From virtually extinct to superabundant in 35 years: establishment, population growth and shifts in management focus of the Swedish wild boar (Sus scrofa) population.

BACKGROUND: The wild boar (Sus scrofa) was extinct in Sweden when a few animals established in the 1970s. Over the past 35 years, the species has made a substantial comeback. In this paper, we analyse wild boar population growth using three indices of population size. We also map the legislative decisions and research prompted by the expanding population. We discuss to what extent, in the eyes of the state, the view of wild boar and the management focus has shifted over time, from a perceived pest (eradication) to scarce (conservation), overabundant (reduction/control) or somewhere in between (sustainable management). RESULTS: Wild boar harvest started in the early 1990s with a few hundred animals annually and peaked at 161,000 in 2020/2021. The distribution now comprises most of southern Sweden. Analyses of harvest and traffic accidents involving wild boar showed that the population grew exponentially until 2010/2011, after which the increase levelled off. Thus, logistic growth models showed the best fit for the full study period. We recorded 38 legislative decisions or commissions to government agencies regarding wild boar. The first decision in 1981 was to eradicate the free-ranging population. In 1987 however, the parliament decided that wild boar is native to Sweden and should be allowed in restricted extent. Later decisions mainly concerned hunting regulations and hunting methods as direct means to increase harvest and regulate the population. Another topic, increasing in importance over time, was to facilitate the use of wild boar meat to indirectly stimulate harvest. A local outbreak of African swine fever in 2023 necessitated a stamping out strategy in the affected area. We found 44 scientific papers regarding the present free-ranging population. Topics include movements and feeding patterns, hunting, reproduction, and population development. CONCLUSIONS: The state historically regarded wild boar as a pest to be eradicated. This changed with the decision that wild boar should be allowed in restricted extent, suggesting a conservation approach. In response to population growth, the focus shifted to means facilitating sustainable management and, lately, reducing growth. The story of wild boar in Sweden illustrates attempts to mitigate conflicts and balance interests in wildlife management.

Possible manufacture of test allergens in public pharmacies for the diagnosis of type I allergies: Legal aspects.

The availability of high-quality skin test allergens is a prerequisite for the reliable diagnosis of occupational type I allergies. Due to the withdrawal of existing marketing authorizations (MAs) by pharmaceutical companies and the lack of new MAs for commercial test allergens, there is an increasing diagnostic gap in Germany and other EU member states, which makes it necessary to investigate alternative ways of providing in vivo diagnostics. The German Medicinal Products Act (Arzneimittelgesetz = AMG) allows for the possibility of preparing medicinal products in pharmacies without the need for an MA or a manufacturing authorization pursuant to Section 13 (2) No. 1 in conjunction with Section 13 (2a) Sentence 2 No. 3 AMG. This also includes test allergens. In addition to the AMG, the requirements of the German Ordinance on the Operation of Pharmacies (Apothekenbetriebsordnung - ApBetrO) and the European Pharmacopoeia apply in particular. Medicolegal and practical challenges, as well as potentials of manufacturing skin prick test solutions in public pharmacies are presented based on examples of different allergen source materials.

The association between county ordinances allowing off-road vehicles on public roads and crash rates.

BACKGROUND: Legislative bodies across the country have increasingly allowed off-road vehicles (ORVs) including all-terrain vehicles (ATVs) and utility task vehicles (UTVs) on public roads, an environment for which they are not designed. In 2004, Iowa gave individual counties the discretion to pass ordinances allowing ORVs on public roadways. The objective of this study was to evaluate the relationship between the passage of ORV ordinances and ORV crash rates, especially on public roads. METHODS: An Iowa ORV roadway ordinance database and an Iowa ORV crash database (2002-2018) for all 99 counties were compiled. Crashes for which county location could not be determined were excluded. Utilizing a zero-inflated Poisson model, correcting for background crash frequency trends and population, investigators compared the relative rates of crashes after ordinance passage to time points before ordinance implementation and to counties without such ordinances. Sub-analyses, including that focused on more recent years (2008-2018), were also performed. RESULTS: Forty-five county ORV roadway ordinances went into effect between 2011 and 2018 and 2,347 crashes (69%) met inclusion criteria. Adjusted for year, there was a 58% greater ORV crash rate in counties after passing an ORV roadway ordinance (incidence rate ratio (IRR) 1.58, 95% CI 1.32-1.90). Roadway crashes (n = 834) increased 48% after ordinance passage (IRR 1.48, 95% CI 1.14-1.94). This roadway crash association remained statistically significant when analysis was limited to the years 2008-2018 (IRR 1.39, CI 1.06-1.83, n = 544); to ATV crashes only (IRR 1.70, CI 1.20-2.40, n = 683); and to ATV crashes excluding counties with UTV-only ordinances (IRR 1.74, CI 1.40-2.15, n = 2,011). CONCLUSIONS: ORV roadway and total crashes increased significantly after implementation of county ordinances allowing ORVs on public roadways and when compared to counties without such ordinances. It is likely that these increased crashes have resulted in more injuries and possibly deaths. Results from this study may help inform policymakers as they consider legislation regarding ORV usage on public roads.

