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Session of 2026
HOUSE BILL No. 2695
By Representative Howe
2-4
AN ACT concerning health and healthcare; relating to children receiving
medical assistance; enacting the enhanced oversight and accountability
for the prescription of psychotropic drug act; enhancing oversight of
psychotropic drug prescriptions for children receiving medical
assistance; requiring the department of health and environment to
establish an adverse drug reaction online reporting system.
WHEREAS, In 2023, KanCare statistics showed that 37,372 children
and adolescents from ages 0-17 were prescribed psychotropic drugs,
including 2,784 aged 0-5; and
WHEREAS, The administration of most psychotropic drugs to children
aged 0-5 is prescribed off-label, meaning that the drugs are being
prescribed for an age group that is not approved by the United States food
and drug administration (FDA); and
WHEREAS, Psychotropic drugs, including stimulants, antidepressants,
antipsychotics and other behavioral drugs, are being prescribed to children
receiving medical assistance and are documented by the FDA to include
severe side effects, including but not limited to, addiction, suicidal
ideation, aggression, hallucinations, cardiovascular events, stunted growth
and developmental concerns; and
WHEREAS, Parents and caregivers are frequently not informed of the
risks posed by the off-label prescription of psychotropic drugs documented
by the FDA, including the pediatric risks; and
WHEREAS, 21 C.F.R. § 208.20 establishes a requirement for FDA
medication guides to provide nontechnical, understandable information
about the potential risks and side effects of prescription drugs to the
average consumer, including parents and caregivers. According to 21
C.F.R. § 208.20, medication guides must detail the particular and
significant public health concern that created the need for a medication
guide, note any pediatric risks, include the risk of patients developing a
dependence on the drug, use a font no smaller than 10-point and not be
promotional in tone or content; and
WHEREAS, To effectively monitor the effects of psychotropic drugs
prescribed to children and adolescents, particularly those drugs cited by
the FDA for having pediatric risks, parents and caregivers must be given a
hard copy of the FDA medication guide for the psychotropic drug
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prescribed; and
WHEREAS, The state's medical assistance program is a state and
federally funded program that provides essential healthcare services to
vulnerable populations, including children and adolescents. It should be
required to distribute the FDA medication guides to ensure patients and
their guardians are fully informed of the risks and potential side effects of
psychotropic drugs, thereby supporting informed consent and promoting
patient safety; and
WHEREAS, A reliable system for parents and caregivers to report
adverse drug reactions to psychotropic drugs is essential to help state
medical assistance program agencies and legislators monitor and assess the
frequency, severity and impact of such reactions within the public sector;
and
WHEREAS, The absence of an accessible reporting mechanism for
psychotropic drug side effects funded by a medical assistance program
limits the ability to identify and address these risks effectively,
compromising the safety of children and adolescents; and
WHEREAS, The state's medical assistance program is the primary
payer for psychotropic drugs prescribed to children and adolescents in the
public sector, including for off-label use in children, making it directly
responsible for ensuring the safety and monitoring of these prescriptions;
and
WHEREAS, Adverse drug reactions to psychotropic drugs can have
significant physical, psychological and developmental impacts on children,
requiring timely identification and response to mitigate harm; and
WHEREAS, The establishment of an online adverse drug reactions
reporting system would enable the state medical assistance program to
fulfill its duty of care by providing a mechanism to collect critical safety
data, support evidence-based decision making and comply with its
responsibility to protect public health; and
WHEREAS, Funding this reporting system aligns with the state
medical assistance program's obligations under federal law to monitor and
improve the quality of care to its beneficiaries, especially vulnerable
pediatric patients, and would facilitate oversight and accountability for the
use of public funds in prescribing psychotropic drugs; and
WHEREAS, The Kansas legislature establishes the following
provisions to enhance oversight, informed consent and accountability for
the prescription of psychotropic drugs to children receiving medical
assistance.
Now, therefore:
Be it enacted by the Legislature of the State of Kansas:
Section 1. Sections 1 through 6, and amendments thereto, shall be
known and may be cited as the enhanced oversight and accountability for
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the prescription of psychotropic drug act.
Sec. 2. As used in this act:
(a) "Adverse drug reaction" means any unintended harmful reaction
of a psychotropic drug.
(b) "Child" means an individual under 18 years of age.
(c) "Medication guide" means a handout produced by the United
States food and drug administration that accompanies certain prescription
medications with significant safety concerns and are used to inform
patients and caregivers about risks, side effects and proper usage.
