Right Drug Dose Now Act
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.
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.
[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6875 Introduced in House (IH)]
<DOC>
117th CONGRESS
2d Session
H. R. 6875
To update the National Action Plan for Adverse Drug Event Prevention to
provide educational information on adverse drug events and
pharmacogenomic testing, to improve electronic health records for
pharmacogenomic information, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
February 28, 2022
Mr. Swalwell (for himself and Mr. Emmer) introduced the following bill;
which was referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To update the National Action Plan for Adverse Drug Event Prevention to
provide educational information on adverse drug events and
pharmacogenomic testing, to improve electronic health records for
pharmacogenomic information, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Right Drug Dose Now Act''.
SEC. 2. TABLE OF CONTENTS.
The table of contents of this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. National Action Plan for Adverse Drug Event Prevention.
Sec. 4. Adverse drug event and pharmacogenomic testing awareness.
Sec. 5. Improving EHR systems to improve the use of pharmacogenomic
information.
Sec. 6. Increased authorization for pharmacogenomics implementation
research.
Sec. 7. Definition.
SEC. 3. NATIONAL ACTION PLAN FOR ADVERSE DRUG EVENT PREVENTION.
The Secretary of Health and Human Services shall--
(1) not later than 180 days after the date of enactment of
this Act, in coordination with the heads of other relevant
Federal departments and agencies including the Director of the
National Human Genome Research Institute, and in consultation
with the Director of the Eunice Kennedy Shriver National
Institute of Child Health and Human Development, the Director
of the National Center for Biotechnology Information, and the
Director of the National Library of Medicine, submit a report
to the Congress on--
(A) the implementation of the National Action Plan
for Adverse Drug Event Prevention of the Department of
Health and Human Services; and
(B) the progress in meeting the target approved by
the Federal Interagency Steering Committee for Adverse
Drug Events for a 10-percent reduction for--
(i) the rate of adverse drug events from
anticoagulants among United States inpatient
stays;
(ii) the rate of adverse drug events from
hypoglycemic agents among United States
inpatient stays;
(iii) the rate of adverse drug events from
opioid analgesics among United States inpatient
stays;
(iv) the rate of visits to United States
hospital emergency departments for adverse drug
events associated with injury from oral
anticoagulants;
(v) the rate of visits to United States
hospital emergency departments for adverse drug
events associated with injury from insulin; and
(vi) the rate of visits to United States
hospital emergency departments for adverse drug
events associated with therapeutic use of
opioid analgesics;
(2) convene the Federal Interagency Steering Committee for
Adverse Drug Events to update the National Action Plan for
Adverse Drug Event Prevention; and
(3) require such Committee, in updating the National Action
Plan for Adverse Drug Event Prevention--
(A) to consider advances in scientific
understanding and technology pertaining to drug-gene-
drug interactions, clinical outcomes, health care
utilization, and the decreasing cost of genetic
testing;
(B) to assess the role of pharmacogenetics testing
combined with clinical decision support as an evidence-
based prevention tool; and
(C) to evaluate operating characteristics for
Federal adverse drug event surveillance systems and
expand capabilities to identify genetic associations in
adverse events.
SEC. 4. ADVERSE DRUG EVENT AND PHARMACOGENOMIC TESTING AWARENESS.
Part P of title III of the Public Health Service Act (42 U.S.C.
280g et seq.) is amended by adding at the end the following:
``SEC. 399V-7. ADVERSE DRUG EVENT AND PHARMACOGENOMIC TESTING
AWARENESS.
``(a) Public Education Campaign.--
``(1) In general.--The Secretary, acting through the
Director of the National Human Genome Research Institute, in
consultation with the Director of the Eunice Kennedy Shriver
National Institute of Child Health and Human Development, the
Director of the National Center for Biotechnology Information,
and the Director of the National Library of Medicine, shall
conduct a national evidence-based education campaign to
increase the public's awareness regarding--
``(A) the prevalence of adverse drug events and
adverse drug reactions;
``(B) specific risk factors that increase an
individual's likelihood of experiencing an adverse drug
event or adverse drug reaction;
``(C) basic information about pharmacogenomic
testing and how its use, including incorporation in
comprehensive medication management, may prevent
adverse drug reactions in certain clinical situations;
``(D) the role of health care providers in
performing pharmacogenomic testing, interpreting the
results of such testing, and adjusting medications
based on such results;
``(E) the availability of pharmacogenomic testing;
``(F) comprehensive medication management; and
``(G) how the benefits of an individual's
pharmacogenomic test results might change or be
relevant over time.
