Pharmacovigilance in Action: Utilizing VigiBase Data to Improve Clozapine Safety.

Purpose: Clozapine is an antipsychotic which was approved in 1989 for treatment-resistant schizophrenia in the United States (US). There were few randomized trials before its approval and potentially lethal clozapine adverse drug reactions (ADRs), such as agranulocytosis and myocarditis were identified by pharmacovigilance. VigiBase, the WHO global database, is a cornerstone of international pharmacovigilance efforts for ADR identification during post-marketing surveillance.

Exploring the Relationship Between Psychological Constructs and Decision-Making Preferences in Psychiatric Outpatients.

Objective: This study aimed to elucidate the relationships among health locus of control, psychological reactance, attitudes toward psychiatric treatment, and patient decision-making preferences within a psychiatric outpatient population.

Methods: A total of 200 consecutive psychiatric outpatients from a community mental health center in Tenerife, Spain, were approached for participation between September 2023 and March 2024. Of these, 151 patients consented to participate in this cross-sectional study.

Psychoeducational group interventions for adults diagnosed with attention-deficit/ hyperactivity disorder: a scoping review of feasibility, acceptability, and outcome measures.

Introduction: Although psychoeducational group interventions are increasingly used for adults diagnosed with attention-deficit/hyperactivity disorder (ADHD), a comprehensive review focused on the feasibility and acceptability indicators of these interventions remains lacking. Furthermore, although previous research has explored various aspects of psychoeducation for ADHD, such as its definition and approaches, limited research has focused on the synthesis for outcome measures and patients' experiences related to these interventions. Therefore, this scoping review aims to map the existing evidence reported on psychoeducational group interventions for adults diagnosed with ADHD.

Revealing the reporting disparity: VigiBase highlights underreporting of clozapine in other Western European countries compared to the UK.

Background: Pharmacovigilance studies indicate clozapine history is marked by adverse drug reactions (ADRs).

Objective: In a 2021 article, the United Kingdom (UK) had >90 % of European clozapine-related fatal outcomes in VigiBase, the World Health Organization's pharmacovigilance database. Two possibly opposing hypotheses could explain this disparity: 1) fewer reported fatal outcomes in other Western European countries mainly reflect underreporting to VigiBase, and 2) the higher number of UK reports reflects higher real relative mortality.

An expert review of clozapine in Latin American countries: Use, monitoring, and pharmacovigilance.

There is growing interest in clozapine clinical use, monitoring, and research, particularly adverse drug reactions (ADRs) other than agranulocytosis. In this study we focused on clozapine pharmacovigilance. Hence, we contacted clinicians and researchers in Latin America and requested information about local psychiatric services, clozapine availability, clinical use, and ADR monitoring with the VigiBase system.

Clozapine-associated pericarditis and pancreatitis in children and adolescents: A systematic literature review and pharmacovigilance study using the VigiBase database.

Background: The literature has paid very little attention to pericarditis, pericardial effusion and pancreatitis during clozapine treatment in children and adolescents.

Methods: Cases of clozapine-associated pericarditis and pancreatitis in children were studied using searches in: 1) PubMed (June 16, 2023), and 2) the World Health Organization's pharmacovigilance database (June 1, 2022), VigiBase. VigiBase uses a logarithmic measure of disproportionality called the information component (IC).

Telepsychiatry: The future is already present.

This review paper analyzes the state of knowledge on Telepsychiatry (TP) after the crisis caused by COVID and the resulting need to use new modalities of care. Six essential aspects of TP are addressed: patient's and mental health staff satisfaction, diagnostic reliability, effectiveness of TP interventions, cost-effectiveness in terms of opportunity cost (or efficiency), legal aspects inherent to confidentiality and privacy in particular and the attitude of professionals toward TP. Satisfaction with TP is acceptable among both patients and professionals, the latter being the most reluctant.

Will ChatGPT3 Substitute for us as Clozapine Experts?

Background: ChatGPT3 is a new artificial intelligence program released on February 13, 2023.

Method: The authors tested ChatGPT3 on February 18, 2023, and repeated the test a week later. They used their expertise on the effects of ethnic ancestry in the stratification of clozapine dosing and the new idea that they published in March 2022 that African-Americans need higher clozapine doses because they have higher clozapine clearance.

Exploring low clozapine C/D ratios, inverted clozapine-norclozapine ratios and undetectable concentrations as measures of non-adherence in clozapine patients: A literature review and a case series of 17 patients from 3 studies.

