Non-proprietary Therapeutic Product (NTP)
This section provides explanation on each of the key components of the NTP: the set of active ingredient substance(s) and their strength(s), the unit of presentation and dose form as well as how each of those components can be used to uniquely describe the NTP in the formal name.
Figure 1: The NTP Model
An NTP is defined by a unique combination of Substance-Strength Set(s), Unit of presentation and Dose Form(s).These entities will build the ntp_formal name but not be separate attributes within the ntp file. The attributes of an NTP will include the following: ntp code, ntp formal name, ntp en description, ntp fr description, ntp status, and ntp status effective time. The NTP formal name is built using the substance-strength set, a dose form and a unit of presentation.
The substance strength set is composed of the basis of strength substance, precise ingredient substance, and the strength, which may be represented as either presentation strength or concentration strength.
The dose form may be a manufactured dose form or an administrable dose form. The administrable dose form will be used for some specific product groups such as, oral solutions or suspensions reconstituted prior to dispensing.
An NTP has a unit of presentation, although in some cases it may be implicit in the dose form and not presented in the formal name. This will be explained further under Unit of Presentation for the NTP.
While most NTPs will have a single dose form and a single substance strength set, a Combination NTP will have more than one dose form and more than one single substance strength set.
Correct identification of therapeutic products is a major safety issue. Vendors who need to map Canadian Clinical Drug Data Set content to their local content must have accurate information to map correctly, prescribers must accurately identify the correct product that they wish the patient to receive, and pharmacists must be able to accurately interpret the prescribed product to dispense a correct actual product for the patient.
If no formal pattern for naming was provided, here is an example of how this might look if a prescriber or pharmacist searched for “hydrocortisone”:
- Hydrocortisone 1% topical cream
- HYDROCORTISONE tablet 10mg
- Hydrocortisone 25mg tablet
- 1mg/g hydrocortisone Eye Ointment
- Solution for Injection 100mg/1ml HYDROCORTISONE (as sodium phosphate)
- Hydrocortisone 500mg/5ml (as Na2 PO4) injection solution
As the supporting classes for the Canadian Clinical Drug Data Set show, there are two things that will always be required to identify an NTP: the substance and strength set and the dosage form, and additionally in some cases, the unit of presentation. The format, pattern or order in which these are presented are controlled so that the information can be well ordered and presented to minimize mapping errors or (if used directly) the accidental selection of an incorrect product.