Rebecca Venables

Determination of formulation factors that affect oral medicines acceptability in a domiciliary paediatric population.

UNLABELLED Acceptability of medicines for children is a challenge, yet critical to ensure adherence to treatment. There is very little literature on formulation factors that influence acceptability of medicines, particularly in the domiciliary environment. This pragmatic study was conducted at University Hospital Coventry and Warwickshire (UHCW) with the aim of identifying the prevalence and nature of oral formulation-related barriers to medicines administration in children suffering from long-term conditions. This study used semi-structured face-to-face interviews with 221 parents/carers of children (0-18 years) and 57 young people (12-18 years). RESULT showed significant medicines refusal and manipulation in the domiciliary environment. Nearly one-third (71/232) of respondents reported medicines refusal. This was associated significantly with the age of child (p=0.016), socioeconomic status (IMD 2010 score) (p=0.002), taste (p<0.001), texture (p=0.017), and volume (of liquid/powder) or quantity (of solid dosage form) (p<0.001). 29% (74/252) of respondents reported manipulating medicines. P-values are based on multivariable statistical analysis models. This study has indicated that formulations prescribed to children with chronic conditions are not meeting the needs of a significant number of patients based on self-report. Age-appropriate medicines are required to provide suitable dose units with an acceptable taste for children. This study should aid pharmaceutical companies to prioritise paediatric formulation work.

G406(P) Oral formulation-related barriers to medicines administration in children with chronic conditions: views of parents and young people

Introduction Limited studies have explored oral formulation-related barriers to medicines administration in children, in narrow patient groups (e.g. HIV). Owing to the lack of licensed medicines suitable for use in children, often manipulation is required to either deliver a dose or to facilitate medicines administration. The need for more age-appropriate medicines has been well acknowledged [1]. Purpose This study adopted a pragmatic approach to determine the nature and prevalence of oral formulation-related barriers to medicines administration in children suffering from a wide range of chronic conditions. Problems reported by patients and their parents/carers about oral formulations were identified with the aim of informing future pharmaceutical development, thus improving future children’s medicines. Materials and methods Semi-structured face-to-face interviews were conducted with 278 parents/carers/young people at UHCW. Children (0- <18 y) were receiving prescribed medicines for a chronic condition (duration ≥1 month). Questions explored barriers to medicines administration, medicines refusal and manipulation. Ethical approval was granted. Results Medicines refusal 19% of all medicines were reported to be refused by childrenTaste was a problem reported for 64% of medicines that were refused. Medicines manipulation 19% of all medicines were reported to be manipulated 79% of manipulations were for the purpose of administering a specific dose (e.g. tablet segmented)26% of manipulations were to facilitate administration (e.g. mixed with foodstuffs). Oral formulation-related barriers to medicines administration: Taste was the most commonly reported (35% of all prescribed medicines) Drugs with highest incidence of taste issues were ranitidine liquid (82%), prednisolone soluble tablets (81%) and trimethoprim liquid (75%) of total usersIssues also reported (in descending order of prevalence) were: texture (8%), volume/quantity (5%), size/swallowing (5%), colour (2%) and smell (2%). Conclusions In total, 19% of medicines were reported to be refused by children. For administration to children, almost one fifth of medicines were reported to require manipulation. Taste was most the most frequently reported oral formulation-related barrier to medicines administration. Findings indicate that age-appropriate medicines should be developed to provide both suitable dose units and acceptable taste for paediatric patients. Reference 1. EMEA (2006) Reflection paper: formulations of choice for the paediatric population. London. EMEA/CHMP/PEG/194810/2005. p1–45. [Online] Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003782.pdf [Accessed on 17/05/2013].

Factors associated with polypharmacy in primary care: a cross-sectional analysis of data from The English Longitudinal Study of Ageing (ELSA)

