Skills and knowledge therapists need to work with foster youth and families: According to key stakeholders in child welfare.

The current study relied on community-based participatory action research and qualitative methodology to explore the necessary skills and knowledge psychotherapists need to work effectively with foster youth and their families. In this study, the research team conducted interviews and focus groups with stakeholders (n = 48) in child welfare to learn how to support therapeutic relationships with foster youth clients. Using qualitative content analysis, the research team identified eight categories for needed knowledge and/or skills, such as collaboration with and inclusion of others in a client's system; flexibility and open-mindedness to individualize care follow the client's lead; and a solid understanding of trauma and attachment supported by therapist training and regular consultation specifically around foster care. These findings offer tangible suggestions for skills that psychotherapists can learn and practice in order to support beneficial mental health services for foster youth.

CBD and THC in Special Populations: Pharmacokinetics and Drug-Drug Interactions.

Cannabinoid use has surged in the past decade, with a growing interest in expanding cannabidiol (CBD) and delta-9-tetrahydrocannabinol (THC) applications into special populations. Consequently, the increased use of CBD and THC raises the risk of drug-drug interactions (DDIs). Nevertheless, DDIs for cannabinoids, especially in special populations, remain inadequately investigated. While some clinical trials have explored DDIs between therapeutic drugs like antiepileptic drugs and CBD/THC, more potential interactions remain to be examined. This review summarizes the published studies on CBD and THC-drug interactions, outlines the mechanisms involved, discusses the physiological considerations in pharmacokinetics (PK) and DDI studies in special populations (including pregnant and lactating women, pediatrics, older adults, patients with hepatic or renal impairments, and others), and presents modeling approaches that can describe the DDIs associated with CBD and THC in special populations. The PK of CBD and THC in special populations remain poorly characterized, with limited studies investigating DDIs involving CBD/THC in these populations. Therefore, it is critical to evaluate potential DDIs between CBD/THC and medications that are commonly used in special populations. Modeling approaches can aid in understanding these interactions.

Take-Home Naloxone Access and Use among Older Adults Living with Pain: A Scoping Review.

Background: Opioids are a common treatment for older adults living with pain. Given high rates of polypharmacy and chronic comorbidities, older adults are at risk of opioid overdose. Evidence is now available that take-home naloxone (THN) supports reduction of opioid-related harms. It is unknown what THN initiatives are available for older adults, especially those living with chronic pain. Objective: To summarize the literature regarding THN, with a focus on older adults using opioids for pain, including facilitators of and barriers to THN access, knowledge gaps, and pharmacist-led initiatives. Data Sources: A scoping review, guided by an established framework and PRISMA-ScR guidelines, was performed. Methods involved searching 6 bibliographic databases (MEDLINE, Embase, Scopus, APA PsycINFO, Web of Science Core Collection, and PubMed), reference harvesting, and citation tracking. Searches were conducted up to March 2023, with no date limits applied; only English publications were included. Study Selection and Data Extraction: Study eligibility was determined according to preset criteria, including age; discrepancies were resolved by discussion and consensus. Data were extracted and categorized through thematic analysis. Data Synthesis: Four studies met the eligibility criteria. All 4 studies detailed THN programs in primary care settings involving older adults taking opioids for pain management. Two of the studies highlighted patient-specific risk factors for opioid overdose, including concomitant use of benzodiazepines and/or gabapentinoids, mean morphine milligram equivalents per day of at least 50, and previous opioid overdose. Two of the studies assessed patient knowledge of opioid overdose management and attitudes toward THN. Educational programs increased patients' interest in THN. Conclusions: The literature about THN for older adults living with pain is limited, and no literature was found on pharmacist-led initiatives in this area. Future research on THN provision for older adults, including pharmacist-led initiatives, could help to optimize care for older adults living with pain.

