Barriers to administering non-oral formulations in a paediatric population: A semi-structured interview study

Venables, Rebecca Hayley; Batchelor, Hannah; Stirling, Heather; Marriott, John

doi:10.1016/j.ijpharm.2015.11.010

Cited by 7 publications

(6 citation statements)

References 22 publications

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“…The peroral route of drug administration was preferred by most participants. This is in accordance with earlier studies that describe barriers to administering non-peroral formulations to children [19]. Thus, in drug development and prescription, the focus should be on peroral drug formulations.…”

Section: Expectations Of the Ideal Pediatric Drug (Part B)supporting

confidence: 90%

Drug-handling problems and expectations of the ideal pediatric drug—reported by children and their parents

et al. 2022

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Experienced drug-handling problems and inadequately considered expectations for drug therapy have an unfavorable influence on therapy. We performed a questionnaire survey in (i) parents of 0–5-year-old children and (ii) 6–17-year olds and their parents. We assessed (A) experienced drug-handling problems and (B) expectations for drug therapy. (i) Forty-six parents and (ii) 103 children and their parents participated in the study. Experienced drug-handling problems were described by (i) 100% of parents and (ii) 62% of children and 70% of parents. Problems concerned with the preparation of the drug, dosing, compliance with the time interval, and acceptance. (i) Sixty-five percent of parents preferred a peroral route of drug administration, while (ii) 74% of children and 86% of parents did so. Preferred characteristics of peroral drug formulations, e.g., liquid versus solid drug formulations or flavor, were highly heterogeneous. Preferences of 6–17-year-old children and their parents matched in 43 to 66%. Conclusion: Most children and their parents had already experienced drug-handling problems. Preferences concerning the ideal pediatric drug were highly heterogeneous and in about half of cases, preferences of children and their parents differed. Thus, the children should be approached directly. If information is solely gained from parents, the children’s needs might remain unmet. What is Known:• Pediatric drug administration is complex and therefore error-prone.•Experiences and expectations of children and their parents should be considered. What is New:•Most pediatric patients and their parents have already experienced drug-handling problems.• Expectations concerning the ideal pediatric drug are highly heterogeneous. Parents are often insufficiently aware of those expectations in their children.

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Section: Expectations Of the Ideal Pediatric Drug (Part B)supporting

confidence: 90%

Drug-handling problems and expectations of the ideal pediatric drug—reported by children and their parents

et al. 2022

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show abstract

“…The peroral route of drug administration was preferred by most participants. This is in accordance with earlier studies that describe barriers to administering non-peroral formulations to children [21]. Thus, in drug development and prescription, the focus should be on peroral drug formulations.…”

Section: Expectations Of the Ideal Pediatric Drug (Part B)supporting

confidence: 90%

Drug-Handling Problems and Expectations of the Ideal Pediatric Drug — Reported by Children and Their Parents

Herziger

Jeschke

Müller

et al. 2021

Preprint

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Experienced drug-handling problems and inadequately considered expectations for drug therapy have an unfavorable influence on therapy. We performed a questionnaire survey in (i) parents of 0–5-year-old children and (ii) 6–17-year-olds and their parents. We assessed (A) experienced drug-handling problems and (B) expectations for drug therapy. (i) 46 parents and (ii) 103 children and their parents participated in the study. Experienced drug-handling problems were described by (i) 100% of parents and (ii) 62% of children and 70% of parents. Problems concerned the preparation of the drug, dosing, compliance with the time interval, and acceptance. (i) 65% of parents preferred a peroral route of drug administration, while (ii) 74% of children and 86% of parents did so. Preferred characteristics of peroral drug formulations, e.g. liquid versus solid drug formulations or flavor, were highly heterogeneous. Preferences of 6–17-year-old children and their parents matched in 43% to 66%. Conclusion: Most children and their parents had already experienced drug-handling problems. Preferences concerning the ideal pediatric drug were highly heterogeneous and in about half of cases, preferences of children and their parents differed. Thus, the children should be approached directly. If information is solely gained from parents, the children’s needs might remain unmet.

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“…The most frequently reported barriers to parenteral formulations were the refusal of the route of administration, the fear of pain and of the effects at the site of administration, and the difficulties in handling the administration devices. The dermal and transdermal routes were mainly associated with barriers related to texture/consistency [32]. Acceptability of rectal drug administration is considered poor and influenced by factors such as the age, the state of health and cultural barriers that illustrate important differences from one country to another [33].…”

Section: Dosage Form and Patient Acceptabilitymentioning

confidence: 99%

“…31 In contrast there is a paucity of evidence on the acceptability of nonoral dosage forms in paediatric patients. For inhaled formulations, Venables et al 32 identified barriers to administration issues related to device handling (face mask/spacer), and the inability of infants and small children to hold their breath, the inconvenience of preparation, uncertainty of dose accuracy, and palatability (taste/consistency/ texture). The most frequently reported barriers to parenteral formulations were the refusal of the route of administration, the fear of pain and of the effects at the site of administration, and the difficulties in handling the administration devices.…”

Section: Dosage Form and Patient Acceptabilitymentioning

confidence: 99%

Path towards efficient paediatric formulation development based on partnering with clinical pharmacologists and clinicians, a conect4children expert group white paper

Walsh¹,

Schaufelberger

Iurian

et al. 2021

Brit J Clinical Pharma

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Improved global access to novel age-appropriate formulations for paediatric subsets, either of new chemical entities or existing drugs, is a priority to ensure that medicines meet the needs of these patients. However, despite regulatory incentives, the introduction to the market of paediatric formulations still lags behind adult products. This is mainly caused by additional complexities associated with the development of acceptable age-appropriate paediatric medicines. This position paper recommends the use of a paediatric Quality Target Product Profile (pQTPP) as an efficient tool to facilitate early planning and decision making across all teams involved in paediatric formulation development during the children-centric formulation design for new chemical entities, or to repurpose/reformulate off-patent drugs. Essential key attributes of a paediatric formulation are suggested and described. Moreover, greater collaboration between formulation experts and clinical colleagues, including healthcare professionals, is advocated to lead to safe and effective, age-appropriate medicinal products. Acceptability testing should be a secondary endpoint in paediatric clinical trials to ensure postmarketing adherence is not compromised by a lack of acceptability. Not knowing the indications and the related age groups and potential dosing regimens early enough is still a major hurdle for efficient paediatric formulation development; however the proposed pQTPP could be a valuable collaborative tool for planning and decision making to expedite paediatric product development, particularly for those with limited experience in developing a paediatric product.

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Barriers to administering non-oral formulations in a paediatric population: A semi-structured interview study

Cited by 7 publications

References 22 publications

Drug-handling problems and expectations of the ideal pediatric drug—reported by children and their parents

Drug-handling problems and expectations of the ideal pediatric drug—reported by children and their parents

Drug-Handling Problems and Expectations of the Ideal Pediatric Drug — Reported by Children and Their Parents

Path towards efficient paediatric formulation development based on partnering with clinical pharmacologists and clinicians, a conect4children expert group white paper

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