Not applicable. Rule corrects a drafting error.
Faxing Schedule II Controlled Substance Prescriptions.
Neither the statutes nor rules establish prima facie permission for pharmacists to dispense schedule II controlled substances faxed by a practitioner on behalf of patients residing in-home that are eligible for nursing home placement.
Iowa:
Pharmacy Alarms, Security.
657—6.7(124,155A) Security. While on duty, each pharmacist shall be responsible for the security of the prescription department, including provisions for effective control against theft of, diversion of, or unauthorized access to prescription drugs, records for such drugs, and patient records as provided in 657—Chapter
21.
6.7(1) Department locked. The prescription department shall be locked by key or combination so as to prevent access when a pharmacist is not on site except as provided in subrule 6.7(2).
6.7(2) Temporary absence of pharmacist. In the temporary absence of the pharmacist, only the pharmacist in charge may designate persons who may be present in the prescription department to perform technical and nontechnical functions designated by the pharmacist in charge. Activities identified in subrule 6.7(3) may not be performed during such temporary absence of the pharmacist. A temporary absence is an absence of short duration not to exceed two hours. In the absence of the pharmacist, the pharmacy shall notify the public that the pharmacist is temporarily absent and that no prescriptions will be dispensed until the pharmacist returns.
8.5(3) Secure barrier. The pharmacy department shall be surrounded by a physical barrier capable of being securely locked to prevent entry when the department is closed. A secure barrier may be constructed of other than a solid material with a continuous surface if the openings in the material are not large enough to permit removal of items from the pharmacy department by any means. Any material used in the construction of the barrier shall be sufficient strength and thickness that it cannot be readily or easily removed, penetrated, or bent. The plans and specifications of the barrier shall be submitted to the board for approval prior to the start of construction. The board may also require on-site inspection of the facility or pharmacy department prior to the pharmacy's opening or relocation. The pharmacy department shall be closed and secured in the absence of the pharmacist except as provided in rule 657—6.7(124,155A) or 657—7.6(124,155A). [4/4/2007]
Utilization Review.
Not applicable. Rule corrects a drafting error.
Faxing Schedule II Controlled Substance Prescriptions.
Neither the statutes nor rules establish prima facie permission for pharmacists to dispense schedule II controlled substances faxed by a practitioner on behalf of patients residing in-home that are eligible for nursing home placement.
Michigan:
Pharmacy Alarms, Security.
R 338.482 Housing of pharmacy.
(3) All pharmacies that occupy less than the entire area of the premises owned, leased, used, or controlled by the licensee shall be permanently enclosed by partitions from the floor to the ceiling. All partitions shall be of substantial construction and shall be securely lockable so that drugs and devices that can only be sold by a pharmacist are unobtainable during the absence of the pharmacist. Identification of this department by the use of the words “drug," “medicines," or “pharmacy" or by the use of a similar term or combination of terms shall be restricted to the area that is registered by the board. The pharmacy department shall be locked when the pharmacist is not in the establishment.
Utilization Review.
Not applicable. Rule corrects a drafting error.
Faxing Schedule II Controlled Substance Prescriptions.
Neither the statutes nor rules establish prima facie permission for pharmacists to dispense schedule II controlled substances faxed by a practitioner on behalf of patients residing in-home that are eligible for nursing home placement.
Minnesota:
Pharmacy Alarms, Security.
6800.0700 PHARMACY, SPACE, AND SECURITY.
Subpart 1 D. The pharmacy must be surrounded by a continuous partition or wall extending from the floor to the permanent ceiling, containing doors capable of being securely locked to prevent entry when the pharmacy is closed.
Utilization Review.
Not applicable. Rule corrects a drafting error.
Faxing Schedule II Controlled Substance Prescriptions.
Neither the statutes nor rules establish prima facie permission for pharmacists to dispense schedule II controlled substances faxed by a practitioner on behalf of patients residing in-home that are eligible for nursing home placement.
Summary of factual data and analytical methodologies:
The board recognized the need to tighten security requirements so that all pharmacies, even if they are located within a larger structure that is alarmed, would be equipped with an alarm. The board was contacted about the barriers to providing care to long term pharmacy care patients who receive care at home. As a result of a subsequent discussion during a board meeting, the board decided to change its controlled substances faxing rule.
Analysis and supporting documents used to determine effect on small business
Requiring all pharmacies to be alarmed may have an impact on small businesses, but its primary impact is on chain or hospital pharmacies that are more typically inside a larger structure. The faxing change will assist small businesses in providing care to long term care patients at home.
Section
227.137, Stats., requires an “agency" to prepare an economic impact report before submitting the proposed rule-making order to the Wisconsin Legislative Council. The Department of Regulation and Licensing is not included as an “agency" in this section.
Small Business Impact
These proposed rules were reviewed and discussed by the department's Small Business Review Advisory Committee which determined that the rules will have no significant economic impact on a substantial number of small businesses, as defined in s.
227.114 (1), Stats.
The Department's Regulatory Review Coordinator may be contacted by email at
hector.colon@wisconsin.gov, or by calling 608-266-8608.
Fiscal Estimate
Summary
The department estimates that this rule will require staff time in the Division of Professional Credentialing. The total one-time salary and fringe costs are estimated at $266.
Anticipated costs incurred by private sector
The department finds that this rule has no significant fiscal effect on the private sector.
Agency Contact Person
Pamela Haack, Paralegal, Department of Regulation and Licensing, 1400 East Washington Avenue, Room 152, P.O. Box 8935, Madison, Wisconsin 53708; telephone 608-266-0495; email at
pamela.haack@wisconsin.gov.
Notice of Hearing
Pharmacy Examining Board
NOTICE IS HEREBY GIVEN that pursuant to authority vested in the Pharmacy Examining Board in ss.
