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Adverse Reaction Reporting for 2005 - Update

Notice type: 3rd Party Publications

Date: 01/10/2007

   

Product name or type:
Adverse Reaction Reporting for 2005 - Update

Background Information Or Related Documents:
Adverse Reaction Reporting for 2005 - Update Document

Further Information:
The IMB monitors the safety of all authorised medicines available on the Irish market on an on-going basis and part of this monitoring is carried out through review and evaluation of suspected adverse reactions. The IMB acknowledges the significant contribution of healthcare professionals to the continued surveillance of the safety of medicines through the voluntary reporting system and while the burdensome nature of form filling is recognised and acknowledged, the collection of adverse reaction reports is essential to ensure the continued surveillance of the safety of authorised medicines. 

In 2006, the IMB received a total 1,907 suspected adverse reaction reports that occurred in Ireland from healthcare professionals and pharmaceutical companies. 

Breakdown of Reports by Source 

Marketing Authorisation Holders       1119
General Practitioners                             212
Hospital Doctors                                     148
Nurses                                                      125
Community Care Doctors                     105
Hospital Pharmacists                              72
Clinical Trials                                             62
Community Pharmacists                         61
Dentists                                                         2
Health Care Professionals (other)          1

                                                                ______   

Total                                                        1907

Individual case reports were followed up by the IMB, where necessary, to ensure availability of comprehensive case information for review and evaluation. Such data is essential in the context of consideration of both individual case reports, as well as cumulative safety information. In keeping with its legal obligations, the IMB continued to exchange anonymised details of relevant adverse reaction reports with pharmaceutical companies and to submit case information to the European Medicines Agency (EMEA) within the agreed timeframes and formats. The IMB also continued to provide details of reports received to the WHO for inclusion on their international database. 

During 2006, the IMB continued to encourage adverse reaction reporting and, in addition to the regular IMB column in this publication, three issues of the IMB’s Drug Safety Newsletter [DSN] on relevant safety issues were circulated to doctors, dentists and pharmacists; one issue was specific to the safe use of Clexane (enoxaparin) and Plavix (clopidogrel), while the remaining two issues covered a variety of safety topics. A copy of the DSNs, general updates on safety issues considered to be of public health interest and copies of the IMB’s regular article in this publication are available from the ‘Publications’ section of the HPRA website (www.hpra.ie). In addition to written publications, a number of presentations on pharmacovigilance and adverse reaction reporting were made to healthcare professionals as part of under-graduate and post-graduate training courses or continuing education programmes. 

Finally, the HPRA is pleased to announce that in addition to ‘freepost’ reporting of adverse reactions to the Pharmacovigilance Section at Health Products Regulatory Authority, The Earlsfort Centre, Earlsfort Terrace, Dublin 2, on-line reporting of adverse reactions will be available through the website in the coming months. 

The HPRA is always keen to help, encourage and establish adverse reaction monitoring and reporting practices. Any centres or practices wishing to develop their reporting systems should contact the HPRA (telephone 01-6764971, fax 01- 6762517, e-mail imbpharmacovigilance@imb.ie).

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