This entry content module makes use of the medicine and instruction entry content
modules. Medi- cations and their prescriptions are perhaps the most difficult data
elements to model due to varia- tions in the ways that medications are prescribed.
This profile identifies the following relevant fields of a medication as being important
to be able to generate in a medical summary. The table below identifies and describes
these fields, and indicates the constraints on whether or not they are required to
be sent. The fields are listed in the order that they appear in the CDA XML content.
Field
CDA Tag
Description
Start and Stop Date
<effectiveTime>
The date (and time if available) when the medication regimen began and is expected
to finish. The first component of the <effectiveTime> encodes the lower and upper
bounds over which the <substanceAdministration> occurs, and the start time is determined
from the lower bound. If the medication has been known to be stopped, the high value
must be present, but expressed as a flavor of null (e.g., Unknown).
Frequency
<effectiveTime>
The frequency indicates how often the medication is to be administered. It is often
expressed as the number of times per day, but which may also include information such
as 1 hour before/after meals, or in the morning, or evening.The second <effectiveTime>
element encodes the frequency. In cases where split or tapered doses are used, these
may be found in subordinate <substanceAdministration> elements.
Route
<routeCode>
The route is a coded value, and indicates how the medication is received by the patient
(by mouth, intravenously, topically, et cetera).
Dose
<doseQuantity>
The amount of the medication given. This should be in some known and measurable unit,
such as grams, milligrams, et cetera. It may be measured in "administration" units
(such as tablets or each), for medications where the strength is relevant. In this
case, only the unit count is specified , no units are specified. It may be a range.
The name of the substance or product. This should be sufficient for a provider to
identify the kind of medication. It may be a trade name or a generic name. This information
is required in all medication entries. If the name of the medication is unknown, the
type, purpose or other description may be supplied. The name should not include packaging,
strength or dosing information. Note: Due to restrictions of the CDA schema, there
is no way to explicitly link the name to the narrative text.
The strength of the medication is expressed as a the ratio of each active ingredient
to a unit of medication. For example, the medication Percocet comes in a variety of
strengths, which indicate specific amounts of two different medications being received
in single tablet. Another example is eye-drops, where the medication is in a solution
of a particular strength, and the dose quantity is some number of drops. Note: Due
to restrictions of the CDA schema, there is no way to separately record the strength.
The epSOS extension is used to provide this
information. In order to be compliant with the IHE PCC template strength information should be
also conveyed through the consumable/code/originalText element as reference to the
narrative block.
A code describing the active ingredient(s) of the product from a controlled vocabulary,
such as ATC, for example.
Instructions
<entryRelationship>
A place to put free text comments to support additional relevant information, or to
deal with specialized dosing instructions. For example, "take with food", or tapered
dosing.
Indication
<entryRelationship>
A link to supporting clinical information about the reason for providing the medication
(e.g., a link to the relevant diagnosis).
Context
Parent nodes of template element with id 1.3.6.1.4.1.12559.11.10.1.3.1.3.4
<substanceAdministrationclassCode="SBADM"moodCode="INT|EVN"> <templateIdroot="2.16.840.1.113883.10.20.1.24"/><templateIdroot="1.3.6.1.4.1.12559.11.10.1.3.1.3.4"/><idroot=""extension=""/><!-- Optional NOT TO BE USED for medication being administered or prescribed --> <codecode=""codeSystem=""displayName=""codeSystemName=""/><text> <referencevalue="#med-1"/></text><statusCodecode="completed"/><effectiveTimexsi:type="IVL_TS"> <lowvalue=""/><highvalue=""/></effectiveTime><effectiveTimeoperator="A"xsi:type="TS|PIVL_TS|EIVL_TS|SXPR_TS"> <!-- ... --> </effectiveTime><routeCodecode=""codeSystem=""displayName=""codeSystemName=""/><doseQuantityvalue=""unit=""/><approachSiteCodecode=""codeSystem=""displayName=""codeSystemName=""/><rateQuantityvalue=""unit=""/><consumable> <!-- ... --> </consumable><author> <time/><assignedAuthor> <id/><assignedPerson> <name/></assignedPerson></assignedAuthor></author><!-- 0..* entries describing the components --> <entryRelationshiptypeCode="COMP"> <sequenceNumbervalue=""/></entryRelationship><!-- An optional entry relationship that indicates the reason for use --> <entryRelationshiptypeCode="RSON"> <actclassCode="ACT"moodCode="EVN"> <templateIdroot="1.3.6.1.4.1.19376.1.5.3.1.4.4.1"/><idroot=""extension=""/></act></entryRelationship><!-- Optional instrctions for Phramacist --> <entryRelationshiptypeCode="SUBJ"> <!-- ... --> </entryRelationship></substanceAdministration>
There are open issues with this item:
epsos-issue-101: templates for Normal Dosing, split dosing and combination medication (Deferred)
epsos-issue-188: Dosing-specific templates do not appear in template ID list (Open)
epsos-issue-199: doseQuantity: value set binding for units (Open)
Item
DT
Card
Conf
Description
Label
hl7:substanceAdministration
R
The general model is to record each prescribed medication in a <substanceAdministration>
intent (moodCode='INT'). To record medications which were taken in the past, the moodCode
shall be set to 'EVN'. The <substanceAdministration> element may contain subordinate
<substanceAdministration> elements in a related component entry to deal with special
cases (see the following sections below on Special Cases). These cases include split, tapered, or conditional dosing, or combination medications.
