Report of the Informal Expert Meeting on Dosage Forms of Medicines for Children WHO Headquarters, Geneva, Switzerland Comments of the Malta Chamber of Pharmacists 15 th February 2008 The Malta Chamber of Pharmacists welcomes the report of the WHO of the Informal Expert Meeting on Dosage Forms of Medicines for Children. The Chamber is aware of the problems, caregivers and parents face when administering medicines to their children and also aware of the lack of appropriate pediatric dosage forms that health care processionals, including pharmacists encounter when dispensing or prescribing medicines to children. This is further compounded by scarcity of research and lack of details of the dose (and age related dose) of paediatric medicines. Last year the EU finalised a directive on research in children and hopefully in the future there will be more information as regards the safety and appropriate dose of paediatric medicines. This will enable better access to safe, effective and appropriate treatment and contribute to decrease mortality and morbidity rates within this age group. Situation in Malta There is a discrepancy in the availability of suitable medicines for children when compared to those available for adults. The rectal route of administration is a preferred route in neonates, due to ease of administration. It is mostly used for the administration of analgesics, ant emetics and steroids. However this route becomes a problem as children gets older. Chewable tablets are usually a preferred dosage form to syrups in the case of vitamin preparations. Palatability of medicines treatments. poses a problem in administering certain Examples include reconstituted antibiotic suspensions, dehydration salts, dispersible tablets and cough syrups. reconstituted oral Priority medicines for which no dosage form for children currently exists include treatment of epilepsy and systemic antifungals ( eg Grisofulvin). There is also the problem of adequate dosage forms to administer systemic steroids to children during an acute attack of asthma, bronchitis or croup.
Off label medicine use of certain treatments is also an area of concern. An important aspect is timing of administration of the treatment. It is important to consider that medicines are usually administered in the morning prior to a child goes to school, afternoon when they return from school or before they go to bed. A twice daily dosage or a single daily dose will influence adherence to treatment. The price of metered dose inhalers, and other devises for use by asthmatic patients and dispersible tablets are a deterrent, as many people find them too expensive Desirable attributes of a paediatric dosage form The Chamber aggress with the points raised as regards desirable attributes of a paediatric dosage form and highlights the need for novel dosage forms to take into consideration the: ease of administration, (ease of giving appropriate dose and the ability to reliably divide the unit dose) price, acceptability by children and caregivers. Package insert which is caregiver and children friendly (in case of older children). Studies carried in Malta identified the use of pictograms to aid administration of medicines. Welcome the proposals made in this report for developments of dosage forms and for research. An area which needs to be also address is Diabetes. Whilst acknowledging that a lot of research has been done in this area, it is noted that paediatric patients do encounter hypoglycaemic problems with current insulin treatment and the frequent monitoring poses problems.. Additionally notwithstanding the use of the pen an alternates route of administration to the SC route can improve considerable their quality of life. The problem increases once children gets older. Epilepsy is also an area which needs to be given more attention so that children will enjoy a good quality of life. The Chamber welcomes this report and would like to see the CPA represented on the committee of WHO to address this important matter. Mary Anne Ciappara