Haemovigilance is an important element of blood regulation. It includes collecting and evaluating the information on adverse events resulting from the use of blood and blood components with the aim to improve donor and patient safety. We describe the results of the pilot of the integrated GBT+ Blood for the haemovigilance function in 10 sub-Saharan African countries.

Transitioning patients from an originator to a corresponding biosimilar has been extensively studied in both randomized controlled trials and observational studies. Although transitioning is considered well-tolerated, with no negative impacts on efficacy and/or safety, 2.6-25.8% of patients restart treatment with the originator (retransitioning). Retransitioning to the originator can be considered an indication of biosimilar treatment failure or dissatisfaction with biosimilar treatment. Increasing our knowledge of patients who retransition might help to reduce the number of patients retransitioning.

To evaluate the association between regulatory drug safety advisories and changes in drug utilisation.

The summary of product characteristics (SmPCs) is an important information source that includes the adverse drug reactions (ADRs) associated with the drug. Drugs with the same mechanism of action are expected to have a similar ADR profile and thus a substantial overlap of the described ADRs in the SmPC. The objective of this study is to assess this overlap. We extracted all ADRs (excluding hypersensitivity and administration site reactions) that were described in the first and all subsequent versions of the SmPCs of all approved TNF-α inhibitors in the European Union. The Medical Dictionary for Regulatory Activities was used to characterize the ADRs. At the end of follow-up, 293 unique ADRs (at high level term level) were described in the SmPCs of the 5 TNF-α inhibitors. There was substantial variation in the number of ADRs described in the SmPC among the TNF-α inhibitors. Of the 293 ADRs, 133 (45%) were described in the SmPC of one TNF-α inhibitor and 39 (13%) in the SmPCs of all 5 TNF-α inhibitors. Serious ADRs and ADRs classified as important risks were described approximately four times more often in a second SmPC than ADRs not classified as such. In conclusion, the ADRs described in the SmPCs of the TNF-α inhibitors differ considerably in number and type. In order to adequately inform prescribers and patients, acquired knowledge of the safety profile of drugs with the same mechanism of action should increasingly be taken into account in the assessment of all drugs within the class.

Decentralised clinical trial activities-such as participant recruitment via social media, data collection through wearables and direct-to-participant investigational medicinal product (IMP) supply-have the potential to change the way clinical trials (CTs) are conducted and with that to reduce the participation burden and improve generalisability. In this study, we investigated the decentralised and on-site conduct of trial activities as reported in CT protocols with a trial start date in 2019 or 2020.

Background Pharmacists may contribute to fall prevention particularly by identifying and deprescribing fall risk-increasing drugs (FRIDs) in patients with high fall risk. Objective To assess community pharmacists' perceptions on providing fall prevention services, and to identify their barriers and facilitators in offering these fall prevention services including deprescribing of FRIDs. Setting A mixed-methods study was conducted with Dutch pharmacists. Method Quantitative (ranking statements on a Likert scale, survey) and qualitative data (semi-structured interviews) were collected. Out of 466 pharmacists who were invited to participate, 313 Dutch pharmacists ranked statements, about providing fall prevention, that were presented during a lecture, and 205 completed a survey. To explore pharmacists' perceptions in-depth, 16 were interviewed. Quantitative data were analysed using descriptive statistics. All interviews were audiotaped and transcribed verbatim. The capability opportunity motivation-behaviour model was applied to interpret and analyse the findings of qualitative data. Main outcome measure Community pharmacists' views on providing fall prevention. Results Pharmacists stated that they were motivated to provide fall prevention. They believed they were capable of providing fall prevention by FRID deprescribing. They perceived limited opportunities to contribute. Major barriers included insufficient multidisciplinary collaboration, patient unwillingness to deprescribe FRIDs, and lack of time. Facilitators included goal-setting behaviour, financial compensation, and skilled communication. Conclusion Despite the complex decision-making process in medication-related fall prevention, community pharmacists are motivated and feel capable of providing fall prevention. Opportunities for pharmacists to provide fall prevention services should be enhanced, for example by implementing multidisciplinary agreements.

