Swedish patients’ trust in the bioequivalence of interchangeable generics. What factors are important for low trust?

Background: Generic substitution (GS), is a cost-containment strategy meant to contain pharmaceutical expenditure without compromising health objectives. In order to shape GS into a policy that is both efficient and safe it is crucial to understand which factors are most important for patients’ trust in GS. Objective: To assess Swedish patients’ level of trust in the bioequivalence of cheap and expensive generic medicines, and the association between trust and various factors. Methods: A cross-sectional study was conducted. Questionnaires were handed out at 12 community pharmacies in Sweden, selected through stratified sampling, between March and April 2015. The questionnaire included seven socio-demographic questions in addition to 18 items divided into three sections: the ‘views on generic medicine’-scale, information on and prior experiences of GS, financial aspects and change of color/name. Odds Ratios (ORs) were estimated applying adjusted logistic regression analyses with trust in the bioequivalence of generic medicines used as outcome variable and various factors as predictors. Results: A total of 719 patients participated (response rate 85.7%). The results show that 70.7% of the respondents’ trust that cheap and expensive interchangeable generic medicines are equal. Of the respondents 36.0% considered the change in appearance and 40.8% the change in names to complicate adherence. Lower trust in the bioequivalence of generic medicines were associated with being female (aOR=1.82, 95%CI 1.20:2.75, p<0.01), patients perceiving that changes in product name and appearance make adherence more complicated (aOR=2.18, 95%CI 1.48:3.19, p<0.001), disagreeing in that GS saves money for me (the customer) (aOR=2.68, 95%CI 1.58:4.55, p<0.001) or that GS saves money for society (aOR=3.21, 95%CI 1.46:7.08, p<0.01). Conclusions: Seven out of ten respondents had trust in the bioequivalence of generic medicines, and one in three considered GS to complicate adherence. Four factors were associated with lower trust in GS, i.e. female gender, agreeing that changes in product name and appearance complicates adherence, disagreeing in that GS saves money for me or disagreeing in that GS saves money for the society. Low trust in GS needs to be addressed, not least in the communication between health professionals and patients

From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding

In 2019, the Innovative Medicines Initiative (IMI) funded the ConcePTION project—Building an ecosystem for better monitoring and communicating safety of medicines use in pregnancy and breastfeeding: validated and regulatory endorsed workflows for fast, optimised evidence generation—with the vision that there is a societal obligation to rapidly reduce uncertainty about the safety of medication use in pregnancy and breastfeeding. The present paper introduces the set of concepts used to describe the European data sources involved in the ConcePTION project and illustrates the ConcePTION Common Data Model (CDM), which serves as the keystone of the federated ConcePTION network. Based on data availability and content analysis of 21 European data sources, the ConcePTION CDM has been structured with six tables designed to capture data from routine healthcare, three tables for data from public health surveillance activities, three curated tables for derived data on population (e.g., observation time and mother-child linkage), plus four metadata tables. By its first anniversary, the ConcePTION CDM has enabled 13 data sources to run common scripts to contribute to major European projects, demonstrating its capacity to facilitate effective and transparent deployment of distributed analytics, and its potential to address questions about utilization, effectiveness, and safety of medicines in special populations, including during pregnancy and breastfeeding, and, more broadly, in the general population

Pattern of statin use changes following media coverage of its side effects

Margit Kriegbaum,1 Kasper Bering Liisberg,2 Helle Wallach-Kildemoes3 1Department of Public Health, 2Department of Media, Cognition, and Communication, 3Department of Pharmacy, University of Copenhagen, Copenhagen, Denmark Background: The media plays a role in shaping opinions about medical decisions, for example, whether to initiate or stop treatment. An association between negative media attention and statin discontinuation has been demonstrated, but it may differ depending on the reason for prescription and whether the user is new (incident) or long term (prevalent).Aim: The aim of this study is to explore whether a Danish newspaper article featuring the side effects of statins affects statin discontinuation in incident versus prevalent users, with the reason for prescription also taken into account.Methods: The study relies on a quasi-experimental design and uses registry data on statin purchases to explore discontinuation and treatment duration. As a proxy for reason for prescription, data on filled prescriptions and hospital diagnoses from a Danish registry were used. We compared statin discontinuation in all statin users in Denmark in 2007 before the media event (n=343,438) and after it in 2008 (n=404,052).Results: Compared to 2007, statin discontinuation among prevalent users in 2008 increased by 2.97 percentage points (pp). The change in discontinuation varied with the indication for statin use. Those with myocardial infarction had the smallest increase (1.98 pp) and those with hypercholesterolemia or primary hypertension had the largest increase (3.54 pp). Incident statin users had a higher level of discontinuation and a larger difference in discontinuation between 2007 and 2008. Compared to 2007, more people (5.52 pp) discontinued statin treatment in 2008. Again, those with myocardial infarction had the smallest decrease in statin discontinuation (1.49 pp), while those with a potential atherosclerotic condition (7.05 pp) and hypercholesterolemia or primary hypertension (6.10 pp) had the largest increase.Conclusion: Statin discontinuation increased in 2008 following a media event, but especially among individuals prescribed statins for primary prevention and among new statin users. Keywords: statin discontinuation, media attention, quasi-experimental study, primary prevention, secondary preventio

Statin prescribing according to gender, age and indication: what about the benefit-risk balance?

Rationales, aims and objectives The increasing dispensing of statins has raised concern about the appropriateness of prescribing to various population groups. We aimed to (1) investigate incident and prevalent statin prescribing according to indication, gender and age and (2) relate prescribing patterns to evidence on beneficial and adverse effects. Methods A cohort of Danish inhabitants (n = 4 424 818) was followed in nationwide registries for dispensed statin prescriptions and hospital discharge information. We calculated incidence rates (2005–2009), prevalence trends (2000–2010) and absolute numbers of statin users according to register proxies for indication, gender and age. Results In 2010, the prevalence became highest for ages 75–84 and was higher in men than women (37% and 33%, respectively). Indication‐specific incidences and prevalences peaked at ages around 65–70, but in myocardial infarction, the prevalence was about 80% at ages 45–80. Particularly, incidences tended to be lower in women until ages of about 60 where after gender differences were negligible. In asymptomatic individuals (hypercholesterolaemia, presumably only indication) aged 50+, dispensing was highest in women. The fraction of statin dispensing for primary prevention decreased with age: higher for incident than prevalent prescribing. Independent of age, this fraction was highest among women, e.g. 60% versus 45% at ages 55–64. The fraction for potential atherosclerotic condition (PAC, e.g. heart failure) increased with age. Conclusion Prevalence of statin utilization was highest for ages 75–84, although indication‐specific measures were relatively low. Despite inconclusive evidence for a favourable risk–benefit balance, statin prescribing was high among people aged 80+, asymptomatic women and PAC patients