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Minnesota Board of Pharmacy |
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Minnesota Board of Pharmacy |
DISCIPLINARY
ACTIVITY. During the months of June, July, and August 2001, the
Board of Pharmacy took formal disciplinary action on the following licensees.
Jonas,
Daniel T., License #114380-1. Licensee
admitted to numerous record keeping and practice violations.
Licensee was placed on probation with the Board with various conditions
of probation.
Kohs,
Gordon L, License #113295-1. Mr.
Kohs admitted to diverting controlled substance drugs from his previous employer
and to the unauthorized personal use of controlled substance drugs.
Licensee was placed on probation with the Board with various conditions
of probation.
RULE
REVISIONS UNDER DEVELOPMENT.
The Board recently concluded the third meeting of an ad hoc group of
pharmacists who assisted the Board in developing language for a package of
proposed rule changes that will be formally proposed and adopted in the coming
months.
The
ad hoc group of over 20 pharmacists represented a wide spectrum of specialty
areas in pharmacy and included representatives from the Minnesota Pharmacists
Association and the Minnesota Society of Health System Pharmacists.
The Board now will begin the somewhat tedious task of formally proposing
the rule changes identified by the committee.
Final language of rules that are ultimately adopted will be published in
a future newsletter.
Language
was developed for rule changes relating to:
1) lighting standards in pharmacies;
2) patient counseling;
3) lunch breaks for pharmacists;
4) expiration dates for unit of use
and blister card packages;
5) rescheduling of certain
controlled substances;
6) changes in internship
requirements; and
7) other minor modifications and
technical changes.
Because
of the technicalities of complying with the state’s administrative procedures
act regarding rulemaking, it is likely to be the beginning of next year before
these rule changes are fully implemented.
JUNE
BOARD EXAM RESULTS OUTSTANDING.
During June of this year, the Board administered Board examinations to
157 candidates for licensure. Of
that number, only seven failed to pass one or more portions of the exam.
This equates to just a 4 1/2 percent failure rate on the exam.
Congratulations
are in order for all of the new licensees.
It
is the Board’s experience that the candidates for licensure did extremely well
on the patient-counseling portion of the Board exam.
Today’s pharmacy school graduates have developed considerable skills in
the area of providing patient counseling and drug information to their patients.
Pharmacists are encouraged to take advantage of the skills these new
graduates possess.
PHARMACIST-IN-CHARGE
ISSUES. The Board continues to discover instances where pharmacists who
are on record as being the pharmacist-in-charge (PIC) of a pharmacy leave that
position and fail to notify the Board of the fact that they are no longer a PIC. All pharmacists who are acting as the pharmacist-in-charge of
a pharmacy in Minnesota are required to notify the Board immediately of the
termination of their employment as a pharmacist-in-charge.
When
a pharmacist-in-charge leaves his or her position as PIC, a new
pharmacist-in-charge must be appointed immediately and must notify the Board of
the fact that they are assuming responsibility for the activities of the
pharmacy. It is a violation of the
Pharmacy Practice Act to operate a pharmacy without a designated
pharmacist-in-charge.
Under
the Board’s rules, when a pharmacist-in-charge leaves that position a new
pharmacist-in-charge must be appointed immediately and the Board must be
notified of the change within ten days.
On
occasion, a pharmacist-in-charge will notify the Board office that they are now
working at a different location, but care should be taken to specifically
mention that they are no longer acting as the PIC of the previous pharmacy.
SUBSTITUTION
IN MINNESOTA.
As was indicated in the article on generic substitution included in the
National News section of this newsletter, issues surrounding generic
substitution are cropping up in a number of states.
In
Minnesota, pharmacists are not limited in their substitution decisions by
ratings of various drugs in the “Orange
Book.” Under the Minnesota
Generic Substitution Law, pharmacists may substitute (and in most cases are
required to substitute) any generically equivalent product, which, in the
professional judgment of the pharmacist, is therapeutically equivalent to the
brand name product prescribed. No
reference is made to Orange Book classifications in the Minnesota law.
