HISO 10041.1 CDA Templates for Medications, Allergies and Adverse Reactions - Continuum of Care Interim Standard March 2014
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HISO 10041.1
CDA Templates for
Medications, Allergies and
Adverse Reactions
Continuum of Care Interim Standard
March 2014
Document information
HISO 10041.1 CDA Templates for Medications, Allergies and Adverse Reactions is an interim
standard for the New Zealand health and disability sector
Published in March 2014 by the Ministry of Health
ISBN 978-0-478-41585-8 (online)
This document carries the Health Information Standards Organisation (HISO) and Connected
Health brands of the National Health IT Board
HISO is the expert advisory group on standards to the National Health IT Board
This document can be found on our website at http://www.ithealthboard.health.nz/standards.
Contributors
The following organisations contributed to the development of this standard through represen-
tation on HISO or one of its working groups:
National Medication Safety Programme Accident Compensation Corporation
Nursing Council of New Zealand Chief Medical Officers Forum
Health Informatics New Zealand Health Sector Architects Group
Patients First
Copyright
Crown copyright (c) – This copyright work is licensed under the Crea-
tive Commons Attribution-No Derivative Works 3.0 New Zealand li-
cence http://creativecommons.org/licenses/by-nd/3.0/nz. You may
copy and distribute this work provided you attribute it to the Ministry of Health, you do not
adapt it and you abide by the other licence terms.
Keeping standards up-to-date
HISO standards are regularly updated to reflect advances in health information science and
technology. Always be sure to use the latest edition of these living documents.
We welcome your ideas for improving this standard and will correct any errors you report. Con-
tact us at standards@moh.govt.nz or write to Health Information Standards, Ministry of Health,
PO Box 5013, Wellington 6145.
See the HISO website for information about our standards development processes.
ii HISO 10041.1 CDA Templates for Medications, Allergies and Adverse ReactionsContents
1 Introduction 1
1.1 Purpose 1
1.2 Context 1
1.3 Scope 2
2 Patient medications 4
2.1 Medicinal product 4
2.2 Medication list 6
2.3 Medications section 14
3 Allergies and adverse reactions 15
3.1 Allergies and adverse reactions section 16
3.2 Allergies 17
3.3 Adverse reactions 24
3.4 Manifestation 28
3.5 Information source 29
4 Patient medications document 30
HISO 10041.1 CDA Templates for Medications, Allergies and Adverse Reactions iii1 Introduction
This standard is a technical specification for interoperability between computer systems. It de-
fines the required format of patient medications, allergies and adverse reactions data exchanged
at transfer of care and supporting shared care.
1.1 Purpose
Knowledge of the patient’s medicines, allergies and adverse reactions is essential for safe and
effective transfer of care and shared care. In order for everyone involved to have ready access to
the same information, the clinical information systems supporting these processes must be in-
teroperable.
HISO 10040 Health Information Exchange Architecture describes our use in New Zealand of
standardised XML documents conforming to HL7 Clinical Document Architecture (CDA)1 as a
common currency for information exchange. Loosely coupled systems and clinical data reposi-
tories interoperate by exchanging payloads of this type via web services.
Figure 1 – CDA documents as currency of health information exchange
In the present context, interoperability means clinical data repositories, clinical workstations
and patient self-care portals having the uniform facility to produce and consume standardised
CDA documents that represent the medications, allergies and adverse reactions dataset.
Here we present a definitive set of CDA templates for this purpose.
1.2 Context
This specification is the first part of the HISO 10041 Continuum of Care Standard.
Later parts of the standard will define CDA templates for referral requests, shared health sum-
maries and discharge summaries.
1 HL7 Clinical Document Architecture Release 2 Normative Edition 2005
HISO 10041.1 CDA Templates for Medications, Allergies and Adverse Reactions 1Our architectural approach is defined by the following specifications:
Reference Architecture for Interoperability – Foundations
http://www.ithealthboard.health.nz
Reference Architecture for Interoperability – Continuum of Care
http://www.ithealthboard.health.nz
HISO 10024 New Zealand Medicines Terminology Recommendations Report
http://www.ithealthboard.health.nz
Many of the CDA templates presented derive from HL7 standards:
ASTM/HL7 Continuity of Care Document (CCD) http://www.hl7.org
HL7 Consolidated CDA Implementation Guide (CCDA) http://www.hl7.org
The applicable clinical documentation standards are:
Medicine Reconciliation Standard http://www.ithealthboard.health.nz
Medication Charting Standard http://www.ithealthboard.health.nz
1.3 Scope
The scope of this standard is CDA templates as they relate to the processes of medicine reconcil-
iation, medicine review, transfer of care, emergency care, multi-disciplinary shared care and pa-
tient self-care.
Specific scope exclusions:
The standard is limited to clinical data exchange purposes and is not intended to address
supply side requirements.
The standard does not address the specific transactional requirements of electronic prescrib-
ing and dispensing.
The standard promotes the creation of structured data but does not attempt to address sec-
ondary use requirements in data analysis.
The standard does not extend to medicines and natural health products beyond the New
Zealand Medicines Terminology (NZMT).
CDA templates are defined for patient medications, allergies and adverse reactions.
The standard pertains to medications, allergies and adverse reactions sections of e-discharge
summaries and to a patient medications document type.
The definitive use case scenarios are:
a) Medicine reconciliation The process of medicine reconciliation produces a list of current
medicines and, at the conclusion of an event such as a hospital
stay, documents the medicines started, stopped or continued
across that event. Any change to dose or frequency etc is record-
ed, with a reason.
