Consent and the use of Foley catheters in epistaxis

The Medicines and Healthcare Products Regulatory Agency stated in 2003 that doctors should endeavour to avoid using products in treatments not covered by their product licence. Foley catheters are commonly used in the management of epistaxis although their product licence does not cover this. We undertook a questionnaire survey of members of the British Association of Otorhinolaryngologists – Head & Neck Surgeons to study the extent of the use of these catheters and the knowledge that members had of their legal status.Most members appear to use Foley catheters in the management of epistaxis; however, many are not aware that the product is not licensed for this purpose. Because of this lack of knowledge, only half obtain verbal consent for treatment with this device and only a very small number obtain written consent from patients.In the era of increasing litigation, documentation of informed consent could be considered mandatory to protect us from possible legal action, and this needs to be known by all practising otolaryngologists.

Oral cholera vaccine given marketing authorisation in European Union

At the end of April 2004, the European Medicines Agency (EMEA, http://www.emea.eu.int) issued a marketing authorisation (comparable to a product licence) applicable to all European Union countries for the oral cholera vaccine Dukoral, produced by Chiron Vaccines Evans.

Prescribing of unlicensed medicines or licensed medicines for unlicensed applications in child and adolescent psychiatry

Aims and MethodChild and adolescent mental health services in north-west England (n=21) participated in a prospective collection of information regarding all instances of new prescribing of medication over the 6–month period September 1999 to February 2000.ResultsA total of 478 new prescriptions were issued to 411 individuals. Eight prescriptions (2%) were for an unlicensed drug and a further 188 (39%) were of licensed drugs but used in a manner outside of their product licence.Clinical ImplicationsThis level of unlicensed and outside-licence prescribing is similar to levels previously found in studies both within paediatric practice and in adult mental health practice. Anxiety about excessive beyond-licence prescribing by child mental health services is unlikely to be justified.