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Updating the NHS dm+d ‘<DRUG_FORM>’ coded attribute within the Virtual Medicinal Product concept class

The coded drug form, the ‘<DRUG_FORM>’ attribute for a product within the Virtual Medicinal Product (VMP) concept class, will where appropriate, contain more detail to align more closely with EDQM dose forms.

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NHS dm+d holds the coded ‘<DRUG_FORM>’ attribute for a product within the Virtual Medicinal Product (VMP) concept class. It is held in the ‘VMP Form information’.

Figure 1. NHS dm+d Data Model illustrating attributes held at VMP level - adapted from Data Model R2 v3.2 February 2023_0.docx (live.com)

NHS dm+d data model illustrating attributes held at VMP level

Some current drug forms are not granular enough allowing for different intended uses. For example ‘capsule’ is attached to both oral capsule VMPs and vaginal capsule VMPs.

This enhancement proposes to revisit a number of drug forms and where appropriate include details of their release characteristics and intended route.

These changes will allow dm+d to more closely align with European Directorate for the Quality of Medicines & HealthCare (EDQM) dose forms and the modelling for dose forms in the International SNOMED CT data.

What will happen in the dm+d files

See Technical Specification of data files R2 v3.2 Jan 2023 (213KB).docx (live.com) for more detail.

In VMP xml file:

TAG name Optional Description
<DRUG_FORM>   Formulation or Form associated with each VMP
<DFORM>   Formulation associated with each VMP (this collection of tags will occur for each VMP/formulation relationship)
<VPID>  

VMP identifier (as above in VMP tag).

Up to a maximum of 18 digits.
<FORMCD>  

Formulation code, narrative can be located in lookup file under tag <FORM>.

Up to maximum of 18 digits.
</DFORM>   End tag
</DRUG_FORM>   End tag

The <FORMCD> will be updated for example from the code for Capsule (385049006) to the new code for Oral capsule (420692007) or Vaginal capsule (385175008).

In the Lookup xml file:

TAG name Optional Description
<FORM>   Code descriptions for formulations (Form)
<INFO>   This collection of tags will occur for each code description pair
<CD>  

Code (SNOMED).

Up to maximum of 18 digits.
<CDDT> Y

Date code is applicable from.

Always 10 characters.
<CDPREV> Y

Previous code.

Up to maximum of 18 digits.
<DESC>  

Description.

Up to maximum of 60 characters.
</INFO>   End tag
</FORM>   End tag

The new codes <CD> along with their description <DESC> (up to 60 characters) will appear in the Lookup file.

Only the coded ‘<DRUG_FORM>’ attribute within the VMP concept class will be updated with the new drug form. No other part of the VMP will be changing because of these updates1.

The name of the VMP will not change.

The ontology form-route information at VMP level will not change.

The Unit Dose and Form Information will not change.

Figure 2: NHS dm+d Browser - Product search - dm+d browser (nhsbsa.nhs.uk)

NHS dm+d browser product search

In figure 2, above, please note that:

  • ‘Capsule’ in Unit Dose and Form Information is the Unit of Measure SNOMED code 428641000
  • ‘Capsule’ in Summary - Form is the Drug Form SNOMED code 385049006

1 Whilst unlikely, it is possible that the updating of the drug form may coincide with another separate update to the VMP - for example the updating of the VMP ID. Every step will be taken to avoid more than one update to the same VMP but this cannot be guaranteed.

Timeframes

During April and May 2023

Initial consultation with users by feedback survey and follow up calls where required.

A small sample of five ‘enema’ VMPs that had the drug form of ‘foam’ and the route of ‘rectal’ were updated in dm+d to the form of Rectal foam in Week 18, Release 5.0.0. These were:

  • Budesonide 2mg foam enema
  • Hydrocortisone 1% / Pramocaine 1% foam enema  - all Actual Medicinal Products (AMPs) discontinued
  • Hydrocortisone 10% foam enema - all AMPs discontinued
  • Mesalazine 1g/application foam enema
  • Prednsiolone 20mg/application foam enema

June 2023

Website update with examples of new forms.

Further engagement with stakeholders and the opportunity for stakeholders and users to provide feedback on the proposals.

Q3 2023

July 2023 - 2 drug forms were identified as only requiring their description to be updated – Paint and Wash. 

  • Paint (3095111000001104) became Cutaneous paint (3095111000001104)
  • Wash (3097511000001104) became Cutaneous wash (3097511000001104)

Where the new form has been agreed the SNOMED code and description of the form will appear in the NHS dm+d Lookup XML file however these descriptions and codes will not be attached to VMPs until the date confirmed (see below).

Updating the ‘<DRUG_FORM>’ attribute will begin with a sample batch. The sample batch will include the new drug forms for ‘Ointment’ and will be updated in the TRUD extract Monday 28 August 2023.