Medical warnings relating to allergies and adverse reactions are
2 HISO 10041.1 CDA Templates for Medications, Allergies and Adverse Reactionsupdated as part of the process.
A standardised CDA document represents this output at reposi-
tory and health information exchange interfaces.
b) Medicine review A list of current medicines is created or updated when a medica-
tion history is taken or as a result of a medicine use review or
when medicines are prescribed or dispensed.
c) Transfer of care Structured information about medications, allergies and adverse
reactions is communicated at transfer of care.
This dataset is conveyed as sections of a standard CDA docu-
ment type for discharge summaries, for example.
Clinical workstations in the hospital and community are capable
of producing and consuming these CDA documents, which can
also be displayed by a web browser.
d) Emergency care Emergency care by paramedics and in hospital and community
settings relies on access to medical warnings, including docu-
mented allergies and adverse reactions, and knowledge of cur-
rent medications.
Medical warnings and the current medication list are made
available via web services, with a standard CDA document type
as payload.
e) Shared care ‘My List of Medicines’ is the concept of the medication list in the
cloud – a repository-held resource that can be viewed and up-
dated at all points of care.
Consider a patient who enrols with a community pharmacy for
long-term conditions services. The pharmacist and family doctor
use their own practice software to retrieve and update a shared
medication list, transacted as a CDA document.
f) Patient self-care Patients have home access to their own health records via self-
care portals, offered by integrated family health centres.
The portal retrieves the repository-held medication list as a CDA
document before displaying it in the form of an electronic yellow
card.
HISO 10041.1 CDA Templates for Medications, Allergies and Adverse Reactions 32 Patient medications
In this section, we present CDA templates defining the required format of medication lists in
CDA documents.
HISO 10043 CDA Common Templates explains the style of presentation we use here and defines
a number of base templates.
2.1 Medicinal product
Our CDA templates reference the medicinal products described by the New Zealand Medicines
Terminology and catalogued in the New Zealand Universal List of Medicines (NZULM).
NZMT defines several product classes:
Figure 2 – NZMT product classes
(Panadol is a registered trademark of the GlaxoSmithKline group of companies.)
Instances of all classes are represented as SNOMED Clinical Terms concepts in a New Zealand
extension to the international release. Each concept has a numeric identifier, a unique fully
specified name and (see examples) a preferred name.
NZMT product references in CDA documents include both the numeric identifier and the pre-
ferred name:
{nzmt product reference}
@code : NZMT SNOMED Code
@displayName (preferred name) : text
@codeSystem = 2.16.840.1.113883.2.18.26
4 HISO 10041.1 CDA Templates for Medications, Allergies and Adverse ReactionsMost often the medication list references Medicinal Product Unit of Use (MPUU) concepts,
which for each product associates a formulation of active ingredients – the Medicinal Product
(MP) – with a manufactured dose form, strength and unit of use. The concept as a whole and the
medicine name capture these properties.
When a particular Trade Product (TP) is prescribed (eg for safety reasons), the Trade Product
Unit of Use (TPUU) is recorded.
Some products such as eye drops or aerosol inhalers for which the packs are not divisible have
to be represented at Medicinal Product Pack (MPP) and Trade Product Pack (TPP) level.
Here are some examples (two MPUUs followed by one TPUU):
Medicine …
chloramphenicol 0.5% (2.5 mg/0.5 mL) eye drops, unit dose
prednisolone (as sodium phosphate) 5 mg/mL oral liquid
Dilzem (diltiazem hydrochloride 60 mg) tablet: film-coated, 1 tablet
(DILZEM is a registered trademark of Douglas Pharmaceuticals Limited.)
In the case of diltiazem, you can see that dose form is film-coated tablet, strength is 60 mg, and
unit of use is one tablet.
NZMT code sets exist for all dose forms and units of use, and all active ingredient substances.
Strengths are expressed in Unified Code for Units of Measure (UCUM) units of measure1, sub-
ject to NZMT editorial rules, sometimes as fractions with split units of measure (eg 40 mg/5
mL).
The medicinal product template and its display counterpart are:
{medicinal product} {medicinal product text}
consumable
templateId
@root = 2.16.840.1.113883.2.18.7.24
manufacturedProduct
@classCode = MANU
templateId
@root = 2.16.840.1.113883.2.18.7.25
manufacturedMaterial
code
@code : NZMT SNOMED Code
@displayName (preferred name) : text td (eg "simvastatin 20 mg tablet")
…
1 http://unitsofmeasure.org
HISO 10041.1 CDA Templates for Medications, Allergies and Adverse Reactions 52.2 Medication list
The patient’s medication list is a structured dataset of the following elements:
Medicine name and SNOMED code – as above, specifying an MP, TP, MPUU or TPUU
Dose – either (1) a counted quantity in terms of a unit of use (eg 2 tablets) or (2) a total
measured quantity in terms of a unit of measure (5 mL) – or it may be expressed both ways
Frequency of administration – specific frequency or period or set of event-related times of
day
Whether an as-required medicine
Route of administration
Indications – set of coded problems or symptoms
Instructions and special care requirements – narrative text
Interval of use – exact or approximate dates for starting and stopping the medicine
Whether a long term medicine
Whether medicine started, stopped, changed or continued
Reason for last change to dose, frequency or route, or for starting or stopping the medicine
Prescriber – identity details from the Healthcare Provider Index (HPI)
Information source – who supplied the details about the medication
The medication list can include over the counter medicines, as well as prescribed medicines. It
can include clinical trial medicines, provided they are properly listed in the NZULM. The list in-
cludes all current medicines and medicines used recently or taken as needed.
