[Safety signal detection by the French Addictovigilance Network: Innovative methods of investigation, examples and usefulness for public health]. / Détection des signaux du réseau français d'addictovigilance : méthodes innovantes d'investigation, illustrations et utilité pour la santé publique.

The French Addictovigilance Network aims to monitor all psychoactive substances with abuse potential including prescription drugs and other legal and illegal substances such as new psychoactive substances (NPS) and its consequences in humans. Created in 1990 through a network of regional addictovigilance centres covering the entire country, these pharmacologists with expertise in addictovigilance have developed interface with different partners (physicians, toxicologists, network of community pharmacies, addictology care centers…) and implemented several original tools of pharmacosurveillance (such as DRAMES [death related to the abuse of medicines] in strong collaboration with toxicologists or such OPPIDUM [observation of illegal products and misuse of psychotropic medications]), complementary to the spontaneous reporting. A such multidimensional approach including proactive surveillance by these tools and also among several heterogenous data sources (such as data from hospitals or claims database) is able to detect early addictovigilance signals and warnings as illustrated with three following examples: cannabis use and acute serious cardiovascular disorders, new synthetic opioids (ocfentanil, carfentanil) and severe opiate overdose or deaths, the diverted use of psychoactive drugs (codeine analgesics or sedative H1 antihistamines called purple drank) by adolescents and young adults. The choice of a broad strategy and the multifaceted system implemented by the French Addictovigilance Network using elements of pharmacology (fundamental, clinical, pharmacoepidemiology) expertise is an innovative method to detect early addictovigilance signals, and to describe its characteristics in order to increase awareness of psychoactive substances by patients, users and health professionals.

Nonmedical prescription psychiatric drug use and the darknet: A cryptomarket analysis.

BACKGROUND: Nonmedical prescription psychiatric drug use (NMPDU) is an increasing global health problem, with recent concern focusing on darknet cryptomarkets as sources of procurement. There is a shortage of evidence regarding comparative worldwide NMPDU trends, due in part to data collection difficulties. This problem is particularly marked for non-opioid drugs, particularly those psychiatric drugs which act on the central nervous system (CNS) and have high misuse potential and are associated with high levels of dependency and fatal overdose. This paper therefore has two goals: 1) to report on the kinds of psychiatric prescription drugs available on cryptomarkets, and 2) to use this data to uncover temporal and geographical trends in sales of these products, potentially informing policy regarding NMPDU more generally. METHOD: Digital trace data collected from 31 cryptomarkets in operation between September 2013 and July 2016 was analysed by country of origin descriptively and for trends in the sales for 7 psychiatric drug groupings, based on their main indication or intended use in psychiatric practice. RESULTS: Sedatives (such as diazepam and alprazolam) and CNS stimulants (mainly Adderall, modafinil and methylphenidate) had the greatest share of sales, but usage and trends varied by location. The UK has high and rising levels of sedative sales, whilst the USA has the greatest stimulant sales and increasing sedative rates. Sales of drugs used in the treatment of opioid dependency are also substantial in the USA. The picture is less clear in mainland Europe with high sales levels reported in unexpected Central and Northern European countries. There is evidence of a move towards the more potent sedative alprazolam - already implicated as a source of problematic NMPDU in the USA - in Australia and the UK. Sales of drugs such as antidepressants, antipsychotics, mood stabilisers and antidementia drugs - all drugs with limited abuse potential - were negligible, indicating minimal levels of online cryptomarket procurement for self-medicating mental health problems. CONCLUSION: Predominantly, psychiatric drugs with potent sedative, stimulant or euphoriant effects are sold on cryptomarkets and this varies by country. With some caveats regarding the limitations of cryptomarket digital trace data taken into account, the study of trends of these products sold online over time may offer a novel and increasingly important window onto wider drug purchasing habits.

[Prescription of Psychotropic Drugs with Potentially Restraining Effect: An Analysis of Care Need Assessment Data by MDK Bayern]. / Psychopharmakaverordnungen mit potentiell freiheitseinschränkender Wirkung ­ eine Auswertung von Pflegebegutachtungsdaten des MDK Bayern.