In studies evaluating the effectiveness of additional risk minimisation measures (aRMMs), the need for speed must be properly balanced with the quality of the study. We assessed the duration of aRMM effectiveness evaluations, using additional pharmacovigilance activities, for centrally authorised medicinal products in the European Union.

Adherence to medication is often low. Pharmacists may improve adherence, but a one-size-fits-all approach will not work: different patients have different needs. Goal of the current study is to assess the effectiveness of a patient-tailored, telephone-based intervention by a pharmacist at the start of pharmacotherapy aimed at improving medication adherence, satisfaction with information and counselling and the beliefs about medicines.

Several studies have suggested that anti-diabetic insulin analogue treatment might increase cancer risk. The aim of this study was to review the postulated association between insulin and insulin analogue treatment and breast cancer development, and plausible mechanisms.

To identify pharmacoepidemiological multi-database studies and to describe data management and data analysis techniques used for combining data.

The case-crossover (CXO) and self-controlled case series (SCCS) designs are increasingly used in pharmacoepidemiology. In both, relative risk estimates are obtained within persons, implicitly controlling for time-fixed confounding variables.

Data on medication-related hospital admissions suggest that there is an opportunity for improved pharmaceutical care. Hence, concerns about medication-related hospital admissions is a driver to extend and integrate the role of community pharmacists in general practice.

Background Pharmacists are increasingly involved in patient care. This new role in a complex healthcare system with demanding patients may lead to moral dilemmas. There has been little research into pharmacy ethics, and existing data are limited by their retrospective nature and small sample sizes. A thematic overview of the moral dilemmas experienced by community pharmacists is still missing. Objective To make a thematic overview of moral dilemmas experienced in daily pharmacy practice. Setting Dutch community pharmacy. Methods Dutch community pharmacists wrote a narrative about a moral dilemma they had experienced in clinical practice. The narratives were analysed using qualitative content analysis to identify underlying themes. Main outcome measure Themes of moral dilemmas. Results Twenty-two themes were identified in 128 narratives. These moral dilemmas arose predominantly during pharmacists' contact with patients and other health professionals. The relationship between the pharmacist, patient and other health professionals was complicated by other parties, such as legal representatives, health insurance companies, and regulators. Conclusion The moral dilemmas experienced by community pharmacists are more diverse than previously reported. The main dilemmas arose in their professional contacts, frequently when their professional autonomy was challenged by the behaviour of patients and other health professionals.

Over the past decades, opioid prescriptions have increased in the Netherlands. The Dutch general practitioners' guideline on pain was recently updated and now aims to reduce opioid prescriptions and high-risk opioid use for non-cancer pain. The guideline, however, lacks practical measures for implementation.

Several monoclonal antibodies (mAbs) have been linked to neuropsychiatric adverse effects in patients, including depression and suicidal ideation and behavior.

The aim was to recognise the professional core values in the moral dilemmas of pharmacists in community pharmacy and to customise the descriptions of these values for community pharmacy practice.

An association of insulin use and risk of cancer has been reported but evidence is conflicting and methodological issues have been identified.

The aims of the present study were to assess antiplatelet drug use patterns after a first myocardial infarction (MI) and to evaluate the determinants of antiplatelet nonpersistence.

Patient adherence to antidepressants is poor. However, this is rather unsurprising, given the equivocal efficacy, side effects, and practical problems of antidepressants. The aim of this study was to examine a wide array of patient experiences and perceptions regarding the efficacy, side effects, and practical problems of antidepressants, as well as their associations with nonadherence, and whether patients' perceived self-efficacy moderated these associations.

To identify the occurrence and determinants of protocol-publication discrepancies in clinical drug trials.