A mixed methods study of the administration of flucloxacillin oral liquid; identifying strategies to overcome administration issues of medicines with poor palatability

Rouse, Claudia; Mistry, Punam; Rayner, Oli; Nickless, Jess; Wan, Mandy; Southern, Kevin W; Batchelor, Hannah

doi:10.1111/ijpp.12308

Cited by 13 publications

(13 citation statements)

References 18 publications

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“…Because of the uncertainty of translating these findings into clinical practice it would be useful to study pharmacodynamic target attainment of flucloxacillin concentrations in the variety of clinical settings in which oral flucloxacillin is prescribed. These findings in adults may not translate directly into the paediatric population and this would be worthy of further study given that oral administration of flucloxacillin is particularly difficult in children [ 27 ]. Finally, it should not be assumed that the findings of this study extend to other isoxazolyl penicillins, but this too warrants further investigation.…”

Section: Discussionmentioning

confidence: 99%

In healthy volunteers, taking flucloxacillin with food does not compromise effective plasma concentrations in most circumstances

et al. 2018

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It is usually recommended that flucloxacillin is given on an empty stomach. The aim of this study was to compare total and free flucloxacillin concentrations after oral flucloxacillin, given with and without food, based on contemporary pharmacokinetic and pharmacodynamic targets. Flucloxacillin 1000 mg orally was given to 12 volunteers, after a standardised breakfast and while fasting, on two separate occasions. Flucloxacillin concentrations over 12 hours were measured by liquid chromatography-tandem mass spectrometry. Pharmacokinetic parameters, and pharmacodynamic endpoints related to target concentration achievement, were compared in the fed and fasting states. For free flucloxacillin, the fed/fasting area under the concentration-time curve from zero to infinity (AUC0-∞) ratio was 0.80 (p<0.01, 90% CI 0.70–0.92), the peak concentraton (Cmax) ratio 0.51 (p<0.001, 0.42–0.62) and the time to peak concentration (Tmax) ratio 2.2 (p<0.001, 1.87–2.55). The ratios for total flucloxacillin concentrations were similar. The mean (90% CI) fed/fasting ratios of free concentrations exceeded for 30%, 50% and 70% of the first 6 hours post-dose were 0.74 (0.63–0.87, fed inferior p<0.01), 0.95 (0.81–1.11, bioequivalent) and 1.15 (0.97–1.36, fed non-inferior), respectively. Results for 8 hours post-dose and those predicted for steady state were similar. Comparison of probability of target attainments for fed versus fasting across a range of minimum inhibitory concentrations (MICs) were in line with these results. Overall, this study shows that food reduced the AUC0-∞ and Cmax, and prolonged the Tmax of both free and total flucloxacillin concentrations compared with the fasting state, but achievement of free concentration targets associated with efficacy was in most circumstances equivalent. These results suggest that taking flucloxacillin with food is unlikely to compromise efficacy in most circumstances.

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Section: Discussionmentioning

confidence: 99%

In healthy volunteers, taking flucloxacillin with food does not compromise effective plasma concentrations in most circumstances

et al. 2018

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“…Concentrated liquids had 1.5 times greater odds of being changed, indicating that the advantage of having a smaller volume may not compensate for the stronger taste. The opposite was found in a study of children with chronic disease, although this was believed to be caused by an age factor (24).…”

Section: Discussionmentioning

confidence: 81%

“…Drops were included as a separate variable, as the concentration of antibiotic liquids is believed to influence their use in children (24).…”

Section: Methodsmentioning

confidence: 99%

Requests for new oral antibiotic prescriptions in children within 2 days: a Norwegian population-based study