Effects of different nitrogen fertilization systems on crop yield and nitrogen use efficiency - Results of a field experiment in southern Germany.

The effects of the German Fertilizer Application Ordinance (GFO) on crop yield, nitrogen use efficiency and economical performance are highly controversial in science and practice in Germany. This study presents the results of a multi-year field experiment conducted at an experimental farm in southern Germany, in which the effects of different fertilizer systems on crop yield, protein concentration and nitrogen balance were analyzed. At this study site, relatively low N mineralization from the soil N pool was detected. Wheat (triticum aestivum L.) and barley (hordeum vulgare L.) showed strong yield declines from annual to multi-annual unfertilized plots, for maize (zea mays L.), this yield decrease was not observed. The recommendations according to GFO meets the fertilizer requirement at the trial site well. A 20% reduction of fertilization compared to GFO resulted in a 5% yield reduction and a decrease in protein concentration of wheat and barley. According to the quadratic N response function, the GFO treatment was slightly below the economic optimum nitrogen rate (Nopt) for wheat, and close to Nopt for winter barley on average over the trial years. For maize, a relatively high yield variability has been observed in the trial period so far. Sensor-based fertilization resulted in very high yields with high N use efficiency (up to 85%). This fertilization system can help to reduce nitrogen input and minimize nitrogen surplus. For wheat and barley, N fertilization and N uptake were well balanced, for maize clearly negative N surpluses were calculated. Despite all the discussion and criticism of GFO, the results of the plot trial show that high yields with high N use efficiency can be achieved with fertilization according to GFO.

[Allergen-specific immunotherapy : A brief overview in association with allergic conjunctivitis]. / Allergenspezifische Immuntherapie : Ein kurzer Überblick im Zusammenhang mit der allergischen Konjunktivitis.

Allergen-specific immunotherapy (AIT) is the only causal and disease-modifying treatment for immunoglobulin E (IgE)-mediated type I allergies. Regular exposure to the causative allergen results in an immunomodulatory effect by which the predominant T­helper (Th) 2 lymphocyte response is shifted to a Th1 lymphocyte response and more allergen-specific blocking immunoglobulins are produced. The approval of substances for AIT is regulated by the Therapy Allergens Ordinance (TAV). There are subcutaneous and/or sublingual AITs for the following indications: allergic rhinitis, allergic conjunctivitis, allergic asthma and insect venom allergy. In this article the indications for allergic conjunctivitis are discussed in particular. Clinical symptoms and a relevant type 1 sensitization are the prerequisites for the indications for AIT. The assessment of the indications and carrying out an AIT should only be carried out by physicians who have been trained in allergology.

[Skin cancer from solar ultraviolet radiation exposure at work]. / Hautkrebs durch solare Ultraviolettstrahlung am Arbeitsplatz.