``(2) Consideration of advice of stakeholder experts.--The
education campaign under paragraph (1) shall take into
consideration the advice of stakeholder expects, such as those
specializing in medical genetics and pharmacogenetics and
collaborative communities focused on pharmacogenomics.
``(3) Media campaign.--In conducting the education campaign
under paragraph (1), the Secretary, after considering the
advice of stakeholder experts pursuant to paragraph (2), may
award grants or contracts to entities to establish national
multimedia campaigns that may include advertising through
television, radio, print media, billboards, posters, all forms
of existing and especially emerging social networking media,
other Internet media, and any other medium determined
appropriate by the Secretary.
``(4) Rural regions, health professional shortage areas,
and underserved communities.--The Secretary shall ensure that
the education campaign under paragraph (1)--
``(A) reaches rural and medically underserved
communities (as defined in section 799); and
``(B) includes the involvement of community health
centers, community pharmacies, and other local health
clinics.
``(b) Health Care Professional Education Campaign.--
``(1) In general.--The Secretary, acting through the
Director of the National Human Genome Research Institute, in
consultation with the Director of the Eunice Kennedy Shriver
National Institute of Child Health and Human Development, the
Director of the National Center for Biotechnology Information,
the Director of the National Library of Medicine, and the
Administrator of the Health Resources and Services
Administration, shall establish a national health education
program for health care providers and health care leaders,
including administrators, pharmacists, nurse practitioners,
physicians' assistants, physician medical geneticists,
laboratory medical geneticists, genetic counselors, medical
educators, and the faculty of schools of medicine and other
schools of health professions, on the following:
``(A) Pharmacogenomic testing and the extent of its
ability to prevent adverse drug reactions.
``(B) Pharmacogenomic testing, drug interaction
alerting systems, when to refer to or consult with a
genetics provider, and the standards of care for
patients who are suspected or known to have a genetic
variant that is known to impact drug metabolism.
``(C) 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
appropriate.
``(D) The role of medical professionals who
specialize in genetics and genomics.
``(E) How to incorporate pharmacogenomics into
comprehensive medication management.
``(2) Grants.--
``(A) Award.--In carrying out the national health
education program under this subsection, the Secretary,
acting through the Director of the National Human
Genome Research Institute, may award grants to
nonprofit organizations to carry out educational
activities with respect to the topics listed in
subparagraphs (A) through (D) of paragraph (1).
``(B) Use of funds.--A grant under subparagraph (A)
may be used to support one or more of the following
activities:
``(i) Increasing the knowledge and
awareness of health care providers and health
care leaders about pharmacogenomic testing and
drug interactions.
``(ii) Increasing the number of health
professional schools that incorporate
pharmacogenomic curricula in classroom
instruction.
``(iii) Increasing the ability of health
care providers to note and respond to the
impact of gender, ethnicity, age, and other
relevant characteristics on drug metabolism.
``(iv) Developing principles, practices,
and curriculum instruction that prepare
medical, nursing, pharmacy, and other health
professions students to effectively apply
knowledge and skills needed to recognize--
``(I) when a patient is eligible
for pharmacogenomic testing, including
as part of comprehensive medication
management when appropriate, and in
accordance with the patient's health
care team, a drug product's label, and
professional clinical guidelines; and
``(II) how to appropriately use the
test results to adjust a prescription
or otherwise change a patient's health
care plan.
``(v) Providing opportunities for
practicing health care professionals to receive
pharmacogenomics training and education through
a variety of modalities including in-person,
electronic media, professional meetings and
conferences, and social media.
``(c) Reporting.--At least every three years, the Secretary, acting
through the Director of the National Human Genome Research Institute,
in consultation with the Director of the Eunice Kennedy Shriver
National Institute of Child Health and Human Development, the Director
of the National Center for Biotechnology Information, the Director of
the National Library of Medicine, the Administrator of the Centers for
Medicare & Medicaid Services, and relevant stakeholders with expertise
in developing quality measures of label and peer-reviewed professional
guidelines on drug-gene interactions, shall publish data on--
``(1) the public's awareness regarding adverse drug events
and pharmacogenomic testing;
``(2) the number or percentage of individuals utilizing
information to inform their health care decisions regarding
prescription medications and pharmacogenomic testing;
``(3) the change in the number or percentage of individuals
enrolled in a prescription drug plan under part D of the title
XVIII of the Social Security Act receiving a pharmacogenetic
test, as recommended in alignment with a drug product's label
or peer-reviewed professional guidelines; and
``(4) the number or percentage of changes, beginning one
year after the date of enactment of this section, in medication
management as a result of incorporating information from
pharmacogenomic testing.