(d) "Medical assistance" means the same as defined in K.S.A. 39-702,
and amendments thereto.
(e) "Parent" includes a parent or guardian and every person who is by
law liable to maintain, care for or support the child.
(f) "Prescriber" means the same as defined in K.S.A. 65-1626, and
amendments thereto.
(g) "Psychotropic drugs" mean medications that affect the mind,
emotions or behavior, including, but not limited to, stimulants,
antidepressants, antipsychotics or other behavioral drugs authorized or
funded under the state medical assistance program.
(h) "Online reporting system" means a web-based platform through
which a child receiving medical assistance or such child's parent can report
an adverse drug reaction related to psychotropic drug use.
Sec. 3. (a) Before prescribing or administering a psychotropic drug to
a child receiving medical assistance, a prescriber shall provide any
medication guide for such drug to such child's parent.
(b) Medication guides shall be provided to a parent in writing and
reviewed with the parent to make them aware of:
(1) Potential side effects identified by the United States food and drug
administration, as well as cautionary monitoring citations;
(2) any United States food and drug administration black box
warning that details serious or life-threatening risks; and
(3) pediatric-specific side effects or warnings relating to children and
adolescents.
(c) Before prescribing or administering a psychotropic drug, written
informed consent shall be obtained from a parent. Such written informed
consent shall be:
(1) Signed by a parent, confirming that they have received and
reviewed the medication guide and understand the associated risks of the
medication that is being prescribed; and
(2) kept on file by the prescriber, with a copy provided to the parent
or legal guardian.
Sec. 4. (a) The secretary of health and environment shall develop and
maintain a secure online reporting system for adverse drug reactions
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related to psychotropic drugs prescribed to children. The reporting system
shall include, at minimum, the following fields:
(1) Name of the patient;
(2) age of the patient;
(3) class of the prescribed psychotropic drug;
(4) name of the prescribed psychotropic drug;
(5) type of adverse reaction, including, but not limited to:
(A) Physical reactions, such as gastrointestinal issues, neurological
issues, cardiovascular symptoms, endocrine or metabolic effects or allergic
reactions;
(B) physiological reactions, such as mood changes, increased anxiety,
hallucinations or delusions, agitation or restlessness or suicidal thoughts;
and
(C) behavioral reactions, such as sleep disturbances, increased
aggression, mania, cognitive impairments, self-harm or disassociation;
(6) severity level of such reaction, to be measured as either mild,
moderate or severe; and
(7) name of the person reporting the reaction, such person's relation
to the patient and the phone number and email address of the person
reporting the reaction.
(b) (1) Documents or other information reported or maintained by the
secretary pursuant to subsection (a) shall be confidential and privileged
and shall not be subject to disclosure under the open records act, K.S.A.
45-215, et seq., and amendments thereto.
(2) The provisions of this subsection shall expire on July 1, 2031,
unless the legislature reviews and reenacts this provision pursuant to
K.S.A. 45-229, and amendments thereto, prior to July 1, 2031.
(c) On and after the first day of the legislative session of 2027, the
secretary of health and environment shall compile and submit quarterly
reports that summarize the adverse drug reaction data related to
psychotropic drugs prescribed to children and adolescents and submit such
reports to the senate standing committee on ways and means, the house of
representatives standing committee on appropriations, the house of
representatives standing committee on social services budget and the
Robert G. Bethell joint committee on home and community-based services
and KanCare oversight. Such reports shall include:
(1) The overall number of adverse drug reactions reported and
categorized by age;
(2) the total number of adverse reactions categorized by severity
level; and
(3) a breakdown of adverse drug reactions by adverse drug reaction
category, detailing the number of incidents for each category.
(d) Any information submitted to committees shall be disaggregated
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by age, gender and race and shall not include any personally identifiable
information. Such legislative committees shall review such reports and
may recommend actions to improve the safety of prescribing psychotropic
drugs.
(e) The secretary of health and environment shall allocate moneys to
establish and maintain the adverse drug reaction online reporting system
and may seek additional moneys as needed.
Sec. 5. On and after the first day of the legislative session of 2027,
the secretary of health and environment shall submit annual reports to the
senate standing committee on ways and means, the house of
representatives standing committee on appropriations, the house of
representatives standing committee on social services budget and the
Robert G. Bethell joint committee on home and community-based services
and KanCare oversight summarizing implementation efforts, compliance
statistics and the impact of sections 1 through 4, and amendments thereto,
including fiscal analysis and health outcomes.
Sec. 6. This act shall take effect and be in force from and after its
publication in the statute book.
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