Consultation on the draft Critical and Vulnerable Drug List

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Overview

In June 2024, Health Canada committed to publishing a list of drugs that are critical to patients and vulnerable to shortages. The list will help drug shortage stakeholders focus their actions and resources on the drugs that are the most likely to cause harm if they go into shortage.

We developed the first draft of the Critical and Vulnerable Drug List (CVDL) for consultation. It contains drugs for which we consider a shortage could present a serious risk of injury to human health. Drugs on this list also have characteristics that may make them more vulnerable to shortage. A drug being listed on the CVDL doesn't indicate that it's presently in shortage or is expected to experience a shortage.

We're seeking stakeholder feedback on the draft CVDL and the methodology for creating it. The draft CVDL is included at the end of this page.

Learn more about our plan:

Purpose and use of the list

The draft CVDL:

Proposed amendments

We're proposing changes to the Food and Drug Regulations that would require:

Learn more:

Health Canada interprets serious risk of injury to human health due to a shortage as the likelihood that interruption, lack or delay of treatment due to a shortage could cause serious harm to human health.

Elements that determine the seriousness of the harm caused by interruption, lack or delay in treatment due to a shortage include an injury that:

As an MAH or DEL holder, you must determine if a shortage of your drug could present a serious risk of injury to human health. The CVDL contains drugs that if a shortage of a drug were to occur, it could present a serious risk of injury to human health. Use the CVDL to help you determine if SPMPs or demand surge reporting are required for the drug that you manufacture, import or wholesale.

Methodology used to develop the draft list

We used a systematic process to develop the draft CVDL. The first step was to use a tool created as part of the At-Risk Medicines project, followed by several validation steps.

The At-Risk Medicines project is a Canadian multidisciplinary research effort led by the University of Toronto. This work was funded by the Canadian Institutes of Health Research (CIHR) and sponsored by Canada's Drug Agency. Health Canada was an observer on the project and provided advice to the research team on methodological considerations.

The project research team developed a risk framework and a risk assessment tool to assess the clinical importance of drugs and their vulnerability to shortage. Their work to create the framework included:

As part of the project, independent reviewers evaluated 1,650 drugs for clinical importance and vulnerability to shortage using the risk assessment tool. In this context, drugs were represented as a medicinal ingredient and route of administration.

The project framework provides a description of the full project methodology, including the project team and panel members.

To develop and validate the draft CVDL, Health Canada first included drugs with clinical importance scores greater than the 75th percentile, as well as drugs on similar lists from international jurisdictions. Internal Health Canada experts in shortage case management and clinical practice and members of the external At-Risk Medicines project team then reviewed the list. They considered the parameters in the At-Risk Medicines project scoring tool and the Canadian context. Drugs in the draft CVDL were further considered for vulnerability to shortages using the ARM project vulnerability threshold of greater than 10%.

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.

How to provide feedback on the draft list and methodology

Use the CVDL questionnaire to submit your feedback on the draft CVDL and the methodology used to create it. The questionnaire will be available from January 6th to March 8th, 2025.

CVDL questionnaire

If you would like to receive the questionnaire in an alternative format, contact us by email at hpsdpdcorr-corrdgppsdp@hc-sc.gc.ca.

Next steps

We will collect and analyze feedback from the consultation on the draft CVDL, including drugs recommended for removal or addition. The final CVDL will be published at the same time as any future final amendments, following the regulatory process.

Related links

Draft CVDL

The following table lists the drugs on the draft CVDL. Health Canada considers these to be drugs for which a shortage could present a serious risk of injury to human health.

Drugs are listed alphabetically by ingredient or description. For each drug, the route of administration is indicated.

