�The NPA believes that the reclassification of the bottle presentation of Calpol Six Plus from P to GSL could compromise patient base hit, is anomalous in relation to other paracetamol products and is unnecessary as the product can be obtained in alternative packaging that carries less risk.
Changes to the Prescription Only Medicines Order in 1998 were made to shrink the pack sizes of paracetamol available for sale to the public to prevent both accidental and intentional intoxication. It seems anomalous to us, thence, that the Government now intends to increase the availability of paracetamol for use in older children. This would certainly flurry the populace who ingest got ill-used to the message of caution which was tending when paracetamol sales were restricted.
Whilst we appreciate that this strength of paracetamol is available over-the-counter in whole dose forms, Calpol Six Plus Suspension Sugar Free in sachets and Calpol Six Plus Fastmelts, we believe that GSL handiness of a multi-dose bottle is likely to step-up the potential difference for to inadvertent overdosing. Indeed MHRA updated advice of 23 March regarding OTC cough and cold medicines for young children expressed the same concern regarding the administration of cough medicines to children under two and withdrew the licenses for some cough mixtures aimed at this age group.
The NPA considers that the issue of Calpol 6+ in bottle introduction without the advice of a health care professional carries indefensible risks to patient safety. Unintentional overdose is known to occur when patients take more than one preparation containing paracetamol. When paracetamol preparations are supplied from pharmacies, pharmacists and their staff will check that patients are cognizant that the product contains paracetamol and will cue patients or their carers to fend off taking other paracetamol-containing products concurrently. Such advice is not available in non-pharmacy outlets.
The rationale for this reclassification is given as increased convenience and accessibility; however as the liquid production is already available in sachet grade as well as the orodispersible tablets there seems to be no motivation for the bottle presentation.
National Pharmacy Association
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