The FDA requires pharmaceutical manufacturers to create risk evaluation and mitigation strategies (REMS) for medications with known or potential serious risks. In some of these cases, these companies are required to establish a process to verify patient compliance with protocol, referred to as Elements to Assure Safe Use ( ETASU ).
MedTrigger provides a comprehensive ETASU program that reminds patients to comply with all events required by their risk management plan (e.g. lab tests, doctors appointments, medication injections) and reports their level of compliance. It provides a comprehensive, 360 view of each patient's compliance across different tasks.
Keeps patients compliant with their RiskMAP protocol
MedTrigger delivers treatment messages to patients and reminds them to comply with their protocol's requirements at the relevant times in their refill cycle. For example, if a patient is required to get blood tests before a prescription can be refilled, MedTrigger can send a series of reminder messages ( e.g., two weeks, one week and if necessary two days) before the refill date. Patients receive the messages in the modality that best suits their lifestyle (phone, email, SMS, iPhone calendar ).
With each reminder, patients are asked to confirm they will be getting the required blood tests prior to the refill. MedTrigger also features interactive questioning of patients who indicate they will not follow the protocol, to determine their barriers to adherence.
Reduces Health Care Provider (HCP) Workload
By automating delivery and tracking of patient communications, HCPs can be assured that their patients have received the REMS-required health information. Since the messages are automated, HCPs can more easily participate in REMS programs without adding to their staff's burden.
Message text is completely customizable and may vary by location, stage of treatment, a milestone event, etc. Messages are tailored to patients' literacy levels and are delivered in English or their preferred language. Patients who do not speak English get the messages in their native language, even languages that do not use Roman Characters ( Russian, Hebrew, Chinese, etc. ).
Reduces pharmacy workload
MedTrigger reduces time-consuming patient tracking and refill delays. It helps patients stay compliant with their protocol requirements, enabling pharmacies to avoid multiple patient re-checks and delayed refills. If a patient indicates that he does not plan on meeting his scheduled requirements, the pharmacy has time to intervene.
Coordinates care among patients, HCPs and pharmacies
HCPs and pharmacies are alerted if patients indicate that they are not planning to maintain their RiskMAP health events. MedTrigger allows the HCP, pharmacy and patient to view the patient's refill schedule, calendar of scheduled health events and historical log. Monthly reports regarding each patient's status are sent to HCPs and the patient's pharmacy.
Monitoring success at the brand team level
Brand teams have access to an online dashboard where they can view which HCPs and pharmacies are participating, and de-identified patient compliance scores.
Auditable tracking of all patient communications and responses
MedTrigger tracks whether patients have received their educational and instructional communications and identifies those who are not following the protocol.
Contact iReminder to learn more about how MedTrigger.can support your REMS programs.
Recommendations for Designing Efficient REMS ETASU Programs
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