Contexte: Les opioïdes sont un traitement courant pour les personnes âgées souffrant de douleur. Compte tenu des taux élevés de polypharmacie et de comorbidités chroniques, les personnes âgées courent un risque de surdose d'opioïdes. Il est désormais prouvé que la distribution de trousses de naloxone contribue à la réduction des méfaits liés aux opioïdes. On ne sait pas quelles initiatives de distribution de trousses de naloxone existent pour les personnes âgées, en particulier celles souffrant de douleurs chroniques. Objectif: Résumer la documentation concernant la distribution des trousses de naloxone chez les personnes âgées qui utilisent des opioïdes contre la douleur, y compris les facilitateurs et les obstacles à l'accès aux trousses, les lacunes dans les connaissances et les initiatives menées par les pharmaciens. Sources des données: Un examen de la portée, guidé par un cadre éprouvé et les lignes directrices PRISMA-ScR, a été réalisé. Les méthodes impliquaient la recherche dans 6 bases de données bibliographiques (MEDLINE, Embase, Scopus, APA PsycINFO, Web of Science Core Collection et PubMed), la récolte de références et le suivi des citations. Les recherches ont été effectuées jusqu'en mars 2023, sans limites quant à la date; seules les publications en anglais ont été incluses. Sélection des études et extraction des données: L'admissibilité à l'étude a été déterminée selon des critères prédéfinis, notamment l'âge; les divergences ont été résolues par discussion et consensus. Les données ont été extraites et catégorisées grâce à une analyse thématique. Synthèse des données: Quatre études répondaient aux critères d'admissibilité. Les 4 études ont détaillé des programmes de distribution de trousses de naloxone dans des établissements de soins primaires chez les personnes âgées prenant des opioïdes pour gérer la douleur. Deux des études ont mis en évidence des facteurs de risque spécifiques aux patients en matière de surdosage aux opioïdes, notamment l'utilisation concomitante de benzodiazépines et/ou de gabapentinoïdes, une moyenne d'équivalents en milligrammes de morphine par jour d'au moins 50 et un surdosage antérieur aux opioïdes. Deux des études ont évalué les connaissances des patients en matière de gestion des surdosages aux opioïdes et leur attitude envers la distribution de trousses de naloxone. Les programmes éducatifs ont accru l'intérêt des patients pour les trousses de naloxone. Conclusions: La documentation sur la distribution de trousses de naloxone chez les personnes âgées souffrant de douleur est limitée et aucune littérature n'a été trouvée sur les initiatives menées par les pharmaciens dans ce domaine. Les recherches futures sur la distribution de trousses de naloxone aux personnes âgées, y compris les initiatives menées par des pharmaciens, pourraient contribuer à optimiser les soins aux personnes âgées souffrant de douleur.

Chinese expert consensus recommendations for the administration of immune checkpoint inhibitors to special cancer patient populations.

Immune checkpoint inhibitors (ICIs) targeting programmed cell death 1, programmed cell death ligand 1, and cytotoxic T lymphocyte-associated antigen-4 have shown significantly durable clinical benefits and tolerable toxicities and have improved the survival of patients with various types of cancer. Since 2018, the National Medical Products Administration of China has approved 17 ICIs as the standard treatment for certain advanced or metastatic solid tumors. As ICIs represent a broad-spectrum antitumor strategy, the populations eligible for cancer immunotherapy are rapidly expanding. However, the clinical applications of ICIs in cancer patient populations with special issues, a term that refers to complex subgroups of patients with comorbidities, special clinical conditions, or concomitant medications who are routinely excluded from prospective clinical trials of ICIs or are underrepresented in these trials, represent a great real-world challenge. Although the Chinese Society of Clinical Oncology (CSCO) has provided recommendations for screening before the use of ICIs in special populations, the recommendations for full-course management remain insufficient. The CSCO Expert Committee on Immunotherapy organized leading medical oncology and multidisciplinary experts to develop a consensus that will serve as an important reference for clinicians to guide the proper application of ICIs in special patient populations. This article is a translation of a study first published in Chinese in The Chinese Clinical Oncology (ISSN 1009-0460, CN 32-1577/R) in May 2022 (27(5):442-454). The publisher of the original paper has provided written confirmation of permission to publish this translation in Therapeutic Advances in Medical Oncology.

