Question Period Note: Pediatric analgesics shortage

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• Health Canada is aware that supply of many formats of non-prescription pediatric acetaminophen and ibuprofen products remains limited in retail locations and hospitals in various parts of the country, causing significant concerns for people in Canada.
• Our Government shares the concerns of many parents and caregivers who may not be able to easily access these important medications to treat their children.
• To increase the supply of these products on store shelves, Health Canada has approved the exceptional importation of over 1.2 million units, including acetaminophen from the global market that has started to become available to consumers in retail and community pharmacies.
• This also includes supply of the recently approved exceptional importation of ibuprofen from the U.S. and acetaminophen from Australia, to supply hospitals in Canada. Importation of ibuprofen has occurred, and distribution to hospitals has started. Children’s acetaminophen from Australia for hospitals has arrived in Canada and distribution will begin shortly. These supplies are in addition to the 1.1M ibuprofen units produced in Canada by Haleon during the month of November 2022.
• All options continue to be on the table to address this situation.
• The Department will continue to work with multiple players along the supply chain, right to patient groups, hospitals and pharmacies, to take any and all additional measures necessary to ensure access to needed supply of these important medications for our children.

IF PRESSED ON WHY THE SHORTAGE ISN’T YET RESOLVED?
• My Department has been actively working with manufacturers and distributors of pediatric acetaminophen and ibuprofen products, the provinces and territories, children’s hospitals, the Canadian Pediatric Society, the Canadian Pharmacists Association, and Food, Health and Consumer Products of Canada since first learning about supply constraints to help increase the supply of these medications.
• In response to unprecedented demand, manufacturers that supply the Canadian market have increased production, some producing at record levels, and they are exploring options to further increase production and expedite re-supply where product is needed most. For example, during the month of November a total of 1.1M units of domestically produced Children’s Advil products from Haleon will have been made available for the Canadian market.
• In addition to the products already authorized for exceptional importation, we will continue to work with suppliers to bring in additional imported products to increase the supply in Canada.
• I have spoken directly to the manufacturers of these medications and hosted two roundtables with multiple stakeholders who are playing a role to resolve this situation.
• We will continue to treat this as a priority, with Health Canada reviewing additional proposals for exceptional importation.

IF PRESSED ON WHY IS THIS SO PRONOUNCED IN CANADA (ARE OTHER COUNTRIES EXPERIENCING THE SAME SHORTAGE?)
• Other countries have reported signals of supply constraints, but none have seen the demand that we have seen in Canada.
• We saw demand for analgesics rise over the summer months, which is the period manufacturers normally use to restock analgesics for the fall and winter seasons.
• Combined with the increased attention on the issue in Canada in mid-August, and the viral infections circulating, it has resulted in a drastic and unprecedented spike in demand.

IF PRESSED ON WHY DIDN’T HEALTH CANADA PERMIT IMPORTATION OF FOREIGN PRODUCTS EARLIER?
• Exceptional importation of foreign authorized drugs is considered when the Canadian drug is at risk, or in critical shortage. This measure is always available for any shortage and was offered to suppliers when we began to hear about supply constraints in the spring.
• When demand spiked to unprecedented levels in August, my Department intensified ongoing efforts with industry and other stakeholders to explore all possible solutions. This included options to further increase supply in the Canadian market, such as ramping up production and accessing foreign supply.
• We are now seeing the positive results of these efforts. In addition to importing products from the U.S. and Australia to supply hospitals in Canada, we have started to see children’s acetaminophen on retail shelves in the last few days.
• We are continuing to work with manufacturers to increase supply in Canada and bring in additional foreign-authorized products.

IF PRESSED ON WHY IT WILL TAKE SO LONG TO GET THE EXCEPTIONALLY IMPORTED ACETAMINOPHEN TO STORE SHELVES?
• Each proposal received from a company to import a foreign authorized product undergoes careful review by Health Canada to confirm that the product was manufactured according to the same high quality standards the people of Canada expect.
• After careful review, the Department has approved the exceptional importation of acetaminophen from the global market and products are already appearing on store shelves.
• The Department is actively working with distributors and retailers to ensure fair distribution of supply across Canada.

