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 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 the causality relationship with the administered medicine 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 integration of pharmacovigilance into their professional practice, as part of routine activities.

Healthcare professionals

Professional involvement of healthcare workers in this field has an important role in the safe use of medicines/medical devices and health protection of patients.

Reporting of adverse reactions to human medicine

Reporting of adverse reactions to medical device

Patients

Reporting of adverse reactions to marketed medicines / medical devices by the patients:

Reporting of adverse reactions to human medicine

Reporting of adverse reactions to medical device

Marketing authorization holders