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      <ownedComment xmi:id="_L5hUA-LiEduGJrQyRGTO1A" annotatedElement="_420A62FD03B6418AC0B002D1">
        <body>An adverse drug reaction is any unwanted or harmful reaction experienced following the administration of a drug or combination of drugs under normal conditions of use and suspected to be related to the drug. Adverse drug reactions can be divided into two types:

Type A (augmented) reactions result from an exaggeration of a drug's normal pharmacological actions when given at the usual therapeutic dose and are normally dose-dependent (e.g. low blood pressure with antihypertensives, low blood sugar with insulin). They also include reactions that are not directly related to the desired clinical action of the drug (e.g. dry mouth associated with tricyclic antidepressants).

Type B (bizarre) reactions represent a novel response not expected from the known pharmacological actions of the drug (e.g. anaphylaxis with penicillin, angioedema with angiotensin-converting enzyme-inhibiting drugs). They are not normally dependent on the dose.
</body>
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          <body>Date/time this allergy/adverse reaction was entered into the system.</body>
        </ownedComment>
        <type xmi:type="uml:Class" href="Datatypes.efx#_420A62FD03B64244824602F5?VHIM/gov/va/med/cds/cdm/basedatatypes/PointInTime?"/>
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          <body>Indicates the symptom observed that is suspected to have been caused by adverse reaction.</body>
        </ownedComment>
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          <body>Captures participation information (who, when, comments) of the person who created the Reaction Observation record.

&quot;A party that originates the Act and therefore has responsibility for the information given in the Act and ownership of this Act.  ... The author (or authors) has ownership of the Acts that they originate. This means that a party other than this author (or those authors) cannot cancel, abort, complete or modify the state or content of this Act in any other way. A party other than the author may only amend, reverse, override, replace, or follow up in other ways on this Act, whereby the Act remains intact and is linked to another Act authored by that other party.&quot; (HL7)
</body>
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    <packagedElement xmi:type="uml:Class" xmi:id="_420A62FD03B6418BB10D01EB" name="IntoleranceCondition">
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        <body>Adverse reactions are a subset of adverse events including those that are suspected of being related to the drug.</body>
      </ownedComment>
      <ownedAttribute xmi:id="_420A62FD03B6418BB10D0214" name="recordIdentifier" visibility="public">
        <ownedComment xmi:id="_L59_8-LiEduGJrQyRGTO1A" annotatedElement="_420A62FD03B6418BB10D0214">
          <body>Uniquely identifies this Intolerance Condition record.</body>
        </ownedComment>
        <type xmi:type="uml:Class" href="Datatypes.efx#_eE_dREeDEdyIZay-9vWL7Q?VHIM/gov/va/med/cds/cdm/basedatatypes/EntityIdentifier?"/>
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          <body>Date/time this allergy/adverse reaction was entered into the system.</body>
        </ownedComment>
        <type xmi:type="uml:Class" href="Datatypes.efx#_420A62FD03B64244824602F5?VHIM/gov/va/med/cds/cdm/basedatatypes/PointInTime?"/>
      </ownedAttribute>
      <ownedAttribute xmi:id="_420A62FD03B6418B9EB90252" name="agentCode" visibility="public">
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          <body>A substance that is foreign to the body and can cause an allergic reaction in certain people. For examples, pollen, dander, mold.&#xD;
&#xD;
Note that in VistA today, this information is stored in two fields: The .02 Reactant field, which is free text and the 1 GMR Allergy field, which is a variable pointer to 5 files.  Theoretically, the Reactant field should contain the text value of the record pointed to by the GMR Allergy field, but can differ if the user enters something that does not exist in one of these 5 files. &#xD;
&#xD;
In VistA 2.0, the agent should be a coded value with a VUID assigned, and the user should never be able to enter an allergy that does not have a VUID.  So this is modeled as a code.&#xD;
&#xD;
However, in the meantime, the Alternate Code attribues of the coded value can be used to hold the free text version.&#xD;
&#xD;
In other words, 1 GMR Allergy is mapped to the Designation VUID and Display Name, and .02 Reactant is mapped to the Alternate Display Text.&#xD;
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        </ownedComment>
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      <ownedAttribute xmi:id="_420A62FD03B6459424D00146" name="allergyTypeCode" visibility="public">
        <ownedComment xmi:id="_L50O9eLiEduGJrQyRGTO1A" annotatedElement="_420A62FD03B6459424D00146">
          <body>Indentifys whether the allergy is a Food, Food/Drug, Drug, or Other</body>
        </ownedComment>
        <type xmi:type="uml:Class" href="Datatypes.efx#_dtt5gEncEdyXcM5TklTDNg?VHIM/gov/va/med/cds/cdm/basedatatypes/CodedElementLite?"/>
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          <body>Indicates whether the Intolerance Condition was observed by a clinician (or was medically verified) or was merely reported by the patient.  Provides a measure of trustworthiness of the information.

