Administration of drugs outside of Product Licence: awareness and current practice.
An interactive audience response system was used to collect information from members of the Obstetric Anaesthetists' Association at the 1997 Annual Meeting about the drug use that is unsupported by the Product Licence. The responses confirm that both licensed and unlicensed drugs are widely used in clinical practice outside the limitations imposed by Product Licence. The commonest types of unlicensed administration in obstetric anaesthetic practice are the use of mixtures and epidural or spinal administration of opioids. Despite widespread awareness of the subject, there appears to be considerable ignorance about the indications for which many commonly used drugs are licensed, even amongst a specialist audience. A majority of audience members expressed a view that the OAA should play a pro-active role, either by polling members about their current practice, or by issuing guidelines on reasonable drug practice in obstetric anaesthesia, or both. Potential implications of these are discussed.
St Bartholomew's Hospital, West Smithfield, London EC1A 7BE, UK.
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Howell
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Madej