Adverse events in healthcare are unexpected or unintended harms that arise directly from medical care, rather than from a patient’s underlying health condition. These incidents are a significant focus in enhancing patient safety. Identifying and learning from these events is crucial for improving healthcare outcomes and preventing future harm.
What Are Adverse Events?
Adverse events are undesirable clinical outcomes resulting from medical diagnosis or therapy, distinct from the patient’s underlying disease process. They encompass any unfavorable symptoms, signs, or medical conditions that appear during medical treatment, even if a direct causal link to a specific medication or procedure has not been definitively established. While medical errors can certainly lead to adverse events, not all adverse events are the result of an error; some can occur despite proper care.
Examples of adverse events include adverse drug reactions, healthcare-associated infections, complications from surgical procedures, or issues related to medical devices. An adverse drug reaction, for instance, is a harmful and unintended response to a medication that occurs at doses normally used for treatment. Healthcare-associated infections, such as central line-associated bloodstream infections or catheter-associated urinary tract infections, can develop during a hospital stay. Surgical complications might involve unintended foreign objects left inside a patient or operating on the wrong site.
Methods of Detection
Detecting adverse events relies on both passive and active surveillance methods. Passive methods involve spontaneous reporting systems, where healthcare professionals or patients voluntarily submit reports of suspected adverse events. In the United States, systems like MedWatch, operated by the Food and Drug Administration (FDA), allow for reporting of adverse events related to drugs, medical devices, and other regulated products. The Vaccine Adverse Event Reporting System (VAERS), co-managed by the Centers for Disease Control and Prevention (CDC) and the FDA, serves a similar purpose for vaccine-related events.
Passive reporting systems are valuable for generating initial signals but often underestimate the true incidence of adverse events due to underreporting. This limitation necessitates active surveillance, which involves proactive efforts by healthcare organizations to identify adverse events. These methods include systematic chart reviews, where personnel examine patient medical records for indications of harm.
Trigger tools are another active method, utilizing specific indicators within patient records, such as an order for an antidote or a sudden change in vital signs, that suggest an adverse event may have occurred. Automated surveillance systems leverage electronic health records (EHRs) to analyze large datasets for patterns or alerts that might signal an event. Many hospitals also employ internal incident reporting systems, allowing staff to document any event or near-miss that could potentially lead to patient harm.
Evaluating the Event
After an adverse event is detected, a structured evaluation process begins to understand its nature and causes. The initial step involves a severity assessment, classifying the event’s impact on the patient. This classification can range from mild (requiring minimal intervention) to moderate (requiring additional treatment or prolonged hospitalization) to severe (resulting in permanent disability or life-threatening consequences). A serious adverse event, for instance, might lead to death, hospitalization, or significant disability.
Following severity, a causality assessment determines the likelihood that the event was related to the medical intervention, treatment, or product, rather than the patient’s underlying condition. This assessment often uses standardized algorithms or expert review to assign a probability, such as “unlikely,” “possibly,” “probably,” or “definitely” related. For example, if a patient develops a rash shortly after starting a new medication, and the rash resolves upon discontinuation, it would likely be considered “probably” or “definitely” related to the drug.
A preventability assessment then evaluates whether the event could have been avoided with different actions or protocols. This involves analyzing the circumstances leading to the event, identifying system weaknesses, and determining if care fell below an expected standard. For instance, a medication error due to incorrect dosage might be deemed preventable if standard double-check procedures were not followed.
The Patient’s Role in Reporting and Safety
Patients and their caregivers play an important role in the detection and evaluation of adverse events. If a patient or their family suspects an adverse event has occurred, the first step is to communicate directly with their healthcare providers. Open and clear communication about new symptoms, unexpected reactions, or concerns regarding treatment is vital for early identification.
Patients should also understand the importance of reporting concerns to the hospital’s patient safety department or quality improvement teams. These internal departments investigate incidents and implement corrective actions to enhance safety within the facility. Beyond direct communication with providers and hospital staff, patients have avenues for external reporting to government agencies.
For adverse drug reactions or medical device issues, patients can submit reports directly to the FDA’s MedWatch program. For suspected adverse events following vaccination, reports can be made to the Vaccine Adverse Event Reporting System (VAERS). Patient reports are an important source of information, often providing the first signal of new or rare adverse events not detected through other surveillance methods. Their active participation contributes to a safer healthcare system for everyone.