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Minnesota Board of Pharmacy |
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Minnesota Board of Pharmacy |
DISCIPLINARY
ACTIONS. During the months of March, April, and May, the Board of
Pharmacy took the following disciplinary actions on its licensees.
Astrup,
Daniel B., License #113575-4.
Licensee surrendered his license to practice
pharmacy subsequent to allegations that he violated the terms of his probation
with the Board.
Darling,
Douglas J., License #111251-5.
Licensee
was revoked as a result of a notice from the Department of Revenue that he was
delinquent in payment of taxes. Revocation
remains in effect until a clearance certificate is issued by the Minnesota
Department of Revenue.
Melhus,
Jacquelyn L., License #111261-2. Licensee
was revoked as a result of a notice from the Department of Revenue that she was
delinquent in payment of taxes. Revocation
remains in effect until a clearance certificate is issued by the Minnesota
Department of Revenue.
DISPENSING
ERRORS AND STAFFING LEVELS – IS THERE A CONNECTION.
As regular readers of this newsletter are aware, the Board is very
concerned over the issue of dispensing errors and the fact that studies have
shown that 80 – 90 percent of the errors made in the dispensing activities of
a pharmacy can be identified and corrected prior to reaching the patient during
appropriate patient counseling.
Pharmacists-in-charge
at Minnesota pharmacies are responsible under MN Rule 6800.2400, Subp.
1.J., “to ensure that staffing and operational quality assurance policies are
developed, implemented, and followed for the purpose of decreasing and
monitoring prescription errors.”
During
the investigation of dispensing errors that come to the Board’s attention,
Board inspectors will be looking at staffing levels and operational quality
assurance policies in accordance with this rule.
Pharmacists-in-charge
are encouraged to perform a self-assessment on their pharmacy to assure
compliance with these requirements.
CONTINUING
EDUCATION REPORTING COMING UP SOON.
While a fair number of Minnesota
licensed pharmacists have already reported the completion of their continuing
education requirements for the period October 1, 2000 – September 30, 2002,
the majority of Minnesota pharmacists are still in the process of completing
their continuing education requirements.
Please
keep in mind that, unless you are one of the pharmacists randomly selected for
continuing education auditing, you do not need to submit proof of attendance for
your continuing education programs. Once
you have completed the continuing education requirement, simply complete the
continuing education certification statement that was previously sent to you and
return it to the Minnesota Board of Pharmacy office.
Those
pharmacists randomly selected for auditing will be notified in late summer that
they will need to submit proof of attendance for all of their continuing
education participation.
GUIDELINES
ON THE USE OF AUTOMATED COUNTING MACHINES.
As pharmacies are becoming
increasingly busier, many are turning to automation in the form of the automated
counting machines to assist in the prescription-filling process.
The
Board of Pharmacy has developed some guidelines regarding the use of automated
counting machines. Pharmacists should note that because Board of Pharmacy rules
require pharmacists to “check the original labeled container from which the
medication was withdrawn” as part of the certification process, a variance
will be necessary for pharmacies that will be installing automated counting
devices.
Below
are the Board’s guidelines that should be consulted when contemplating the
purchase of automated counting machines.
AUTOMATED COUNTING MACHINE GUIDELINES
The Board of Pharmacy must be notified in writing, before
distributing, dispensing, or vending any legend drug by automatic or vending
machine. The written notification
must include the name and address of the pharmacy responsible for control of the
system, and the name of the pharmacist-in-charge of the pharmacy.
Policies and procedures should also be included with the notification.
See MN Rule 6800.2600.
All filling of cells/cassettes needs to be addressed as prepackaging,
with compliance and documentation of all steps in MN Rule 6800.3200, Subp. 1.
All filling of cells/cassettes should be done with only one drug at a
time.
When multiple stock bottles of a drug are used to fill a cell/cassette,
all stock bottles used must be available for the pharmacist to check.
A
system must be in place that addresses calibration, sanitation, and cross
contamination.
Labeling of the vials, cells, or cassettes must be addressed as required
in MN Rule 6800.3200, Subp. 2, to prevent errors.
Certification as required in
MN Rule 6800.3100, Subp. 3, must be
complied with and documented. Specifically
how will a pharmacist check the original labeled container of a product from the
automated counting machine? This
must be determined and stated in your policies and procedures.
Those drugs that can be safely returned, can only be returned to the
cell/cassette by a pharmacist. Commingling
of lot numbers must be tracked and documented.
Lot numbers not tracked and documented shall result in such medication
being deemed misbranded and subject to embargo under MN Statutes, §151.38.
Implement a Quality Assurance/Quality Improvement monitoring system with
concurrent corrective measures when necessary.
See MN Rule 6800.2400, Subp. 1.J., which states the
Pharmacist-in-charge, must ensure that staffing and operational quality
assurance policies are developed, implemented, and followed for the purpose of
decreasing and monitoring prescription errors.
Any proposed variance request that is a deviation from these rules must
follow MN Rule 6800.9900 which states that any alternative measure taken must be
equivalent or superior to current rules.
RULE
PACKAGE ADOPTED. The Board has recently adopted the final language of the
package of proposed rule changes that have been under development.
As readers of this newsletter will recall, the section of the proposed
rules relating to lunch breaks for pharmacists was removed from the overall rule
package and will be addressed at a public hearing later this year.
The time and place of the public hearing have not yet been established.
The
rest of the rule package originally proposed is in the process of being
implemented and, by the time this newsletter is published it is anticipated that
the rules will be in effect.
The
rule package contains requirements for minimum lighting standards in pharmacies,
modification to the expiration date applicable to unit of use on blister card
packaging done by pharmacists, rescheduling of certain controlled substances
including Marinol®, application of the OBRA 90 patient counseling and DUR
requirements to all patients, and modifications to the Board’s internship
requirements.
The
full text of the Board’s rules is available on the Board’s website at
www.phcybrd.state.mn.us.
JUNE
BOARD EXAM LARGEST EVER.
The Board exam administered June 4, 2002, was by
far the largest ever conducted by the Board.
Approximately 185 new graduates participated in the Board’s Practical
examination. The previous record number was 157 candidates for licensure.
With
the NAPLEX basic pharmacy practice exam and the MPJE law exam now being offered
on computer, the Practical exam is the only portion of the Board exam where all
of the candidates take the exam at the same time.
In that exam candidates now make their own appointments for the NAPLEX
and MPJE portions of the exams, exam scores are mailed out on a weekly basis
rather than all at once.
Potential
employers of new graduates are again cautioned not to schedule the individuals
taking the June Board exam for work as pharmacists until the individual has
received confirmation on passing the Board exam and has paid the original
license fee. Only then can the
individual begin their career as a pharmacist in Minnesota.
