Children

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9 pages, 1596 KiB

Open AccessArticle

Acceptability of Prednisolone in an Open-Label Randomised Cross-Over Study—Focus on Formulation in Children

by Sissel Sundell Haslund-Krog, Inger Merete Jørgensen, Kim Dalhoff and Helle Holst

Children 2022, 9(8), 1236; https://doi.org/10.3390/children9081236 - 16 Aug 2022

Cited by 2 | Viewed by 1671

Abstract

Developing acceptable medicines for children is a complicated task. Several factors must be considered, including age, physiology, texture preference, formulation, and legal framework among others. In the development of new paediatric medicines, these factors are assessed. However, for older medicines, e.g., prednisolone, acceptability [...] Read more.

Developing acceptable medicines for children is a complicated task. Several factors must be considered, including age, physiology, texture preference, formulation, and legal framework among others. In the development of new paediatric medicines, these factors are assessed. However, for older medicines, e.g., prednisolone, acceptability is still a challenge. This study was an open-label randomised three-arm cross-over study investigating different formulations of prednisolone (crushed tablets, whole tablets, and oral solution) in paediatric patients with asthma and asthma-like symptoms. Participants were randomised into two different formulations on two consecutive days. For each formulation, the child or caregiver was asked to evaluate acceptability using a modified five-point Wong Baker Face scale. An analysis of variance (ANOVA) model was used to test for significance. For the 41 children, included mean age was 4.7 years (SD ± 3.6), and mean weight was 21 kg (SD ± 10.8). Sixty-one percent were boys. The participants were divided accordingly into three age groups: 6 to 23 months (N = 11), 2 to 5 years (N = 14), and 6–11 years (N = 16). The overall acceptability was low, with only 23 out of 71 scores rating the treatment either 1 or 2 (32%). The ANOVA test showed a significant difference in acceptability score between crushed tablets and whole tablets (p < 0.003). The mean acceptability score for the crushed tablet was the least favourable at 3.9 compared to oral solution (3.1), oro-dispersible tablet (2.8), and whole tablets (2.4). This is problematic in long-term treatment and for the youngest children who cannot swallow tablets. The improvement of age-appropriate and acceptable formulations is necessary. Full article

(This article belongs to the Special Issue Challenges in Children's Medicine Treatments: From Off-Label Use to Extemporaneous Formulations)

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13 pages, 244 KiB

Open AccessArticle

Systems Challenges in Accessing Medicines among Children under Thailand’s Universal Health Coverage: A Qualitative Study of a Provincial Public Hospital Network

by Rangsan Daojorn, Puckwipa Suwannaprom, Siritree Suttajit, Penkarn Kanjanarat, Prangtong Tiengket and Marc Lallemant

Children 2022, 9(4), 552; https://doi.org/10.3390/children9040552 - 13 Apr 2022

Cited by 2 | Viewed by 2227

Abstract

Lack of access to child-appropriate medicines results in off-label use. This study aimed to explore medicine management for paediatric patients and to highlight the challenges of the healthcare system under the universal health coverage of Thailand. Semi-structured interviews were conducted with 35 healthcare [...] Read more.

Lack of access to child-appropriate medicines results in off-label use. This study aimed to explore medicine management for paediatric patients and to highlight the challenges of the healthcare system under the universal health coverage of Thailand. Semi-structured interviews were conducted with 35 healthcare practitioners working in the public hospital network of Chiang Mai province from February to September 2020. Participants were asked about their experiences in managing the medicine supply for children. Findings revealed that paediatric patients had limited access to age-appropriate medicines. Children’s medicines are rarely selected for inclusion into hospital formularies because of constraining regulations and limited budgets. Additionally, child-appropriate formulations are unavailable on the market. Pharmaceutical compounding is unavoidable. Prepared products are provided weekly or monthly because of product stability concerns. Often, tablets are dispensed, and caregivers are instructed to cut up a tablet and disperse it in syrup in order to obtain a smaller dose in a dosage form appropriate for children to use at home. Without systematic support, access to safe and quality medicines for children is limited. Full article

(This article belongs to the Special Issue Challenges in Children's Medicine Treatments: From Off-Label Use to Extemporaneous Formulations)

11 pages, 2561 KiB

Open AccessArticle

Gaps in Accessibility of Pediatric Formulations: A Cross-Sectional Observational Study of a Teaching Hospital in Northern Thailand

by Prangthong Tiengkate, Marc Lallemant, Pimlak Charoenkwan, Chaisiri Angkurawaranon, Penkarn Kanjanarat, Puckwipa Suwannaprom and Phetlada Borriharn

Children 2022, 9(3), 301; https://doi.org/10.3390/children9030301 - 22 Feb 2022

Cited by 8 | Viewed by 2534

Abstract

The lack of appropriate medicines for children has a significant impact on health care practices in various countries around the world, including Thailand. The unavailability of pediatric medicines in hospital formularies causes issues regarding off-label use and extemporaneous preparation, resulting in safety and [...] Read more.

