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Children & Medicine - FP Book1
Children & Medicine - FP Book1
Children & Medicine - FP Book1
BOOK 1
March 2012 CENTRE FOR PHARMACY
FP115/1 P O S T G R A D U AT E E D U C AT I O N
Content contributors
Brian Conn, local tutor, CPPE
focal point Children and their medicines: enhancing your practice – Book 1
This programme uses some of the content from NHS Education Scotland programme, Introduction to
paediatric pharmaceutical care, and the CPPE open learning programme, Child health: working with the National
Service Framework for children, young people and maternity services. CPPE recognises the contribution made by
the authors and reviewers.
Reviewers
Emma Gilchrist, senior paediatric pharmacist, Evelina Children’s Hospital, Guy’s and St Thomas’ NHS
Foundation Trust
Steve Tomlin, consultant pharmacist for children’s services, Evelina Children’s Hospital, Guy’s and
St Thomas’ NHS Foundation Trust
CPPE reviewers
Suzanne Cutler, regional manager, North West
Piloted by
Angela Brockbank, local tutor, CPPE
Disclaimer
We have developed this learning programme to support your practice in this topic area. We recommend that
you use it in combination with other established reference sources. If you are using it significantly after the date
of initial publication, then you should refer to current published evidence. CPPE does not accept responsibility
for any errors or omissions.
External websites
CPPE is not responsible for the content of any non-CPPE websites mentioned in this programme or for the
accuracy of any information to be found there.
Published in March 2012 by the Centre for Pharmacy Postgraduate Education, School of Pharmacy and
Pharmaceutical Sciences, University of Manchester, Oxford Road, Manchester, M13 9PT
http://www.cppe.ac.uk
Production
Design and artwork by Ambassador
Printed by Gemini Press Ltd
focal point Children and their medicines: enhancing your practice – Book 1
Learning with CPPE 4
Learning objectives 6
Directing change 45
References 47
3
Learning with CPPE
focal point Children and their medicines: enhancing your practice – Book 1
The Centre for Pharmacy Postgraduate Education (CPPE) offers a wide range of
learning opportunities for the pharmacy workforce. We are based in the University of
Manchester’s School of Pharmacy and Pharmaceutical Sciences and are funded by
the Department of Health to provide continuing education for practising
pharmacists and pharmacy technicians providing NHS services in England. For
further information about our learning portfolio, visit http://www.cppe.ac.uk.
We recognise that people have different levels of knowledge and not every CPPE
programme is suitable for every pharmacist or pharmacy technician. We have
created three categories of learning to cater for these differing needs:
Supporting specialties (CPPE may not be the provider and will direct you
to other appropriate learning providers).
This is a learning programme and assumes that you already have some
knowledge of the topic area.
Continuing professional development (CPD) – You can use this focal point unit to
support your CPD. Consider what your learning needs are in this area. Use your
CPD record sheets to plan and record your learning.
Feedback – We hope you find this learning programme useful for your practice.
Please help us to assess its value and effectiveness by visiting the my CPPE record
page on our website. Alternatively, please email us at feedback@cppe.ac.uk.
4
About CPPE focal point programmes
focal point Children and their medicines: enhancing your practice – Book 1
We have developed focal point to give you short, clinically focused learning sessions.
It will help you learn with your colleagues and improve the services you offer your
patients. Each unit presents information and activities that are relevant for pharmacy
professionals working in primary care and in the community. There are two types of
learning event for you to choose between when using focal point units – you can
either attend a CPPE tutor-led event or can learn as part of a CPPE ‘learning
community’. Have a look at the CPPE website (http://www.cppe.ac.uk/) for more
information about how to set up a learning community.
Reference sources for all the books, articles, reports and websites mentioned in the
text can be found at the end of the programme. References are indicated in the text
by a superscript number (like this 3).
This book gets you started. It provides key information to help you meet the
learning objectives presented overleaf, but it also encourages you to identify your
own learning needs. It then challenges you to relate what you have learnt to your
own area of practice and professional development. We have included practice points
and talking points to stimulate your thinking and we will refer to these again at the
focal point event. Make sure you have studied these activities before your event.
You will receive Book 2 when you attend the focal point event. It uses a case study
and ‘clinical vignettes’ to help you apply what you have learnt and includes a
Directing change section that offers a framework to encourage you to make changes
to improve your practice. We also include some suggested answers to the learning
activities.
n the differences in drug handling and effects between children and adults
n the use of unlicensed and off-label medicines in children and the role of the
pharmacy team in their use
n a holistic approach to the treatment of children with long-term conditions
n appropriate and effective communication with children and their parents or carers
to ensure safe and effective use of medicines
n approaches that can be implemented to ensure safe medicines use in children
n information sources useful in dealing with paediatric patients. 5
Learning objectives
focal point Children and their medicines: enhancing your practice – Book 1
You can meet the learning objectives that we identify here by reading the
information that we provide and refer you to, undertaking the various activities that
we suggest and putting what you have learnt into practice. We have split our learning
objectives into appropriate sections. This should help you determine how to meet
them. We have also linked the learning objectives in this programme to the General
Level Framework (GLF) and the NHS Knowledge and Skills Framework (KSF)
dimensions. We have suggested some competences, but you may be able to apply
your learning to other aspects of these frameworks.
