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Release of the Report of the Psychiatric Drug Safety Expert Advisory Panel

24 December 2009

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Update to TGA response to recommendations made by the Psychiatric Drug Safety Expert Advisory Panel

This update provides information about the TGA's response to recommendations made by the Psychiatric Drug Safety Expert Advisory Panel (PDSEAP).

The PDSEAP's report was published in late 2009 and the panel made recommendations in three main areas:

  • changes to Australian Product Information (PI) documents
  • educational activities for prescribers
  • enhancements to post-marketing surveillance.

The TGA response to the PDSEAP recommendations has been provided to the Advisory Committee on the Safety of Medicines and is outlined below.

Changes to Product Information documents

The PDSEAP's recommendations related to updating the PIs of psychiatric drugs have been addressed.

The relevant PIs have been updated with information on mania/hypomania, use with monoamine oxidase inhibitors, serotonin syndrome, akathisia, recommendations to undertake glycaemic monitoring.

Information regarding the risk of persistent pulmonary hypertension in newborns has also been included in the PIs for selective serotonin reuptake inhibitors (SSRIs).

The TGA found that there was insufficient evidence to support the panel's recommended changes to the PI for robexitine in regard to additional potential neonatal effects.

Educational activities for prescribers

Articles on the association between psychiatric drugs and serotonin syndrome and akathisia were published in Medicines Safety Update (included in Australian Prescriber and published on the TGA website).

Enhancements to post-marketing surveillance

In late 2011 the TGA published TGA reforms: a blueprint for TGA's future, with an implementation plan released in July 2012. The panel's recommendations fed into the adoption of this broader approach to increasing the transparency of the TGA to stakeholders.

The Panel recommended the TGA commission epidemiological studies to enhance post-market surveillance. While the TGA can request or commission studies, the most effective mechanism for this is through the inclusion of a study as part of the Risk Management Plan (RMP).

RMPs include a number of pharmacovigilance activities and interventions are designed to identify, characterise and manage risks relating to high risk medicines.

The TGA requires sponsors of new high-risk medicines to submit an RMP. Each RMP covers the entire life cycle of the product and is periodically updated to reflect new knowledge and understanding of the safety profile of the medicine.

In 2013 the Sansom Institute for Health Research was funded as a Centre of Research Excellence for Medicine and Medical Device Surveillance by the National Health and Medical and Research Council (NH&MHC). The TGA works with this institution, as well as other researchers, to enhance its spontaneous adverse event reporting system and monitoring of therapeutic products, including through linked databases.

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