What is the Onsolis Communication Plan?
The company that makes Onsolis, BioDelivery Sciences International, Inc. (BDSI), will execute a communication plan to healthcare providers. This includes letters to prescribers telling them about Onsolis and about the FOCUS Program. Elements to Assure Safe Use: The FOCUS Program includes safe use conditions described below to manage the risks of Onsolis. The program is directed to prescribers, patients, distributors, and pharmacies. The FOCUS Program database maintains an enrollment list and the status of enrollees (i.e., active or inactive). Prescriber enrollment will include mandatory review of the educational material and enrollment renewal on a periodic basis. Prescribers are required to review the information in the prescribing information and to: Ensure appropriate patient selection, including that the patient is opioid tolerant Provide the Medication Guide for patient review Complete the FOCUS Program prescriber enrollment form (including prescriber knowledge assessment); sign a
