INTRODUCTION
Before a drug can be approved for sale in a given market, governmental authorities in each country have to assess its safety, efficacy, and quality. At the end of this process, pharmaceutical companies are granted market authorization, and the drug gets a license for marketing in the country (e.g., Notice of Compliance in Canada). The drug also has a label (i.e. drug monograph), specifying the details for drug use (e.g., target population, dose, indication, specific use).
Virtually all drugs that get an approval for use in adults should also get an approval for use in children; this is often not the case considering the paucity of clinical research for that population. Therefore, drug monographs are frequently silent about the use of the drug in children. However, in most legislation, clinicians can prescribe to children a drug approved for adult (i.e., an off-label use). In some case, clinicians must also import from another country a drug that has not obtained a license for marketing (i.e., an unlicensed use). Both situations expose clinicians and patients to delays, costs, and risks. In response to these challenges, governmental authorities have established various strategies and regulations to oversee and promote clinical research in children and hopefully to decrease both unlicensed and off-label drug uses.
In 1997, the US Food and Drug Administration (FDA) adopted the FDA Modernization Act (FDAMA),1 followed in 2002 by the Best Pharmaceuticals for Children Act (BPCA),2 which provided an incentive for drug companies to conduct FDA-requested pediatric studies. In 2003, the FDA also created the Pediatric Research Equity Act (PREA), which requires drug companies to study their products in children under certain circumstances.3 In Europe, the European Medicines Agency (EMA) created the European (EU) Pediatric Regulation, in 2007.4 Its objective was to improve the health of children in Europe by facilitating the development and availability of medicines for that population. In other countries, such as in Canada, the Pediatric Expert Advisory Committee was created in 2009 to provide advice to Health-Canada in the development, licensing, and post-approval monitoring of drugs.5
Our hypothesis was that even though these initiatives were not implemented to decrease unlicensed or off-label drug use rates, they probably would have a favorable consequence on those uses. Ten years after the first regulations, we could expect that the prevalence of unlicensed and off-label prescriptions in children would have decreased. Thus, we reviewed the literature to explore the effect of the regulatory changes.
The primary objective of this literature review was to determine the effect of governmental initiatives to improve clinical research in children on unlicensed and off-label drug uses in inpatient and outpatient settings in the world. The secondary objective was to determine the unlicensed and off-label drug use rates in countries where no governmental initiatives to improve clinical research in children have been implemented.
Panther, S. G., Knotts, A. M., Odom-Maryon, T., Daratha, K., Woo, T., & Klein, T. A. (2017). Off-label prescribing trends for ADHD medications in very young children. The Journal of Pediatric Pharmacology and Therapeutics, 22(6), 423–429. doi:10.5863/1551-6776-22.6.423
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Solution
Off-label prescribing involves the prescription of drugs approved by the U.S. Food and Drug Administration (FDA) for the treatment of diseases other than the condition being treated (Panther et al., 2017). Prescription of these drugs to children is done under multiple circumstances including when limited clinical research is available regarding the treatment of children with particular infections. The absence of effective, licensed, standard and safe therapeutic options for specific health conditions also promote the use of off-label drugs in children. Moreover, the easy access of these medicines as well as the doctor’s knowledge of the child’s illness can result in these prescriptions. For example the FDA prohibitive costs makes the availability of approved drugs expensive and time consuming especially when the child is in a critical condition (Corny et al., 2015).
The strategies for making the off-label use and dosage of drugs safer for children from infancy to adolescence include development of medications suitable for all age groups (Rosenthal & Burchum, 2018). As such, the formulation, taste and strength of drugs should be accommodative to various ages. In addition, pharmaceuticals should be restricted from manufacturing and marketing these products for purposes other than safety and effectiveness. Physicians should also prescribe the drugs for t
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