Focusing on Paediatric and Maternal Health

It is increasingly understood that children are not small adults. Paediatric tissues, organs, and biological systems are still developing. Rapid growth and development from infancy through adolescence means that the absorption, distribution and elimination of health products are different for children than for adults. Similarly, pregnant and nursing women's bodies and biological systems differ from those of other women.

The challenge is that children are at risk to illnesses and injuries that may require therapies like medicines. Likewise, a woman with a chronic health condition may become pregnant or start nursing, while some develop a condition during their pregnancy or while nursing.

Health Canada, like other regulatory authorities around the world, recognizes the need to strengthen information related to paediatric and maternal health. The Office of Paediatric Initiatives was established to address this need.

Closing the Information Gap for Health Products

The challenge is that children are often treated with health products developed and tested on adults. As a result, many health products may not have sufficient information on the label to guide their proper use in this population. This information gap makes it difficult to make informed health decisions. Parents, health care professionals and paediatricians often have to research information from a variety of technical resources, usually on a case-by-case basis.

Health product labelling information usually states what health condition(s) it can be used to treat, who should or should not use it, how much to take, and how often to take it. This information is rigorously tested and verified before it can be authorized for sale through human clinical trials.

Clinical trials are used to determine whether a drug is safe and effective, what dosages are most effective, and what side effects a drug may cause. Many clinical trials, however, exclude children because of real or perceived potential harm. Likewise, pregnant and nursing women are generally excluded from clinical trials because of real or perceived potential harm to the woman, developing foetus and/or infant.

In the past, data from adult clinical trials was used to help determine how a health product could be used in children. While many manufacturers of health products simply added a warning "do not use if pregnant or while nursing" without having adequately confirmed benefits or risks. It's becoming better understood that these approaches may not always work and that more and better information could be made available to address the unique safety needs of these populations. It is hoped this would then improve access to health products appropriately tested and labelled for use by children, pregnant and nursing women.

Promoting good food and nutrition

While health products play a key role in protecting and promoting the health and safety of Canada's children and pregnant and nursing women, eating a nutritious and balanced diet is one of the best ways to protect and promote good health.

Health Canada's Office of Nutrition Policy and Promotion and Food Directorate are responsible for matters related to food safety and nutrition. There is a need to ensure that Health Canada's policies and standards on the safety and nutritional value of food address the unique needs of children and pregnant and nursing women, and that these populations have access to reliable information to guide healthy food choices and meet nutritional needs.

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