Medication Therapy Management Practice of A Chronic Disease Patient with Adverse Drug Reactions Caused by Candesartan / 中国药房

OBJECTIVE： To provide reference for the evaluation of the correlation between drugs and adverse drug reaction （ADR） and the implementation of medication therapy management （MTM）. METHODS： Clinical information of a elderly patient with chronic disease （hypertension and coronary heart disease） whose suffered from leukocyte and platelet counts reduction and abnormal liver biochemical examination after taking candesartan were analyzed retrospectively in outpatient department of Tianjin Third Central Hospital. MTM pharmacists analyzed the correlation of candesartan with ADR using Naranjo evaluation scale method. The reasons for abnormal liver biochemical examination were analyzed by Naranjo evaluation scale method combined with Roussel Uclaf causality analysis method （called RUCAM method for short）. The medication reconciliation was conducted according to the results， and pharmacists cooperated with doctors to set individualized medication regimen and follow-up. RESULTS： By Naranjo evaluation scale method， analysis results showed that candesartan was “probably related” to ADR. By RUCAM method， analysis results showed that candesartan was “probably related” to liver biochemical abnormalities. MTM pharmacists suggested that candesartan should be stopped in time and the patient’s medication should be adjusted. The physician and the patient adopted the pharmacist’s advice. After 38 days of drug withdrawal， the patient’s ADR symptoms disappeared， and leukocyte count， platelet count and liver biochemical examination were normal. After adjustment of medication， the patient was followed up for 6 months with normal blood pressure. CONCLUSIONS： Naranjo evaluation scale method and RUCAM are simple and feasible in evaluating the correlation of drugs with ADR and hepatotoxicity. The two methods are consistent in evaluating the correlation between drugs and hepatotoxicity. Naranjo scale method and RUCAM method can be combined to analyze the correlation between drugs and ADR with abnormal liver biochemical examination.

Advances in Roussel Uclaf Causality Assessment Method for diagnosis of drug-induced liver injury and its comparison with structured expert opinion process / 临床肝胆病杂志

Up to now, the diagnosis of drug-induced liver injury (DILI) still relies on the exclusive method, and the Roussel Uclaf Causality Assessment Method (RUCAM) is the most commonly used scale. Since the release of the first version of RUCAM scale in 1993, the second version was released in 2015, in which the definition and scoring criteria of each key element were revised appropriately and explained in detail. The Structured Expert Opinion Process (SEOP) was designed by the workgroup of DILI network prospective study, but since it is too complicated and time- and energy-consuming, its application in clinical practice is limited. This article introduces the research and development history and application method of RUCAM, as well as the modifications made in the 2015 version of RUCAM, and briefly compares the difference in bias between RUCAM and SEOP in the diagnosis of DILI. It is pointed out that both RUCAM and SEOP have marked interobserver and intraobserver variabilities, and therefore, it is necessary to explore a more objective, reproducible, accurate, and convenient strategy for the diagnosis of DILI.