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Copyright of Medizinische Klinik: Intensivmedizin & Notfallmedizin is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Given the increase in the number of aesthetic plastic surgeries, it is imperative to keep in mind the obligations of health personnel. In Mexico, this type of complacency surgery can only be performed by doctors who complete the specialty of Aesthetic Plastic and Reconstructive Surgery, so all the complications and consequences that arise from a procedure carried out by non-legitimized medical personnel, are considered due to malpractice subject to the corresponding legal sanctions. It is considered in many countries, without ours being an exception, that aesthetic plastic surgery implies the obligation of diligence and results, leaving the proof of non-fault in the hands of the aesthetic plastic surgeon in case of malpractice litigation, therefore, it is essential to know the legal and medical ethics framework that allows to exercise the profession in accordance with the law, so this article aims to be a guide to collaborate in the good practice of aesthetic plastic surgery. [ABSTRACT FROM AUTHOR]

Dental Service Organizations (DSOs) are an increasingly visible and available practice option for new dental graduates. While guidance has been published to help dental students make informed decisions when considering a DSO affiliation, they have not focused on the complexities of assessing compliance with controlling state laws. Accordingly, this Perspectives article provides a concise summary of the common components of state regulatory provisions across the United States to support an understanding of the corporate practice of dentistry and compliance considerations. The guiding principles to consider include ownership or proprietorship of and control over a dental practice; control over dental offices, equipment, and materials; employment of dental personnel; and control over clinical judgment. This article should be helpful to students who are considering a DSO affiliation and educators who prepare them to enter dental practice. [ABSTRACT FROM AUTHOR]

Background: In 2018, the German Federal Constitutional Court decided that mechanical restraint is the most intrusive coercive measure and its use requires a judge's decision after bedside assessment if lasting longer than 30 min. Subsequently, legal changes were realized. The objective of our study was to determine the number of saved coercive episodes and saved hours in seclusion or restraint in 2019 compared to the average of the previous years, 2015-2017, as well as costs per saved episode, hour, and case saved from any coercive measure. Methods: We used data from the Baden-Wuerttemberg case registry for coercive measures, covering all 32 psychiatric hospitals of the Federal State and 435,767 admissions in the study period. Time expenditure was calculated as 3.5 h with an average of 51.95 € per working hour on the side of the justice system and 1.5 h (45.94 €/h) on the side of the hospital per case. Results: The number of coercive episodes decreased by 10.0% from 28,181 (average 2015-2017) to 25,371 (2019). The number of hours in seclusion or restraint decreased by 17.9% from 321,956 (2015-2017) to 264,423 (2019). This resulted in the cost of 872.33 € per saved episode and 42.61 € per saved hour in seclusion or restraint. Conclusion: Given the correctness of our estimations, saving 1 h in coercion by less than 1 h of an expert's work might be justified from an ethical and economic perspective. [ABSTRACT FROM AUTHOR]

Background: On September 25, 2023, the law requiring the mandatory installation and operation of closed circuit television (CCTV) in the operating room went into effect. In this study, doctors' perceptions of the law were re-examined on September 23, 2023 (just prior to the law's enforcement), following a survey conducted on July 21, 2021 (before the re-examination of the bill). This study aimed to confirm doctors' perceptions of the infringement of fundamental rights of this law, the collapse of essential medical services due to the avoidance of surgery, and other concerns and priority solutions ahead of the law's enforcement. Methods: The survey was conducted from 8 to 18 September, 2023, by the Korean Medical Association Doctor Survey; a total of 1,267 doctors responded to the survey. Results: Out of 1,267 respondents, 1,156 (91.2%) said "yes," and 111 (8.8%) said "no" to issue concerning constitutional violations of fundamental rights--such as the freedom of medical personnel to practice their profession--and moral rights. A total of 1,149 (90.7%) respondents agreed with the concern regarding the collapse of essential medical care due to the avoidance of surgeons. Conclusion: Sufficient guidance should be provided, along with guidelines that provide explicit standards for the installation and operation of the CCTV systems, along with safety management measures. Medical disputes and the heavy legal responsibility of medical personnel are the main reasons as to why essential medical care collapses, given the avoidance of surgery. Medical disputes should be avoided in order to prevent essential medical care collapse, as the video is used as evidence for criminal sanctions. [ABSTRACT FROM AUTHOR]

BackgroundIn 2018, the German Federal Constitutional Court decided that mechanical restraint is the most intrusive coercive measure and its use requires a judge’s decision after bedside assessment if lasting longer than 30 min. Subsequently, legal changes were realized. The objective of our study was to determine the number of saved coercive episodes and saved hours in seclusion or restraint in 2019 compared to the average of the previous years, 2015–2017, as well as costs per saved episode, hour, and case saved from any coercive measure.MethodsWe used data from the Baden–Wuerttemberg case registry for coercive measures, covering all 32 psychiatric hospitals of the Federal State and 435,767 admissions in the study period. Time expenditure was calculated as 3.5 h with an average of 51.95 € per working hour on the side of the justice system and 1.5 h (45.94 €/h) on the side of the hospital per case.ResultsThe number of coercive episodes decreased by 10.0% from 28,181 (average 2015–2017) to 25,371 (2019). The number of hours in seclusion or restraint decreased by 17.9% from 321,956 (2015–2017) to 264,423 (2019). This resulted in the cost of 872.33 € per saved episode and 42.61 € per saved hour in seclusion or restraint.ConclusionGiven the correctness of our estimations, saving 1 h in coercion by less than 1 h of an expert’s work might be justified from an ethical and economic perspective.