et al. 2018

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Background. Children commonly refuse to take antibiotics, which may induce parents to request new antibiotic prescriptions with different pharmaceutical characteristics. Objectives. To investigate prescription changes for children 0-12 years receiving oral liquid or solid antibiotic formulations and to explore the relationships between prescription changes and characteristics related to the child, prescriber and antibiotic. Methods. A population-based registry study based on data from the Norwegian Prescription Database (NorPD) from 2004 to 2016. Antibiotic prescription changes were defined as the dispensing of subsequent antibiotics with different pharmaceutical characteristics to the same child within 2 days after initial prescriptions. Data were analysed using multivariable logistic regression and generalized estimating equations. Results. Requests for new prescriptions followed 3.0% of 2 691 483 initial antibiotic prescriptions for children. Young children who received solid formulations (10.9%) and certain poor-tasting antibiotics (8.6%) had the highest proportions of new prescriptions. Penicillin V was most commonly changed, while macrolides/lincosamides dominated subsequent prescriptions. In order of magnitude, the characteristics associated with requests for new prescriptions were the children's ages, poor taste and concentration of liquids, size and shape of solids, prescribers born in recent decades, and girl patients. Reimbursed prescriptions and scored solids were associated with fewer requests. Conclusions. While only 3% of the antibiotic prescriptions were changed, the preference of broadspectrum over narrow-spectrum antibiotics for young children in this study mirrors international prescription patterns. Avoiding the costs of children's refusal and consequent changes may thus be a motivation for choosing more preferred antibiotics.

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“…In total, 16 articles describing nine existing questionnaires that primarily focus on assessing the acceptability of oral formulations among children (aged < 18 years) were identified [ 10 , 17 , 26 , 28 – 30 , 32 , 35 , 36 , 40 , 44 , 45 , 47 , 49 , 50 , 54 ], as shown in Fig. S2 (Additional file 5 ).…”

Section: Resultsmentioning

confidence: 99%

Development and content validation of the Pediatric Oral Medicines Acceptability Questionnaires (P-OMAQ): patient-reported and caregiver-reported outcome measures

Turner-Bowker

Haack

Krohe

et al. 2020

J Patient Rep Outcomes

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Background Evolving regulatory guidelines recommend routine assessment of the acceptability of pediatric oral medicines throughout clinical development processes. However, such assessment is problematic owing to a lack of standard methods or criteria that define acceptability for children and their caregivers. This research aimed to identify the attributes of acceptability for targeted oral formulation types that are important to children, and to develop content-valid patient- and caregiver-reported outcome acceptability measures for use in the context of clinical drug development. Methods A concept-focused literature review and two advisory panel meetings involving researchers, clinicians, and measurement scientists were conducted to identify acceptability attributes that may be relevant to children taking targeted oral medicine formulations. The Pediatric Oral Medicines Acceptability Questionnaires (P-OMAQs), including patient (P-OMAQ-P) and caregiver (P-OMAQ-C) versions, were drafted to assess these attributes. Qualitative concept elicitation (CE) and cognitive debriefing (CD) patient and caregiver interviews were conducted to confirm key acceptability attribute concepts for measurement and to evaluate patient and caregiver ability to understand and respond to the questions. Results A full-text review of 40 articles identified 24 acceptability attributes that were categorized into 10 overarching domains and organized into a preliminary conceptual model. Feedback from the advisory panel refined the preliminary model. In total, 14 attributes were reported during the CE phase of the interviews (n = 23 pediatric patients, n = 13 caregivers); six attributes were included in the final model. The draft P-OMAQ was refined over four waves of CD interviews (n = 31 pediatric patients, n = 48 caregivers). The final version of the P-OMAQ-P is a 12-item questionnaire designed for young people aged 8–17 years. The P-OMAQ-C is a 19-item questionnaire designed for adult caregivers of young people aged 6 months to 17 years. There are two versions of each questionnaire: one with a 24-h recall period and one with a 7-day recall period. All items are answered on a 5-point numerical rating scale. Conclusions This research supports the content validity of the patient and caregiver versions of the P-OMAQ. Both questionnaires appropriately assess the acceptability of oral medicine formulations from the perspective of pediatric patients and their caregivers.

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A mixed methods study of the administration of flucloxacillin oral liquid; identifying strategies to overcome administration issues of medicines with poor palatability

Abstract: The administration of flucloxacillin oral liquid is perceived as a challenge by parent/carers because of palatability. For chronic use, a more concentrated oral liquid and certain brands are likely to improve acceptability.

Cited by 13 publications

References 18 publications

In healthy volunteers, taking flucloxacillin with food does not compromise effective plasma concentrations in most circumstances

In healthy volunteers, taking flucloxacillin with food does not compromise effective plasma concentrations in most circumstances

Requests for new oral antibiotic prescriptions in children within 2 days: a Norwegian population-based study

Development and content validation of the Pediatric Oral Medicines Acceptability Questionnaires (P-OMAQ): patient-reported and caregiver-reported outcome measures

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