FIRST REGULAR SESSION
HOUSE COMMITTEE SUBSTITUTE FOR
HOUSE BILL NOS. 545 & 590
94TH GENERAL ASSEMBLY
Reported from the Special Committee on General Laws February 6, 2007 with recommendation that House Committee Substitute for House Bill Nos. 545 & 590 Do Pass. Referred to the Committee on Rules pursuant to Rule 25(21)(f).
D. ADAM CRUMBLISS, Chief Clerk
To repeal sections 338.010 and 338.095, RSMo, and to enact in lieu thereof three new sections relating to pharmacists.
Be it enacted by the General Assembly of the state of Missouri, as follows:
Section A. Sections 338.010 and 338.095, RSMo, are repealed and three new sections enacted in lieu thereof, to be known as sections 338.010, 338.095, and 338.380, to read as follows:
338.010. 1. The "practice of pharmacy" [shall mean] means the interpretation, implementation, and evaluation of medical or veterinary prescription orders, including receipt, transmission, or handling of such orders or facilitating the dispensing of such orders; the designing, initiating, implementing, and monitoring of a medication therapeutic plan as defined by the prescription order so long as the prescription order is specific to each patient for care by a specific pharmacist; the compounding, dispensing [and] , labeling, and administration of drugs and devices pursuant to medical or veterinary prescription orders and administration of vaccines by written protocol authorized by a physician; the participation in drug selection according to state law and participation in drug utilization reviews; the proper and safe storage of drugs and devices and the maintenance of proper records thereof; consultation with patients and other health care practitioners about the safe and effective use of drugs and devices; and the offering or performing of those acts, services, operations, or transactions necessary in the conduct, operation, management and control of a pharmacy. No person shall engage in the practice of pharmacy unless he is licensed under the provisions of this chapter. This chapter shall not be construed to prohibit the use of auxiliary personnel under the direct supervision of a pharmacist from assisting the pharmacist in any of his duties. This assistance in no way is intended to relieve the pharmacist from his responsibilities for compliance with this chapter and he will be responsible for the actions of the auxiliary personnel acting in his assistance. This chapter shall also not be construed to prohibit or interfere with any legally registered practitioner of medicine, dentistry, podiatry, or veterinary medicine, or the practice of optometry in accordance with and as provided in sections 195.070 and 336.220, RSMo, in the compounding or dispensing of his own prescriptions.
2. Any pharmacist who accepts a prescription order for a medication therapeutic plan shall have a written protocol from the physician who refers the patient for medication therapy services. The written protocol and the prescription order for a medication therapeutic plan shall come from the physician only, and shall not come from a nurse engaged in a collaborative practice arrangement under section 334.104, RSMo, or from a physician assistant engaged in a supervision agreement under section 334.735, RSMo.
3. Nothing in this section shall be construed as to prevent any person, firm or corporation from owning a pharmacy regulated by sections 338.210 to 338.315, provided that a licensed pharmacist is in charge of such pharmacy.
[3.] 4. Nothing in this section shall be construed to apply to or interfere with the sale of nonprescription drugs and the ordinary household remedies and such drugs or medicines as are normally sold by those engaged in the sale of general merchandise.
5. No health carrier as defined in chapter 376, RSMo, shall require any physician with which they contract to enter into a written protocol with a pharmacist for medication therapeutic services.
6. This section shall not be construed to allow a pharmacist to diagnose or independently prescribe pharmaceuticals.
7. The state board of registration for the healing arts, under section 334.125, RSMo, and the state board of pharmacy, under section 338.140, shall jointly promulgate rules regulating the use of protocols for prescription orders for medication therapy services. Such rules shall require protocols to include provisions allowing for timely communication between the pharmacist and the referring physician, and any other patient protection provisions deemed appropriate by both boards. In order to take effect, such rules shall be approved by a majority vote of a quorum of each board. Neither board shall separately promulgate rules regulating the use of protocols for prescription orders for medication therapy services. Any rule or portion of a rule, as that term is defined in section 536.010, RSMo, that is created under the authority delegated in this section shall become effective only if it complies with and is subject to all of the provisions of chapter 536, RSMo, and, if applicable, section 536.028, RSMo. This section and chapter 536, RSMo, are nonseverable and if any of the powers vested with the general assembly pursuant to chapter 536, RSMo, to review, to delay the effective date, or to disapprove and annul a rule are subsequently held unconstitutional, then the grant of rulemaking authority and any rule proposed or adopted after August 28, 2007, shall be invalid and void.
8. The state board of pharmacy may grant a certificate of medication therapeutic plan authority to a licensed pharmacist who submits proof of successful completion of a board-approved course of academic clinical study beyond a bachelor of science in pharmacy, including but not limited to clinical assessment skills, from a nationally accredited college or university, or a certification of equivalence issued by a nationally recognized professional organization and approved by the board of pharmacy.
9. Any pharmacist who has received a certificate of medication therapeutic plan authority may engage in the designing, initiating, implementing, and monitoring of a medication therapeutic plan as defined by a prescription order from a physician that is specific to each patient for care by a specific pharmacist.
10. Nothing in this section shall be construed to allow a pharmacist to make a therapeutic substitution of a pharmaceutical prescribed by a physician unless authorized by the written protocol or the physician's prescription order.
338.095. 1. The terms "prescription" and "prescription drug order" are hereby defined as a lawful order for medications or devices issued and signed by an authorized prescriber within the scope of his professional practice which is to be dispensed or administered by a pharmacist or dispensed or administered pursuant to section 334.104, RSMo, to and for the ultimate user. The terms "prescription" and "drug order" do not include an order for medication requiring a prescription to be dispensed, which is provided for the immediate administration to the ultimate user or recipient.