Given the increase in the number of aesthetic plastic surgeries, it is imperative to keep in mind the obligations of health personnel. In Mexico, this type of complacency surgery can only be performed by doctors who complete the specialty of Aesthetic Plastic and Reconstructive Surgery, so all the complications and consequences that arise from a procedure carried out by non-legitimized medical personnel, are considered due to malpractice subject to the corresponding legal sanctions. It is considered in many countries, without ours being an exception, that aesthetic plastic surgery implies the obligation of diligence and results, leaving the proof of non-fault in the hands of the aesthetic plastic surgeon in case of malpractice litigation, therefore, it is essential to know the legal and medical ethics framework that allows to exercise the profession in accordance with the law, so this article aims to be a guide to collaborate in the good practice of aesthetic plastic surgery. [ABSTRACT FROM AUTHOR]

Copyright of Die Dermatologie is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

While it is hoped that medical practice errors will be minimized in parallel with the development and widespread use in science and technology; the increasing number of lawsuits filed for unfair medical malpractice claims and the amount of compensation paid leads to the development of defensive medicine. Consequently, physicians’ defensive behavior models such as using radiological methods such as unnecessary magnetic resonance imaging, computed tomography, X-ray, ultrasonography and mammography, unnecessary hospitalization of the patient, unnecessary tests, unnecessary consultations, unnecessary biopsy, unnecessary consultations, unnecessary cesarean section and unnecessary drug prescribing are developing. In addition, it is observed that physician candidates with higher success they avoid branches which have more medical malpractice claims, but that are vital to human life. In this study, in order to prevent defensive medical behaviors and to protect physicians from unfair medical malpractice claims, the literature including the discussions made especially in the United States of America was reviewed, and in the light of these, solution proposals were defined by taking into account the facts of our country.

Background Due to its abuse potential, propofol has been classified as a controlled substance since February 2011 in South Korea. Healthcare workers are exposed to propofol abuse considering their easy access to this substance in hospitals. Therefore, we aimed to investigate propofol abuse among healthcare workers through the database of the Supreme Court in South Korea. Methods We retrospectively analyzed adjudicated criminal cases related to propofol abuse among healthcare workers from January 1, 2013, to December 31, 2020, using the database of the Supreme Court of South Korea’s judgments. We collected the clinical characteristics and punishment-related information of healthcare workers who abused propofol. Results Of the 194 cases collected using the search term ‘propofol,’ 20 were included in the final analysis. The most common healthcare workers who abused propofol were nursing aides (n = 15). Among them, 40% (n = 8) of the defendants had previously been punished for substance abuse, and 35% (n = 7) had a history of psychological disease. Of the defendants, 65% (n = 13) self-administered propofol more than twice, and the median number of self-administrations was three. Except for two, the defendants were sentenced to imprisonment, including suspended sentences, and the median values of their duration of prison and probation were 9 months and 24 months. Conclusions Despite propofol being strongly regulated as a controlled substance in South Korea, its abuse among healthcare workers remains. Healthcare workers should be vigilant against its abuse among themselves.

Copyright of Bulletin of Legal Medicine / Adli Tıp Bülteni is the property of Galenos Yayinevi Tic. LTD. STI and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

In order to provide a deeper understanding of the mechanisms and background leading to the persecution and expulsion, particularly of physicians labelled as "Jewish" in Nazi Germany, this article outlines their gradual disenfranchisement, through laws and decrees in the years 1933–1939. As the publicly visible terror immediately after the Nazi takeover was rejected in large parts of society, the regime resorted early on to supposedly legal forms of exclusion. With the Law for the Restoration of the Professional Civil Service of 7 April 1933, "non-Aryan" (§ 3) and politically unreliable (§ 4) persons could be removed from office, if necessary, even without any further comment (§ 6). However, regulations for long-standing civil servants as well as the "front-line fighter privilege" reduced the desired effect, e.g. in university medicine in a way that was not intended by those in power. The Reich Citizenship Law of 1935, as part of the so-called Nuremberg Laws introduced the criterion of "German blood". This resulted in a second large wave of dismissals. Outside the universities, a plethora of further defamatory legal norms, from the regulation on the approval of physicians for activities with the health insurances and the Law on Honorary Appointments (both in 1933), the so-called Flag Decree (1937) and withdrawal of the approbation (1938), aimed at the gradual "elimination" of Jewish physicians, which for many of them ended in extermination in the Holocaust. This practice implemented over years was based on a jurisdiction devised especially for that purpose and in hindsight it has been perfectly defined as "legal injustice". [ABSTRACT FROM AUTHOR]

