Welcome to Allied Health Telehealth - NCHN...3/11/2015 If you experience connection problems or issues during the session please ring HNE Telehealth Helpdesk 4985 5400 Option 1 1 Welcome

3/11/2015

If you experience connection problems or issues during the session please ring HNE Telehealth

Helpdesk 4985 5400 Option 1

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Welcome to Allied Health

Telehealth

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https://www.surveymonkey.com/r/qualitymedicines

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

https://www.surveymonkey.com/r/qualitymedicines

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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/

https://children.wcha.asn.au/



http://childhealth.cochrane.org/

http://childhealth.cochrane.org/

http://www.medicinesforchildren.org.uk/

http://www.medicinesforchildren.org.uk/

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

Documents

Welcome to Allied Health Telehealth - NCHN...3/11/2015 If you experience connection problems or issues during the session please ring HNE Telehealth Helpdesk 4985 5400 Option 1 1 Welcome