1. Medication data in patient summaries
June , 2016
US FDA White Oak Campus
Medication data in patient summaries
Dipak Kalra, EuroRec
Julie James, Blue Wave Informatics

2. The context for sharing summaries
Unscheduled care
(emergency, unexpected)
Generic patient summary
Scheduled care
(planned by clinician, arranged by patient)
Procedure referral summaries
Cross-border health care
Long term care,
and acute exacerbations, complications (predictable, even if not predicted)
Condition specific summaries are needed,
including care plans
Specialist referral
(e.g. within a European Reference Network)
Customised summaries, multimedia, molecular…
All of these kinds of summary require the accurate sharing of a patient’s medication profile, across borders

3. undertaking clinical and industry research
planning and budgeting national health services
commissioning purchasing healthcare services
public health
screening, prevention
optimising clinical outcomes
Date:
Whittington
Hospital
Healthcare Record
John Smith
DoB :
delivering person-centred,
empowered care
maximising reimbursement
practicing personalised / predictive medicine
optimising costs
complying to clinical guidelines and practising safely
managing local services and resources
aligning clinical workflows

4. The “Medication Profile”
Use of medicines is the commonest intervention in healthcare
Information about an individual’s medication use over their lifetime and managed as a coherent whole but presented appropriately for context, is central to providing good quality care: this is “the Medication Profile”
Patient summaries describe a “point in time” sharing of (medication) information, which is one of the use cases of the “Medication Profile”

5. Medication Data in Patient Summaries
The Continuity of Care Record (CCR) in the US
European Patient Summary Guidelines in Europe
Similar description, purpose and intentions…..
Both specifications include medication information as core to their requirements
But neither give much if any definition of the data elements, OR how they should be populated
As a “snapshot” there is no sense that, for these specifications, that the data elements need maintaining over time, but neither is there any sense of how long their information could or should be considered “valid”
EHR specifications were also examined, but not detailed here
© Blue Wave Informatics LLP, 2016

6. © Blue Wave Informatics LLP, 2016
CCR / EuPS Comparison
CCR
EuPS
Description
Core data set of the most relevant administrative, demographic, and clinical information facts about a patient’s healthcare, covering one or more healthcare encounters
Minimum set of information needed to assure healthcare coordination and the continuity of care
Purpose
A means for one healthcare practitioner, system, or setting to aggregate all of the pertinent data about a patient and forward it to another practitioner, system, or setting to support the continuity of care
To support the objective of continuity of care and patient safety across borders
Secondary purpose of being available as reference material for Member States
Intent
enhance patient safety, reduce medical errors, reduce costs, enhance efficiency of health information exchange, and assure at least a minimum standard of health information transportability when a patient is referred, transferred, or is otherwise seen by, another practitioner
“Essential and understandable health information” made available “at the point of care to deliver safe patient care during unscheduled care [and planned care]” but which should have its “maximal impact in unscheduled care”
© Blue Wave Informatics LLP, 2016

7. Medication Data Elements
Definition
CCR
EuPS
Medication
Description of the medicinal product itself (be it prescribed, dispensed, (self) administered, statement about)
“List and describe the patient’s current medications and pertinent medication history”
“List of current medicines”
Medication “Activity” and Status
Description of the role in the Medication Process that the medicinal product played (e.g. being prescribed, administered, or statemented)
[Active, On Hold, Prior History No Longer Active]”
dispensed or not
Dosage Instructions
Description of the full set of information that supports the correct administration of a medication to a patient in order for it to have its therapeutic effect
“<Directions> is the instructions (SIG) component describing the intended patient use of the <Product>. Can be used to map a single SIG or a complex recurring SIG like a tapered dose or sliding scale. Recurring SIG segments are represented by repeating the <Directions> tag and its children.”
Described as individual components only, not as a whole unit (e.g. dose quantity, frequency, duration etc.)
IDMP
© Blue Wave Informatics LLP, 2016

8. EuPS “Medication List”
Currently, the EuPS does not require a machine readable identifier for the “Medication” – whereas other specifications do - because no pan-European Medication code system is available
EuPS requires “active ingredient substance(s)”, strength(s) and dose form
But, as epSOS showed, this is not enough because there is no fully suitable code system(s) (terminology) for these concepts, especially when one moves away from simple chemical substances into biologics etc.
© Blue Wave Informatics LLP, 2016

9. © Blue Wave Informatics LLP, 2016
How could IDMP help?
IDMP can provide machine readable identifiers (“codes”) for the “Medication” available for each jurisdiction, and human readable names
It also provides a generic representation of all medications, that is independent of jurisdiction (the PhPIDs of 11616)
This information can be used directly in patient summaries or provide input to existing healthcare medication terminologies such as the NHS dm+d (UK), the G-Standaard (the Netherlands) or RxNorm (the US)
© Blue Wave Informatics LLP, 2016

10. And to support “Interoperability”
The PhPIDs can support mapping between different medication terminologies, including those of different jurisdictions
A medication is described using a code from a particular code system in one application or jurisdiction can still be “understood” in another environment, by means of the PhPID representation
© Blue Wave Informatics LLP, 2016

11. Diltiazem hydrochloride 300mg modified release capsule
Example
In France:
Deltazen LP Gé 300 mg Gélule à libération prolongée (Sanofi-Aventis)
IDMP PhP4 ID
Diltiazem hydrochloride 300mg modified release capsule
In Ireland:
Adizem-XL 300mg Prolonged release capsules (Mundipharma)
Tildiem LA 300mg Prolonged release capsules (B&S Healthcare)
© Blue Wave Informatics LLP, 2016

12. Challenges for a trustworthy medication profile
Identifying medicinal products - across countries - is an important priority!
Standards are needed for the structure and semantics for representing medication items in a profile AND for populating these items from data from the Medication Processes
How are particular items described? One off prescriptions, as required items…
The Profile needs clear removal or archiving criteria: on what basis are items deprecated? How to document the rationale?
How is "currency to be defined", and conflicts between EHR systems to be reconciled?
Should the “archive” always be communicated as part of the profile?
The Profile needs clear inclusion criteria: grey areas include immunisations, purchased medication, medical devices, herbal and other complementary therapies, blood products…

13. Conclusions
Health summaries (not one standard summary!) can play important roles in cross-border and within-border care co-ordination
Standardised representations of (most of) the summary content are vital to enable EHR systems support (care pathway tracking, decision support, trends etc.) and wider uses of the health data
Harmonising the unplanned care summary (~ International Patient Summary) is an important first step
Since medication information vitally underpins continuity and safety of care, globally robust medicinal product identification is also an important step
However we next need urgently to standardise on a trustworthy Medication Profile (= structure + content + workflows + policies)