Background and Objectives: The first inquisitorial processes were developed against Muslims and Jews. Then, they focused on women, especially those dedicated to care. Progressively, they were linked to witchcraft and sorcery due to their great assistance, generational and empirical knowledge. The health historiography of the 15th–18th centuries still has important bibliographic and interpretive gaps in the care provided by women. The main objective was to analyse the care provided by midwives in the legislative and socio-sanitary context of New Castile, in the inquisitorial Spain of the 15th–18th centuries. Materials and Methods: A historical review was conducted, following the Dialectical Structural Model of Care. Historical manuals, articles and databases were analysed. Results: The Catholic Monarchs established health profession regulations in 1477, including midwives. However, all legislations were annulled by Felipe II in 1576. These were not resumed until 1750. Midwives assumed a huge range of functions in their care commitment (teaching, care and religion) and were valued in opposing ways. However, many of them were persecuted and condemned by the Inquisition. They used to accompany therapeutic action with prayers and charms. Midwives were usually women in a social vulnerability situation, who did not comply with social stereotypes. Conclusions: Midwives, forerunners of current nursing and health sciences, overcame sociocultural difficulties, although they were condemned for it. Midwives achieved an accredited title, which was taken from them for two centuries. They acted as health agents in a society that demanded them while participating in a "witch hunt". [ABSTRACT FROM AUTHOR]

The obligatory post-mortem examination and the issuing of a death certificate are among the more unpopular medical tasks. Nevertheless, the legislature has entrusted the medical profession with a socially important task that should be carried out carefully. The examining physician decides whether the death remains a private matter or whether an official death investigation should first shed light on the circumstances of the death. The post-mortem examination system is the only instrument for the systematic detection of homicide offences. The prerequisite for issuing a death certificate is a carefully conducted external post-mortem examination, which must be carried out in full at least when certifying a natural or unexplained cause of death. In addition, the medical information on the death certificate serves epidemiological and health policy purposes and contains important information on infection control., (© 2024. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

Unlabelled: The rapid evolution of artificial intelligence (AI) is structuralizing social, political, and economic determinants of health into the invisible algorithms that shape all facets of modern life. Nevertheless, AI holds immense potential as a public health tool, enabling beneficial objectives such as precision public health and medicine. Developing an AI governance framework that can maximize the benefits and minimize the risks of AI is a significant challenge. The benefits of public health engagement in AI governance could be extensive. Here, we describe how several public health concepts can enhance AI governance. Specifically, we explain how (1) harm reduction can provide a framework for navigating the governance debate between traditional regulation and "soft law" approaches; (2) a public health understanding of social determinants of health is crucial to optimally weigh the potential risks and benefits of AI; (3) public health ethics provides a toolset for guiding governance decisions where individual interests intersect with collective interests; and (4) a One Health approach can improve AI governance effectiveness while advancing public health outcomes. Public health theories, perspectives, and innovations could substantially enrich and improve AI governance, creating a more equitable and socially beneficial path for AI development., (© Jennifer K Wagner, Megan Doerr, Cason D Schmit. Originally published in JMIR Public Health and Surveillance (https://publichealth.jmir.org).)

Copyright of Turkish Journal of Child & Adolescent Mental Health / Çocuk ve Gençlik Ruh Sagligi Dergisi is the property of Galenos Yayinevi Tic. LTD. STI and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: A bill for the mandatory installation of closed-circuit television (CCTV) in operating rooms, still likely in breach of the constitution, was approved. When a bill infringing on individuals' fundamental rights is drafted, alternative means of minimizing the infringement of the offender's rights should be considered ahead of the draft. To this end, alternatives on the bill identified through the consciousness of the offender would be most realistic and much more effective. Thus, this study examined doctors' consciousness on the mandatory installation of CCTV in operating rooms, the appropriateness of punishment for members who commit immoral and unethical behaviors, and doctors' alternative ideas to CCTV installation in operating rooms. Methods: The online survey was conducted for a week from July 9, 2021, to July 16, 2021, by the Korean Medical Association Doctors News, and 2,345 doctor members responded to the investigation. Results: According to the survey, the following alternatives to CCTV installation in operating rooms were proposed: strengthening punishment for performing ghost surgery (38.3%), placing cameras at the entrance of the operating room (21.8%), mandatory written consent (pledge) (13.7%) to prevent ghost surgery for medical staff participating in the surgery, promoting self-purification (whistle-blowing) (11.5%), and a biometrics function for entering operating rooms (8.8%). Conclusion: The revised medical law delegated legislative devices to subordinate statutes for minimizing infringement. Thus, new regulations should be set to reduce infringement of fundamental rights. It is hoped that doctors' consciousness on new law could be preliminary data to regulate new rules in discussing lower statutes. [ABSTRACT FROM AUTHOR]

