Risk Situations Research Articles

The synergy effect of multi-country policy actions announced in reaction to global risk: A network structure perspective.

The policy actions of countries reflect adaptive responses of local components within the system to the dynamic global risk landscape. These responses can generate interactions and synergy effects on alleviating the evolution of global risks. Adopting a network perspective, the study proposes a theoretical framework that connects three structural characteristics of policy synergy, namely, synergy scale, alignment intensity, and timing synchronization. Focusing on the Covid-19 pandemic as a typical global risk context, the study finds that policy synergy with a larger scale, stronger alignment intensity, and more synchronized timing has a positive impact on mitigating global risks. The effect of alignment intensity is particularly pronounced when polycentric governance involves 20 countries facing severe risks, whereas the effect of timing synchronization is more significant when the multicenter group comprises more countries. Building upon the concept of an efficient scale of polycentric governance in various dimensions, this study develops a policy synergy index model. Through multiple empirical analyses, this study validates the causal relationship between policy synergy and the future evolution of global pandemic risk. Policymakers can leverage the dynamic changes in the policy synergy to predict future risk situations and implement well-rounded and appropriate policy actions, thereby enhancing the efficacy of the synergy effect of multi-country policy actions for risk governance.

The role of social capital in managing risks: a bibliometric analysis and literature review

Disasters and crises affect more people around the world than reported in official documents by national or international agencies. Meanwhile, climate change, the COVID-19 pandemic, several wars worldwide and other crises expose a large proportion of the entire population to substantial risks, as well as profoundly affecting human health globally. Many of these impacts remain unnoticed by governance authorities, since many coping strategies are based on bottom-up activities rather than top-down policies. This raises the question: how can we be adequately prepared for a next pandemic or other unforeseen extreme events? Social capital could provide some clues for resilient responses that could be integrated in risk planning and management practice. In this paper, a comprehensive review is provided based on bibliometric analysis. A total number of 2872 published articles were documented and classified. In addition, the geographic locations and the institutional affiliations were assessed and visualized. Four salient research themes were identified as follows: (1) Knowledge sources of the research domain; (2) Individual social capital and risky behaviors; (3) Disaster management and resilience building; and (4) Health issues in the COVID-19 Era. This study offered some practical insights for mobilizing and developing social capital in different phases of risk management. Nevertheless, more inter- and transdisciplinary research across domains is needed to articulate a more comprehensive view of the development of social capital in various risk situations.

Addiction and pregnancy: case report on gender perspective.

IntroductionIn recent years, interest has grown in understanding the particularities of addiction in women. One of these singularities, with an important impact on public health, is pregnancy. Substance use during pregnancy has increased in recent decades. Given that addiction is mainly a chronic disease of the brain circuits of reward, motivation and memory, an event such as pregnancy does not exempt people who suffer from substance use disorder (SUD) from the difficulties of achieving abstinence. Moreover, as addiction often involves cycles of relapse and remission, pregnant women can also suffer a relapse even if they previously had achieved abstinence. On the other hand, given that addiction is a disease with a significant social component, we can find patients in precarious economic and social situations who suffer unwanted and therefore unplanned pregnancies.ObjectivesTo describe the case of a pregnant woman with SUD for multiple drugs who is admitted to the inpatient ward of the Hospital Clínic of Barcelona for detoxification. Also to reflect, taking in to account gender perspective, on the particularities of substance use in women on childbearing age.MethodsWe present the case of a 25-year-old woman, six weeks pregnant and homeless, who was admitted to the inpatient ward for presumed psychotic symptoms. Even if the patient had a history of intravenous heroin, cocaine, and methamphetamine use, during the admission she only admitted current alcohol consumption (3 UBE/day). During admission, the patient decided to undergo a legal voluntary abortion. Regarding this case, we did a literature review on the consequences of different substances use to pregnancy (to both the fetus and the mother’s health). Likewise, we reflected on interventions that could be carried out in community mental health facilities to detect cases like the one exposed and provide help.Results Poor obstetric outcomes are six times higher in patients who use substances. Newborns can have withdrawal syndrome, spontaneous abortion, pre-term birth, fetal malformations and fetal growth restriction. More than 50% of women of reproductive age use drugs, mainly alcohol. Routine screening and education of women of reproductive age is the best way to reduce substance use during pregnancy.ConclusionsWe consider it essential for a better management of these patients to remember that the evidence suggests that the decisions that addicts make are mainly driven by a pathology, not by a moral failure. However, pregnancy can be a moment of greater motivation to stop using drugs, given that it is a high risk situation for the mother and the fetus.Disclosure of InterestNone Declared

