clinicaltrials.gov Identifier: NCT00921960.

Increasing numbers of biosimilar medicines are becoming available. The objective of this survey was to assess awareness of and attitudes to biosimilars amongst physicians (medical specialists and General Practitioners (GPs)) and community pharmacists in Ireland. Physicians were invited to complete an online questionnaire during April and May 2016. Community pharmacists received a postal questionnaire in August 2015. Responses from 102 medical specialists, 253 GPs and 125 community pharmacists were analysed. The majority of medical specialists (85%) and pharmacists (77%) claimed to be either very familiar or familiar with the term biosimilar, whereas many GPs (60%) were unable to define or had never heard of the term. One in five (21%) healthcare professionals responded that biosimilars were the same as generic medicines. The majority of medical specialists opposed pharmacist-led substitution of biological medicines but some thought it could be appropriate if agreed with the clinician in advance. Medical specialists who prescribe biosimilars (n = 43) were more likely to do so on treatment initiation (67%), than switch a patient from an originator medicine to a biosimilar (28%). The findings will aid the design of educational initiatives for healthcare professionals and highlight attitudes of healthcare professionals to biosimilars, so informing regulators, policy makers and industry.

Competition arising from the increasing availability of biosimilar medicines has resulted in healthcare savings and has provided greater patient access to high cost therapeutics in Europe. The biosimilar market in the USA is relatively new so the full impact of biosimilar availability remains to be seen. Educational initiatives relating to the use of biosimilar medicines are currently being undertaken by regulators, policy makers and industry. The debate on biosimilars has moved on from the appropriateness of the regulatory framework which governs their approval, to the practice of interchangeability. Interchangeability is an important issue for healthcare professionals but different definitions and regulatory frameworks exist in the USA and Europe. In the USA, an interchangeable biological product is a biosimilar which may be substituted by a pharmacist, subject to local State policies. The interchangeability of a biosimilar with its reference medicine will be evaluated by the United States Food and Drug Administration (FDA) in cases where approval as an 'interchangeable product' is sought. In contrast, the European Medicines Agency (EMA) does not assess or make recommendations on interchangeability, therefore, in Europe, interchangeability does not mean substitution but is generally physician-led or driven by national policy. This paper provides an overview of the regulation of biosimilar medicines. Challenges associated with the demonstration of interchangeability and practical considerations relating to switching are also discussed. Finally, we present policies that have been adopted to date in several European countries, the USA and Australia, which aim to promote the use of biosimilar medicines.

OBJECTIVE: The aim of this study was to identify speci®cally which biochemical indices predict excessive weight gain over time in a cohort of pre-pubertal children. SUBJECTS: Fifty nine healthy pre-pubertal children (age: 6.3 ± 9.8 y). MEASUREMENTS: Children were de®ned anthropometrically and biochemically at baseline. Height and weight measurements were then repeated after six (n 52) and 12 months (n 37). RESULTS: Weight change after six months (de®ned by a change in body mass index (BMI) z-score from baseline) demonstrated no correlation with fasting plasma levels of leptin, insulin, insulin:glucose (IG) ratio, cholesterol, triglyceride or high density lipoprotein (HDL) cholesterol. However, after 12 months there was a signi®cant negative correlation between BMI z-score change and initial plasma leptin (r À0.35, P 0.048) and this relationship strengthened when adjusted for body fat (from bio-electrical impedance; r À0.46, P 0.009). In addition, there was a signi®cant positive relationship between plasma total cholesterol and BMI z score change (r 0.38, P 0.03) and this relationship remained unchanged when adjusted for body fat. No relationship was observed between weight change after 12 months and plasma levels of insulin, IG ratio, HDL cholesterol or triglyceride. CONCLUSION: Plasma leptin and total cholesterol were found to be predictive of weight gain over 12 months in a cohort of pre-pubertal children. These two potential predictors can be readily measured in clinical practice and these ®ndings may represent a method of de®ning the`at risk of obesity' state in childhood.

