179-LB: Characteristics of Children with Medication-Induced Diabetes (MID): A Canadian Pediatric Surveillance Program (CPSP) Study

Patel, Trisha; Ayub, Aysha; Irvine, Michael; Hadjiyannakis, Stasia; Henderson, Mélanie; Nour, Munier; Pinto, Teresa; Wicklow, Brandy; Hamilton, Jill B.; Sellers, Elizabeth; Amed, Shazhan

doi:10.2337/db20-179-lb

Cited by 3 publications

(3 citation statements)

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“…A Canadian Pediatric Surveillance Program (CPSP) Study found that if a pediatric patient’s parents have acanthosis nigricans or type 2 diabetes (T2D), blood glucose should be closely monitored when using diabetogenic medication. 43 Another prospective observational study found that approximately 17.7% of treated pediatric patients experienced at least one ADR, and the incidence of adverse reactions in children who had received general anesthesia was more than six times that of non-anesthetized children. 44 It is important to recognize that any neglected adverse reaction may result in long-term consequences that can affect the whole life of a pediatric patient.…”

Section: Child Patientmentioning

confidence: 99%

Opportunities and challenges of pharmacovigilance in special populations: a narrative review of the literature

Li,

Wu,

Jiang

et al. 2023

Therapeutic Advances in Drug Safety

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The relatively new discipline of pharmacovigilance (PV) aims to monitor the safety of drugs throughout their evolution and is essential to discovering new drug risks. Due to their specific and complex physiology, children, pregnant women, and elderly adults are more prone to adverse drug reactions (ADRs). Additionally, the lack of clinical trial data exacerbates the challenges faced with pharmacotherapy in these populations. Elderly patients tend to have multiple comorbidities often requiring more extensive medication, which adds additional challenges for healthcare professionals (HCPs) in delivering safe and effective pharmacotherapy. Clinical trials often have inherent limitations, including insufficient sample size and limited duration of research; as some ADRs are attributed to long-term use of a drug, these may go undetected during the course of the trial. Therefore, the implementation of PV is key to insuring the safe and effective use of drugs in special populations. We conducted a thorough review of the scientific literature on PV systems across the European Union, the United States, and China. Our review focused on basic physiological characteristics, drug use, and PV for specific populations (children, pregnant women, and the elderly). This article aims to provide a reference for the development of follow-up policies and improvement of existing policies as well as provide insight into drug safety with respect to patients of special populations.

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Section: Child Patientmentioning

confidence: 99%

Opportunities and challenges of pharmacovigilance in special populations: a narrative review of the literature

Li,

Wu,

Jiang

et al. 2023

Therapeutic Advances in Drug Safety

View full text Add to dashboard Cite

show abstract

“…115 Outside of Europe, programs such as the Canadian Paediatric Surveillance Program (CPSP) involve partnerships with government (Public Health Agency of Canada), professional societies (the Canadian Paediatric Society) and more than 1800 paediatricians and paediatric subspecialists. 116 The CPSP was established to evaluate rare exposures (fewer than 500 cases per year expected), address an important public health issue of scientific importance, and fill significant knowledge gaps for which surveillance is the most appropriate means. Surveillance studies provide vital insight into clinical uses for approved medicines which can lead to revised marketing authorisations that improve patient safety and encourage access to effective therapies.…”

Section: General Aspects Of Paediatric Spontaneous Reportsmentioning

confidence: 99%

c4c: Paediatric pharmacovigilance: Methodological considerations in research and development of medicines for children – A c4c expert group white paper

Aurich

Apele-Freimane

Banaschewski

et al. 2021

Brit J Clinical Pharma

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Children frequently respond differently to therapies compared to adults. Differences also exist between paediatric age groups for pharmacokinetics and pharmacodynamics in both efficacy and safety. Paediatric pharmacovigilance requires an understanding of the unique aspects of children with regard to, for example, drug response, growth and development, clinical presentation of adverse drug reactions (ADRs), how they can be detected and population‐specific factors (e.g., more frequent use of off‐label/unlicensed drugs). In recognition of these challenges, a group of experts has been formed in the context of the conect4children (c4c) project to support paediatric drug development. This expert group collaborated to develop methodological considerations for paediatric drug safety and pharmacovigilance throughout the life‐cycle of medicinal products which are described in this article. These considerations include practical points to consider for the development of the paediatric section of the risk management plan (RMP), safety in paediatric protocol development, safety data collection and analysis. Furthermore, they describe the specific details of post‐marketing pharmacovigilance in children using, for example, spontaneous reports, electronic health care records, registries and record‐linkage, as well as the use of paediatric pharmacoepidemiology studies for risk characterisation. Next the details of the assessment of benefit–risk and challenges related to medicinal product formulation in the context of a Paediatric Investigation Plan (PIP) are presented. Finally, practical issues in paediatric signal detection and evaluation are included. This paper provides practical points to consider for paediatric pharmacovigilance throughout the life‐cycle of medicinal products for RMPs, protocol development, safety data collection and analysis and PIPs.

