This resource is used to provide a single place within the health record to document a range of clinical statements about adverse reactions to substances/products, including:
– Record a clinical assessment of the individual’s propensity to a potential future reaction upon re-exposure
– Record cumulative information about the reaction to each exposure, including ‘no reaction’ if appropriate
Use to record information about the positive presence of the risk of an adverse reaction:
– To support direct clinical care of an individual
– As part of a managed adverse reaction or allergy/intolerance list
– To support exchange of information about the propensity and events related to adverse reactions
– To inform adverse reaction reporting
– To assist computerized knowledge-based activities such as clinical decision support and alerts
Use to record information about adverse reactions to a broad range of substances, including: biological & blood products; incipients and excipients in medicinal preparations; foods; metal salts; and organic chemical compounds.
Adverse reactions may be:
– An allergy (typically type I hypersensitivity, plus other “allergy-like” reactions, including pseudoallergy)
– An intolerance (typically non-immune adverse reactions that are not determined or perceived to be allergic or “allergy-like”, and are to some degree idiosyncratic and/or individually specific.
In clinical practice distinguishing between allergy and intolerance is difficult and might not be practical. Often the term “allergy” is used rather generically and may overlap with “intolerance”, and the boundaries between these concepts might not be well-defined or understood. The term “intolerance” should generally be applied to a propensity for adverse reactions which is either determined (to the extent that is possible) or perceived to not be allergic or “allergy-like”. If it is not possible to determine whether a particular propensity condition is an allergy or an intolerance, then the type element should be omitted from the resource. Identification of the type of reaction is not a proxy for seriousness or risk of harm to the patient, which is better expressed in the documentation of the clinical manifestation and the assessment of criticality.
The sensitivity in the case of either an allergy or intolerance is unique to the individual, and is distinguished from those reactions that are a property of the circumstance, such as toxicity of a food or drug, overdose, drug-drug, drug-food, or drug-disease interaction (which are reactions that would be expected to occur for any individual given the same circumstances).
This resource has been designed to allow recording of information about a specific substance (e.g., amoxicillin, oysters, or bee sting venom) or pharmaceutical product or, alternatively, a class of substance (e.g., penicillins). If a class of substance is recorded, then identification of the exact substance can be recorded on a per exposure basis.
The scope of this Fast Healthcare Interoperability Resources (FHIR) resource has deliberately focused on identifying a pragmatic data set that is used in most clinical systems or will be suitable for most common clinical scenarios; extensions can be used to add additional detail if required. Examples of clinical situations where the extension may be required include: a detailed allergist/immunologist assessment, for reporting to regulatory bodies or use in a clinical trial.
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.