依据《药品不良反应信息通报》探讨避免药品不良反应发生的措施

Measures to prevent ADR according to Bulletin About Information of ADR

目的:探讨如何利用官方发布的权威信息资源如国家药品不良反应监测中心的《药品不良反应信息通报》来确定处方干预监测重点,以避免一些严重ADR的重复发生。方法:对2001—2013年间的58期《药品不良反应信息通报》所涉及的药品、发布频度、累及器官或系统、主要临床表现及引发原因等进行回顾性研究分析,以确定在处方干预中重点监测项目及采取避免一些严重ADR发生的措施。结果:2001—2013年国家药品不良反应监测中心共发布《药品不良反应信息通报》58期,涉及药品115种,其中化学药97种,占84.35%,涉及15个类别药品。中成药18种,占15.65%。在通报的化学药品中抗感染药所占比例最大,为30.93%。被通报药品中化学药和中成药的注射剂和口服制剂引发的ADR大致相当。ADR累及器官或系统及主要临床表现以皮肤及其附件受损或过敏、全身性损害、泌尿系统及肾功能受损、肝功能异常或损害等最多。引发ADR除药品原因、患者个体差异外,还与临床不合理用药如超适应证、用法用量不规范、禁忌证用药、药物配伍、儿童用药不规范问题等有密切关系。结论:药品不良反应除药品本身性质引起和患者个体差异外,许多是由于临床不规范用药造成的,应予以重视,通过《药品不良反应信息通报》等官方信息资源可以确定处方干预监测重点,将可避免的ADR发生率降低到最低,在这一过程中药师将最大程度地发挥专业作用。

OBJECTIVE To investigate how to utilize authoritative information resources,such as BULLETIN ABOUT INFORMATION OF ADR issued by the National Center for ADR Monitoring,to define monitoring focuses to intervene prescriptions,to avoid recurrence of ADR.METHODS Drugs,distribution frequency,involved organs or systems,clinical manifestations and causes listed in 58 issues of BULLETIN ABOUT INFORMATION OF ADR from2001 to 2013 were retrospectively analyzed,to define major monitoring items in prescription intervention and to take measures for preventing serious ADR.RESULTS There were 115 drugs listed,including 97 chemical drugs accounting for 84.35%,involving 15 drug categories;18TCM drug accounting for 15.65%.In the chemical drugs listed,anti-infective drugs occupied the largest proportion of 30.93%.Injection and oral preparations of chemical drugs and TCM drugs induced relatively equivalent ADR.Major organs or systems or clinical manifestations involved in ADR included injuries or allergies of skin and its appendages,systemic injuries,impairments of urinary system and renal functions,hepatic functions,etc.Besides of drug and individual differences,ADR was also closely correlated with irrational drug use,including drug administration beyond indications,irregular usage and dosage,contraindicated medication,drug compatibility,irregular medication in children,etc.CONCLUSION ADRs are caused by irregular medication besides of drug natures and individual differences.Monitoring focuses can be defined for prescription intervention by utilizing official information resources,such as BULLETIN ABOUT INFORMATION OF ADR,which will help to lower ADR rate to the lowest level.During this process,TCM pharmacist can play a major role professionally.