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“…In Canada, the number of children with obesity has more than doubled over the past 40 years [1], with the prevalence in children aged 2 to 17 years increasing from 6% between 1978 to 1979 to 12% in 2015 [2]. In parallel, the rates of lifelong chronic disease caused by childhood obesity have also increased; for example, a recent Canadian surveillance study reported a 68% increase in the minimum incidence of childhood-onset type 2 diabetes over a 10-year period [3]. Obesity in childhood tends to persist into adulthood, along with its associated physical and psychosocial consequences [4].…”

Section: Introductionmentioning

confidence: 99%

Using Human-Centered Design and Cocreation to Create the Live 5-2-1-0 Mobile App to Promote Healthy Behaviors in Children: App Design and Development

Yau¹,

Tang²,

Görges³

et al. 2023

JMIR Pediatr Parent

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Background The prevalence of obesity among Canadian children is rising, partly because of increasingly obesogenic environments that limit opportunities for physical activity and healthy nutrition. Live 5-2-1-0 is a community-based multisectoral childhood obesity prevention initiative that engages stakeholders to promote and support the message of consuming ≥5 servings of vegetables and fruits, having <2 hours of recreational screen time, participating in ≥1 hour of active play, and consuming 0 sugary drinks every day. A Live 5-2-1-0 Toolkit for health care providers (HCPs) was previously developed and piloted in 2 pediatric clinics at British Columbia Children’s Hospital. Objective This study aimed to co-create, in partnership with children, parents, and HCPs, a Live 5-2-1-0 mobile app that supports healthy behavior change and could be used as part of the Live 5-2-1-0 Toolkit for HCPs. Methods Three focus groups (FGs) were conducted using human-centered design and participatory approaches. In FG 1, children (separately) and parents and HCPs (together) participated in sessions on app conceptualization and design. Researchers and app developers analyzed and interpreted qualitative data from FG 1 in an ideation session, and key themes were subsequently presented separately to parents, children, and HCPs in FG-2 (co-creation) sessions to identify desired app features. Parents and children tested a prototype in FG 3, provided feedback on usability and content, and completed questionnaires. Thematic analysis and descriptive statistics were used for the qualitative and quantitative data, respectively. Results In total, 14 children (mean age 10.2, SD 1.3 years; 5/14, 36% male; 5/14, 36% White), 12 parents (9/12, 75% aged 40-49 years; 2/12, 17% male; 7/12, 58% White), and 18 HCPs participated; most parents and children (20/26, 77%) participated in ≥2 FGs. Parents wanted an app that empowered children to adopt healthy behaviors using internal motivation and accountability, whereas children described challenge-oriented goals and family-based activities as motivating. Parents and children identified gamification, goal setting, daily steps, family-based rewards, and daily notifications as desired features; HCPs wanted baseline behavior assessments and to track users’ behavior change progress. Following prototype testing, parents and children reported ease in completing tasks, with a median score of 7 (IQR 6-7) on a 7-point Likert scale (1=very difficult; 7=very easy). Children liked most suggested rewards (28/37, 76%) and found 79% (76/96) of suggested daily challenges (healthy behavior activities that users complete to achieve their goal) realistic to achieve. Participant suggestions included strategies to maintain users’ interest and content that further motivates healthy behavior change. Conclusions Co-creating a mobile health app with children, parents, and HCPs was feasible. Stakeholders desired an app that facilitated shared decision-making with children as active agents in behavior change. Future research will involve clinical implementation and assessment of the usability and effectiveness of the Live 5-2-1-0 app.

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179-LB: Characteristics of Children with Medication-Induced Diabetes (MID): A Canadian Pediatric Surveillance Program (CPSP) Study

Cited by 3 publications

References 0 publications

Opportunities and challenges of pharmacovigilance in special populations: a narrative review of the literature

Opportunities and challenges of pharmacovigilance in special populations: a narrative review of the literature

c4c: Paediatric pharmacovigilance: Methodological considerations in research and development of medicines for children – A c4c expert group white paper

Using Human-Centered Design and Cocreation to Create the Live 5-2-1-0 Mobile App to Promote Healthy Behaviors in Children: App Design and Development

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