OBJECTIVE: Physical restraints in home care and residential care settings in the form of restraining devices have been reduced in the last years. Now psychotropic drugs with sedating and thus potentially restraining effect are of increasing interest. The objective of this study was to describe prescription of psychotropic drugs for insurants in need of care and factors influencing such prescription. METHODS: On the "Annual Word Elder Abuse Awareness Day", the Medical Service of the Statutory Health Insurance undertook a reference day analysis. During the regular assessment of care needs, distribution of psychotropic drugs according to relevant aspects of care were analyzed. Additionally, prescribed drugs were rated with respect to inappropriateness for elder people according to the Priscus list. RESULTS: Data on 706 insured people were analyzed; 43% of them received at least one psychotropic drug as a regular medication, 22% of them at least one potentially sedating drug. According to the Priscus list, 16% of prescribed drugs were identified as potentially inappropriate for elder people. Significant correlation was shown between prescription of psychotropic drugs and location of assessment, care need, diagnosis and the degree of limitation in daily living skills. CONCLUSION: This paper supports results in literature and emphasizes the discrepancy between restraint in the prescription of psychotropic drugs as advised by experts and distribution of these drugs in reality. Further studies analyzing the quality of prescriptions taking into consideration the individual circumstances of patients are desirable.

Responding to New Psychoactive Substances in the European Union: Early Warning, Risk Assessment, and Control Measures.

New psychoactive substances (NPS) are drugs that are not controlled by the United Nations international drug control conventions of 1961 and 1971 but that may pose similar threats to public health. Many of them are traded as "legal" replacements to controlled drugs such as cannabis, heroin, benzodiazepines, cocaine, amphetamines, and 3,4-methylenedioxymethamphetamine (MDMA). Driven by globalization, there has been a large increase in the availability and, subsequently, harms caused by these substances over the last decade in Europe. The European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) is monitoring more than 670 NPS that have appeared on Europe's drug market in the last 20 years, of which almost 90% have appeared in the last decade. While some recent policy responses have been successful in reducing availability and sales of these substances in some settings - such as "legal highs" and "research chemicals" sold openly in the high street and online - and there are signs that growth in the market is slowing, new challenges have emerged. This includes monitoring a growing number of highly potent substances - including 179 synthetic cannabinoid receptor agonists and 28 fentanils - that can pose a high risk of life-threatening poisoning to users and can cause explosive outbreaks. This chapter briefly traces the origins of NPS, provides an overview of the situation in Europe, and discusses the work of the EMCDDA as part of a legal framework of early warning, risk assessment, and control measures that allows the European Union to rapidly detect, assess, and respond to public health and social threats caused by these substances.

Public health psychopharmacology: a new research discipline comes of age?

Research evidence guiding the identification of pragmatic and effective actions aimed at improving the selection, availability, affordability and rational prescribing of medicines for mental disorders is sparse and inconsistent. In order to boost the development of new research, in this commentary we suggest to organise and classify all the activities in this area under a common theoretical framework and nomenclature, adopting the term 'public health psychopharmacology'. Public health psychopharmacology is proposed as a research discipline, based on contributions from the fields of regulatory science, health services research and implementation science. Implementing the term public health psychopharmacology may offer advantages, as the scientific community would be more focused on common goals and objectives, with, likely, an increasing body of research evidence of practical use.

LEGAL REGULATION OF PROCUREMENT OF NARCOTIC DRUGS IN UKRAINE WITH INVOLVEMENT OF INTERNATIONAL SPECIALIZED ORGANIZATIONS.

The purpose of the study is to analyze specific problems of legal regulation of the procurement of narcotic drugs in Ukraine with the involvement of international specialized organizations. To achieve this goal, statistics have been analyzed concerning the number of people who receive narcotic drugs for the SMT program, the number of their treatment applications, the quantity of drugs purchased for them from the state budget. It is proposed to divide the regulatory legal acts regulating the purchase of narcotic drugs, general and special, and analyze them. The understanding of legal constructions "state procurement" and "public procurement" in scientific literature, national legislation and international legal documents is analyzed. Two groups of subjects of legal relations in the field of procurement of narcotic drugs with the involvement of international specialized organizations have been distinguished out. In the course of the study, a number of problems have been identified that require urgent solutions: insufficient budget financing of drug provision for SMT programs; absence of control over the use of methadone and buprenorphine for SMT programs at the legislative level, as well as the differentiation of the terms "narcotic drugs", "psychotropic substances" and "drugs containing narcotic drugs, psychotropic substances and precursors"; absence of the price of the drug in the selection criteria of international organizations, the lack of economic competition in this field, existence of prepayment for SMT drugs for more than one year, which affects the efficiency of using budgetary funds. It is proposed to make a number of changes to the relevant legal acts.

