A Complaint Involving the Supply of Paralink® Suppositories for a Child

The Professional Conduct Committee (PCC) heard a complaint in which Paralink® suppositories 500mg were supplied in error by a pharmacist for the treatment of a one year old child.

The child’s parent presented a prescription to the pharmacist for Tamiflu oral suspension and Motilium suppositories. The pharmacist dispensed the prescription and counselled the parent with regard to how to administer these two medicines to the child.
During this interaction the parent also requested to buy Paralink® (paracetamol) suppositories and Dioralyte® sachets for the child, as suggested by an out-of-hours doctor which they had attended during the night.
The pharmacist counselled the child’s parent on how to use these two products, but in error a box of Paralink® 500mg adult suppositories was supplied, rather than Paralink® 180mg suppositories which are the appropriate strength for a one year old child.
Over the next two days the child received a total of seven Paralink® 500mg suppositories at 6 hourly intervals, in addition to one Paralink® 180mg suppository which had been provided by the out-of-hours doctor just before they presented at the pharmacy.
The child’s symptoms persisted and hospital admission was required. The child was diagnosed with acute liver failure caused by accidental paracetamol overdose; and underwent an emergency liver transplant.

Important Learnings

Learnings from this complaint should be shared with all staff members. You should review your pharmacy’s procedures for supply of non-prescription medicines for infants and children, as well as your own practice, to help ensure a similar incident does not happen in your pharmacy.

This complaint highlights the following important learning points:

Children and infants are particularly vulnerable to drug overdose and side effects; this is true even with non-prescription medicines. It is essential that extra time and care is taken to ensure the correct product is supplied and the parent/carer has accurate and detailed information regarding dosing amount and frequency; in these cases supply only by the pharmacist should be considered.
It should be highlighted to the parent/carer that medicines containing paracetamol are extremely safe and highly beneficial when used correctly; however they can be toxic and indeed fatal when used inappropriately. Therefore it is imperative that the patient/carer are advised to always check the recommended dose for the age and weight of their child and not to give more than this.
It is recommended that you explain the directions for use to the parent/carer using the information given on the product’s outer packaging and/or the Package Leaflet, and confirm with them their understanding of this information. This can help to ensure that the correct product has been selected and identify an error that may otherwise be missed.
You should encourage the parent/carer to read the Package Leaflet themselves before administering the medicine to the infant or child and if they have any queries to contact the pharmacist or their doctor.
Non-prescription medicines for infants and children should be separated on the shelf from medicines for adults to help reduce the chance of them being mixed up during supply.
All members of staff should be appropriately trained on non-prescription medicines for infants and children and aware that the dose needed can be dependent on age and weight. It should be clear when it is necessary to refer to the pharmacist before making a supply.
In this particular case, a supply error had detrimental effects on the infant. You should consider ways in which a similar error may be prevented in your pharmacy, for example, by highlighting the information on the product’s box and patient leaflet during counselling to confirm who the product is for and what it is needed to treat. What other procedures or safe guards could you put in place?
An error log should be completed for all errors made in the pharmacy, and the staff members involved should be informed of the error. Recording errors should not be used as a way to blame individuals, but rather to encourage an environment of openness and learning, so that procedures can be reviewed and amended, and practices changed to guard against similar errors happening again.

An accidental paediatric paracetamol overdose was highlighted in the March 2013 PSI newsletter. This article highlighted potential sources of error which could lead to paracetamol overdose in children and provided advice on patient counselling when supplying paediatric paracetamol products to a parent or carer. This article may also help you to review your practice