Service development project to pilot a digital technology innovation for video direct observation of therapy in adult patients with asthma.

BACKGROUND: Adherence to pharmacotherapy and use of the correct inhaler technique are important basic principles of asthma management. Video- or remote-direct observation of therapy (v-DOT) could be a feasible approach to facilitate monitoring and supervising therapy, supporting the delivery of standard care. OBJECTIVE: To explore the utility and the feasibility of v-DOT to monitor inhaler technique and adherence to treatment in adults attending the asthma outpatient service in a tertiary hospital in Northern Ireland. METHOD: The project evaluated use of the technology with 10 asthma patients. Patient and clinician feedback was obtained, in addition to measures of patient engagement and disease-specific clinical markers to assess the feasibility and utility of v-DOT technology in this group of patients. RESULTS: The engagement rate with v-DOT for participating patients averaged 78% (actual video uploads vs expected video uploads) over a median 7 week usage period. Although 50% of patients reported a technical issue at some stage during the usage period, all patients and clinicians reported that the technology was easy to use and that they were satisfied with the outcomes. A range of positive impacts were observed, including optimised inhaler technique and an observed improvement in lung function. An increase in asthma control test scores aligned with clinical aims to promote adherence and alleviate symptoms. CONCLUSION: The v-DOT technology was shown to be a feasible method of assessing inhaler technique and monitoring adherence in this small group of adult asthma patients. A range of positive impacts for participating patients and clinicians were observed. Not all patients invited to join the project agreed to participate or engage with using the technology, highlighting that in this setting, digital modes of delivering care provide only one of the approaches in the necessary "tool kit" for clinicians and patients.

Medication Adherence in Children with Asthma.

Asthma is the most common chronic disease in childhood. If untreated, asthma can lead to debilitating daily symptoms which affect quality of life, but more importantly can lead to fatal asthma attacks which unfortunately still occur globally. The most effective treatment strategy for controlling asthma is for the patient to follow a personalised asthma action plan (PAAP) which will invariably include regular use of an inhaled corticosteroid. To examine medication adherence in children with asthma, we collated recent evidence from systematic reviews in this area to address the following 5 key questions; What is adherence? Is there evidence that children are not adhering to preventer medication? Why is adherence poor and what are the barriers to adherence? Does good adherence improve outcomes in asthma? And lastly, how can treatment adherence be improved?

The use of remote video directly observed therapy to improve both inhaler technique and adherence to asthma medications.

Incorrect inhaler technique and non-adherence to inhaled preventer therapy often is the cause of poorly controlled asthma. Detecting and correcting non-adherence in asthma therapy has proven difficult. In addition, while patients may be able to demonstrate correct inhaler technique at the clinic recent evidence suggests that critical errors in inhaler technique occur in the home setting. Remote video directly observed therapy (vDOT) has recently been described as a potentially useful tool for addressing non-adherence while also allowing timely correction of inhaler technique errors. In this mini-review we describe the use of vDOT in asthma management.

Potential of UK and US newspapers for shaping patients' knowledge and perceptions about antidiabetic medicines: a content analysis.

BACKGROUND: Information about how newspapers portray antidiabetic medicines to readers is lacking. This study investigated the reporting on antidiabetic medicines in the most widely circulated newspapers published in the United Kingdom (UK) and the United States (US) over a 10-year period. METHODS: The Nexis UK database was used to identify and select relevant articles. Systematic content analysis of the articles which met the inclusion criteria (articles of any format that contained reference to antidiabetic medicines) within the highest circulated newspapers in the UK and US between 2009 and 2018 was conducted. Inter-rater reliability of coding was established using a 10% sample of the identified articles. RESULTS: A total of 560 (369 UK and 191 US) relevant newspaper articles were retrieved. In the UK, the number of relevant articles showed a slightly increasing trend over the study period, while in the US, article numbers declined over the study period. Safety/risk of antidiabetic medicines was the most frequent theme covered by the articles (34.6%). Over one-third of the newspaper articles were written from a clinical perspective (37.7%). Insulin was the most commonly discussed class of antidiabetic medicine (23.1%). Control of blood sugar levels (53.1%) and side effects/toxicity (92.7%) were the most frequently reported benefit and risk of antidiabetic medicines, respectively. The most frequently reported organ systems harmed by antidiabetic medicines were the cardiovascular, endocrine and gastrointestinal systems. The UK newspapers were more likely to report the benefits of antidiabetic medicines (p = 0.005), while the US articles were more likely to report on harms/risks (p = 0.001). The majority of relevant articles (91.8%) were judged as having a balanced judgement, while 8.2% of the articles were rated as exaggerated. CONCLUSIONS: This study has revealed that antidiabetic medicines are indeed reported on by UK and US newspapers. As media portrayal has the potential to negatively or positively influence patients' views of their medication for diabetes, healthcare professionals should check on patients' beliefs and knowledge about their medication and proactively provide objective and balanced information (including promotion of medication adherence).

Adherence to metformin in adults with type 2 diabetes: a combined method approach.