15.08 (5) (b),
227.11 (2),
450.02 (3) (d) and
450.062, Stats., the Pharmacy Examining Board will hold a public hearing at the time and place indicated below to consider an order to create section
Phar 7.095, relating to remote dispensing sites.
Hearing Information
Date: December 2, 2009
Time: 9:30 a.m.
Location: 1400 East Washington Avenue
(Enter at 55 North Dickinson Street)
Room 121A
Madison, Wisconsin
Appearances at the Hearing and Submission of Written Comments
Interested persons are invited to present information at the hearing. Persons appearing may make an oral presentation but are urged to submit facts, opinions and argument in writing as well. Facts, opinions and argument may also be submitted in writing without a personal appearance by mail addressed to Pamela Haack, Paralegal, Department of Regulation and Licensing, Division of Board Services, 1400 East Washington Avenue, Room 152, P.O. Box 8935, Madison, WI 53708-8935, or by email to pamela.haack@ wisconsin.gov. Comments must be received on or before December 2, 2009, to be included in the record of rule-making proceedings.
Copies of Proposed Rule
Copies of this proposed rule are available upon request to Pamela Haack, Paralegal, Department of Regulation and Licensing, Division of Board Services, 1400 East Washington Avenue, P.O. Box 8935, Madison, Wisconsin 53708, or by email at
pamela.haack@wisconsin.gov.
Analysis Prepared by Department of Regulation and Licensing
Statutes interpreted
Statutory authority
Explanation of agency authority
The board is authorized under s.
450.02 (3) (d), Stats., to promulgate rules necessary for the administration of ch.
450, Stats., and under s.
450.062, Stats., to promulgate rules relating to the establishment and operation of remote dispensing sites.
Related statute or rule
Section
Phar 7.09 relates to the use of automated dispensing systems.
Plain language analysis
SECTION 1 creates s.
Phar 7.095, which sets forth the process and procedures for establishing and operating remote dispensing sites.
As stated in s.
450.06 (1), Stats., except as provided in rules adopted by the board under s.
450.062, Stats., no pharmacist may dispense at any location that is not licensed as a pharmacy by the board. The board is proposing to adopt these rules to set forth the process and procedures for establishing and operating remote dispensing sites.
The proposed rules include definitions for “health care facility," “managing pharmacist," “practitioner," “remote dispensing site," and “supervising pharmacy." The proposed rules also clarify that a remote dispensing site shall not be licensed as a pharmacy and that no person may use or display certain titles in connection with the operation of a remote dispensing site. In addition, the proposed rules identify where remote dispensing sites may be located; the requirements for operating remote dispensing sites; the requirements for dispensing; the responsibilities of managing pharmacists, and the requirements for pharmacy technicians and interns.
Comparison with federal regulations
There is no existing or proposed federal regulation.
Comparison with rules in adjacent states
Illinois:
Statutes: Section 225 ILCS 85
Rules: Section 1330.98
Illinois' statutes provide a significant amount of detail as to tele-pharmacy, remote prescription processing, common electronic filing, automated dispensing and storage systems, and centralized prescription filling. Tele-pharmacy is included as part of the definition of the practice of pharmacy. Tele-pharmacy models must meet a set of conditions regarding pharmacist responsibility, technician training, supervision and patient counseling. Remote prescription processing, or “outsourcing" occurs when at least one of eight listed functions are identified. Conditions under which remote prescription processing may occur are also specified, including ownership, electronic filing and record maintenance provisions. The statutes are very detailed regarding automated pharmacy systems/remote dispensing. Subjects covered include: security; procedures; confidentiality; designated personnel; storage (temperature, proper containers, handling outdated drugs), dispensing and delivery, home pharmacy supervision and re-stocking of systems that use removable cartridges. The rules provide additional detail for automated dispensing and storage systems, including provisions relating to documentation, storage, security, record keeping, stocking, proper containers, and quality assurance.
Iowa:
Rules: Chapters
9 and
18.
Chapter
9 of Iowa's rules relates to automated medication dispensing systems, including: pharmacist responsibilities; quality assurance; policies and procedures; system, site and process requirements; dispensing and distributing; security and confidentiality; records; error identification and logging; verification and accuracy; reporting; and outpatient automated medication dispensing. Chapter
18 addresses centralized filling and processing, including: system qualifications; labeling; legal compliance; patient notification; originating pharmacy compliance; policies and procedures; and records.
Michigan:
Statutes: Section
333.17753, Michigan Public Health Code
Michigan's statutes include a section on centralized prescription filling, which lists the record-keeping, security and quality improvement conditions that apply to outsourcing. The rules state that a license is required at each separate location where drugs are prepared or dispensed.
Minnesota:
Rules: Section 6800.0800, 2600, 4075, 6600
Minnesota's statutes define central service pharmacy as a pharmacy that may provide dispensing functions, drug utilization review, packaging, labeling, or delivery of a prescription product to another pharmacy for the purpose of filling a prescription. Minnesota's rules provide definitions for community and hospital satellite pharmacies. Plans for satellite pharmacies must be submitted to the board for approval. The rules also specify the requirements for vending machines (responsibility, policies and procedures), centralized processing and filling (ownership, filing, policy and procedures manual, records, tracking of drugs, security, quality improvement, counseling and notification), and freedom of choice.
Summary of factual data and analytical methodologies
The board created a committee to draft remote dispensing guidelines after
2007 Wisconsin Act 202 (Senate Bill 409) became effective. The committee met once and devised several safeguards to protect the public. Since the remote dispensing model departs from the traditional dispensing model, the board sought to address drug security, training and supervision of remote site staff, privacy, labeling and quality assurance in the context of remote site dispensing. The final guidelines, which have been written into this rule draft, are the result of committee discussions and recommendations that were finalized by the full board.
