OAH 8-0906-21799-1
Governor’s Tracking No. AR 468
STATE OF
OFFICE OF
ADMINISTRATIVE HEARINGS
FOR THE
|
In the Matter of the Proposed Amendments
to Rules Governing Pharmacy Practice and Drug Wholesaling, |
REPORT OF THE ADMINISTRATIVE LAW JUDGE |
The rules proposed to be amended concern Definitions,
Applications for Pharmacy Licenses, Pharmacy License Categories, Transfers of
Pharmacy Ownership, Pharmacy Counseling Areas, Supervision of Pharmacy Areas,
Automated Counting Devices, Closing a Pharmacy, Applications for Pharmacist
Licensure, Drug Manufacturer and Wholesaler Licensure, Registration of Pharmacy
Technicians, Training and Educational Requirements for Pharmacy Technicians,
Unprofessional Conduct, Answering Machines and Electronic Voice Recording
Devices, Compounding, Prospective Drug Reviews, Patient Profiles, Transfer of
Prescriptions between Pharmacies, Prepackaging and Labeling, Radiopharmaceutical
Labeling, Veterinary Prescription Drug Labels, Interns and Preceptors,
Consulting Services to Licensed Nursing Homes, Emergency Kits, Pharmaceutical
Services Policies, Variances, and Medical Gas Distributor Registrations.
The rules proposed to be repealed are about
Community Satellites, Minnesota Rules 6800.0100, subpart 2a; Licensure
Transfer, Minnesota Rules 6800.1300, subpart 6; Patient Medication Profiles,
Minnesota Rules 6800.3110, subpart 6; Definitions, Minnesota Rules 6800.5100,
subparts 1, 7, 8, 9, and 10; Registration and Reporting, 6800.5300, subpart 4;
and Consulting Services to Licensed Nursing Homes, 6800.6500, subpart 3.
Administrative Law Judge Eric L. Lipman of the
Office of Administrative Hearings conducted a hearing on Wednesday, March 3,
2011. The hearing commenced at 9:00 a.m.,
in the University Room,
The hearing and this Report are part of a
larger rulemaking process under the Minnesota Administrative Procedure Act.[1] The Minnesota Legislature has designed this
process so as to ensure that state agencies have met all of the requirements
that the state has specified for adopting rules.
The hearing was conducted so as to permit
agency representatives and the Administrative Law Judge to hear public comment
regarding the impact of the proposed rules and what changes might be
appropriate. Further, the hearing
process provides the general public an opportunity to review, discuss and
critique the proposed rules.
The agency must establish that the proposed
rules are necessary and reasonable; that the rules are within the agency’s
statutory authority; and that any modifications that the agency may have made
after the proposed rules were initially published in the State Register are within the scope of the matter that was
originally announced.[2]
Cody Wiberg, Executive Director of the
Minnesota Board of Pharmacy (Board), appeared at the rule hearing on behalf of
the Board. Also present on behalf of the
Board were Pat Eggers, Office Manager, Candace Fleming, Compliance Officer;
Karen Schreiner, Les Kotek, Stu Vandenberg and Michelle Matilla, Board
Surveyors; and Laura Schwartzwald, Jim Koppem, Kay Hanson, Stacey Jassey and
Karen Bergrud, Pharmacy Board Members.
Approximately 37 people attended the hearing
and signed the hearing register. The
proceedings continued until all interested persons, groups or associations had
an opportunity to be heard concerning the proposed rules. In addition to Mr.
Wiberg, 20 members of the public made statements or asked questions at the
hearing.
After the hearing ended, the Administrative
Law Judge kept the administrative record open for another 20 calendar days –
until March 23, 2011 – to permit interested persons and the Board to submit
written comments. Following the initial
comment period, the hearing record was open an additional five business days so
as to permit interested parties and the Board an opportunity to reply to
earlier-submitted comments.[3] The hearing record closed on March 30, 2011.
SUMMARY OF
CONCLUSIONS
With five exceptions listed below, the Board
has established that it has the statutory authority to adopt the proposed rules
and that the rules are necessary and reasonable.
Based upon
all the testimony, exhibits, and written comments, the Administrative Law Judge
makes the following:
FINDINGS OF FACT
I. Nature of the Proposed
Rules
1.
The Board is charged with adopting rules for the
conduct of its business; and with making and publishing uniform rules for
carrying out the provisions of Minnesota Statutes, chapter 151 governing the
Board of Pharmacy.[4]
2. With this rulemaking process, the Board seeks to amend numerous provisions of its rules relating to pharmacy licensure, ownership, operations, staffing and dispensing practice.
3.
The Board’s purpose follows from changes in the
professional practice of pharmacy, along with actions of the United States
Congress, the Food and Drug Administration and the Drug Enforcement
Administration and other federal agencies that oblige changes in
4.
In addition, the Board used this rulemaking to
respond to requests from certain licensees and registrants regarding technician
registration requirements and the proper use of automated counting and
distribution devices.[6]
II. Procedural Requirements of Chapter 14
5.
On July 21, 2008, the Board published in the State Register a Request for Comments
seeking comments on its possible amendment to rules governing pharmacy practice
and drug wholesaling. The Request for Comments was published in the State Register at 33 S.R. 174.[7]
6.
On December 27, 2010, the Board requested approval
of its Dual Notice of Intent to Adopt Rules With or Without a Hearing (Dual
Notice, or Notice of Intent to Adopt), Additional Notice Plan and asked for
permission to omit the text of the proposed rule changes in the State Register.
7.
By letter
dated January 11, 2011, the undersigned Administrative Law Judge approved the Board’s
Dual Notice and Additional Notice Plan.
8.
The Dual Notice of Intent to Adopt Rules, published
in the January 18, 2011 State Register,
set February 17, 2011 as the deadline for comments or to request a hearing.[8]
9.
Also by letter dated January 11, 2011, the Chief
Administrative Law Judge approved the Board’s request to omit the text of the
proposed rule changes from the publication of the Dual Notice of Intent to
Adopt Rules in the State Register as
unduly cumbersome and expensive, subject to the following conditions:
(a) the Board will post the Dual Notice of Intent
to Adopt Rules on its website and include an embedded link directly to the
proposed rules on the Board’s website; and,
(b) the Board will maintain the link to the
proposed rules on the Board’s website for 30 days following publication of the
Board’s Notice of Adoption.
10.
On January 18, 2011, the Board sent by
11.
12.
The Board mailed its Dual Notice to all persons and
associations who had registered their names with the Board for the purpose of
receiving such notice and to all persons and associations identified in
the additional notice plan 30 days before the end of the comment period. Accordingly, the mailing was made three days
late.
13.
On January 21, 2011, the Board mailed a copy of the
SONAR to the Legislative Reference Library as required by Minn. Stat. §§ 14.131
and 14.23.[10]
14.
Minn. Stat. § 14.23 requires the agency to send a
copy of the SONAR to the Legislative Reference Library when the Notice of
Intent to Adopt is mailed.
15.
The Board mailed the SONAR to the Legislative
Reference Library three days after the Notice of Intent to Adopt was mailed. Accordingly, this mailing was made six days
after it should have occurred.
16.
Also on January 21, 2011, the Board sent a copy of
the Notice of Hearing and the Statement of Need and Reasonableness to
Legislators as required by Minn. Stat. § 14.116.[11]
17.
Minn. Stat. § 14.116 requires the agency to send a
copy of the Notice of Intent to Adopt and the SONAR to certain legislators on
the same date that it mails its Notice of Intent to Adopt to persons on its
rulemaking list and pursuant to its additional notice plan.
18.
The Board mailed the Notice of Intent to Adopt and
the SONAR to the required legislators three days after the Notice of Intent to
Adopt was mailed. Thus, this mailing was
likewise made six days after it should have occurred.
19.
Minn. Stat. § 14.15, subd. 5 requires an
administrative law judge to disregard an error or defect in the proceeding due
to an “agency’s failure to satisfy any procedural requirement” if the
administrative law judge finds “that the failure did not deprive any person or
entity of an opportunity to participate meaningfully in the rulemaking process
. . . .”
20.
The Administrative Law Judge finds that the Board’s
three late mailings did not deprive any person or entity of an opportunity to
participate meaningfully in the rulemaking process and that these errors were
harmless errors.
