Effective 28 Aug 2011

338.400. Standard of care, definitions, rules. — 1. As used in this section, the following terms shall mean:

(1) "Ancillary infusion equipment and supplies", the equipment and supplies required to infuse a blood clotting therapy product into a human vein, including syringes, needles, sterile gauze, field pads, gloves, alcohol swabs, numbing creams, tourniquets, medical tape, sharps or equivalent biohazard waste containers, and cold compression packs;

(2) "Assay", the amount of a particular constituent of a mixture or of the biological or pharmacological potency of a drug;

(3) "Bleeding disorder", a medical condition characterized by a deficiency or absence of one or more essential blood-clotting components in the human blood, including all forms of hemophilia, von Willebrand's disease, and other bleeding disorders that result in uncontrollable bleeding or abnormal blood clotting;

(4) "Blood clotting product", a medicine approved for distribution by the federal Food and Drug Administration that is used for the treatment and prevention of symptoms associated with bleeding disorders, including but not limited to recombinant Factor VII, recombinant-activated Factor VIIa, recombinant Factor VIII, plasma-derived Factor VIII, recombinant Factor IX, plasma-derived Factor IX, von Willebrand factor products, bypass products for patients with inhibitors, prothrombin complex concentrates; and activated prothrombin complex concentrates;

(5) "Home nursing services", specialized nursing care provided in the home setting to assist a patient in the reconstitution and administration of blood clotting products;

(6) "Home use", infusion or other use of a blood clotting product in a place other than a hemophilia treatment center, hospital, emergency room, physician's office, outpatient facility, or clinic;

(7) "Pharmacy", an entity engaged in practice of pharmacy as defined in section 338.010 that provides patients with blood clotting products and ancillary infusion equipment and supplies.

2. The Missouri state board of pharmacy shall promulgate rules governing the standard of care for pharmacies dispensing blood clotting therapies. Such rules shall include, when feasible, the standards established by the medical advisory committees of the patient groups representing the hemophilia and von Willebrand diseases, including but not limited to Recommendation 188 of the National Hemophilia Foundation's Medical and Scientific Advisory Council. Such rules shall include safeguards to ensure the pharmacy:

(1) Has the ability to obtain and fill a physician prescription as written of all brands of blood clotting products approved by the federal Food and Drug Administration in multiple assay ranges of low, medium, and high, as applicable, and vial sizes, including products manufactured from human plasma and those manufactured from recombinant technology techniques, provided manufacturer supply exists and payer authorization is obtained;

(2) Provides for the shipment of prescribed blood clotting products to the patient within two business days or less for established patients and three business days or less for new patients in nonemergency situations;

(3) Provides established patients with access to blood clotting products within twelve hours of notification by the physician of the patient's emergent need for blood clotting products;

(4) Provides all ancillary infusion equipment and supplies necessary for established patients for administration of blood clotting products;

(5) Has a pharmacist available twenty-four hours a day, seven days a week, every day of the year, either onsite or on call, to fill prescriptions for blood clotting products;

(6) Provides patients who have received blood clotting products with a designated contact telephone number for reporting problems with a delivery or product;

(7) Provides patients with notification of recalls and withdrawals of blood clotting products and ancillary infusion equipment within twenty-four hours of receipt of the notification; and

(8) Provides containers for the disposal of hazardous waste, and provides* patients with instructions on the proper collection, removal, and disposal of hazardous waste under state and federal law.

3. Notwithstanding the provisions of subsection 2 of this section, pharmacies and pharmacists shall exercise that degree of skill and learning ordinarily exercised by members of their profession in the dispensing and distributing of blood clotting products.

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(L. 2011 H.B. 552)

*Word "provide" appears in original rolls.