20 Feb 2013, BioSpectrum Bureau , BioSpectrum
Singapore: Department of Health and Ageing under the Australian Government's National Medicines Policy framework, is conducting a post-market review of medicines that are used to treat asthma in children, including salmeterol with fluticasone, eformoterol with budesonide, beclomethasone dipropionate, ciclesonide, sodium cromoglycate and nedocromil sodium, montelukast, and eformoterol.
The objective of the review is to systematically evaluate the body of clinical evidence regarding asthma medicine interventions to ensure the most appropriate management of children with asthma in clinical practice.
The need for this review was first identified by the Paediatric Medicines Advisory Group (PMAG), which found that 40 percent of the children supplied with a fixed dose combination (FDC) product (of inhaled long-acting beta-agonists and inhaled corticosteroids), had not first been prescribed a single ingredient product (an inhaled corticosteroid). PMAG considered that the extent of FDC use in paediatric asthma was a serious quality use of medicines issue and subsequently referred the matter to the Drug Utilization Sub-Committee (DUSC) of the Pharmaceutical Benefits Advisory Committee (PBAC).
In 2011, the DUSC review indicated that there was a very high rate of initiation to a FDC without prior use of a single ingredient inhaler. This is contrary to current asthma management guidelines (Asthma Management Handbook 2006, National Asthma Council Australia). The DUSC noted the issues and advised sponsors that this is a complex area of treatment and further clarification of the issues surrounding asthma management in children was needed.
In April 2012, the National Medicines Policy (NMP) Committee recommended to the Minister for Health the initiation of a post-market review of Pharmaceutical Benefits Scheme (PBS) listed medicines used for treating asthma in children, to ensure that these medicines continue to be used safely and appropriately. The NMP Committee developed the draft Terms of Reference for this review.