Release Notes: Version 20181113

DateNovember 13, 2018
AccessTerminology Gateway
Release TypeMaintenance Release

About this maintenance release 

This release includes the Canadian Clinical Drug Data Set files (version 20181113).  

The Editorial Guidelines and the Technical Specification have not been revised with this release. 

The Canadian Clinical Drug Data Set is available for browsing and download via the Infoway Terminology Gateway.  There have been enhancements made to the Gateway change logs with this release.  Stakeholders can now distinguish concept changes made to the status and effective date in addition to name changes.

Supporting general information can be found on Infoway Canadian Clinical Drug Data Set InfoCentral page where all the standards are provided.  

General Notes

The following files will be available as full release files within this version:

  • Manufactured Product,
  • Non-proprietary Therapeutic Product,
  • Therapeutic Moiety,
  • Manufactured Product, Non-proprietary Therapeutic Product, Therapeutic Product Relationship,
  • Special Groupings, 
  • Coded Attribute, and
  • Device Non-proprietary Therapeutic Product.

The 'Full" release contains one entry for every concept that has ever been released and new content added for that release.   New content added for a specific release may at times include “Inactive” content.

NOTE:  The “Delta" release which is intended to contain only those concepts that have been added or changed since the previous release will be considered for a future enhancement at a later date.  

This release continues to add additional content from the DPD and includes most of the top 250 moieties and approximately 86% of the DPD content in scope for CCDD.  

The table below provides the number of concepts within each CCDD file for this release.

November 2018 CCDD Files
Number of Concepts
Types of Changes in this release
Therapeutic Moiety Full Release1108

112 additions

1 status change from active to inactive

1 status change from active to deprecated (see details below)

Non-proprietary Therapeutic Product Full Release3268

247 additions (242 for new TMs; 4 new-correction and 1 totally new NTP for existing TMs)

3 NTP formal name changes (see details below)

4 status changes from active to inactive

12 status date changes (with no change of status)

3 status change from active to deprecated (see details below)

11 existing deprecated concepts changed status date

Manufactured Product Full Release9576

434 additions (see specific details below)

  • 64 MPs for existing TMs
  • 369 MPs for new TMs
  • 1 MP for the new NTP for an existing TM

Formal name changes made:

  • 5 DPD company change
  • 20 DPD product name changes
  • 16 DPD product and company name changes
  • 8 as a result of NTP changes

19 status changes from active to inactive

6 status changes from inactive to active

17 status date changes (no change of status)

2 status changes from active to deprecated (see details below)

Manufactured Product, Non-proprietary Therapeutic Product, Therapeutic Moiety Relationship

9573

Includes concept additions and changes as above

Deprecated concepts have been excluded.

Note also that the two entries relating to the deprecated ensulizole products have been removed

Device Non-proprietary Therapeutic Product3no change
Special Groupings1550

23 additional entries due to new concepts

35 changes due to product and product+company name changes

2 changes due to products changing policy type code (dextroamphetamine - see below)

3 sets of data removed (dextroamphetamine - see below)

Coded Attributes7

no change

TM Changes

The following TM concept was added to the October Release in error.  As a sunscreen and cosmetic product, this concept is out of the current scope of the CCDD.  It has been deprecated in the November Release. 

Code

Formal Name

8001643             

ensulizole

NTP Changes 

The following NTP concept was added to the October Release in error.  As a sunscreen and cosmetic product, this concept is out of the current scope of the CCDD.  It has been deprecated in the November Release. 

NTP Code

NTP Formal Name

9005130             

ensulizole 3 % cutaneous emulsion


The following NTP errors previously published have been addressed in the November Release.  The product strength has been corrected resulting in the creation of 2 new NTP concepts; two existing concepts have been deprecated.

November Release

October Release

NTP Code

NTP Formal Name

Status

NTP Code

NTP Formal Name

Status

9013290

ethinyl estradiol 35 mcg per 24 hours and norelgestromin 200 mcg per 24 hours transdermal patch

Active   

9013289

ethinyl estradiol 30 mcg and levonorgestrel 150 mcg oral tablet with ethinyl estradiol 10 mcg oral tablet

Active   

9006562

ethinyl estradiol 35 mcg per 24 hours and norelgestromin 20 mcg per 24 hours transdermal patch

Deprec

9006562

ethinyl estradiol 35 mcg per 24 hours and norelgestromin 20 mcg per 24 hours transdermal patch

Active

9009384

ethinyl estradiol 30 mcg and levonorgestrel 150 mcg oral tablet with ethinyl estradiol 100 mcg oral tablet

Deprec

9009384

ethinyl estradiol 30 mcg and levonorgestrel 150 mcg oral tablet with ethinyl estradiol 100 mcg oral tablet

Active

 

The following two new NTPs have been created for SENSORCAINE products (see below).  The NTPs previously associated with the SENSORCAINE products continue to be used by other MPs and therefore do not need deprecating.

NTP Code

NTP Formal Name

9013269

bupivacaine hydrochloride 25 mg per 10 mL solution for injection ampoule

9013270

bupivacaine hydrochloride 50 mg per 10 mL solution for injection ampoule

 

The following three NTPs  have had a name change due to changes made within the DPD.  The changes have not altered the meaning of the concepts therefore the NTP code is unchanged.  

