PSI concerned over ulcer drug dispensing errors

The Pharmaceutical Society of Ireland (PSI) has expressed concern over dispensing errors by pharmacists when supplying Zantac Syrup to paediatric patients.

In children (aged three-to-18 years), Zantac Syrup is indicated for the short-term treatment of peptic ulcer and treatment of gastro-oesophageal reflux, including reflux oesophagitis and symptomatic relief of gastro-oesophageal reflux disease.

According to the report of the PSI registrar in February, “further to previous recommendations” from the professional conduct committee on this matter, the Society was writing to the marketing authorisation holder (MAH) and Health Products Regulatory Authority (HPRA) to propose “actions to facilitate safer care”.

“The PSI is suggesting changes to the packaging and the formulation of Zantac Syrup, which may reduce the risk of dispensing errors when this product is supplied by pharmacists to paediatric patients,” according to the report. “As the safety issues which have come to our attention relate to dose miscalculations, the PSI is also writing to the schools of pharmacy, in an advisory capacity, to alert them to this particular safety issue.”

A PSI spokesperson told the Medical Independent (MI) it had recently raised with the HPRA “that we wish to engage with them to explore this matter further”.

The PSI has received five complaints that relate to errors in the dispensing of this medication in paediatric patients. Of the five complaints, four inquiries have been conducted and concluded before the professional conduct committee between 2014 and 2018.  “Any action in relation to the fifth complaint is not concluded.”

A HPRA spokesperson informed MI: “Since authorisation in 1989, the HPRA has received two reports of medication errors in association with Zantac Syrup. In one case, the error was intercepted prior to treatment and no adverse reaction/event was experienced. In the second case, the patient concerned was reported to have experienced vomiting and diarrhoea.”

A spokesperson for GSK said: “Patient safety is of the utmost importance to GSK and we take all possible signals related to the safety of our medicines seriously.”