Health Canada’s Critical and Vulnerable Drug List

On this page

• Overview
• Purpose and use of the list
• Methodology used to develop the list
• The Critical and Vulnerable Drug List
• Contact

Overview

In June 2024, Health Canada committed to publishing a list of drugs that are critical to patients and vulnerable to shortages. The Critical and Vulnerable Drug List (CVDL) is intended to help Health Canada and drug shortage stakeholders focus their efforts on drugs that:

• are most likely to present a serious risk of harm to human health if there is a shortage
• have characteristics that may make them more vulnerable to shortage

A drug being listed on the CVDL doesn't mean that there's presently a shortage or that there's expected to be a shortage. The CVDL isn't linked to any regulatory requirements.

We published a draft of this list for consultation in December 2024. We refined the methodology and draft list based on consultation feedback and expert review.

We will update the list from time to time so that the clinical importance and shortage vulnerability assessments continue to align with the Canadian context, including considerations for new drugs that enter the Canadian market.

Learn more about our plan:

• Building resilience: Health Canada's plan to address health product shortages

Purpose and use of the list

Drug shortages can put patients at risk and create burden for health care providers who must find alternatives or adjust treatment plans. Not all drugs carry the same level of shortage risk.

Canada's health product market is large and complex. People in Canada use thousands of prescription and non-prescription drugs every day. This makes it difficult to address all shortage risks. The CVDL helps identify the drugs that are critical to the health care system and most vulnerable to shortages. For example, it can be used to:

• support proactive planning by manufacturers, distributors and pharmacies
• guide government actions to strengthen supply chain resilience and reduce the risk of harm due to shortages

Methodology used to develop the list

Systematic process for developing the CVDL

We used a systematic process to develop the final CVDL, selecting drugs by medicinal ingredient and route of administration. We assessed the criticality and vulnerability to shortages of drugs on the Canadian market using a tool created as part of the At-Risk Medicines project. Health Canada and other experts validated this assessment. This methodology incorporates feedback from the public consultation that we published in December 2024.

The At-Risk Medicines Project risk assessment tool

The At-Risk Medicines project is a Canadian multidisciplinary research effort led by the University of Toronto. The project research team developed a risk assessment tool to assess the criticality (clinical importance) of drugs and their vulnerability to shortage. Their tool assigns scores to each drug based on:

• criticality, as assessed by clinicians based on 9 criteria to determine clinical importance
• vulnerability to shortage, based on a model that includes data from past shortage reports, supply chain factors and market dynamics

Learn more:

• At-Risk Medicines project

Consideration for criticality and vulnerability thresholds

Health Canada selected drugs:

• with criticality scores greater than the 75th percentile
• on similar lists from Australia, France, the European Union and the United States

We reviewed and included drugs that were recommended during the December 2024 public consultation where appropriate.

We then assessed the list for vulnerability to shortage using the risk assessment tool developed by the At-Risk Medicine project. We used a vulnerability score of 10% or greater as a threshold for inclusion.

Consideration for specific risk factors for vulnerability to shortage

We considered drugs that didn't meet the vulnerability score threshold for inclusion if the drug had at least 2 of the risk factors that disproportionately increase vulnerability to shortage:

• drugs for infectious diseases
• drugs with a sole manufacturer
• intravenous (IV) drug products

Expert validation and final review

Health Canada experts in shortage case management and clinical practice and members of the At-Risk Medicines project team reviewed the list. They considered the parameters in the At-Risk Medicines project scoring tool and the Canadian context in validating the final CVDL.

The Critical and Vulnerable Drug List

The CVDL lists drugs alphabetically by ingredient or description, and indicates the route of administration.

Drugs included are for human use.

Contact

For questions or comments on the CVDL, please contact us at hpsdpdcorr-corrdgppsdp@hc-sc.gc.ca.