Bill Text: MN SF2173 | 2011-2012 | 87th Legislature | Engrossed
NOTE: There are more recent revisions of this legislation. Read Latest Draft
Bill Title: Automated drug distribution systems authorization; physicians drugs dispensing in health care facilities located in health professional shortage areas
Spectrum: Bipartisan Bill
Status: (Passed) 2012-04-16 - Secretary of State Chapter 166 04/09/12 [SF2173 Detail]
Download: Minnesota-2011-SF2173-Engrossed.html
Bill Title: Automated drug distribution systems authorization; physicians drugs dispensing in health care facilities located in health professional shortage areas
Spectrum: Bipartisan Bill
Status: (Passed) 2012-04-16 - Secretary of State Chapter 166 04/09/12 [SF2173 Detail]
Download: Minnesota-2011-SF2173-Engrossed.html
1.2relating to health; providing for a limited service pharmacy license; authorizing
1.3automated drug distribution systems;amending Minnesota Statutes 2010, section
1.4151.01, by adding subdivisions; Minnesota Statutes 2011 Supplement, section
1.5151.19, by adding a subdivision; proposing coding for new law in Minnesota
1.6Statutes, chapter 151.
1.7BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
1.8 Section 1. Minnesota Statutes 2010, section 151.01, is amended by adding a
1.9subdivision to read:
1.10 Subd. 2a. Limited service pharmacy. "Limited service pharmacy" means a
1.11pharmacy that has been issued a restricted license by the board to perform a limited range
1.12of the activities that constitute the practice of pharmacy.
1.13 Sec. 2. Minnesota Statutes 2010, section 151.01, is amended by adding a subdivision
1.14to read:
1.15 Subd. 34. Health professional shortage area. "Health professional shortage area"
1.16means an area designated as such by the federal Secretary of Health and Human Services,
1.17as provided under Code of Federal Regulations, title 42, part 5, and United States Code,
1.18title 42, section 254E.
1.19 Sec. 3. Minnesota Statutes 2011 Supplement, section 151.19, is amended by adding a
1.20subdivision to read:
1.21 Subd. 4. Licensing of physicians to dispense drugs; renewals. (a) The board may
1.22grant a license to any physician licensed under chapter 147 authorizing the physician to
1.23dispense drugs to individuals for whom pharmaceutical care is not reasonably available.
2.1The license may be renewed annually. Any physician licensed under this subdivision shall
2.2be limited to dispensing drugs in a limited services pharmacy and shall be governed by the
2.3rules adopted by the board when dispensing drugs.
2.4(b) For the purposes of this subdivision, pharmaceutical care is not reasonably
2.5available if the pharmacy in which the physician is dispensing drugs is located in a health
2.6professional shortage area.
2.7(c) For the purposes of this subdivision, section 151.15, subdivision 2, shall not
2.8apply, and section 151.215 shall not apply provided that a physician granted a license
2.9under this subdivision certifies each filled prescription in accordance with Minnesota
2.10Rules, part 6800.3100, subpart 3.
2.11(d) Notwithstanding section 151.102, a physician granted a license under this
2.12subdivision may be assisted by a pharmacy technician if the technician holds a valid
2.13certification from the Pharmacy Technician Certification Board or from another national
2.14certification body for pharmacy technicians that requires passage of a nationally recognized
2.15psychometrically valid certification examination for certification as determined by the
2.16board. The physician may supervise the pharmacy technician as long as the physician
2.17assumes responsibility for all functions performed by the technician. For purposes of this
2.18subdivision, supervision does not require the physician to be physically present if the
2.19physician or a licensed pharmacist is available, either electronically or by telephone.
2.20(e) Nothing in this subdivision shall be construed to prohibit a physician from
2.21dispensing drugs pursuant to section 151.37 and Minnesota Rules, parts 6800.9950
2.22to 6800.9954.
2.23 Sec. 4. [151.58] AUTOMATED DRUG DISTRIBUTION SYSTEMS.
2.24 Subdivision 1. Scope. This section applies only to the use of automated drug
2.25distribution systems located within the facilities specified in subdivision 2. Except as
2.26provided in this section, all applicable provisions of this chapter, chapter 152, and
2.27Minnesota Rules, chapter 6800, must be followed.
2.28 Subd. 2. Definitions. For purposes of this section only, the terms defined in this
2.29subdivision have the meanings given.
