Effect of the UK Psychoactive Substances Act 2016 on episodes of toxicity related to new psychoactive substances as reported to the National Poisons Information Service. A time series analysis.

BACKGROUND: There have been recent increases in use of new psychoactive substances (NPS) associated with acute health harms including hospital presentations due to toxicity and increasing numbers of deaths. In response, the UK Government enacted generic legislation on 26th May 2016 (the Psychoactive Substances Act) making it an offence to produce, possess with intent to supply, supply, import or export, or possess within a custodial setting a psychoactive substance. We studied the impact of this Act on monthly frequency of enquiries made by health professionals to the UK National Poisons Information Service (NPIS) about NPS. We also studied five commonly used 'conventional' drugs of misuse that had been controlled prior to January 2009. METHOD: Anonymised clinical enquiries to the NPIS and accesses to the poisons information database TOXBASE were reviewed retrospectively from January 2009 to December 2018 to ascertain the trends in reported toxicity for NPS, cocaine, heroin, cannabis, amphetamines and MDMA. Data were analysed using interrupted time series analysis with the date of the PSA used as an independent predictor. RESULTS: Over the period of study there were 3,866 NPIS telephone enquiries and 79,271 TOXBASE user accesses made by UK health professionals concerning NPS. There were increases in monthly TOXBASE accesses (t = 7.408, P < 0.0001) and telephone enquiries (t = 4.74, P < 0.001) over the pre-specified period January 2009 to May 2016. Comparing the period after the PSA with that before, there were significant reductions in TOXBASE accesses (t = -3.327, P < 0.001) and telephone enquiries (t = -6.97, P < 0.001), although reductions started before May 2016. There were no significant changes for the five conventional drugs. There were significant reductions in telephone enquiries (t = -3.418, P < 0.001) and non-significant reductions in TOXBASE accesses (t = -1.713, P = 0.089) for NPS between June 2016 and December 2018. Increases in telephone enquiries for cocaine and reductions TOXBASE accesses for MDMA were also observed over that period. CONCLUSIONS: There have been significant recent reductions in NPIS enquiry activity relating to NPS; although these began before enactment of the PSA in May 2016.

Legal aspects of information sharing and communication by poison centers in the United States.

To keep pace with changing technology and to provide better treatment to the public, U.S. poison control centers have increasingly implemented new ways of communicating with healthcare providers and with patients, including electronic transfer of patient information. Innovation in communication and information sharing raises concerns over patient privacy and compliance with applicable laws. This narrative review analyzes both typical activities and emerging innovations of PCCs in relation to U.S. law and regulation regarding privacy, specifically the Health Insurance Portability and Accountability Act, the Substance Abuse and Mental Health Treatment Act, and the Federal Trade Commission Act. PCCs that are "covered entities" under HIPAA may exchange patient health information with other providers by telephone for purposes of treatment, and certainly during the emergency management of poisonings. SAMHSA regulations, however, limit information that can be shared outside of emergencies without patient consent. The FTC Act prohibits unfair or deceptive trade practices which may in some circumstances involve privacy violations. Text message exchanges between PCCs and patients present particularly difficult privacy challenges under these laws.

The association between pain clinic laws and prescription opioid exposures: New evidence from multi-state comparisons.

OBJECTIVES: States in the US are controlling opioid prescribing to combat the opioid epidemic. Prescription Drug Monitoring Programs (PDMPs) were widely adopted, whereas less attention was given to pain clinic laws. This study examined the associations of mandatory use of PDMPs and pain clinic laws with prescription opioid exposures. METHODS: State-level quarterly prescription opioid exposures reported to the National Poison Data System during 2010-2017 were analyzed. The primary outcome was age-adjusted rates of prescription opioid exposures per 1,000,000 population. The primary policy variables included the implementation of mandatory use of PDMPs alone, the implementation of pain clinic laws alone, and the implementation of both mandatory use of PDMPs and pain clinic laws. Linear regressions were used to examine the associations, controlling for other opioid policies, marijuana policies, socioeconomic factors, state fixed effects, time fixed effects, and state-specific time trends. RESULTS: Requiring mandatory use of PDMPs alone was not associated with significant changes in prescription opioid exposures. The implementation of pain clinic laws with or without concurrent mandatory use of PDMPs was associated with 5 fewer prescription opioid exposures per 1,000,000 population or a 9 % reduction compared to the pre-policy period (p < 0.01). Further analysis revealed that the reduction associated with pain clinic laws was pronounced in exposures reported by healthcare facilities. CONCLUSIONS: This multi-state study provided new evidence that the implementation of pain clinic laws was associated with a significant reduction in prescription opioid exposures. Pain clinic laws may deserve further evaluation and consideration.

