The Study On The Characteristics And Risk Factors Of Adverse Drug Events In Type2Diabetes Inpatients

Background:Diabetes, a lifelong disease, has become a worldwide public health problem. Currently, there are nearly200million diabetics patient in the world, while type2diabetes accounts for90%to95%.Type2diabetes mellitus (T2DM) is a lifelong disease, which can lead to multi-organ damages, resulting in a variety of complications. And patients often receive two or more medications to lower blood glucose levels and relief related symptoms, which lead the occurrence of adverse drug events (ADEs) to significantly increase. ADEs are the common cause of hospitalization and exacerbation, and determine mortality and morbidity to a large extent. It is essential to study on the causes, incidence, manifestations and characteristics of ADEs in T2DM inpatients, and develop prevention strategies against the causes, in order to decrease the incidence of ADEs and minimize harm related to pharmacotherapy.Europe, America, Japan and other developed countries started earlier in the study of the prevention of ADR, and achieved notable results depending on the extensive use of information system and computer technology. Great attention was also paid to prevention of ADE in China. Adverse Drug Reaction monitoring network was established in1998, and in2012International Network for Rational Use of Drugs (INRUD) Chinese central group of clinical drug safety monitoring network was set up. ADEs are reported to relevant department through network and shared by health professionals, so that they can discuss the causes and prevention measures of ADEs.ADE has been widely studied at home and abroad, yet most domestic researches were retrospective. We conducted synchronous acquisition by communicate with patients face to face in this study, and then analyzed the information to reveal the incidence, manifestations, and risk factors of ADRs.Aims:To ensure drug safety and promote clinical rational drug use by revealing the incidence, manifestations and risk factors of ADEs in T2DM inpatients, and exploring the prevention strategies of ADEs.Methods:Inpatients diagnosed with T2DM from July2012to June2013were included in the study. Information Recording Form of T2DM Patients and Adverse Drug Event Recording Form were designed according to the investigation and research contents. Basic characteristics and disease related information were collected and filled in Information Recording Form of T2DM Patients within24hours after admission. Patients’ response to medication was daily observed during medical and pharmaceutical rounds, and filled in the form. Investigators should inquire the patients or relations to detail if suspicious ADEs occurred, assist physicians with handling ADEs, and fill overall process (sign, manifestation, and clinical laboratory etc.) and handling information in Adverse Drug Event Recording Form. We summarized and analyzed the Data for the incidence and causes of ADEs, and further developed preventive measures respectively according to the preventability and severity of ADEs.Results:696cases were included, and128ADEs were identified in123patients (17.67%).ADEs mainly resulted from insulins (31.64%), cardiovascular agents (24.29%), oral hypoglycemic agents (17.51%), antibiotics (10.73%), and nervous system agents (7.34%).ADEs in128patients were involved in endocrine system (35.16%), dermal system (24.29%) and systemic injury (11.72%); follow-up showed79cases were improved (61.72%),48cured (37.5%) and1unimproved (0.78%), no sequelae or death cases were identified. Classification analysis indicated that71(55.47%) ADEs were preventable, and57(44.53%) unpreventable. The primary cause of preventable ADEs was overdose (30cases,42.25%), and second drug interactions (12cases,16.9%), other causes included poor patient compliance, ect.16ADEs were defined as severe,112moderate.Number of combinations, age, number of concomitant medications, hospitalization days and number of admissions were significantly higher in patients with ADEs compared with those without ADEs. In addition, we found more ADE in female patients than in male.ConclusionsOur study suggested that T2DM patients are prone to ADEs which is associated with number of comorbidities, sex, age, number of concomitant medications, hospitalization days and number of admissions. A considerable part of ADEs were preventable. Prevention strategies can be established to minimize the incidence of ADEs, thus to ensure drug safety and improve the quality of medical services.