Aims Heart failure (HF) patients may be at risk of prescription of potentially inappropriate medicines (PIMs) yet no disease‐specific list is available to assess PIM use in this population. A Consensus Potentially Inappropriate Medicines in Heart Failure (PIMHF) list was developed, assessed, and compared with an established, general tool in an ambulatory HF population. Methods and results The Consensus PIMHF list was compiled using modified Delphi methodology with a multidisciplinary team. The list consisted of 11 items. The medication profile of 350 patients was assessed. The association of a Consensus PIMHF item use over a median follow‐up period of 1.8 (interquartile range 1.3–2.1) years with the primary endpoint of death, acute hospitalization, or unscheduled outpatient visit was examined. Fifty‐one patients (14.6%) were prescribed ≥1 Consensus PIMHF item. In univariable analysis, patients prescribed ≥1 Consensus PIMHF item were 58% more likely to experience the primary endpoint than those with none [95% confidence interval (CI) 1.02–2.45]. When adjusted for age, sex, and HF severity, this difference remained [hazard ratio (HR) 1.88, 95% CI 1.16–3.06] and these associations were in contrast to the use of a more general tool (HR 1.24, 95% CI 0.83–1.84). However, when further adjusted to include co‐morbidity score and polypharmacy, there was no association with outcome using either tool (HR 1.40, 95% CI 0.83–2.38; HR 1.05, 95% CI 0.69–1.60, respectively). Conclusion The Consensus PIMHF list provides the first HF‐specific medicines review tool. These results provide some support for more disease‐specific tools with limited lists of PIMs to rationalize medicines management in HF. However, more prospective work on the application of these tools in practice is needed.

BackgroundIn Europe, changes to pharmacovigilance legislation, which include additional monitoring of medicines, aim to optimise adverse drug reaction (ADR) reporting systems. The legislation also makes provisions related to the traceability of biological medicines.ObjectiveThe objective of this study was to assess (i) knowledge and general experience of ADR reporting, (ii) knowledge, behaviours, and attitudes related to the pharmacovigilance of biologicals, and (iii) awareness of additional monitoring among healthcare professionals (HCPs) in Ireland.MethodsHospital doctors (n = 88), general practitioners (GPs) (n = 197), nurses (n = 104) and pharmacists (n = 309) completed an online questionnaire.ResultsThere were differences in mean knowledge scores relating to ADR reporting and the pharmacovigilance of biologicals among the HCP groups. The majority of HCPs who use biological medicines in their practice generally record biologicals by brand name but practice behaviours relating to batch number recording differed between some professions. HCPs consider batch number recording to be valuable but also regard it as being more difficult than brand name recording. Most respondents were aware of the concept of additional monitoring but awareness rates differed between some groups. Among those who knew about additional monitoring, there was higher awareness of the inverted black triangle symbol among pharmacists (> 86.4%) compared with hospital doctors (35.1%), GPs (35.6%), and nurses (14.9%). Hospital pharmacists had more experience and knowledge of ADR reporting than other practising HCPs.ConclusionThis study highlights the important role hospital pharmacists play in post-marketing surveillance. There is a need to increase pharmacovigilance awareness of biological medicines and improve systems to support their batch traceability.Electronic supplementary materialThe online version of this article (10.1007/s40259-018-0281-6) contains supplementary material, which is available to authorized users.

Objective: To identify whether measures of energy intake and expenditure predict excessive weight gain over time in children and to describe how these measures relate to similar measures in parents. Design: Prospective, descriptive study over 12 months with no intervention. Setting: University teaching hospital. Subjects: Children aged between 6.0 and 9.0 y. Recruitment was through advertisement. A total of 59 children (30 F), 41 mothers and 29 fathers. In all, 41 (69%) of the children were reviewed at 12 months (20 F). Results: No significant correlations were identified between body mass index (BMI) z-score change in children over 12 months for any dietary variable or for any measures of energy expenditure, including hours of television viewing or percent time spent in low-, moderate-or high-intensity activity. The BMI z-score change over 12 months was significantly correlated with LDL cholesterol and Apo B/ApoA-1 ratio, independent of percent body fat (r ¼ 0.45, P ¼ 0.01; r ¼ 0.37, P ¼ 0.03). A significant positive correlation was found for mothers and girls for percent time in moderate to high activity (r ¼ 0.44, P ¼ 0.03) and between fathers and children for percent time spent in low activity (r ¼ 0.43, P ¼ 0.005). Conclusions: The study has been unable to identify environmental predictors that indicate propensity to faster weight gain over time in this cohort of children, but has extended the evidence on lifestyle-influenced biochemical predictors that do. An overall lack of vigorous activity in this age group, and correlations between parental and child activity and inactivity have been identified.

Objective: To identify the prevalence of coronary risk factors among South Asian Indians in Australia and India. Design: Cross-sectional intercountry comparison. Subjects: Healthy volunteers aged 23-75 y recruited from the Indian community in Sydney Australia (n¼125), and their nominated relatives in India, (n¼125). Results: The two groups were of similar background with over 90% of the group in India being siblings, parents or relatives of the group in Australia. There was no difference in the populations between India and Australia with regard to mean age (40711.5 vs 39710. Conclusion:The group in Australia (especially women) have a more favourable disease risk profile than those in India. The fact that the groups are of such similar background and partly related, make it unlikely that changes due to migration have a strong genetic bias. In contrast to other studies, the absence here of excessive weight gain on migration may be a key factor in disease risk prevention.