Question Period Note: COVID-19 Critical Drug Reserve

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• COVID-19 created an increased demand for drugs used in supporting patients with the disease, against the backdrop of multiple global supply chain challenges. Drug shortages, particularly in the context of COVID-19 critical drugs, could put the health of Canadians at risk.
• Working with provinces, territories and other partners, Health Canada established a COVID-19 Critical Drug Reserve to support patients with COVID-19.
KEY MESSAGES
• Ensuring Canadians have access to the drugs they need is a top priority. The Government of Canada took proactive measures to help mitigate the risk of drug shortages, a global issue, throughout the pandemic.
• Working with provinces and territories and other partners, Health Canada established the COVID-19 Critical Drug Reserve in 2020. The Reserve came to a close on June 30, 2022 and the remaining inventory in the Critical Drug Reserve was delivered to hospitals in participating jurisdictions.
• The Reserve complemented other federal, provincial and territorial drug shortage management efforts. Over the course of the pandemic, the Critical Drug Reserve mitigated several shortages of key drugs used in treating patients with COVID-19, and functioned as a safety net by augmenting Canada’s critical drug supply.
• We will continue to collaborate with provinces and territories, industry, healthcare and patient groups and international partners to closely monitor the situation and take necessary action to help prevent and minimize the impact of shortages.
IF PRESSED ON WHAT DRUGS HEALTH CANADA PURCHASED FOR THE CRITICAL DRUG RESERVE …
• The Critical Drug Reserve held twelve drugs used in hospitals to support patients with COVID-19, including sedatives, pain relievers, and antibiotics. These drugs were included in the Reserve based on Canada’s experience in managing drug supply, consultation with provinces and territories, and advice provided by health care experts.
IF PRESSED ON PARTICIPATION …
• The Critical Drug Reserve functioned as an additional safety net in the event of shortages of key drugs used in the treatment of COVID-19 symptoms, and complemented Canada’s current drug shortage mitigation measures.
• Participation in the Critical Drug Reserve was voluntary, with most provinces and territories participating. Although the Governments of Quebec and New Brunswick decided not to participate, they, too, accessed some drugs from the reserve.
IF PRESSED ON COST …
• The final cost of the three month supply of drugs in the Critical Drug Reserve was $27 million, which was cost-shared between the federal government and participating provinces and territories.
• Drug pricing is influenced by a number of factors, including availability, supply chain constraints, global import/export restrictions, and competition in the global marketplace.
• As with all purchasing, value for money was a key consideration.
IF PRESSED ON DIVESTMENT …
• Provinces and territories were able to adjust their inventory in the reserve by reallocating to other jurisdictions that needed it, or through vendor contract adjustments.
• At closure, the remaining Critical Drug Reserve inventory was delivered, as directed by the provinces and territories, to hospitals across Canada.
• Inventory that was in excess of provincial and territorial needs was reallocated among jurisdictions, sold back to the vendor, transferred to other federal departments, donated internationally, or transferred to the provinces and territories as additional supply.
• Avoiding waste was a top priority when managing these valuable products. Health Canada procured approximately 3.5 million doses for the CDR, and only 0.1% of the doses could not be reallocated, sold back, donated or transferred.

Health Canada’s role

Health Canada works with provinces and territories and stakeholders across the drug supply chain to identify mitigation strategies, which include regulatory measures and exploring access to alternative products available in other jurisdictions. Creating a reserve for drugs critical to the treatment of COVID-19 symptoms is one such strategy.

During the first wave of the pandemic, shortages were identified for key drugs used in treating patients with COVID-19. The Critical Drug Reserve served as a backstop for Canada’s existing supply, complemented the existing drug shortage management systems, and helped to prevent critical drug shortages, which in turn, relieved pressures on provincial and territorial health care systems.

Factors that were considered in the pursuit of a critical drug reserve included whether the drug was important for the treatment of COVID-19 symptoms, whether the drug was in shortage or likely to be in shortage, and whether alternative or substitute drugs were available. The following drugs were in the Critical Drug Reserve:

• Cisatracurium (Neuromuscular blocker);
• Epinephrine (Adrenergic agonists);
• Fentanyl (Opioid analgesic);
• Norepinephrine (Adrenergic agonists);
• Propofol (Sedative);
• Rocuronium (Neuromuscular blocker);
• Salbutamol (Bronchodilator);
• Ceftriaxone (antibiotic);
• Dexamethasone (corticosteroid);
• Hydromorphone (analgesic);
• Midazolam (sedative); and
• Vasopressin (vasopressor).

Engagement with Provinces and Territories

To address drug supply issues, Health Canada has strengthened existing mechanisms for managing drug shortages, and has leveraged existing FPT infrastructure and increased cooperation with multiple partners to identify shortage signals earlier, particularly for critical drugs required for COVID-19.

Given the need for close cooperation on the shortage of critical drugs, a Framework for the Effective Management of Drug supply in the Context of the COVID-19 Pandemic was developed and agreed to by provinces, territories and the federal government. This Framework sets out the common principles for managing drug shortages and guiding decisions in the context of the COVID-19 pandemic. Principles include solidarity, fairness, openness and transparency, and FPT collaboration. These principles have been implemented through the federal government facilitating access to alternative drug supplies to prevent shortages, and building the Critical Drug Reserve to support patients with COVID-19.

The CDR was established as a backstop for a limited period of time and came to a close on June 30, 2022. At closure, the remaining CDR inventory was delivered to provincial and territorial hospitals with optimal shelf life remaining.

Partners and stakeholders agree that the CDR was critically important to ensuring a supply of key drugs for the treatment of COVID-19. Health Canada worked with provinces and territories to document lessons learned from this innovative pandemic initiative and has shared recommendations that leverage this experience to inform broader shortage mitigation efforts and supply chain resilience planning in Canada.

• The Critical Drug Reserve was established with a three-month supply of 12 key drugs used in the treatment of COVID-19 symptoms.
• The final cost of the three-month supply of drugs was $27M, which was shared between provinces / territories (70%) and the federal government (30%).
• Participation in the Critical Drug Reserve was voluntary. All jurisdictions except for Quebec and New Brunswick formally participated, however, all PTs benefited from some inventory in the reserve.