About manufactured dose forms and clinical drugs

SNOMED Groups Drugs Extension User Group
1

Dear All,
Could you please share how you manage your national drug extension?
Do you apply specific guidelines or rules for the creation of clinical drugs and for their mapping to pharmaceutical products (brand names)? If so, would you be willing to share these procedures?
We have noticed some potential issues in the content of the international edition and would appreciate your insights.

  1. For injectable drugs, in some cases, the manufactured dose form includes specific details regarding the preparation methods prior to drug administration, whereas in other cases, such information is not provided:
  • The dosage form “Concentrate for conventional release solution for infusion” is available in SNOMED CT: the solution must not be administered to the patient before it has been properly diluted, and this requirement is clearly stated in the description of the manufactured dosage form (1237267003 |Concentrate for conventional release solution for infusion (dose form)|.
  • By contrast, the dosage form “Powder for concentrate for solution for infusion” is not included in SNOMED CT.
    The designation of the manufactured dose form, “Powder for concentrate for solution for infusion,” implies a two-step preparation process prior to administration:
    • First step: reconstitution
    • Second step: dilution of the reconstituted solution
      This distinction is critical from a safety standpoint, as the reconstituted solution must not be administered to the patient before it has been properly diluted.
  1. Some clinical drugs seems to be duplicates:
    For example : there are 3 clinical drugs with same strength for 430153008 |Product containing ganciclovir in parenteral dose form (medicinal product form)|
  • 1237153003 |Product containing precisely ganciclovir (as ganciclovir sodium) 500 milligram/1 vial powder for conventional release solution for infusion (clinical drug)|
  • 324781006 |Product containing precisely ganciclovir (as ganciclovir sodium) 500 milligram/1 vial powder for conventional release solution for injection (clinical drug)|
  • 1237154009 |Product containing precisely ganciclovir (as ganciclovir sodium) 500 milligram/1 vial powder for conventional release solution for infusion and/or injection (clinical drug)|
    But sources indicate that “Ganciclovir must be administered by intravenous infusion over 1 hour at a concentration not exceeding 10 mg/mL. Do not administer by rapid or bolus intravenous injection because the resulting excessive plasma levels may increase the toxicity of ganciclovir.”
    “Do not administer by intramuscular or subcutaneous injection because this may result in severe tissue irritation due to the high pH (~11) of ganciclovir solutions”
2

Hi @Elisase

I can add a bit of information here:

  1. In the Editorial Guide under Pharmaceutical Dose Form Pharmaceutical Dose Form | Specifications SNOMED CT Editorial Guide | SNOMED International Documents
    Out of Scope section: Concepts in pattern “x for y for z” (e.g. Powder for concentrate for dispersion for infusion)
  2. 324781006 |Product containing precisely ganciclovir (as ganciclovir sodium) 500 milligram/1 vial powder for conventional release solution for injection (clinical drug)| has a date of 2018. This is when the new drug model was implemented some of it by batch automation. So 2002 concept 376055000 |Ganciclovir sodium 500mg powder (product)| was inactivated and replaced by 324781006 |Product containing precisely ganciclovir (as ganciclovir sodium) 500 milligram/1 vial powder for conventional release solution for injection (clinical drug)|. If this concept is erroneous please submit a CRS request for inactivation. Many thanks Nicki