Global ADR Reporting Systems
INTRODUCTION
Medical and pharmaceutical advances have increased the availability of drugs for disease prevention and control. Despite the advantages, tracking adverse drug reactions (ADRs) in a large population is challenging. Pharmacovigilance focuses on the detection, control, understanding, and prevention of adverse effects from drugs.
According to a recent study, ADRs lead to 3.5% of hospitalizations and affect 1 in 10 hospitalized patients in Europe. They are the leading cause of death in the US and account for approximately 197,000 deaths annually in Europe.
The World Health Organization (WHO) has established some adverse drug reaction (ADR) reporting systems that are caused by therapeutic agents, including prescription and over-the-counter (OTC) drugs, vaccines, and complementary medicines. An individual case safety report (ICSR) is a comprehensive document that contains all relevant information regarding an individual case of an adverse drug reaction occurring in one patient at a particular time. Reporting all side effects is essential.
What is the Adverse Drug Reaction Reporting System?
The Adverse Drug Reaction Reporting System includes reports of adverse drug reactions to drugs, vaccines, and treatments from different countries.
Why should ADR be reported?
To increase patient safety.
Small drug samples from approximately 1,500 people make it difficult to detect adverse effects due to limited experience and short exposure times.
It can enable continuous monitoring of the safety of old and new drugs.
To identify rare side effects
What to report
Adverse effects that occur as a result of both prescription and over-the-counter medications
Adverse drug reaction to a new drug
All suspected side effects should be reported, regardless of the information provided by the company about the product.
Adverse effects caused by the device, radiocontrast, and herbal medicines
unexpected side effects of the drug.Adverse effects occur due to an overdose or the wrong medication.
How to report side effects
Systems or methods used to report adverse reactions
Spontaneous Reporting System (SRS):
The Global Adverse Drug Reaction Reporting System is widely used by healthcare professionals, pharmaceutical companies, and patients. SRS helps to identify and report unknown drug side effects, thereby improving their safety. The SRS can be used for all drugs throughout their lifetime, not just for a specific study period.
Reporting through MedWatch:
Established by the FDA in 1993, MedWatch was created to encourage and expand voluntary reporting of serious adverse drug events (ADEs) by healthcare providers and manufacturers. Adverse drug reaction reporting is required by the FDA to reveal unknown side effects of drug use.
VigiBase, VigiAccess, and VigiLyze:
VigiAccess is a web application that provides public data on drug reactions reported to the WHO Program for International Drug Monitoring (PIDM) through access to VigiBase.
VigiBase is a web-based ICSR management system accessible to national pharmacovigilance centers such as SAHPRA of the WHO International Pharmacovigilance Programme. VigiBase has been managed by the Uppsala Monitoring Center (UMC) on behalf of WHO since 1978.
VigiLyze retrieves global ICSR data from VigiBase.
VigiBase process
4) Argus Oracle Method for ADR Reporting:
This software is designed to monitor ADRs and is primarily used by drug manufacturers in the United States.
The software has several features that include a single global database, case processing updates, periodic submissions, advanced-level querying and reporting, automatic unsticking, etc.
5) By filling in the ADR form:
Forms for reporting suspected ADRs are available on the official website of the IPC (www.ipc.gov.in).
ADR form
6) Adverse effects can also be reported through the PvPI helpline (18001803024) or by email at pvpi@ipcindia.net or pvpi.ipcindia@gmail.com.
7) For adverse reaction reporting, an Android mobile app has been made available to the public as an adverse reaction reporting app developed by the Indian Pharmacopoeia Commission and the Pharmacovigilance Program of India (ADR-PvPI).
8) Adverse effects can also be reported directly to manufacturers if an adverse effect is detected in a newly introduced drug or the case of trial drugs.
9) By completing a yellow card:
In response to the thalidomide tragedy, the MHRA set up the yellow card system in 1964. This system serves as an early warning system to identify adverse drug reactions (ADRs) and potential risk factors. The MHRA can identify duplicate messages. Patients have various options for reporting any side effects they experience. They are
You can access it online at www.yellowcard.gov.uk.
Taking forms from pharmacies.
By calling the yellow card hotline at 0808 100 3352.
Yellow card
Conclusion:
Recently, there has been increased emphasis on drug safety and the risks associated with drugs and treatments. By detecting and reporting adverse drug reactions early, we can reduce or prevent mortality and unnecessary treatments and investigations.
The World Health Organization (WHO) has cooperated with some organizations and established many adverse reaction reporting systems for the public, such as forms, apps, various software, etc., to easily report suspected adverse reactions to WHO drugs. By using these ADR reporting systems, we can prevent adverse events from occurring.
References:
World Health Organization, International Drug Monitoring: The Role of National Centers, WHO Meeting Report, Geneva, 1972.
Patient reporting of suspected adverse drug reactions: a review of the published literature and international experts.
Student Name: S Lakshmi Sai Lahari
Student ID: 154/082023
Qualification: B. Pharmacy
e-Mail ID: suralahari2001@gmail.com
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