Opening

2 min

Shane

Welcome & Notification of Recording

Dosage Instructions

20 min

Alejandro

Request for review/updates to dosage instructions contained in qualifier value hierarchy.

• Is anyone using these at the moment? (Origin UK BNF labels?)

• Do you see any impact if changes are made?

FHIR ValueSet: https://build.fhir.org/valueset-additional-instruction-codes.html (Forms part of Dosage Resource Dosage - FHIR v6.0.0-ballot3 ) - also used in UK  UK NHS dose syntax https://developer.nhs.uk/apis/dose-syntax-implementation/dosage-additional-patient.html

To view list in SNOMED: Parent Concept: 419492006 |Additional dosage instructions|

Noteworthy issues in additional dosage instructions:

1. In some cases, very specific combinations of individual pieces of information have been combined into a single term, e.g.:

a.      Allow to dissolve under the tongue. Do not transfer from this container. Keep tightly closed. Discard eight weeks after opening (qualifier value) 419111009

b.     Warning. Causes drowsiness which may continue the next day. If affected, do not drive or operate machinery. Avoid alcoholic drinks (qualifier value) 418071006à May still be useful as it is often used in combination (?)

c.      Do not take indigestion remedies or medicines containing iron or zinc at the same time of day as this medicine (qualifier value) 420082003à may still be useful as often in combination (?)

d.     Do not take milk, indigestion remedies, or medicines containing iron or zinc at the same time of day as this medicine (qualifier value) 419115000à May still be useful as often used in combination (?)

e.      Do not take more than 2 at any one time. Do not take more than 8 in 24 hours (qualifier value) 419437002à May still be useful as often used in combination (?)

2. Contains brand names or names of medicinal substances that are not commonly used internationally (everywhere), e.g.:

a.      Contains an aspirin-like medicine (qualifier value) 418194009à Aspirin: better to refer to it at the NSAID or antiplatelet agent level (?)

b.     Contains aspirin (qualifier value) 417980006à Aspirin: better to designate at NSAID or platelet aggregation inhibitor level (?)

c.      Contains aspirin and paracetamol. Do not take with any other paracetamol products (qualifier value) 418850000à Aspirin: better to label at NSAID or antiplatelet agent level (?)à Paracetamol is better known as acetaminophen in English usage

d.     Do not take anything containing aspirin while taking this medicine (qualifier value) 418281004à Aspirin: better to refer to NSAIDs or antiplatelet agents (?)

e.      Do not take with any other paracetamol products (qualifier value) 418637003à Paracetamol is better known as acetaminophen in English

3. Very "broadly summarised" drug groups

a.      Do not take indigestion remedies at the same time of day as this medicine (qualifier value) 420110001à Can this be generalised in this way? Isn't it more explicitly about PPIs and/or antacids ("complexing agents")?

b.     Do not take indigestion remedies or medicines containing iron or zinc at the same time of day as this medicine (qualifier value) 420082003à Can this be generalised? Isn't it more explicitly about PPIs and/or antacids ("complexing agents"), for example?

c.      Do not take milk, indigestion remedies, or medicines containing iron or zinc at the same time of day as this medicine (qualifier value) 419115000à Can this be generalised? Isn't it more explicitly about PPIs and/or antacids ("complexing agents"), for example?

4. "Placeholders" within SNOMED terms, e.g. to enter a specific maximum amount of a drug – cannot be used in SNOMED CT and would always be listed with placeholders when using the codes

a.      Do not take more than . . . in 24 hours (qualifier value) 420003005

b.     Do not take more than . . . in 24 hours or . . . in any one week (qualifier value) 418443006

5. Full addition "Dosing instruction fragment" in the code

a.      Then discontinue - dosing instruction fragment (qualifier value) 421484000

b.     Then stop - dosing instruction fragment (qualifier value) 422327006

c.      Until finished - dosing instruction fragment (qualifier value) 421984009

d.     Until gone – dosing instruction fragment (qualifier value) 420652005

In Meeting:

Link to BNF (source): https://bnf.nice.org.uk/about/labels/

DK: Changes being discussed for R6 is for nested dosage instructions. Requirements to have sequences in dosage instructions. Also, rendered dosage instructions change (breaking change). FHIR changes under discussion don’t relate to this addtional instructions ValueSet. Link to medication reuqest: https://build.fhir.org/ig/hl7-eu/mpd/StructureDefinition-MedicationRequest-eu-mpd.html Most binding were inherited from existing FHIR work, or brought in from EU Standards.

Current work is mix of HL7, and EU working groups.

JJ/MH: What is on FHIR is an exemplar ValueSet, users can extend binding or use different binding. Pharmacy SIG in HL7 is good first port of call. Request was from SNOMED Member to review content rather than this being a request from HL7

AU: Have some dosage instructions in older RefSets (pre-dating FHIR) includes dose-rate concepts etc.

