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Drug-related problems (DRPs), which encompass medication errors (MEs), adverse drug reactions and adverse drug events (ADEs), represent significant challenges in healthcare settings. While medication safety has been extensively studied in hospitals and primary care settings leading to development of improvement strategies, there is limited understanding of these issues within prison healthcare environments. This knowledge gap is concerning given that prisoners often have complex medication needs due to higher rates of chronic physical and mental ill health and substance use disorders compared with the general population. Time in prison presents an opportunity to provide treatment for this socially disadvantaged group, making it an important setting to optimise medication management. This scoping review aimed to understand the nature and frequency of medication safety incidents, their contributory factors and evaluate strategies for enhancing medication safety within prison healthcare environments, where unique institutional constraints and security requirements may impact safe medication use.
This study conducted a systematic search across six databases to appraise the published literature from 2000 to 2023 (Embase, Medline, PsycINFO, CINAHL Plus, Cochrane and Web of Science), with reporting according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses-Scoping Review guidelines. Data extraction was completed by one author, with validation of a sample by the other authors. The review included quantitative, qualitative and mixed-methods studies examining DRPs in prison healthcare.
The review included 42 studies on medication safety in prison healthcare, comprising epidemiological perspectives (52.4%, n=22/42), aetiological exploration of DRPs (45.2%, n=19/42) and intervention evaluation (11.9%, n=5/42). Studies were predominantly from the USA (30.9%, n=13/42) and the UK (26.1%, n=11/42). Most studies focused on infectious disease management (52.3%, n=22/42), particularly HIV treatments (42.8%, n=18/42), followed by mental health medications (23.8%, n=10/42). Non-adherence emerged as the most commonly studied DRP, reported in both epidemiological (68.1%, n=15/22) and aetiological studies (68.4%, n=13/19). Contributing factors included medication delivery problems, psychosocial factors, accessibility challenges and conflicts between healthcare delivery and security requirements. Five intervention studies were identified, with two from the USA (40%, n=2/5). These interventions included those addressing medication non-adherence (40%, n=2/5) and potentially inappropriate prescribing (20%, n=1/5), and highlighted the potential efficacy of multidisciplinary and pharmacist-led approaches in addressing medication safety challenges within prison healthcare settings.
This represents the first comprehensive study to present a narrative report on the existing evidence regarding the epidemiology, aetiology and interventions for medication safety events in prison healthcare. While intervention studies demonstrate promising findings from multidisciplinary and pharmacist-led initiatives, further evidence is needed to address DRPs beyond medication non-adherence, guided by a deeper understanding of their contributory factors. Future studies should target preventable MEs and ADEs, as well as wider health conditions to broaden our understanding of prison-specific contributory factors to develop targeted interventions for this vulnerable population.
Intracranial atherosclerotic stenosis (ICAS) is a leading cause of ischaemic stroke, particularly among Asian populations, and continues to impose a significant burden across the region. Despite this, evidence from Asia remains fragmented. Findings from our previously conducted scoping review revealed an absence of standardised diagnostic criteria and imaging protocols. This resulted in marked methodological inconsistencies in regional ICAS research, thereby limiting the validity and interpretability of existing data. To address this, we have initiated a consensus process that aims to establish standardised definitions, develop harmonised diagnostic protocols and outline research standards and priorities for ICAS across Asia.
A modified Delphi approach will be employed to formulate consensus-based recommendations through a structured, iterative, multistage process. Draft Delphi statements will be informed by targeted literature reviews and formatted into five-point Likert scale questionnaires with fields allowing for qualitative feedback. An expert core group was selected based on their established clinical and research expertise in intracranial atherosclerosis, cerebrovascular imaging and stroke, with deliberate consideration for geographic and disciplinary diversity. This group will serve as the formal voting panel. The process will comprise three to four anonymous online rounds, with a predefined consensus threshold of ≥80% agreement. Statements that do not reach consensus will be revised based on aggregated feedback and re-evaluated in subsequent rounds. A non-voting hybrid conference, open to the public, will follow the second round to facilitate broader engagement and discussion; relevant points will be incorporated into the subsequent round. Consensus on research standards and priorities will follow the finalisation of recommendations on standardised definitions and harmonised diagnostic protocols to ensure alignment with preceding outcomes.
This consensus was granted exemption by the Jose R. Reyes Memorial Medical Center Institutional Review Board (No. 2025–221). Resulting recommendations will be disseminated through peer-reviewed publication and presentation at scientific fora.
Minimally invasive endoscopic procedures constitute the cornerstone of first-line treatment for bulbar urethral strictures, although their long-term effectiveness is limited by high recurrence rates. The Optilume drug-coated balloon (DCB) is a novel intervention combining mechanical dilation with localised delivery of paclitaxel to reduce recurrence by inhibiting scar tissue formation. While its efficacy has been demonstrated in patients with recurrent strictures, its potential as a first-line option in treatment-naïve patients remains unexplored. The FIRST-CARE trial aims to assess the efficacy and safety of Optilume DCB compared with standard endoscopic treatment in treatment-naïve patients with bulbar urethral strictures.
Design: Two-arm, randomised, single-blind (participant), investigator-initiated, parallel-group, multicentre clinical trial. Patients: The study will enrol 140 adult male patients with treatment-naïve, single bulbar urethral strictures ≤3 cm in length. Interventions: All patients will undergo the assigned procedure under general anaesthesia with 1.5 g intravenous cefuroxime. Optilume group patients will receive ≥5 min balloon dilation with localised paclitaxel delivery. The control group will receive standard endoscopic treatment (eg, direct visual internal urethrotomy, laser or dilatation). In both groups, a 12–14 French Foley catheter will be left in place for 3–5 days. Primary outcome: Freedom from repeat intervention within 12 months of follow-up. Primary analysis: Time-to-event will be defined from the date of intervention to the date a repeat intervention is decided (indicated and planned) due to confirmed recurrence, with censoring at 12 months. Groups will be compared using Kaplan-Meier survival analysis and the log-rank test. Cox regression and modified Poisson regression will be used to estimate HRs and relative risks.
The trial is approved by the Danish National Committee on Health Research Ethics (2401370) and will be conducted in accordance with the Declaration of Helsinki and principles of Good Clinical Practice. In line with national guidelines, all eligible patients are counselled regarding available treatment options prior to enrolment. Results will be disseminated via peer-reviewed publications and scientific presentations.
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