2.30(a) "Automated drug distribution system" or "system" means a mechanical system
2.31approved by the board that performs operations or activities, other than compounding or
2.32administration, related to the storage, packaging, or dispensing of drugs, and collects,
2.33controls, and maintains all required transaction information and records.
2.34(b) "Health care facility" means a nursing home licensed under section 144A.02; a
2.35housing with services establishment registered under section 144D.01, subdivision 4, that
3.1provides centralized storage of medications; or a community behavioral health hospital or
3.2Minnesota sex offender program facility operated by the Department of Human Services.
3.3(c) "Managing pharmacy" means a pharmacy licensed by the board that controls and
3.4is responsible for the operation of an automated drug distribution system.
3.5 Subd. 3. Authorization. A pharmacy may use an automated drug distribution
3.6system to fill prescription drug orders for patients of a health care facility. The automated
3.7drug distribution system may be located in a health care facility that is not at the same
3.8location as the managing pharmacy. When located within a health care facility, the system
3.9is considered to be an extension of the managing pharmacy.
3.10 Subd. 4. Notification. (a) At least 60 days prior to the initial use of an automated
3.11drug distribution system, the managing pharmacy must provide the board with written
3.12notification of the address at which the automated drug distribution system will be
3.13located, the manufacturer and model of the automated drug distribution system, and
3.14written policies and procedures that govern the operation of the system. The policies
3.15and procedures must address the requirements of subdivision 5 and the rules of the
3.16board. If the managing pharmacy will be using a system identical to the one for which
3.17it has previously provided notification to the board, and will be using identical policies
3.18and procedures, it must notify the board of the address at which the automated drug
3.19distribution system will be located and the manufacturer and model of the automated drug
3.20distribution system at least seven days in advance of using the system.
3.21(b) The managing pharmacy must notify the board whenever an automated drug
3.22distribution system is taken permanently out of service.
3.23(c) The managing pharmacy must notify the board whenever an automated drug
3.24distribution system is replaced. It must also provide the board with new written policies
3.25and procedures, unless an identical system is used as the replacement, 60 days prior to
3.26the replacement of the system.
3.27 Subd. 5. Operation of automated drug distribution systems. (a) The managing
3.28pharmacy and the pharmacist in charge are responsible for the operation of an automated
3.29drug distribution system.
3.30(b) Access to an automated drug distribution system must be limited to pharmacy
3.31and nonpharmacy personnel authorized to procure drugs from the system, except that field
3.32service technicians may access a system located in a health care facility for the purposes of
3.33servicing and maintaining it while being monitored either by the managing pharmacy, or a
3.34licensed nurse within the health care facility. In the case of an automated drug distribution
3.35system that is not physically located within a licensed pharmacy, access for the purpose
3.36of procuring drugs shall be limited to licensed nurses. Each person authorized to access
4.1the system must be assigned an individual specific access code. Alternatively, access to
4.2the system may be controlled through the use of biometric identification procedures. A
4.3policy specifying time access parameters, including time-outs, log-offs, and lock-outs,
4.4must be in place.
4.5(c) For the purposes of this section only, the requirements of section 151.215 are met
4.6if the following clauses are met:
4.7(1) a pharmacist employed by and working at the managing pharmacy must review,
4.8interpret, and approve all prescription drug orders before any drug is distributed from the
4.9system to be administered to a patient. A pharmacy technician may perform data entry of
4.10prescription drug orders provided that a pharmacist certifies the accuracy of the data entry
4.11before the drug can be released from the automated drug distribution system. A pharmacist
4.12must certify the accuracy of the filling of any cassettes, canisters, or other containers that
4.13contain drugs that will be loaded into the automated drug distribution system; and
4.14(2) when the automated drug dispensing system is located and used within the
4.15managing pharmacy, a pharmacist must personally supervise and take responsibility for all
4.16packaging and labeling associated with the use of an automated drug distribution system.
4.17(d) Access to drugs when a pharmacist has not reviewed and approved the
4.18prescription drug order is permitted only when a formal and written decision to allow such
4.19access is issued by the pharmacy and the therapeutics committee or its equivalent. The
4.20committee must specify the patient care circumstances in which such access is allowed,
4.21the drugs that can be accessed, and the staff that are allowed to access the drugs.
4.22(e) The loading of a automated drug dispensing system located in a health care
4.23facility may be performed by a pharmacy technician, so long as the activity is continuously
4.24supervised, through a two-way audiovisual system by a pharmacist on duty within the
4.25managing pharmacy.
