Draft for consultation: Guide to reporting drug shortages and discontinuations (GUI-0120): Appendices
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On this page
- Appendix A: Shortage scenarios and guidance on reporting
- Appendix B: Discontinuation scenarios and guidance on reporting
- Appendix C: Reasons for shortages and discontinuation
Appendix A: Shortage scenarios and guidance on reporting
| Scenario | Action taken in response | Reporting requirements and timelines |
|---|---|---|
| Allocation based on historic demand | ||
| You have 6 months of inventory on hand for a drug. Your supplier has just informed you that resupplies are not expected for 12 months. | You do not implement allocation measures and, as a result, anticipate you will run out of stock in 6 months. |
You must submit an anticipated shortage report as you will not be able to fill orders after you run out of stock. Start date: The anticipated date for running out of stock is the day you will not be able to fill all the orders. |
| You immediately implement an allocation based on 50% of historical demand, so you can avoid running out of stock. |
You must submit a shortage report as you will not be able to fill all the orders. Start date: The day you implement the allocation. Recommendation: Include a comment in your shortage report about the 50% allocation. |
|
| You have an alternate format of the drug (for example, a different vial size) that is available. You decide to allocate remaining supplies at 50% (to avoid running out of stock) and meet the remaining demand with the alternate format. |
You must submit a shortage report as you are not able to meet demand for the drug and format. Start date: The day you implement the allocation. Recommendation: Include a comment in your shortage report about the 50% allocation and the alternate format. |
|
| You learn that the next delivery of a drug will not arrive for another 3 months. Your current inventory is anticipated to last 3½ months. | You implement an allocation based on 100% of historical demand, so you can avoid running out of stock. The 100% allocation means you can fill all customer orders on time. |
You do not need to submit a shortage report as you will be meeting the demand in full. Note: A shortage report is required if the 100% allocation is not able to meet demand (for example, if a competitor is experiencing a shortage). |
| Short-term shortage | ||
| You learn that your next importation will be delayed for a few weeks. | The shipment delay means that you will experience a short period of time (a few days) where you will only be able to partially fill orders. All impacted orders will, however, be immediately filled to completion once the shipment is received and the lot is released. |
You must submit a shortage report as you will not be able to fill orders in their entirety and on time. Start date: The day you cannot fill all the orders. |
| The shipping delay will cause you to run out of stock. You have, however, confirmed that wholesalers have enough stock to meet demand and that you do not expect patients will be affected. |
You must submit an anticipated shortage report as you will not be able to fill all customer orders and on time. Start date: The day you first expect to not be able to meet demand. Recommendation: Include a comment in your shortage report that product may be available at the wholesale or pharmacy level. |
|
| Shortage from a sudden increase in demand | ||
| You are able to meet contracted demand based on historic customer demand. A competitor's product, however, goes into shortage, which means you are receiving increased orders. | You do not have enough inventory to fill all additional orders, so you decide to only fill orders from existing customers (will all be filled and on time). |
You must submit a shortage report as you will not be able to fill every order you receive. Start date: The date you decided to not accept orders from new customers. Recommendation: Include a comment in your shortage report that you will be filling contracted customer orders only. |
| Shortage mitigated by foreign-authorized supply | ||
| You will not be able to provide Canadian authorized supply due to a quality issue. You do, however, receive approval to exceptionally import foreign-authorized supply to mitigate the shortage. Consult the Guide to the exceptional importation and sale of drugs in response to drug shortages (GUI-0148). | The foreign supply will allow you to meet all orders for the drug while you try to resolve the Canadian authorized supply shortage. |
You must submit a shortage report as you will not be able to fill all orders with Canadian authorized product. Start date: The day that you cannot meet demand with Canadian authorized product. Recommendation: Include a comment in your shortage report that foreign authorized supply is available to meet demand. |
| Shortage mitigated by competitor's product | ||
| You have a shortage of a drug due to a manufacturing delay and you cannot meet demand for the drug for the next 6 months. | You inform your competitor of the shortage, and they confirm they will be able to cover full market demand (their orders and yours) for the next 6 months. Patients will not be affected. |
You must submit a shortage report as you will not be able to fill all orders. Start date: The date you are no longer able to meet demand. Recommendation: Include a comment in your shortage report that your competitor will cover your orders. |
| Shortage partially mitigated by safety stock | ||
| You are not able to meet demand for your drug with normal inventory. However, you have enough of the product in safety stock to partially cover the inventory gap. Safety stock refers to inventory held according to regulations explained in Guide to safety stocks. | You use your safety stock to fill as much of the inventory gap as possible after you've reported the actual or anticipated shortage. The shortage is partially mitigated but there is or will still be unmet demand. |
You must submit a shortage report as you will not be able to fill all orders with regular inventory. Start date (actual shortage): The day you cannot fill all the orders using regular inventory. Start date (anticipated shortage): The day you expect to no longer be able to fill orders using regular inventory. End date: The day resupplies are present, and demand is being met without using safety stock. Recommendation: Include a comment in your shortage report indicating how long safety stock is expected to last. If known, include a comment when the shortage is expected to reach the customer level. |
| Shortage fully mitigated by safety stock | ||
| You have either run out or expect to run out of your regular inventory for a given product. However, you have enough of the product in safety stock to fully cover the inventory gap. Safety stock refers to inventory held according to regulations explained in Guide to safety stocks. | You use your safety stock to fill the inventory gap after you've become aware of the actual or anticipated shortage. The shortage is completely mitigated, and therefore resolved. |
