Harmonisation Proposals

List of Harmonisation Topics for November 2009

POME Based

The following items wewre noted on the DMIM used as a basis for the normative version. These changes have probably all been resolved for the COmmon Product Model.

1) Add into appropriate domain (may already have been approved at harmonisation) SubstanceAdministrationMethod

CountryCode (in Country) (no harmonisation issue - should use CountryEntityType)

ContainerEntityType (in PackagedMedicine) (no harmonisation issue - valaue set does now exist)

RegulatiuonPolicyActCode (in Policy)

ActMedicineapproval (in approoval) (no harmonisation issue - has been defined)

2) Add domain descriptions for:

RouteOfAdministration - afms should fix this

MedicationObservationType (in Characteristic) (no harmonisation issue - definition now exists)

3) Find better vocab domains for

AdministrationGuideline.code : ActCode

PORX Based

• more appropriate ActCode domains for Header and SubstanceAdministration

SubstanceAdministrationRequest.code should be constrained to a suitable concept domain. CombinedMedicationRequest.code should be constrained to a suitable concept domain.

Common Product Model Based

• Vocabulary for SpecialisedKind roleCode

There is currently a concept domain of MedicationGeneralisationRoleType that is defined as Identifies the specific hierarchical relationship between the playing and scoping medications. THis currntly has examples of Generic, Generic FOrmulation and Therapeutic Class. We need to provide a more structured representative vocabulary set to cover the IDMP concepts of MPID, PharmaceuticalProduct and PhPID and also the classification concepts of “medicine”, “vaccine”, “biologicals” without disrupting the more general concepts that are used in the medication model and are only shown as examples at present.

• Name Parts

In the Entity Name data type there is vocabulary for person and address name parts. We need to extend this vocabulary to cover medication name parts used for building formal alternative names.

• ActProductApprovalType

Need a representative vocabulary to provide a hierarchy under which specific approval events are defined: - first marketing authorisation; - renewal; - variation; - withdrawal; - marketing start; - marketing stop

• Devices as Ingredients

Add vocabulary to the hierarchy of values under RoleClassIngredientEntity to distinguish a "Mechanical Ingredient" from other types of ingredient.