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

24 December 2009

The Australian community has an expectation that all therapeutic goods available in Australia are safe, effective and of high quality. The work of the TGA is based on applying scientific and clinical expertise to decision-making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines and other therapeutic goods by:

  • identifying, analysing and evaluating the risks and benefits presented by a product before it can be approved for supply in Australia;
  • identifying, analysing and evaluating any risks that may arise following approval of the product to ensure that the benefit risk balance remains positive (post market surveillance).

The TGA adopts a number of different post-market risk assessment approaches to ensure the continued safe supply of medicines and other therapeutic goods. A core component in monitoring drug safety in Australia is the spontaneous voluntary reporting system, which has been in operation for more than 4 decades and has generated more than 200,000 adverse drug reaction (ADR) reports. Unfortunately, all medicines can cause adverse reactions in a proportion of patients who take them and the TGA relies on the public, healthcare professionals and industry to report these reactions. All serious ADRs reported to the TGA are reviewed by medical officers within the TGA, and followed up for further assessment where necessary. Potential safety issues are referred to the Adverse Drug Reactions Advisory Committee (ADRAC), and any subsequent regulatory action is informed by the committee's assessment.

In addition, from time to time the TGA may draw upon additional scientific and clinical expertise to undertake a review of the specific issue and to inform its ongoing assessment of the risk-benefit balance of the product or products in question.

In August 2008 the TGA established an independent panel of psychiatrists and epidemiologists to undertake a specific review of selective serotonin reuptake inhibitors (SSRIs) and atypical antipsychotic medicines. The panel, known as the Psychiatric Drug Safety Expert Advisory Panel (PDSEAP) was tasked with undertaking a detailed review of the safety of these particular psychiatric medications. The PDSEAP has now completed its work and its report is being made public.

The PDSEAP has concluded that the risk-benefit balance for each of these medicines remains positive and that they are an effective part of treatment regimens for patients with certain psychiatric conditions.

The PDSEAP has made recommendations in three main areas:

  • Changes to Australian Product Information documents;
  • Educational activities for prescribers; and
  • Enhancements to post-marketing surveillance.

The TGA's Office of Prescription Medicines will be working with sponsors to progress changes to the Product Information documents in line with these recommendations. Regular review of these documents was also recommended and this is consistent with process reforms being implemented by the TGA's Office of Medicines Safety Monitoring as part of a larger series of regulatory reforms currently underway within the TGA. In addition, in early 2010 a new Advisory Committee on the Safety of Medicines (ACSOM) will be convened and the views of the new Committee will inform the TGA's consideration of how best to take the remaining recommendations forward.

The members of the PDSEAP were:

  • Professor Wayne Hall, a pharmacoepidemiologist who is an NHMRC Australia Fellow, Professor of Public Health Policy at the University of Queensland and Chair of the Drug Utilisation Subcommittee of the Pharmaceutical Benefits Advisory Committee (PBAC);
  • Professor Steve Kisely, a psychiatrist, epidemiologist and public health physician at the University of Queensland, and Director of the Queensland Centre for Health Data Services; and
  • Dr Frances Wilson, a consultant psychiatrist at Westmead Hospital, Sydney.

The Panel members have declared to the TGA that they have no known, real or perceived, conflict of interest in relation to their authorship and to the provision of advice to the Commonwealth on this subject.

Report of the Psychiatric Drug Safety Expert Advisory Panel

The full report of the Psychiatric Drug Safety Expert Advisory Panel is available below.

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

3 October 2014

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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