Design Comments: An oprional unique identifier for one (set of) product use instruction for the purpose of specific reference or recall.

Design Comments: Optionally used to describe the full use and indication situation in words.

Design Comments: Timing patterns (e.g., twice a day, every 8 hours, etc.) and timing boundaries (e.g., for 10 days) can be specified for the main SubstanceAdministration and its component SubstanceAdministration.In addition, SubstanceAdministration.effectiveTime can give general timing constraints, such as, "give 1 hour before meal". However, more specific clinical situations in which to give the medicine (e.g., "15 minutes before exercise" or "before sexual intercourse", etc.) must be specified using preconditions to a ClinicalSituationCriterion.

Design Comments: The route by which the product is to be given according to this instruction.

Design Comments: Amount of the medicine given at one single administration. The medicine in terms of which this dose is specified can be clarified using the consumable participation which leads either to the Medicine or to an ActiveIngredient. This can be specified by means of reference to the ManufacturedProduct.id or the ActiveIngredient.id, without requiring repeating the detail of these roles and entities playing the roles.

Design Comments: Reveals the products used as inputs into reconstitution.

UsageNotes: Dose unit must be specified when not dosing based on the specific formulation (e.g., tablet, actuation) otherwise the strength is not known.

Design Comments: An ActRelationship of type "reason" representing the indication of the substance administration by linking to an observation criterion. The typeCode of the reason ActRelationship can be further refined to indicate different motivations, such as therapeutic reason (as a remedy), prophylactic reason (as a means of prevention), or as diagnostic reason (something done to diagnose the disease.

Design Comments: Links a SubstanceAdministation to a specified kind of Observation which is used for calculated dosage. An example would be:

<substanceAdministration>

...

<maxDoseQuantity>

<numerator xsi:type="EXPR_PQ" unit="mg">

<expression mediaType="application/hl7-factor+xml"/>

<factor value="57" unit="mg/kg">

<factor>bodyMass</factor>

</expression>

</numerator>

<denominator value="1" unit="d"/>

</maxDoseQuantity>

...

<consumable>

<activeIngredient ... />

</consumable>

<derivedFrom>

<localVariableName>bodyMass</localVariableName>

<monitoringObservation>

<code code="29463-7" codeSystem="&LOINC;" displayName="BODY WEIGHT:MASS:PT:^PATIENT:QN"/>

</monitoringObservation>

</derivedFrom>

</substanceAdministration>

Note: the EXPR data type is forthcoming in the release 2 of the HL7 data type specification under ballot at the same time as release 4 of this specification is being balloted. Also note, the unit attribute on the maxDoseQuantity numerator indicates the unit of the expression value, i.e., it guarantees that the expression evaluates to a physical quantity in this specified unit.

Design Comments: If dosage regimens should vary, this can be specified by component SubstanceAdministrations. In that case, the main SubstanceAdministration must not have a doseQuantity of itself, and instead the subordinate component SusbtanceAdministration would carry the doseQuantity for each different dose. This is used for example, to specify a loading dose, or a tapering dose. A regimen with a loading dose is specified using two components, the first representing the initial dose, with repeatNumber = 1 (meaning "once") or any other limitation in number or time. That first component would be followed by a second component that can repeat for the rest of the duration of the therapy. For tapering doses, the first component would represent the duration of the therapy and the second (or following) components specify the tapering-off scheme.

Design Comments: Links an issue to the product use substance administration.

Design Comments: An observation criterion that is specified as the "reason" (ActRelationship) of the SubstanceAdministration. The observation criterion consists of a code to indicate that the observation is a diagnoses, symptoms, conditions, etc. and a value-code to represent the specific indication, e.g. hypertension, etc.

Design Comments: An indication criterion in terms of a procedure, e.g., to specify a use that would accompany a procedure or be given subsequent or in preparation of a certain procedure.

Design Comments: Fixed value (true) indicating that this is a criterion and not an event that actually took place.

Design Comments: A code specifying the kind of procedure.

Design Comments: The local variable is the name by which the referenced observation is referred to in the formula expression.

Design Comments: Specifies which observation instance from a set of matching ones is selected (e.g., first, last, maximum, minum, or summaries, such as average.)

Design Comments: Specifies a kind of Observation which is used for calculated dosage.

Design Comments: For a sequence of dosage variants, specify 1 for the first, 2 for the following, and so on. This may be inferred or held consistent with the ordering of the variants in the message or document, but the meaning of sequencing is independent of the ordering of data items in messages or documents.

Design Comments: A subordinate component SusbtanceAdministration which carries the doseQuantity for a step in a complex dosage plan. This is used for example, to specify a loading dose, or a tapering dose.

Design Comments: See the RIM description of rateQuantity.

Design Comments: Adverse events, interactions, contraindications and other issues of special caution are represented in one uniform structure. The Pharmacy SIG has established a special kind of Act, called Issue for this purpose. An Issue has one or more other Acts as subjects and indicate that there is a certain problem requiring special caution with its subject Acts. In the case of SPL, the subject is the SubstanceAdministration described in the label. One or more additional subjects can be used to specify additional ClinicalSituationCriteria such as ObservationCriteria or SubstanceAdministrationCriteria. The latter is used to represent interactions which is an Issue involving the administration of two substances.

