Advocating for Improved Care Guidelines

Advocating for Improved Care Guidelines

Citizen Petition

Citizen Petition to the US Food and Drug Administration (FDA) requesting the addition of pre-screening and dose adjustment practices to the drug labels for fluorouracil and capecitabine. The FDA accepted the petition for review in November 2020. See the petition and offer your support here.

Petition to the Colorectal Cancer Panel of the National Comprehensive Cancer Network (NCCN)

The petition asks this panel to revise treatment guidelines, that set the standard of care in the US, to include pre-screening and dose adjustment practices to the drug labels for fluorouracil and capecitabine. The panel will review the petition in August and September of 2021.
You may read the petition here.

Collaboration

Collaboration

#FourthCause:

The American Society of Pharmacovigilance (ASP) officially announced the establishment of March 24th as National Adverse Drug Event Awareness Day, in a coordinated effort to help spark a national discussion over the ongoing tragedy and staggering healthcare costs directly related to adverse drug events (ADE), the fourth leading cause of death in the US. As part of its ongoing mission, ASP also launched a national awareness campaign to encourage victims of ADEs to share their stories and begin building community support, while urging healthcare professionals and organizations to talk about how they can champion medication safety.

AUDT is proud to participate in the #FourthCause initiative by sharing stories of our loved ones lost due to the lack of upfront DPD/DPYD testing prior to starting 5-FU or capecitabine. Our individual stories can be viewed here.

AUDT will support the National Adverse Drug Event Awareness Day annually on March 24th by encouraging our members to create public awareness in their local communities through the media and through family and friend participation in events such as walks or runs. Details to follow.

STRIPE – Standardizing Laboratory Practices in Pharmacogenomics:

We are proud to participate in the ASP’s STRIPE initiative. It is a ​​ continuing forum where public and private sector members work together to achieve common objectives and leverage collective opportunities to accelerate the development of precision medicine practices as a standard of care. With the standardization of pharmacogenomics testing as a goal, it will result in accurate and reliable information about a patient’s medication and drug-gene interactions. This standardization will ultimately have a direct effect on reducing the number of deaths from 5-FU and capecitabine.

For more information on these two initiatives, please visit the ASP website: https://www.stopadr.org/stripe

Legislation

Legislation

NJ Assembly Bill A986:

Requires physician to offer to test patients for dihydropyrimidine Dehydrogenase deficiency prior to undergoing chemotherapy

NJ Senate Bill S179:

Requires physician to offer to test patients for dihydropyrimidine Dehydrogenase deficiency prior to undergoing chemotherapy

NY Senate Bill S1462

Relates to dihydropyrimidine dehydrogenase deficiency testing