Technical and health governance aspects of the external quality assessment system for classical and new psychoactive substances analysis testing in blood.

New psychoactive substances (NPS) are uncontrolled analogues of existing drugs or newly synthesized chemicals that exhibit psychopharmacological effects. Due to their diverse nature, composition, and increasing prevalence, they present significant challenges to the healthcare system and drug control policies. In response, healthcare system laboratories have developed analytical methods to detect NPS in biological samples. As a Regional Reference Centre, the Sicilian CRQ Laboratory (Regional Laboratory for Quality Control) developed and conducted an External Quality Assessment (EQA) study to assess, in collaboration with the Istituto Superiore di Sanità (ISS), the ability of different Italian laboratories to identify NPS and traditional drugs of abuse (DOA) in biological matrices. Two blood samples were spiked with substances from various drug classes, including synthetic cannabinoids, cathinones, synthetic opiates, and benzodiazepines, at concentrations ranging from 2 to 10 ng/mL. The blood samples were freeze-dried to ensure the stability of DOA and NPS. Twenty-two laboratories from the Italian healthcare system participated in this assessment. The information provided by the laboratories during the registration in an in-house platform included a general description of the laboratory, analytical technique, and the chosen panels of analytes. The same platform was employed to collect and statistically analyze the data and record laboratory feedback and comments. The evaluation of the results revealed that the participating laboratories employed three different techniques for analyzing the samples: GC-MS, LC-MS, and immunoenzymatic methods. Approximately 90 % of the laboratories utilized LC-MS techniques. Around 40 % of false negative results were obtained, with the worst results in the identification of 5-chloro AB PINACA. The results showed that laboratories that used LC-MS methods obtained better specificity and sensitivity compared to the laboratories using other techniques. The results obtained from this first assessment underscore the importance of external quality control schemes in identifying the most effective analytical techniques for detecting trace molecules in biological matrices. Since the judicial authorities have not yet established cut-off values for NPS, this EQA will enable participating laboratories to share their analytical methods and expertise, aiming to establish common criteria for NPS identification.

Impact of COVID-19 pandemic on prescription of psychotropic medications in the Italian paediatric population during 2020.

BACKGROUND: There is a global perception that psychotropic utilization in children and adolescents is increasing, especially with the onset of COVID-19 pandemic. Available literature data on paediatric psychotropic medication prescriptions in Italy are limited to one or few regions and not updated. The aim of this study was to provide updated data on psychotropic prescriptions referred to the whole Italian paediatric population, as overall and by subgroups of medications and to evaluate if the COVID-19 pandemic during 2020 had an impact on prescription rates. METHODS: A descriptive study on psychotropic drug utilization in children and adolescents (< 18 years) resident in all Italian regions during 2020 was performed. Patients registered in the Pharmaceutical Prescriptions database with at least one prescription/dispensing of a psychotropic medication (antipsychotics-N05A), (antidepressants-N06A) and (psychostimulants-N06BA) during the study period were considered. The indicators used were the prescription rate (number of prescriptions per 1000 children) and prevalence of use (proportion of the paediatric population with at least one prescription in the relevant year). RESULTS: During the 2020 the prevalence of psychotropic drug use in the paediatric population was 0.3%, increased of 7.8% if compared to 2019. The same trend was observed for the prescription rate, which recorded an average of 28.2 per 1000 children with an increase of 11.6% if compared to previous year, representing the 0.6% of the overall drug use in this age group. The data showed a growing trend prescription by age, reaching the peak in adolescents aged 12-17 years old, with a prescription rate of 65 per 1000 children and a prevalence of 0.71%. Considering the subgroups of psychotropic medications, the highest prevalence of use was found for antipsychotic drugs, received by the 0.19% of the paediatric population during 2020. CONCLUSIONS: Psychotropic drug utilization in children and adolescents has grown during 2020 in Italy and worldwide, raising alarms from health care clinicians and patient advocates about the increase of burden of mental diseases in paediatric population during the COVID-19 pandemic. A more systematic monitoring of the use of psychotropic medications should be implemented in all countries for collecting relevant information about children and adolescents taking psychotropic drugs, in order to address the present and the future of the mental health of the paediatric population.