Objectives While older age and ill health are known to be associated with polypharmacy, this paper aims to identify whether wealth, body mass index (BMI), smoking and alcohol consumption are also associated with polypharmacy (5–9 prescribed medications) and hyperpolypharmacy prevalence (≥10 prescribed medications), among older people living in England. Design Cross-sectional study. Setting The English Longitudinal Study of Ageing Wave 6 (2012–2013). Participants 7730 participants aged over 50 years. Data synthesis Two multivariate models were created. HR with corresponding 95% CI, for polypharmacy and hyperpolypharmacy, were calculated after adjusting for gender, age, wealth, smoking, alcohol consumption, BMI, self-rated health and the presence of a chronic health condition. Results Lower wealth (lowest wealth quintile vs highest wealth quintile, adjusted HR 1.28; 95% CI 1.04 to 1.69, P=0.02) and obesity (adjusted HR 1.81; 95% CI 1.53 to 2.15, p<0.01) were significantly associated with polypharmacy. Increasing age (50–59 years vs 70–79 years, adjusted HR 3.42; 95% CI 2.81 to 4.77, p<0.01) and the presence of a chronic health condition (adjusted HR 2.94; 95% CI 2.55 to 3.39, p<0.01) were also associated with polypharmacy. No statistically significant association between smoking and polypharmacy (adjusted HR 1.06; 95% CI 0.86 to 1.29, P=0.56) was established; while, very frequent alcohol consumption (consuming alcohol >5 times per week) was inversely associated with polypharmacy (never drank alcohol vs very frequently, adjusted HR 0.64; 95% CI 0.52 to 0.78, p<0.01). The adjusted HR for hyperpolypharmacy was accentuated, compared with polypharmacy. Conclusion This study has identified that lower wealth, obesity, increasing age and chronic health conditions are significantly associated with polypharmacy and hyperpolypharmacy prevalence. The effect of these factors, on polypharmacy and especially hyperpolypharmacy prevalence, is likely to become more pronounced with the widening gap in UK wealth inequalities, the current obesity epidemic and the growing population of older people. The alcohol findings contribute to the debate on the relationship between alcohol consumption and health.

P20 Pic study: prednisolone in children: prescribing, dispensing and administering prednisolone formulations to children with acute asthma or wheeze

Aim To explore the current prescribing, dispensing and administration practice for oral prednisolone to children with acute asthma or wheeze. Method A semi-structured telephone interview following a course of oral prednisolone. The interview questions were designed during consultation with a multidisciplinary team and explored: doses prescribed, formulations prescribed and dispensed, parent/legal guardian/patients’ experiences and perceptions of prednisolone administration and medicines manipulation and adherence. Parents/legal guardians of children aged 2–11 years and young people over 12 years with acute asthma/wheeze prescribed a short course (≤7 days) of oral prednisolone on the Children’s Assessment Unit (CAU) or in the out-patients department were eligible to consent/assent to this study. Ethical approval was granted. Results 20 families completed the study. The ages of children ranged from 2–16 years (average=5 years). Specific formulation details (e.g. tablets, soluble tablets, EC tablets) were provided by prescribers in only 20% of the oral prednisolone prescriptions. There was variability in dispensing soluble versus tablet formulations across child ages; the average ages of children prescribed soluble tablets and non-soluble tablets were 4 years and 11 years respectively. 80% of oral prednisolone formulations dispensed were soluble tablets. In 40% of cases, manipulation techniques were provided by parents to improve patient acceptance of prednisolone soluble owing to its poor palatability. In addition, 2 parents discussed using coercion to improve acceptance. A high level of adherence to prednisolone was reported:95% of prednisolone courses were completed. All prescriptions were for duration of 2 or 3 days. Of the prednisolone doses recorded: 53% were in-line with trust guidance (0.5 mg/kg rounded up to the nearest 5 mg), 13% – BNFC guidance, 13% – BTS SIGN guidance and 20% (not in the guidance listed) were between 0.32 mg/kg and 0.76 mg/kg. Conclusion There is no gold standard for prescribing, dispensing and administering prednisolone in young children, thus dosages and formulations prescribed vary widely. This study highlighted variability in dosing of prednisolone across different guidelines. There is very little information regarding the appropriateness of prescribing non-soluble versus soluble formulations for children, however tablet size should be considered when formulating medicines for children.1 Soluble prednisolone tablets were dispensed more commonly than non-soluble in this hospital setting; however, the taste of prednisolone has been described as a barrier to medicines acceptance.2 Although adherence in this cohort was high, the majority of children had received the formulation previously and palatability was described as an adherence issue during initial prescribing. Further information at the prescribing and dispensing stage is required to understand the factors influencing formulations and doses prescribed and dispensed. This research will inform larger studies investigating the suitability of formulations, advising: prescribers, Formulation teams and Healthcare Institutions on improving patient acceptability and medicines optimisation and increasing cost-benefit (e.g. through improving patient adherence and reducing medicines wastage and hospital admissions). Findings will support wider prescribing in other healthcare settings as the results will be easily translational across chronic conditions in all healthcare sectors. References EMA. 2006. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003782.pdf [Accessed: 03 July 2016]. Venables R, Marriott J, Stirling H. Find out: Key problems with children’s medicines formulations … It’s a taste issue! IJPP2012;20(Supplement 2):23.