Jeongsoo Kim,1 SuHwan Shin,2,3 YoungHyun Jeong,4 So Yoon Kim,5,6 Ho-Jin Lee4,7 1Department of Anesthesiology and Pain Medicine, SMG-SNU Boramae Medical Center, Seoul, Republic of Korea; 2Department of Medical Law and Ethics, Graduate School, Yonsei University, Seoul, Republic of Korea; 3Blue Urology Clinic, Seoul, Republic of Korea; 4Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul, Republic of Korea; 5Division of Medical Law and Bioethics, Department of Medical Humanities and Social Sciences, Yonsei University College of Medicine, Seoul, Korea; 6Asian Institute for Bioethics and Health Law, Yonsei University, Seoul, Korea; 7Department of Anesthesiology and Pain Medicine, Seoul National University College of Medicine, Seoul, Republic of KoreaCorrespondence: Ho-Jin LeeDepartment of Anesthesiology and Pain Medicine, Seoul National University College of Medicine, Seoul, Republic of KoreaTel +82-2-2072-0039Fax +82-2-747-8363Email zenerdiode03@gmail.comPurpose: Although the use of opioids is increasing in South Korea, there have been no studies on the serious complications caused by the opioids. The aim of this study was to investigate the rare but serious complications through medicolegal analysis.Materials and Methods: From January 1994 to December 2019, we retrospectively reviewed the closed cases of lawsuits involving the complications of opioids using the database of judgments of the Supreme Court of Korea. General characteristics, opioid-induced complications, and judicial characteristics were analyzed.Results: Of the 46 cases, 31 cases of complications were finally included in the analysis. There were 28 (90.3%) cases of opioid administration for acute pain and 3 (9.7%) cases for chronic pain. The most commonly prescribed opioid was pethidine (n = 13, 41.9%), and the most common complication was respiratory depression (n = 17, 54.8%). All except two cases were associated with permanent injuries, including 18 (58%) deaths. Twelve (38.7%) cases were ruled in favor of the plaintiff in the claims for damages, with a median payment of United States dollar (USD) 126,346 (IQR: USD 77,275– 379,219). Of these cases, the most frequently admitted complaint by the court was the neglect of observation (n = 10, 32.3%), followed by the inappropriate drug choice (n = 4, 12.9%). Eleven (36.7%) cases were plaintiffs’ claims for violating explanation obligations, of which 2 (6.7%) were recognized in the court.Conclusion: Our results suggest that physicians must be aware of the serious complications related to opioids and health policies to prevent such complications and malpractice should be adopted.Keywords: acute pain, adverse drug events, complications, legislation and jurisprudence, medical liability, opioids

Background and Objectives: The first inquisitorial processes were developed against Muslims and Jews. Then, they focused on women, especially those dedicated to care. Progressively, they were linked to witchcraft and sorcery due to their great assistance, generational and empirical knowledge. The health historiography of the 15th–18th centuries still has important bibliographic and interpretive gaps in the care provided by women. The main objective was to analyse the care provided by midwives in the legislative and socio-sanitary context of New Castile, in the inquisitorial Spain of the 15th–18th centuries. Materials and Methods: A historical review was conducted, following the Dialectical Structural Model of Care. Historical manuals, articles and databases were analysed. Results: The Catholic Monarchs established health profession regulations in 1477, including midwives. However, all legislations were annulled by Felipe II in 1576. These were not resumed until 1750. Midwives assumed a huge range of functions in their care commitment (teaching, care and religion) and were valued in opposing ways. However, many of them were persecuted and condemned by the Inquisition. They used to accompany therapeutic action with prayers and charms. Midwives were usually women in a social vulnerability situation, who did not comply with social stereotypes. Conclusions: Midwives, forerunners of current nursing and health sciences, overcame sociocultural difficulties, although they were condemned for it. Midwives achieved an accredited title, which was taken from them for two centuries. They acted as health agents in a society that demanded them while participating in a “witch hunt”.

Confidentiality is an important part of adolescent health care, providing a safe arena for young people to address sensitive health concerns and develop independent relationships with their providers. State and federal laws support a range of adolescent confidentiality protections. However, the full implementation of the 21st Century Cures Act, with the release of all medical records to patients and caregivers, may endanger this expectation of privacy. This policy brief reviews implications of the open notes requirement of the Cures Act, suggests strategies to improve care for adolescent patients, and recommends advocacy to improve the 2020 Final Rule implementation. [ABSTRACT FROM AUTHOR]

The spread of venereal diseases after the Second World War constituted a grave public health danger in Europe. Especially in all four occupation zones in Germany and the Polish People's Republic high morbidity rates were observed. In order to limit the spread of diseases, respective administrations adopted specific regulations. The aim of this research is the analysis and comparison of legal regulations for controlling and combating venereal diseases in these countries. We have analyzed legislative and administrative acts concerning combatting venereal diseases issued by the official organs of the Soviet Occupation Zone, the German Democratic Republic, and the Polish People's Republic from 1945 to 1989. Subsequently, the analyzed sources were evaluated in light of the existing literature on the topic. Our analysis shows that policy approaches in both countries were based the Soviet Union's model for fighting venereal diseases. Visible are similarities of the approaches. They include organization of anti-venereal services, compulsory hospitalization, and actions against social groups perceived as sources of venereal diseases. Beside the purpose of breaking the spread of the epidemics, the approaches had also a political aim of sanctioning behavior that diverged from prescribed socialist moral norms.

