Recommendations for wider adoption of clinical pharmacy in Central and Eastern Europe in order to optimise pharmacotherapy and improve patient outcomes.

Clinical pharmacy as an area of practice, education and research started developing around the 1960s when pharmacists across the globe gradually identified the need to focus more on ensuring the appropriate use of medicines to improve patient outcomes rather than being engaged in manufacturing and supply. Since that time numerous studies have shown the positive impact of clinical pharmacy services (CPS). The need for wider adoption of CPS worldwide becomes urgent, as the global population ages, and the prevalence of polypharmacy as well as shortage of healthcare professionals is rising. At the same time, there is great pressure to provide both high-quality and cost-effective health services. All these challenges urgently require the adoption of a new paradigm of healthcare system architecture. One of the most appropriate answers to these challenges is to increase the utilization of the potential of highly educated and skilled professionals widely available in these countries, i.e., pharmacists, who are well positioned to prevent and manage drug-related problems together with ensuring safe and effective use of medications with further care relating to medication adherence. Unfortunately, CPS are still underdeveloped and underutilized in some parts of Europe, namely, in most of the Central and Eastern European (CEE) countries. This paper reviews current situation of CPS development in CEE countries and the prospects for the future of CPS in that region.

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.

Informing critical care drug requirements in response to the COVID-19 pandemic.

OBJECTIVES: The main aim was to develop a process to estimate critical care drug requirements to robustly inform regional procurement planning and preparedness in response to the COVID-19 pandemic. The objectives were to identify critical care drugs required, obtain patient usage data and consider current regional practice to establish the requirement. METHOD: Health and Social Care (HSC) Trusts across Northern Ireland (NI) identified critical care drugs required and an estimation of average daily usage data. The Microsoft Excel database was constructed to compile Trust data and establish regional requirement. The database was refined further according to real-world data from NI HSC Trusts, Intensive Care National Audit and Research Centre report on COVID-19 in critical care, daily regional COVID-19 figures and other available National data. Components of a tool originally developed for H1N1 and updated for COVID-19 were adapted to reflect the NI context and used in the regional database. The database was clinically reviewed to ensure that it accurately reflected current regional practice given the evolving nature of the pandemic. RESULTS: The critical care drugs required in the pandemic, usage data and current regional practice were identified to establish requirement. A regional database was constructed and used to produce a model for calculating approximate critical drug requirements. The model was used to map critical drug requirements to available stock in Trusts and wholesalers/suppliers, enabling the identification of treatment capacity for these medicines regionally, both currently and for projected surges. Data have also been used in the preparation of weekly regional situation reports provided to both the HSC Board and the Department of Health. CONCLUSION: The process developed is a robust approach to assist in informing regional critical care drug requirements in response to the COVID-19 pandemic. Further application has been demonstrated in regional procurement planning and preparedness.

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.

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.

ACE inhibitors for the treatment of hypertension drug selection by means of the SOJA method.

ACE inhibitors have proven to be effective blood pressure lowering agents with an excellent tolerability profile. The family of these drugs is still expanding, necessitating the definition of selection criteria in order to choose the "right drug". In this article the ACE inhibitors available in the United Kingdom (UK) are scored by means of the SOJA method. The System of Objectified Judgement Analysis (SOJA) method is a model for rational drug selection. The relevant selection criteria for a certain group of drugs are defined and judged by a panel of experts and each selection criterion is given a relative weight. The more important that a selection criterion is considered, the higher the relative weight that is given to that criterion. The ideal properties for each selection criterion are determined and each drug is scored as a percentage of the score of the ideal drug for all selection criteria. The following selection criteria were used (relative weight): number of formulations (20), number of indications (20), variation in bioavailability (40), interactions (40), trough/peak ratio diastolic blood pressure lowering effect (20), efficacy (250), side-effects (150), dosage frequency (100), documentation (100) and effect on clinical endpoints (260). Ramipril showed the highest score, followed by perindopril, lisinopril and enalapril. The well documented effects on clinically relevant end points, such as cardiovascular morbidity and mortality contributed to the high score for ramipril.

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.