Releases Saturday 8 January 2000
No 7227 Volume 320

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(1) CHILDREN RECEIVE APPROPRIATELY TESTED
MEDICINES

(2) EPISIOTOMY INCREASES THE RISK OF ANAL
INCONTINENCE

(3) ONE SIXTH OF EPILEPTIC PATIENTS CONCEAL
SEIZURES FROM DOCTORS



(1) CHILDREN RECEIVE APPROPRIATELY TESTED
MEDICINES
(Survey of unlicensed and off label drug use in paediatric
wards in European countries)
http://www.bmj.com/cgi/content/full/320/7227/79

Children in Europe are being denied the same rights as adults
in relation to receiving treatment with drugs that have been
fully tested, report a team of European researchers in this
week's BMJ. Unlicensed and "off label" drug prescribing in
children is a problem across Europe that needs action
conclude Sharon Conroy from the University of Nottingham
and colleagues from Sweden, Germany, Italy and the
Netherlands.

Many drugs are not tested in children, which means they are
not specifically licensed for use in children, say the authors.
However, because clinical trials of drugs are usually not
performed on this age group, licensed drugs are often
prescribed outside the terms of the product license in relation
to age, dose, frequency or the intended use of the drug. Using
licensed drugs in this manner renders them "off label". As a
result, considerable concern exists within Europe and the
United States about the use of unlicensed and off label drugs
in children, report the team.

Conroy et al investigated the prescribing practices in the
children's wards of five hospitals in Derby, Uppsala,
Marburg, Bergamo and Rotterdam. They found that over a
four week period during 1998, 2,262 drug prescriptions
were administered to 624 children in the five hospitals.
Almost half of all the drug prescriptions (1036) were either
unlicensed or off label (872 were off label and 164 were
unlicensed). This led to two thirds of the children (67 per
cent) receiving an unlicensed or off label drug prescription
during their stay in hospital. The most frequently prescribed
off label drugs were those used in the treatment of asthma
and pain relief, say the authors.

Conroy et al conclude that based on their findings, the use of
off label or unlicensed drugs to treat children is widespread
and that this problem is likely to affect children throughout
Europe. They say that this requires action from the European
Union, national departments of health and politicians as well
as the European Medicines Evaluation Agency.

Contact:

Professor Imti Choonara, Academic Division of Child Health
(University of Nottingham), Derbyshire Children's Hospital,
Derby
Email: Imti.Choonara@nottingham.ac.uk

(2) EPISIOTOMY INCREASES THE RISK OF ANAL
INCONTINENCE

(Midline episiotomy and anal incontinence: retrospective
cohort study)
http://www.bmj.com/cgi/content/full/320/7227/86

Women who undergo episiotomy during childbirth have
higher rates of anal incontinence during the first six months
after giving birth compared to women who did not have
episiotomies and even compared to those who experienced
perineal tearing, report researchers in this week's BMJ.

Dr Lisa Signorello and colleagues from Harvard Medical
School investigated 209 women who underwent a midline
episiotomy whilst delivering a full term singleton baby
vaginally; 206 who experienced spontaneous perineal tearing
and 211 who experienced neither. They found that compared
with women who tore naturally, episiotomy tripled the risk of
faecal incontinence and doubled the risk of flatus incontinence
in the six months after giving birth.

Signorello et al also determined that this effect of episiotomy
was not due to its frequent association with instrumental
delivery (for example forceps) and was independent of
maternal age and complications during labour.

Based on their findings the authors conclude that episiotomy
is not effective in protecting the perenium and sphincters
during child birth and that the restricted use of episiotomy
may prevent anal incontinence.

Contact:

Dr Lisa Signorello, Study Co-ordinator, International
Epidemiology Institute, Rockville, USA
Email: lbsignore@aol.com

Or

Dr Bernard Harlow, Obstetrics and Gynaecology
Epidemiology Center, Brigham and Women's Hospital,
Harvard Medical School, Boston, USA

(3) ONE SIXTH OF EPILEPTIC PATIENTS CONCEAL
SEIZURES FROM DOCTORS

(Cross sectional study of reporting of epileptic seizures to
general pratitioners)
http://www.bmj.com/cgi/content/full/320/7227/94

One sixth of patients who experienced seizures in the past
year, did not reveal details to their general practitioner, finds a
study published in this week's BMJ. Dr Jamie Dalrymple
from the University of East Anglia and Dr John Appleby from
the King's Fund in London suggest that a reluctance to
report seizures may be because epilepsy affects their eligibility
for a driving licence and access to various employment and
leisure activities.

Dalrymple and Appleby analysed responses from 111
epileptic patients to an anonymous questionnaire. 42 patients
had previously admitted to their family doctor that they had
experienced a seizure within the last twelve months, however
in the anonymous questionnaire 60 patients admitted to a
recent seizure. Of these 40 per cent held a driving licence,
only a quarter of whom admitted this to their doctor, say the
authors.

They conclude that some patients clearly perceive that the
benefits of concealment of seizures outweigh the risks, but
that such concealment can lead to inadequate treatment - if
doctors don't know that they have experienced a seizure
then they will be unable to treat them appropriately. They say
that doctors need to put more effort into explaining this to
patients.

Contact:

Dr Jamie Dalrymple, General Practitioner, Schools of Health,
University of East Anglia, Norwich
Email: j.dalrymple@uea.ac.uk


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