- There are two types of substitution: same common name, or therapeutic.
- A “do not substitute” note may be set aside for the same common name, with the patient’s consent.
- Substitution is always recorded in the file.
What is the difference between the two types?
Substitution by common name replaces the drug with another of the same name, such as a generic or a biosimilar. Therapeutic substitution replaces the drug with a different one, in certain circumstances, through a new prescription signed by the pharmacist.
Can they override a “do not substitute” note?
If the patient’s situation requires it, and with their consent, the pharmacist may make a same-name substitution despite this note. They must first establish that the clinical issues behind the note are absent. If in doubt, they contact the prescriber.
When is therapeutic substitution possible?
- A supply shortage, after reasonable efforts to obtain the drug.
- A market withdrawal or announced shortage, no earlier than three months before the planned date for a withdrawal.
- An administration problem, for example a drug that cannot be crushed for a person with dysphagia.
- An adverse effect or risk of one, if the prescriber cannot be reached in time.
- A drug not on a health institution’s formulary.
- A drug not covered that the patient cannot afford: it may be replaced by a drug on the RAMQ’s general list.
What must the pharmacist do afterwards?
- Tell the patient and record the substitution in the file, with its circumstances.
- Inform the prescriber or follow-up professional if they judge it relevant. The guide gives the example of adverse effects.
- Ensure follow-up, and refer the patient if the situation worsens.
What about designated substances?
The pharmacist may substitute, in their own name, a designated substance prescribed by a practitioner with another designated substance. However, a drug that is not a designated substance cannot be replaced by a designated substance, according to the guide.
Sources: OPQ, summary of what is new (in French) · OPQ, practice guide on professional activities (in French) · OPQ, practice guide on professional activities (in French) · OPQ, practice guide on professional activities (in French)
General information based on the publications cited. This text does not replace professional or legal advice, or the Ordre’s guides.