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Objectives: This study aimed to assess compliance with legal requirements, safe medication storage and staffing standards in community pharmacies in Punjab, Pakistan., Method: We conducted a three-step cross-sectional study using observations, questionnaires and face-to-face interviews in 544 systematically-selected community pharmacies. We used descriptive statistic and one-way ANOVA to assess the data., Results: Only 23 (4.2 %) pharmacies had accurate area and only 3.9 % had appropriate walls. In total, 23.3 % had glass-fronted shelves and 38.2 % had a glass door. More than half (53.8 %) had separate narcotics shelves and 43.0 % a separate shelf of expired medicines. Less than half (47.5 %) of the pharmacies were able to maintain hygiene. About 36.2 % of the pharmacies segregated different types of product. Drugs were protected from direct sunlight in most (61.3 %) pharmacies, but the refrigerator was working properly in less than half (43.4 %) and only a very small number (2.4 %) had an alternative power supply for the refrigerator. Only 37 (6.8 %) were able to maintain an appropriate room temperature. The vast majority (93.0 %) displayed a valid drug sale license, but a qualified person/pharmacist was only present in 4.8 %. The average number of employees was 4.2, and more than 71.0 % of staff had 10-12 years of formal education. Only 0.2 % of employees could explain term "PRN", although 57.3 % explained "IV" correctly. About 22.8 % replied correctly about the room temperature but the vast majority (97.6 %) did not know about cold chain temperature. The location of the pharmacy ( p -value = 0.045) affected its performance., Conclusions: Noncompliance with legal requirements, unsafe drug storage and limited human resources reflect the poor enforcement of drug laws in Pakistan. The findings suggest that there is a need to strengthen inspection and management of community pharmacies., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2023 The Authors.)

Introduction: An important dimension of care and case managers is to support geriatric patients in obtaining social services in medical, nursing, therapeutic and social fields. To this, they advise and represent their patients., Methods: The documentation of patient contacts with case managers of a network of physicians was evaluated. In particular, activities involving legal advice were analysed in detail, compared with the current legal situation in Germany and evaluated. In addition, qualitative expert interviews were conducted. The content and the legal requirements of legal services law were determined by applying legal interpretation methods (esp. wording, telos, systematics). The results of the evaluation of the documentation were compared with legal requirements., Results: Care and case management touches activities in some fields of action without having a legal basis in legal services law. This leads to the fact that these services may not be provided and to - uninsured and uninsurable - liability risks., Discussion: With the introduction of care and case management into standard care, both social law and the Legal Services Act must be adapted to enable the legally compliant use of care and case managers. Otherwise, certain services that are useful for the care of patients may not be provided., (© 2022. The Author(s).)

Consent in medical practice is a process riddled with layers of complexities. To some extent, this is inevitable given that different medical conditions raise different sets of issues for doctors and patients. Informed consent and risk assessment are highly significant public health issues that have become even more prominent during the course of the Covid-19 pandemic. In this article we identity relevant factors for clinicians to consider when ensuring consent for solid organ transplantation. Consent to undergo solid organ transplantation is more complex than most surgical and other clinical interventions because of the many factors involved, the complexity of the options and the need to balance competing risks. We first out the context in which consent is given by the patient. We then outline the legal principles pertaining to consent in medical practice as it applies in the UK and the implication of recent legal judgments. The third section highlights specific complexities of consent in organ transplantation and identifies relevant factors in determining consent for organ transplantation. The fourth section offers practical recommendations. We propose a novel 'multi-factor approach' to informed consent in transplantation which includes understanding risk, effective communication, and robust review processes. Whilst understanding risk and communication are a given, our suggestion is that including review processes into the consent process is essential. By this we specifically mean identifying and creating room for discretion in decision-making to better ensure that informed consent is given in practice. Discretion implies that health care professionals use their judgement to use the legal judgements as guidance rather than prescriptive. Discretion is further defined by identifying the relevant options and scope of clinical and personal factors in specified transplantation decisions. In particular, we also highlight the need to pay attention to the institutional dimension in the consent process. To that end, our recommendations identify a gap in the current approaches to consent. The identification of areas of discretion in decision-making processes is essential for determining when patients need to be involved. In other words, clinicians and healthcare professionals need to consider carefully when there is room for direction and where there is little or no room for exercising discretion. In sum, our proposed approach is a modest contribution to the on-going debate about consent in medicine., (© 2022. The Author(s).)