The use of subordinate
<substanceAdministration> elements to deal with these cases is optional. The comment
field should always be used in these cases to provide the same information as free
text in the top level <substanceAdministration> element. There are a variety of special
cases for dosing that need to be accounted for. These are described below. Most of
these special cases involve changing the dosage or frequency over time, or based on
some measurement. When the dosage changes, then additional entries are required for
each differing dosage. The last case deals with combination medications.
For the purposes of WP3.5 only the normal, the split dosing and the combination medications
are addressed.
Normal Dosing 1.3.6.1.4.1.19376.1.5.3.1.4.7.1 This template identifier is used to identify medication administration events that
do not require any special processing. The parent template is 1.3.6.1.4.1.19376.1.5.3.1.4.7.
Medications that use this template identifier shall not use subordinate <substanceAdministation>
acts.
This template identifier is used to identify medication administration events that
require special processing to handle combination medications. The parent template
is 1.3.6.1.4.1.19376.1.5.3.1.4.7. A combination medication is made up of two or more
other medications. These may be prepackaged, such as Percocet, which is a combination
of Acetaminophen and oxycodone in predefined ratios, or prepared by a pharmacist,
such as a GI cocktail.
In the case of the prepackaged combination, it is sufficient to supply the name of
the combination drug product, and its strength designation in a single <substanceAdministation>
entry. The dosing information should then be recorded as simply a count of administration
units.
In the latter case of a prepared mixture, the description of the mixture should be
provided as the product name (e.g., "GI Cocktail"), in the <substanceAdministration>
entry. That entry may, but is not required, to have subordinate <substanceAdministration>
entries included beneath it to record the components of the mixture.
Split Dosing 1.3.6.1.4.1.19376.1.5.3.1.4.9 This template identifier is used to identify medication administration events that
require special processing to handle split dosing. The parent template is 1.3.6.1.4.1.19376.1.5.3.1.4.7.
A split dose is often used when different dosages are given at different times (e.g.,
at different times of day, or on different days). This may be to account for different
metabolism rates at different times of day, or to simply address drug packaging deficiencies
(e.g., and order for Coumadin 2mg on even days, 2.5mg on odd days is used because
Coumadin does not come in a
2.25mg dose form). In this case a subordinate <substanceAdministration> entry is required for each separate
dosage.
Other template IDs exist for the tapered doses, split dosing, conditional dosing,
and combination medications. The reader is pointed to the PCC-TF:2 section 6.1.4.16.5.
For the epSOS purposes, only the normal, the combination and the split dosing are
described.
IHE PCC templateId Note: The usage of statusCode values different from “completed” makes this specification
not formally compliant with the current IHE PCC specification of the Medication Item
Entry Content Module. All the requirements of conformance assertion with these IHE
PCC templates cannot therefore be applied until the revision – if any - of the referenced
IHE PCC templates.
A top level <substanceAdministration> element must be uniquely identified. This can
be the prescription item ID if appropriate. Although HL7 allows for multiple identifiers,
one and only one shall be used.
