Time for a regulatory framework for pediatric medications in Canada

Gilpin, Andréa; Bérubé, Sophie; Hepburn, Charlotte Moore; Lacaze‐Masmonteil, Thierry; Samiee-Zafarghandy, Samira; Rieder, Michael J.; Gruenwoldt, Emily; MacLeod, Stuart; Litalien, Catherine

doi:10.1503/cmaj.220044

Cited by 4 publications

(2 citation statements)

References 7 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In summary, regulatory approval of medications for the treatment of paediatric IBD lags behind approval in adults, and a regulatory framework for drug approval and labelling in paediatrics is overdue ( 60 ). In addition, drug cost reimbursement (whether by private or public payors) should change to reflect the latest scientific evidence rather than relying on old research and the clinical trials that resulted in regulatory approval.…”

Section: Treatment Of Paediatric Ibdmentioning

confidence: 99%

The 2023 Impact of Inflammatory Bowel Disease in Canada: Special Populations—Children and Adolescents with IBD

El-Matary,

Carroll,

Deslandres

et al. 2023

Journal of the Canadian Association of Gastroenterology

View full text Add to dashboard Cite

Rates of inflammatory bowel disease (IBD) in Canadian children and adolescents are among the highest in the world, and the incidence is rising most rapidly in children under five years of age. These young children may have either a typical form of IBD with multi-factorial aetiology, or they may have a monogenic form. Despite the growing number of children in Canada living with this important chronic disease, there are few available medical therapies approved by Health Canada due to the omission of children from most clinical trials of newly developed biologics. As a result, off-label use of medications is common, and physicians have learned to use existing therapies more effectively. In addition, most Canadian children are treated in multidisciplinary, specialty clinics by physicians with extra training or experience in IBD, as well as specialist nurses, dietitians, mental health care providers and other allied health professionals. This specialized clinic approach has facilitated cutting edge research, led by Canadian clinicians and scientists, to understand the causes of IBD, the optimal use of therapies, and the best ways to treat children from a biopsychosocial perspective. Canadians are engaged in work to understand the monogenic causes of IBD; the interaction between genes, the environment, and the microbiome; and how to address the mental health concerns and medical needs of adolescents and young adults transitioning from paediatric to adult care.

show abstract

Section: Treatment Of Paediatric Ibdmentioning

confidence: 99%

The 2023 Impact of Inflammatory Bowel Disease in Canada: Special Populations—Children and Adolescents with IBD

El-Matary,

Carroll,

Deslandres

et al. 2023

Journal of the Canadian Association of Gastroenterology

View full text Add to dashboard Cite

show abstract

“…• Canada lags behind the US, EU and other leading regulators in the implementation of paediatric-sensitive drug regulations. Without a mandate for manufacturers to submit paediatric data, many new medications are brought to the Canadian market without a paediatric indication, even when paediatric use can be anticipated and despite paediatric indications having been secured in comparable jurisdictions (Gilpin et al 2022). Paediatric regulation is necessary to ensure children benefit from the same regulatory standards as adults.…”

Section: Why Is Paediatric Regulation In Canada An Imperative?mentioning

confidence: 99%

Reforming Paediatric Drug Regulations in Canada: A Clinical and an Access Imperative

Hepburn,

Chang,

Levy

2023

hcpol

View full text Add to dashboard Cite

show abstract

Urgent call for guidance supporting gene-based drug dosing in children and adolescents

Scodellaro

Cohn

2023

Paediatrics &Amp; Child Health

View full text Add to dashboard Cite

In the past decade, there have been tremendous advancements in the field of genomics that have led to significant progress in redefining the concept of precision medicine. Pharmacogenetics (PGx) is one of the most promising areas of precision medicine and is the ‘low hanging fruit’ of this individualized approach to medication dosing and selection. Although a variety of regulatory health agencies and professional consortia have established PGx clinical practice guidelines, implementation has been slow given numerous barriers faced by health care professionals. Many lack the training needed to interpret PGx and there are no paediatric specific guidelines. As the field of PGx continues to grow, an emphasis on collaborative inter-professional education, coupled with ongoing efforts to increase accessibility to advancing testing technology are necessary to translate this branch of precision medicine from the bench to the bedside.

show abstract

Time for a regulatory framework for pediatric medications in Canada

Abstract: In Canada, numerous medications prescribed to children are used off label and do not have an age-appropriate formulation.

Cited by 4 publications

References 7 publications

The 2023 Impact of Inflammatory Bowel Disease in Canada: Special Populations—Children and Adolescents with IBD

The 2023 Impact of Inflammatory Bowel Disease in Canada: Special Populations—Children and Adolescents with IBD

Reforming Paediatric Drug Regulations in Canada: A Clinical and an Access Imperative

Urgent call for guidance supporting gene-based drug dosing in children and adolescents

Contact Info

Product

Resources

About