21.
The Notice of Hearing identified the date and
location of the hearing in this matter.[12]
22.
The Notice of Hearing included electronic links to
the Revisor’s draft of the rules as well as an electronic link to the SONAR, along
with instructions for obtaining copies of these documents from the Board.[13]
23.
As required by Minn. Stat. § 14.131, by letter dated
January 4, 2011, the Commissioner of Minnesota Management and Budget (MMB) responded
to a request by the Board to evaluate the fiscal impact and benefit of the
proposed rules on local units of government.
MMB reviewed the Board’s proposed rule and concluded:
I believe
the proposed rules may have a fiscal impact on a small number of local
government units that own public hospitals containing pharmacies, but any costs
would be limited to meeting requirements for private counseling areas,
something that many pharmacies have already implemented under previous rules. [14]
24.
At the hearing on March 3, 2011, the Board filed
copies of the following documents as required by Minn. R. 1400.2220:
a.
the Board’s
Request for Comments as published in the State
Register on July 21, 2008;[15]
b.
the proposed rules dated January 7, 2011,
including the Revisor’s approval;[16]
c.
the Board’s
Statement of Need and Reasonableness (SONAR);[17]
d.
the Certificate of Mailing the SONAR to
Legislative Reference Library on January 21, 2011[18]
e.
the Dual
Notice as mailed and as published in the State
Register on January 18, 2011;[19]
f.
the Certificate
of Mailing the Dual Notice to the rulemaking mailing list on January 18, 2011, and
the Certificate of Accuracy of the Mailing List;[20]
g.
the
Certificate of Giving Additional Notice Pursuant to the Additional Notice Plan
on January 18, 2011;[21]
h.
the
written comments on the proposed rules that the Board received during the
comment period that followed the Dual Notice;[22]
i.
the
written comments on the proposed rules that the Board received after the close
of the comment period but before the rules hearing;[23]
j.
the
January 11, 2011 letter from Chief Administrative Law Judge Krause approving
the Board’s request to omit the text of the proposed rules changes from the
publication of the Dual Notice of Intent to Adopt Rules in the State Register as unduly expensive and
burdensome.[24]
k.
the Certificate
of Sending the Dual Notice and the Statement of Need and Reasonableness to Legislators
on January 21, 2011.[25]
l.
January
4, 2011 memorandum from Minnesota Management and Budget;[26]
m.
the
Certificate of the Board of Pharmacy Authorizing Resolution authorizing Cody
Wiberg to act as the Board’s representative in the Notice and Hearing phases of
the rulemaking;[27]
n.
the
Board Analysis of and Response to Comments Received during the 30-day Comment
Period that Followed Publication of the Dual Notice.[28]
III. Statutory
Authority
25. The Board cites Minn. Stat. § 151.06 as its source of statutory authority for these proposed rules. Minn. Stat. § 151.06, subdivision 1(a)(8) grants the Board authority “to . . . adopt rules for the conduct of its business;” and subdivision 1(c) requires the Board “to make and publish uniform rules for carrying out and enforcing the provisions of this chapter. The board shall adopt rules regarding prospective drug utilization review and patient counseling by pharmacists.”[29]
26. The Administrative Law Judge concludes that the Board has the statutory authority to adopt rules governing pharmacy practice and drug wholesaling.
IV. Impact
on Farming Operations
27.
Minn. Stat. § 14.111 imposes additional
notice requirements when the proposed rules affect farming operations. The statute requires that an agency provide a
copy of any such changes to the Commissioner of Agriculture at least 30 days
prior to publishing the proposed rules in the State Register.
28.
The proposed rules do not impose restrictions or
have an impact on farming operations.
The Administrative Law Judge finds that the Board was not required to
notify the Commissioner of Agriculture.
V. Additional
Notice Requirements
29.
Minn. Stat. §§ 14.131 and 14.23 requires that an
agency include in its SONAR a description of its efforts to provide additional
notification to persons or classes of persons who may be affected by the
proposed rule; or alternatively, the agency must detail why these notification
efforts were not made.
30.
On January 18, 2011, the Board provided the Dual
Notice of Intent to Adopt in the following manner, according to the Additional
Notice Plan approved by the Office of Administrative Hearings:[30]
· The Dual Notice of Intent to Adopt Rules was posted on the Board’s website, http://www.phcybrd.state.mn.us/rulemake2010.htm. The Dual Notice included embedded links directly to the proposed rules and the SONAR on the website. The Board has maintained the links continuously since they were posted, pursuant to the Chief Administrative Law Judge’s direction as part of the approval to omit publication of the rules with the Dual Notice in the State Register.
· A notice of the website posting of the Dual Notice of Intent to Adopt was sent, via e-mail, to every licensee and registrant for whom the Board has an e-mail address. These individuals were also notified that the Request for Comments, the SONAR and other relevant documents were posted on the Board’s website.
· A notice of the website posting of the Dual Notice and related documents was posted on the Board’s Facebook page.
31. The Administrative Law Judge concludes that the Board has fulfilled its additional notice requirements.
VI. Statutory
Requirements for the SONAR
32.
The
Administrative Procedure Act obliges an agency adopting rules to address seven
factors in its Statement of Need and Reasonableness.[31] Those factors
are:
(1) a
description of the classes of persons who probably will be affected by the
proposed rule, including classes that will bear the costs of the proposed rule
and classes that will benefit from the proposed rule;
(2) the
probable costs to the agency and to any other agency of the implementation and
enforcement of the proposed rule and any anticipated effect on state revenues;
(3) a
determination of whether there are less costly methods or less intrusive
methods for achieving the purpose of the proposed rule;
(4) a description of any alternative methods for achieving the purpose of
the proposed rule that were seriously considered by the agency and the reasons
why they were rejected in favor of the proposed rule;
(5) the probable costs of complying with the
proposed rule, including the portion of the total costs that will be borne by
identifiable categories of affected parties, such as separate classes of
governmental units, businesses, or individuals;
(6) the probable costs or consequences of not
adopting the proposed rule, including those costs or consequences borne by
identifiable categories of affected parties, such as separate classes of
government units, businesses, or individuals; and
(7) an
assessment of any differences between the proposed rule and existing federal
regulations and a specific analysis of the need for and reasonableness of each
difference.
A. Regulatory Analysis
(1) A
description of the classes of persons who probably will be affected by the
proposed rule, including classes that will bear the costs of the proposed rule
and classes that will benefit from the proposed rule.
33.
The Board
states that the following groups will be affected by the proposed rules:[32]
·
Individuals
or businesses that are licensed or registered by the Board, including
pharmacists, pharmacy technicians, pharmacist interns, pharmacy owners, drug
wholesalers and manufacturers, controlled substance researchers and medical gas
manufacturers and distributors.
·
Staff
in hospitals, long-term care facilities and home health agencies will be
affected by some of the proposed changes that relate to drug distribution and
pharmacy services in those settings.
·
The
public will benefit from the proposed regulatory changes because the updates
will result in safer and better pharmacy practice.
The Board asserts the following
particular costs of the proposed rules:
·
Some pharmacies
will be obliged to upgrade their counseling areas and thus will bear a cost.
·
Pharmacies
may incur new costs to ensure that temperature-sensitive drugs are delivered in
appropriate containers and handled according to appropriate procedures.
·
Some
Pharmacy Technicians may experience slightly increased costs when meeting the
new continuing education standards.
·
Applicants
for pharmacy, wholesaler and manufacturer, controlled substance researcher, and
medical gas distributor licenses or registrations will face an increased cost
if they fail to complete the application process within 12 months of the date
in which the application was originally submitted.
·
Wholesalers
and manufacturers that currently license only the primary location of the
parent entity will experience increased costs to the extent that they seek to
license additional facilities to receive shipments in
·
A
pharmacy that is slated to close and the pharmacy that purchases its
prescription files may bear a cost if the closing pharmacy has to notify
the public in advance about the closing.
The pharmacy purchasing the files may find them to be less valuable
because patients may transfer their prescriptions to a third pharmacy before
the closing date.
The Board asserts the following
particular benefits of the proposed rules:
·
Individuals
wanting to open “limited service” pharmacies will benefit by having a more
formal process for gaining Board approval.
