Lack of appropriate formulations of medicines for children in the community

Abstract

Aim: Appropriate formulations are essential in pharmacotherapy. This study surveyed the use of different formulations by children in the community, and examined the reported lack of appropriate formulations (oral solutions) in relation to the licensing status of drugs.

Methods: A cross-sectional study based on 68,019 pharmacy dispensing records was performed in The Netherlands. For each prescription the formulation was assessed, and all prescriptions were categorized: unlicensed (no product licence), off-label (licensed drugs used outside the licence terms) and authorized (licensed drugs used according to the licence). The types of formulation used were assessed in relation to age and licensing status.

Results: In all age groups, approximately half of all prescriptions were for oral drugs. The only major age-related trend was within oral drugs: younger children were more likely to be prescribed oral solutions. For authorized drugs the proportion of tablet/capsules exceeded oral solutions at the age of 7 y, whereas for off-label drugs this occurred at 3 y of age. For those medicines prepared by the pharmacy, tablets and capsules were more likely to be prescribed from the age of 9 y.

Conclusion: Many children in the community receive inappropriate oral formulations. Regulatory authorities and the pharmaceutical industry need to ensure that children have access to medicines with appropriate formulations.