New terminology of medication adherence enabling and supporting activities: ENABLE terminology.

Introduction: Medication non-adherence negatively affects the effectiveness of evidence-based therapies and sustainability of healthcare systems. Lack of agreed terminology of medication adherence enabling and supporting activities leads to underuse of the available tools. The ENABLE COST Action was aimed at proposing a new terminology for these activities in order to help both scientific research and its clinical application. Methods: Initial discussions within the ENABLE Working Groups allowed for the conceptualization of four interlinked terms related to adherence, i.e., "medication adherence technology", "medication adherence enhancing intervention", "best practice" and "reimbursement". The iterative process of internal discussion was structured around two dedicated international workshops. Moreover, extensive stakeholder consultations have been organised, including an interactive online survey used to assess the level of agreement with, and the clarity of relevant terms and definitions proposed. Results: Detailed analysis of the results of this process allowed for fine-tuning of the items, and finally, for proposing the final set of definitions. Across all the three phases of this process, the definitions were substantially modified to better reflect the concepts, simplify the language, and assure completeness and cohesiveness of terminology. Feedback obtained from the stakeholders helped this process and confirmed that the final terms and definitions were well received by the experts active in the field of medication adherence. Discussion: Covering the gap in the existing terminology, this work proposes a cohesive set of terms and definitions applicable to medication adherence enabling and supporting activities. Promoting evidence-based approach to this field, this terminology may help research, clinical practice and policy.

Pharmacist-led clinical medication review service in primary care: the perspective of general practitioners.

BACKGROUND: An advanced level medication review service (CMR) is systematically reimbursed and available nationwide in Slovenian primary care since 2016. CMR is performed by clinical pharmacists (CP). Close collaboration with general practitioner (GP) is required as they perform patient selection and make clinical decisions regarding patient's medication. METHODS: A prospective observational study was conducted in 2018 aiming to evaluate the perspective of GPs on the implementation of pharmacist-led medication review service in Community Health Care Centre Ljubljana, Slovenia. GPs of the patients, who provided written informed consent were invited for the interviews. The semi-structured interview consisted of 5 open ended questions addressing reasons for referral of the patients, implementation of CP recommendations and the GPs' perspective of the service in general. Interviews were audio recorded with GPs written consent, transcribed verbatim and inductive content analysis was performed in NVivo11 Pro. RESULTS: In total 38 interviews with 24 GPs were performed. The emerged themes were nested under 3 main domains representing Donabedian model of quality healthcare - structure, process, outcomes. The service structure is built on broad pharmacotherapy knowledge as the main CP competency, good accessibility, and complementarity of healthcare professions. Patients are mainly referred to the CMR due to polypharmacotherapy, however in majority there is a more in-depth reason behind (e.g., adverse events, etc.). Lack of time to recognize eligible patients and additional workload to study and implement the recommendations present the major challenges in the service process and therefore low number of referrals. CPs recommendations are mostly accepted, although the implementation time varies. When recommendation addresses medicines prescribed by a clinical specialist, the CMR report is forwarded to them for decision regarding implementation. The empowerment of the patients in medicines use was emphasized as the major benefit of the CMR, which consequently supports and enhances the quality of GP's patient care. Transferability of recommendations to similar cases and high satisfaction with the service of GPs and patients, were mentioned. CONCLUSION: GPs experiences with CMR are encouraging and supportive and present a base for further growth of the service.

Developing a medication adherence technologies repository: proposed structure and protocol for an online real-time Delphi study.

INTRODUCTION: An online interactive repository of available medication adherence technologies may facilitate their selection and adoption by different stakeholders. Developing a repository is among the main objectives of the European Network to Advance Best practices and technoLogy on medication adherencE (ENABLE) COST Action (CA19132). However, meeting the needs of diverse stakeholders requires careful consideration of the repository structure. METHODS AND ANALYSIS: A real-time online Delphi study by stakeholders from 39 countries with research, practice, policy, patient representation and technology development backgrounds will be conducted. Eleven ENABLE members from 9 European countries formed an interdisciplinary steering committee to develop the repository structure, prepare study protocol and perform it. Definitions of medication adherence technologies and their attributes were developed iteratively through literature review, discussions within the steering committee and ENABLE Action members, following ontology development recommendations. Three domains (product and provider information (D1), medication adherence descriptors (D2) and evaluation and implementation (D3)) branching in 13 attribute groups are proposed: product and provider information, target use scenarios, target health conditions, medication regimen, medication adherence management components, monitoring/measurement methods and targets, intervention modes of delivery, target behaviour determinants, behaviour change techniques, intervention providers, intervention settings, quality indicators and implementation indicators. Stakeholders will evaluate the proposed definition and attributes' relevance, clarity and completeness and have multiple opportunities to reconsider their evaluations based on aggregated feedback in real-time. Data collection will stop when the predetermined response rate will be achieved. We will quantify agreement and perform analyses of process indicators on the whole sample and per stakeholder group. ETHICS AND DISSEMINATION: Ethical approval for the COST ENABLE activities was granted by the Malaga Regional Research Ethics Committee. The Delphi protocol was considered compliant regarding data protection and security by the Data Protection Officer from University of Basel. Findings from the Delphi study will form the basis for the ENABLE repository structure and related activities.

European Network to Advance Best Practices and Technology on Medication Adherence: Mission Statement.

Medication non-adherence is associated with almost 200,000 deaths annually and €80-125 billion in the European Union. Novel technological advances (smart pill bottles, digital inhalers and spacers, electronic pill blisters, e-injection pens, e-Health applications, big data) could help managing non-adherence. Healthcare professionals seem however inadequately informed about non-adherence, availability of technological solutions in daily practice is limited, and collaborative efforts to push forward their implementation are scarce. The European Network to Advance Best practices and technoLogy on medication adherencE (ENABLE, COST Action 19132) aims to 1) raise awareness of adherence enhancing solutions, 2) foster knowledge on medication adherence, 3) accelerate clinical application of novel technologies and 4) work collaboratively towards economically viable policy, and implementation of adherence enhancing technology across healthcare systems.

