R6 Ballot (1st Draft)

This page is part of the FHIR Specification v6.0.0-ballot1: Release 6 Ballot (1st Draft) (see Ballot Notes). The current version is 5.0.0. For a full list of available versions, see the Directory of published versions

Work Group Pharmacy icon & Public Health icon Standards Status: Informative

11.0 Medications Module

11.0.1 Introduction

This module is concerned with resources and functionality in 3 main domains:

  • The ordering, dispensing, administration of medications and recording statements of medication use.
  • Recording of Immunizations given (or not given), evaluation of given immunizations and recommendations for an individual patient at a point in time.
  • The creation or querying for medications as part of drug information or drug knowledge.

11.0.2 Index

11.0.2.1 Medications

NameDescription
MedicationRequest

Represents an instruction for the administration of medication to a patient - both in the inpatient (hospital) and community setting. It can also include instructions for the dispensing, the reasons why the administration should occur and other data.

It is called an 'Request' to be consistent with other FHIR resources and the workflow pattern, but a common alias for this resource is a 'Prescription' or an 'Order'. The Order itself represents the content of the instruction and is not, by itself, actionable. The workflow process around 'fulfilling' the order is part of the generic FHIR workflow (see below), with the MedicationRequest representing the contents.

MedicationDispense The provision of a supply of a medication with the intention that it is subsequently consumed by a patient (usually in response to a prescription).
MedicationAdministration A record of a patient actually consuming a medicine, or if it has otherwise been administered to them
MedicationStatement This is a record indicating that a patient may be taking a medication now, has taken the medication in the past, or will be taking the medication in the future. The source for this information can be the patient, significant other (such as a family member or spouse), or a clinician. A common scenario where this information is captured is during the history taking process during a patient visit or stay. A medication statement is not a part of the prescribe->dispense->administer sequence, but is a report that such a sequence (or at least a part of it) did take place, resulting in a belief that the patient has received a particular medication. It may be used to construct a patients 'Current Medications' list.
Medication The medication resource represents an actual medication that can be given to a patient, and referenced by the other medication resources. In many cases, this resource is not needed and the drug is indicated by a reference to the appropriate terminology and so can be represented using a codeable concept. In other cases, however, it may be desired to indicate more details than the simple drug (such as the packaging, whether it is a generic medication or the active and inactive ingredients) and so the Medication resource can be used for this.
MedicationKnowledge The MedicationKnowledge resource is draft and is included for comment purposes. This resource represents information about a medication, for example, details about the medication including interactions, contraindications, cost, regulatory status, administration guidelines, etc.

11.0.2.2 Immunizations

NameDescription
Immunization The Immunization resource is intended to cover the recording of current and historical administration of vaccines to patients across all healthcare disciplines in all care settings and all regions. This includes immunization of both humans and animals, but does not include the administration of non-vaccine agents, even those that may have or claim to have immunological effects.
ImmunizationRecommendation A patient's point-in-time immunization and recommendation (i.e. forecasting a patient's immunization eligibility according to a published schedule) with optional supporting justification
ImmunizationEvaluation The ImmunizationEvaluation resource is intended to cover communicating the results of an evaluation of a vaccine administration event (documented using the Immunization resource) against a set of published recommendations (protocols).

11.0.3 Common Use Cases

  • Placing a Medication Request (aka Prescription or Order). The MedicationRequest resource represents the details of what medication the prescriber intends the patient to receive and other details such as the dose, timing and route. However, while it represents that order, the actual workflow around the supply (dispensing) and administration of that medication is managed by the common workflow functionality, resulting in the creation of the other medication resources (MedicationDispense, MedicationAdministration) as it executes.
  • Listing a patient's current medications. This is represented using the List resource, which allows an author to construct a 'curated' list. This has features beyond a simple collection of resources - such as the ability to state that the patient is not currently taking any medications at the time that the list is constructed, or changes that are made at a point in time (sometimes called medication reconciliation). FHIR defines a number of specific functional lists for this purpose, and a specific operation to retrieve it. Note that FHIR does not describe how the list should be maintained by the individual system, as that will vary widely between implementations.
  • Retrieving a list of Immunizations. This can be achieved using a simple query against the Immunization resource type. Note that an Immunization resource can specifically state that it was not given, as well as any reactions that occurred. Note that if the reaction is considered to be an indication of an allergy or intolerance, then a separate AllergyIntolerance resource should be created.
  • Retrieving recommendations for a specific patient at a point in time. The recommendation for immunizations to give would be represented by an ImmunizationRecommendation resource, but the determination of that recommendation is a part of Decision Support, with the actual immunization schedule being represented by a generic Plan Definition, individual Care Plan or some other record.
  • Dispensing a medication based on a Medication Request (aka Prescription or Order). The MedicationDispense resource represents the details of the dispensing event including the actual product provided to the patient and the dosage to be administered or consumed.
  • Retrieving the planned medication therapy for specific patient at a point in time. The intended medication therapy may be represented by an individual Care Plan.
  • Retrieving information about a medication either as a stand alone request or as while reviewing a patients' medication list

11.0.3.1 Medication Reconciliation List

Overview

Medication reconciliation is a process that collects all available medication information about a patient e.g., existing medication orders, patient reported medication orders, over-the-counter medication information (e.g., supplements, vitamins and other medications), medication dispenses, medication administrations, medication history and medication related claims or bills.  After aggregating the medication information, the provider determines if any action needs to be taken related to the known medications. These actions include updating an existing prescription, writing a new prescription, writing a new order indicating that a patient should not take a medication, including one or more of the over-the-counter medications, etc.  The end point of the medication reconciliation process is to end up with a reconciled medication list that can be shared with a provider or patient or patient representative.    