You must submit a shortage report as you were in a situation of not being able, or not expecting to be able to meet all customer orders and on time, without using safety stock. Start date (actual or anticipated shortage): The day you would not have been able to fill the inventory gap. End date: The day you won't need to use your safety stock anymore. Recommendation: Include a comment in your shortage report indicating how much of your safety stock was used to fully mitigate the shortage. |
| Shortage with ongoing resupplies | ||
| You are expecting to run out of stock from time to time over the next 12 months. Resupplies are expected on an ongoing basis for the next year, but will not be enough to continually meet demand. | You do not implement allocation measures, which means that supply will be intermittently available over the next 12 months. |
You must submit a shortage report as you will not be able to meet all customer orders and on time. Start date: The day you first expect you cannot meet demand. The estimated shortage end date should be the date when you expect supply can meet demand (when further intermittent shortages are no longer expected). Recommendation: Include a comment in your shortage report about the intermittent availability of your drug. |
| Shortage – order management | ||
| Your current inventory is depleted. However, last week you shipped 3 months' worth of supply to wholesalers and distributors. You are expecting resupplies next month. | Wholesalers and distributors have enough supply for the next 3 months. You do not anticipate receiving any additional orders over the next month (before you receive resupplies). | A drug shortage report is not required as you are not expecting any orders (demand) for your product before the next resupply. |
| You receive unexpected orders that you will not be able to fill before the resupplies arrive. |
You must submit a shortage report as you will not be able to meet all customer orders on time. Start date: The day you cannot meet demand. Recommendation: Include a comment in your shortage report that product may be available at the wholesale or pharmacy level. |
|
| Long-term shortage | ||
| Your drug is in shortage and you have not been able to supply your Canadian clients for some time. You submitted a drug shortage report and are keeping it up to date. | You determine that there is no longer demand for your drug. |
The shortage report can be marked as resolved, with the shortage end date as the date you determined there was no longer demand for the drug. Include a comment in the shortage report that the drug is not available, but you have determined there is no longer any demand for the drug. Note: You are required to file a discontinuation report if you decide to discontinue the drug. |
| Your drug goes into dormant status (more than 12 months without a sale). You then determine there is still demand for your drug. | You should maintain the shortage report with the estimated end date as "unknown" if a return-to-market date cannot be established. | |
Appendix B: Discontinuation scenarios and guidance on reporting
| Scenario | Action taken in response | Reporting requirements and timelines |
|---|---|---|
| Your drug is in shortage and you have not been able to supply your Canadian clients for some time. You have submitted a drug shortage report and are keeping it up to date. | After not being able to supply the drug for a continued period of time, you decide to discontinue the drug. |
You must submit a discontinuation report. Discontinuation date: The date when you decide to discontinue the drug. Mark the shortage report as resolved with the shortage end date as the discontinuation date. Include a comment in the shortage report that the drug has been discontinued. |
| Due to business reasons, you decide to discontinue the sale of your drug in 6 to 12 months. | You intend to meet demand until the discontinuation date. You have listed the discontinuation date as the date you expect all product to be consumed. |
You must submit a discontinuation report. Discontinuation date: The date you intend to stop selling your drug permanently. Remaining supply date: The expiration date of the latest lot numbers of the product distributed in Canada. Recommendation: Include a comment on the discontinuation report indicating that the remaining supply date refers to the expiration date of the lots available after the product is discontinued. |
Appendix C: Reasons for shortage and discontinuation
When you report an actual or anticipated shortage for a drug, you must also report the reason for the shortage or discontinuation. Choose the most appropriate option based on the following descriptions.
| Reason | Description |
|---|---|
| Shortage – Requirements for complying with good manufacturing practices (GMPs) |
Choose this option when GMP compliance issues have resulted in shortage of active ingredients or finished products. Examples:
|
| Shortage – Shortage of an active ingredient (AI) |
Choose this option when shortages are caused by a lack of supply of active ingredients (when not related to GMP compliance issues). Examples:
|
| Shortage – Shortage of inactive ingredient or component |
Choose this option when there are inadequate excipient or component quantities to allow for demand of the drug to be met. Examples:
|
| Shortage – Disruption in the manufacture of the drug |
Choose this option when the manufacturing of the drug has been disrupted for reasons that are not related to complying with good manufacturing practices. Examples:
|
| Shortage – Delay in shipping the drug |
Choose this option when the finished product has been manufactured but is experiencing delays due to shipping issues. Examples:
|
| Shortage – Increased demand for the drug |
Choose this option when increased demand results in a shortage. Examples:
|
| Shortage – Other (describe in comments) |
Choose this option when none of the other options are appropriate. You must provide additional information for the actual or anticipated shortage in the "company comments" section of the report. |
| Discontinuation – Business reasons |
Choose this option when the drug is being discontinued for business reasons only. Examples:
|
| Discontinuation- Raw material availability |
Choose this option when the drug is being discontinued because the raw materials are no longer available to manufacture the product. Examples:
|
| Discontinuation – Manufacturing issues |
Choose this option when the drug is being discontinued due to manufacturing issues. Examples:
|
| Discontinuation – Other (describe in comments) |
Choose this option when none of the other options are appropriate. You must provide additional information for the discontinuation in the "company comments" section of the report. |