Olivia Mitchell (Dublin South, Fine Gael)
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Question 284: To ask the Minister for Health and Children the action she has taken or will take on the recommendations issued by the Sub-Committee on the Adverse Side Effects of Pharmaceuticals; and if she will make a statement on the matter. [39616/08]

Mary Harney (Dublin Mid West, Progressive Democrats)
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Following the publication by a Sub-Committee of the Joint Oireachtas Committee on Health and Children of its Report on the Adverse Side Effects of Pharmaceuticals in April 2007, the Irish Medicines Board (IMB) initiated a process to carefully examine the various items raised. This process involved the appointment of independent external consultants and experts in the field of pharmacovigilance and drug safety who have conducted a robust assessment of the proposals. This assessment was completed in November 2007.

I am advised that the proposals concerning conduct of clinical trials and post authorisation studies are already provided for in legislation and are the subject of a range of initiatives. One such initiative is a European Medicines Agency project to establish a European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) to look at ways of establishing studies in the various member states and enhancing the sharing of study data across the EU. The IMB's intensive involvement with the Agency and European medicines regulation ensures our full engagement with this initiative and access to all resultant patient safety information.

Regarding of Adverse Drug Reaction (ADR) reporting, a number of items highlighted in the Sub-Committee's report reflected submissions made by the IMB and the consultant's assessment drew attention to the following opportunities which are currently being progressed by the IMB:

further development of stakeholder education strategy to include safety issues across the organisation,

expanding the current IMB adverse reaction education and awareness programme to a wider healthcare professional base, members of the public and to enhance the profile of the topic in the media,

targeted campaign focussed on improving awareness of adverse reaction reporting among health professionals and the public,

the publication of high level adverse reaction data.

The Sub-Committee's report referred to the need to increase the reporting of ADRs. In response to this, the IMB has developed a website which has the capacity to take on-line reporting of adverse reaction reports. This system has been fully operational in 2008 and reports are being taken from both health care professionals and patients. The website can be accessed at; http://www.imb.ie/EN/Safety--Quality/Online-Forms/Human-Medicine-Adverse-Drug-Reaction.aspx

With regard to the establishment of a patient safety agency as recommended by the Sub-Committee, in January 2007, I established a Commission on Patient Safety and Quality Assurance to develop clear and practical recommendations to ensure that quality and safety of care for patients is paramount within the healthcare system.

The Commission's Report — 'Building a Culture of Patient Safety' was published on 7th August 2008. The report contains 134 recommendations spanning across almost every area of the health service including a number relating to the reporting, managing and learning from adverse events in the health system generally. It also made recommendations in the area of medication safety which are being addressed by the Irish Medicines Board and other bodies with a stake in the medication sector.

I will be submitting proposals to Government in the near future arising from the report of the Commission.