S.F. No. 2173, 3rd Engrossment - 87th Legislative Session (2011-2012) Posted on Apr 04, 2012
1.2relating to health; allowing a licensed physician to dispense drugs in a health
1.3care facility located in a designated health professional shortage area under
1.4certain conditions; authorizing automated drug distribution systems;amending
1.5Minnesota Statutes 2010, section 151.01, by adding subdivisions; Minnesota
1.6Statutes 2011 Supplement, section 151.19, by adding a subdivision; proposing
1.7coding for new law in Minnesota Statutes, chapter 151.
1.8BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
1.9 Section 1. Minnesota Statutes 2010, section 151.01, is amended by adding a
1.10subdivision to read:
1.11 Subd. 2a. Limited service pharmacy. "Limited service pharmacy" means a
1.12pharmacy that has been issued a restricted license by the board to perform a limited range
1.13of the activities that constitute the practice of pharmacy.
1.14 Sec. 2. Minnesota Statutes 2010, section 151.01, is amended by adding a subdivision
1.16 Subd. 34. Health professional shortage area. "Health professional shortage area"
1.17means an area designated as such by the federal Secretary of Health and Human Services,
1.18as provided under Code of Federal Regulations, title 42, part 5, and United States Code,
1.19title 42, section 254E.
1.20 Sec. 3. Minnesota Statutes 2011 Supplement, section 151.19, is amended by adding a
1.21subdivision to read:
1.22 Subd. 4. Licensing of physicians to dispense drugs; renewals. (a) The board may
1.23grant a license to any physician licensed under chapter 147 who provides services in a
2.1health care facility located in a designated health professional shortage area authorizing
2.2the physician to dispense drugs to individuals for whom pharmaceutical care is not
2.3reasonably available. The license may be renewed annually. Any physician licensed under
2.4this subdivision shall be limited to dispensing drugs in a limited service pharmacy and
2.5shall be governed by the rules adopted by the board when dispensing drugs.
2.6(b) For the purposes of this subdivision, pharmaceutical care is not reasonably
2.7available if the limited service pharmacy in which the physician is dispensing drugs is
2.8located in a health professional shortage area, and no other licensed pharmacy is located
2.9within 15 miles of the limited service pharmacy.
2.10(c) For the purposes of this subdivision, section 151.15, subdivision 2, shall not
2.11apply, and section 151.215 shall not apply provided that a physician granted a license
2.12under this subdivision certifies each filled prescription in accordance with Minnesota
2.13Rules, part 6800.3100, subpart 3.
2.14(d) Notwithstanding section 151.102, a physician granted a license under this
2.15subdivision may be assisted by a pharmacy technician if the technician holds a valid
2.16certification from the Pharmacy Technician Certification Board or from another national
2.17certification body for pharmacy technicians that requires passage of a nationally recognized
2.18psychometrically valid certification examination for certification as determined by the
2.19board. The physician may supervise the pharmacy technician as long as the physician
2.20assumes responsibility for all functions performed by the technician. For purposes of this
2.21subdivision, supervision does not require the physician to be physically present if the
2.22physician or a licensed pharmacist is available, either electronically or by telephone.
2.23(e) Nothing in this subdivision shall be construed to prohibit a physician from
2.24dispensing drugs pursuant to section 151.37 and Minnesota Rules, parts 6800.9950
2.26 Sec. 4. [151.58] AUTOMATED DRUG DISTRIBUTION SYSTEMS.
2.27 Subdivision 1. Scope. This section applies only to the use of automated drug
2.28distribution systems located within the facilities specified in subdivision 2. Except as
2.29provided in this section, all applicable provisions of this chapter, chapter 152, and
2.30Minnesota Rules, chapter 6800, must be followed.
2.31 Subd. 2. Definitions. For purposes of this section only, the terms defined in this
2.32subdivision have the meanings given.
2.33(a) "Automated drug distribution system" or "system" means a mechanical system
2.34approved by the board that performs operations or activities, other than compounding or
3.1administration, related to the storage, packaging, or dispensing of drugs, and collects,
3.2controls, and maintains all required transaction information and records.
3.3(b) "Health care facility" means a nursing home licensed under section 144A.02;
3.4a housing with services establishment registered under section 144D.01, subdivision 4,
3.5in which a home provider licensed under chapter 144A is providing centralized storage
3.6of medications; or a community behavioral health hospital or Minnesota sex offender
3.7program facility operated by the Department of Human Services.
3.8(c) "Managing pharmacy" means a pharmacy licensed by the board that controls and
3.9is responsible for the operation of an automated drug distribution system.
