National audit of antidote stocking in UK emergency departments.

BACKGROUND: Previous audits of antidote stocking in UK hospitals have demonstrated variable but improving compliance with joint Royal College of Emergency Medicine and National Poisons Information Service guidance on antidote availability in emergency departments. The guidance was updated in 2017. AIM: To provide a current picture of compliance with the 2017 antidote guidance and compare this to previous audits. METHODS: Questionnaires were distributed to all hospitals in the UK with an emergency department via medicines information and regional pharmacy procurement networks. Data were collected on availability and stock levels of category A (immediately available) and category B (available within 1 hour) antidotes. Additionally, data were collected on holdings of category C (held supra-regionally) antidotes and arrangements for sourcing these if not stocked locally. RESULTS: 233 hospitals were surveyed and 178 replies (76.4%) were received. There were 73 hospitals (41.7%) fully compliant with guidance for category A, 34 hospitals (19.1%) for category B and 18 hospitals (10.1%) for both categories A and B antidotes. Few hospitals stocked category C antidotes (1.1%-34.8%). Evidence of formalised regional holding arrangements for category C antidotes, as advised in the guidance, was noted in some areas but many regions remain without such agreements. CONCLUSIONS: Most hospitals remain not fully compliant with stocking recommendations for categories A and B antidotes, with limited recent improvement. Category C antidotes are stocked by few hospitals although awareness of where these can be sourced appears to be increasing. Emergency departments should review their antidote stocking arrangements to ensure compliance with guidance. Formal arrangements for stocking of the more rarely used category C antidotes at a regional level are also required, where not already in existence, in order to assure their availability in an equitable way across the country.

A Look at the History of Biosimilar Adoption: Characteristics of Early and Late Adopters of Infliximab and Etanercept Biosimilars in Subregions of England, Scotland and Wales - A Mixed Methods Study.

BACKGROUND: Regions within England, Scotland and Wales show variation in rate of adoption of biosimilar infliximab and etanercept. OBJECTIVES: This study aims to examine how local decisions and practices in regions within England, Scotland and Wales might explain initial variation in market dynamics of biosimilar and originator infliximab and etanercept. METHODS: Market data provided by the National Health Service (NHS) on biosimilar and originator infliximab and etanercept uptake were analysed for the 10 historical regions of England, 14 health boards in Scotland and 7 health boards in Wales (2015-2018). Findings were discussed in ten semi-structured interviews: on a national level with an industry representative (1), on a regional level with NHS employees in England (6), Scotland (1) and Wales (1), and on a local level with a representative of a clinical commissioning group in England (1). RESULTS: Tenders for infliximab and etanercept in England, Scotland and Wales have consistently resulted in a biosimilar as the best value biological. Early and late biosimilar adopters are seen, with overall convergence towards high biosimilar market shares over time. Qualitative results suggest that biosimilar adoption was positively influenced by (a) a price difference between biosimilar and originator product making it worthwhile to switch patients; (b) a good relationship between commissioner and provider in England resulting in gain share agreements; (c) leadership on biosimilars in regional NHS offices in England or Scottish and Welsh health boards; (d) key opinion leaders or leading hospitals that start using biosimilars early and gain experience. CONCLUSIONS: This study has shown that the savings potential drives biosimilar use. Regions with a proactive attitude, good stakeholder relationships, and clinician engagement were identified as early adopters.

Integrative Review of Managed Entry Agreements: Chances and Limitations.

BACKGROUND AND OBJECTIVE: Managed entry agreements (MEAs) consist of a set of instruments to reduce the uncertainty and the budget impact of new high-priced medicines; however, there are concerns. There is a need to critically appraise MEAs with their planned introduction in Brazil. Accordingly, the objective of this article is to identify and appraise key attributes and concerns with MEAs among payers and their advisers, with the findings providing critical considerations for Brazil and other high- and middle-income countries. METHODS: An integrative review approach was adopted. This involved a review of MEAs across countries. The review question was 'What are the health technology MEAs that have been applied around the world?' This review was supplemented with studies not retrieved in the search known to the senior-level co-authors including key South American markets. It also involved senior-level decision makers and advisers providing guidance on the potential advantages and disadvantages of MEAs and ways forward. RESULTS: Twenty-five studies were included in the review. Most MEAs included medicines (96.8%), focused on financial arrangements (43%) and included mostly antineoplastic medicines. Most countries kept key information confidential including discounts or had not published such data. Few details were found in the literature regarding South America. Our findings and inputs resulted in both advantages including reimbursement and disadvantages including concerns with data collection for outcome-based schemes. CONCLUSIONS: We are likely to see a growth in MEAs with the continual launch of new high-priced and often complex treatments, coupled with increasing demands on resources. Whilst outcome-based MEAs could be an important tool to improve access to new innovative medicines, there are critical issues to address. Comparing knowledge, experiences, and practices across countries is crucial to guide high- and middle-income countries when designing their future MEAs.

Ensuring innovation in diagnostics for bacterial infection: implications for policy

The inappropriate use of antibiotics is a primary cause of the ongoing increase in drug resistance amongst pathogenic bacteria. The resulting decrease in the efficacy of antibiotics threatens the ability to combat infectious diseases. Rapid, point-of-care tests to identify pathogens and better target the appropriate treatment could greatly improve the use of antibiotics, yet few such tests are available or being developed, despite the rapid pace of medical innovation. Clearly, something is inhibiting the much-needed development of new and more convenient diagnostic tools. This study delineates priorities for developing diagnostics to improve antibiotic prescription and use, in order to manage and curb the expansion of drug resistance. It calls for new approaches, particularly in the provision of diagnostic devices, and, in doing so, outlines some of the inadequacies in health, science and policy initiatives that have led to the dearth of such devices. The authors make the case that innovation is clearly and urgently needed, not only in the technology of diagnosis but also in public policy and medical practice to support the availability and use of better diagnostic tools. This book explores the complexities of the diagnostics market from the perspective of both supply and demand, unearthing interesting bottlenecks: some obvious, some more subtle. It calls for a broad, multifaceted policy response, and an overhaul of current practice, so that the growth of bacterial resistance can be stemmed.