Usually, there is one entry per medicinal product, reflecting its most recent interval of use.
However, as an output of medicine reconciliation at discharge, the list will have a pair of before
and after entries for any medicine changed in dose, route or frequency.
The medication list as a whole is represented as at some fixed date, recorded in the CDA docu-
ment header.
The template for medication list entries is:
{medication list entry} {medication list entry text}
entry
@typeCode = DRIV
substanceAdministration
@classCode = SBADM
@moodCode = INT
templateId
@root = 2.16.840.1.113883.2.18.7.54.1
text? (patient instructions) : text td (eg "Take with food")
statusCode
@code = completed
6 HISO 10041.1 CDA Templates for Medications, Allergies and Adverse Reactions{interval of use} {interval of use text}
{timing} td
{route} td
{dose} td
{medicinal product} {medicinal product text}
{prescriber}? td
{information source}1? td
{indication}* td
{last change} td
{last change reason}? td
{long term medicine} td
{as required medicine}* td
2.2.1 Dose
Our templates permit medicine dose to be expressed as either:
a counted quantity in terms of a unit of use (such as capsule) – which works for any MPUU
or TPUU product in a discrete dose form
a measured quantity in terms of a unit of measure (such as specify mass or volume) – which
is used when (a) the product is in a continuous dose form or (b) the original prescription
stated the active ingredient quantity.
Medicine Dose …
Dilzem (diltiazem hydrochloride 60 mg) tablet: film-coated, 1 tablet 2 tablets = 120 mg
chloramphenicol 0.5% (2.5 mg/0.5 mL) eye drops, unit dose 1
prednisolone (as sodium phosphate) 5 mg/mL oral liquid 5 mL
salbutamol 100 microgram/actuation inhalation 2
paracetamol 500 mg
Provided the medicine is specified as an MPUU or a TPUU – concepts that embody unit of use –
a dose quantity that is simply a number of tablets, for example, is expressed like this:
{dose} (counted)
doseQuantity
@value (numeric value) : decimal
Measured quantities are expressed with a unit of measure:
{dose} (measured)
doseQuantity
@value (numeric value) : decimal
@unit : UCUM unit of measure (eg mL)
1 Refer to HISO 10043 CDA Common Templates
HISO 10041.1 CDA Templates for Medications, Allergies and Adverse Reactions 7Safety rules require prescribers and pharmacists to select units of measure that avoid fractional
quantities, eg 500 micrograms instead of 0.5 mg.1
The two forms of representation can be combined to express both the counted quantity and the
(equivalent) total measured quantity.
{dose} (counted and measured)
doseQuantity
@value (numeric value) : decimal
doseQuantity
@value (numeric value) : decimal
@unit : UCUM unit of measure (eg mL)
2.2.2 Frequency
Our templates permit the intended timing of administration to be specified by frequency or pe-
riod or with respect to events such as mealtimes.
Medicine … Timing As required …
chloramphenicol 0.5% (2.5 mg/0.5 mL) eye drops, 3 times per day -
unit dose
prednisolone (as sodium phosphate) 5 mg/mL oral Every 8 hours -
liquid
salbutamol 100 microgram/actuation inhalation Up to 6 times per day As required
dabigatran etexilate 110 mg capsule After breakfast and dinner
Examples of the three options follow.
For a medicine administered three times per day:
{timing} (frequency) {timing text} (frequency)
effectiveTime
@xsi:type = PIVL_TS
@institutionSpecified = true
@operator = A
period td = "3 times per day"
@value (count) = 8
@unit : UCUM time unit = h
The UCUM time units permitted in this context are seconds (s), minutes (min), hours (h), days
(d), weeks (wk) and months (mo).
For a medicine administered every eight hours:
{timing} (period) {timing text} (period)
effectiveTime
1 Medicine Reconciliation Standard
8 HISO 10041.1 CDA Templates for Medications, Allergies and Adverse Reactions@xsi:type = PIVL_TS
@institutionSpecified = false
@operator = A
period td = "Every 8 hours"
@value (count) = 8
@unit : UCUM time unit = h
Multiple event-related timings can be listed:
{timing} (set of event-related timings)
{event-related timing}*
For a medicine administered after breakfast:
{timing} (event-related) {timing text} (event-related)
effectiveTime
@xsi:type = EIVL_TS
@institutionSpecified = true
@operator = A
event
@code : HL7 event related timing code = PCM td = "After breakfast"
The coding scheme used enables administration before breakfast, after breakfast, between
breakfast and lunch etc to be indicated.
Medicine Breakfast Lunch Dinner Bedtime
… Before/After Between Before/After Between Before/After Between Before
2.2.3 As-required medicine
Our templates permit SNOMED-coded preconditions to be recorded for any as-required medi-
cine. The existence of any such an element signifies that this is an as-required medicine.
{as required medicine}
precondition
templateId
@root = 2.16.840.1.113883.2.18.7.27
criterion
code
@code = ASSERTION
@codeSystem = 2.16.840.1.113883.5.4
value
@xsi:type = CV
@code : SNOMED Code
…
HISO 10041.1 CDA Templates for Medications, Allergies and Adverse Reactions 92.2.4 Route of administration
Our templates use the HL7 code set for route of administration: PO for oral, TP for topical, IH
for inhalation etc.