2. The term "telephone prescription" is defined as an order for medications or devices transmitted to a pharmacist by telephone or similar electronic medium by an authorized prescriber or his authorized agent acting in the course of his professional practice which is to be dispensed or administered by a pharmacist or dispensed or administered pursuant to section 334.104, RSMo, to and for the ultimate user. A telephone prescription shall be promptly reduced to written or electronic medium by the pharmacist and shall comply with all laws governing prescriptions and record keeping.
3. A licensed pharmacist may lawfully provide prescription or medical information to a licensed health care provider or his agent who is legally qualified to administer medications and treatments and who is involved in the treatment of the patient. The information may be derived by direct contact with the prescriber or through a written protocol approved by the prescriber. Such information shall authorize the provider to administer appropriate medications and treatments.
4. Nothing in this section shall be construed to limit the authority of other licensed health care providers to prescribe, administer, or dispense medications and treatments within the scope of their professional practice.
5. It is unlawful for any person other than the patient or the patient's authorized representative to accept a prescription presented to be dispensed unless that person is located on a premises licensed by the board as a pharmacy.
338.380. 1. As used in this section the term "committee" means the "Well-being Committee" established under subsection 3 of this section.
2. The board may refuse to issue any certificate of registration or authority, permit or license, required under this chapter for one or any combination of causes stated in subsection 2 of section 338.055, or the board may, as a condition to issuing or renewing any such certificate of registration or authority, permit or license, require a person to submit himself or herself for identification, intervention, treatment, or rehabilitation by the well-being committee as provided in this section. The board shall notify the applicant in writing of the reasons for the refusal and shall advise the applicant of his or her right to file a complaint with the administrative hearing commission as provided by chapter 621, RSMo.
3. The board may establish an impaired licensee committee, to be designated as the "Well-being Committee", to promote the early identification, intervention, treatment, and rehabilitation of licensees identified within this chapter, who may be impaired by reasons of illness, substance abuse, or as a result of any physical or mental condition. The board may enter into a contractual agreement with a nonprofit corporation or an association for the purpose of creating, supporting and maintaining such a committee. The board may promulgate rules subject to the provisions of this section to effectuate and implement any committee formed under this section. The board may expend appropriated funds necessary to provide for operational expenses of the committee formed under this section. Any member of the committee, as well as any administrator, staff member, consultant, agent or employee of the committee, acting within the scope of his or her duties and without actual malice and, all other persons who furnish information to the committee in good faith and without actual malice, shall not be liable for any claim of damages as a result of any statement, decision, opinion, investigation or action taken by the committee or by any individual member of the committee.
4. All information, interviews, reports, statements, memoranda or other documents furnished to or produced by the committee, as well as communications to or from the committee, any findings, conclusions, interventions, treatment, rehabilitation, or other proceedings of the committee which in any way pertain to a licensee who may be, or who actually is, impaired shall be absolutely privileged and confidential.
5. All records and proceedings of the committee which pertain or refer to a licensee who may be, or who actually is, impaired shall be privileged and confidential and shall be used by the committee and its members only in the exercise of the proper function of the committee and shall not be considered public records under chapter 610, RSMo, and shall only be subject to discovery or introduction as evidence in any civil, criminal, or administrative proceedings except as provided in subsection 6 of this section.
6. The committee may disclose information relative to an impaired licensee only when:
(1) It is essential to disclose the information to further the intervention, treatment, or rehabilitation needs of the impaired licensee and only to those persons or organization with a need to know;
(2) Its release is authorized in writing by the impaired licensee;
(3) The committee is required to make a report to the board;
(4) The information is subject to a court order.
7. In lieu of the pursuing discipline against a licensee for violating one or more causes stated in subsection 2 of section 338.055, the board may enter into a diversion agreement with a licensee to refer the licensee to the committee under such terms and conditions as are agreed to by the board and licensee. The board shall enter into no more than two diversion agreements with any individual licensee. If the licensee violates a term or condition of a diversion agreement entered into under this section, the board may elect to pursue discipline against the licensee under chapter 621, RSMo, for the original conduct that resulted in the diversion agreement, or for any subsequent violation of subsection 2 of section 338.055. While the licensee participates in the committee, the time limitations of section 620.154, RSMo, shall toll under subsection 7 of section 620.154, RSMo. All records pertaining to diversion agreements are confidential and may only be released under subdivision (7) of subsection 14 of section 620.010, RSMo.
8. The committee shall report to the board the name of any licensee who fails to enter treatment within forty-eight hours following the provider's determination that the pharmacist needs treatment or any failure by a licensee to comply with the terms of a treatment contract during inpatient or outpatient treatment or aftercare or report a licensee who resumes the practice of pharmacy before the treatment provider has made a clear determination that the pharmacist is capable of practicing according to acceptable and prevailing standards.
9. The board may disclose information and records to the committee to assist the committee in the identification, intervention, treatment, and rehabilitation of any licensee who may be impaired by reason of illness, substance abuse, or as the result of any physical or mental condition. The committee shall keep all information and records provided by the board confidential to the extent the board is required to treat the information and records as closed to the public under chapter 620, RSMo.
10. Any rule or portion of a rule, as that term is defined in section 536.010, RSMo, that is created under the authority delegated in this section shall become effective only if it complies with and is subject to all of the provisions of chapter 536, RSMo, and, if applicable, section 536.028, RSMo. This section and chapter 536, RSMo, are nonseverable and if any of the powers vested with the general assembly pursuant to chapter 536, RSMo, to review, to delay the effective date, or to disapprove and annul a rule are subsequently held unconstitutional, then the grant of rulemaking authority and any rule proposed or adopted after August 28, 2007, shall be invalid and void.