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Vol 280 No 7496 p386
5 April 2008

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Adverse reactions to paediatric medicines studied

Family in a pharmacy

Parents will be asked to report adverse events in their children to pharmacists

A new community pharmacy-based system to identify paediatric adverse drug reactions (ADRs) is being piloted in Scotland.

The study — which began last week — involves community pharmacists providing questionnaires to the parents or guardians of children taking medicines for epilepsy, depression or attention deficit hyperactivity disorder.

“The aim is to develop a system to detect signals of ADRs in children at an early stage,” said James McLay, clinical pharmacologist at the University of Aberdeen, who is leading the study in collaboration with the Robert Gordon University and the Yellow Card Centre Scotland. He hopes results will be collated by the end of the year.

Dr McLay explained that ADRs in children are currently under-reported. Possible reasons for this include a failure to recognise ADRs in children, or children being less able than adults to explain that they are experiencing a reaction. The study will tackle this by using a questionnaire in which parents are asked if they have noticed any adverse effects in the child after the medicine has been taken.

Initially, the study will take place in the Grampian and Lothian regions. It will eventually be extended to other parts of Scotland. “Altogether we need 150–200 pharmacies to take part,” said Dr McLay.

Each pharmacy will participate for two to three months. Every time an anticonvulsant, antidepressant or medicine for attention deficit hyperactivity disorder is dispensed, the pharmacist will provide the parent or guardian with a questionnaire, a leaflet explaining the study and a pre-paid envelope for the questionnaire’s return.

Pharmacists will also need to log the number of questionnaires supplied. On patient numbers, Dr McLay commented: “An average pharmacy will see 11 or 12 children on these medicines in a two-month period.”

Any community pharmacy in Grampian or Lothian can participate in the study. “So far, we have between 35 and 40 pharmacies signed up, and they were sent questionnaires at the end of March,” said Dr McLay.

He hopes more pharmacists will be recruited at an evening meeting about the study, to be held on 14 April 2008.
(further details are available by e-mailing childstudy@abdn.ac.uk)

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