Introduction: The need for quality standards in pharmaceutical services, that provides a safety, responsible and effectiveness use of medication, has led several changes in health systems over the years. There is also a struggle to position the pharmacy and pharmaceutical professionals as potential axes to enact health care. As a result of these changes, there are structural differences in pharmacy models between developed and developing countries. The present study sets out to provide a comparative analysis of Ecuador and Spain pharmacy office model, differentiating legislations concerning the functioning of pharmacies and comparing the pharmacy office models. Method: Documentary based research and a comparative study, regarding regulations and legislation of community pharmacies in Ecuador and Spain. Results: In this paper, the current legislation that regulates the Spanish and Ecuadorian pharmacy is analyzed, in reference to the establishment of new pharmacies, pharmaceutical ownership, prohibition of pharmacy chains, as well as the quality of the training of community pharmacists. Conclusions: In Latin American countries, as in the case of Ecuador, the pharmacy adopts a more liberal model, referring to the deregulation of the opening of new pharmacies, property issues, territorial planning system, as well as the non-presence of the professional pharmacist; resulting in a system with a strong commercial focus; thus emphasizing the ideal role to be played by the community pharmacy. [ABSTRACT FROM AUTHOR]

The legal doctrine of capacity, which governs legally-authorized intervention in the decision-making of persons with dementia, has been subject to recent scholarly criticism and reform efforts. Such efforts require a coherent normative theory of when and how intervention in the decision-making of those with dementia is appropriate. This mixed-methods study sought to understand the perspectives of seniors on this normative question. A survey, including closed- and open-ended questions and conversational interviews, was conducted. Quantitative results of 236 seniors were heterogeneous but showed important patterns. Qualitative results from survey data and interviews of 25 seniors presented 6 key themes: (1) a difficulty of giving concrete answers; (2) reliance on professional opinions; (3) concern for personal identity; (4) fear of abuse; (5) trust of family; and (6) fear of dementia. The study suggests support among seniors for: (1) a model of "supported decision-making" rather than "surrogate decision-making;" (2) a presumption that in order to preclude a person with dementia from making more "personal" decisions a more heightened showing of incapacity is required; and (3) a shift to a model of capacity as based more on features such as long term memory and relationships rather than cognitive functions or values. In reforming our understandings of capacity, ethicists and practitioners will have to navigate tensions found in the qualitative data, including: (1) between participants' fear of abuse and their expressions of trust in family members to decide when intervention is appropriate; and (2) between expressions of confidence in medical professionals' ability to tell participants when they are no longer able to make decisions and participants' own understanding of the question in terms of the philosophical construct of personal identity. [ABSTRACT FROM AUTHOR]

The application of assisted human reproduction techniques after the death of one of the genitors is a reality that has gained relevance and support among judges and doctrinaires, although it still finds a wide social rejection, mainly in the face of serious moral, ethical and religious conflicts. Several countries in the region have discussed adapting their laws to the growth of casuistry. In the study, a comparative analysis of the legal, ethical and medical sphere of ibero-American countries is carried out through an integrative review. 21 primary studies were obtained addressing the regulatory situation in Argentina, Brazil, Colombia, Spain, Peru, Portugal and Uruguay. From these countries, only Uruguay and Spain have permissive regulation for post-mortem reproduction. The first, expressly and the last implicitly. Portugal's legislation is prohibitive for most techniques, with the exception of the posthumous transfer of embryos. Argentina, Colombia and Peru are not regulated. Brazil is in a special situation, as, there is no specific regulation, the binding nature of some regulations is discussed. Finally, the role of legal medicine has been discussed in the face of new bioethical and biolegal challenges, in practical and theoretical terms, posing participation in the debate that precedes any possible authorization. [ABSTRACT FROM AUTHOR]

Objective: Understand the way in which the legalization process of marihuana has affected university students in relation to its medical and recreational use. Method: Cross-sectional and correlational study of 17,986 participating students which have not consumed marihuana in the last year. The questionnaire The Consumption of Drugs in University Students (CODEU-2) was utilized. Study variables: sex, intention of consumption, perception of the consumption of third parties, public politics for the regulation and opinion regarding incremental consumption in case of legalization. The bivariate analysis utilized the Chi- Square (p <,05) and multinomial logistic method to estimate variations for the intention to consume under the assumption of itslegalization. Results: Faced with the possible legalization in Mexico, the participants demonstrated: low intention of consumption, more in men than women; larger approval for medical than recreational use; the majority preferred the State´s control; and a larger perception of the increase in consumption, in women than in men. Conclusions: Even though the participants did not consume marihuana, the results demonstrate it would be important to rely on institutional politics and preventative programs to prevent the acceptance of the offer of such products in young people, while health systems should be prepared to provide care to the derived problems. [ABSTRACT FROM AUTHOR]