4.26(f) The automated drug distribution system must be under the supervision of a
4.27pharmacist. The pharmacist is not required to be physically present at the site of the
4.28automated drug distribution system if the system is continuously monitored electronically
4.29by the managing pharmacy. A pharmacist on duty within the managing pharmacy must be
4.30continuously available to address any problems detected by the monitoring or to answer
4.31questions from the staff of the health care facility.
1.3automated drug distribution systems;amending Minnesota Statutes 2010, section
1.4151.01, by adding subdivisions; Minnesota Statutes 2011 Supplement, section
1.5151.19, by adding a subdivision; proposing coding for new law in Minnesota
1.6Statutes, chapter 151.
1.7BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
1.8 Section 1. Minnesota Statutes 2010, section 151.01, is amended by adding a
1.9subdivision to read:
1.10 Subd. 2a. Limited service pharmacy. "Limited service pharmacy" means a
1.11pharmacy that has been issued a restricted license by the board to perform a limited range
1.12of the activities that constitute the practice of pharmacy.
1.13 Sec. 2. Minnesota Statutes 2010, section 151.01, is amended by adding a subdivision
1.14to read:
1.15 Subd. 34. Health professional shortage area. "Health professional shortage area"
1.16means an area designated as such by the federal Secretary of Health and Human Services,
1.17as provided under Code of Federal Regulations, title 42, part 5, and United States Code,
1.18title 42, section 254E.
1.19 Sec. 3. Minnesota Statutes 2011 Supplement, section 151.19, is amended by adding a
1.20subdivision to read:
1.21 Subd. 4. Licensing of physicians to dispense drugs; renewals. (a) The board may
1.22grant a license to any physician licensed under chapter 147 authorizing the physician to
1.23dispense drugs to individuals for whom pharmaceutical care is not reasonably available.
2.1The license may be renewed annually. Any physician licensed under this subdivision shall
2.2be limited to dispensing drugs in a limited services pharmacy and shall be governed by the
2.3rules adopted by the board when dispensing drugs.
2.4(b) For the purposes of this subdivision, pharmaceutical care is not reasonably
2.5available if the pharmacy in which the physician is dispensing drugs is located in a health
2.6professional shortage area.
2.7(c) For the purposes of this subdivision, section 151.15, subdivision 2, shall not
2.8apply, and section 151.215 shall not apply provided that a physician granted a license
2.9under this subdivision certifies each filled prescription in accordance with Minnesota
2.10Rules, part 6800.3100, subpart 3.
2.11(d) Notwithstanding section 151.102, a physician granted a license under this
2.12subdivision may be assisted by a pharmacy technician if the technician holds a valid
2.13certification from the Pharmacy Technician Certification Board or from another national
2.14certification body for pharmacy technicians that requires passage of a nationally recognized
2.15psychometrically valid certification examination for certification as determined by the
2.16board. The physician may supervise the pharmacy technician as long as the physician
2.17assumes responsibility for all functions performed by the technician. For purposes of this
2.18subdivision, supervision does not require the physician to be physically present if the
2.19physician or a licensed pharmacist is available, either electronically or by telephone.
2.20(e) Nothing in this subdivision shall be construed to prohibit a physician from
2.21dispensing drugs pursuant to section 151.37 and Minnesota Rules, parts 6800.9950
2.22to 6800.9954.
2.23 Sec. 4. [151.58] AUTOMATED DRUG DISTRIBUTION SYSTEMS.
2.24 Subdivision 1. Scope. This section applies only to the use of automated drug
2.25distribution systems located within the facilities specified in subdivision 2. Except as
2.26provided in this section, all applicable provisions of this chapter, chapter 152, and
2.27Minnesota Rules, chapter 6800, must be followed.
2.28 Subd. 2. Definitions. For purposes of this section only, the terms defined in this
2.29subdivision have the meanings given.
2.30(a) "Automated drug distribution system" or "system" means a mechanical system
2.31approved by the board that performs operations or activities, other than compounding or
2.32administration, related to the storage, packaging, or dispensing of drugs, and collects,
2.33controls, and maintains all required transaction information and records.
2.34(b) "Health care facility" means a nursing home licensed under section 144A.02; a
2.35housing with services establishment registered under section 144D.01, subdivision 4, that
3.1provides centralized storage of medications; or a community behavioral health hospital or
3.2Minnesota sex offender program facility operated by the Department of Human Services.
