|
Minnesota Board of Pharmacy |
|
Minnesota Board of Pharmacy |
DISCIPLINARY
ACTIONS.
No formal disciplinary actions were concluded by the Board, during
the period September 1, 2001 through November 30, 2001.
NOTICE OF INTENT TO ADOPT RULES WITHOUT A PUBLIC HEARING.
Proposed Amendment to Rules Relating to Lighting Standards, Patient
Counseling, Internship, Controlled Substance Rescheduling, Expiration Dates, and
Lunch Breaks for Pharmacists, Minnesota Rules, 6800.0100 et seq.
For State
Register Notice click here- 
Introduction. The Board of Pharmacy intends to adopt rules without a public
hearing following the procedures set forth in the Administrative Procedure Act, Minnesota
Statutes, sections 14.22 to 14.28, and rules of the Office of
Administrative Hearings, Minnesota Rules, parts 1400.2300 to 1400.2310.
You may submit written comments on the proposed rules and may also submit
a written request that a hearing be held on the rules until February 15,
2002.
Agency
Contact Person. Comments or questions on the rules and written requests for a
public hearing on the rules must be submitted to the agency contact person.
The agency contact person is: David
Holmstrom, at the Minnesota Board of Pharmacy, 2829 University Avenue SE, Suite
530, Minneapolis, MN 55414-3251, phone (612) 617-2201, FAX (612) 617-2212.
Subject
of Rules and Statutory Authority. The proposed rules are
about Lighting Standards, Patient Counseling, Internship, Controlled Substance
Rescheduling, Expiration Dates, and Lunch Breaks for Pharmacists.
The statutory authority to adopt the rules is Minnesota Statutes,
section 151.06 and
152.02. The
proposed rule package establishes minimum lighting standards for prescription
dispensing areas of a pharmacy, expands the patient counseling standards of OBRA
90 to all patients, not just Medicaid patients, schedules or reschedules several
controlled substances in order to bring Minnesota’s requirements into
conformity with federal requirements, amends expiration date limits on
repackaged drugs to conform with USP standards, provides authorization of lunch
or rest breaks for pharmacists, and repeals an obsolete section of the rules (
6800.7520 subp. 1 G ) relating to dispensing of drugs from hospital emergency
rooms. A free copy of the rules proposed for change is available
upon request from the agency contact person listed above or from the Board’s
website at www.phcybrd.state.mn.us.
Comments. You have until 4:30 p.m. on February 15, 2002, to submit
written comments in support of or in opposition to the proposed rules and any
part or subpart of the rules. Your
comments must be in writing and received by the agency contact person by the due
date. Comments are encouraged.
Your comments should identify the portion of the proposed rules addressed
and the reason for the comments. You
are encouraged to propose any change desired.
Any comments that you would like to make on the legality of the proposed
rules must also be made during this comment period.
Request
for a Hearing. In addition to submitting comments, you may also request that
a hearing be held on the rules. Your
request for a public hearing must be in writing and must be received by the
agency contact person by 4:30 p.m. on February 15, 2002.
Your written request for a public hearing must include your name and
address. You must identify the
portion of the proposed rules to which you object or state that you oppose the
entire set of rules. Any request
that does not comply with these requirements is not valid and cannot be counted
by the agency when determining whether a public hearing must be held.
You are also encouraged to state the reason for the request and any
changes you want made to the proposed rules.
Withdrawal
of Requests. If 25 or more persons submit a valid written request for a
hearing, a public hearing will be held unless a sufficient number withdraw their
requests in writing. If enough
requests for hearing are withdrawn to reduce the number below 25, the agency
must give written notice of this to all persons who requested a hearing, explain
the actions the agency took to effect the withdrawal, and ask for written
comments on this action. If a
public hearing is required, the agency will follow the procedures in Minnesota
Statutes, sections 14.131 to 14.20.
Modifications. The proposed rules may be modified as a result of public
comments. The modifications must be
supported by comments and information submitted to the agency, and the adopted
rules may not be substantially different than these proposed rules.
If the proposed rules affect you in any way, you are encouraged to
participate in the rulemaking process.
