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%).

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.

Shaping the Future of Digitally Enabled Health and Care.

People generally need more support as they grow older to maintain healthy and active lifestyles. Older people living with chronic conditions are particularly dependent on healthcare services. Yet, in an increasingly digital society, there is a danger that efforts to drive innovations in eHealth will neglect the needs of those who depend on healthcare the most-our ageing population. The SHAPES (Smart and Healthy Ageing through People Engaging in Supportive Systems) Innovation Action aims to create an open European digital platform that facilitates the provision of meaningful, holistic support to older people living independently. A pan-European pilot campaign will evaluate a catalogue of digital solutions hosted on the platform that have been specifically adapted for older people. 'Medicines control and optimisation' is one of seven themes being explored in the campaign and will investigate the impact of digital solutions that aim to optimise medicines use by way of fostering effective self-management, while facilitating timely intervention by clinicians based on remote monitoring and individualised risk assessments powered by artificial intelligence. If successful, the SHAPES Innovation Action will lead to a greater sense of self-sufficiency and empowerment in people living with chronic conditions as they grow older.

A novel approach to medicines optimisation post-discharge from hospital: pharmacist-led medicines optimisation clinic.

Background There is a major drive within healthcare to reduce patient readmissions, from patient care and cost perspectives. Pharmacist-led innovations have been demonstrated to enhance patient outcomes. Objective To assess the impact of a post-discharge, pharmacist-led medicines optimisation clinic on readmission parameters. Assessment of the economic, clinical and humanistic outcomes were considered. Setting Respiratory and cardiology wards in a district general hospital in Northern Ireland. Method Randomised, controlled trial. Blinded random sequence generation; a closed envelope-based system, with block randomisation. Adult patients with acute unplanned admission to medical wards subject to inclusion criteria were invited to attend clinic. Analysis was carried out for intention-to-treat and per-protocol perspectives. Main Outcome Measure 30-day readmission rate. Results Readmission rate reduction at 30 days was 9.6% (P = 0.42) and the reduction in multiple readmissions over 180-days was 29.1% (P = 0.003) for the intention-to-treat group (n = 31) compared to the control group (n = 31). Incidence rate ratio for control patients for emergency department visits was 1.65 (95% CI 1.05-2.57, P = 0.029) compared with the intention-to-treat group. For unplanned GP consultations the equivalent incident rate ratio was 2.00 (95% CI 1.18-3.58, P = 0.02). Benefit to cost ratio in the intention-to-treat and per-protocol groups was 20.72 and 21.85 respectively. Patient Health Related Quality of Life was significantly higher at 30-day (P < 0.001), 90-day (P < 0.001) and 180-day (P = 0.036) time points. A positive impact was also demonstrated in relation to patient beliefs about their medicines and medication adherence. Conclusion A pharmacist-led post-discharge medicines optimisation clinic was beneficial from a patient care and cost perspective.

Ensuring continuity of patient care across the healthcare interface: Telephone follow-up post-hospitalization.

AIMS: To implement pharmacist-led, postdischarge telephone follow-up (TFU) intervention and to evaluate its impact on rehospitalization parameters in polypharmacy patients, via comparison with a well-matched control group. METHOD: Pragmatic, prospective, quasi-experimental study. Intervention patients were matched by propensity score techniques with a control group. Guided by results from a pilot study, clinical pharmacists implemented TFU intervention, added to routine integrated medicines management service. RESULTS: Using an intention to treat approach, reductions in 30- and 90-day readmission rates for intervention patients compared with controls were 9.9% [odds ratio = 0.57; 95% confidence interval (CI): 0.36-0.90; P < 0.001] and 15.2% (odds ratio = 0.53; 95% CI: 0.36-0.79; P = 0.021) respectively. Marginal mean time to readmission was 70.9 days (95% CI: 66.9-74.9) for intervention group compared with 60.1 days (95% CI: 55.4-64.7) for controls. Mean length of hospital stay compared with control was (8.3 days vs. 6.7 days; P < 0.001). Benefit: cost ratio for 30-day readmissions was 29.62, and 23.58 for 90-day interval. Per protocol analyses gave more marked improvements. In intervention patients, mean concern scale score, using Beliefs about Medicine Questionnaire, was reduced 3.2 (95% CI: -4.22 to -2.27; P < 0.001). Mean difference in Medication Adherence Report Scale was 1.4 (22.7 vs. 24.1; P < 0.001). Most patients (83.8%) reported having better control of their medicines after the intervention. CONCLUSIONS: Pharmacist-led postdischarge structured TFU intervention can reduce 30- and 90-day readmission rates. Positive impacts were noted on time to readmission, length of hospital stay upon readmission, healthcare costs, patient beliefs about medicines, patient self-reported adherence and satisfaction.

