| 17 September 2020
| By Tom Pasquariello, PharmD, BCPS, BCMAS, PMSP, PRS
Veradigm, along with the World Health Organization, is excited to celebrate World Patient Safety Day on September 17, 2020. The primary objectives of World Patient Safety Day are to “enhance global understanding of patient safety, increase public engagement in the safety of health care and promote global actions to enhance patient safety and reduce patient harm.” With the ongoing COVID-19 pandemic, patient safety continues to be a top priority across the globe.
One example of how Veradigm promotes safety is through the support of FDA Risk Evaluation and Mitigation Strategy (REMS) programs. REMS are drug safety programs that “focus on preventing, monitoring and/or managing a specific serious risk by informing, educating and/or reinforcing actions to reduce the frequency and/or severity of the event.” The Food and Drug Administration Amendments Act of 2007 (FDAAA) gave the Food and Drug Administration (FDA) the authority to require a REMS from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks.
One specific REMS medication stands out to me since I personally used it. It is an acne medication that has strict requirements for patients because of the potential for severe adverse events in all patients, especially pregnant women. In addition to restricted distribution to patients, prescribers and pharmacists must both be registered and activated with the program. Each REMS medication—there are 59 currently approved—has different requirements for physician, pharmacist, and patient.
One of the major pain points seen with all REMS is obtaining specific program enrollment consent. AccelRx™, Veradigm’s automated and comprehensive solution that helps streamline specialty medication fulfillment for patients, helps facilitate REMS consent capture electronically. The REMS consent feature of AccelRx™ captures patient consent electronically from desktop or mobile applications. Capturing electronic consent is built into the workflow to allow for proper documentation to help increase the speed with which patients receive their medications.
REMS programs are a dynamic tool to help increase awareness and communication about severe patient safety events. In the spirit of World Patient Safety Day, it is our goal at Veradigm® to continually identify strategies and develop solutions to aid our clinicians in providing safe, high-quality care for their patients.