Efficient magnetic solid-phase extraction, UPLC-MS/MS detection, and consumption assessment of five trace psychoactive substances.

Wastewater-based epidemiology (WBE) has become an objective and updated surveillance strategy for monitoring and estimating consumption trends of psychoactive substances (PSs) in the population. Firstly, magnetic shrimp shell biochar-based adsorbent (DZMBC) was synthesized and employed for extraction trace PSs from municipal wastewater. Proper pyrolysis temperature and increased KOH activator content favored the pore structure and surface area, thus facilitating extraction. DZMBC delivered exceptional extraction performance such as pH stability, anti-interference property, fast magnetic separation ability, reusability, and reproducibility. Then, a method based on magnetic solid-phase extraction (MSPE) followed by ultra-high-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) was developed, validated, and utilized for the quantitative determination of five PSs in real wastewater samples. Methodological validation results indicated a favorable linearity, low method limits of detection (1.00-4.75 ng/L), and good precisions (intra-day and inter-day relative standard deviations < 4.8%). Finally, an objective snapshot of Chongqing drug use and consumption pattern was obtained. Methamphetamine (MAMP) and 3,4-methylenedioxymethamphetamine (MDMA) were the prevalent illegal drugs in local. Both concentrations and per capita consumption of MDMA displayed a change (P < 0.05) between July and September, while no statistical differences were observed for each week.

Guideline for evaluating the effects of psychotropic drugs on motor vehicle driving performance in Japan: A tiered approach for the assessment of clinically meaningful driving impairment.

In December 2022, the Ministry of Health, Labour and Welfare (MHLW) of Japan issued and implemented the guideline for evaluating the effects of psychotropic drugs on motor vehicle driving performance. This guideline recommends the use of a tiered approach to assess clinically meaningful driving impairment. It is noted that adverse events cannot be solely explained by pharmacokinetics, as the onset and duration of these events vary. Among these adverse events, those affecting alertness, such as drowsiness caused by psychotropic drugs on driving performance, are more frequently observed during initial treatment stages and dose escalation. Hence, when evaluating the effects of psychotropic drugs on driving performance, it becomes crucial to assess the persistence of clinically meaningful impairment. Therefore, the MHLW guideline, developed by the authors, emphasizes the need to assess the temporal profile of adverse events affecting driving in all clinical trials. Additionally, the guideline states that when conducting driving studies, the timing of multiple dosing should consider not only the pharmacokinetics of the investigational drug but also its tolerance.

Psychotherapy duration and work disability: A prospective Finnish register study.

INTRODUCTION: The influence of psychotherapy duration on common mental disorder (CMD) outcomes remains a topic of ongoing debate. Whereas most research has focused on CMD symptom change, the evidence on the psychotherapy duration of subsequent CMD-related work disability and the change in psychotropic drug purchases is scarce. METHODS: We used a register-based cohort representing 33% of the Finnish population. The participants included working-age individuals (N = 12,047, 76% women, mean age = 36) who initiated long-term psychotherapy, between 2014 and 2017. They were followed from 2011 to 2021 and psychotherapy duration ranged from less than a year to over 3 years. We used an interrupted time series design to analyze the psychotherapy duration-dependent changes in CMD-related work disability (primary outcome, operationalized as depression or anxiety-related sickness absence, SA, days) and the annual number of psychotropic drug purchases or distinct drugs purchased (secondary outcomes). RESULTS: There were no differences in the levels of work disability or drug purchases before the psychotherapy. We observed a decreasing level and trend in all outcomes across all psychotherapy duration groups. The largest decline in level was observed in the <1-year duration group (88% decline for SA and 43%-44% for drug purchases) while the smallest decline was in the 3+ years duration group (73% for SA and 27% for drug purchases). CONCLUSION: Work disability outcomes and duration varied among individuals, even with similar initial mental health-related work disability or use of auxiliary psychotropic treatments. Compared to longer psychotherapy, shorter psychotherapy was associated with sharper improvements.