A case study of polypharmacy management in nine European countries: Implications for change management and implementation.

BACKGROUND: Multimorbidity and its associated polypharmacy contribute to an increase in adverse drug events, hospitalizations, and healthcare spending. This study aimed to address: what exists regarding polypharmacy management in the European Union (EU); why programs were, or were not, developed; and, how identified initiatives were developed, implemented, and sustained. METHODS: Change management principles (Kotter) and normalization process theory (NPT) informed data collection and analysis. Nine case studies were conducted in eight EU countries: Germany (Lower Saxony), Greece, Italy (Campania), Poland, Portugal, Spain (Catalonia), Sweden (Uppsala), and the United Kingdom (Northern Ireland and Scotland). The workflow included a review of country/region specific polypharmacy policies, key informant interviews with stakeholders involved in policy development and implementation and, focus groups of clinicians and managers. Data were analyzed using thematic analysis of individual cases and framework analysis across cases. RESULTS: Polypharmacy initiatives were identified in five regions (Catalonia, Lower Saxony, Northern Ireland, Scotland, and Uppsala) and included all care settings. There was agreement, even in cases without initiatives, that polypharmacy is a significant issue to address. Common themes regarding the development and implementation of polypharmacy management initiatives were: locally adapted solutions, organizational culture supporting innovation and teamwork, adequate workforce training, multidisciplinary teams, changes in workflow, redefinition of roles and responsibilities of professionals, policies and legislation supporting the initiative, and data management and information and communication systems to assist development and implementation. Depending on the setting, these were considered either facilitators or barriers to implementation. CONCLUSION: Within the studied EU countries, polypharmacy management was not widely addressed. These results highlight the importance of change management and theory-based implementation strategies, and provide examples of polypharmacy management initiatives that can assist managers and policymakers in developing new programs or scaling up existing ones, particularly in places currently lacking such initiatives.

A modified Delphi study to determine the level of consensus across the European Union on the structures, processes and desired outcomes of the management of polypharmacy in older people.

BACKGROUND: Inappropriate use of multiple medicines (inappropriate polypharmacy) is a major challenge in older people with consequences of increased prevalence and severity of adverse drug reactions and interactions, and reduced medicines adherence. The aim of this study was to determine the levels of consensus amongst key stakeholders in the European Union (EU) in relation to aspects of the management of polypharmacy in older people. METHODS: Forty-six statements were developed on aspects of healthcare structures, processes and desired outcomes, with consensus defined at ≥ 80% agreement. Panel members were strategists (e.g. directors, leading clinicians and commissioners) from each of the 28 EU member states, with a target recruitment of five per member state. Three Delphi rounds were conducted via email, with panel members being provided with summative results and collated, anonymised comments at the commencement of Rounds 2 and 3. RESULTS: Ninety panel members were recruited (64.3% of target), with high participation levels throughout the three Delphi rounds (91.1%, 83.3%, 72.2%). During Round 1, consensus was obtained for 27/46 statements (58.7%), with an additional two statements in Round 2 and none in Round 3. Consensus was obtained for statements relating to: potential gain arising from polypharmacy management (3/4 statements); strategic development (7/7); change management (5/7) indicator measures (4/6); legislation (0/3); awareness raising (5/5); polypharmacy reviews (5/7); and EU vision (0/7). Analysis of free text comments indicated that the vision statements were too ambitious and not achievable by the specified timeframe of 2025. CONCLUSION: Consensus was obtained amongst key EU strategists around many aspects of polypharmacy management in older people. Notably, no consensus was achieved in relation to statements relating to the need to alter legislation in areas of healthcare delivery, remuneration and practitioner scope of practice. While the vision for the EU by 2025 was considered rather ambitious, there is great potential and clear opportunity to advance polypharmacy management throughout the EU and beyond.

Provision of pharmaceutical care by community pharmacists across Europe: Is it developing and spreading?

