DEPARTMENT OF EDUCATION

Office of the Secretary

PROPOSED

Education Impact Analysis Pursuant To 14 Del.C. Section 122(d)

817 Medications and Treatments

A. Type of Regulatory Action Required

Amendment to Existing Regulation

B. Synopsis of Subject Matter of the Regulation

The Secretary of Education intends to amend 14 DE Admin. Code 817 Medications and Treatments. This regulation is amended to be in compliance with Senate Bill 246 as amended by Senate Amendment #1 of the 147th General Assembly. It clarifies what constitutes an emergency medication, who can administer that medication and whether it can be administered to a diagnosed or undiagnosed individual, and in what school setting.

Persons wishing to present their views regarding this matter may do so in writing by the close of business on or before January 5, 2015 to Tina Shockley, Education Associate, Department of Education, Regulatory Review, at 401 Federal Street, Suite 2, Dover, Delaware 19901. A copy of this regulation may be viewed online at the Register of Regulation’s website, http://regulations.delaware.gov/services/current_issue.shtml, or obtained at the Department of Education, Finance Office located at the address listed above.

C. Impact Criteria

1. Will the amended regulation help improve student achievement as measured against state achievement standards? The amended regulation is related to medications and treatments and is not specifically related to improving student achievement as measured against state achievement standards.

2. Will the amended regulation help ensure that all students receive an equitable education? The amended regulation is intended to continue to ensure all students receive an equitable education.

3. Will the amended regulation help to ensure that all students’ health and safety are adequately protected? The amendments address students’ health and safety in relation to the emergency medications for diagnosed medical conditions.

4. Will the amended regulation help to ensure that all students’ legal rights are respected? The amended regulation continues to ensure that all student’s legal rights are respected.

5. Will the amended regulation preserve the necessary authority and flexibility of decision making at the local board and school level? The amended regulations does not change the decision making at the local board and school level.

6. Will the amended regulation place unnecessary reporting or administrative requirements or mandates upon decision makers at the local board and school levels? The amended regulation does not place any unnecessary reporting or administrative requirements on decision makers.

7. Will the decision making authority and accountability for addressing the subject to be regulated be placed in the same entity? The decision making authority and accountability for addressing the subject to be regulated does not change because of the amendment.

8. Will the amended regulation be consistent with and not an impediment to the implementation of other state educational policies, in particular to state educational policies addressing achievement in the core academic subjects of mathematics, science, language arts and social studies? The amendment is consistent with and not an impediment to the implementation of other state educational policies.

9. Is there a less burdensome method for addressing the purpose of the regulation? There is not a less burdensome method for addressing the purpose of the regulation.

10. What is the cost to the State and to the local school boards of compliance with the regulation? There may be costs for school districts and charter schools for additional emergency medications. The Department of Education will need to reallocate resources for training.

817 Medications and Treatments

The purpose of this regulation is to provide guidance regarding the medications and treatments to be provided to students pursuant to current Delaware Code.

The following words and terms, when used in this regulation, shall have the following meaning unless the context clearly states otherwise:

“Approved School Activity” means a school-sponsored field trip or approved school activity outside of the traditional school day or off-campus.

“Assist(ance) with Self-Administration of Medication” means assisting a student in kindergarten through grade 12 in the self-administration of a medication taken orally, by inhalation, or applied topically, provided that the medication is in a properly labeled container. Assistance may include holding the medication container for the student, assisting with the opening of the container, and assisting the student in self-administering the medication. Assistance does not include making nursing judgments. Lay assistants shall not assist with injections. The one exception is with emergency medications where standard emergency procedures prevail in lifesaving circumstances for life-threatening symptoms of a diagnosed condition, and includes the administration of the medication based on the healthcare provider’s order and parent permission.

“Controlled Medication” means those prescribed drugs regulated by Federal (CSA of 1970) and/or State Controlled (dangerous) Substances Act.

“Current” means a medication or prescription that is not outdated or expired according to the date on the label. A current prescription is written for a specific time period, not to exceed one year.

“Dosage” or “Dose” means a specific amount of medication prescribed or directed to be taken at any one time.

“Educators” means teachers, administrators, and paraeducators employed by a school serving students in Pre-Kindergarten through Grade 12.

“Emergency Medication” means a medication necessary for response to a life-threatening allergic reaction.

“Emergency Medication for a Diagnosed Medical Condition” means a medication prescribed to treat a life-threatening symptom of a diagnosed medical condition.

“Emergency Medication Summary Sheet” means a document developed by the Department of Education and the Division of Public Health to report the use of Emergency Medication in the school setting.

"Field Trip" means any off campus, school sponsored activity.

“Licensed Health Care Healthcare Provider” means anyone lawfully authorized to prescribe medications and treatments.

"Medication" means a legal drug, which has been authorized for a student to use and includes both prescription and non-prescription drugs.

“Non-prescription Medication” means any over-the-counter medication that can be sold legally without a prescription.

