National Health Authorities Research Articles

Skandinaviske retningslinjer for behandling av psykisk lidelse hos barn og unge: En kvalitetsvurdering

Children and young people with untreated mental health disorders can develop chronic disorders and severe somatic diseases later in life. The right treatment at the right time is therefore important to promote good mental health. Healthcare personnel are required to follow national guidelines, and high-quality guidelines are thus important for patient safety. We wanted to assess the quality of Norwegian national guidelines for the treatment of mental disorders in children and young people and compare these with corresponding guidelines in Sweden and Denmark. We conducted manual searches in the relevant national health authorities’ websites and selected five Norwegian guidelines (treatment of ADHD, bipolar disorders, psychosis, suicide and eating disorders), three Danish guidelines (ADHD, anorexia and bulimia) and one Swedish guideline (ADHD). For the purpose of quality assessment, we used an internationally recognised checklist (AGREE II), on which Norwegian guidelines must be developed in accordance with the Norwegian Directorate of Health’s own guide for developing guidelines. The checklist consists of 23 items divided into six domains: scope and purpose, stakeholder involvement, rigour of development, clarity of presentation, applicability, and editorial independence. We found that the overall quality of the Danish and Swedish guidelines was very high and met most of the 23 criteria organised within six domains. The Norwegian guidelines met the criteria for scope and purpose and stakeholder involvement, but had major shortcomings in terms of rigour of development, clarity of presentation, applicability, and transparency of editorial independence. Keywords: evidence-based practice, national guidelines, children and adolescents, mental disorders

Amphimeriasis in Ecuador-Prevalence, Knowledge, and Socio-Cultural Practices Among Indigenous Chachi and Montubios Populations: A Mixed-Methods Cross-Sectional Study.

Amphimerus, a liver fluke, is the causative agent of amphimeriasis, a foodborne disease acquired thought the consumption of infected raw or undercooked river fish-a practice embedded in traditional culinary customs. Amphimeriasis represents a significant public health issue and has been endemic in Ecuador since 2011, particularly among the Chachi Amerindians and Montubios populations residing in tropical ecoregions. By employing a mixed-methods research design, we conducted a community-based, cross-sectional study. A survey comprising of 63 questions on KAP was administrated in person to community members, health personnel, and academic staff in the two populations. Additionally, 67 semi-structured interviews were performed. Microscopy was achieved on 273 human and 80 dog fecal samples to detect Amphimerus eggs. A total of 86 questionnaires (54 Chachi) and 67 interviews (44 Chachi), out of 300 residents, were completed. Among the respondents, 31.4% were aware of Amphimerus, locally referred to as "liver worm". Although 79.1% reported not consuming raw fish, most admitted eating raw fish with lime juice and salt, a preparation known as "curtido", and 59.3% reported consuming smoked fish. Here, 86.1% of participants considered "liver worm" a serious disease, and 55.8% recognized raw or marinated fish as a potential transmission route. The Chachi showed a preference for smoked fish, whereas the Montubios favoured "curtido". The prevalence of Amphimerus infection was 23% in humans and 16.2% in dogs. Differences in KAP were observed between infected and non-infected individuals. Local health and academic personnel demonstrated insufficient knowledge about amphimeriasis. Some religious individuals refrained from participating, stating that they were "with God". Despite the high prevalence of Amphimerus infection in both humans and dogs, knowledge about the parasite, the disease, and its transmission routes remains limited. Health education initiatives should be designed to modify the population's KAP. It is crucial for national and local health authorities, as well as religious leaders, to be informed and actively involved in the prevention and control of amphimeriasis.

Establishing national hospital costing systems: insights from the qualitative assessment of cost surveillance pilot in Indian hospitals

ObjectiveThe Indian Government launched Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (PM-JAY), the world’s largest health insurance scheme, in 2018. To reform pricing and gather evidence on healthcare costs, a...

COVID-19 vaccination in low and middle-income countries: Creating a sustainable roadmap for promoting public health intervention.

