Florida Regulations 65E-9.014: Medication Administration and Use of Psychotropic Medication
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(1) The provider shall develop, implement and maintain written policies and procedures governing the administration of medication and the supervision of and assistance with self-administered medication. These policies and procedures shall include, but not be limited to, management of the medication administration program, training, inventory control, accounting, and disposal of medications. In addition, these policies and procedures shall be consistent with the Comprehensive Drug Abuse Prevention and Control Act of 1970, 21 U.S.C.; Florida Statutes Chapter 893, the Drug Abuse and Prevention and Control Act; DEA compliance policy guidelines on disposal of controlled substances, C.F.R. 21, Title 21, Section 1307.21, Disposal of Controlled Substances, and related department rules and regulations.
(2) Children shall never be permitted to have medication in their possession or to take any medication without direct supervision of an authorized person.
(3) Psychotropic medication shall not be used as a substitute for treatment, for the convenience of staff, or in quantities that interfere with the child’s treatment progress.
(4) The use of psychotropic medication shall be described in the child’s treatment plan and shall include the desired goals and outcomes of the medication.
(5) Informed consent for the administration of psychotropic medication.
(a) Informed consent from the parents or legal guardian of any child must be obtained by the provider, in accordance with Florida Statutes § 394.459, when the dosage of current approved medications are changed and when the type of medication is changed.
(b) The requirements for obtaining express and informed consent for a child in the care and custody of the state are governed by Florida Statutes § 39.407
(6) If the circumstances requiring the administration of the medication constitute an emergency, such administration shall be governed by the provisions of Section 743.064 or 394.463(2)(f), F.S., as applicable.
(7) There shall be no pro re nata (PRN) orders for psychotropic medications.
(8) There shall be no standing orders for psychotropic medications.
(9) Children receiving antipsychotic medications shall be assessed for abnormal involuntary movements by a physician or registered nurse using a recognized standardized rating scale upon admission and quarterly thereafter.
(10) Refills for medications shall be ordered only by a physician or nurse licensed in the state of Florida. Prescriptions shall be timely refilled to prevent missed dosages.
(11) Administration of medication by unlicensed staff.
(a) For therapeutic group homes or residential treatment centers with 12 beds or less, where services are rendered in a smaller home-like setting, unlicensed staff employed by the facility, who have satisfactorily completed a competency-based training for administration of unit dose medication, shall administer prescribed prepackaged, pre-measured, oral medications, prescribed topical, otic, nasal and ophthalmic medications in accordance with Florida Statutes § 464.022(1)
(b) Medications requiring subcutaneous or intra-muscular administration and rectal and vaginal suppository medications will be administered, at a minimum, by a Florida licensed nurse.
(c) The medication administration course used to train unlicensed staff shall be eight hours, at a minimum, in length and must meet the following criteria:
1. The course must consist of at least the following topics:
a. Basic knowledge and skills necessary for safe and accurate medication administration and charting.
b. Roles of the physician, nurse, pharmacist, and direct care staff in medication ordering, dispensing, and administration.
c. Procedures for recording/charting medications.
d. Interpretation of common abbreviations used in administration and charting of medications.
e. Knowledge of facility medication system.
f. Safety precautions used in medication administration and charting.
g. Methods and techniques of medication administration.
h. Problems and intervention in the administration of medication.
i. Observation and reporting of medication side effects and adverse effects.
j. Observation and reporting of effects of medications including outcomes of psychotropic medication treatment.
k. Documenting and reporting of medication errors.
l. Appropriate storage of medications.
2. The content must be taught by a Florida licensed physician, consulting pharmacist, physician assistant, advanced registered nurse practitioner, or registered nurse.
3. Training must be competency-based and shall consist of lecture and a clinical practicum. This training shall be documented and such documentation filed in the staff member’s personnel file.
4. During the practicum, the trainee must be observed twice administering medications error free during their regularly scheduled medication time. The observation must include error free charting completed by the trainee after the medication(s) has been administered. The practicum observations must be made by a Florida licensed physician, consulting pharmacist, physician assistant, advanced registered nurse practitioner, or registered nurse.
5. Training regarding the administration of prescribed topical, otic, nasal and ophthalmic medications will only be completed by unlicensed staff authorized to do so following competency-based training and observation of proficiency by a licensed practitioner.
6. Monitoring of medication administration shall be performed, at a minimum, quarterly by the supervising registered nurse for each facility. In addition, a Florida registered nurse must be available to facility staff via telephone or paging device 24 hours per day.
7. At a minimum, four (4) hours of continuing education is required on an annual basis.
8. When a psychotropic medication is initiated, a registered nurse or pharmacist will assure or make provisions for the instruction of the facility staff regarding side effects and adverse effects of the prescribed medication, including when to notify the physician if undesirable side effects or adverse effects are observed.
