Paediatric pharmacotherapy and drug regulation: Moving past the therapeutic orphan

The development of specific drug therapy for children was a paradigm-changing event that transformed paediatric medical practice. However, a series of tragedies involving drug treatment for children resulted in a gap developing between drug regulation and practice, with the majority of drugs used in child healthcare being used off-label, rendering children therapeutic orphans. Over the past two decades changes in drug regulation led by the US Food and Drug Administration and followed by the European Union\u27s European Medicines Agency have led to substantial changes in how new drugs with potential use in children are studied and labelled. While these changes have substantially improved labelling for new drugs, there has been much less progress with older drugs. Although the unique challenges of conducting clinical research in children have been addressed by novel clinical trial designs, many of these innovations have not been translated into approaches accepted for the drug approval process. The regulations applying to the need for paediatric studies currently are only applicable in the United States and the European Union, and there is less impetus for paediatric labelling in other jurisdictions. This impacts on a number of issues beyond labelling, including the availability of child-friendly formulations. Finally, the impact of Brexit on paediatric drug studies in the UK remains unclear and is subject to ongoing negotiations between the UK government and the European Union

Firearm injury epidemiology in children and youth in Ontario, Canada : a population-based study

BACKGROUND AND OBJECTIVE: Despite firearms contributing to significant morbidity and mortality globally, firearm injury epidemiology is seldom described outside of the USA. We examined firearm injuries among youth in Canada, including weapon type, and intent. DESIGN: Population-based, pooled cross-sectional study using linked health administrative and demographic databases. SETTING: Ontario, Canada. PARTICIPANTS: All children and youth from birth to 24 years, residing in Ontario from 1 April 2003 to 31 March 2018. EXPOSURE: Firearm injury intent and weapon type using the International Classification of Disease-10 CM codes with Canadian enhancements. Secondary exposures were sociodemographics including age, sex, rurality and income. MAIN OUTCOMES: Any hospital or death record of a firearm injury with counts and rates of firearm injuries described overall and stratified by weapon type and injury intent. Multivariable Poisson regression stratified by injury intent was used to calculate rate ratios of firearm injuries by weapon type. RESULTS: Of 5486 children and youth with a firearm injury (annual rate: 8.8/100 000 population), 90.7% survived. Most injuries occurred in males (90.1%, 15.5/100 000 population). 62.3% (3416) of injuries were unintentional (5.5/100 000 population) of which 1.9% were deaths, whereas 26.5% (1452) were assault related (2.3/100 00 population) of which 18.7% were deaths. Self-injury accounted for 3.7% (204) of cases of which 72.0% were deaths. Across all intents, adjusted regression models showed males were at an increased risk of injury. Non-powdered firearms accounted for half (48.6%, 3.9/100 000 population) of all injuries. Compared with handguns, non-powdered firearms had a higher risk of causing unintentional injuries (adjusted rate ratio (aRR) 14.75, 95% CI 12.01 to 18.12) but not assault (aRR 0.84, 95% CI 0.70 to 1.00). CONCLUSIONS: Firearm injuries are a preventable public health problem among youth in Ontario, Canada. Unintentional injuries and those caused by non-powdered firearms were most common and assault and self-injury contributed to substantial firearm-related deaths and should be a focus of prevention efforts

A qualitative analysis of information sharing for children with medical complexity within and across health care organizations

Abstract Background Children with medical complexity (CMC) are characterized by substantial family-identified service needs, chronic and severe conditions, functional limitations, and high health care use. Information exchange is critically important in high quality care of complex patients at high risk for poor care coordination. Written care plans for CMC are an excellent test case for how well information sharing is currently occurring. The purpose of this study was to identify the barriers to and facilitators of information sharing for CMC across providers, care settings, and families. Methods A qualitative study design with data analysis informed by a grounded theory approach was utilized. Two independent coders conducted secondary analysis of interviews with parents of CMC and health care professionals involved in the care of CMC, collected from two studies of healthcare service delivery for this population. Additional interviews were conducted with privacy officers of associated organizations to supplement these data. Emerging themes related to barriers and facilitators to information sharing were identified by the two coders and the research team, and a theory of facilitators and barriers to information exchange evolved. Results Barriers to information sharing were related to one of three major themes; 1) the lack of an integrated, accessible, secure platform on which summative health care information is stored, 2) fragmentation of the current health system, and 3) the lack of consistent policies, standards, and organizational priorities across organizations for information sharing. Facilitators of information sharing were related to improving accessibility to a common document, expanding the use of technology, and improving upon a structured communication plan. Conclusions Findings informed a model of how various barriers to information sharing interact to prevent optimal information sharing both within and across organizations and how the use of technology to improve communication and access to information can act as a solution

Opportunities and challenges in capturing severe vaping-related injuries among Canadian children and youth

