scholarly journals Monitoring of Adverse Drug Reaction-Related Parameters in Children and Adolescents Treated With Antipsychotic Drugs in Psychiatric Outpatient Clinics

2021 ◽  
Vol 12 ◽  
Author(s):  
Lenneke Minjon ◽  
Ivona Brozina ◽  
Toine C. G. Egberts ◽  
Eibert R. Heerdink ◽  
Els van den Ban

Aim: To assess the frequency of monitoring of adverse drug reaction (ADR) related parameters in children and adolescents treated with antipsychotic drugs in psychiatric outpatient clinics and the considerations when monitoring was not performed.Methods: This retrospective follow-up study included 100 randomly selected outpatients aged ≤18 years who had a first prescription of an antipsychotic drug recorded in the electronic medical records of psychiatric outpatient clinics between 2014 and 2017. They were followed for up to 3 years. This study assessed the frequency of monitoring for physical parameters (weight, height, body mass index, waist circumference, pulse, blood pressure, and an electrocardiogram) and laboratory parameters (glucose, lipids, and prolactin) before the first prescription of an antipsychotic drug as well as during its use. Monitoring frequencies were stratified by the patient characteristics (sex, age, cardiovascular risk factors, and use of other psychotropic drugs), and by location of antipsychotic drug initiation (psychiatric outpatient clinic or elsewhere). Additionally, this study assessed the considerations mentioned in the medical records for not monitoring ADR-related parameters.Results: Overall, physical parameters were monitored more frequently (weight: 85.9% during the first half-year) than laboratory parameters (glucose and cholesterol: both 23.5%). There were no significant differences in monitoring at least one physical as well as in monitoring at least one laboratory parameter during the baseline period and during the total follow-up of antipsychotic drug treatment between the patient characteristics. In total, 3% of the children and adolescents were never monitored for any physical parameter, and 54% were never monitored for any laboratory parameter. For a minority of the children (14.8%) who were never monitored for laboratory parameters, considerations were recorded in their medical records, including refusal by the child or parents and monitoring performed by the general practitioner or elsewhere.Conclusion: Monitoring frequencies of ADR-related parameters in children and adolescents treated with antipsychotic drugs in psychiatric outpatient clinics varied and especially monitoring of laboratory parameters was infrequent. Considerations why monitoring was not performed were rarely recorded. The optimal method of monitoring and documentation thereof should become clear to optimize the benefit-risk balance of antipsychotic drug treatment for each child.

2020 ◽  
Vol 46 (Supplement_1) ◽  
pp. S149-S150
Author(s):  
Petros Drosos ◽  
Erik Johnsen ◽  
Christoffer A Bartz-Johannessen ◽  
Rune A Kroken

Abstract Background Schizophrenia is a serious illness and treatment with antipsychotic drugs remains one of the most effective types of treatment. The course of schizophrenia, however, is highly heterogeneous and currently it is not possible to predict which patient will respond adequately to which antipsychotic drug. The aim of our study was to define trajectories regarding response to antipsychotic drug treatment in patients with schizophrenia spectrum disorders. A second aim was to evaluate demographic factors and antipsychotic drugs as predictors for the different trajectories. Methods Best Intro is a randomized, rater-blind, head-to-head comparison of amisulpride, aripiprazole and olanzapine. Adult patients with a diagnosis in the schizophrenia spectrum (ICD-10 diagnoses F20-29) were included. Participants had symptoms of ongoing psychosis as determined by a score of four or more on at least one of the following PANSS (Positive and Negative Syndrome Scale) items: P1 (delusions), P3 (hallucinations), P5 (grandiosity), P6 (suspiciousness/persecution) or G9 (unusual thought content). Patients were followed over a period of 52 weeks and the assessment points were at baseline, after one week, three weeks, six weeks, three months, six months, nine months, and 12 months. Totally 359 patients were assessed for eligibility, and 144 of them were enrolled and randomized to one of the study drugs. We used the R statistical program to define trajectories of antipsychotic response. Results We identified three different trajectories regarding the reduction of PANSS total score, with Bayesian information criterion (BIC) = 6157 (BIC for two groups=6164 and for four groups=6171). A large group of patients (N=106, 74%) showed a trajectory of good improvement in PANSS total score over the first 26 weeks of follow-up and maintained it after one year with a total of 35% reduction in PANSS total score (Good response group). A second group of patients (N=19, 13%) followed a trajectory of quick response (already at one week) and a large reduction of PANSS total score (Strong response group). After one year, the reduction of PANSS total score was 58%. There was a difference in the starting point for PANSS total score in these two groups with a higher value at baseline in the Strong response group, but the ending point was quite similar. A third group of patients (N= 19, 13%) followed a trajectory of poor improvement and a 9% reduction in PANSS total score over the studied period (Slight response group). The demographic variables age, sex, civil status and living alone, or drug naivety did not predict participants grouping in the various trajectories. Furthermore, we examined the predictive value of different antipsychotic drug treatment for the different trajectories with the “Intention to treat” method. There was a statistically significant difference in favor of amisulpride treatment for belonging to the Strong response group, while olanzapine strongly predicted the belonging to the Slight response group. There was no significant difference among the antipsychotic drugs regarding the Good response group. Discussion Most patients (74%) with a schizophrenia spectrum diagnosis showed a good response during the one year follow-up and another 13% showed a remarkable strong improvement. That means that a total of 87% of patients had a satisfactory course of illness during the first year. Use of amisulpride predicts a better course compared to aripiprazole and olanzapine. This finding can be useful for clinicians when selecting antipsychotic drugs for their patients.


