The Study of Risk Factors, Prognoses and Medical Consumptions on Adverse Drug Reactions

Patient safety and medical quality are top issues for both clinical practitioners and administrators in the current health care systems world wide. One of the major concerns in patient safety or medical quality is the safety related to drug medications, such as adverse drug reactions (ADR). There are over 106,000 inpatients expired due to Adverse Drug Reactions every year in the United States, which severely damage both to patient’s health and health care systems. Under the supports from department of health in Taiwan, the association of pharmacists had constructed a nation wide reporting system for ADR in 1998. Chang Gung Memorial Hospital (CGMH) began to build up the similar reporting system for ADR in 2002, and the system became established and reliable with the appropriate deployments of related human resources in 2004. The analyses of such ADR data were primarily based on descriptive statistics, which was far from the purposes of high risk group prediction and active intervention planning. A large number of documents had emphasized the importance of identifying risk factors related to ADR, while there were significant implications for both health care administration and academic values. Therefore, this study will utilize data base from reporting system and other sources of medical records to explore factors related to the occurrence of ADR, the subsequent prognoses, and additional medical consumptions from ADR. With the information, the healthcare providers may conduct a more safe practice and interventions for reducing harms from ADR in the future. A serial of case-control study nested in a large cohort of CGMH patient file during 2005-2011 will be performed for ADR studies. The severity of ADR will be evaluated with Naranjo algorithms by senior pharmacists in the medical center. The variables to be collected as major risk factors for ADR are age, sec, BMI, life-style variables, comorbidities/complications, drug type, and physician’s professional background. Additional length of stay and medical expenditures are two primary indicators for medical consumptions in this study. Various regression models will be applied to analyze data under diverse conditions. The objectives of this study are as follows. 1. Test the association between hypothesized risk factors and the occurrence or severity of ADR. 2. Identify the characteristics of high risk group in developing ADR or becoming severe ADR cases. 3. Explore the additional medical consumptions caused by the occurrence of ADR. 4. Further understand the disease prognoses affected by the occurrence of ADR. It is synchronized responsibility of all health care providers including physicians, nurses, pharmacists, and administrators to do whatever efforts in preventing the occurrence and harms from ADR. The anticipated findings from this study will help to design an effective system for preventing ADR in health care management. From the identification of high risk group, this study offers clues for interventions and future pharmaco-genomic studies. The battle on reducing ADR will receive more attentions and achievements from the study so that patient safety and quality of care will be gradually more secured under reasonable cost in the future.

Project ID:PF9902-0817
External Project ID:NSC98-2410-H182-011-MY3