Post-marketing surveillance in New Zealand.

Medical toxicology Pub Date : 1986-01-01
I R Edwards
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Abstract

In early 1977, the Intensive Medicines Monitoring Programme (IMP) was instigated for selected medicines with novel chemistry or pharmacology and those expected to be widely used. Pharmacists are requested to record the patient and prescribing doctor's details along with the medicine dose and duration of the prescription. Doctors are asked to send details of any unexpected clinical events. Doctors' spontaneous returns are low and have been supplemented by regular surveys. Now a new self-carboned prescription form has recently been introduced upon which doctors indicate if events have occurred. Since trial introduction of the new system the rate of event reporting in the test areas has increased 15-fold. In view of this, the duplicate prescription system will be introduced to the whole country over the next 3 years. In the past, the IMP has been used to follow up signals of new adverse events, to establish adverse drug reaction profiles and to establish risk-benefit indications.

新西兰的上市后监督。
1977年初,对具有新化学或药理学的选定药物和预期广泛使用的药物启动了强化药物监测计划(IMP)。药剂师被要求记录病人和开处方的医生的详细信息以及药物剂量和处方的持续时间。医生被要求发送任何意外临床事件的详细信息。医生的自发回访率很低,并辅以定期调查。现在,一种新的自碳处方表格最近被引入,医生根据它来指示是否发生了事件。自从试行新系统以来,试验区的事件报告率增加了15倍。鉴于此,今后3年内将在全国推行重复处方制度。过去,IMP已被用于跟踪新不良事件的信号,建立药物不良反应概况和建立风险-收益适应症。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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