9. All staff identified to receive training in medication administration must be high school graduates or have passed an equivalency exam (GED).
(12) Self administration of medication.
(a) For therapeutic group homes or residential treatment centers with 12 beds or less unlicensed staff employed by the facility, who have satisfactorily completed competency-based training in administering medication and supervising children with self administration of unit dose medication, shall be authorized to supervise with self administration of prescription and over-the-counter medications.
(b) Only children who have been assessed by a physician and determined to be capable of self-administering their medications shall be permitted to do so under the supervision of an authorized person. Documentation of such assessment and determination shall be filed in the child’s medical records.
(c) Staff involved with supervising and assisting with the self-administration of medications shall complete competency-based training of a minimum of four hours annually by a registered nurse or licensed pharmacist. This training shall be documented and filed in the staff member’s personnel file.
(d) The course shall consist of at least the following topics:
1. Basic knowledge and skills necessary for providing supervision for self-administration of medication;
2. Understanding a prescription label;
3. Procedures for recording/charting medications in the medication log;
4. Interpretation of common abbreviations used in administration and charting of medications;
5. Observation and reporting of side effects, adverse effects and outcomes of psychotropic medication treatment; and
6. Recognizing, documenting and reporting of medication errors.
(e) Upon completion of the course, the trainee shall be able to demonstrate the ability to:
1. Measure liquid medications, break scored tablets, and crush tablets in accordance with prescription directions;
2. Recognize the need to obtain clarification of an “”as needed”” prescription order;
3. Recognize a medication order which requires judgment or discretion, and advise the child, child’s health care provider or facility employer of the inability to assist in the administration of such orders;
4. Complete a medication observation record;
5. Retrieve and store medication; and
6. Recognize the general signs of adverse reactions to medications and report such reactions.
(13) Storage of medications.
(a) All drugs, including nonprescription drugs, shall be stored under double lock (e.g., a locked cabinet within a locked room or in a locked container within a locked cabinet).
(b) External and internal medications and ophthalmic preparations shall be stored separately from each other.
(c) Each child’s medications shall be stored separately from each other.
(d) Poisons and other toxic chemicals shall not be stored in a medication storage area.
(e) No medication shall be repackaged by facility staff.
(14) Telephone physician orders for medication may only be accepted by another physician, a licensed practical nurse, a registered nurse, a physician’s assistant, ARNP or a licensed pharmacist. Telephone orders shall be immediately recorded in the child’s medical record. Faxed physician orders are acceptable with a physician’s signature. The original physician’s order must be obtained within 72 hours of receipt of the faxed order.
Specific Authority 39.407, 394.875(10) FS. Law Implemented Florida Statutes § 394.875. History-New 7-25-06.
Terms Used In Florida Regulations 65E-9.014
- Guardian: A person legally empowered and charged with the duty of taking care of and managing the property of another person who because of age, intellect, or health, is incapable of managing his (her) own affairs.
(3) Psychotropic medication shall not be used as a substitute for treatment, for the convenience of staff, or in quantities that interfere with the child’s treatment progress.
(4) The use of psychotropic medication shall be described in the child’s treatment plan and shall include the desired goals and outcomes of the medication.
(5) Informed consent for the administration of psychotropic medication.
(a) Informed consent from the parents or legal guardian of any child must be obtained by the provider, in accordance with Florida Statutes § 394.459, when the dosage of current approved medications are changed and when the type of medication is changed.
(b) The requirements for obtaining express and informed consent for a child in the care and custody of the state are governed by Florida Statutes § 39.407
(6) If the circumstances requiring the administration of the medication constitute an emergency, such administration shall be governed by the provisions of Section 743.064 or 394.463(2)(f), F.S., as applicable.
(7) There shall be no pro re nata (PRN) orders for psychotropic medications.
(8) There shall be no standing orders for psychotropic medications.
(9) Children receiving antipsychotic medications shall be assessed for abnormal involuntary movements by a physician or registered nurse using a recognized standardized rating scale upon admission and quarterly thereafter.
(10) Refills for medications shall be ordered only by a physician or nurse licensed in the state of Florida. Prescriptions shall be timely refilled to prevent missed dosages.
(11) Administration of medication by unlicensed staff.
(a) For therapeutic group homes or residential treatment centers with 12 beds or less, where services are rendered in a smaller home-like setting, unlicensed staff employed by the facility, who have satisfactorily completed a competency-based training for administration of unit dose medication, shall administer prescribed prepackaged, pre-measured, oral medications, prescribed topical, otic, nasal and ophthalmic medications in accordance with Florida Statutes § 464.022(1)
(b) Medications requiring subcutaneous or intra-muscular administration and rectal and vaginal suppository medications will be administered, at a minimum, by a Florida licensed nurse.