Synthetic cathinone adulteration of illegal drugs.

RATIONALE: Current prevalence estimates of synthetic cathinone ("bath salt") use may be underestimates given that traditional metrics (e.g., surveys, urinalysis) often fail to capture the emergent issue of synthetic cathinone adulteration of more common illegal drugs, such as ecstasy (3,4-methylenedioxymethamphetamine). OBJECTIVES: This review examines the evolution of synthetic cathinones and prevalence of use over the past decade in the United States. We also review methods of self-report and biological testing of these compounds as well as adverse outcomes associated with adulterated drug use. RESULTS: Synthetic cathinone use emerged in the United States by 2009 with use associated with tens of thousands of poisonings. Reported poisonings and self-reported use have substantially decreased over the past five years. However, our review suggests that current estimates of use are underestimates due to underreporting stemming primarily from unknown or unintentional use of adulterated formulations of relatively popular illegal drugs, such as ecstasy. CONCLUSIONS: While intentional synthetic cathinone use has decreased in recent years, evidence suggests that prevalence of use is underestimated. Testing of drugs and/or biological specimens can improve the accuracy of synthetic cathinone use estimates. Furthermore, we advocate that researchers and clinicians should become better aware that exposure to these potent compounds (e.g., as adulterants) often occurs unknowingly or unintentionally. To improve our understanding of synthetic cathinone adulteration, research utilizing a combinatorial approach (survey and biological testing) will help more accurately estimate the prevalence and impact of this public health issue.

New legal requirements for submission of product information to poisons centres in EU member states.

INTRODUCTION: In the past eight years, the European Association of Poisons Centres and Clinical Toxicologists (EAPCCT) has been intensively involved in a European Commission led process to develop EU legislation on the information of hazardous products that companies have to notify to EU Poisons Centres (or equivalent "appointed bodies"). As a result of this process, the Commission adopted Regulation (EU) No 2017/542, amending the CLP Regulation by adding an Annex on harmonised product submission requirements. Harmonised mixture information requirements: Detailed and consistent information on the composition of the hazardous product will become available to EU Poisons Centres (PC). The information will be submitted by companies to PCs (or equivalent "appointed bodies") using a web-based software application or in-house software. Two new important features are introduced. Firstly, to be able to rapidly identify the product formula, a Unique Formula Identifier (UFI) on the product label links to the submitted information. Secondly, for better comparability of reports on poisonings between EU member states, a harmonised Product Categorisation System will specify the intended use of a product. Rapid product identification and availability of detailed composition information will lead to timely and adequate medical intervention. This may lead to considerable reduction in healthcare costs. Additionally, for companies trading across the EU, costs of submission of this information will be reduced significantly. Next steps: From 2017, an implementation period has started, consisting of a three-year period for stakeholders to implement the new requirements, followed by a gradual applicability for consumer products (2020), professional products (2021) and industrial use-only products (2024). Technical tools to generate the electronic format and the UFI together with guidance documents are expected to be made available by the end of 2017 by the European Chemicals Agency (ECHA). Guidance on interpretation of legal text and ECHA helpdesk support are planned to be ready at the end of 2018.

Bath salts and other emerging toxins.

Novel classes of synthetic drugs, including synthetic cathinones ("bath salts") and synthetic cannabinoids ("spice" or "K2"), have recently emerged as popular drugs of abuse. Salvia divinorum, a naturally occurring herb, has gained popularity in the last decade as a hallucinogenic as well. The legal status of these substances has been undergoing rapid changes and has been confusing to lawmakers and medical practitioners alike. We present an up-to-date information about the legality of these substances. We also discuss the historical background, chemical composition, patterns of abuse, clinical presentations, laboratory analysis, and management strategies for these drugs, with an emphasis on synthetic cathinones.

Harmonisation of product notification to Poisons Centres in EU Member States.

