SENATE, No. 2706

[Senate, May 15, 2008 - Substituted by amendment by the Senate (Moore) for Senate, No. 420]

Version with line numberspdf logo

The Commonwealth of Massachusetts

Seal of the Commonwealth of Massachusetts

In the Year Two Thousand and Seven.


AN ACT TO ESTABLISH COLLABORATIVE DRUG THERAPY MANAGEMENT.

Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority of the same, as follows:

SECTION 1.  Subsection (g) of section 7 of chapter 94C, as appearing in the 2006 Official Edition, is hereby amended by adding the following 3 paragraphs:–
The commissioner shall issue regulations that provide for the registration of pharmacists, who have been duly registered in accordance with section 24 ½ of chapter 112, to engage in collaborative drug therapy management and to issue written prescriptions in accordance with the provisions of said section 24 ½ and guidelines mutually developed and agreed upon by the supervising physician and the pharmacist in a collaborative practice agreement, as defined in section 24 ½ of chapter 112, established in accordance with regulations of the board of registration in medicine and board of registration in pharmacy.  Prior to issuing such regulations, the commissioner shall consult with the board of registration in medicine and the board of registration in pharmacy with regard to those schedules of controlled substances for which a pharmacist may be authorized to prescribe within the scope of his collaborative practice.

The commissioner may gather patient outcome and cost-savings data if available from objective sources and review community retail drug business-based collaborative drug therapy management.  If the commissioner finds that sufficient data and funding sources exist to conduct a valid study, he shall conduct a study within 2 years after that finding.  The study shall include representatives of the board of registration in medicine and the board of registration in pharmacy.  In conducting the study, the commissioner shall hold at least 1 public hearing to receive testimony from the public, including representatives of pharmacy and medicine and other concerned parties.

SECTION 2.  Said chapter 94C is hereby further amended by striking out section 9, as so appearing, and inserting in place thereof the following section: –
           
Section 9.  (a) A physician, dentist, podiatrist, optometrist as limited by sections 66 and 66B of chapter 112 and paragraph (h) of section 7 of this chapter, nurse practitioner and psychiatric nurse mental health clinical specialist as limited by paragraph (g) of said section 7 and section 80E of said chapter 112,  physician assistant as limited by said paragraph (g) of said section 7 and section 9E of said chapter 112, certified nurse-midwife as provided in section 80C of said chapter 112, pharmacist as limited by said paragraph (g) of said section 7 and section 24B½  of said chapter 112, or veterinarian when registered pursuant to said section 7, may, when acting in accordance with applicable federal law and any provision of this chapter which is consistent with federal law and in good faith and in the course of a professional practice for the alleviation of pain and suffering or for the treatment or alleviation of disease, possess controlled substances as may reasonably be required for the purpose of patient treatment and may administer controlled substances or may cause the same to be administered under his direction by a nurse.
           
(b) Notwithstanding section 17, a physician, physician assistant, dentist, podiatrist, optometrist, certified nurse-midwife, nurse practitioner, psychiatric nurse mental health clinical specialist, pharmacist as limited by said paragraph (g) of said section 7 and section 24B½ of said chapter 112, or veterinarian registered pursuant to said section 7, may, when acting in good faith and in the practice of medicine, dentistry, podiatry, optometry, nurse-midwifery, pharmacy or veterinary medicine or as a nurse, as the case may be, and when authorized by a physician, dentist, podiatrist, optometrist, nurse practitioner, physician assistant, certified nurse-midwife, psychiatric nurse mental health clinical specialist or veterinarian in the course of such nurse's professional practice, dispense by delivering to an ultimate user a controlled substance in a single dose or in a quantity that is, in the opinion of such physician, dentist, podiatrist, optometrist, nurse practitioner, physician assistant, certified midwife, psychiatric nurse mental health clinical specialist or veterinarian, essential for the treatment of the patient.  The amount or quantity of any controlled substance dispensed under this subsection shall not exceed the quantity of a controlled substance necessary for the immediate and proper treatment of the patient until it is possible for the patient to have a prescription filled by a pharmacy.  All controlled substances required by the patient as part of his treatment shall be dispensed by prescription to the ultimate user in accordance with this chapter.
           
This section shall not prohibit or limit the dispensing of any prescription medication that is classified by the department of public health as schedule VI and that is provided by the manufacturer as part of an indigent patient program or for use as samples if the prescription medication is: (i) dispensed to the patient by a professional authorized to dispense controlled substances pursuant to this section; (ii) dispensed in the package provided by the manufacturer; and (iii) provided at no charge to the patient.  The department shall promulgate rules and regulations governing the dispensing of medication pursuant to this section. These rules and regulations shall include, but not be limited to, those concerning the types and amounts of medications that may be dispensed and the appropriate safeguards for the labeling and dispensing of such medications.
           