UK: Lot of work on dose syntax in UK. These concepts are referenced in that work. Newer concepts have also been added to these in UK extension in recent years. Changes to this area in International will affect UK.

India: These are in use, translated into local languages. Changes will impact India. Also part of FHIR IG. https://nrces.in/ndhm/fhir/r4/StructureDefinition-MedicationRequest.html

Uruguay: Not in use in Uruguay, use a free text field for ‘comments’ in the medication section

Monica: Whats the best process to progress this, would be through HL7 Pharmacy group? Jose: Will bring this to HL7 pharmacy, and DK EU groups are busy at moment but can bring there for discussion and feedback also.

Less Granular Clinical Drug

2 min

Guillermo

Currently working on examples & analysis. Will share an update in next meeting

Open

Mapping of Modelling Variation in precisely clinical drugs - Guillermo

Adding |Dose form after transformation| to the Dose form concept model

10 min

Karen / Nicki / Yong

Proposed for International inclusion or national extension use only?

Discussion around specificity of target value to new axiom:

• Basic dose form versus pharmaceutical dose form (e.g. solution versus oral solution versus rectal solution?)

PDFs with Transformations = 96

< 736542009 |Pharmaceutical dose form (dose form)| : 736473005 |Has dose form transformation (attribute)| != 761954006 |No transformation (transformation)|

e.g.

Powder for prolonged-release oral suspension (dose form)

Powder for conventional release solution for hemodialysis (dose form)

Powder for conventional release intravesical solution and solution for injection (dose form)

Porous impregnated material for conventional release pulmonary vapor inhalation (dose form)

Tablet for conventional release oromucosal solution for mouthwash (dose form)

Concentrate for conventional release emulsion for cutaneous spray (dose form)

Concentrate for conventional release oromucosal solution for gargle (dose form)

Concentrate for conventional release solution for nebulizer (dose form)

Updates from Yong pre-meeting: On the subject of the dose form attribute, I suggest we add a text definition for `736473005 |Has dose form transformation (attribute)|` and update the Editorial Guide accordingly. This definition could state that “dose transformation” refers to the process where a manufactured medicinal product (manufactured item/dose form) requires further manipulation or alteration by a healthcare professional or patient before administration. This is aligned with IDMP and represents the manufactured dose form that requires transformation before administration. 385223009 |Powder for conventional release solution for injection (dose form)| is currently defined in the release.
=== 1209021002 |Powder for conventional release solution for infusion and/or injection (dose form)| :
    736476002 |Has basic dose form (attribute)| = 739005008 |Powder (basic dose form)|,
    736474004 |Has dose form intended site (attribute)| = 738984000 |Parenteral (intended site)|,
    736475003 |Has dose form release characteristic (attribute)| = 736849007 |Conventional release (release characteristic)|,
    736473005 |Has dose form transformation (attribute)| = 736853009 |Dissolve (transformation)|,
    736472000 |Has dose form administration method (attribute)| = 740685003 |Inject (administration method)|New attribute and remodeling
=== 1209021002 |Powder for conventional release solution for infusion and/or injection (dose form)| :
    Has basic dose form = |Powder|
    Has dose form after transformation = |Conventional release solution for injection (dose form)|
    Has dose form transformation = |Dissolve|The proposed alternative is not simply adding an additional attribute to the international model. This is a significant change to the existing dose form model. The administration method and release characteristic are embedded into the dosage form after transformation. This will require careful analysis and evaluation. In particular, the “dose form after transformation” is almost an “administration dose form”. It is a nested representation where the (manufactural) dose form has (adminstration) dose form.

Patches/Vaginal Ring Strength Representation

10 min

Karen / Nicki / Yong

Item not covered due to time - push to next meeting

How to represent reservoir size and release rate.

Submit exceptions/examples to CRS to review. Estring

Open

Example of ESTRING 7.5 microgram/24 hours from MHRA

Updates from Yong pre-meeting: Regarding the modeling of patches, I agree that there is no single ideal solution. The decision to use presentation strength is a pragmatic choice to prevent confusion with concentration strength normalization. To represent these products in extensions, a two-role group solution appears necessary to capture both the release rate and the total quantity of the active ingredient. One role group would represent the release rate (e.g., 7.5 microgram/24 hour), and the second would represent the total amount per unit (e.g., 2 mg/1 patch).

Substances Project Update

5 min

Monica

Item not covered due to time - push to next meeting

Brief update on substances project

Substances Co-ordinationPreview

AOB

Community Informational Briefing Note - Update of Case Significance of Descriptions for Drug Related Content .pdf

Next Meeting: Nov 20, 2025 11am UTC