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Safe medication levels for children





The pediatric population is especially prone to medication errors, as age- and weight-based dosing guidelines are often inapplicable to children. Historically, performing studies in children was considered immoral and even unnecessary. But, with children increasingly diagnosed with conditions previously thought to afflict only adults, the need to conduct clinical trials in this population became apparent by the 1990s.

Recognizing the unmet need, Congress passed the Pediatric Exclusivity Provision under the FDA Modernization Act in 1997, allowing manufacturers an additional six months of patent protection for new drugs, if pediatric studies were conducted. Additionally, the Food & Drug Administration's "Pediatric Rule," mandated in 1998, required manufacturers to conduct pediatric studies if it was anticipated that a new drug might be widely used in children or if the new drug offered significant medical advantages over other available products. As a result of these initiatives, more than 200 studies in children have been launched, leading to the realization that drugs that are effective for adults do not always work well in children. As Benedetto Vitiello, M.D., a physician with the Child and Adolescent Treatment and Preventive Intervention Research Branch at the National Institute of Mental Health, recently said on PBS' "Frontline," "Children are not just young adults. They can react to medication in different ways. It is not safe to take information from adults and try to apply it to children."



Currently, more than two thirds of medications used in pediatric populations remain unstudied in children. The situation has become increasingly problematic as more children are prescribed medications previously thought only to be appropriate in adults, including diabetic medications, antihypertensives, antihyperlipidemic agents, psychotropic drugs, and cough and cold products. What are the current prescribing trends and controversial issues that impact pediatric therapeutic management?

Diabetes and cardiovascular disease

When most pharmacists think of Type 2 diabetes or cardiovascular disease, children are not usually the patients that come to mind. However, the incidence of these conditions is rising among young people, according to a recent report presented at the annual American Public Health Association meeting in Washington, D.C., which detailed a collaboration between Saint Louis University School of Medicine and School of Public Health as well as Express Scripts, the pharmacy benefits manager.



Using claims and eligibility information for more than 3.5 million children enrolled with Express Scripts, a substantial increase in the use of oral hypoglycemic agents was noted between 2002 and 2005. Specifically, among adolescent females, a 166% increase was observed, followed by a lower increase in use —39%—among adolescent males.

According to Emily Cox, Ph.D., R.Ph., a senior research director at Express Scripts, "From our data, metformin accounts for 83% of all oral hypoglycemic drugs prescribed to adolescents." Why the sharp increase in use of hypoglycemics among female youngsters? "Without further research, conclusions can't be made about the unusual trend of such a large rate of increase in Type 2 diabetic medications in girls and not boys," said Cox, but she speculated, "the magnitude of increase in female use over males may be due to differing rates of screening, office visits, and medication compliance."


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