November Data

October Data

Reason

NTP Code

NTP Formal Name


NTP Code

NTP Formal Name


9001070

montelukast (montelukast sodium) 4 mg per sachet granules for oral suspension

9001070

montelukast (montelukast sodium) 4 mg per pck granules for oral suspension

DPD strength now “per sachet”

9004200

dextromethorphan hydrobromide 5 mg and phenylephrine hydrochloride 2.5 mg orodispersible film

9004200

dextromethorphan hydrobromide 5 mg and phenylephrine hydrochloride 2.5 mg orodispersible tablet

DPD update to dose form

9001231

esomeprazole (esomeprazole magnesium) 10 mg per sachet gastro-resistant granules for oral suspension

9001231

esomeprazole (esomeprazole magnesium) 10 mg per pck gastro-resistant granules for oral suspension

DPD strength now “per sachet”

MP Changes

The following MP concepts were added to the October Release in error.  As sunscreen and cosmetic products, these concepts are out of the current scope of the CCDD.  They have been deprecated in the November Release. 

MP Code

MP Formal Name

02381788

COVERGIRL OUTLAST ALL DAY STAY FABULOUS 3-IN-1 FOUNDATION (ensulizole 3 % cutaneous emulsion) HFC PRESTIGE INTERNATIONAL CANADA INC

02459027

COVERGIRL VITALIST ELIXIR FOUNDATION (ensulizole 3 % cutaneous emulsion) HFC PRESTIGE INTERNATIONAL CANADA INC

 

The following MP concepts are now associated with new NTPs to correct a unit of presentation error:

November Release

October Release

MP Code

MP Formal Name

MP Code

MP Formal Name

77700656

SENSORCAINE (bupivacaine hydrochloride 25 mg per 10 mL solution for injection ampoule) ASPEN PHARMACARE CANADA INC.

77700656

SENSORCAINE (bupivacaine hydrochloride 25 mg per 10 mL solution for injection vial) ASPEN PHARMACARE CANADA INC.

77700658

SENSORCAINE (bupivacaine hydrochloride 50 mg per 10 mL solution for injection ampoule) ASPEN PHARMACARE CANADA INC.

77700658

SENSORCAINE (bupivacaine hydrochloride 50 mg per 10 mL solution for injection vial) ASPEN PHARMACARE CANADA INC.

 

The following MP concept errors previously published have been addressed in the November Release.  The MP code remains the same, but the strength has been corrected.

November Release

October Release

MP Code

MP Formal Name

MP Code

MP Formal Name

02248297

EVRA (ethinyl estradiol 35 mcg per 24 hours and norelgestromin 200 mcg per 24 hours transdermal patch) JANSSEN INC

02248297

EVRA -(6/0.60) (ethinyl estradiol 35 mcg per 24 hours and norelgestromin 20 mcg per 24 hours transdermal patch) JANSSEN INC

02346176

SEASONIQUE (ethinyl estradiol 30 mcg and levonorgestrel 150 mcg oral tablet with ethinyl estradiol 10 mcg oral tablet) TEVA WOMEN'S HEALTH INC

02346176

SEASONIQUE (ethinyl estradiol 30 mcg and levonorgestrel 150 mcg oral tablet with ethinyl estradiol 100 mcg oral tablet) TEVA WOMEN'S HEALTH INC

Special Grouping File Changes

Three sets of data previously present in the Special Groupings File have been removed due to updates to the DPD drug schedule information for dextroamphetamine.  These are:

ccdd_code

ccdd_formal_name

ccdd_type

policy_type

policy_reference

special_groupings_status

special_groupings_status_effective_time

8000162

dextroamphetamine

TM

500002

http://laws-lois.justice.gc.ca/eng/acts/C-38.8/FullText.html

Active

20170919

9000414

dextroamphetamine sulfate 10 mg prolonged-release oral capsule

NTP

500002

http://laws-lois.justice.gc.ca/eng/acts/C-38.8/FullText.html

Active

20170919

9000415

dextroamphetamine sulfate 15 mg prolonged-release oral capsule

NTP

500002

http://laws-lois.justice.gc.ca/eng/acts/C-38.8/FullText.html

Active

20170919

 

In addition, two sets of data have been changed to be in line with the DPD drug schedule information for dextroamphetamine.  These are:

 

November Release

October Release

ccdd_code

ccdd_formal_name

policy_type

policy_reference

policy_type

policy_reference

02448319

ACT DEXTROAMPHETAMINE SR (dextroamphetamine sulfate 10 mg prolonged-release oral capsule) ACTAVIS PHARMA COMPANY

500003

http://laws-lois.justice.gc.ca/eng/acts/C-38.8/FullText.html

500002

http://laws-lois.justice.gc.ca/eng/acts/C-38.8/FullText.html

02448327

ACT DEXTROAMPHETAMINE SR (dextroamphetamine sulfate 15 mg prolonged-release oral capsule) ACTAVIS PHARMA COMPANY

500003

http://laws-lois.justice.gc.ca/eng/acts/C-38.8/FullText.html

500002

http://laws-lois.justice.gc.ca/eng/acts/C-38.8/FullText.html

Questions, Concerns, Changes

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