One-third Of Community Pharmacists Don't Tell Parents They Are Dispensing Off-label Drugs To Children

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.

"Community pharmacists in the UK are responsible for overseeing the supply of prescription and over-the-counter medicine for use by children and ensuring that any off-label drugs are prescribed and dispensed appropriately.

"Give their role, we feel that greater emphasis should be placed on providing them with both undergraduate and postgraduate education in off-label dispensing, together with evidence-based information and training."

More than 60 per cent of the community pharmacists surveyed said that they had been asked by a member of the public to sell over-the-counter medicines, such as antihistamines, analgesics and steroids, for off-label use in children.

Nearly all the respondents said that they used general drug guidelines or the pack insert to decide whether to dispense the drug, rather than specialist formularies or guidelines on dispensing to children.

"Despite the wide availability of specialised resources, such as Medicine for Children, published by the Royal College of Paediatricians, only one respondent said they used them" says Dr McLay.

"The situation should hopefully improve, as copies of the British National Formulary for Children have been made freely available to community pharmacists since the survey was carried out."

Reference: Attitudes and experiences of community pharmacists towards paediatric off-label prescribing: a prospective survey. Stewart et al. British Journal of Clinical Pharmacology. 64.1, pages 90-95. July 2007.

Further study sample details: 1,500 randomly selected community pharmacists were sent questionnaires and 482 (32 per cent) responded. 52 per cent were female. 42 per cent had been registered for more than 19 years and 22 per cent for less than five. More than half (53 per cent) had attended more than 29 hours of continuing education in the last year and four per cent had attended less than five hours. 82 per cent had contact with patients for more than 30 hours a week, including 47 per cent who stated that this exceeded 39 hours a week.