Carer uncertainties on appropriate and safe use in

infants and children

Of all accidental poisonings by pharmaceuticals resulting in hospital admissions
reported in Australia during 2009–2010, around 3% occurred in children aged 0–4 years
and were attributable to non-opioid analgesics, antipyretics and antirheumatics. Of
these most were due to paracetamol, and non-steroidal anti-inflammatory medicines. 2

Knowledge gaps in carers of young children may contribute to unintentional misuse and
overdose of paracetamol.11,16,17 In a cross-sectional study performed in the USA, only
38% of participants correctly selected and measured the appropriate paracetamol dose
for infants or children.18

Knowledge gaps with respect to paracetamol use in children included:

 the perception that paracetamol is a safe medicine 17

 an uncertainty around appropriate indications 16,17,19
 a lack of awareness of strengths and formulations 16,17
 the methods used to measure the correct dose.16,17
Multivariate analysis demonstrated that limited literacy was a significant independent
predictor of paracetamol overdose.14,15 Therefore, in addition to simple and effective
package labelling, education on the appropriate and safe use of paracetamol in adults
and children is an important contributor to safe use.
 
Information for patients
Ensure your patients are aware that:

 Paracetamol is the active ingredient in a number of pain and fever relief

medicines and combination medicines (eg, for cold and flu).
 Overdose can occur when taking more than one paracetamol-containing
medicine.
 The maximum daily dose of 4 g in any given 24 hour period should not be
exceeded for adults and children aged > 12 years.

When recommending paracetamol for pain relief in children and infants less than 12
years of age, ensure carers know the following:

 Paracetamol comes in different formulations and strengths for different ages. It is

important to choose the correct paracetamol product for the child's age.
 Always read the medicine label and packaging before use.
 Knowing the child's weight – the recommended dose of paracetamol for children
is based on ideal body weight (15 mg/kg).a
  Never exceed the maximum recommended dosage for children of 15 mg/kg
every 4–6 hours to a maximum of 1 g, and no more than 4 doses in a 24-hour
period.
 It is important to measure liquid medicines accurately using the syringe or device
provided.
 Keep track of all medicines given to the child, and when they were given.
 Store medicines out of reach of children.
a
 Children more than 20% above their ideal body weight should be dosed according to
their lean body weight which can be estimated by determining their predicted weight for
height.20
 
References
1. Australian Institute of Health and Welfare. National drug strategy household survey detailed
report. Canberra: Australian Institute of Health and Welfare, 2014. [Online] (accessed 27 April 2015).
2. Tovell A, McKenna K, Bradley C, et al. Hospital separations due to injury and poisoning,
Australia. Canberra: Australian Institute of Health and Welfare, 2012. [Online] (accessed 27 April
2015).
3. Drug Free Australia. Australian Bureau of Statistics - Deaths collection. Broadview, South
Australia: Drug free Australia, 2007. [Online] (accessed 27 April 2015).
4. US Food and Drug Administration. New steps aimed at cutting risks from acetaminophen.
Silver Spring, Maryland: US Food and Drug Administration, 2011. [Online] (accessed 27 April 2015).
5. Medicines and Healthcare Products Regulatory Agency. Press release: More exact
paracetamol dosing for children to be introduced. London: Medicines and Healthcare Products
Regulatory Agency, 2011. [Online] (accessed 27 April 2015).
6. US Food and Drug Administration. Acetaminophen information. Maryland: US Food and
Drug Administration, 2015. [Online] (accessed 1 May 2015).
7. Expert group for analgesic. Therapeutic guidelines: analgesic. Melbourne: Therapeutic
Guidelines Ltd, 2015. [Online] (accessed 27 April 2015).
8. Australian Medicines Handbook. Paracetamol. Adelaide: AMH Ltd, 2015. [Online] (accessed
27 April 2015).
9. Therapeutic Goods Administration. Recommended paracetamol doses. Canberra:
Therapeutic Goods Administration, 2013. [Online] (accessed 27 April 2015).
10. Amar PJ and Schiff ER. Acetaminophen safety and hepatotoxicity--where do we go from
here? Expert Opin Drug Saf 2007;6:341\u201355. [PubMed].
11. King JP, Davis TC, Bailey SC, et al. Developing consumer-centered, nonprescription drug
labeling a study in acetaminophen. Am J Prev Med 2011;40:593\u20138. [PubMed].
12. Bower WA, Johns M, Margolis HS, et al. Population-based surveillance for acute liver failure.
Am J Gastroenterol 2007;102:2459\u201363. [PubMed].
13. Hornsby LB, Whitley HP, Hester EK, et al. Survey of patient knowledge related to
acetaminophen recognition, dosing, and toxicity. J Am Pharm Assoc (2003) 2010;50:485\u20139.
[PubMed].
14. Shone LP, King JP, Doane C, et al. Misunderstanding and potential unintended misuse of
acetaminophen among adolescents and young adults. J Health Commun 2011;16 Suppl
3:256\u201367. [PubMed].
15. Wolf MS, King J, Jacobson K, et al. Risk of unintentional overdose with non-prescription
acetaminophen products. J Gen Intern Med 2012;27:1587\u201393. [PubMed].
16. Therapeutic Goods Administration. Labelling and packaging practices: A summary of some
of the evidence. Canberra: Therapeutic Goods Administration, 2013. [Online] (accessed 27 April
2015).
17. Graudins LV and Gazarian M. Promoting safe use of paracetamol in children. J Pharmacy
Pract Res 2006;36:297\u2013300. [Online].
18. Hurwitz J, Sands S, Davis E, et al. Patient knowledge and use of acetaminophen in over-the-
counter medications. J Am Pharm Assoc (2003) 2014;54:19\u201326. [PubMed].
19. Walsh A, Edwards H and Fraser J. Over-the-counter medication use for childhood fever: a
cross-sectional study of Australian parents. J Paediatr Child Health 2007;43:601\u20136. [PubMed].
20. Beggs S. Paediatric analgesia. Australian Prescriber 2008;31:63\u20135. [Online].