G434(P) Improving prescribing for children: Healthcare professionals’ understanding of children’s medicines

Introduction and purpose One in ten prescriptions for children in primary care is for an unlicensed or off-label medicine which can lead to an unsuitable formulation. Manufacture of “specials” is a major issue with significant cost implications. Doctors and health care professionals at all levels of training are often unaware of the licensing requirements for paediatric drugs and the implications of these, but there is little information assessing their knowledge. Method Health care professionals attending a paediatric continuing professional development afternoon were invited to complete a questionnaire at the start of the session. The participants were asked to provide five definitions related to the prescribing of children’s medicines: 1) Off-licence, 2) Off-label 3) Specials, 4) NICE approved and 5) Marketing authorisation. The answers were analysed as to whether they were correct, partly correct or incorrect/unknown according to standard definitions. Ethics approval was not necessary. Results 36 questionnaires were distributed and 32 (89%) were returned from 12 paediatric consultants, 9 paediatric trainee doctors, 4 senior paediatric nurses and 7 pharmacists. Participants were asked to provide 5 definitions each, giving a total of 160 potentially correct answers. Correct Partly correct Incorrect/unknown Paediatric consultants 33/60 (55%) 9/60 (15%) 18/60 (30%) Paediatric trainees 3/45 (7%) 7/45 (16%) 35/45 (77%) Paediatric nurses 5/20 (25%) 5/20 (25%) 10/20 (50%) Pharmacists 23/35 (66%) 7/35 (20%) 5/35 (14%) There were also differences in the ability to define the definitions. There was particularly poor understanding of the term “special”. 50% of consultants were able to define it adequately, yet no doctors in training were. The pharmacists had the best understanding. Conclusion There is limited knowledge regarding paediatric prescribing amongst all levels of doctors, but most worryingly the junior doctors who do not understand when they are prescribing off -label or off-licence drugs. They are unlikely to be aware when they are prescribing a “special” and therefore unaware of the problems the child and family may have obtaining it, the variations in the formulations’ pharmacokinetics, and the cost. The paediatric consultants fared a little better, but have gaps in understanding. Doctors’ lack of knowledge regarding paediatric prescribing needs to be addressed. The strength of paediatric pharmacists’ knowledge could be utilised more to guide doctors in prescribing the most suitable and cost-effective formulations for children.

G413(P) Problems with the administration of oral formulations to children: Perspectives of medical practitioners, pharmacists and nurses

Introduction There is limited evidence regarding healthcare professionals (HCP)s knowledge of issues with medicines administration in paediatric patients with chronic conditions. The few studies that have been conducted have included HCPs working in disease-specific groups1, 2 and those investigating knowledge on the use of unlicensed medicines.3, 4 Purpose The objective was to explore problems with medicines administration in children suffering from chronic conditions from the perspectives of medical practitioners, pharmacists and nurses, and additionally to identify common and unique themes of problems with oral medicines prescribed to children. Materials and methods Four focus groups (FG) were conducted at two NHS trusts. FG1 (n = 5): neonatal nurse practitioners, nurse practice educator, community paediatric nurses. FG2 (n = 8): GP, general paediatric consultants, specialist paediatric consultants, paediatric registrar. FG3 (n = 2): paediatric pharmacist, specialist pharmacist. FG4 (n = 4): paediatric pharmacists. Themes explored problems experienced when prescribing, dispensing and administering medicines for children. Ethical approval was granted. Results Themes identified included taste, texture, colour, smell, size/swallowing, quantity/volume and manipulation with food. Taste was the most commonly reported oral-formulation related barrier to medicines administration across the groups. Flucloxacillin solution was discussed with regard to its poor palatability in all groups. Texture was reported to be a significant problem for the learning disability population across the groups. Medicines manipulation techniques (e.g. mixing with foodstuffs) were revealed across the groups, yet there was limited knowledge regarding the evidence base for such activity. Problems surrounding the supply of Specials medicines were discussed in-depth by the pharmacists. Conclusions Taste was perceived to be the major barrier to medicines administration in children. Further organoleptic and physical properties of medicines were also identified as barriers to medicines administration and should not be overlooked. A robust scientific evidence-base approach is warranted to inform standardised protocols guiding HCPs to support safe and effective medicines manipulation in both domiciliary (i.e. by parents/carers) and hospital (i.e. by nurses) settings. Pharmacists should collaborate with prescribers and provide advice on Specials prescribing owing to their increased knowledge. Findings of this study should help to optimise paediatric prescribing and also direct future formulation work.

