Establishing data-intensive learning health systems: an interdisciplinary exploration of the planned introduction of hospital electronic prescribing and medicines administration systems in Scotland

Background Creating learning health systems, characterised by the use and repeated reuse of demographic, process and clinical data to improve the safety, quality and efficiency of care, is a key aim in realising the potential benefits and efficiency savings associated with the implementation of health information technology.Objectives We sought to investigate stakeholder perspectives on and experiences of the implementation of hospital electronic prescribing and medicines administration (HEPMA) systems in Scotland and use these to inform political decisions on approaches to promoting the use and reuse of digitised prescribing and medication administration data in order to improve care processes and outcomes.Methods We identified and recruited key national stakeholders involved in implementing and/or using HEPMA data from generic and specialty systems. These included representatives from healthcare settings (i.e. doctors, pharmacists and nurses), managers of existing national databases, policy makers, healthcare analytics companies, system suppliers and patient representatives. We conducted multi-disciplinary focus group discussions, audio-recorded these, transcribed data verbatim and thematically analysed the transcripts with the help of NVivo10. In analysing the data, we drew on theoretical and previous empirical work on information infrastructures.Results We identified the following key themes: 1) micro-factors – usability of systems and motivating users to input data; 2) meso-factors – developing technical and organisational infrastructures to facilitate the aggregation of data; and 3) macro-factors – facilitating interoperability and data reuse at larger scales to ensure that data are effectively generated and used.Conclusions This work is relevant not only to countries in the early stages of data strategy development but also to countries aiming to aggregate data at national levels. An overall shared vision of a learning health system at individual, organisational and national levels can help to catalyse such data-intensive transformational efforts

Improving the managed introduction of new medicines : sharing experiences to aid authorities across Europe

The 3-day course on the managed introduction of new drugs was organised by the Piperska group together with the Agency for Health Technology Assessment and Tariff System (AOTMiT) and WHO Europe to share experiences and case histories among health authority and health insurance company personnel, academics and those from commercial organisations from across Europe on potential ways to optimise the managed entry of new medicines. This starts pre-launch with horizon scanning and budgeting, then peri-launch including critical drug evaluation, and finally post launch including monitoring prescribing of new medicines against agreed guidance and indicators. There were also discussions on issues regarding managed entry schemes and procurement strategies including biosimilars

New models are needed to optimise the management of new medicines

Abstract: Countries struggling to fund new premium priced medicines with ever increasing prices. In addition, substantial savings as medicines lose their patents. This requires co-ordinated approaches. Models are being developed centring on three pillars: pre-launch including horizon scanning; peri-launch including P & R/ risk sharing; post-launch including assessing effectiveness. This will continue to enable access to safe, effective and affordable medicines. Introduction: Countries are struggling to fund new premium priced medicines with ever increasing prices. In addition, substantial savings as medicines lose their patents. This requires co-ordinated approaches. Models are being developed centring on three pillars: pre-launch including horizon scanning; peri-launch including P & R/ risk sharing; post-launch including assessing effectiveness [1,2]. This will continue to enable access to safe, effective and affordable medicines. Methodology: Desk research of regulatory and other relevant policy documents as well as a thorough and extensive literature search in peer-reviewed databases. Results: Models to optimise the use of new medicines are being developed. These centre on three pillars: pre-launch activities including horizon scanning with a specific focus on unmet needs, drugs’ expected place in therapy, drugs’ preliminary budget impact and forecasting (including medicines likely to lose their patents); peri-launch activities including P & R assessment and assessments of risk sharing arrangements; post-launch activities include assessing the effectiveness and safety of new medicines in routine clinical care [1,2]. Pre-launch activities to agree the number of potential patients for new cancer medicines resulted in hospitals staying within budget [3]; and health authorities that had instigated activities pre-launch saw limited excess bleeding with dabigatran [3]. Risk-sharing arrangements have increased access to new medicines; however, concerns with their confidential nature and administrative burden [2,3]. Qualitative and/or quantitative approaches are also being developed to better value (new) medicines. There is also growing use of patient level data post launch, e.g. studies highlighted concerns with dabigatran prescribing in Spain and anti-obesity medicines in Sweden. Long-term follow-up studies have shown greater effectiveness of ciclosporin vs. tacrolimus for transplants despite the rhetoric. Conclusion: Stakeholders in the health care field are working together and developing methods to increase funding for new valued medicines whilst restricting their use where there are concerns to optimise resource use. This will (need to) continue to enable access to safe, (cost-) effective and affordable medicines

Are new models needed to optimize the utilization of new medicines to sustain healthcare systems?

