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Related Concept Videos

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions01:15

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure (CHF).
Pharmacovigilance01:19

Pharmacovigilance

Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...

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Related Experiment Video

Updated: May 11, 2026

Utilizing Percutaneous Ventricular Assist Devices in Acute Myocardial Infarction Complicated by Cardiogenic Shock
06:10

Utilizing Percutaneous Ventricular Assist Devices in Acute Myocardial Infarction Complicated by Cardiogenic Shock

Published on: June 12, 2021

PCA safety data review after clinical decision support and smart pump technology implementation.

Judy Prewitt1, Susan Schneider, Monica Horvath

  • 1Duke University Hospital, Durham, North Carolina 27710, USA. prewi004@mc.duke.edu

Journal of Patient Safety
|May 24, 2013
PubMed
Summary

Implementing clinical decision support with CPOE and smart pumps significantly reduced patient-controlled analgesia (PCA) errors. This technology enhances opioid safety and decreases adverse events in hospitals.

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Last Updated: May 11, 2026

Utilizing Percutaneous Ventricular Assist Devices in Acute Myocardial Infarction Complicated by Cardiogenic Shock
06:10

Utilizing Percutaneous Ventricular Assist Devices in Acute Myocardial Infarction Complicated by Cardiogenic Shock

Published on: June 12, 2021

Area of Science:

  • Medical Informatics
  • Patient Safety
  • Pharmacology

Background:

  • Medication errors constitute 20% of U.S. medical errors, with prescribing and administration posing the highest risks.
  • Opioid analgesics, frequently used for pain management, can lead to patient harm if not prescribed or administered correctly.
  • Duke University Hospital implemented clinical decision support (CDS) using CPOE and smart pumps in February 2008 to mitigate patient-controlled analgesia (PCA) adverse events.

Purpose of the Study:

  • To evaluate the impact of CDS technology on PCA safety events.
  • To assess the reduction in adverse drug events (ADEs) related to opioid therapy in adult patients requiring analgesia.
  • To compare PCA safety pre- and post-implementation of CPOE and smart pump technology.

Main Methods:

  • A retrospective analysis of PCA safety events was conducted.
  • Data were collected from voluntary report systems and adverse drug events via surveillance (ADE-S).
  • Intermediate and step-down units were included, comparing pre- and post-implementation periods of CDS.

Main Results:

  • Adverse drug events via surveillance (ADE-S) PCA events per 1000 PCA days decreased by 22% (5.3 to 4.2, P=0.09).
  • Voluntary report system PCA events decreased by 72% (2.4 to 0.66 per 1000 PCA days, P < 0.001).
  • Causality in ADE-S data showed statistical significance (P < 0.0001), with sleep apnea and renal insufficiency approaching significance; obesity and weight were significant for voluntary reports.

Conclusions:

  • The study demonstrated a significant decrease in PCA events following the implementation of CDS.
  • Both ADE-S and voluntary reporting systems indicated improved patient safety.
  • Clinical decision support via CPOE and PCA smart pump technology is recommended for enhancing opioid safety.