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Public awareness and views on unlicensed use of medicines in children
Ist Teil von
British journal of clinical pharmacology, 2008-12, Vol.66 (6), p.838-845
Ort / Verlag
Oxford, UK: Blackwell Publishing Ltd
Erscheinungsjahr
2008
Quelle
Wiley-Blackwell Journals
Beschreibungen/Notizen
WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT
• There is increasing concern about the use of those medicines in children which have not been fully studied and licensed for childhood use. Such use is not uncommon, due in large part to a lack of availability of fully licensed products and formulations that are suitable for children.
• There is little published information on the views of the public on this important area of paediatric care.
WHAT THIS STUDY ADDS
• A survey of 1000 members of the public in Northern Ireland indicated that such use of medicines in children is not well known.
• However, when informed about this practice, the majority believed that it would compromise safety and increase the likelihood of adverse effects. They also believed that parents/guardians should be told if their child was prescribed a medicine that had not been fully tested in children.
• Participants in the survey indicated that they would be reluctant to involve their child in a clinical trial to help with the licensing process unless the child was suffering from a life‐threatening illness.
AIMS
To explore awareness and views of the general public on unlicensed use of medicines in children and on the participation of children in clinical trials.
METHODS
Members of the public completed a questionnaire survey administered by face‐to‐face interview in public areas in N. Ireland. The main outcome measures were the views on unlicensed use of medicines in children and on clinical trials in children.
RESULTS
One thousand participants (59.2% female) took part; 610 were parents. Most participants (86%) had no previous knowledge about unlicensed use of medicines in children. Being a parent did not influence this nor did being a parent of a child who suffered from a health problem (P > 0.05). Most participants (92%) felt that parents should be told about unlicensed use of medicines, with the doctor most frequently selected as the person who should inform parents. At the outset, only 1.8% of participants felt that the use of medicines in children was unsafe. However, having been informed about unlicensed use of medicines, this proportion increased dramatically (62.4%; P < 0.001). Views on whether participants would enter a child of their own into a clinical trial varied according to the health status of the child (P < 0.05) i.e. a child in good health (3.9%) vs a child with a life‐threatening condition (41.9%).
CONCLUSIONS
There is limited public knowledge of unlicensed use of medicines in children and a general reluctance to involve children in clinical trials unless the child to be involved has a life‐threatening condition.