6
Practice points, talking points, case study and clinical vignettes
focal point Children and their medicines: enhancing your practice – Book 1
Objective KSF GLF
You will need to: This will take I will do this by:
about: (Insert date)
7
Moving into focus
focal point Children and their medicines: enhancing your practice – Book 1
Consider the following questions. Use them to focus your thoughts and stimulate
your learning. Are you confident you know the answers?
1. Can you give four examples of how drug handling in children differs from
drug handling in adults? List them here.
2. Do you have a responsibility to notify a child’s parent or carer that a drug they
have been prescribed is unlicensed?
3. What are the regulatory requirements of carrying out a medicines use review
in a child?
4. Medication errors are most commonly made when patients move between
primary and secondary care. What action can you take to reduce the risk?
5. Where could you access a patient information leaflet for a drug used off-label
in a child?
8
What do you want to learn?
focal point Children and their medicines: enhancing your practice – Book 1
Write down three things that you would like to gain from this focal point learning
unit. These will help you plan your own CPD entry. You will need to tell others
about them at the focal point event.
1.
2.
3.
Now you have completed your reflection and planning for this focal point unit, it’s
time to undertake the background reading.
9
Reading
focal point Children and their medicines: enhancing your practice – Book 1
The aim of this focal point programme is to help pharmacists and pharmacy
technicians enhance their care of children and management of their medicines.
Paediatric patients pose issues that are not commonly seen in adult patients. Issues
such as altered drug handling, use of unlicensed or off-label drugs and difficult
communication often make children a challenging patient group for community
pharmacists. This programme will help you consider how you can deal with such
issues and ultimately maximise your input into the care of children and the
management of their medicines.
n rate of absorption
n extent of absorption.
The more rapidly a drug is absorbed, the higher the peak drug plasma concentration
10 will be and the sooner the required therapeutic effect (or side-effects) will be
experienced. The extent of absorption will determine the
Notes
focal point Children and their medicines: enhancing your practice – Book 1
level of exposure to the drug; anything that decreases
absorption will necessitate the administration of a larger dose
in order to achieve a therapeutic effect. Many routes of
absorption in children are similar to adults, but there are also
variations. Let us now look at the main differences in the
most common routes of administration.
Oral
There is some evidence to suggest that, in neonates and
young infants, gastric emptying and gastrointestinal transit
time may be prolonged (relative to adults and older
children), resulting in slower rates of absorption.1 Also,
reduced gastric acid secretion during the first few months of
life can affect the extent of absorption of some drugs.2
However, the available evidence suggests that the clinical
significance of these differences is small and that most orally
administered drugs will be absorbed into the systemic
circulation of children at a rate and extent similar to that
observed in healthy adults.
Rectal
The rectal route is useful when oral drug administration is
not possible (due to nausea, vomiting or seizure activity).
The longer the period for which any rectal dosage form is
retained, the greater the extent to which it is absorbed. For
this reason, solid as well as liquid preparations should be
placed well up into the rectal vault, but not so far that it
passes the absorption surface of the rectum.
11
The rate and extent of absorption of diazepam is improved when rectal solutions
focal point Children and their medicines: enhancing your practice – Book 1
rather than suppositories are used. The use of rectal solutions of diazepam is
preferred in children who have either febrile convulsions or recurrent, poorly
controlled epilepsy when immediate vascular access is not possible. However,
buccal midazolam is now generally used in preference to rectal diazepam.
Percutaneous
Percutaneous absorption of drugs occurs more readily in infants and young children
due to the immature epidermal barrier, increased skin hydration and a higher surface
area to body weight ratio.4 This has resulted in reported toxicities for a number of
compounds administered topically, including hexachlorophane, povidone-iodine,
chlorhexidine gluconate, boric acid, salicylic acid and corticosteroids.5
Intramuscular
The intramuscular route of administration is usually avoided in children for several
good reasons. Firstly, it is very painful to administer intramuscularly if there is little
muscle mass (which is the case in young children). Secondly, muscle is poorly
perfused in infants and so good drug concentrations are unlikely to be reached.
This situation is used to good effect in newborn babies who are given vitamin K
immediately after birth to prevent haemorrhagic disease of the newborn.