Although the long-term harms associated with vaping remain largely unknown, there have been numerous accounts of acute vaping-related injuries in the paediatric population. The study of vaping-related injuries is an important yet challenging undertaking, complicated by a lack of appropriate reporting mechanisms and the absence of consensus on definitions and diagnostic codes. We discuss the results of a 12-month national cross-sectional study from the Canadian Paediatric Surveillance Program conducted in 2021–2022 and situate these results within the broader context of other Canadian surveillance and reporting mechanisms. Fewer than five cases of vaping-associated injuries were reported, contrasting with previous surveys which had revealed much higher case numbers. Hypotheses for the low case numbers include decreased exposure to vaping in the context of COVID-19, changes in vaping products, increases in public awareness of vaping-related harms, as well as recent modifications in policies related to vaping product marketing and sales. There is a great need for a multi-pronged surveillance approach leveraging multiple data sources, including self-reported provider and consumer data, as well as administrative data to help inform clinicians and policymakers on how to prevent vaping-associated injuries among youth

Healthcare utilization and costs following non-fatal powdered and non-powdered firearm injuries for children and youth

Little is known about the healthcare and economic burdens of non-fatal firearm injuries for children/youth beyond the initial admission. This study sought to estimate healthcare utilization and total direct healthcare costs of non-fatal powdered and non-powdered (air gun) firearm injuries 1-year post-injury. Using administrative data from 2003 to 2018 on all children/youth 0-24 years old in Ontario, Canada, a matched 1:2 cohort study was conducted to compare children/youth who experienced powdered and non-powdered firearm injuries with those who did not. Mean and median number of healthcare encounters and costs, and respective 95% confidence intervals (CIs) and interquartile ranges (IQRs), were estimated for both weapon type groups and controls and by intent. Children/youth who experienced a powdered and non-powdered firearm injury had a higher number of healthcare encounters and costs per year than those who did not. Mean 1-year costs for those with powdered and non-powdered firearm injuries were $8825 ($8007-$9643) and$2349 ($2118-$2578), respectively, versus $812 ($567-$1058) and$753 ($594-$911), respectively, for those without. Mean 1-year costs were highest for handgun injuries ($12,875 [95$9941-$15,808]), and for intentional assault-related ($13,498 [$11,843-$15,153]; $3287 [$2213-$4362]), and intentional self-injuries ($14,773 [$6893-$22,652]; $6005 [$2193-$9817]) for both powdered and non-powdered firearm injuries, respectively. Conclusion: Firearm injuries have substantial healthcare and economic burdens beyond the initial injury-related admission; this should be accounted for when examining the overall impact of firearm injuries. What is Known: • Child/youth firearm injuries have significant health and economic burdens. • However, existing work has mainly examined healthcare utilization and costs of initial admissions and/or have been limited to single-center studies and no studies have provide cost estimates by weapon type and intent. What is New: • Children/youth who suffered powdered firearm injuries had higher mean healthcare utilization and costs than those with non-powdered firearm injuries as well as comparable healthy children/youth. • Mean 1-year costs were highest for handgun injuries ($12,875), and for intentional assault-related ($13,498;$3287), and intentional self-injuries ($14,773;$6005) for powdered and non-powdered firearm injuries, respectively

New and continuing physician-based outpatient mental health care among children and adolescents during the COVID-19 pandemic in Ontario, Canada: a population-based study

ObjectiveTo assess physician-based mental health care utilization during the COVID-19 pandemic among children and adolescents new to care and those already engaged with mental health services, and to evaluate differences by sociodemographic factors.Study designWe performed a population-based repeated cross-sectional study using linked health and administrative databases in Ontario, Canada among all children and adolescents 3–17 years. We examined outpatient visit rates per 1,000 population for mental health concerns for those new to care (no physician-based mental healthcare for ≥1 year) and those with continuing care needs (any physician-based mental healthcare <1 year) following onset of the pandemic.ResultsAmong ~2.5 million children and adolescents (48.7% female, mean age 10.1 ± 4.3 years), expected monthly mental health outpatient visits were 1.5/1,000 for those new to mental health care and 5.4/1,000 for those already engaged in care. Following onset of the pandemic, visit rates for both groups were above expected [adjusted rate ratio (aRR) 1.22, 95% CI 1.17, 1.27; aRR 1.10, 95% CI 1.07, 1.12] for new and continuing care, respectively. The greatest increase above expected was among females (new: aRR 1.33, 95% CI 1.25, 1.42; continuing: aRR 1.22 95% CI 1.17, 1.26) and adolescents ages 13–17 years (new: aRR 1.31, 95% CI 1.27, 1.34; continuing: aRR 1.15 95% CI 1.13, 1.17). Mood and anxiety concerns were prominent among those new to care.ConclusionIn the 18 months following onset of the pandemic, outpatient mental health care utilization increased for those with new and continuing care needs, especially among females and adolescents