The Coronavirus Disease 2019 (COVID-19) pandemic is a global public health threat ravaging the health systems. In low and middle-income countries (LMICs), COVID-19 and several other challenges concurrently worsen the health outcome indicators. Interestingly, vaccines have been identified as the most reliable and cost-effective public health intervention, and the governments in LMICs have instituted an array of plans to ensure every eligible person gets vaccinated. However, there is still considerable apathy around the use of the available COVID-19 vaccines in LMICs which is impeding the fight against the COVID-19 pandemic. In this paper, we explore the multiple interrelated factors behind low COVID-19 vaccination coverage in LMICs. It is therefore recommended that the governments in LMICs embrace multicomponent and wide-ranging strategies. This should involve utilising community-based approaches such as community pharmacy-led vaccination to promote community access to COVID-19 vaccines and to revive trust in national health authorities by offering population-specific, target-driven, transparent, and timely communication to the community who they serve about the safety and efficacy of the COVID-19 vaccine. Communication strategies should be tailored to reflect diverse political orientations as this can enhance vaccine acceptance. Additionally, local political parties and representative should be engaged in broad alliances to facilitate community mobilisation and support for vaccination campaigns. Also, relevant Nongovernmental Organisations and Community-based Organisations should institute programs at the grassroots that incorporate the gatekeepers to the community aimed at influencing population behaviour regarding COVID-19 vaccine hesitancy. Besides, the public health department in the ministry of health in LMICs should create more awareness, through social and mass media, particularly in the rural, semi-urban, and slum communities about the pivotal role of vaccination. Thus, we opined that these strategies will help LMICs achieve the COVID-19 vaccination target and further reposition the healthcare systems, and promote other public health interventions now and in the future.

Case studies using a simple airborne infection risk calculator to minimize COVID-19 infection risk: Common approaches and challenges

Following the recognition of the role of airborne transmission in the spread of SARS-CoV-2, the role of building ventilation in minimising indoor respiratory events has become of significant interest, with numerous risk assessment tools developed to understand infection risk in different indoor environments. To date there has been limited retrospective analysis of how such tools were applied to assess indoor infection risk and inform building occupancy during the COVID-19 pandemic. In this paper we document case studies from Australia and New Zealand using one such risk assessment tool, the Airborne Infection Risk Calculator (AIRC), and describe how the AIRC was used to assess COVID-19 risk in different indoor settings and how users customized the tool for their own purposes. While inherent uncertainties mean the AIRC model could not calculate the exact risk in any of the case studies, the model's framework enabled objective discussion about the role of ventilation in infection risk reduction and public health. Future use of tools such as the AIRC would be improved with development of policies or regulations that promote or require a standardized approach for this assessment, translation of improvement in ventilation in a room or building scale into overall public health benefits, and endorsement of such tools by Global and/or National health authorities.

Effect of seasonal variability on the increased malaria positivity rate in drought-prone malaria endemic areas of Ethiopia.

Malaria is a climate-sensitive and season-dependent disease that mainly affects the populations of tropical and subtropical regions of the world. Climatic variables such as rainfall, temperature, and humidity are identified as the driving factors affecting the epidemiology of malaria. In Ethiopia, recently unexpectedly high malaria burden accompanied by substantial morbidity and mortality is observed. The incidence rate of vector-borne diseases such as malaria is largely influenced by fluctuation of seasonal variables due to the proceeding global warming. Therefore, the study aimed to assess the impact of seasonal and climate variability on the burden of malaria in one of drought-prone areas of north central Ethiopia. The study was conducted in the Oromia zone of the Amhara regional state in Ethiopia. Data from patients tested and diagnosed with malaria between 2014 and 2019 were extracted from the medical records of the patients registered in all health facilities found in the zone. Additionally, meteorological data such as rainfall and temperature (maximum and minimum) were collected from the regional meteorological agency. Data were analyzed using R software. The malaria positivity rate recorded in this study was 12.7% (64,522/508,057). Months from June to December were significantly (p < 0.05) associated with high malaria positivity. Rainfall had a significant negative effect on malaria positivity (p = 0.042). Also, three to four months of lagged rainfall is associated with high malaria positivity (p < 0.05). However, monthly minimum temperature positivity influenced the rate of malaria positivity (exp = 0.037, p = 0.0098). While monthly mean maximum temperature showed a negative association with malaria positivity, although it was insignificant. In addition, malaria positivity significantly decreased from 2014 to 2019 by 20.5% (exp = 0.205, p < 0.0001). The seasonal and climatic variables evaluated in this study substantially affected the malaria positivity rate. Monthly mean temperature was the leading and predictor variable for malaria infection. Despite vigorous efforts by health authorities in the country at this level, following the neglected implementation of interventional activities in the nation for a couple of years, malaria-associated burdens have increased. As seasonal and climate variables could play a key role in the rising burden, concerned national or local health authorities, and policymakers should prioritize urgent interventional activities to control malaria in one of the drought-prone areas of Ethiopia.

