An event within a care setting, might or might not impact an individual but had the potential to cause an adverse event. An adverse event is the result of an intervention that caused unintentional harm to a specific subject or group of subjects. Examples of adverse events include the administration of an incorrect drug or an incorrect dose of a drug causing an adverse reaction, the use of an implanted device that causes an infection, or a biologic used during a research study that causes unanticipated renal failure. These events are characterized by the need to capture cause and effect (although they might not be known at the time of the event), severity, and outcome.
The context of an adverse event is also important. A subject may have conditions or current treatments (medications, diet, devices) that impact their response to a newly introduced medication, device or procedure. Knowledge of these variables is essential in establishing a cause and effect relationship for an adverse event.
A potential adverse event may also be called a near miss or an error. These are also events but because they were detected but did not cause harm to a subject. Examples of potential adverse events include a product problem such as a faulty pacemaker that is detected prior implantation, a doctor working simultaneously on two electronic health records realizing the order for a drug was entered on the incorrect patient and then canceling the order, or a patient with a peanut allergy notices that his hospital dinner tray includes peanuts, and he does not eat the peanuts.
The Adverse Event resource is designed to represent events that have a harmful impact on a subject or had the potential to cause harm to a subject but were avoided. In the course of medical care, there are many actions that may impact how a subject responds to a particular treatment impacting patient safety. Therefore, the Adverse Event resource may reference multiple other resources to represent the context or details of an adverse event including but not limited to Observation, Condition, Medication Adminsitration, Immunization, Procedure, or Research Study.
A Detected Issue reference is also related to the context of an Adverse Event to the extent that a known risk for a potential issue such as a drug-drug interaction is documented. If in the context of a known issue, and adverse event occurs, citing this relationship is important for preventing such an occurrence in the future.
The Adverse Event resource should not be used when a more specific resource exists. The Adverse Event resource is not intended to be used to capture potential subject risk in a prospective manner. A more appropriate resource for this purpose would be Risk Assessment which captures predicted outcomes for a patient or population on the basis of source information. Examples include a prognosis statement for a particular condition, risk of health outcome (heart attack, particular type of cancer) on the basis of lifestyle factors and/or family history or list of potential health risks based on a patient’s genetic analysis.
Fast Healthcare Interoperability Resources (FHIR) is a draft standard describing data formats and elements (known as “resources”) and an application programming interface (API) for exchanging electronic health records. The standard was created by the Health Level Seven International (HL7) health-care standards organization.
Its goal is to facilitate interoperation between legacy healthcare systems, to make it easy to provide healthcare information to healthcare providers and individuals on a wide variety of devices from computers to tablets to cell phones, and to allow third-party application developers to provide medical applications which can be easily integrated into existing systems.
FHIR provides an alternative to document-centric approaches by directly exposing discrete data elements as services. For example, basic elements of healthcare like patients, admissions, diagnostic reports and medications can each be retrieved and manipulated via their own resource URLs (Uniform Resource Locators). FHIR was supported at an American Medical Informatics Association meeting by many EHR (Electronic Health Record) vendors which value its open and extensible nature.