All Posts

Regulatory Reporting of Adverse Events: Things You Should Know 

01 Aug 2023
regulatory reporting qualityze

Businesses must prioritize customer safety at all times. Even though adverse event data is valuable for improving quality systems and processes, it can be challenging without standardized reporting standards. However, Quality professionals can minimize adverse events through proper planning and react appropriately if they do happen to prevent the situation from spiraling out of control.

In this post, we will go through all the essential elements of adverse event reporting so you can manage them more efficiently and effectively than ever.

What is an Adverse Event?

In medical terminology, an “adverse event” is harm associated with medical treatment rather than disease-causing damage. An adverse event can be classified into several subcategories, including:

  • An adverse event that could have been prevented: one caused by an error or the failure to follow a prevention strategy.
  • “Ameliorable adverse events” refers to events that could have been avoided if care had been different, though they cannot be prevented.
  • Negligence-related adverse events occur because clinicians in the community do not meet clinical standards.

Another term that defines hazards to patients without causing harm is:

  • Near Miss: A near miss happens when there is no difference between the outcome of an unsafe situation and a preventable adverse event. As a result of either luck or early detection, a patient does not suffer harm from a hazardous condition.
  • Error: negligence that exposes patients to potentially dangerous situations by committing an error or omitting to do so.

When to Report an Adverse Event?

It is considered a severe event and must be reported to FDA when the patient outcomes are:

  • Death

    You should report any death that may have been caused by an adverse event, including the date if you know it.

  • Potentially fatal

    It is important to report if it is deemed likely that the patient is at substantial risk of death at the adverse event or if the product or device may have led to the patient’s death.

  • Inpatient or outpatient hospitalization

    Adverse events may result in hospital admission or prolongation of hospitalization.

    A patient visiting the emergency room should be evaluated for other serious outcomes without being admitted to the hospital.

  • A permanent injury or disability

    When an adverse event substantially disrupts a person’s everyday life function, such as when the adverse event alters, impairs, damages, or disrupts the patient’s body function/structure, physical activities, and quality of life in a significant, persistent, or permanent manner.

  • Defects at birth/congenital anomalies

    It is important to report if you suspect your child may have experienced an adverse outcome due to exposure to a medical product before conception or during pregnancy.

  • Prevention of Permanent Impairment or Damage (Devices)

    If you suspect a medical product damaged a body structure or impaired a body function permanently, you should notify the FDA.

  • Other Important Medical Events

    You need to report a medical or surgical intervention (treatment) if the event doesn’t fit every outcome but is likely to jeopardize the patient and require medical or surgical intervention.

Adverse Event Reporting: 4 Benefits

Reporting systems are essential to understanding adverse events and implementing preventative measures. Reporting adverse events consistently and uniformly has four key benefits:

  • A better workplace and a safer patient environment

Consistent reporting is essential when it comes to increasing patient safety. This is especially important given the troubling surgical safety statistics.

Approximately one in ten hospital patients suffer an injury while receiving care, and 25 percent of surgical procedures are unsafe. The majority of adverse events during surgery occur in hospitalized patients. Positively, half of the adverse surgical incidents are preventable.

Health and safety legislation is based on consistent and comprehensive data. It is difficult to improve the safety of patients and workers when adverse events are not reported or underreported, thus distorting results.

Many non-fatal and non-harmful medical events go unreported within the healthcare sector. As a result, surgical facilities cannot identify hazards and develop interventions to lower the incidence of future risk by reporting these incidents.

A consistent reporting system provides risk managers with the information they need to optimize worker and patient safety policies and practices.

  • Understand what contributes to system failures

Adverse events and near misses should be reported rigorously, following best practices. With this information, a surgical facility can better identify safety protocol breakdowns or system failures.

Analyzing individual cases of adverse patient events can help identify areas for system improvement. For example, what interventions can we implement to stop these events from happening in future surgeries?

To improve systems, a data-focused approach naturally shifts away from blaming individuals. In this environment, employees at all levels will feel comfortable and empowered to do what is best for patients and the company.

  • Transparency & Trust within Facilities

The Bureau of Labor Statistics (BLS) says there are several reasons why adverse events are still underreported. For example, workers generally resent reporting adverse events for fear of losing their jobs, incentive programs discourage reporting, and barriers within OSHA recordkeeping regulations affect the collection of comprehensive data sets in the healthcare sector.

