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Marketing authorisation and BNF advice
In gen-
eral
the
doses,
indications,
cautions,
contra-indica-
tions,
and
side-effects
in the BNF reflect
those in the
manufacturers’
data sheets or
Summaries of
Product
Characteristics (SPCs)
which,
in turn,
reflect
those in
the corresponding marketing authorisations (formerly
known as Product
Licences).
The BNF does not
gen-
erally include proprietary medicines that
are not
sup-
ported by a valid Summary of Product Characteristics or
when the marketing authorisation holder has not been
able to supply essential
information.
When a prepara-
tion is available from more than one manufacturer,
the
BNF reflects advice that is the most clinically relevant
regardless of any variation in the marketing authorisa-
tions.
Unlicensed products can be obtained from ‘spe-
cial-order’
manufacturers or specialist importing com-
panies,
see p.
988.
Where an unlicensed drug is included in the BNF, this is
indicated in square brackets after the entry.
When the
BNF suggests a use (or route) that is outside the licensed
indication of
a product
(‘off-label’
use),
this
too is
indicated. Unlicensed use of medicines becomes neces-
sary if
the clinical
need cannot
be met
by licensed
medicines; such use should be supported by appropriate
evidence and experience.
The doses stated in the BNF are intended for general
guidance and represent,
unless otherwise stated,
the
usual
range of
doses that
are generally regarded as
being suitable for adults.
Prescribing medicines outside the recommendations
of their marketing authorisation alters (and probably
increases) the prescriber’s professional responsibility
and potential liability. The prescriber should be able
to justify and feel
competent
in using such medi-
cines.
Oral syringes
An oral syringe is supplied when oral
liquid medicines are prescribed in doses
other
than
multiples of
5 mL.
The oral
syringe is marked in 0.5-
mL divisions from 1 to 5 mL to measure doses of
less
than 5 mL (other
sizes
of
oral
syringe may also be
available). It is provided with an adaptor and an instruc-
tion leaflet.
The
5-mL spoon
is used for doses of 5 mL
(or multiples thereof).
To avoid inadvertent intravenous administration of
oral
liquid medicines,
only an appropriate oral
or
enteral syringe should be used to measure an oral
liquid medicine (if
a medicine spoon or graduated
measure cannot be used); these syringes should not
be compatible with intravenous or other parenteral
devices.
Oral
or enteral
syringes should be clearly
labelled ‘Oral’ or ‘Enteral’ in a large font size; it is the
healthcare practitioner’s responsibility to label
the
syringe with this information if the manufacturer has
not done so.
Strengths and quantities
The strength or quantity
to be contained in capsules,
lozenges,
tablets,
etc.
should
be
stated
by
the
prescriber.
In
particular,
strengths of liquid preparations should be clearly stated
(e.g.
125 mg/5 mL).
If a pharmacist receives an incomplete prescription for a
systemically administered preparation and considers it
would not be appropriate for the patient to return to the
doctor,
the following procedures will apply
1
:
(a)
an attempt
must
always be made to contact
the
prescriber to ascertain the intention;
(b)
if
the attempt
is successful
the pharmacist
must,
where practicable,
subsequently arrange for details
of quantity,
strength where applicable,
and dosage
to be inserted by the prescriber on the incomplete
form;
(c)
where, although the prescriber has been contacted,
it
has not
proved possible to obtain the written
intention
regarding
an
incomplete
prescription,
the pharmacist
may endorse the form ‘p.c.’
(pre-
scriber contacted)
and add details of
the quantity
and strength where applicable of
the preparation
supplied,
and of
the dose indicated.
The endorse-
ment should be initialled and dated by the pharma-
cist;
(d)
where the prescriber cannot be contacted and the
pharmacist
has sufficient
information to make a
professional
judgement
the preparation may be
dispensed. If the quantity is missing the pharmacist
may supply sufficient
to complete up to 5 days’
treatment;
except
that
where a combination pack
(i.e.
a proprietary pack containing more than one
medicinal
product)
or
oral
contraceptive is
pre-
scribed by name only,
the smallest
pack shall
be
dispensed.
In all
cases the prescription must
be
endorsed ‘p.n.c.’
(prescriber
not
contacted),
the
quantity,
the dose,
and the strength (where applic-
able) of the preparation supplied must be indicated,
and the endorsement must be initialled and dated;
(e)
if
the pharmacist
has any doubt
about
exercising
discretion,
an incomplete
prescription must
be
referred back to the prescriber.
Excipients
Branded oral
liquid preparations that
do
not contain
fructose
,
glucose
,
or
sucrose
are described
as
‘sugar-free’
in the
BNF.
Preparations
containing
hydrogenated glucose syrup,
mannitol,
maltitol,
sorbi-
tol, or xylitol are also marked ‘sugar-free’ since there is
evidence that they do not cause dental
caries.
Patients
receiving
medicines
containing
cariogenic
sugars
should be advised of
appropriate dental
hygiene mea-
sures to prevent caries.
Sugar-free preparations should
be used whenever possible.
Where
information on the
presence
of
aspartame,
gluten
,
sulphites
,
tartrazine
,
arachis
(peanut)
oil
or
sesame oil
is available,
this is indicated in the BNF
against the relevant preparation.
Information is provided on
selected excipients
in skin
preparations (section 13.1.3), in vaccines (section 14.1),
and on
selected preservatives
and
excipients
in eye
drops and injections.
The presence of
benzyl alcohol
and
polyoxyl castor oil
(polyethoxylated castor oil) in injections is indicated in
the BNF. Benzyl alcohol has been associated with a fatal
1.
These recommendations are acceptable for prescription-
only medicines (A).
For
items
marked C see also
Controlled Drugs and Drug Dependence,
p.
8.
2
General guidance
BNF 61
General guidance