·
Individuals
who are purchasing a pharmacy will benefit by having an additional time period
during which they can operate under the existing license.
·
The
public will benefit by not having their pharmacy unexpectedly close if there is
some last-minute problem during the ownership transfer process.
·
Members
of the public who obtain prescriptions from certain pharmacies will benefit
when those pharmacies improve their counseling areas.
·
Members
of the public will benefit from this proposed rule change because there will be
better notice of a pharmacy closure. As
the Board argues, with more notice, pharmacy patrons will likely have less trouble
refilling prescriptions and greater choices in selecting another pharmacy.
·
Pharmacists
who apply for licensure transfer (reciprocity) and the pharmacies that want to
hire these professionals will benefit from the elimination of the requirement
that pharmacists must practice in another state for at least 12 months before
they can obtain reciprocal licensure in
·
Pharmacists
who are also registered preceptors will benefit from a wider selection of preceptor
Continuing Education programs.
·
Pharmacists
and pharmacies operating under a variance will benefit because, under the
revised rules, certain practices will be approved by rule – thus reducing the
need for submitting a request for a variance to the Board.
·
Members
of the public will benefit from authorizations to pharmacies to deliver filled
prescriptions to a customer’s place of employment.
·
Members
of the public relying upon temperature-sensitive medications will benefit from
more stringent handling practices and a reduction in the likelihood of adverse
reactions from improperly delivered drugs.
·
Members
of the public, pharmacists and pharmacy owners will benefit from more stringent
standards for registration of pharmacy technicians. The Board predicts that the new standards will
raise the quality of technicians.
(2) The
probable costs to the Agency and to any other agency of the implementation and
enforcement of the proposed rule and any anticipated effect on state revenues.
34.
The
Board states it will incur some costs because of the proposed changes – most
notably, associated with upgrades to the systems for registering technicians
and licensing of pharmacies. The Board
has anticipated those costs and included them in its biennial budget request. None of the other Board proposals result in
any costs to the Board. To the extent
that any pharmacy has increased costs due to these proposed changes, pharmacies
operated by state agencies (DHS, MnSCU, Veteran’s Homes, etc.) may have similar
increased costs. No other state agencies
should have any increased costs.
35.
There
may be a slight increase in the amount of fees collected from drug wholesalers
and manufacturers, on account of the licensing of additional locations.[33]
(3) The determination of whether there are less costly methods or less intrusive methods for achieving the purpose of the proposed rule.
36.
The
Board asserts that most of its proposed changes do not involve any costs to
licensees, registrants or the Board.
37.
In
other instances, the Board redrafted its originally-proposed rule so as to meet
its regulatory objective in ways that involved fewer compliance costs to
regulated parties.
(4) A description of any alternative methods for achieving the purpose of the proposed rule that were seriously considered by the agency and the reasons why they were rejected in favor of the proposed rule.
38.
Most of
the Board’s proposed changes do not involve costs, new burdens or features that
are not part of widely accepted pharmacy practice.
39.
Where
the proposed changes did prompt additional compliance costs the Board engaged
stakeholders – including the major trade groups and its own advisory panels –
to develop cost-effective, consensus solutions to regulatory problems. For example, the proposed changes to the technician
registration system were developed through consultation with an advisory group
of associations from within the pharmacy profession.[34] The proposed registration rules reflect the
consensus, but not unanimous view, that emerged from the meetings of the
Minnesota Pharmacists Association Technician Task Force and the Board’s
Technician Rules Advisory Committee.[35]
(5) The probable costs of complying with the
proposed rules.
40.
Pharmacies
that need to remodel their facilities in order to have adequate counseling
areas will incur costs associated with the upgrades. The Board predicts that
these costs may range from hundreds of dollars to thousands of dollars.
41.
Individuals
that do not complete applications for pharmacy, wholesaler, manufacturer,
medical gas distributor and controlled substance researcher licenses or
registrations within 12 months of the original submission date will have to
submit a new application. The new
application fees range from $50 to $180.
42.
Manufacturers
and wholesalers that have only licensed the primary location of their business
will need to pay a fee ranging from $130 to $180 for each additional location that
is licensed. A location from which the
manufacturer or wholesaler ships products to
43.
Those
closing a pharmacy will incur costs associated with notifying the public about
the closure.
44.
Because
some, but not all, technician continuing education courses require an
enrollment fee, some Pharmacy Technicians may experience slightly increased
costs when meeting the new continuing education standards.
(6) The probable costs or consequences of not adopting the proposed rule, including those costs borne by individual categories of affected parties, such as separate classes of governmental units, businesses, or individuals.
45.
The
Board contends that the proposed rule changes will promote safer use of
medications, reduce medication errors and reduce drug-related morbidity and
mortality.
46.
It
further asserts that if the changes are not adopted,
(7) An assessment of any differences between the proposed rules and existing federal regulation and a specific analysis of the need for and reasonableness of each difference.
47.
The
Board is unaware of any differences between the proposed rule changes and
existing federal regulations.[37]
B. Performance-Based Regulation
48.
The
Administrative Procedure Act[38] also
requires an agency to describe how it has considered and implemented the
legislative policy supporting performance based regulatory systems. A performance based rule is one that
emphasizes superior achievement in meeting the agency’s regulatory objectives
and maximum flexibility for the regulated party and the agency in meeting those
goals.[39]
49.
In
developing these rules, the Board has allowed flexibility in meeting the
requirements in several areas. For example, as noted above, pharmacies will be
allowed to propose designs for counseling areas other than ones that utilize
the partitions that most pharmacies use.
Likewise, technicians will be able to choose from several training
options and most will have up to one year to complete the required
training. The owners of pharmacies that
will be closed will be allowed to choose from several different options for
notifying customers of the closure. Preceptors will be able to choose from a wider
selection of preceptor continuing education programs than before. The Board has responded to calls for
regulatory flexibility from its regulated parties.[40]
C. Consultation with the Commissioner of
50.
The
Board consulted with Minnesota Management and Budget. It received a written
evaluation from MMB on January 4, 2011. MMB
concluded that:
51.
The Administrative Law Judge finds that the Board
has met the requirements set forth in Minn. Stat. § 14.131 for assessing the
impact of the proposed rules, including consideration and implementation of the
legislative policy supporting performance-based regulatory systems, and the
fiscal impact on units of local government.
D. Cost
to Small Businesses and Cities under
52.
Minn. Stat. § 14.127,
requires the Board to “determine if the cost of complying with a proposed rule
in the first year after the rule takes effect will exceed $25,000 for: (1) any one business that has less than 50
full-time employees; or (2) any one statutory or home rule charter city that
has less than ten full-time employees.”
The Board must make this determination before the close of the hearing
record, and the Administrative Law Judge must review the determination and
approve or disapprove it.[42]
53.
The
Board determined that the cost of complying with the proposed rule changes will
not exceed $25,000 for any business or any statutory or home rule charter
city. A business or a city that owns a
pharmacy might have to remodel in order to have a counseling area that provides
a reasonable assurance of privacy. However, the cost of such a remodeling
project – particularly after the Board’s most recent set of clarifying
amendments – is not likely to exceed $25,000. The probable costs, if any, associated with
the proposed technician registration requirements are unknown – because claims
of increased labor costs (following from more stringent education requirements)
and reduced labor costs (as technicians assume some duties now only performed
by higher-paid pharmacists) are both grounded in this record. Because these requirements will be phased in
over several years, it is unlikely that the thresholds in Minn. Stat. §
14.127 will be met in any one year.[43]
54.
The Administrative Law Judge finds that the
agency has made the determination required by Minn. Stat. § 14.127 and approves
that determination.
E. Adoption or Amendment of Local Ordinances
55.
Under
Minn. Stat. § 14.128, the agency must determine if a local government
will be required to adopt or amend an ordinance or other regulation to comply
with a proposed agency rule. The agency must make this determination
before the close of the hearing record, and the Administrative Law Judge must
review the determination and approve or disapprove it.[44]
56.
The
Board concluded that no local government will need to adopt or amend an
ordinance or other regulation to comply with the proposed rules. The Board is
unaware of any local governments that adopt ordinances and regulations
concerning the operation of pharmacies. Local
governments might have ordinances and regulations that apply to all retail businesses
– such as zoning restrictions. The
Board’s proposed rule should not require local governments to adopt or amend
those more general ordinances and regulations.[45]
57.
