Side effects of child medicines studied

Parents, guardians and their children are to be asked to help researchers identify any unwanted effects of drugs given to children with epilepsy, depression and Attention Deficit Hyperactivity Disorder.

Scotland's first full scale study of its kind to evaluate a community pharmacy system for monitoring adverse drug reactions associated with paediatric medicines will begin shortly in  Aberdeen and Aberdeenshire and Lothian before spreading to Tayside, Dumfries and Galloway, Greater Glasgow, Lanarkshire and Ayrshire and Arran.

Data suggests over 3 million acute and 3.5 million repeat prescriptions for all kinds of medical conditions are issued annually to 780,000 Scots children aged 12 years or less.

Researchers suggest that 12,000 to 88,000 of these children could experience adverse drug reactions such as upset stomachs, anxiety and changes in behaviour.

Participating chemists will offer questionnaires to parents and guardians when they attend for a prescription medicine for their child, for one or more of these three conditions.

Dr James McLay, a Clinical Pharmacologist and Senior Lecturer at the University of Aberdeen, is leading the study in collaboration with The Robert Gordon University Aberdeen, and the Scottish Adverse Drug Reaction Monitoring Centre - YCC Scotland - in Edinburgh.

He said: "This is the first full scale study of its kind in Scotland and what we want to do is identify any unwanted effects experienced by children taking medicines for epilepsy, depression and Attention Deficit Hyperactivity Disorder (ADHD).

"We have chosen these three conditions because although the medicines used are very effective, they can also have a range of side effects.

"Although the safe and effective use of medicine in children is a national and European priority, the systems that are currently in place for picking up any unwanted effects of medicines are recognised as being less than ideal, with many being missed.

"The situation is complicated by the fact that children often have to be given medicines designed for adults that have not been studied in young people.

"Also depending on their age, children may be less able than adults to explain the unwanted effects that they are experiencing, or to link them to the medicine.

"We therefore want to establish whether working in partnership with parents and pharmacists can provide a better picture of the real level of the unwanted side effects of medicines used in children.

"Ultimately we hope our study will go some way to making overall medical care for children much safer."

Parents/guardians who agree to take part in the study, will be given questionnaires by the chemist for completion at home.

These ask a number of questions such as how long the child has taken the medicine; what it is being given for and whether there have been any side effects. These could be anything from an upset stomach to changes in behaviour and school performance.

Short telephone interviews may also be conducted to obtain more detailed information from a smaller number of participants.

Children and parents who take part in the study – which is funded by the Chief Scientist Office of the Scottish Government – will remain anonymous. 

• Approximately 3,300 Scots children under 16 are prescribed anticonvulsants each year; 3,100 are prescribed antidepressants and 7,000 are prescribed medication for AHDH.