Immunisations are also administered by the intramuscular route. The thigh is the
preferred site of injection in children under one year of age.
12
Table 1: Extracellular fluid, TBW and fat volumes
Notes
focal point Children and their medicines: enhancing your practice – Book 1
according to age
Pre- Full- 4-6 1 Greater Adult
term term months year than
1 year
13
1.3 Drug metabolism
focal point Children and their medicines: enhancing your practice – Book 1
The final determinant of drug plasma concentrations is the ability of the child to
remove the drug from the body. This will normally involve metabolism and/or
excretion of unchanged drug in urine. The primary organ for drug metabolism is the
liver. At birth, the ability of this organ to metabolise drugs is not fully developed.
The liver metabolises drugs in a number of different ways which are classed as either
hepatic phase I reactions or hepatic phase II reactions. The capacity of the liver to
carry out these reactions is dependent on the age of the child.
Table 2: Hepatic phase I and II reactions
Hepatic phase I Oxidation, reduction, Mature over first few months of life
hydrolysis Adult levels reached at six months
The immaturity of this pathway in infancy can lead to significantly extended half-
lives of hydroxylated drugs, such as diazepam.
However, values for the elimination half-life of paracetamol are similar in adults
and children but lower in newborn (especially premature) babies. In paracetamol
overdose, the conjugation pathways become saturated and increased amounts of a
reactive intermediate, that covalently binds to hepatocellular macromolecules, are
formed. The result is cell damage and necrosis. Despite the differences in
paracetamol metabolism in children, the risk of paracetamol hepatotoxicity is
probably the same as in adults. There are fewer reported cases in children, but this
probably reflects the fact that children generally ingest less of the drug than adults
and are brought for treatment earlier. There is also some evidence to suggest that
hepatotoxicity in malnourished children can result from therapeutic doses
14 administered chronically to patients with reduced glutathione stores.
1.4 Drug excretion
Notes
focal point Children and their medicines: enhancing your practice – Book 1
Glomerular filtration rate at birth is highly dependent on
gestational age, but increases rapidly over the first week of
postnatal life and reaches adult values (allowing for
differences in body size) by about three months of age.
Tubular secretory and resorptive capacity appears to mature
more slowly, approaching adult values at about seven months
of age.2
Chloramphenicol, if administered in the first few weeks
of life at the high doses used in older children, will
accumulate due to inadequate glucuronyl transferase
activity. In addition, any glucuronide that is formed will
also accumulate, due to inadequate development of the
renal tubular secretion mechanism. Reduced doses must
therefore be used in these babies and serum concentrations
closely monitored.6
Elimination half-lives
The half-life is the time the body takes to clear half of the
drug from the body. The elimination half-life of a drug is
determined both by the volume in which the drug is
distributed and by the ability of the eliminating organs (eg,
the liver and kidneys) to remove it from the blood. Because
of differences in drug distribution volumes and elimination
pathways in children, the elimination half-lives of many
drugs are shorter in children than in adults and neonates.
15
1.5 Pharmacodynamics
focal point Children and their medicines: enhancing your practice – Book 1
There are also differences in the pharmacodynamics (how drugs exert their effects
on the body) of some drugs in children compared to adults. It is this aspect of
variance that makes extrapolation of data from adults even less certain and
potentially dangerous.
14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 52
13.5 GIRLS WEIGHT (kg) 3 4 5 6 7 8 9 10 11
13.5
13 0 –1 year 13
Age in weeks/ months
12.5 99.6th 12.5
12 12
11.5 98th
11.5
11 11
t
9 need extra support. 50th
8.5
8
e i g h 25th
9th
8.5
8
w
7.5 7.5
Weight (kg)
7 2nd 7
6 6
th
98
5.5 5.5
st
91
5 th
5
99.6th 75
4.5 th 4.5
98th 50
91st th
4 25 4
75th
9th
50th 3.5 d 3.5
2n
25th th
3 0.4 3
9th
2nd
2.5 2.5
0.4th
2 2
1.5 1.5
Age in weeks/ months 1
1
1 2 3 4 5 6 7 8 9 10 11
0.5 0.5
0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 52
focal point Children and their medicines: enhancing your practice – Book 1
Is the prescription below, for a three-year-old (weight
16 kg) for treatment of tonic-clonic seizures, within
the licensed dose?
2.1 Background
Although many unlicensed and off-label drugs are initiated in
secondary or tertiary care, many of these patients are ultimately
managed in the community. Families often have problems
getting a prescription for further supplies from their GP, as
communication from the hospital regarding the drug,
indication, dose and formulation can be slow. Some GPs are
reluctant to prescribe the medicines due to cost and a lack of
familiarity with them.
be checked for clinical appropriateness and how/where to procure the drug in time to
satisfy the family’s requirements. Community pharmacy teams also report a lack of
communication from secondary care and also from GPs.
