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A FocAl point leArning progrAmme

CHILDREN AND THEIR MEDICINES:


ENHANCING YOUR PRACTICE

BOOK 2
March 2012 CENTRE FOR PHARMACY
FP115/2 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 2

Sharon Conroy, lecturer in paediatric clinical pharmacy, University of Nottingham


Nishma Khetani, pharmacist, Lloydspharmacy
Zoe Lansdowne, specialist pharmacist, child health, University Hospital Southampton NHS Foundation Trust
Bhavna Patni, pharmacy proprietor, Allens Pharmacy
Steve Tomlin, consultant pharmacist for children’s services, Evelina Children’s Hospital, Guy’s and
St Thomas’ NHS Foundation Trust
Helen Williamson, specialist research and development pharmacist, Birmingham Children’s Hospital NHS
Foundation Trust

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.

CPPE programme developer


Alison Levine, learning development pharmacist

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

Karen Wragg, regional manager, South Central

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.

All weblinks were last accessed on 15 February 2012.

Brand names and trademarks


CPPE acknowledges the following brand names and registered trademarks mentioned throughout this
programme: Clenil Modulite®, Losec® MUPS®, Serevent® and Volumatic®.

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

2 Printed on FSC® certified paper stocks using vegetable based inks.


Contents

focal point Children and their medicines: enhancing your practice – Book 2
Learning with CPPE 4

About your focal point event 5

Case studies 6

Clinical vignettes 9

Directing change 12

Putting your learning into practice 13

Suggested answers 17

References 29

3
Learning with CPPE
focal point Children and their medicines: enhancing your practice – Book 2

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:

Core learning (limited expectation of prior knowledge)

Application of knowledge (assumes prior learning)

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.

Programme guardians – A programme guardian is a recognised expert in an area


relevant to the content of a learning programme. They will review the programme
every six months to ensure quality is maintained. We will post any alterations or
further supporting materials that are needed as an update on our website. We
recommend that you check for these updates if you are using a programme more
than six months after its initial publication date.

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 your focal point event

focal point Children and their medicines: enhancing your practice – Book 2
Before coming along to this event you will have already completed Book 1 to help
you identify your own learning needs, read the key information and then related it to
your own area of practice and professional development.

This book uses case studies and clinical vignettes to help you apply what you have
learnt so far and encourages you to measure the changes in your practice. We also
include some suggested answers to the learning activities.

At this event you will work through more detailed case studies and some brief
clinical vignettes with your professional colleagues, and discuss your approach to the
Directing change activity from Book 1. You may be attending a CPPE tutor-led
event or have arranged to meet with your own CPPE ‘learning community’.

Just to remind you, in this unit we consider:

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.

This is to certify that

attended the CPPE focal point event on children and their medicines on

Location

CPPE pharmacy tutor signature

CPPE tutor name

5
Case studies
focal point Children and their medicines: enhancing your practice – Book 2

Time to prepare: 15 minutes to review the following mini-cases and answer the
questions individually or in small groups.

Time to discuss: 15 minutes to discuss the answers with your colleagues.

Case study 1 – Philip


Philip Mather is a one-year-old boy (weight 9 kg) with cerebral palsy. He was
discharged from hospital on diazepam 2 mg / 5 mL liquid, 5 mL twice a day for
spasticity.

Last week, his mum brought an FP10 to the community pharmacy to collect a
further supply of the new medicine. The pharmacist correctly dispensed the item
against the prescription.

She returns to the pharmacy several days later very concerned about Philip. He is
very confused and unusually drowsy. She says that she has followed the instructions
on the label by continuing to give 5 mL twice a day.

1. List four things that may have caused or contributed to these


symptoms.
Focus on medicines safety and ADRs

2. You subsequently find out that the doctor had prescribed 5 mg /


5 mL diazepam liquid and this had been supplied. What steps
could you take to prevent this type of error from happening in
the future?

6
Case study 2 – Harpreet

focal point Children and their medicines: enhancing your practice – Book 2
Harpreet Pillai is a five-year-old girl. Her mother is a single parent with no other
children.