2009 ◽  
Vol 1 ◽  
pp. CMT.S2175 ◽  
Author(s):  
René Ernst Nielsen ◽  
Jimmi Nielsen

The cornerstone in treatment of psychosis is antipsychotic drugs. Treatment options have increased over the years; newer antipsychotic drugs with a proposed increased efficacy regarding negative and cognitive symptoms, but also a shift in side-effects from neurological side-effects to metabolic side-effects have arisen as the new challenge. The basis of successful pharmacological treatment is a fundamental understanding of the mechanisms of action, the desired effects and side-effects of antipsychotic drugs, a good relationship with the patient and a thorough monitoring of the patient before and during treatment. The clinically relevant aspects of antipsychotic drug treatment are reviewed; mechanism of antipsychotic drug action, clinical considerations in treatment, switching antipsychotic drugs, polypharmacy, safety and patient preference.


2020 ◽  
Vol 26 ◽  
Author(s):  
Felix-Martin Werner ◽  
Rafael Coveñas

Background: Schizophrenia and schizoaffective disorder are treated with antipsychotic drugs. Some patients show treatment-resistant forms of psychotic disorders and, in this case, they can be treated with clozapine. In these patients and based on previous reviews on novel antipsychotic drugs, it is important to know whether an add-on therapy with new drugs can ameliorate the positive and negative schizophrenic scale (PANSS) total score. Objective: The aim of this review is to suggest an appropriate treatment for patients with treatment-resistant forms of psychotic disorders. A combination of current available antipsychotic drugs with novel antipsychotic or modulating drugs might improve negative schizophrenic symptoms and cognitive function and thereby social functioning and quality of life. Results: The mechanisms of action, the therapeutic effects and the pharmacokinetic profiles of novel antipsychotic drugs such as cariprazine, brexipiprazole and lumateperone are up-dated. Published case reports of patients with treatmentresistant psychoses are also discussed. These patients were treated with clozapine but a high PANSS total score was observed. Only an add-on therapy with cariprazine improved the score and, above all, negative schizophrenic symptoms and cognitive functions. To ensure a constant antipsychotic drug concentration, long-acting injectable antipsychotic drugs may be a choice for a maintenance therapy in schizophrenia. New modulating drugs, such as receptor positive allosteric modulators (N-methyl-D-aspartate receptor; subtype 5 of the metabotropic glutamatergic receptor) and encenicline, an alpha7 nicotinic cholinergic receptor agonist, are being investigated in preclinical and clinical trials. Conclusion: In clinical trials, patients with treatment-resistant forms of psychosis should be examined to know whether a combination therapy with clozapine and a novel antipsychotic drug can ameliorate the PANSS total score. In schizophrenia, long-acting injectable antipsychotic drugs are a safe and tolerable maintenance therapy. In further clinical studies, it should be investigated whether patients with treatment-resistant forms of psychoses can improve negative schizophrenic symptoms and cognitive functions by an add-on therapy with cognition enhancing drugs.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jurriaan M. J. L. Brouwer ◽  
Erien Olde Hengel ◽  
Arne J. Risselada ◽  
Eric N. van Roon ◽  
Hans Mulder

Abstract Background Clinical practice guidelines (CPGs) recommend the monitoring of somatic parameters in patients treated with antipsychotic drugs in order to detect adverse effects. The objective of this study was to assess, in adult and (frail) elderly populations, the consistency and applicability of the somatic monitoring instructions recommended by established CPGs prior to and during antipsychotic drug use. Methods A search for national and international CPGs was performed by querying the electronic database PubMed and Google. Somatic monitoring instructions were assessed for adult and (frail) elderly populations separately. The applicability of somatic monitoring instructions was assessed using the Systematic Information for Monitoring (SIM) score. Somatic monitoring instructions were considered applicable when a minimum SIM score of 3 was reached. Results In total, 16 CPGs were included, with a total of 231 somatic monitoring instructions (mean: 14; range: 0–47). Of the somatic monitoring instructions, 87% were considered applicable, although critical values and how to respond to aberrant values were only present in 28 and 52% of the available instructions respectively. Only 1 CPG presented an instruction specifically for (frail) elderly populations. Conclusions We emphasize the need for a guideline with somatic monitoring instructions based on the SIM definition for both adult and (frail) elderly populations using antipsychotic drugs. In addition, CPGs should state that clear agreements should be made regarding who is responsible for interventions and somatic monitoring prior to and during antipsychotic drug use.