The <code> element is used to supply a code that describes the <substanceAdminstration>
act, not the medication being administered or prescribed. This may be a procedure code, such as those found in ICD-10, or may describe the
method of medication administration, such as by intravenous injection. The type of
medication is coded in the consumable; do not supply the code for the medication in
this element. This element is optional.
Note: One of the values from the Value Set epSOSCodeNoMedication shall be used in the
<code> element to record that a patient is either not on medications, or that medications
are not known.
The URI given in the value attribute of the <reference> element points to an element
in the narrative content that contains the complete text describing the medication.
In a CDA document, the URI given in the value attribute of the <reference> element
points to an element in the narrative content that contains the complete text describing
the medication.
The status of all <substanceAdministration> elements must be either "active" or "completed".
Status of "active" indicates a currently valid prescription, status of completed indicates
a previously taken medication.
The first <effectiveTime> element encodes the start and stop time of the medication
regimen. This an interval of time (xsi:type='IVL_TS'), and must be specified as shown.
This is an additional constraint placed upon CDA Release 2.0 by this profile, and
simplifies the exchange of start/stop and frequency information between EMR systems.
The <low> and <high> values of the first <effectiveTime> element represent the start
and stop times for the medication. The <low> value represents the start time, and
the
<high> value represents the stop time. If either the <low> or the <high> value is
unknown, this shall be recorded by setting the nullFlavor attribute to UNK.
The <high> value records the end of the medication regime according to the information
provided in the prescription or order. For example, if the prescription is for enough
medication to last 30 days, then the high value should contain a date that is 30 days
later then the <low> value. The rationale is that a provider, seeing an un-refilled
prescription would normally assume that the medication is no longer being taken, even
if the intent of the treatment plan is to continue the medication indefinitely.
The second <effectiveTime> element records the frequency of administration. This <effectiveTime> element must be intersected with the previous time specification
(operator='A'), producing the bounded set containing only those time specifications
that fall within the start and stop time of the medication regimen. Several common
frequency expressions appear in the table below, along with their XML representations.
This effectiveTime has a xsi:type of either TS, PIVL_TS, EIVL_TS, or SXPR_TS.
The mean (average) of the low and high values is specified for the period. The mean
of 4 and 6 is 5. The standard deviation is recorded as one half the differences between
the high and low values, with an unspecified distribution. The type attribute of the
<effectiveTime> element describes the kind of frequency specification it contains.
More detail is given for each type in the table below.
xsi:type
Description
TS
An xsi:type of TS represents a single point in time, and is the simplest of all to
represent. The value attribute of the <effectiveTime> element specifies the point
in time in HL7 date-time format (CCYYMMDDHHMMSS)
PIVL_TS
An xsi:type of PIVL_TS is the most commonly used, representing a periodic interval
of time. The <low> element of <phase> may be present. If so it specifies the starting
point, and only the lower order components of this value are relevant with respect
to the <period>. The <width> element represents the duration of the dose administration
(e.g., for IV administration). The <period> indicates how often the dose is given.
Legal values for the unit attribute of <period> are s, min, h, d, wk and mo representing
seconds,
minutes, hours, days, weeks, and months respectively.
EIVL_TS
An xsi:type of EIVL_TS represents an event based time interval, where the event is
not a precise time, but is often used for timing purposes (e.g. with meals, between
meals, before breakfast, before sleep). Refer to the HL7 TimingEvent vocabulary for
the codes to use for the <event> element. This interval may specify an <offset> which
provides information about the time offset from the specified event (e.g., <offset><low
value='-1' unit='h'/><width value='10' unit='min'/></offset> means 1 hour before the
event. In that
same example, the <width> element indicates the duration for the dose to be given.
SXPR_TS
An xsi:type of SXPR_TS represents a parenthetical set of time expressions. This type
is used when the frequency varies over time (e.g., for some cases of tapered dosing,
or to handle split dosing). The <comp> elements of this <effectiveTime> element are
themselves time expressions (using any of the types listed above). Each <comp> element
may specify an operator (e.g. to intersect or form the union of two sets).
The <routeCode> element specifies the route of administration using the EDQM route
of administration vocabulary. A code must be specified if the route is known, and
the displayName attribute should be specified. If the route is unknown, this element
shall not be sent.
The dose is specified in the <doseQuantity> element.
