ABSTRACT Objective::To analyze the mechanisms, risk factors and preventions of serious adverse drug reactions(ADRs) in Peking Union Medical College Hospital(PUMCH) in order to provide the basis for safe drug use in clinical practice.Methods::The ADRs were collected from doctors, pharmacists and nurses from January 2008 to December 2012 in PUMCH.The serious ADRs were diagnosed according to the clinical manifestations and the“Serious Adverse Drug Reaction Technology Standards and Evaluation Criterion”of Ministry of Public Health in China.The type and time of ADR,drugs associated with adverse reactions,duration of hospitalization,cost of hospitalization and outcome of patients were retrospectively analyzed.Results:: A total of 545 ADRs were reported in the period between January 2008 and December 2012 in PUMCH.According to the evaluation criterion,42 reports were determined as serious ADRs.They comprised 22 males and 20 females with an average age of 46 years,an average duration of hospitalization of 41 days,and an average cost of273 015.39 yuan. Five patients had their drug or food allergic history.The type of serious ADRs included anaphylactic shock, aplastic anemia, agranulocytosis,thrombocytopenia, pancytopenia, acute liver failure,acute pancreatitis, acute renal failure and toxic epidermal necrolysis. Thirty-nine patients improved and were discharged after drug withdrawal and symptomatic treatment, and three patients died. The top three drugs caused serious ADRs were contrast agent,antineoplastic drug and antibiotics.Conclusion::The hospital needs to have medical alart training regularly, and establishs the rescue proscess and emergency measures.The clinicians and pharmacists need to closely moniter the signs and symptoms of adverse reactions especially new and serious ADRs. |