Nitroglycerin spray/tablet shortage

A Tier 3 shortage was declared in late February for Nitroglycerin Spray 0.4 MG/ACT. Subsequently, a Tier 3 status was also applied to Nitroglycerin Tablets in mid-April.

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.

Working with Health Canada, 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. The availability of nitroglycerin spray in hospitals and community pharmacies is expected to be extremely limited for the next few months (resupply expected June/July). 

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

It is important that pharmacists have as much information about the shortage as possible. We have drafted some messages to help you explain the situation to patients (see below).

Information for patients

• There is a severe shortage of nitroglycerin spray in Canada because of raw material supply issues for the manufacturer (Mylan) and subsequent increases in demand for other products (Sandoz and Sanofi). Due to increased demand, this is also now impacting nitroglycerin tablets. 
• Pharmacists across Canada have been asked to limit dispensing where possible to help extend inventory and ensure that all patients can access this medication.
• If you have nitroglycerin sublingual spray at home please speak to your pharmacist as some of the expiry dates have been extended by Mylan.
• Efforts are underway nationally to conserve supply, expedite resupplies, and access foreign-authorized supply, including alternative drugs.

Products impacted

Mylan - Mylan-Nitro Sublingual Spray	Shortage due to delay in supply of raw materials. Mylan is reporting an estimated resupply by November 15, 2023 (date revised).
Sandoz – RHO-Nitro Pumpspray	Shortage due to increased demand. Shortage resolved May 22, 2023
Sanofi-Nitrolingual Pumpspray	Shortage due to increased demand. Sanofi is reporting an estimated resupply by December 31, 2023 (date revised).
Mylan Nitrostat 0.3mg tablets	Shortage due to increased demand. Shortage anticipated from August 31, 2023 to November 15, 2023.
Mylan Nitrostat 0.6mg tablets	Shortages due to increased demand. Shortage anticipated from August 31, 2023 to November 15, 2023

Expiry dates

In response to the shortage Health Canada requested that manufacturers determine if certain products could be safely used beyond their printed expiry. Health Canada reviews the information to ensure that the product is safe and will work beyond the printed expiry date. Products with extended expiry dates will be listed below. The chart will be updated as information becomes available.

Product Name	Lot Number	Original (Printed) Expiry Date	Extended Expiry Date
Mylan-Nitro Sublingual Spray (DIN: 02243588)	9F715	06/2022	06/2023
	9F717	06/2022	06/2023
	0B847	02/2023	02/2024
	0B853	02/2023	02/2024
	OF904	06/2023	06/2024
	OG910	07/2023	07/2024
	0H919	08/2023	08/2024

Shelf-life extension data is unavailable for other Nitrospray products. Pharmacists should use their own clinical judgement on a case-by-case basis in advising patients to use any product beyond the expiry date considering the limitation in efficacy/stability with the risk of the patient not having any drug on hand in an emergency situation.

Alternatives

There are nitroglycerin sublingual tablets in 0.3mg and 0.6mg strengths. Due to increased demand on these products, a Tier 3 shortage has also been declared for nitroglycerin tablets.

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, if available.

CPhA will continue to participate in stakeholder calls and provide information as this shortage develops.

 

Last updated: August 29 2023