Childhood and adolescent schizophrenia and networking

IntroductionReviewing the histories of patients with childhood and adolescent schizophrenia, on numerous occasions, traumatic factors with great emotional and social impact are observed, such as situations of mistreatment, abuse and emotional deprivation, where help is requested but resources are scarce and the approach is limited without work in network.Objectives1. Analysis of the consultation pathways in adolescents with severe psychiatric and socio-familial symptoms and the time delay in optimal guidance. 2. Evaluate the services involved. 3. Evaluate the clinical control of treatment with aripiprazole.MethodsRetrospective observational analysis, 5 months, of prodromal symptoms of childhood psychosis and help-seeking pathways in a 13-year-old adolescent, as well as a description of the pharmacological approach and professional teams involved.ResultsA 13-year-old adolescent who went to the emergency room with her mother for ingesting anti-cockroaches with self-inflicted intent. Reviewing his medical history, 4 serious autolytic gestures were detected in the last 2 months. Referred to Mental Health who did not attend.On clinical examination, florid psychotic, with perplexity, self-reference, ideation of harm, language and behavioral disorganization. Auditory and kinesthetic hallucinations. A situation of neglect of the minor and abuse by the parents is detected; the risk had not been previously reported. Oral aripiprazole (up to 15 mg/day) was prescribed with good tolerance and progressive improvement in symptoms.We worked jointly with Social Services, the Juvenile Prosecutor’s Office, Education and the hospital Psychiatry unit. In some of the resources the situation was already evident, the scope of their action was limited and delaying attention for months.ConclusionsBased on cases like this, we ask ourselves if psychiatrists are sensitized to the comorbidity of serious mental pathology and the existence of risk situations in minors and if they are oriented toward multiprofessional management. Networking provides us with an early diagnosis, improving the therapeutic approach.Disclosure of InterestNone Declared

Risk of child sexual abuse: A mixed-methods analysis of judicial decisions in the Youth Court of Québec

In Québec, Canada, the Youth Protection Act allows child protection services to intervene in situations of serious risk of sexual abuse. Although the litigation of these cases is frequent, few studies have focused on the decision-making process of judges in Youth Court. The present study aims to document the criteria used by the judges to substantiate allegation of serious risk of sexual abuse and to render a placement order. Using a sequential explanatory mixed-method design, we analyzed 104 judicial decisions of the Youth Court of Québec between January 2016 and January 2023 involving a situation of risk of sexual abuse in families with children aged 0 to 12 years. The quantitative phase of the study revealed that psychosocial difficulties of children and parents, as well as the number of reasons for intervention are associated to a placement order. Based on a thematic analysis (n = 24), the qualitative phase of the study highlighted three main types of criteria used by the judges to substantiate allegation of serious risk of sexual abuse: 1) the vulnerability of the child; 2) the characteristics of the family system; and 3) the parents' compliance with external demands.

Clinical risk assessment of modelled situations in a pharmaceutical decision support system: a modified e-Delphi exploratory study.

Pharmaceutical decision support systems (PDSSs) use reasoning software to match patient data to modelled situations likely to cause drug-related problems (DRPs) or adverse drug events. To aid decision-making, modelled situations must be linked to well-defined systemic clinical risks. To obtain expert consensus on the level of clinical risk for patients associated with each modelled situation that could be addressed using a PDSS. A two-round e-Delphi survey was conducted from February to April 2022, involving 20 experts from four French-speaking countries. Participants had to rate modelled situations on two five-point Likert scales, assessing the likelihood of clinical consequences and their severity. The degree of consensus was determined as the proportion of participants providing risk scores in line with the median. The combined median scores for likelihood and severity provided the level of risk according to the Clinical Risk Situation for Patients (CRiSP) scale, formalized via validated tools. The expert panel achieved consensus (≥ 75% agreement) on 48 out of 52 modelled clinical situations. Among these, 45 were categorized as high or extreme risk. The most common DRP identified was overdosing, accounting for 22% of cases. Furthermore, DRPs involving cardiovascular, psychiatric, and endocrinological drug classes were prevalent, constituting 45, 13, and 9% of cases, respectively. Through consensus, our study identified 45 modelled clinical situations associated with high or extreme risks. This study highlights the interest of using PDSSs to prevent harm in patients and, on a large scale, document the impact of the pharmacist in preventing, intercepting and managing iatrogenic drug risk.