Harpreet has suffered with epilepsy for two years and has just been discharged from
hospital after being admitted for increased seizures. In addition to her usual
medication (sodium valproate syrup and lamotrigine dispersible tablets), she has
been started on clobazam 5 mg / 5 mL oral solution.

Her mum is unsure about how this new medication should be taken and asks you for
advice. She shows you a bottle that is labelled ‘use as directed three times daily’. She is
especially distressed as staff at Harpreet’s school have refused to administer it.

1. How would you deal with the ‘use as directed three times daily’
clobazam?
Focus on long-term conditions

2. How could the issue with Harpreet’s school be resolved?

7
Case study 3 – Grazyna
focal point Children and their medicines: enhancing your practice – Book 2

Grazyna Kaminska is a ten-year-old girl and lives with her mother and father. Her
mother is a regular customer to your pharmacy and presents you with the following
script at 3:00pm on a Friday afternoon:

n Paraldehyde / olive oil 50 percent enema x 25 mL, 5 mL as needed

You are aware that this item is unlicensed.

Grazyna has been having regular seizures and this item was previously supplied by
the local hospital. Grazyna’s mother explains that this supply ran out this morning.

When you ring the GP to find out some more information, he explains that he
copied the item off a hospital request and has no other knowledge of the product.

1. What options are available to you for obtaining a supply of


paraldehyde?
Focus on unlicensed medication

2. What is the difference between an unlicensed and off-label


medicine?

3. What are the responsibilities of the pharmacist in supplying an


unlicensed medication?

8
Clinical vignettes

focal point Children and their medicines: enhancing your practice – Book 2
Time to prepare: 15 minutes to review and answer the questions individually or
in small groups.
Time to discuss: 15 minutes to discuss the answers with your colleagues.

In this section of focal point, we look at brief clinical scenarios and particularly focus
on decision making and communication. Review each of the clinical vignettes and
come up with a suitable response to manage the situation. You may wish to practise
these responses using role play.

Clinical vignette 1
Luke Omar is 13 years old and comes to your pharmacy with his mum to collect the
following prescription:

n Beclometasone (Clenil Modulite) 200 micrograms metered-dose inhaler, two puffs


twice a day

n Serevent 25 micrograms metered-dose inhaler, two puffs twice a day

n Salbutamol 100 micrograms metered-dose inhaler, when required

You overhear Luke’s mum telling the counter assistant that he has just been
discharged from hospital after another asthma attack – “number six in 18 months!”
You decide that Luke may benefit from a medicines use review (MUR).

When you ask him how he uses his inhalers, he tells you that he has heard that
steroids make you fat, spotty and stop you growing, so he doesn’t like using his
brown inhaler too often. He doesn’t use any of his medicines in the morning as he is
too busy getting ready for school. You see on his medical record that he was issued
with a Volumatic spacer two months ago. He tells you that he doesn’t take his spacer
to his dad’s house at the weekend because it’s too big.

Construct your response to:

a) Luke

b) Luke’s mum.

9
Clinical vignette 2
focal point Children and their medicines: enhancing your practice – Book 2

Your preregistration trainee Sam approaches you with a prescription for


flucloxacillin 125 mg / 5 mL suspension that he has just taken in. It is for a
two-week-old baby and the prescribed dose is 90 mg, three times a day for one
week. He says: “I think this dose is wrong – shouldn’t it be four times a day?”
You quickly check the BNF for Children and see that the dose is correct for the
patient’s age.

Construct your response to Sam.

Clinical vignette 3
Shabina Hasan is a 10-year-old girl who has been taking amoxicillin 500 mg three
times a day for a chest infection. Her dad brings her to see you. She has been
suffering with diarrhoea for two days. He feels that the antibiotics are causing the
problem and asks whether she should continue to take them.

On further questioning you ascertain that she does not have a fever or abdominal
cramps. She has no past medical history and does not take any other medicines.

Construct your response to:

a) Shabina

b) Shabina’s dad.

10
Clinical vignette 4

focal point Children and their medicines: enhancing your practice – Book 2
Your preregistration trainee comes to you with a prescription for paracetamol
500 mg / 5 mL suspension for a 12-year-old boy called Jackson Campbell. She says
that Jackson’s dad is waiting for the medicine and is in a hurry to get to work. She
has already explained that this is not a strength that the pharmacy keeps in stock but
Jackson’s dad was adamant that you supply exactly what the doctor has prescribed.
You decide to speak to Jackson’s father yourself.

