A survey of the use of unapproved medicines in anaesthesia practice in New Zealand

Abstract

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.