What will happen with the Ointment Sample Batch

Below is a table showing the existing forms of ‘Ointment’ in NHS dm+d and the new Ointment forms that were released in TRUD extract Monday 31 July 2023:

Description Code
Ointment 385101003 Existing
Eye ointment 385123004 Existing
Nasal ointment 385151008 Existing
Rectal ointment 385184008 Existing
Homeopathic ointment 420434002 Existing
Inhalation vapour ointment 1231564001 Existing
Cutaneous ointment 425753008 New
Cutaneous or nasal ointment 41627611000001108 New
Ear ointment 385135000 New
Transdermal ointment 762893001 New

The sample batch will result in all VMPs that have the coded form of 385101003 ointment being reviewed. The VMP will either: 

  • retain the existing form of ointment
  • will be updated to one of the new ‘ointment forms’
  • will be updated to an existing ointment form if that is more appropriate

Retain the existing form of ointment

The following VMPs will retain the existing form of ointment:

  • where the VMP has 3 or more ‘routes’, such as Lidocaine ointment
  • where the VMP has the route ‘Route of Administration not applicable’, such as combination products and special order products
  • where there is no route information (Nil), such as ointments that are medical devices
  • invalid concepts will not be updated and so will retain their existing form

Updated to a ‘new form’

The following will be updated to a 'new form':

  • where the VMP has a route of auricular the VMP drug form will be updated to ear ointment
  • where the VMP has a route of cutaneous the VMP drug form will be updated to cutaneous ointment
  • where the VMP has the routes cutaneous and nasal the VMP drug form will be updated to cutaneous or nasal ointment
  • where the VMP has a route of transdermal the VMP drug form will be updated to transdermal ointment

Updated to an ‘existing form’

The following will be updated to an 'existing form':

  • where the VMP has the routes of Cutaneous and Rectal the VMP drug form will be updated to Rectal ointment

Route(s)

The dm+d definition of transdermal is under review as it no longer aligns with the EDQM definition.

EDQM transdermal use is for systemic effect only whilst dm+d allows local and systemic effect. dm+d intends to align to the EDQM definition which will result in:

  • 1 ‘ointment’ VMP having the new drug form of transdermal ointment
  • a number of special order ‘ointment’ products that currently have the route of transdermal will have this route removed and the route of ‘Route of administration not applicable’ applied - these VMPs will then retain the existing form of ‘ointment’
  • 3 other ‘ointment’ VMPs that currently have the route of transdermal will have this route removed and the route of cutaneous added (as they are applied to obtain a local effect) and these will become cutaneous ointments.

Q4 2023

The exact date that the updating of the forms will occur has yet to be finalised but this information is to provide advance notice to users to allow them to make any preparations for the changes.

We are planning for the ‘<DRUG_FORM>’ changes to be made in 2 phases. Phase 1 is expected to take place towards the end of 2023 and will consist of:

  • Capsule
  • Cream 
  • Foam
  • Gel
  • Granules
  • Paste 
  • Tablet

The remaining‘<DRUG_FORM>’ changes (Phase 2) are expected to take place in early 2024.

How forms will be updated and examples

Only single or dual ‘site’ new drug forms will be created with this piece of work.

There is an existing drug form of ear/eye/nose drops solution attached, for example, to Betamethasone 0.1% ear/eye/nose drops. If in the future a new drug form for ear/eye/nose was required this would be authored as an exception.

An update is available which advises how technical queries might be written to query dm+d data to identify VMP drug form changes from either TRUD or the NHS England Terminology Server.

Where a VMP has three or more ‘sites’, this will not be given a new drug form but will retain the existing drug form of ‘gel’.

For example, Lidocaine 1% gel which has routes of oromucosal, cutaneous, rectal and urethral.

Where a VMP has ‘Route of administration not applicable’, this will be retained.

For example, Clotrimazole 500mg pessary and Clotrimazole 2% cream is a ‘combination product’ and Diltiazem 1% cream is only available as a ‘special order’ AMP. These will retain the existing ‘Route of administration not applicable’

Where a VMP has no route of administration information, this will be retained.

For example, Generic Epaderm cream is a medical device.

Invalid concepts will not be updated.

VMPs where all of the AMPs are discontinued will be updated.

No drug forms will be removed from the xml files although some may no longer be attached to a VMP.

The following seven drug forms will have updated forms.

Capsule will have the updated drug forms:

  • Oral capsule
  • Vaginal capsule

Cream will have the updated drug forms:

  • Cutaneous cream
  • Nasal cream
  • Rectal cream
  • Vaginal cream

Foam will have the updated drug forms:

  • Cutaneous foam
  • Vaginal foam

Gel will have the updated drug forms:

  • Cutaneous gel
  • Periodontal gel
  • Transdermal gel

Granules will have the updated drug forms:

  • Oral granules
  • Granules for oral solution
  • Granules for oral suspension
  • Granules for intrauterine suspension
  • Granules for oral or rectal suspension
  • Granules for gastroenteral or oral suspension

Ointment will have the updated drug forms:

  • Cutaneous ointment
  • Ear ointment
  • Transdermal ointment
  • Cutaneous or nasal ointment

Paste will have the updated drug forms:

  • Cutaneous paste
  • Dental paste
  • Oromucosal paste

Tablet will have the updated drug forms:

  • Oral tablet
  • Vaginal tablet

On-going work is currently looking at the drug forms of Powder, Irrigation, Irrigation solution and Liquid and the website will be updated when available. It is intended to start work looking at Implant and Implantation suspension following this. 

What you need to do

Consider:
  • Do you currently use or intend to use the ‘<DRUG_FORM>’ field in the future?
  • What impact will this change have upon your system or end users?
  • Is there a lead time needed in order for you to cope with these changes?
  • What would be the impact to you, your system or end users if a ‘<DRUG_FORM>’ change was to occur in the same extract as a VMP ID change?
  • If you don’t use the ‘<DRUG_FORM>’ field in your system, do you foresee any issues with the dm+d files being updated with the ‘new form’?

Further help

If you would like to discuss these changes further please contact UKMEDS at [email protected].
 

Last edited: 22 August 2023 1:09 pm