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Clinical and Research Tools
ShowCardiovascular and Metabolism
ShowThis tool is only available on desktop devices.
This tool is only available on tablet and desktop devices.
The CardioVascular Health Endpoints and Real-world data Tutorial (CV-HEART) tool is a web-based eLearning application developed to enhance your understanding of clinical research and real-world evidence pertaining to anticoagulation treatment and to provide important points to consider when interpreting study design, endpoints, and methodologies. This application provides a didactic overview of three chapters: Chapter 1 discusses study design for anticoagulation treatment; Chapter 2 discusses common endpoints used in clinical studies of anticoagulation treatment; and lastly Chapter 3 discusses some methodological considerations in clinical studies. The module concludes with a checklist, which can be used as a reference when evaluating published clinical studies.
This tool is only available on desktop devices.
This tool is only available on tablet and desktop devices.
The Health Outcomes Research Tutorial Tool for Type 2 diabetes (HORTT T2DM) is a web-based eLearning application developed to enhance your understanding of clinical research in T2DM and to provide important points to consider when interpreting study design, endpoints, and methodologies. This application provides a didactic overview of three chapters: Chapter 1 discusses study design in T2DM; Chapter 2 discusses common endpoints used in clinical studies of T2DM; and lastly Chapter 3 discusses some methodological considerations in clinical studies. The module concludes with a checklist, which can be used as a reference while evaluating published clinical studies.
Neuroscience
ShowThis tool is only available on desktop devices.
This tool is only available on tablet and desktop devices.
The Autism Behavior Inventory (ABI), is a 62-item caregiver report developed for assessing changes in core and associated symptoms of autism spectrum disorder (ASD). It is designed to capture the behavior of individuals with ASD, aged three to adult, that have occurred over the past week. It is a web or paper based tool which assesses behavior across five domains (two ASD core domains: social communication, restrictive and repetitive behaviors; three associated domains: mental health, self-regulation, and challenging behavior). The paper version of the ABI is available for download and use, subject to conditions.
This tool is only available on desktop devices.
This tool is only available on tablet and desktop devices.
The Autism Behavior Inventory Short Form (ABI-S), is a 24-item caregiver report developed for assessing changes in core and associated symptoms of autism spectrum disorder (ASD). It is designed to capture the behavior of individuals with ASD, aged three to adult, that have occurred over the past week. It is a web or paper based tool which assesses behavior across five domains (two ASD core domains: social communication, restrictive and repetitive behaviors; three associated domains: mental health, self-regulation, and challenging behavior). The ABI-S takes less time to complete than the full ABI and may be used for more frequent assessments. The paper version of the ABI-S is available for download and use, subject to conditions.
This tool is only available on desktop devices.
This tool is only available on tablet and desktop devices.
The Schizophrenia Health Outcomes Research Tutorial Tool (SHORTT) is a web-based eLearning application developed to enhance your understanding of clinical research in schizophrenia and to provide important points to consider when interpreting study design, endpoints, and methodologies. This application provides a didactic overview of three chapters: Chapter 1 discusses study design in schizophrenia; Chapter 2 discusses common endpoints used in clinical studies of schizophrenia; and lastly Chapter 3 discusses some methodological considerations in clinical studies. The module concludes with a checklist, which can be used as a reference while evaluating published clinical studies.
Population Health Tools
ShowImmunology
ShowThis tool is only available on desktop devices.
This tool is only available on tablet and desktop devices.
Inflammatory Bowel Disease Population Analyzer Tool for Health Systems (IBD PATH) is a Symantec Code Signing Certificate software that can be used to identify gaps in care between recognized best practices and practice patterns in IBD populations. The tool is designed to conduct retrospective analyses of claims (medical and pharmacy) and/or electronic health record (EHR) data. The intended use is to provide population health decision makers with insights to inform population health analysis about their patient populations diagnosed with IBD in order to identify potential population-level gaps in care for further assessment. Patient-level data is provided solely to facilitate deeper analysis of the population trends at the patient and physician levels. The data is not appropriate to use to share with physicians or patients for any purposes.
Cardiovascular and Metabolism
ShowThis tool is only available on desktop devices.