Stimulant Patterns, Alone or with Other Psychotropic Classes, in Medicaid-Insured Youth Continuously Enrolled for 3-8 Years.

Objective: Little U.S. pharmacoepidemiologic study is based on treatment during continuous enrollment for periods more than a year. This study aims to show pediatric patterns of stimulant use (alone or with other psychotropic classes) from Medicaid administrative claims data for stimulant patterns of 3- to 8-year continuous enrollees. Methods: A retrospective cohort study was derived from Medicaid enrollment, pharmacy, and diagnosis claims data (2007-2014) in a mid-Atlantic state. Youth aged 2-17 years with 3-8 years of continuous enrollment treated with stimulants were compared with a date-matched comparison group treated without stimulants. Major outcomes include prevalence and duration of stimulant use and patterns of stimulant polypharmacy across relatively long enrollments (3-8 years). Results: Among 264,518 unique 2- to 17-year olds with 3-8 years of continuous enrollment, 16.5% had stimulant prescription dispensings, doubling the annual national prevalence of 8.1%. Subgroup analysis showed that the highest prevalence of stimulant use was for 6- to 11-year olds (20.4%), foster care eligible youth (42.3%), and those with 7-8 years of continuous enrollment (20.1%). Externalizing psychiatric disorders were far more common in those treated with stimulants than in those treated without stimulants. The duration of stimulant exposure overall was a median of 487 days, half that of foster care stimulant users. Stimulant polypharmacy with two or more psychotropic classes concomitantly characterized 29.8% of stimulant users. Among those with three or four or more class polypharmacy, 85% and 88%, respectively, had concomitant stimulant and antipsychotic use. The adjusted odds ratio (AOR) of three or more class polypharmacy significantly increased in 12- to 17-year-old age group (AOR = 1.8), foster care eligibility (AOR = 4.5), and among those with the longest enrollment (AOR = 1.7). Conclusions and Relevance: Stimulant prevalence in Medicaid-insured youth with continuous enrollment of 3-8 years was twice as common as in annual data sets. Future research should investigate three to five interclass stimulant polypharmacy effectiveness in reliably diagnosed community populations.

Psychotropic Polypharmacy Among Youths Enrolled in Medicaid.

This cross-sectional study aims to identify temporal changes and characteristics associated with psychotropic polypharmacy among youths aged 17 years or younger who were enrolled in Medicaid in Maryland.

Adverse childhood experiences and psychotropic medication prescription among cancer patients.

BACKGROUND: This study aimed at identifying and characterizing adverse childhood experiences (ACEs) in a sample of cancer patients and subsequently evaluating the relationship between ACEs and prescription of psychotropic medication among them. Individuals with ACEs have a higher risk of mental health conditions and are more likely to be prescribed psychotropic medications. METHODS: A sample of 178 adult patients receiving Supportive Oncology & Survivorship (SOS) services at Huntsman Cancer Hospital in Utah was obtained. ACEs and Brief Resilient Coping Scale (BRCS) questionnaires were administered confidentially. A multivariable mixed effect model, adjusting for sex, age, and insurance type while controlling for zip-codes clustering were employed. RESULTS: Compared to the prevalence of ACEs in the general population, from the CDC-Kaiser Permanente ACEs Study, we found no significant difference in the prevalence of people who had experienced an adverse childhood event (ACEs score > = 1) between our study of cancer patients and the CDC-Kaiser study (67.4% vs. 63.6%, p = 0.29372), but found a significant difference in the prevalence of people who had experienced severe adverse childhood experiences (ACES score > =4) (25.3% vs. 12.1%, p < 0.00001). Furthermore, this study reveals a significant association between an increase of one unit in the total ACEs score and the odds of psychotropic medication prescription in the past 12 months (OR: 1.233; 95% CI: 1.025, 1.483). Those with a total ACEs score of three or more were found to have 280% higher odds of being prescribed psychotropic medication compared to those with ACEs ≤ 2 (OR: 3.822; 95% CI: 1.404,10.407). CONCLUSION: A significant proportion of cancer patients have a history of ACEs, and thus trauma-informed care approach is essential during their treatment.