Health system preparedness for integration of mental health services in rural Liberia.

BACKGROUND: There are increasing efforts and attention focused on the delivery of mental health services in primary care in low resource settings (e.g., mental health Gap Action Programme, mhGAP). However, less attention is devoted to systematic approaches that identify and address barriers to the development and uptake of mental health services within primary care in low-resource settings. Our objective was to prepare for optimal uptake by identifying barriers in rural Liberia. The country's need for mental health services is compounded by a 14-year history of political violence and the largest Ebola virus disease outbreak in history. Both events have immediate and lasting mental health effects. METHODS: A mixed-methods approach was employed, consisting of qualitative interviews with 22 key informants and six focus group discussions. Additional qualitative data as well as quantitative data were collected through semi-structured assessments of 19 rural primary care health facilities. Data were collected from March 2013 to March 2014. RESULTS: Potential barriers to development and uptake of mental health services included lack of mental health knowledge among primary health care staff; high workload for primary health care workers precluding addition of mental health responsibilities; lack of mental health drugs; poor physical infrastructure of health facilities including lack of space for confidential consultation; poor communication support including lack of electricity and mobile phone networks that prevent referrals and phone consultation with supervisors; absence of transportation for patients to facilitate referrals; negative attitudes and stigma towards people with severe mental disorders and their family members; and stigma against mental health workers. CONCLUSIONS: To develop and facilitate effective primary care mental health services in a post-conflict, low resource setting will require (1) addressing the knowledge and clinical skills gap in the primary care workforce; (2) improving physical infrastructure of health facilities at care delivery points; and (3) implementing concurrent interventions designed to improve attitudes towards people with mental illness, their family members and mental health care providers.

Mapping actions to improve access to medicines for mental disorders in low and middle income countries.

AIMS: In recent years a number of intergovernmental initiatives have been activated in order to enhance the capacity of countries to improve access to essential medicines, particularly for mental disorders. In May 2013 the 66th World Health Assembly adopted the World Health Organization (WHO) Comprehensive Mental Health Action Plan 2013-2020, which builds upon the work of WHO's Mental Health Gap Action Programme. Within this programme, evidence-based guidelines for mental disorders were developed, including recommendations on appropriate use of medicines. Subsequently, the 67th World Health Assembly adopted a resolution on access to essential medicines, which urged Member States to improve national policies for the selection of essential medicines and to promote their availability, affordability and appropriate use. METHODS: Following the precedent set by these important initiatives, this article presents eleven actions for improving access and appropriate use of psychotropic medicines. RESULTS: A 4 × 4 framework mapping actions as a function of the four components of access - selection, availability, affordability and appropriate use - and across four different health care levels, three of which belong to the supply side and one to the demand side, was developed. The actions are: developing a medicine selection process; promoting information and education activities for staff and end-users; developing a medicine regulation process; implementing a reliable supply system; implementing a reliable quality-control system; developing a community-based system of mental health care and promoting help-seeking behaviours; developing international agreements on medicine affordability; developing pricing policies and a sustainable financing system; developing or adopting evidence-based guidelines; monitoring the use of psychotropic medicines; promoting training initiatives for staff and end-users on critical appraisal of scientific evidence and appropriate use of psychotropic medicines. CONCLUSIONS: Activating these actions offers an unique opportunity to address the broader issue of increasing access to treatments and care for mental disorders, as current lack of attention to mental disorders is a central barrier across all domains of the 4 × 4 access framework.

Assessing the 'added value' of European policy on new psychoactive substances.

BACKGROUND: New psychoactive substances (NPS) are reported to be on the rise throughout Europe, and are often presented as the latest challenge facing drug-policy makers. At the European level, legislation on NPS has existed since 1998. Several evaluations, however, have suggested that this legislation is not effective and the European Commission has submitted a new proposal on NPS seeking to extend its powers in this area. METHODS: This article critically evaluates the new proposal against its predecessor's three main criticisms: (i) being unable to tackle the large number of NPS because of lengthy European legislative approaches, (ii) being reactive rather than proactive, and (iii) lacking options for regulatory and control measures. RESULTS AND CONCLUSION: In determining whether or not European interventions can bring added value to what is being done at the national level, it finds that, while the new proposal is more efficient, it is not necessarily more effective, and that there is a disappointing focus on legal frameworks at the expense of research and harm reduction.

