Adapting Prescriptions for Controlled Drug Substances During Drug Shortages

Adapting Prescriptions for Controlled Drug Substances During Drug Shortages

Health Canada has recently provided clarification on the federal regulatory provisions applicable to pharmacists adjusting medications containing controlled substances in light of drug shortages.

According to Health Canada, dispensing the constituent components oxycodone and acetaminophen when the combination product (for example, oxycodone/acetaminophen 5 mg/325 mg, brand name Percocet®) has been prescribed would not be considered “substitution”. Instead, this activity is considered a change in dosage form/formulation as per Health Canada’s guidance document Prescription management by pharmacists with controlled substances under the Controlled Drugs and Substances Act and its regulations.

What this means in British Columbia

In accordance with the College’s Professional Practice Policy 58 – Adapting a Prescription (PPP-58), Section 13, a pharmacist may change the dose, formulation, and/or regimen of a prescription for a narcotic, controlled drug, or targeted substance only if all principles and requirements in PPP-58 are met. This includes, but is not limited to:

• The quantity dispensed does not exceed the amount originally authorized in the prescription, and
• The change meets one of the criteria outlined in PPP-58 (e.g., strength not commercially available)

Therefore, in shortage situations, adapting oxycodone/acetaminophen into separate oxycodone and acetaminophen products may be permitted if the requirements in PPP-58 are met.

Use professional judgement and ensure appropriateness

Pharmacists must determine that any adaptation is appropriate and in the best interest of the client, must obtain informed consent, and must ensure complete and sufficient documentation. 

Consider the following examples of potential risks, noting that other client-specific risks may also apply: 

• Dispensing single-entity narcotics may increase the risk of diversion or misuse.
• The prescriber may have selected the combination product for specific therapeutic reasons.
• Upon contact, the prescriber may prefer to change therapy rather than dispense the single-entity components.

Pharmacists should communicate with the prescriber where appropriate, and document the rationale for any adaptation in accordance with PPP-58 and other applicable legislation.