Young HIV-Infected Children and Their Adult Caregivers Prefer Tablets to Syrup Antiretroviral Medications in Africa

Nahirya-Ntege, P.; Cook, Adrian; Vhembo, Tichaona; Opilo, Wilfred; Namuddu, R.; Katuramu, Richard; Tezikyabbiri, Jessica; Naidoo-James, Bethany; Gibb, Diana M

doi:10.1371/journal.pone.0036186

Cited by 34 publications

(31 citation statements)

References 23 publications

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“…In contrast to our findings, a recent study in Zambia and Uganda found that parents/caregivers preferred pills over syrups for antiretroviral therapy for children above age 3 due to the number, weight, difficult transportation and conspicuousness of the bottles, though investigators did not explore the drawbacks of crushing solid formulations (reduced palatability, lower dosing accuracy, and pharmacokinetic changes) in depth [23].…”

Section: Discussioncontrasting

confidence: 99%

Children’s Medicines in Tanzania: A National Survey of Administration Practices and Preferences

et al. 2013

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ObjectiveThe dearth of age-appropriate formulations of many medicines for children poses a major challenge to pediatric therapeutic practice, adherence, and health care delivery worldwide. We provide information on current administration practices of pediatric medicines and describe key stakeholder preferences for new formulation characteristics.Patients and MethodsWe surveyed children aged 6–12 years, parents/caregivers over age 18 with children under age 12, and healthcare workers in 10 regions of Tanzania to determine current pediatric medicine prescription and administration practices as well as preferences for new formulations. Analyses were stratified by setting, pediatric age group, parent/caregiver education, and healthcare worker cadre.ResultsComplete data were available for 206 children, 202 parents/caregivers, and 202 healthcare workers. Swallowing oral solid dosage forms whole or crushing/dissolving them and mixing with water were the two most frequently reported methods of administration. Children frequently reported disliking medication taste, and many had vomited doses. Healthcare workers reported medicine availability most significantly influences prescribing practices. Most parents/caregivers and children prefer sweet-tasting medicine. Parents/caregivers and healthcare workers prefer oral liquid dosage forms for young children, and had similar thresholds for the maximum number of oral solid dosage forms children at different ages can take.ConclusionsThere are many impediments to acceptable and accurate administration of medicines to children. Current practices are associated with poor tolerability and the potential for under- or over-dosing. Children, parents/caregivers, and healthcare workers in Tanzania have clear preferences for tastes and formulations, which should inform the development, manufacturing, and marketing of pediatric medications for resource-limited settings.

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Section: Discussioncontrasting

confidence: 99%

Children’s Medicines in Tanzania: A National Survey of Administration Practices and Preferences

et al. 2013

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“…For example, Yeung and Wong found that children with HIV as young as 3 years were prescribed stavudine as a solid dosage form. In a recent study in Uganda and Zimbabwe, 36% of children were able to swallow antiretroviral tablets intact (mean age 3.3 years), while 64% required them to be crushed or dispersed (mean age 2.9 years) …”