The Presence of New Psychoactive Substances in a Tor Network Marketplace Environment.

Prior research has documented the availability of drugs on many Tor Network websites, with the Internet playing a particularly vital role in the global new psychoactive substances (NPS) market. The primary objective of this research was to document types of NPS for sale on the largest operating Tor site (Agora) over a period of four months. Secondary objectives were to analyze countries and vendors sourcing NPS on Agora. Data from Agora were collected in February and June 2015. The number of total advertisements on Agora increased from 20,742 to 27,431 over the four months, while the number of NPS advertisements increased from 2,205 to 2,271 and the number of vendors increased from 157 to 288. The composition of NPS listings and source countries for NPS advertised on Agora diversified over time. Advertisements for ketamine and unclassified NPS experienced substantial growth, while the availability of phenethylamines decreased. However, phenethylamines remained the most frequently advertised NPS type. China and the U.S. were found to be the top two countries by volume selling NPS on Agora over the fpir months, but the number of countries identified as advertising NPS increased by nearly 43%. The United States housed the most NPS vendors.

Legal high industry business and lobbying strategies under a legal market for new psychoactive substances (NPS, 'legal highs') in New Zealand.

BACKGROUND: The establishment of a regulated legal market for new psychoactive substances (NPS, 'legal highs') under New Zealand's Psychoactive Substances Act (PSA) 2013 created a new commercial sector for psychoactive products, previously limited to alcohol and tobacco. AIM: To explore how the newly-recognised 'legal high' industry (LHI) viewed and responded to the changing regulatory and market environment. METHODS: In-depth interviews with six key informants (KI) from the LHI: a leading entrepreneur, chemist, industry spokesperson, retailer, product buyer and a researcher commissioned by the LHI - were conducted, transcribed and analysed thematically. Formative work for the study included review of official LHI documents (websites, public submissions, self-regulation documents). RESULTS: The LHI stakeholders espoused an idealistic mission of shifting recreational users of alcohol, tobacco and illegal drugs towards "safer alternatives". Passage of the PSA was viewed as a success after years of lobbying led by pioneering LHI actors. The growth and professionalisation of the LHI resulted in an increasingly commercial market which challenged idealistic views of the original operators. LHI KI reported the targeting of young and low income customers, price cutting and increasing the strength of products as business strategies. Attempts by the LHI to self-regulate did not prevent escalation in the strength of products and fall in retail prices. The LHI reported outsourcing of manufacturing and exporting of their products to other countries, demonstrating an international business model. CONCLUSION: There was a tension between profit and idealistic motivations within the LHI and this increased as the sector became more commercialised. While the LHI distanced itself from both alcohol and tobacco, they reported the use of similar marketing, business and political lobbying strategies. Rules for engagement with new 'addictive consumption industries' are required to clarify the role they are permitted to play in the development of regulatory regimes for new psychoactive substances.

Reporting mental health problems of undocumented migrants in Greece: A qualitative exploration.

BACKGROUND: Mental health problems are highly prevalent amongst undocumented migrants (UMs), and often part of their consultations with general practitioners (GPs). Little empirical data are available of how GPs and UMs engage around mental health in Greece, a country with a lack of balance between primary and secondary care and limited healthcare provisions for UMs. OBJECTIVES: To acquire insight in the barriers and levers in the provision of mental healthcare for UMs by GPs in Greece. METHODS: This was a qualitative study using semi-structured interviews with 12 GPs in Crete, Greece with clinical expertise in the care of UMs. All interviews were audio-taped and transcribed verbatim and were analysed using thematic content analysis. RESULTS: Greek GPs recognized many mental health problems in UMs and identified the barriers that prevented them from discussing these problems and delivering appropriate care: growing societal resistance towards UMs, budget cuts in healthcare, administrative obstacles and lack of support from the healthcare system. To overcome these barriers, Greek GPs provided UMs with free access to care and psychotropic drugs free of charge, and referred to other primary care professionals rather than to mental healthcare institutions. CONCLUSION: Greek GPs experienced substantial barriers in the provision of mental healthcare to UMs and political, economic and organizational factors played a major role.

