Partnering with Compounders to Address the Pediatric Acetaminophen Shortage in Canada

We all hear and talk about ‘drug shortages’ and medication ‘back-orders’ – but what do they really mean? A shortage occurs when a drug manufacturer is unable to produce adequate supply in order to meet the demands of consumers; meaning the product is on back-order or completely out-of-stock1. This can be caused by manufacturing delays, difficulty obtaining raw ingredients, discontinuation of the drug, or – as we have seen recently with the COVID-19 pandemic – a sudden increase in the demand for a medication.

Drug shortages in Canada – which are reported on Drug Shortages Canada– impact more than 1 in 4 drugs sold annually2. Drug shortages can have drastic clinical outcomes by contributing to treatment delays and disease proliferation3. The use of wrong therapeutic alternatives becomes a concern and the risk of medication errors and adverse drug reactions can increase3. While commercial substitutions are sometimes available during drug shortages, what happens when there are none and the shortage is ongoing? That is what we are all now experiencing with the pediatric acetaminophen shortage in Canada – a shortage impacting one of the most vulnerable patient populations at a time when pain and fever medication is needed the most.

Shortage of Pediatric Acetaminophen

Occurring just as the season of flu, respiratory syncytial virus (RSV), COVID-19, and other respiratory illnesses is beginning, the nationwide shortage of pediatric acetaminophen – an essential pain and antipyretic medication – has left parents, children, and healthcare providers feeling helpless. Health Canada cites increased demand as the reason for the acetaminophen shortage – mostly due to COVID-19 and an early spike in viral illnesses over the spring and summer of 20224. In response to the shortage, Health Canada is working to secure alternate supplies of children’s medication5– but this may not be enough. When and if supply comes in, there may still be an insufficient amount to meet consumer demand. Further adding to commercial unavailability is medication stockpiling, fueled by media coverage of the shortage and the fear of not having enough medication on hand in case of need.

Parents and caregivers are left scrambling for options, and some have resorted to using adult acetaminophen products for pediatric patients, which presents many challenges. While pediatric acetaminophen typically comes in liquid format for ease of weight-based dosing and administration, adult acetaminophen typically comes in fixed-dose increments and hard-to-swallow tablets. This places the burden on parents and caregivers to figure out how to dose and administer essential medication to their children, leaving room for error. A better solution must be out there – and for our compounding pharmacies, you know firsthand what is possible.

Compounded Acetaminophen – Addressing the Shortage

Defined as the practice of preparing customized medications in accordance with a licensed practitioner’s prescription, pharmaceutical compounding allows providers the opportunity to explore patient-tailored therapeutic plans that are otherwise not commercially available6. This includes personalizing dosage strengths so it is more suitable to the patient, considering alternative dosage forms such as a liquid over a tablet, eliminating unwanted ingredients that a patient may be allergic to, combining therapeutics, or – perhaps the most critical of all – filling demands during product unavailability, like we are experiencing with the pediatric acetaminophen shortage.

Medisca – Partnering to Support Compounders and Health Authorities with the Pediatric Acetaminophen Shortage

As a supplier of pharmaceutical compounding products and services, Medisca is witnessing first-hand the impact of the Canadian pediatric acetaminophen shortage through drastic increases in demand. To put some numbers to this impact – the demand for Medisca acetaminophen raw ingredient has increased by 600%, Medisca oral bases has risen by 300%, and requests for Medisca Formulas to support the on-going shortage has increased by 1,000%. This recent volume of demand is estimated to support 3 -12 million doses of acetaminophen for children across Canada. This is an unprecedented demand for compounded medication and an illustration of how critical the practice of pharmaceutical compounding is, particularly during times of drug shortages.

All things considered, it is not hard to imagine that compounding pharmacies across the country are working around the clock to ensure parents, children, and providers have access to this important medication. To support compounding pharmacies and hospitals, Medisca Supply Chain has been actively leveraging our vast manufacturer and supplier network to meet the demand for product. Medisca has also been collaborating closely with Healthcare authorities, keeping them regularly informed of inventory levels and incoming supply, as well as supporting their efforts with formula development and technical support services. Medisca Compounding Services – led by a team of highly skilled formulation chemists, pharmacists, and technical support service representatives – have been fielding an increasingly high volume of calls to support compounders with formula searches, preparatory questions, pharmaceutical calculations, ingredient selection, formula customization, and more. The demand for compounding formulation support is often at its highest during a drug shortage, and Medisca has the resources and processes in place to assist.