2021 ◽  
Vol 12 ◽  
pp. 204209862110128
Author(s):  
Hanan Khalil ◽  
Dimi Hoppe ◽  
Nabil Ameen

Background: Retrospective analyses of large databases of treated patients can provide useful links to the presence of drug misuse or rare and infrequent adverse effects, such as agranulocytosis, diabetic ketoacidosis or neuroleptic malignant syndrome. The aim of this study is to describe the adverse effects to antipsychotics reported in the Australian Database of Adverse Event Notifications (DAEN). Methods: Data were collected from the DAEN – a spontaneous reporting database. The database, which covered the period from January 2004 to December 2017, was obtained from the Therapeutic Goods Administration (TGA) website ( www.TGA.gov ). The drugs selected for this investigation are the following: aripiprazole, clozapine, olanzapine, paliperidone, risperidone, ziprasidone, quetiapine, haloperidol and pimozide. All data were analysed descriptively. Comparison of reporting and management of adverse events between adults (older than 20 years) and children (5–19 years) was undertaken using chi squared test, where p < 0.05 is significant. Results: A total of 7122 adverse events associated with the antipsychotics aripiprazole, clozapine, haloperidol, olanzapine, paliperidone, pimozide, quetiapine and risperidone were reported to the TGA between January 2004 and December 2017. On average, there were 2.6 adverse events reported for each case. The most common adverse event reported for antipsychotics was neuroleptic malignant syndrome. There were no significant differences in the number of co-medications, formulations, indications, therapeutic dose, hospital admission and overdose among the antipsychotics between paediatric and adult populations. However, there were significant differences between causality, death and the management of adverse events between adult and paediatric populations (5–19 years) ( p < 0.05, chi squared test). Conclusion: The antipsychotic drug associated with the highest adverse events in adults was clozapine, followed by olanzapine. The most common adverse event in adults, and reported with a number of antipsychotic drugs, was neuroleptic malignant syndrome. In children, the highest numbers of adverse events reported in the database were associated with risperidone, clozapine and olanzapine. Plain language summary Adverse events reported of antipsychotics Background: Retrospective analyses of large databases of treated patients can provide useful clues to the presence of drug misuse or rare and infrequent adverse effects associated with antipsychotics. The drugs selected for this investigation are the following: aripiprazole, clozapine, olanzapine, paliperidone, risperidone, ziprasidone, quetiapine, haloperidol and pimozide. Methods: All data were analysed descriptively and investigated for any associations between the variables collected. Comparison of reporting and management of adverse events between adults (older than 20 years) and children (5–19 years) was undertaken using chi squared test, where p < 0.05 is significant. Results: The antipsychotic drug associated with the highest adverse events was clozapine, followed by olanzapine. In children, the highest numbers of adverse events reported in the database were associated with risperidone, clozapine and olanzapine. The most common adverse event in adults, and reported with a number of antipsychotic drugs, was neuroleptic malignant syndrome. Conclusion: There were significant differences between causality, death and the management of adverse events between adult and paediatric populations (5–19 years).Keywords: Antipsychotics, adverse effects, adverse events, safety


Author(s):  
Daiki Sakai ◽  
Wataru Matsumiya ◽  
Sentaro Kusuhara ◽  
Makoto Nakamura

Abstract Purpose To evaluate the factors associated with the development of ocular candidiasis (OC) and ocular prognosis with echinocandin therapy for candidemia. Methods The medical records of 56 consecutive patients with a positive blood culture for Candida species between November 2016 and October 2019 were retrospectively reviewed. Information on patient characteristics, isolated Candida species, treatment details for candidemia, and ocular findings were extracted to identify factors associated with OC development. Results The leading pathogen of candidemia was Candida albicans (C.albicans) (41.1%). Of 56 patients, 18 (32.1%) were diagnosed with chorioretinitis, categorized as either probable (8 patients) or possible OC (10 patients). There was no case of endophthalmitis with vitritis. The incidence of probable OC was not significantly different between the groups treated with echinocandins and other antifungal drugs (15.2% vs. 11.1%, p = 1.00). In all probable OC cases, systemic antifungal therapy was switched from echinocandins to azoles, and no case progressed to endophthalmitis. A multivariate logistic analysis revealed that female sex (adjusted odds ratio [aOR], 8.93; 95% confidence interval [CI], 1.09–72.9) and C. albicans (aOR, 23.6; 95% CI, 1.8–281) were independent factors associated with the development of probable OC. Conclusion One-seventh of patients with candidemia developed probable OC. Given the evidence of female and C. albicans as the factors associated with OC development, careful ophthalmologic management is required with these factors, especially in candidemia. Although echinocandins had no correlation with OC development and did not lead to the deterioration of ocular prognosis, further investigation is required.


2020 ◽  
Vol Volume 16 ◽  
pp. 881-890 ◽  
Author(s):  
Takashi Tsuboi ◽  
Takefumi Suzuki ◽  
Takaharu Azekawa ◽  
Naoto Adachi ◽  
Hitoshi Ueda ◽  
...  

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