HISO CDA Templates for Medications, Allergies and Adverse Reactions. Continuum of Care Interim Standard

Transcription

1 HISO CDA Templates for Medications, Allergies and Adverse Reactions Continuum of Care Interim Standard March 2014

2 Document information HISO 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 (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 Contributors The following organisations contributed to the development of this standard through representation on HISO or one of its working groups: National Medication Safety Programme Nursing Council of New Zealand Health Informatics New Zealand Patients First Accident Compensation Corporation Chief Medical Officers Forum Health Sector Architects Group Copyright Crown copyright (c) This copyright work is licensed under the Creative Commons Attribution-No Derivative Works 3.0 New Zealand licence 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. Contact us at or write to Health Information Standards, Ministry of Health, PO Box 5013, Wellington See the HISO website for information about our standards development processes. ii HISO CDA Templates for Medications, Allergies and Adverse Reactions

3 Contents 1 Introduction Purpose Context Scope 2 2 Patient medications Medicinal product Medication list Medications section 14 3 Allergies and adverse reactions Allergies and adverse reactions section Allergies Adverse reactions Manifestation Information source 29 4 Patient medications document 30 HISO CDA Templates for Medications, Allergies and Adverse Reactions iii

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5 1 Introduction This standard is a technical specification for interoperability between computer systems. It defines 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 interoperable. HISO 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 repositories 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 Continuum of Care Standard. Later parts of the standard will define CDA templates for referral requests, shared health summaries and discharge summaries. 1 HL7 Clinical Document Architecture Release 2 Normative Edition 2005 HISO CDA Templates for Medications, Allergies and Adverse Reactions 1

6 Our architectural approach is defined by the following specifications: Reference Architecture for Interoperability Foundations Reference Architecture for Interoperability Continuum of Care HISO New Zealand Medicines Terminology Recommendations Report Many of the CDA templates presented derive from HL7 standards: ASTM/HL7 Continuity of Care Document (CCD) HL7 Consolidated CDA Implementation Guide (CCDA) The applicable clinical documentation standards are: Medicine Reconciliation Standard Medication Charting Standard Scope The scope of this standard is CDA templates as they relate to the processes of medicine reconciliation, medicine review, transfer of care, emergency care, multi-disciplinary shared care and patient 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 prescribing and dispensing. The standard promotes the creation of structured data but does not attempt to address secondary 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 recorded, with a reason. Medical warnings relating to allergies and adverse reactions are 2 HISO CDA Templates for Medications, Allergies and Adverse Reactions

7 updated as part of the process. A standardised CDA document represents this output at repository and health information exchange interfaces. b) Medicine review A list of current medicines is created or updated when a medication 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 document 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 documented allergies and adverse reactions, and knowledge of current 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 updated 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 selfcare 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 CDA Templates for Medications, Allergies and Adverse Reactions 3

8 2 Patient medications In this section, we present CDA templates defining the required format of medication lists in CDA documents. HISO 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 preferred name: {nzmt product : NZMT SNOMED (preferred name) : = HISO CDA Templates for Medications, Allergies and Adverse Reactions

9 Most 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 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 measure 1, subject 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} = = = : NZMT SNOMED (preferred name) : text {medicinal product text} (eg "simvastatin 20 mg tablet") 1 HISO CDA Templates for Medications, Allergies and Adverse Reactions 5

10 2.2 Medication list The patient s medication list is a structured dataset of the following elements: Medicine name and SNOMED 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 d 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 includes 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 document header. The template for medication list entries is: {medication list entry} = DRIV = = = text? (patient instructions) : text = completed {medication list entry text} (eg "Take with food") 6 HISO CDA Templates for Medications, Allergies and Adverse Reactions

11 {interval of use} {timing} {route} {dose} {medicinal product} {prescriber}? {information source} 1? {indication}* {last change} {last change reason}? {long term medicine} {as required medicine}* {interval of use text} {medicinal product text} 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) (numeric value) : decimal Measured quantities are expressed with a unit of measure: {dose} (measured) (numeric value) : : UCUM unit of measure (eg ml) 1 Refer to HISO CDA Common Templates HISO CDA Templates for Medications, Allergies and Adverse Reactions 7