The Administrative Law Judge finds that the
agency has made the determination required by Minn. Stat. § 14.128 and approves
that determination.
VII. Rulemaking
Legal Standards
58.
The
Administrative Law Judge must make the following inquiries: Whether the agency has statutory authority to
adopt the rule; whether the rule is unconstitutional or otherwise illegal;
whether the agency has complied with the rule adoption procedures; whether the
proposed rule grants undue discretion to government officials; whether the rule
constitutes an undue delegation of authority to another entity; and whether the
proposed language meets the definition of a rule.[46]
59.
Under
Minn. Stat. § 14.14, subd. 2, and Minn. R. 1400.2100, the agency must establish the need for, and
reasonableness of, a proposed rule by an affirmative presentation of
facts. In support of a rule, the agency
may rely upon materials developed for the hearing record,[47]
“legislative facts” (namely, general and well-established principles, that are
not related to the specifics of a particular case, but which guide the
development of law and policy),[48]
and the agency’s interpretation of related statutes.[49]
60.
A
proposed rule is reasonable if the agency can “explain on what evidence it is
relying and how the evidence connects rationally with the agency’s choice of
action to be taken.”[50] By contrast, a proposed rule will be deemed
arbitrary and capricious where the agency’s choice is based upon whim, devoid
of articulated reasons or “represents its will and not its judgment."
[51]
61.
An
important corollary to these standards is that when proposing new rules an agency
is entitled to make choices between different possible regulatory approaches, so long as the alternative
that is selected by the agency is a rational one.[52] Thus, while reasonable minds might differ as
to whether one or another particular approach represents “the best
alternative,” the agency’s selection will be approved if it is one that a
rational person could have made.[53]
62.
Because both the Board and the Administrative
Law Judge suggest changes to the proposed rule language after the date it was
originally published in the State
Register, it is also necessary for the Administrative Law Judge to
determine if this new language is substantially different from that which was
originally proposed. The standards to
determine whether any changes to proposed rules create a substantially
different rule are found in Minn. Stat. § 14.05, subd. 2. The statute specifies that a modification
does not make a proposed rule substantially different if:
“the differences are within the scope of the matter announced . . . in the notice of hearing and are in character with the issues raised in that notice;”
the differences “are a logical outgrowth of the contents of the . . . notice of hearing, and the comments submitted in response to the notice;” and
the notice of hearing “provided fair warning that the outcome of that rulemaking proceeding could be the rule in question.”
63.
In reaching a determination regarding whether
modifications result in a rule that is substantially different, the Administrative
Law Judge is to consider:
whether “persons who will be affected by the rule should have understood that the rulemaking proceeding . . . could affect their interests;”
whether the “subject matter of the rule or issues determined by the rule are different from the subject matter or issues contained in the . . . notice of hearing;” and
whether “the effects of the rule differ from the effects of the proposed rule contained in the . . . notice of hearing.”
VIII.
Rule by Rule Analysis
64.
Several
sections of the proposed rules were not opposed by any member of the public and
were adequately supported by the SONAR.
Accordingly, this Report will not necessarily address each comment or
rule part. Rather, the discussion that
follows below focuses on those portions of the proposed rules as to which
commentators prompted a genuine dispute as to the reasonableness of the Board’s
regulatory choice or otherwise requires closer examination.
65.
The
Administrative Law Judge finds that the Board has demonstrated by an affirmative
presentation of facts the need for and reasonableness of all rule provisions
that are not specifically addressed in this Report.
66.
Further, the Administrative Law Judge finds that
all provisions that are not specifically addressed in this Report are authorized
by statute and that there are no other defects that would bar the adoption of
those rules.
6800.0100 - DEFINITIONS
A.
Subp.
2a. Community Satellites
67.
The
Board had originally proposed to repeal the regulatory definition and category
for “community satellite” pharmacies.
68.
In
response to stakeholder comment, the Board has decided to withdraw its proposed
repeal of this regulation so that it might have the opportunity to more fully
assess the continued viability of this category.
69.
The
Board’s action in maintaining the existing regulation is needed and reasonable.
B.
Subpart
11b. Chart orders
70.
At the suggestion of certain commentators the
Board proposes to modify its definition of chart orders to require the
inclusion of an identifier in addition to the patient’s name. The Board proposes to revise Revisor’s Draft RD3900
as follows:
Subp. 11b. Chart order. “Chart
order” means a prescription drug order for a drug that is to be dispensed by a
pharmacist, or by a pharmacist-intern under the direct supervision of a
pharmacist, and administered by an authorized person only during the patient's
stay in a hospital or long-term care facility. The chart order shall contain
the name of the patient, another
patient identifier such as a birth date or medical record number, the
drug ordered, and any directions as the practitioner may prescribe concerning
strength, dosage, frequency, and route of administration. The manual or
electronic signature of the practitioner shall be affixed to the chart order at
the time it is written or at a later date in the case of verbal chart orders.
Many hospitals
and long-term care facilities already use birth dates, medical record numbers
or other identifiers for such purposes.[54] Requiring the use of the second identifier in
chart order would prevent medical errors, is a needed and reasonable alternative and would not be a substantial change
from the rule as originally proposed.
C.
Subpart
14. Nonsterile product compounding
Subpart 15. Sterile product compounding
71.
The
Board proposes to revise the definition of “nonsterile product compounding”
to harmonize it with the terminology used in United States Pharmacopeia Chapter
795. The Board proposes to revise
Revisor’s Draft RD3900 as follows:
Subp. 14. Nonsterile preparation compounding. “Nonsterile
preparation compounding” means the
preparation, mixing, assembling, altering,
packaging and labeling of a nonsterile drug preparation,
according to
Subp. 15. Sterile preparation compounding. “Sterile preparation
compounding” means the preparation, mixing, assembling, altering, packaging and labeling of a drug preparation that achieves sterility, according to
Using the same terminology that
is found in the referenced source would avoid confusion by regulated parties,
is a needed and reasonable alternative
and would not be a substantial change from the rule as originally proposed.
D.
Subpart 18. High-alert drug.
72.
In the
rules as originally proposed, the Board used both the terms “high-risk drug”
and “high-alert drug,” without distinguishing or defining the two terms of
art.
73.
To
clarify the rules, the Board proposes to eliminate the term “high-risk drug”
from the regulatory text[55] and to define “high alert drug.” Defining the term as the Institute for
Safe Medication Practices does, the Board proposes to add the following
definition to Part 6800.0100:
Subp.
18. High-alert drug. “High-alert
drug” means a drug that bears a heightened risk of causing significant patient
harm when it is used in error.
The addition of the missing
definition, and deletion of the potentially conflicting term, are needed and reasonable and would not be a
substantial change from the rule as originally proposed.
6800.0350 - LICENSE CATEGORIES
74.
The
Board proposes to revise the rule providing for pharmacy license categories and
renewal of licensure so as to clarify the rule, simplify the renewal and
inspection process, and list the key regulated activities that are permitted at
a licensed facility.
75.
Following
the receipt of public comments, the Board proposes to further revise
Revisor’s Draft RD3900 as follows:
A pharmacy must be licensed in one or more of the following categories:
A.
community/retailoutpatient;
B. hospital;
C.
parenteral-enteral/home
health care;
D. long-term care;
E. nuclear;
F. central service;
G.
non-sterile preparation
compounding;
H.
sterile preparation
compounding;
J limited service.
Licensing of a pharmacy in more than one category shall not result in an increase in the license fee.
No pharmacy may engage in providing products or services in categories for which it is not licensed. A pharmacy must designate its category or categories on license renewal or application for an initial license. Effective July 1, 2012, an initial or renewed license issued by the Board shall list each license category for which the pharmacy has received Board approval; a pharmacy must receive Board approval before providing services in a license category not listed on its license; a pharmacy must notify the Board if it no longer provides services in a license category; and the Board shall issue a revised license, without imposing an additional fee, if it approves a pharmacy's request to provide services in additional license categories or if a pharmacy no longer provides services in one or more license categories.