The First Nations Health Authority's Self-Assessment Aligning With the British Columbia Cultural Safety and Humility Standard.

The First Nations Health Authority (FNHA) completed a self-assessment of the organization's alignment to the British Columbia Cultural Safety and Humility Standard in collaboration with Elder Th'et-simiya and a group of Sisemó:ya Change Champions from across the organization (FNHA and HSO 2022). This article details the organization's processes, including the determination and selection of methods, self-assessment tools used and the lessons learned throughout. Other health and social services organizations are encouraged to use these learnings to guide their own self-assessment processes for continuous learning and development.

Lessons from the COVID-19 pandemic for ventilation and indoor air quality.

The rapid global spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at the beginning of 2020 presented the world with its greatest health challenge in decades. It soon became clear that governments were unprepared to respond appropriately to this crisis. National and international public health authorities were confused about the transmission routes of the virus and the control measures required to protect against it. In particular, the need to reduce the risk of infection through sufficient and effective ventilation of indoor spaces was given little attention. In this review, we discuss insights and key lessons learned from the COVID-19 pandemic regarding the role of ventilation as an effective means against airborne transmission of pathogens and, more broadly, for supporting good indoor air quality.

Method Development and Validation of an Aerosol Sampling Technique for the Analysis of Nicotine in Electronic Cigarette Aerosols.

Because of the increasing popularity of e-cigarettes, monitoring the e-cigarette market has become important for national health authorities to guarantee safety and quality. In the EU, the Tobacco Products Directive requires emission studies for e-cigarette products. The absence of industry guidelines for studying these emissions and the lack of proper validation in the literature led us to develop and validate a method using the total error approach for the determination of nicotine in e-cigarette aerosols. A commercial vaping device was used to generate aerosols, which were then collected on Cambridge filter pads and measured for nicotine concentration by UHPLC-DAD after extraction. The method was successfully validated by generating accuracy profiles, which show that the β-expectation tolerance intervals remained below the acceptance limits of ±20%. Within-run repeatability and intermediate precision were considered acceptable since the highest RSD value obtained was below 5%. The method was applied to 15 commercial e-liquids. A complete validation of a method for the analysis of e-cigarette emissions is presented, including several parameters that impact the accuracy and reproducibility. Similar systematic approaches for method development and validation could be used for other e-cigarette emission analysis methods to ensure the reliability of the measurements.

Neurological outcomes and mortality of hyperoxaemia in patients with acute brain injury: protocol for a systematic review and meta-analysis

IntroductionOxygen is frequently prescribed in neurocritical care units. Avoiding hypoxaemia is a key objective in patients with acute brain injury (ABI). However, several studies suggest that hyperoxaemia may also be...

Incidence of cutaneous Leishmaniasis in humans during the COVID-19 pandemic in Baluchistan Province, Pakistan.