Acetaminophen Formulas – A Complimentary Resource to Support Current Shortages

The bread and butter of compounding and the most sought after support during a drug shortage, second to the ingredients themselves, are compounding formulas. Akin to a recipe, compounding formulas provide all the pertinent details and instructions needed for pharmacists and pharmacy technicians to prepare a compounded medication. With over 10,000 compounding formulas in our library, Medisca is well-recognized in the industry as the go-to resource for formulation support. Packed with all the essential information a compounder needs to prepare a compounded medication, Medisca formulas include the step-by-step breakdown on the preparatory process with details on ingredient sensitivities, calculation templates that support batch variations and ingredient adjustments, auxiliary labels, beyond-use dating instructions, references, and more. The formulations themselves are further supported by the Medisca Compounding Services team who assist with day-to-day calls and email inquiries. Compounding pharmacies can learn more about Medisca Compounding Services.

For drug shortages – given the critical nature of them – we provide all Medisca formulas that are on potential shortage to the Healthcare community free of charge. Shortage formulas are consolidated on the Medisca Shortage Support section of our website, packaged in an easy-to-filter through table format. Shortages are continuously monitored across the globe and the Medisca Compounding Services team proactively develops formulas to support the need. As mentioned earlier, the team has increased their output for shortage formulas by 1,000% in the last month alone, a reflection of the acetaminophen shortage crisis. Currently, there are over 170 formulas on the Canadian Shortage Support page, created to address current or former shortages, 7 of which are intended to support the current pediatric acetaminophen shortage.

Listed below are the acetaminophen formulas organized by the base used.

Formulas using Medisca Oral Suspend / Medisca Oral Syrup:

• F 009 757 Acetaminophen 32 mg/mL Oral Liquid

• F 009 758 Acetaminophen 80 mg/mL Oral Liquid

• F 004 369 Acetaminophen 100 mg/mL Oral Liquid

Formulas using ORA Blend®:

• F 009 744 Acetaminophen 100 mg/mL Oral Liquid

• F 009 755 Acetaminophen 32 mg/mL Oral Liquid

• F 009 756 Acetaminophen 80 mg/mL Oral Liquid

• Formulas using Methylcellulose Gel (1%):

• F 009 778 Acetaminophen 80 mg/mL Oral Liquid

• In addition to the formulas themselves, we are currently offering free compounding services related to the pediatric acetaminophen drug shortage – including support with formula searches, preparatory questions, pharmaceutical calculations, and more – to compounding pharmacies and hospitals across the country. Inquiries can be sent to compoundingservices@medisca.com or to call directly dial 1-800-665-6334 ext. 1203.

• If you are a provider, caregiver, or patient in need of this care, we encourage you to reach out to your local compounding pharmacy or physician.

• References:

  • Health Canada. (2022). Drug shortages in Canada. Government of Canada.https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-shortages.html.
  • Health Canada. (2022). Drug shortages in Canada and their implications on public drug plans, 2017/18 to 2019/20. Government of Canada.https://www.canada.ca/en/patented-medicine-prices-review/services/npduis/analytical-studies/posters/capt2022-drug-shortages-canada.html.
  • Atif, M., Sehar, A., Malik, I. et al. (2021). What impact does medicines shortages have on patients? A qualitative study exploring patients’ experience and views of healthcare professionals. BMC Health Serv Res 21, 827 (2021).https://doi.org/10.1186/s12913-021-06812-7.
  • Caring for Kids. (2022). Shortage of infant and children’s liquid pain and fever medication. Canadian Pediatric Society.https://caringforkids.cps.ca/handouts/health-conditions-and-treatments/shortage-of-childrens-liquid-pain-and-fever-medications.
  • Health Canada. (2022). Health Canada secures additional supply of children’s acetaminophen products. Government of Canada.https://www.canada.ca/en/health-canada/news/2022/11/health-canada-secures-additional-supply-of-childrens-acetaminophen-products.html.
  • NAPRA. (2018). Guidance document for pharmacy compounding of non-sterile preparations. Companion to the model standard for pharmacy compounding od non-sterile preparations.https://www.napra.ca/wp-content/uploads/2022/09/NAPRA-Mdl-Stnds-Pharmacy-Compounding-Nonsterile-Preparations-Guidance-EN-June-2018-CLAR-Jan-2022.pdf.