On August 16, 2022, media reported that the SickKids Hospital in Toronto was warning parents and caregivers that, due to nationwide shortages, a prescription would be required for liquid acetaminophen and ibuprofen products, and that a pharmacist would provide the medication to them.

CBC News and Sick Kids issued corrective statements clarifying that prescriptions for these products were not required. However, this media attention triggered a further spike in demand for these products nationally, following reports of intermittent supply constraints that had been previously reported. Companies have indicated they have ramped up production beyond normal historical demand levels but that the current demand is outpacing production.

On August 30, the Canadian Pediatric Society issued guidance directed to caregivers and parents on the use of these products.

Health Canada is actively working with the manufacturers and all stakeholders across the supply chain to identify mitigation measures to increase supply and meet demand for these products, including reviewing proposals that may require regulatory flexibility or consideration of foreign supply. Manufacturers are maximizing production, with some companies producing at 100% more than they were at the same time in 2021, including Haleon’s production of 1.1M units of children’s Advil during the month of November 2022.

The Department has prioritized information-sharing with provinces and territories via various FPT tables. The Department has also involved PTs in broader multi-stakeholder discussions to identify solutions as quickly as possible.

Health Canada has approved the importation of foreign supply of children’s ibuprofen and infant’s acetaminophen for use in hospitals. Further to this, on November 4, 2022, the Department approved a proposal from Johnson & Johnson for the exceptional importation of U.S.-labelled acetaminophen that will help to fill the current supply gap in retail and community pharmacies. On November 10, 2022, the Department approved the company’s proposed distribution and risk communication plan for the product, including bilingual safety information and measures to enhance the supply of bilingually labelled product to Quebec and to French language minority communities in Canada. More than 1.2 million bottles of product have already entered Canada to supply hospitals, community pharmacies and retailers and products are already appearing on store shelves. An addition 500K units are expected at retail within the next three weeks. The additional amount to be imported will help increase the supply available to consumers and will continue to help address the immediate situation. Health Canada continues to assess additional proposals for exceptional importation to further supplement this increased supply.

Health Canada is prioritizing public communication by providing information and advice to Canadians. This was done via a Departmental Statement, and Public Advisory issued on October 7, 2022. As well a webpage was launch on October 26, 2022 dedicated to the analgesic shortage. Health Canada will continue to keep Canadians up to date on this shortage and the products that have been approved for importation through this webpage.

In addition to discussions with suppliers, on November 2, 2022, and November 17, 2022, the Honourable Jean-Yves Duclos, Minister of Health, hosted roundtable discussions on the pediatric and children’s analgesics shortage in Canada. In attendance were external participants representing manufacturers, distributors, pharmacists, children’s hospitals, and pediatricians. The objective of the roundtable was to highlight actions to date and provide participants with an opportunity to share perspectives on the shortage, measures taken, and ongoing challenges, while underscoring the need for all stakeholders to continue taking measures to end this shortage as soon as possible.

• Suppliers of pediatric acetaminophen and ibuprofen products are experiencing supply constraints and intermittent stock-outs, due to unprecedented and unexpected demand levels. It is unknown when balance will be restored between supply and demand.
• Supply of these products has been constrained since earlier this year, becoming more acute over the late summer and fall.
• Health Canada continues to take action to address the shortage by working collaboratively with key stakeholders, including industry and health care system partners, to implement shortage mitigation measures to increase the supply of these important products, and monitor their supply across the country.
• As of November 28 over 1.2 million units of foreign authorized supply of both ibuprofen and acetaminophen have been imported. Distribution of exceptionally imported ibuprofen for use on hospitals began on Nov 4th, while distribution of imported children’s acetaminophen began reaching retail shelves on November 25.