title: Barriers to administering non-oral formulations in a paediatric population: A semi-structured interview study.
abstract: There is a paucity of research exploring barriers to non-oral medicines administration in paediatric patients; however, these undoubtedly influence medicines adherence. Studies conducted with healthcare professionals have identified various issues with the administration and acceptance of non-oral medicines and devices (Venables et al., 2012; Walsh et al., 2015). EMA (2014) guidelines specify that formulation teams should demonstrate 'acceptability' of paediatric formulations when developing pharmaceutical formulations. Semi-structured interviews exploring barriers to administering non-oral medicines were conducted with young persons and the parents/legal guardians of children (0-17 years) with chronic conditions at the University Hospital of Coventry and Warwickshire, UK. 90 children prescribed a total of 148 non-oral medicines were recruited to the study; 88 barriers to administering non-oral medicines were reported. The most commonly reported barriers were: poor acceptance of face mask/difficulties with spacer for inhaled formulations (38% of reports); disliking parenteral/preferring alternative formulations (38% of reports); greasy texture of topical preparations; difficulty with administering an ocular ointment and the large dose volume of a nasal preparation. Formulation teams should consider the use of child-friendly, age-appropriate designs to improve usability and acceptance, thus medicines adherence. These findings should be used to inform future development of non-oral formulations and devices, suitable in terms of safety, efficacy and acceptability to paediatric patients.
authors.affiliation: School of Pharmacy, Keele University, Keele, Staffordshire ST5 5BG, UK; Pharmacy and Therapeutics Section, School of Clinical and Experimental Medicine, College of Medical and Dental Sciences (CMDS), Medical School Building, University of Birmingham, Edgbaston B15 2TT, UK. Electronic address: becv_20@hotmail.co.uk.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Venables
authors.affiliation: Pharmacy and Therapeutics Section, School of Clinical and Experimental Medicine, College of Medical and Dental Sciences (CMDS), Medical School Building, University of Birmingham, Edgbaston B15 2TT, UK.
authors.forename: Hannah
authors.initials: H
authors.lastname: Batchelor
authors.affiliation: Pharmacy and Therapeutics Section, School of Clinical and Experimental Medicine, College of Medical and Dental Sciences (CMDS), Medical School Building, University of Birmingham, Edgbaston B15 2TT, UK; University Hospitals Coventry and Warwickshire, Paediatric Department, Clifford Bridge Road, Walsgrave, Coventry CV22DX, UK.
authors.forename: Heather
authors.initials: H
authors.lastname: Stirling
authors.affiliation: Pharmacy and Therapeutics Section, School of Clinical and Experimental Medicine, College of Medical and Dental Sciences (CMDS), Medical School Building, University of Birmingham, Edgbaston B15 2TT, UK.
authors.forename: John
authors.initials: J
authors.lastname: Marriott
mesh_terms: D000279:Administration, Cutaneous; D000280:Administration, Inhalation; D000281:Administration, Intranasal; D060433:Administration, Ophthalmic; D000285:Administration, Rectal; D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D004343:Drug Implants; D005260:Female; D017144:Focus Groups; D007722:Health Knowledge, Attitudes, Practice; D006282:Health Personnel / Q000523:psychology; D006801:Humans; D007223:Infant; D007267:Injections / Q000523:psychology; D007407:Interviews as Topic; D008297:Male; D055118:Medication Adherence / Q000523:psychology*; D010290:Parents / Q000523:psychology; D010372:Pediatrics / Q000379:methods*; D004364:Pharmaceutical Preparations / Q000008:administration & dosage*; D057566:Self Report
chemical_list: D004343:Drug Implants; D004364:Pharmaceutical Preparations
keywords: Acceptability; Barriers to administration; Device; Formulation; Medicine; Pediatric; Usability