3.10 Subd. 3. Authorization. A pharmacy may use an automated drug distribution
3.11system to fill prescription drug orders for patients of a health care facility. The automated
3.12drug distribution system may be located in a health care facility that is not at the same
3.13location as the managing pharmacy. When located within a health care facility, the system
3.14is considered to be an extension of the managing pharmacy.
3.15 Subd. 4. Notification. (a) At least 60 days prior to the initial use of an automated
3.16drug distribution system, the managing pharmacy must provide the board with written
3.17notification of the address at which the automated drug distribution system will be
3.18located, the manufacturer and model of the automated drug distribution system, and
3.19written policies and procedures that govern the operation of the system. The policies
3.20and procedures must address the requirements of subdivision 5 and the rules of the
3.21board. If the managing pharmacy will be using a system identical to the one for which
3.22it has previously provided notification to the board, and will be using identical policies
3.23and procedures, it must notify the board of the address at which the automated drug
3.24distribution system will be located and the manufacturer and model of the automated drug
3.25distribution system at least seven days in advance of using the system.
3.26(b) The managing pharmacy must notify the board whenever an automated drug
3.27distribution system is taken permanently out of service.
3.28(c) The managing pharmacy must notify the board whenever an automated drug
3.29distribution system is replaced. It must also provide the board with new written policies
3.30and procedures, unless an identical system is used as the replacement, 60 days prior to
3.31the replacement of the system.
3.32 Subd. 5. Operation of automated drug distribution systems. (a) The managing
3.33pharmacy and the pharmacist in charge are responsible for the operation of an automated
3.34drug distribution system.
3.35(b) Access to an automated drug distribution system must be limited to pharmacy
3.36and nonpharmacy personnel authorized to procure drugs from the system, except that field
4.1service technicians may access a system located in a health care facility for the purposes of
4.2servicing and maintaining it while being monitored either by the managing pharmacy, or a
4.3licensed nurse within the health care facility. In the case of an automated drug distribution
4.4system that is not physically located within a licensed pharmacy, access for the purpose
4.5of procuring drugs shall be limited to licensed nurses. Each person authorized to access
4.6the system must be assigned an individual specific access code. Alternatively, access to
4.7the system may be controlled through the use of biometric identification procedures. A
4.8policy specifying time access parameters, including time-outs, logoffs, and lockouts,
4.9must be in place.
4.10(c) For the purposes of this section only, the requirements of section 151.215 are met
4.11if the following clauses are met:
4.12(1) a pharmacist employed by and working at the managing pharmacy must review,
4.13interpret, and approve all prescription drug orders before any drug is distributed from the
4.14system to be administered to a patient. A pharmacy technician may perform data entry of
4.15prescription drug orders provided that a pharmacist certifies the accuracy of the data entry
4.16before the drug can be released from the automated drug distribution system. A pharmacist
4.17must certify the accuracy of the filling of any cassettes, canisters, or other containers that
4.18contain drugs that will be loaded into the automated drug distribution system; and
4.19(2) when the automated drug dispensing system is located and used within the
4.20managing pharmacy, a pharmacist must personally supervise and take responsibility for all
4.21packaging and labeling associated with the use of an automated drug distribution system.
4.22(d) Access to drugs when a pharmacist has not reviewed and approved the
4.23prescription drug order is permitted only when a formal and written decision to allow such
4.24access is issued by the pharmacy and the therapeutics committee or its equivalent. The
4.25committee must specify the patient care circumstances in which such access is allowed,
4.26the drugs that can be accessed, and the staff that are allowed to access the drugs.
4.27(e) In the case of an automated drug distribution system that does not utilize bar
4.28coding in the loading process, the loading of a system located in a health care facility may
4.29be performed by a pharmacy technician, so long as the activity is continuously supervised,
4.30through a two-way audiovisual system by a pharmacist on duty within the managing
4.31pharmacy. In the case of an automated drug distribution system that utilizes bar coding
4.32in the loading process, the loading of a system located in a health care facility may be
4.33performed by a pharmacy technician or a licensed nurse, provided that the managing
4.34pharmacy retains an electronic record of loading activities.
4.35(f) The automated drug distribution system must be under the supervision of a
4.36pharmacist. The pharmacist is not required to be physically present at the site of the
5.1automated drug distribution system if the system is continuously monitored electronically
5.2by the managing pharmacy. A pharmacist on duty within a pharmacy licensed by the
5.3board must be continuously available to address any problems detected by the monitoring
5.4or to answer questions from the staff of the health care facility. The licensed pharmacy
5.5may be the managing pharmacy or a pharmacy which is acting as a central services
5.6pharmacy, pursuant to Minnesota Rules, part 6800.4075, for the managing pharmacy.