Safe Prescribing in Children Flashcards

1
Q

Why is paediatrics a high risk prescribing area?

A
  • Children are not small adults with respect to pharmacokinetics and pharmacodynamics of drugs.
  • More prone to drug errors which can have serious consequences.
  • Often have to manipulate adult formulations due to lack of syrups etc on market.
  • Licencing issues – may not be licenced for use in children therefore potential lack of evidence for safe use.
  • Calculations galore!
  • Missed doses are a common problem due to poor adherence.
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2
Q

What are the common problems with calculations when prescribing for children?

A
  • 10 fold and 100 fold overdoses common.
  • mg/Kg dose confused with mg/Kg/day.
  • Confusion between doses expressed as mgs or mLs.
  • Confusion between units as often dealing with much smaller doses - milligrams/ micrograms/ nanograms.
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3
Q

Define the following terms:

  • Neonate
  • Infant
  • Child
  • Adolescent
A
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4
Q

What are the legal issues surrounding licensing in paediatric prescribing?

A
  • Medicine may be:
    • Licensed but not for use in children.
    • Licensed in children but used outwith the license - this is ‘off-label’ prescribing.
    • Not licensed in the UK.
  • Prescribing unlicensed medicines or medicines outside their marketing authorisation alters (and probably increases) the prescriber’s professional responsibility and potential liability.
  • The prescriber must be able to justify and feel competent in using such medicines in that particular age group or condition.
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5
Q

Describe how absorption varies according to route of administration in children.

A
  • Oral
    • At birth – 3 years : reduced gastric acids, increased gastric emptying. Leads to e.g. Increased oral absorption of penicillins and reduced oral absorption of phenobarbitone, phenytoin, rifampicin in infants.
    • Over 3 – similar to adults.
  • Intramuscular
    • Erratic absorption.
    • Painful due to small muscle mass.
    • Tends to be ineffective in neonates.
    • Not to be used for convenience.
    • Needle phobia common.
  • Intravenous
    • Requires extreme care with dilutions and calculations, need to bear in mind displacement values of drugs.
    • Extravasation risk.
    • Needle phobia common in children.
  • Percutaneous (topical)
    • Enhanced absorption in infants due to:
    • Thinner skin, better hydrated, increased surface area.
    • May be harmful as more drug absorbed - eg steroids, chlorhexidine – increased side-effects.
  • Rectal
    • Variation in blood supply to rectum – may yield variable response.
    • Useful in vomiting or if reluctant to take.
    • Useful for some drugs like diazepam, paracetamol.
  • Buccal
    • Good route for some drugs as doesn’t require swallowing e.g. midazolam.
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6
Q

What are the factors which affect drug distribution in children?

A
  • The two main factors influencing drug distribution are body composition and plasma protein binding.
    • Protein binding reduced
    • Volume of distribution increased
  • Result? This may affect the therapeutic window for a drug (i.e. the level in which to aim for of the drug in the body which maximises efficacy and safety).
  • Examples:
    • Phenytoin therapeutic window lower in neonates.
    • Greater doses of water soluble drugs (Penicillin, Gentamicin) on weight / weight basis in newborns.
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7
Q

How does body composition affect drug distribution in children?

A
  • Extracellular fluid is much higher in newborn infants (45%).
  • It decreases gradually with increasing age - 25% at 1 year, and 20% by adulthood.
    • This means greater doses of water-soluble drugs e.g. penicillin and aminoglycosides on a weight to weight basis are required.
    • For example the normal dose of IV Flucloxacillin for a premature neonate is 25mg/kg. If you were to give this to a 70kg adult the dose would be 1.75g but the usual adult dose is a wide range between 0.25g – 2g.
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8
Q

How does protein binding affect drug distribution in children?

A
  • In premature neonates, plasma protein binding is reduced resulting in higher concentrations of free (active) drug.
  • This is due to reduced levels of circulating proteins and a reduced ability to bind.
  • Therefore these patients have a higher apparent volume of distribution than adults.
  • Therapeutic window for phenytoin is lower in neonates than older children due to increased free phenytoin as a proportion of the whole plasma level (aiming for therapeutic level between 6-15mg/L rather than 10-20mg/L).
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9
Q

Describe drug metabolism in children (pre-term and newborns and also older children).

