How to create or edit a drug Shortage or Discontinuation report

2017-03-15

How to create or edit a drug Shortage or Discontinuation report

Creating a Shortage or Discontinuation Report

Select the type of report you want to create: <Shortage Report> or <Discontinuation Report>, shown below <Submit Report>.

Note: Shortage and Discontinuation reports are required for:

drugs included in Schedule I, II, III, IV or V to the Controlled Drugs and Substances Act,

prescription drugs,

drugs listed on Schedule C or D, and,

drugs that are permitted to be sold without a prescription but are administered only under the supervision of a practitioner.

Enter the DIN of the product in the drug identification number field.

Click <Validate DIN> button.

Your username must be associated with the licence holder for the DIN.

DINs must be active and approved and have a Drug Product Database status of Marketed.
Several fields will be auto-populated at this step (Brand name, active ingredients, strength, dosage form, route of administration, ATC code, ATC description).

Packaging size refers to the quantity of drug contained in its package. Some examples would be:

100 for 100 tablets or capsules in a bottle,

5mL for the sale of an individual vial with a volume of 5mL,

10mL x 5 vials for the sale of a package of five vials with a volume of 10mL each,

100 doses for a metered dose pump/product,

30g for a tube containing 30g of ointment.

Select <Reason For Shortage>, select from:

Requirements related to complying with good manufacturing practices
Shortage of an active ingredient
Shortage of an inactive ingredient or component
Disruption of the manufacture of the drug
Delay in shipping of the drug
Demand increase of the drug
Other (Please describe in comments)

Or <Reason for Discontinuation>, select from:

Business decision
Raw material availability
Manufacturing issues
Other (Please describe in comments)
Note: English Anatomical Therapeutic Chemical (ATC) classification codes and descriptions can be found on the WHO Collaborating Centre for Drug Statistics at the Norwegian Institute for Public Health’s website at https://www.whocc.no/atc_ddd_index/. You must post the fourth level code and third level description for the product.

Note: The proper name for a drug product includes the dosage form and is the name assigned to that final product in one of the Schedule B publications (e.g., Azithromycin Capsules). A common name is used in the case where there is no proper name. Additional information on Proper and Common names can be found in the Health Canada Guidance document, Labelling of Pharmaceutical Drugs for Human Use at http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/label_guide_ld-eng.php#a342.

For Shortage reports:

Enter <Anticipated Shortage Start Date> or, if known, <Actual Shortage Start Date>, and,

Enter <Estimated Shortage End Date> or, if known, <Actual Shortage End Date>.

Note: The <Unknown> option may be selected if an Estimated End Date cannot be predicted with any level of certainty.

For Discontinuation reports:
Enter <Anticipated Discontinuation Date>, or, <Discontinuation Date>, if known, and,

Enter <Remaining Supply Date>.

Complete all remaining mandatory fields (identified by a red asterisk *) and, as applicable, optional fields. Include information on the shortage, mitigation efforts, additional information for caregivers or general comments in the Comments field.

Click <Save and Preview>.

Click <Continue to French Form>.

Complete remaining mandatory fields (identified by a red asterisk *) and, as applicable, optional fields.

Click <Save and Preview>.

Click <Submit Report>.

Editing a Shortage or Discontinuation Report

Edit the report by making any needed updates, such as changing estimated dates or adding additional information or comments.
Click <Save Changes>.