Most women today are the primary, sole, or cobreadwinners for their families; their continued ability to work during and after pregnancy is crucial for their families' well‐being. Midwives and other health care providers are regularly asked to provide work notes for patients who need adjustments to how, when, or where their job is done to continue working while maintaining a healthy pregnancy or breastfeeding. Whereas an improperly written work note can result in the patient being forced out on leave or losing their job, an effectively written work note from a health care provider can ensure the patient will receive the adjustments they need to stay safe and healthy on the job. Health care providers can also play an important role by incorporating discussions about workplace issues into care conversations. This article provides an overview of pregnancy‐related employment rights, guidelines for writing effective work notes, and a discussion of common workplace issues patients face and how health care providers can respond. [ABSTRACT FROM AUTHOR]

Modern research projects in healthcare research and medical research are oftentimes multi-centered, multi-disciplinary, and conducted by a consortium of multiple collaborators. Increasingly, the resulting data emanating emerging from different primary and secondary sources is linked on a personal level. The General Data Protection Regulation regulates many fundamental processes in such research projects. Despite the regulatory framework given, it can happen that a collaborator does not handle data properly. We propose a systematic risk management for the handling of data as well as a systematic error management. [ABSTRACT FROM AUTHOR]

Background: Although there is a low incidence of complications associated with epidural injections, pain physicians should still remain vigilant for potentially serious adverse outcomes. This study aimed to identify and describe the major complications of epidural injections.Methods: This retrospective, observational, medicolegal study analyzed closed cases of precedents involving complications of epidural injections from January 1997 to August 2019 using the database of the Supreme Court of Korea's judgement system. Clinical characteristics and judgement statuses were analyzed.Results: Of the 73 potential cases assessed for eligibility, a total of 49 malpractice cases were included in the final analysis. Thirty-three claims resulted in payments to the plaintiffs, with a median payment of US$103 828 (IQR: US$45 291-US$265 341). The most common complication was infection (n=13, 26.5%), followed by worsening pain (n=8, 16.3%). Physician malpractice before, during, and after the procedure was claimed by plaintiffs in 18 (36.7%), 44 (89.8%), and 31 (63.3%) cases, respectively. Of these cases, 6 (33.3%), 19 (43.2%), and 15 (48.4%), respectively, were adjudicated in favor of the plaintiffs by the courts. In cases involving postprocedural physician errors, the majority (13/15) of the plaintiff verdicts were related to delayed management. Violation of the physician's duty of informed consent was claimed by plaintiffs in 31 (63.3%) cases, and 14 (45.2%) of these cases were judged medical malpractice.Conclusions: Our data will allow pain physicians to become acquainted with the major epidural injection-associated complications that underlie malpractice cases. [ABSTRACT FROM AUTHOR]

The Tobacco Free Initiative announces the release of a best practices report highlighting Canadian tobacco product regulation. The Canadian tobacco regulatory regime, identified as one of the best by TFI and the WHO Study Group on Tobacco Product Regulation (TobReg), incorporates mandatory periodic emissions testing, emissions disclosure based on all characteristics of the tobacco product, and labeling requirements which mandate large, clear health warnings and informational messages. And most noteworthy, this best practice shows how Canada, in an effort to promote public health goals, creatively maneuvered around the limitations of the ISO smoking machine testing protocol by amending their regulation to require manufacturers to additionally test using a more intense testing regimen. Henceforth, this Canadian intense testing regimen, has since been adopted by the TobReg in its first recommendation: Guiding principles for the development of tobacco product research and testing capacity and proposed protocols for the initiation of tobacco product testing. TFI hopes that Member States will glean valuable insights and inspiration from Canada’s experience.

Advanced therapy medicinal products (ATMPs) are a fast-growing field of innovative therapies. The European Union (EU) and the United States (US) are fostering their development. For both regions, ATMPs fall under the regulatory framework of biological products, which determines the legal basis for their development. Sub-classifications of advanced therapies are different between regions, while in EU, there are four major groups, i.e., gene therapy, somatic cell therapy, tissue-engineered therapies, and combined advanced therapies; in US, the sub-classification covers two major groups of products, i.e., gene therapy and cellular therapy. The inclusion criteria that define a gene therapy are equivalent in both regions, and the exclusion criteria are directly related to the indications of the product. In the EU, there is a clear differentiation between cell- and tissue-based products regarding their classification as advanced therapies or coverage by other legal frameworks, whereas in US, there is a broader classification about whether or not these products can be categorized as biologic products. Both in EU and in US, in order to classify a cell- or a tissue-based product as an advanced therapy, it must be ensured that the processing of the cells implies a manipulation that alters their biological characteristics, although the term of manipulation in US differentiates between structural and non-structural cells and tissues. The regulatory terminology used to define ATMPs and their sub-classification reveals some differences between EU and US.