MSCs products as well as their derived extracellular vesicles, are currently being explored as advanced biologics in cell-based therapies with high expectations for their clinical use in the next few years. In recent years, various strategies designed for improving the therapeutic potential of mesenchymal stromal cells (MSCs), including pre-conditioning for enhanced cytokine production, improved cell homing and strengthening of immunomodulatory properties, have been developed but the manufacture and handling of these cells for their use as advanced therapy medicinal products (ATMPs) remains insufficiently studied, and available data are mainly related to non-industrial processes. In the present article, we will review this topic, analyzing current information on the specific regulations, the selection of living donors as well as MSCs from different sources (bone marrow, adipose tissue, umbilical cord, etc.), in-process quality controls for ensuring cell efficiency and safety during all stages of the manual and automatic (bioreactors) manufacturing process, including cryopreservation, the use of cell banks, handling medicines, transport systems of ATMPs, among other related aspects, according to European and US legislation. Our aim is to provide a guide for a better, homogeneous manufacturing of therapeutic cellular products with special reference to MSCs., Competing Interests: FS-G has received honoraria and/or research support from Novartis, Kite/Gilead, Celgene/BMS, Pfizer, Takeda and Roche. DG-O is a member of the Advisory Board of Tigenix SAU and received fees from Takeda. ML-P has received honoraria from Novartis, Kite/Gilead and Celgene/BMS. JM has received research support from Roche, Pfizer, Jazz Pharma, Sandoz-Novartis, Gilead, Celgene, and Takeda not related to this manuscript. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Fernández-Santos, Garcia-Arranz, Andreu, García-Hernández, López-Parra, Villarón, Sepúlveda, Fernández-Avilés, García-Olmo, Prosper, Sánchez-Guijo, Moraleda and Zapata.)

In 2021 the number of electric vehicles (EV) circulating in the European Union (EU) was higher than ever before. The innovative solutions of the user centric charging infrastructure (USER-CHI) project aim at devising the basic guidelines for an interoperable charging infrastructure for EV. The future goal is for users to be able to charge "anywhere, anytime". USER-CHI works towards a large-scale e-mobility market and the development of integrated smart solutions and new business models. These will be demonstrated in five urban areas, which are part of the Trans-European Transport Network corridor (Barcelona metropolitan area, Rome, Berlin, Budapest, and Turku). To make access to the charging infrastructure possible irrespectively of vehicle brands and operators, an analysis of the existing interoperability framework was considered essential within the USER-CHI project. Pursuant to this, the Institute for Climate Protection, Energy and Mobility (IKEM) developed INFRA (Interoperability Framework) , a study that contains an analysis of the four layers that condition interoperability in the electromobility sector (organizational, semantic, technical and legal). Building on this analysis, the existing barriers for interoperability in each layer were identified and guidelines and recommendations were elaborated. The baseline of this paper are the role schemes, guidelines and recommendations elaborated for INFRA summarized in minimum requirements within each layer. The INFRA results are already available on CORDIS. In addition, further desk research shows the latest developments in the EU regarding electromobility and puts INFRA in the context of the most recent discourse. The new insights of this paper offer an updated overall short summary of the main requirements for an interoperability framework for electromobility in the EU. In conclusion the current developments underline the importance of the minimum requirements identified in INFRA and first steps towards a more interoperable infrastructure system have been taken., Competing Interests: No competing interests were disclosed., (Copyright: © 2022 Csillak K and Moreno Kuhnke M.)