Due to their professional activities, outdoor workers are exposed to an increased risk of developing occupational skin cancer caused by solar ultraviolet (UV) radiation as defined by occupational disease (OD) number 5103. Since the amendment to the Occupational Diseases Ordinance ("Berufskrankheitenverordnung", BKV) in 2015, squamous cell carcinomas or multiple actinic keratoses of the skin caused by natural UV radiation in outdoor workers in Germany can be recognized as occupational disease in the sense of OD number 5103. The main cause of nonmelanoma skin cancer (NMSC) is solar UV radiation; it is the most relevant occupational carcinogen in terms of the number of exposed workers (i.e., outdoor workers). Circumstances associated with climate change include increased terrestrial UV radiation, an increase in the number of cloudless days and therefore the number of hours of direct sunshine, adverse meteorological effects to the stratospheric ozone layer, and so-called low ozone events and associated more intense UV radiation. In the future, comprehensive considerations will have to be made as to how prevention concepts can be effectively designed to avoid the development of occupational skin cancer in outdoor workers. The treatment of future cases of skin cancer will be a particular challenge due to their high number and only a limited number of dermatologists available. Hopefully, prevention of skin cancer will become even more important in the future.

Defects and Amendment Suggestions of Human Organ Transplantation Ordinance / 中国医学伦理学

This paper put forward suggestions on the Human Organ Transplantation Ordinance, including: clarify the priority of the protection of the rights and interests of organ owner in Article 1; conditionally increase the range of relatives who can donate cadaver organs; clarify whether relatives can donate cadaver organs of people without full civil capacity and strictly regulate them; allow matured juveniles to donate living organs under strict restrictions; distinguish between donor and organ owner in legal expression.

Allergen-specific immunotherapy and evidence: A European regulatory perspective.

Allergen immunotherapy (AIT) has been performed for 112 years. In this article we summarize regulatory standards and challenges based on scientific evidence on AIT. Most crucial and timely aspects concerning AIT are addressed from the regulatory perspective of the authors as employees of a national competent authority in Europe: (1) product specificity; (2) clinical efficacy; (3) treatment for adults and children (needs for extrapolation); (4) allergen exposure chambers; (5) biomarkers; (6) standardization; (7) real-world evidence; (8) independent official batch release (benefit and challenges); (9) harmonization on the EU level. The Paul-Ehrlich-Institut (PEI), the Federal Institute for Vaccines and Biomedicines, in Langen near Frankfurt/Main in Germany, examines and evaluates the benefits and risks of AIT products within the course of clinical development, marketing authorization, and subsequently throughout their entire life cycle to ensure high-quality, safe, and effective AIT products.

AIT in pediatric allergology: Opportunities and difficulties on the home stretch of the Therapy Allergen Ordinance.

Allergen immunotherapy (AIT) is the only causal therapy for allergic diseases and therefore particularly important. Allergen preparations have been classified as medicinal products since 1989 (Directive 89/342/EEC) and were taken over into Directive 2001/83/EC in 2001. In addition, in 2008 the Therapy Allergen Ordinance (TAO) came into force to stricter regulate the exception for named patient products (NPP) by exclusion of common therapy allergens from the exception to be marketed as NPP. The TAO regulates the requirements for testing safety and efficacy for these common therapy allergens. Due to the long transitional provisions, the last deadlines for solving clinical shortcomings will end in 2026. The advantage of this regulation is that the market for common allergens has been cleared of products without proof of efficacy, and new preparations with an optimal dose range are developed through dose-finding studies. The demand for long-term pediatric studies has been outlined by the standard Pediatric Investigation Plan (PIP) on allergen products from the Pediatric Committee of the EMA (PDCO). This is particularly problematic, as it is foreseeable that recruitment of patients will be limited and ethical problems arise from the prolonged use of placebo. Furthermore, many newly approved preparations will not be used in pediatrics for the foreseeable future, as no marketing authorization has yet been granted for this age group. This will result in a serious supply gap for children.

DGAKI and PEI in dialogue 2023: Diagnostics and allergen immunotherapy.

A roundtable discussion on February 10, 2023 between the German Society for Allergology and Clinical Immunology (DGAKI) and the Paul-Ehrlich-Institut (PEI) aimed to discuss in detail current aspects of allergen immunotherapy (AIT), its regulatory framework under the transitional provision of the Therapy Allergen Ordinance (TAO), and the consequences for the planned guideline work of the DGAKI, regulatory challenges in the approval of AIT products for children and adolescents as well as allergy diagnostics. The content and discussion points of this dialogue are summarized and are set in context with the current literature.

[Fitness to drive with glaucoma]. / Verkehrstauglichkeit beim Glaukom.

