SF 339

1st Engrossment - 86th Legislature (2009 - 2010) Posted on 02/09/2010 02:12am

A bill for an act
relating to health; requiring the Board of Pharmacy to adopt rules to govern
pharmaceutical services for individuals needing plasma protein therapies;
proposing coding for new law in Minnesota Statutes, chapter 151.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

Section 1.

new text begin [151.58] PHARMACIES PROVIDING PLASMA PROTEIN
THERAPIES.
new text end

new text begin Subdivision 1. new text end

new text begin Definitions. new text end

new text begin (a) For purposes of this section, the terms defined in
this subdivision have the meanings given.
new text end

new text begin (b) "Assay" means the amount of a particular constituent of a mixture or of the
biological or pharmacological potency of a drug.
new text end

new text begin (c) "Ancillary infusion equipment and supplies" means the equipment and supplies
required to infuse a plasma protein therapy into a human vein including, but not limited
to, syringes, needles, sterile gauze, field pads, gloves, alcohol swabs, numbing creams,
tourniquets, medical tape, sharps or equivalent biohazard waste containers, and cold
compression packs.
new text end

new text begin (d) "Plasma protein therapy" means a medicine manufactured from human plasma
or recombinant biotechnology techniques, approved for distribution by the federal Food
and Drug Administration, that is used for the treatment and prevention of symptoms
associated with alpha1-antitrypsin deficiency, primary immunodeficiency diseases, and
von Willebrand disease.
new text end

new text begin (e) "Home nursing services" means specialized nursing care provided in the home
setting to assist a patient in the reconstitution and administration of plasma protein
therapies.
new text end

new text begin (f) "Home use" means infusion or other use of a plasma protein therapy in a place
other than a hemophilia treatment center, hospital, emergency room, physician's office,
outpatient infusion facility, or clinic.
new text end

new text begin (g) "Pharmacy" means a pharmacy that provides patients with plasma protein
therapies and ancillary infusion equipment and supplies.
new text end

new text begin Subd. 2. new text end

new text begin Rules for standards of care. new text end

new text begin The Board of Pharmacy shall promulgate
rules that govern standards of pharmaceutical services for individuals needing plasma
protein therapies. The rules shall include when feasible the standards established by the
medical advisory committees of the patient groups and professional societies representing
individuals with primary immunodeficiency diseases, alphal-antitrypsin deficiency, and
von Willebrand disease. The rules shall include safeguards to ensure the pharmacy
provides:
new text end

new text begin (1) all brands of plasma protein therapies needed by the patients served that are
approved by the federal Food and Drug Administration in all available assays and vial
sizes;
new text end

new text begin (2) the shipment of prescribed plasma protein therapies to the patient within:
new text end

new text begin (i) two business days or less, for established patients once coverage is verified;
new text end

new text begin (ii) three business days or less for new patients in nonemergency situations; and
new text end

new text begin (iii) in cases of emergency, within the time necessary to meet the patient's need;
new text end

new text begin (3) all necessary ancillary infusion equipment and supplies for administration of
plasma protein therapies;
new text end

new text begin (4) coordination of pharmacy services with home nursing services when home
nursing services are deemed necessary by the treating physician; and
new text end

new text begin (5) patients who have received plasma protein therapies with a designated contact
telephone number for emergency refills and for reporting problems with a delivery or
product.
new text end