(c) The medication administration course used to train unlicensed staff shall be eight hours, at a minimum, in length and must meet the following criteria:
1. The course must consist of at least the following topics:
a. Basic knowledge and skills necessary for safe and accurate medication administration and charting.
b. Roles of the physician, nurse, pharmacist, and direct care staff in medication ordering, dispensing, and administration.
c. Procedures for recording/charting medications.
d. Interpretation of common abbreviations used in administration and charting of medications.
e. Knowledge of facility medication system.
f. Safety precautions used in medication administration and charting.
g. Methods and techniques of medication administration.
h. Problems and intervention in the administration of medication.
i. Observation and reporting of medication side effects and adverse effects.
j. Observation and reporting of effects of medications including outcomes of psychotropic medication treatment.
k. Documenting and reporting of medication errors.
l. Appropriate storage of medications.
2. The content must be taught by a Florida licensed physician, consulting pharmacist, physician assistant, advanced registered nurse practitioner, or registered nurse.
3. Training must be competency-based and shall consist of lecture and a clinical practicum. This training shall be documented and such documentation filed in the staff member’s personnel file.
4. During the practicum, the trainee must be observed twice administering medications error free during their regularly scheduled medication time. The observation must include error free charting completed by the trainee after the medication(s) has been administered. The practicum observations must be made by a Florida licensed physician, consulting pharmacist, physician assistant, advanced registered nurse practitioner, or registered nurse.
5. Training regarding the administration of prescribed topical, otic, nasal and ophthalmic medications will only be completed by unlicensed staff authorized to do so following competency-based training and observation of proficiency by a licensed practitioner.
6. Monitoring of medication administration shall be performed, at a minimum, quarterly by the supervising registered nurse for each facility. In addition, a Florida registered nurse must be available to facility staff via telephone or paging device 24 hours per day.
7. At a minimum, four (4) hours of continuing education is required on an annual basis.
8. When a psychotropic medication is initiated, a registered nurse or pharmacist will assure or make provisions for the instruction of the facility staff regarding side effects and adverse effects of the prescribed medication, including when to notify the physician if undesirable side effects or adverse effects are observed.
9. All staff identified to receive training in medication administration must be high school graduates or have passed an equivalency exam (GED).
(12) Self administration of medication.
(a) For therapeutic group homes or residential treatment centers with 12 beds or less unlicensed staff employed by the facility, who have satisfactorily completed competency-based training in administering medication and supervising children with self administration of unit dose medication, shall be authorized to supervise with self administration of prescription and over-the-counter medications.
(b) Only children who have been assessed by a physician and determined to be capable of self-administering their medications shall be permitted to do so under the supervision of an authorized person. Documentation of such assessment and determination shall be filed in the child’s medical records.
(c) Staff involved with supervising and assisting with the self-administration of medications shall complete competency-based training of a minimum of four hours annually by a registered nurse or licensed pharmacist. This training shall be documented and filed in the staff member’s personnel file.
(d) The course shall consist of at least the following topics:
1. Basic knowledge and skills necessary for providing supervision for self-administration of medication;
2. Understanding a prescription label;
3. Procedures for recording/charting medications in the medication log;
4. Interpretation of common abbreviations used in administration and charting of medications;
5. Observation and reporting of side effects, adverse effects and outcomes of psychotropic medication treatment; and
6. Recognizing, documenting and reporting of medication errors.
(e) Upon completion of the course, the trainee shall be able to demonstrate the ability to:
1. Measure liquid medications, break scored tablets, and crush tablets in accordance with prescription directions;
2. Recognize the need to obtain clarification of an “”as needed”” prescription order;
3. Recognize a medication order which requires judgment or discretion, and advise the child, child’s health care provider or facility employer of the inability to assist in the administration of such orders;
4. Complete a medication observation record;
5. Retrieve and store medication; and
6. Recognize the general signs of adverse reactions to medications and report such reactions.
(13) Storage of medications.
(a) All drugs, including nonprescription drugs, shall be stored under double lock (e.g., a locked cabinet within a locked room or in a locked container within a locked cabinet).
(b) External and internal medications and ophthalmic preparations shall be stored separately from each other.
(c) Each child’s medications shall be stored separately from each other.
(d) Poisons and other toxic chemicals shall not be stored in a medication storage area.
(e) No medication shall be repackaged by facility staff.
(14) Telephone physician orders for medication may only be accepted by another physician, a licensed practical nurse, a registered nurse, a physician’s assistant, ARNP or a licensed pharmacist. Telephone orders shall be immediately recorded in the child’s medical record. Faxed physician orders are acceptable with a physician’s signature. The original physician’s order must be obtained within 72 hours of receipt of the faxed order.
Specific Authority 39.407, 394.875(10) FS. Law Implemented Florida Statutes § 394.875. History-New 7-25-06.