Adjusting medications containing controlled substances due to drug shortages

ACP is aware of growing shortage of multiple controlled substances, including oxycodone/acetaminophen 5/325 mg (brand name Percocet®). Pharmacy teams have inquired whether pharmacists can adjust medications containing controlled substances. Regulations under the Controlled Drugs and Substances Act (CDSA) authorize pharmacists to sell or provide a controlled substance to a person if they have received a prescription or a written order from a practitioner. Based on consultations with National Association of Pharmacy Regulatory Authorities (NAPRA) and Health Canada, ACP reminds pharmacy teams that the following factors must be considered when navigating controlled substance shortages:

• Per Health Canada’s guidance document Prescription management by pharmacists with controlled substances under the CDSA and its regulations, pharmacists are permitted to adjust the formulation, dose, and regimen of a controlled substance that has been prescribed to a patient, as long as the quantity dispensed does not exceed the amount originally authorized.

• The total units dispensed must not exceed the quantity originally prescribed. While the guidance from Health Canada uses the terms “quantity” and “amount,” this refers to the total dosage (i.e., mg) that cannot be exceeded.

• Assess the patient to consider whether a change in dosage form/formulation is appropriate. Pharmacy teams continue to regularly assess and monitor patients using opioid medications to determine the therapy is indicated, effective, and safe, and that the patient is willing and able to use the therapy. These assessments must also be completed when considering change in dosage form/formulation. For example, changing the formulation to a controlled- or sustained-release formulation of oxycodone 5 mg would not be appropriate for a patient using the oxycodone/acetaminophen 5/325 mg for breakthrough pain as oxycodone 5 mg in the oxycodone/acetaminophen 5/325 mg is an immediate release formulation.

• Collaborate and communicate with other healthcare professionals in the patient’s circle of care. The original prescriber may have prescribed the combination acetaminophen-oxycodone formulation due to potential adherence concerns. Notifying the original prescriber of the change in formulation enables the pharmacist to discuss the therapy and obtain a new prescription for a different therapy if appropriate.

• The pharmacist must explain to the patient that a different product is being dispensed due to a shortage and clarify that the dose remains the same. The pharmacist must also ensure the patient understands any resulting changes to the directions for administering the drug.
• The pharmacist must assess and counsel the patient about the potential increased risk of opioid and acetaminophen toxicity, especially with multiple acetaminophen-containing products and other opioid drugs that the patient may be taking.
• The pharmacist must clearly note in pharmacy records that a substitution was made due to a shortage.
• For additional clarity, as the CDSA is specific to the substance, the pharmacist would NOT be authorized to change from one substance to another (e.g., change from oxycodone to hydromorphone) under the CDSA and regulations.