3.3(c) "Managing pharmacy" means a pharmacy licensed by the board that controls and
3.4is responsible for the operation of an automated drug distribution system.
3.5 Subd. 3. Authorization. A pharmacy may use an automated drug distribution
3.6system to fill prescription drug orders for patients of a health care facility. The automated
3.7drug distribution system may be located in a health care facility that is not at the same
3.8location as the managing pharmacy. When located within a health care facility, the system
3.9is considered to be an extension of the managing pharmacy.
3.10 Subd. 4. Notification. (a) At least 60 days prior to the initial use of an automated
3.11drug distribution system, the managing pharmacy must provide the board with written
3.12notification of the address at which the automated drug distribution system will be
3.13located, the manufacturer and model of the automated drug distribution system, and
3.14written policies and procedures that govern the operation of the system. The policies
3.15and procedures must address the requirements of subdivision 5 and the rules of the
3.16board. If the managing pharmacy will be using a system identical to the one for which
3.17it has previously provided notification to the board, and will be using identical policies
3.18and procedures, it must notify the board of the address at which the automated drug
3.19distribution system will be located and the manufacturer and model of the automated drug
3.20distribution system at least seven days in advance of using the system.
3.21(b) The managing pharmacy must notify the board whenever an automated drug
3.22distribution system is taken permanently out of service.
3.23(c) The managing pharmacy must notify the board whenever an automated drug
3.24distribution system is replaced. It must also provide the board with new written policies
3.25and procedures, unless an identical system is used as the replacement, 60 days prior to
3.26the replacement of the system.
3.27 Subd. 5. Operation of automated drug distribution systems. (a) The managing
3.28pharmacy and the pharmacist in charge are responsible for the operation of an automated
3.29drug distribution system.
3.30(b) Access to an automated drug distribution system must be limited to pharmacy
3.31and nonpharmacy personnel authorized to procure drugs from the system, except that field
3.32service technicians may access a system located in a health care facility for the purposes of
3.33servicing and maintaining it while being monitored either by the managing pharmacy, or a
3.34licensed nurse within the health care facility. In the case of an automated drug distribution
3.35system that is not physically located within a licensed pharmacy, access for the purpose
3.36of procuring drugs shall be limited to licensed nurses. Each person authorized to access
4.1the system must be assigned an individual specific access code. Alternatively, access to
4.2the system may be controlled through the use of biometric identification procedures. A
4.3policy specifying time access parameters, including time-outs, log-offs, and lock-outs,
4.4must be in place.
4.5(c) For the purposes of this section only, the requirements of section 151.215 are met
4.6if the following clauses are met:
4.7(1) a pharmacist employed by and working at the managing pharmacy must review,
4.8interpret, and approve all prescription drug orders before any drug is distributed from the
4.9system to be administered to a patient. A pharmacy technician may perform data entry of
4.10prescription drug orders provided that a pharmacist certifies the accuracy of the data entry
4.11before the drug can be released from the automated drug distribution system. A pharmacist
4.12must certify the accuracy of the filling of any cassettes, canisters, or other containers that
4.13contain drugs that will be loaded into the automated drug distribution system; and
4.14(2) when the automated drug dispensing system is located and used within the
4.15managing pharmacy, a pharmacist must personally supervise and take responsibility for all
4.16packaging and labeling associated with the use of an automated drug distribution system.
4.17(d) Access to drugs when a pharmacist has not reviewed and approved the
4.18prescription drug order is permitted only when a formal and written decision to allow such
4.19access is issued by the pharmacy and the therapeutics committee or its equivalent. The
4.20committee must specify the patient care circumstances in which such access is allowed,
4.21the drugs that can be accessed, and the staff that are allowed to access the drugs.
4.22(e) The loading of a automated drug dispensing system located in a health care
4.23facility may be performed by a pharmacy technician, so long as the activity is continuously
4.24supervised, through a two-way audiovisual system by a pharmacist on duty within the
4.25managing pharmacy.
4.26(f) The automated drug distribution system must be under the supervision of a
4.27pharmacist. The pharmacist is not required to be physically present at the site of the
4.28automated drug distribution system if the system is continuously monitored electronically
4.29by the managing pharmacy. A pharmacist on duty within the managing pharmacy must be
4.30continuously available to address any problems detected by the monitoring or to answer
4.31questions from the staff of the health care facility.
