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40% of community pharmacists don't tell parents they are dispensing off-label drugs to children

Published on July 12, 2007 at 12:53 PM · No Comments

Forty per cent of community pharmacists have dispensed an off-label drug to a child in the last month, according to research published in the July issue of the British Journal of Clinical Pharmacology.

And although 78 per cent said they would tell a family doctor that the prescription they had written would have to be dispensed off-label , outside the terms of the drug's product license , only 66 per cent felt they had a similar responsibility to inform the child's parents.

Pharmacists said the most common off-label dispensing of prescribed and over-the-counter medicines involved giving a drug to a child who was younger than the recommended minimum age for the drug or giving them higher than the recommended dose.

Just under 500 community pharmacists, with wide-ranging experience and post-registration education, took part in the research, carried out by the Department of Medicine and Therapeutics at the University of Aberdeen, UK.

"The community pharmacists who responded to the questionnaire appeared to be aware of , and concerned by - the issues surrounding off-label prescribing to children, says co-author Dr James McLay.

"What did concern us was that only 40 per cent of pharmacists said they had dispensed off-label medicines to children in the month before the survey.

"Having reviewed primary care prescribing levels, this 40 per cent figure was lower than expected and leads us to conclude that many pharmacists may not realise that they are dispensing off-label.

"And a third said they didn't feel they had a responsibility to inform parents of off-label prescribing, possibly because this could suggest criticism of the family doctor who prescribed the drug."

The researchers also found that most of the 482 randomly-selected pharmacists gained their knowledge of off-label dispensing through work experience rather than education.

"While all licensed medicines used to treat children have been rigorously tested before their general use, not all are specifically licensed for use by children, says Dr McLay.

"Until this situation is rectified, community pharmacists need to be competent and confident in recognising and dealing with drugs that are prescribed and dispensed outside their licensed use.

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