The National Pharmacy Association (NPA) welcomes this opportunity to respond to the consultation ARM 54 on proposals to reclassify a bottle presentation of Calpol Six Plus from P to GSL. The NPA has concerns regarding this proposal as the organisation is not convinced that the product can be used safely and effectively without the supervision of a health care professional. In deed the MHRA up dated advice of 23rd March ‘Over-the-counter 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 changes to the Prescription Only Medicines Order in 1998, regarding the sale of paracetamol, highlighted the Government’s views on the safety of paracetamol. It was felt necessary to reduce the pack sizes available for sale to the public to prevent both accidental and intentional poisoning. It seems anomalous to us, therefore, that the Government now intends to increase the availability of paracetamol for use in older children. This would certainly confuse the public who have got used to the message of “caution” which was given when paracetamol sales were restricted.
Children under 10 are involved in over a third of enquiries to the National Poisons Information Centre (NPIS)1 according to the report published for 2005-06. Queries about paracetamol still top the list of enquiries. NPIS Edinburgh Director Professor Nick Bateman of the Royal Infirmary, Edinburgh said, "Accidental poisoning of children under 10 is still a significant problem and we feel more measures should be taken to reduce this.”
Unintentional overdose is known to occur when patients take more than one preparation containing paracetamol. When paracetamol preparations are supplied in the pharmacy the pharmacist and their staff will check that the patient is aware that the product contains paracetamol and will remind patients or their carers to avoid taking other paracetamol containing products concurrently. Such advice is not available in non-pharmacy outlets.
Whilst we appreciate that this strength of paracetamol is available over-the-counter in unit dose forms, Calpol Six Plus Suspension Sugar Free in sachets and Calpol Six Plus Fastmelts, we believe that the availability of a multi-dose bottle is likely to increase the potential for children to inadvertently be given an overdose over and above that likely when administering from unit dose forms.
The application states that as the product is already classified as a GSL product when provided in packs of 16 x 250mg orodispersible tablets (Calpol Six Plus Fastmelts) (Packs of Calpol Six Plus Sachets, a form less likely to be taken in overdose contain only 12 sachets (total 3gm of paracetamol), the difference in legal status is based on packaging format. However overdose, whether accidental or intentional, would be more likely to occur if the product is available in larger liquid volumes such as 80ml bottles. In addition when the product is available in unit dose format the potential for error is reduced as the correct dose has been already calculated.
The rationale for this reclassification is given as increased convenience and accessibility however as the liquid product is already available in sachet form as well as the orodispersible tablets there seems to be no need for the bottle presentation.
In conclusion, we believe that making paracetamol products for older children more widely available outside pharmacies is not in the interest of public safety and is out of line with the Government’s policy on paracetamol pack sizes. It is likely to have cost implications for the NHS if there are an increased number of inquiries to the Poisons Centres or presentations at accident and emergency departments due to accidental overdose. This proposal will give out mixed messages to the public about the Government’s policy on paracetamol and lead to confusion regarding the safety issues surrounding paracetamol.
References
1 New poisoning statistics released Pharmaceutical Journal Vol 277 no 7418 p 329 16th September 2006.