Intervention of the self-care and continuous care program for university students

The Self-care and Continuous Student Care Program (AACES) emerged as a proposal from the Integral Development Unit (UDI), based on suggestions from the General Directorate of Medical Services (DGSM) regarding the results of the global health diagnosis at FES Zaragoza in 2005. In this program, approximately six months of work were carried out, involving various activities that served as interventions to address the identified risk situations among university students. The research aimed to promote self-care and the development of psycho-affective and socio-cultural skills contributing to the overall development of individuals to enhance academic performance among young people at Zaragoza. The study was a qualitative action research, employing interviews for evaluation and feedback. The AACES Program offers a variety of products such as informative modules, preventive campaigns, public educational spaces, university fairs on health and responsible sexuality, reflection forums with experts, informative workshops, personalized attention, and research projects. These efforts consolidate intervention with university students, emphasizing the importance of promoting healthy lifestyles and involving students in contests and activities related to gender equity, sexual diversity, risk prevention, peace culture, and non-violence.

Immigration and work, considerations about the challenges in Brazil: bibliographic review of the literature

Introduction: Migratory flows towards countries that have more labor supply are not recent. In this sense, the arrival of immigrants in host countries, in many cases, makes this population more susceptible to health risk situations because of work activities, lack of integration with the local population and the immigration process itself. Methods: The study used a bibliographic review of the literature as a method. In this context, integration policies and the recognition of educational training in the country of origin can contribute to improving the living conditions of this population in Brazil. Results: In this context, this study aims to provide a summary of the challenges faced by immigrants in search of improved living conditions. Furthermore, this study contributes to identifying the main challenges facing immigrants recently arrived in Brazil and the difficult process of integration into local society. It is observed that the authors highlight in common that, worldwide, in the different receiving countries, regardless of the social, political, and economic context in which the immigrants find themselves, there is some destructive process that conditions the health-disease process of this population, resulting from the various factors mentioned above. Conclusion: Yet the positive contribution of migration to development is increasingly recognized, and these targeted policies will maximize their benefits in both countries of origin and destination.

Indebtedness in India- A Region Wise Analysis Leveraging Machine Learning By IJISRT

The risk of indebtedness across region level is higher among the households having less human and physical assets and human resources. However, because of their better borrowing capacities, the extent of indebtedness among them is significantly higher than other segment of the rural society. The same is true about the households self-employed in various agricultural and non-agricultural activities in the rural areas. The region level analysis also rejects the contention that the higher consumptive expenditure of the rural people as a cause of their risk of indebtedness whereas the extent of indebtedness confirms that consumptive expenditure plays a major role in their indebtedness. Similarly, the hypothesis of agricultural prosperity and indebtedness going together lacks wider generalization for household located in all the regions except North-West states in Logistic regression and in North-Western, Eastern and Southern region in Tobit regression. Exposure of rural households to higher risk and uncertain situations like droughts, floods, crop failure due to pest attack pushes rural households deeper into debt.

Telephone fraud as a complex social problem

The article studies telephone fraud as a new type of crime and an acute social problem. Attention is drawn to the complex nature of the problem, as it should be considered in the plane of different disciplines: general jurisprudence, criminology, social psychology, social engineering, information technology. The Bank of Russia estimates the scale of spread of this type of crime and the amount of stolen money. According to statistics, the majority of fraudulent schemes are based on social engineering techniques. The results of a sociological survey of the population conducted under the guidance of the authors of the article are indicated. It is stated that at present the coverage of the population by this type of crime is insignificant, but at the same time the majority of citizens admit that they can become a victim of telephone fraudsters. One tenth of people who receive calls from an unknown number do not interrupt the conversation, even if they realize that a fraudster is calling. Thus, they find themselves in a situation of the greatest risk. It is concluded that citizens do not take an active position in the fight against telephone fraud and very rarely report suspicious calls to the police. Based on the results of the study recommendations are given regarding the improvement of the system of prevention and fight against telephone fraud.

