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.
Analysis and supporting documents used to determine effect on small business
This rule will have an impact on small businesses, though it is not clear exactly what impact it will have. The board received correspondence expressing concerns and suggesting that the remote sites will adversely impact chain and independent pharmacies in the region, making it more difficult to compete. One pharmacy owner suggested protective language in the remote dispensing rules that would disallow remote sites within a pre-determined radius of existing pharmacies. The board took up the concerns at its July 22, 2009 meeting and deliberated on the benefits and costs of the legislation, noting that its primary purpose is to increase access to prescription drugs. The board also noted that small business concerns were heard while the legislation was pending, resulting in Amendment 1 to Senate Bill 409, which limited remote dispensing to sites specifically identified in the legislation. It was noted in testimony that there is a likelihood that small businesses will benefit from new ventures with clinics and practitioners. The board also considered other possibilities, such as improved care coordination and the increased likelihood of patients to fill prescriptions at a remote site located at a health clinic.
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 these rules will have no significant economic impact on a substantial number of small businesses, as defined in s.
227.114 (1), Stats.
Fiscal Estimate
Summary
The department estimates that this rule will require staff time in the Division of Board Services. The total on-going salary and fringe costs are estimated at $7,100.
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, Division of Board Services, 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
Public Defender Board
NOTICE IS HEREBY GIVEN that pursuant to ss.
977.02 (5),
(6) and
(8), and
977.03 (3), Stats., the State Public Defender (SPD) will hold a public hearing to consider a proposed order to revise Chapter
PD 1, relating to the certification of private bar attorneys to accept appointments to provide legal representation for state public defender clients.
Hearing Information
SPD will hold a public hearing at the time and place shown below.
November 30, 2009
1:00 pm to 3:00 pm
SPD Administrative Office, Banoul Conference Room
315 N. Henry Street, 2nd Floor
Madison, Wisconsin 53703
Handicap accessibility is in the rear of the building. If you require communication accommodation at the hearing, please call Marla Stephens, (414) 227-4891, at least 10 days prior to the hearing date.
Appearances at Hearing and Submission of Written Comments
Interested persons are invited to attend the hearing and comment on the proposed rule. Persons appearing may make an oral presentation and are requested to submit their comments in writing. Written comments on the proposed rule will be accepted into the record and receive the same consideration as testimony presented at the hearing if they are received by Monday, December 7, 2009. Written comments should be addressed to: Marla Stephens, SPD, PO Box 7923, Madison, WI 53707-7923, or by email:
stephensm@opd.wi.gov.
Copies of Proposed Rule
To view the proposed rule and certification application forms online, go to:
http://www.wisspd.org/html/appellate/ PropPD1.asp. You may contact Marla Stephens at
stephensm@opd.wi.gov or by telephone at (414) 227-4891 to request a copy of the proposed rule and certification application forms be sent to you by U.S. mail. Copies of the rule and certification application forms will also be available at the hearing.
Analysis Prepared by the State Public Defender Board
Statutes interpreted
Statutory authority
Explanation of Agency Authority
Sections
977.05 (4) and
(5) and
977.08 (1) require the state public defender to appoint attorneys to represent indigent clients in specified cases. Section
977.08 (2) and
(3) require the state public defender to notify all attorneys that they may be appointed to provide legal representation to state public defender clients, to review the qualifications of attorneys seeking appointment, and to certify lists of attorneys qualified to accept appointments. Section
977.02 (5) allows the state public defender board to promulgate rules that establish procedures to assure that the legal representation of indigent clients by the private bar at the initial stages of cases assigned under ch.
977 is at the same level as the representation provided by the state public defender. Section
977.02 (6) allows the state public defender board to establish rules to accommodate the handling of certain potential conflict of interest cases by the office of the state public defender. Section
977.03 (3) allows the state public defender board to promulgate rules to establish procedures under which the state public defender may appoint attorneys based upon the state public defender's evaluation of the attorneys' performance. Section
977.02 (8) allows the state public defender board to perform all other duties necessary and incidental to the performance of any duty enumerated in ch.
977, Stats.
Related statute or rule
None
Plain language analysis
The ethical rules in Supreme Court Rules Chap. 20, Rules of Professional Conduct for Attorneys, prohibit conflicts of interest and require zealous representation. Consequently, the state public defender appoints some cases to private attorneys who are not employees. Because the state public defender does not have direct oversight of the legal representation provided in these cases, the state public defender uses other means, including certification lists, to ensure that the private attorneys are competent to represent clients in different types of cases. The proposed rules modify certification criteria and procedures to:
•
Update the certification lists to reflect changes in substantive and procedural law.
•
Permit the state public defender to exercise discretion to certify, recertify, sanction, suspend, caution, place conditions upon or decertify a private attorney for cause.
•
Establish criteria for the exercise of discretion.
•
Permit the state public defender to consider an attorney's prior disciplinary record and other conduct, in addition to experience and education, when making certification decisions.
•
Require an attorney to reapply for certification after decertification or voluntary removal from any certification list.
•
Permit the state public defender to require a period of provisional certification to allow the state public defender to monitor the representation provided to clients.