INTRODUCTION: In the European Union (EU), notification of product information by industry to poisons centres and/or competent authorities is a legal obligation for mixtures classified as hazardous. However, EU legislation does not specify the precise information needed for this product notification. As a consequence, varying requirements have been developed in different EU Member States. The European Commission (EC) carried out an assessment of whether harmonisation of product notification can be achieved. This manuscript provides an overview of the most important (discussion) points to reach harmonisation. COMPOSITION AND CONCENTRATION OF INGREDIENTS: Discussions have focused mainly on whether non-classified ingredients should be notified only above a concentration threshold and on the use of defined, narrow concentration ranges instead of exact concentrations for hazardous ingredients. ELECTRONIC DATA EXCHANGE FORMAT: All stakeholders agree to the development of an electronic data exchange format for product notification and identify the eXtensible Markup Language (XML) as the most appropriate format. EUROPEAN PRODUCT DATABASE: Instead of multiple notifications to national databases, the EC will analyse the benefits, feasibility and costs of a European product database to provide a centralised portal for companies to upload their product information. Poisons centres and competent authorities need to have access to this information. UNIQUE PRODUCT IDENTIFIER: A Unique Product Identifier (UPI) on the product label can unambiguously identify the product and its formula and links it to the corresponding notified product information. A procedure for the creation of a UPI by companies has already been proposed. PRODUCT CATEGORY SYSTEM: There is broad support for the development of a hierarchical product category system to facilitate statistical analyses and comparability of poisoning incidents in EU Member States. OUTLOOK: Following a 3-year assessment period, the EC concluded that harmonisation of product notification is an achievable goal. In order to draft an Annex to the CLP Regulation concerning this topic, a new working group with representatives of EU Member States, European Association of Poisons Centres and Clinical Toxicologists (EAPCCT) and other stakeholders will attempt to find consensus on harmonisation of product notification.

Estudio epidemiológico de las intoxicaciones agudas atendidas en un hospital gallego entre 2005 y 2008 / Epidemiological study of acute poisoning cases treated at a Galician hospital between 2005 and 2008

Se realizó un estudio descriptivo retrospectivo de las intoxicaciones agudas registradas en el Complexo Hospitalario de Pontevedra (CHOP) entre enero de 2005 y diciembre de 2008, para conocer el número y tipo de intoxicaciones atendidas, su distribución según el sexo y edad del paciente, cronología, tipo de agentes tóxicos implicados, intencionalidad, antecedentes, clínica, evolución, tratamiento y análisis toxicológico empleado en el diagnóstico. Mediante los programas informáticos Clínica e IANUS y la consulta de todas las historias clínicas en papel de los pacientes atendidos con síntomas de intoxicación, se registraron los datos necesarios. Se incluyeron un total de 1893 pacientes con una edad media de 35,6 ± 17,6 años (66% hombres). La mayor incidencia se alcanzó los sábados y domingos durante los meses de verano (junio, julio y agosto). Los agentes tóxicos más frecuentes fueron las drogas de abuso (70,4%), destacando entre ellas el alcohol etílico (61%), frecuentemente asociado al sexo masculino y a un elevado grado de dependencia. En segundo lugar se situaron las intoxicaciones medicamentosas, frecuentemente asociadas al sexo femenino y producidas, en un 73,2% de los casos, por benzodiacepinas. La mayoría de las intoxicaciones registradas fueron voluntarias y en el 18,8% hubo intencionalidad suicida. Ésta se asoció mayoritariamente al sexo femenino. Las manifestaciones neurológicas fueron las más frecuentes y la mortalidad tan solo fue del 0,2% (AU)

A descriptive retrospective study of acute intoxication cases registered at the Complexo Hospitalario de Pontevedra (CHOP) between January 2005 and December 2008 was performed to find out the number and types of poisoning cases treated, their distribution according to patient’s sex and age, chronology, type of toxic agents involved, intentionality, history, symptoms, clinical development, treatment and toxicological analysis used for diagnosis. Data were recorded using Clinica and IANUS software and consulting all paper records of patients with symptoms of poisoning. Data from a total of 1893 patients with a mean age of 35.6 ± 17.6 years (66% men) were included. Highest rates of poisoning were recorded on Saturdays and Sundays during the summer months (June, July and August). Drugs of abuse were the most common toxic agents (70.4%), ethyl alcohol accounting for 61% of these cases, which often involved males and with people with high degrees of dependency. In second place was poisoning resulting from the abuse of medical drugs, more commonly associated with females, and involving benzodiazepines in 73.2% of cases. The majority of these intoxications were intentional, and suicide attempts accounted for 18.8%. The problems most commonly resulting from the poisoning were neurological, and mortality rate was just 0.2% (AU)

Budget cuts and U.S. Poison Centers - regional challenges create a nationwide problem.

