Patient information leaflets for anaesthetic drugs

European Directive 92/27/EEC, which became effective in January 1999, requires a patient information leaflet (PIL) to be included in every package of drugs, even if it is not intended that the package be dispensed directly to the patient [1]. Concern has recently been raised that the information presented in PILs is both confusing and alarming to patients [2]. Examination of the contents of the average anaesthetic-room drug cupboard may be a revealing exercise [3]. The majority of drug packages do indeed contain patient information leaflets. These range in length and utility from those accompanying ampoules of water and saline for injection to those for propofol and etomidate. Cursory perusal yields some interesting findings: The PIL for succinylcholine (Antigen Pharmaceuticals) advises the patient to be `fully asleep under a general anaesthetic 1⁄4' before administration and warns of sideeffects such as `difficulty breathing' and `feeling too hot'. The PIL for aprotinin (Trasylolw; Bayer plc) reminds thepatient: `This medicine has been prescribed for you. Do not give it to anyone else under any circumstances.' The PIL for phentolamine (Rogitinew; Novartis Pharma A.G.) ± a drug commonly used during cardiac surgery ± advises that the drug is used for the diagnosis and treatment of hypertension associated with phaeochromacytoma. Our supplies of St Thomas I cardioplegia perfusion solution (Plegivexw, Ivex Pharmaceuticals) curiously contain no PIL ± we can only speculate what it might contain! At our institution, it is not uncommon for a patient to receive more than 30 drugs during the course of a typical cardiac surgical procedure. Is the anaesthetist seriously expected to offer the PILs for these drugs to the patient before surgery? Would patients want to receive or benefit from receiving this information? A survey of 10 patients recovering from elective cardiac surgery revealed that the answer is quite clearly ± `No'. None of the patients questioned reported being offered, or indeed expected to be offered, any PILs before surgery. When each patient was then presented with the PILs for each of the drugs that they had received, the majority (9/10) found them difficult to understand, confusing and likely to cause more, rather than less, anxiety. Only one patient felt that he might have benefited from receiving this information before surgery. This patient later revealed that he was, in fact, a pharmacist! We consider that it is inappropriate to provide information that is both confusing and which generates unnecessary anxiety about drugs that the patient is unlikely to ever administer to themselves.

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