Medicines have made an appreciable contribution to improving health. However, even high-income countries are struggling to fund new premium-priced medicines. This will grow necessitating the development of new models to optimize their use. The objective is to review case histories among health authorities to improve the utilization and expenditure on new medicines. Subsequently, use these to develop exemplar models and outline their implications. A number of issues and challenges were identified from the case histories. These included the low number of new medicines seen as innovative alongside increasing requested prices for their reimbursement, especially for oncology, orphan diseases, diabetes and HCV. Proposed models center on the three pillars of pre-, peri- and post-launch including critical drug evaluation, as well as multi-criteria models for valuing medicines for orphan diseases alongside potentially capping pharmaceutical expenditure. In conclusion, the proposed models involving all key stakeholder groups are critical for the sustainability of healthcare systems or enhancing universal access. The models should help stimulate debate as well as restore trust between key stakeholder groups

Initiatives and reforms across Scotland in recent years to improve prescribing; findings and global implications of drug prescriptions

Objective: Global expenditure on medicines is increasing driven by a number of factors. These include the launch of new premium-priced medicines for complex diseases including oncology, rise in non-communicable diseases especially with ageing populations and changes in clinical practice. There are also concerns with the rise in antimicrobial resistance due to inappropriate prescribing of antimicrobials as well as concerns with polypharmacy. Both situations increase morbidity, mortality and costs. We are aware of ongoing activities across Scotland to improve the managed entry of new medicines, including new oncology medicines, improve the prescribing of antimicrobials as well as enhance the prescribing of low-cost multiple sourced medicines and biosimilars without compromising care. In addition, seeking to address concerns with polypharmacy. Consequently, we wanted to document these multiple measures and their outcomes to provide an overview to inform all key stakeholders in Scotland as well as the global community as resource pressures grow. Methods: A narrative review of the literature documenting examples of ongoing national and regional initiatives across Scotland to influence future prescribing and their impact where known across multiple disease areas. Significant findings: The co-ordinated approach to improve the prescribing of new medicines limited the prescribing of dabigatran when first launched with recent research providing guidance on the effectiveness and safety of different direct oral anticoagulants as more are launched. The patient reported outcome measures project and other ongoing research activities, including linking datasets, is progressing under the Cancer Medicines Outcomes Programme in Scotland to improve future care with typically differences in the effectiveness of new cancer medicines in routine care versus clinical trials. The Scottish Antimicrobial Prescribing Group is also active in Scotland instigating multiple measures to improve antimicrobial prescribing. This includes improving the dosing of gentamicin and vancomycin as well as reducing the prescribing of antibiotics for women with urinary tract infections. Multiple activities have also resulted in high International Non-proprietary Name (INN) prescribing in Scotland at between 91.4% to 100% across a range of medicines. In addition, increased the prescribing of low-cost multiple sourced medicines versus patented medicines in a class or related class, as well as biosimilars, leading to considerable savings without compromising care. There have also been initiatives to address concerns with the rising costs of combination inhalers for patients with respiratory diseases as well as areas of polypharmacy with varying success. Conclusion: Multiple and co-ordinated approaches have improved the quality and efficiency of prescribing in Scotland. Additional measures are still needed and we will continue to monitor the situation

Barriers for Access to New Medicines: Searching for the Balance Between Rising Costs and Limited Budgets

Introduction: There is continued unmet medical need for new medicines across countries especially for cancer, immunological diseases and orphan diseases. However, there are growing challenges with funding new medicines at ever increasing prices along with funding increased medicine volumes with the growing prevalence of both infectious diseases and non-communicable diseases across countries. This has resulted in the development of new models to better manage the entry of new medicines, new financial models being postulated as well as strategies to improve prescribing efficiency. However, more needs to be done. Consequently, the primary aim of this paper is to consider potential ways to optimise the use of new medicines balancing rising costs with increasing budgetary pressures to stimulate debate especially from a payer perspective. Methods: A narrative review of pharmaceutical policies and implications, as well as possible developments, based on key publications and initiatives known to the co-authors principally from a health authority perspective. Results: A number of initiatives and approaches have been identified including new models to better manage the entry of new medicines based on three pillars (pre-, peri-, and post-launch activities). Within this, we see the growing role of horizon scanning activities starting up to 36 months before launch, managed entry agreements and post launch follow-up. It is also likely there will be greater scrutiny over the effectiveness and value of new cancer medicines given ever increasing prices. This could include establishing minimum effectiveness targets for premium pricing along with re-evaluating prices as more medicines for cancer lose their patent. There will also be a greater involvement of patients especially with orphan diseases. New initiatives could include a greater role of multicriteria decision analysis, as well as looking at the potential for de-linking research and development from commercial activities to enhance affordability. Conclusion: There are a number of ongoing activities across countries to try and fund new valued medicines whilst attaining or maintaining universal healthcare. Such activities will grow with increasing resource pressures and continued unmet need

Ongoing and planned activities to improve the management of patients with Type 1 diabetes across Africa : implications for the future