Due to the lack of appropriate clinical evidence, children are often required to take
medicines which are either unlicensed (ie, they have not been subjected to the
licensing process) or off-label (ie, they are being used outside the terms of the
licence). Many manufacturers choose to write disclaimers stating that their products
should not be used in children, or make recommendations limited to specific age
groups, indications or routes of administration.
The same safety, efficacy and quality standards are not guaranteed for unlicensed or
off-label products, as they are not supported by the reassurances that the licensing
system was introduced to provide. This does not mean that unlicensed and off-label
prescribing implies inappropriate prescribing; sometimes the evidence to support
such use is considerable. Unlicensed and off-label prescribing is needed when there
is a lack of availability of medicines licensed for use in children and, consequently, a
lack of formulations which children can take in strengths appropriate to the dose
ranges required.
focal point Children and their medicines: enhancing your practice – Book 1
are not licensed in children. Examples include aspirin being
contraindicated for management of fever due to its link with
Reyes syndrome – a very serious condition leading to
neurological impairment or death. More commonly, however,
the lack of suitable licensed products is a result of the lack of
clinical trials due to costs.
Consent is often obtained before unlicensed and off-label drugs are prescribed for
an adult. However, to do so in children would be impractical due to the incidence
and nature of unlicensed and off-label prescribing in paediatrics. The RCPCH and
NPPG advise that it is not necessary to obtain consent from parents/carers/patients
to prescribe or administer such drugs, beyond the steps taken when prescribing
licensed drugs. This means that it is not necessary to specifically point out to families
that a drug is unlicensed or off-label; instead, pharmacists need only engage in a
discussion with them around which medicines they are happy to take and how,
irrespective of licence status.
20
enforced by regulatory authorities. This will involve trained
Notes
focal point Children and their medicines: enhancing your practice – Book 1
personnel and strict checking and documentation procedures,
suitable equipment and ingredients of a high standard. At the
other end of the spectrum, extemporaneous dispensing may be
done on the dispensary bench in a pharmacy with little
equipment and documentation available.
Purchase of Specials
Unlicensed products, purchased from a ‘Specials’
pharmaceutical manufacturer or hospital/commercial
manufacturing unit, will have been prepared under
controlled manufacturing conditions. Some may have
undergone quality assurance processes. There is therefore
less risk involved than with extemporaneous dispensing.
The increased risk of medication errors associated with unlicensed medicines will
be discussed in Section 5.
The cost of unlicensed Specials has escalated in the UK in the past few years. On
1 November 2011, a list of 50 Specials was added to the Drug Tariff (Part VIIIB)
in order to rationalise the reimbursement price of these products to community
pharmacists. This is an attempt to improve transparency in the costs of Specials
and to reduce their significant financial impact. To learn more, read the frequently
asked questions document compiled by the Pharmaceutical Services Negotiating
Committee at http://www.psnc.org.uk/data/files/Specials_changes/Unlicensed
_specials_and_imports_FAQs.pdf and access the CPPE e-learning programme,
Safer supply and use of Specials, at http://www.cppe.ac.uk/e-learning.
focal point Children and their medicines: enhancing your practice – Book 1
English, or at least a translation provided – some
importation companies now provide an assurance to have
this information available with the product.
Further options for using unlicensed medicines
Several other options are possible in the provision of
medicines where a licensed product is unavailable.
n Solutions for injection can be given orally (off-label route
of administration). This must be done with care, as
different formulations may include different salts, with
varying bioavailability and stability; the pH of some
injection solutions can cause problems; and other
excipients must be checked to be safe. The taste of many
injections is problematic and the cost of using an expensive
injectable form orally must be considered. Sodium chloride
30 percent injection is given orally to neonates who have
low sodium due to immaturity.
n Use of tablet cutters to half or quarter-sized tablets may
help, though this is inaccurate and dose equivalence is
unlikely to be achieved.
n Soluble tablets can be dissolved in 10 mL water – giving a
proportion of the resulting solution will deliver a dose that
is a fraction of a tablet.
n Pharmaceutical companies may occasionally supply
unlicensed drugs on a ‘named-patient’ basis.
n Use of chemicals may be necessary to treat rare conditions
for which there is no licensed preparation or
pharmaceutical grade material available.
Practice point 3
You receive a phone call from a GP who wants to
prescribe a three-month-old baby (weight 6 kg)
omeprazole at a dose of 4.2 mg once daily.
She would like to know what form to prescribe. What
options are available? Which one would you advise?
