Paeds Vivas · clinical-pharmacology-and-therapeutics
Medication adherence and formulation challenges — branching viva
Branching oral examination on the dimensions of adherence, the formulation gap and palatability science, age-appropriate formulation choice, excipient safety in neonates, the stepwise formulation-and-adherence pathway, and the regional regulatory frameworks closing the formulation gap.
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Medication adherence and formulation challenges — branching viva
Opening (warm-up)
Examiner: "You are the general paediatric registrar in the transplant clinic. A six-year-old renal transplant recipient has had erratic tacrolimus levels for three months despite a correct weight-based dose. I've just asked the mother how he takes it, and she tells me he spits out the bitter liquid and the half-tablets crumble. Reframe this for me — is this a pharmacology problem?" [2]
Model answer: No — this is a formulation-and-adherence problem wearing a pharmacology disguise. The dose is correct but the child cannot take the formulation he has been given, so the level bounces. Before I touch the dose I would treat the erratic level as adherence-until-proven-otherwise, ask openly how he actually takes the medicine, and fix the formulation. Adherence is a property of the prescribing, not of the child. [1] [2]
References8ShowHide
- [1]Nunn T Formulation of medicines for children. Br J Clin Pharmacol, 2005.PMID 15948931
- [2]Dean AJ A systematic review of interventions to enhance medication adherence in children and adolescents with chronic illness. Arch Dis Child, 2010.PMID 20522463
- [3]Mennella JA Optimizing oral medications for children. Clin Ther, 2008.PMID 19108800
- [5]Salunke S The STEP (Safety and Toxicity of Excipients for Paediatrics) database: part 2 - the pilot version. Int J Pharm, 2013.PMID 24070789
- [6]Allegaert K Neonates need tailored drug formulations. World J Clin Pediatr, 2013.PMID 25254168
- [7]Palmeirim MS Efficacy, safety and acceptability of a new chewable formulation versus the solid tablet of mebendazole against hookworm infections in children: a randomised controlled trial. EClinicalMedicine, 2020.PMID 33150325
- [9]Münch J, Sessler I, Bosse HM, et al. Evaluating the Acceptability, Swallowability, and Palatability of Film-Coated Mini-Tablet Formulation in Young Children. Pharmaceutics, 2023.PMID 37376177
- [12]Edgcomb JB Medication Adherence Among Children and Adolescents with Severe Mental Illness: A Systematic Review and Meta-Analysis. J Child Adolesc Psychopharmacol, 2018.PMID 30040434