A Comprehensive List of Items to be Included on a Pediatric Drug Monograph

Abstract

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.

Development of a provisional essential medicines list for children in Canada: consensus process

“…21,22 The process for developing the British National Formulary for Children and the Dutch Paediatric Formulary is aligned with the process for developing our child essential medicines list: collaboration; consulting expert clinical advisors, the literature, systematic reviews, consensus guidelines, reference sources and comments from readers; and continuous revision are important components. 23 The British National Formulary for Children also includes information in such areas as how to use the formulary, selecting suitable preparations, dosage selection and writing prescriptions. 21 Likewise, South Africa includes these details around the development process for their Standard Treatment Guidelines and Essential Medicines List for hospital-level pediatrics, as does India for their Essential Medicines List for Children of India.…”

Development of one paediatric and one neonatal formulary list in hospital settings

“…Since dosages guidelines were not part of the presented lists, this issue was discussed in depth with the medical doctors. The lack of evidenced‐based drug monographs containing information regarding paediatric prescribing is clearly a threat to safe and effective medicine use . This step will be very time‐consuming, will require national collaboration, was not feasible within the initial 3‐year funding and is an obvious limitation of this project.…”

Development and Evaluation of a Web-Based Paediatric Drug Information System for Germany

“…A Delphi survey with 31 HCP from more than six continents by Kelly et al demonstrated that besides dosing information (licensed and off-label indications), formulations, adverse drug reactions, precautions, and drug-drug interactions should be included in a paediatric drug monograph [7]. Particularly the answers to the open-ended questions of the user test helped to adapt the PDIS to the needs of the German end-users, which were in line with the items identified by Kelly et al Another important finding of the online user test was the high demand for a dosage calculator.…”

“…For some drugs and indications, data from, e.g., clinical trials are available, and a well-established, evidence-based use can be assumed. On the other hand, a paediatric license does not imply high-level evidence for the use in children and that the latest scientific data are integrated into the license [ 6 , 7 ]. Furthermore, off-label use leads to significant variability of therapeutic approaches [ 8 , 9 ].…”

“…Paediatric drug formularies are an essential source of information regarding the use of medicines for children [ 7 ]. They are needed to support the rational use of drugs, particularly when they are used outside the terms of their license, and to move away from practice-based, empirical to systematic and evidence-based pharmacotherapy [ 11 ].…”