A hybrid transformer with domain adaptation using interpretability techniques for the application to the detection of risk situations

A hybrid transformer with domain adaptation using interpretability techniques for the application to the detection of risk situations

How our population is aging. Factors associated with the functional capacity of older adults in Bucaramanga-Colombia: The ARENA Study

Introduction. As a demographic aging result, societies have experienced effects such as the increase of functional limitations in older adults and high demand for social and health care. The objective is to analyze factors associated with the functional level of daily life activities and socio-family risk factors of older adults in an urban population in Bucaramanga-Colombia. Methodology. Analytical cross-sectional secondary data study. 196 older adults were studied after excluding individuals with incomplete records. The Barthel and the Lawton Index were used for functional status, and Socio-Family Assessment Scale for social risk. The STATA software was used for doing the logistic regression that helped to determine association between variables. Results. Above half of older adults presented functional limitations when performing daily life activities (59.69%). The prevalence of a socio-family risk was 47.45%. Functional limitation was associated with age, cognitive dysfunction and falls risk. Discussion. The study demonstrated lower scores in the Barthel Index and high scores in risk and social problematic situations compared to other studies. Moreover, results support that high blood pressure is a risk factor for functional limitations situations. Conclusion. It is important to continue interventions about health status in older people to identify risk factors, such as cognitive dysfunction, high Falls risk and chronic diseases control.

Maximization delays decision-making in acute care nursing

The maximization personality trait refers to the tendency to face decision-making situations along a continuum from exhaustively analysing all the options (maximize) to choosing the one that exceeds a subjective threshold of acceptability (satisfy). Research has revealed the influence of maximizing on decision making, although little is known about its possible role in high risk and high uncertainty situations. A sample of 153 active Spanish nurses, with an average experience of 11 years, completed a maximization questionnaire and responded to written vignettes depicting time-demanding decision making in which three options were offered, representing delayed action, non-action, and immediate action. Two vignettes presented critical situations related to acute care during the COVID-19 pandemic, whilst two vignettes presented non-nursing scenarios. People high in maximization took longer to choose and were more likely to choose non-action. No relationship was found between maximization score and the subjective experience of the person making the choice. Maximization had no significant correlation with years of experience nor perceived expertise. Greater perceived expertise was associated with lower indecision and greater confidence. When participants answered nursing vignettes, they took longer to respond, but chose less delayed action and more immediate action. Our results suggest that maximization plays only a relative role in acute care decision-making in nursing, as compared to contextual variables and expertise. They also support a domain general approach to this personality trait. Findings are consistent with Nibbelink and Reed's Practice-Primed Decision Model for nursing.

Avaliação da Educação para paz e aprendizagem ética em uma escola

Abstract This article discusses Education for Peace based on Aristotelian virtues with children in situation of risk. The problem of the research is violence at school and the necessity of building peace there. The Hypothesis is the possibility of Education for Peace at areas of risk. The objective is that 4th grader students can learn and practice the virtue of Friendship. The locus of the research is a public Elementary School in an area of risk in the city of Rio de Janeiro, Brazil. The Living Peace project is the core concept for this research on Education for Peace. We concluded that the practice of Ethics and Education for Peace through Virtue is possible if the students learn to practice virtues as the basis of a Culture of Peace.

Cognitive Modeling of Cargo Port Risk Management

Рurpose of research. Increasing the efficiency of cargo port business processes through the use of risk management technology based on the application of a cognitive modeling.Methods. A cognitive modeling of cargo port risk management is proposed, based on a comprehensive step-by-step application of the concept of multi-level goal setting, which involves a thorough elaboration of the cargo port's goals, as well as indicators for assessing the achievability of goals by developing a balanced scorecard (BSS) and constructing a logicalprobabilistic (LP) model; a logical-ontological model developed on the basis of the connections established by the LP model; a simulation model used to check recommendations for adjusting the elements of the system under consideration, developed on the basis of queries to the ontological model, in order to select the most acceptable options for recommendations or combinations thereof and formulate management decisions based on them. Results. Based on the formulated purpose of the study and the assigned tasks, a concept of cognitive modeling was developed, which involves the use of knowledge about the connections between risks, goals, indicators for assessing port activities, as well as clarifying coefficients and the nature of their influence on each other in order to develop recommendations for managing the risks of a cargo port at based on queries to the ontological model. The simulation model within the framework of the proposed conceptual approach allows us to develop management decisions on adjusting the operational components of the system in order to prevent risk situations in the long term (at the tactical and strategic levels) taking into account the influence of external factors. Cognitive modeling is based in this work on the integration of logical-probabilistic, logical-ontological and simulation modeling. Conclusion. As a result of the implementation of the set goals and objectives, a cognitive model of cargo port risk management was proposed. This model combines various types of modeling and takes into account different levels of management. As a result of experiments with a simulation model, the most effective recommendations generated based on a query to the ontological model are selected as management decisions.

