Detection and Reporting of Adverse Drug Reactions Related to Antibiotics in Primary Healthcare in Greece

Abstract

Background: Detection of adverse drug reactions (ADRs) is a challenging matter for healthcare professionals who contribute significantly to the pharmacovigilance system through their participation inspontaneous reporting.

Objective: The objective of this study was the detection and reporting of ADRs related to antibiotics in primary health care in the region of Peloponnese.

Methods: A cross-sectional study was conducted in all national health system primary health units of the Peloponnese region in Greece. A self-administered questionnaire was distributed to a total of 404 physicians who provided services in these settings. Descriptive and multivariate statistical analysis was performed using the SPSS 25.0. Levels of significance were two-tailed and statistical significance was set at p =0.05.

Results: 306 out of 404 physicians responded to the questionnaire, giving a response rate of 75.8%. 81.6% of physicians stated that they rarely observe ADRs related to antibiotic administration during their practice, 49.8% rarely report them, and 33.7% never report them. Non-serious side effects (42.5%), physicians' workload (24.1%), and the lack of knowledge about the reporting obligation (20.6%) have been declared as the main reasons of non - reporting. In addition, physicians with ≤10 years of clinical practice rarely reported that they experienced ADRs after antibiotics' administration compared to those with more work experience and specialized physicians (p= 0.001).

Conclusion: ADRs reporting rates among physicians in primary healthcare are low. Changes in physicians' attitudes are vital and can be achieved through consistent and continuous training programs as well as the inclusion of ADRs and pharmacovigilance themes into the tertiary education curricula.

Keywords: Adverse drug reactions reporting; Greece; antibiotics; detection; pharmacovigilance; physicians; primary healthcare.