23
It must be remembered that if an unlicensed medicine provided for a child in
focal point Children and their medicines: enhancing your practice – Book 1
hospital needs to be continued at home, plans should be made with and on behalf of
the family to avoid problems occurring. Depending on the shelf-life of the
preparation, the family may need to obtain a prescription from their GP quickly,
then find a community pharmacist to organise further supplies, in order to avoid
delays and breaks in treatment. Problems can be avoided if the hospital pharmacist
communicates with the patient’s community pharmacist, preferably prior to patient
discharge. By providing information on dose, formulation, ingredients and/or
product sources, seamless care for the patient can be assured. The hospital
pharmacist must be aware and proactive both to facilitate this and to make sure that
the family are aware that these products are unlikely to be available ‘off the shelf’
and must be ordered well in advance.
Off-label drug use refers to use outside the conditions of the product licence or
marketing authorisation in terms of dose, age of patient, indication, route of
administration, and contraindications, as outlined in the table below.
24
Knowledge of excipients
Notes
focal point Children and their medicines: enhancing your practice – Book 1
Awareness of inappropriate excipients in some medicine
formulations (even some actually licensed for children) is
important. The problems with food colourings and ‘E’
numbers have been highlighted in the press but, if a parent
phones up to say that their child has become hyperactive two
months after discharge from hospital, would you consider a
prescribed medicine formulation as the cause? Some
excipients are undesirable in children with specific disorders.
Advanced formulations
More advanced formulations are becoming increasingly
available for adult patients. For example, transcutaneous
delivery systems, fast-dissolving drug formulations and
multiple unit dose systems all offer potential major
improvements.16 Generally, however, children are not
considered when these innovative products are being
developed. 25
3. Managing long-term conditions in children
focal point Children and their medicines: enhancing your practice – Book 1
These aspects may not be made obvious in a short-contact counselling session and
truly concordant relationships can only take place with a full understanding of the
child’s background and family set-up. One thing is clear, however: it is important to
involve the child as much as possible in any discussions about medicines-taking. If
a two-year-old believes that a puffer and spacer are theirs and they must use it
twice a day, it will often be them who takes responsibility, walking into the room
with it to their lips (perhaps holding it the wrong way round, but that is another
matter) to say “it’s time for my puffer”. Children tend to like routine and the right
stickers on their spacer device may make all the difference.
focal point Children and their medicines: enhancing your practice – Book 1
Age
Adolescents may
be less compliant
than younger
children in taking
their medicines.
The compliance of
infants and
toddlers is very
much determined
by the parents, depending on factors such as their success in
administering each dose to the child (administering eye
drops to a reluctant two-year-old is no easy task!). School-
age children gradually learn to regulate their own medicines
management, with increasing influence from their peers and
social environment (which may be negative or positive).
Adolescents vary enormously in their compliance record,
although it is often poor. Life has many issues to contemplate
at this age and medicines are just one tiny part of the picture.
Palatability
Children are unlikely to be motivated to take a poor-tasting
medicine. For example, flucloxacillin liquid and prednisolone
soluble tablets are known to be especially unpleasant.
Different medicines and brands have different flavours and
acceptability to individual children. Assessment of palatability
should be a key part in the development of a medicine,
particularly where administration to children is likely. Up to
40 percent of mothers have been reported to use things such
as jam, sugar or juice to flavour medicines in order to get
some sort of compliance.17 However, parents and carers
must be advised to seek guidance from their pharmacy
before mixing medication with food to ensure that there are
no compatibility issues. Parents can also try giving liquids by
oral syringe down the side of a dummy to improve
compliance.
Generally, children under 12 years old find it difficult to understand the concept of
long-term preventative drugs, especially if they have no symptoms of being ill.
Children with asthma or cystic fibrosis seem to be exceptions to this; their degree of
autonomy in the use of drugs is often considerable.
Administration issues
The practical issues of administrating medicines may limit compliance, particularly
in neonates and young infants. Parents and carers should be counselled by the
pharmacy team on how to administer their child’s medication and how to resolve
any potential issues. This advice should be tailored to each individual child.
28
Another approach that often works well in improving
Notes
focal point Children and their medicines: enhancing your practice – Book 1
compliance and adherence is the use of reward materials,
such as sticker charts. Ways in which you can enhance your
communication with children is discussed later in the
programme.
Practice point 4
Make a list of child patient groups who could
potentially benefit from an MUR or inclusion in the
NMS.
29
3.3 Medicines in schools
focal point Children and their medicines: enhancing your practice – Book 1
Administering medicines in schools poses many problems and policies will vary
considerably between individual schools. There are problems in who will give the
medicine, where to store it and who takes responsibility for ensuring that the child
takes the correct dose.