Biosafety laboratory accidents are a normal part of laboratory science, but the frequency of such accidents is unclear due to current reporting standards and processes. To better understand accident reporting, a survey was created, with input from ABSA International, which included a series of questions about standards, requirements, and likely motivations for reporting or nonreporting. A total of 60 biosafety officers completed the survey. Respondents reported working with more than 5,000 people in laboratories, including more than 40 biosafety level 3 or animal biosafety level 3 laboratories, which work with higher-risk pathogens. Most of the respondents were located in the United States, Canada, or New Zealand, or did not identify their location. Notable results included that 97% of surveyed biosafety officers oversee laboratories that require reporting exposure to at least some pathogens. However, 63% relayed that the reports are not usually sent outside of the institution where they occurred. A slight majority (55%) stated that paper reports were used, with the rest reporting they used a variety of computer systems. Even in laboratories that used paper-based reporting systems, 67% relayed that these reports were used alongside, or entered into, a digital system. While 82% of these biosafety officers agreed that workers understood the importance of reporting for their own safety, 82% also agreed that a variety of disincentives prevent laboratory workers from reporting incidents, including concerns about job loss and loss of funding.

Background: This study aimed to reflect on scientific experts' and executive stakeholders' opinions on how charitable organizations can participate in the health care system properly and cope with problems, challenges, strategies, and executive requirements at three major levels of prevention, treatment, and rehabilitation., Methods: A total number of 20 semi-structured interviews were conducted with scientific experts and executive stakeholders, selected for this qualitative study, based on an interview guide. Using the purposeful sampling method, we selected scientific experts with 5 years of experience in the health care system and executive stakeholders who had 5 years of experience in charitable activities. We applied a framework method for data analysis, and the main themes were extracted through MAXQDA software., Results: Our findings revealed that charitable organizations at the major levels of the health care system, i.e., prevention, treatment, and rehabilitation, possessed the necessary capacities to provide services effectively. Nevertheless, charities encountered some problems, e.g., financial instability, non-recognition of donors' legal status, non-involvement in policy-making, inadequate cooperation from other agencies, absence of transparent programs and goals, together with weaknesses in advertising and attracting donations. It was noted that the government should take more operational steps towards supporting such organizations, e.g., by granting special facilities and exemptions, engaging charities in policy-making and training processes, and empowering them in terms of the production of resources. Charitable organizations are also recommended to establish external communications with other bodies such as municipalities, secretaries of state, governorate offices, welfare organizations, relief committees, and medical sciences universities., Conclusions: Charitable organizations have the potentials to provide health care services at prevention, treatment, and rehabilitation levels. Thus, it is of utmost importance to adopt strategies such as creating sustainable funding sources, training charity managers with a wide variety of scientific management techniques, and implementing their intellectual capacities in legislative and planning processes.

Precision health leverages information from various sources, including omics, lifestyle, environment, social media, medical records, and medical insurance claims to enable personalized care, prevent and predict illness, and precise treatments. It extensively uses sensing technologies (e.g., electronic health monitoring devices), computations (e.g., machine learning), and communication (e.g., interaction between the health data centers). As health data contain sensitive private information, including the identity of patient and carer and medical conditions of the patient, proper care is required at all times. Leakage of these private information affects the personal life, including bullying, high insurance premium, and loss of job due to the medical history. Thus, the security, privacy of and trust on the information are of utmost importance. Moreover, government legislation and ethics committees demand the security and privacy of healthcare data. Besides, the public, who is the data source, always expects the security, privacy, and trust of their data. Otherwise, they can avoid contributing their data to the precision health system. Consequently, as the public is the targeted beneficiary of the system, the effectiveness of precision health diminishes. Herein, in the light of precision health data security, privacy, ethical and regulatory requirements, finding the best methods and techniques for the utilization of the health data, and thus precision health is essential. In this regard, firstly, this paper explores the regulations, ethical guidelines around the world, and domain-specific needs. Then it presents the requirements and investigates the associated challenges. Secondly, this paper investigates secure and privacy-preserving machine learning methods suitable for the computation of precision health data along with their usage in relevant health projects. Finally, it illustrates the best available techniques for precision health data security and privacy with a conceptual system model that enables compliance, ethics clearance, consent management, medical innovations, and developments in the health domain., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Digital public health applications are becoming increasingly popular; for example, about 45% of smartphone users have health or fitness apps on their devices. Most of these applications transfer the user's personal data to the provider of the health app. Application providers must comply with the relevant data protection statutes.In this article we provide a survey of important data protection requirements and the necessary technical measures for data security that the provider of a health app must observe. This includes - amongst other things - mechanisms for consent, determination of and compliance with the legitimate purposes of the processing, and the granting of so-called "rights of the data subject" (e.g. right of access). Furthermore, the provider of the health application must follow best practice recommendations from the area of data security. Therefore, the provider must ensure that, for example, unauthorized access, manipulation, loss, and destruction of personal data are prevented by appropriate technical and organizational measures. State-of-the-art procedures such as encryption, rights management, securing integrity, pseudonymization, and logging are some examples of technical and organizational measures. When implementing these measures, it must be taken into account that the processing of health data generally entails high risk for the rights and freedoms of the data subjects and that unauthorized access to and/or manipulation of data, for example, can lead to the publication of a stigmatizing diagnosis or incorrect medication.

