Introducing consultant outpatient clinics to community settings to improve access to paediatrics:an observational impact study

Objectives - In line with a national policy to move care ‘closer to home’, a specialist children's hospital in the National Health Service in England introduced consultant-led ‘satellite’ clinics to two community settings for general paediatric outpatient services. Objectives were to reduce non-attendance at appointments by providing care in more accessible locations and to create new physical clinic capacity. This study evaluated these satellite clinics to inform further development and identify lessons for stakeholders. Methods - Impact of the satellite clinics was assessed by comparing community versus hospital-based clinics across the following measures: (1) non-attendance rates and associated factors (including patient characteristics and travel distance) using a logistic regression model; (2) percentage of appointments booked within local catchment area; (3) contribution to total clinic capacity; (4) time allocated to clinics and appointments; and (5) clinic efficiency, defined as the ratio of income to staff-related costs. Results - Satellite clinics did not increase attendance beyond their contribution to shorter travel distance, which was associated with higher attendance. Children living in the most-deprived areas were 1.8 times more likely to miss appointments compared with those from least-deprived areas. The satellite clinics’ contribution to activity in catchment areas and to total capacity was small. However, one of the two satellite clinics was efficient compared with most hospital-based clinics. Conclusions - Outpatient clinics were relocated in pragmatically chosen community settings using a ‘drag and drop’ service model. Such clinics have potential to improve access to specialist paediatric healthcare, but do not provide a panacea. Work is required to improve attendance as part of wider efforts to support vulnerable families. Satellite clinics highlight how improved management could contribute to better use of existing capacity.

Gender and general practice: the single-handed woman General Practitioner

This research examines women GPs' careers, how they run their practices and how they reconcile professional and domestic lives. It looks at the particular experiences of women GPs who practise alone, and at the pressures in past practice experience which have led them to do so. It is argued that many of the problems of group practice which can be identified are attributable to gender. For example, one reason given for entering general practice is a desire to be able to provide the full range of medical care and not to specialise. Women GPs, however, may find themselves seeing more women patients for "women's problems" and children than they would freely choose. Women have not entered general practice in order to specialise in these areas of medicine. Indeed, if they had wanted to specialise in obstetrics, gynaecology or paediatrics they would have had difficulty advancing very far in these male-dominated areas of hospital hierarchy. Other gender related problems exist for women in general practice and practising single-handedly is one strategy that women GPs have used to counter the problems of working in male-dominated practices and partnerships. However, the twenty-four hour commitment of single-handed practice may bring further pressures in reconciling this with responsibility for home life. Out-of-hours cover, which can be viewed as the link between professional and domestic life, where the one intrudes into the other, is also examined in terms of the gender issues it raises. The interaction of gender and ethnicity is also considered for the 11 Asian women GPs in the study. Interviews were conducted with 29 single-handed women GPs in the Midlands. In addition, some cases were studied in greater depth by being observed in their surgeries and on home visits for a day each. A qualitative/feminist approach to analysis has been employed.

Strategic development and physicochemical analysis of oral preparations for unstable drugs

Oral liquid formulations are ideal dosage forms for paediatric, geriatric and patient with dysphagia. Dysphagia is prominent among patients suffering from stroke, motor neurone disease, advanced Alzheimer’s and Parkinson’s disease. However oral liquid preparations are particularly difficult to formulate for hydrophobic and unstable drugs. Therefore current methods employed in solving this issue include the use of ‘specials’ or extemporaneous preparations. In order to challenge this, the government has encouraged research into the field of oral liquid formulations, with the EMEA and MHRA publishing list of drugs of interest. The current work investigates strategic formulation development and characterisation of select API’s (captopril, gliclazide, melatonin, L-arginine and lansoprazole), each with unique obstacles to overcome during solubilisation, stabilisation and when developing a palatable dosage from. By preparing a validated calibration protocol for each of the drug candidates, the oral liquid formulations were assessed for stability, according to the ICH guidelines along with thorough physiochemical characterisation. The results showed that pH and polarity of the solvent had the greatest influence on the extent of drug solubilisation, with inclusion of antioxidants and molecular steric hindrance influencing the extent of drug stability. Captopril, a hydrophilic ACE inhibitor (160 mg.mL-1), undergoes dimerisation with another captopril molecule. It was found that with the addition of EDTA and HP-β-CD, the drug molecule was stabilised and prevented from initiating a thiol induced first order free radical oxidation. The cyclodextrin provided further steric hindrance (1:1 molar ratio) resulting in complete reduction of the intensity of sulphur like smell associated with captopril. Palatability is a crucial factor in patient compliance, particularly when developing a dosage form targeted towards paediatrics. L-arginine is extremely bitter in solution (148.7 g.L-1). The addition of tartaric acid into the 100 mg.mL-1 formulation was sufficient to mask the bitterness associated with its guanidium ions. The hydrophobicity of gliclazide (55 mg.L-1) was strategically challenged using a binary system of a co-solvent and surfactant to reduce the polarity of the medium and ultimately increase the solubility of the drug. A second simpler method was developed using pH modification with L-arginine. Melatonin has two major obstacles in formulation: solubility (100 μg.mL-1) and photosensitivity, which were both overcome by lowering the dielectric constant of the medium and by reversibly binding the drug within the cyclodextrin cup (1:1 ratio). The cyclodextrin acts by preventing UV rays from reaching the drug molecule and initiated the degradation pathway. Lansoprazole is an acid labile drug that could only be delivered orally via a delivery vehicle. In oral liquid preparations this involved nanoparticulate vesicles. The extent of drug loading was found to be influenced by the type of polymer, concentration of polymer, and the molecular weight. All of the formulations achieved relatively long shelf-lives with good preservative efficacy.