12 Safety 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) (numeric value) : decimal (numeric value) : : UCUM unit of measure (eg ml) Frequency Our templates permit the intended timing of administration to be specified by frequency or period or with respect to events such as mealtimes. Medicine Timing As required chloramphenicol 0.5% (2.5 mg/0.5 ml) eye drops, unit dose 3 times per day - prednisolone (as sodium phosphate) 5 mg/ml oral liquid Every 8 hours - 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) = = = A (count) = : UCUM time unit = h {timing text} (frequency) = "3 times per day" 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) effectivetime {timing text} (period) 1 Medicine Reconciliation Standard 8 HISO CDA Templates for Medications, Allergies and Adverse Reactions

13 @xsi:type = = = A (count) = : UCUM time unit = h = "Every 8 hours" 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) = = = A : HL7 event related timing = PCM {timing text} (event-related) = "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 As-required medicine Our templates permit SNOMED-d preconditions to be recorded for any as-required medicine. The existence of any such an element signifies that this is an as-required medicine. {as required medicine} = = = = : SNOMED Code HISO CDA Templates for Medications, Allergies and Adverse Reactions 9

14 2.2.4 Route of administration Our templates use the HL7 set for route of administration: PO for oral, TP for topical, IH for inhalation etc. {route} : HL7 Route Of Administration (eg : text (eg = Medicine Route Dilzem (diltiazem hydrochloride 60 mg) tablet: film-coated, 1 tablet chloramphenicol 0.5% (2.5 mg/0.5 ml) eye drops, unit dose salbutamol 100 microgram/actuation inhalation Oral Ophthalmic Nasal Indications Our templates permit the indications for each medication to be recorded as a set of SNOMEDd problems or conditions. {indication} = RSON = = = : LOINC = "Indication" = (problem) : SNOMED : text Multiple indications for one medication are listed in the same cell of the displayable medication list entry. 10 HISO CDA Templates for Medications, Allergies and Adverse Reactions

15 Medicine Indications prednisolone (as sodium phosphate) 5 mg/ml oral liquid Rheumatoid arthritis Ankylosing spondylitis Instructions General instructions to the patient, such as to take with food, along with any special care requirements that might relate to pregnancy, breastfeeding or renal impairment, for example, can be attached to medication list entries 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} = IVL_TS (start date) : date 1 (finish date) : date {interval of use text} : dd-mmm-yyyy : 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 May 2013 salbutamol 100 microgram/actuation inhalation dabigatran etexilate 110 mg capsule Jun Long term medicine In each case, we indicate whether the medicine is prescribed for long term use. {long term medicine} = COMP = : SNOMED Code = The required date format is YYYYMMDD HISO CDA Templates for Medications, Allergies and Adverse Reactions 11

16 @displayname = "Long term medicine" text = yes no Last change The medication list can capture details of the last change made to each of its entries. More generally, 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: film-coated, 1 tablet Continued - prednisolone (as sodium phosphate) 5 mg/ml oral liquid Changed Dose increase for better management chloramphenicol 0.5% (2.5 mg/0.5 ml) eye drops, unit dose Stopped Eye infection cleared 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 CDA Templates for Medications, Allergies and Adverse Reactions

17 The actual s employed in the template are limited to choices from SNOMED, which means SNOMED s for New is used to indicate Started, while Current indicates Continued. In both cases the more meaningful display name is used. {last change} = COMP = : LOINC Code = = : Profile Item Status Code (New, Stopped, Current, : text = Started Stopped Continued Changed 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} = SPRT = = = = "Reason stopped or = text (reason) : text (eg "Anticoagulation indicated") 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 CDA Common Templates HISO CDA Templates for Medications, Allergies and Adverse Reactions 13

18 Medicine Prescriber chloramphenicol 0.5% (2.5 mg/0.5 ml) eye drops, unit dose Dr John Smith (Family doctor) 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 = : LOINC Code = = "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 CDA Templates for Medications, Allergies and Adverse Reactions

