Section 3 - Section 3 Production and Compounding: Statement 3.1 Section 4 - Clinical Pharmacy Services: Statements 4.5, 4.7
To minimise the risks in the reconstitution of medication preparations to neonates in clinical areas there is an EU resolution for i) risk handling, ii)handling requirements and iii) responsibilities (reference below). When considering the formulation of the medication, availability of suitable administration forms and concentration as well as appropriate osmolarity must be considered. Despite widespread use of different excipients in medicines for neonates, there is a lack of detailed description regarding the extent of such use in neonatal medicines, the pharmacokinetics and safety of many of these agents (e.g., ethanol, benzoates) are still not well described. Although excipients should have limited pharmacological activity, there is an increasing number of adverse reports in a paediatric population. This is mainly because pharmacokinetics and pharmacodynamics of excipients in neonates may have different activity if to be compared with adults and therefore could create adverse reactions.
After the seminar, participants should be able to: • describe effects of potentially harmful excipients; • list examples of potentially harmful excipients; • describe preparation risks in the ward and risk mitigation strategies.
Educational need addressed
Hospital pharmacists need to be aware of effects of potentially harmful excipients and should be able to educate other health care specialists.