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Welcome to Allied Health
Telehealth
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Quality use of medicines in
children
Quality Use of Medicines in Children
Pathma D Joseph
Medicine Information and Quality Use of Medicine
The Pharmacy Department
The Children’s Hospital at Westmead
3 November 2015
3/11/2015
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"A person's a person,
no matter how small." -Dr. Seuss
Overview
• Unique medicine needs of children.
• Medicines related to harm.
• Prescribing and dosing principles.
• Administration of medicines.
• Paediatric medicine information resources.
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Unique medicine needs of children
• ‘Therapeutic orphans’- inadequate safety and efficacy
evaluation through clinical trials.
• Children are not ‘little adults’:
– Pharmacokinetic and pharmacodynamic differences.
– Physiological, developmental, psychological and pharmacological
specificities.
– Paediatric disease presentation and pathophysiology differs from
adults.
• Diseases that may be specific to children.
Medicine associated harm in children
1990
1983
1962
1957
1950
1938
1937
Sulfanilamide elixir – solvent diethylene
glycol 34 children died
Food, Drug and
Cosmetic Act(FDCA):
adequate directions
for use
Chloramphenicol – “gray” baby syndrome in
neonates
Thalidomide – treatment of morning sickness
- birth defects (phocomelia)
FDCA amendment:
drugs effective in
population marketed
E-Ferol – IV vitamin E supplement - ascites,
thrombocytopenia, liver and renal failure, and
death
Propofol – long-term, high IV doses -
metabolic acidosis and myocardial failure
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Medication errors in children
• Inconsistent presentation and interpretation of
information.
• Use of medicines not labelled for use in children
(“off-label”).
• Lack of familiarity with paediatric doses.
• Complex calculations.
Therapeutic challenges
• Paucity of safety and efficacy evidence.
• “Off-label” use of medicines.
• Lack of small dose strengths of tablets - requiring
dividing tablets into halves or quarters.
• Lack of child-friendly formulations.
• Dosing inconsistencies when using
non-marketed formulations.
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Children are a vulnerable population
and need to be protected from
harm of medicines through evidence-based
prescribing, administration and monitoring!
Age classification
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Dosing considerations in children
• Most doses are expressed in terms of body weight.
• Some medicines are dosed by body surface area (mg/m2).
• Confusion may arise with mg/kg/dose and mg/kg/day in divided doses.
• Do NOT exceed the adult maximum dose (40kg).
Dosing considerations in obese children
• Volume of distribution of the medicine.
• Therapeutic range of the medicine.
• Side effect profile of the medicine.
• Ideal body weight related to height and age or
50th percentile weight is used to calculate certain
medicine doses for obese patients eg. gentamicin.
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Administration of medicines
• Can be challenging in children.
• Important to select the appropriate formulation.
• Switching formulations may alter the
bioavailability, efficacy and side-effect profile.
• Remember to give:
– Correct medicine
– Correct time
– Correct dose
– Correct route
Medicine formulations • Oral medicines (by mouth or enteral feeding tube) eg.
oral liquids, lozenges, wafers and meltlets, tablets or
capsules
• Inhaled medicines eg. sprays, nose drops, nebulisation
• Topical
– Transdermal patches, topical creams and ointments
– Ear drops/ointments
– Ear drops/ointments
• Rectal eg. ointments, suppositories
• Injections (intravenous, intramuscular)
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Child with swallowing difficulties
• Child may be trained to swallow tablets or
capsules.
• Disperse/crush tablets or capsules-may have an
unpleasant taste or numb the mouth.
• Taste of medicines may be masked by mixing with
suitable food or drink. Caution: food and
medicine interactions eg. dairy products
“Don’t rush to crush”
• Information to consider before giving a medicine
to a person who cannot swallow or has an enteral
feeding tube.
• Individual medicine monographs with specific
guidelines.
Available to order from: http://www.shpa.org.au/lib/pdf/publications/publist.pdf
Reference: Society of Hospital Pharmacist of Australian (SHPA), Don’t Rush To Crush Handbook, Second edition, 2015
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“Do not rush to crush”: also available via e-MIMs
General Information
Administration guidelines for medicine
Swallowing difficulties or enteral feeding tube consider:
• Oral liquids or dispersible tablets – May need to dilute viscous or high osmolarity liquid medicines.
– Sorbitol can cause diarrhoea.
• Dispersing tablets and capsule contents – Use a closed system eg. oral dispenser.
– Less hazardous and less loss of medicine.
• Crushing tablets – For tablets that do not readily disperse.
– 5-10% dose is lost when using a pestle and mortar to crush.
• Formulations that dissolve in the mouth – Eg. fastabs, melts, wafers, orally disintegrating tablet.
• Give the injection orally if suitable e.g. vancomycin
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Do NOT crush
• Delayed-release formulations – initials EC or EN in the product name
– enteric coating of tablet, beads or pellets in capsules – dissolves
in small intestine
• Extended-release formulations – Contin, Slow release, Slow, Duro, Mono or the letters ER, SR, LA,
SA, XR, MR, CD, XL, CR or HBS in name
– Release medicine over a prolonged time
• Cytotoxic/immunosuppressant medicines
• Buccal and sublingual tablets
Alternative oral formulations options
• Different route of administration.
• Changing to a different liquid or dispersible
medicine.
• Extemporaneously prepared liquid formulation.
