OBJECTIVE: New psychoactive substances (NPS), are a range of drugs designed to mimic the effects of established illicit drugs, being legal at the time of their distribution in illicit markets. The review aims to shed a light on the growing threat caused by NPS, and on the dynamics and developments that have led to their spread, including the risk of new adulteration practices which can cause a serious health threat, due to their increased toxicity, e.g., through fentanyl and its analogs. MATERIALS AND METHODS: An overview of statistical trends relative to NPS use has been provided, in addition to regulatory and legislative approaches in several countries and recommendations and data from International institutions: UN Office on Drugs and Crime, United Nations Commission on Narcotic Drugs, WHO, European Parliament, European Monitoring Centre for Drugs and Drug Addiction, Europol and international collaborative efforts such as the Trans European Drug Information (TEDI) project and the Spanish Energy Control. RESULTS: Given the elusive nature of NPS, spontaneous pharmacovigilance reporting systems are needed to identify new trends of drug abuse. Broad-ranging legislative initiatives are needed in order to set common international standards (e.g., the European Parliament Regulation 2017/2101, with information exchange, an early warning system and risk assessment procedure for NPS) to tackle a potentially catastrophic and growing threat. CONCLUSIONS: By virtue of all the complexities and hurdles that have to be overcome in the fight against NPS, and to assist national governments in their identification and reporting, supranational organizations can come to play a key role. Only through international measures, supplementing national legislative initiatives, can this multi-faceted problem be effectively addressed and information about NPS be gathered and disseminated in a timely fashion.
The paper's main goal is to elaborate on the ethical issues that heterologous fertilization has raised as to the right of children thus conceived to find out about their origins. Such a quandary revolves around the following questions: Is it the right thing to inform the child as to the way he or she was conceived? If it is, does said child have a right to know his or her biological parent and genetic background too? Authors point out that there is no unanimity of judgment among experts, and it is worth weighing all reasons in favor and against acknowledging the children's right to full knowledge of their biological parents' data. Laws regulating the issue in different countries vary substantially as well. Therefore, the authors advocate for shared legislation, centered on the children's best interest.
The paper's authors aim to elaborate on the innovations brought by law n. 24/2017, issued by the Italian Parliament with a close focus on art. 5, which pertains to the drafting of guidelines and the adoption of best practices. The guidelines constitute in fact an element of innovation brought by the above-mentioned law, and compliance with them can shield from possible liability those health care professionals who find themselves embroiled in professional accidents while in the fulfillment of their duties. Besides, there are several critical aspects within the law that need to be highlighted as well. As far as best practices are concerned, the lawmakers who drafted the legislation make no mention as to the standards of evidence needed in order to characterize any given professional behavior as "best practice". The reform appears unlikely to be effective in providing doctors with clear behavioral standards, thus reducing the margin for liability claims against them.
Countries responded to the COVID-19 pandemic with various levels of restrictions and lockdown in an effort to save lives and prevent the saturation and collapse of national health systems. Unfortunately, the blockades have entailed hefty socioeconomic costs. In order to contrast the spread of the virus, states have used contact tracing technology, in the form of mobile phone applications designed to track close contacts of those infected with COVID-19. Recent research has shown the effectiveness of this solution, particularly when used in conjunction with manual tracking. Nonetheless, the contact tracing app raises concerns due to the potential privacy implications. The authors have delved into the European legislation that protects privacy through the principles of proportionality and minimization, arguing that in order to quickly resolve the pandemic caused by COVID-19, one cannot blindly trust the exclusive help of technology. Instead, we need the involvement of health personnel, scientists, and no less importantly, the citizenry's sense of solidarity and the duty to abide by the rules of social distancing, the use of protective devices and hygiene rules to protect public health.