19 3 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 adverse 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 comments and the date last verified could also be recorded in future. HISO CDA Templates for Medications, Allergies and Adverse Reactions 15

20 It 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 pharmacological 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 whenever 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 expressed. 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 CDA Templates for Medications, Allergies and Adverse Reactions

21 @root = : LOINC Code = = "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 d entries. 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} {drug allergies} {food allergies} {other allergies} {allergies text} {drug allergies text} {food allergies text} {other allergies text} We permit explicit statements to the effect that there are no known allergies of a given class or overall No known allergies The fact that the patient has no known allergies is represented explicitly, using that particular SNOMED concept. {allergies} (no known) = = = = completed value {allergies text} (no known) table thead tr HISO CDA Templates for Medications, Allergies and Adverse Reactions 17

22 @xsi:type = : SNOMED Code = = "No known allergies" th = "No known allergies" The text displayed is: No known allergies 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 allergy}* {drug allergies text} = "Drug allergies" thead tr th = "Drug allergy" {manifestation etc headings} tbody {drug allergy text}* Following the structure of entries in the problem list 1, 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} = DRIV = = = NA {drug allergy observation} {drug allergy text} {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} CDA Templates for Shared Health Summaries 18 HISO CDA Templates for Medications, Allergies and Adverse Reactions

23 = SUBJ = = = = = completed {onset date and resolution} = : SNOMED Code = = "Drug allergy" {information source} 1? = CSM = MANU = = CV {causative agent} {manifestation}* tr {onset date and resolution text} (name and role/relationship) 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} effectivetime (onset date) : date (resolution date) : date {onset date and resolution text} : dd-mmm-yyyy : dd-mmm-yyyy 1 Refer to HISO CDA Common Templates HISO CDA Templates for Medications, Allergies and Adverse Reactions 19

24 All 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 d with TP or TPUU concepts. {causative agent} (specific : NZMT SNOMED (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 : NZMT SNOMED (preferred term) : = 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) No known drug allergies The fact that the patient has no known drug allergies is represented explicitly. {drug allergies} (no known) = DRIV = = ASSERTION {drug allergies text} (no known) table thead tr 20 HISO CDA Templates for Medications, Allergies and Adverse Reactions

25 @System = = completed = = = "No known history of drug allergy" th = "No known history of drug allergy" The following text appears where a list of allergies would otherwise. No known drug allergies 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 allergy}* Each observation is framed within a parent concern. {food allergy} = DRIV = = = NA {food allergy observation} {food allergies text} table = "Food allergies" tr th = "Food allergy" {manifestation etc headings} tbody {food allergy text}* {food allergy text} {food allergy observation text} HISO CDA Templates for Medications, Allergies and Adverse Reactions 21

26 In each case, the specific allergy is indicated by a SNOMED food allergy concept, eg allergy to peanuts. {food allergy observation} = SUBJ = = = = = completed {onset date and resolution} = : SNOMED : text {information source} 1? {manifestation}* Food allergies are displayed in their own table. {food allergy observation text} tr {onset date and resolution text} (eg "Allergy to peanuts") Food allergies Food allergy Reaction and severity Onset date Allergy to peanuts Hives (Severe) No known food allergies When the patient has no known food allergies, this is stated explicitly. {food allergies} (no known) = DRIV {food allergies text} (no known) table thead tr 1 Refer to HISO CDA Common Templates 22 HISO CDA Templates for Medications, Allergies and Adverse Reactions

27 = = = = completed = = = "No known food allergy" th = "No known food allergy" The following is displayed in place of a table of allergies: No known food allergy Other allergies Following drug and food allergies, a third heading permits environmental allergies, insect allergies, latex allergies and other kinds of allergy to be listed. {other allergies} {other allergy}* Each observation is framed within a parent concern. {other allergy} = DRIV = = = NA {other allergy observation} {other allergies text} = "Other allergies" thead tr th = "Allergy" {manifestation etc headings} tbody {other allergy text}* {other allergy text} {other allergy observation text} HISO CDA Templates for Medications, Allergies and Adverse Reactions 23