BACKGROUND: Medication adherence, one of the most important aspects in the process of optimal medicines use, is unfortunately still a major challenge in modern healthcare, and further research is required into how adherence can be assessed and optimised. The aim of this study was to use a combined method approach of self-report and dried blood spot (DBS) sampling coupled with population pharmacokinetic (PopPK) modelling, to assess adherence to metformin in adult patients with type 2 diabetes. Further aims were to assess metformin exposure levels in patients, determine factors associated with non-adherence with prescribed metformin, and to explore the relationship between adherence and therapeutic outcomes. METHODS: A combined method approach was used to evaluate metformin adherence in patients with type 2 diabetes who had been prescribed metformin for a minimum period of 6 months. Patients were recruited from consultant-led diabetic outpatient clinics at three hospitals in Northern Ireland, UK. Data collection involved self-reported questionnaires [Medication Adherence Report Scale (MARS), Beliefs about Medicines Questionnaire and Centre for Epidemiologic Studies Depression Scale], direct measurement of metformin concentration in DBS samples, and researcher-led patient interviews. The DBS sampling approach was coupled with population pharmacokinetic (PopPK) modelling, which took account of patient characteristics, metformin dosage and type of formulation prescribed (immediate or sustained release). RESULTS: The proportion of patients considered to be adherent to their prescribed metformin, derived from self-reported MARS scores and metformin concentration in DBS samples, was 61.2% (74 out of 121 patients). The majority (n = 103, 85.1%) of recruited patients had metformin exposure levels that fell within the therapeutic range. However, 17 patients (14.1%) had low exposure to metformin and one patient (0.8%) had undetectable metformin level in their blood sample (non-exposure). Metformin self-administration and use of a purchased adherence pill box significantly increased the probability of a patient being classified as adherent based on logistic regression analysis. Both HbA1c and random glucose levels (representing poor glycaemic control) in the present research were, however, not statistically linked to non-adherence to metformin (P > 0.05). CONCLUSIONS: A significant proportion of participating patients were not fully adherent with their therapy. DBS sampling together with the use of a published PopPK model was a useful, novel, direct, objective approach to estimate levels of adherence in adult patients with type 2 diabetes (61.2%).

Telecare Service Use in Northern Ireland: Exploratory Retrospective Cohort Study.

BACKGROUND: Telecare is a health service that involves the home installation of a number of information technology support systems for individuals with complex needs, such as people with reduced mobility or disabilities and the elderly. It involves the use of sensors in patients' homes to detect events, such as smoke in the kitchen, a front door left open, or a patient fall. In Northern Ireland (NI), outputs from these sensors are monitored remotely by the telecare team, who can provide assistance as required by telephone or through the emergency services. The facilitation of such rapid responses has the aim of promoting early intervention and therefore maintaining patient well-being. OBJECTIVE: The aims of this study were to construct a descriptive summary of the telecare program in NI and evaluate hospital-based service use by telecare patients before and after the installation of telecare equipment. METHODS: An exploratory retrospective cohort study was conducted involving more than 2000 patients. Data analysis included the evaluation of health care use before and after the telecare service was initiated for individual participants. Individuals with data for a minimum of 6 months before and after the installation of the telecare service were included in this analysis. RESULTS: A total of 2387 patients were enrolled in the telecare service during the observation period (February 26, 2010-February 22, 2016). The mean age was 78 years (median 81 years). More women (1623/2387, 68%) were enrolled in the service. Falls detectors were the most commonly deployed detectors in the study cohort (824/1883, 43.8% of cases). The average number of communications (calls and/or alarms) between participants and the coordinating center was the highest for patients aged ≥85 years (mean 86 calls per year). These contacts were similarly distributed by gender. The mortality rate over the study period was higher in men than women (98/770, 14.4% in men compared to 107/1617, 6.6% in women). The number of nonelective hospital admissions, emergency room visits, and outpatient clinic visits and the length of hospital stays per year were significantly higher (P<.001) after the installation of the telecare equipment than during the period before installation. CONCLUSIONS: Despite the likely benefits of the telecare service in providing peace of mind for patients and their relatives, hospital-based health care use significantly increased after enrollment in the service. This likely reflects the increasing health care needs over time in an aging population.

Mobile video directly observed therapy can be used to improve at-home inhaler technique in children with asthma.

Most children and parents have mobile smartphones that can be used to record videos while the child uses their inhaler. The timed (stamped with date and time) videos can be submitted to a secure repository. An asthma nurse then can review the video. https://bit.ly/2UyG11W.

General practitioner practice-based pharmacist input to medicines optimisation in the UK: pragmatic, multicenter, randomised, controlled trial.