Use of both cannabis and synthetic cannabinoids has been regularly linked to the development of psychotic illness. Thus, semisynthetic cannabinoids such as hexahydrocannabinol (HHC), which have a similar neurobiological profile to delta-9-THC, may also be expected to lead to psychotic illness. However, no such relationship has yet been reported in scientific literature. HHC is readily available online and in many vape shops in Ireland. Here, we present two cases of psychotic illness which appear to have been precipitated by use of legally purchased HHC and discuss its psychotogenic role and factors linked to its current widespread availability.

In 2017, the group of 109 experts from various countries developed the international consensus definition of advance care planning (ACP), which is defined as enabling individuals to define objectives and preferences for future medical treatment and care, to discuss these goals and preferences with family and healthcare providers, and to record and review these preferences if appropriate. ACP plays a significant role in the care of patients with chronic diseases, and especially may have an impact on the situation of palliative care patients, their families and healthcare professionals who look after them. This article analyses the legal constraints of ACP in Poland, and presents legal regulations related to some selected issues of ACP. One of the essential features of ACP is disclosing information to the patient and taking into account the patient's decisions concerning the treatment and medical care. This is provided for in Polish law and healthcare professionals are obliged to observe it. Moreover, the Polish law includes broad principles applying to providing the patient's family with information about diagnosis and prognosis of the disease. However, advance directives and health care proxy have not been regulated by national law yet. Therefore, it seems that the incorporation of ACP into Polish healthcare system requires the development of new legal regulations. [ABSTRACT FROM AUTHOR]

Advanced therapy medicinal products (ATMPs) are a fast-growing field of innovative therapies. The European Union (EU) and the United States (US) are fostering their development. For both regions, ATMPs fall under the regulatory framework of biological products, which determines the legal basis for their development. Sub-classifications of advanced therapies are different between regions, while in EU, there are four major groups, i.e., gene therapy, somatic cell therapy, tissue-engineered therapies, and combined advanced therapies; in US, the sub-classification covers two major groups of products, i.e., gene therapy and cellular therapy. The inclusion criteria that define a gene therapy are equivalent in both regions, and the exclusion criteria are directly related to the indications of the product. In the EU, there is a clear differentiation between cell- and tissue-based products regarding their classification as advanced therapies or coverage by other legal frameworks, whereas in US, there is a broader classification about whether or not these products can be categorized as biologic products. Both in EU and in US, in order to classify a cell- or a tissue-based product as an advanced therapy, it must be ensured that the processing of the cells implies a manipulation that alters their biological characteristics, although the term of manipulation in US differentiates between structural and non-structural cells and tissues. The regulatory terminology used to define ATMPs and their sub-classification reveals some differences between EU and US. [ABSTRACT FROM AUTHOR]

An environmental risk assessment (ERA) consists of an analysis of the risks to human health and the environment that a medicinal product may cause due to its release during clinical development or after entering the market. Regulators in European Union (EU) and the United States (US) require that advanced therapy medicinal products (ATMPs) that are also genetically modified organisms (GMOs) undergo an ERA in order to be approved for marketing authorization. This work aims to review the regulatory issues that need to be taken into consideration for carrying out an ERA, comparing the EU and the US. The European regulatory framework for environmental procedures and the dissimilarities in its implementation across the Member States and its implications at a logistical level are analyzed in detail. In addition, this review provides a brief insight into the non-clinical and clinical assessments that should be carried out during the development of the product in order to conduct a successful ERA, and thus facilitate its marketing authorization and post-marketing monitoring. Finally, the need for a European harmonization regarding environmental procedures for ATMPs is discussed. [ABSTRACT FROM AUTHOR]

Abstract Background There is an urgent need to address the safety problems caused by the use of skin lightening cosmetics. Evidence suggests that some of them may contain heavy metals. Objectives We conducted a systematic review of global legal regulations regarding the permissible level of mercury, lead, arsenic, and cadmium in cosmetic products, with particular emphasis on skin lightening preparations. Methods The systematic search of documents was a two-stage process. First, official websites of 17 regional organizations and subsequently regulations for countries with a population over 100 million were searched. Results Fifteen legislative acts, encompassing more than 67·2% of the global population were reviewed. Regulations were identified for 44/59 high income countries, 16/55 upper middle income countries, 9/45 lower income countries, 0/34 low income countries. The median adult literacy rate was 91·4% and 64·2% in countries with and without regulations, respectively. The use of mercury, lead, arsenic, and cadmium has been banned in 67, 67, 65, and 65 out of 69 countries, respectively. Conclusions While regulations exist in most of the high income countries, in low income countries there is a lack of similar standards. In most countries for which these legal regulations have been identified, restrictions on the permissible level of heavy metals are strict. There is a need for enforcement of existing rules, and rigorous assessment of the effectiveness of these regulations. Highlights • We identified and assessed regulations for 69 out of 193 United Nations member states. • The regulations encompass more than 67.2% of the global population. • Most of the identified regulations cover high and upper middle income countries. • Legal rules cover most of the high income countries. • None of the low income countries has adequate legislation. [ABSTRACT FROM AUTHOR]