{route}
routeCode
@code : HL7 Route Of Administration (eg PO)
@displayName : text (eg Oral)
@codeSystem = 2.16.840.1.113883.5.112
Medicine … Route …
Dilzem (diltiazem hydrochloride 60 mg) tablet: film-coated, 1 tablet Oral
chloramphenicol 0.5% (2.5 mg/0.5 mL) eye drops, unit dose Ophthalmic
salbutamol 100 microgram/actuation inhalation Nasal
2.2.5 Indications
Our templates permit the indications for each medication to be recorded as a set of SNOMED-
coded problems or conditions.
{indication}
entryRelationship
@typeCode = RSON
observation
@classCode = OBS
@moodCode = EVN
templateId
@root = 2.16.840.1.113883.2.18.7.22.4
statusCode
@code = completed
code
@code : LOINC Code
@displayName = "Indication"
…
value?
@xsi:type = CV
@code (problem) : SNOMED Code
@displayName : text
…
Multiple indications for one medication are listed in the same cell of the displayable medication
list entry.
10 HISO 10041.1 CDA Templates for Medications, Allergies and Adverse ReactionsMedicine … Indications …
prednisolone (as sodium phosphate) 5 mg/mL Rheumatoid arthritis
oral liquid
Ankylosing spondylitis
2.2.6 Instructions
General instructions to the patient, such as to take with food, along with any special care re-
quirements that might relate to pregnancy, breastfeeding or renal impairment, for example, can
be attached to medication list entries.
2.2.7 Interval of use
We specify the time interval for which a medication is used or prescribed by its start and finish
dates – which can be exact or approximate (ie rounded to months or years). The finish date can
be indefinite. Whether the medicine is in current use is determined from these dates.
{interval of use} {interval of use text}
effectiveTime
@xsi:type = IVL_TS
low
@value (start date) : date1 td : dd-mmm-yyyy
high?
@value (finish date) : date td : dd-mmm-yyyy
Intervals of use are displayed like this:
Medicine … Start date Finish date …
chloramphenicol 0.5% (2.5 mg/0.5 mL) eye drops, unit dose 03 May 2013 14 May 2013
salbutamol 100 microgram/actuation inhalation 2004 -
dabigatran etexilate 110 mg capsule Jun 2010 -
2.2.8 Long term medicine
In each case, we indicate whether the medicine is prescribed for long term use.
{long term medicine}
entryRelationship
@typeCode = COMP
act
@classCode = ACT
@moodCode = EVN
code
@code : SNOMED Code = 416239002
1 The required date format is YYYYMMDD
HISO 10041.1 CDA Templates for Medications, Allergies and Adverse Reactions 11@displayName = "Long term medicine"
…
text = yes | no
2.2.9 Last change
The medication list can capture details of the last change made to each of its entries. More gen-
erally, our templates permit recording of the changed state of the medication list across some
event or definite interval of time – an output of medicine reconciliation.
The table shows the example of five medicines in a patient’s use before and after a hospital stay.
The event itself is described in the CDA document header.
Medicine … Last change Last change reason …
Dilzem (diltiazem hydrochloride 60 mg) tablet: Continued -
film-coated, 1 tablet
prednisolone (as sodium phosphate) 5 mg/mL oral Changed Dose increase for better man-
liquid agement
chloramphenicol 0.5% (2.5 mg/0.5 mL) eye drops, Stopped Eye infection cleared
unit dose
dabigatran etexilate 110 mg capsule, 1 capsule Started Anticoagulation indicated
salbutamol 100 microgram/actuation inhalation Continued -
We represent this situation with a sequence of six clinical statements, with two entries for the
medication undergoing a dose change during the event:
Figure 3 – Changed medication list across an event
The last change that occurred relative to the event is recorded per entry – whether the medicine
was started, stopped, continued as is, or continued with changed dose or frequency. Transient
medications confined to the event are not recorded.
Changes in dose or frequency are represented by a pair of consecutive entries: a before image
flagged ‘Stopped’ followed by an after image flagged ‘Changed’.
12 HISO 10041.1 CDA Templates for Medications, Allergies and Adverse ReactionsThe actual codes employed in the template are limited to choices from SNOMED, which means
SNOMED’s code for ‘New’ is used to indicate ‘Started’, while ‘Current’ indicates ‘Continued’. In
both cases the more meaningful display name is used.
{last change}
entryRelationship
@typeCode = COMP
observation
@classCode = OBS
@moodCode = EVN
code
@code : LOINC Code = 33999-4
…
value
@xsi:type = CV
@code : Profile Item Status Code (New, Stopped, Current, Started)
@displayName : text = Started | Stopped | Continued | Changed
…
2.2.10 Last change reason
Narrative text giving the reason for the last change to the medication is recorded – why it was
started, stopped or changed.
{last change reason}
entryRelationship
@typeCode = SPRT
act
@classCode = INFRM
@moodCode = EVN
code
@xsi:type = CV
@code = CHGRSON
@displayName = "Reason stopped or changed"
@codeSystem = 2.16.840.1.113883.2.18.38
text (reason) : text (eg "Anticoagulation indicated")
2.2.11 Prescriber
The health practitioner who was the most recent prescriber of the medicine is recorded with
name, role and HPI number details.