Most teachers are not trained in medicines administration and do not have a legal
duty to administer medicine; this is a voluntary role. Pharmacists may be in a
position to help train teachers, either directly or by assisting school nurses with this
task. Pharmacies may also help by dispensing school medicines separately, labelled
with appropriate directions, to avoid midday doses being taken to school in
unlabelled bottles or envelopes.
The Department for Education and Skills and the Department of Health issued a
good practice guide in 2005 called Managing Medicines in Schools and Early Years
Settings,20 which states that education authorities, schools and governing bodies must
formulate their own policies for managing medicines.
A school policy needs to be clear to all parents and pupils, and might include
issues such as:
n whether the head teacher accepts responsibility, in principle, for school staff
giving or supervising children taking prescribed medicine during the school day
n the circumstances when non-prescription medicine may be taken (eg,
painkillers)
n the school’s policy on long-term conditions or complex medical needs
n the need for prior written agreement from parents or guardians for any
medicine, prescribed or non-prescribed, to be given to a child
n the policy on pupils carrying and taking their medicines themselves
n staff training in dealing with medical needs
n record-keeping
n storage and access to medicines
n the school’s emergency procedures.
Once or twice-daily dosing can help to avoid the problem of children having to take
medicines during the school day. For example, clarithromycin and erythromycin can
both be given to treat respiratory infections. In a school-age child, clarithromycin
would be preferable due to its twice-daily dosing, as opposed to four times a day
with erythromycin. Modified-release preparations may also avoid the need for the
administration during school hours. In some situations, taking medicines three times
daily – before school, after school and before bedtime – may be appropriate.
30
If medication must be administered at school, it is reasonable
Notes
focal point Children and their medicines: enhancing your practice – Book 1
to ask for a second prescription so that dual dispensing can
take place, allowing for medicine to be kept at school and at
home.
31
4. Communicating with children and their
focal point Children and their medicines: enhancing your practice – Book 1
parents/carers
As a pharmacist or pharmacy technician, you do not need
If the parent is reminding of the importance of adequate
administering a medicine,
communication with patients as an essential element of
they are the person I need
to speak to. your role. Indeed, you may be a parent (or a
grandparent) and will be aware that, when communicating
with children, a number of barriers need to be overcome in order to
get your message across. To avoid dealing with these barriers,
pharmacists and pharmacy technicians may consider talking
directly to a child’s parent or carer. Although in some circumstances this may be
appropriate (eg, in a very sick child), in the majority of cases the child should be
included in any discussion relating to them and/or their medications. The pharmacy
team should always try to engage with a child, irrespective of their age.
Children are creatures of habit. They like routine and familiarity, and so every
opportunity should be taken to speak to them. Once you become a familiar face to a
child, you will find that getting your message across to them will become much
easier. There are numerous opportunities for you to start building a relationship with
your paediatric patients. Such opportunities include MURs, provision of NMS,
OTC advice and counselling on prescription items. Errors have been known to
occur when a patient moves from primary to secondary care. Time should therefore
be taken to speak with patients (and their parents/carers) who have recently been
discharged from hospital to reduce the risk of harm.
Communication will often be verbal, but it could also be in a written format. Younger
children may respond well to adherence tools such as sticker charts. Such charts can
be used when counselling on a new medicine to help explain how it should be taken
and will help improve compliance when the child is at home.
Building a rapport with paediatric patients is especially important for those with
long-term conditions. In Section 3.2, we talked about establishing compliance to
ensure that children gain the maximum benefit from their medication. Excellent
communication skills are needed if a child is to understand:
focal point Children and their medicines: enhancing your practice – Book 1
communication with the school – as discussed earlier,
systems will vary between schools. If written information is
available to support your discussion, you may have to
consider providing duplicates for the child’s school or for a
second parent.
Here are some tips from our child health experts and
community pharmacists:
If I do an MUR with a
child, I always make Try and crouch down to
sure they sit in the their level. It’s very
consulting room chair so intimidating if you’re
that they feel important. standing over them.
Do anything to make
it fun for the child. A Nothing will work for
sticker (it can be any every child. Be prepared
sticker) will usually get to adapt and try a
their attention. different approach if
what you are doing
isn’t working.
Talking point A
What is your ‘top tip’ to help engage with children?
33
5. Medication safety issues in children
focal point Children and their medicines: enhancing your practice – Book 1
Errors are more likely to occur when dealing with unfamiliar drugs or those
prescribed in unfamiliar doses. If you have any doubts about the clinical
appropriateness of a medicine prescribed for a child, you should query this with the
prescriber. Specialist paediatric pharmacists and pharmacy technicians in secondary
care are a useful source of information for children who are known to that hospital.
Doses expressed as a volume of liquid may not appear at first glance to be out of the
ordinary. However, when the dose is calculated in milligrams or milligrams per
kilogram, the appropriateness of the dose is far more apparent. When dealing with
medicines in a liquid form, it is good practice to check with the patient or carer what
strength the child was previously taking. When labelling a liquid, the directions
should express the required dose in millilitres and milligrams (ie, ‘give 5 mL (50 mg)
once daily’).
