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].

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.
   

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

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:

1. Ensuring prescribers are educated on the following:
   • the risks of embryo-fetal toxicity
2. 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
3. Ensuring that pharmacies are educated on the following:
   • the risks of embryo-fetal toxicity
4. Ensuring that pharmacies are educated on and adhere to the following:
   • confirming that the appropriate patient monitoring and counseling has occurred before dispensing Opsumit
5. 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/

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