• Importing a product available overseas (Special
Access Scheme).
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Children with enteral feeding tube • Evaluate:
– Type of enteral feeding tube
– Location in the gastrointestinal tract
– Effects of food on absorption of medicine
• Use liquid medicines whenever possible.
• Suspensions are viscous- may need to be diluted to
prevent the tube from blocking.
• Disperse effervescent tablets or powders in ~ 50mL
water – allows effervescing gases to escape.
• Monitor for consistency of administration, side effects
and effectiveness of medicines.
Prevent enteral tubes blockage
• Select most appropriate dose form.
• Finely crush and disperse medicine well.
• Give medicines one at a time, flushing in between.
• Avoid drug interactions with feeds and other medicines.
• Avoid acidic liquids.
• Consider the tube size.
• Flush tube before and after administration of medicines.
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Review medicines
• Necessary and appropriate.
• Availability of more suitable formulations and medicines.
Follow instructions
• Both the background information and the individual medicine monograph.
• Ensure that the medicine is prepared the same way each time, using the correct equipment - minimises the risk of harm.
Document changes
• Always document changes made to a medicine.
• Minimises variation in preparation, administration and dose of the medicine.
• Important if adverse event occur.
Give medicines
• Never use an IV syringe to prepare or give oral medicines.
• Always use an oral dispenser or medicine cup to give crushed, dispersed or liquid medicines.
Guiding principles to crushing or dispersing oral medicines
Injectable Medicines Considerations • Stability: prepare immediately prior to administration
using aseptic technique.
• Diluents: for reconstitution or dilution must be sterile and
suitable for injection, preservative free where possible.
• Displacement volume: volume that the powder
component of a drug takes up upon reconstitution:
• Single Use Injections: When only a portion of the dose is
required unused medication should be discarded. No
ampoule or vial should be shared between patients.
Volume of diluent to reconstitute a vial + displacement
volume of drug powder = Final volume of vial
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Paediatric Injectable Medicines Handbook, available via CIAP
Trissel's™ 2 IV compatibility on Micromedex.®
Caution: compatibility is usually
under specific conditions, duration
and concentration
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Problem excipients in medicines Excipient Possible effects
Glucose and sucrose Obesity, and tooth decay if taken orally
Benzyl alcohol A gasping syndrome in neonates (in large quantities)
Ethanol CNS effects
Aspartame A source of phenylalanine in patients with phenylketonuria
Polyoxyl castor or arachis
(peanut) oils Severe anaphylactoid reactions
Propylene glycol CNS effects especially in neonates and children under 4 years
Colourants (e.g. tartrazine) Hypersensitivity and behavioural disturbances
Carbohydrate content Carbohydrate content needs to be minimised in a ketogenic
diet (for patients with refractory seizures).
Reference: SHPA, Australian Medicines Information Training workbook, 1st ed. 2011
Acceptable abbreviations
• Caution: Do not abbreviate drug names
• Follow guidelines for approved abbreviations
• Australian Commission on safety and quality of
health care: Recommendations for Terminology,
Abbreviations and Symbols used in the
Prescribing and Administration of Medicines
http://www.safetyandquality.gov.au/wp-
content/uploads/2012/01/32060v2.pdf
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‘Alarm bell’ medicines
• Aspirin - Reyes Syndrome (except for Kawasaki’s
disease and low-dose anticoagulation)
• Vigabatrin – visual field toxicity (except last line
anticonvulsant)
• Tetracyclines – <8 years permanent teeth
discolouration
• Ceftriaxone in neonates- precipitates with
calcium containing products – severe reaction +
death
Medicine Information Resources • Australian Medicines Handbook Children’s Dosing Companion
• British National Formulary for Children
• CHW Paediatric Injectable Medicines Handbook
• Paediatrics Manual: The Children’s Hospital at Westmead
• NSW Kids + Families. Policy Directives/Guidelines
• UpToDate
• Pediatric & Neonatal Dosage Handbook
• PemSoft
• BMJ Best Practice
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Medicine Information Resources • Australian Don’t Rush to Crush Handbook
• e-MIMS
• Micromedex
• Toxinz
• Australian Immunisation Handbook
• Joanna Briggs Institute
• Maternity and Infant care
• Neonatal Formulary. Drug use in pregnancy and the first year of life
• Neofax
• AAP Pediatrics Journal
Useful Paediatric websites
• Children’s Healthcare Australasia: https://children.wcha.asn.au/
• Cochrane Child Health: http://childhealth.cochrane.org/
• Medicines for Children http://www.medicinesforchildren.org.uk/
• About Kids Health http://www.aboutkidshealth.ca/
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Recommendations for practice
• Children are not “little adults” and there are particular
peculiarities that need to be considered when prescribing
and administering medicines.
• There is a great need for advocacy of more clinical trials
to test the safety and efficacy of medicines in children to
support evidence-base practice.
• It is important to synthesise existing evidence to inform
the therapeutic needs of children and protect them from
harm.
References
• Society of Hospital Pharmacist of Australian (SHPA),
Don’t Rush To Crush Handbook, Therapeutic options for
people unable to swallow solid oral medicines, 2nd ed.
2015.
• SHPA NSW Medicines Information Specialist Interest
Group. Paediatric Chapter. Australian Medicines
Information Training Workbook. 1st ed, 2011.
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"Children are one third of our
population and all of our future." - Select Panel for the Promotion of Child Health,
1981