Glaucoma is one of the eye diseases that are particularly relevant to driving in old age. The ophthalmologist often has to take on the task of traffic medical consultation or medical appraisal. It is essential to distinguish between fitness to drive and driving ability or driving safety and driving capability. The medical examination of fitness to drive can only be carried out over long intervals and basically requires an ophthalmological examination in compliance with all the requirements of the driving license ordinance. This is not a healthcare task. In the case of clarification of the fitness to drive in people with known glaucoma on behalf of the test persons themselves or a driving license authority, visual field testing must be performed using manual kinetic perimetry according to Goldmann, especially for all borderline case decisions by traffic experts. The ophthalmologist faces the particular difficulty of maintaining a balance between the legal duty of care and patient-centered care in order not to strain the patient-physician relationship.

Changes in Opioid Agonist Treatment Practice in Germany during the COVID-19 Pandemic: What Have Physicians Done, and What Would They Like to Keep Doing?

INTRODUCTION: Opioid agonist treatment (OAT) is the most common and most effective treatment option for persons with opioid use disorders (OUD). In Germany, the prescription of OAT medications is regulated by the Narcotic Drugs Prescription Ordinance. With the introduction of restrictions to contain the SARS-CoV-2 virus, the German OAT regulations have been amended to ensure a legal continuation of OAT for people with OUD. In this study, we aimed to examine the use of the OAT regulations in practice, the experience made by physicians prescribing OAT medications, and their perspective on OAT regulations. METHODS: Between September and December 2021, a questionnaire on the current situation and potential changes in the provision of OAT during the COVID-19 pandemic was sent out to 2,416 German physicians prescribing OAT medications. Differences between physicians with and without addiction medicine certification were analyzed. RESULTS: The response rate of physicians was 22.8%. Their average age was 57.4 (±10.1) years, and 62.3% were male. During the COVID-19 pandemic, take-home periods for stable patients have been extended by 48.2% of physicians, and 52.6% would like to maintain this prescribing practice in the future. Most physicians (71.6%) indicated that patients handled the extended take-home prescriptions predominantly responsibly. A total of 71.8% of the physicians generally did not use video consultation. A corona pandemic-related switch of the OST medication to depot buprenorphine injection did rather not occur, as 71.2% reported no patients treated with depot buprenorphine, and only 2.6% switched first-time or more patients to depot buprenorphine due to the COVID-19 pandemic. CONCLUSION: The corona situation opened up opportunities for physicians and patients and enabled change processes in OAT. Physicians had positive experiences implementing expanded take-home prescriptions for stable patients. Video contacts rarely took place, suggesting resistance to digital consultation. The number of depot buprenorphine prescriptions has not increased substantially since the pandemic's beginning and has remained at low levels. Further research is needed to assess to what extent the changes in OAT will be maintained over time and whether they will also lead to long-term benefits for OAT patients.

[Legal aspects of driving and cardiovascular diseases : Guidelines of German Cardiac Society and the German government in comparison]. / Rechtliche Aspekte der Fahreignung : Empfehlungen der DGK und der Begutachtungsleitlinie des Bundes im Vergleich.

BACKGROUND: The general regulations for an active participation in the road traffic in the Federal Republic of Germany are laid down in the Driving License Ordinance ("Fahrerlaubnisverordnung" ) (including appendices). Cardiovascular diseases with a need for precautionary measures and the circumstances according to which the driving fitness is to be determined are reviewed in appendix 4 of the ordinance. The guidelines of the Federal Highway Research Institute ("Bundesanstalt für Straßenwesen") must also be considered when assessing the fitness to drive. OBJECTIVES: Presentation of the current legal recommendations in the assessment of the driving fitness in the respect to cardiovascular diseases. MATERIALS AND METHODS: The current official regulations and the recommendations on the fitness to drive in the case of cardiovascular diseases were assessed. In addition, the pocket guidelines of the German Society for Cardiology (DGK) on the subject were reviewed. RESULTS: As the type of vehicle and time at the wheel influence the probability and the extent of damage in the case of a traffic accident, the official requirements for driving aptitude distinguish between private (group 1) and professional drivers (group 2). The official recommendations for assessing fitness to drive in the case of cardiac arrhythmias, device therapy, coronary heart disease, cardiac insufficiency, valve diseases and syncope are presented. CONCLUSION: Driving fitness plays an important role in the cardiological patient collective and should be determined in accordance with the official recommendations. For everyday clinical practice, the DGK recommendations for fitness to drive are presented in a clearer and more practice-relevant manner.

