Medication safety illustration

Decoding Drug Reactions: A Guide to Safe Medication Use

Kai Mendoza in Health & Wellness November 2025 • 4 min read.

"Understand adverse drug reactions, reporting, and how to protect your health."

Adverse drug reactions (ADRs) are a serious concern in healthcare, impacting patient well-being and contributing to socioeconomic losses. Understanding the landscape of ADRs is essential for improving patient safety and minimizing potential harm. This article sheds light on ADRs, reporting systems, and practical steps you can take to protect yourself and your loved ones.

In the United States, a study by Lazarou, et al. revealed that approximately 6.7% of hospital inpatients experience serious ADRs annually, with 0.3% resulting in fatalities. This highlights the critical importance of pharmacovigilance—the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem.

To monitor ADR occurrences, many countries have established specialized reporting systems tailored to their unique cultural, medical, and socioeconomic contexts. These systems play a vital role in detecting signals from post-marketing surveillance, confirming newly identified ADRs, and uncovering previously unknown risk factors.

Understanding Adverse Drug Reaction Reporting Systems

Spontaneous reporting systems (SRS) are a cornerstone of pharmacovigilance, serving as essential tools for identifying potential safety concerns related to medications. In Korea, the Korea Food and Drug Administration (KFDA) initially established a centralized SRS in 1988. However, due to challenges in motivating healthcare professionals to report ADRs, the system was decentralized in 2006, leading to the establishment of regional pharmacovigilance centers (RPVCs) across the country.

While the decentralization of the SRS led to an increase in reporting rates, the overall quantity and quality of ADR reports remained lower than in many other developed countries. To address this, efforts have focused on developing more accessible reporting systems, including internet-based electronic submission (e-sub) platforms.

Accessibility: Easy-to-use reporting systems encourage more healthcare professionals and patients to report ADRs.
Accuracy and Speed: Internet-based reporting allows for quicker and more accurate data collection compared to traditional methods like telephone, fax, and mail.
Data Utilization: Electronic databases facilitate statistical analysis and signal detection, enabling timely identification of potential safety issues.

The Pharmacovigilance Research Network (PVnet) in Korea developed a homepage (http://www.pvnet.or.kr) to collect ADRs through e-sub starting in October 2007. This platform enables private clinics, pharmacies, general hospitals without their own PV systems, and patients/guardians to report ADRs conveniently.

Key Findings and Implications

A study analyzing ADRs collected through the PVnet homepage in 2008 revealed valuable insights into common culprits and manifestations. Among 933 ADR cases, involving 1,241 culprit drugs and 3,049 symptom-drug matched matters, antibiotics were the most frequently implicated drugs, followed by neurologic agents and non-steroidal anti-inflammatory drugs (NSAIDs). Skin-related symptoms, such as rash and urticaria, were the most common clinical manifestations reported.

About this Article -

This article was crafted using a human-AI hybrid and collaborative approach. AI assisted our team with initial drafting, research insights, identifying key questions, and image generation. Our human editors guided topic selection, defined the angle, structured the content, ensured factual accuracy and relevance, refined the tone, and conducted thorough editing to deliver helpful, high-quality information.See our About page for more information.

This article is based on research published under:

DOI-LINK: 10.3349/ymj.2012.53.5.1022, Alternate LINK

Title: Spontaneous Reporting Of Adverse Drug Reactions Through Electronic Submission From Regional Society Healthcare Professionals In Korea

Subject: General Medicine

Journal: Yonsei Medical Journal

Publisher: Yonsei University College of Medicine

Authors: Jae-Hyun Lee, Kyung Hee Park, Hyun Joo Moon, Yong Won Lee, Jung-Won Park, Chein-Soo Hong

Published: 2012-01-01

Everything You Need To Know

What are adverse drug reactions (ADRs), and why are they important?

Adverse drug reactions (ADRs) are unintended and harmful responses to a medication. They are a significant concern in healthcare, affecting patient well-being and leading to potential harm, even fatalities. The study by Lazarou, et al. found that a notable percentage of hospital inpatients experience serious ADRs annually, highlighting their prevalence and the need for vigilance. Understanding ADRs is critical for improving patient safety and minimizing harm.

What is pharmacovigilance, and why is it important?

Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. It is essential for monitoring ADR occurrences and ensuring the safe use of medications. Pharmacovigilance systems, such as spontaneous reporting systems (SRS), are used to identify potential safety concerns and emerging risks associated with medications. In the United States, pharmacovigilance helps to monitor and mitigate ADRs.

How do spontaneous reporting systems (SRS) work in identifying drug safety issues?

Spontaneous reporting systems (SRS) are crucial tools for identifying potential safety concerns related to medications. The Korea Food and Drug Administration (KFDA) initially established a centralized SRS. However, due to challenges, the system was decentralized, leading to the establishment of regional pharmacovigilance centers (RPVCs). These systems allow healthcare professionals and patients to report ADRs, which aids in detecting and addressing potential safety issues. Efforts to improve SRS include internet-based electronic submission (e-sub) platforms for increased accessibility, accuracy, and data utilization.

What is the role of electronic submission (e-sub) platforms in monitoring drug reactions?

Electronic submission (e-sub) platforms, like the Pharmacovigilance Research Network (PVnet) homepage, are designed to improve the reporting of ADRs. These platforms offer several advantages, including increased accessibility, accuracy, and speed compared to traditional methods. The PVnet homepage allows private clinics, pharmacies, general hospitals without their own PV systems, and patients/guardians to report ADRs conveniently. These platforms facilitate the timely identification of potential safety issues through efficient data collection and analysis.

What were the key findings regarding ADRs collected through the PVnet homepage?

The most frequently implicated drugs in ADRs collected through the PVnet homepage in 2008 were antibiotics, followed by neurologic agents and non-steroidal anti-inflammatory drugs (NSAIDs). The most common clinical manifestations reported were skin-related symptoms, such as rash and urticaria. These findings provide valuable insights into common culprits and manifestations of ADRs. Understanding these patterns helps in identifying potential risks and implementing strategies to mitigate them.