Section: Discussionmentioning

confidence: 99%

Evidence of acceptability of oral paediatric medicines: a review*

Mistry

Batchelor

2016

Journal of Pharmacy and Pharmacology

109

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Objectives The aim of this review was to map the currently available evidence on acceptability of oral paediatric medicines to aid in the selection of suitable platform formulations for the development of new acceptable paediatric products. Methods This process used a defined search strategy of indexed publications and included methods to assess the quality of the evidence retrieved. Key findings Taste/palatability was the most extensively studied area of paediatric medicine acceptability yet standard methods or criteria that define what is classed as acceptable to children is still to be defined. There have been many reports on the acceptability of medicines to paediatric populations yet major gaps in the acceptability knowledge base exist including the shape and dimensions of tablets, minitablets and capsules swallowed whole in infants and children; size and overall volume of multiparticulates; volume of liquids completely swallowed in infants and children; duration of retention within the oral cavity, size and taste of orodispersible tablets, lozenges and chewable tablets and the number of solid units dosed at each time point. Conclusions The review highlights where further information is required to support knowledge around acceptability of age-appropriate medicines. An algorithm to aid in selection of a formulation that is likely to be acceptable based on the age range to be treated by the medicine is presented as a result of this review. IntroductionThere is much evidence to support the need for age-appropriate medicines to treat paediatric patients. Pharmaceutical products for the paediatric population have a number of considerations that may not apply to adult products. In particular, the acceptability of a product needs to be clearly defined for paediatric populations and this is currently an area of great interest.The importance and incentive to study the acceptability, including palatability, of paediatric formulations was discussed in the reflection paper [1] and endorsed in the latest European Paediatric guideline on pharmaceutical development of formulations for paediatric use.[2] Before this regulatory change, there was no requirement for medicines to be demonstrated to be acceptable to children. Guidance issued by the European Medicines Agency (EMA) in 2013 states that patient acceptability must be an integral part of paediatric formulation development and described in the paediatric investigation plan (PIP).[3] Acceptability has previously been defined as 'an overall ability of the patient and caregiver (defined as "user") to use a medicinal product as intended (or authorised)'.[4] The palatability of paediatric medicines is one of the most important formulation factors in the acceptability of liquid medicines with potential to influence adherence to therapeutic regimens and outcomes.[5] Palatability has been defined as, 'the overall appreciation of a (often oral) medicine by organoleptic properties such as vision (appearance), smell, taste, aftertaste and mouth feel (e.g. texture, cooli...

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“…Nevertheless, evidence has shown that children as young as 3 years old are able to swallow conventional tablets and capsules (Nahirya-Ntege et al, 2012, Kaplan et al, 2010, Czyzewski et al, 2000. On the other hand, older children and adolescents have reported swallowing difficulties, including as a barrier to adherence in chronic conditions (Hansen et al, 2008, Polaha et al, 2008, Hommel and Baldassano, 2010, Modi et al, 2013.…”

Section: Tablets and Capsulesmentioning

confidence: 99%

Age-appropriate and acceptable paediatric dosage forms: Insights into end-user perceptions, preferences and practices from the Children’s Acceptability of Oral Formulations (CALF) Study

Ranmal¹,

Cram

Tuleu³

2016

International Journal of Pharmaceutics

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A lack of evidence to guide the design of age-appropriate and acceptable dosage forms has been a longstanding knowledge gap in paediatric formulation development. The Children's Acceptability of Oral Formulations (CALF) study captured end-user perceptions and practices with a focus on solid oral dosage forms, namely tablets, capsules, chewables, orodispersibles, multiparticulates (administered with food) and mini-tablets (administered directly into the mouth). A rigorous development and testing phase produced age-adapted questionnaires as measurement tools with strong evidence of validity and reliability. Overall, 590 school children and adolescents, and 428 adult caregivers were surveyed across hospitals and various community settings. Attitudes towards dosage forms primarily differed based on age and prior use. Positive attitudes to tablets and capsules increased with age until around 14 years. Preference was seen for chewable and orodispersible preparations across ages, while multiparticulates were seemingly less favourable. Overall, 59.6% of school children reported willingness to take 10mm diameter tablets, although only 32.1% of caregivers perceived this size to be suitable. While not to be taken as prescriptive guidance, the results of this study provide some evidence towards rational dosage form design, as well as methodological approaches to help design tools for further evaluation of acceptability within paediatric studies.

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Young HIV-Infected Children and Their Adult Caregivers Prefer Tablets to Syrup Antiretroviral Medications in Africa

Cited by 34 publications

References 23 publications

Children’s Medicines in Tanzania: A National Survey of Administration Practices and Preferences

Children’s Medicines in Tanzania: A National Survey of Administration Practices and Preferences

Evidence of acceptability of oral paediatric medicines: a review*

Age-appropriate and acceptable paediatric dosage forms: Insights into end-user perceptions, preferences and practices from the Children’s Acceptability of Oral Formulations (CALF) Study

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