The influence of accessory dwelling unit (ADU) policy on the contributing factors to ADU development: an assessment of the city of Los Angeles.

Since the accessory dwelling unit (ADU) has emerged as a policy alternative to increase housing stock and provide affordable options for areas impacted by housing shortages, many local governments recently adopted ADU policies that promote the construction of ADUs. Taking the City of Los Angeles as the study area, this paper examines how the city's ADU ordinance impacts the relationship of the characteristics of the properties and neighborhoods with ADU development by constructing multilevel logistic regression models. The outputs of the models suggest that the ordinance contributes to diversifying the types and locations of the properties and neighborhoods where ADUs are built. The influence of the property characteristics associated with ADU development before the implementation of the ordinance significantly diminished after the ordinance. The outputs also indicate that the ordinance probably attracted ADU developments in the areas with higher accessibility to bus transit. These findings will help planners take appropriate actions and policies that support ADU developments.

[Maternity Protection - A Guide for Pregnant Physicians and Their Employers]. / Im Dschungel des Mutterschutzes ­ ein Leitfaden für schwangere Ärztinnen und deren Arbeitgebende.

Maternity Protection - A Guide for Pregnant Physicians and Their Employers Abstract. The proportion of women in the medical profession is high and shows an upward trend. When a woman becomes pregnant, she has a legal right to various measures to protect herself and the unborn child. Practice and literature show that even 20 years after the introduction of the Maternity Protection Ordinance, the knowledge and ultimately the implementation of the existing legislation in everyday clinical practice is still expandable. For example, it is important to know that a competent professional must perform a risk assessment for dangerous and arduous activities. In addition, there are special regulations regarding permitted working hours and a protection against dismissal.

Control in the community: A qualitative analysis of the experience of persons on conditional discharge in Hong Kong.

Mandatory outpatient treatment schemes such as community treatment orders remain controversial despite being commonly used around the world. Given concerns about patient autonomy and civil liberties, such schemes need to be closely scrutinised. Though Hong Kong's mandatory outpatient treatment scheme, the conditional discharge (CD) regime, has a number of significant legal concerns, empirical research on how it operates on the ground remains limited, and data on the subjective experience of relevant stakeholders is limited to healthcare professionals. This two-part cross-sectional study, the first on the service user perspective in Hong Kong, rectifies this gap. Data was collected through a self-reported survey and semi-structured interviews. Results demonstrated that, while similar themes to those in the literature were raised, such as powerlessness, a lack of understanding about the regime and in particular their rights thereunder, concerns about restrictive aspects of the regime and poor attitudes of healthcare professionals, and in some cases positive sentiments about beneficial aspects, the Hong Kong experience differs in the significant extent to which many of these concerns are demonstrated. The insights which this data provides in relation to how the implementation of the CD regime can be improved prior to legal reform is discussed, and suggestions for the way forward are proposed.

[Opioid agonist therapy and the German Narcotic Drugs Prescription Ordinance from the pharmacist's perspective]. / Opioidsubstitutionstherapie im Rahmen der neuen Betäubungsmittel-Verschreibungsverordnung aus Sicht von Apothekerinnen und Apothekern.