Construct your response to:

a) Jackson’s dad

b) Jackson.

11
Directing change
focal point Children and their medicines: enhancing your practice – Book 2

Time to prepare: none – you should have done this before the event.
Time to discuss: 15 minutes to discuss the answers with your colleagues.

Revisit your notes in Book 1. Discuss your experience with your colleagues. If you
were faced with the same situation again, what could you do differently?

You have reached the end of the activities for this focal point event; the remainder of
this booklet contains follow-up activities and the suggested answers. You may wish to
spend some time after the event looking through these with colleagues.

12
focal point Children and their medicines: enhancing your practice – Book 2
After your focal point event: putting your
learning into practice
Now it is time to assess your learning, determine your readiness
to change and put your new knowledge into practice.

13
Putting your learning into practice
focal point Children and their medicines: enhancing your practice – Book 2

There are four actions you should undertake to ensure that what you have learnt in
this focal point unit influences your future practice.

1. Work through the practice activities listed below


2. Evaluate your learning by revisiting the Moving into focus questions
3. Complete the CPPE online e-assessment
4. Reflect on the Steps for change outlined on page 16

1. Practice activities (45 minutes)


You might wish to start to put some of your learning into practice by undertaking
the following activities.

n Carry out two MURs / new medicine service (NMS) interventions on suitable
child patients.
n Ensure you have some contact details for hospital paediatric departments in your
area.

When will you complete these activities?

2. Evaluate your learning (15 minutes)


The second step is to revisit the Moving into focus questions.

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 an MUR 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?

14
Can you answer these now?

focal point Children and their medicines: enhancing your practice – Book 2
3. Access e-assessment (30 minutes)
The next step in assessing your learning is to access the online e-assessment on our
website.

n Go to http://www.cppe.ac.uk

n Choose login and complete the login process. If you are a new user you will need
to follow the instructions to register with CPPE, gain your password and follow
the instructions to sign up.
n When you have logged in, go to assessment in the top menu bar, click on
e-assessment portfolio, and then scroll down to find the e-assessment entitled
Children and their medicines: enhancing your practice – focal point.
n Click on the icon and follow the on-screen instructions.
n If you complete the e-assessment successfully you will be able to print your own
certificate of achievement.

When will you access the e-assessment?

15
4. Reflection – steps for change (15 minutes)
focal point Children and their medicines: enhancing your practice – Book 2

The final step is to think about the following statements and note down how you feel
about them. This should help you determine any requirements for your further
development.

I have achieved my personal learning objectives that I set myself on page 9 in


Book 1.

Strongly disagree Disagree Agree Strongly agree

I have identified additional learning I need to undertake to improve my


knowledge of the therapeutic management of children.

Strongly disagree Disagree Agree Strongly agree

I would like to follow up a best practice idea expressed by a colleague at the focal
point event / within my learning community.

Strongly disagree Disagree Agree Strongly agree

After reflecting on these statements, what steps will you take now to make them
reality?

16
focal point Children and their medicines: enhancing your practice – Book 2
Suggested answers to:
n Moving into focus questions

n Practice points

n Case studies

n Clinical vignettes

Please remember that these answers


are suggestions only.

17
These are the authors’ suggested responses to the learning activities and they should
focal point Children and their medicines: enhancing your practice – Book 2

be used as a guide during your focal point event. Where possible, use your own local
guidelines and policies to inform the discussion and answers. We have provided short
answers to the questions and case studies and, where appropriate, these are followed
by discussion points that provide a little more detail.

Moving into focus


1. Can you give four examples of how drug handling in children differs from
drug handling in adults? List them here.

The absorption of drugs in children may differ compared to that seen in adults
due to differences in gastric emptying, gastrointestinal transit time and/or
immature epidermal barrier. Distribution is affected by changes in protein
binding and displacement caused by high bilirubin.

Drug metabolism differs in children due to immature enzyme systems. Excretion


differs due to lower tubular secretory and resorptive capacity and glomerular
filtration rates.