RATIONALE, AIMS, AND OBJECTIVES: Pharmaceutical care involves patient-centred pharmacist activity to improve medicines management by patients. The implementation of this service in a comprehensive manner, however, requires considerable organisation and effort, and indeed, it is often not fully implemented in care settings. The main objective was to assess how pharmaceutical care provision within community pharmacy has evolved over time in Europe. METHOD: A cross-sectional questionnaire-based survey of community pharmacies, using a modified version of the Behavioural Pharmaceutical Care Scale (BPCS) was conducted in late 2012/early 2013 within 16 European countries and compared with an earlier assessment conducted in 2006. RESULTS: The provision of comprehensive pharmaceutical care has slightly improved in all European countries that participated in both editions of this survey (n = 8) with progress being made particularly in Denmark and Switzerland. Moreover, there was a wider country uptake, indicating spread of the concept. However, due to a number of limitations, the results should be interpreted with caution. Using combined data from participating countries, the provision of pharmaceutical care was positively correlated with the participation of the community pharmacists in patient-centred activities, routine use of pharmacy software with access to clinical data, participation in multidisciplinary team meetings, and having specialized education. CONCLUSIONS: The present study demonstrated a slight evolution in self-reported provision of pharmaceutical care by community pharmacists across Europe, as measured by the BPCS. The slow progress suggests a range of barriers, which are preventing pharmacists moving beyond traditional roles. Support from professional bodies and more patient-centred community pharmacy contracts, including remuneration for pharmaceutical care services, are likely to be required if quicker progress is to be made in the future.

Enhanced clinical pharmacy service targeting tools: risk-predictive algorithms.

RATIONALE, AIMS AND OBJECTIVES: This study aimed to determine the value of using a mix of clinical pharmacy data and routine hospital admission spell data in the development of predictive algorithms. Exploration of risk factors in hospitalized patients, together with the targeting strategies devised, will enable the prioritization of clinical pharmacy services to optimize patient outcomes. METHODS: Predictive algorithms were developed using a number of detailed steps using a 75% sample of integrated medicines management (IMM) patients, and validated using the remaining 25%. IMM patients receive targeted clinical pharmacy input throughout their hospital stay. The algorithms were applied to the validation sample, and predicted risk probability was generated for each patient from the coefficients. Risk threshold for the algorithms were determined by identifying the cut-off points of risk scores at which the algorithm would have the highest discriminative performance. Clinical pharmacy staffing levels were obtained from the pharmacy department staffing database. RESULTS: Numbers of previous emergency admissions and admission medicines together with age-adjusted co-morbidity and diuretic receipt formed a 12-month post-discharge and/or readmission risk algorithm. Age-adjusted co-morbidity proved to be the best index to predict mortality. Increased numbers of clinical pharmacy staff at ward level was correlated with a reduction in risk-adjusted mortality index (RAMI). CONCLUSIONS: Algorithms created were valid in predicting risk of in-hospital and post-discharge mortality and risk of hospital readmission 3, 6 and 12 months post-discharge. The provision of ward-based clinical pharmacy services is a key component to reducing RAMI and enabling the full benefits of pharmacy input to patient care to be realized.

Integrated medicines management - can routine implementation improve quality?

RATIONALE, AIMS AND OBJECTIVES: Previous service development work in the area of integrated medicines management (IMM) has demonstrated clear quality improvements in a targeted group of patients within a hospital in Northern Ireland. In order to determine whether this programme could be transferable to routine practice and thereby assess its generalizability, research has been carried out to quantify the health care benefits of incorporating the concept of IMM as routine clinical practice. METHOD: The IMM programme of care was delivered to all eligible patients (subject to inclusion criteria) across two hospital sites in Northern Ireland during normal pharmacy opening hours. All patients were followed up for a period of 12 months from their time of hospital admission. All patient data were collected using the custom-designed Electronic Pharmacist Intervention Clinical System at each stage of their hospital journey, that is, admission, inpatient stay and discharge. RESULTS: Patients who received the IMM service benefited from a reduced length of hospital stay on their reference admission (1.42 days; P = 0.020) as well as a reduced length of stay during the first rehospitalization (5.86 days; P = 0.013). There was also a trend of a reduced number of readmissions and a longer time to readmission during the 12-month follow-up period. Potential significant opportunity cost savings were demonstrated as well as a significant improvement in medication appropriateness (discharge vs. reference admission). CONCLUSIONS: The IMM programme of care has proven to be transferable to routine hospital care within two hospitals in Northern Ireland. It is anticipated that this current research will further inform the development of IMM as routine clinical practice across Northern Ireland and beyond.

Comparison of tools for the assessment of inappropriate prescribing in hospitalized older people.

