Regulatory policy and pharmaceutical innovation in the United Kingdom after Brexit: Initial insights.

Brexit was presented as an opportunity to promote innovation by breaking free from the European Union regulatory framework. Since the beginning of 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) has operated as the independent regulatory agency for the United Kingdom. The MHRA's regulatory activity in 2021 was analyzed and compared to that of other international regulatory bodies. The MHRA remained reliant on EU regulatory decision-making for novel medicines and there were significant regulatory delays for a small number of novel medicines in the UK, the reasons being so far unclear. In addition, the MHRA introduced innovation initiatives, which show early promise for quicker authorization of innovative medicines for cancer and other areas of unmet need. Longer-term observation and analysis is needed to show the full impact of post-Brexit pharmaceutical regulatory policy.

Benefits and Challenges of Video Consulting for Mental Health Diagnosis and Follow-Up: A Qualitative Study in Community Care.

Mental health services continue to experience rising demand that exceeds capacity. The COVID-19 pandemic exacerbated this crisis, with access to services being reduced. Although video consultations (VCs) are a solution, usage in UK community mental healthcare settings remains limited. This study aims to investigate psychiatrists' and general practitioners' (GPs) perceptions of the benefits and challenges of VC for the diagnosis and follow-up of general adult mental health patients in the community during the COVID-19 pandemic. Semi-structured interviews in NHS community mental healthcare settings were conducted. Psychiatrists (n = 11) and GPs (n = 12) were recruited through purposive sampling. An explorative qualitative approach was employed. Data were analysed using thematic analysis. Four key themes were identified: (1) patient access to VC, (2) suitability of VC for mental health consultations, (3) information gathering with VC and (4) clinician satisfaction with VC. This study provides valuable insights into the experiences of psychiatrists and GPs working in the UK during the COVID-19 pandemic. To facilitate a digital-first future for the NHS, greater investment in remote technologies is required, particularly in the context of growing mental healthcare demand. Though face-to-face consultations remain the gold standard, VC provides an efficient way of communicating with patients, particularly those with less severe forms of mental illness.

The biological responses of vitamin K2: A comprehensive review.

Vitamin K1 (VitK1) and Vitamin K2 (VitK2), two important naturally occurring micronutrients in the VitK family, found, respectively, in green leafy plants and algae (VitK1) and animal and fermented foods (VitK2). The present review explores the multiple biological functions of VitK2 from recently published in vitro and in vivo studies, including promotion of osteogenesis, prevention of calcification, relief of menopausal symptoms, enhancement of mitochondrial energy release, hepato- and neuro-protective effects, and possible use in treatment of coronavirus disease. The mechanisms of action associated with these biological effects are also explored. Overall, the findings presented here suggest that VitK, especially VitK2, is an important nutrient family for the normal functioning of human health. It acts on almost all major body systems and directly or indirectly participates in and regulates hundreds of physiological or pathological processes. However, as biological and clinical data are still inconsistent and conflicting, more in-depth investigations are warranted to elucidate its potential as a therapeutic strategy to prevent and treat a range of disease conditions.

Medication safety incidents associated with the remote delivery of primary care: a rapid review.

OBJECTIVES: The COVID-19 pandemic triggered rapid, fundamental changes, notably increased remote delivery of primary care. While the impact of these changes on medication safety is not yet fully understood, research conducted before the pandemic may provide evidence for possible consequences. To examine the published literature on medication safety incidents associated with the remote delivery of primary care, with a focus on telemedicine and electronic prescribing. METHODS: A rapid review was conducted according to the Cochrane Rapid Reviews Methods Group guidance. An electronic search was carried out on Embase and Medline (via PubMed) using key search terms 'medication error', 'electronic prescribing', 'telemedicine' and 'primary care'. Identified studies were synthesised narratively; reported medication safety incidents were categorised according to the WHO Conceptual Framework for the International Classification for Patient Safety. KEY FINDINGS: Fifteen studies were deemed eligible for inclusion. All 15 studies reported medication incidents associated with electronic prescribing; no studies were identified that reported medication safety incidents associated with telemedicine. The most commonly reported medication safety incidents were 'wrong label/instruction' and 'wrong dose/strength/frequency'. The frequency of medication safety incidents ranged from 0.89 to 81.98 incidents per 100 electronic prescriptions analysed. SUMMARY: This review of medication safety incidents associated with the remote delivery of primary care identified common incident types associated with electronic prescriptions. There was a wide variation in reported frequencies of medication safety incidents associated with electronic prescriptions. Further research is required to determine the impact of the COVID-19 pandemic on medication safety in primary care, particularly the increased use of telemedicine.

