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

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)

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 and HealthCare (EDQM) dose forms and the modelling for dose forms in the International SNOMED CT data.

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

In VMP xml file:

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:

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 form¹.

The name of the VMP will not change apart from a few exceptions. An example can be found in the table in the section 'Ointment Sample Batch'

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)

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

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.

Quarter 3 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 began with a sample batch. The sample batch included the new drug forms for ‘Ointment’ and was included in the TRUD extract Monday 28 August 2023.

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:

The sample batch resulted in all VMPs that had the coded form of 385101003 ointment being reviewed. The VMP either: 

• retained the existing form of ointment
• was updated to one of the new ‘ointment forms’
• was updated to an existing ointment form if that was more appropriate

Retain the existing form of ointment

The following VMPs retained 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 were not updated and so retained their existing form

Updated to a ‘new form’

The following were updated to a 'new form':

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

Updated to an ‘existing form’

The following were updated to an 'existing form':

• where the VMP had the routes of Cutaneous and Rectal the VMP drug form was updated to Rectal ointment

Ointment sample batch - impact upon VMP names

Route(s)

The dm+d definition of transdermal has been reviewed to align it with the EDQM definition. EDQM transdermal use is for systemic effect.

This resulted in the following changes being made to the Ointment sample batch:

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

Quarter 4 2023

We are planning for the ‘<DRUG_FORM>’ changes to be made in 2 phases. Phase 1 took place for the TRUD extract Monday 20 November 2023 and consisted of:

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

Quarter 1 2024

The new Phase 2 drug forms were released in the TRUD extract Monday 15 January 2024, however these descriptions and codes were not attached to VMPs until the dates confirmed (see schedule below)

The work to update these forms took place over several weeks rather than the ‘big bang’ approach for the Phase 1 forms. 

Updates to the following drug forms took place in the dm+d:

Confirmation of these changes is provided in the Weekly release notes for dm+d.

Existing dm+d forms affected by further alignment with EDQM

The two existing dm+d forms of ‘Gastroenteral liquid’ and ‘Powder for gastroenteral liquid’ have been reviewed to more closely align with EDQM. As a result of this, the definitions of these two forms will be amended in the dm+d Editorial Policy and will no longer be applied to products being given orally.

• where a product is given only by a gastroenteral (into the stomach or duodenum) route it will be a ‘Gastroenteral liquid’ or a ‘Powder for gastroenteral liquid’
• where it can be given both orally and gastroenterally then it will be a ‘Gastroenteral or oral liquid’ or ‘Powder for gastroenteral or oral liquid’
• where it is only given orally it will be an ‘oral liquid’

This has resulted in a number of updates in our Phase 2 changes to VMPs with Gastroenteral liquid and Powder for gastroenteral liquid as their form.

The new definitions are as follows:

Gastroenteral liquid

Liquid preparation intended for administration to the stomach or duodenum by means of a suitable device.

Gastroenteral or oral liquid

A liquid administered via the enteral route i.e. oral, or into the stomach or duodenum (nasogastric, PEG, jejunostomy etc). This term covers solutions, suspensions and emulsions.

Powder for gastroenteral liquid

A powder that can be reconstituted to produce a liquid that is administered  to the stomach or duodenum by means of a suitable device

Powder for gastroenteral or oral liquid

A powder that can be reconstituted to produce a liquid that is administered via the enteral route i.e. oral, or into the stomach or duodenum (nasogastric, PEG, jejunostomy etc). This term covers solutions, suspensions and emulsions.

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.

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.

Phase 1

The following 7 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
• Transdermal 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

Phase 2

The following 6 drug forms will have updated forms: 

Implant will have the updated drug forms:

• Powder solvent and matrix for implantation matrix 
• Prolonged - release intralesional implant
• Prolonged - release intravitreal implant
• Prolonged - release subcutaneous implant
• Sealant matrix

Implantation suspension will have the updated drug forms: 

• Prolonged - release intraarticular implantation suspension
• Prolonged - release intraosseous implantation suspension

Irrigation and Irrigation solution will have the updated forms: 

• Powder and solvent for solution for intraocular irrigation
• Intraperitoneal irrigation solution 
• Ocular irrigation solution 
• Cutaneous irrigation solution 
• Cutaneous or intravesical irrigation solution 

Liquid will have the updated forms: 

• Cutaneous or ear solution 
• Buccal liquid 
• Cutaneous or inhalation liquid 
• Cutaneous or oromucosal liquid 
• Dental liquid 
• Endocervical solution 
• Suspension for endotracheopulmonary instillation
• Oromucosal liquid 
• Intraarterial solution 
• Intraperitoneal solution 
• Nasal solution 
• Oral or rectal solution
• Oral or rectal suspension
• Vaginal solution 
• Cutaneous liquid 
• Oral liquid 
• Gastroenteral or oral liquid 

Powder will have the updated forms: 

• Ear powder 
• Cutaneous powder 
• Powder for suspension for endotracheopulmonary instillation
• Powder for oral or rectal suspension 
• Oral powder 
• Powder for oral solution 
• Powder for oral suspension 
• Powder for gastroenteral or oral liquid 

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