Logical ontological modeling of cargo port risk management

Enterprises in any field, including those in the transport and logistics sector, are faced with the need to gain a competitive advantage through the use of innovative management methods. These include the integrated use of methods for managing organizational systems along with the use of advanced tools and technologies. Particular attention is paid to risk management in order to prevent undesirable situations. This paper is the first to present a description of a logical ontological model for the integrated application of multi-level goal setting based on a balanced scorecard (BSC) and logical probabilistic (LP) modeling to support decision-making on cargo port risk management. Situations of failure to achieve the goals of the cargo port, including failure to achieve standard values of indicators, are considered as risks. The integrated use of BSC and LP modeling technologies made it possible to build a general concept of multi-level goal setting. Its main advantage lies in the detailed elaboration of the company’s goals, which are subordinated to the main strategic goal. This makes it possible to influence operational events and obtain positive results in tactical and strategic plans. The ontological model contains all the information about the components interaction that influence the risk events and makes it possible to select options for exiting a risk situation in accordance with specified conditions. The results of queries to a risk-oriented ontological model are options for management decisions aimed at reducing risks in the operation of a cargo port.

Cardiovascular prevention in diabetes mellitus. Is it appropriate to speak of moderate or intermediate risk?

Diabetes, especially type 2 (DM2), is considered a risk situation for atherosclerotic cardiovascular disease (ASCVD). Subjects with DM2 have a mortality rate due to ASCVD three times higher than that found in the general population, attributed to hyperglycemia and the frequent association of other cardiovascular risk factors, such as atherogenic dyslipidemia.Numerous scientific societies have established a risk classification for ASCVD in diabetes based on 3 degrees (moderate, high and very high). The objectives of dyslipidemia control are clearly defined and accepted, and vary depending on the previously established cardiovascular risk.In moderate or intermediate risk, the guidelines propose a less aggressive intervention, maintaining LDL-C levels <100mg/dL and NO-HDL-C levels <130mg/dL, and waiting 10 years until reaching the high-risk category to initiate more aggressive treatment. However, during the decade of follow-up recommended in the guidelines, cholesterol deposition in the arterial wall increases, facilitating the development of an unstable and inflammatory atheromatous plaque, and the development of ASCVD. Alternatively, diabetes could be considered from the outset to be a high-risk situation and the goal should be LDL-C <70mg/dL. Furthermore, maintaining LDL-C levels <70mg/dL contributes to reducing and stabilizing atheromatous plaque, avoiding or reducing mortality episodes due to ASCVD during those years of diabetes evolution.Should we maintain the proposed objectives in subjects with diabetes and moderate risk for a decade until reaching the high cardiovascular risk phase or, on the contrary, should we adopt a more aggressive stance from the beginning seeking to reduce cardiovascular risk in the majority of patients with diabetes? Is it better to wait or prevent with effective therapeutic measures from the first moment?

지리 교과에서 안전교육 내용 구성을 위한 방사능에 대한 위험 인식 분석

Objectives This study aims to provide basic data for the construction of safety education contents in geography subject by examining university students' risk perception of radioactivity with an optimism bias through a real case of the Fukushima nuclear power plant accident in Japan.&#x0D; Methods To this end, a questionnaire composed of questions asking about risk perception of radioactivity and optimism bias in risk perception of radioactivity was distributed and collected to 134 university students in Seoul, South Korea. A one-way ANOVA was conducted to see the difference in risk perception of radioactivity according to the type of visit to Japan (visit to Tokyo, non-visit to Japan, visit to Japan). In addition, factor analysis and multiple regression analysis were performed to identify the optimism bias in the risk perception of radioactivity, and then the difference in optimism bias according to the type of visit to Japan was analyzed through MANOVA (Multivariate Analysis of Variance).&#x0D; Results The terms of risk perception of radioactivity, the degree of perception that Tokyo is safe from radiation was significantly higher in the Tokyo visiting group than in the other two groups. As a result of factor analysis to identify optimism bias, three factors (optimistic perception, avoidance perception, and wait-and-see perception) were derived, and as a result of multiple regression analysis, it was found that optimistic perception and avoidance perception had a positive effect on optimism bias in order. As a result of MANOVA, the Tokyo visiting group showed significantly higher perceptions of both optimistic and avoidance compared to the other two groups.&#x0D; Conclusions Optimism bias and its sub-factors, optimistic perception and avoidance perception, were identified in the risk perception of radioactivity. Because optimism bias makes it difficult to make logical judgments and rational decision-making in risk situations, meta-cognition for optimism bias in relation to risk perception should be considered when constructing safety education contents in geography subject.&#x0D;