{prescriber}
performer
{health worker}1
1 Refer to HISO 10043 CDA Common Templates
HISO 10041.1 CDA Templates for Medications, Allergies and Adverse Reactions 13Medicine … Prescriber …
chloramphenicol 0.5% (2.5 mg/0.5 mL) eye drops, Dr John Smith (Family doctor)
unit dose
2.3 Medications section
The medication list appears in its own section in CDA documents.
The text block can be displayed in yellow card format or as a medications changes summary.
Stylesheets can be used to produce output of the desired format.
{medications section}
component
section
templateId
@root = 2.16.840.1.113883.2.18.7.54
code
@code : LOINC Code = 18605-6
@displayName = "Medication list"
…
title = "Medication list"
text
table
thead
tr
th = "Medicinal product"
th = "Interval of use"
th = "Frequency"
th = "Route"
th = "Dose"
th = "Prescriber"
th = "Indications"
th = "Instructions"
th = "Last change"
th = "Last change reason"
th = "As required"
tbody
{medication list entry text}*
{medication list entry}*
14 HISO 10041.1 CDA Templates for Medications, Allergies and Adverse Reactions3 Allergies and adverse reactions
Here is our data model for a summary view of the patient’s allergies and adverse reactions,
showing the corresponding SNOMED concepts.
Figure 4 – Patient allergies and adverse reactions
SNOMED collectively classes allergies and what we call adverse reactions as propensities to ad-
verse reactions (distinguishing the concept of propensity from that of actual occurrence).
In simple terms, an allergy is understood to be a hypersensitivity of the immune system while an
adverse reaction is a non-immunological sensitivity or intolerance. Severities range from mild to
life threatening, in either case.
Each allergy and adverse reaction is recorded with these details:
Type or causative agent
Onset and resolution dates
Certainty – definite, probable or possible
Episodicity – first episode, ongoing episode, new episode etc (SNOMED episodicities)
Clinical course – gradual onset, subacute, chronic etc (SNOMED clinical courses)
In fact, our templates don’t yet cater for certainty, episodicity or clinical course. General com-
ments and the date last verified could also be recorded in future.
HISO 10041.1 CDA Templates for Medications, Allergies and Adverse Reactions 15It is our intention here to provide a summary view rather than to document every incidence of
an adverse reaction.
While adverse drug reaction and drug intolerance are essentially synonymous, we follow the
medicine reconciliation standard and use the former term.
The causative agent associated with each drug allergy or adverse drug reaction can be either an
individual medicine or an identified medicine group. SNOMED concepts representing pharma-
cological and allergy-related medicine groups are defined in the New Zealand Formulary as an
extension to the New Zealand Medicines Terminology.
It can be flexible to record an individual medicine as the causative agent, especially when the
medicine belongs to more than one medicine group. This allows an alert to be generated when-
ever a new patient medicine is found to be in a common medicine group with a known causative
agent.
Figure 5 – Information sources, manifestations and interventions
Where the source of information about a particular allergy or adverse reaction is known, the
identity of that person or organisation is recorded.
The manifestation of the allergic response or adverse reaction is recorded as a set of signs or
symptoms. The fact that a certain reaction is pertinent negative (ie not observed) can be ex-
pressed. The date of last reaction could also be recorded.
While it can be useful to know the success of any interventions, our templates don’t yet record
this information.
3.1 Allergies and adverse reactions section
Allergies and adverse reactions lists appear together in their own section in CDA documents.
This section documents a summary view of current allergies and adverse reactions.
{allergies and adverse reactions section}
component
section
16 HISO 10041.1 CDA Templates for Medications, Allergies and Adverse ReactionstemplateId
@root = 2.16.840.1.113883.2.18.7.46
code
@code : LOINC Code = 48765-2
@displayName = "Allergies and adverse reactions"
…
title = "Allergies and adverse reactions"
text
{allergies text}
{adverse reactions text}
{allergies}
{adverse reactions}
The two lists have the same layout, with a captioned table and a corresponding set of coded en-
tries. One small difference is that ‘no known allergies’ has an explicit clinical statement, while
there is no equivalent for adverse reactions.
3.2 Allergies
In our CDA documents, drug allergies, food allergies and allergies of all other types are listed
consecutively as three distinct sets, each displayed in its own table.
{allergies} {allergies text}
{drug allergies} {drug allergies text}
{food allergies} {food allergies text}
{other allergies} {other allergies text}
We permit explicit statements to the effect that there are no known allergies of a given class or
overall.
3.2.1 No known allergies
The fact that the patient has no known allergies is represented explicitly, using that particular
SNOMED concept.
{allergies} (no known) {allergies text} (no known)
table
thead
observation tr
@classCode = OBS
@moodCode = EVN
code
@code = ASSERTION
@codeSystem = 2.16.840.1.113883.5.4
statusCode
@code = completed
value
HISO 10041.1 CDA Templates for Medications, Allergies and Adverse Reactions 17@xsi:type = CV
@code : SNOMED Code = 160244002
@displayName = "No known allergies" th = "No known allergies"
…
The text displayed is:
No known allergies
3.2.2 Drug allergies
The record of every drug allergy or adverse drug reaction explicitly states the causative agent
involved, which must be a particular NZMT medicine or medicine group. SNOMED includes
many drug allergy types as individual concepts, but our templates eschew these for now.