G392 Tablets or liquids for children: who decides and why?

Aims This study investigated the opinions of healthcare professionals, specialist paediatric consultants, nurses, and pharmacists as well as general practitioners (GPs) regarding the age at which they would prescribe, supply or administer a solid dosage form to a child in order to understand if age significantly influenced formulation choice between healthcare professional groups. Materials and methods A mixed methods (quantitative and qualitative) questionnaire was distributed to 97 healthcare professionals. This included paediatric: consultants (n = 17), hospital doctors (n = 27), pharmacists (n = 16), nurses (n = 9) and also GPs (n = 28) during routine CPD training sessions at University Hospitals Coventry and Warwickshire and Birmingham Children’s Hospital. Statistical analysis was conducted using IBM SPSS 20. Statistical tests conducted were an ANOVA, followed by Tukey’s HSD post-hoc test. Results The age at which tablets were considered to be appropriate for use in children was lower amongst the specialist paediatric healthcare professionals (median ages were 7.5 years for consultants; 9 years for nurses; 8 years for pharmacists) compared to GPs (median age 12 years). Statistical analysis demonstrated differences between the age at which tablets would first be used as reported by different healthcare professionals (p = 0.001). Significant differences were detected between mean values reported by GPs and pharmacists (p = 0.012) and also GPs and paediatric consultants (p = 0.006). The age at which GPs first use tablets was higher than that reported by pharmacists and paediatric consultants as shown in Figure 1. Abstract G392 Figure 1 The mean age of tablet use and 95% confidence intervals for each of the healthcare professional groups. Conclusions There is an educational need for GPs to understand the cost and practical implications associated with liquid formulations where tablets may be an acceptable and readily available alternative. This is particularly relevant where liquids are supplied as Specials which are associated with a higher costs yet inferior quality compared to licensed products supplied as tablets; a switch to tablet is better both economically and for the patient in many cases. Communication between specialist paediatric healthcare professionals and those in primary care settings needs to be optimised regarding the use of tablet formulations in younger children.

G403(P) Tablet preferences in children and young people

Aims The aim was to determine the optimum size, shape and colour intensity of tablets for children and young people using both images and physical models. Materials and methods This study used photo-realistic life-size 2D images (5 to 20 mm in length) and their corresponding identical physical 3D tablet models to assess the acceptability of tablet size. Exact replicas of tablets ranging in girth from caplet to oval to diamond shaped units were manufactured. These models were coated with three coloured coatings; white, pale lilac and dark purple. The images and models were the basis of a questionnaire administered to children and young people in schools, hospitals and at community events. Results 183 individuals participated in the study; 74 children 6–7 years; 40 children 8–10 years; 40 young people 14–18 years and 29 adults. Most participants accepted a larger tablet size when looking at models compared to images. The largest tablet was the least acceptable as both an image and a physical model (<35 and <50% in all children and young people respectively). The 5 mm tablet gave unusual results as it was less popular than the next largest size in participants over the age of 8 years. In all populations the results showed that the caplet was the most popular shape followed by the oval and then the diamond as shown in Figure 1. Abstract G403(P) Figure 1 Preference for tablet shape by age; 6–7yr; 8–10yr; 14–18yr; adults. The shape preference was most pronounced in the younger populations; where differences of over 20% were observed in acceptance of the caplet tablet compared to the diamond. In the majority of cases the pale tablet was preferred to the dark tablet. This may be associated with familiarity with pale tablets and therefore they are more acceptable. Within this study all participants were presented tablets in 3 different shades; white, pale and intense purple; in children the white tablets were preferred over either coloured tablet. Conclusions The design of tablets for paediatric populations should aim for a small caplet or other narrow girth shaped tablet that is white or pale to maximise acceptability in children.