RESEARCH 55lifelong effects as a result of toxicity occurring at a sensitive
point in development (a ‘critical window’) during fetal
or neonatal life (‘programming’) as with thalidomide/
phocomelia or hypothyroid drugs/congenital hypothy-
roidism
RESEARCH
Research in paediatric clinical pharmacology is limited. Not
only is there concern about the potential for adverse effects
of new drugs on those who are growing and developing
mentally, but there are also considerable ethical problems
encountered in research involving individuals who are too
young to give informed consent. New drugs are often given to
children for the first time only when no alternative is available
or when unacceptable side effects have been encountered in a
particular individual with established drugs. Pharmaceutical
companies seldom seek to license their products for use in
children. When drugs are prescribed to children that are
not licensed for use in this age group, it is important to
make careful records of both efficacy and possible adverse
effects. Prescribers take sole responsibility for prescribing
unlicensed preparations (e.g. formulated to appeal to chil-
dren) or for prescribing licensed preparations outside the
licensed age range. Parents should be informed and their con-
sent obtained.
FURTHER READING
Baber N, Pritchard D. Dose estimation in children. British Journal of
Clinical Pharmacology2003; 56 : 489–93.
British National Formulary for Children2007. http://www.bnfc.org
Kearns GL, Abdel-Rahmen SM. Developmental pharmacology – drug
disposition, action and therapy in infants and children. New
England Journal of Medicine2003; 349 : 1157–67.
Paediatric Special Issue. British Journal of Clinical Pharmacology2005; 59 (6).
Paediatric formulary, 7th edn. London: Guy’s, St Thomas’, King’s
College and Lewisham Hospitals, revised 2005.Case history
A 14-year-old boy with a history of exercise-induced
asthma, for which he uses salbutamol as necessary (on aver-
age two puffs twice daily and before exercise) is seen by his
GP because of malaise and nocturnal cough. On examina-
tion, he has a mild fever (38°C), bilateral swollen cervical
lymph nodes and bilateral wheeze. Ampicillin is prescribed
for a respiratory tract infection. The next day the boy
develops a widespread maculopapular rash.
Question 1
What is the cause of the rash?
Question 2
What is the likely cause of the nocturnal cough and how
may this be treated?
Answer 1
Ampicillin rash in infectious mononucleosis (glandular fever).
Answer 2
Poorly controlled asthma. Regular inhaled glucocorticos-
teroid or cromoglicate.