Availability of prescription drugs for bipolar disorder at online pharmacies.

BACKGROUND: There is increasing use of online pharmacies to purchase prescription drugs. While some online pharmacies are legitimate and safe, there are many unsafe and illegal so-called "rogue" online pharmacies. This study investigated the availability of psychotropic drugs online to consumers in the US, using 5 commonly prescribed drugs for bipolar disorder. METHODS: Using the search term "buy [drug name]" in the Google, Yahoo and Bing search engines, the characteristics of the online pharmacies found on the first two pages of search results were investigated. The availability of the requested dosage and formulations of two brand (Seroquel XR, Abilify) and three generic drugs (lamotrigine, lithium carbonate and bupropion SR) were determined. RESULTS: Of 30 online pharmacies found, 17 (57%) were rated as rogue by LegitScript. Of the 30 pharmacies, 15 (50%) require a prescription, 21 (70%) claim to be from Canada, with 20 of these having a Canadian International Pharmacy association (CIPA) seal on the website. Only 13 of the 20 sites with a CIPA seal were active CIPA members. There were about the same number of trust verification seals on the rogue and legitimate pharmacy sites. Some rogue pharmacies are professional in appearance, and may be difficult for consumers to recognize as rogue. All five brand and generic drugs were offered for sale online, with or without a prescription. However, many substitutions were presented such as different strengths and formulations including products not approved by the FDA. LIMITATIONS: No evaluation of product quality, packaging or purchasing. CONCLUSIONS: Psychotropic medications are available online with or without a prescription. The majority of online pharmacy websites were rogue. Physicians should ask about the use of online pharmacies. For those who choose to use online pharmacies, two measures to detect rogue pharmacies are recommended: (1) only purchase drugs from pharmacies that require a prescription, and (2) check all pharmacy verification seals directly on the website of the certifying organization, every time, before purchase.

The Public Health Framework of Legalized Marijuana in Colorado.

On January 1, 2014, Colorado became the first state in the nation to sell legal recreational marijuana for adult use. As a result, Colorado has had to carefully examine potential population health and safety impacts as well as the role of public health in response to legalization. We have discussed an emerging public health framework for legalized recreational marijuana. We have outlined this framework according to the core public health functions of assessment, policy development, and assurance. In addition, we have discussed challenges to implementing this framework that other states considering legalization may face.

"Spice," "kryptonite," "black mamba": an overview of brand names and marketing strategies of novel psychoactive substances on the web.

UNLABELLED: Abstract Introduction: Novel Psychoactive Substances (NPSs) are often sold online as "legal" and "safer" alternatives to International Controlled Drugs (ICDs) with captivating marketing strategies. Our aim was to review and summarize such strategies in terms of the appearance of the products, the brand names, and the latest trends in the illicit online marketplaces. METHODS: Scientific data were searched in PsychInfo and Pubmed databases; results were integrated with an extensive monitoring of Internet (websites, online shops, chat rooms, fora, social networks) and media sources in nine languages (English, French, Farsi, Portuguese, Arabic, Russian, Spanish, and Chinese simplified/traditional) available from secure databases of the Global Public Health Intelligence Network. RESULTS: Evolving strategies for the online diffusion and the retail of NPSs have been identified, including discounts and periodic offers on chosen products. Advertisements and new brand names have been designed to attract customers, especially young people. An increased number of retailers have been recorded as well as new Web platforms and privacy systems. DISCUSSION: NPSs represent an unprecedented challenge in the field of public health with social, cultural, legal, and political implications. Web monitoring activities are essential for mapping the diffusion of NPSs and for supporting innovative Web-based prevention programmes.

An Internet snapshot study to compare the international availability of the novel psychoactive substance methiopropamine.

