Adverse Events

Christy L. Skelly; Manouchkathe Cassagnol; Sunil Munakomi; Vincent R. Lee

Adverse Events

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Continuing Education Activity

Adverse events (AE) frequently occur in our medical system, and at least one in ten patients are affected. An AE is a harmful and negative outcome that happens when a patient has been provided with medical care. This activity reviews the evaluation and management of an adverse event and highlights the role of interprofessional team members in collaborating to evaluate and manage the adverse event.

Objectives:

Explain the importance of monitoring patients for an adverse event.
Identify the common causes of an adverse event.
Review the management of an adverse event.
Review the importance of improving care coordination among interprofessional team members to improve outcomes for patients affected by an adverse event.

Introduction

Adverse events (AE) frequently occur in any medical system, and at least one in ten patients are affected.[1] An AE is a harmful and negative outcome that happens when a patient has been provided with medical care.[2] Medical treatment may include a procedure, surgery, or medication. Any patient who undergoes treatment may experience a negative outcome as a result of that treatment. Adverse events that occur with medical treatment can include medication side effects, injury, psychological harm or trauma, or death. Adverse events can be either preventable or unpreventable and are often associated with medication errors.[3] Adverse events can occur with any provision of care or treatment have a wide range of severity.

Etiology

Adverse events are caused by medical treatment, which injures a patient.[4] There are many methodologies in which an adverse event can occur. The adverse event may be a result of treatment such as surgery or medication. In these instances, the cause may be due to human error or a substance within a medication. Other causes, such as equipment or device failure, can contribute to the occurrence of an adverse event. An adverse event may occur unintended or as a side effect during treatment. However, often the benefit of the treatment may be greater than the temporary harm. Many medications can cause an adverse event to occur, and often patients are on multiple medications.[5][6]

Poor communication and improper orders or documentation may also contribute to medical errors.[7] When a client is assessed, the potential of a missed diagnosis or an incorrect diagnosis may cause the client to experience an adverse event.[8] Surgical errors are another cause of potential adverse events. Every year, many clients die from surgery or suffer from improper care during treatment, such as wrong-site errors.[8] The place of treatment can also become the cause of treatment. Many adverse events occur from hospitalization. Nosocomial infections are a major cause of deaths every year, and hospitals employ scrutiny in infection control measures.[9] Finally, an early discharge can often result in adverse events such as readmittance or injury.[10]

Epidemiology

In the United States, over 250,000 patients who receive medical care each year will experience an adverse event.[11] Even worse, over 100,000 patients will die from the care that they received.[12] Many vulnerable patients are more at risk for adverse events.[13][14] Globally, it is estimated that approximately ten percent of patients have been affected by at least one adverse event.[15] Countries with less income report higher rates of adverse events.[16] Age disparities exist in the occurrence of adverse events with children and elderly patients affected at higher rates.[17] Racial disparities occur in the populations of patients affected by adverse events, with black patients being affected at significantly higher rates.[18] Socioeconomic factors such as lack of education have been associated with a higher burden of many chronic diseases.[19].

A systemic analysis review found an annual incidence of adverse events of around 10%, among which 50% were found to be preventable.[20] The mortality rate following such adverse events was estimated at around 8%. The most common adverse events reported in the literature include:[15]

Relating to surgical specialties
Medications and fluid-related
Healthcare-associated infections

History and Physical

Any patient who has any untoward effect or outcome experienced with medical treatment is experiencing an adverse event. This can include a wide range of symptoms that fall between the parameters of temporary harm to death.[21][22] At the beginning of care, the healthcare provider should conduct a thorough history and physical. During the history and physical, any limitations of the patient to withstand the treatment should be noted.[23] For example, an elderly patient with limited kidney function should not be placed on a treatment that is excreted in the renal system. The treatment must be tailored to the findings of this history and physical so that the minimalization of adverse events can be achieved.

Evaluation

When a severe adverse event occurs, it must be evaluated. Evaluation of adverse events should include a patient assessment and related causes. A patient who is receiving treatment should be educated about any potential side effects, and the health care provider should be monitoring the patient for such effects. Symptoms reported by the patient should be assessed. Severe adverse events, such as patient injury or death, are reported and evaluated as sentinel events. The agency will assess the event and discuss the outcome and potential alternative treatments that may have been necessary.[24] Systemic flaws may be evaluated and corrected to prevent future such events. An outside agency will conduct a root cause analysis and issue a response.[8]

As information technology continues to evolve, there are many systems developed to record or even prevent these events.[25] Nationally, the Agency for Healthcare Research and Quality (AHRQ) has developed a list of patient safety indicators (PSI) that should be communicated, and statistical evaluations are continuing to give the medical system and healthcare providers valuable information.[26][27][28] Hospitals can redesign system flaws that are found to contribute to the related adverse event.[29] Treatments that often result in adverse events can be adapted, eliminated, or placed on high alert.[30]

