Pharmacy laws and practices vary from state to state, particularly when it comes to managing interchangeable biosimilars.
In Arizona, if the medical provider who prescribes the biologic does not indicate an intent to prevent substitution, then substitution would be allowed by the dispensing pharmacist.
“Interchangeable biological product” means a biological product that either:
• The FDA has licensed and determined meets the safety standards for determining interchangeability; or
• Is determined to be therapeutically equivalent as set forth in the latest edition of the supplement to the FDA’s approved drug products with therapeutic equivalence evaluations.
A pharmacist in Arizona may substitute a biological product for a prescribed biological product only if all of the following conditions are met:
- The FDA has determined the substituted product to be an interchangeable biological product.
- The prescribing physician does not indicate that substitution is prohibited.
- The pharmacy informs the patient or person presenting the prescription of the substitution in advance.
Within five (5) business days after dispensing a biological product, the dispensing pharmacist:
- Makes an entry of the specific product provided, including the name of the product and the manufacturer
- The communication shall be conveyed by making an entry that is electronically accessible to the prescriber through:
• Electronic medical records system
• An electronic prescribing technology
• Pharmacy benefit management system
• Pharmacy record
• Via fax, telephone, electronic transmission or other prevailing means - The pharmacy retains a record of the biological product dispensed.
The Purple Book
With “biosimilars” being on a roll and a wave of biosimilar products arriving into the US market constantly, it is important to know where and how to access reliable information to aid in the decision making when prescribing the right biosimilar. For example, this year alone the U.S. market will potentially see as many as 10 adalimumab biosimilars (Humira).
The FDA has a searchable online database called the Purple Book, which is a dedicated list of licensed biological products, biosimilar and interchangeable biological products, licensed and approved by the FDA under the Public Health Service Act.