In the late 2019, an epidemic of cases with severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) has spread from China to the rest of the world, resulting in a global pandemic (COronaVIrus Disease 19, COVID-19 pandemic). Starting from the first months of 2020, several restrictions have been imposed by governments to face the public health threat, impacting the usual patterns of drug abuse throughout the world (1). The temporary border closure affected the usual illicit drug route of shipping from country to country, resulting in scarcity of classic street drugs (2). Moreover, restrictive measures internationally adopted by several countries made necessary to close all the usual recreational settings in which stimulants drugs are commonly abused. On the contrary, since in house drugs abuse became the most feasible option, other private encounters might have caught on, such as chemsex (3). In particular this phenomenon, which originated mainly in the large cities of Northern Europe, has gradually spread across the continent and is now a worrying reality in western European countries. Other rising trends of substance abuse include cognitive enhancers and new psychoactive substances (4, 5). Furthermore, the consequent social isolation and the likely limited access to detoxification centers caused additional psychological distress, pushing drug addicts toward alternative psychotropic drugs, possibly through illegal online marketplaces. An international overview of the new trends of drug abuse during the current COVID-19 pandemic and the related health risks are hereby discussed, taking into consideration different points of view.
Background: The Authors have laid out an analysis of Italian COVID-19 confirmed data and fatality rates, pointing out how a dearth of health care resources in northern regions has resulted in hard, ethically challenging decisions in terms of granting patient access to intensive care units (ICU). Main text: Having to make such decisions certainly entails substantial difficulties, and that has led many health care professional to seek ethical guidance. The Italian Society of Anesthesia, Analgesia, Resuscitation and Intensive Care (SIAARTI) has attempted to meet that growing need by a set of recommendations, applying "clinical soundness" as a beacon standard; that approach tends to prioritize patients with higher life expectancy, which could be characterized as a "moderately utilitarian" approach. Yet, such a selection has engendered daunting ethical quandaries. The authors believe it can only be warranted and acceptable if rooted in a transparent decision-making process and verifiable, reviewed criteria. Moreover, the authors have stressed how clinical experimentation in a pandemic setting is a subtext of great interest from an ethical perspective. In Italy, no drug therapy and trials were undertaken for COVID-19 patients for a rather long period of time. When the epidemic was already circulating, an intervention proved necessary on the system of administrative procedures, aimed at expediting the authorization and validation of protocols, then bogged down by bureaucracy. A new system has since been instituted by a government decree that was signed about one month after the first Covid-19 case was officially recorded in the country. Such a swift implementation, which took just a few weeks, is noteworthy and proves that clinical trials can be initiated in a timely fashion, even with a pandemic unfolding. The concerted, action of supportive care and RCTs is the only way to attain effective forms of treatments for COVID-19 and any other future outbreak. Conclusions: The authors have arrived at the conclusion that the most effective and ethically sound response on the part of any national health care system would be to adequately reconfigure its organizational mechanisms, by making clinical trials and all related administrative procedures consistent with the current state of emergency.
In medical practice, cognitive enhancers (also called nootropics) are defined as therapeutic drugs treating specific cognition impairments in patients with attention deficit hyperactivity disorder, Alzheimer's disease, stroke schizophrenia or aging. However, the non-medical use of cognitive enhancers with the aim of increasing mental alertness and concentration, improving memory, fighting wakefulness and boosting energy has been spreading worldwide2. In this concern, scarce investigations have been carried out on the possible risks of chronic non-medical use of nootropics, and these risks seem to be largely overlooked, especially among students3. Considering the ever more competitive nature of modern societies, which also reverberates into workplaces, cognitive enhancers are reasonably expected to become even more common over time4. Nonetheless, long-term consequences are as yet unknown. Cognitive enhancers, used by healthy individuals, are widely known as nootropics: they consist of drugs, supplements and other substances that are allegedly known to improve cognitive function, particularly executive functions, and to strengthen memory, creativity or even motivation. Pharmaceutical substances and compounds known as 'cognitive-enhancers' allegedly boost mental performance and the ability to focus and keep concentration. In broader terms, such drugs are often claimed to heighten and foster the acquisition of motor capabilities and affective