Introduction

Recently, as interest in the safe use of drugs has increased, the demand for the role of medical professionals to systematically monitor and respond to adverse drug reactions is growing. The Ministry of Food and Drug Safety has established a comprehensive pharmacovigilance system suited to Korea's circumstances and developed an operating system model that can quickly report adverse drug reactions when they occur. Subcommittees for the evaluation of adverse drug reactions were formed in hospitals and regions under the affiliated organizations, and regional drug safety centers were established in 27 regions across the country to promote reporting of drug side effects and promote safe drug use using existing evaluation standards. Chosun University Hospital was designated as a regional drug safety center in 2011 and plans to actively monitor adverse drug reactions not only in the hospital but also in the Jeollanam-do region, including Gwangju.
As a regional base, the Regional Drug Safety Center establishes work procedures for systematic collection, evaluation, and prevention of adverse drug reactions in hospitals, and ensures that information on the efficacy and safety of drugs is quickly provided to doctors treating patients. We carry out business. The goal is to improve the level of medical consumption in the community by educating patients and their guardians on the concept of adverse drug reactions and providing counseling on correct medication administration, thereby contributing to building trust between patients and medical staff through safe medication administration. The Chosun University Hospital Regional Drug Safety Center is expected to bring about progress in establishing the correct use of medicines by renewing our awareness of adverse events that inevitably occur due to the use of medicines.

Pharmacovigilance Terminology

1. What is Pharmacovigilance?

It refers to scientific research and activities related to the detection, evaluation, interpretation, and prevention of harmful effects of drugs or drug-related problems. (CIOMS VI, ICH E2E, WHO) Pharmacovigilance is a compound word derived from the Greek word Pharmakon, meaning “medicine,” and the Latin word, meaning “keep awake, watch, and be on guard.” Pharmacovigilance is an activity that continues throughout the entire life cycle of pharmaceuticals, from collecting safety information about pharmaceuticals to risk management.

2. What are side effects?

It refers to all unintended effects that occur when medicines, etc. are administered according to normal usage, and includes unintended and desirable effects.

3. What is an Adverse Event/Adverse Experience (AE)?

It refers to undesirable and unintended signs (e.g., abnormalities in laboratory test values), symptoms, or diseases that occur during the administration or use of medicines, etc., and do not necessarily have a causal relationship with the medicines in question.

4. What is Adverse Drug Reaction (ADR)?

This refers to a harmful and unintended reaction that occurs while administering or using a drug, etc. according to normal usage, and a causal relationship with the drug in question cannot be ruled out. Among voluntarily reported adverse events, if the causal relationship with medicines, etc. is unknown, they are considered adverse drug reactions.

Adverse Drug Cases Report

If an adverse event occurs in a patient after administering the drug, please visit a hospital or clinic to provide guidance and take action so that the patient can receive appropriate treatment, and report the adverse event to the local drug safety center.

• Korea Drug Safety Management Institute Internet website: https://www.drugsafe.or.kr/ko/index.do
• Address: 365 Pilmun-daero, Dong-gu, Gwangju, 1st floor, main building, Chosun University Hospital, East Regional Drug Safety Center, zip code 501-717
• Phone: 062)220-3969
• Fax: 062)223-0192
• Email: drugsafety@csuh.co.kr
• You can apply at the front door of our outpatient pharmacy and consult with a pharmacist.
• During outpatient treatment, consultation with medical staff is possible.

Reporting method

Suspected side effects can be reported to the Regional Drug Safety Center at Chosun University Hospital by fax or mail by accessing the Regional Drug Safety Center site on our hospital website and obtaining a report form. Download format

• You can also report online by accessing the Food and Drug Administration's drug complaints website.
• When reporting, please be sure to enter essential information such as patient information such as the patient's name, age, and gender, information on adverse events that occurred, information on the suspected drug, and the reporter's name and contact information.
• The information you send will be used only to determine whether drug side effects have occurred, and the personal information of patients and reporters will be strictly protected.
• The Food and Drug Administration analyzes reported cases to scientifically evaluate the causal relationship between drugs and side effects, and the confirmed safety information is reflected in the precautions for drug use, contributing to the safe use of drugs.

Consultation regarding damage compensation

You can receive necessary help, including counseling regarding damage compensation, from the Korea Consumer Agency.

Reporting target

• All side effects other than those intended for treatment are subject to reporting. In particular, please be sure to report any serious side effects listed below.
• Serious side effects
  If your life is in danger or you are hospitalized
  If you are hospitalized or the hospitalization period is extended due to side effects
  If aftereffects remain
  
• You can also report side effects caused by defects in the medicine, such as expired use or damage.