,i #aaith ,,congress #ast ,session ,h4 ,r4 #bdga ,,in ,,the ,,house ,,of ,,representatives ,march #bg1 #bjbe,mr4 ,swalwell 7for himself and ,mr4 ,crenshaw7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to update the ,national ,action ,plan for ,adverse ,drug ,event ,prevention to consider advances in pharmacogenomic research and testing1 to improve electronic health records for pharmacogenomic information1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,right ,drug ,dose ,now ,act of #bjbe4 #b4 ,table of contents ,the table of contents of this ,act is as follows3 ,sec4 #a4 ,short title4 ,sec4 #b4 ,table of contents4 ,sec4 #c4 ,national ,action ,plan for ,adverse ,drug ,event ,prevention4 ,sec4 #d4 ,adverse drug event and pharmacogenomic testing education for health care professionals4 ,sec4 #e4 ,improving ,,ehr systems to improve the use of pharmacogenomic information4 #c4 ,national ,action ,plan for ,adverse ,drug ,event ,prevention ,the ,secretary of ,health and ,human ,services 7in this ,act referred to as the ,secretary7 shall-- 7#a7 not later than #ahj days after the date of enactment of this ,act1 in coordination with the heads of other relevant ,federal departments and agencies1 submit a report to the ,congress on the implementation of the ,national ,action ,plan for ,adverse ,drug ,event ,prevention of the ,department of ,health and ,human ,services1 including on the progress in meeting the target outcomes approved by the ,federal ,interagency ,steering ,committee for ,adverse ,drug ,events2 7#b7 convene the ,federal ,interagency ,steering ,committee for ,adverse ,drug ,events to update the ,national ,action ,plan for ,adverse ,drug ,event ,prevention2 and 7#c7 require such ,committee1 in updating the ,national ,action ,plan for ,adverse ,drug ,event ,prevention-- 7,a7 to consider advances in scientific understanding and technology pertaining to drug-gene interactions 7including interactions among multiple drugs and genes71 clinical outcomes1 health care utilization1 and the decreasing cost of genetic testing2 7,b7 to assess the role of pharmacogenetics testing combined with clinical decision support as an evidence-based prevention tool2 and 7,c7 to evaluate operating characteristics for ,federal adverse drug event monitoring systems and expand capabilities to identify genetic associations in adverse events4 #d4 ,adverse drug event and pharmacogenomic testing education for health care professionals ,the ,secretary shall issue guidance for health care providers and health care leaders1 including administrators1 primary and specialty care physicians1 pharmacists1 nurse practitioners1 physician assistants1 physician medical geneticists1 laboratory medical geneticists1 genetic counselors1 medical educators1 and the faculty of schools of medicine and other schools of health professions1 on the following3 7#a7 ,pharmacogenomic testing and the extent of its ability to prevent adverse drug reactions4 7#b7 ,pharmacogenomic testing1 drug interaction alerting systems1 when to refer to or consult with a genetics provider1 and the applicable ,federal standards of care for patients who are suspected or known to have a genetic variant that is known to impact drug metabolism or adverse reactions4 7#c7 ,evidence-based information that would encourage individuals and their health care professionals to consider pharmacogenomic testing as part of their health care plan to the extent appropriate4 7#d7 ,the role of medical professionals who specialize in genetics and genomics4 7#e7 ,how to incorporate pharmacogenomics into comprehensive medication management4 7#f7 ,the importance of reporting information about known and relevant pharmacogenomic information when reporting adverse drug events to the ,,fda ,adverse ,event ,reporting ,system4 #e4 ,improving ,,ehr systems to improve the use of pharmacogenomic information 7a7 ,certification criteria ,the ,secretary shall provide guidance for health care providers and health care leaders1 including administrators1 primary and specialty care physicians1 pharmacists1 nurse practitioners1 physician assistants1 physician medical geneticists1 laboratory medical geneticists1 genetic counselors1 medical educators1 and the faculty of schools of medicine and other schools of health professions1 on health information technologies1 including for electronic prescribing systems and real-time pharmacy benefit checks1 regarding how1 before a medication order is completed and acted upon during computerized provider order entry1 interventions might automatically indicate to a user-- 7#a7 when pharmacogenomic testing is appropriate based on a drug product's label or peer-reviewed professional guidelines2 and 7#b7 drug-gene and drug-drug-gene associations1 established by a drug product's label or peer-reviewed professional guidelines1 based on a patient's medication list1 medication allergy list1 and results from pharmacogenomic testing4 7b7 ,guidance on drug-,gene interaction alerting systems 7#a7 ,issuance and updates ,the ,secretary shall-- 7,a7 issue routine guidance on drug-gene interaction alerting systems in electronic health records2 and 7,b7 not less than biannually1 update such guidance to incorporate pharmacogenomic information from-- 7i7 new or updated drug labels2 and 7ii7 newly established peer-reviewed professional guidelines on drug-gene associations4 7#b7 ,rule of construction ,nothing in paragraph 7#a7 shall be construed as prohibiting an entity from updating the results of pharmacogenomic testing1 or alerting the provider1 if a medication is contraindicated by the results of pharmacogenomic testing4 7c7 ,reducing adverse drug events reporting burdens ,the ,secretary shall encourage the development of electronic health record systems that allow for adverse drug event information to be directly reported to the ,,fda ,adverse ,event ,reporting ,system4 7d7 ,updating ,,faers2 patient-,friendly reporting ,the ,secretary shall-- 7#a7 update the ,,fda ,adverse ,event ,reporting ,system1 including to-- 7,a7 create an optional selection tool that allows individuals to report whether an adverse drug event is associated with a drug-gene or drug-drug-gene interaction2 and 7,b7 accept information directly from health care providers' electronic health record systems2 7#b7 work with relevant ,federal agencies and offices1 and stakeholders1 to create patient-friendly electronic options for reporting adverse drug events such as submission through an optional designated mobile device application or mobile device messaging application2 and 7#c7 not later than #a year after the date of enactment of this ,act1 report to the ,congress on the progress made in implementing paragraphs 7#a7 and 7#b74 7e7 ,,gao study and recommendations on inclusion of information on drug-,gene interactions on drug labels ,not later than #ahj days after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall-- 7#a7 study1 and formulate recommendations on1 how the ,food and ,drug ,administration can include and update information on drug-gene interactions on drug labels2 and 7#b7 submit recommendations to the relevant committees of jurisdiction4 7f7 ,report on additional improvements to electronic health record systems 7#a7 ,in general ,not later than #ahj days after the date of enactment of this ,act1 the ,secretary shall-- 7,a7 complete a report on additional improvements to electronic health record systems that are needed to further the development of real world evidence 7as defined in section #eje;,f of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;g77 in pharmacogenomics2 and 7,b7 submit such report to the ,congress4 7#b7 ,consideration of needed advancements ,as part of the report under paragraph 7#a71 the ,secretary shall consider what advancements are needed in electronic health record systems to capture information about the laboratory and the test used as part of pharmacogenomic testing4