Making medicines that children can take

The role of the pharmacist The Medicines Act of 1968 and subsequent UK and European legislation established the process of licensing (now authorisation) to assure the safety, efficacy, and quality of medicines. While the majority of medicines for adults are licensed, many medicines used for children are not licensed for purpose (they are used “off-label”) or have not been licensed at all (unlicensed). Suitable licensed medicines are usually available for common problems such as infections but there are few, if any, available for less common conditions such as hypertension. The success of financial incentives to encourage pharmaceutical companies to licence medicines for children in the USA would suggest that the main reason for the dearth of licensed children’s medicines is profit related. There may also be other reasons related to perceived and actual difficulties in conducting clinical trials, such as recruitment and consent and the cost of developing paediatric formulations. There is also a worrying trend for UK companies to discontinue licensed paediatric formulations (but not the adult versions) because of low demand (for example, dantrolene, griseofulvin, naproxen, and nitrofurantoin suspensions). The Department of Health and the Association of the British Pharmaceutical Industry (ABPI) has agreed a voluntary system for early notification of discontinuations to allow time for alternative arrangements to be made.1 If not discontinued globally it is possible (but expensive) to import the product, but it is then considered to be an unlicensed medicine in the UK. If totally discontinued it may be necessary for the pharmacist to prepare extemporaneously if therapeutic alternatives are unsuitable. Extemporaneous dispensing is the compounding of ingredients to prepare a medicine for an individual patient. Several surveys have now established the frequency of use of off-label and unlicensed medicines in different situations. Thus about 11% of medicines used for children in UK …