Qualitative Study of General Public Views towards Adverse Drug Reactions in Lithuania.

Agne Valinciute-Jankauskiene,Loreta Kubiliene

doi:10.3390/healthcare9030303

Agne Valinciute-Jankauskiene, Loreta Kubiliene

Open Access

https://doi.org/10.3390/healthcare9030303

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Journal: Healthcare	Publication Date: Mar 9, 2021
Citations: 2	License type: CC BY 4.0

Affiliation: Lithuanian University of Health Sciences

Abstract

Direct patient reporting of adverse drug reactions (ADRs) is available in many countries, as patients are often knowledgeable about their health conditions and medicines. This study aimed to assess whether patients can recognize ADRs and whether they know how to proceed with ADR reporting. The study also assesses ADR information sources and the main barriers to reporting. Through the purposive and snowball sampling techniques, 42 consumers participated in focus group discussions. All discussions were audio recorded, transcribed verbatim, and analyzed for thematic content analysis. The thematic content analysis yielded four major themes: knowledge about medication safety, ADRs, and pharmacovigilance; information sources about medicines and ADRs; knowledge about ADR reporting; attitudes towards ADR reporting; benefits of ADR reporting; barriers to ADR reporting. Participants were able to identify ADRs and used different information sources about medicines and ADRs to confirm their beliefs. However, the poor communication between consumers, pharmacists, and physicians is the main barrier to ADR reporting. This study identified the challenges in relation to pharmacovigilance in Lithuania from patients’ perspectives. Our study indicated a lack of clearly set standards and communication guidelines between patients, physicians, and pharmacists. Active pharmacovigilance might help develop consumer habits regarding the reporting of ADRs in the presence of spontaneous pharmacovigilance.

Highlights

Spontaneous reporting of adverse drug reactions (ADRs) is the most extensively used method for the post-marketing safety surveillance of medicines
Most found that direct reporting makes positive contributions in ways that differ from the perspectives of healthcare professionals and leads to the detection of new drug safety signals [6,7,8]
As studies performed in Malaysia and the United Kingdom found, our findings suggested that participants did not have proper knowledge about the possible ADRs associated with their medicines [18,19,20]

Summary

Introduction

Spontaneous reporting of adverse drug reactions (ADRs) is the most extensively used method for the post-marketing safety surveillance of medicines. It involves various stakeholders, including competent authorities, marketing authorization holders, and healthcare professionals. Since 2012, it has been mandatory (by law) for countries in the EU to provide an opportunity for patients to report suspected ADRs directly to the national competent authority [2]. Most found that direct reporting makes positive contributions in ways that differ from the perspectives of healthcare professionals and leads to the detection of new drug safety signals [6,7,8]

Objectives

Discussion

Conclusion