Almost 500 municipal solid waste incineration plants in the EU, Norway and Switzerland generate about 17.6 Mt/a of incinerator bottom ash (IBA). IBA contains minerals and metals. Metals are mostly separated and sold to the scrap market and minerals are either disposed of in landfills or utilised in the construction sector. Since there is no uniform regulation for IBA utilisation at EU level, countries developed own rules with varying requirements for utilisation. As a result from a cooperation network between European experts an up-to-date overview of documents regulating IBA utilisation is presented. Furthermore, this work highlights the different requirements that have to be considered. Overall, 51 different parameters for the total content and 36 different parameters for the emission by leaching are defined. An analysis of the defined parameter reveals that leaching parameters are significantly more to be considered compared to total content parameters. In order to assess the leaching behaviour nine different leaching tests, including batch tests, up-flow percolation tests and one diffusion test (monolithic materials) are in place. A further discussion of leaching parameters showed that certain countries took over limit values initially defined for landfills for inert waste and adopted them for IBA utilisation. The overall utilisation rate of IBA in construction works is approximately 54 wt%. It is revealed that the rate of utilisation does not necessarily depend on how well regulated IBA utilisation is, but rather seems to be a result of political commitment for IBA recycling and economically interesting circumstances., (Copyright © 2019 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Objectives: This study has analyzed the policy-making requirements related to basic health insurance package at the national level with a systematic view., Results: All the documents presented since the enactment of universal health insurance in Iran from 1994 to 2017 were included applying Scott method for assuring meaningfulness, authenticity, credibility and representativeness. Then, content analysis was conducted applying MAXQDA10. The legal and policy requirements related to basic health insurance package were summarized into three main themes and 11 subthemes. The main themes include three kinds of requirements at three level of third party insurer, health care provider and citizen/population that contains 5 (financing insurance package, organizational structure, tariffing and purchasing the benefit packages and integration of policies and precedents), 4 (determining the necessities, provision of services, rules relating to implementation and covered services) and 2 (expanded coverage of population and insurance premiums) sub themes respectively. According to the results, Iranian policy makers should notice three axes of third party insurers, health providers and population of the country to prepare an appropriate basic benefit package based on local needs for all the people that can access with no financial barriers in order to be sure of achieving UHC.

Legal and ethical demands for more transparent and strict data protection measures to enhance research participant privacy have grown with an increasing number of human biobanks providing biomaterial collections long term for unspecified future research questions. The design of a data protection scheme that minimizes the risk of donor reidentification and promotes biomaterial and data use in research is a big challenge to all kinds of human biobanks. Yet, there is a lack of publications which address this basic building block of a biobank. In this study, we present the data protection concept of our project driven, stand-alone biobank, focusing on meeting two biomaterial and data management areas simultaneously: operation of primary research projects involved in sample collection and long-term provision of biomaterial for future research purposes. The concept is based on national and international laws and ethical demands. Since the presented measures are transparent and basic, they should encourage biobanks in defining their own data protection concept and be easily transferable to different legal requirements.

