This blog features:
- Lack of awareness in reporting Adverse event
- Why is it important to reporting adverse event
- The causes and results of missing AE reports
Table of Contents:
- Introduction
- WHO’s Exclusive Insights on Real-World AE Reports
- Exploring Possible Reasons Behind Unreported Adverse Events
- Importance of reporting adverse event(s)
- Conclusion
- References
Introduction
Since we have several systems regarding adverse event reporting, but many cases missing unreported. I may due to lack of awareness and carelessness among the population. As we take ourselves how many think or spend time to file adverse events if we feel one, even we are educated. So this blog explains the impact of unreported events and its importance.
WHO report on patient safety
The World Health Organization (WHO) finds that one in 10 patients is harmed while receiving hospital care, and that unsafe surgical care procedures cause complications in up to 25% of patients.
Further, about 50% of adverse events in hospitalized patients happen in surgical care. The silver lining is that at least half of adverse surgical incidents are preventable.
- One in every 10 patients is harmed while receiving hospital care
- The occurrence of adverse events due to unsafe care is likely one of the 10 leading causes of death and disability across the world
- At least 1 out of every 7 Canadian dollars is spent treating the effects of patient harm in hospital care
- Investment in patient safety can lead to significant financial savings
- Unsafe medication practices and medication errors harm millions of patients and costs billions of US dollars every year
- Inaccurate or delayed diagnosis is one of the most common causes of patient harm and affects millions of patients
- Hospital infections affect up to 10 out of every 100 hospitalized patients
- More than 1 million patients die annually from complications due to surgery
- Medical exposure to radiation is a public health and patient safety concern
“All systems are designed with good intentions, yet they may not be perfect and require continuous improvement.”
Exploring Possible Reasons Behind Unreported Adverse Events
1. Lack of Awareness
- Adverse Event: Initially, it’s essential to educate individuals on what constitutes adverse events.
- Importance of Reporting: Many individuals remain uninformed about the significance of reporting adverse events, leading to a lack of awareness regarding its importance.
- Reporting Methods: Providing guidance on how to report adverse events, along with detailing the various methods and mediums available for lodging such reports, is crucial.
2. Complications in reporting
- Challenges in Monitoring Adverse Events in Multicenter Clinical Studies.
- In rural areas where access to digital technology may be limited, it’s essential to establish communication channels that are easily accessible and user-friendly.
3. Delayed Identification of Illness
In certain instances, physicians fail to inquire about side effects from patients, and patients also neglect to report symptoms promptly. This failure to adhere to safety protocols can lead to delayed identification of illness.
4. Overlooking or carelessness
Despite many being well-aware, individuals often remain careless and overlook the reporting of adverse events they encounter. This negligence is evident in numerous real-life examples.
5. No transparency
Factors driven by fear or concerns about potential negative consequences associated with reporting errors or adverse events (ADEs) may include fear of retribution, litigation expenses, damage to reputation, or adverse impacts on career advancement.
Such fears can contribute to a culture of silence among healthcare providers, resulting in underreporting of adverse drug events (ADEs) that may ultimately harm patients.
6. Under-reporting
Within the healthcare world, non-fatal or non-harmful events are sometimes referred to as near misses, and many of these go unreported. The U.S. Bureau of Labor Statistics (BLS) cites several reasons for the ongoing practice of under-reporting, or not reporting adverse events at all.
Importance of reporting adverse event(s)
According to AMA code of Medical ethics, Physicians’ professional commitment to advance scientific knowledge and make relevant information available to patients, colleagues, and the public carries with it the responsibility to report suspected adverse events resulting from the use of a drug or medical device.
A physician who suspects that an adverse reaction to a drug or medical device has occurred has an ethical responsibility to:
(a) Communicate that information to the professional community through established reporting mechanisms.
(b) Promptly report serious adverse events requiring hospitalization, death, or medical or surgical intervention to the appropriate regulatory agency
All medicinal products authorized in the European Union are subjects of constant drug-safety monitoring processes.
It is organized in a pharmacovigilance system that is designed to protect human health and life by the detection, analysis and prevention of adverse drug reactions (ADRs) and other drug-related problems.
All marketed drugs and health products have benefits and risks.
- identify potential safety issues
- improve health product safety for all
- identify previously unrecognized, rare or serious adverse reactions or problems
- add to international data on the benefits, risks or effectiveness of drugs, health
- communicate changes in product safety information to industry, hospitals, health care providers and consumers
- undertake regulatory actions, such as changing the product label or removing a product from the Canadian market
Patient safety is a serious global public health concern. The requirement of report from “Manufacturer” or “Applicant” is mandatory. Adverse events are no only limited to patients using medicines (drugs) and also included with medical devices, Cosmetics, healthcare facilities and also veterinary medicines.
Conclusion
Many are aware, while some may not fully grasp, the critical importance of reporting adverse events for public safety.
Our aim was to shed light on this vital aspect through the above write-up. We hope to have provided some new insights. If there’s anything more you’d like to explore about pharmacovigilance.
Feel free to share your thoughts in the comments below. Thank you for reading.
Leave a Reply