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Detecting and Reporting Adverse Drug Reactions

Mateja Cesarec ; PLIVA Hrvatska d. o. o., Zagreb
Martino Grizelj ; PLIVA Hrvatska d. o. o., Zagreb
Ina Novak ; PLIVA Hrvatska d. o. o., Zagreb
Zvjezdana Rehorović ; PLIVA Hrvatska d. o. o., Zagreb

Puni tekst: hrvatski pdf 615 Kb

str. 59-67

preuzimanja: 416


Puni tekst: engleski pdf 615 Kb

str. 59-59

preuzimanja: 1.074



The Croatian tradition of spontaneous reporting of suspected adverse drug reactions (ADRs) is over forty years long. The system that focuses on drug safety (before and after marketing authorisation was granted) and detects changes in their benefit/risk ratio is called pharmacovigilance system. An ADR is every harmful and unintended reaction including adverse and undesirable effects resulting from medication errors and administration of the drug outside of conditions the product was approved for, including drug misuse and abuse. According to their mechanism, ADRs can be divided into 5 types: augmented reactions which result from the pharmacological effect of the drug, bizarre reactions (not expected from the known pharmacological actions of the drug), continuing reactions, delayed reactions and end-of-use reactions associated with the withdrawal of a medicine. It is important to distinguish an ADR from an adverse event. ADRs are those adverse events for which there is a reasonable possibility of a causal relationship with the drug/medicinal product. Healthcare professionals (HCPs), who are in contact with the patient or drug user, are obliged to report any suspected ADR, especially if serious and unexpected. The Croatian Agency for Medicinal Products and Medical Devices, and the Croatian Institute for Public Health if vaccines are involved, need to be informed of the report. Specification of minimum criteria is necessary for a valid case report: identifiable reporter, patient, suspect drug, and suspected reaction. Each case report contributes to patient safety and HCPs, particularly doctors and pharmacists, have an opportunity to identify and report ADRs.

Ključne riječi

adverse drug reaction (ADR), therapeutic agent, patient safety, CIOMS, healthcare professional (HCP), Local Safety Officer (LSO)

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Podaci na drugim jezicima: hrvatski

Posjeta: 2.431 *