Background: Respect for patient autonomy and the requirement of informed consent is an essential basic patient right. It is constituted through international conventions and implemented in health law in Norway and most other countries. Healthcare without informed consent is only allowed under specific exceptions, which requires a record in the patient charts. In this study, we investigated how surgeons recorded decisions in situations where the elderly patient's ability to provide a valid informed consent was questionable or clearly missing., Method: We investigated all medical records of patients admitted to surgical departments in a Norwegian large academic emergency hospital over a period of 38 days (approximately 5000 patients). We selected records of patients above the age of 70 (570 patients) and searched through these 570 medical records for any noted clear indications of inability to consent such as "do not understand", "confused" etc. (102 patients). We read through all the medical records on these 102 patients noting any recordings on lack of informed consent, any recordings on reasoning and process hereto. We also took note whether there were clear indications on the use of coercion., Results: None of the 102 included patients´ charts contained legally valid recorded assessments (for example related to the patients´ competence to consent) when patients without the ability to consent were admitted and provided healthcare.Some charts contained records that the patient resisted treatment, thus indicating treatment with coercion. In these situations, we did not find any documentation related to legal requirements that regulate the use of coercion., Discussion and Conclusion: We found a substantial lack of compliance with the legal requirements that apply when obtaining valid informed consent. There are many possible reasons for this: Lack of knowledge of the legal requirements, disagreement about the rules, or that it is simply not possible to comply with the extensive formal and material legal requirements in clinical practice. The results do not point out whether the appropriate measures are amending the law, educating and requiring more compliance from surgeons, or both., Competing Interests: Competing interestsThe authors declare that they have no competing interests.

During the last 20 years Austrian prehospital emergency medical services (EMS) have significantly improved. The structure and organization of Austrian EMS comply with European standards but training requirements for prehospital EMS physicians are insufficient when compared with other countries. Although some EMS systems follow the German or Swiss postgraduate training concepts, the legal requirements in Austria defining the scope of mandatory training for physicians in the prehospital setting are only minimal. Thus, besides board certification as a general practitioner or specialist of any discipline, the only formal requirement is a 1-week theoretical course comprising some manikin simulations. Experience in anesthesia or intensive care medicine is still not mandatory. The Austrian Society of Anesthesiology, Resuscitation and Intensive Care Medicine (ÖGARI) drafted a reform paper in 2009, which was adapted by the Austrian Chamber of Physicians, section of emergency medicine, and subsequently presented to the Austrian Ministry of Health. Due to the slowness of the legislation process, the relevant § 40 of the Austrian Physician 's Act is still unchanged. In the meantime, Austrian specialist training regulations were restructured in 2015 with significant consequences. Due to changes in the residency programs, board certification and subsequent full working permit becomes more difficult to obtain, thus further aggravating the shortage of emergency physicians in Austria. In order to counteract the threatening shortage of prehospital EMS physicians, the ÖGARI section of emergency medicine was requested by the Ministry of Health to develop a reasonable model for how physicians could be qualified and subsequently employed in EMS prior to full board certification. Presently, the Austrian Ministry of Health, the Chamber of Physicians and medical societies are in discussion on whether this approach might fit into the legal framework. This manuscript details the development and present status as well as key points of an ongoing discussion on how high-quality EMS care in Austria can be safeguarded in the future or could even make it impossible.