CONTEXT: With the increased use of novel psychoactive substances, there is an increasing availability of these substances from Internet-based suppliers. Methiopropamine, first reported in 2011, is a recreational drug available over the Internet. The aim of this study was to investigate availability and cost of methiopropamine in three different countries: the UK, France, and Canada. METHODS: Using the European Monitoring Centre for Drugs and Drug Addiction Internet snapshot methodology, this study, conducted in June 2013, was undertaken in two different languages: in English (the UK and Canada) and in French (France and Canada), using three Internet searching engines: " google.co.uk ", " google.fr " and " google.ca ". RESULTS: A total of 62 sites were found, most of them were found from the English searches. 45% of the suppliers seemed to originate from the UK. The prices of methiopropamine were comparable between suppliers, no matter which search engine or language was used. The cost of a unit of methiopropamine was inversely related to the purchased quantity, going from 19.49 ± 0.15 GBP per gram for a purchase amount of 500 mg to 3.54 ± 0.13 GBP per gram for a purchase amount of 1 kg. DISCUSSION: The results of the present study demonstrate that the sale of methiopropamine has the potential to reach users across the world. It also appears to support that snapshot studies could be used for toxicovigilance across different countries, by studying the Internet market of novel psychoactive substances. CONCLUSION: To date, snapshot studies, used to monitor the Internet novel psychoactive substances market, have only been undertaken in Europe. We have shown that the flexibility of this methodology enables comparison of the online activity of drug sellers between different countries and continents and that, at least for methiopropamine, the UK is the predominant source for Internet supply.

Prescribing in prison: minimizing psychotropic drug diversion in correctional practice.

Correctional facilities are a major provider of mental health care throughout the United States. In spite of the numerous benefits of providing care in this setting, clinicians are sometimes concerned about entering into correctional care because of uncertainty in prescribing practices. This article provides an introduction to prescription drug use, abuse, and diversion in the correctional setting, including systems issues in prescribing, commonly abused prescription medications, motivation for and detection of prescription drug abuse, and the use of laboratory monitoring. By understanding the personal and systemic factors that affect prescribing habits, the clinician can develop a more rewarding correctional practice and improve care for inmates with mental illness.

A critical first assessment of the new pre-market approval regime for new psychoactive substances (NPS) in New Zealand.

BACKGROUND: New Zealand has recently attempted to address the underlying drivers of the escalating new psychoactive substances (NPS) ('legal highs') problem by establishing the world's first pre-market approval regulatory regime for NPS. NPS products which can be shown with clinical trial data to pose a 'low risk' of harm will be approved for legal manufacture and sale. AIMS AND METHOD: This paper critically assesses the new regime, drawing on experience of the pharmaceutical sector and legal BZP market. FINDINGS: A number of characteristics of the recreational use of NPS may not be well addressed by standard medical clinical trials, including binge use, polydrug use, use by vulnerable groups and high-risk modes of administration. The overt advertising and covert promotion of approved NPS products on the internet may make them fairly visible to young people. The black market for unapproved NPS may be difficult to suppress given that unapproved NPS will be physically identical to approved NPS. If the legal market for NPS encourages the use of NPS, alcohol and other drugs there may be an increase in drug-related harm. Alternatively, if the legal NPS market reduces the use of more harmful drugs, there may be a considerable public health benefit. CONCLUSIONS: The clinical trials required for NPS products should address the characteristics of recreational NPS use. Enforcement resources and technical solutions are required to clearly distinguish legal NPS products. The impact the new NPS regime has on other drug use is a key issue and demands further study.

From 32 ounces to zero: a medical geographic study of dispensing a cultivated batch of "plum" cannabis flowers to medical marijuana patients in Washington State.

The medicinal use of cannabis is a growing phenomenon in the U.S. predicated on the success of overcoming specific spatial challenges and establishing particular human-environment relationships. This article takes a medical geographic "snapshot" of an urban site in Washington State where qualifying chronically ill and debilitated patients are delivered locally produced botanical cannabis for medical use. Using interview, survey, and observation, this medical geographic research project collected information on the social space of the particular delivery site and tracked the production cost, reach, and health value of a 32-ounce batch of strain-specific medical cannabis named "Plum" dispensed over a four-day period. A convenience sample of 37 qualifying patients delivered this batch of cannabis botanical medicine was recruited and prospectively studied with survey instruments. Results provide insight into patients' self-rated health, human-plant relationships, and travel-to-clinic distances. An overall systematic geographic understanding of the medical cannabis delivery system gives a grounded understanding of the lengths that patients and care providers go, despite multiple hurdles, to receive and deliver treatment with botanical cannabis that relieves diverse symptoms and improves health-related quality-of-life.