National Pharmacovigilance Issues
The number of SAE reports received during 2010 represents a significant increase on previous years (148 in 2009; 104 in 2008). The reason for the increase in numbers of reports is unclear but is likely to reflect a greater awareness of the need to report SAEs rather than an absolute increase in the number of reactions occurring.
Reports of suspected adverse events
Eight reports of SAEs in humans related to local reaction following accidental self injection or topical exposure.
Suspected adverse event reports to veterinary medicinal products 2010 up significantly on previous years
The Irish Medicines Board (IMB) received 209 national reports
The Pending EU Review of the Regulatory Framework for veterinary medicines
J. Gabriel Beechinor, Director of Veterinary Medicines, IMB
The European Commission is expected to make a proposal to amend the regulatory framework for veterinary medicines during 2012. The objective of the review process is to:
Vigilance in prescribing and using antimicrobials in dry cows
J.G. Beechinor, Director of Veterinary Medicines, IMB
Veterinary practitioners and health-care professionals will appreciate that care is needed in prescribing and using veterinary medicines in dry cows and heifers in order to avoid the presence of drug residues in milk.