skills (i.e., one's ability to deal with anxiety stemming from performing certain work tasks or eliciting feelings of trust and affiliation). It is worth noting, however, that no drugs are licensed by medical authorities to be recommended and prescribed as 'cognitive enhancers'. Thus, the definition of 'performance-enhancing drug' is usually linked to the off-label use of drugs prescribed for specific medical conditions. These substances are usually stimulants that preferentially target the catecholamines of the prefrontal cortex of the brain to induce their effects5. Historically, amphetamines have been the first drugs used off-label for the purpose of fostering memory consolidation and increasing concentration6. Since these substances are legally controlled as drugs of abuse, they can only be obtained on illegal markets. This purchase channel is also used to obtain methylphenidate, which is undoubtedly the most misused drug as cognitive enhancer5,7. Mostly prescribed for treating Attention Deficit Hyperactive disorder (ADHD) and narcolepsy, methylphenidate has been scheduled as an illegal drug in many countries for its abuse liability and side effects, resulting in a rapid expansion of methylphenidate legal analogs onto the drug market. Alternative prescription drugs for the treatment of narcolepsy and ADHD, such as modafinil and armodafinil, are also used as cognitive enhancers8. Finally, two last drugs should be mentioned among nootropics: atomoxetine, a selective nor-adrenaline reuptake inhibitor licensed for the treatment of children with methylphenidate-resistant ADHD or undergoing methylphenidate side effects9, and donepezil, a second-generation acetylcholinesterase inhibitor licensed for the treatment of mild to moderately severe symptoms of Alzheimer-related dementia10. At the same time, there has been renewed interest in older prescription drugs (e.g., beta blockers, to decrease performance anxiety) and illicit psychostimulants (e.g., cocaine, amphetamines), sometimes in different forms or doses. Whereas there is still little consensus on the actual effectiveness and nature of the cognitive benefits of the above-mentioned drugs in healthy subjects13, their use to enhance the level of performance in specific workplaces has been reported for decades14. In fact, cognitive enhancement has been a mainstay of military research in the US since the Second World War with the use of amphetamines, modafinil and other cognitive enhancers in the most recent military operations (e.g., Vietnam war, Korean war, operations Desert Shield and Desert Storm in Iraq, later sustained military operations in the Middle East)15,16. Whereas the military use of cognitive enhancers has been known for many years, not only in the US but internationally. More recent studies reported that other occupations present a high prevalence of use: medical doctors and health professionals (e.g., surgeons, surgical technicians' anesthetists), transportation workers (e.g., truck drivers, car drivers, taxi drivers), financial traders, clinical investigators, research managers and lawyers. Finally, the increase of precarious and part-time home works has been recently associated to psychological discomfort and an increase in prescriptions of psychotropic drugs, and a rise in the misuse of cognitive enhancers can be hypothesized17-19. Another important factor to be taken into account is the role of the internet as a source of information through web forums and as a way of obtaining those substances. Such dynamics also constitute a cultural shift in the way drugs are obtained and consumed: they are anonymously received and safer than street drugs trafficking, although the actual composition and nature of the substances cannot be precisely ascertained. This latter fact creates a gap of information on the diagnosis of misuse in cases of possible intoxications and fatalities, since neither analytical screening nor confirmation methodologies are currently available for documenting exposure to those profuse and chemically diverse substances. In addition, apart from intoxications and fatalities, it has to be reminded that several of these substances present a potential for abuse liability and abstinence symptoms, which, instead of improving work pressure and overload, can worsen the environmental situation. In conclusion, we wish to draw the attention of the whole scientific community and policy makers to the increasing importance of the misuse of cognitive enhancers, and to improve public awareness of the phenomenon and contextual political strategies to stop this incoming threat for the health of current and future workers