This tool is only available on tablet and desktop devices.
The Risk Stratification Tool (RST) is a user-friendly Symantec Code Signing Certificate software to identify opportunities to develop interventions that identify patients based on their risk level and promote quality improvement. RST is designed to conduct retrospective analyses of claims (medical and pharmacy) and/or electronic health record (EHR) data.
RST may identify:
- Chronic coronary artery disease/peripheral artery disease patients that are associated with a higher risk of cardiovascular death, myocardial infarction, or stroke
- Atrial fibrillation patients with a higher risk of bleeding and/or stroke risk
- Pulmonary embolism patients with a higher mortality risk or low risk for adverse clinical outcomes for treatment as an outpatient
- The risk of developing a venous thromboembolism (VTE) in patients who are hospitalized and have risk factors for developing VTE (eg acute medical inpatients or medically ill)
RST generates customized population level reports with the functionality to provide patient and provider level insights to help facilitate quality improvement initiatives and functionality to enable continued monitoring for the effectiveness of these initiatives. RST will also provide additional descriptive and actionable measures at the patient, provider, and organization levels that are potentially meaningful to pharmacy, medical, and quality improvement directors.
This tool is only available on desktop devices.
This tool is only available on tablet and desktop devices.
The Anticoagulation Quality Improvement Analyzer (AQuIA), previously called AQUIA integrated, is a Symantec Code Signing Certificate software that can be used to identify gaps in care between recognized anticoagulation guidelines and practice patterns in a population. The tool is designed to conduct retrospective analyses of claims (medical and pharmacy) and/or electronic health record (EHR) data. The purpose of the tool is to assist your organization’s evaluation of current practice patterns, resource utilization, and quality measure attainment over time. In addition to customized population level data, this analyzer has the functionality to provide patient and provider level measures to identify opportunities to for the organization to develop interventions that promote quality improvement, increased treatment of at risk patients, and potentially decrease health care resource utilization. The user-friendly interface will also provide additional descriptive and actionable measures at the patient, provider, and organization levels that are potentially meaningful to pharmacy, medical, and quality improvement directors.
Neuroscience
ShowThis tool is only available on desktop devices.
This tool is only available on tablet and desktop devices.
The Assessment for Quality Improvement and Risk Evaluation program assists customers in identifying opportunities to improve treatment for patients with schizophrenia. Using actual client data, this tool provides a quick look into adherence rates, hospitalizations, and likelihood of future non-adherence and hospitalizations.
More information on the Assessment for Quality Improvement and Risk Evaluation (QI-RE) Tool [PDF] and QI-RE Data Preparation Guide [PDF].
REMS Tools
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Bosentan REMS Program
The Bosentan REMS Program is a single shared REMS program for brand and generic approved bosentan medications for the treatment of pulmonary arterial hypertension (PAH). Due to the risks of hepatotoxicity and embryo-fetal toxicity, bosentan is only available through the Bosentan REMS Program.
Due to the risks of hepatotoxicity and embryo-fetal toxicity, bosentan is only available through a single shared system required and approved by the Food and Drug Administration (FDA), called the Bosentan REMS Program. The Bosentan REMS Program is a shared program including all brand and generic bosentan products.
The goal of the Bosentan Risk Evaluation and Mitigation Strategy (REMS) Program is to mitigate the risk of hepatotoxicity and embryo-fetal toxicity associated with bosentan by:
- Ensuring prescribers are educated on the following:
- the risks of hepatotoxicity and embryo-fetal toxicity
- Ensuring prescribers are educated on and adhere to the following:
- counseling patients about these risks and the need for monthly monitoring
- enrolling patients in the Bosentan REMS Program
- monitoring patients at baseline and monthly
- Ensuring that pharmacies are educated on the following:
- the risks of hepatotoxicity and embryo-fetal toxicity
- Ensuring that pharmacies are educated on and adhere to the following:
- confirming that the appropriate patient monitoring and counseling has occurred before dispensing bosentan
- Ensuring that patients are informed about:
- the risks of hepatotoxicity and embryo-fetal toxicity
- appropriate baseline and monthly patient monitoring
- appropriate contraception
Access comprehensive information on Risk Evaluation and Mitigation Strategies for Bosentan. https://www.bosentanremsprogram.com
CARVYKTI™ REMS
The goal of the CARVYKTI™ REMS is to mitigate the risks of cytokine release syndrome (CRS) and neurological toxicities by:
- Ensuring that Hospitals and their Associated Clinics that dispense CARVYKTI™ are specially certified and have on-site, immediate access to tocilizumab.