Discussion points
n Differences in drug handling are taken into account by the paediatric doses given
in the BNF for Children.

2. Do you have a responsibility to notify a child’s parent or carer that a drug


they have been prescribed is unlicensed?

The Neonatal and Paediatric Pharmacists Group and the Royal College of
Paediatrics and Child Health advise that it is often not necessary to gain consent
when an unlicensed or off-label drug is prescribed for a child. However, the
context of each specific situation should be considered when discussing
medicines use with parents and carers.

Discussion points
n If parents/carers are concerned about their child taking unlicensed medicines, it is
important to explain why it is being used and provide reassurance that it is an
appropriate treatment.

18
3. What are the regulatory requirements of carrying out an MUR in

focal point Children and their medicines: enhancing your practice – Book 2
a child?

An MUR needs to be conducted with a patient in order to comply with the


Secretary of State directions. An MUR can be conducted in a child if they are
competent (ie, they have the capacity to give informed consent) and are able to
fully engage in the discussion with the pharmacist.

Under the current regulatory framework it is not appropriate to conduct an MUR


with the parent, carer or guardian of a person who is not competent.

Discussion points
n Were an MUR to be conducted with a competent child, the pharmacist should be
aware of the local safeguarding (child protection) policy and guidelines and
should know where to refer any young person if there are concerns.

4. Medication errors are most commonly made when patients move between
primary and secondary care. What action can you take to reduce the risk?

Time should be taken to speak to the child’s parent/carer to check if any changes
have been made and what supplies they were given by the hospital. If possible,
continuity of supply should be established to avoid switching between different
strengths and different brands (which may vary in their bioavailability).

Pharmacists and pharmacy technicians should ask the parent or carer to see a
copy of any discharge letters from the hospital to be aware of any changes to a
child’s medication. The pharmacy team should try to ensure that patient
medication records are kept up to date.

5. Where could you access a patient information leaflet for a drug used
off-label in a child?

The Medicines for Children website (http://www.medicinesforchildren.org.uk)


produces patient information leaflets written by pharmacists specifically on the
paediatric use of medicines, including unlicensed and off-label use.

19
Practice points
focal point Children and their medicines: enhancing your practice – Book 2

Practice point 1
Is the prescription below, for a three-year-old (weight 16 kg) for treatment
of tonic-clonic seizures, within the licensed dose?

Carbamazapine 100 mg / 5 mL liquid – 40 mg twice daily for five days, then


80 mg twice daily for five days, then 80 mg three times daily thereafter.

This dose equates to 2.5 mg/kg twice daily for five days, then 5 mg/kg twice daily
for five days and 5 mg/kg three times daily thereafter. Therefore the prescribed
dose of carbamazapine is within the terms of the product licence.

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?

The possible options would be:

n Change drug choice to an appropriate licensed alternative (such as ranitidine,


which is available as a liquid).

n Omeprazole suspension (unlicensed Special).

n Dissolve one 10 mg Losec MUPS tablet in 10 mL of non-carbonated water to


produce 1 mg / mL solution. Administer 4.2 mL via oral syringe (may not give
an accurate dose). This would be an off-label use of a licensed product.

n Contact the prescriber and advise dose change to 5 mg once daily to facilitate
easier administration. Dissolve half a 10 mg Losec MUPS tablet in 10 mL of
non-carbonated water and administer the full 10 mL dose. This would be an
off-label use of a licensed product.

20
Practice point 4

focal point Children and their medicines: enhancing your practice – Book 2
Make a list of child patient groups who could potentially benefit from an
MUR or inclusion in the NMS.

Suggested patient groups who may benefit from MURs include those with:

n chronic respiratory conditions – asthma (opportunity to check inhaler


technique), cystic fibrosis

n type 1 diabetes (especially adolescent patients to discuss compliance)

n epilepsy.

Out of the four conditions / therapy areas selected for inclusion in the initial
rollout of the NMS, asthma is likely to be the condition that is the most applicable
to children. The other conditions / therapy areas included in the NMS are COPD,
type 2 diabetes, antiplatelet/anticoagulant therapy and hypertension.1

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 lady wants to know what vaccinations The ‘green book’, BNF for Children
her two-year-old daughter should
have received.