Background and objectives: To explore the ethical and legal complexities arising from the controversial issue of surrogacy, particularly in terms of how they affect fundamental rights of children and parents. Surrogacy is a form of medically-assisted procreation (MAP) in which a woman "lends" her uterus to carry out a pregnancy on behalf of a third party. There are pathological conditions, such as uterine agenesis or hysterectomy outcomes, that may prevent prospective mothers from becoming pregnant or carry a pregnancy to term; such patients may consider finding a surrogate mother. Many issues relating to surrogacy remain unresolved, with significant disagreements and controversy within the scientific community and public opinion. There are several factors called into play and multiple parties and stakeholders whose objectives and interests need to somehow be reconciled. First and foremost, the authors contend, it is essential to prioritize and uphold the rights of children born through surrogacy and heterologous MAP. Materials and methods: To draw a parallel between Italy and the rest of the world, the legislation in force in twelve European countries was analyzed, eleven of which are part of the European Union (France, Germany, Italy, Spain, Greece, Netherlands, Belgium, Denmark, Lithuania, Czech Republic and Portugal) and three non-members of the same (United Kingdom, Ukraine and Russia), as well as that of twelve non-European countries considered exemplary (United States, Canada, Australia, India, China, Thailand, Israel, Nigeria and South Africa); in particular, legislative sources and legal databases were drawn upon, in order to draw a comparison with the Italian legislation currently in force and map out the evolution of the Italian case law on the basis of the judgments issued by Italian courts, including the Constitutional and Supreme Courts and the European Court of Human Rights (ECHR); search engines such as PubMed and Google Scholar were also used, by entering the keywords "surrogacy" and "surrogate motherhood", to find scientific articles concerning assisted reproduction techniques with a close focus on surrogacy. Results: SM is a prohibited and sanctioned practice in Italy; on the other hand, it is allowed in other countries of the world, which leads Italian couples, or couples from other countries where it is banned, to often contact foreign centers in order to undertake a MAP pathway which includes surrogacy; in addition, challenges may arise from the legal status of children born through surrogacy abroad: to date, in most countries, there is no specific legislation aimed at regulating their legal registration and parental status. Conclusion: With reference to the Italian context, despite the scientific and legal evolution on the subject, a legislative intervention aimed at filling the regulatory gaps in terms of heterologous MAP and surrogacy has not yet come to fruition. Considering the possibility of "fertility tourism", i.e., traveling to countries where the practice is legal, as indeed already happens in a relatively significant number of cases, the current legislation, although integrated by the legal interpretation, does not appear to be effective in avoiding the phenomenon of procreative tourism. Moreover, to overcome some contradictions currently present between law 40 and law 194, it would be appropriate to outline an organic and exhaustive framework of rules, which should take into account the multiplicity of interests at stake, in keeping with a fair and sustainable balance when regulating such practices.
Since the first outbreak of SARS-CoV-2 (severe acute respiratory syndrome-coronavirus-2) in China in December 2019, the infection has rapidly spread all over the world. This new virus has caused many cases of Coronavirus disease 2019 (COVID-19), a potentially fatal respiratory syndrome (1). Due to its global diffusion, the World Health Organization rapidly issued an international warning and declared a worldwide pandemic in March 2020. Currently, most countries are experiencing COVID-19 outbreaks with new infections and fatalities every day and all over the world (2). Due to the mode of transmission of the virus via droplets or direct contact, governments were compelled to adopt restrictive strategies to contain the pandemic and preserve the public health (2, 3). These interventions include limited international mobility, temporary closure of non-essential businesses and more stringent measures like social distancing or complete isolation for prolonged periods. Therefore, this unprecedented crisis has seriously impacted the global economy and people's daily life. The market of addictive substances has been impacted from the production to the distribution, modifying consumption patterns. An increased consumption of cannabis products and benzodiazepines was reported due to the general feeling of stress caused by the pandemic and associated restrictions, while a decrease in the demand of stimulants was observed due to the inaccessibility of usual recreational settings (4). Moreover, drug misuse may have shifted toward alternative substances and home-made New Psychoactive Substances (NPS) (5–7), which consist of molecules, like pharmaceutical drug analogs, research chemicals and prescription drugs eliciting the psychoactive effects of common illicit addictive drugs or prescription pharmaceuticals (8, 9). The current situation is complex due to the heterogeneity of policies applied in diverse countries and the drugs involved. In this concern, the drug market is constantly monitored by international agencies, such as the United Nation Office on Drug and Crime (UNODC), the European Monitoring Centre on Drugs and Drug Addiction (EMCDDA) and Europol, which collaborate to form a crucial network to prevent the emergence of new dangerous trends. In this article, the authors critically discuss the most recent data on the impact of COVID-19 on the illicit trafficking of substances and the possible developments of NPS trends in the near future. The authors also draw the attention on the essential role of international networking against drug misuse, especially in times of global crisis.
