Monitoring Of Drug Utilization Research Articles

Suggestion of a simpler and faster influenza-like illness surveillance system using 2014\u20132018 claims data in Korea

Influenza is an important public health concern. We propose a new real-time influenza-like illness (ILI) surveillance system that utilizes a nationwide prospective drug utilization monitoring in Korea. We defined ILI-related claims as outpatient claims that contain both antipyretic and antitussive agents and calculated the weekly rate of ILI-related claims, which was compared to weekly ILI rates from clinical sentinel surveillance data during 2014–2018. We performed a cross-correlation analysis using Pearson’s correlation, time-series analysis to explore actual correlations after removing any dubious correlations due to underlying non-stationarity in both data sets. We used the moving epidemic method (MEM) to estimate an absolute threshold to designate potential influenza epidemics for the weeks with incidence rates above the threshold. We observed a strong correlation between the two surveillance systems each season. The absolute thresholds for the 4-years were 84.64 and 86.19 cases per 1000claims for claims data and 12.27 and 16.82 per 1000 patients for sentinel data. The epidemic patterns were more similar in the 2016–2017 and 2017–2018 seasons than the 2014–2015 and 2015–2016 seasons. ILI claims data can be loaded to a drug utilization review system in Korea to make an influenza surveillance system.

Post-authorization research, registries, and drug development

In the last decade regulators, payers and health care providers tried to react to three major problems in drug development and drug use in clinical practice: the pharmaceutical R&D productivity crisis, the immaturity of benefit-risk profile for several newly approved drugs and the overall impact on economic sustainability of reimbursing new high cost drugs in their systems. The potentiality of create a continuum between the evidence requirements relevant for registration, for reimbursement and for post authorization research is clear. All different parties involved, like regulators, HTA agencies, scientific communities and manufacturers, are working to improve the knowledge profile of new drugs in order to anticipate the patient access to innovation, limiting or preventing the clinical and economical risks deriving from an incomplete safety and effectiveness profile. The Italian example of "New Drugs AIFA Registries", with or without the application of risk sharing schemes (cost sharing, pay for performance, etc.), introduced a new process and increased the sensitivity on this topic. However this might probably represents only a partial answer to the problem of how to set up the governance of coverage with evidence, drug utilization monitoring, comparative effectiveness research, outcome research programs and may be how to link them to access, pricing and reimbursement. The step change in post authorization research could be to "integrate" different sources and stakeholders in a wider and continuous approach, in a well designed and inclusive "second generation" HTA approach, where all resources (competencies, data, funding) will concur to increase the evidence profile and reduce the risks, and where any "evidence generation approach" is really compliant with the standard and rules of best research practices.

Drug Utilization Monitoring and Educational Parameters, Second Edition

Drug Utilization Monitoring and Educational Parameters, Second Edition