Julian K A, Stapelberg F
Department ofAnaesthesia, Middlemore Hospital, Auckland, New Zealand.
Anaesth Intensive Care. 2008 Jan;36(1):102-6. doi: 10.1177/0310057X0803600118.
The Medicines Act (1981) and its amendments regulate the manufacture, sale and supply of medicines, medical devices and related products in New Zealand. Medications are approved for supply under the provisions of this Act. Supply and administration of unapproved medications is permitted. When this occurs, the supplier must report this to the Director-General of Health. Additionally, the patient must be informed of the unapproved status of the drug and be advised of the forwarding of information related to their health care to a third party. For apparently commercial reasons, approval has not been sought for a number of formulations of medications commonly used in anaesthesia practice. There has been no published literature of the impact of this legislation on the practice of anaesthesia in New Zealand. A survey was undertaken to determine how commonly anaesthetists administer unapproved drugs, whether the requirements for informed consent were met and any perceived impact the status of these medications has on patient care. The survey findings indicated that the majority of New Zealand anaesthetists practise 'outside the law' with respect to unapproved medicines. Seventy-eight percent do not inform patients about the potential use of unapproved medications during their anaesthetic, despite 65% administering these medications to patients "every few weeks" or even more often.
《药品法》（1981年）及其修正案对新西兰药品、医疗设备及相关产品的生产、销售和供应进行监管。药品须根据该法案的规定获得供应批准。未经批准的药品允许供应和使用。发生这种情况时，供应商必须向卫生总干事报告。此外，必须告知患者该药物未获批准的情况，并告知患者其医疗保健信息将转发给第三方。出于明显的商业原因，一些麻醉实践中常用药物的制剂未寻求批准。目前尚无关于该立法对新西兰麻醉实践影响的公开文献。开展了一项调查，以确定麻醉师使用未经批准药物的频率、是否满足知情同意的要求，以及这些药物的状态对患者护理的任何潜在影响。调查结果表明，大多数新西兰麻醉师在使用未经批准的药物方面“违法行事”。78%的麻醉师在麻醉过程中未告知患者可能使用未经批准的药物，尽管65%的麻醉师“每隔几周”甚至更频繁地给患者使用这些药物。