[LEGAL BASIS FOR THE MOVEMENT OF MEDICINES ACROSS THE CUSTOMS BORDER OF THE EURASIAN ECONOMIC UNION BY LEGAL ENTITIES].

The issues of the movement of medicines across the customs border of the Eurasian Economic Union are timely and relevant, due to the increase in the turnover of medicines in the Russian Federation. The article deals with the issues of import and export through the customs border of the Eurasian Economic Union of both registered and unregistered medicines in the Russian Federation by legal entities. In addition, the authors investigated the regulatory and legal procedure for the movement of medicines across the customs border of the Eurasian Economic Union containing narcotic and psychotropic substances. Topical issues of falsification of medicines and criminal norms of the law on combating it are touched upon. The analysis carried out in the work allowed the authors to identify the existing problems of regulatory regulation of the issue under study and propose a solution.

Factitious disorder imposed on self: A retrospective study of 2232 cases from health insurance databases.

OBJECTIVE: Patients with factitious disorder imposed on self (FDIS) seek medical care for deliberately falsified problems. Although a large amount of work has been published, the scientific literature lacks robust data on FDIS. The present study aimed to estimate the annual mean of in-hospital FDIS codings in France, describe the sociodemographic characteristics of subjects with FDIS, assess healthcare utilisation and medical nomadism, and describe the pathologies most frequently associated with FDIS. METHOD: Subjects with at least one coding of FDIS in French health insurance databases between January 1, 2009, and December 31, 2017 were included. Subjects younger than 18 years of age at the time of first coding were excluded from the study. Sociodemographic data of subjects and diagnoses associated with the first coding of FDIS were collected. Healthcare utilisation and medical nomadism were analysed descriptively from one year before to one year after the first FDIS coding. RESULTS: 2232 subjects were included, representing an average of 248 new in-hospital FDIS codings per year. The subjects included were 58.2% female. The mean age at diagnosis was 48.5 years. In the year following the first coding of FDIS, 1268 subjects (56.8%) were re-hospitalised at least once, including 159 (7.1%) with at least one new coding for FDIS. From one year before to one year after the first coding of FDIS, 66% of the subjects included had received at least one prescription for benzodiazepines, 58.3% for antidepressants, and 42.6% for antipsychotics. CONCLUSIONS: Our findings bring new data working towards a better understanding of FDIS. The consumption of psychotropic drugs is particularly frequent in patients with FDIS.

Assessment of psychotropic medications prescribing pattern in Gebretsadik Shawo General Hospital, South West Ethiopia.

Introduction: due to the widespread prescription of antipsychotic medications, their usage is cumulative. Evidence on the trends of medication use in Ethiopia and other parts of the world is lacking. The scant information on prescription trends and medication usage suggests that drug use is generally not sensible in both industrialized and emerging nations. So, the aim of this study was to assess the psychotropic medications prescribing pattern in Gebretsadik Shawo General Hospital, South West Ethiopia. Methods: from June 1st to July 31st, 2019, a cross-sectional study on prescriptions for psychiatric drugs was conducted at Gebretsadik Shawo General Hospital. Using systematic random sampling, prescription records were obtained from the pharmacy dispensing book. Version 21 of the statistical program for social science was used to code and analyze the data. Results: the study included 355 prescription records containing psychotropic drugs in total. The bulk of those taking the psychotropic medication were aged 20 to 49. The most often administered classes of drugs remained antipsychotic, followed by tricyclic antidepressants, antiepileptics, anxiolytics/sedatives, anticholinergic and selective serotonin reuptake inhibitors. The most often ordered antipsychotic medication, which included 102 (23.18%) medications, was chlorpromazine. Tricyclic antidepressants, which included 56 medicines (12.73%) and 24 medications (5.45%), included amitriptyline and imipramine. Conclusion: the results of this investigation showed that psychiatrists preferred traditional psychotropic medications, such as Antipsychotic tricyclic, antidepressants (TCAs) and phenothiazines, in high amounts possibly because these medications were readily available in this hospital and their prices suited patients' needs. Health care workers' interdisciplinary relationships and coherence would improve for the benefit of patients and services of higher quality.