Cutaneous leishmaniasis (CL) is one of the neglected tropical diseases that affects impoverished communities throughout the world. In Pakistan CL is an endemic disease. This study aimed to determine the incidence of CL infection in the Baluchistan province of Pakistan from January 2020 to March 2022 during the COVID-19 pandemic. A total of 1047 clinically suspected cases of CL from Bolan Medical College Hospital, Quetta, were followed up in the study. The data regarding the epidemiological characterstics, pathological information, and treatment of patients was collected. Out of 1047 probable cases of CL, 594 (56.73%) cases were found to be positive for CL. Females had the highest infection rate, with the majority of reported cases being in the 0-9-year age group. Most CL cases were reported in April in the year 2020, with a few cases reported in June. But in the year 2021, the highest number of cases were reported in December. The number of overall cases has gradually increased in the year 2022, most likely because of the reduction in COVID-19 pandemic restrictions. The p value for the positive as compared to suspected cases in the years 2020, 2021, and 2022 was calculated as 0.8925, 0.8763, and 0.8535 respectively. Further epidemiological studies and health education campaigns are recommended to increase public awareness. It is strongly advised that local, provincial, and national health authorities establish and maintain effective leishmaniasis surveillance systems to promptly identify disease outbreaks and implement timely control measures.

Epidemiological and clinical trends of visceral leishmaniasis in Portugal: retrospective analysis of cases diagnosed in public hospitals between 2010 and 2020

BackgroundLeishmania infantum is endemic in the Mediterranean region, presenting mostly as visceral leishmaniasis (VL). In Portugal, reporting of VL cases to public health authorities is mandatory, but significant underreporting is likely. This study aimed to describe the epidemiological and clinical aspects of the VL cases diagnosed in hospitals of the Portuguese National Health Service (NHS), between 2010 and 2020.MethodsCollaboration was requested to every hospital of the Portuguese NHS in Mainland Portugal. Cases were screened through a search of diagnostic discharge codes or, if not available, by a search of positive laboratory results for Leishmania infection. Sociodemographic and clinical data was retrieved from medical records. Simultaneously, the National Health authority was contacted to request access to data of notified cases of VL between 2010 and 2020. Descriptive, hypothesis testing and multiple binary logistic regression models were performed.ResultsA total of 221 VL cases were identified. A significant increase in estimated national incidence was seen in the years after 2016 (P = 0.030). VL was predominantly diagnosed in people living with HIV (PLWH) and in children (representing around 60% of the new cases), but the outcome was generally poorer in non-HIV patients with associated immunosuppression, with significantly lower rates of clinical improvement at 7 (P = 0.003) and 30 days (P = 0.008) after treatment. Atypical presentations, with gastrointestinal and/or respiratory involvement, were seen in 8.5% of VL cases. Hemophagocytic lymphohistiocytosis was diagnosed in 40.0% of children under 5 years of age. Only 49.7% of incident VL cases were reported. Simultaneous involvement of the skin was confirmed in 5.9% of patients.ConclusionsVL presents a continuing threat in Portugal, especially to PLWH and children, and an increasing threat to other immunosuppressed groups. Recent increases in incidence should be closely monitored to allow prompt interventions. Programs to control the disease should focus on providing tools for earlier diagnosis and on reducing underreporting and promoting an integrated surveillance of human and animal disease. These data should be combined with asymptomatic infection and vector information, following a One Health approach.Graphical

Évaluation médicoéconomique du PRADO-BPCO, programme d’accompagnement post-exacerbation

The "Programme d'Accompagnement du retour à Domicile" (PRADO) COPD is a home discharge support program dedicated to organizing care pathways following hospitalization for COPD exacerbation. This study aimed at assessing its medico-economic impact. This was a retrospective database study of patients included in the PRADO BPCO between 2017 and 2019. Data were extracted from the National Health Data System. A control group was built using propensity score matching. Morbi-mortality and costs (national health insurance perspective) were measured during the year following hospitalization. While the proportion of patients with a care pathway complying with recommendations from the National Health Authority was higher in the PRADO group, there was no significant effect on mortality and 12-month rehospitalization. In the PRADO group, the rehospitalization rate was lower when the care pathway was optimal. Healthcare costs per patient were 670 € higher in the PRADO group. The PRADO COPD improves quality of care but without decreasing rehospitalizations and mortality, although rehospitalizations did decrease among PRADO group patients benefiting from an optimal care pathway.

