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HF 53

as introduced - 86th Legislature (2009 - 2010) Posted on 02/09/2010 01:33am

KEY: stricken = removed, old language.
underscored = added, new language.
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A bill for an act
relating to health; changing a provision for pharmacy practice in administering
influenza vaccines; amending Minnesota Statutes 2008, sections 151.01,
subdivision 27; 151.37, subdivision 2.


Section 1.

Minnesota Statutes 2008, section 151.01, subdivision 27, is amended to read:

Subd. 27.

Practice of pharmacy.

"Practice of pharmacy" means:

(1) interpretation and evaluation of prescription drug orders;

(2) compounding, labeling, and dispensing drugs and devices (except labeling by
a manufacturer or packager of nonprescription drugs or commercially packaged legend
drugs and devices);

(3) participation in clinical interpretations and monitoring of drug therapy for
assurance of safe and effective use of drugs;

(4) participation in drug and therapeutic device selection; drug administration for
first dosage and medical emergencies; drug regimen reviews; and drug or drug-related

(5) participation in administration of influenza vaccines to all eligible individuals
deleted text begin overdeleted text end ten years of age new text beginand older new text endand all other vaccines to patients 18 years of age and
older under standing orders from a physician licensed under chapter 147 or by written
protocol with a physician provided that:

(i) the pharmacist is trained in a program approved by the American Council of
Pharmaceutical Education for the administration of immunizations or graduated from a
college of pharmacy in 2001 or thereafter; and

(ii) the pharmacist reports the administration of the immunization to the patient's
primary physician or clinic;

(6) participation in the practice of managing drug therapy and modifying drug
therapy, according to section 151.21, subdivision 1, according to a written protocol
between the specific pharmacist and the individual dentist, optometrist, physician,
podiatrist, or veterinarian who is responsible for the patient's care and authorized to
independently prescribe drugs. Any significant changes in drug therapy must be reported
by the pharmacist to the patient's medical record;

(7) participation in the storage of drugs and the maintenance of records;

(8) responsibility for participation in patient counseling on therapeutic values,
content, hazards, and uses of drugs and devices; and

(9) offering or performing those acts, services, operations, or transactions necessary
in the conduct, operation, management, and control of a pharmacy.

Sec. 2.

Minnesota Statutes 2008, section 151.37, subdivision 2, is amended to read:

Subd. 2.

Prescribing and filing.

(a) A licensed practitioner in the course of
professional practice only, may prescribe, administer, and dispense a legend drug, and may
cause the same to be administered by a nurse, a physician assistant, or medical student or
resident under the practitioner's direction and supervision, and may cause a person who
is an appropriately certified, registered, or licensed health care professional to prescribe,
dispense, and administer the same within the expressed legal scope of the person's practice
as defined in Minnesota Statutes. A licensed practitioner may prescribe a legend drug,
without reference to a specific patient, by directing a nurse, pursuant to section 148.235,
subdivisions 8 and 9
, physician assistant, deleted text beginordeleted text end medical student or residentnew text begin,new text end new text beginor pharmacist
according to section 151.01, subdivision 27,
new text endto adhere to a particular practice guideline or
protocol when treating patients whose condition falls within such guideline or protocol,
and when such guideline or protocol specifies the circumstances under which the legend
drug is to be prescribed and administered. An individual who verbally, electronically, or
otherwise transmits a written, oral, or electronic order, as an agent of a prescriber, shall
not be deemed to have prescribed the legend drug. This paragraph applies to a physician
assistant only if the physician assistant meets the requirements of section 147A.18.

(b) A licensed practitioner that dispenses for profit a legend drug that is to be
administered orally, is ordinarily dispensed by a pharmacist, and is not a vaccine, must
file with the practitioner's licensing board a statement indicating that the practitioner
dispenses legend drugs for profit, the general circumstances under which the practitioner
dispenses for profit, and the types of legend drugs generally dispensed. It is unlawful to
dispense legend drugs for profit after July 31, 1990, unless the statement has been filed
with the appropriate licensing board. For purposes of this paragraph, "profit" means (1)
any amount received by the practitioner in excess of the acquisition cost of a legend drug
for legend drugs that are purchased in prepackaged form, or (2) any amount received
by the practitioner in excess of the acquisition cost of a legend drug plus the cost of
making the drug available if the legend drug requires compounding, packaging, or other
treatment. The statement filed under this paragraph is public data under section 13.03.
This paragraph does not apply to a licensed doctor of veterinary medicine or a registered
pharmacist. Any person other than a licensed practitioner with the authority to prescribe,
dispense, and administer a legend drug under paragraph (a) shall not dispense for profit.
To dispense for profit does not include dispensing by a community health clinic when the
profit from dispensing is used to meet operating expenses.

(c) A prescription or drug order for the following drugs is not valid, unless it can be
established that the prescription or order was based on a documented patient evaluation,
including an examination, adequate to establish a diagnosis and identify underlying
conditions and contraindications to treatment:

(1) controlled substance drugs listed in section 152.02, subdivisions 3 to 5;

(2) drugs defined by the Board of Pharmacy as controlled substances under section
152.02, subdivisions 7, 8, and 12;

(3) muscle relaxants;

(4) centrally acting analgesics with opioid activity;

(5) drugs containing butalbital; or

(6) phoshodiesterase type 5 inhibitors when used to treat erectile dysfunction.

(d) For the purposes of paragraph (c), the requirement for an examination shall be
met if an in-person examination has been completed in any of the following circumstances:

(1) the prescribing practitioner examines the patient at the time the prescription
or drug order is issued;

(2) the prescribing practitioner has performed a prior examination of the patient;

(3) another prescribing practitioner practicing within the same group or clinic as the
prescribing practitioner has examined the patient;

(4) a consulting practitioner to whom the prescribing practitioner has referred the
patient has examined the patient; or

(5) the referring practitioner has performed an examination in the case of a
consultant practitioner issuing a prescription or drug order when providing services by
means of telemedicine.

(e) Nothing in paragraph (c) or (d) prohibits a licensed practitioner from prescribing
a drug through the use of a guideline or protocol pursuant to paragraph (a).

(f) Nothing in this chapter prohibits a licensed practitioner from issuing a
prescription or dispensing a legend drug in accordance with the Expedited Partner Therapy
in the Management of Sexually Transmitted Diseases guidance document issued by the
United States Centers for Disease Control.

(g) Nothing in paragraph (c) or (d) limits prescription, administration, or dispensing
of legend drugs through a public health clinic or other distribution mechanism approved
by the commissioner of health or a board of health in order to prevent, mitigate, or treat
a pandemic illness, infectious disease outbreak, or intentional or accidental release of a
biological, chemical, or radiological agent.

(h) No pharmacist employed by, under contract to, or working for a pharmacy
licensed under section 151.19, subdivision 1, may dispense a legend drug based on a
prescription that the pharmacist knows, or would reasonably be expected to know, is not
valid under paragraph (c).

(i) No pharmacist employed by, under contract to, or working for a pharmacy
licensed under section 151.19, subdivision 2, may dispense a legend drug to a resident
of this state based on a prescription that the pharmacist knows, or would reasonably be
expected to know, is not valid under paragraph (c).