最新基于超说明书用药潜在安全隐患的思考及管理对策.doc

County continuation records has examined and approved the draft, spirit, believe, comprehensive Yearbook of zhuanglang aanglang already prepared draft, entered the phase of evaluation. Civil air defense work
１．２　给药剂量超说明书用药　病人投诉反映药师告知细菌溶解产物胶囊〔７mg／粒，１０粒／盒〕的用法有误。男性病人，７６岁，诊断为慢性支气管炎，上呼吸道感染。处方：细菌溶解产物胶囊７ mg／粒，１０粒／盒，共３盒。用法为：１次／d，７mg／次，空腹口服。由于该药的用法比拟特殊，急性期的治疗和稳固及预防治疗用法不同。说明书【用法用量】中，急性期的治疗：每日早晨空腹口服７mg，直至病症消失〔至少用１０d〕；稳固及预防治疗：每日早晨空腹口服７mg，连服１０d，停２０d，再连服１０d，停２０d，再连服１０d。连续使用３个月为１个疗程。病人复诊时发现，药师告知病人的用法为稳固及预防治疗用法，即每日早晨空腹口服７mg，连服１０ d，停２０d，再连服１０d；而医师告知病人的用法为急性期的用法，即每日早晨空腹口服７mg，连服３０d。药师认为上呼吸道感染病程一般为５～１０d，如果１个月连用３盒，那么属于与用药疗程相关的给药剂量超说明书用药。
１．３　适应人群超说明书用药　医师为１名１７岁的诊断为“双侧结核性胸膜炎，耐药；结核性腹膜炎伴不完全性肠梗阻；结核性心包炎〞的病人开具的处方用药中有左氧***沙星片，药师拒绝调配。药师的理由是左氧***沙星片说明书【儿童用药】明确指出：本品在婴幼儿及１８岁以下青少年的平安性尚未确定。但本品用于数种幼龄动物时，可致关节病变。因此不宜用于１８岁以下的小儿及青少年〔目前大多数企业已将说明书中的
County continuation records has examined and approved the draft, spirit, believe, comprehensive Yearbook of zhuanglang already prepared draft, entered the phase of evaluation. Civil air defense work
County continuation records has examined and approved the draft, spirit, believe, comprehensive Yearbook of zhuanglang already prepared draft, entered the phase of evaluation. Civil air defense work
County continuation records has examined and approved the draft, spirit, believe, comprehensive Yearbook of zhuanglang already prepared draft, entered the phase of evaluation