Draft for consultation: Guide to reporting drug shortages and discontinuations (GUI-0120): Understanding the regulations

On this page

• Shortages and discontinuations
• Best practices for reporting shortages and discontinuations
• Reporting 12 months without sale of a drug

Shortages and discontinuations

What is a drug shortage

A drug "shortage" is defined in the regulations as being when a market authorization holder (MAH) is unable to meet the demand for the drug in Canada. "Demand" refers to orders received from Canadian clients. Thus, a shortage occurs when you cannot fill all the orders from your Canadian clients on time.

A shortage can occur when the demand for a drug increases or the supply of a drug decreases (or both), and you can no longer meet demand. A shortage is considered resolved when you can once again fill all the orders from your Canadian clients and fill them on time.

Drug shortages can be actual or anticipated. An actual shortage means a manufacturer's current supply cannot meet current demand in Canada. An anticipated shortage means a manufacturer's future supply may not meet projected demand in Canada. As a market authorization holder, you are required to report both actual and anticipated shortages.

Appendix A gives examples of shortage scenarios and associated reporting requirements.

What is a drug discontinuation

"Discontinue" means to permanently stop selling the drug in Canada (subsection C.01.001(1) of the FDR).

Reporting shortages and discontinuations

MAHs are required to report shortages and discontinuations to the Drug Shortages Canada website when:

• they believe a shortage is likely to occur (an anticipated shortage)
• a shortage is occurring (an actual shortage)
• a decision is made to permanently stop the sale of a drug (discontinuation)

Reporting shortages and discontinuations as soon as possible makes it possible for Health Canada, provincial and territorial governments, drug supply chain stakeholders and health professionals to monitor shortage risk and prevent and mitigate the impacts of shortage on the people of Canada.

Many factors can cause a shortage. Some shortages last longer and are more complex than others.

Because companies have to report every time they cannot fully meet demand, not all of the reports on the Drug Shortages Canada website are cause for concern for patients. Most shortages are successfully managed before they can affect patients.

When to post shortages

A shortage begins on the day that you can no longer meet demand. You must report when a shortage has begun or is anticipated to begin, and when you expect it will be resolved.

For anticipated shortages, determine the date when you anticipate the shortage will begin. You must report:

• at least 6 months before the anticipated start date if you believe the shortage will occur in more than 6 months' time
• within 5 calendar days of becoming aware of the anticipated shortage if the anticipated shortage start date is less than 6 months away

For actual shortages, you must report:

• within 5 calendar days of becoming aware of the shortage if the shortage was not anticipated
• within 2 calendar days of the shortage starting if the shortage was anticipated and an anticipated shortage report already exists

For changes, including changes to information outlined in What to post and information posted voluntarily, you should update the report within 2 calendar days of becoming aware that the shortage information has changed. This includes changing:

• the anticipated start date or estimated end date of a shortage
• a shortage status to "resolved" or "avoided"
• key dates or other information about the shortage
• any information previously voluntarily provided

When to post discontinuations

For discontinuations, you must report:

• at least 12 months before the anticipated discontinuation date if the upcoming discontinuation is known more than 12 months in advance
• within 5 calendar days of deciding to discontinue selling a drug if the discontinuation date is less than 12 months away

For changes to information in the discontinuation report, including changes to information outlined in What to post and information posted voluntarily, you should update the report within 5 calendar days of becoming aware that the discontinuation information has changed. This includes changing:

• the anticipated date of discontinuation
• a shortage status to "resolved" or "avoided"
• key dates or other information about the shortage
• any information previously provided voluntarily

Note: There are 2 key reporting fields on the website for providing important information on remaining supply related to a discontinuation:

• actual discontinuation date:
  • last date that you sell a drug (in cases where you are actively selling a drug and decide to discontinue it) or
  • date that you decide to formally discontinue the sale of the drug (for drugs that you have stopped selling but had not yet made the decision to formally discontinue)
• remaining supply date:
  • date you expect your remaining supply to be sold or distributed or otherwise no longer available

For more information on shortage and discontinuation reporting requirements, including examples, refer to Appendix A and Appendix B.

Where to post

You must create or hold a valid account and post all shortages and discontinuations directly on the Drug Shortages Canada website:

Visit:

• Drug Shortages Canada
• How to create an account with Drug Shortages Canada

What to post

You must post all information required in subsections C.01.014.9 (shortages) or C.01.014.92 (discontinuations) of the regulations.

The mandatory fields are marked with an asterisk. The fields include:

• the MAH's name, contact information and drug identification number (DIN)
• information about the drug
  • drug brand name and proper name (if it does not have a proper name, its common name)
  • medicinal ingredients
  • strength
  • dosage form
  • quantity of the drug contained in its package
  • route of administration
• the English anatomical therapeutic chemical (ATC) code
  • for ATC codes and descriptions, visit the World Health Organization's Collaborating Centre for Drug Statistics Methodology
• shortage start and expected end date or date of discontinuation
• shortage or discontinuation reasons

For more information, refer to:

• Appendix C
• When to post shortages
• When to post discontinuations

If any of this information changes, as per subsection C.01.014.92(3) of the FDR you must update your report within 5 days of becoming aware of the change. This requirement applies to all information you post, including additional information that you provide voluntarily.

