Section 393.506 - Administration of medication(1) An unlicensed direct service provider may supervise the self-administration of medication or may administer oral, transdermal, ophthalmic, otic, rectal, inhaled, enteral, or topical prescription medications to a client if the unlicensed direct service provider meets the requirements of this section.(2) In order to supervise the self-administration of medication or to administer medications as provided in subsection (1), an unlicensed direct service provider must satisfactorily complete an initial training course conducted by an agency-approved trainer of not less than 6 hours in medication administration and be found competent to supervise the self-administration of medication by a client and to administer medication to a client in a safe and sanitary manner. (a) The competency of the unlicensed direct service provider to supervise and administer otic, transdermal, and topical medication must be assessed and validated using simulation during the initial training course, and need not be revalidated annually.(b) Competency must be validated initially and revalidated annually for oral, enteral, ophthalmic, rectal, and inhaled medication administration. The initial validation and annual revalidations of medication administration must be performed onsite with an actual client using the client's actual medication and must include the validating practitioner personally observing the unlicensed direct service provider satisfactorily: 1. Supervising the oral, enteral, ophthalmic, rectal, or inhaled self-administration of medication by a client; and2. Administering medication to a client by oral, enteral, ophthalmic, rectal, or inhaled medication routes.(c)1. An unlicensed direct service provider who completes the required initial training course and is validated in the oral or enteral route of medication administration is not required to retake the initial training course unless he or she fails to maintain annual validation in the oral or enteral route, in which case the provider must complete the initial 6-hour training course again and obtain all required validations before he or she may supervise the self-administration of medication by a client or administer medication to a client.2. If the unlicensed direct service provider has already completed an initial training course of at least 4 hours and has a current validation for oral or enteral routes of medication administration on or before July 1, 2018, he or she is not required to complete the initial 6-hour training course. If for any reason the unlicensed direct service provider fails to meet the annual validation requirement for oral or enteral medication administration, or the annual inservice training requirement in subsection (4), the unlicensed direct service provider must satisfactorily complete the initial training course again and obtain all required validations before he or she may supervise the self-administration of medication by a client or administer medication to a client.3. If an unlicensed direct service provider has completed an initial training course of at least 4 hours but has not obtained validation for otic, transdermal, or topical medication administration before July 1, 2018, that direct service provider must obtain validation before administering otic, transdermal, and topical medication, which may be performed through simulation.(3) Only an unlicensed direct service provider who has met the training requirements of this section and who has been validated as competent may administer medication to a client. In addition, a direct service provider who is not currently licensed to administer medication may supervise the self-administration of medication by a client or may administer medication to a client only if the client, or the client's guardian or legal representative, has given his or her informed written consent.(4) An unlicensed direct service provider must annually and satisfactorily complete a 2-hour agency-developed inservice training course in medication administration and medication error prevention conducted by an agency-approved trainer. The inservice training course shall count toward annual inservice training hours required by agency rules or by the rules of the Agency for Health Care Administration. This subsection may not be construed to require an increase in the total number of hours required for annual inservice training for direct service providers.(5) The training, determination of competency, and initial and annual validations required in this section shall be conducted by a registered nurse licensed pursuant to chapter 464 or by a licensed practical nurse in accordance with the requirements of chapter 464. A physician licensed pursuant to chapter 458 or chapter 459 may validate or revalidate competency.(6) The agency shall establish by rule standards and procedures that an unlicensed direct service provider must follow when supervising the self-administration of medication by a client and when administering medication to a client. Such rules must, at a minimum, address qualification requirements for trainers, requirements for labeling medication, documentation and recordkeeping, the storage and disposal of medication, instructions concerning the safe administration of medication or supervision of self-administered medication, informed-consent requirements and records, and the training curriculum and validation procedures. The agency shall adopt rules to establish methods of enforcement to ensure compliance with this section. s.1, ch. 2003-57; s.113, ch. 2004-267; s.1, ch. 2006-37; s.16, ch. 2006-197; s.11, ch. 2008-244; s.1, ch. 2018-107.Amended by 2018 Fla. Laws, ch. 107, s 1, eff. 7/1/2018.