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A Comprehensive List of Items to be Included on a Pediatric Drug Monograph
Insights
Healthcare providers identified 116 essential items for pediatric drug monographs. This consensus-based list will standardize international pediatric formulary development and improve medication safety for children.
Area of Science:
- Pediatric pharmacology
- Drug information science
Background:
- Children require specialized drug information for safe prescribing.
- Pediatric drug monographs are crucial for effective medication use in children.
- Current knowledge on information needs for pediatric drug monographs is limited.
Purpose of the Study:
- To identify key information items for pediatric drug monographs.
- To establish a consensus-based list of essential monograph components.
Main Methods:
- An expert steering committee and environmental scan were established.
- A 2-round Delphi survey was conducted with 46 international participants.
- An international consensus meeting finalized the list of monograph items.
Main Results:
- Pediatric formularies are the primary resource for medication information in children.
- 116 important items were identified for comprehensive pediatric drug monographs.
- Key items include general information, adverse reactions, dosages, precautions, drug interactions, formulation, and drug properties.
Conclusions:
- International consensus identified 116 critical items for pediatric drug monographs.
- This list will aid in developing standardized pediatric drug monographs globally.
- The findings support international formulary development for pediatric medication safety.
Objectives:
Children require special considerations for drug prescribing. Drug information summarized in a formulary containing drug monographs is essential for safe and effective prescribing. Currently, little is known about the information needs of those who prescribe and administer medicines to children. Our primary objective was to identify a list of important and relevant items to be included in a pediatric drug monograph.
Methods:
Following the establishment of an expert steering committee and an environmental scan of adult and pediatric formulary monograph items, 46 participants from 25 countries were invited to complete a 2-round Delphi survey. Questions regarding source of prescribing information and importance of items were recorded. An international consensus meeting to vote on and finalize the items list with the steering committee followed.
Results:
Pediatric formularies are most commonly the first resource consulted for information on medication used in children by 31 Delphi participants. After the Delphi rounds, 116 items were identified to be included in a comprehensive pediatric drug monograph, including general information, adverse drug reactions, dosages, precautions, drug-drug interactions, formulation, and drug properties.
Conclusions:
Health care providers identified 116 monograph items as important for prescribing medicines for children by an international consensus-based process. This information will assist in setting standards for the creation of new pediatric drug monographs for international application and for those involved in pediatric formulary development.
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