Uptake of new antidiabetic medicines in 11 European countries.

BACKGROUND: Several new antidiabetic medicines (GLP-1 receptor agonists, DPP-4 inhibitors, and SGLT-2 inhibitors) have been approved by the European Medicines Agency since 2006. The aim of this study was to evaluate the uptake of new antidiabetic medicines in European countries over a 10-year period. METHODS: The study used IQVIA quarterly value and volume sales data January 2006-December 2016. The market uptake of new antidiabetic medicines together with intensity of prescribing policy for all antidiabetic medicines were estimated for Austria, Croatia, France, Germany, Hungary, Italy, Poland, Slovenia, Spain, Sweden, and the United Kingdom. The following measures were determined: number of available new active substances, median time to first continuous use, volume market share, and annual therapy cost. RESULTS: All countries had at least one new antidiabetic medicine in continuous use and an increase in intensity of prescribing policy for all antidiabetic medicines was observed. A tenfold difference in median time to first continuous use (3-30 months) was found. The annual therapy cost in 2016 of new antidiabetic medicines ranged from EUR 363 to EUR 769. Among new antidiabetic medicines, the market share of DPP-4 inhibitors was the highest. Countries with a higher volume market share of incretin-based medicines (Spain, France, Austria, and Germany) in 2011 had a lower increase in intensity of prescribing policy. This kind of correlation was not found in the case of SGLT-2 inhibitors. CONCLUSIONS: This study found important differences and variability in the uptake of new antidiabetic medicines in the included countries.

Improved adherence with Medicines Use Review service in Slovenia: a randomized controlled trial.

BACKGROUND: Based on several existing patient-oriented activities, Medicines Use Review (MUR) service was standardized and officially adopted in Slovenia in 2015. Service aims to provide adherence support and ensure safe and effective medicines use. Therefore, the aim of the study was to evaluate the benefits of MUR in Slovenia, primarily the impact on medication adherence. METHODS: A randomised controlled trial was performed in community pharmacies to compare MUR with standard care. Patients were randomised into either the test (patients received MUR by a certified MUR provider at visit 1), or control group. The study primary outcome was self-reported adherence to multiple medications, assessed by electronic ©Morisky Widget MMAS-8 Software at the first visit (V1) and after 12 weeks (V2). A sub-analysis of intentional and unintentional non-adherence was performed. MUR impact was defined as the relative difference in ©MMAS-8 score after 12 weeks between the test and control group. A multiple linear regression model was used to predict MUR impact based on baseline adherence (low versus medium and high). Several secondary outcomes (e.g. evaluation of drug-related problems (DRPs)) were also assessed. RESULTS: Data from 153 (V1) and 140 (V2) patients were analysed. Baseline adherence was low, moderate and high in 17.6, 48.4 and 34.0% patients, respectively. In the low adherence subpopulation, test group patients showed a 1.20 point (95% CI = 0.16-2.25) increase in total ©MMAS-8 score (p = 0.025) compared to control group patients. A 0.84 point (95% CI = 0.05-1.63) increase was due to intentional non-adherence (p = 0.038), and a 0.36 point (95% CI = - 0.23-0.95) was due to unintentional non-adherence (p = 0.226). Additionally, statistically significant decrease in the proportion of patients with manifested DRPs (p < 0.001) and concerns regarding chronic medicines use (p = 0.029) were revealed. CONCLUSION: MUR service in Slovenia improves low medication adherence and is effective in addressing DRPs and concerns regarding chronic medicines use. TRIAL REGISTRATION: ClinicalTrials.gov - NCT04417400 ; 4th June 2020; retrospectively registered.

Community pharmacists' perspectives on implementation of Medicines Use Review in Slovenia.

Background In December 2014 Slovene Chamber of Pharmacies defined procedures for Medicines Use Review (MUR) in Slovenia, together with an educational program and certification to ensure pharmacists' competency to perform MUR. The first 15 pharmacists were certified in June 2015 and implemented the service in their practices. Objective This study aimed to understand the implementation of MUR from the perspectives of the first community pharmacists providing the service in practice. Methods A focus group with first MUR providers took place in February 2016, 6 months after the first pharmacists were certified to provide MUR service. Based on regional and institutional criteria ten pharmacists from the first certified group were chosen and invited to participate in guided discussion, where the development and assurance of competencies, the provision of the service in practice and the future of the service were addressed. The discussion was voice recorded with written consent obtained from all participants. Analysis was performed in NVivo 11 software with the use of inductive qualitative content analysis approach. Main outcome measure Views, challenges and opportunities for the Medicines Use Review service in Slovenia. Results Seven pharmacists attended the focus group, 5 from public pharmaceutical institution and 2 from concessionary pharmacies. Three main thematical categories were identified: quality assurance of MUR, different stakeholders' perceptions of MUR and MURs' management. Pharmacists' broad knowledge in pharmacotherapy was emphasized as the basis of quality provision and main advantage in performing MUR in comparison with other healthcare professions. Recognisability of MUR among different stakeholders should be improved with comprehensive approach in marketing of the service. Positive patient feedback was reported, however persuading them to attend MUR presented a challenge. Better management of the service, especially in terms of work organization, would facilitate MUR provision. Conclusion Overall, positive experiences with implementation and provision were reported. To ensure MUR sustainability, the service needs to become more widely known and opportunities must be provided for continuing professional development of providing pharmacists.