Reporting of Adverse Drug Reactions

Adverse drug reaction reporting is the main method for post-marketing surveillance of a medicine which leads to new insights about its safety profile.

The Medicines and Medical Devices Agency of Serbia (ALIMS) is responsible for monitoring adverse drug reactions. Thus, in the Republic of Serbia, all cases of adverse drug reactions are collected in ALIMS i.e. its National Pharmacovigilance Centre (NPC).

Adverse reactions are reported to ALIMS by healthcare institutions and healthcare professionals, as well as patients (spontaneous reporting), marketing authorization holders and sponsors of clinical trials.

Spontaneous adverse drug reaction reporting

The main and most important part of post-marketing safety monitoring of medicines, i.e. the cornerstone of the national pharmacovigilance system, is spontaneous adverse drug reaction reporting.

Spontaneous reporting involves the voluntary reporting of adverse reactions to medicines placed on the market by healthcare professionals and patients.

The unique position of healthcare workers in their day-to-day professional practice enables them to identify and report adverse reactions to medicines placed on the market. Therefore, healthcare professionals should report recorded and suspected adverse reactions even when there is no reliable evidence of a causal relationship with the medicine administered in order to protect the health of patients.

The efficiency and success of the national program for monitoring safety of medicines, from the moment they are placed on the market, directly depends on the active participation of healthcare professionals in reporting suspected adverse reactions. Spontaneous reporting should be viewed through the prism of professional and ethical responsibility, and healthcare professionals should direct their future efforts towards intensifying the reporting of adverse drug reactions and integrating pharmacovigilance into their professional practice, as part of routine activities.

The healthcare professional and patient/user of the medicinal product should report suspected adverse reactions to a medicinal product via the Adverse reaction reporting form for healthcare professionals or patient/user of the medicinal product or via the online application for ADRs reporting (available in Serbian).