A three-year-old girl, newly Medicines for Children website


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.

A lady wants to know if she can continue British National Formulary,


breastfeeding while taking a five-day electronic Medicines Compendium,
course of trimethoprim. UK Medicines Information

A father asks you: how long should a child NHS Choices, school policy
with measles be kept out of school?

21
Case studies
focal point Children and their medicines: enhancing your practice – Book 2

Case study 1 – Philip


Philip Mather is a one-year-old boy (weight 9 kg) with cerebral palsy. He was
discharged from hospital on diazepam 2 mg / 5 mL liquid, 5 mL twice a day
for spasticity.

Last week, his mum brought an FP10 to the community pharmacy to collect a
further supply of the new medicine. The pharmacist correctly dispensed the item
against the prescription.

She returns to the pharmacy several days later very concerned about Philip. He is
very confused and unusually drowsy. She says that she has followed the instructions
on the label by continuing to give 5 mL twice a day.

1. List four things that may have caused or contributed to these


symptoms.
There are a number of potential reasons for Philip’s symptoms:
n deterioration in clinical status
Focus on medicines safety and ADRs

n the initial dose of diazepam is too high for Philip


n his mum is not administering the correct volume
n the product supplied several days ago was not the correct strength
n interaction between other medications is enhancing the sedative effect.

2. You subsequently find out that the doctor had prescribed 5 mg /


5 mL diazepam liquid and this had been supplied. What steps
could you take to prevent this type of error from happening in
the future?

Always check the prescribed dose for the age and weight of child against
the BNF for Children to ensure a proper clinical screen of the FP10. A
dose expressed in mg or mg/kg will often stand out as being unusual in
comparison to a dose expressed in mL.

22
Check with the patient’s parent or carer to ensure that the product
Focus on medicines safety and ADRs

focal point Children and their medicines: enhancing your practice – Book 2
supplied is the same as previous supplies. Improve communication and
transfer of documentation between primary and secondary care by asking
parents/carers for a copy of the discharge letter. For more information, the
hospital pharmacy may be contacted.

Explain to parents and carers of children on long-term medication the


benefits of using the same community pharmacy for the supply of
medication.

A note added to the patient’s medication record would serve as an extra


reminder.

Case study 2 – Harpreet

Harpreet Pillai is a five-year-old girl. Her mother is a single parent with no other
children.

Harpreet has suffered with epilepsy for two years and has just been discharged from
hospital after being admitted for increased seizures. In addition to her usual
medication (sodium valproate syrup and lamotrigine dispersible tablets), she has
been started on clobazam 5 mg / 5 mL oral solution.

Her mum is unsure about how this new medication should be taken and asks you for
advice. She shows you a bottle that is labelled ‘use as directed three times daily’. She is
especially distressed as staff at Harpreet’s school have refused to administer it.

1. How would you deal with the ‘use as directed three times daily’
clobazam?

Check the BNF for Children for the recommended dose (for a child of
Focus on long-term conditions

1 month to 12 years – initially 125 micrograms/kg twice daily, increased


every five days to usual maintenance dose of 250 micrograms/kg twice daily).

Ask Harpreet’s mum if she was given a discharge letter from the hospital.
If she was, ask if you can have a look at it.

If the discharge letter does not include the required information or it is not
available, contact the pharmacist or pharmacy technician at the hospital to
confirm what dose Harpreet should be taking.

Record information on the patient medication record so that it can be


referred to in the future.
Continued on next page
23
2. How could the issue with Harpreet’s school be resolved?
focal point Children and their medicines: enhancing your practice – Book 2

Contact the prescriber and enquire if clobazam could be changed to twice


daily dosing (as is the British National Formulary recommendation),
increasing the dose if necessary. A hospital pharmacist may be able to help
Focus on long-term conditions

facilitate this discussion.

If Harpreet is taking clobazam twice daily, she won’t need to have doses
while in school. Suggest to her mum that she can have a dose before school
and the second dose in the evening.

If the medicine needs to be kept in school to facilitate three times daily


dosing, the school should be contacted to check what their medicines policy
is and what information they require from you for the medicine to be
administered.

