About

In Australia, medicines submitted by a sponsor (usually a pharmaceutical company) are assessed by the Therapeutic Goods Administration (TGA) for safety, quality and efficacy prior to registration. The registration label for a medicine describes the indications, dose, route of administration and patient group in the TGA-approved Product Information.

Some registered medicines are prescribed ‘off-label’ (beyond the limits of registration). This practice is known to occur when there is no alternative treatment available and may be appropriate where some scientific and medical evidence exists to support that particular off-label use.  Evidence from the international literature suggests off-label prescribing rates of up to 40% in adults and 90% in hospitalised paediatric patients. Off-label use is not subsidised through the Pharmaceutical Benefits Scheme (PBS) and can have out of pocket cost implications for patients.

Once a registered medicine has lost patent protection and market exclusivity due to the availability of generic medicines, sponsors tend not invest time or money into submitting registration updates to the TGA. Unless registration information for off-patent prescription medicines used for off-label indications is updated, patient access is likely to remain prescriber dependent with out of pocket costs presenting barriers for some.

This research project aims to describe the extent, nature and implications of the use of registered off-patent prescription medicines for off-label indications in Australia. Research evidence will support the proposal of a policy to facilitate the submission of registration updates for off-patent prescription medicines used for off-label indications.

Bio

Katrina is a Sir Roland Wilson Foundation Scholar from the Commonwealth Department of Health.  Whilst working for government, Katrina helped patients with rare life threatening conditions access effective treatments; improved the sustainability of the health system through PBS pricing reviews; increased patient access to new and expanded pharmacy programs and protected public health through the scheduling of medicines and poisons. Prior to 2010, Katrina worked in clinical research for pharmaceutical companies both nationally and internationally.