Adverse Reaction Reporting - MIMS Publication

Notice type: 3rd Party Publications

Date: 04/02/2009


Product name or type:
Adverse Reaction Reporting

MIMS Publication - February 2009

Problem Or Issue:
The Irish Medicines Board monitors the safety of authorised medicinal products for human use available on the Irish market, on an on-going basis. Part of this monitoring is carried out through review and evaluation of suspected adverse reactions and the IMB encourages all healthcare professionals to notify suspected adverse reactions observed during their practice. The IMB greatly appreciates the interest in reporting and acknowledges the enormous contribution of busy healthcare professionals to the continued surveillance of the safety of medicines through this voluntary reporting system. While the burdensome nature of form filling is recognised and acknowledged, the collection of adverse reaction reports is essential to facilitate early detection of potential safety issues and ensure effective monitoring of the safety of authorised medicines 

The IMB’s national database includes anonymised case details of >38,000 suspected adverse reaction reports provided by healthcare professionals and pharmaceutical companies since the national reporting programme was established in 1968. This information is helpful to the IMB in its evaluation of the safety profile of medicinal products, and is also used for provision of anonymised summaries of information in response to enquiries. 

Spontaneous reporting of suspected adverse reactions 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 they 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 adverse reaction. 

The terms “Adverse Reaction” and “Serious Adverse Reaction” are defined as follows: 

Adverse Reaction 

A reaction which is noxious and unintended and which occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease or for the correction or modification of physiological function. 

Serious Adverse Reaction 

A serious adverse reaction means an adverse reaction which results in death, is life-threatening*, requires in-patient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly/birth defect. 

*Life-threatening in this context refers to a reaction in which the patient was at risk of death at the time of the reaction; it does not refer to a reaction that hypothetically might have caused death if more severe. 

Criteria for Reporting Suspected Adverse Reactions 

The IMB welcomes reporting of any suspected adverse reactions, but particularly encourages healthcare professionals to report the following: 

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

• Serious suspected 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. 

Suspected adverse reactions associated with the use of medicinal products may be reported through the online reporting system, as well as via post-paid report cards. A downloadable version of the report form is also available from the ‘Publications’ area of the website These may be completed and forwarded in an envelope marked ‘Freepost’, Pharmacovigilance Section, Health Products Regulatory Authority, Kevin O’Malley House, The Earlsfort Centre, Earlsfort Terrace, Dublin 2. 

To avail of the new on-line facility, reporters can log on to and follow the link to ‘On-line Reporting’ under the Safety & Quality Section of the website where further instructions on how to complete the individual case report forms are available. Certain mandatory fields are required to successfully submit a report on-line and these include reporter details and a contact email address. The latter will facilitate return of a unique adverse reaction report identifier number as confirmation of a successfully submitted report. 

Background Information Or Related Documents:
Adverse Reaction Reporting - MIMS Publication Document

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