Federal funding of poison centers (PCs) in the United States was established in 2000 through the Poison Control Center Enhancement and Awareness Act. Unfortunately, the problems with financial stability of PCs that this legislation was intended to improve persist because of continued reliance on fragile local funding sources. In the past few months budget cuts have had an impact on PC activity and threaten the continued existence of a nationwide network of PCs in the United States. This commentary discusses the problems faced by PCs in this changing environment and illustrates the many competing tasks that the PC network performs for the U.S. population. PCs face continuing challenges in coming months and a unified approach at a national level may provide the best opportunity for a solution to this crisis.

Legal liability of medical toxicologists serving as poison control center consultants: a review of relevant legal statutes and survey of the experience of medical toxicologists.

INTRODUCTION: Legal liability is an increasing concern in many areas of medicine, although the extent to which this alters the practice of medicine is unclear. To date the risk for litigation against medical toxicologists serving in the role of poison control center (PCC) consultants has not been assessed. METHODS: A survey questionnaire was mailed to medical toxicologists in the United States to assess their litigation history with regard specifically to their role as PCC consultants. In addition, state laws were examined for statutes that provide protective language with regard to medical toxicologists working as PCC consults. RESULTS: This survey revealed that most medical toxicologists have served or currently serve as PCC consultants. Most had some degree of concern over legal liability, and several had been sued as a result of PCC consultations. Several states have specific statutes that limit the legal liability of PCCs and their employees, including medical directors and consulting medical toxicologists. DISCUSSION: Based on the survey results, legal action against toxicologists serving as PCC consultants appears to be an uncommon occurrence. Lawsuits are usually based upon nonfeasance and have typically been settled or dropped before trial. CONCLUSIONS: Legal liability is a concern for PCC consultants. However, legal action against consultants appears to be rare, and respondents to the survey indicated that it did not affect their advice or willingness to serve as PC consultants. A limited number of states have enacted laws that provide protection for medical toxicologists serving as PCC consultants.

[Accreditation criteria and quality standards for Poisons centres: development of a quality management system within the Milan Poisons centre]. / Criteri di accreditamento e standard di qualità dei Centri antiveleni: sviluppo di un sistema di gestione della qualità all'interno del Centro antiveleni di Milano.

Poisons centres throughout Italy and Europe vary considerably in terms of their institutions and organisation. The European Association of Poisons Centres and Clinical Toxicologists (EAPCCT) has laid down the activities that a poisons centre must carry out, specifying minimum and maximum standards required. These directions allow an evaluation of the service provided. In 2002 Milan Poisons Centre began a project aiming to introduce concepts and methodology proper of the quality systems within poisons centres' institutional activity. Concluded, the project resulted in the centre's certification and the documentation of its procedures: this may now contribute to help define the status and activity of poisons centres in Italy.

La responsabilidad legal de los centros de información y asesoramiento toxicológico / Legal responsability of the poison control centers

En el desempeño de sus funciones, los Centros de información y Asesoramiento Toxicológico realizan diversos actos que en ocasiones, pueden llevarlos a enfrentar procesos judiciales. El articulo analiza los diversos factores que particularizan la responsabilidad legal de los CIAT, en especial la frecuente disociación entre las situaciones concretas planteadas por el solicitante y la información de las fluentes disponibles. Se definen, a partir de la experiencia de los autores, las solicitudes más propensas a desembocar en procesos judiciales. Se enfatiza la necesidad de la aplicación de buenas practicas de información como medio para elevar la calidad de la misma, así como el empleo de fuentes de información computarizados y expertos en las diversas áreas de la toxicología. Por ultimo se señala, la escasa divulgación que sobre esta temática existe en América Latina en particular, y en la literatura especializada en general (AU)

Use of telephone recording devices by poison centers in the United States.

To determine the extent of and rationale for the use of telephone recording devices by poison centers, a survey was distributed to 93 poison centers in the US during September 1991. Of the 62 respondents, 23 (37%) utilized and 39 did not utilize a telephone recording device. Telephone recording devices were primarily installed to address liability concerns followed by use for quality assurance, staff evaluation and training. The most frequent reason for not using a telephone recording device was the high cost and lack of funds (19) followed by considering it an unnecessary practice (8) and liability concerns (7). Poison centers certified by the AAPCC were more likely to record telephone conversations (p < 0.05) and accounted for 70% of centers with a recording device. A telephone recording device is employed by 1/3 of poison centers primarily to address liability concerns.