The lack of appropriate medicines for children has a significant impact on health care practices in various countries around the world, including Thailand. The unavailability of pediatric medicines in hospital formularies causes issues regarding off-label use and extemporaneous preparation, resulting in safety and quality risks relating to the use of medicines among children. This research aimed to identify missing pediatric formulations based on the experience of healthcare professionals in a teaching hospital in northern Thailand. A cross-sectional survey was conducted to collect data on missing pediatric formulations, the reasons for their inaccessibility, their off-label uses, their reactions to the situation, and suggestions to improve access to these identified medications. The survey was distributed to all physicians, nurses, and pharmacists involved in prescribing, preparing, dispensing, and administering pediatric medicines. A total of 218 subjects responded to the survey. Omeprazole, sildenafil, and spironolactone suspension were most often identified as missing formulations for children by physicians and pharmacists. They are unavailable on the Thai market or in any hospital formulary. For nurses, sodium bicarbonate, potassium chloride, and chloral hydrate were the most problematic formulations in terms of preparation, acceptability, and administration. These medicines were difficult to swallow because of their taste or texture. Full article

(This article belongs to the Special Issue Challenges in Children's Medicine Treatments: From Off-Label Use to Extemporaneous Formulations)

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9 pages, 229 KiB

Open AccessArticle

Status of Medications Prescribed for Psychiatric Disorders in Korean Pediatric and Adolescent Patients

by In-Woo Jang, Ji-Eun Chang, Jongyoon Kim and Kiyon Rhew

Children 2022, 9(1), 68; https://doi.org/10.3390/children9010068 - 5 Jan 2022

Cited by 1 | Viewed by 1999

Abstract

While mental health services for children are increasing, few psychiatric drugs have been approved for such use. We analyzed claim data from 19,557 South Korean pediatric and adolescent patients (<20 years) who were diagnosed with schizophrenia, bipolar disorder, major depressive disorder, anxiety disorder, [...] Read more.

While mental health services for children are increasing, few psychiatric drugs have been approved for such use. We analyzed claim data from 19,557 South Korean pediatric and adolescent patients (<20 years) who were diagnosed with schizophrenia, bipolar disorder, major depressive disorder, anxiety disorder, attention deficit-hyperactivity disorder (ADHD), or a tic disorder. Among these diseases, depressive episodes were the most common, followed by an anxiety disorder, ADHD, bipolar disorder, tic disorder, and schizophrenia. For each disease, prescriptions were categorized as full-label (approved indication with pediatric dosing in the package insert (PI)), partial-label (approved indication without pediatric dosing in the PI), and contraindication (contraindicated for the specific pediatric age in the PI). For schizophrenia, major depressive disorder, and anxiety disorder, more than 50% of the patients were prescribed partial-labeled medications. Additionally, more than 5% of patients with major depressive disorder were prescribed medications that were contraindicated for their age group. Our findings reveal that children with full-labeled psychiatric conditions are commonly administered drugs that are not explicitly approved for either their disease state or age, including off-label and unlicensed drugs. To use pharmaceuticals more safely, expanding drug indications using real-world data are needed. Full article

(This article belongs to the Special Issue Challenges in Children's Medicine Treatments: From Off-Label Use to Extemporaneous Formulations)

Review

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12 pages, 272 KiB

Open AccessReview

Current Antithrombotic Therapy Strategies in Children with a Focus on Off-Label Direct Oral Anticoagulants—A Narrative Review

by Stefana Maria Moisa, Laura Mihaela Trandafir, Crischentian Brinza, Ingrith Crenguta Miron, Elena Tarca, Lacramioara Ionela Butnariu and Alexandru Burlacu

Children 2022, 9(7), 1093; https://doi.org/10.3390/children9071093 - 21 Jul 2022

Cited by 7 | Viewed by 3053

Abstract

(1) Background: The incidence of thromboembolic events is relatively low in the general population, but it increases in hospitalized children and those who underwent thrombogenic procedures. Although the evidence regarding direct oral anticoagulants (DOACs) in children with venous thromboembolism (VTE) is growing, DOACs [...] Read more.

(1) Background: The incidence of thromboembolic events is relatively low in the general population, but it increases in hospitalized children and those who underwent thrombogenic procedures. Although the evidence regarding direct oral anticoagulants (DOACs) in children with venous thromboembolism (VTE) is growing, DOACs were excluded from existing guidelines due to the lack of reliable data at that moment. Therefore, current evidence on VTE management in children needs to be critically reviewed. (2) Methods: We have conducted a literature search in the Scopus, EMBASE, and MEDLINE databases using prespecified keywords to retrieve studies published between 2010 and 2022. (3) Results: Clinical trials highlighted that rivaroxaban and dabigatran had predictable pharmacokinetic and pharmacodynamic profiles in children, similar to those observed in adults. Dabigatran and rivaroxaban had a similar safety profile to standard therapy but improved thrombotic burden and resolution during follow-up. Most studies involving apixaban and edoxaban are ongoing, and results are awaited. (4) Conclusions: Dabigatran and rivaroxaban could be valid therapeutic options for VTE management in children. In the case of apixaban and edoxaban, results from ongoing clinical studies are required before using them in pediatric VTE. Full article