Protocol for a qualitative study exploring the pharmacist's role in supporting postsecondary students with psychotropic medication management.

INTRODUCTION: Findings from the National College Health Assessment (2019) stated that anxiety and depression are the most prevalent diagnosed mental illnesses among Canadian postsecondary students with one-fifth of students self-reporting a lifetime diagnosis. Psychotropic medications can be an important component of a multifaceted approach to the management and treatment of mental illness and are the most commonly dispensed via community pharmacies. Community pharmacies provide an opportunity for pharmacists to have a prominent role in supporting patients' psychotropic medication management. However, there has been limited exploration of how pharmacists can address patients' psychotropic medication management needs, experiences and opportunities for improvements especially for emerging adults. METHODS AND ANALYSIS: This qualitative study will incorporate Thorne's approach to interpretative description. Purposeful snowball sampling will be used to identify students (18-25 years) taking psychotropic medication(s) to manage their mental health. Participants will be interviewed one on one using a semistructured interview guide virtually. Inductive thematic analysis is underway with data analysis being iterative and reflexive using NVivo. Information provided from the interviews will be reviewed and summarised into key themes. ETHICS AND DISSEMINATION: This study was approved by the University of Toronto Health Sciences Research Ethics Board (REB #43185). It is expected that there will be a very low risk for mild psychological and social harm for participants as they will have the ability to stop the interview at any time and will be aware of confidentiality. The results from this study will be used to create or adapt healthcare team services including the role of pharmacists within the healthcare ecosystem at the university and contribute to developing the next stage of research to evaluate feasibility and effectiveness of programmes at the university that help postsecondary students to manage psychotropic medication.

Coprescribing of opioids and psychotropic medications among Medicare-enrolled older adults on long-term opioid therapy.

BACKGROUND: Pressures to reduce opioid prescribing have potential to incentivize coprescribing of opioids (at lower dose) with psychotropic medications. Evidence concerning the extent of the problem is lacking. This study assessed trends in coprescribing and characterized coprescribing patterns among Medicare-enrolled older adults with chronic noncancer pain (CNCP) receiving long-term opioid therapy (LTOT). METHODS: A cohort study was conducted using 2012-2018 5% National Medicare claims data. Eligible beneficiaries were continuously enrolled and had no claims for cancer diagnoses or hospice use, and ≥ 2 claims with diagnoses for CNCP conditions within a 30-day period in the 12 months before the index date (LTOT initiation). Coprescribing was defined as an overlap between opioids and any class of psychotropic medication (antidepressants, benzodiazepines, antipsychotics, anticonvulsants, muscle relaxants, and nonbenzodiazepine hypnotics) based on their prescription fill dates and days of supply in a given year. The occurrence of coprescribing, coprescribing intensity, and number of days of overlap with psychotropic medications were calculated for each calendar year. RESULTS: The eligible study population of individuals on LTOT ranged from 2038 in 2013 to 1751 in 2018. The occurrence of coprescribing among eligible beneficiaries decreased from 73.41% in 2013 to 70.81% in 2015 and then increased slightly to 71.22% in 2018. Among eligible beneficiaries with at least one overlap day, the coprescribing intensity with any class of psychotropic medications showed minimal variation throughout the study period: 74.73% in 2013 and 72.67% in 2018. Across all the years, the coprescribing intensity was found to be highest with antidepressants (2013, 49.90%; 2018, 50.33%) followed by benzodiazepines (2013, 25.42%; 2018, 19.95%). CONCLUSION: Coprescribing was common among older adults with CNCP who initiated LTOT but did not rise substantially in the period studied. Future research should investigate drivers behind coprescribing and safety of various patterns of use.

Costs of psychotropics for outpatients with bipolar disorder in Japan; the MUSUBI 2016 survey.