Design Comments: A text description of the issue. This could be displayed as part of a reminder.

Design Comments: An ActRelationship linking an Issue to a risk, i.e. a coded ConsequenceObservation criterion with information about severity and frequency of the undesired outcome.

Design Comments: An observation criterion specifying the adverse outcome as the usual code-value pair of an observation.

Design Comments: Fixed value (true) indicating that this is a criterion and not an event that actually took place.

Design Comments: The description of the risk can nest to refine to a level of specificity that makes the adverse event actually recognizable. For example, a risk may be specified as a "hypersensitivity syndrome" but then specific manifestations may be given including "rash," or "Guillain-Barre Syndrome", or even quantitative measures as "leukopenia with WBC below 1000/mm3."

Design Comments: A specification of severity of an adverse event as an observation criterion.

Design Comments: A specification of frequency of occurrence of an adverse event as an observation criterion.

Design Comments: This attribute is fixed to 2. See the sequenceNumber attribute of component[monitoringObservation] for its use.

Design Comments: Specifies a criterion (e.g., range) within which certain test results should remain, such as blood levels of the drug or its metabolites should remain to ensure efficacy and avoid toxicity. MonitoringObservation.code specifies the observations that would be performed (e.g. digoxin level, gentamicin level, etc.) and the MonitoringObservation.value specifies a result-value interval with single bounds (e.g. maximal limits) or two bounds (range) that should be maintained throughout the treatment.

The indication can be further specified to express an objective as to what the treatment should accomplish. For instance, if the goal of the treatment is absence of acute asthma attacks, the maintenance goal can describe this. This is used to allow the treatment effect to be coded and still keep the indication a simple code that is comparable with actual patient problem list data. For instance, the indication would be "asthma" and the maintenance goal would be "no bronchiospasm" to indicate "prevention of bronchiospasm in patients with asthma".

Design Comments: An ActRelationship that links ClinicalSitutaionCriteria with the pivotal SubstanceAdministration. A ClinicalSituationCriterion is a choice of either ObservationCriterion, SubstanceAdministrationCriterion or general ActCriterion. These preconditions further limit the indication to a specific population or other clinical situation. Multiple preconditions can be specified. When multiple criteria are specified, they are logically conjoined (AND), i.e., they must all hold true.

Design Comments: Specifies an observation that would be made in the described situation, and would characterize the situation. Used as a precondition to the situation. The observation criterion consists of a code to indicate that the observation is a diagnoses, symptoms, conditions, etc. and a value to represent the specific condition, e.g. renal failure, impaired liver function (as value code); systolic blood pressure < 100 mmHg (as numeric value range), etc.

Design Comments: A unique identifier for this criterion.

Design Comments: A textual description of the criterion. To be used infrequently.

Design Comments: This is "false" by default, i.e., no negation. If "true", it means that the inverse of the observation is specified. Note: this was negationInd in previous releases.

Design Comments: Specifies a certain time constraint between the clinical situation and the use of the drug. E.g., "use 15 minutes before exercise" or "X should be given at least 8 hours after Y".

Design Comments: Specifies an observation that would be made in the described situation, and would characterize the situation. Used as a precondition to the situation. The observation criterion consists of a code to indicate that the observation is a diagnoses, symptoms, conditions, etc. and a value to represent the specific condition, e.g. renal failure, impaired liver function (as value code); systolic blood pressure < 100 mmHg (as numeric value range), etc.

Design Comments: The ActCriterion is a general criterion to give a procedure code or a code of any other clinical service that would be used to limit either positively or negatively the indication of the drug.

Design Comments: The SubstanceAdministrationCriterion specifies another treatment and is used by Issue to specify an interacting treatment, and with a Precondition to specify adjunctive treatment.

Design Comments: A unique identifier by which the criterion may be recalled.

Design Comments: A code for an activity.

Design Comments: True if the meaning is "activity not done". Note: this was negationInd in previous releases.

Design Comments: This attribute is set to 1 for "screening" tests or first-line preferred or preparatory treatments, i.e., those that should be performed before start of treatment protocol, 2 for monitoring observations and co-therapies that should be done during the treatment with the main drug,and 3 for follow-up/weaning/tapering. The underlying semantics is that sequenceNumber orders the components of the protocol. If the sequence number is equal in both components, it means these are done in parallel. Otherwise the components are to be executed in the order of ascending sequenceNumber. For simplicity of use and interpretation, the sequenceNumber of the treatment component has been fixed to 30, so that the choice between screening and monitoring can be done in a single element.

Design Comments: Prescribe the tests that should be performed and in what frequency. MonitoringObservation.code detailing the tests that should be performed (e.g. thrombocytes count, liver enzymes, etc.) The MonitoringObservation.effectiveTime is used to specify the recommended frequency of these tests in the same way as the frequency of SubstanceAdministration is specified.

Design Comments: Since the clinical medication module is all about appropriate and safe use of the drug, this "use" of the drug, i.e., the central SubstanceAdministration is the pivot of all structured data of the highlights. This SubstanceAdministration is a definition and defines the key data of a proper use of the medicine.