Non-proprietary Therapeutic Product (NTP)
An NTP is defined by a unique combination of Substance-Strength Set(s), unit of presentation and Dose Form(s). See Figure 1 below. The information in the blue boxes in Figure 1 is not provided as part of the Canadian Clinical Drug Data Set, but it is necessary for the maintenance of the Canadian Clinical Drug Data Set, as well as building the content represented in the formal name of each NTP.
Figure 1: The NTP Model
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.
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 a 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 be 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.