BACKGROUND: Opioid agonist therapy (OAT) has been established to be the most important therapy option for improving health and social burdens of people with opioid dependence. Pharmacies provide drug substitutes to substitution practices or outpatient clinics and administer drugs to substituted patients (medication under visual control) or supply prescriptions for unsupervised, at-home use by patients. Given the gaps in medical care, the relevance of pharmacies for the comprehensive treatment of opioid-dependent patients will become even more important in the future. The 3rd Revision of the Narcotic Drugs Prescription Ordinance (NDPO) adopted sweeping reforms to the framework of OAT in 2017. This paper examines the impact of this reform from the pharmacist's perspective. METHODS: Between November 2020 and March 2021, pharmacists in the German federal states of Hamburg, North-Rhine Westphalia, Saxony, and Bavaria were informed by their State Chambers of Pharmacists about participation in this online study. A total of 480 questionnaires were evaluated. The analysis differentiates between pharmacists who are currently involved in the substitution of opioid-dependent patients (54.2%), pharmacists who were involved in the past (21.4%), and those who have never been involved in opioid substitution (24.4%). RESULTS: Pharmacists involved in OAT have not seen any positive changes resulting from the 3rd Revision of the NDPO. According to 97.9% of the pharmacists, remuneration for administering medication under visual control should be analogous to remuneration in doctors' practices. Mixed prescriptions (prescription of take-home dose and intermediate medication under visual control) increase the administrative workload and have been rejected by a quarter of the pharmacists. Non-involved pharmacists significantly overestimated the occurrence of critical situations with substituted patients in the pharmacy. While only 2.7% of pharmacists involved in OAT reported drug emergencies, 23.1% of non-involved pharmacists expressed such concerns. 39.3% of the pharmacists felt they could be motivated to participate in OAT if they were approached directly, and 73.9% of the pharmacists who are currently involved in OAT said they could provide substitution medication under visual control to additional opioid-dependent patients. CONCLUSIONS: The 3rd Revision of the NDPO has no influence on the situation and willingness of pharmacists to be involved in OAT. However, to ensure that pharmacists continue to be actively involved in OAT and attract new substituting pharmacies, their importance for comprehensive OAT must be upgraded. This includes, and not least, the funding of pharmacists' administration of substitution drugs under visual control. In addition, knowledge about OAT, attitudes toward opioid-dependent patients, and contact anxiety could be addressed by promoting educational awareness and training.

A review of the status of environmental impact assessment in Pakistan.

Environmental impact assessment (EIA) is a process that examines the potential impacts of development projects on society and the environment. The concept of EIA originated in 1969 by the US National Environmental Policy Act (NEPA), followed by other developed and developing countries all over the globe. This paper reviews the legal status of EIA and its implementation, effectiveness, and deficiencies in Pakistan. EIA received legal status in Pakistan when the Environmental Protection Ordinance (PEPO) was drafted in 1983. This ordinance was then converted into the Pakistan Environmental Protection Act (PEPA) in 1997. Currently, EIA is conducted for many development projects in Pakistan, including infrastructure and industry projects. Environmental protection acts containing sections related to EIA and Initial Environmental Examinations (IEE; a small preliminary study for an EIA project) have been established by all Pakistani provinces, which conduct its systematic facilitation in the country. The effectiveness of the EIA/IEE process in Pakistan can be enhanced by ensuring stakeholder participation, guaranteeing transparency, providing resources to environmental agencies, and post-monitoring of EIA/IEE processes. Integr Environ Assess Manag 2022;18:314-318. © 2021 SETAC.

Defects and Amendment Suggestions of Human Organ Transplantation Ordinance / 中国医学伦理学

This paper put forward suggestions on the Human Organ Transplantation Ordinance, including: clarify the priority of the protection of the rights and interests of organ owner in Article 1; conditionally increase the range of relatives who can donate cadaver organs; clarify whether relatives can donate cadaver organs of people without full civil capacity and strictly regulate them; allow matured juveniles to donate living organs under strict restrictions; distinguish between donor and organ owner in legal expression.

Easing Restrictions During Vaccine Scarcity. How Mitigation Measures Help Tackling Associated Moral and Behavioral Challenges.

Background: When vaccines became first available during the Covid-19 pandemic, their demand significantly exceeded their supply. In consequence, the access to vaccines, initially, was distributed unequally. At the same time, governments started easing pandemic restrictions for vaccinated and recovered persons and restoring their freedoms since their risk of transmitting the virus is significantly reduced. Evidence: We show that restoring freedoms for vaccinated and recovered persons - while upholding restrictions for the rest of the population - is morally unfair during vaccine scarcity. Further, it may yield unintended side-effects, including perverse incentives, growing rifts in society, and the expansion of marginalization. Policy Options & Recommendations: We recommend accompanying easing for vaccinated and recovered individuals by mitigation measures for those who are neither vaccinated nor recovered. We propose, first, to temporarily lift the same restrictions for negative-tested individuals, as for vaccinated or recovered people. Second, the state must ensure broad and easy access to testing for everyone - free of charge. Conclusion: If done right, these mitigation measures create (at least temporarily) equal access to freedom for everybody - solving the moral problem of unfair access to freedoms and counteracting possible negative consequences.