“Other sSchool eEmployees” means coaches or persons hired or contracted by schools serving students in Kindergarten through Grade 12.

"Paraeducators" mean teaching assistants or aides in a school.

“Prescription Medication” means a legal drug that has a written order for an individual student by a licensed health care provider licensed to prescribe medication.

“School” means an educational facility serving students in kindergarten through grade 12 and any associated pre-kindergarten program in such facility.

“School Nurse” means a Registered Nurse licensed to practice in the State of Delaware, who is employed by a school district, charter school, or private school.

“Traditional School Day” means the hours within the days counted to meet the state minimum number of school days each year and summer school.

“Trained Assistant for Self-Administration” means an Educator or Other School Employee who has completed the training to assist a student with self-administration of medications. This person may render emergency care to any student, including injection, for life-threatening symptoms of a diagnosed condition based on the healthcare provider’s order and parent permission.

“Trained Person” means an Educator or Other School Employee who has completed the training to administer Emergency Medicine to diagnosed and undiagnosed students with symptoms of a life-threatening allergic reaction in the school setting.

13.1 Medications may be administered to a public school student by the School Nurse when a written request to administer the medication or treatment is on file from the parent, guardian or Relative Caregiver or the student if 18 years or older, or an unaccompanied homeless youth (as defined by 42 USC 11434a).

13.1.1 The School Nurse shall check the student health records and history for contraindications and all allergies, especially to the medications, and shall provide immediate medical attention if an allergic reaction is observed or make a referral if symptoms or conditions persist.

13.1.2 The School Nurse shall also document the student's name, the name of medication and treatment administered, the date and time it was administered and the dosage if medication was administered.

13.2 In addition to the requirements set forth in 2.1 below 3.1 above, in the case of a Prescription Medications, the requirements set forth below in 2.2.1 through 2.2.4 3.2.1 through 3.2.4 shall also apply.

13.2.1 Prescription medications shall be provided to the School in the original container and properly labeled with the student's name; the prescribing licensed health care provider's name; the name of the medication; the dosage; how and when it is to be administered; the name and phone number of the pharmacy and the current date of the prescription. The medication shall be in a container which meets United States Pharmacopoeia National Formulary standards.

13.2.2 Medications and dosages administered by the School Nurse shall be limited to those recommended by the Federal Drug Administration (FDA), peer review journal that indicates doses or guidelines that are both safe and effective, or guidelines that are specified in regional or national guidelines.

13.2.3 The prescription and the medication shall be current and long term prescriptions shall be re authorized reauthorized at least once a year.

13.2.4 All medications classified as controlled substances shall be counted and reconciled each month by the School Nurse and kept under double lock. Such medications should be transported to and from School by an adult.

13.3 Non-prescription Medication must be in an original container with full label and may be given by the School Nurse after the School Nurse assesses the complaint and the symptoms to determine if other interventions can be used before medication is administered.

Treatments, including specialized health procedures, shall be prescribed by a licensed health care provider with directions relative to administration or supervision.

45.0 IEP Team

For a student who requires significant medical or nursing interventions, the Individual Education Program (IEP) team shall include the School Nurse.

56.1 Educators and Other School Employees who are Trained Assistants for Self-Administration are authorized by 24 Del.C. §1921(a)(17) to assist a student with self-administration of mMedications on a field trip or approved school activity outside of the traditional school day or off-campus are at an Approved School Activity for students in kindergarten through Grade 12. The Trained Assistant for Self-Administration is subject to the following provisions:

56.1.1 Assistance with Self-Administration of mMedication shall not be provided without the prior written request or consent of a parent, guardian or Relative Caregiver, or the student if 18 years or older, or an unaccompanied homeless youth (as defined by 42 USC 11434a). Said written request or consent shall contain clear instructions including: the student's name; the name of the medication; the dose; the time(s) and date(s) of administration; and the method of administration. At least one copy of said written request or consent shall be in the possession of the person assisting a student with medication on a field trip or approved School activity outside of the traditional School day or off-campus.

56.1.1.1 Medications shall be prescribed by a licensed health care provider and are ones that cannot be rescheduled for times when a person, who may legally administer medication, is available.

56.1.1.1.1 Doses may be provided for up to one week, unless covering a Field Trip lasting longer than this time period, and shall be maintained in a secure location.

56.1.1.2 Prescription medications shall be provided to the School Nurse and shall be properly labeled with the student’s name; the licensed health care provider's name; the name of the medication; the dosage; how and when it is to be administered; the name and phone number of the pharmacy; and the current date of the prescription. The medication shall be in a container which meets United States Pharmacopoeia National Formulary standards.

56.1.1.2.1 Controlled medications must be stored on the person assisting or in a secure location under double lock. Maintaining doses for greater than one day is not permitted except in the case of an overnight activity.

56.1.1.3 Non-prescription medications shall be provided to the School Nurse by the parent in an original container along with a current, written directive from the student’s licensed health care provider and shall include the student’s name; the licensed health care provider's name; the name of the medication; the dosage; and how and when it is to be administered.