BACKGROUND: Although the costs of bipolar disorder (BD) treatments are associated with local and universal factors, data from non-Western countries remain limited. The associations between clinical features and costs of outpatient pharmacotherapy have not been well characterize. To estimate the costs of outpatient BD treatments and their associations with clinical features in a Japanese population, we investigated with special reference to the costs of medicines constituted the bulk of the total healthcare expense and were steadily increasing. METHODS: The Multicenter Treatment Survey for Bipolar Disorder (MUSUBI) retrospectively evaluated 3130 patients with BD who visited 176 Japanese psychiatric outpatient clinics in 2016. Clinical features and drug prescriptions were recorded, and the total daily costs of psychotropic drug treatment were calculated. The annual medical costs related to outpatient BD treatments in Japan were estimated based on the corresponding demographics. The associations between daily medical costs and patients' clinical features were analyzed using multiple regression analysis. RESULTS: The daily costs of psychotropic drugs ranged from zero to JPY3245 (mean, JPY349 equivalent to USD32.5) and were exponentially distributed. The annual costs for outpatients BD treatments were approximately 51.9 billion Japanese yens (519 million US dollars). Subsequent multiple regression analysis revealed that social adjustment, depressive symptoms, age, rapid cycling, psychotic symptoms, and comorbid mental disorders correlated strongly with the daily cost of psychotropic drugs. CONCLUSION: The estimated annual costs for outpatient BD treatment in Japan were equivalent to those in OECD countries (except for the US) and higher than those in some Asian countries. The cost of psychotropic treatments was associated with individual characteristics and psychopathological conditions.Key MessagesPsychotropic treatment for an outpatient with bipolar disorder has a daily cost approximately JPY350.The annual outpatient treatment cost for bipolar disorder in Japan was estimated to 51.9 billion Japanese yen in 2016.Individual characteristics and psychopathological conditions affected the cost of drug treatment.

Nail analysis for the assessment of caffeine abuse in Northwest China: A population-based study.

Caffeine is the most widely consumed psychoactive agent worldwide and has the potential for abuse, but studies monitoring caffeine abuse in China are scarce. This study aims to estimate the prevalence of caffeine abuse in northwest China and investigate the correlation between caffeine and other drugs in hair and nails using an ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS). Fingernail clippings were collected from 376 participants in northwest China to detect caffeine and 13 other illicit psychoactive drugs and their metabolites. Paired hair and nail samples were collected from 39 participants to investigate the correlation between caffeine and other drugs in hair and nails. The samples were decontaminated, pulverized, and extracted by a high-throughput nail sample preparation method and analyzed by UPLC-MS/MS. The results showed a risk of caffeine abuse in northwest China, with concentrations ranging from 0.43 to 10.6 ng/mg for healthy volunteers, 0.49-246 ng/mg for caffeine abusers, and 0.25-363 ng/mg for drug addicts in community rehabilitation centers. Caffeine was detected together with other illicit psychoactive drugs and their metabolites. Furthermore, positive detection correlations were found between hair and nail samples. This study provides a current perspective on caffeine abuse in northwest China and demonstrates the practical use of UPLC-MS/MS for the simultaneous detection of caffeine and 13 illicit psychoactive drugs and their metabolites in hair and nails. The results highlight the potential of nails as a supplementary matrix when hair samples are unavailable and emphasize the need for handling caffeine carefully given its potential for abuse.

National trends in psychotropic medication prescribing before and during the COVID-19 pandemic.

The early months of the COVID-19 pandemic saw a decline in psychotropic medication use; however, little is known about how this trend evolved as the pandemic progressed and how it varied across different payers in the United States. Using a national multi-payer pharmacy claims database and adopting a quasi-experimental research design, this study examines trends in psychotropic medication prescriptions dispensed from July 2018 - June 2022. The study finds that the number of patients with dispensed psychotropic medications and the number of psychotropic medications dispensed declined during the early months of the pandemic but experienced a statistically significant growth in later periods compared to the pre-pandemic rate. Average days supply of psychotropic medications dispensed increased significantly throughout the pandemic. Commercial insurance remained the primary payer for psychotropic medication during the pandemic, but there was a significant increase in the number of prescription fills covered under Medicaid. This implies that public insurance programs played an increasing role in financing psychotropic medication use during the COVID-19 pandemic.