Emergency contraception (EC) has been prescribed for decades, in order to lessen the risk of unplanned and unwanted pregnancy following unprotected intercourse, ordinary contraceptive failure, or rape. EC and the linked aspect of unintended pregnancy undoubtedly constitute highly relevant public health issues, in that they involve women's self-determination, reproductive freedom and family planning. Most European countries regulate EC access quite effectively, with solid information campaigns and supply mechanisms, based on various recommendations from international institutions herein examined. However, there is still disagreement on whether EC drugs should be available without a physician's prescription and on the reimbursement policies that should be implemented. In addition, the rights of health care professionals who object to EC on conscience grounds have been subject to considerable legal and ethical scrutiny, in light of their potential to damage patients who need EC drugs in a timely fashion. Ultimately, reproductive health, freedom and conscience-based refusal on the part of operators are elements that have proven extremely hard to reconcile; hence, it is essential to strike a reasonable balance for the sake of everyone's rights and well-being.
In 2018, the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) reported the appearance of new psychoactive substances (NPS) on European Union (EU) at a rate of about one per week for a total of 55 new drugs detected in 2018. On one hand, this figure is similar to that communicated in 2017 (N=51) and both of them are significantly lower if compared to those, above one hundred, appeared in 2014 and 2015. On the other hand, it has to be underlined that there has been a change in the type of substances coming into illegal market, since the most recent new psychoactive substances are increasingly more targeted in the long-term and to drug users with more addictive behavior. Specifically, new synthetic opioids and benzodiazepines are now the most reported substances by the EU Early Warning System, together with a distinct range of other recreational substances. The epidemics of both classes of substances come from United States and Canada, where both caused severe intoxications and fatalities purposely related to the use of synthetic opioids, particularly fentanyl derivatives. Although these two phenomena have not been so diffused in Europe, concerns do exist also in this area. About 50 new synthetic opioids, mainly fentanyl illicit analogs, have been reported up to now to the EU Early Warning System and the seizures of carfentanil, one of the most hazardous and potent opioids, have been particularly alarming. In this latter case and in that of many other fentanyl derivatives, due to the extreme potency of these compounds, they can be trafficked in very small quantities, which are difficult to detect. In addition, the synthetic opioids and new illegal benzodiazepine share the occurrence that they have been sold as fake kinds of commonly prescribed pain-relievers and antianxiety drugs. Regarding synthetic opioids, the fake OxyContin tablets containing metoxyacetylfentanyl, or fentanyl itself, have been reported by EU early warning system in the last two years. In case of new benzodiazepines, some of these are trafficked as fake types of Xanax, containing alprazolam or other compounds of the same class but illegally produced and sold, or even containing fentanyl and analogs. In this concern, the values of accurate and immediately available toxicological and forensic data are crucial.
This review illustrates some brief considerations of the medical use of cannabis recently issued in Italy. History and uses of cannabis throughout centuries and different countries are illustrated together with a description of botany and active phytocannabinoids. Then, medical use of cannabis anti-pain treatment for patients resistant to conventional therapies is described in case of chronic neuropathic pain, spasticity, for anticinetosic and antiemetic effect in nausea and vomiting caused by chemotherapy, for appetite stimulating effect in cachexia, anorexia, loss of appetite in cancer patients or patients with AIDS and in anorexia nervosa, hypotensive effect in glaucoma resistant to conventional therapies and for reduction of involuntary body and facial movements in Gilles de la Tourette syndrome. Italian most recent legislation on medical cannabis is detailed with some law proposals, also showing the inconsistent legislation within European Union. Some final considerations of future studies are also reported.
