Appendix A: Drug, natural health product and biocide recall guide (GUI-0039)

Determining medical necessity of a drug product

Health Canada recommends that you consider these questions to determine whether a drug product that you plan to recall is medically necessary in order to assess the potential shortage implications that may result from the recall. You should report the medical necessity of a recalled drug product to us as part of your initial recall notification.

1. Is the product used to diagnose, prevent or treat a serious, life-threatening or severely debilitating disease or medical condition?
   • If yes: What is the name of the disease or medical condition? Consider potential effects of stopping therapy. Is the drug acutely life-saving over time? Does it reduce intolerable symptoms of disease?
2. What are the labelled indications for this product? Consider all indications included in the product monograph. Include relevant information about approval (or specific lack of approval) for use in pediatric or geriatric populations.
3. How is the drug product presented (for example, sterile injection, immediate release tablet, modified release tablet)?
   • Are there other marketed products with:
     • the same active ingredient
     • the same route of administration
     • the same approved indications
     • similar strengths
   • If yes: Document alternative products and their manufacturers. This may include innovative products or generic products.
   • If no: Are there products with the same active ingredient but different routes of administration that could be substituted for this one? What are they?
4. Are there marketed products with different active ingredients that have with similar indications and, where relevant, the same routes of administration? What are they?
   • Note: There might be substitution concerns (such as for a highly titrated drug). Switching might also lead to concerns about effectiveness.
5. What is the market share of the affected product(s) by strength in comparison with any alternative products you identified in question 4? What units were used to make these calculations? (To make direct comparisons, convert units to milligrams [mg] and express them as a percentage of the total Canadian market share.)
6. How is the market share calculated (for example, is it based on units sold to retail pharmacies and hospital pharmacies or on extended units sold)?
7. Do you fully report sales data for the affected drug product(s) to IQVIA?
8. Are there niche on-label sub-populations that may need this medication? Is it used as a second- or third-line therapy for patients who have failed to respond to other therapies?
9. Are there important, identified off-label uses of the product that may make it medically necessary? Do you foresee that this would not apply to a majority of products, with some exceptions (for example, old chemotherapies that are used off-label in several oncology settings)? You may identify this information through a literature search and by verifying clinical practice guidelines. Identify sources of information.
10. Does the drug have any unique characteristics that may make it medically necessary? For example, is it a life-saving medication with a quicker onset of action? Is it a liquid for children or patients who cannot swallow pills? Are the excipients important for any particular patient population (for example, is it a benzyl-alcohol-free formulation to be used in infants)? Is the format size critical for certain health care system needs?
11. Is there an ongoing shortage of any approved alternatives that may put further pressure on the ability of the health care system to absorb a shortage of the product?
    • Document any known information about the general supply situation. Check the Drug Shortages Canada site for a list of products in shortage.
    • Note: Whether a drug appears in the Drug Shortage Database does not confirm that there is enough supply of product alternatives to make up the gap caused by a recall.