What is the Prolia® Safety Program?
Practice Fusion has partnered with Amgen Inc. (Amgen) to help providers report adverse events of special interest (AESIs) for patients who are taking or have taken Prolia®. Your participation in the Prolia® Safety Program can help us monitor the long-term safety of patients on Prolia®.
Providers with patients taking Prolia® or who have previously taken Prolia® will be presented with the opportunity to record the AESIs described below that these patients may have experienced. Practice Fusion will provide aggregate information on the Prolia® Safety Program to Amgen, the manufacturer of Prolia®, to help them understand certain adverse events associated with this medication.
Providers may also voluntarily report adverse events and additional details directly to Amgen on the manufacturer’s website using the reporting links provided in the Prolia® Safety Program questionnaire in the Practice Fusion EHR. Amgen will report information submitted to them to the Food and Drug Administration (FDA) as required by applicable law. For the purposes of this program, providers may report on the following AESIs:
- Hypocalcemia - Hypocalcemia was the primary reason for ER visit or hospitalization
- Osteonecrosis of the jaw - Exposed jaw bone did not heal in 8 weeks and there was no history of jaw radiation
- Atypical femoral fractures - Low trauma femur fracture occurring between lesser trochanter and epicondyles
- Serious infections - Infection required IV antibiotics or was primary reason for ER visit or hospitalization
- Serious dermatologic reactions - Skin condition was the primary reason for ER visit or hospitalization
What are the benefits of reporting adverse events?
To help keep safe and effective medications on the market, the FDA and drug manufacturers rely on healthcare professionals to voluntarily report on adverse events in patients who are taking or who have previously taken certain medications. By fully participating in the Prolia® Safety Program, you are helping health care providers and patients have access to information that be can be used to inform future health care decisions and potentially prompt treatment improvements. While there is no immediate benefit to participants, you are making important contributions to public health through your participation in the Prolia® Safety Program. For additional information on reporting adverse events or other product problems (e.g. product quality problems, product use errors, and/or therapeutic failure) to the FDA, visit the FDA’s external website.
How do I report adverse events for patients on Prolia®?
notifications to record and report AESIs
When documenting Prolia® in a patient’s medication list, you’ll be prompted to participate in the Prolia® Safety Program by selecting the patient’s Prolia® history from the drop-down menu.
If you have indicated that Prolia® is a past and/or current medication (the patient is currently on it or has been on it within the last 16 months), you’ll be presented with a Prolia® Safety Program questionnaire to document whether the patient has experienced any AESIs. If you have indicated that the patient has experienced at least one of the listed events, you may follow the link at the bottom of the window to report the adverse events to the manufacturer. Note: To report other adverse events or product problems not listed in the questionnaire, please contact Amgen at 800-772-6436.
If you are unable to report additional information regarding the applicable adverse events to Amgen at that time, click Save and create task to report later to continue your workflow. A Medication Safety task will be generated in your Tasks list as a reminder to report this information to Amgen at a later time.
If a patient has an active record of Prolia® treatment in the prior 16 months and you have not completed a questionnaire for the patient in the prior six months, you will also be presented with the Safety Program questionnaire upon opening the patient’s encounter. Follow the workflow outlined above to record and report AESIs.
A clinical decision support (CDS) notification will also display at the top of the patient’s encounter. Click Record within the notification to document the patient’s Prolia® history. If you have indicated that Prolia® is a past and/or current medication, you’ll be asked to record the patient’s AESIs and report the events to Amgen through the questionnaire or at a later time via the Tasks section. Note: If you have reported the patient’s Prolia® history and whether or not they have experienced AESIs, you will not be prompted to participate via the encounter notification or CDS notification for another six months.
and report adverse events of special interest as needed
In addition to recording AESIs via the proactive notifications, you can record AESIs directly from a patient’s medication list on the Summary tab or within an encounter. Select Record adverse events for Prolia® safety below the Prolia® entry to begin completing the questionnaire.
events to Amgen on your own time
If you have documented that a patient experienced one or more AESIs but selected to report this information to the manufacturer at a later time, you can do so from the Tasks list. Filter by Medication safety tasks and select Report to navigate to Amgen’s Prolia® Safety Program website. Once you have reported the AESIs at Amgen’s Prolia® Safety Program website, click the down arrow and select Mark as complete. Please note that these tasks expire after 30 days.