In
summary, the Minnesota drug product selection law does not require products to
be of the same dosage form in order to be substitutable so long as the products
are generically equivalent and, in the best professional judgment of the
pharmacist, the products are also therapeutically equivalent.
In exercising one’s professional judgment, however, a pharmacist might
be well advised to inform himself of what the experts have to say on the issue,
which brings us right back to the “orange
book” (the twenty-first edition, 2001) of “Approved Drug Products With
Therapeutic Equivalence Evaluations” produced by the FDA and hence brings
us right back to FDA’s position that dosage form is a consideration.
In
making their decision on substitutability, Minnesota pharmacists should consider
FDA’s position on dosage form equivalence but that position is not binding on
the decision making employed by Minnesota pharmacists.
TECHNICIAN
REGISTRATIONS. Board
of Pharmacy surveyors continue to report finding unregistered technicians
employed at pharmacies across Minnesota. Under
the Board rules, technicians must be registered with the Board from the time
they begin employment. There is no
allowance made in the Board rules for a “training period” or a
“probationary period.”
There
also seems to be some confusion regarding certification of technicians.
The Pharmacy Technician Certification Board in Washington, D.C., provides
a certification for technicians who successfully pass competency examinations
developed by the PTCB.
Certification of a pharmacy technician does not eliminate the need for
registration with the Board of Pharmacy. Certification
and registration are two distinctly different things. Certified technicians have demonstrated a certain minimum
level of knowledge and skills which is recognized by the certificate issued by
the PTCB.
They still need to register with the Board of Pharmacy if they intend to
work in Minnesota, however.
INSTALLATION
OF AUTOMATED MEDICATION MANAGEMENT SYSTEMS REQUIRES NOTIFICATION.
Just a reminder to pharmacists who might be installing automated
medication distribution systems of one kind or another.
Under Board
of Pharmacy rules, all such automated systems require notification of the
Board and, if the site at which the automated distribution system is being
installed is remote from that of the pharmacy, Board approval must be obtained.
Pharmacy
Board surveyors report finding several instances where automated distribution
systems have been installed and where the Board has not been notified of the
installation.
MEDICATION
ERRORS CONTINUE TO RISE. By
now I’m sure most readers of this newsletter are becoming tired of the
constant stream of editorials and news reports on medication errors.
Nevertheless, medication error is a significant issue and one that
pharmacists must come to terms with.
At
the current rate, it appears that the Board of Pharmacy will receive a record
number of complaints from the public relating to pharmacy practice issues this
calendar year. As has been the case
for the past several years, the leading cause of complaints from the public
relate to medication errors.
It’s
hard to determine precisely the effect increased prescription volume over the
past few years has had on the number of dispensing errors reported to the Board,
but periodically errors are reported to us that have no explanation other than
either inattentiveness by the pharmacist or the pharmacist trying to do more
than can be safely handled.
Recently,
the Board received yet another complaint regarding a dispensing error involving
Prozac and Prilosec. Over the past
several years, this has become a classic dispensing error.
There is absolutely no reason that this error should continue to be made.
Obviously, the pharmacist involved in the most recent Prozac/Prilosec
error did not look at the drug in the prescription vial before certifying that
the prescription was accurately filled and did not perform any kind of patient
consultation regarding this medication. If
either of those safety checks had been accomplished, the error would never have
occurred.
Pharmacists
are encouraged to do what is necessary and take the time that’s necessary to
ensure that prescriptions are dispensed accurately and that patients receive the
information they need to maximize the effectiveness of their drug therapy.
Studies have shown that 85 percent or more of the errors made in the
dispensing of prescriptions can be caught during patient counseling by the
pharmacist. Yet, pharmacists seldom
take the time to do a “show and tell” with the patient receiving new
prescriptions.
Certainly,
the vast majority of patients would rather wait a few extra minutes to receive
the correct prescription as opposed to receiving an incorrect prescription
immediately.
What
with the negative publicity pharmacy is receiving from the recent incident in
Missouri, pharmacists must go out of their way to do what’s right for their
patients if the profession is to regain its standing as the most trusted
profession.