Errors have resulted when patients are provided with different strengths of liquid
medicines without them realising. Parents tend to be familiar with the volume of
medicine which they need to administer to their child, but not necessarily the
strength of the preparation. If they are prescribed a different strength, they may not
realise this unless it is carefully explained to them. Consequently, they may continue
to administer the same volume, with potentially serious consequences. This may
occur due to lack of communication at the interface between primary, secondary
and/or tertiary care, or due to errors when a GP tries to prescribe an unlicensed
product which is not on his computerised prescribing system.
34
Children taking tacrolimus suspension, provided as an
Notes
focal point Children and their medicines: enhancing your practice – Book 1
unlicensed Special following liver transplantation, have
required readmission to hospital with graft rejection, due to
inadvertent prescribing of lower concentrations of the liquid
and continued administration of the same volume.
Talking point B
Review the case of Abbie Jones on the Telegraph website at
http://www.telegraph.co.uk/news/uknews/7457772/
Baby-died-after-GP-surgery-issued-wrong-
prescription.html (this article has not been critiqued for
accuracy).
35
5.2 Adverse drug reactions in children
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Incidence in children
A study22 published on the incidence of
ADRs in children in different healthcare
settings found that:
Another study has suggested that the risk of ADRs associated with the use of
unlicensed or off-label drugs may be greater than that for licensed medicines.23 This
highlights the critical importance of reporting all suspected ADRs in children. As in
adults, polypharmacy was found to be a consistent risk factor for ADRs.23
36
Fatal outcomes
Notes
focal point Children and their medicines: enhancing your practice – Book 1
A review was published in 2002 of all yellow-card reports of
suspected ADRs with a fatal outcome in children received by
the Committee on Safety of Medicines (CSM) from 1964 to
2000.24 There were 331 deaths relating to 390 suspected
medicines among children aged under 16. The yellow card
scheme depends on voluntary reporting and is not a
complete dataset of ADRs.
n antibiotics
n anticonvulsants
n cytotoxic agents
n anaesthetic gases.
A more recent study, carried out at Alder Hey Children’s
Healthcare Hospital, implicated the following drugs in
admissions attributable to ADRs:25
n cytotoxic agents
n immunosuppressants (prednisolone, tacrolimus,
myophenolate, ciclosporin)
n anti-infectives (cefaclor, amoxicillin, mefloquine)
n vaccines
n analgesics
n antiemetics.
37
Table 5: Examples of drug reactions
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38
Some ADRs occur less frequently in children. These include:
Notes
focal point Children and their medicines: enhancing your practice – Book 1
n cholestatic jaundice due to erythromycin
n gastrointestinal bleeds with non-steroidal
anti-inflammatory drugs
n hepatotoxicity with flucloxacillin
n severe skin reactions with trimethoprim/sulfamethoxazole.
The clinical trials carried out before drugs are licensed test
them in a relatively small number of patients (1500 on
average) in very strict conditions. It is important to bear in
mind that children are often excluded from these trials, due
to the issues discussed in Section 2. However, in practice,
millions of patients, including children, may take these
medicines.
39
These patients may vary in their rates of distribution and excretion, in their
focal point Children and their medicines: enhancing your practice – Book 1
For these reasons, although clinical trials will identify the more common and
predictable side-effects of medicines, rarer side-effects will only be seen when the
medicine is used in larger numbers. This is why pharmacovigilance (also referred to
as post-marketing surveillance) of licensed medicines is so important.
The CSM has an expert working group on paediatric medicines. Its remit is to
improve the availability of medicines for children within the regulatory framework
and to advise on the safety issues relating to specific medicines used in children.
The CSM requests that all suspected ADRs in children should be reported, even if it
is an established drug and regardless of whether the medicine is licensed for use in
children. If a baby is born with a congenital abnormality, or if a pregnancy results in
a malformed aborted foetus, the CSM asks health professionals to consider if this
should be reported.
Further details on what to report can be found in the British National Formulary
(BNF) or on the CSM website. Further information on the yellow card scheme and
how to report an ADR can be found at http://yellowcard.mhra.gov.uk. Yellow
cards can be submitted electronically.
Side-effects
There is very little published research on children’s need for information about their
medicines. Ideally, the risks and benefits of taking a drug should be fully explained
to a patient, but doing so is very difficult in children.
40
Alternatively, this discussion should be had with the parents,
Notes
focal point Children and their medicines: enhancing your practice – Book 1
who should also be made aware both of the common side-
effects when their children start a new drug and of what
action to take if those side-effects occur.