The Board may
establish special conditions for licensure, appropriate to the situation,
before approving a license application for a pharmacy with a limited service
license category. Such pharmacies must also apply for and receive any necessary
variances, pursuant to part 6800.9900, before an application for licensure will
be approved.
The revised rule will improve the
Board processes, reduce the numbers of variances requested, is a needed and reasonable alternative, and would
not be a substantial change from the rule as proposed.
6800.0700 - PHARMACY, SPACE AND SECURITY
76.
A key
component of this rulemaking is the establishment of new and more rigorous
standards for pharmacy consulting areas.
77.
The
Board proposes to further revise its original proposal to clarify that
partitions, computer terminals or solid enclosures are not mandated by the new standards.[56] The
Board proposes to revise Revisor’s Draft RD3900 as follows:
E. in the case of a community/retail community/outpatient
pharmacy, contains an area where consultation between the patient and the
pharmacist must be conducted with an reasonable assurance of
privacy. Community/retail pharmacies
in existence on February 1, 1999, have until February 1, 2001, to comply with
this item; and All
new and remodeled community/outpatient pharmacies must meet the standards of this
paragraph. A pharmacy licensed before
January 1, 2011, must meet the standards within two years of that date, unless
the pharmacy has an existing counseling area that has been deemed by the
Board to provide a reasonable assurance of privacy. If pharmacies use partitions to create
a consultation area in which the patient will typically remain standing, the
partitions must be sound-dulling and at least 7 feet high and 24 inches deep.
The patient must be able to enter into the area created by the
partitions so that the partitions are on each side of the patient. Consultation
areas not involving the use of partitions may be approved if the Board deems
that they will provide a reasonable assurance of privacy. Consultation areas
must not contain any item for sale apart from the articles needed for
counseling sessions. Pharmacists
must have access to patient profiles in order to comply with part 6800.0910. Consultation areas must be accessible to the
patient from the outside of the prescription dispensing area and be open at all
times when the pharmacy is open.
These revisions reduce the compliance costs associated with a more robust
privacy rule. The revised rule
will improve patient privacy, is a needed
and reasonable alternative and would not be a substantial change from the rule
as proposed.
6800.1010 - CLOSING
A PHARMACY
78.
As part of its original proposal, the Board
established a requirement that the public be given notice in advance of a planned closing of a pharmacy. In response to stakeholder comment, the Board
proposes to clarify the rule still further by making the following additions,
at Page 9, Line 19 of Revisor’s Draft RD3900:
In the case of patients who are residents of long-term care facilities, the pharmacy shall provide a written notice to the patients, the caregivers of the patients or to the long-term care facilities in which the patients reside at least 30 days prior to the date on which the pharmacy will be closed.
The proposed rule and modifications are needed and reasonable and would not be a substantial change from the rule as proposed.
6800.1250 - APPLICATIONS FOR LICENSURE
79.
The
Board proposes to promulgate the licensure requirements for graduates of
colleges approved by the Accreditation
Council for Pharmacy Education,
graduates of Canadian colleges of pharmacy and graduates of other foreign
pharmacy schools.
80.
The proposed rule is consistent with the
standards of the National Association of Boards of Pharmacy and the Foreign
Pharmacy Graduate Examination Committee.
Likewise, the proposed rule codifies the Board’s existing (but as yet unpromulgated)
practices regarding licensure of foreign graduates.[57] Accordingly, the rule is needed and
reasonable.
6800.1440 - REQUIREMENTS FOR WHOLESALE DRUG
DISTRIBUTORS.
81.
The Board proposes to correct a reference to the
publisher of the United States Pharmacopeia / National Formulary and to
withdraw the formulary-related mandate proposed at page 19, lines 19 and 20 of
the Revisor’s Draft RD3900.
82.
Both adjustments are needed and reasonable and
do not make a substantial change from
the rule as originally proposed.
6800.1500 - CONTINUING EDUCATION
83.
The Board proposes to establish a new continuing
education standard for pharmacy technicians.
Once fully implemented, the Board would require 20 hours of approved
continuing education as a condition of receiving the annual registration as a
pharmacy technician.
84.
Several stakeholders urged the Board to soften
the new requirement – either by accepting a technician’s initial certification
in lieu of the required credit hours or by permitting technicians to meet the
requirement by attending course work aimed at, and accredited for, licensed
pharmacists. Concerned that these
modifications would undermine its regulatory objectives (particularly as to
cost and quality of the program), the Board declined these invitations.[58]
85.
The proposed rule is needed and reasonable.
6800.2600 - AUTOMATED COUNTING AND
DISTRIBUTION
A.
Subparts
1, 2 and 3
86.
In response to a number of Board investigations of
complaints involving the improper
loading of automated counting devices (and the dispersal of drugs in error),
the Board proposed new rules regulating the operation of automatic counting
and distribution devices.
87.
Several commentators suggested that the rule
originally proposed by the Board was unduly restrictive and prohibited safe and
familiar pharmaceutical practice.
Specifically, the commentators suggested that it unnecessarily restricted
the deployment of these machines, re-stocking of dispensed but unused drugs,
certification of device accuracy after a prescription had been filled and
labeling that was appropriate to such devices.[59]
88.
Agreeing, the Board proposes to modify Revisor’s
Draft RD3900, beginning on Page 27, line 9, as follows:
The
pharmacy responsible for the control of the automated counting device or
automated drug distribution system may proceed with its use unless the Board
has provided written notification to the pharmacy that the device or system may
not be used. The Board must provide such written notification within 60 days of
receiving the documents required under this paragraph. The written notification
must specify the steps that the pharmacy must take in order to use the
system.
….
Subp. 2. Automated counting devices. In addition to the requirements in subpart 1, the following requirements apply to automated counting devices.
A.
The filling of cells
or cassettes is considered to be
prepackaging subject to the requirements of Part 6800.3200, subp. 1, paragraphs A, B, E, G, F and H, except
that paragraph F shall only apply if the pharmacy’s policies and procedures are
such that a pharmacist must verify the accuracy of the filling of the cell or
cassette. Only one cell or cassette may be filled at a time. Drugs previously removed from a
manufacturer's stock container may not be used to fill a cell or cassette. No
drug may be distributed from an automated counting device unless a pharmacist
has certified the accuracy of the filling of each cell or cassette. All manufacturer stock containers used to
fill a cell or cassette must be available for the pharmacist to check during
the certification process.
B.
The labeling of cells and cassettes is subject to the requirements of Part 6800.3200,
Subp. 2, paragraphs A, B, C and F.
The requirements of Part 6800.3200, Subp. 2, paragraphs D and E also apply
unless the information required under those paragraphs is maintained in the
packaging control record.
….
Subp.
3. Automated drug distribution systems.
….
D. The pharmacy and therapeutics or
relevant committee shall
develop and regularly review a list of drugs or categories of drugs
that are prohibited from being distributed through an automated
distribution system….
E. The use of an open matrix drawer that
allows access to one drug at a time must be limited to noncontrolled substance
drugs, unless the entire drawer contains only one controlled substance
product….
(1)
large bulky items such as intravenous
infusion bags;
(2) nonlegend drugs that are safely arranged ….
The revised rule balances the
pharmacist’s need to use automated counting devices as they were designed while
still holding licensed professionals accountable for the accuracy of their
dispensing activities.
89.
For
added clarity, the Board may wish to further revise the first sentence of
subpart 2 (A) so that it reads: “The filling of cells or cassettes is subject to the requirements of
Part 6800.3200, subp. 1, paragraphs A, B, E, G, F and H, except that
paragraph F shall only apply if the pharmacy’s policies and procedures are
such that require a pharmacist to must verify the
accuracy of the filling of the cell or cassette.” The revised rule as written is not
defective. Accordingly, the Board may
elect to make this technical correction if it sees fit.
90.
The modifications to the proposed rules are
needed and reasonable and do not make a substantial
change from the rules as they were originally proposed.
B.
Subpart
3 (F)
91.
As part of its original proposal, the Board proposed a requirement that obliged
pharmacists to have the removal of a high-alert drug verified by a second
licensed health care professional “whenever possible.”
92.