Idiopathic pulmonary fibrosis therapy development: a clinical pharmacology perspective.

Drug development for idiopathic pulmonary fibrosis (IPF) has been challenging due to poorly understood disease etiology, unpredictable disease progression, highly heterogeneous patient populations, and a lack of robust pharmacodynamic biomarkers. Moreover, because lung biopsy is invasive and dangerous, making the extent of fibrosis as a direct longitudinal measurement of IPF disease progression unfeasible, most clinical trials studying IPF can only assess progression of fibrosis indirectly through surrogate measures. This review discusses current state-of-art practices, identifies knowledge gaps, and brainstorms development opportunities for preclinical to clinical translation, clinical populations, pharmacodynamic endpoints, and dose optimization strategies. This article highlights clinical pharmacology perspectives in leveraging real-world data as well as modeling and simulation, special population considerations, and patient-centric approaches for designing future studies.

Addressing health disparities in the criminal legal system: Translational benefits, challenges, and facilitators of impactful research with incarcerated pregnant women.

This in-depth analysis illuminates a translational journey of a community-university research collaboration that examined health disparities among incarcerated pregnant women and spanned the translational spectrum, with the initial collaboration in 2011 paving the way for consequent research grants, publications, practices, programs, and legislation passed years later. The case study utilized data from interviews with research stakeholders, institutional and governmental sources, peer-reviewed publications, and news stories. Identified research and translational challenges included cultural differences between research and prison system; the prison system's lack of transparency; politics of using and translating research to policy change; and issues of capacity, power, privilege, and opportunity when doing community-engaged research/science. Among the facilitators of translation were the Clinical and Translational Science Award and institutional support; engagement of key stakeholders and influencers; authentic collaboration and team science; researchers as translation catalysts; pragmatic scientific approach; and policies and legislative activities. The research contributed to a variety of community and public health, policy/legislative, clinical/medical, and economic benefits. The case study findings enhance our understanding of translational science principles and processes leading to improved wellbeing and serve as a call for advancing the research agenda addressing health disparities related to criminal and social justice issues.

Application of oral inorganic iodine in the treatment of Graves' disease.

Iodine is a crucial trace element for the human body and the basic raw material for the synthesis of thyroid hormones. Oral inorganic iodine includes dietary iodine and therapeutic iodine, both of which are closely associated with thyroid immunity and metabolism. Graves' disease (GD), also known as diffuse toxic goiter, is characterized by hyperthyroidism and high iodine metabolism. Clinically, patients diagnosed with GD are often asked to limit iodine intake or even avoid iodine in their diet. The latest research has demonstrated that the interference of dietary iodine with antithyroid drugs (ATDs) treatment may be overestimated. In addition, as a medication for GD treatment, the administration of inorganic iodine has shown positive results in patients with mild hyperthyroidism, a low thyroid autoantibody concentration, a small thyroid volume, a high iodine diet and so on. Inorganic iodine may also be used as an alternative when patients experience side effects with traditional ATDs and for those who still prefer conservative treatment. Due to its low teratogenicity, blood toxicity and bone marrow toxicity, inorganic iodine plays a unique role in special populations, such as pregnant or lactating patients and patients receiving tumor radiotherapy or chemotherapy. In this review, the research progress, biological function, doses and effects, applicable populations and specific applications of dietary iodine and therapeutic iodine are summarized to provide references for the diagnosis and treatment of GD, thus improving the quality of life of GD patients.

Use of Second-Generation Basal Insulin Gla-300 in Special Populations: A Narrative Mini-Review.

