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Adverse reactions to drugs
Any
drug
may
produce
unwanted
or
unexpected
adverse reactions.
Rapid detection and recording of
adverse drug reactions is of
vital
importance so that
unrecognised
hazards
are
identified
promptly
and
appropriate regulatory action is taken to ensure that
medicines are used safely. Healthcare professionals and
coroners (see also Self-reporting below)
are urged to
report suspected adverse drug reactions directly to the
Medicines and Healthcare products Regulatory Agency
(MHRA)
through the Yellow Card Scheme using the
electronic
form at
www.yellowcard.gov.uk.
Alterna-
tively,
prepaid Yellow Cards for reporting are available
from the address below and are also bound in this book
(inside back cover).
Send Yellow Cards to:
FREEPOST YELLOW CARD
(No other address details required)
Tel:
0800 731 6789
Suspected adverse drug reactions to
any
therapeutic
agent should be reported, including drugs
(self-medica-
tion
as well
as those
prescribed)
,
blood products,
vac-
cines, radiographic contrast media, complementary and
herbal products.
A 24-hour Freefone service is available to all parts of the
UK for advice and information on suspected adverse
drug reactions; contact the National Yellow Card Infor-
mation Service at the MHRA on 0800 731 6789. Outside
office hours a telephone-answering machine will
take
messages.
The following Yellow Card Centres can be contacted for
further information:
Yellow Card Centre
Northwest
Freepost SW2991
70 Pembroke Place
Liverpool
L69 3GF
Tel:
(0151) 794 8122
Yellow Card Centre Wales
Freepost SW2991
University Hospital of
Wales
Cardiff
CF4 1ZZ
Tel:
(029) 2074 4181
Yellow Card Centre
Northern & Yorkshire
Freepost SW2991
Wolfson Unit
Claremont Place
Newcastle upon
Tyne NE2 4HH
Tel:
(0191) 260 6181
Yellow Card Centre West
Midlands
Freepost SW2991
City Hospital
Birmingham B18 7QH
Tel:
(0121) 507 5672
Yellow Card Centre Scot-
land
Freepost NAT3271
CARDS,
Royal Infirmary
of Edinburgh
Edinburgh EH16 4SA
Tel:
(0131) 242 2919
The
MHRA’s
database
facilitates
the
monitoring of
adverse drug reactions.
More detailed information on reporting and a list
of
products currently under intensive monitoring can be
found on the MHRA website: www.mhra.gov.uk.
Drug Safety Update
is a monthly newsletter from
the MHRA and the Commission on Human Medi-
cines (CHM);
it
is available at
www.mhra.gov.uk/
drugsafetyupdate.
Self-reporting
Patients
and their
carers
can also
report
suspected
adverse
drug
reactions
to
the
MHRA.
Reports
can
be
submitted directly
to
the
MHRA through the Yellow Card Scheme using the
electronic form at
www.yellowcard.gov.uk, by telephone
on 0808 100 3352,
or by downloading the Yellow Card
form from www.mhra.gov.uk.
Alternatively,
patient Yel-
low Cards
are
available
from pharmacies
and GP
surgeries.
Information for
patients
about
the Yellow
Card
Scheme
is
available
in
other
languages
at
www.yellowcard.gov.uk.
Prescription-event monitoring
In addition to the
MHRA’s Yellow Card Scheme,
an independent scheme
monitors the safety of new medicines using a different
approach.
The Drug Safety Research Unit
identifies
patients who have been prescribed selected new med-
icines
and collects
data on clinical
events
in these
patients.
The data are submitted on a voluntary basis
by general practitioners on green forms. More informa-
tion about the scheme and the Unit’s educational mate-
rial is available from www.dsru.org.
Newer drugs and vaccines
Only limited information
is available from clinical
trials on the safety of
new
medicines.
Further
understanding about
the safety of
medicines depends on the availability of
information
from routine clinical practice.
The black triangle symbol (T) identifies newly licensed
medicines that are monitored intensively by the MHRA.
Such medicines include new active substances, biosimi-
lar
medicines,
medicines that
have been licensed for
administration by a new route or drug delivery system,
or for significant new indications which may alter the
established risks and benefits of that drug,
or that con-
tain a new combination of active substances. There is no
standard time for which products retain a black triangle;
safety data are usually reviewed after 2 years.
Spontaneous
reporting
is
particularly
valuable
for
recognising possible new hazards rapidly. For medicines
showing the black triangle symbol, the MHRA asks that
all suspected reactions (including those considered not
to be serious)
are reported through the Yellow Card
Scheme. An adverse reaction should be reported even if
it
is not
certain that
the drug has caused it,
or if
the
reaction is well recognised, or if other drugs have been
given at the same time.
Established drugs and vaccines
Healthcare profes-
sionals and coroners are asked to report
all
serious
suspected reactions
to established drugs
(including
over-the-counter,
herbal,
and
unlicensed
medicines
and medicines
used off-label)
and vaccines.
Serious
reactions include those that
are fatal,
life-threatening,
disabling,
incapacitating,
or which result in or prolong
hospitalisation;
they should be reported even if
the
effect is well recognised. Examples include anaphylaxis,
blood disorders,
endocrine disturbances,
effects on fer-
tility,
haemorrhage from any site,
renal
impairment,
jaundice,
ophthalmic
disorders,
severe CNS effects,
severe skin reactions,
reactions in pregnant
women,
and any drug interactions.
Reports of
serious adverse
reactions are required to enable comparison with other
drugs of a similar class. Reports of overdoses (deliberate
or accidental) can complicate the assessment of adverse
drug reactions,
but
provide important
information on
the potential toxicity of drugs.
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Adverse reactions to drugs
BNF 61
Adverse reactions to drugs