(This article belongs to the Special Issue Challenges in Children's Medicine Treatments: From Off-Label Use to Extemporaneous Formulations)

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Other

Jump to: Research, Review

5 pages, 206 KiB

Open AccessPerspective

Creating Data Standards to Support the Electronic Transmission of Compounded Nonsterile Preparations (CNSPs): Perspectives of a United States Pharmacopeia Expert Panel

by Richard H. Parrish II, Scott Ciarkowski, David Aguero, Sandra Benavides, Donna Z. Bohannon, Roy Guharoy and on behalf of the United States Pharmacopeia Compounded Drug Preparation Information Exchange Expert Panel

Children 2022, 9(10), 1493; https://doi.org/10.3390/children9101493 - 29 Sep 2022

Viewed by 1750

Abstract

The perspectives of the Compounded Drug Preparation Information Exchange Expert Panel of the United States Pharmacopeia (CDPIE-EP) on the urgent need to create and maintain data standards to support the electronic transmission of an interoperable dataset for compounded nonsterile preparations (CNSPs) for children [...] Read more.

The perspectives of the Compounded Drug Preparation Information Exchange Expert Panel of the United States Pharmacopeia (CDPIE-EP) on the urgent need to create and maintain data standards to support the electronic transmission of an interoperable dataset for compounded nonsterile preparations (CNSPs) for children and the elderly is presented. The CDPIE-EP encourages all stakeholders associated with the generation, transmission, and preparation of CNSPs, including standards-setting and informatics organizations, to discern the critical importance of accurate transmission of prescription to dispensing the final product and an urgent need to create and adopt a seamless, transparent, interoperable, digitally integrated prescribing and dispensing system benefiting of all patients that need CNSPs, especially for children with special healthcare needs and medical complexity (CSHCN-CMC) and for adults with swallowing difficulties. Lay summary: Current electronic prescription processing standards do not permit the complete transmission of compounded nonsterile preparations (CNSPs) from a prescriber to dispenser. This lack creates multiple opportunities for medication errors, especially at transitions of care for children with medical complexity and adults that cannot swallow tablets and capsules. The United States Pharmacopeia Expert Panel on Compounded Drug Preparation Information Exchange aims to reduce this source of error by creating ways and means for CNSPs to be transmitted within computer systems across the continuum of care. Twitter: Digitizing compounded preparation monographs and NDC-like formulation identifiers in computerized prescription systems will minimize error. Full article

(This article belongs to the Special Issue Challenges in Children's Medicine Treatments: From Off-Label Use to Extemporaneous Formulations)

6 pages, 194 KiB

Open AccessCase Report

Third-Line Antiretroviral Therapy: What Do We Do When the Appropriate Formulations Are Not Available?

by Lisa Jane Frigati and Helena Rabie

Children 2022, 9(4), 473; https://doi.org/10.3390/children9040473 - 30 Mar 2022

Cited by 1 | Viewed by 1827

Abstract

Children on antiretroviral therapy have limited options, particularly if they are failing therapy and live in resource-poor settings. We describe three cases where children accessed third-line antiretroviral therapy off-label, or used them extemporaneously with successful outcomes. We then review the evidence for performing [...] Read more.

Children on antiretroviral therapy have limited options, particularly if they are failing therapy and live in resource-poor settings. We describe three cases where children accessed third-line antiretroviral therapy off-label, or used them extemporaneously with successful outcomes. We then review the evidence for performing this measure. There is an urgent need for appropriate formulations to treat young children who require a third-line or salvage regimen. Full article

(This article belongs to the Special Issue Challenges in Children's Medicine Treatments: From Off-Label Use to Extemporaneous Formulations)

6 pages, 352 KiB

Open AccessCase Report

Daptomycin for Treatment of S. Epidermidis Endocarditis in an Extremely Preterm Neonate—Outcome and Perspectives

by Chiara Minotti, Ilaria Zuccon, Elena Priante, Luca Bonadies, Costanza Di Chiara, Daniele Donà, Eugenio Baraldi and Paola Costenaro

Children 2022, 9(4), 457; https://doi.org/10.3390/children9040457 - 24 Mar 2022

Cited by 3 | Viewed by 2327

Abstract

With a considerable morbidity and mortality burden, infective endocarditis still represents a challenge for clinicians. This is a case of persistent Staphylococcus epidermidis endocarditis in an extremely preterm newborn. The infection, initially treated with vancomycin, was successfully cured with daptomycin. Its use was [...] Read more.

With a considerable morbidity and mortality burden, infective endocarditis still represents a challenge for clinicians. This is a case of persistent Staphylococcus epidermidis endocarditis in an extremely preterm newborn. The infection, initially treated with vancomycin, was successfully cured with daptomycin. Its use was safe and effective, ensuring a complete remission without adverse effects. Full article

(This article belongs to the Special Issue Challenges in Children's Medicine Treatments: From Off-Label Use to Extemporaneous Formulations)

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