Over one hundred medicines available over-the-counter (OTC) have the unwanted potential to cause drowsiness. This report describes the British National Formulary’s (BNF) recommended range of advisory labels warning of possible drowsiness, and the accuracy and clarity of these labels on products available OTC. There are four types of such label for sedating medicines, relating to the operation of machinery or driving, and the inadvisability of consuming alcohol whilst taking the medication. As these are only recommendations they are not always followed closely by manufacturers. The accuracy of information regarding drowsiness and dosage provided by some manufacturers is worryingly inconsistent. Medicines containing the same generic drug at similar doses ought to have the same advice on their packaging, but this is not always the case. Some medications have different advice on the insert compared to that of the exterior packaging, often with the more substantial warning in the small print of the insert, where it is less likely to be seen. Two products have no drowsiness warning, even though this would be recommended by the BNF. One product liable to cause drowsiness has no dosage information on the exterior packaging, only on the insert – thus there is the potential for overdose if the insert is lost. The packaging of some second-generation antihistamines is misleading inasmuch that their “non-drowsy” statements, used as a key marketing feature, are not strictly true. As well as the accuracy of the information given to consumers, the clarity of its presentation is also an issue. The location of the warning label and size and colour of its lettering are important, but few products have clear and well presented labelling and most require improvement in at least one of these areas. There is a need for improved guidelines for manufacturers on these issues. The introduction of a standard symbol, warning of drowsiness, should be considered in the UK. It would provide more uniformity and reduce the possibility of people driving drowsy after taking medication that they believe to be safe. (Author/publisher)
Samenvatting