(c) A nurse who has obtained from a physician, dentist, physician assistant, podiatrist, certified nurse-midwife, nurse practitioner, psychiatric nurse mental health clinical specialist, pharmacist or veterinarian a controlled substance for dispensing to an ultimate user pursuant to paragraph (b) or for administration to a patient pursuant to paragraph (a) during the absence of the physician, physician assistant, dentist, podiatrist, certified nurse-midwife, nurse practitioner, psychiatric nurse mental health clinical specialist, pharmacist or veterinarian, shall return to the physician, physician assistant, dentist, podiatrist, certified nurse-midwife, nurse practitioner, psychiatric nurse mental health clinical specialist, pharmacist or veterinarian any unused portion of the controlled substance which is no longer required by the patient.
           
(d) Every physician, physician assistant, dentist, podiatrist, certified nurse-midwife, nurse practitioner, psychiatric nurse mental health clinical specialist, pharmacist or veterinarian shall, in the course of a professional practice, keep and maintain records, open to inspection by the commissioner during reasonable business hours, which shall include the following: the names and quantities of any controlled substances in schedules I, II or III received by the practitioner; the name and address of each patient to whom such controlled substance is administered or dispensed; the name, dosage and strength per dosage unit of each such controlled substance; and the date of such administration or dispensing.    
     
(e) Notwithstanding paragraph (b), a physician, nurse practitioner, physician assistant, pharmacist as limited by paragraph (g) of section 7 of this chapter and section 24B½ of said chapter 112 or certified nurse-midwife, when acting in good faith and providing care under a program funded in whole or in part by 42 U.S.C. 300, or in a clinic licensed by the department to provide comparable medical services or a registered nurse, registered pursuant to section 74 of chapter 112 and authorized by such physician, nurse practitioner, physician assistant, pharmacist as limited by said paragraph (g) of said section 7 and section 24B½ of said chapter 112, or certified nurse-midwife, may lawfully dispense controlled substances pursuant to schedule VI to recipients of such services in such quantity as needed for treatment and shall be exempt from the requirement that such dispensing be in a single dosage or as necessary for immediate and proper treatment under subsection (b).  A registered nurse shall dispense under this subsection only as provided in section 17.  The department may establish rules and regulations controlling the dispensing of these medications, including, but not limited to, the types and amounts of medications dispensed and appropriate safeguards for dispensing.

SECTION 3. Chapter 112 of the General Laws is hereby amended by inserting after section 24B the following 2 sections:-
           
Section 24 B½. (a) As used in this section, the following terms shall have the following meanings unless the context clearly requires otherwise:

“Collaborative drug therapy management”, the initiating, monitoring, modifying and discontinuing of a patient's drug therapy by a pharmacist in accordance with a collaborative practice agreement; provided, however, that “collaborative drug therapy management” may include: collecting and reviewing patient histories; obtaining and checking vital signs, including pulse, temperature, blood pressure and respiration; and, under the supervision of, or in direct consultation with, a physician, ordering and evaluating the results of laboratory tests directly related to drug therapy when performed in accordance with approved protocols applicable to the practice setting and when the evaluation shall not include a diagnostic component. 
           
“Collaborative practice agreement”, a written and signed agreement between a pharmacist with training and experience relevant to the scope of the collaborative practice and a supervising physician that defines the collaborative practice in which the pharmacist and supervising physician propose to engage.  The collaborative practice shall be within the scope of the supervising physician’s practice.  Each collaborative practice agreement shall be subject to review and renewal on a biennial basis. A collaborative practice agreement shall include individually developed guidelines for any prescriptive practice of the pharmacist.

“Patient”, a person who is referred to a pharmacist by his supervising physician for the purpose of receiving collaborative drug therapy management services from the pharmacist.  The supervising physician shall assess the patient and include a diagnosis when referring the patient to the collaborating pharmacist.  The patient shall be notified of and consent to the collaborative drug therapy management services in the retail drug business setting. Individual referral and consent shall be recorded by the pharmacist and the supervising physician in the patient’s record.

(b)  In order for a pharmacist to enter into a collaborative practice agreement, the pharmacist shall: (1) hold a current license to practice pharmacy in the commonwealth and currently be engaged in pharmacy practice in the commonwealth; (2) have at least $1,000,000 of professional liability insurance; (3) have earned a doctor of pharmacy degree or have completed 5 years of experience as a licensed pharmacist or the equivalent; (4) agree to devote a portion of his practice to the defined drug therapy area that the pharmacist shall co-manage; and (5) agree to complete, in each year of the agreement, at least 5 additional contact hours or 0.5 continuing education units of board-approved continuing education that  addresses areas of practice generally related to collaborative practice agreements.

