Special Groupings
There is a requirement in Canada for a nationally consistent way to identify opioid products and other controlled substances to enable digital health solutions and medication processes in the implementation of appropriate (additional) actions in the medication process to assist in the opioid crisis and the monitoring of controlled substances. The Canadian Clinical Drug Data Set (CCDD) will identify opioid products and controlled substances at the following levels of granularity; Manufactured Product (MP), Non-proprietary Therapeutic Product (NTP) and Therapeutic Moiety (TM). The solution to identify these concepts is extensible to support other future requirements (hence the term "Special Groupings").
Currently, the scope of this information is constrained to the scope of the CCDD, which is medicinal products authorized for supply in Canada. As such, any information about unlicensed substances and the recording of any substance used “recreationally” is out of scope. Compounded products containing an opioid active ingredient substance are also currently out of scope.
The approach to provide the information is via a relationship table to associate the desired "special grouping" to any/all appropriate concepts in the CCDD. This approach has the advantage of being very flexible, allowing each concept, of whatever class within the CCDD, to be associated to its correct information directly.
The delivery of the Special Groupings information is provided in a separate table, as shown below. The first two columns provide the relevant CCDD concept, the next column provides the CCDD file type the concept can be found in, the second two columns provides the policy information (please note the policy type is encoded and a separate file provides the details for the coded information in the coded_attribute file), and the final two columns provide the status and date of the association between the product and the policy. Any one concept could be part of multiple policy types (see examples in the table below). For more information please refer to the Technical Specification.
The Special Groupings file example:
ccdd_code | ccdd_formal_name | ccdd_type | policy_type | policy_reference | special_groupings_status | special_groupings_status_effective_time |
---|---|---|---|---|---|---|
9000195 | acetylsalicylic acid 325 mg and oxycodone hydrochloride 5 mg oral tablet | NTP | 500002 | http://laws-lois.justice.gc.ca/eng/acts/C-38.8/FullText.html | active | 20170919 |
9000195 | acetylsalicylic acid 325 mg and oxycodone hydrochloride 5 mg oral tablet | NTP | 500001 | http://www.gazette.gc.ca/rp-pr/p1/2017/2017-06-17/html/reg8-eng.php | active | 20170919 |
8000774 | acetylsalicylic acid and oxycodone | TM | 500002 | http://laws-lois.justice.gc.ca/eng/acts/C-38.8/FullText.html | active | 20170919 |
8000774 | acetylsalicylic acid and oxycodone | TM | 500001 | http://www.gazette.gc.ca/rp-pr/p1/2017/2017-06-17/html/reg8-eng.php | active | 20170919 |
0608157 | RATIO-OXYCODAN (acetylsalicylic acid 325 mg and oxycodone hydrochloride 5 mg oral tablet) TEVA CANADA LIMITED | MP | 500002 | http://laws-lois.justice.gc.ca/eng/acts/C-38.8/FullText.html | active | 20170919 |
0608157 | RATIO-OXYCODAN (acetylsalicylic acid 325 mg and oxycodone hydrochloride 5 mg oral tablet) TEVA CANADA LIMITED | MP | 500001 | http://www.gazette.gc.ca/rp-pr/p1/2017/2017-06-17/html/reg8-eng.php | active | 20170919 |