Pharmacist and patient experiences of primary care during the COVID-19 pandemic: An interview study.

Introduction: A number of significant changes designed to reduce the spread of COVID-19 were introduced in primary care during the COVID-19 pandemic. In Ireland, these included fundamental legislative and practice changes such as permitting electronic transfer of prescriptions, extending duration of prescription validity, and encouraging virtual consultations. Although such interventions served an important role in preventing the spread of infection, their impact on practice and patient care is not yet clear. The aim of this study was to investigate patient and healthcare professional (pharmacist and general practitioner) experiences to understand the impact of COVID-19 on primary care and medication safety during the first two years of the COVID-19 pandemic in Ireland. Methods: A qualitative study using semi-structured interviews was undertaken between October 2021 and January 2022. Participants included twelve patients, ten community pharmacists, and one general practitioner. Interviews were transcribed verbatim and analysed using thematic analysis. Only patient and pharmacist interviews were included. Findings: Themes from the interviews included: 1) Access to care, 2) Technological changes, 3) Experiences of care, and 4) Patient safety. Particular challenges identified included the difficulty faced by patients when accessing care, impacts on experiences of patient care, and extensive changes to pharmacy practice during the pandemic. Conclusions: This study found that COVID-19 countermeasures considerably impacted patient and pharmacist experiences of primary care in terms of care and medication safety. While many changes were welcomed, others such as virtual consultations were received more cautiously likely due to the rapid and unplanned nature of their introduction. Further research is needed to identify how to optimise these changes to improve pharmacist and patient experience, and to understand the impact on patient safety.

Changes to primary care delivery during the COVID-19 pandemic and perceived impact on medication safety: A survey study.

Introduction: The COVID-19 pandemic has had a profound impact on the delivery of primary care around the world. In Ireland, the use of technologies such as virtual consultations and the electronic transfer of prescriptions became widespread in order to deliver care to patients while minimising infection risk. The impact of these changes on medication safety is not yet known. Objectives: The aims of this survey study were to investigate 1) the changes that have occurred in Irish primary care since the start of the COVID-19 pandemic and 2) the impact of these changes on medication safety. Methods: Anonymous, online surveys were distributed to general practitioners (GPs) and pharmacists from August-September 2021. Surveys contained quantitative (multiple-choice, Likert scale) and qualitative (free-text) questions concerning workflow changes, medication safety incidents and near misses, and GP/pharmacist perspectives on medication safety and COVID-19. Reported medication safety incidents and near misses were categorised according to the WHO Conceptual Framework for the International Classification for Patient Safety. Results: In total, there were 251 responses to the survey, comprising of 211 pharmacists and 40 GPs. The most significant workflow changes during the pandemic were the widespread use of a secure clinical email service (Healthmail) that facilitates electronic prescription transfer and communication (75.3% of respondents) and the increased use of telephone consultations (49%). Overall, Healthmail was widely perceived to have had a positive impact on medication safety. Most GPs did not perceive a change in the frequency of medication safety incidents during the pandemic, while most pharmacists reported a slight increase in incidents. Survey participants highlighted pressure, patient expectations, and patient monitoring as significant challenges encountered during the pandemic. Conclusions: During the pandemic, a number of significant changes occurred in primary care in Ireland, particularly involving communication of healthcare information, with varying impacts on workflow and medication safety. Future research should focus on the optimisation of electronic prescribing and telemedicine services in Ireland, patient perspectives on the changes in primary care, and interventions to improve medication safety in primary care.

Educating pharmacy students through a pandemic: Reflecting on our COVID-19 experience.

The impact of the COVID-19 pandemic on pharmacy education worldwide has been immense, affecting students, educators and regulatory agencies. Pharmacy programmes have had to rapidly adapt in their delivery of education, maintaining standards while also ensuring the safety of all stakeholders. In this commentary, we describe the challenges, compromises and solutions adopted by our institution throughout the pandemic, the lessons learnt, adaptive measures taken, and strategies to develop and future-proof our curricula.