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New Research: 1 in 10 Children at Risk of Undetected Adverse Drug Reactions.

British Pharmaceutical Conference, MANCHESTER, England, September 27 /PRNewswire/ --

British Pharmaceutical Conference, MANCHESTER, England, September 27 /PRNewswire/ --

More than 1 in 10 (12%) children are at risk of undetected/unreported adverse drug reactions (ADRs) according to new research launched today at the British Pharmaceutical Conference.

A pilot study carried out in community pharmacies in Grampian showed that more than 1 in 10 children were reported by parents to have suffered an ADR from drugs they had been prescribed or had bought over the counter. The most common reported problem was diarrhoea as a result of taking amoxicillin.

Little is known about ADRs in children. However, available information suggests that up to 2% of paediatric hospital admissions are due to an ADR. Furthermore, between 9%-11% of children are thought to suffer from an ADR either as hospital inpatients or in the community.(1,2,3)

The Grampian study collected data on children under 12 years old. Relevant information was obtained in the pharmacy and the parent was then asked to complete a five-day diary recording any perceived side effects.

Clinical Pharmacologist, Dr James McLay, said that there is a clear need for an efficient and comprehensive way to monitor ADRs in children. "ADRs in children are slipping through the net. We needed to find a systematic way to encourage parents to report on behalf of their children,'' he said.

Dr McLay said that this study proved the suitability of community pharmacies for reporting and monitoring ADRs in children for both prescribed and over the counter medicines. "Based in the heart of the community, pharmacists are accessible and ideally placed for parents who want to report ADRs in their children," he said.

Dr McLay added that community pharmacists are key professionals for reporting ADRs to the Committee on Safety of Medicines for the whole population.

Notes to Editors

1. (1)Impicciatore P, Choonara I, Clarkson A, Provasi D, Pandolfini C, Bonati M. Incidence of adverse drug reactions in paediatric in/out patients: a systematic review and meta-analysis of prospective studies. Br J Clin Pharmacol 2001; 52: 77-83.

2. (2)Turner S, Nunn AJ, Fielding K, Choonara I. Adverse drug reactions to unlicensed and off-label drugs on paediatric wards: a prospective study. Acta Paediatr 1999; 88: 965-968.

3. (3)Jonville-Bera AP, Giraudeau B, Blanc P, Beau-Salinas F, Autret-Leca E. Frequency of adverse drug reactions in children: A prospective study. Br J Clin Pharmacol 2002; 53: 207-210.

4. The research included children who received prescriptions for amoxicillin and salbutamol, and those who were given paracetamol based medicines or ibuprofen based medicines either by prescription or bought as an over the counter medicine. Over the four-week period 360 prescriptions for and purchases of the study medicines were recorded. Thirty of these were excluded and a further 18 missed mainly due to periods of high demand. Of the remaining 312 instances, 267 parents (85.5%) agreed to participate. One hundred and six participants (40%) returned a total of 122 questionnaires, some receiving more than one study medication.

5. Spontaneous suspected adverse drug reaction (ADR) reporting to the Committee on Safety of Medicines by healthcare professionals is the main source of information used for regulatory pharmacovigilance in the UK.


BPC 2004 is being held at Manchester International Convention Centre between Monday 27 and Wednesday 29 September. The conference theme this year is `Medicines: from cell to society'. The science and technology that underpins the design of today's medicines is developing fast. At the same time, the demands of patients are increasing and the priorities of the health service are changing. BPC 2004 will examine all of these issues, alongside sessions drawing on the experience of leading edge good practice and the latest in continuing professional development.

For further information please contact the press office on: +44(0)161-832-1050, +44(0)161-839-9163 or +44(0)161-839-9161 (27 - 29 September)+44(0)20-7572-2335/6 (pre and post conference); +44(0)7971-022297 or +44(0)7958-547727 (available at all times)
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Publication:PR Newswire Europe
Date:Sep 26, 2004
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