BACKGROUND: Currently about 19 million people in Africa are known to be living with diabetes, mainly Type 2 diabetes (T2DM) (95%), estimated to grow to 47 million people by 2045. However, there are concerns with early diagnosis of patients with Type 1 diabetes (T1DM) as often patients present late with complications. There are also challenges with access and affordability of insulin, monitoring equipment and test strips with typically high patient co-payments, which can be catastrophic for families. These challenges negatively impact on the quality of care of patients with T1DM increasing morbidity and mortality. There are also issues of patient education and psychosocial support adversely affecting patients' quality of life. These challenges need to be debated and potential future activities discussed to improve the future care of patients with T1DM across Africa. METHODOLOGY: Documentation of the current situation across Africa for patients with T1DM including the epidemiology, economics, and available treatments within public healthcare systems as well as ongoing activities to improve their future care. Subsequently, provide guidance to all key stakeholder groups going forward utilizing input from senior-level government, academic and other professionals from across Africa. RESULTS: Whilst prevalence rates for T1DM are considerably lower than T2DM, there are concerns with late diagnosis as well as the routine provision of insulin and monitoring equipment across Africa. High patient co-payments exacerbate the situation. However, there are ongoing developments to address the multiple challenges including the instigation of universal health care and partnerships with non-governmental organizations, patient organizations, and pharmaceutical companies. Their impact though remains to be seen. In the meantime, a range of activities has been documented for all key stakeholder groups to improve future care. CONCLUSION: There are concerns with the management of patients with T1DM across Africa. A number of activities has been suggested to address this and will be monitored

Challenges and innovations brought about by the Covid-19 pandemic regarding medical and pharmacy education especially in Africa and implications for the future

Background: Multiple measures introduced early to restrict COVID-19 have dramatically impacted the teaching of medical and pharmacy students, exacerbated by the lack of infrastructure and experience with e-learning at the start of the pandemic. In addition, the costs and reliability of the Internet across Africa pose challenges alongside undertaking clinical teaching and practical programmes. Consequently, there is a need to understand the many challenges and how these were addressed, given increasingly complex patients, to provide future direction. Method: An exploratory study was conducted among senior-level medical and pharmacy educators across Africa, addressing four key questions, including the challenges resulting from the pandemic and how these were dealt with. Results: Staff and student members faced multiple challenges initially, including adapting to online learning. In addition, concerns with the lack of equipment (especially among disadvantaged students), the costs of Internet bundles, and how to conduct practicals and clinical teaching. Multiple activities were undertaken to address these challenges. These included training sessions, developing innovative approaches to teaching, and seeking ways to reduce Internet costs. Robust approaches to practicals, clinical teaching, and assessments have been developed. Conclusions: Appreciable difficulties to teaching arising from the pandemic are being addressed across Africa. Research is ongoing to improve education and assessments

Variation in the prices of oncology medicines across Europe and the implications for the future

Introduction/ Objectives: There are increasing concerns among health authorities regarding the sustainability of healthcare systems with growing expenditure on medicines including new high-priced oncology medicines. Medicine prices among European countries may be adversely affected by their population size and economic power to negotiate. There are also concerns that prices of patented medicines do not change once the prices of medicines used for negotiations substantially change. This needs to be investigated as part of the implications of low-cost generic oncology medicines. Methodology: Analysing principally reimbursed prices of patented oral oncology medicines (imatinib, erlotinib and fludarabine) between 2013 and 2017 across Europe and exploring correlations between GDP, population size, and prices. Comparing the findings with previous research regarding prices of oral generic oncology medicines. Results: The prices of imatinib, erlotinib and fludarabine did vary among European countries but showed limited price erosion over time in the absence of generics. There appeared to be no correlation between population size and prices. However, higher prices were seen among countries with higher GDP per capita which is a concern for lower income countries referencing these. Discussion and Conclusion: It is likely that the limited price erosion for patented oncology medicines will change across Europe with increased scrutiny over their prices and value as more medicines used for pricing decisions lose their patents combined with growing pressures on the oncology drug budget. In addition, discussions will continue regarding fair pricing for new oncology medicines and other approaches given ever rising prices with research showing substantial price reductions for oral oncology medicines (up to -97.8% for imatinib) once generics become available. We are also seeing appreciable price reductions for biosimilars further increasing the likelihood of these developments

An Unusual Case of Sclerosing Inflammatory Pseudotumor in a 11-year-old Female

Idiopathic sclerosing orbital inflammation (ISOI) is an uncommon non-infectious condition with poorly understood pathogenesis distinct from the spectrum of orbital inflammatory disorders. It frequently affects anterior orbital structures and may masquerade as orbital cellulitis, lymphoma, or rhabdomyosarcoma. We describe a 11-year old girl with dacryoadenitis who presented with diplopia and proptosis