A number
of stakeholders objected to the proposal on the grounds that the requirement
was potentially burdensome, particularly when a pharmacist had earlier reviewed
the order[60]
Agreeing that medical errors are far less likely to occur following
review of an order by a pharmacist, the Board proposed to revise the Revisor’s
Draft RD3900, beginning on page 32, line 21, as follows:
F.
Whenever possible, removal of a high-alert drug from the system, when
a pharmacist has not reviewed the order for the drug, should be checked
by a second licensed health care professional to ensure that the prescription
drug order is being correctly interpreted and followed.
93.
While the revision perhaps addresses some of the
stakeholders’ concerns, it does not cure the defect in the original proposal –
namely, that regulated parties cannot discern from the text when a review by a
second licensed health care professional is required. In order to comply with the rule as proposed,
the regulated party will need to guess as to what the Board will regard as
“possible.” Likewise, the standards that the Board’s inspectors
might use in making this determination are neither stated, nor a part of common
understanding, so as to make the intended meaning clear.[61]
94.
If a
proposed rule fails to provide a reasonable notice of when the regulatory
standards will apply, the proposed rule is defective.[62]
95.
One
possible cure to this defect is to state that among the factors the Board will
consider when imposing regulatory discipline for improper removal or dispensing
of a high-alert drug, is whether a licensed pharmacist had earlier reviewed the
order and whether a second licensed health care professional had reviewed the
order. In this way, the Board might
encourage the best and safe practices for dispensing these drugs, while
removing confusion as to when the obligation to follow these practices applies.
96.
Alternatively,
the Board could specify the circumstances when it is “possible” for an order to
be checked by a second licensed health care professional.
97.
Modifying the proposed rules in these ways is
needed and reasonable and would not make a substantial change from the rules as they were originally proposed.
C.
Subpart
3 (J)
98.
In its
original draft of the new rules, the Board proposed a requirement that obliged
licensees with automated distribution devices to undertake monthly inspection
of the machines so as to ensure safe and accurate operation. Several stakeholders commented that, because
licensed staff may be in frequent contact with these devices – in effect,
continually assessing them – a monthly inspection requirement was burdensome
and ineffective.
99.
Agreeing
in part, the Board proposes to remove the requirement for monthly evaluation
and substitute a requirement that licensees conduct “[r]outine evaluations of automated distribution
devices ….”
100.
As before, with subpart 3F above, the Board’s
addition introduces ambiguity into the proposed regulation. If a
proposed rule fails to provide a reasonable notice of when the regulatory
standards will apply, it is defective.
101.
One
possible cure to this defect is to re-introduce the concept of a monthly
inspection as the regulatory minimum.
Accordingly, page
31, line 10 of Revisor’s
“J. A monthly Routine inspection
evaluations of automated distribution devices must be performed, at
least monthly, to ensure, at a minimum, that:”
Modifying the
proposed rules in this way is needed and reasonable and would not make a substantial change from the rules as they
were originally proposed.
D.
Subpart
3 (N)
102.
As part
of its original proposal, the Board proposed to codify its existing guidelines for
automated medication storage and distribution systems[63] into a formal rule –
including the practice that pharmacies use failure mode effect analysis, or
some other process, to resolve failures in the dispensing system. As
part of the new requirement, the Board proposed:
An ongoing failure mode effect
analysis or quality assurance process should be developed that addresses
possible system failures, process failures, high-risk drugs, medication errors
and controlled substance discrepancies.
To the extent that this language sets forth an aspirational standard that a licensee should, but is not required to meet, it is not a rule.[64]
103.
One
possible cure to this defect is to require such processes as regulatory
minimum. Accordingly, page 32, line 2 of Revisor’s
An ongoing failure mode effect
analysis or quality assurance process should be developed that addresses
must be in place and address possible system failures, process failures,
high-risk drugs, medication errors and controlled substance discrepancies.
Alternatively, the
Board could delete the sentence that begins at page 32, line 2. Modifying the proposed rules in either of
these ways would be needed and reasonable and would not make a substantial change from the rules as they
were originally proposed.
6800.3000 - PRESCRIPTIONS AND DISTRIBUTION
OF DRUGS
104.
In its
original draft of the new rules, the Board proposed a requirement that
permitted pharmacies, with proper authorization, to deliver prescribed drugs to
a patient’s place of employment.
105.
While
the authorization of this practice is welcomed by the stakeholders who
commented, some suggested that the phrasing of Revisor Draft RD3900 obliged
licensed entities to obtain authorization in writing before the materials are
dispensed – a requirement that these stakeholders regarded as impractical and
burdensome in many instances. Still
other commentators argued that to the extent that the draft rule obliged mail
order pharmacies to document that each of its customers refused pharmaceutical
counseling, it was unnecessarily costly and burdensome. Lastly, one commenter suggested that the
requirement that pharmacies follow both the “recommendations of the
manufacturer and the United States Pharmacopeia Chapter 1079,” was unduly
restrictive.
106.
Agreeing
in part, the Board proposes to modify Revisor’s Draft 3900 to make the
following changes.
A
pharmacy may deliver filled prescriptions at the place of employment of the
patient or a designated caregiver of the patient only if the pharmacy
(1)
obtains and documents the
authorization of the patient or patient’s caregiver for delivery at the place
of employment;
(2)
ensures the filled prescription order is delivered directly to the patient or the patient’s caregiver as authorized; and
(3)
ensures the security of protected health information.
B. Direct prescription delivery. A pharmacy that employs the United States
Postal Service or other common carrier to deliver a filled prescription
directly to a patient must, based on the judgment of the pharmacist:
(1)
use adequate storage or shipping containers and shipping processes to ensure
drug stability and potency. The shipping
processes must include the use of appropriate packaging material and devices,
according to the recommendations of the manufacturer or the
….
(4)
provide for an electronic, telephonic or written communication mechanism for a
pharmacist or a pharmacy intern working under the direct supervision of a
pharmacist, to offer counseling to the patient, unless the patient refuses
the consultation. Refusal of
consultation by patients must be documented. The patient must receive information
indicating what the patient should do if the integrity of the packaging or
medication has been compromised during shipment.
These revisions
reduce the costs of complying with the proposed rules, are needed and
reasonable and do not make a substantial
change from the rules as they were originally proposed.
6800.3100 - COMPOUNDING
AND DISPENSING
107.
In its
original draft of the new rules, the Board proposed revisions to clarify the
licensed professional’s role in assuring that the correct drug is dispensed.
108.
Several
stakeholders commented that the proposed clarifications, while helpful, did not
clearly recognize current hospital practice or the practice under variances
that are now often granted by the Board.
Agreeing, the Board proposes to modify Revisor’s Draft 3900 to make the
following additional changes:
Subp. 3. Certiifcation. In certifying the completed filled
prescription order under subpart 1, item F, an individual
pharmacist, practitioner or pharmacist-intern shall include:
A. checking of check the original
labeled container from which the medication was withdrawn, except as
provided in part 6800.2600, or when the
pharmacy uses a computerized process to identify oral, solid drugs through the
use of images;
B. checking of check the labeling on the prescription
medication container that will be dispensed;
C. checking check the contents of
the prescription medication container that will be dispensed and
the appearance of the total product to
ensure that all of the doses that are dispensed are of the correct drug,
strength and dosage form prescribed.
These
modifications maintain widespread practices, are needed and reasonable and do
not make a substantial change from the
rules as they were originally proposed.
6800.3200 - PREPACKAGING AND LABELING
109.
As part of its original proposal, the Board
modified the standards for labeling pre-packaged drugs. So as to make clear that the revised
standards apply both to repackaging drugs to unit-dose containers, as well as
other types of pre-packaging drugs into containers, the Board proposed the
following addition to its rules:
Subpart
1. Prepackaging. Pharmacies may prepackage and label drugs in
convenient quantities for subsequent complete labeling and dispensing according
to. Pre-packaging into unit-dose containers shall be done according
to United States Pharmacopeia, chapter 1146.
The addition is
consistent with the Board’s enforcement practice, is needed and reasonable, and
would not make a substantial change
from the rules as they were originally proposed.
6800.3300 - PHARMACY COMPOUNDING PRACTICES
110.
In its
original draft, the Board proposed a new rule requiring a pharmacist to certify
elements of the compounding procedure for certain drugs.
111.