Background Following the legal provisions on the termination of pregnancies in Art. 13 of the SFHG (Law on the Assistance for Pregnant Women and Families, passed on 27.07.1992, BGBl. I, p. 1398) the so-called embryopathic indication for termination was abandoned. Since then, sec. 218a para. 2 of the German Criminal Code (StGB) states that for late terminations, i.e., terminations after the 12th week of gestation post conception, the pregnant woman must be in exceptional distress "according to medical opinion". Method Between 01.05.2012 and 25.07.2016, a total of 160 pregnancy terminations were carried out in Gießen University Hospital under sec. 218a para. 2 StGB. The following data were obtained from the patients' files: age of the pregnant woman, number of pregnancies, type of fetal disease or malformation, time of diagnosis, medical and psychosocial counseling given to the pregnant woman, time of termination or delivery, type of termination, fetal gender. Results 160 pregnant women (mean age: 31.6 years) underwent termination of pregnancy between the 13th - 37th week of gestation. Chromosomal anomalies were diagnosed prenatally in 60 cases, and anomalies were diagnosed on ultrasonography in 100 cases, with the preponderance of cases presenting with developmental disorders of the central nervous system and cardiovascular system. Conclusion In addition to recording intrauterine fetal disorders, when pregnancies are terminated under sec. 218a para. 2 StGB, treating physicians are expected to give plausible reasons why "according to medical opinion" the pregnancy represents a danger to the life of the pregnant woman or of grave injury to her physical or mental health and enter these reasons in the patient's medical records.

This paper describes a traceability system developed for the Stem cells for Biological Assays of Novel drugs and prediCtive toxiCology consortium. The system combines records and labels that to biological material across geographical locations and scientific processes from sample donation to induced pluripotent stem cell line. The labeling system uses a unique identification number to link every aliquot of sample at every stage of the reprogramming pathway back to the original donor. Only staff at the clinical recruitment site can reconnect the unique identification number to the identifying details of a specific donor. This ensures the system meets ethical and legal requirements for protecting privacy while allowing full traceability of biological material. The system can be adapted to other projects and for use with different primary sample types.

The utilization of Fenton's oxidation for the depuration of elderberry juice wastewater was studied. The aim was to select the adequate cost-effective operating conditions suitable to lead to an effluent within the legal thresholds to be discharged into the natural water courses. The treatment efficacy was assessed by chemical oxygen demand (COD), colour, phenolic content and total solids removal besides its ability to improve biodegradability (biochemical oxygen demand (BOD5)/COD). Moreover, the costs of the applied reactants were also considered. Fenton's reaction was able to abate at least 70% of COD (corresponding to a final value below 150 mg O2 L(-1)). Besides, total phenolic content degradation was always achieved. Within these conditions, the resulting effluent is able to be directly discharged into the natural hydric channels. Fenton oxidation could be successfully applied as a single treatment method with a reactant cost of 4.38 € m(-3) ([Fe(2+)] = 20 mmol L(-1), [H2O2] = 100 mmol L(-1), pH = 3 and 4 h of oxidation procedure).

The clinical benefits of early prophylaxis in the treatment of haemophilia have been unquestioned since publication of the results of the first randomized study. The question of whether or not prophylaxis is cost-effective remains to be proven. For European physicians treating haemophilia patients, and for German clinicians in particular, the law largely supports the use of prophylaxis in haemophilia, but many doctors are unaware of this. The aim of this review was therefore to describe the German legal framework and outline how it can be used to support appropriate clinical decision-making in the treatment of haemophilia and justify the use of prophylaxis to health insurers and third-party payers. The German Disability Equalisation Law and German Social Law Books V and IX outline legal requirements to prevent or ameliorate disability, and support the argument that all haemophilia patients, including adults, have the right to receive appropriate, adequate, and cost-effective treatment. "Appropriate" treatment means that it must be in accordance with state-of-the-art medical knowledge taking into account medical progress. "Adequate" treatment must be conducive to the goals of haemophilia management, which are to prevent bleeds, treat bleeding episodes, maintain and/or restore joint function, and integrate patients into a normal social life. This can only be achieved when long-term treatment is adequately dosed and regularly administered for as long as it is required. Thankfully, with the availability of virus-safe factor concentrates, the introduction of home treatment programmes, and the law on our side, we are in a very strong position to achieve these goals., (© 2013.)