Isotonitazene, a synthetic opioid from an emerging family: The nitazenes

From 2019, in the United States and Europe, the synthetic opioid market has diversified with the appearance of the 2-benzylbenzimidazole family, commonly named "nitazenes". In vitro studies show that these synthetic opioids have much higher affinities on μ-opioid receptors: 100times more than morphine, and slightly higher than fentanyl for isotonitazene, increasing the risk of overdose. In south of France, isotonitazene (IZN) was identified for the first time in March 2023. In this context, there were 9 reports concerning the use of IZN in the south of France over a short period (March-April 2023), with identification of IZN in 4 cases and suspicion in others. They concerned 6 men and 3 women, with a mean age of 44.9±2years. When available (2cases), the product had been purchased from a dealer. IZN was identified on sample in 2cases of overdose. Isotonitazene was also identified in biological samples in 2cases: 1case of overdose and coma requiring hospitalization with a favorable outcome (urinary analysis), and a death with post-mortem identification. This was the first identification of this product in France. The immediate broadcast of the alert limited the risks for users and made it possible to quickly inform regional and national health authorities. IZN is under intensive surveillance by the EMCDDA and classified as a narcotic in France since 2021. The analysis of the literature made it possible to identify cases of overdoses requiring very high doses of naloxone and deaths. The emergence of these synthetic opioids constitutes an important signal, due to their superior effects to heroin, their incomplete response to naloxone and the current difficulty in identifying them (devices for analyzing products in the reduction of risks, toxicology laboratories).

How the French national authority for health assesses medicines for use in pediatrics

Children deserve to be treated with appropriate medicines based on robust assessments. Despite the introduction of new regulations, the availability of medicines for children is suboptimal because of the frequent lack of relevant clinical trials due to the difficulty of conducting such trials. Thus, the Transparency Committee (TC) of the French National Authority for Health, who oversees the assessment of medicinal products in France, set up a pediatric working group with two aims: (1) The first aim was to review all opinions on medicines for pediatric use. Out of 536 opinions delivered between 2020 and 2022, 181 (34 %) concerned medicines for pediatric use. Whereas oncology largely dominated the medicines for adults, medicines for infectious diseases, endocrinology/metabolism, neurology, and hematology mostly prevailed for children. (2) The second aim was to clarify the evaluation criteria assessed by the TC, namely, the clinical benefit (CB), the clinical added value (CAV), and the public health impact (PHI) for pediatric medicinal products. An important CB was given to 113 out of 161 (71 %) opinions on medicines for pediatric use when it concerned pathologies with a severe prognosis. The quality of the demonstration (e.g., double-blind randomized trial vs. placebo or another active medicine) played a major role in the CB level. Clinical pediatric studies were also consistently associated with higher CAV levels: levels I (major) to III (moderate) in 26 out of 42 (62 %) opinions, level IV (minor) and level V (no therapeutic progress) in 43 out of 84 (51 %) and 30 out of 43 (70 %) opinions granting a sufficient CB, respectively. Conversely, 22 out of 30 (73 %) dossiers based only on literature reviews were given a level V. The main criteria leading to the qualification of a medicine for pediatric use as providing a PHI included a significant change in the morbidity and mortality of the disease and an improvement in the care pathway. Assessments were mostly aligned on the adults in the case of subsequent extensions of indications to children. Lastly, new measures were taken aimed at shortening median delays in the assessment process in order to reduce off-label use of medicines in France.

Spatio-temporal dynamics and drivers of highly pathogenic avian influenza H5N1 in Chile.