In the United States, many of our healthcare facilities include electronic event reporting systems to collect the voluntary report of an adverse event, but the rates vary widely among facilities.[31][32] A culture of safety currently provides additional avenues for reporting and analysis of medical errors.[33] Quality assurance of care given in our healthcare system includes the further development of adverse event reporting and the systematic response to collected data.[34]

The study pertaining to the incidence of adverse events in the hospital can be analyzed by the usage of the Global trigger tool and the Harvard method.[15]

There are various strategies in improving the patient's safety and upraising the quality of the relevant tools of quality assurance, such as Plan-Do-Study-Act (PDSA) and the Root Cause Analysis (RCA).[35]

Treatment / Management

Adverse events should be treated at the patient level and ultimately managed at the systemic level. When a patient experiences an adverse event, the healthcare provider should provide timely and appropriate treatment. For example, a patient who experiences nausea can be given an antiemetic medication. Adverse events that occur within the medical system must be reported.[36][37][38]

Databases of reported adverse events can provide valuable information that can be used to make the necessary changes in care that can decrease or eliminate adverse events.[39][40][41] There has been a discussion about the under-reporting of adverse events.[42] To promote a true culture of doing no harm, clinicians must adopt the approach of reporting all adverse events.[43] The analysis of the information reported will determine the appropriate system management.

Differential Diagnosis

An adverse event is associated with medical treatment. Therefore a medical treatment occurred before or during the occurrence of the adverse event.[8][44][45] There is much variation in the constitution of an adverse event. For example, a medication may cause nausea, and medication may also result in death. The term adverse event is a broad term that can encompass any negative effect. However, a sentinel event is a term used when the result is serious harm or death. Healthcare providers must report adverse events that result in serious harm or death to the patient as sentinel events.[46][47]

Prognosis

A patient who experiences an adverse event from medical care can become harmed or deceased.[7][48] The level of harm that occurred from the adverse event will greatly contribute to the prognosis. A temporary side effect that is quickly managed has a prognosis of complete recovery. A more severe injury may result in a negative prognosis. The prognosis of the adverse event should be clearly communicated with the patient.

Complications

The ultimate complication from an adverse event is multispectral patterns of patient harm.[8][49] Fortunately, many adverse events are treatable. However, permanent injury and patient death can also occur. The healthcare provider should fully inform the patient about any potential complications of medical treatment. This will allow the patient to make informed choices about any care decisions needed by the patient. When the healthcare provider and the patient work together to make informed decisions, shared decision-making is achieved. The patient always has the right to refuse treatment. Unfortunately, other factors, such as cost and convenience, can impair proper health care decision-making.[50]

The mortality following the adverse events in the hospital is reported at a median of around 8%, and the annual secondary cost factor procured in managing them is estimated at around 17 billion dollars.[15]

Deterrence and Patient Education

Patients can deter the incidence of adverse events by becoming involved and knowledgeable in their care.[51][52] Healthcare providers who fully inform the patient, allow for shared decision-making, and tailor treatments to the patient's needs can deter the incidence of adverse events. Adverse events that are expected should be completely reviewed with the patient receiving the care. Furthermore, healthcare providers who report adverse events provide data needed to determine the incidence and significance of the adverse events. Therefore, the medical system needs to support a culture of safe care by providing the resources and support needed to report adverse events.

Pearls and Other Issues

Adverse events frequently occur in healthcare. Healthcare providers must ensure that proper care is given and that patients are monitored for any adverse events. The fragmentation of our current healthcare system poses additional strains on the prevention of adverse events.[53] Patient education upon admission and discharge can help to ensure that the communication of negative outcomes is reported and addressed. When adverse events occur, a thorough review of the incident should be completed, and any needed changes should be made to the care protocols and process. These actions can decrease future adverse events from occurring and improve patient safety.[54]

Enhancing Healthcare Team Outcomes

Every member of the healthcare team can play a part in decreasing the incidence of adverse events. Proper prevention, reporting, follow-up, and analysis can all contribute to better care and the lowered incidence of adverse events. Healthcare team outcomes can be improved through the analysis of adverse events and the development of safer or alternative treatments.[55][56][57][8][58]

The list of reportable adverse events include:[59]

Surgical events - wrong patient, wrong site, wrong procedure, retained foreign body
Product/device related - contaminated products, air embolism
Patient protection events - patient elopement, suicide
Care management issues - medication errors, mismatched blood transfusion
Environmental factors - burn, electric shock, wrong gas
Criminal events - sexual assault, impersonation, physical assault

There is a pivotal need for developing a 'safety first' culture to prioritize our accountability in safeguarding the health of our patients. The implementation of WHO's surgical safety checklist can be the yardstick in minimizing the occurrence of adverse events in surgical specialties.[60]

Details

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