Q&A on supply challenges affecting children's pain and fever medications
There continues to be supply challenges affecting infant and children's acetaminophen and ibuprofen products. Though the situation has been ongoing for months, a significant increase in media attention starting in mid-August and the onset of a very challenging cold/flu season has only exacerbated the situation. We’ve put together this brief Q&A to help keep you updated on the situation.
- What is driving these supply issues?
- What are manufacturers doing to increase supply?
- What is the federal government doing to address the situation?
- What do I need to know about the imported products?
- Is this a nation-wide issue?
- What is CPhA doing to represent pharmacists?
- When will the situation be resolved?
- How can I help mediate supply and demand?
- Is a prescription required for over-the-counter acetaminophen and ibuprofen?
- Is a prescription required when compounding children’s and infant’s acetaminophen and ibuprofen?
- What resources are available to me to help educate parents and caregivers?
- How can I stay up to date on the situation?
- Related links
There have been no disruptions to the manufacturing of children’s acetaminophen and ibuprofen medications. The current supply challenges are being driven by a significant increase in demand for these products. This demand is primarily being fuelled by high levels of virus activity (COVID-19, RSV, flu and other viruses) in the community, as well as some stockpiling/panic buying.
When it comes to domestic supply, manufacturers have ramped up production to help meet the soaring demand, with some companies producing about 100% more than they were at the same time in 2021. To put it into context, the spike in demand we've seen since August is 200%-300% above historical highs, so increased production alone has not been able to meet the current needs.
Health Canada is working with a broad range of stakeholders to address the situation, including manufacturers, distributers, and others. All mitigation options are being explored, including work to further boost production of Canadian-approved drugs and importation of foreign authorized drugs. Health Canada has imported ibuprofen and acetaminophen products to supply hospitals in Canada and has also imported a supply of children’s acetaminophen that is being allocated to community pharmacies. As of November 29, over 1.1 million bottles of children’s pain and fever medications have been imported into Canada. (List of products eligible for importation).
On November 14, 2022 the federal government announced that they secured a foreign supply of children’s acetaminophen that is being allocated to community pharmacies. The supply started to arrive on pharmacy shelves during the week of November 21. We’re hopeful that this supply will bring some much-needed relief, both to Canadian families and the pharmacy teams who have been supporting them. In addition to the 1.1 million units already imported, an additional supply is expected to be imported and distributed to community pharmacies over the coming weeks.
Product information: The imported Children’s TYLENOL® acetaminophen suspension products will be temporarily available in two flavours, grape and dye free cherry. These products are the same concentration, and the weight- and age-based doses are the same as the Children’s TYLENOL® (DIN 02046040) acetaminophen suspension products that Canadians know and trust. In addition, the imported product, like the Canadian product, is packaged in a child-resistant container. NOTE: These imported products do have some differences when compared to our Canadian Children’s TYLENOL® acetaminophen suspension, including but not limited to:
- Differences in inactive ingredients
- English-only labelling (Click here to access French labelling)
- Larger product size (120mL) compared to Canadian product (100mL), and
- Some differences in warnings and precautions – Click here to access Canadian Children’s TYLENOL® acetaminophen suspension products labelling.
Additional product information and labelling requirements have been distributed to pharmacies by the manufacturer.
We will also continue to urge parents and caregivers to purchase only what they need and we will continue to encourage pharmacies to place temporary limits on purchasing these products to help ensure availability for all who require them. We will continue to update you with further details as they become available.
While the situation might vary from community to community, the supply issues affecting these products are present across the country. High demand and supply challenges related to these products have been reported in other countries and are not unique to Canada.
CPhA continues to participate in regular stakeholder meetings convened by Health Canada to better understand the supply pipeline, collaborate on messaging and represent the front-line pharmacist perspective.
On October 6, we met with federal health minister Jean-Yves Duclos directly to discuss the issue and the impact that this has had on pharmacy teams. The Minister expressed gratitude for everything the profession has done to address the situation and was interested in how the government could support the pharmacy community and our communications efforts. We raised concerns about the amount of time and resources these types of shortages require, particularly given that pharmacy teams are so stretched at the moment. We further cautioned against broad messaging suggesting that all pharmacies could compound on demand.
We also participated in a roundtable meeting with the federal health minister on November 2 alongside representatives from stakeholders across the supply chain, including manufacturers, distributors, pharmacies and pediatric groups. At the meeting, CPhA shared how pharmacy teams are supporting caregivers and the impact this shortage is having on pharmacists’ workload during an already extremely busy time.
CPhA has also been working with Health Canada and other stakeholders to support the importation of foreign products to help address the situation and ensure important product information is available in both English and French. We are pleased to hear that the government has secured foreign supply that should soon start to bring some relief.
CPhA has also conducted dozens of national media interviews to help clarify a number of issues, communicate the role of pharmacy professionals and stress the importance of not stockpiling/panic buying.
While it’s difficult to predict what future demand will look like over the coming months, we are hopeful that the arrival of imported supply of children’s acetaminophen products the federal government recently secured will help improve the situation and help address our immediate needs. As more stock comes in, from both regular domestic supply and imported products, and purchasing demand goes down, we are hopeful the supply situation will improve to the point where we can maintain stock at pharmacies once again.
We understand this is a challenging situation for pharmacy professionals that is putting further pressures on your already demanding workload. Here are some things that you can do to help manage supply:
- Place temporary limits on purchases of these products (e.g., one product per customer) where appropriate
- Keep product behind the pharmacy counter
- Use appropriate signage on any empty shelves
- Educate parents/caregivers
We encourage pharmacists to use their expertise and professional judgement to educate patients about the situation and how to manage fever and pain. As a trusted health-care provider and a source of credible health information, pharmacists can play an important role in putting parents/caregivers at ease and offering suitable alternatives as appropriate.
No, a prescription is not required for these over-the-counter products. Pharmacists should avoid referring parents/caregivers to other healthcare professionals to receive a prescription for these products.
Given the significant impact the shortage is having on Canada’s health system, Health Canada has clarified that it does not object to allowing compounding of these products without a prescription but within a patient-healthcare professional relationship, until this shortage resolves.
Health Canada recommends that, at the pharmacy level, appropriate documentation is maintained to demonstrate a patient-healthcare professional relationship. In practical terms, CPhA suggests that when dispensing a compounded medication, that pharmacists create a patient record to keep track of the patient’s name, contact information, the product and dosage and date dispensed. It’s recommended that pharmacists keep these records in accordance with the compounding standards of practice and other requirements set out by the regulatory authority of their province/territory .
Pharmacists should follow any provincial/territorial regulations set forth and seek further guidance from their provincial/territorial regulatory authority if necessary.
CPhA collaborated with a number of pediatric experts in Canada to develop a resource for parents and caregivers to help them navigate these supply challenges, which includes information about managing a child’s fever, some helpful do’s and don’ts, and guidance on when to seek the advice of a health-care professional. This webpage and handout can be utilized to help facilitate and support your conversations with patients. We’ve also included some helpful links below. CPhA has also developed a dosing resource for health-care professionals to assist with the administration of acetaminophen during the shortage of children’s products.
CPhA will continue to keep pharmacy professionals updated and share any new developments, via email or social media. We will also continue to update our webpage for pharmacy professionals on the issue.
- CPhA information for pharmacy professionals webpage
- Information for families and caregivers
- Infant and children’s acetaminophen and ibuprofen shortage (Health Canada)
- Update on the Health Canada temporary exception to import a limited amount of Children’s TYLENOL® acetaminophen suspension (TYLENOL®)
Last updated: December 1, 2022