Note that in VistA, this is called Observed if observed by a clinician, or Historical if patient-reported.
</body>
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          <body>The clinician will need to determine if the allergy can be categorized (mechanism) as either an allergy, an unknown or is a pharmacologic reaction.

Allergy:
An allergy reaction must have symptoms (reaction)r consistent with an actual allergy - rash, hives, severe swelling, redness, itchiness, difficulty breathing (due to swelling around breathing areas), etc.

Unknown:
An unknown reaction is a reaction experienced by the patient that cannot be explained by either of the other two mechanisms, for example, eating a pear and developing a cough or taking a blood pressure medication and developing right elbow pain. This type of reaction is consistent, disappears upon withdrawing the agent, and reappears when the agent or food item is restarted/eaten again.

Pharmacologic
A pharmacologic reaction is an adverse event rather then an allergy.  It is a reaction based on the pharmacologic properties of the drug and has to do with a reaction that can be expected due to the pharmacologic activity of the drug. It can occur when the patient takes the right amount or an amount greater or less than the recommended doses. Some examples are: an antidiarrheal agent (like Immodium) causing constipation, a laxative causing diarrhea, a beta blocker causing bradycardia (slow heart rate), furosemide (a diuretic) causing excessive urination, or a blood pressure medication causing low blood pressure (will be fully modeled in a subsequent phase).
</body>
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      <ownedAttribute xmi:id="_420A62FD03B642C57E0302A4" name="status" visibility="public">
        <ownedComment xmi:id="_L6HJ5-LiEduGJrQyRGTO1A" annotatedElement="_420A62FD03B642C57E0302A4">
          <body>A code specifying the state of the Act.&#xD;
&#xD;
When the StatusCode is set to 'Nullified' iindicates the allergy was entered in error.&#xD;
</body>
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        <ownedComment xmi:id="_L6Q65uLiEduGJrQyRGTO1A" annotatedElement="_420A62FD03B6460A7F1D033A">
          <body>Indicates whether this record has been verified.</body>
        </ownedComment>
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        <ownedComment xmi:id="_L7dNvuLiEduGJrQyRGTO1A" annotatedElement="_420A62FD03B6418BB10D0264">
          <body>The patient may have either a drug, food, or any other type of reaction, such as a reaction to pollen, dust, a cat, or a dog. These types of allergies are represented in the model as individual observations holding their own characteristics.
A drug allergy is a symptom or a group of symptoms caused by an allergic reactionr to a drug (medication). Adverse reactions to drugs are not uncommon, and almost any drug can cause an adverse reaction. Reactions range from irritating or mild side effects (such as nausea and vomiting) to an allergic response including life-threatening anaphylaxis. Some drug reactions are idiosyncratic (unusual effects of the medication). For example, aspirin can cause nonallergic hives (no antibodies formed), or it may trigger asthma. Only a small proportion of these reactions are allergic in nature. Many individuals may confuse an uncomfortable but not serious side effect of a medicine, such as nausea, with a drug allergy, which can be life threatening.

Drug allergies can be entered into the system at the level of a drug class, as the drug itself, or as a specific drug ingredient. A VHA clinician can check from a drop down selection list that contains six different drug files (drug ingredients, drug classes, local drug, national drug (generic and trade), or the GMR Allergy)s. If the drug is an experimental drug and was not yet on any of the lists, then the clinician can request that the drug be added to the list. The system will send an automatic mail message to various recipients requesting the addition of the new drug. The clinician will have to wait to enter the allergy until the drug has been added to the list.

</body>
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          <body>Captures participation information (who, when, comments) of the person who verified the Intolerance Condition record.

Note that while the term &quot;verifier&quot; is commonly used throughout VistA, the equivalent term in HL7's vocabulary is unclear.  Several terms seem to be close, but are not exact matches.  More research is needed.
</body>
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          <body>Captures participation information (who, when, comments) of the person who created the Intolerance Condition record.

&quot;A party that originates the Act and therefore has responsibility for the information given in the Act and ownership of this Act.  ... The author (or authors) has ownership of the Acts that they originate. This means that a party other than this author (or those authors) cannot cancel, abort, complete or modify the state or content of this Act in any other way. A party other than the author may only amend, reverse, override, replace, or follow up in other ways on this Act, whereby the Act remains intact and is linked to another Act authored by that other party.&quot; (HL7)
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