If a dose range is given (e.g., 1-2 tablets, or 325-750mg), then the <low> and <high>
bounds are specified in their respective elements...
If the dose is in countable items (tablets, caplets, "eaches"), then the unit should
be valorized = ‘1’. In this case it is allowed to used the UCUM annotations for describing
the type of countable items (e.g. .{tablet}, {puff},..).
The unit attribute – when expresses unit of measures- shall be derived from the Value
Sets epSOSUnits, 1.3.6.1.4.1.12559.11.10.1.3.1.42.16 based on the UCUM code system.
The countable units attribute is derived from the value set epSOSDoseForm, OID 1.3.6.1.4.1.12559.11.10.1.3.1.42.2
The rate is specified in the <rateQuantity> element. The rate is given in units that
have measure over time. In this case, the units should be specified as a string made
up of a unit of measure (see doseQuantity above), followed by a slash (/), followed
by a time unit (s, min, h or d). Again, if a range is given, then the <low> and <high> elements contain the lower and
upper bound of the range, otherwise, they contain the same value. Any <low> and <high> elements used for <doseQuantity> or
<rateQuantity> should contain a <translation> element that provides a <reference>
to the <originalText> found in the narrative body of the document.
In a CDA document, any <low> and <high> elements used for <doseQuantity> or <rateQuantity>
SHOULD contain a <translation> element that provides a <reference> to the <originalText>
found in the narrative body of the document.
(Medtem)
hl7:consumable
1 … 1
R
The <consumable> element shall be present, and shall contain a <manufacturedProduct>
element, conforming to the Medicine Entry Content module template. Contains 1.3.6.1.4.1.12559.11.10.1.3.1.3.1epSOS CDA ManufacturedProduct (DYNAMIC)
(Medtem)
where [hl7:manufacturedProduct [hl7:templateId [@root='1.3.6.1.4.1.12559.11.10.1.3.1.3.1']]]
@typeCode
cs
0 … 1
F
CSM
Included
0 … *
R
from 2.16.840.1.113883.3.1937.777.11.10.103epSOS CDA author prescriber (DYNAMIC) In the case where there is a prescriber of a medication, the prescriber is represented
by the <author> element of the entry. See the Prescriber description for the structure
of the <author> element.
The author/time element represents the start time of the author’s participation in
the creation of the clinical document. The author/time element SHALL be present.
(Medtem)
hl7:assignedAuthor
1 … 1
R
(Medtem)
@classCode
cs
0 … 1
F
ASSIGNED
Schematron assert
role
error
test
@nullFlavor or hl7:assignedPerson or hl7:assignedAuthoringDevice
Message
If assignedAuthor has an associated representedOrganization with no assignedPerson
or assignedAuthoringDevice, then the value for "ClinicalDocument/author/assignedAuthor/id/@NullFlavor"
SHALL be "NA" "Not applicable" 2.16.840.1.113883.5.1008 NullFlavor STATIC.
An entry relationship may be present to provide the fulfillment instructions. When
present, this entry relationship shall contain a Medication Fulfillment Instructions
entry content module.
Again, a related statement is made about the medication or immunization. In CDA, this
observation is recorded inside an <entryRelationship> element occurring at the end
of the substance administra- tion or supply entry. The containing <act> is the subject
(typeCode='SUBJ') of this new observation, which is the inverse of the normal containment
structure, thus inversionInd='true'.
where [@typeCode='SUBJ'] [hl7:act [hl7:templateId [@root='2.16.840.1.113883.10.20.1.43']
and hl7:templateId [@root='1.3.6.1.4.1.19376.1.5.3.1.4.3.1']]]
@typeCode
cs
1 … 1
F
SUBJ
@inversionInd
bl
1 … 1
R
hl7:entryRelationship
0 … *
R
A top level <substanceAdministration> element may contain one or more related components,
either to handle split dosing, or to support combination medications. In the first case, the subordinate components shall specify only the changed <effectiveTime>
and/or <doseQuantity> elements. The value of the <sequenceNumber> shall be an ordinal
number, starting at 1 for the first component, and increasing by 1 for each subsequent
component. Components shall be sent in <sequenceNumber> order.
This information is given for
informative purposes as only normal or combination medications are administered in
epSOS.
Template Medication Item
tem)
error