Drug allergies appear as a consecutive group of entries within our CDA documents:
{drug allergies} {drug allergies text}
table
@caption = "Drug allergies"
thead
tr
th = "Drug allergy"
{manifestation etc headings}
tbody
{drug allergy}* {drug allergy text}*
Following the structure of entries in the problem list1, each allergy is represented as a lasting
concern supported by a number of observations over time. For simplicity, we limit this to exactly
one such observation per allergy.
{drug allergy} {drug allergy text}
entry
@typeCode = DRIV
act
@classCode = ACT
@moodCode = EVN
templateId
@root = 2.16.840.1.113883.2.18.7.46.2
code
@nullFlavor = NA
{drug allergy observation} {drug allergy observation text}
This clinical statement represents the existence of a drug allergy to a specific causative agent:
{drug allergy observation} {drug allergy observation text}
1 10041.2 CDA Templates for Shared Health Summaries
18 HISO 10041.1 CDA Templates for Medications, Allergies and Adverse Reactionstr
entryRelationship
@typeCode = SUBJ
observation
@classCode = OBS
@moodCode = EVN
templateId
@root = 2.16.840.1.113883.2.18.7.46.3
code
@code = ASSERTION
@codeSystem = 2.16.840.1.113883.5.4
statusCode
@code = completed
{onset date and resolution} {onset date and resolution text}
value
@xsi:type = CV
@code : SNOMED Code = 416098002
@displayName = "Drug allergy"
…
{information source}1? td (name and role/relationship)
participant
@typeCode = CSM
participantRole
@classCode = MANU
playingEntity
@classCode = MMAT
code
@xsi:type = CV
{causative agent} td
{manifestation}* td
Currently active allergies are recorded with an onset date. A resolution date is recorded when
applicable. These can be exact dates or approximate. The presence or absence of a resolution
date determines the allergy status displayed.
{onset date and resolution} {onset date and resolution text}
effectiveTime
low
@value (onset date) : date td : dd-mmm-yyyy
high?
@value (resolution date) : date td : dd-mmm-yyyy
1 Refer to HISO 10043 CDA Common Templates
HISO 10041.1 CDA Templates for Medications, Allergies and Adverse Reactions 19All classes of allergies and adverse reactions are displayed in tables of the same layout.
{manifestation etc headings}
th = "Reaction and severity"
th = "Onset date"
th = "Information source"
Where the causative agent is an individual medicine, this is usually indicated by reference to the
applicable MP concept. However, reactions specific to individual trade products are possible
(usually caused by excipients) and these need to be coded with TP or TPUU concepts.
{causative agent} (specific medicine)
@code : NZMT SNOMED Code
@displayName (preferred term) : text (eg doxycycline)
…
Alternatively, the causative agent can be recorded at the level of an NZMT allergy-related or
pharmacological medicine group, eg tetracycline antibiotic. (Note that these groups are yet to be
created.)
{causative agent} (medicine group)
@code : NZMT SNOMED Code
@displayName (preferred term) : text
@codeSystem = 2.16.840.1.113883.3.88.12.80.18
The table of drug allergies is displayed like this:
Drug allergies
Causative agent Reaction and severity Onset date …
sulfonamide antibiotic Hives (Mild to moderate) 1990 …
doxycycline Rash (Moderate) 2005 …
3.2.3 No known drug allergies
The fact that the patient has no known drug allergies is represented explicitly.
{drug allergies} (no known) {drug allergies text} (no known)
table
thead
tr
entry
@typeCode = DRIV
observation
@classCode = OBS
@moodCode = EVN
code
@code = ASSERTION
20 HISO 10041.1 CDA Templates for Medications, Allergies and Adverse Reactions@codeSystem = 2.16.840.1.113883.5.4
statusCode
@code = completed
value
@xsi:type = CV
@code = 160244002
@displayName = "No known history of th = "No known history of
drug allergy" drug allergy"
…
The following text appears where a list of allergies would otherwise.
No known drug allergies
3.2.4 Food allergies
The template for food allergies is similar to that for drug allergies, but without a causative agent
element. The difference here is that we rely on individual SNOMED concepts to indicate the
type of allergy.
{food allergies} {food allergies text}
table
thead
@caption = "Food allergies"
tr
th = "Food allergy"
{manifestation etc headings}
tbody
{food allergy}* {food allergy text}*
Each observation is framed within a parent concern.
{food allergy} {food allergy text}
entry
@typeCode = DRIV
act
@classCode = ACT
@moodCode = EVN
templateId
@root = 2.16.840.1.113883.2.18.7.46.2
code
@nullFlavor = NA
{food allergy observation} {food allergy observation text}
HISO 10041.1 CDA Templates for Medications, Allergies and Adverse Reactions 21In each case, the specific allergy is indicated by a SNOMED food allergy concept, eg allergy to
peanuts.
{food allergy observation} {food allergy observation text}
tr
entryRelationship
@typeCode = SUBJ
observation
@classCode = OBS
@moodCode = EVN
templateId
@root = 2.16.840.1.113883.2.18.7.46.3
code
@code = ASSERTION
@codeSystem = 2.16.840.1.113883.5.4
statusCode
@code = completed
{onset date and resolution} {onset date and resolution text}
value
@xsi:type = CV
@code : SNOMED Code
@displayName : text td (eg "Allergy to peanuts")
…
{information source}1? td
{manifestation}* td
Food allergies are displayed in their own table.
Food allergies
Food allergy Reaction and severity Onset date …
Allergy to peanuts Hives (Severe) 1998 …
3.2.5 No known food allergies
When the patient has no known food allergies, this is stated explicitly.
