Notice type: 3rd Party Publications

Date: 03/09/2006


Product name or type:
Adverse Drug Reactions - MIMS Advisory

MIMS Publication September 2006

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Problem Or Issue:
The IMB monitors the safety of all authorised medicinal products available on the Irish market on an on-going basis. Part of this monitoring is carried out through review and evaluation of suspected adverse drug reactions (ADRs) and the IMB acknowledges the enormous contribution of busy healthcare professionals to the continued surveillance of the safety of medicines through the voluntary reporting system. While the burdensome nature of form filling is recognised and acknowledged, the collection of ADR reports is essential to ensure continued, effective surveillance of the safety of licensed medicines. 

In 2005, the IMB received a total 1,861 suspected adverse drug reaction (ADR) reports that occurred in Ireland from healthcare professionals and pharmaceutical companies. 

Breakdown of reports by source: 

Marketing Authorisation Holders        856 
General Practitioners                           322 
Community Care Doctors                   183 
Hospital Doctors                                   152 
Clinical Trials                                        127 
Nurses                                                   110 
Hospital Pharmacists                           60 
Community Pharmacists                     45 
Dentists                                                     6  
Total                                                     1,861 

All cases were followed up with feedback information provided to reporters, as appropriate. Relevant reports (i.e. all serious, suspected cases) notified directly to the IMB by healthcare professionals were forwarded to the appropriate marketing authorisation holders (MAHs) and the European Medicines Agency (EMEA) within the agreed timeframes and formats. The IMB also continued to provide details of reports received to the WHO on a monthly basis, for inclusion on their international database. 

During 2005, the IMB continued to encourage adverse reaction reporting and, in addition to the regular IMB column in this publication, one issue of the IMB’s Drug Safety Newsletter [DSN] on the safety issues associated with the cyclo-oxygenase (cox-2) selective inhibitors was circulated to doctors, dentists and pharmacists in June 2005. A copy of the DSN, 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 ( In addition to written publications a number of presentations on pharmacovigilance and ADR reporting were made to healthcare professionals as part of post-graduate training courses or continuing education programmes. 

Spontaneous reporting of suspected ADRs is an inexpensive and effective method for the lifetime surveillance of medicines following their introduction to the marketplace. While an individual’s experience may be limited to one or two cases, when collated with additional reports from other sources, it may contribute considerably to the assessment of a potential safety hazard. Healthcare professionals are reminded that it is not necessary to determine a causal relationship between a drug and subsequent event prior to reporting a suspected ADR. 

You are particularly reminded to report: 

All suspected adverse reactions to new medicinal products (i.e. those available for less than two years). 

Serious suspected adverse reactions to established medicines (a serious reaction is defined as one which is fatal, life threatening, results in persistent or significant disability/incapacity, results in or prolongs hospitalisation. This definition also includes congenital abnormalities or birth defects and serious adverse clinical consequences). 

Any suspected increase in the frequency of minor reactions. 

Any suspected teratogenic effects. 

Any suspected reactions associated with the use of vaccines. 

The IMB is always keen to help, encourage and establish ADR 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 ADR report forms are available on request from the Pharmacovigilance Section at the above contact details. ADR report forms are also available to download from the ‘Publications’ area of our website at These may be completed and forwarded in an envelope marked ‘Freepost’ to Pharmacovigilance Section, Health Products Regulatory Authority, The Earlsfort Centre, Earlsfort Terrace, Dublin 2.

Background Information Or Related Documents:

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