Clarity and applicability of adverse drug reaction-related monitoring instructions in clinical practice guidelines for children and adolescents treated with antipsychotic drugs: a review of six clinical practice guidelines.

OBJECTIVES: Monitoring instructions related to adverse drug reactions (ADRs) are not always clearly described in clinical practice guidelines (CPGs) and not always easily applicable in daily clinical practice. The aim of this study was to assess the clarity of presentation and the applicability of ADR-related monitoring instructions in CPGs for children and adolescents treated with antipsychotic drugs. SETTING: Guidelines from different countries were selected, and monitoring instructions for 13 ADR-related parameters were assessed. PRIMARY AND SECONDARY OUTCOME MEASURES: To assess the clarity and the applicability of the sections concerning monitoring instructions in each CPG, the Appraisal of Guidelines for Research and Evaluation instrument was used. To assess the clarity and the applicability of the monitoring instructions for each ADR-related parameter, the Systematic Information for Monitoring score was used. RESULTS: Six CPGs were included. Overall, the presentation of the monitoring instructions in the different CPGs was clear; three CPGs scored >75%. All CPGs scored lower on applicability, as, for example, the barriers and facilitators were poorly described. The number of ADR-related parameters included in the CPGs varied between 8 and 13. Why and what to monitor was always described for each parameter. When to start monitoring was also often described (90.2%), but when to stop monitoring was less frequently described (37.4%). CONCLUSIONS: The CPGs differed on the parameters that needed to be monitored. Overall, the monitoring instructions were clearly presented, but improvement in their applicability is required. By improving the monitoring instructions, CPGs can provide better guidance on monitoring ADRs in daily clinical practice.

Monitoring of Adverse Drug Reaction-Related Parameters in Children, Youth, and Young Adults Prescribed Antipsychotic Drugs by General Practitioners.

Objective: The aim of the study was to assess monitoring of adverse drug reaction (ADR)-related parameters in children, youth, and young adults treated with second-generation antipsychotic drugs (SGAs) prescribed by general practitioners (GPs). Methods: This retrospective follow-up study included children, youth, and young adults aged 0 - 24 years, who had an initial prescription of an SGA recorded in the Clinical Practice Research Datalink between 2000 and 2017, and who were prescribed an SGA more than once for a duration of at least 6 months. It included an assessment of which ADR-related physical parameters (weight, height, body-mass index, waist circumference, pulse, blood pressure, and heart examination) and laboratory parameters (glucose, HbA1c, lipids, and prolactin) were monitored in children, youth, and young adults at least once every 6-month period, stratified by sex, age categories, and calendar years. Results: In total, 7006 patients were included and the mean duration of follow-up was 1.6 years. Monitoring frequencies of all parameters were below 25%. Blood pressure and weight were monitored in 23.6% and 23.4%, respectively, of all children, youth, and young adults during the first half year; waist circumference was monitored in 0.2%. Females were monitored more often than males, some differences between age categories were observed, and monitoring frequencies increased after 2000, but did not exceed 35% in any year. Conclusion: Monitoring frequencies of ADR-related parameters in children, youth, and young adults treated with SGAs prescribed by a GP were low. Monitoring in primary care should be improved to enable a better evaluation of the benefit-risk balance during antipsychotic drug therapy.

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

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.

Design of a Pharmacy Curriculum on Patient Centered Communication Skills.

For delivering high quality pharmaceutical care pharmacy students need to develop the competences for patient centered communication. The aim of the article is to describe how a curriculum on patient centered communication can be designed for a pharmacy program. General educational principles for curriculum design are based on the theories of constructive alignment, self-directed learning and the self-determination theory. Other principles are paying systematic and explicit attention to skills development, learning skills in the context of the pharmacy practice and using a well-balanced system for the assessment of students' performance. Effective educational methods for teaching communication skills are small group training sessions preferably with (simulation) patients, preceded by lectures or e-learning modules. For (formative or summative) assessment different methods can be used. The Objective Structured Clinical Exam (OSCE) is preferred for summative assessment of communication competence. The principles and educational methods are illustrated with examples from the curriculum of the master Pharmacy program of Utrecht University (The Netherlands). The topics 'pharmaceutical consultations on prescription medicine,' 'pharmaceutical consultations on self-care medication' and 'clinical medication reviews' are described in detail. Finally, lessons learned are shared.

Reported Adverse Drug Reactions in Children and Adolescents Treated with Antipsychotics.

OBJECTIVES: To characterize reported adverse drug reactions (ADRs) in children and adolescents treated with antipsychotics and determine differences in relative reporting frequency between genders, age classes, and reporter types. METHODS: Individual case safety reports of children ages 1 - 17 years in whom an antipsychotic drug was the suspected or interacting drug from the worldwide database, VigiBase, from 1968 until March 2017, were included. Reported ADRs were categorized based on the Standardized Medical Dictionary for Regulatory Activities (MedDRA) Queries and clinical reasoning. Proportional reporting ratios (PRRs) and 95% confidence intervals (95% CIs) were calculated for genders, age classes, and reporter types. RESULTS: In total, 45,201 reported ADRs were included. The most frequently reported were ADRs related to extrapyramidal syndrome (14.7%), breast disorders or blood prolactin level changes (4.7%), and cardiac arrhythmias (4.6%). Differences in relative reporting frequencies were observed between age classes and reporter types, and less prominent between genders. For example, ADRs related to hyperglycemia/new-onset diabetes mellitus were less frequently reported in children ages 1 - 5 than in children ages 12 - 17 (PRR: 0.4, 95% CI: 0.2 - 0.5). ADRs related to cardiac arrhythmias were less frequently reported by consumers compared with health care professionals (PRR: 0.5, 95% CI: 0.5 - 0.6), whereas ADRs related to a change in weight/body mass index were more frequently reported by consumers (PRR: 3.2, 95% CI: 2.9 - 3.5). CONCLUSION: A wide spectrum of ADRs were reported in children treated with antipsychotics. The relative differences in reporting frequency between age classes and reporter types can be of help to tailor information about possible ADRs and to monitor for ADRs.

Monitoring of Metabolic, Cardiac, and Endocrine Indicators in Youth Treated With Antipsychotics as Reported by Health Care Professionals.

BACKGROUND: It is unclear how youth treated with antipsychotics are monitored. The purpose of this study was to assess monitoring of metabolic, cardiac, and endocrine indicators in youth (<18 years old) treated with antipsychotics as reported by health care professionals in the Netherlands. METHODS: A questionnaire was designed to collect information from health care professionals regarding the monitoring of youth treated with antipsychotics. Data were collected at a national conference. FINDINGS AND RESULTS: Fifty-nine health care professionals completed the questionnaire, of which 53 (89.8%) were child and adolescent psychiatrists (approximately 20% of all child and adolescent psychiatrists in the Netherlands). More than 80% of respondents reported monitoring physical indicators-weight, height, body mass index, heart rate, and blood pressure-and over 50% reported monitoring laboratory indicators-lipid profile, blood glucose, and prolactin level. Most of the respondents reported monitoring physical indicators more than twice per year and laboratory indicators once per year. Almost all respondents (56/59, 94.9%) reported monitoring according to a clinical guideline or protocol. Only 1 respondent reported monitoring the indicators completely according to the clinical guideline. Respondents mentioned that facilitating factors for monitoring, such as access to electrocardiogram facilities, were insufficiently available. CONCLUSIONS: Although all health care professionals reported monitoring metabolic, cardiac, and endocrine indicators in youth treated with antipsychotics, great variability exists in reported monitoring practices. Factors contributing to this variability must be assessed to optimize the benefit-risk ratio for the individual patient.