56.1.2 In order to be qualified to assist with provide Assistance with Self-Administration of mMedications, each such person shall complete a Board of Nursing approved training course developed by the Delaware Department of Education, pursuant to 24 Del.C. §1921(a)(17). Training shall be renewed minimally every five years. No person shall assist a student with provide Assistance with Self-Administration of mMedications without written acknowledgment that he/she has completed the course and that he/she understands the same, and will abide by the safe practices and procedures set forth therein. A School Nurse employed by the public or private district or charter in which the student is enrolled shall:

56.1.2.1 Complete instructor training as designated by the Department of Education and shall submit a list of educators and other school employees, who have completed the training, to the Department of Education.

56.1.2.2 Provide Oversee the training for eEducators and Other School Employees.

56.1.2.3 Coordinate the collection and review of the written parental consent.

56.1.2.4 Provide the appropriately labeled medication, copy of the consent, and directions on assistance to the trained educator or other school employee Trained Assistant for Self-Administration.

56.1.3 Each School district shall maintain a record of all students receiving aAssistance with Self-Administration of mMedications pursuant to this regulation. Said record shall contain the student's name; the name of the medication; the dose; the time of administration; the method of administration; and the name of the person assisting.

56.1.4 Except for a school nurse, no educator or other school employee shall be compelled to assist a student with medication. If a facility is otherwise required to have a school nurse, nothing contained here shall be interpreted to relieve the school of such obligation. The School Nurse may prepare a Trained Assistant for Self-Administration to render emergency care to a student, with a known, diagnosed condition, who is in pre-kindergarten through Grade 12 and shows life-threatening signs and symptoms of the condition at an Approved School Activity.

6.1.4.1 Response shall include immediate activation of emergency medical services.

6.1.4.2 Preparation shall include instruction in the provision of the student’s Emergency Medication for a Diagnosed Medical Condition, including injection, for symptoms related to the condition. Instruction will be based on the healthcare provider’s order and the manufacturer’s instructions for administration.

6.1.4.3 The Trained Assistant for Self-Administration shall annually demonstrate his/her ability to provide Emergency Medication for a Diagnosed Medical Condition.

6.1.4.4 An Emergency Medication for a Diagnosed Medical Condition shall be a current prescription provided by the student's licensed healthcare provider for a diagnosed medical condition that requires immediate medication to save or sustain life and is one which can be safely provided by a Trained Assistant for Self-Administration.

6.1.4.5 In addition to 6.1.3, the Trained Assistant for Self-Administration shall provide documentation related to the rendering of emergency care, to include at a minimum, the student’s symptoms, time of the incident, medication administered, other actions taken, and the response by emergency medical services.

7.1 School Nurses and Trained Persons are authorized by 16 Del.C. Ch. 30E to administer Emergency Medication Without an Order at School to a student in pre-K through grade 12, who is symptomatic of a life-threatening allergic reaction in the school building.

7.1.1 Public School Nurses shall follow the Division of Public Health’s medical emergency standing orders for allergic reactions and anaphylaxis in previously undiagnosed individuals.

7.1.2 Trained Persons shall follow the guidance issued by the Division of Public Health. on the administration of Emergency Medications without an order in the school setting to undiagnosed individuals.

7.2 The School, in consultation from the School Nurse, shall annually identify and train a sufficient number of Educators and Other School Employees to become Trained Persons.

7.2.1 An identified person cannot be compelled to become a Trained Person, unless training is a requirement of their position, hire, or contract.

7.2.2 The training shall be a program approved by the Department of Education and the Division of Public Health.

7.3 The School shall maintain current, stock Emergency Medication.

7.3.1 Emergency Medication shall be stored in a minimum of two secure and accessible locations in the school setting as identified by the School Nurse: one for the School Nurse and the other or the Trained Person.

7.4 The School shall maintain documentation of the use of Emergency Medication.

7.4.1 The Trained Person shall complete the Emergency Medication Administration by Trained Person Sheet on the day of the any administration and shall submit to the School Nurse.

7.5 The School Nurse shall submit the Emergency Medication Summary Sheet to the Department of Education and the Division of Public Health within 48 hours of the use of an Emergency Medication.

Except for a School Nurse, no Educator or Other School Employee shall be compelled to assist a student with medication or to administer emergency medication. If a facility is otherwise required to have a School Nurse, nothing contained here shall be interpreted to relieve the school of such obligation.

Nonregulatory note: 14 DE Admin. Code 612, Possession, Use and Distribution of Drugs and Alcohol addresses student self-administration of a prescribed asthmatic quick relief inhaler and student self-administration of prescribed autoinjectable epinephrine.

Nonregulatory note: 16 Del.C. §3007E provides liability protection for any Trained Person or School Nurse, who, in good faith and without expectation of compensation from the person aided or treated, administers Emergency Medication.