Yes / Implementation and uptake of novel and cost-effective medicines can improve patient health outcomes and healthcare efficiency. However, the uptake of new medicines into practice faces a wide range of obstacles. Earlier reviews provided insights into determinants for new medicine uptake (such as medicine, prescriber, patient, organization, and external environment factors). However, the methodological approaches used had limitations (e.g., single author, narrative review, narrow search, no quality assessment of reviewed evidence). This systematic review aims to identify barriers and facilitators affecting the uptake of new medicines into clinical practice and identify areas for future research. A systematic search of literature was undertaken within seven databases: Medline, EMBASE, Web of Science, CINAHL, Cochrane Library, SCOPUS, and PsychINFO. Included in the review were qualitative, quantitative, and mixed-methods studies focused on adult participants (18 years and older) requiring or taking new medicine(s) for any condition, in the context of healthcare organizations and which identified factors affecting the uptake of new medicines. The methodological quality was assessed using QATSDD tool. A narrative synthesis of reported factors was conducted using framework analysis and a conceptual framework was utilised to group them. A total of 66 studies were included. Most studies (n = 62) were quantitative and used secondary data (n = 46) from various databases, e.g., insurance databases. The identified factors had a varied impact on the uptake of the different studied new medicines. Differently from earlier reviews, patient factors (patient education, engagement with treatment, therapy preferences), cost of new medicine, reimbursement and formulary conditions, and guidelines were suggested to influence the uptake. Also, the review highlighted that health economics, wider organizational factors, and underlying behaviours of adopters were not or under explored. This systematic review has identified a broad range of factors affecting the uptake of new medicines within healthcare organizations, which were grouped into patient, prescriber, medicine, organizational, and external environment factors. This systematic review also identifies additional factors affecting new medicine use not reported in earlier reviews, which included patient influence and education level, cost of new medicines, formulary and reimbursement restrictions, and guidelines. PROSPERO database (CRD42018108536). / This work presents research funded by the Pharmacy Research UK (grant reference: PRUK-2018-GA-1-KM) and Leeds Teaching Hospitals NHS Trust.

Yes / Introduction: Oral anticoagulant therapy choices for patients with atrial fibrillation (AF) expanded in the last decade with the introduction of direct oral anticoagulants (DOAC). However, the implementation of DOACs was slow and varied across different health economies in England. There is limited evidence on the patient role in the uptake of new medicines, including DOACs, apart from considering their demographic and clinical characteristics. Hence, this study aimed to address the gap by exploring the view of patients with AF on factors affecting DOAC use. Methods: A qualitative study using semi-structured interviews was conducted in three health economies in the North of England. Adult patients (>18 years) diagnosed with non-valvular AF, prescribed an oral anticoagulant (vitamin K antagonist or DOAC), and able to give written consent were recruited. Data were collected between August 2018 and April 2019. Audio recorded interviews were transcribed verbatim and analyzed using the framework method. Results: Four themes with eleven subthemes discussed identified factors affecting the use of DOACs. They were linked to limited healthcare financial and workforce resources, patient involvement in decision-making, patient knowledge about DOACs, safety concerns about oral anticoagulants, and oral anticoagulant therapy impact on patients' daily lives. Lack of a) opportunities to voice patient preferences and b) information on available therapy options resulted in some patients experiencing difficulties with the prescribed therapy. This was reported to cause negative impact on their daily lives, adherence, and overall satisfaction with the therapy. Conclusion: Greater patient involvement in decision-making could prevent and resolve difficulties encountered by some patients and potentially improve outcomes plus increase the uptake of DOACs. / Pharmacy Research UK (PRUK-2018-GA-1-KM) and Leeds Teaching Hospitals NHS Trust

Yes / The New Medicines Service (NMS) is provided by community pharmacists in England to support patient adherence after the initiation of a new treatment. It is provided as part of the National Health Service (NHS) pharmacy contractual framework and involves a three-stage process: patient engagement, intervention and follow-up. The study aims to explore community pharmacists’ experiences and perceptions of NMS within one area of the United Kingdom. Methods In-depth semi-structured telephone interviews were conducted with 14 community pharmacists. Interviews were audio-recorded, independently transcribed and thematically analysed. Key findings Pharmacists gave a mixed response to the operationalisation, ranging from positive opportunities for improving adherence and enhancement of practice to difficulties in terms of its administration. Pharmacists generallywelcomed opportunities to utilise their professional expertise to achieve better patient engagement and for pharmacy practice to develop as a patient resource. There was a perceived need for better publicity about the service. Different levels of collaborative working were reported. Some pharmacists were working closely with local general practices most were not. Collaboration with nurses in the management of long-term conditions was rarely reported but desired by pharmacists. Where relationships with general practitioners (GPs) and nurses were established, NMS was an opportunity for further collaboration; however, others reported a lack of feedback and recognition of their role. Conclusions Community pharmacists perceived the NMS service as beneficial to patients by providing additional advice and reassurance, but perceptions of its operationalisation were mixed.Overall, our findings indicate that NMS provides an opportunity for patient benefit and the development of contemporary pharmacy practice, but better collaboration with GPs and practice nurses could enhance the service.

Student Number : 0310496H - MPH research report - Faculty of Health Sciences / This study compares pharmaceutical company research on new medicines in South Africa with the country’s burden of disease and describes the process and criteria that companies use to set their research priorities. A quantitative survey of pharmaceutical companies shows that company research conducted from 2000 to 2003 is moderately associated with the country’s burden of disease estimates for 2000. The degree of association is dependent on which measures of company research and burden of disease are compared, and which comparative statistic is used. A qualitative analysis of company interviews reveals that feasibility of clinical trials, market forces, and environmental factors are core criteria for company research priority setting. The burden of disease, although important, is not a sole criterion, and has considerable limitations. Furthermore, this study reveals the complex nature of health priority setting by pharmaceutical companies and thus can assist policy decision makers in identifying practical strategies to encourage research in diseases of need by pharmaceutical companies.

Implementation and uptake of novel and cost-effective medicines can improve patient health outcomes and healthcare efficiency. However, the relative uptake of new medicines recommended by the National Institute for Health and Care Excellence often lags behind other comparative countries’ health systems. One example is the uptake of direct oral anticoagulants (DOACs) for stroke prevention in atrial fibrillation, which was slow and had a high level of unexplained variation across different health economies in England. This research aimed to explore barriers and enablers to the uptake of DOACs from the perspectives of patients, healthcare professionals, and key stakeholders by conducting systematic and narrative reviews and semi-structured interviews. Data collected from 21 patients, 23 healthcare professionals, and 23 key stakeholders recruited from three different health economies was analysed using the Framework method. The findings identified a range of intersecting factors acting as barriers and/or enablers to the uptake DOACs. While there were a wide range of experiences and views, an agreement between patients and healthcare professionals/key stakeholders on several identified factors was observed. Attributes of the innovation, characteristics of patients and prescribers, local health economy readiness for change, implementation process, and external health system context were suggested as influences. Mapping of the findings to the Diffusion of Innovations in Service Organisations model identified 11 components for a future toolkit development to facilitate uptake of nationally recommended new medicines. This thesis highlighted the role of patients, consideration of all costs associated with new medicines, and compatibility with the health economy’s care model impact on the uptake.