CCDD Editorial Guideline correction planned for Feb Release

Hello Raymond
thankyou for your feedback. There are 2 terms that we have used and defined in the CCDD Editorial Guidelines that relate to your comments

Multi-Ingredient Products
This term refers to products which have more than one active ingredient in a single dose form. And currently we are only including products with up to 5 ingredients. The word "and" is used to separate the ingredients as below.

<< Substance A name(s) (both BoSS and precise ingredient substance if required) and Strength A>> <<and>> << Substance B name(s) (both BoSS and precise ingredient substance if required) and Strength B>> <<Dose Form>>

Combination Products:
The phraseology that will clearly differentiate a combination product from a multi-ingredient product will be to use “with” as the conjunction between each manufactured item component.

We recognize there are several terms that could have been used to describe what we ultimately landed on with Combination Products.
The Section on Combination Products within the CCDD Editorial Guidelines is here infoscribe.infoway-inforoute.ca/display/CCDD/Combination+Products

Regards
Beverly

The expression "combination product" is ambiguous. It is typically used in reference to a single product containing more than one active ingredient (e.g. Caduet: amlodipine + atorvastatin). What you are referring to here is a "combined package" containing different products in the same package.
Two different expressions should be used consistently to avoid any ambiguity.
Raymond

Hello
We have received a question that highlighted an error within the CCDD Editorial Guidelines. Within the Combination Products section the following currently exists:
NTP Type Attribute
To indicate that combination products are a different type of medicinal product, rather than use an additional qualifier (such as “combination product”) in the NTP description, combination products will be indicated using a “type” attribute in the NTP class.

The NTP type attribute will be used to indicate only those combination products that contain two or more manufactured items that contain active ingredient substance(s). The NTP Type attribute will not be used on combination products where the second manufactured item is:

a therapeutically inactive diluent
a therapeutically inactive “placebo” (as in the Brevicon 28-day product)
Examples: the combination products shown in normal text below would have the type code applied; those shown in grey would not

clotrimazole 1 % cutaneous cream with clotrimazole 500 mg vaginal tablet
ethinylestradiol 35 microgram oral tablet and norethindrone 500 microgram with lactose oral tablet
conjugated estrogen 625 microgram oral tablet with medroxyprogesterone acetate 2.5 mg oral tablet
amoxicillin (amoxicillin trihydrate) 500 mg oral capsule with clarithromycin 500 mg film coated oral tablet with lansoprazole prolonged release 30 mg oral capsule
budesonide 2 mg dispersible tablet for rectal solution with vehicle for rectal solution
glucagon 1 mg powder for solution for injection with water for injection 1.5 mL
follitropin alfa 33 mcg powder for solution for injection with diluent solution

The words in bold above did not appear in "grey font" on InfoScribe. We will edit this section as follows to correct this error:
To indicate that combination products are a different type of medicinal product, rather than use an additional qualifier (such as “combination product”) in the NTP description, combination products will be indicated using a “type” attribute in the NTP class.

The NTP type attribute will be used to indicate only those combination products that contain two or more manufactured items that contain active ingredient substance(s). The NTP Type attribute will not be used on combination products where the second manufactured item is:
a therapeutically inactive diluent
a therapeutically inactive “placebo” (as in the Brevicon 28-day product)

Examples of the combination products shown below would have the type code applied:

clotrimazole 1 % cutaneous cream with clotrimazole 500 mg vaginal tablet
ethinylestradiol 35 microgram oral tablet and norethindrone 500 microgram with lactose oral tablet
conjugated estrogen 625 microgram oral tablet with medroxyprogesterone acetate 2.5 mg oral tablet
amoxicillin (amoxicillin trihydrate) 500 mg oral capsule with clarithromycin 500 mg film coated oral tablet with lansoprazole prolonged release 30 mg oral capsule
Examples of the combination products shown below would NOT have the type code applied:

budesonide 2 mg dispersible tablet for rectal solution with vehicle for rectal solution
glucagon 1 mg powder for solution for injection with water for injection 1.5 mL
follitropin alfa 33 mcg powder for solution for injection with diluent solution

Since this is a minor technical correction we plan to make this correction available with the February Release of CCDD. if anyone has any questions, please send an email to Cette adresse courriel est protégée contre les robots spammeurs. Vous devez activer le JavaScript pour la visualiser.
Regards
Beverly and the CCDD Team