- Ensuring those who prescribe, dispense, or administer CARVYKTI™ are aware of how to manage the risks of CRS and neurological toxicities.
Access comprehensive information on Risk Evaluation and Mitigation Strategies for CARVYKTI™. https://carvyktirems.com
Opioid REMS
A Risk Evaluation and Mitigation Strategy (REMS) is a program to manage known or potential serious risks associated with a drug product and is required by the Food and Drug Administration (FDA) to ensure that the benefits of a drug outweigh its risks.
The FDA has required a REMS for opioid analgesics. Details and resources can be found at: www.opioidanalgesicrems.com
Under the conditions specified in this REMS, providers of opioid analgesics and HCPs that provide care to patients and their caregivers are strongly encouraged to do all of the following:
- Educate Yourself - Complete an FDA REMS-compliant accredited continuing education (CE) program offered by an accredited provider of CE for your discipline.
- Counsel Your Patients - Discuss the safe use, serious risks, storage, and disposal of opioid analgesics with patients and/or their caregivers every time you prescribe these medicines.
- Emphasize Patient and Caregiver Understanding of the Medication Guide - Stress to patients and their caregivers the importance of reading the Medication Guide that they will receive from their pharmacist every time an opioid is dispensed to them.
- Consider Using Other Tools - In addition to the Patient Counseling Guide, there are other publicly available tools to improve patient, household and community safety, including Patient-Provider Agreement (PPA) and risk assessment instruments.
OPSUMIT® REMS
The Opsumit® REMS is for females only. Male patients are not required to enroll in the Opsumit® REMS.
The goal of the Opsumit® REMS is to mitigate the risk of embryo-fetal toxicity associated with Opsumit by:
- Ensuring prescribers are educated on the following:
- the risks of embryo-fetal toxicity
- Ensuring prescribers are educated on and adhere to the following:
- counseling patients about these risks and the need for monthly monitoring
- enrolling patients in the Opsumit® REMS
- monitoring patients at baseline and monthly
- Ensuring that pharmacies are educated on the following:
- the risks of embryo-fetal toxicity
- Ensuring that pharmacies are educated on and adhere to the following:
- confirming that the appropriate patient monitoring and counseling has occurred before dispensing Opsumit®
- Ensuring that patients are informed about:
- the risks of embryo-fetal toxicity
- appropriate baseline and monthly patient monitoring
- appropriate contraception
Access comprehensive information on the Risk Evaluation and Mitigation Strategy for OPSUMIT®. https://www.opsumitrems.com/
SPRAVATO® REMS
The goal of the REMS is to mitigate the risks of serious adverse outcomes resulting from sedation and dissociation caused by SPRAVATO® administration, and abuse and misuse of SPRAVATO® by:
- Ensuring that SPRAVATO® is only dispensed to and administered in medically supervised healthcare setting that provides patient monitoring.
- Ensuring that pharmacies and healthcare settings that dispense SPRAVATO® are certified.
- Ensuring that each patient is informed about serious adverse outcomes from dissociation and sedation and need for monitoring.
- Enrollment of all patients in the REMS (registry) to further characterize the risks and support safe use.
SPRAVATO® is intended for patient administration under the direct observation of a healthcare provider, and patients are required to be monitored by a healthcare provider for at least 2 hours. SPRAVATO® must never be dispensed directly to a patient for home use.
Details and resources can be found at: www.SPRAVATOrems.com
TECVAYLI™ REMS
The purpose of the TECVAYLI™ REMS is to mitigate the risks of cytokine release syndrome (CRS) and neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity (ICANS) by educating prescribers on the importance of monitoring patients for signs and symptoms of CRS and neurologic toxicity, including ICANS.
Access comprehensive information on Risk Evaluation and Mitigation Strategies for: https://www.tecvaylirems.com/