BACKGROUND AND AIMS: Hypoglycemia and insulin-related adverse events are crucial barriers to effective diabetes management, particularly in the elderly, people with renal impairment, people with diabetes fasting during Ramadan, or people with type 1 diabetes mellitus (T1DM). There is a scarcity of clinical and real-world evidence assessing the effectiveness and safety of insulin glargine 300 U/mL (Gla-300) in these special populations. To understand the entirety of evidence, this mini-review elaborates on the use of Gla-300 in diabetes management among special populations. METHODS: Clinical and real-world evidence related to the use of Gla-300 among special populations with diabetes were retrieved using PUBMED and Google Scholar. RESULTS: Gla-300 has shown improved glycemic control with stable insulin action and low risk of hypoglycemia in diverse groups with diabetes. It also appears to have an acceptable safety profile during Ramadan fasting. However, adequate monitoring and adjustment of insulin dose on an individual basis should be considered. CONCLUSION: Gla-300 is a second-generation basal insulin with proven benefits of reduced risk of hypoglycemia and improved glycemic control in special populations of people with diabetes.

Predicting transporter mediated drug-drug interactions via static and dynamic physiologically based pharmacokinetic modeling: A comprehensive insight on where we are now and the way forward.

The greater utilization and acceptance of physiologically-based pharmacokinetic (PBPK) modeling to evaluate the potential metabolic drug-drug interactions is evident by the plethora of literature, guidance's, and regulatory dossiers available in the literature. In contrast, it is not widely used to predict transporter-mediated DDI (tDDI). This is attributed to the unavailability of accurate transporter tissue expression levels, the absence of accurate in vitro to in vivo extrapolations (IVIVE), enzyme-transporter interplay, and a lack of specific probe substrates. Additionally, poor understanding of the inhibition/induction mechanisms coupled with the inability to determine unbound concentrations at the interaction site made tDDI assessment challenging. Despite these challenges, continuous improvements in IVIVE approaches enabled accurate tDDI predictions. Furthermore, the necessity of extrapolating tDDI's to special (pediatrics, pregnant, geriatrics) and diseased (renal, hepatic impaired) populations is gaining impetus and is encouraged by regulatory authorities. This review aims to visit the current state-of-the-art and summarizes contemporary knowledge on tDDI predictions. The current understanding and ability of static and dynamic PBPK models to predict tDDI are portrayed in detail. Peer-reviewed transporter abundance data in special and diseased populations from recent publications were compiled, enabling direct input into modeling tools for accurate tDDI predictions. A compilation of regulatory guidance's for tDDI's assessment and success stories from regulatory submissions are presented. Future perspectives and challenges of predicting tDDI in terms of in vitro system considerations, endogenous biomarkers, the use of empirical scaling factors, enzyme-transporter interplay, and acceptance criteria for model validation to meet the regulatory expectations were discussed.

Overview of Clinical Pharmacology Packages of New Drug Applications Approved for the Treatment of Rare Diseases.

There are more than 7000 rare diseases affecting approximately 30 million people in the United States. More than 90% of these diseases lack approved therapies. Several challenges face the development of "orphan drugs", such as the small populations of patients, high development costs, and long development timelines. This study evaluates clinical pharmacology assessments conducted during the development of drugs to treat rare diseases approved by the United States Food and Drug Administration in 2020 and 2021. Thirty-nine new drug applications (NDAs) have been identified and the associated regulatory reviews, approved labels, and approval letters were reviewed. Approximately, 95%, 74%, and 77% of these submissions contained at least one type of drug-drug interaction, the effect of organ impairment (hepatic and renal) on drug exposure, and QT liability assessment, respectively. Modeling and simulation approaches were utilized to address many clinical pharmacology questions, with population pharmacokinetic analyses used extensively in the evaluation of the effect of organ impairment on drug exposure and with physiologically based pharmacokinetic analyses used mainly in assessing drug interaction risks. In general, the clinical pharmacology packages in the NDAs of orphan drugs are not optimal and more work is needed to obtain a complete clinical pharmacology package at the time of initial approval to ensure the safe and effective use of these drugs across the spectrum of the target patient population. This study provides insights into the clinical pharmacology studies needed for drugs to treat rare diseases and would help both the regulators and drug developers to identify challenges and opportunities in conducting clinical pharmacology assessments for drugs developed to treat rare diseases.