A prescription could be requested from the GP so that a second bottle can


be dispensed with clear instructions on how to administer.

Discussion point
Clobazam liquid is a very difficult Special to make and there is considerable
variation between products. It is produced by suspending clobazam powder in a base
liquid but does not stay equally suspended over time. Consequently, Harpreet’s mum
should be advised to always get the same product and shake the bottle well before
measuring out each dose.

Case study 3 – Grazyna

Grazyna Kaminska is a ten-year-old girl and lives with her mother and father. Her
mother is a regular customer to your pharmacy and presents you with the following
script at 3:00pm on a Friday afternoon:

n Paraldehyde / olive oil 50 percent enema x 25 mL, 5 mL as needed

You are aware that this item is unlicensed.

Grazyna has been having regular seizures and this item was previously supplied by
the local hospital. Grazyna’s mother explains that this supply ran out this morning.

When you ring the GP to find out some more information, he explains that he
copied the item off a hospital request and has no other knowledge of the product.

24
1. What options are available to you for obtaining a supply of

focal point Children and their medicines: enhancing your practice – Book 2
paraldehyde?

If there is a hospital with a paediatric department nearby, ask the team


there whether they would supply the paraldehyde if you faxed the
prescription to them. If the patient is under the care of that hospital, they
may write their own script.

Community pharmacies close to children’s hospitals may stock specialist


paediatric items such as paraldehyde.
Focus on unlicensed medication

Enquire about the patient’s management plan and whether other


preparations such as midazolam have any effect. Although a new script
would have to be issued, buccal midazolam is licensed and may be suitable
to see them through the weekend.

2. What is the difference between an unlicensed and off-label


medicine?

An unlicensed drug has not gone through the licensing process in the UK.

An off-label drug has been through the licensing process but is being used
outside the terms of the licence (eg, for a different indication, in a different
age group or via an alternative route of administration).

3. What are the responsibilities of the pharmacist in supplying an


unlicensed medication?

Pharmacists must ensure that any unlicensed Specials that they are
supplying are of suitable quality. Certificates of Analysis or Conformity
must be obtained where possible when purchasing unlicensed medication.

Discussion point
Do you know how to counsel a parent or carer on the administration of buccal
midazolam?

25
Clinical vignettes
focal point Children and their medicines: enhancing your practice – Book 2

Clinical vignette 1
Luke Omar is 13 years old and comes to your pharmacy with his mum to collect the
following prescription:

n Beclometasone (Clenil Modulite) 200 micrograms metered-dose inhaler, two puffs


twice a day
n Serevent 25 micrograms metered-dose inhaler, two puffs twice a day
n Salbutamol 100 micrograms metered-dose inhaler, when required.

You overhear Luke’s mum telling the counter assistant that he has just been
discharged from hospital after another asthma attack – “number six in 18 months!”
You decide that Luke may benefit from an MUR.

When you ask him how he uses his inhalers, he tells you that he has heard that
steroids make you fat, spotty and stop you growing, so he doesn’t like using his
brown inhaler too often. He doesn’t use any of his medicines in the morning as he is
too busy getting ready for school. You see on his medical record that he was issued
with a Volumatic spacer two months ago. He tells you that he doesn’t take his spacer
to his dad’s house at the weekend because it’s too big.

The bottom line


Luke needs to engage with you and other healthcare professionals and take
responsibility for his asthma and its management. As the pharmacist, you need to
assist Luke in becoming compliant, involve him in the decision-making process
and allay his fears about steroids.

Why?
Luke’s poor compliance is undoubtedly the cause of his poorly controlled asthma.
Only when he is compliant with his medication can the control of the condition
be properly assessed.

Supporting the statements


British Thoracic Society guidance defines persistent symptoms and/or frequent
exacerbations despite treatment at step 4 or 5 as ‘difficult asthma’. Poor adherence
with maintenance therapy should be considered as a possible mechanism in difficult
asthma.2

26
Clinical vignette 2

focal point Children and their medicines: enhancing your practice – Book 2
Your preregistration trainee Sam approaches you with a prescription for
flucloxacillin 125 mg / 5 mL suspension that he has just taken in. It is for a two-
week-old baby and the prescribed dose is 90 mg, three times a day for one week. He
says: “I think this dose is wrong – shouldn’t it be four times a day?” You quickly
check the BNF for Children and see that the dose is correct for the patient’s age.