Is there anything healthcare systems can do about this? First, all employees must be encouraged to report all incidents to create a fair working environment. In addition, emphasize, mitigate risks, and assess system failures instead of individual mistakes. Reporting becomes more transparent and consistent as a result.

  • A heightened sense of security & peace of mind

It’s not just about patient safety when reporting adverse events. It also protects healthcare organizations from costly liability claims by reducing reimbursements for preventable hospital-acquired conditions.

A healthcare facility should report an adverse event immediately if it is responsible for it in any way. Then, when a case goes to court, rapid action can be taken to address patient needs and establish the grounds for demonstrating prompt resolution.

Healthcare facilities need a streamlined system like Qualityze Field Safety Action Management for adverse event reporting to keep pace with compliance requirements and safety standards.

Post market surveillance: keeping adverse events to a minimum

A post market surveillance program (PMS) is responsible for monitoring the safety of pharmaceutical drugs and medical devices after they are released on the market and is an essential part of pharmacovigilance.

FDA approvals are based on clinical trials, which involve relatively few people, which means they do not generally have other medical conditions that may exist in the population as a whole. Post market surveillance can confirm or deny a drug’s safety after it has been used in large numbers of people with a wide range of medical conditions.

The post market surveillance process monitors drug and device safety by using a number of approaches, including spontaneous reporting databases, prescription event monitoring, electronic health records, patient registries, and record linking. A process known as data mining is used to review these data in order to identify potential safety concerns.

Adverse Events: Best Practices to Manage Them

• Set up a safe environment. First, the surgery center must create a nonjudgmental environment. Staff should feel comfortable reporting mistakes promptly if they occur. It’s not to blame anyone; the emphasis is on the system.

• Plan your strategy. It is essential for staff to know who to report adverse events, how to report them, and the expectations regarding timeliness when an adverse event occurs. For example, it is essential not to throw away trash or empty syringes if the adverse event is severe.

• Find someone good at communicating. It is best to speak to a patient about an adverse event with a person who is known as a good communicator by leaders. Ideally, this person would be a physician, nurse, director, or anyone who can build trust with others.

• Assess the need for malpractice insurance. Determining whether malpractice insurance carriers must be notified and involved in serious adverse events is crucial.

• Assess track records. Managing risk involves identifying near-misses and abnormal events. For example, a surgery leader could assess whether people with frequent mistakes are more likely to make errors and collect data about their track records.

• Monitor medication errors. Patients who react negatively to a drug may need a different medication to counteract the reaction.

• Simplify the system. You can always find a solution to any problem. The weakest approach is to educate the employee involved in the adverse event about how to prevent it from happening again.

Adverse Events: Reporting and Managing Them Made Simple

With the advent of cloud solutions, it has become simpler and better to manage and report adverse events timely. You just need one solution to standardize the workflow for adverse events from identification to documentation, evaluation to resolution, and regulatory reporting.

Yes, you heard it right!

Qualityze Field Safety Action Management Software is a cloud-based solution for the enterprises striving to achieve post market excellence. Qualityze provides reliable integration capabilities to ensure efficient management of post-market surveillance activities such as Field Safety Interventions, Recalls, Complaints Handling, and Adverse Events. This software solution helps standardize data fields so that you can consistently capture all required details regarding Field Safety Actions (FSA). This will result in improved decision-making. To ensure the safety of consumers, Qualityze Field Safety Action Management allows enterprises to continuously analyze and improve their field safety management processes.

You can enforce standardized processes using Qualityze Field Safety Action Management to:

  • Track, manage, and capture all the details of the FSA in one place.
  • Perform a health hazard analysis.
  • Monitor distribution data for affected lots and batches of products.
  • Communicate directly with your customers.
  • Report Product Issues/Recalls to the Regulatory Authorities.
  • Integrate with Enterprise Quality Systems for improved control over adverse events.

In addition to medical industry, Qualityze is suitable for Manufacturing, Food and Beverages, Oil and Gas, Electric Vehicles and much more. You can easily configure this cloud-based solution to your business and compliance needs.

The Bottom Line

Managing and reporting adverse events in time is crucial to limit the impact that the slightest error, defect, or deviation can make. In addition, having the right software to manage your post market surveillance activities can reduce the workload for you and your quality inspectors – no matter your industry.



Request Demo

© 2024 Qualityze | All rights reserved. | Privacy Policy