Several
stakeholders questioned whether the drugs subject to the certification
procedure would be the same across pharmacy settings and whether the new certification
procedures could be implemented by the planned effective date of the rules.
112.
Agreeing, the Board proposes to further modify
the proposed rule so as to require the drugs subject to the procedure to be
listed in advance and to extend the effective date of the rule by eighteen
months. The Board proposes to revise the
rule as follows:
Subp.
6. Certifying compounding procedure. A
pharmacy must develop a list of high-risk compounded preparations for which
a pharmacist shall certify that each component used in the compounding of the
drug preparation has been accurately weighed, measured or subdivided
as appropriate, at each stage of the compounding procedure in order to verify
conformance with the formula being prepared.
Subsequent stages of the compounding process may not be completed until
this certification occurs. This
subpart shall become effective on January 2, 2013.
Because the revised rule carefully balances the need for protection of the public with the needs of the regulated parties in achieving compliance it is needed and reasonable.
113.
Yet, mindful that the Board seeks to eliminate
the term “high-risk drug” from its regulations, and instead use the terms
“high-alert drug,”[65] the
Administrative Law Judge urges the Board to consider whether the reintroduction
of this phrase into its rules is consistent with its intent. Further, without a regulatory definition of
“high-risk,” use of this term might render the regulation ambiguous.
114.
The changes proposed by the Board, with the
further addition of the terms “high-alert,” would not make a substantial change from the rules as they
were originally proposed.
6800.3850 - PHARMACY TECHNICIANS
115.
As part
of a move to improve the quality and capabilities of pharmacy technicians, the
Board proposed new minimum age and education requirements for these
registrants.
116.
While
there were a number of stakeholders in support of the proposals, the new
standards drew sharp criticism from other commentators. These commentators asserted that the new
requirements imposed genuine barriers to entry into the pharmacy profession,
established costly and burdensome certification requirements, would negatively
impact pharmacy staffing in rural areas, and would sharply reduce the pool of
persons who could remain compliant with the Board’s registration standards.[66]
117.
Finding
merit in these comments, the Board proposes to revise its earlier draft to
reduce the number of required hours of “theoretical and practical instruction”
(in subpart 1 (B) (4)) from 480 to 240 hours, and to withdraw the proposed
staffing ratio in subpart 6 (D).
Additionally, so as to mitigate the costs of compliance, the
Board proposed the following addition to
Subp. 4. Written procedures. Written procedures for the use of pharmacy technicians in a pharmacy shall be prepared by the pharmacist-in-charge. A copy of the procedures must be given to each technician and a copy must be kept on file in the pharmacy. The written procedures must be made available for inspection by the board upon request. These procedures must comply with the standards in this chapter and will be reviewed for compliance on that basis.
These procedures
must indicate in detail the tasks performed by the pharmacy technician; the
name, address, and registration number of the pharmacy technician; and the
certification steps performed by the licensed pharmacist in verifying the
technician's work. Procedures shall must be updated at least every
five years. and whenever a significant change in the way in which
pharmacy technicians are utilized occurs. The pharmacist-in-charge shall document ensure that each
technician has reviewed the procedures when he or she is
first employed by the pharmacy as a technician, and when any substantial changes to the procedures have been made. and
at least annually. The pharmacist-in-charge must ensure that proper
documentation of such training is maintained in the pharmacy for a period of at
least two years after the training occurs.
118.
In
general, the Board’s proposals to upgrade the standards for pharmacy
technicians are needed, reasonable and in line with the practices of other
states. Additionally, the recent
changes proposed by the Board would not make a substantial change from the rules as they were originally proposed.
119.
However, the Board’s proposed changes to Minn.
R. 6800.3850, subpart 1 (B) (4) are ambiguously phrased and confer too much
discretion upon the Board. Those
proposed revisions state in part:
The Board may
renew the registration of a pharmacy technician who has not
completed this training requirement provided that: less than six months has
elapsed between the date of initial registration as a pharmacy technician and
the date of the pharmacy technician’s first renewal of registration; or the
pharmacy technician shows satisfactory evidence of being enrolled in a pharmacy
technician training program offered by a board approved, accredited
vocational/technical institution or college, when such program is longer than
six months in length.
(Emphasis added). Because the phrasing “the Board may renew the
registration” does not provide
reasonable notice of the standards that will apply to renewals, it is
defective.
120.
One
possible cure to this defect would be to re-phrase the rule so as to emphasize
the technician’s option to reapply, in certain circumstances, notwithstanding
the more general requirement for 240 hours of professional instruction. Accordingly, page 52, line 8 of Revisor’s
The Board may
renew the registration of a A pharmacy technician who has not
completed this training requirement, but is otherwise eligible for renewal of
his or her registration, may apply for renewal provided that: less than six
months has elapsed between the date of initial registration as a pharmacy
technician and the date of the pharmacy technician’s first renewal of
registration; or the pharmacy technician shows satisfactory evidence of being
enrolled in a pharmacy technician training program offered by a board approved,
accredited vocational/technical institution or college, when such program is
longer than six months in length.
In this way, the rule makes clear
that a pharmacy technician who otherwise would not be eligible for renewal may
be permitted to apply under the circumstances set forth in the remainder of the
paragraph. Yet, such a phrasing does not
imply that the Board has unrestricted discretion to reject a conforming
application for renewal. Modifying the proposed rules in this way is
needed and reasonable and would not make a substantial change from the rules as they were originally proposed.
6800.5350 -
PRECEPTORS
121.
As part
of an effort to improve the professional training and educational opportunities
of pharmacy interns, the Board proposed a new rule that would oblige an
intern’s professional mentor – known as a preceptor – to meet with the intern
at least weekly.
122.
While
agreeing that a strong and collaborative intern-preceptor relationship is an
important goal, several stakeholders asserted that the requirement to meet
weekly was overly rigid and impracticable.
Agreeing, the Board proposes to revise its earlier draft to provide:
C. they will provide time on a regular basis for the purpose of helping the intern their interns meet
the competencies of the internship requirement;
123.
In
general, the Board’s proposal to make the supervision requirement more flexible
is needed and reasonable. Additionally, these
changes would not make a substantial
change from the rules as they were originally proposed.
124.
However, the Board’s proposed changes to Minn.
R. 6800.5350, subpart 2 (C) are ambiguously phrased and fail to provide a reasonable notice of when the regulatory standards
will apply. It is not clear from the
text whether preceptor-intern meetings that occur monthly, quarterly or yearly,
would meet the requirement of “time on a regular basis.” Accordingly, the rule is defective.
125.
One
possible cure to this defect is to re-introduce a time-based standard as the
regulatory minimum. Accordingly, page 62, line 24 Revisor’s
C. they will provide time on a regular
basis, at least three
times each month, for the
purpose of helping the intern their interns meet the competencies
of the internship requirement;
Modifying the proposed rules in this way is needed and reasonable and would
not make a substantial change from the
rules as they were originally proposed.
6800.5400 - TRAINING
126.
In
order to improve the supervision of pharmacy interns who undertake compounding
or dispensing tasks, the Board proposed minimum staffing ratios between
licensed pharmacists and interns.
127.
Several
stakeholders associated with the
Subp. 4a. Supervision, dispensing and compounding.
An intern performing tasks associated
with dispensing or compounding shall be immediately and personally supervised
by a licensed pharmacist stationed within the same work area who has the
ability to control and is responsible for the actions of the intern. Except
in the case of internship experience conducted as part of the experiential
education program of an accredited college or school of pharmacy, a licensed pharmacist may not supervise
more than one intern who is performing tasks associated with dispensing or
compounding. In the case of an
internship experience conducted as part of the experiential education program
of an accredited college or school of pharmacy, a licensed pharmacist may
supervise two interns who are performing tasks associated with dispensing or
compounding. The ultimate responsibility for the actions of an
intern performing tasks associated with dispensing or compounding shall remain
with the licensed pharmacist who is supervising the intern.
Modifying the proposed rules in this way is needed and reasonable and would
not make a substantial change from the
rules as they were originally proposed.
IX. Additional Actions Urged By Stakeholders
128.