{food allergies} (no known) {food allergies text} (no known)
table
thead
tr
entry
@typeCode = DRIV
1 Refer to HISO 10043 CDA Common Templates
22 HISO 10041.1 CDA Templates for Medications, Allergies and Adverse Reactionsobservation
@classCode = OBS
@moodCode = EVN
code
@code = ASSERTION
@codeSystem = 2.16.840.1.113883.5.4
statusCode
@code = completed
value
@xsi:type = CV
@code = 160244002
@displayName = "No known food allergy" th = "No known food allergy"
…
The following is displayed in place of a table of allergies:
No known food allergy
3.2.6 Other allergies
Following drug and food allergies, a third heading permits environmental allergies, insect aller-
gies, latex allergies and other kinds of allergy to be listed.
{other allergies} {other allergies text}
table
@caption = "Other allergies"
thead
tr
th = "Allergy"
{manifestation etc headings}
tbody
{other allergy}* {other allergy text}*
Each observation is framed within a parent concern.
{other allergy} {other allergy text}
entry
@typeCode = DRIV
act
@classCode = ACT
@moodCode = EVN
templateId
@root = 2.16.840.1.113883.2.18.7.46.2
code
@nullFlavor = NA
{other allergy observation} {other allergy observation text}
HISO 10041.1 CDA Templates for Medications, Allergies and Adverse Reactions 23In each case, the specific allergy is pinpointed by a SNOMED allergy to substance concept, eg
latex allergy.
{other allergy observation} {other allergy observation text}
tr
entryRelationship
@typeCode = SUBJ
observation
@classCode = OBS
@moodCode = EVN
templateId
@root = 2.16.840.1.113883.2.18.7.46.3
code
@code = ASSERTION
@codeSystem = 2.16.840.1.113883.5.4
statusCode
@code = completed
{onset date and resolution} {onset date and resolution text}
value
@xsi:type = CV
@code : SNOMED Code
@displayName : text td (eg "Latex allergy")
…
{information source}1? td
{manifestation}* td
These allergies are displayed in their own separate table.
Other allergies
Allergy Reaction and severity Onset date …
Latex allergy Rash (Moderate) Jun 2006 …
3.3 Adverse reactions
In our CDA documents, adverse drug reactions and food intolerances – there might be other
kinds of adverse reaction in future – appear in consecutive lists.
{adverse reactions} {adverse drug reactions text}
{adverse drug reactions} {adverse drug reactions text}
{food intolerances} {food intolerances text}
The appearance of an empty list indicates that there are no known adverse reactions (there is no
such SNOMED concept).
1 Refer to HISO 10043 CDA Common Templates
24 HISO 10041.1 CDA Templates for Medications, Allergies and Adverse Reactions3.3.1 Adverse drug reactions
Adverse drug reactions are recorded in a similar way to drug allergies, ie with reference to a me-
dicinal product or drug class as the causative agent.
{adverse drug reactions} {adverse drug reactions text}
table
@caption = "Adverse drug reactions"
thead
tr
th = "Adverse drug reaction"
{manifestation etc headings}
tbody
{adverse drug reaction}* {adverse drug reaction text}*
Each observation is framed within a parent concern.
{adverse drug reaction} {adverse drug reaction text}
entry
@typeCode = DRIV
act
@classCode = ACT
@moodCode = EVN
templateId
@root = 2.16.840.1.113883.2.18.7.46.2
code
@nullFlavor = NA
{adverse drug reaction observation} {adverse drug reaction observation text}
The causative agent indicates the type of adverse reaction.
{adverse drug reaction observation} {adverse drug reaction observation text}
tr
entryRelationship
@typeCode = SUBJ
observation
@classCode = OBS
@moodCode = EVN
templateId
@root = 2.16.840.1.113883.2.18.7.46.3
code
@code = ASSERTION
@codeSystem = 2.16.840.1.113883.5.4
statusCode
@code = completed
{onset date and resolution} {onset date and resolution text}
value
HISO 10041.1 CDA Templates for Medications, Allergies and Adverse Reactions 25@xsi:type = CV
@code : SNOMED Code = 419511003
@displayName =
"Propensity to adverse reactions to drug"
…
{information source}1? td
participant
@typeCode = CSM
participantRole
@classCode = MANU
playingEntity
@classCode = MMAT
code
@xsi:type = CV td
{causative agent} td
{manifestation}* td
Adverse drug reactions are displayed in the way as drug allergies.
Adverse drug reactions
Causative agent Reaction and severity Onset date …
pseudoephedrine Insomnia (Mild to moderate) 2010 …
Tachycardia (Moderate)
beta blocker Bradycardia (Moderate to severe) 2005 …
3.3.2 Food intolerances
Food intolerances are recorded in essentially the same way as food allergies. They display in
their own table.
{food intolerances} {food intolerances text}
table
@caption = "Food intolerances"
thead
tr
th = "Food intolerance"
{manifestation etc headings}
tbody
{food intolerance}* {food intolerance text}*
Each observation is framed within a parent concern.
{food intolerance} {food intolerance text}
1 Refer to HISO 10043 CDA Common Templates
26 HISO 10041.1 CDA Templates for Medications, Allergies and Adverse Reactionsentry
@typeCode = DRIV
act
@classCode = ACT
@moodCode = EVN
templateId
@root = 2.16.840.1.113883.2.18.7.46.2
code
@nullFlavor = NA
{food intolerance observation} {food intolerance observation text}
SNOMED classifies food intolerance as malabsorption due to intolerance to carbohydrate or to
protein or to fat – these are the three children of the SNOMED food intolerance concept.