28 In each case, the specific allergy is pinpointed by a SNOMED allergy to substance concept, eg latex allergy. {other allergy observation} = SUBJ = = = = = completed {onset date and resolution} = : SNOMED : text {information source} 1? {manifestation}* These allergies are displayed in their own separate table. {other allergy observation text} tr {onset date and resolution text} (eg "Latex allergy") Other allergies Allergy Reaction and severity Onset date Latex allergy Rash (Moderate) Jun 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} {food intolerances} {adverse drug reactions text} {adverse drug reactions text} {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 CDA Common Templates 24 HISO CDA Templates for Medications, Allergies and Adverse Reactions

29 3.3.1 Adverse drug reactions Adverse drug reactions are recorded in a similar way to drug allergies, ie with reference to a medicinal product or drug class as the causative agent. {adverse drug reactions} {adverse drug reaction}* Each observation is framed within a parent concern. {adverse drug reaction} = DRIV = = = NA {adverse drug reaction observation} The causative agent indicates the type of adverse reaction. {adverse drug reaction observation} = SUBJ = = = = = completed {onset date and resolution} value {adverse drug reactions text} = "Adverse drug reactions" thead tr th = "Adverse drug reaction" {manifestation etc headings} tbody {adverse drug reaction text}* {adverse drug reaction text} {adverse drug reaction observation text} {adverse drug reaction observation text} tr {onset date and resolution text} HISO CDA Templates for Medications, Allergies and Adverse Reactions 25

30 @xsi:type = : SNOMED Code = = "Propensity to adverse reactions to drug" {information source} 1? = CSM = MANU = = CV {causative agent} {manifestation}* 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) Tachycardia (Moderate) 2010 beta blocker Bradycardia (Moderate to severe) Food intolerances Food intolerances are recorded in essentially the same way as food allergies. They display in their own table. {food intolerances} {food intolerance}* Each observation is framed within a parent concern. {food intolerance} {food intolerances text} = "Food intolerances" thead tr th = "Food intolerance" {manifestation etc headings} tbody {food intolerance text}* {food intolerance text} 1 Refer to HISO CDA Common Templates 26 HISO CDA Templates for Medications, Allergies and Adverse Reactions

31 = DRIV = = = 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} = SUBJ = = = = = completed {onset date and resolution} = : SNOMED : text {information source} 1? {manifestation}* {food intolerance observation text} tr {onset date and resolution text} (eg "Malabsorption due to ") 1 Refer to HISO CDA Common Templates HISO CDA Templates for Medications, Allergies and Adverse Reactions 27

32 Food 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 Manifestation The manifestation of each of the patient s allergies and adverse reactions is captured as a set of SNOMED-d signs and symptoms, with their severity. {manifestation} = = true = = = = completed = (sign or symptom) : SNOMED (preferred term) : text (eg Hives) {reaction severity} The severity of each sign or symptom is recorded, using SNOMED severities concepts. {reaction severity} = = true = = statuscode 28 HISO CDA Templates for Medications, Allergies and Adverse Reactions

33 @ = = = = (severity) : SNOMED = Mild Moderate Severe Reactions and severities are displayed in the same way for all types of allergy and adverse reaction. 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 important 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 CDA Common Templates for this template specification. HISO CDA Templates for Medications, Allergies and Adverse Reactions 29

34 4 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 = NZ = = = (document identifier) : : LOINC Code = = "Medication list" title = "Medication List" (when created) : datetime = N (normal) = en-nz recordtarget patientrole {patient} 1 {author} 1 * {information source} 1 * {custodian} 1 {legal approver} 1? {approver} 1 * {participant} 1 * 1 Refer to HISO CDA Common Templates 30 HISO CDA Templates for Medications, Allergies and Adverse Reactions

35 {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, security and persistence of its content. As an output of medicine reconciliation, the document records details of (1) the clinicians responsible (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 medicine reconciliation was performed. The document records change in the medication list with respect to the interval of this event. {encounter} documentationof = PCPR effectivetime (start) : datetime (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 CDA Templates for Medications, Allergies and Adverse Reactions 31