Sexually violent predator (SVP) laws in the United States are controversial. They tend to be opposed by academics, libertarians, and professional organisations but are supported by states and the Supreme Court. This study reviews the history of SVP legislation, compares features of SVP laws among states, and summarise requirements by the Supreme Court that shaped these laws. Features of SVP laws include identification of sexual offenders with mental abnormality that predisposes them to sexually offending behaviours in the future, and standards of proof for conditional or unconditional release. A comprehensive understanding of all statutes can inform policymakers about SVP laws, whether supportive or restrictive of such legislation. [ABSTRACT FROM AUTHOR]

The new tobacco products that include electronic cigarettes (called "E Cig", "e-hookahs", "mods", "vape-pens"), electronic nicotine delivery systems (SEAN, Spanish acronym), similar systems without nicotine (SSSN, Spanish acronym) and alternative nicotine consumption systems (SACN, Spanish acronim), are positioned in the global market with a discourse of harm reduction and risk minimization. This manuscript summarizes the scientific evidence and present a regulatory proposal for this technological innovation, oriented to guide the decision making of legislators, government institutions and organized civil society. The scientific evidence concludes that there is no safe tobacco product for health, the addictive nature of nicotine and the health damages for children, adolescents and pregnant women is the fundamental argument. These new products promote the transition to conventional cigarettes and have not shown efficacy for smoking cessation, on the contrary, they promote dual use. High-level regulation must be formulated without the intervention of the manufacturers or institutions with a conflict of interest in the context of the complete and integral World Health Organization Framework Convention on Tobacco Control implementation. [ABSTRACT FROM AUTHOR]

Involuntary psychiatric admission is an established practice for patients who are acutely or severely mentally ill but the factors contributing to involuntary (as opposed to voluntary) admission are not fully clear. Nor is it clear why rates of involuntary admission often vary between hospitals within the same jurisdiction. We studied all admissions, voluntary and involuntary, in three inpatient psychiatry units in Dublin, Ireland, which cover a population of 552,019 people, over a one-year period (1 July 2014 until 30 June 2015, inclusive), as part of the Dublin Involuntary Admission Study (DIAS). During the study period, there was a total of 1136 admissions to these three units, of which 17% were involuntary for all or part of their admission. The overall admission rate (205.8 admissions per 100,000 population per year) was lower than the national rate (387.9) but this varied substantially across the three units studied. On multi-variable analysis, involuntary admission status was associated with male gender, being unmarried, and a diagnosis of schizophrenia, and was not significantly associated with age, occupation or which inpatient unit the person was admitted to. We conclude that variations in involuntary admission rates between different psychiatry admission units in Dublin are significantly explained by patient-level variables (such as gender, marital status and diagnosis) rather than centre-level variables, but that much of the variation in admission status between patients remains unexplained. Future, multi-level research could usefully focus on other patient-level factors of possible relevance (e.g. symptom severity), centre-level factors (e.g. local mental health service resourcing) and community-level factors (e.g. socio-economic circumstances in different areas) in order to further elucidate unexplained variance in admission status between patients. [ABSTRACT FROM AUTHOR]

Objective: To identify the factors that lead to the legalization and jurisdiction of health care by patients and health customers of the Unified Health System of Brazil, SUS.Subjects and methods: The legalization of health care is effective when the citizen searches for health care in health institutions without success. Thus, his or her last alternative is to seek legal resources. This is a systematic review of the PubMed database carried out in February, March and April 2017 using the integrated method and three searches. The eligibility criteria for the studies were being published in English, Portuguese or Spanish, working with humans and articles being available in the full version. Dissertations, letters to the author, editorials, current themes and free themes were excluded.Results: A total of 3338, 6 and 16 studies were found, respectively, in the first, second and third search. After refinement, there were 29 articles published between 2009 and 2016, of which 11 met the established criteria. The findings demonstrate that the population seeks the intervention of a legal system for access to medicine, treatment and therapy, medium and high complexity procedures and to obtain food formulas, supplies and medical hospital products.Conclusion: The factors that contributed to legalization were predominantly related to medications and being in agreement with the other studies in the literature, with emphasis on requests for vacancies in the unit/intensive care center with new determining factors. [ABSTRACT FROM AUTHOR]

Background: Directive 2004/24/EC, which came into force in 2011, created new regulatory requirements for traditional herbal medicines (THM). This study compared the Spanish THM registry before and after the Directive came fully into force in 2011. Methods: We consulted the herbal medicinal plant and drug catalogues (General Council of the Official Colleges of Pharmacists), the website of the European Medicines Agency (EMA), and retail web sites. Results: Of 315 THM (from 39 companies) licensed in Spain in 2010, only 48 (10 companies) remained licensed in 2013, mainly due to their withdrawal: the EMA had received just 123 applications from Spain and at least 34% formerly licensed THM had shifted to the less strictly regulated food sector, while up to 54% might have disappeared from the market. However, there is still a significant presence of retail websites making illegal health claims. Conclusion: In Spain, the public health benefits of the Directive 2004/24/EC might be less than expected.