BUSINESS NEED AND SOLUTION. Adverse Drug Events in the senior (65+) population account for a major portion of Adverse Drug Events in the United States which constitutes a large portion of healthcare expenditures in the United States. These Adverse Drug Events are mostly attributed to certain drugs that are used to treat major diseases, especially within the senior population. These Adverse Drug Events are counted when a patient is hospitalized for an emergency resulting from the adverse drug interaction or reaction. Adverse Drug Events (ADEs) are reactions and events associated with prescription medications. They occur for many reasons including medication errors that occur in the ordering, transcribing, dispensing, and administration stages. Twenty percent of ADEs are caused by medication errors and are preventable. Twenty-six percent of medication errors are caused in the administration stage.viii Administration errors include taking the wrong dose, wrong drug, with the wrong technique, at the wrong time, or missed dose. ixThey may be caregiver errors, while many occur from self-medication errors in the patient’s own home. The outcomes can be significant including an Emergency Room visit resulting in further hospitalization, disability, or death. Elderly use over 30% of the drugs prescribed and experience over 33.6% of severe or serious ADEs which are defined by the FDA as resulting in death, disability, or hospitalizations. x With interventions, these human administration errors can be prevented. There is a need for a tool to use as an aid to assist them with remembering when, how, and what drugs to take. And they need to be able to communicate with their family member or caregiver when they are unattended. The current post-market surveillance system for ADEs is the Federal Drug Administration’s Adverse Drug Event Reporting System (FAERS). Drug manufacturers are required to use it and it is voluntary for physicians/providers and patients. This is a passive surveillance system and reports are made after an Emergency Room visit, hospitalization, or death, or otherwise voluntarily reported from consumers directly. The current FAERS system was implemented in the 4th quarter of 2012 and data from the quarterly reports are publicly available. Prior to 2012, there was a legacy AERS surveillance system for ADEs, which was active from 2004 until the 3rd quarter of 2012 and those quarterly reports are also publicly available. The FDA FAERS data are limited in their use since they are volunt...
BUSINESS NEED AND SOLUTION. Billions of dollars are spent each year on the development and conduct of clinical research in the United States alone. Clinical trials, especially phase III trials have gotten larger and become increasingly more complex with the average length of one trial increasing by 70% and the clinical research staff work burden by 67% from 1995 to 2005. This impact is thought to have grown even greater in recent years (Xxxxxx, 2017). The exponential growth in the complexity of conducting clinical research drives the need for a system that maximizes the use of staff time and existing data. This project will propose a solution that allows for a reduction in data duplication and errors within clinical research systems and databases. Studies have reported that error rates between EHR and research databases as high as 27% (Xxxxxxxx et al., 2008). An integration that bridges EHR with clinical research allows for an innovative solution for academic medical centers to maximize productivity as well as deliver cleaner more accurate clinical research data. More reliable data has the potential to decrease research costs by reducing study timelines and time to market for health treatments by decreasing data cleanup periods post study completion. Integration also has the potential to improve long term follow up data quality if adherence to follow up study visits declines. This project will contribute to organizational missions to conduct innovative and collaborative research and integrate this knowledge into the practice of medicine, and facilitate operational processes that support the efforts of the clinical research team in the timely initiation, management and completion of clinical trials at Emory. Through these missions, Emory University will have the ability to directly contribute to national initiatives to: • Support the use of seamless data exchange • Advocate the need for capturing source data, including data originating in health care systems • Advance the health, safety, and well-being of the American people • Increase the economic impact of Federally- funded research and development by accelerating and improving the transfer of new technologies from the laboratory to the commercial marketplace Currently, information for patients who consent to research studies is entered into four major information systems; the hospital EHR which serves as the primary source of information, two research management systems, and an EDC system. Once information is dictated, scanned, or ...