As part
of the public comment process, a number of stakeholders urged the Board to
adopt still other revisions to Chapter 6800 – specifically, requests to modify
rule parts 6800.0100, subpart 16 (Limited Service Pharmacy); 6800.0300
(Pharmacy License and Fee Required); 6800.0910 (Patient Access to Pharmacists);
6800.1050 (Required References); 6800.1400 (Drug Manufacturer or Wholesale
License); 6800.2160 (Pharmacy Work Conditions); and 6800.7100 (Prescription
Labeling). In each instance, the Board’s rationale in declining to make the requested
revisions to its rules was well grounded in this record and reasonable.
1. The Minnesota Board of Pharmacy gave notice to interested persons in this matter.
2. The Department has fulfilled the procedural requirements of Minn. Stat. § 14.14 and all other procedural requirements of law or rule, with the exceptions noted in Findings 12, 15 and 18. The Administrative Law Judge concludes that these omissions are harmless errors under Minn. Stat. § 14.15, subd. 5.
3. The Board has demonstrated its statutory authority to adopt the proposed rules, and has fulfilled all other substantive requirements of law or rule within the meaning of Minn. Stat. §§ 14.05, subd. 1; 14.15, subd. 3; and 14.50 (i) and (ii), except as noted in Findings 93, 94, 100, 102, 119 and 124.
4. The Administrative Law Judge has suggested action to correct the defects cited in Conclusion 3, as noted in Findings 95, 96, 101, 103, 120 and 125.
5. The Notice of Hearing, the proposed rules and Statement of Need and Reasonableness (SONAR) complied with Minn. R. 1400.2080, subp. 5.
6. The Board has demonstrated the need for and reasonableness of the proposed rules by an affirmative presentation of facts in the record within the meaning of Minn. Stat. §§ 14.14 and 14.50.
7. The modifications to the proposed rules suggested by the Administrative Law Judge after publication of the proposed rules in the State Register are not substantially different from the proposed rules as published in the State Register within the meaning of Minn. Stat. § 14.05, subd. 2, and 14.15, subd. 3.
8. Due to Conclusion 3, this Report has been submitted to the Chief Administrative Law Judge for his approval pursuant to Minn. Stat. § 14.15, subd. 3.
9. A Finding or Conclusion of need and reasonableness with regard to any particular rule subsection does not preclude and should not discourage the Board from further modification of the proposed rules based upon this Report and an examination of the public comments, provided that the rule finally adopted is based upon facts appearing in this rule hearing record.
Based upon the
foregoing Conclusions, the Administrative Law Judge makes the following:
IT IS HEREBY RECOMMENDED that the proposed amended rules be adopted, except as otherwise noted.
Dated: April 29, 2011
|
__s/Eric L. Lipman____________________ |
|
ERIC L. LIPMAN |
|
Administrative
Law Judge |
Reported: Transcript Prepared (1 Volume).
NOTICE
The Board must make this Report available for review by anyone who wishes to review it for at least five working days before it may take any further action to adopt final rules or to modify or withdraw the proposed rules. If the Board makes changes in the rules, it must submit the rules, along with the complete hearing record, to the Chief Administrative Law Judge for a review of those changes before it may adopt the rules in final form.
Because the Administrative Law
Judge has determined that the proposed rules are defective in certain respects,
state law requires that this Report be submitted to the Chief Administrative
Law Judge for his approval. If the Chief Administrative Law Judge approves the
adverse findings contained in this Report, he will advise the Board of actions
that will correct the defects, and the Board may not adopt the rules until the
Chief Administrative Law Judge determines that the defects have been corrected.
If the Board elects to adopt the
actions suggested by the Chief Administrative Law Judge and make no other
changes and the Chief Administrative Law Judge determines that the defects have
been corrected, it may proceed to adopt the rules. If the Board makes changes
in the rules other than those suggested by the Administrative Law Judge and the
Chief Administrative Law Judge, it must submit copies of the rules showing its
changes, the rules as initially proposed, and the proposed order adopting the
rules to the Chief Administrative Law Judge for a review of those changes before
it may adopt the rules in final form.
After adopting the final version of the rules, the Board must submit the final version to the Revisor of Statutes for a review as to its form. If the Revisor of Statutes approves the form of the rules, the Revisor will submit certified copies to the Administrative Law Judge, who will then review the same and file them with the Secretary of State. When the final rules are filed with the Secretary of State, the Administrative Law Judge will notify the Board, and the Board will notify those persons who requested to be informed of their filing.
[1] See,
[2]
[3] See, Minn. Stat. § 14.15, subd. 1.
[4] Minn. Stat. § 151.06, subd. 1(a)(8) and 1(c)(2010).
[5] Notice of Intent to Adopt Rules With or Without a Public Hearing (Notice of Intent or Dual Notice) at 3.
[6]
[7] Ex. A.
[8] Ex. F.
[9] Exs.
G and I.
[10] Ex. C.
[11] Ex. M.
[12]
Exs. E. and F.
[13] Exs. E. and F.
[14] Ex. I.
[15]
Ex. A.
[16]
Ex. B.
[17]
Ex. C.
[18] Ex. D.
[19] Exs.
E and F.
[20] Exs. G and H.
[21]
Ex. I.
[22]
Ex. J.
[23] Ex. K.
[24] Ex. L.
[25]
Ex. M.
[26] Ex. N.
[27] Ex. O.
[28] Ex. P.
[29]
[30] Ex. I; see SONAR at 51-52.
[31]
[32] SONAR at 45-47.
[33] SONAR at 47.
[34] See, SONAR at 2 (“The Technician Rules Advisory Committee (TRAC) included representatives of the Minnesota Pharmacists Association (MPhA), the Minnesota Society of Health-System Pharmacists (MSHP), the National Association of Chain Drug Stores, the Minnesota Retailer’s Association, and the University of Minnesota College of Pharmacy”).
[35]
[36] SONAR at 49-50.
[37] SONAR at 50.
[38]
[39]
[40] SONAR at 50.
[41] Ex. N.
[42] Minn. Stat. § 14.127, subds. 1 and 2.
[43] SONAR at 51.
[44] Minn. Stat. § 14.128, subd. 1. Moreover, a determination that the proposed rules require adoption or amendment of an ordinance may modify the effective date of the rule, subject to some exceptions. Minn. Stat. § 14.128, subds. 2 and 3.
[45] SONAR at 51.
[46] See,
[47] See, Manufactured Housing Institute v.
Pettersen, 347 N.W.2d 238, 240 (
[48] Compare generally, United States v. Gould, 536 F.2d 216, 220 (8th Cir. 1976).
[49] See, Mammenga v. Board of Human Services,
442 N.W.2d 786, 789-92 (
[50] Manufactured Hous. Inst., 347 N.W.2d at 244.
[51] See, Mammenga, 442 N.W.2d at 789;
[52] Peterson v.
[53]
[54] SONAR at 51.
[55] See, e.g., Revisor’s Draft RD3900 at page 32, line 4.
[56] See, Board’s Post-Hearing Comments, at 11-12.
[57] See, id., at 13-14.
[58]
[59]
[60]
[61] Compare, e.g., In the Matter of the Proposed Rules Governing the Licensure of Treatment Programs for Chemical Abuse and Dependency and Detoxification Programs, Minnesota Rules, Chapter 9530, OAH Docket No. 3-1800-15509-1 (2004) (“The Administrative Law Judge finds the requirement that a program have a particular licensure, and ‘any additional certifications required by the department,’ to be impermissibly vague and a defect in the rule") (http://www.oah.state.mn.us/aljBase/180015509.rr.htm).
[62] See, In the Matter of Proposed Amendments to Rules Governing Apprenticeship Wages, OAH Docket No. 7-1900-17022-1, slip op. at 36 (2006) (http://www.oah.state.mn.us/aljBase/190017022.rr.htm).
[63] See, Guidelines for Automated Medication Storage and Distribution Systems (Minnesota Board of Pharmacy, March 1, 2001) (http://www.phcybrd.state.mn.us/forms/autohosp.pdf).
[64] See, Minn. Stat. § 14.02 (“Rule means every agency statement of general applicability and future effect, including amendments, suspensions, and repeals of rules, adopted to implement or make specific the law enforced or administered by that agency or to govern its organization or procedure”).
[65] See, Board’s Post-Hearing Comments, at 22.
[66] See, e.g., Hearing Transcript, at 30 - 40.