Healthcare Professionals and Pharmacovigilance

Healthcare professionals (including doctors, dentists, pharmacists and nurses) are requested to report suspected adverse reactions observed in their practice. Of particular importance are all suspected reactions to newly authorised products, serious reactions to established products, products undergoing additional monitoring and suspected reactions to vaccines or medicines used in pregnancy. Healthcare professionals play a critical role in pharmacovigilance. The limitations of clinical trials mean that when a drug is first marketed, much may be known about its efficacy while relatively less may be known about its safety profile. Therefore post-marketing surveillance is essential to help identification of drug safety problems not detected during pre-marketing evaluation.

Pharmacovigilance uses spontaneous adverse reaction reporting to generate hypotheses and signals about potential hazards of marketed drugs that require further investigation. Spontaneous reporting of suspected adverse reactions is particularly useful in identifying rare or delayed reactions. It provides a system whereby the safety of a medicine can be monitored throughout its life cycle.  Thus drug safety assessment should be considered an integral part of everyday clinical practice for healthcare professionals. It is essential for healthcare professionals to be aware of the toxicity profile of medicines, to be ever vigilant for the occurrence of unexpected adverse reactions and to report suspected adverse reactions to the Health Products Regulatory Authority in order to facilitate timely and accurate detection and assessment of drug safety signals.


How do I report an adverse reaction?

You can report a suspected side effect in a number of ways:
  • To your doctor, pharmacist or nurse who can then notify the HPRA.
  • By using our online form.
  • By downloading a copy of our adverse reaction report form (Word version). You can e-mail completed forms to medsafety@hpra.ie
  • By printing our adverse reaction report form (Word version) and posting a completed copy to the HPRA by freepost.
  • By calling us on (01) 676 4971.