Creativity and Decision Making in Giftedness

Creativity is the ability to re-experience mental representations and is the basis of intuitive thinking when constructing images prior to the elaboration of an action plan. Creativity is thought to be related to orbitofrontal functions that govern decision making, such as inhibitory control, risk–benefit evaluation and acceptance of limits and rules, given that these processes prepare one against possible scenarios. Objective: In this study, the relationship between creativity and decision making is investigated to understand the needs of gifted students. Method: A cross-sectional descriptive study was carried out with gifted students (IQ mean = 133) aged 8–10 years old (n = 25). Instruments: Creative Imagination Test (PIC) and subtests of the Neuropsychological Battery of Executive Functions and Frontal Lobes (BANFE-2) were employed. Analysis: A Spearman correlation analysis was conducted between the normalized BANFE-2 scores and the percentiles of PIC. Results: Moderate correlations were found between creative/narrative flexibility and decision making/risk percentage (r = 0.432, p ≤ 0.05) and decision making/response-effectiveness (r = 0.426, p ≤ 0.05), as well as between graphic creativity/shadow and color with decision making/response-effectiveness (r = 0.452, p ≤ 0.05) and inhibition (r = 0.673, p ≤ 0.01); moderate negative correlations were found between inhibition and graphic creativity/title (r = −0.570, p ≤ 0.05) and general graphic creativity (r = −0.489, p ≤ 0.05). Conclusions: Creativity in students with intellectual giftedness is favored by a relationship with orbitofrontal functions. Analysis of risk situations and effective decision making increase narrative creation and diminished inhibition allows for greater creative graphic production.

Réforme de l’accès dérogatoire : impact sur la gestion dans une PUI et identification des risques

The reform of derogatory access authorisations (DAs) on 1st July 2021 has distorted the routine of the hospital pharmacists dealing with innovative medicines that are waiting for marketing authorization or approval. There are two distinct categories of DAs: Compassionate Access Authorisations (CAAs) are granted by the French National Agency for the Safety of Medicines (ANSM) while Early Access Authorisations (EAPs) are granted at the request of pharmaceutical companies by the French National Authority for Health (HAS). All AAPs and a majority of the AACs are supported by a Protocol for Therapeutic Use and Data Collection (PTU-DC).The aim of this study is to assess the impact of the reform on pharmacy process one year following its implementation, and to identify the risks related to the new circuits.The working group, composed of three pharmacists carried out an initial assessment of the effects first measured the impact of the reform on medicine processes in DAs. They performed a comparison of the changes in their management methods: 3 months prior to the reform (M0), and 3 months (M3) and 12 months (M12) post-reform.Risks analysis was conducted using the FMEA (Failure Modes, Effects and Criticality Analysis) method. The analysis was limited to the process steps specific related to DAs drugs were analyzed. The critical severity of the risk situations identified was rated. A critical hierarchy matrix was used to establish priority actions. The priority actions to be taken were determined using the critical hierarchy matrix.Over the span of one year, the number of DAs in our establishment showed a 31.7% increase, from 41 at M0 to 54 at M12. At M0, the proportion of drugs needed inclusion via a drug- specific digital platform, specific to each drug, stood at 27% (11/41) of drugs at M0 while at M12, it rose to 52% (28/54).The percentage of PTU-DCs therefore increased by a factor of 1.7, rising from 29% (12/41) at M0 to 47% (21/45) at M3 and 60% (32/54) at M12. For orders, which are always nominative, approval depends on both the presence of the PTU-DC tracking sheet being present in 12% of PAAs, and the inclusion number in 26% of PAAs.The risk analysis shows 44 failure modes and 28 risk situations. Among the failure modes, 33 have a consequence of acceptable or tolerable criticality under control, whilst 11 are deemed of unacceptable criticality. A suitable control method exists has been identifies for 3 of them. Finally, the ranking evaluation of criticalities has highlighted 4 situations which require immediate action as a priority: delivery times, obtaining completed tracking sheets and ordering procedures.The aim of the DAs reform is to simplify access to innovative medicines. However, the reform has significant and damaging repercussions on pharmaceutical activities. Corrective measures need to be taken in conjunction with all parties involved in the circuits including laboratories and service providers (CROs), authorities and healthcare professionals.