Q&A for pharmacy professionals: What you need to know about the nitroglycerin spray shortage

There is an ongoing shortage of nitroglycerin spray in Canada. As the impact of this shortage is felt at the pharmacy level, we’ve put together this brief Q&A to help keep you updated on the situation.

Why is there a shortage of nitroglycerin spray?
What products are impacted?
Is this shortage only in Canada?
When will this shortage be resolved?
As a pharmacist, how can I help manage this shortage?
What should patients do?
What is the federal government doing to manage this shortage?
What is CPhA doing to help support pharmacists?
Can expired products be used?
Are there alternative products available?
Related links

Why is there a shortage of nitroglycerin spray?

There is a severe shortage of nitroglycerin spray in Canada because of raw material supply issues for the predominant manufacturer (Mylan) and subsequent increases in demand for other marketed products (Sandoz and Sanofi). The shortage has now extended to nitroglycerin tablets as well.

On February 28, 2023 a Tier 3 shortage was declared by Health Canada for Nitroglycerin Spray 0.4 MG/ACT. Subsequently, in mid-April a Tier 3 shortage was also declared for Nitroglycerin tablets. A Tier 3 Shortage is a shortage with no available therapeutic alternatives marketed in Canada and with the greatest potential impact on the Canadian drug supply and health care systems by virtue of availability of alternative supplies, ingredients or therapies.

What products are impacted?

Company	Product	Product DIN
Mylan	Mylan-Nitro Sublingual Spray	02243588
Mylan	Nitrostat 0.3mg tablets	00037613
Mylan	Nitrostat 0.6mg tablets	00037621
Sandoz	RHO-Nitro Pumpspray	02238998
Sanofi	Nitrolingual Pumpspray	02231441

Is this shortage only in Canada?

At this time, we do not have information to suggest that this is a widespread, global shortage issue.

When will this shortage be resolved?

The availability of nitroglycerin spray as well as tablets in hospitals and community pharmacies is expected to be extremely limited for the next few months.

See Products impacted chart for resupply estimates

We are hopeful that the efforts underway to conserve supply, expedite resupplies, and access foreign-authorized supply, will bring a quicker resolution to this shortage and mitigate the impact on patients.

As a pharmacist, how can I help manage this shortage?

CPhA is recommending that pharmacists across Canada limit the dispensing of these products as much as possible to conserve supply throughout the shortage, as well as protect against possible stockpiling. Like other drug shortages, pharmacists will play an important role in helping patients to understand and navigate the shortage.

The Canadian Cardiovascular Society (CCS) and Canadian Cardiovascular Pharmacists Network (CCPN) have developed a guidance resource that offers some practical tips to help manage the shortage at the community pharmacy level.

What should patients do?

This shortage is undoubtedly very challenging for many people who use nitroglycerin spray to treat heart-related chest pain. People who rely on this drug are encouraged to talk to their healthcare team about how to manage their angina during the shortage.

People who have nitroglycerin spray at home are advised not to discard or use any expired product until Health Canada advises if expired product can be used. Health Canada has approved extended expiry dates for specific lots of Mylan product so far.

Due to the limited supply available, Health Canada is urging people to only obtain what they need to ensure everyone has access to the medications they need.

What is the federal government doing to manage this shortage?

Health Canada is working closely with stakeholders across the supply chain and health-care system on mitigation strategies, including ways to conserve existing supply, expedite resupplies, extend the expiry date of the product, and access foreign-authorized supply, including alternative drugs. Health Canada issued a public advisory on March 17, 2023.

What is CPhA doing to help support pharmacists?

CPhA has been and will continue to work with Health Canada and other stakeholders to represent front-line pharmacists and ensure pharmacists across Canada stay updated on the situation so they can appropriately manage the shortage and support their patients. CPhA is part of the Tier Assignment Committee and is involved in regular stakeholder meetings to discuss mitigation strategies.

Can expired products be used?

Currently, only certain lots of Mylan-Nitro Sublingual Spray have been approved to have their expiry dates extended beyond the printed expiry date throughout the shortage.

Health Canada is working with the other Canadian manufacturers to determine if extending product expiry dates is also an option. More information will be provided by Health Canada as soon as it’s available.

At this time, Canadians are being advised not to discard any expired product they have at home and talk to their pharmacist about which products can be used beyond the printed expiry date. Pharmacists should exercise their professional judgement when discussing management of the shortage with individuals.

Are there alternative products available?

Nitroglycerin sublingual tablets are available in 0.3mg and 0.6mg strengths. However, due to increased demand, this product is also in shortage.

The tablets may not be an appropriate alternative for all patients. The tablets are very small, the bottles may be difficult for some patients to open and the product has a short shelf life because the tablets are vulnerable to temperature and moisture.