The Board proposes the rule promulgation in order to create standards of practice for othotics and pedorthics.

 

DEPARTMENT OF HEALTH
Board of Pharmacy

RULE NO: RULE TITLE
64B16-27.850: Standards of Practice for Othotics and Pedorthics
PURPOSE AND EFFECT: The Board proposes the rule promulgation in order to create standards of practice for othotics and pedorthics.
SUBJECT AREA TO BE ADDRESSED: Standards of Practice for Othotics and Pedorthics.
SPECIFIC AUTHORITY: 468.808, 468.812(3) FS.
LAW IMPLEMENTED: 468.808, 468.812(3) FS.
IF REQUESTED IN WRITING AND NOT DEEMED UNNECESSARY BY THE AGENCY HEAD, A RULE DEVELOPMENT WORKSHOP WILL BE NOTICED IN THE NEXT AVAILABLE FLORIDA ADMINISTRATIVE WEEKLY.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE DEVELOPMENT AND A COPY OF THE PRELIMINARY DRAFT, IF AVAILABLE, IS: Rebecca Poston, Executive Director, Board of Pharmacy/MQA, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254

THE PRELIMINARY TEXT OF THE PROPOSED RULE DEVELOPMENT IS:

64B16-27.850 Standards of Practice for Othotics and Pedorthics.

(1) Definitions.

(a) “Orthosis” means a medical device used to provide support, correction, or alleviation of neuromuscular or musculoskeletal dysfunction, disease, injury, or deformity, but does not include the following assistive technology devices: upper extremity adaptive equipment used to facilitate the activities of daily living, including specialized utensils, combs, and brushes; finger splints; wheelchair seating and equipment that is an integral part of the wheelchair and not worn by the patient; elastic abdominal supports that do not have metal or plastic reinforcing stays; arch supports; nontherapeutic accommodative inlays and nontherapeutic accommodative footwear, regardless of method of manufacture; unmodified, over-the-counter shoes; prefabricated foot care products; durable medical equipment such as canes, crutches, or walkers; dental appliances; or devices implanted into the body by a physician. For purposes of this subsection, “accommodative” means designed with the primary goal of conforming to the individual’s anatomy and “inlay” means any removable material upon which the foot directly rests inside the shoe and which may be an integral design component of the shoe.

(b) “Orthotics” means the practice, pursuant to a licensed physician's written prescription, of evaluating, treatment formulating, measuring, designing, fabricating, assembling, fitting, adjusting, servicing, or providing the initial training necessary to accomplish the fitting of an orthosis or pedorthic device; however, the repair, replacement, adjustment, or servicing of any existing orthosis may be performed without an additional prescription from the patient's physician, unless the original prescription states otherwise. If a patient is under the care of a licensed occupational therapist or physical therapist, the pharmacist must consult with the therapist if the therapist has requested consultation regarding the fitting, design, or fabrication of an orthosis or regarding treatment with an orthosis.

(d) “Pedorthic device” means therapeutic shoes, shoe modifications made for therapeutic purposes, prosthetic fillers of the forefoot, and foot orthoses for use from the ankle and below, but does not include arch supports; nontherapeutic accommodative inlays and nontherapeutic accommodative footwear, regardless of method of manufacture; unmodified, over-the-counter shoes; or prefabricated foot care products. For purposes of this subsection, “accommodative” means designed with the primary goal of conforming to the individual's anatomy and “inlay” means any removable material upon which the foot directly rests inside the shoe and which may be an integral design component of the shoe.

(e) “Pedorthics” means the practice, pursuant to a licensed physician's written prescription, of evaluating, treatment formulating, measuring, designing, fabricating, assembling, fitting, adjusting, servicing, or providing the initial training necessary to accomplish the fitting of a pedorthic device; however, the repair, replacement, adjustment, or servicing of any existing pedorthic device may be performed without an additional prescription from the patient's physician, unless the original prescription states otherwise. If a patient is under the care of a licensed occupational therapist or physical therapist, the pharmacist must consult with the therapist if the therapist has requested consultation regarding the fitting, design, or fabrication of a pedorthic device or regarding treatment with a pedorthic device.

(2) Pursuant to a licensed physician's written prescription, the pharmacist shall assume the responsibility for assessing the patient, planning the patient's treatment program, and directing the program. No pharmacist shall implement a prescription that, in the pharmacist's judgment, is contraindicated. No change shall be made in the prescription without the authorization of the prescribing physician.

(3) The pharmacist’s professional responsibilities include:

(a) Ongoing consultation with the prescribing physician regarding information that will impact the patient's medical and functional outcomes.

(b) Orthotic and or pedorthic evaluation of the patient.

(c) Identification and documentation of precautions, special problems, or contraindications.

(d) Development of a treatment plan including the short and long terms goals.

(e) Implementation of a treatment plan.

(f) Periodic review and update of the treatment plan, including reassessment of the patient in reference to goals and, when necessary, modification of the treatment plan.

(g) Collaboration with members of the health care team when appropriate.

(h) Advising the patient, in terms which the patient can understand, of the nature and purpose of the services to be rendered and the techniques for use and care of an orthosis or pedorthic device.

(i) Determination of the appropriateness of proper fit and function of any orthosis or pedorthic device.

(4) A pharmacist may delegate duties to nonlicensed supportive personnel if those duties are performed under the supervision of the pharmacist. In such instances the supervising pharmacist is responsible for all acts performed by such persons. It is below the standard of practice and prohibited for a pharmacist to delegate or assign activities, tasks or procedures that fall within the scope of any practice defined in Section 468.812(3), F.S., to support personnel, without providing supervision for the performance of the activities, tasks or procedures.

Specific Authority 468.808, 468.812(3) FS. Law Implemented 468.808, 468.812(3) FS. History–New________.