6. Sources of information
There is, unfortunately, much less
information for healthcare
professionals relating to paediatric
treatments than to those for adults.
It can be very difficult to find the
information you need when handed
a prescription for an unlicensed
drug. It is therefore important to be
aware of what resources are
available to you.
and has a section on the use of unlicensed medicines in children. Leaflets on specific
drugs can be downloaded which (among other things) explain what the medicines are
used to treat, possible side-effects and what to do if a dose is missed.
Source Use
Drug Tariff Part VIIIB Amount that will be reimbursed for the
supply of Specials
focal point Children and their medicines: enhancing your practice – Book 1
internet access. However, you should be able to request
access to useful websites.
Practice point 5
Spend some time looking at the resources in this
section and then consider which information
source(s) you would access in the following situations.
Situation Source(s)
A three-year-old girl,
newly diagnosed with
epilepsy, has been
prescribed sodium
valproate and buccal
midazolam. Her mum
would like some written
information about these
medicines to pass on to
the school.
43
Summary
focal point Children and their medicines: enhancing your practice – Book 1
Children can present the pharmacy team with a number of challenges that often
make them a tricky group of patients. However, a greater understanding of children
and their medicines will enable pharmacists and pharmacy technicians to enhance
their input into their care.
The differences in the ways in which children handle drugs must be appreciated
when considering the appropriateness of drug doses. Effective communication with
the child, parents and carers, as well as with colleagues in secondary care, is
absolutely essential in reducing the risk of medication-related errors (especially with
unlicensed preparations) and optimising treatment. When providing information to
children, parents, carers and schools, it is important to be aware of the helpful
information resources that are available to you.
44
Directing change
focal point Children and their medicines: enhancing your practice – Book 1
Here we give you the opportunity to reflect and consider how you could improve
your practice in this area.
At the focal point event we would like you to share with your colleagues an
experience that you have had regarding the care of a child. Take some time to make
some notes to support you on the evening.
45
Checklist for action
focal point Children and their medicines: enhancing your practice – Book 1
At this point in the learning programme you will have carried out the following.
Signed:
Date:
Take this book with you to your focal point event. Make sure that you know when
and where it is and what time it starts. Enjoy your learning.
46
References
focal point Children and their medicines: enhancing your practice – Book 1
1. Heimann G. Enteral absorption and bioavailability in children in relation to age.
European Journal of Clinical Pharmacology 1980;18: 43-50.
4. Fluhr JW et al. Direct comparison of skin physiology in children and adults with
bioengineering methods. Paediatric Dermatology 2000;17(6): 436-439.
9. European Parliament and the Council of the European Union. Regulation (EC)
No 1901/2006 of the European Parliament and of the Council on medicinal
products for paediatric use. Official Journal of the European Union 2006;49:
L378/1-L378/19.
12. Bendall C. The prescription and supply of drugs in children from a legal
viewpoint. Paediatric and Perinatal Drug Therapy 1999;3: 49-54.
47
14. Jevon P et al (eds.). Medicines Management: A Guide for Nurses. Oxford: Wiley-
focal point Children and their medicines: enhancing your practice – Book 1
Blackwell; 2010.
15. European Commission. ENTR/F2/BL D(2003). Medicinal products for human use
– Safety, environment and information: Excipients in the label and package leaflet of
medicinal products for human use. Brussels: EC; 2003.
17. Higa SK et al. Oral antibiotic suspension: do adult taste tests predict compliance
in infants and young children? Journal of International Pediatric Pharmacy
Practice 1997;2(5): 265-270.
20. Department of Health and Department for Education and Skills. Managing
Medicines in Schools and Early Years Settings. London: DH and DfES; 2005.
21. Department of Health and Department for Education and Skills. National
Service Framework for Children,Young People and Maternity Services: Medicines for
Children and Young People. London: DH and DfES; 2004.
23. Turner S et al. Adverse drug reactions to unlicensed and off label drugs on
paediatric wards: a prospective study. Acta Paediatrica 1999;88(9): 965-968.
24. Clarkson A, Choonara I. Surveillance for fatal suspected adverse drug reactions
in the UK. Archives of Diseases in Childhood 2002;87: 462-466.
48
49
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Notes
Notes
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51
focal point Children and their medicines: enhancing your practice – Book 1
Notes
For information on your orders or bookings, or any Supported by:
general enquiries, please contact us by email, telephone,
fax or post. A member of our customer services team
will be happy to help you with your enquiry.
Email: info@cppe.ac.uk
Website: http://www.cppe.ac.uk
Address:
Centre for Pharmacy Postgraduate Education
School of Pharmacy and Pharmaceutical Sciences
1st Floor, Stopford Building
The University of Manchester
Oxford Road
Manchester M13 9PT