Earlier this week, SickKids Hospital published a “Dear Caregiver” letter, which was intended to inform parents and caregivers of the potential difficulties they may face when accessing over-the-counter acetaminophen and ibuprofen products during the nationwide shortage. The letter recommended that parents and caregivers speak with their SickKids care providers about obtaining a prescription for these products due to the supply issues surrounding children’s over-the-counter fever and pain medicine.
In response to this letter, news outlets have published stories implying that prescriptions are now required for the sale of pediatric acetaminophen and ibuprofen. OPA would like to clarify for our members that the NAPRA scheduling of acetaminophen and ibuprofen have not changed and that a prescription is not necessary for OTC formulations of these products. Pharmacy professionals may receive inquiries on this matter and will play a key role in educating patients, caregivers, and the broader public on this issue.
Pharmacies can assist their patients during the ibuprofen and acetaminophen shortage by repackaging bulk stock bottles of acetaminophen and ibuprofen into smaller quantities. The NAPRA Drug Schedule lists immediate-release formulations of acetaminophen (including suppositories, tablets, capsules and liquid formulations) and ibuprofen, when sold in an immediate release dosage form containing 400mg or less per oral dosage unit (in pack sizes containing up to 18,000mg), as Unscheduled drug products.
In this situation, although a prescription or pharmacist intervention is not required for the sale of these products, pharmacy professionals repackaging bulk stock bottles of acetaminophen and ibuprofen into smaller quantities for sale should ensure that proper labelling is provided for dosing and safety.
Best Practices for Labelling of Repackaged Unscheduled Ibuprofen and Acetaminophen:
When dispensing repackaged medications, pharmacists are encouraged to use their professional judgement to ensure that relevant information is included on the repackaged container label, including but not limited to:
- The identification of the drug as to its chemical name (ex. Acetaminophen), its strength, and its manufacturer
- The product DIN
- The quantity of the drug provided
- General directions and instructions for use
- Drug lot number and expiry date
- Any applicable auxiliary labelling or precautions
Pharmacists should avoid bulk preparations of decanted liquid acetaminophen and ibuprofen products. Instead, repackaged products should be prepared on a case-by-case basis using the pharmacist’s professional judgement. Pharmacies that prepare these smaller quantities in bulk are strongly advised to not make them available for self-selection by the patient, as the repackaging of commercially available sizes to re-sell on a larger scale could be considered manufacturing and may be subject to federal oversight. Pharmacy professionals can refer to Health Canada’s Policy on Manufacturing and Compounding Drug Products in Canada for additional information.
Guidance for Managing the Ongoing Shortage
It has been communicated to OPA that the shortage of these products has been a result of increased public demand and not a result of supply chain issues. With high public levels of concern and high demand for these products likely to continue, pharmacies should consider communicating to all team members their location-specific information and guidance on the sales process and details for repackaged acetaminophen and ibuprofen products. This practice helps to ensure clarity and consistency for the public in accessing these products at individual pharmacies.
Consistent with recommendations made to pharmacy professionals on the handling of other drug shortages, pharmacists are encouraged to use their professional judgement in limiting the amount of medication that can be purchased by an individual to ensure equitable and fair access to these products..
As a reminder to pharmacy professionals, the typical doses for acetaminophen and ibuprofen in pediatric patients are weight-based and general dosing guidelines are available in reputable drug references such as CPS:
- Acetaminophen: 10–15 mg/kg Q4–6H PO/PR PRN for symptom management; maximum 75 mg/kg/day; do not exceed the adult dose.
- Ibuprofen: Children <6 months: 5 mg/kg Q8H PO PRN; maximum 40 mg/kg/day; Children >6 months: 5–10 mg/kg Q6–8H PO PRN for symptom management; maximum 40 mg/kg/day (do not exceed the adult dose)
In the event that all liquid preparations become unavailable, pharmacists are encouraged to use their professional judgement in recommending alternative therapies and options to patients. Some potential alternatives include:
- Chewable tablets
- Acetaminophen suppositories (suppositories are not available for ibuprofen).
- Cutting or crushing a regular tablet
- Compounding liquid formulations pursuant to all applicable regulations and standards
OPA will continue to provide updates to pharmacy professionals through our Professional Practice Bulletins and ad hoc Important Updates as required to ensure the timely and efficient delivery of information. OPA members may also access the Practice Support Network at [email protected] for any additional questions or concerns.