Drugs included are for human use.
Ingredients or product group description Route of administration
acetylcysteine oral
acetylsalicylic acid (when sold or recommended as a platelet aggregation inhibitor) oral
acyclovir parenteral
adenosine parenteral
alteplase parenteral
amikacin parenteral
amino acids parenteral
amino acids and electrolytes parenteral
amiodarone parenteral
amoxicillin oral
amphotericin b parenteral
ampicillin parenteral
anthrax immunoglobulin parenteral
anti-D (rh) immunoglobulin parenteral
atezolizumab parenteral
atropine parenteral
axicabtagene ciloleucel parenteral
azithromycin parenteral
bacillus calmette-guerin (when sold or recommended as an antineoplastic agent) parenteral
bevacizumab parenteral
blinatumomab parenteral
botulinum antitoxin parenteral
brentuximab vedotin parenteral
brexucabtagene autoleucel parenteral
buprenorphine parenteral
buprenorphine and naloxone oral
calcium parenteral
caspofungin parenteral
catridecacog parenteral
cefazolin parenteral
cefixime oral
cefotaxime parenteral
ceftazidime parenteral
ceftobiprole parenteral
ceftriaxone parenteral
cefuroxime parenteral
cemiplimab parenteral
cerliponase alfa parenteral
ciprofloxacin oral
clindamycin parenteral
cloxacillin parenteral
coagulation factor II, VII, IX and X parenteral
coagulation factor VIII parenteral
coagulation factor VIII and von Willebrand factor parenteral
coagulation factor XIII parenteral
cyclophosphamide parenteral
daptomycin parenteral
daratumumab parenteral
deferoxamine parenteral
defibrotide parenteral
desmopressin parenteral
dexamethasone parenteral
dextrose parenteral
dextrose and heparin parenteral
dextrose and sodium chloride parenteral
diazepam oral, parenteral
diphtheria and tetanus vaccines parenteral
diphtheria, haemophilus influenzae B, hepatitis B, pertussis, polio and tetanus vaccines parenteral
diphtheria, haemophilus influenzae B, pertussis, polio and tetanus vaccines parenteral
diphtheria, pertussis and tetanus vaccines parenteral
diphtheria, pertussis, polio and tetanus vaccines parenteral
doxorubicin (liposomal form) parenteral
durvalumab parenteral
enfortumab vedotin parenteral
epinephrine parenteral
ertapenem parenteral
ethambutol oral
fentanyl oral
fibrinogen parenteral
fluconazole parenteral
flumazenil parenteral
fomepizole parenteral
glucagon parenteral
heparin parenteral
heparin and sodium chloride parenteral
hepatitis B immunoglobulin parenteral
hepatitis vaccines parenteral
human insulin parenteral
human papillomavirus vaccines (nonavalent form) parenteral
human plasma proteins parenteral
hydrocortisone parenteral
hydroxocobalamin parenteral
idarubicin parenteral
idursulfase parenteral
immunoglobulin G parenteral
ipilimumab parenteral
isoniazid oral
ivabradine oral
ledipasvir and sofosbuvir oral
leucovorin parenteral
levofloxacin parenteral
levothyroxine parenteral
linezolid parenteral
lithium oral
luspatercept parenteral
magnesium parenteral
manganese parenteral
measles, mumps and rubella vaccines parenteral
measles, mumps, rubella and varicella vaccines parenteral
meningococcal vaccines (tetravalent form) parenteral
meropenem parenteral
methotrexate (when sold or recommended as an antineoplastic agent) parenteral
methylene blue parenteral
methylprednisolone parenteral
metronidazole oral, parenteral
micafungin parenteral
mifepristone and misoprostol oral
morphine parenteral
naloxone inhaled, parenteral
nitroglycerin oral, parenteral
nivolumab parenteral
norepinephrine parenteral
obinutuzumab parenteral
oxytocin parenteral
paclitaxel (nanoparticle form) parenteral
pegaspargase parenteral
pegfilgrastim parenteral
pembrolizumab parenteral
penicillin G parenteral
pertuzumab parenteral
pertuzumab and trastuzumab parenteral
phenytoin parenteral
piperacillin and tazobactam parenteral
pneumococcal vaccines parenteral
polatuzumab vedotin parenteral
polio vaccines parenteral
potassium parenteral
protamine parenteral
pyrazinamide oral
rabies immunoglobulin parenteral
rabies vaccines parenteral
ribavirin inhaled
rifampin oral
rituximab parenteral
romiplostim parenteral
rotavirus vaccines oral
ruxolitinib oral
salbutamol parenteral
sebelipase alfa parenteral
selenium parenteral
smallpox and mpox vaccines parenteral
sodium parenteral
sulfamethoxazole and trimethoprim parenteral
succinylcholine chloride parenteral
tenecteplase parenteral
tetanus immunoglobulin parenteral
thiamine parenteral
tigecycline parenteral
tisagenlecleucel parenteral
trastuzumab parenteral
trastuzumab deruxtecan parenteral
trastuzumab emtansine parenteral
typhoid vaccines oral, parenteral
valganciclovir oral
vancomycin oral, parenteral
varicella zoster immunoglobulin parenteral
varicella zoster vaccines parenteral
vasopressin parenteral
vitamin K1 parenteral
voriconazole parenteral
yellow fever vaccines parenteral

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