This bill sets out requirements and activities to address adverse drug events, including using pharmacogenomic testing to prevent them. (Pharmacogenomic testing uses a patient's genetic information to help determine the safety, efficacy, and dosage of medications for treatments.)
Specifically, the Department of Health and Human Services (HHS) must report to Congress about the implementation of a national plan to prevent adverse drug events. Additionally, HHS must coordinate with relevant federal agencies on the report and convene a steering committee to update the plan.
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HHS must also (1) require, as a condition of certification, that health information technologies automatically indicate when pharmacogenomic testing is appropriate before a medication order is completed; and (2) assess electronic health records to identify improvements necessary for developing the capacity for collecting real-world evidence in pharmacogenomics.
Furthermore, HHS must consult with the Food and Drug Administration (FDA) to carry out a program to improve reporting of adverse drug events and their association with a patient's genetic status. In addition, the FDA must issue regulations and make other administrative changes to update adverse drug event reporting processes, including to facilitate the acceptance of information directly from electronic health records.
The bill also requires the National Human Genomics Research Institute, which is part of the National Institutes of Health, to (1) carry out a public awareness campaign on adverse drug events, and (2) establish a program to educate health care providers and related professionals about pharmacogenomic testing and associated issues.
No related bills are listed in this snapshot. This does not establish whether the proposal has appeared in earlier Congresses.
Source last updated: Jan 3, 2025. Consult Congress.gov for the current record.
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