This reconciliation process is often done when a patient is:

  • admitted or discharged from a hospital or other healthcare setting, or home
  • visits to ER/ED
  • comes into a healthcare setting for an outpatient procedure
  • has a primary care visit at a clinic or GP practice setting e.g., episodic care, annual exam, one time visit
  • is transferred from one inpatient location to another e.g., emergency department (ED) to a med-surg unit, ICU to med surg unit, ED to operating room, etc.
  • is transferred from one healthcare setting (e.g., hospital) to another healthcare setting (e.g., long term care, or rehab facility, psychiatric hospital) 

At transitions of care, it is best practice to perform a medication reconciliation process in order to determine the status of:

  • existing medication prescription orders
  • orders from other providers that the patient is aware of, but that their primary care provider or other clinical staff might not be aware of
  • reported over the counter medications the patient is taking
  • medication history – this may include herbals, illegal drugs, supplements, etc.
  • adherence to taking/not-taking drugs is a separate process; this information may be useful when creating a Medication Reconciliation list.  This process documents whether the patient is taking or not taking a medication or whether a patient is taking or not taking a medication as prescribed 

Sources for Medication Information

The source of uncurated medication information is often taken from one or more of the following:   

  • Medication requests/orders/prescriptions
  • Medication dispense transactions
  • Medication administration events
  • Medication usage history e.g., often patient reported, but not exclusively patient reported
  • Medication related claims
  • Previous medication list that a clinician or patient has access to

The source data may be captured from systems, often EHRs, MARs, ePrescribing systems, pharmacy or billing systems.  Depending on the architecture of the healthcare organization and the larger cross enterprise system the data may involve data housed in centralized healthcare data repositories that include medication related data, e.g., dispenses, orders, claims, Personal Health Records (PHR), or patient portals 

How to represent the data that is pulled together and in turn make it available via a FHIR API?

Depending on the business requirements the overall list of medications may include data from diverse systems and if it is important to maintain the relationship of the data to the primary FHIR resources this could end up with a collection of data that is represented with the following resources:

  • MedicationRequest
  • MedicationDispense
  • MedicationAdministration
  • MedicationStatement

Often, however the internal systems may make a business determination that they will expose the data via one of the resources e.g. If the list of medication data is to reflect what the patient "should" be taking, it would be accurate to represent this using the MedicationRequest resource.  See US Core for one example for how to represent this type of approach.

As additional requirements evolve additional resources may be required to support creating a medication list.  For example, if you want to include whether the patient is taking or not taking a medication, or whether the patient is taking or not taking the medication as prescribed, you may want to include MedicationStatement to reflect the taking or not taking.

Another example of an additional requirement may be if you want to create a reference to what type of data was used to create the entry on the medication list – this may result in exposing the referenced data as a MedicationRequest (common), MedicationDispense (often), MedicationAdministration(rare), or MedicationStatement (situational). 

A strong suggestion is to consider carefully how you want to expose this information.  This will influence what resources may be used in a FHIR API interface.  A simple medication list may only include one or two of the primary Pharmacy resources e.g. MedicationRequest or MedicationStatement, but a more complex or full featured medication list may include many if not all of the Pharmacy resources. 

Context Impacts Medication Reconciliation

  • When a patient is discharged from one healthcare organization, what happens related to the medication reconciliation process?
  • Third party (often, but not always this may be an insurer) may collect the current medication discharge orders, and other medication information from the patient and provide a reconciled medication list to a provider. 
  • In long term care settings in the US, pharmacists take on a role that is reflected in the Medication Reconciliation process.  The pharmacist serves as a key contributor in this Medication Reconciliation process.  Note this regulatory requirement may exist in other settings for other healthcare professionals.
  • In other settings, reconciliation events will occur that include only components of a comprehensive medication reconciliation and may be executed by non-pharmacy personnel.
  • A different example of how context may impact Medication Reconciliation is when one looks at Medication Profiles or similar named groupings of clinical data that will include the patients reconciled medication information and ALSO include non-medication information e.g., allergy information, diagnoses, problem lists, patient weight, and other relevant healthcare information deemed significant to include in this larger summary.
  • Another example may focus solely on the patient’s understanding of their medication information - what is the list of medications the patient is stating they are taking. 

In any example it is possible that some medication information may be constrained or even excluded from the medication reconciliation e.g., exclude history of long-past substance abuse, constrain to only prescribed medications.  These limited Medication Reconciliation outputs will have some value to some end-uses, but not to all end-uses. 

How is Medication Reconciliation information made available to patients or clinicians?

Patients often access the list of medications via a patient facing portal, or they may be provided a paper copy of their medications. 

Providers may access the output of Medication Reconciliation directly in their ePrescribing system or EHR which reflects all known medications the patient should be taking at a point in time. 

11.0.4 Other resources

There are other resources that are of particular interest in the medication domain.

11.0.5 Security and Privacy

As with all clinical data, Medications (in particular) can be sensitive information as specific medications can indicate the presence of private information such as mental health disorders or HIV. However, withholding information about what medications a person is taking can lead to catastrophic results, and so needs to be considered very carefully. At the least, a clinician should be made aware that there is information available that they have not been given when making clinical decisions.

For more general considerations, see the Security and Privacy module.

11.0.6 Developmental Roadmap

The Pharmacy workgroup has plans to improve all existing resources e.g. adding in features that support detailing our conditional orders in a structured way; evaluating requirements for supporting drug formularies and medication knowledge. This work is expected to include the development and approval of a new resource and may involve updates to the Medication Resource.