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Related Experiment Video

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Event Related Potentials ERPs and other EEG Based Methods for Extracting Biomarkers of Brain Dysfunction: Examples from Pediatric Attention Deficit/Hyperactivity Disorder ADHD
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Regulatory action and moderate decrease in methylphenidate use among ADHD diagnosed patients aged five and under in

Ju-Young Shin1, Shin Haeng Lee1, Sun Mi Shin1

  • 1Korea Institute of Drug Safety and Risk Management (KIDS), Seoul, Republic of Korea.

Regulatory Toxicology and Pharmacology : RTP
|May 11, 2015
PubMed
Summary
This summary is machine-generated.

Korean regulators restricted methylphenidate for young children due to cardiac risks. This action moderately decreased its contraindicated use in children with attention deficit-hyperactivity disorder (ADHD), despite an earlier decline.

Keywords:
ADHDChildrenMethylphenidatePopulation-based study

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Area of Science:

  • Pharmacovigilance and Public Health Policy
  • Pediatric Pharmacology
  • Regulatory Science

Background:

  • Methylphenidate is a common treatment for attention deficit-hyperactivity disorder (ADHD).
  • Concerns regarding cardiac risks, including sudden cardiac death, led to regulatory scrutiny for its use in young children.
  • A Korean regulatory agency issued a directive in December 2009 restricting methylphenidate use in children aged five and under.

Purpose of the Study:

  • To evaluate the impact of the Korean regulatory action on methylphenidate prescribing patterns in children with ADHD.
  • To quantify the reduction in contraindicated methylphenidate use following the regulatory announcement.

Main Methods:

  • A time series analysis was performed using the Korea National Health Insurance Service database.
  • The study included children under 18 years old diagnosed with ADHD from January 2007 to December 2011.
  • Contraindicated use was defined as methylphenidate prescription in children aged five and under; reductions were analyzed around control points (2007, 2008, 2009, 2010).

Main Results:

  • The study analyzed 376,298 ADHD patients.
  • Overall, a 70.87% relative reduction and a 0.93% absolute reduction in contraindicated methylphenidate use were observed.
  • Significant reductions were noted in the years following the regulatory action, although a decline was already apparent prior to the directive.

Conclusions:

  • The Korean regulatory action contributed to a moderate decrease in the contraindicated use of methylphenidate in young children with ADHD.
  • The findings highlight the impact of regulatory interventions on medication prescribing, even when trends are already shifting.
  • Continued monitoring of drug safety and prescribing practices in pediatric populations is crucial.