Advance healthcare directives (AD) are still intensively animating debates in Europe and worldwide, leading to the enactment of different laws, according to the diverse legal, sociocultural, religious and philosophical traditions of each society1 . After a long complicated seemingly ever-lasting process, on the 14th of December 2017 the Italian Parliament finally approved the Law on "Informed consent and Advance healthcare directives" putting Italy on the same level as other European countries, which have previously regulated this complicated matter2 . The most controversial point of the law is represented by AD. Section 4 states that everyone able to make a proper judgment, regarding any possible future inability to self-determine, can, through AD, express their beliefs and preferences concerning health treatments, consent or refusal to any diagnostic or therapeutic choice, including artificial nutrition and hydration. One can also indicate a person of trust to represent him/her in the relationships with doctors and hospitals2 . Furthermore, the same provision specifies that the doctor is obliged to respect the AD, unless: a) the patient requests a treatment opposing the law or medical deontology, or b) the AD is clearly incongruous, or c) new and unpredictable therapies have come into force. Therefore, ADs are binding; conscientious objection is not foreseen. The reference of the law to medical deontology finds its rationale in section 38 of the Italian Code of Medical Ethics, updated in May 2014, where the requirements that AD must meet are stated3 . With this new law2 Italy conforms to the orientation of the other main European countries, obliging the respect of ADs, even if the limits are slightly different, France4 , Germany5 , Spain6 and England7 they are binding. We wish to draw the attention of the whole medical scientific community to this matter, advocating for an open dialogue to discuss the ethical and medical issues concerning AD, thereby facilitating the improvement and implementation of guidelines and policies to safeguard patients together with healthcare providers1 . There has been considerable progress in addressing all the ethical issues regarding AD and as a consequence of the constant innovation in medical science and an increase in life expectancy we can demand more research into this topic.
At the end of the 90s in Europe, the new psychoactive substances (NPS) phenomenon was limited to a small number of molecules created to mimic the actions and psychoactive effects of licensed medicines and existing drugs that are controlled by the United Nations drug conventions and therefore traded as their "legal" replacements. NPS were mostly circulating in rave parties and electronic music festivals. The globalization, the evolution of e-commerce and the growing popularity of NPS, facilitated the development of a wide illegal market in constant expansion. The dynamic nature of this phenomenon has led to an evolution in the prevention and monitoring of NPS trafficking within the European Union. The European legislative system has been amended with the aim of creating a faster and more effective regulatory system to tackle NPS diffusion and ban their sale and circulation. At the end of 2008, in compliance with the European Council Decision 2005/387/JHA, the Anti-Drug Policies Department of the Presidency of the Council of Ministers activated the National Early Warning System to promote a rapid exchange of information on NPS between Italy and the EU.
Introduction: The abuse of New Psychoactive Substances (NPS) has been a major issue since the 1990s, due to the significant impact this phenomenon has on the society and public health. The Italian legislation, in line with the European legislation, is aimed to limit the NPS use in the Country through different intervention strategies. Methods: The Department for Anti-Drug Policies (DPA) of the Presidency of the Council of Ministers, has activated in Italy the National Early Warning System (SNAP) on NSP reporting, aimed at the early detection of potentially health-threatening phenomena related to the appearance of NPSs in the market. A second aim of the SNAP is the promotion of the technical-analytical expertise of laboratories for the detection of these substances. Since June 2016, the DPA, where the National Focal Point (NFP) for the verification of the phenomenon of drug dependence is established, has entrusted the coordination of SNAP with the National Centre for Addiction and Doping (NCAD) of the "Istituto Superiore di Sanità". The Centre works with several partners, including the Pavia Poison Control Centre for clinical toxicology, the Unit of Forensic Toxicology of Sapienza University of Rome for bio-toxicological aspects, and the Central Directorate for Anti-Drug Services for national coordination of seizures operated by law enforcement agencies. To implement this network of collaboration, the NCAD has developed and activated a strategic 'web application' that simplifies the collection of information across the Country, optimizing incoming/outgoing reports between all the involved authorities. Results: The analysis of the information collected on NPS during 2020 through the SNAP platform, highlighted the circulation of 47 NSPs in Europe, including two synthetic cannabinoids with potential public health risks and the emergence of NPS belonging to the class of benzodiazepines and the benzimidazole family. Conclusions: The SNAP is an important tool for identifying and notifying the spread of NSPs in our ...