Statement
of Need and Reasonableness. A statement of need and
reasonableness is now available from the agency contact person.
This statement contains a summary of the justification for the proposed
rules, including a description of who will be affected by the proposed rules and
an estimate of the probable cost of the proposed rules.
Copies of the statement may be obtained at the cost of reproduction from
the agency.
Adoption
and Review of Rules.
If no hearing is required, the agency may adopt the rules after the end
of the comment period. The rules and supporting documents will then be submitted to
the Office of Administrative Hearings for review for legality.
You may ask to be notified of the date the rules are submitted to the
office. If you want to be so
notified, or want to receive a copy of the adopted rules, or want to register
with the agency to receive notice of future rule proceedings, submit your
request to the agency contact person listed above.
PROPOSED RULE CHANGES
Minn. Rule 6800.0700.
In this rule, under subpart 1, the Board is proposing to add an item F that establishes a minimum lighting level of 75-foot candles measured in the major work areas of the prescription department. Poor lighting, while relatively rare among Minnesota pharmacies, is a contributing factor to medication dispensing errors. As a result, the Board is taking this step to ensure a minimum lighting level in all prescription departments.
Minn. Rule 6800.0910.
In this rule the Board is eliminating the differentiation
between Medicaid and non-Medicaid patients regarding the patient counseling and
DUR provisions of OBRA 90. Minnesota
is one of fewer than ten states that have not expanded the patient counseling
and DUR provisions of OBRA 90 to all patients.
The Board believes that it is now time to provide a uniform level of
pharmacy services to all patients in Minnesota, regardless of socioeconomic
status.
Minn. Rule 6800.2150.
Under this proposal, a pharmacist working as the only pharmacist on duty may, at their option, leave the prescription department for a 30-minute lunch break without requiring all ancillary personnel to exit the prescription department and without locking the prescription department. The pharmacist would not be able to leave the building for the lunch break, but would not be required to remain in the prescription department.
Any work done by a pharmacy technician during the pharmacist’s absence would need to be checked by the pharmacist upon returning from lunch. During the pharmacist’s temporary absence, no prescription medication may be provided to a patient or a patient’s agent, unless the medication is a refill that the pharmacist has checked and released for furnishing to the patient and for which the pharmacist has determined that consultation by the pharmacist is not required.
This
proposal is virtually identical to language currently in place in California and
at least 15 other states. At last
report, no problems associated with pharmacist lunch breaks have been reported.
Minn. Rule 6800.3110.
Here, as in Minn. Rule 6800.0910, the Board is simply
removing the differentiation between Medicaid patients and non-Medicaid
patients, insofar as the requirements of OBRA 90 are concerned.
Minn. Rule 6800.3350.
Here, in subpart 3, the Board is proposing to change the
expiration date of unit of use on blister card packaging done by pharmacists to
a one-year expiration date from the date of packaging.
This change conforms to a change in expiration date standards by the USP.
Minn. Rules 6800.4210, 4220, 4230 and 4240.
These
sections are proposed for amendment as part of the scheduling and rescheduling
of various controlled substance drugs, in order to bring Minnesota’s
controlled substance schedules into conformity with federal schedules.
Minn. Rule 6800.5300 and 5400.
The
Board is proposing some changes relating to internship.
In the first instance, the Board is eliminating reference to the
internship competency examination, which has been discontinued and is inserting
reference to an internship manual, which has been developed by the Board’s
Internship Advisory Committee as a replacement for the internship competency
examination.
The Board is also proposing to phase in a change in the total number of hours of internship required prior to licensure and the make-up of those hours. By the spring of 2003, the Board is proposing that students obtain a total of 1,600 hours of internship with 800 of those hours being required through PharmD clinical rotations and the remaining 800 being of a traditional compounding, dispensing and patient counseling nature.
Minn. Rule 6800.7520.
The Board is eliminating the requirement that hospital
pharmacists develop a system allowing drug dispensing out of hospital emergency
rooms in the absence of pharmacists and physicians. Statutory changes made by the legislature over the past few
years have eliminated the need for this provision in Board rules.