BACKGROUND: Changing demographics across the UK has led to general practitioners (GPs) managing increasing numbers of older patients with multi-morbidity and resultant polypharmacy. Through government led initiatives within the National Health Service, an increasing number of GP practices employ pharmacist support. The purpose of this study is to evaluate the impact of a medicines optimisation intervention, delivered by GP practice-based pharmacists, to patients at risk of medication-related problems (MRPs), on patient outcomes and healthcare costs. METHODS: A multi-centre, randomised (normal care or pharmacist supplemented care) study in four regions of the UK, involving patients (n = 356) from eight GP practices, with a 6-month follow-up period. Participants were adult patients who were at risk of MRPs. RESULTS: Median number of MRPs per intervention patient were reduced at the third assessment, i.e. 3 to 0.5 (p < 0.001) in patients who received the full intervention schedule. Medication Appropriateness Index (MAI) scores were reduced (medications more appropriate) for the intervention group, but not for control group patients (8 [4-13] to 5 [0-11] vs 8 [3-13] to 7 [3-12], respectively; p = 0.001). Using the intention-to-treat (ITT) approach, the number of telephone consultations in intervention group patients was reduced and different from the control group (1 [0-3] to 1 [0-2] vs 1 [0-2] to 1 [0-3], p = 0.020). No significant differences between groups were, however, found in unplanned hospital admissions, length of hospital stay, number of A&E attendances or outpatient visits. The mean overall healthcare cost per intervention patient fell from £1041.7 ± 1446.7 to £859.1 ± 1235.2 (p = 0.032). Cost utility analysis showed an incremental cost per patient of - £229.0 (95% CI - 594.6, 128.2) and a mean QALY gained of 0.024 (95% CI - 0.021 to 0.065), i.e. indicative of a health status gain at a reduced cost (2016/2017). CONCLUSION: The pharmacist service was effective in reducing MRPs, inappropriateness of medications and telephone consultations in general practice in a cost-effective manner. TRIAL REGISTRATION: ClinicalTrials.Gov, NCT03241498. Registered 7 August 2017-Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03241498.

A Drug Content, Stability Analysis, and Qualitative Assessment of Pharmacists' Opinions of Two Exemplar Extemporaneous Formulations.

Despite a decline in the number of active pharmaceutical ingredients prepared extemporaneously using proprietary products, there remains a need for such products in the community (for example, liquid medicines for paediatrics which may be otherwise commercially unavailable). A lack of experience and quality assurance systems may have diminished pharmacist's confidence in the extemporaneous preparation process; therefore, pharmacists were asked to prepare two proprietary products, omeprazole and amlodipine. The resulting products were characterised in terms of variability in drug quantity, stability, particle size and antimicrobial properties. Furthermore, a self-administered questionnaire was used to assess 10 pharmacists' opinions on the perceived complexity of the extemporaneous compounding process and their overall confidence in the final extemporaneously compounded products. Drug content studies revealed that 88.5% and 98.0% of the desired drug content was obtained for omeprazole and amlodipine, respectively. Antimicrobial properties were maintained for both drugs, however variability in particle size, particularly for amlodipine, was evident between formulations. While pharmacists who partook in the study had some or high confidence in the final products, they reported difficulty formulating the suspensions. Findings from this study provide insight into pharmacists' views on two extemporaneously prepared products and highlight the variability obtained in preparations prepared by different pharmacists.

Development and characterisation of novel poly (vinyl alcohol)/poly (vinyl pyrrolidone)-based hydrogel-forming microneedle arrays for enhanced and sustained transdermal delivery of methotrexate.

Methotrexate (MTX) is one of the mainstays of treatment for rheumatoid arthritis (RA) and juvenile idiopathic arthritis (JIA) and it is mainly administered either orally or by subcutaneous (SC) injection, which are not so satisfactory. While orally administered MTX is associated with variable bioavailability and causes gastrointestinal side effects, including nausea and vomiting, SC injection is painful and produces high peak blood levels of MTX. Transdermal delivery presents an attractive alternative administration route. However, MTX passive permeation through the skin is hindered by the skin barrier and MTX physicochemical properties. To address these issues, hydrogel-forming microneedle arrays (HFMN) and a patch-like reservoir loaded with MTX (MTX-RV) were developed and combined to form a minimally invasive patch to deliver MTX transdermally in a sustained manner. HFMN were prepared from an aqueous blend of poly (vinyl alcohol) (PVA) and poly (vinyl pyrrolidone) (PVP) which was crosslinked chemically with citric acid (CA) at 130˚C. MTX-RV was prepared from hydroxypropyl methylcellulose (HPMC) and glycerol. Both the HFMN and MTX-RV were fully characterised and then combined to form an integrated patch, which was evaluated ex vivo and in preclinical studies. The HFMN demonstrated a satisfactory mechanical strength and insertion capability into excised neonatal porcine skin, as well as moderate swelling properties. The MTX-RV incorporated a high dose of MTX (150.3 ± 5.3 µg/mg) without precipitation. The integrated patch delivered MTX at a steady-state flux of 506.8 ± 136.9 µg.cm2/h in an ex vivo setup. Furthermore, in preclinical studies performed in Sprague Dawley rats, MTX appeared in blood after 1 h from patch application at a concentration of 7.6 ± 2.0 nM. MTX blood level increased gradually to reach its peak, Cmax = 35.1 ± 5.1 nM, at 24 h. Importantly, the HFMN were removed intact from the skin with only mild erythema, despite the cytotoxic nature of MTX. Accordingly, the integrated patch produced in this work represents a promising minimally invasive transdermal drug delivery system that can overcome the skin barrier and deliver MTX in a sustained manner. This may help in minimising or even avoiding the nausea and vomiting, associated with the conventional administration routes.