Date Published: February 28, 2018
Publisher: Public Library of Science
Author(s): Hamad Alyami, Jasdip Koner, Chi Huynh, David Terry, Afzal R. Mohammed, Catherine Tuleu.
The appropriate prescribing of paediatric dosage forms is paramount in providing the desired therapeutic effect alongside successful medication adherence with the paediatric population. Often it is the opinion of the healthcare practitioner that dictates which type of dosage form would be most appropriate for the paediatric patient, with liquids being both the most commonly available and most commonly used. Orally disintegrating tablets (ODTs) are an emerging dosage form which provide many benefits over traditional dosage forms for paediatric patients, such as rapid disintegration within the oral cavity, and the reduction in the risk of choking. However the opinion and professional use of healthcare practitioners regarding ODT’s is not known. This study was designed to assess the opinions of several types of healthcare professionals (n = 41) regarding ODTs, using a survey across two hospital sites. Results reaffirmed the popularity of liquids for prescribing in paediatrics, with 58.0% of participants preferring this dosage form. ODTs emerged as the second most popular dosage form (30.0%), with healthcare practitioners indicating an increasing popularity amongst patients in the hospital setting, belief with 63.0% of practitioners agreeing that many liquid formulations could be substituted with a suitable ODT. The desired properties of an ideal ODT were also identified by healthcare practitioners preferring a small, fast disintegrating tablet (90.2% and 95.1% respectively), with the taste, disintegration time and flavour being the three most important attributes identified (29.5%, 28.7% and 21.7% respectively). This study provided a pragmatic approach in assessing healthcare professional’s opinions on ODTs, highlighting the ideas and thoughts of practitioners who are on the frontline of paediatric prescribing and treatment and gave an indication to their preference for ODT properties.
The European Medicines Agency (EMA) recognised that there was limited data concerning paediatric population acceptance of oral dosage forms in relation to age and developmental status, along with the inadequate availability of licensed medicines appropriate for administration to children . In addition, there is anecdotal evidence that there are increasing concerns amongst healthcare professionals about paediatric patients failing to take their prescribed medication . Many medicines are formulated to enable usage in adults, which may not be suitable for use by children. There may be difficulties in swallowing solid dosage forms (e.g. tablets) and there may be issues concerning the availability of the dose strength, based on current dosage forms available. Many children will require doses smaller than adults, prompting the use of liquids or splitting the dose of solid tablets by cutting them into halves and quarters. If suitable dosage forms are not available then patient compliance with prescribed medication may be reduced with potential adverse clinical consequences .
The presentation of the findings is divided into three phases. The first phase reports the focus groups of healthcare professionals; the second phase addresses the semi-structured interviews and the third phase (main phase) presents the online survey for healthcare professionals concerning paediatric dosage forms. The healthcare professionals that were selected to participate in this study were medical practitioners, pharmacists and nurses. The rational for selection of HCPs was to show the relationship leading from the prescribing (doctor) through to dispensing medicine (pharmacist) and lastly administration (nurse).
In summary, this study identified a plethora of recommendations and opinions for paediatric dosage forms, particularly how ODTs are perceived by healthcare professionals. Secondly, the study identified that HCP perceived suitable organoleptic properties of ODTs (e.g. disintegration time) which influenced acceptability in paediatric patients. As a result this pragmatic study explored healthcare professional’s views and recommendations of the acceptability and characteristic properties of ODT using a mixed methods approach (focus group, semi-structured- interviews and online survey). The overall results from dual sites demonstrated that 58.0% of respondents preferred to prescribe/administer liquid dosage forms form followed by ODTs. Factors found to significantly influence choice of formulations for paediatric patients were age, weight, parent/care giver and cost effectiveness of dosage forms. Although, 63.0% of respondents agreed that liquid formulations could be substituted with ODTs in paediatric patients, the number of available ODTs were insufficient to be prescribed or administered. From the characteristics results in this study, it was concluded that taste, disintegration time and flavour were the most important properties related to ODT administration as highlighted by 29.5%, 28.7% and 21.7% of respondents. Additionally, the other important characteristics of solid dosage forms were white colour, small size, round shape, strawberry flavour and rapid disintegration time. Further studies exploring the opinions of parents concerning paediatric dosage forms would complement this research. This study also suggests that there is a need for further research to develop a wider range of ODTs for use in the paediatric population.