Assessing the Clinical, Economic, and Health Resource Utilization Impacts of Prefilled Syringes Versus Conventional Medication Administration Methods: Results From a Systematic Literature Review.

OBJECTIVE: The objective of this systematic review was to assess the clinical, economic, and health resource utilization outcomes associated with the use of prefilled syringes in medication administration compared with traditional preparation methods. DATA SOURCES: We conducted a systematic literature review to evaluate outcomes such as medication errors, wastage, time savings, and contamination in prefilled syringes. Our search encompassed multiple databases, including PubMed and Embase, for studies published between January 1, 2017, and November 1, 2022. STUDY SELECTION AND DATA EXTRACTION: Peer-reviewed publications meeting our inclusion criteria underwent rigorous screening, including title, abstract, and full-text article assessments, performed by two reviewers. DATA SYNTHESIS: Among reviewed articles, 24 met our eligibility criteria. Selected studies were primarily observational (46%) and conducted in Europe (46%). Our findings indicated that prefilled syringes consistently reduced medication errors (by 10%-73%), adverse events (from 1.1 to 0.275 per 100 administrations), wastage (by up to 80% of drug), and preparation time (from 4.0 to 338.0 seconds) (ranges varied by drug type, setting, and dosage). However, there was limited data on contamination. Economically, prefilled syringes reduced waste and error rates, which may translate into overall savings. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: This review highlights the value of prefilled syringes, which can streamline medication delivery, save nursing time, and reduce preventable medication errors. Moreover, prefilled syringes have the potential to minimize medication wastage, optimizing resource utilization and efficiency in health care settings. CONCLUSION AND RELEVANCE: Our findings provide new insights into clinical and economic benefits of prefilled syringe adoption. These benefits include improved medication delivery and safety, which can lead to time and cost reductions for health care departments, hospitals, and health systems. However, further real-world research on clinical and economic outcomes, especially in contamination, is needed to better understand the benefits of prefilled syringes.

Creating an evidence-based economic model for prefilled parenteral medication delivery in the hospital setting.

OBJECTIVES: Prefilled syringes (PFS) may offer clinical and economic advantages over conventional parenteral medication delivery methods (vials and ampoules). The benefits of converting from vials and ampoules to PFS have been explained in previous drug-specific economic models; however, these models have limited generalisability to different drugs, healthcare settings and other countries. Our study aims to (1) present a comprehensive economic model to assess the impact of switching from vials to PFS delivery; and (2) illustrate through two case studies the model's utility by highlighting important features of shifting from vials to PFS. METHODS: The economic model estimates the potential benefit of switching to PFS associated with four key outcomes: preventable adverse drug events (pADE), preparation time, unused drugs, and cost of supplies. Model reference values were derived from existing peer-reviewed literature sources. The user inputs specific information related to the department, drug, and dose of interest and can change reference values. Two hypothetical case studies are presented to showcase model utility. The first concerns a cardiac intensive care unit in the United Kingdom administering 30 doses of 1 mg/10 mL atropine/day. The second concerns a coronavirus (COVID-19) intensive care unit in France that administers 30 doses of 10 mg/25 mL ephedrine/day. RESULTS: Total cost savings per hospital per year, associated with reductions in pADEs, unused drugs, drug cost and cost of supplies were £34 829 for the atropine example and €104 570 for the ephedrine example. Annual preparation time decreased by 371 and 234 hours in the atropine and ephedrine examples, respectively. CONCLUSIONS: The model provides a generalisable framework with customisable inputs, giving hospitals a comprehensive view of the clinical and economic value of adopting PFS. Despite increased costs per dose with PFS, the hypothetical case studies showed notable reductions in medication preparation time and a net budget savings owing to fewer pADEs and reduced drug wastage.

Live Biotherapeutic Products, A Road Map for Safety Assessment.

Recent developments in the understanding of the relationship between the microbiota and its host have provided evidence regarding the therapeutic potential of selected microorganisms to prevent or treat disease. According to Directive 2001/83/EC, in the European Union (EU), any product intended to prevent or treat disease is defined as a medicinal product and requires a marketing authorization by competent authorities prior to commercialization. Even if the pharmaceutical regulatory framework is harmonized at the EU level, obtaining marketing authorisations for medicinal products remains very challenging for Live Biotherapeutic Products (LBPs). Compared to other medicinal products currently on the market, safety assessment of LBPs represents a real challenge because of their specific characteristics and mode of action. Indeed, LBPs are not intended to reach the systemic circulation targeting distant organs, tissues, or receptors, but rather exert their effect through direct interactions with the complex native microbiota and/or the modulation of complex host-microbiota relation, indirectly leading to distant biological effects within the host. Hence, developers must rely on a thorough risk analysis, and pharmaceutical guidelines for other biological products should be taken into account in order to design relevant non-clinical and clinical development programmes. Here we aim at providing a roadmap for a risk analysis that takes into account the specificities of LBPs. We describe the different risks associated with these products and their interactions with the patient. Then, from that risk assessment, we propose solutions to design non-clinical programmes and First in Human (FIH) early clinical trials appropriate to assess LBP safety.

Effects of selective and non-selective cyclooxygenase inhibition against neurological deficit and brain oedema following closed head injury in mice.

The implication of cyclooxygenase (COX) type 2 in post-traumatic consequences is so far controversial. In experimental models of traumatic brain injury (TBI), genetic disruption or pharmacological inhibition of COX-2 has been shown to be neuroprotective, deleterious or without effect. Therefore, the aim of our study was to investigate the effect of COX-2 inhibition against neurological deficit and brain oedema after TBI that was induced by mechanical percussion in male Swiss mice. Despite the increased level and activity of COX-2, its inhibition either with nimesulide (12 mg/kg) or meloxicam (2mg/kg) modified neither the neurological score nor the brain water content that were evaluated at 6 and 24h after injury. Interestingly, the non-selective COX inhibition with indomethacin (5mg/kg) significantly promoted neurological recovery at 6 and 24h after trauma, without improving brain oedema. In conclusion, the present study yields considerable evidence that COX-2 may not solely constitute an interesting target for the treatment of TBI consequences. Our data point to a potentially deleterious role of COX-1 in the development of neurological impairment in brain-injured mice. However, the neuroprotective mechanism of indomethacin remains to be clarified.

Long-term histological and behavioural characterisation of a collagenase-induced model of intracerebral haemorrhage in rats.

Although intracerebral haemorrhage (ICH) entails the highest rates of mortality and disability of all stroke subtypes, efficient neuroprotective therapy is still needed. As functional recovery is a major endpoint in clinical trials, preclinical studies must demonstrate the potential of drugs to improve the sensorimotor and cognitive function of animals. In addition, behavioural studies should be performed on the long-term in order to truly mimic clinical needs. The aim of our study was to characterise a model of intracerebral haemorrhage using both histology and long-term behaviour. ICH was induced in rats by an intrastriatal injection of collagenase. Histology was performed 24h, 7 days and 2 months after ICH. Among a set of sensorimotor tests, we discriminate those able to reveal long-term deficits (up to 2 months) after cerebral haemorrhage. Our five behavioural tests (a neurological score, an adhesive removal test, two beam-walking tests and ipsilateral circling induced by dexamphetamine) proved to be effective in revealing sensorimotor deficits up to 35 days or more after cerebral haemorrhage. In conclusion, these behavioural tests appear of particular interest to screen protective agents that may exhibit benefits in patients who suffer ICH.