Highly pathogenic avian influenza A H5N1 clade 2.3.4.4b (hereafter H5N1) is causing vast impacts on biodiversity and poultry around the globe. In Chile, lethal H5N1 cases have been reported in a wide range of wild bird species, marine mammals, backyard and industrial poultry, and humans. This study describes the spatio-temporal patterns of the current epizootic of H5N1 in Chile and test drivers that could be associated with outbreak occurrence. We used H5N1 cases reported by the Chilean National Animal Health Authority from 5 December 2022 to 5 April 2023. These included wild bird cases confirmed through an avian influenza-specific real-time reverse transcription PCR assay (RT-qPCR), obtained from passive and active surveillance. Data were analyzed to detect the presence of H5N1 clusters under space-time permutation probability modeling, the association of H5N1 with distance and days since the first outbreak through linear regression, and the correlation of H5N1 presence with a number of ecological and anthropogenic variables using general linear modeling. From 445 H5N1 identified outbreaks involving 613 individual cases in wild birds, a consistent wave-like spread of H5N1 from north to south was identified, which may help predict hotspots of outbreak risk. For instance, seven statistically significant clusters were identified in central and northern Chile, where poultry production and wildlife mortality are concentrated. The presence of outbreaks was correlated with landscape-scale variables, notably temperature range, bird richness, and human footprint. In less than a year, H5N1 has been associated with the unusual mortality of >100,000 individuals of wild animals in Chile, mainly coastal birds and marine mammals. It is urgent that scientists, the poultry sector, local communities, and national health authorities co-design and implement science-based measures from a One Health perspective to avoid further H5N1 spillover from wildlife to domestic animals and humans, including rapid removal and proper disposal of wild dead animals and the closure of public areas (e.g., beaches) reporting high wildlife mortalities.

Macrolide resistance among Streptococcus agalactiae during COVID-19 public health emergency in Brazil.

During COVID-19 public health emergence, azithromycin was excessively used in Brazil, as part of a controversial "early treatment", recommended by former national health authorities. Excessive usage of macrolides may increase resistance rates among beta-hemolytic streptococci. Therefore, this study aimed to investigate the occurrence of resistance to erythromycin and clindamycin among Streptococcus agalactiae recovered from February 2020 to May 2023. Bacterial isolates (n = 116) were obtained from pregnant women and submitted to antimicrobial susceptibility testing, investigation of macrolide resistance phenotypes and genotypes, and identification of capsular type. The overall rate of erythromycin not susceptible (NS) isolates was 25.9%, while resistance to clindamycin was 5.2%. Drug efflux, associated with the M phenotype and mef(A) gene, was the prevalent mechanism of resistance (80%). Capsular type Ia was predominant (39.8%), followed by II, III, and V (17.7% each). A higher diversity of types was observed in the last years of the study. Type IV has had an increasing trend over time, being the fourth most common in 2023. The majority of the isolates that expressed the M phenotype presented capsular type Ia, while those with iMLS phenotype presented capsular type V. Despite no causal relationship can be established, azithromycin excessive usage may be a possible factor associated with this higher rate of erythromycin NS isolates, compared with most previous national studies. On the other hand, resistance to clindamycin has not changed significantly. Therefore, in the studied clinical setting, clindamycin remains a useful alternative to intrapartum prophylaxis among penicillin-allergic pregnant women.

Radiopharmaceuticals Adverse Events Management.

Radiopharmaceuticals are radioactive compounds used for diagnostic or therapeutic purposes which are most often administered intravenously. Adverse events that may induce both adverse reactions and drug-to-drug interactions with changes in expected biodistribution, potentially affecting patient safety and diagnostic accuracy. Adverse reactions are relatively rare due to the small doses and under-reporting is the norm. The aim of this study is to increase awareness of the need to report in order to create protocols for the management of such adverse events among professionals in a Nuclear Medicine Department. A reporting system was established a decade ago through an electronic form to enhance adverse event registration. The radiopharmacist collects data for further communication with National Health authorities and develops an annual report with recommendations on the management of these adverse events. A total of 128 reports were collected, including 65 cases of extravasations, 18 adverse reactions, and 45 drug interactions. Over the years, reporting has been increasing, adverse reactions occurred at a higher incidence than reported in the literature, and each anomalous biodistribution was analysed for possible drug interaction. The annual reports have been used to develop a local guideline for the management of adverse reactions and recommendations for discontinuation of treatment to avoid interactions with radiopharmaceuticals. The recognition of adverse events associated with radiopharmaceuticals is increasing, underlining the need for vigilant reporting and improved management strategies. An efficient reporting system promotes awareness of possible interactions between radiopharmaceuticals and other medicines and their potential adverse reactions to enhance patient safety.

