Consultation on the draft Critical and Vulnerable Drug List
On this page
- Overview
- Purpose and use of the list
- Proposed amendments
- Methodology used to develop the draft list
- How to provide feedback on the draft list and methodology
- Related links
- Draft CVDL
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 gathered 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:
Proposed regulatory amendments
We proposed changes to the Food and Drug Regulations that would require:
- MAHs to complete SPMPs for any drugs for which a shortage could present a serious risk of injury to human health
- We recommend that DEL holders also maintain SPMPs for these drugs.
- DEL holders that import or wholesale a drug and who are not the MAH to report demand surges for drugs for which a shortage could present a serious risk of injury to human health
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:
- results in death
- is life threatening
- requires inpatient hospitalization or prolongs existing hospitalization
- results in persistent or significant disability or incapacity
Purpose and use of the list
The draft CVDL:
- is intended as guidance for market authorization holders (MAHs) to determine whether their drugs meet the proposed regulatory requirements to create and maintain shortage prevention and mitigation plans (SPMPs)
- will also help drug establishment licence (DEL) holders determine whether their drugs are in scope for mandatory demand surge reporting
- as defined in the proposed amendments to the Food and Drug Regulations
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:
- independent clinician expert review
- consideration for the Canadian context
- collaboration with an expert panel of clinicians, policymakers and industry stakeholders
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%.
When the list becomes final, we will update it 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.
Contact us
If you have any questions or comments, contact us by email at hpsdpdcorr-corrdgppsdp@hc-sc.gc.ca.
Next steps
The consultation is closed. We will analyze feedback, 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
- France's Ministère de la santé et de L'accès aux soins Liste des médicaments essentiels
- European Medicines Agency (EMA) and European Commission First Union List of Critical Medicines
- Australia's Therapeutic Goods Administration (TGA) Therapeutic Goods (Medicines watch List) Determination 2018
- United States Food and Drug Administration (FDA) List of Essential Medicines, Medical Countermeasures, and Critical Inputs
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.
| 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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