Background: Up to 1/2 of outpatients prescribed clozapine may be partially/fully non-adherent, based on therapeutic drug monitoring (TDM). Three indices for measuring partial/full non-adherence are proposed a: 1) clozapine concentration/dose (C/D) ratio which drops to half or more of what is expected in the patient; 2) clozapine/norclozapine ratio that becomes inverted; and 3) clozapine concentration that becomes non-detectable.

Methods: These 3 proposed indices are based on a literature review and 17 cases of possible non-adherence from 3 samples: 1) an inpatient study in a Chinese hospital, 2) an inpatient randomized clinical trial in a United States hospital, and 3) and a Uruguayan outpatient study.

Psychiatric Patients' Perceived Health Control and Reactance: Implications for Medication Adherence.

Adherence to prescribed treatment is a major challenge in psychiatry, with non-adherence rates estimated to be as high as 50%. Two factors that have been suggested to influence medication adherence in psychiatric patients are perceived health control and psychological reactance. Perceived health control refers to the belief that one can control their own health outcomes, while psychological reactance refers to the negative response that occurs when individuals perceive their freedom or autonomy to be threatened.

Adverse drug reactions and their fatal outcomes in clozapine patients in VigiBase: Comparing the top four reporting countries (US, UK, Canada and Australia).

Background: Pharmacovigilance findings and box warnings in the clozapine package inserts have marked the history of clozapine.

Objective: This is the largest review of clozapine adverse drug reactions (ADRs) and their associated fatal outcomes. Reports to the World Health Organization's global pharmacovigilance database, VigiBase™, were analyzed, extending from clozapine's introduction to December 31, 2022.

Respiratory aspiration during treatment with clozapine and other antipsychotics: a literature search and a pharmacovigilance study in vigibase.

Introduction: Antipsychotics (APs), during treatment or overdose, may be associated with respiratory aspiration.

Areas Covered: A PubMed search on 30 September 2022, provided 3 cases of respiratory aspiration during clozapine therapy and 1 case during an AP overdose. VigiBase records of respiratory aspiration associated with APs from inception until 5 September 2021, were reviewed.

Clozapine-induced myocarditis in children and adolescents: a pharmacovigilance study using VigiBase and a systematic literature review.

Introduction: Clozapine-induced myocarditis in children (age ≤18 yo) was studied from a PubMed search (18 July 2022) (9 cases) and from the World Health Organization's pharmacovigilance database, called Vigibase, of adverse drug reaction (ADR) reports (72 non-duplicated cases). VigiBase uses a logarithmic measure of disproportionality called the information component (IC). A logistic regression model of presence/absence (40/32) of seriousness in VigiBase was developed.

Clozapine-associated myocarditis in the World Health Organization's pharmacovigilance database: Focus on reports from various countries.

Introduction: The incidence of clozapine-associated myocarditis varies by country. These variations were explored in VigiBase, the World Health Organization's global database which has >25 million spontaneously reported adverse drug reaction (ADR) reports from 145 national drug agencies.

Methods: On January 15, 2021, a search of VigiBase since inception focused on myocarditis in clozapine patients.

Respiratory aspiration during treatment with benzodiazepines, antiepileptic and antidepressant drugs in the pharmacovigilance database from VigiBase.

Introduction: Three psychotropic drug classes, benzodiazepines, antiepileptic drugs (AEDs) and antidepressants (ADs), whether used in treatment or overdose, may be associated with respiratory aspiration. Polypharmacy was defined by counting suspected drugs from these classes or two others, antipsychotics and opioids. The confounding effects of polypharmacy were considered in this study.

Psychometric Properties of the WHO-5 Well-Being Index among Nurses during the COVID-19 Pandemic: A Cross-Sectional Study in Three Countries.

Nurses' well-being has been increasingly recognised due to the ongoing pandemic. However, no validation scales measuring nurses' well-being currently exist. Thus, we aimed to validate the WHO-5 Well-Being Index (WHO-5) in a sample of nurses.

An international guideline with six personalised titration schedules for preventing myocarditis and pneumonia associated with clozapine.

White blood cell (WBC) monitoring has reduced clozapine-treated patient deaths associated with agranulocytosis to a rarity. However, clozapine protocols and package inserts worldwide provide no instructions for preventing myocarditis or pneumonia during clozapine titrations. Prescribers worldwide are largely unaware of that.