The bottom line


Although paediatric doses are adjusted according to the patient’s weight, there are
differences other than this that need to be accounted for when dosing certain
drugs.

Why?
In young children (especially neonates), drug handling is different to that seen in
adults. Variances in pharmacokinetics and pharmacodynamics need to be
accounted for.

Supporting the statements


Flucloxacillin is renally cleared and neonates have poorer renal function compared to
older children and adults. It is therefore administered less frequently.

Clinical vignette 3
Shabina Hasan is a 10-year-old girl who has been taking amoxicillin 500 mg three
times a day for a chest infection. Her dad brings her to see you. She has been
suffering with diarrhoea for two days. He feels that the antibiotics are causing the
problem and asks whether she should continue to take them.

On further questioning you ascertain that she does not have a fever or abdominal
cramps. She has no past medical history and does not take any other medicines.

The bottom line


Shabina should continue to take the antibiotics at present.

Why?
Diarrhoea is a recognised and common side-effect of amoxicillin. As Shabina is
not systemically unwell, she should persevere with the course until it has been
completed.

27
Supporting the statements
focal point Children and their medicines: enhancing your practice – Book 2

There are three types of antibiotic-induced diarrhoea:3

n Simple diarrhoea due to altered bowel flora. This is quite common – for example,
it occurs in about eight percent of patients who take ampicillin.
n Diarrhoea due to loss of bowel flora and overgrowth of Clostridium difficile with
toxin production. This is much less common.
n A rare form of diarrhoea that is due to allergy.
The most likely cause of Shabina’s diarrhoea is simple diarrhoea. If an antibiotic
course is not completed, the infection may not be fully treated and may develop
resistance to treatment.

Clinical vignette 4
Your preregistration trainee comes to you with a prescription for paracetamol
500 mg / 5 mL suspension for a 12-year-old boy called Jackson Campbell. She says
that Jackson’s dad is waiting for the medicine and is in a hurry to get to work. She
has already explained that this is not a strength that the pharmacy keeps in stock but
Jackson’s dad was adamant that you supply exactly what the doctor has prescribed.
You decide to speak to Jackson’s father yourself.

The bottom line


The prescription should be changed to a licensed preparation: paracetamol
tablets, paracetamol soluble tablets or paracetamol 250 mg / 5 mL suspension.

Why?
A 500 mg / 5 mL suspension would be an unlicensed product and should not be
used if a licensed alternative is available when there is no clinical need for this
strength. The use of a licensed product is safer for the patient, will enable the
medicine to be supplied promptly and will be less costly for the NHS.

Supporting the statements


A product should be dispensed extemporaneously only when no product with a
marketing authorisation is available.4

28
References

focal point Children and their medicines: enhancing your practice – Book 2
1. Pharmaceutical Services Negotiating Committee. New Medicine Service – list of
medicines. Buckinghamshire: PSNC; 2011.
http://www.psnc.org.uk/data/files/PharmacyContract/Contract_changes_20
11/NMS_medicines_list_Sept_2011.pdf.

2. British Thoracic Society and Scottish Intercollegiate Guidelines Network. British


Guideline on the Management of Asthma: A national clinical guideline.
London/Edinburgh: BTS/SIGN; 2008 (revised 2009).
http://www.brit-thoracic.org.uk.

3. Aronson JK (ed.). Meyler’s Side Effects of Drugs: The International Encylcopedia of


Adverse Drug Reactions and Interactions. 15th ed. Oxford: Elsevier; 2006.

4. British Medical Association and the Royal Pharmaceutical Society. British


National Formulary. 62nd ed. London: BMJ Group and RPS; 2011.

29
Notes

30
focal point Children and their medicines: enhancing your practice – Book 2
31
focal point Children and their medicines: enhancing your practice – Book 2
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

Telephone: 0161 778 4000

Fax: 0161 778 4030

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

Do you have any comments on your focal point learning


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