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Background: Rising expenditure for new cancer medicines is accelerating concerns that their costs will become unsustainable for universal healthcare access. Moreover, early market access of new oncology medicines lacking appropriate clinical evaluation generates uncertainty over their cost-effectiveness and increases expenditure for unknown health gain. Patient-level data can complement clinical trials and generate better evidence on the effectiveness, safety and outcomes of these new medicines in routine care. This can support policy decisions including funding. Consequently, there is a need for improving datasets for establishing real-world outcomes of newly launched oncology medicines. Aim: To outline the types of available datasets for collecting patient-level data for oncology among different European countries. Additionally, to highlight concerns regarding the use and availability of such data from a health authority perspective as well as possibilities for cross-national collaboration to improve data collection and inform decision-making. Methods: A mixed methods approach was undertaken through a cross-sectional questionnaire followed-up by a focus group discussion. Participants were selected by purposive sampling to represent stakeholders across different European countries and healthcare settings. Descriptive statistics were used to analyze quantifiable questions, whilst content analysis was employed for open-ended questions. Results: 25 respondents across 18 European countries provided their insights on the types of datasets collecting oncology data, including hospital records, cancer, prescription and medicine registers. The most available is expenditure data whilst data concerning effectiveness, safety and outcomes is less available, and there are concerns with data validity. A major constraint to data collection is the lack of comprehensive registries and limited data on effectiveness, safety and outcomes of new medicines. Data ownership limits data accessibility as well as possibilities for linkage, and data collection is time-consuming, necessitating dedicated staff and better systems to facilitate the process. Cross-national collaboration is challenging but the engagement of multiple stakeholders is a key step to reach common goals through research. Conclusion: This study acts as a starting point for future research on patient-level databases for oncology across Europe. Future recommendations will require continued engagement in research, building on current initiatives and involving multiple stakeholders to establish guidelines and commitments for transparency and data sharing., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Pisana, Wettermark, Kurdi, Tubic, Pontes, Zara, Van Ganse, Petrova, Mardare, Fürst, Roig-Izquierdo, Melien, Bonanno, Banzi, Marković-Peković, Mitkova and Godman.)

Background: Diabetes mellitus rates and associated costs continue to rise across Europe enhancing health authority focus on its management. The risk of complications is enhanced by poor glycaemic control, with long-acting insulin analogues developed to reduce hypoglycaemia and improve patient convenience. There are concerns though with their considerably higher costs, but moderated by reductions in complications and associated costs. Biosimilars can help further reduce costs. However, to date, price reductions for biosimilar insulin glargine appear limited. In addition, the originator company has switched promotional efforts to more concentrated patented formulations to reduce the impact of biosimilars. There are also concerns with different devices between the manufacturers. As a result, there is a need to assess current utilisation rates for insulins, especially long-acting insulin analogues and biosimilars, and the rationale for patterns seen, among multiple European countries to provide future direction. Methodology . Health authority databases are examined to assess utilisation and expenditure patterns for insulins, including biosimilar insulin glargine. Explanations for patterns seen were provided by senior-level personnel., Results: Typically increasing use of long-acting insulin analogues across Europe including both Western and Central and Eastern European countries reflects perceived patient benefits despite higher prices. However, activities by the originator company to switch patients to more concentrated insulin glargine coupled with lowering prices towards biosimilars have limited biosimilar uptake, with biosimilars not currently launched in a minority of European countries. A number of activities were identified to address this. Enhancing the attractiveness of the biosimilar insulin market is essential to encourage other biosimilar manufacturers to enter the market as more long-acting insulin analogues lose their patents to benefit all key stakeholder groups., Conclusions: There are concerns with the availability and use of insulin glargine biosimilars among European countries despite lower costs. This can be addressed., Competing Interests: The authors have no relevant conflicts of interest to declare. However, a number of the coauthors work for health authorities or are advisers to them., (Copyright © 2021 Brian Godman et al.)

Background: Antineoplastic medicines affect the patients' physical and psychosocial well-being posing challenges for patients, caregivers and healthcare professionals. However, little is known about the patients' lived experience with medicines (PLEM) for antineoplastic treatment. It is the lived experience that gives meaning to each individual's perception of a particular phenomenon which is influenced by internal and external factors relevant to the individual., Objectives: To critically appraise, synthesise and present the available evidence of patients' lived experience with antineoplastic medicines prescribed for the management of malignant solid tumours., Method: A systematic literature search was conducted in six electronic databases for articles published in English with no date restrictions. The search terms were related to beliefs, practice and burden in relation to patient, antineoplastic medicines, tumours and lived experience. Study selection, quality assessment and data extraction were performed independently by 2 reviewers. Research findings were analysed using narrative and meta-synthesis approaches., Results: The search retrieved 31,004 articles with only 10 studies satisfying the inclusion and exclusion criteria. These studies were published between 2005 and 2016 in Europe (n = 6), America (n = 3) and Asia (n = 1). Nine themes were identified to contribute to the patients' lived experience with antineoplastic medicines. These were (a) influence from family members, healthcare professionals, media and culture, (b) general attitude towards medicine, (c) accepting medicine, (d) modifying or altering medicine regimen or dose, (e) medicine characteristics, (f) medicine routine, (g) medicine adverse events, (h) medicine and social burden and (i) healthcare associated medicine burden. Patients tend to undergo a continuous process of reinterpretations of their experience with medicines throughout their treatment journey., Conclusion: The use of antineoplastic medicines has a profound effect on the patients' lives. Further longitudinal in-depth studies are required to provide deeper insight into PLEM and support patients in their treatment journey., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Aim: To identify medication errors in the Maltese pharmacovigilance database and describe the frequency and characteristics of these events., Method: A retrospective analysis of the Adverse Drug Events (ADEs) reported over 5 years in Malta was conducted. Medication errors were identified by comparing use against the product's Summary of Product Characteristics (SmPC) and then classified by type of medication error, seriousness and the stage of the medication use chain at which they occurred., Results: 319 consolidated ADE reports met the inclusion criteria and were analysed. 56/319 consolidated ADEs were associated with serious patient harm. The 80-89 and the 50-59 age groups were associated with most medications used in error. 65% of errors originated in the community. Errors were identified in prescribing (52%), therapeutic monitoring (26%), patients' own (12%), dispensing (7%) and administration (3%) stages. The non-steroidal anti-inflammatory drugs (NSAIDs) and antibiotics were most commonly used in errors involving wrong doses, lack of therapeutic monitoring, interactions; contra-indications, prescribing for an unlicensed indication as well as an inappropriate duration of therapy., Conclusion: Pharmacovigilance databases are a useful source of information on medication errors and can be used to detect risks associated with the use of medicinal products.