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Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
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Related Experiment Video

Updated: May 6, 2026

Multiplex Therapeutic Drug Monitoring by Isotope-dilution HPLC-MS/MS of Antibiotics in Critical Illnesses
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A single institution's effort to translate codeine knowledge into specific clinical practice.

Joel Jerome1, Jean C Solodiuk2, Navil Sethna3

  • 1Boston Children's Hospital, Boston, Massachusetts, USA; Northeastern University, Boston, Massachusetts, USA.

Journal of Pain and Symptom Management
|November 12, 2013
PubMed
Summary
This summary is machine-generated.

Codeine, an unpredictable pain reliever, was successfully eliminated from a pediatric hospital formulary through orderset changes and prescriber education, significantly reducing its use.

Keywords:
CYP 2D6Quality improvementadverse effectsanalgesicscodeineopioidpainpediatrics

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Area of Science:

  • Pediatric pharmacology
  • Medication safety
  • Quality improvement initiatives

Background:

  • Codeine exhibits unpredictable analgesic effects due to variable pharmacokinetics, pharmacodynamics, and pharmacogenetics.
  • This variability can result in inadequate pain relief or serious adverse events like respiratory depression.
  • Despite known risks, codeine remained in use at a pediatric tertiary medical institution.

Purpose of the Study:

  • To assess the frequency of codeine orders compared to similar institutions.
  • To implement interventions aimed at reducing codeine utilization.
  • To eliminate codeine from the hospital formulary.

Main Methods:

  • A retrospective/prospective metric using Pediatric Health Information Systems data was employed.
  • Interventions included prescriber education and modifying ordersets to substitute codeine with oxycodone or age-appropriate alternatives.
  • Key barriers to change were identified and addressed.

Main Results:

  • Codeine use decreased by 97% between Q1 2008 and Q3 2012.
  • Orderset modifications and educational efforts were key to this reduction.
  • Codeine was fully removed from the hospital formulary in January 2013.

Conclusions:

  • The quality improvement initiative effectively eliminated codeine from the hospital formulary.
  • While education played a role, direct orderset changes and addressing barriers were most impactful for knowledge translation.
  • This demonstrates a successful strategy for removing problematic medications from clinical practice.