Vaccination coverage and immunization safety among children with special health status in Chongqing, China.

Vaccination of children with special health status has become one of the most urgent issues in China. We aim to evaluate vaccination coverage and safety as well as its associated factors among children with special health status in China during 2016‒2020. We conducted a retrospective cohort review of all children with special health status recorded in the Electronic Immunization Registries System in Chongqing, China, between 2016 and 2020. Univariate and multivariate logistic regression analyses were used to analyze the influence factors. Among the 2,175 children with special health status enrolled in the study, the overall vaccination coverage rate was lower than that among the general population, and the incidence of adverse event in them following immunization was very rare. Children with congenital heart disease were better vaccinated (aOR = 1.508-6.331), while most of the jaundice children had missed vaccination (aOR = 0.441‒0.556). The purchase of vaccine compensation insurance was associated with higher completion rate of basic immunization for Bacillus Calmette-G vaccine (aOR = 1.706, 95% CI: 1.249‒2.329) and rotavirus vaccine (aOR = 1.346, 95% CI: 1.061‒1.708). Children with special health status can be safely vaccinated. However, the vaccination coverage in these huge and vulnerable group is too low to protect them from vaccine-preventable diseases through immunization. More researches and interventions should be conducted to ensure a higher vaccination rate among the children with special health status.

A review on the clinical pharmacokinetics of hydralazine.

INTRODUCTION: Hydralazine is a vasodilator used to treat hypertension, pre-eclampsia, and heart failure. The current article reviews the clinical pharmacokinetics (PK) of hydralazine, which can be useful for clinicians in optimizing its dose and dosing frequency to avoid adverse effects and unexpected interactions that could risk patients' lives. AREAS COVERED: This review has summarized the PK parameters for hydralazine after performing an extensive literature search. It includes 20 publications that were selected after applying eligibility criteria out of a pool of literature that was searched using Google Scholar, PubMed, Cochrane Central, and EBSCO databases. The included studies consisted of concentration vs. time profiles of hydralazine. If the PK data were not tabulated in the given study, the concentration vs. time profiles were scanned for the extraction of the PK data. The PK parameters were calculated by applying a non-compartmental analysis (NCA). EXPERT OPINION: The current review will aid clinicians in understanding hydralazine PK in different disease populations. This clinical PK data might also be helpful in the development of a pharmacokinetic model of hydralazine.

Prevalence of Dental Caries and Gingivitis among children with Intellectual Disability in India.

Introduction: Down syndrome (DS) is one of the most common genetic abnormalities, with highly variable prognosis. Oral diseases such as periodontal disease, malocclusion, mouth breathing, macroglossia, delayed teeth eruption, missing and malformed teeth, microdontia, diastema, and bruxism are common among individuals with DS. Hence, a study was planned to assess the caries experience and periodontal status of subjects with DS. Materials and Methods: A cross-sectional study was conducted among 92 DS patients in two different centers in Chennai and Pondicherry to assess the prevalence of dental caries and gingivitis, using dft/DMFT and Modified Loe and Silness Gingival Index, respectively. The subjects were examined by three trained and calibrated examiners using a pre-tested and pre-validated proforma. Data were entered in a Microsoft Excel spreadsheet and analyzed using SPSS software (version 20). Descriptive statistics were used. A value of P < 0.05 was considered significant. Results: The mean DMFT was low among male (1.47 ± 2.31) when compared to female (2.57 ± 4.57) which was found to be significant statistically. The gingival score was low among male (.85 ± 0.36) when compared to female (1 ± 1.00) which was found to be significant statistically. The mean dft among male and female were (.49 ± 1.37;.43 ± 1.09), respectively, which was found to be not significant statistically. Conclusion: Dental caries and gingival diseases are higher among children with DS. Dental caries was found both in primary dentition and permanent dentition.

