Medication data in patient summaries June 20 - 21, 2016 US FDA White Oak Campus Medication data in patient summaries Dipak Kalra, EuroRec Julie James, Blue Wave Informatics

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

undertaking clinical and industry research planning and budgeting national health services commissioning purchasing healthcare services public health screening, prevention optimising clinical outcomes Date: 1.7.94 Whittington Hospital Healthcare Record John Smith DoB : 12.5.46 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

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”

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

© 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

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

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

© 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

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

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

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…

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)