What is a compounded medication?
Pharmacy compounding is the science of preparing personalized medications for individual patients. Compounded medications are made based on a practitioner’s prescription in which individual ingredients are mixed together in the exact strength and dosage form required by the patient.
Do Compounded Medications Require Health Canada Approval?
The Health Canada Drug Manufacturers approval process is intended for mass-produced drugs made by large manufacturers only. Because compounded medications are personalized for individual patients, it is not possible for each formulation to go through Health Canada’s drug approval process, which takes years to complete and is prohibitively expensive, often costing hundreds of millions of dollars.
Physicians may prescribe an individually compounded medication for a patient with a non-standard health need. Compounding preparations are especially prevalent for:
• Children/infants who require drugs in liquid form or in strengths that aren’t commercially available e.g. anti-seizure medication.
• Patients who cannot take commercially prepared prescriptions due to allergies to the ingredients used, e.g. dyes or fillers such as lactose and gluten.
• Patients requiring a different formulation of a commercially available product, e.g. turning pills into a liquid or transdermal gel for people who cannot swallow pills due to disability.
• Patients requiring an individualized compounded formulation. This is often a topical preparation from a dermatologist.
• Patients who absorb or excrete medications abnormally, possibly due to malabsorption caused by conditions like Crohn’s Disease or radical surgery.
• Many types of bioidentical hormone replacement therapy.
Co-operators Policy Wording
Extemporaneous preparations or compound mixtures must contain at least one active prescription by law ingredient in a therapeutic concentration that is considered an eligible prescription drug under this provision.
No benefits are payable for the following extemporaneous preparations or compound mixtures:
• drug compounds used primarily for cosmetic purposes;
• compounded medications which are similar to a commercially available pre-manufactured drug.
We have seen a marginal increase in volumes but the overall incidence is low (less than 1% of overall drug claim volumes)
Patients should be aware that not all compounded medications will be covered. If they are unsure and concerned about potentially being out of pocket, they should be contacting the Co-operators with details of the ingredients/strengths to obtain confirmation.
They should also be aware that submitting thru their pay direct card is possible, however the pharmacist needs to contact the pharmacy benefit manager and obtain a special “pseudo DIN” or PIN which will facilitate the electronic submission. Due to the variations in coverage of compounds and the complexity of mixing the compound itself, these PINs are not universal among insurance carriers and pharmacy benefit managers.
In addition, not all pharmacies have resource capacities that allow the time to make that call and may request the patient pay out of pocket and submit manually.