Search

Aims: The United Kingdom (UK) Prescribing Safety Assessment (PSA) is a 2‐h online assessment of basic competence to prescribe and supervise the use of medicines. It has been undertaken by students and doctors in UK medical and foundation schools for the past decade. This study describes the academic characteristics and performance of the assessment; longitudinal performance of candidates and schools; stakeholder feedback; and surrogate markers of prescribing safety in UK healthcare practice. Methods: We reviewed the performance data generated by over 70 000 medical students and 3700 foundation doctors who have participated in the PSA since its inception in 2013. These data were supplemented by Likert scale and free text feedback from candidates and a variety of stakeholder groups. Further data on medication incidents, collected by national reporting systems and the regulatory body, are reported, with permission. Results: We demonstrate the feasibility, high quality and reliability of an online prescribing assessment, uniquely providing a measure of prescribing competence against a national standard. Over 90% of candidates pass the PSA on their first attempt, while a minority are identified for further training and assessment. The pass rate shows some variation between different institutions and between undergraduate and foundation cohorts. Most responders to a national survey agreed that the PSA is a useful instrument for assessing prescribing competence, and an independent review has recommended adding the PSA to the Medical Licensing Assessment. Surrogate markers suggest there has been improvement in prescribing safety in practice, temporally associated with the introduction of the PSA but other factors could be influential too. Conclusions: The PSA is a practical and cost‐effective way of delivering a reliable national assessment of prescribing competence that has educational impact and is supported by the majority of stakeholders. There is a need to develop national systems to identify and report prescribing errors and the harm they cause, enabling the impact of educational interventions to be measured. [ABSTRACT FROM AUTHOR]

Aims: CYP2C19 is a hepatic enzyme involved in the metabolism of antidepressants associated with increased gastrointestinal bleed (GIB) risk. The aim of our study was to explore a possible association between loss‐of‐function CYP2C19 genotypes and GIB in South Asian ancestry participants prescribed antidepressants. Methods: Genes & Health participants with a record in Barts Health NHS Trust (N 22 753) were studied using a cross‐sectional approach. CYP2C19 diplotypes were assessed and metabolizer type inferred from consortia guidance. Fisher's exact test was used to compare the prevalence of GIB in different metabolizer categories. Multivariable regression was used to test for association between antidepressant prescriptions and GIB, and between CYP2C19 metabolizer state and GIB in the subcohort prescribed antidepressants. Results: Antidepressants were frequently prescribed (47%, N = 10 612). A total of 864 participants (4%) had a GIB; 534 (62%) had been prescribed a CYP2C19 metabolized antidepressant. There was an independent association between antidepressant prescriptions and GIB events (odds ratio 1.8, confidence interval 1.5‐2.0, P < 0.0001). There was no relationship between CYP2C19 inferred poor (P 0.56) or intermediate (P 0.53) metabolizer status and GIB in those prescribed an antidepressant in unadjusted analysis. A multivariable logistic regression model did not show an independent association between poor (P 0.54) or intermediate (P 0.62) CYP2C19 metabolizers and GIB in the subcohort prescribed antidepressants. Conclusions: CYP2C19 dependent antidepressants are associated with increased GIB prevalence. GIB appeared independent from CYP2C19 metabolizer genotype in individuals who had been prescribed antidepressants. Precision dosing based on CYP2C19 genetic information alone is unlikely to reduce GIB prevalence. [ABSTRACT FROM AUTHOR]

Direct‐acting oral anticoagulants (DOACs) are licensed for the prevention of thromboembolism in non‐valvular atrial fibrillation, amongst other indications. Prescribers use information derived from the summary of product characteristics which is based on the key trials supporting the DOAC's market authorisation. However, prescribers may not be aware of the limitations within these trials regarding underrepresentation of patient populations commonly encountered in clinical practice and how this may adversely impact them. This review highlights the gaps in the licensing evidence using four clinical vignettes that explore prescribing challenges in older adults, female patients, patients with obesity and patients from non‐Europid ethnic backgrounds. [ABSTRACT FROM AUTHOR]

Equal access to pharmacogenomics testing: The ethical imperative for population-wide access in the UK NHS The UK's National Health Service (NHS) has a proud heritage of providing equal access to healthcare of a high standard that is free to all at the point of care. Clinical pharmacologists are uniquely well suited to support a broad PGx implementation campaign.[17] As a community we must ensure proportionate representation in data underpinning PGx implementation and make testing accessible in a fair and timely manner. [Extracted from the article]

Pharmacogenonomics (PGx) is the intersection of genomic medicine and pharmacology whereby knowledge of variation in an individual's genome is utilized to inform prescribing practice. In conclusion, PGx represents a novel piece in the jigsaw of factors that should be collectively considered when developing novel drugs and prescribing current drugs to improve the safety and efficacy of pharmacotherapy. For instance, it is possible that some clinical pharmacologists with a particular interest in PGx may become PGx specialists, similar to how some clinical pharmacologists have specialized in hypertension or clinical toxicology. [Extracted from the article]

Pharmacogenomics is increasingly moving into mainstream clinical practice. Careful consideration must be paid to inclusion of diverse populations in research, translation and implementation, in the historical and social context of population stratification, to ensure that this leads to improvements in healthcare for all rather than increased health disparities. This review takes a broad and critical approach to the current role of diversity in pharmacogenomics and addresses potential pitfalls in order to raise awareness for prescribers. It also emphasizes evidence gaps and suggests approaches that may minimize negative consequences and promote health equality. [ABSTRACT FROM AUTHOR]

There has been a flurry of genomic activity in the United Kingdom, which has led to expanded discussions regarding feasibility of national implementation of personalised medicine using genomic data to guide prescribing. Based on Youssef et al., a panel test for nine genes ( I CYP2D6 i , I CYP2C19 i , I HLA-B i , I SLCO1B1 i , I CYP2C9 i , I F5 i , I HLA-A i , I TPMT i , and I VKORC1 i ) could inform one in every 11 new prescriptions issued in primary care in the United Kingdom.2 Challenges to implementing pharmacogenomics may be somewhat different in hospital settings. GLOBAL PHARMACOGENOMICS AND CHALLENGES TO IMPLEMENTATION WORLDWIDE There is continuing interest in studying pharmacogenomics worldwide and understanding of both ethnic differences and local challenges is increasing. [Extracted from the article]

2021. https://doi.org/10.1111/bcp.14983 6 Tusino S, Furfaro M. Rethinking the role of Research Ethics Committees in the light of Regulation (EU) No 536/2014 on clinical trials and the COVID-19 pandemic. Tusino et al address the evolving role of research ethics committees, and how a drive toward centralization has been accelerated by the global COVID-19 pandemic.6 Yet the role of ethics is not finished when the study is complete. The COVID-19 global pandemic setting has highlighted the role of trust in mediating relationships between experts, who design, manufacture, market and prescribe medication, and the lay public, who ingest medication.1 Ethical interventions in science and medicine are intended to cultivate and preserve trust within the larger community. [Extracted from the article]