(c)  Collaborative drug therapy management shall only be allowed in the following settings: (1)  hospitals licensed pursuant to section 51 of chapter 111, subject to approval by the medical staff executive committee at a licensed hospital or designee; (2) long-term care facilities licensed  pursuant to section 71 of chapter 111, subject to approval by the long-term care facilities’ medical director or designee; (3) inpatient or outpatient hospice settings licensed  pursuant to section 57D of chapter 111, subject to approval by the hospice’s medical director or designee; (4) ambulatory care clinics licensed  pursuant to section 51 of chapter 111, with on-site supervision by the attending physician and a collaborating pharmacist, subject to approval by the ambulatory care clinic’s medical staff executive committee or designee, or medical director or designee; (5) a collaborating pharmacist in a retail drug business, as registered in section 38 of chapter 112 and limited by this section, with supervision by a physician according to the terms of his collaborative practice agreement and limited to the following:  patients 18 years of age or older; an extension by 30 days of current drug therapy prescribed by the supervising physician; administration of vaccines or the modification of dosages of medications prescribed by the supervising physician for asthma, chronic obstructive pulmonary disease, diabetes, hypertension, hyperlipidemia, congestive heart failure, HIV or AIDS, osteoporosis and  co-morbidities identified by the supervising physician for the individual patient along with the primary diagnosis.  The collaborative practice agreement shall specifically reference each disease state being co-managed.  A patient shall be referred by a supervising physician to that physician’s collaborating pharmacist and shall be given notice of the collaboration and consent to the collaboration.  No collaborative practice agreement in the retail drug business setting may permit the prescribing of schedule II through V controlled substances, as defined in section 3 of chapter 94C.  A pharmacist in the retail setting, who has a collaborative practice agreement with a supervising physician which specifically allows initial prescriptions for referred patients of the supervising physician, may issue prescriptions for schedule VI controlled substances, as defined in subsection 6 of section 3 of chapter 94C. Such prescriptions shall be for a patient diagnosis specified in the supervising physician’s individual referral of that patient. A copy of the prescription shall be sent to the supervising physician within 24 hours.

(d) A retail drug business practicing in collaborative drug therapy management under this section shall not be required to register as a Health Facility under 105 CMR 700.004(A)(2)(d).

(e) A physician or a physician group may hire pharmacists for the purpose of practicing collaborative drug therapy management under a collaborative practice agreement, as defined in subsection (a), for the benefit of a patient of that physician or physician group. No retail pharmacy may employ a physician for the purpose of maintaining, establishing or entering into a collaborative practice agreement with a patient.  Nothing shall prohibit a retail pharmacy from hiring a physician or licensed medical practitioner for the purpose of conducting quality assurance reviews of its pharmacists that are engaged in the practice of collaborative drug therapy.

Section 24 B¾. The board of registration in medicine and the board of registration in pharmacy shall issue rules and regulations to implement collaborative drug therapy management pursuant to section 24 B½ of this chapter and sections 7 and 9 of chapter 94C.  To aid in the implementation, the board of registration in medicine and the board of registration in pharmacy shall consult with at least 1 individual from each of the following groups:  the department of public health; the Massachusetts Society of Health-System Pharmacists; the Massachusetts chapter of the American Society of Consultant Pharmacists; the Massachusetts Pharmacists Association; the Massachusetts Independent Pharmacists Association; the Massachusetts Chain Pharmacy Council; the Massachusetts College of Pharmacy and Health Sciences; the Bouvé College of Health Sciences at Northeastern University; the Massachusetts Medical Society; the Massachusetts Academy of Family Physicians; the Massachusetts Chapter of the American Academy of Pediatrics; the Massachusetts Psychiatric Society; the Massachusetts chapter of the American Academy of Emergency Physicians; the Massachusetts Chapter of the American Medical Directors Association; and the Massachusetts Hospital Association.  The rules and regulations shall govern each collaborative practice agreement, shall be defined and limited by section 24B½ of this chapter, chapter 94C and other applicable statutes. The board of registration in medicine and the board of registration in pharmacy shall address the following issues:  (a) further limitations and conditions on sites and settings where a collaborative practice may take place beyond those of section 24; (b) the qualifications of participating pharmacists and physicians; (c) the scope of conditions or diseases to be managed, the initial list of which shall not include more than 5 disease states considered appropriate for collaborative management, providing that the 5 diseases selected for collaborative management in the retail setting must be from among those referenced in clause (5) of section (c) of section 24B½; (d) practice protocols; (e) risk management activities; (f) documentation of any initiation, modification or discontinuation of a patient's medication therapy in the patient's permanent medical record; (g) outcome measurements; and (i) informed consent procedures.  The board of registration in medicine and the board of registration in pharmacy shall reconsider these regulations on a periodic basis, as considered appropriate by the commissioner of public health for the purposes of adding or removing disease states to be managed under collaborative drug therapy treatment, as well as for the purpose of updating the rules and regulations governing collaborative drug therapy management, as necessary.