Note: A drug shortage that is deemed to be a Tier 3 shortage has the greatest potential impact on the health of people in Canada. This type of shortage appears on the Tier 3 drug shortages list. You are not required to update this information.

If your drug is in shortage when you decide to discontinue its sale, as per section C.01.014.10 you must:

• post a drug discontinuation report
• update the reason for the shortage in your drug shortage report and
• change the end date to the date of discontinuation

For scenarios and associated reporting requirements, refer to Appendix A and Appendix B.

Reasons for shortages and discontinuations

When you post a shortage or discontinuation report, you must also post the reason for the shortage or discontinuation as per paragraphs C.01.014.9 (1)(l) and C.01.014.10 (1)(k).

For information on how to select a shortage or discontinuation reason, refer to Appendix C.

Note: We encourage you to include comments with your shortage and discontinuation reports. Comments provide additional context, and are an easy and transparent way to ensure that information is widely available to everyone who is affected.

Comments could, for example, include information on whether:

• the drug is stocked out or available on protective allocation (with a description of the protective allocation, if possible)
• there are alternate drugs or stock keeping units (SKUs)

Best practices for reporting shortages and discontinuations

Health Canada recommends that you implement the following best practices to help prevent or mitigate the impacts of a shortage or discontinuation on public health.

Sole-source supplier or dominant market share of a drug

If you are the only MAH or if you are aware that you hold a dominant market share of a marketed drug in Canada at the time of posting a report, you can choose to include a note indicating this in the "company comments" section. Also inform Health Canada by email at drug.shortages-penurie.de.medicament@hc-sc.gc.ca. This information can help us and other stakeholders determine appropriate options to mitigate the impact.

Transparency on remaining inventory and safety stock

You can choose to include in your drug shortage report the following information:

• how much inventory remains
• how long this inventory is expected to last based on the current distribution rate
  • for example, there are 1,000 vials on November 1, and based on historical demand, the supply will be depleted by the week of December 1

All actual and anticipated shortages must be reported on the Drug Shortages Canada website in line with the appropriate regulatory timelines that correspond to your situation. Safety stocks must not be used unless an actual or anticipated shortage has been reported. See Appendix A for shortage scenarios and guidelines on reporting.

You can choose to include in your drug discontinuation report the following information:

• actual quantity of supply remaining, including any quantities that are part of your safety stock, if applicable
• date when you expect to have no more inventory, including any safety stock inventory

This information can help other manufacturers, for example, determine whether they can mitigate the impact of a shortage or discontinuation by:

• making their inventory available for purchase by your customers or
• adjusting production to accommodate the changes

Allocation plans

An allocation plan is when a manufacturer limits the purchase of a drug based on a percentage of historical sales over a given period.

If you have implemented an allocation plan (for example, supply is being allocated to customers based on 80% of their historical monthly demand), you can choose to include this information in your report.

This information can help:

• assist with equitable distribution of a drug during a period of constraint or until inventory is depleted for a drug that is being discontinued
• distributors, hospitals and pharmacies plan procedures and dispensing practices accordingly

Shortage prevention and mitigation plans

Plans to prevent and mitigate shortages can help minimize shortage risks and impacts.

Under subsection C.01.014.81(1) of the regulations, you are required to establish and maintain a shortage prevention and mitigation plan (known as an SPMP) to help prevent or mitigate shortage risks and impacts for drugs for which a shortage could present a serious risk of injury to human health. An SPMP is a good idea to have regardless of whether your drug meets the criteria for a mandatory plan.

You can choose to share relevant elements of your SPMP in the "company comments" section of your report. Or, you can email Health Canada at drug.shortages-penurie.de.medicament@hc-sc.gc.ca.

For more information, consult:

• Draft for consultation: Guide to shortage prevention and mitigation plans

Sharing additional information on reason for shortage

The report has a section where you can choose to indicate the reason for the shortage or discontinuation. You are also encouraged to provide additional background information to help stakeholders better understand the reason or root cause.

Company-issued communications

We encourage you to include a link in your report to any public communication you have issued about the shortage or discontinuation. This will ensure that customers, the public and health care providers are aware of the situation (status, mitigation measures implemented).

The communication should be issued in both English and French.

Reporting 12 months without sale of a drug

You must notify us within 30 calendar days and keep your drug shortage report up to date on the Drug Shortages Canada website within prescribed timelines:

• if you have not sold your drug in Canada for 12 consecutive months and
• when you resume selling your drug

In both cases, you should include the reason for the notification in the information you provide to us.

These requirements apply to drugs with a drug identification number (DIN) or notice of compliance (NOC), and that have been sold in Canada.

For more information on how to submit this type of information to Health Canada, consult:

• Filing submissions electronically for regulatory activities in eCTD format or
• Guidance document: Preparation of drug regulatory activities in the "non-eCTD electronic-only" format for regulatory activities in non-eCTD electronic-only format