Paediatric drug development:reformulation, in vitro, genomic and in vivo evaluation

Angiotensin converting enzyme (ACE) inhibitors lisinopril and ramipril were selected from EMA/480197/2010 and the potassium-sparing diuretic spironolactone was selected from the NHS specials list for November 2011 drug tariff with the view to produce oral liquid formulations providing dosage forms targeting paediatrics. Lisinopril, ramipril and spironolactone were chosen for their interaction with transporter proteins in the small intestine. Formulation limitations such as poor solubility or pH sensitivity needed consideration. Lisinopril was formulated without extensive development as drug and excipients were water soluble. Ramipril and spironolactone are both insoluble in water and strategies combating this were employed. Ramipril was successfully solubilised using low concentrations of acetic acid in a co-solvent system and also via complexation with hydroxypropyl-β-cyclodextrin. A ramipril suspension was produced to take formulation development in a third direction. Spironolactone dosages were too high for solubilisation techniques to be effective so suspensions were developed. A buffer controlled pH for the sensitive drug whilst a precisely balanced surfactant and suspending agent mix provided excellent physical stability. Characterisation, stability profiling and permeability assessment were performed following formulation development. The formulation process highlighted current shortcomings in techniques for taste assessment of pharmaceutical preparations resulting in early stage research into a novel in vitro cell based assay. The formulations developed in the initial phase of the research were used as model formulations investigating microarray application in an in vitro-in vivo correlation for carrier mediated drug absorption. Caco-2 cells were assessed following transport studies for changes in genetic expression of the ATP-binding cassette and solute carrier transporter superfamilies. Findings of which were compared to in vitro and in vivo permeability findings. It was not possible to ascertain a correlation between in vivo drug absorption and the expression of individual genes or even gene families, however there was a correlation (R2 = 0.9934) between the total number of genes with significantly changed expression levels and the predicted human absorption.

Support tools for paediatric inpatient prescribers:a review

Prescribing support for paediatrics is diverse and includes both standard texts and electronic tools. Evidence concerning who should be supported and by what method is limited. This review aims to collate the current information available on prescribing support in paediatrics. Many tools designed to support prescribers are technology based. For example, electronic prescribing and smart phone applications. There is a focus on prescriber education both at undergraduate and postgraduate level. In the UK, the majority of inpatient prescribing is done by junior medical staff. It is important to ensure they are competent on qualification and supported in this role. A UK national prescribing assessment is being trialled to test for competence on graduation and there are also tools available to test paediatric prescribing after qualification. No information is available on the tools and resources UK prescribers currently use to support their decision making. One US study reported a decrease in the availability of paediatric prescribing information in a popular reference text. There is limited evidence to show that decisionsupport tools improve patient outcomes, however, there is growing confirmation that electronic prescribing reduces medication errors. There have been reports of new error types, such as selection errors, occurring with the use of electronic prescribing. Another concern with computerised decision-support systems is deciding what alerts should be presented to the prescriber and when/how often in order to avoid alert fatigue. There is little published concerning paediatric alerts perhaps as a consequence of commercial systems often not including paediatric specific support.

Paediatric prescribing practice and opinions of paediatric prescribers on ePrescribing

Objective The aim of this study was to provide an initial insight into current UK paediatric prescribing practice. Methods In 2012 focus groups were conducted at Birmingham Children's Hospital (UK specialist hospital) with both medical and non-medical prescribers and analysed using thematic analysis. Key findings Both sets of prescribers used a wide range of resources to support their prescribing decisions. Dosing information was most commonly checked, and a lack of specialist paediatric information was reported in existing resources. All groups had high expectations of the support functions that should be included in an electronic prescribing system and could see many potential benefits. Participants agreed that all staff should see the same drug alerts. The overwhelming concern was whether the current information technology infrastructure would support electronic prescribing. Conclusions Prescribers had high expectations of electronic prescribing, but lacked confidence in its delivery. Prescribers use a wide range of resources to support their decision making when prescribing in paediatrics.