``(d) Definitions.--In this section:
``(1) Adverse drug event.--The term `adverse drug event'
means an injury resulting from any medical intervention with a
drug.
``(2) Adverse drug reaction.--The term `adverse drug
reaction' means a response to a drug that--
``(A) is noxious and unintended; and
``(B) occurs at doses normally used in humans for
prophylaxis, diagnosis, or therapy of disease or for
the modification of physiologic function.
``(e) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated $50,000,000 for each of fiscal
years 2022 through 2027.''.
SEC. 5. IMPROVING EHR SYSTEMS TO IMPROVE THE USE OF PHARMACOGENOMIC
INFORMATION.
(a) Certification Criteria.--The Secretary of Health and Human
Services (in this section referred to as the ``Secretary'') shall adopt
pursuant to subtitle A of title XXX of the Public Health Service Act
(42 U.S.C. 300jj-11 et seq.) certification criteria for health
information technology, including for electronic prescribing systems
and real-time pharmacy benefit checks, such that before a medication
order is completed and acted upon during computerized provider order
entry, interventions must automatically indicate to a user--
(1) when pharmacogenomic testing is appropriate based on a
drug product's label or peer-reviewed professional guidelines;
and
(2) drug-gene and drug-drug-gene associations, established
by a drug product's label or peer-reviewed professional
guidelines, based on a patient's medication list, medication
allergy list, and results from pharmacogenomic testing.
(b) Reporting and Association of Adverse Drug Events.--The
Secretary, in consultation with the Commissioner of Food and Drugs,
shall carry out a program to improve the reporting of adverse drug
events and the association, if any, of such events to a patient's
genetic status. As part of the program, the Secretary shall issue
regulations pursuant to the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.) and other applicable statutory authorities to--
(1) ensure that drug-gene interaction alerting systems are
continuously updated to incorporate information from new or
updated drug labels with pharmacogenomic information and newly
established peer-reviewed professional guidelines on drug-gene
associations;
(2) facilitate the reporting of adverse drug events to the
FDA Adverse Event Reporting System directly through the use of
the health care provider's electronic health record system; and
(3) allow for the reporting of whether an adverse drug
event is caused by pharmacogenetic interactions to the FDA
Adverse Event Reporting System directly through the use of the
health care provider's electronic health record system.
(c) Updating FAERS; Patient-Friendly Reporting.--The Secretary,
acting through the Commissioner of Food and Drugs, shall--
(1) update the FDA Adverse Event Reporting System,
including to--
(A) accept information directly from health care
providers' electronic health record systems;
(B) improve the collection of real world evidence
(as defined in section 505F of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355g)); and
(C) create a selection tool that allows individuals
to report whether an adverse drug event is associated
with a drug-gene interaction;
(2) work with relevant Federal agencies and offices, and
stakeholders, to create patient-friendly electronic options for
reporting adverse drug events such as submission through a
designated mobile device application or mobile device messaging
application; and
(3) not later than 1 year after the date of enactment of
this Act, report to the Congress on the progress made in
implementing paragraphs (1) and (2).
(d) Assessment on Additional Improvements to Electronic Health
Record Systems.--
(1) In general.--Not later than 180 days after the date of
enactment of this Act, the Secretary shall--
(A) complete an assessment on additional
improvements to electronic health record systems that
are needed to further the development of real world
evidence (as defined in section 505F of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355g)) in
pharmacogenomics; and
(B) submit a report to the Congress on the findings
on the assessment.
(2) Consideration of needed advancements.--As part of the
assessment under paragraph (1), the Secretary shall consider
what advancements are needed to capture information about the
laboratory and the test used as part of pharmacogenomic
testing.
SEC. 6. INCREASED AUTHORIZATION FOR PHARMACOGENOMICS IMPLEMENTATION
RESEARCH.
There is authorized to be appropriated to the National Institutes
of Health $7,000,000 for each of fiscal years 2022 through 2025 for the
conduct, support, and maintenance of pharmacogenomics implementation
research through the Genomic Community Resources program.
SEC. 7. DEFINITIONS.
In this Act:
(1) The term ``adverse drug event'' means an injury
resulting from any medical intervention with a drug.
(2) The term ``comprehensive medication management'' means
medication management pursuant to a standard of care that
ensures each patient's medications are individually assessed to
determine that each medication is appropriate for the patient,
effective for the medical condition, and safe given the
comorbidities and other medications being taken and able to be
taken by the patient as intended.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Llama 3.2 · runs locally in your browser
Ask anything about this bill. The AI reads the full text to answer.
Enter to send · Shift+Enter for new line