A
  • Pre-term and newborns have decreased rates of hepatic metabolising capacity due to immature enzyme systems in the liver, particularly oxidation and glucuronidation. This can increase the half-life of some drugs and cause worse side-effects.
    • e.g. Increased half-life of diazepam in neonates means it will take longer to excrete so increases side-effect profile.
  • Older children (aged 1-9yrs) have greater hepatic metabolising compacity than adults.
  • This is thought to be due to the fact that, relative to body size, the liver is larger in children than in adults.
    • e.g. theophylline and most anti-epileptics require a larger dose per kilogram than adults to achieve therapeutic plasma concentrations.
  • These differences make it difficult to predict correct doses and frequencies of drugs so must be assessed and reviewed frequently to be patient-centered.
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10
Q

Describe drug elimination in the neonate.

A
  • The neonatal liver and kidneys are immature in their capacity to eliminate drugs.
  • Both hepatic metabolism and kidney function are reduced in premature babies resulting in increased plasma half-lives of both hepatically and renally cleared drugs.
  • This leads to longer plasma half-lives and increased plasma drug concentrations.
  • The elimination of a drug from the body is often the most important indices for dosing, so if there is organ (renal or liver) immaturity or impairment there is usually a need to:
    • decrease dose OR
    • increase dosing interval
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11
Q

What is the advice for prescribing for children with renal impairment.

A
  • Avoid nephrotoxic drugs.
  • Examples of problem drugs:
    • Opiates
    • NSAIDs
    • ACE-I
    • Immunosuppressants
    • Gentamicin
  • Creatinine levels change with age, weight and muscle mass and are more difficult to interpret.
  • Look at trends for serum creatinine.
  • Use local lab references.
  • Equation in BNFC to estimate creatinine clearance but consult specialist immediately if impairment is suspected.
  • Monitor for symptoms and signs of kidney injury - e.g. oliguria, nephritis, hypoperfusion.
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12
Q

What is the advice for prescribing for children with hepatic impairment?

A
  • Avoid hepatotoxic drugs.
  • Problem drugs:
    • sedatives
    • opioids
    • diuretics
    • amphotericin
    • anticoagulants
  • In hypoproteinaemia – extra care with protein bound drugs (e.g. Phenytoin, prednisolone, warfarin, benzodiazepines).
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13
Q

What are the other ‘alarm bell’ drugs in paediatrics?

A
  • Tetracyclines (e.g. doxycycline) – avoid in under 12 years of age – deposited in growing bone and teeth, by binding to calcium, causes staining and occasionally dental hypoplasia).
  • Systemic chloramphenicol causing “grey baby syndrome” in newborns if dosing too high.
  • Aspirin associated with Reye’s syndrome, not licenced if 16 years of age and under.
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14
Q

What are the considerations when prescribing by the oral route for children?

A
  • Young children find it difficult to swallow tablets or capsules so liquid preparations are usually first choice.
  • Use paediatric formulations where available.
  • Flavourings, colourings or preservatives may be allergenic.
  • Check if child is lactose intolerant, as this is a common excipient in medicines.
  • Choose sucrose and alcohol-free (e.g. Phenobarbitone solution - this is alcohol free; whereas elixir contains 38% alcohol).
  • Taste, colour and smell? These all affect adherence.
  • Different brands may need to be tried depending on if it is strawberry or banana flavour!
  • Juice / yoghurt can help mask tastes but drugs should only be added to small quantities of food / drink.
    • E.g. added to a teaspoon of yoghurt, not a carton as full dose may not be taken.
  • Never add drugs to feeding bottle.
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15
Q

What are the problems with excipients?

A
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16
Q

What are the safe paediatric prescribing principles?

A
17
Q

What are the measures used to ensure dosing safety in paediatrics?

A
  • “If required / PRN” meds - when and why and how much in 24 hours? Is it also regular?
  • If you have to prescribe in mLs, you must specify strength of formulations unless it is a combination of more than one drug in the preparation.
  • Avoid decimal points
    • 500 micrograms, not 0.5mg.
    • 2mg, not 2.0mg.
18
Q

What should you do (in terms of documentation) if a child has an adverse drug reaction?

A
  • Yellow card it!
  • Why?
    • ADR may be different in children.
    • Drugs are not extensively tested in children.
    • Not licensed / off-label.
    • Need to build on limited body of evidence.