UNLABELLED: RATIONAL, AIMS AND OBJECTIVE: The aim of the present study was to compare the ease of use and the capability of four approaches [Medication Appropriateness Index (MAI), the Beers' criteria 2003, the Improved Prescribing in the Elderly Tool (IPET) and Health Plan Employer Data and Information Set (HEDIS)] in assessing changes in medication appropriateness in elderly patients over a period of hospitalization. METHODS: A retrospective observational study in two hospitals in Northern Ireland using the four measures was undertaken, involving a cohort of 192 patients (aged > 65 years). Medication appropriateness assessments were made at three stages during the patients' hospital 'journey', that is, at admission, during their inpatient stay and at discharge. The identifying rates of inappropriate prescribing in elderly patients in hospital used validated screening tools: MAI, the Beers' criteria 2003, the IPET and HEDIS. RESULTS: The MAI was the most comprehensive approach but was also the most time consuming to apply. Data derived using the MAI indicated clearly that there was improved medication appropriateness over the three hospital stay stages (P < 0.001). Although this trend was also significant for the Beers' criteria 2003 (P < 0.05) and the IPET (P < 0.05) approaches, the HEDIS was unable to differentiate changes in appropriateness over time. There was a good correlation between data derived using the MAI and the Beers' criteria 2003 and the IPET approaches; this correlation was not evident for the HEDIS. CONCLUSIONS: The MAI is the most convincing tool in evaluating medication appropriateness, but is very time consuming to apply. Beers' criteria 2003 and the IPET perform to an acceptable standard within the clinical setting and are more practical in their application. The HEDIS, although simplest to apply, does not have the sensitivity to measure change in appropriateness over time.

Provision of pharmaceutical care by community pharmacists: a comparison across Europe.

OBJECTIVE: To investigate the provision of pharmaceutical care by community pharmacists across Europe and to examine the various factors that could affect its implementation. METHODS: A questionnaire-based survey of community pharmacies was conducted within 13 European countries. The questionnaire consisted of two sections. The first section focussed on demographic data and services provided in the pharmacy. The second section was a slightly adapted version of the Behavioral Pharmaceutical Care Scale (BPCS) which consists of three main dimensions (direct patient care activities, referral and consultation activities and instrumental activities). RESULTS: Response rates ranged from 10-71% between countries. The mean total score achieved by community pharmacists, expressed as a percentage of the total score achievable, ranged from 31.6 (Denmark) to 52.2% (Ireland). Even though different aspects of pharmaceutical care were implemented to different extents across Europe, it was noted that the lowest scores were consistently achieved in the direct patient care dimension (particularly those related to documentation, patient assessment and implementation of therapeutic objectives and monitoring plans) followed by performance evaluation and evaluation of patient satisfaction. Pharmacists who dispensed higher daily numbers of prescriptions in Ireland, Germany and Switzerland had significantly higher total BPCS scores. In addition, pharmacists in England and Ireland who were supported in their place of work by other pharmacists scored significantly higher on referral and consultation and had a higher overall provision of pharmaceutical care. CONCLUSION: The present findings suggest that the provision of pharmaceutical care in community pharmacy is still limited within Europe. Pharmacists were routinely engaged in general activities such as patient record screening but were infrequently involved in patient centred professional activities such as the implementation of therapeutic objectives and monitoring plans, or in self-evaluation of performance.

An innovative approach to integrated medicines management.

RATIONALE, AIMS AND OBJECTIVES: To determine whether an increased input by clinical pharmacists at each stage of the patient's hospital journey, from admission through discharge, resulted in an enhanced level of patient care as measured by a number of clinical and economic outcomes. METHODS: This project was designed to address medicines management issues in patients deemed at risk of drug-related problems. During the project, these latter patients at the time of admission were randomly assigned to an integrated medicines management (IMM) service group (n = 371) or regular hospital care group (n = 391). The IMM service involved comprehensive pharmaceutical care provided by a pharmacy team throughout each of three stages: patient admission, inpatient monitoring and counselling, and patient discharge. RESULTS: Patients who received the IMM service benefited from a reduced length of hospital stay [by 2 days (P = 0.003; independent samples t-test log(e))]. IMM patients also had a decreased rate of readmission over a 12-month follow-up period (40.8% vs. 49.3%; p = 0.027; Fisher's exact test) and an increased time to readmission [20 days longer (P = 0.0356; log rank test)]. A numbers-needed-to-treat calculation indicated that for approximately every 12 patients receiving the IMM service, one readmission to hospital, within 12 months of discharge, would be prevented. The new service was welcomed by cognate health care professionals. CONCLUSION: The IMM service proved very effective and can be used as a template to support the implementation of comprehensive pharmaceutical care as a routine service across Northern Ireland and beyond.