageing worldwide, dementia poses one of the greatest global challenges for health and social care in the 21st century. In 2019, around 55 million people were affected by dementia, with the majority living in low- and middle-income countries. Dementia leads to increased costs for governments, communities, families and individuals. Dementia is overwhelming for the family and caregivers of the person with dementia, who are the cornerstone of care and support systems throughout the world. To assist countries in addressing the global burden of dementia, the World Health Organisation (WHO) developed the Global Action Plan on the Public Health Response to Dementia 2017–2025. It proposes actions to be taken by governments, civil society, and other global and regional partners across seven action areas, one of which is dementia risk reduction. This paper is based on WHO Guidelines on risk reduction of cognitive decline and dementia and presents recommendations on evidence-based, multisectoral interventions for reducing dementia risks, considerations for their implementation and policy actions. These global evidence-informed recommendations were developed by WHO, following a rigorous guideline development methodology and involved a panel of academicians and clinicians with multidisciplinary expertise and representing geographical diversity. The recommendations are considered under three broad headings: lifestyle and behaviour interventions, interventions for physical health conditions and specific interventions. By supporting health and social care professionals, particularly by improving their capacity to provide gender and culturally appropriate interventions to the general population, the risk of developing dementia can be potentially reduced, or its progression delayed.


2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Haiko Kurt Jahn ◽  
James Kwan ◽  
Gerard O’Reilly ◽  
Heike Geduld ◽  
Katherine Douglass ◽  
...  

Abstract Background The number of Global Emergency Medicine (GEM) Fellowship training programs are increasing worldwide. Despite the increasing number of GEM fellowships, there is not an agreed upon approach for assessment of GEM trainees. Main body In order to study the lack of standardized assessment in GEM fellowship training, a working group was established between the International EM Fellowship Consortium (IEMFC) and the International Federation for Emergency Medicine (IFEM). A needs assessment survey of IEMFC members and a review were undertaken to identify assessment tools currently in use by GEM fellowship programs; what relevant frameworks exist; and common elements used by programs with a wide diversity of emphases. A consensus framework was developed through iterative working group discussions. Thirty-two of 40 GEM fellowships responded (80% response). There is variability in the use and format of formal assessment between programs. Thirty programs reported training GEM fellows in the last 3 years (94%). Eighteen (56%) reported only informal assessments of trainees. Twenty-seven (84%) reported regular meetings for assessment of trainees. Eleven (34%) reported use of a structured assessment of any sort for GEM fellows and, of these, only 2 (18%) used validated instruments modified from general EM residency assessment tools. Only 3 (27%) programs reported incorporation of formal written feedback from partners in other countries. Using these results along with a review of the available assessment tools in GEM the working group developed a set of principles to guide GEM fellowship assessments along with a sample assessment for use by GEM fellowship programs seeking to create their own customized assessments. Conclusion There are currently no widely used assessment frameworks for GEM fellowship training. The working group made recommendations for developing standardized assessments aligned with competencies defined by the programs, that characterize goals and objectives of training, and document progress of trainees towards achieving those goals. Frameworks used should include perspectives of multiple stakeholders including partners in other countries where trainees conduct field work. Future work may evaluate the usability, validity and reliability of assessment frameworks in GEM fellowship training.


2016 ◽  
Vol 1 (2) ◽  
Author(s):  
Véronique Le Pêcheur ◽  
Laurence Spiesser-Robelet ◽  
Sandy Vrignaud

Abstract: The aim of this paper is to use the Preliminary Risk Analysis (PRA) method to assess the criticality of the different stages in the process of preparing parenteral nutrition bags for use in neonatal resuscitation and, if necessary, improve the handling of the process itself.: A functional analysis of the preparation process was carried out, and three main phases were identified: Phase 1 – Fielding the request; Phase 2 – Production; Phase 3 – Checks. Risks were mapped under 5 category headings (legal, environmental, physical, human and managerial). After the evaluation criteria had been identified, scenario descriptions were drawn up for each dangerous situation in order to ascertain the criticality level (C1–C3, C1 being the least critical) of the different risks and to seek out risk mitigation measures.: The PRA method identified 63 dangerous situations, 77.7 % of which had a very high level of vulnerability. The highest number of such situations was in the production phase. Seventy one scenarios were drawn up (19 for phase 1, 40 for phase 2 and 16 for phase 3, as the same scenario may occur in more than one phase). The study enabled a reduction in system criticalities: initially there were 6 C1 scenarios, 44 C2’s and 21 C3’s and following the study there were 45 C1’s, 26 C2’s and 0 C3 scenarios. The most significant initial risks were linked to environmental, managerial and human factors whilst the most significant residual risks were environmental or legal in nature.: PRA is a viable assessment method in the health sector and has enabled the establishment of new measures seeking to minimise risk levels in the preparation process of parenteral nutrition bags.


2007 ◽  
Vol 5 (8) ◽  
pp. 800-808 ◽  
Author(s):  
Martin C. Mahoney

Qualitative and quantitative approaches to risk assessment are useful for identifying women at increased risk for developing breast cancer for whom genetics consultation, individualized surveillance recommendations, or chemoprevention may be appropriate. A comprehensive medical and family history review can be used to stratify women into categories of breast cancer risk. A quantitative estimate of the probability of developing breast cancer can be determined using risk assessment tools, such as the Gail and Claus models. Women at increased risk for breast cancer may benefit from individualized approaches to breast cancer risk reduction. Prevention strategies for reducing breast cancer risk include lifestyle modifications, chemoprevention, surgical approaches, and pharmacotherapy.


Geosciences ◽  
2018 ◽  
Vol 8 (10) ◽  
pp. 371 ◽  
Author(s):  
Adrian Schmid-Breton ◽  
Gesa Kutschera ◽  
Ton Botterhuis ◽  
The ICPR Expert Group ‘Flood Risk Analysis’ (EG HIRI)

To determine the effects of measures on flood risk, the International Commission for the Protection of the Rhine (ICPR), supported by the engineering consultant HKV has developed a method and a GIS-tool named “ICPR FloRiAn (Flood Risk Analysis)”, which enables the broad-scale assessment of the effectiveness of flood risk management measures on the Rhine, but could be also applied to other rivers. The tool uses flood hazard maps and associated recurrence periods for an overall damage and risk assessment for four receptors: human health, environment, culture heritage, and economic activity. For each receptor, a method is designed to calculate the impact of flooding and the effect of measures. The tool consists of three interacting modules: damage assessment, risk assessment, and measures. Calculations using this tool show that the flood risk reduction target defined in the Action Plan on Floods of the ICPR in 1998 could be achieved with the measures already taken and those planned until 2030. Upon request, the ICPR will provide this tool and the method to other river basin organizations, national authorities, or scientific institutions. This article presents the method and GIS-tool developed by the ICPR as well as first calculation results.


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