ABSTRACT
This article outlines the purchasing process for personal protective equipment that was established for Health and Social Care in Northern Ireland in response to the outbreak of coronavirus disease 2019. The Business Services Organisation Procurement and Logistics Service, who are the sole provider of goods and services for Health and Social Care organisations, was faced with an unprecedented demand for personal protective equipment in response to the coronavirus disease 2019 pandemic. The usual procurement process was further complicated by changing messages within guidelines which resulted in confusion and anxiety when determining whether or not a product would meet the required safety guidance and was therefore suitable for purchase. In order to address these issues in a rapidly changing and escalating scenario the Department of Health asked the Business Services Organisation Procurement and Logistics Service to work with the Medicines Optimisation Innovation Centre to maximise the availability of personal protective equipment whilst ensuring that it met all requisite quality and standards. A process was implemented whereby the Medicines Optimisation Innovation Centre validated all pertinent essential documentation relating to products to ensure that all applicable standards were met, with the Business Services Organisation Procurement and Logistics Service completing all procurement due diligence tasks in line with both normal and coronavirus disease 2019 emergency derogations. It is evident from the data presented that whilst there were a significant number of potential options for supply, a large proportion of these were rejected due to failure to meet the quality assurance criteria. Thus, by the process that was put in place, a large number of unsuitable products were not purchased and only those that met extant standards were approved.
ABSTRACT
Warfarin dosing is challenging due to a multitude of factors affecting its pharmacokinetics (PK) and pharmacodynamics (PD). A novel personalised dosing algorithm predicated on a warfarin PK/PD model and incorporating CYP2C9 and VKORC1 genotype information has been developed for children. The present prospective, observational study aimed to compare the model with conventional weight-based dosing. The study involved two groups of children post-cardiac surgery: Group 1 were warfarin naïve, in whom loading and maintenance doses were estimated using the model over a 6-month duration and compared to historical case-matched controls. Group 2 were already established on maintenance therapy and randomised into a crossover study comparing the model with conventional maintenance dosing, over a 12-month period. Five patients enrolled in Group 1. Compared to the control group, the median time to achieve the first therapeutic INR was longer (5 vs. 2 days), to stable anticoagulation was shorter (29.0 vs. 96.5 days), to over-anticoagulation was longer (15.0 vs. 4.0 days). In addition, median percentage of INRs within the target range (%ITR) and percentage of time in therapeutic range (%TTR) was higher; 70% versus 47.4% and 83.4% versus 62.3%, respectively. Group 2 included 26 patients. No significant differences in INR control were found between model and conventional dosing phases; mean %ITR was 68.82% versus 67.9% (p = 0.84) and mean %TTR was 85.47% versus 80.2% (p = 0.09), respectively. The results suggest model-based dosing can improve anticoagulation control, particularly when initiating and stabilising warfarin dosing. Larger studies are needed to confirm these findings.