Managing Shifting Visitor Restrictions in Hospitals during the COVID-19 Pandemic from National Authority Level to Charge Nurses’ Practice: A Descriptive Study

Introduction. Little is known about how shifting hospital visitor restrictions issued by national health authorities were communicated, managed, and adapted by hospital charge nurses during the COVID-19 pandemic. Aims. To describe the shifting visitor restrictions and the passing on of restrictions from the national authority level to charge nurses and secondly describe charge nurses’ management of the restrictions and their challenges when enforcing them. Methods. The study consisted of a document analysis and a cross-sectional survey including open-ended questions. Descriptive statistics and qualitative content analysis were used. The survey was distributed online to 88 charge nurses in somatic units in a Danish university hospital from March 2020 to April 2021. Results. Restrictions were communicated from national authority level in an effective administrative cascade. The charge nurses led their enforcement in each unit. In total, 71 charge nurses (81%) responded to the survey. For 70%, the wording of the restrictions was clear, while 31% found them challenging to handle. On a weekly or daily basis, 68% of the charge nurses deviated from the restrictions. They identified both upsides and downsides to the absence of relatives. Communication, collaboration, and leadership were experienced as key tools in the ongoing processes of adapting to shifting restrictions. Conclusion. During this severe health crisis, essential information was passed on through well-defined management levels in an effective communication pathway. Charge nurses and their professional values were challenged when balancing shifting national restrictions against individual needs of patients and relatives. Implications for Nursing Management. Charge nurses serve as vital intermediaries between national authorities and frontline nursing practice in managing shifting visitor restrictions during a pandemic. Their experiences can contribute to further qualifying nurse managers’ considerations when designing family-centred hospital visitor policies for the future. Also, they may strengthen the handling of future sudden major organizational changes.

Impact of Early Access Reform on Oncology Innovation in France: Approvals, Patients, and Costs.

An ambitious reform of the early access (EA) process was set up in July 2021 in France, aiming to simplify procedures and accelerate access to innovative drugs. This study analyzes the characteristics of oncology drug approvals through the EA process and its impact on real-life data for oncology patients. The number and characteristics of EA demands concerning oncology drugs submitted to the National Health Authority (HAS, Haute Autorité de Santé) were reviewed until 31 December 2022. A longitudinal retrospective study on patients treated with an EA oncology drug between 1 January 2019 and 31 December 2022 was also performed using the French nationwide claims database (Systeme National des Données de Santé [SNDS]) to assess the impact of the reform on the number of indications and patients, and the costs. Among 110 published decisions, the HAS granted 88 (80%) EA indications within 70 days of assessment on average, including 46 (52%) in oncology (67% in solid tumors and 33% in hematological malignancies). Approved indications were mostly supported by randomized phase III trials (67%), whereas refused EA relied more on non-randomized (57%) trials. Overall survival was the primary endpoint of 28% of EA approvals versus none of denied EAs. In the SNDS data, the annual number of patients with cancer treated with an EA drug increased from 3137 patients in 2019 to 18,341 in 2022 (+ 484%), whereas the number of indications rose from 12 to 62, mainly in oncohematology (n=17), lung (n=12), digestive (n=9) and breast cancer (n=9). Reimbursement costs for EA treatments surged from €42 to €526 million (+ 1159%). The French EA reform contributed to enabling rapid access to innovations in a wide range of indications for oncology patients. However, the findings highlight ongoing challenges in financial sustainability, warranting continued evaluation and adjustments.