Adolescents with chronic hepatitis C might be good candidates for direct-acting antiviral therapy.

Three Japanese adolescents with chronic hepatitis C were treated by direct-acting antivirals (DAAs). No adverse events or laboratory abnormalities were observed during and after DAA therapy, and a sustained virological response was achieved in all cases. The emotional functioning of the patients and their mothers were improved after DAA therapy.

Chronic Cannabis Users: A New Special Population to Consider for Drug Development.

The use and acceptance of cannabis, either medically or recreationally, has substantially outpaced the collection of data necessary to evaluate it's use in any population. However, the mere widespread availability does not imply the absence of risk or confirmation of efficacy and should not be treated as such. There is enough data to suggest that not only does the potential for pharmacokinetic and metabolic interactions exist, but also that baseline characteristics for a given population could be different in chronic cannabis users. Either or both of these may impact the safety and efficacy profile for any new drug in development. As such, we encourage drug developers to consider that the cannabis user may very well be a special population that warrants its own clinical pharmacology evaluation.

Statistical analysis of medication information labeling of pregnant women and lactating women in the instructions of antiarrhythmic drugs / 中国药房

OBJECTIVE To provide reference for standardizing the labeling of medication information for pregnant women and lactating women in the instructions of antiarrhythmic drugs. METHODS The instructions of antiarrhythmic drugs were collected from the terms of “medication reference ”on official website of Yimaitong Technology Co. ，Ltd. The labeling of medication information of pregnant women and lactating women were sorted out ，counted and analyzed with reference to the Detailed Rules for Specifications of Instructions of Chemical Drugs and Therapeutic Biological Products issued by the State Food and Drug Administration. RESULTS A total of 111 instructions of antiarrhythmic drugs were collected in this study ，of which 102 instructions were marked with “medication for pregnant women ”（91.89％），of which the proportion of those with medication guidance and without medication guidance were 75.68％ and 16.22％ respectively. Eighty-eight drug instructions were marked with the item “medication for lactating women ”（79.28％），of which the proportion of those with medication guidance and without medication guidance were 70.27％ and 9.01％ respectively. Among different categories of antiarrhythmic drugs ，the best labeling of “medication for pregnant women ”was class Ⅰ antiarrhythmic drugs （100％），while class Ⅲ drugs（25.00％）were most missing ； class Ⅳ antiarrhythmic drugs （94.44％）were the best labeled for “medication for lactating women ”，while class Ⅰ（26.47％）were the most missing . There were differences in the labeling contents of “medication for pregnant women ”and“medication for lactating women ”in some drug instructions of the same variety from different manufacturers. Among the 99 drug instructions of domestic pharmaceutical enterprises ， 92 listed the items of “medication for pregnant women”and“medication for lactating women ”，and the proportions of them with medication guidance were 74.75％ and 69.70％ respectively；among the 12 drug instructions of foreign pharmaceutical enterprises ，10（83.33％）listed the items of “medication for pregnant women ”and“medication for lactating women ”，and the proportion with medication guidance was 83.33％ and 75.00％ respectively. CONCLUSIONS There are some problems in the labeling content of domestic antiarrhythmic drug instructions，such as the lack of information related to “medication for pregnant women ”and“medication for lactating women ”， the confusion of guidance expression ， the inconsistent content of drug instructions of the same variety from different manufacturers，the lag of modification and update ，and the poor standardization of drug instructions. Drug supervision and administration departments and drug manufacturers should pay attention to them and constantly strengthen the management and standardization of instructions.