Context:

Recognition that children have not had access to the authorised drugs or age-appropriate dosage forms that they require led to many initiatives (in UK, the Netherlands, France, Germany) that are beginning to make a difference. The USA and EU now have legislation in place that encourages and/or requires companies to research and authorise appropriate medicines for children. Developing age-appropriate formulations remains a challenge and academics, practitioners and industry-based formulation scientists have begun an initiative to share information on excipients, taste and taste-masking, extemporaneous dispensing and administration devices. A similar initiative has been sponsored by NIH in USA and a programme of work sharing has begun. In 2007 an international alliance for better medicines for children was developed between pharmacists and pharmacologists following a meeting in Shanghai. The World Health Organisation followed with an initiative called “Make Medicines Child Size” and has now published two editions of the paediatric Essential Medicines List. This seminar will address the issue of risks factors in paediatric care and outcome. The consequences of the recent changes in the legislation will be developed and illustrated with concrete examples. Eventually, this talk will explore the contribution made by these initiatives to improving access to age-appropriate medicines for children.

Teaching Goals:

The presentation will focus on:

• the risks of using unlicensed or off label medicines for children
• the importance of national, European, global initiatives and cooperation
• the role of pharmacists in advising the proper administration of a medicine to a child- paediatric drug compounding
• presence and perspectives- the manufacturer’s responsibility for providing medicines in a suitable pharmaceutical form, with sufficient information regarding the use of the medicine in children.

Learning objectives:

At the end of the seminar, delegates should be able to:

• address the pharmaceutical and clinical issues of lack of medicines for children
• join and contribute to any initiatives
• promote actions to increase the awareness of caregivers about medicines for children
• develop means/actions to safer prescription, compounding, administration of medicines for children