The UK medicines safety regulator is reviewing the packaging of liquid ranitidine, prescribed for the treatment of ulcers, gastro-oesophageal reflux disease and indigestion, after an audit of dispensing incidents involving children.
The review will focus on the licensed oral product, available on prescription for adults and children aged over three years. It will not consider unlicensed oral ranitidine, which is traditionally prescribed for children aged under two years, the Medicines and Healthcare products Regulatory Agency (MHRA) says.
The review follows the results of an audit carried out by community pharmacy group Pharmacy Voice involving 6,796 community pharmacies in England in 2013 and 2014. Using data supplied by the pharmacies, it calculated that every year in England there are around 60 dispensing incidents involving ranitidine liquid that affect children, of which 40 incidents affect children aged under two years.
The audit was prompted by concerns from members of Pharmacy Voice’s patient safety group that there were recurrent dispensing incidents involving the liquid form of the drug.
“Due to the necessary calculations taking into consideration body weight when preparing the correct oral liquid dose of ranitidine for children, errors can be made, resulting in patient safety incidents,” the audit report says.
The group has now published a list of recommendations for community pharmacists about dispensing any liquid preparation for babies and children, including ranitidine. Suggestions include confirming the actual weight of a child to check dose calculations and getting a second pharmacist to double check calculations. Any medication that has been prescribed outside the recommended age range should be discussed with the prescriber, the group suggests.
“We hope that by providing some recommendations and effective shared learning for pharmacy teams, we will be able to reduce the occurrence of these unfortunate incidents,” says Janice Perkins, the group’s chair.
The group points out that although ranitidine’s action is specific and accidental overdose does not present particular problems, dispensing errors involving young children can be distressing for parents.
According to latest MHRA figures, there were 6,554 reactions to ranitidine reported between 1 July 1963 and 29 June 2015. Of those, 3,959 were classified as an adverse drug reaction. There have been 35 reports involving fatalities.
“Ensuring the correct dose of a medicine is dispensed, particularly those involving liquid preparations for children, is very important,” says an MHRA spokesperson. “We welcome the initiative from Pharmacy Voice to improve communication all the way through the dispensing chain from prescriber to patient. We will be reviewing the packaging of licensed liquid ranitidine medicines to see what improvements could be made.”
The spokesperson adds that the review will be restricted to oral ranitidine prescribed for adults and children aged three years and over. It will not consider ranitidine preparations that do not have a marketing authority.