Naming Conventions for 'Packaged Clinical Drugs'
Dear All,
Please see below member query in relation to naming conventions in the national extension model:
Would it be possible to have agreed names for Packaged Clinical Drugs (VMPPs in the UK) that are combinations as we can see you have these for FSNs but not all PTs (for combination drugs)?
Please see the link below to help with/describe the query:
https://confluence.ihtsdotools.org/pages/viewpage.action?pageId=123904520
From the above link, for example, there a single active ingredient substance presentation strength packaged clinical drug: stated and inferred view example, but not for a combination product which would be most useful if you could share.
Comments
DEUSG Summary: A user request was received for clearer naming rules for combination packaged clinical drugs (PCDs), as examples currently exist in the guidance for single-ingredient products but not for combinations.
Next steps: Editorial guidance for national drug extensions will be enhanced to include clear naming conventions for PCDs, including combinations to assist in authoring and implementation at national level.
The content team has developed some examples for PCDs, starting from on the editorial guidelines for the CDs in the international edition, these are shared here for your consideration:
Clinical Drug (CD) with a single ingredient:
FSN: Product containing precisely amlodipine (as amlodipine besilate) 5 milligram /1 each conventional release oral tablet (clinical drug)
Synonym: Amlodipine (as amlodipine besilate) 5 mg oral tablet
Clinical drug (CD) with multiple ingredients:
FSN: Product containing precisely amlodipine (as amlodipine besilate) 5 milligram and valsartan 80 milligram/1 each conventional release oral tablet (clinical drug)
Synonym: Amlodipine (as amlodipine besilate) 5 mg and valsartan 80 mg oral tablet
PCD Template: Package containing <pack size> of <clinical drug (CD)> (packaged clinical drug)
PCD with single ingredient:
FSN: Package containing 28 tablets of amlodipine (as amlodipine besilate) 5 milligram/1 each conventional release oral tablet (packaged clinical drug)
Synonym: Amlodipine (as amlodipine besilate) 5 mg oral tablet 28 tablet pack
Synonym: Amlodipine (as amlodipine besilate) 5 mg oral tablet 28 tablet
PCD with multiple ingredients:
FSN Package containing 28 tablets of amlodipine (as amlodipine besilate) 5mg and valsartan 80mg/1 each conventional release oral tablet (packaged clinical drug)
Synonym: Amlodipine (as amlodipine besilate) 5mg and valsartan 80mg oral tablet 28 tablet pack
Synonym: Amlodipine (as amlodipine besilate) 5mg and valsartan 80mg oral tablet 28 tablet
Please let us know if you have any feedback or preferences. The plan is to enhance the documentation to include examples of naming conventions for extension classes.
Best regards
Alejandro