{food intolerance observation} {food intolerance observation text}
tr
entryRelationship
@typeCode = SUBJ
observation
@classCode = OBS
@moodCode = EVN
templateId
@root = 2.16.840.1.113883.2.18.7.46.3
code
@code = ASSERTION
@codeSystem = 2.16.840.1.113883.5.4
statusCode
@code = completed
{onset date and resolution} {onset date and resolution text}
value
@xsi:type = CV
@code : SNOMED Code
@displayName : text td (eg "Malabsorption due to …")
…
{information source}1? td
{manifestation}* td
1 Refer to HISO 10043 CDA Common Templates
HISO 10041.1 CDA Templates for Medications, Allergies and Adverse Reactions 27Food intolerances are displayed in their own table.
Food intolerances
Food intolerance Onset date …
Malabsorption due to intolerance to fat 2001 …
Malabsorption due to intolerance to carbohydrate 2008 …
3.4 Manifestation
The manifestation of each of the patient’s allergies and adverse reactions is captured as a set of
SNOMED-coded signs and symptoms, with their severity.
{manifestation}
entryRelationship
@typeCode = MFST
@inversionInd = true
observation
@moodCode = EVN
templateId
@root = 2.16.840.1.113883.2.18.7.47
code
@code = ASSERTION
@codeSystem = 2.16.840.1.113883.5.4
statusCode
@code = completed
value
@xsi:type = CV
@code (sign or symptom) : SNOMED Code
@displayName (preferred term) : text (eg Hives)
…
{reaction severity}
The severity of each sign or symptom is recorded, using SNOMED severities concepts.
{reaction severity}
entryRelationship
@typeCode = SUBJ
@inversionInd = true
observation
@classCode = OBS
@moodCode = EVN
templateId
@root = 2.16.840.1.113883.2.18.7.53
statusCode
28 HISO 10041.1 CDA Templates for Medications, Allergies and Adverse Reactions@code = completed
code
@code = SEV
@codeSystem = 2.16.840.1.113883.5.4
value
@xsi:type = CV
@code (severity) : SNOMED Code
@displayName = Mild | Moderate | Severe | …
…
Reactions and severities are displayed in the same way for all types of allergy and adverse reac-
tion.
Allergy … Reaction and severity …
Latex allergy … Nasal congestion (Moderate) …
Sinusitis (Severe)
3.5 Information source
For every allergy or adverse reaction we document the information source, whether this is the
patient, a health worker or a support person. We record the support person’s relationship to the
patient and the health worker’s professional role. In each case, we record the most authoritative
information source. Knowledge of the source of a piece of information obviously has an im-
portant bearing on the level of confidence that users can attach to it.
Drug allergy … Information source
doxycycline … Dr John Smith (Family doctor)
Sulfonamides … Centre for Adverse Reactions Monitoring
Organisations too can be recorded as information sources, eg the Centre for Adverse Reactions
Monitoring (CARM).
Name, address and contact details are captured, along with HPI number for health workers and
organisations.
{information source} …
Refer to HISO 10043 CDA Common Templates for this template specification.
HISO 10041.1 CDA Templates for Medications, Allergies and Adverse Reactions 294 Patient medications document
Two of our use cases depend on the existence of a CDA document type whose body sections are
simply the medication list and allergy and adverse reaction lists. This is an output of medicine
reconciliation and the payload of My List of Medicines web services. Documents of this kind are
produced on demand in response to authorised requests.
The required document template is:
{medications document}
ClinicalDocument
realmCode
code
@code = NZ
typeId
@root = 2.16.840.1.113883.1.3
@extension = POCD_HD000040
templateId
@root = 2.16.840.1.113883.2.18.7.11
id
@root (document identifier) : UUID
code
@code : LOINC Code = 56445-0
@displayName = "Medication list"
…
title = "Medication List"
effectiveTime
@value (when created) : datetime
confidentialityCode
@code = N (normal)
languageCode
@code = en-NZ
recordTarget
patientRole
{patient}1
{author}1*
{information source}1*
{custodian}1
{legal approver}1?
{approver}1*
{participant}1*
1 Refer to HISO 10043 CDA Common Templates
30 HISO 10041.1 CDA Templates for Medications, Allergies and Adverse Reactions{encounter}1?
component
structuredBody
{allergies and adverse reactions section}
{medications section}
Each such document is identified by a Universally Unique Identifier (UUID).
Patient identity and contact details are recorded.
The document records the organisation acting as its custodian, responsible for the integrity, se-
curity and persistence of its content.
As an output of medicine reconciliation, the document records details of (1) the clinicians re-
sponsible (participants, authors and approvers), and (2) the people or organisations that were
information sources.
The document records the patient’s usual community pharmacy or pharmacist as a participant.
The event described is the hospital episode or encounter of some other kind during which medi-
cine reconciliation was performed. The document records change in the medication list with re-
spect to the interval of this event.
{encounter}
documentationOf
serviceEvent
@classCode = PCPR
effectiveTime
low
@value (start) : datetime
high?
@value (finish) : datetime
performer
assignedEntity
…
Alternatively, the documented encounter can be a shorter event such as a consultation with the
family doctor or community pharmacist.
HISO 10041.1 CDA Templates for Medications, Allergies and Adverse Reactions 31You can also read
